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Ruth Bush takes over as AVF president in Tampa

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Ruth Bush takes over as AVF president in Tampa

Ruth Bush, MD, associate dean in the Office of Educational Affairs at John Sealy School of Medicine, the University of Texas Medical Branch (UTMB), in Galveston, Texas, took over as American Venous Forum (AVF) president in Tampa, Florida, at the close of the society’s meeting (March 3–6), succeeding Glenn Jacobowitz, MD.

Purchase tickets for SVS Foundation Gala’s ‘Night at the Museum’

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Purchase tickets for SVS Foundation Gala’s ‘Night at the Museum’

Ticket information is available for the SVS Foundation’s “Night at the Museum—A Celebration of Science” Gala during the 2024 Vascular Annual Meeting (VAM 2024) on June 21. Ticket sales are expected to launch in coordination with VAM registration on March 20.

The Gala promises an unforgettable evening filled with elegance, entertainment and philanthropy at Chicago’s world-famous Museum of Science and Industry.

Attendees can choose from various ticket and table options, each offering an array of benefits. The options include: Gold table ($12,000) with $8,500 of the total tax-deductible; silver table ($8,500), $5,000 tax-deductible; bronze table ($6,500), $3,000 tax-deductible; and individual ticket sales ($600), $250 tax-deductible.

All tickets to the 2024 Gala will include complimentary round-trip transportation from the Marriott Marquis to the Museum of Science and Industry, featuring champagne and non-alcoholic beverages, admission to the Museum of Science and Industry, an open bar, a three-course dinner and snacks, live entertainment and more.

Gala organizers promise this year’s celebration to be a highlight that brings together leaders in the vascular surgery community for a noble cause. For more, visit vascular.org/Gala2024.

Gain discount on premier vascular review resources

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Gain discount on premier vascular review resources

The Society for Vascular Surgery (SVS) is encouraging members to pre-purchase the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6), a premier digital resource for those preparing for qualifying, certification and recertification examinations. Presales will end on March 26. The presale period provides a 10% discount on the individual license price. Those who participate in the presale will be entered into a lottery to win a complimentary registration for the 2024 Vascular Annual Meeting (VAM 2024) exclusive. This opportunity is open only to SVS members, making membership a valuable investment for those in the field.

VESAP6 is designed to aid professionals in their examination preparation and ongoing education, with more than 600 questions covering more than 10 content areas, and serves as a comprehensive review resource. The product offers up to 102 continuing medical education (CME) credits, with 39.25 eligible for Registered Physician in Vascular Interpretation (re)certification credits. Visit vascular.org/VESAP6.

SVS seeks nominations for vice president

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SVS seeks nominations for vice president

The SVS has opened the nomination period for the position of SVS vice president, with the deadline set for March 15. Anyone can nominate/self-nominate for vice president, but only Active and Senior SVS members in good standing are eligible for the position. Following the deadline, the SVS Nominating Committee will review the nominations and select two-to-four candidates to run for office.

Previously, only two candidates were selected to run for open positions on the SVS Board of Directors. During the 2023 bylaws referendum, SVS members approved an increase in the number of candidates to between two and four, allowing members to have a broader choice when casting their votes for SVS leaders.

The Nominating Committee seeks qualified, eligible members from all aspects of gender, sexual orientation, age, ethnicity, geographic location and practice environment as nominees for the open position.

“The change to the number of potential candidates is exciting,” said SVS Nominating Committee Chair Ronald Dalman, MD. “Being the chair of this committee in a year of such monumental change is an honor, and I look forward to seeing which members will be nominated.”

Once the candidates are selected, eligible voting members can cast their votes through an online portal in June, with the results being announced at the SVS Annual Business Meeting on June 22 at the end of the 2024 Vascular Annual Meeting (VAM 2024) in Chicago.

Anyone looking to submit a nomination for themselves or another eligible candidate can visit vascular.org/2024VP.

SVS invites new compensation study participation, former participants to update information

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SVS invites new compensation study participation, former participants to update information

In 2023, the SVS collaborated with Phairify to launch a compensation study to provide vascular surgeons with tailored insights into compensation, practice and productivity data relevant to their specialty and practice in a bid to help them make informed career decisions. The SVS continues to encourage members to complete the survey and is now asking former participants to log back in to update their data for 2024. The compensation study is an SVS member benefit.

Any SVS member willing to participate can engage in a 15-minute survey to unlock enhanced power-searching capabilities with comparative functionality and an expanded career reach that allows access to a new range of opportunities.

At the end of 2023, 22% of SVS members had participated in the survey, which is two percent over the intended goal. Now all members who previously participated are encouraged to update their information to continue providing the most accurate data to those making career changes. “It is only necessary to update the information if anything has changed,” noted Keith Calligaro, MD, a senior author of the study.

To participate and/or update information, visit vascular.org/CompensationStudy2024.

 

Multi-society PAD Pulse Alliance aims to highlight importance of patient education

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Multi-society PAD Pulse Alliance aims to highlight importance of patient education

Society for Vascular Surgery (SVS) experts are spearheading initiatives as part of the multispecialty PAD Pulse Alliance and its Get a Pulse on PAD public awareness campaign aimed at educating and raising awareness of the risk factors and potential symptoms of peripheral arterial disease (PAD) among Americans. As the campaign gathers steam, the SVS is focused on closing the health equity gap with the aim of equipping patients with essential tools for early detection and treatment.

The collaborative effort with the Association of Black Cardiologists, Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Interventional Radiology (SIR) has already seen SVS members take a central role as the campaign rolls out.

“This particular disease process, even though it’s an epi­demic, is understudied, and the public does not have great awareness about the disease process and unfortunately tend to only find out about it when they’re in dire straits,” said Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital in Boston, one of the spokespeople for the alliance.

“PAD is unique in that it has multiple providers that are involved in caring for these patients. The whole point of the campaign is to show solidarity for our patients and to simul­taneously build public awareness about the disease process.”

The Get a Pulse on PAD campaign, launched Feb. 8, in­cludes a survey, media materials, a new website and a com­prehensive media strategy to promote disease awareness. Dua has completed dozens of media interviews across TV and radio, with the campaign yielding nearly 200 million impressions across various social media platforms.

Additional SVS members will assist with local market media opportunities in the coming weeks and months. The campaign is the first step in a broader branding campaign to be launched by the SVS in the next few months.

The alliance conducted three distinct surveys, covering the general, Black and Hispanic populations, aiming to gain a nuanced understanding of perceptions of PAD.

The surveys demonstrated that 70% of Americans are unaware of PAD and that there is a disconnect between perceived and actual risk, especially among Black and Hispanic populations.

William Shutze, MD, a vascular surgeon at Texas Vascular Associates and one of the initiative’s chairs, ex­pressed his initial astonishment at the survey results, em­phasizing the role of raising awareness as the primary step in addressing the severity of PAD.

To maximize the campaign’s impact, initial media efforts were strategically directed toward regions with higher ampu­tation rates. The campaign features not only digital content but also includes video and media interviews in Spanish, aiming to break down cultural and language barriers.

Dua explained how societies can utilize the information provided by the alliance to shape discussions with patients. “In this particular case, the doctors are unable to do their job for patients unless the patients themselves are aware of the disease process,” she said.

“Societies like the SVS that have a lot of power, reach and credibility can do things like this Get a Pulse on PAD aware­ness campaign where they join forces with other providers to put one message out there that says we care about you, our patients, and this is the way in which we want to provide you with the best care. There’s no point in having all these fancy tools in the hospital if the patient gets to you when it’s too late.”

A reassessment of the campaign is scheduled for October when the societies involved will collaborate to determine the next steps for­ward. Shutze emphasized the persistent nature of the problem, stating, “It’s not going to go away with one campaign. We’re going to have to roll up our sleeves and talk about how to sustain this momentum and keep it going.”

VRIC 2024 to hear from leading light on role of immunity and inflammation in atherosclerosis

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VRIC 2024 to hear from leading light on role of immunity and inflammation in atherosclerosis

Filip Swirski, PhD, a leading figure in cardiovascular immunology research, will deliver this year’s Alexan­der W. Clowes Distinguished Lecture at the 2024 Vascular Research InitSiatives Conference (VRIC).

Swirski, currently the director of the Car­diovascular Research Institute at the Icahn School of Medicine at Mount Sinai in New York City, has made groundbreaking discov­eries on the role of immunity and inflamma­tion in atherosclerosis.

His latest work, published in Nature, opens avenues for potential therapeutic interven­tions against Alzheimer’s disease, showcas­ing the interdisciplinary nature of modern vascular research.

VRIC organizers are gearing up for anoth­er round of surgeon-scientist-student com­munity engagement aimed at translating basic science more efficiently and effectively to positively impact vascular patients.

The Alexander W. Clowes Distinguished Lecture—named after the late Alexander Clowes, a luminary in vascular research—is a key part of VRIC. The lecture pays tribute to Clowes’ significant contributions and sym­bolizes the intersecting realms of surgery and science.

This year’s theme, “Immune and Struc­tural Cells in Cardiovascular Disease,” promises to unravel the complex interplay between immunity, inflammation and cardiovascular health.

“We have the most up-to-date research in this area focused on immune cells, structural cells and cardiovascular diseases,” said Kath­erine Gallagher, MD, chair of the Society for Vascular Surgery (SVS) Basic and Transla­tional Research Committee.

“We’ll be looking at multiple disease pro­cesses, including aneurysms, atherosclerosis, intimal hyperplasia, carotid disease and other themes that are relevant to surgeon-scien­tists and others in the cardiovascular arena.” “We were looking for an internationally known speaker who has transformed the field of cardiovascular therapy and is very cutting-edge at translating basic science into clinical applications,” said Gallagher. “Our speaker certainly fits the bill for all of that and has been published in the highest journals available.”

Scheduled to take place on May 15 at the Hilton Chicago, VRIC is held concurrent­ly with the American Heart Association’s Vascular Discovery: From Genes to Medi­cine Scientific Sessions, held May 15–18 in the same location. The event will provide attendees with an exploration of the latest developments in vascular research.

A translational panel will feature figures such as Kathryn J. Moore, PhD, the Jean and David Blechman professor of cardiology and director of the New York University Cardio­vascular Research Center, and Dianna M. Milewicz, MD, PhD, President George H. W. Bush chair of Cardiovascular Medicine, with insights anticipated to elevate the discourse and foster collaborative initiatives.

Gallagher emphasized VRIC’s intimate nature. “Because it is a smaller meeting and a closer-knit group, there’s a lot more collab­orations that take place and active discussion that can’t necessarily happen in some of the big meetings” she said.

“People that are there are very focused on this particular theme, making it a breeding ground for partnerships and relationships that extend beyond the conference.”

The early-bird rate for the conference is available until March 18. For more informa­tion, visit vascular.org/VRIC24.

New data underscore physician experience levels required to derive benefit from transfemoral carotid artery stenting

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New data underscore physician experience levels required to derive benefit from transfemoral carotid artery stenting

Data from a new study that maps out the levels at which ad­verse postoperative events decrease following transfemoral carotid artery stenting (TfCAS) based on depth of physician experience with the procedure represent an “absolute mini­mum threshold of learning,” the lead author says.

The analysis comes in the wake of the Centers for Medicare & Medicaid Services (CMS) decision to expand carotid stenting coverage, which loosened restrictions on the use of TfCAS.

Findings from an analysis of the Vascular Quality Initiative (VQI), due to be presented at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Ari­zona, will show that the number of procedures a physician had to perform in order to get an in-hospital stroke and death rate below 4% in symptomatic patients was 235.

Similarly, to achieve a stroke and death rate below 2% in asymptomat­ic patients, the threshold physicians had to reach to derive benefit was 13 procedures. Rates were based on the fact the best available VQI registry data relate to in-hospital stroke and death, not the 30-day stroke and death thresholds of 6% and 3% for symptomatic and asymptomatic patients, respectively

Marc Schermerhorn, MD, chief of vascu­lar surgery at Beth Israel Deaconess Medical Center in Boston, the study’s senior author, raised concerns over how the coverage ex­pansion will interplay with data reporting and, ultimately, the tracking of stroke and death rates going forward.

“Now that CMS has done away with all the regulations and restrictions on who can do [TfCAS] proce­dures, where, etc., people may not submit data to VQI anymore, unfortunately,” he said.

“There have been a lot of other studies that have shown transfemoral stenting outcomes are not as good as TCAR [tran­scarotid artery revascularization] and carotid endarterectomy, but I think the concern now is, by opening up the doors for anybody to do carotid stenting, there could be a lot of people who have never done ca­rotid stenting before who now decide to get into the game.

“I think that the way things were before, when you had to be an approved center and you had to have credentialing committees that had to collect data, monitor that local data and submit it to Medicare, that prevent­ed a lot of people from doing the procedure. So it concentrated in the people who have the most experience.”

But the respective thresholds for symp­tomatic and asymptomatic cases repre­sent the basement of learning, continued Schermerhorn.

“You have to remember that transfemoral stenting has been around since the turn of the century—and even before that,” he said. “The VQI didn’t start collecting data on ca­rotid stenting until 2005, and that was only in New England. It wasn’t until 2011 that we started to collect national data. So, most people who were in the carotid stent registries in the VQI had experience before they started submitting data, so we actually don’t think this is a full represen­tation of the learning curve.

“We know almost certainly most people had been doing cas­es prior to entry of data into the VQI, so this is an absolute mini­mum threshold of learning curve, and the true learning curve is likely larger. I don’t know how much, but it’s higher numbers.”

Schermerhorn said that with the possi­bility of “a lot more novices” performing TfCAS in the wake of CMS coverage expan­sion, his team’s latest study clearly demon­strates “results are highly dependent on ex­perience.” Even supposing a lot of TfCAS experience, he added, “the results don’t seem to be as good as with either TCAR or endarterectomy.”

Despite the potential for TfCAS entries into the VQI registry to decrease, Scher­merhorn expects monitoring to continue, including via administrative databases, albeit with a lower level of clinical detail available, but expressed hope enough interest would persist in submitting data to the VQI.

“That’s my other concern,” he said, “The people who are interested in submitting data are probably the ones who are more com­mitted to quality improvement and striving toward knowing what their outcomes are— and improving them.”

That raises another dimension of the study set to be presented at SCVS 2024, not­ed Schermerhorn: the research team also looked at whether those who had bad out­comes when they first started doing proce­dures were less likely to continue perform­ing TfCAS. They found that this was indeed the case.

“The people who went on to do more than 25 procedures had better outcomes than the people who quit at up to 25 and then didn’t do anymore,” he said.

“We presume that there is some feedback to people and that, if they’re finding that their own results are not that good, then they don’t continue to do the procedure. If people don’t track their outcomes somewhere, then they may not know.

“That’s the problem. When you have a procedure with a low adverse outcome event rate, it’s hard for people to gain personal perspective.”

US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable magnesium scaffold

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US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable magnesium scaffold
Freesolve

Biotronik has been granted Breakthrough Device designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold (RMS).

The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischaemia (CLTI).

To qualify for a Breakthrough Device designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the programme is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval.

A press release notes that the newly CE-launched Freesolve RMS for coronary artery lesions, based on the Biomag magnesium alloy and the proven Orsiro drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation. It has shown 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries, the release details.

These characteristics of the Freesolve RMS may be of particular value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free.

“Biotronik’s focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation”, said Jörg Pochert, president of Vascular Intervention at Biotronik. “Our efforts to expand therapeutic possibilities, underlined by the introduction of the Freesolve RMS for coronary artery disease treatment, will continue in the BTK indication with this groundbreaking innovation.”

“This Breakthrough Device designation for the Freesolve RMS for BTK treatment is a significant milestone in advancing treatment options. Biotronik is committed to design our products to enhance the lives of patients,” stated Ryan Walters, US president at Biotronik. “Our next generation RMS represents a leap forward over existing resorbable technology, incorporating technical innovations intended to address physicians’ needs and optimise outcomes for patients suffering from CLTI.”

Vascular external support system use found to boost key functional outcomes for surgical arteriovenous fistula creation

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Vascular external support system use found to boost key functional outcomes for surgical arteriovenous fistula creation
Alik Farber
Alik Farber

Alik Farber, MD, professor of surgery and radiology at Boston University, is set to present the results of a multicenter U.S. study at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, that will show creating arteriovenous fistulas with a vascular external support system, VasQ, decreases the median time to achieve two-needle cannulation by reducing the need to perform maturation procedures.

The study set out to assess the functional outcomes of fistulas created with an external vascular support device as compared with rigorously matched controls of unsupported fistulas for end-stage kidney disease (ESKD) patients by the same surgeons.

Farber focuses on the unreliable trajectory of unsupported fistula functional success that surgeons grapple with: “Arteriovenous fistulas (AVF), when they work, are much more durable and much better for patients [than central venous catheters or arteriovenous grafts],” he said. “But to work, they require maturation, which means that the vein that is plugged into the artery needs to grow in diameter and thickness. We are asking the body to do this, but the problem is, this doesn’t work all the time. Sometimes the vein may grow in diameter but not in thickness, or it may not grow in diameter and simply grow in thickness. So, the corollary to that is many surgically created fistulas do not mature; some fistulas require procedures to help with maturation, and these may or may not be successful.

“In the ideal world, the best thing for the ESKD patient is the creation of a fistula that, after a certain period of time, say six weeks, is usable 100% of the time without any other interventions. That’s the predictable ideal, but doesn’t happen very often. So, anything that improves outcomes to get us closer to that ideal is going to be a very good thing for our patients,” he added bluntly.

One approach to overcoming this quandary is the concept of external support during surgical fistula creation. The VasQ device is a nitinol-based permanent vascular reinforcement implanted around the artery-vein connection. The device is designed to reduce both hemodynamic and mechanical stress to create more functional fistulas. The device, implanted during the surgical creation of either upper arm or forearm fistulas, guides the remodelling in the juxta-anastomotic region to promote outward wall thickening by maintaining the optimal angle, reducing wall tension and facilitating a more stable, laminar flow profile.

“It appears that externally supporting the fistula and making the fistula take an improved angle has promise in increasing functional patency and decreasing the number of interventions to get to maturation,” Farber told Vascular Specialist.

Six U.S. sites that participated in the VasQ U.S. pivotal study and enrolled more than six patients were eligible to participate in a retrospective chart review of unsupported AVFs to compare them to fistulas that had VasQ support. The cohort for this analysis included 104 ESKD patients with 52 in the unsupported group and 52 in the VasQ group. Both groups were well-matched with no significant differences in baseline parameters, including vessel diameter. The researchers evaluated the functional outcomes of time and intervention rate prior to first use, as well as functional success, which was defined as the proportion of fistulas used for hemodialysis at three and six months after AVF creation.

Farber is expected to present the results showing a nearly 30-day reduction in median time to first use driven by a significantly lower need for maturation procedures in the VasQ group as compared to the unsupported cohort. Additionally, significantly more fistulas in the VasQ cohort achieved functional success by the three-month timepoint. The VasQ cohort also showed a trend toward higher functional success rate at six months, but that finding did not reach statistical significance.

“We’re going to present that the immediate days to first use is typically shorter with VasQ fistulas. The ratio of interventions to first use is also significantly less in the VasQ-supported fistulas and the functional success is higher in this group,” commented Farber, adding that the device is relatively easy to place and doesn’t add significant time to the procedure.

Commenting on the results, he said: “The study offers encouraging evidence for the efficacy of an external vascular support of fistulas, especially in lowering intervention rates and shortening the time to achieving functional success.

“I think it’s exciting that there is new clinical science in this space. There’s a huge opportunity that we have with these patients because the maturation rates are currently 50 to 60%, at best. And that’s a pretty small number. So, there’s a considerable need to improve the maturation rates and I applaud Laminate Medical and other companies that are trying to develop ways to address this issue.”

VAM abstract submissions hit near-historic high

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VAM abstract submissions hit near-historic high
Andres Schanzer
VAM 2024 takes place in Chicago in June

A nearly record-breaking 794 Abstracts were submitted for the SVS 2024 Vascular Annual Meeting (VAM 2024). The abstracts were scored by the VAM Program Committee in early February 2024 and notice letters were sent out later that month. VAM 2024 is taking place June 19–22 in Chicago.

Several types of abstracts can be submitted each year for VAM, such as plenary, “How I Do It,” the Vascular and Endovascular Surgery Society (VESS) session, International Forum and posters. The abstracts are submitted topic areas like aortic, practice management, wound care and more. Once the submission period closes, the Program Committee breaks into small groups when the abstracts are blindly reviewed, given a score and then presented to the full Program Committee. Of the 756 submitted abstracts, 407 were accepted and added to the meeting’s program, which is consistent with the levels in previous years.

Andres Schanzer

“I’m really excited about the diversity of content. This year proved to be one of the most difficult when it came to abstract scoring,” said VAM Program Committee Chair Andres Schanzer, MD. “Every submission was great, but we can’t choose them all. I’m confident that the meeting will have pieces of content that will resonate with vascular surgeons at all career levels.”

VAM 2024 will be the third and final year of Schanzer’s tenure as the chair of the VAM Program Committee. The full VAM 2024 program will be available later this month. To learn more, visit vascular.org/VAM.

Registration will launch March 20 with an early-bird rate that will be in place through April 10, after which prices will increase to the advance registration rate, which will last through June 17. An increased, on-site registration fee will be available to anyone who cannot register for VAM 2024 in advance.

In addition to the early-bird registration discounted prices, SVS members will see an additional discount on their rates when compared to those of non-members. Any non-member wanting to take advantage of the member discount can apply for SVS membership by May 1 to receive the refunded difference, pending application approval.

Medical students advocate for women’s vascular health

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Medical students advocate for women’s vascular health
Nishita Vootukuru, Shannon McDonnell, Kundanika Lakkadi
Nishita Vootukuru, Shannon McDonnell, Kundanika Lakkadi

In celebration of Women’s History Month, the Society for Vascular Surgery (SVS) Foundation’s “Voices of Vascular” series is underscoring women’s contributions to the specialty. The SVS Foundation initiative champions female accomplishments, emphasizing the pivotal role they play in helping shape vascular surgery, enhancing patient care and contributing to a healthier world.

Three medical students, Nishita Vootukuru, Shannon McDonnell and Kundanika Lakkadi, have shared their insights on why it is imperative to fund the future of medicine, particularly in the context of women’s health.

Vootukuru, a second-year medical student at Rutgers New Jersey Medical School, emphasizes the urgent need to address women’s unique challenges in receiving diagnoses and treatments for vascular disease.

“As a student in the vascular community, the imperative nature of addressing the unique challenges women face in receiving diagnoses and treatments for vascular disease is evident. Through initiatives like Voices of Vascular, we can work towards supporting research tailored to women’s health needs, ultimately improving outcomes for all,” said Vootukuru.

Throughout the month, the SVS Foundation and the SVS Women’s Section Steering Committee will honor SVS members for their life-saving care and pioneering research in the fight against vascular disease. The Society shared a video from members on its social media channels explaining the importance of giving for Women’s History Month.

McDonnell, currently in her fourth year of medical school at Loyola University in Chicago, credits the mentorship she received from female vascular surgeons as a driving force behind her decision to pursue vascular surgery. She highlights these mentors’ multifaceted roles, serving as researchers, leaders in their field and mothers.

McDonnell emphasizes the importance of representation, stating, “Envisioning myself in similar roles not only served as an enormous inspiration but also underscored the importance of representation as a minority in such an important and ever-growing specialty.

“As the field of vascular surgery continues to evolve, sponsoring women’s research will allow our many female surgeons to improve patient outcomes and recruit more diverse perspectives to the specialty.”

Lakkadi, a fourth-year medical student at the University of Queensland-Ochsner Clinical School, emphasizes the broader significance of supporting vascular research.

Lakkadi believes that funding research contributes to raising public awareness about the critical importance of vascular health.

“I believe it is important to support and fund vascular research to raise public awareness about the critical significance of vascular health. Initiatives like the Voices of Vascular campaign play a vital role in spotlighting the diversity within our field, fostering its growth, innovation and improved health outcomes,” said Lakkadi.

The SVS Foundation extends its support through grant assistance and scholarships that pave the way for opportunities for aspiring female vascular surgeons for years to come. Boston Scientific, the presenting sponsor for the initiative, will give a $25,000 match, doubling every donation made through March 31.

The SVS Foundation calls upon individuals to join in uplifting and celebrating women in vascular medicine by offering their support. Visit vascular.org/Voices to learn more.

I’m just a bill: An overview of health-related committees on Capitol Hill

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I’m just a bill: An overview of health-related committees on Capitol Hill

In the U.S., the legislative process is complex. Among the most important in this process are congressional committees, which play a pivotal role in shaping policy concepts, drafting legislative proposals and shepherding them through the path to becoming law. These committees are specialized groups of members with expertise in relevant policy areas. There are key committees known as our “Committees of Jurisdiction,” where legislation relevant to vascular surgery is channeled.

When a bill is introduced in the House of Representatives or the Senate, it typically undergoes a series of committee hearings and markups. Committee members gather valuable information through hearings. During “markups,” committee members critically review and refine the proposed legislation, incorporate amendments and deliberate the proposed legislation. Following these deliberations, the committee votes on whether to advance the bill to the full chamber for consideration. This process allows for thorough examination and refinement of legislation before reaching the broader legislative body.

The Senate Finance Committee, responsible for matters pertaining to taxation and revenue measures, wields extensive jurisdiction within the Senate. These large and powerful committees are broken down into subcommittees, where legislation is analyzed by subject matter. The Subcommittee on Healthcare has jurisdiction over anything related to healthcare finances, meaning it can have joint or sole jurisdiction over the activities of various agencies and offices. This includes the Department of Health and Human Services (HHS), which oversees the Centers for Medicare & Medicaid Services (CMS). This overarching influence makes this committee powerful regarding any legislation that touches federal revenue streams. Another example is the Senate Appropriations Committee, where subcommittees are tasked with drafting legislation to allocate funds.

Outside of the budgeting process, there are subject matter committees, such as the Committee on Health, Education, Labor, and Pensions, simply known as HELP. The HELP Committee’s jurisdiction includes most federal labor and employment laws, including those that regulate wages and hours of employment. For vascular surgeons, the HELP Committee holds significant importance due to its jurisdiction over legislation related to healthcare policies and regulations. The committee’s decisions on healthcare reform, medical device regulations, workforce training, and research funding profoundly influence the practice environment, reimbursement structures, and access to innovative treatments. The actions and policies shaped by the Senate HELP Committee have a direct bearing on advancing vascular surgery services and patient care outcomes.

The House of Representatives has a complementary structure, with its own Committee on Appropriations with a Subcommittee on Labor, Health and Human Services, Education and Related Agencies. The House of Representatives and Senate committees individually create budgets and then come to an agreement by the end of each fiscal year to prevent a government shutdown.

In terms of subject matter, two of the most influential committees on health policy in the House are the Committee on Ways and Means and the Committee on Energy and Commerce, both of which have health subcommittees. The Ways and Means Committee primarily deals with taxation, social welfare programs and trade, whereas the Energy and Commerce Committee addresses energy, healthcare, telecommunications and consumer protection issues. These committees differ from appropriations as they work with the content of the proposed legislation, compared to the Appropriations Committee, which focuses on simply allocating federal funds.

The committees of jurisdiction in both chambers of Congress serve as crucial gatekeepers in the legislative process, overseeing specific policy areas and shaping the trajectory of proposed bills. Their role is pivotal in ensuring that proposed laws undergo rigorous scrutiny and reflect a comprehensive understanding of the issues. By serving as conduits for legislative action, these committees contribute to the effectiveness and integrity of the legislative process, fostering informed decision-making and accountability within Congress.

Kelli L. Summers, MD, is a graduate of the SVS’ Advocacy Leadership Program.

Grit: The value of growth mindset and persistence as a vascular trainee

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Grit: The value of growth mindset and persistence as a vascular trainee
Kevin Mangum, MD
Kevin Mangum, MD

One of the biggest mental shifts I had to make during residency was my view on failure. I literally had to rebrand failure. As a medical student, and like many of my peers, I had been conditioned to automatically feel shame if I didn’t know an answer. Even as an intern, I held the view that if I didn’t know an answer on rounds, in the operating room, or if I made a mistake during my 24-hour call shift overnight, that I was a terrible resident. Fortunately, this view was gradually debunked through perspectives and experiences that highlighted the necessity, importance and inescapable reality of failure.

Often, our views of failure are self-defined, meaning that when we “fail,” it’s because we haven’t met our own standards and expectations for how we think we should have performed. Such a fixed perception of oneself as a “good” or “bad” resident, with zero gray area in between, impedes that of a growth mindset, in which the central driver is “how can I be better than I was before, even in the smallest way possible?” This concept of a growth mindset is not novel. Referred to in the business field as “continuous improvement” or “incremental theory,” growth mindset has been considered a beacon not just at the individual level but has been applied to improvement within large corporations as well. A Harvard Business Review article distinguishes those who are motivated, arguably even obsessed with learning and growing after failure, in contrast to individuals who are paralyzed and shut down after failure.

So can a growth mindset be taught? In particular, can those who respond negatively to failure be taught how to thrive and perhaps even learn to enjoy failure? The education arena is one of the best and most studied examples of this. In fact, a 2019 national study of learning mindsets published in Nature was the largest intervention-based study on the effect of mindset on achievement and found that teaching growth mindset skills could improve grades among lower-achieving students and increase enrollment in advanced mathematics classes.

But can growth mindset be applied to surgical training, especially in vascular surgery? Vascular surgery is a fluid and growing specialty. In a field of rapidly evolving technology and newly published trials that influence how we practice, it’s fundamental to grow with the specialty. As a vascular trainee, one of the aspects I love most is the need to adapt while staying grounded in fundamental skills. With all of this said, however, I acknowledge that mastering the abundance of skillsets in the field amid an ever-growing body of knowledge is intimidating.

So I go back to my initial question: how can growth mindset be incorporated into vascular surgery, to fully embrace all of these developments in which “failure” to some degree is inevitable? As trainees, we have to start seeing the opportunities for growth in every aspect of our training and patient care. For example, during an operative case, we must be goal-directed and hold ourselves accountable for identifying how we can improve, especially seeking out targeted, specific feedback. Effective strategies can include asking attendings for three areas of improvement at the conclusion of a case, or even going into a case knowing precisely what skills you want to develop. How we receive the feedback is equally as important as getting it; we can’t take it personally, which can be challenging, since so much of our identities as surgeons in training is wrapped up in our performance. We can also detach from our performative view of ourselves, instead leaning into our identity as continuous learners.

With our own recognition of and connection to our identity as seekers of continuous improvement, we can become more resilient and persistent in the face of challenge, since we no longer count ourselves out of the game if we don’t meet our own expectations. In this manner, we can give ourselves some grace, such that in the face of real challenge, we can persevere and insist of ourselves that we keep going—that we keep growing.

So perhaps we can reframe training as a bridge to continuous improvement of our patients and ourselves as practitioners, realizing that the specialty we’ve chosen is naturally and excitingly one that is constantly growing. We have the privilege to grow with it.

Kevin Mangum, MD, is a PGY5 vascular surgery resident in his second research year at the University of Michigan.

The devil we don’t know: The case against private equity in medicine

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The devil we don’t know: The case against private equity in medicine
Malachi Sheahan III

My household had a longstanding Christmas tradition. In the months leading up to the big day, my wife would craft a gift budget for our three sons. She would then blow said budget on mirth-busters like socks, books and, heaven forbid, educational toys.

Around Dec. 20, I’d look through this impending wreckage of our children’s hopes and dreams and offer up a passive-aggressive comment like, “I never would have thought to buy the New York Times crossword puzzle desk calendar for a four-year- old.” Her standard reply isn’t really printable here, but let’s just say I knew what to do. I understood the secret about boys that eluded my wife. They don’t really want specific things. They just want things. So every year I take what’s left of the budget and it’s go time. Shock and awe.

Pulling up to the Toys R Us on Christmas Eve, I looked much like the other deadbeat dads. But I was different. I had a PLAN. Grabbing two shopping carts, as I strolled down the center aisle my demeanor announced: “Make way fools, amateur hour is OVER. We may all be slackers and procrastinators here, but I am your king.”

There are three general categories of toys that my sons love. Things with teeth, things with wheels, and things that can be used to (hopefully just) simulate maiming your brothers. With Terminator-like efficiency, I quickly process the aisle labels. Jurassic Park Playsets (things with teeth), Matchbox/Monster Trucks (things with wheels), Nerf Missile Launchers (things that maim), Barbie/Disney Princesses (abandon all hope ye who enter here).

Passing this last aisle, I avoid eye contact with all of its desperate residents. Dads (it’s always dads) who clearly have not spent enough time with their daughters and are now trying to make up for it with a grand gesture. They are the Last and the Furious. It’s almost midnight Chad. Which My Little Pony does Sophie have her heart set on? Rainbow Sparkle or Pinkie Pie? Tick tock.

My secret power was that I actually knew my kids. This may not seem like much but compared to my fellow consumers in this rural Louisiana Toys R Us at 10:33 p.m. on Christmas Eve, I was Father of the Frickin’ Year.

Our time-honored tradition ended in 2017 with the bankruptcy of Toys R Us. What killed this profitable national chain? Private equity.

And now, as they say, the barbarians are at our gates. Are we ready? First, let’s review private equity FAQ style. Don’t worry, my financial education capped at ECON 101. There will be no mention of Adam Smith or The Wealth of Nations.

What is private equity?

Private equity (PE) is best thought of as a financial strategy. The basic goal is to achieve higher returns than are generally possible in the public market. Therefore, PE investments are made in companies or entities that are not publicly traded. If the company is public, the PE firm takes it private after the acquisition.

Why does PE take their companies private?

In response to the rampant corporate fraud that led to the stock market collapse of 1929, Congress passed the Securities Act of 1933 and the Securities Exchange Act of 1934. These laws forced corporations seeking money from the public to disclose a wide array of financial and legal information. All of this information would be regularly reviewed by the Securities and Exchange Commission (SEC). Private companies were limited to only 100 investors. However, following a wave of deregulation in the 1980s, the National Securities Markets Improvement Act of 1996 allowed private funds to raise unlimited money from an unlimited number of investors. Following this Act, the number of private companies skyrocketed as they faced significantly less regulation than public firms.

Why is the strategy so successful?

PE investments usually have a time horizon of four to seven years to yield favorable returns. General strategies revolve around cost-cutting: pay cuts, store closings and layoffs. In addition to Toys R Us, Sports Illustrated, Nabisco, Twitter and even Taylor Swift were all significantly affected by PE investments. However, not all PE interactions have negative outcomes. Dollar General and Michaels survived their buyouts as healthy companies. Under ideal circumstances, PE firms can offer the expertise to turn around poorly performing businesses by eliminating operational inefficiencies and increasing profits.

How does a PE firm finance its acquisitions?

Most of the money is borrowed, and this debt is immediately transferred to the acquired company. In the case of Toys R Us, the PE firm transferred billions of debt to the corporation. This is referred to as a leveraged buyout. So, at a time when Toys R Us should have been overhauling its infrastructure and strategies to compete with the growing online market, it had to use its revenue to pay off this massive debt. Despite remaining profitable, Toys R Us ultimately had to declare bankruptcy.

What else can PE firms do to ensure profit even if the acquired business eventually fails?

Since the PE firm now owns the acquired business, it can do a lot to harvest cash. A common tactic is the sale- leaseback. In this case, the PE firm will instruct the company to sell assets to pay off the debt it has now incurred from the leveraged buyout. Often, a company’s most valuable asset is its real estate. In a sale-leaseback, the PE firm directs the company to sell its land to the firm, and then the firm will lease it back to the company. PE firms can also charge the acquired corporation exorbitant “management” fees. Since the firm owns the business, it doesn’t need to do anything to earn these fees.

One instructive example is the purchase of the nursing home chain HCR ManorCare by a PE firm, the Carlyle Group, in 2007. As detailed in the New York Times, Carlyle paid just over $6 billion, most of which was borrowed. It then saddled ManorCare with the debt and recovered its investment by selling ManorCare’s real estate. ManorCare then had to pay rent for the buildings it once owned. Carlyle also charged ManorCare $80 million in transaction and advisory fees. ManorCare began cost-cutting programs and layoffs, resulting in health code violations. Eleven years after the purchase, ManorCare filed for bankruptcy with over $7 billion in debt. Carlyle, however, made millions over its initial investment. Carlyle executives even give talks at industry conferences about structuring investment portfolios to include nursing homes.

What would it look like if you planned a PE takeover of your household?

I’m glad you asked this oddly specific and leading question. I imagine the conversation with my wife would go as follows, “Look, you’re a good earner, but under investments and assets you wrote one word, ‘shoes.’ The nanny seems pretty frugal. I’m making Luisa the CFO. The two older kids are sunk costs at this point. But the youngest’s grammar school is crazy expensive. Also, he says he wants to be an artist. That’s a long road to a return on our investment. We are going to have to lay off Luke. And the dog.”

What makes healthcare attractive to PE firms?

The healthcare industry is often seen as recession proof. The U.S. spends about $4.5 trillion on healthcare, almost 20% of its gross domestic product, the highest among developed countries. PE firms see this spending as a spigot, unlikely to be turned down.

Over the past decade, almost $1 trillion has been spent by PE in acquiring medical practices. And now that we know the PE playbook, the results are predictable. The goal of purchasing physician practices is the same as for buying companies. Turn a 20–30% profit on investment in four to seven years.

PE acquisitions of physician practices rose from 75 in 2012 to 484 in 2021. In more than one fourth of metropolitan areas, a PE firm has at least a 30% market share in a medical specialty. Studies have shown that prices rise when PE firms achieve this 30% threshold. Nationally, 25–40% of emergency rooms are staffed by PE firms.

A JAMA Internal Medicine study by La Forgia and colleagues showed that prices charged by PE-backed anesthesia groups rose 26% from 2012–2017. The financial burden is passed on to patients through higher out- of-pocket fees and rising premiums. The No Surprises Act was a response to unsavory PE billing policies. It is unlikely that physicians see much of the increased revenue, as PE’s goal is to increase profits for its investors. In fact, many PE-owned anesthesia practices replace physicians with nurse anesthetists to save money.

In dermatology practices, physicians have been told to generate profits by increasing elective procedures, ancillary services, and charges. This profit-driven model also threatens health equity. Reimbursements can be maximized by prioritizing commercially insured patients in higher-income communities. Quicker, lower-complexity procedures are also emphasized over delivering complex care.

Scale of PE role in medicine

The true influence of PE in medicine is difficult to measure as their firms have few ownership disclosure requirements. Also, the physicians are routinely required to sign non-disclosure agreements. Even for doctors getting acquired, it can be impossible to tell who is truly buying their practice. This lack of transparency makes monitoring the actual effects of PE on healthcare nearly impossible. Still, what we do know is damning. In deference to my poorly enforced word count and readers’ attention span, I will not detail all of PE’s plundering and blundering exploits in medicine. But for those not convinced, simply search Envision Healthcare, US Anesthesia Partners, Kool Smiles, or Prospect Medical Holdings.

I believe PE acquisitions are just a symptom of healthcare’s overall problems. Physicians are selling their practices because it is too hard to remain financially solvent on their own. Paperwork, legal requirements, electronic health records and insurance practices have all placed incredible strain on private practitioners. The majority of physicians enter practice with extraordinary educational debt. Hospital system consolidations make it difficult for smaller practices to compete. Many physicians reject the notion of hospital employment but have few options. PE employment offers a potentially lucrative alternative.

The specter of non-compete clauses and loopholes

In addition to raising prices, PE firms strive to generate more income from physician practices by purchasing lower-cost supplies, substituting lower-paid staff such as medical assistants for nurses, having physicians see more patients, and seeking a better payor mix. The firms also lock the physicians into the practice through non-compete clauses.

The American Academy of Emergency Physicians notes: “The goal of non-compete clauses is to intimidate the emergency physician into unquestioning servitude to business interests. Given physicians’ ethical obligation to patients, many continue to speak out for patient safety; however, knowing that they can be fired at will and then forced to relocate their family to another city or state can have a chilling effect on physicians’ advocacy for patients.”

The legal ability of PE firms and their medical management companies to control medical decision- making and clinical care is determined at the state level and varies enormously. Nearly 20 states have no rule prohibiting medical management companies from manipulating clinical practice and medical judgment. Even where regulations exist, PE firms can find loopholes, such as naming the physicians as practice owners while having a parent company control the actual finances.

In the world of corporate medicine, these are known as “friendly” or “straw” doctors. Often, they will have their name attached to hundreds of practices. Amazon’s One Medical primary care subsidiary and UnitedHealth-owned Optum Health have been accused of this practice. Oregon is currently debating a bill to outlaw this “corporate practice of medicine.” Both Amazon and UnitedHealth Group have retained lobbyists to oppose it.

PE firms also protect themselves politically. Their employees include former cabinet members, secretaries of state, chairmen of the SEC, chairmen of the Federal Trade Commission. speakers of the House, a CIA director, a vice president, and various senators.

Still, much can be done to combat PE’s influence on medicine. Financial and bureaucratic burdens on practicing physicians must be eased. Indiana, for example, recently passed a tax credit for independent physicians. Other possible financial improvements include Centers for Medicare & Medicaid Services (CMS) payment reforms, reconsidering fee-for-service, and capitated payments for quality care.

Uniting with other specialties to support complete ban

The most direct and achievable method for curbing the undesired aspects of PE influence on physician practices may be to enforce the FTC’s proposed ban on non-compete clauses. If PE firms could not prevent physicians from walking away, it would force them to change their approach to management. Instead of rampant cost-cutting and forcing physicians to do more with less, this could incentivize PE to retain doctors by improving salaries and working conditions.

Even if enacted, the FTC’s proposed non-compete ban will likely face many challenges in court. Most conservative judges, including some on the Supreme Court, have signaled that they don’t favor federal agencies asserting new regulatory authority based on old statutes.

Vascular surgeons should join with other specialties that have already been pillaged by PE to support a complete ban on non-compete clauses for doctors. Only by uniting our physician advocacy efforts do we stand a chance against the private equity-backed lobbyists.

Malachi Sheahan III, MD, is the chief medical editor of Vascular Specialist. His opinions do not reflect SVS policy or positions. 

Longer fasting before venography appears to impact stent size selection, new study finds

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Longer fasting before venography appears to impact stent size selection, new study finds
Kurt S. Schultz
Kurt S. Schultz

During the 2024 American Venous Forum (AVF) annual meeting in Tampa, Florida (March 3–6), Kurt S. Schultz, MD, a general surgery resident at the Yale University School of Medicine in New Haven, Connecticut, presented data from a study exploring how fasting duration prior to venography is associated with stent sizing in patients with iliac vein compression, finding that a longer fasting duration was associated with a smaller iliac vein stent size. 

He stated that, while iliac vein stenting is a viable treatment option, “inappropriate sizing of venous stents can have catastrophic complications, and there’s been an increased rise in reports of stent migration to the heart and lungs. Iliac vein size, as we know, depends on several factors, like BMI [body mass index] and whether the patient is prone or supine.” 

Schultz and colleagues divided patients into two groups— those who received their procedures before 11 a.m. (early group) and those who received their procedures after 11 a.m. (late group). 

The number of patients in the study was 64, with 30 being in the early group and 34 in the late group. Of the 64 patients, the mean age was 52 years old and 48 of the 64 were female. 

Since these patients are typically fasting starting at midnight the day of their surgeries, “patients who are having elective procedures later in the day are likely to be more dehydrated,” Schultz told the audience. 

“So, our hypothesis was patients undergoing iliac vein stenting later in the day would have smaller stents placed compared to those who had stents placed earlier in the day.” 

The clinical outcomes supported the hypothesis, with the left common iliac vein and external iliac vein being larger in terms of surface area in the early group when compared with the late group. However, Schultz explained, “this didn’t reach statistical significance.” 

The study found that, while delayed start times were associated with a smaller stent size, patients who were prone were also more likely to have a smaller stent size. The difference in fasting times for the two groups was significant, with a mean of eight hours and 45 minutes for the early group and 13 hours and 33 minutes for the late group. 

“In conclusion, based on our linear regression we found that a nine-hour fasting duration was associated with an approximately 2mm decrease in stent size,” Schultz stated. “So, the longer fasting duration was associated with smaller iliac vein stent size.” 

During the question-and-answer portion of the presentation, Schultz was asked about whether there were any complications in patients due to the size of the stents. He explained that, while he and his team have these data, they have yet to analyze it. 

When asked about whether the patients had chronic pain associated with the oversized stents, as there is a larger issue with chronic pain as compared to catastrophic complications such as a stent migration, Schultz responded by saying that his team has the data to look at those complications, adding, “I think that’s an appropriate next step.” 

Schultz explained that the study group will now look to develop a pre-procedural hydration protocol. 

Vascular surgery resident reflects on Match Day experience

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Vascular surgery resident reflects on Match Day experience
Eric Smith
Integrated vascular surgery resident Eric Smith, MD, tells Vascular Specialist how he handled the lead up to Match Day. 

For medical students hoping to specialize in vascular surgery, the eagerly anticipated Match Day (March 15) marks a pivotal career moment. Organized by the National Resident Matching Program (NRMP), it is the culmination of years of hard work, education and clinical experience. 

The excitement of imminent professional growth is tinged with the uncertainty of where they will spend the next phase of their medical journey. The days preceding Match Day are a flurry of final preparations, with SVS members revisiting residency programs and seeking advice from mentors to navigate the pivotal decisions ahead. 

Eric Smith, a postgraduate year one (PGY-1) integrated vascular surgery resident at the University of California San Francisco and a 2021 SVS Diversity Medical Student Vascular Annual Meeting (VAM) Travel Scholarship winner, shares insights into the emotional whirlwind leading up to Match Day. 

“Once your exams are done, the thing that people should try to remember is to focus on everything that you’ve accomplished to reach this point, so that it keeps you grounded. Medical school goes by so fast, and it’s nice to just sit and take a breather,” said Smith. 

Recalling the sleepless nights and stressful dreams preceding the decision, Smith emphasizes the importance of maintaining mental well-being during this anxious period. His advice to medical students is to take control of their situation and time, ensuring a comfortable mental space. He and his partner would engage in activities such as hiking or spending time with family to clear his mind. 

“I spent a lot of time travelling—but even though I wanted to be back in the operating room, people had to keep me away for my own good,” said Smith. 

Finally, Match Day arrives, and the anticipation peaks. Medical students, alongside their counterparts across the nation, will open their envelopes to discover where they will be completing their vascular surgery residencies. The mixed emotions are evident—joy, relief and perhaps a touch of nostalgia for the programs that brought them to this point. 

Smith shared his personal experience, recounting how, by 9 a.m., he learned he was matched with his top choice. The waves of excitement that swept over him were met with a surreal sense of disbelief, prompting him to reread the acceptance letter. However, even after securing his first preference, Smith grappled with the experience of mourning the many alternative paths in front of him. 

“What’s particular about Match Day is that you have all these different versions of yourself that were split apart with each decision of what could have been,” said Smith. 

Match Day for vascular residents is not just a day, but a culmination of years of dedication and perseverance, Smiths reflected. The days leading up to this event are filled with a unique blend of excitement, camaraderie and support from the SVS community, he added. 

New analysis points to lack of vascular surgical voices in news coverage of vascular disease

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New analysis points to lack of vascular surgical voices in news coverage of vascular disease
Babak Abai
Babak Abai

A new study set to be aired at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, sheds a statistical spotlight on the state of the specialty’s reach into the mainstream consciousness.

A team led by Babak Abai, MD, program director of the vascular surgery fellowship at Thomas Jefferson University in Philadelphia, performed a Google News analysis across both the medical and lay press to detect the scale of representation of vascular surgical voices in news coverage of vascular disease compared to other specialists who treat vascular pathologies.

What they found, Abai told Vascular Specialist ahead of SCVS 2024, demonstrated that vascular surgeons are “very underrepresented” in articles focused on both peripheral arterial disease (PAD) and carotid disease. In the case of the former, almost 20% of the articles included in their analysis involved vascular surgical voices, with just 17% of the items focused on carotid disease involving vascular surgeons.

The study comes in the wake of a series of articles appearing in the mainstream press in recent months, some of it controversial and involving coverage of inappropriateness in vascular interventions. More recent popular media reports saw the Society for Vascular Surgery (SVS) join a multispecialty coalition aimed at raising public awareness of PAD, which led to widespread coverage of vascular surgical voices in mainstream outlets.

Since initially performing the analysis on articles related to PAD and carotid disease, Abai and colleagues—including medical student Joshua Chen, BS, who helped develop the study—have probed vascular surgical involvement in news covering aneurysmal disease, arteriovenous fistulas and venous disease. Altogether, the results are “astounding,” he said.

Abai emphasized the need for vascular surgeons to push themselves to the front of vascular disease coverage to help the specialty gain brand awareness.

“The question becomes: how do we become the leaders in the dissemination of data, because we are the experts in these areas,” Abai said. “To us, it was very surprising we had such a low percentage in terms of our representation.”

He continued: “We have a branding issue. We need to go out there, do interviews on news channels, on TV, in newspapers and on the internet—the latter, in fact, might be the best channel for us to disseminate and use to promote vascular surgery as a brand and have much better representation on the disease processes that are key to vascular surgery.”

Addressing some of the more negative coverage that has appeared in the mainstream press in recent times, Abai sees a potential silver lining. “It’s just like Hollywood,” he said. “Even bad press is not necessarily bad because it can bring visibility to your cause and what you are doing. Ultimately our goals are good. Our goals are to save limbs, our goals are to prevent strokes.

“Although I would hope we could [promote vascular surgery] in a more positive way because we don’t want the population to lose trust in us as physicians and as people who provide care for them.”

Tackling DVT head on: Single-session, wall-to-wall thrombus removal with the ClotTriever BOLD

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Tackling DVT head on: Single-session, wall-to-wall thrombus removal with the ClotTriever BOLD
Nicolas Mouawad

This advertorial is sponsored by Inari Medical.

Several years ago, when Nicolas Mouawad, MD, division chief of vascular surgery at McLaren Health in Bay City, Michigan, was confronted with an emergency case of deep vein thrombosis (DVT) in which the patient presented with phlegmasia, he faced a dilemma. With the traditional lytic intervention off the table due to the urgent need for an immediate response, Mouawad turned to a new device he hadn’t used before. For the first time, the ClotTriever® System provided Mouawad a DVT intervention procedure with a lytic-free approach in a single-session treatment with wall-to-wall thrombus removal, providing the patient with immediate symptom relief.1 

Here, he outlines the current picture of his venous thromboembolism (VTE) practice, how that emergency case helped evolve how he tackles DVTs in appropriate patients, and how he sees the DVT treatment landscape developing going forward. 

What does your current venous disease practice look like? 

We have a comprehensive venous practice. We manage superficial veins and deep venous disease as well as pulmonary embolism (PE)—the full VTE disease spectrum. We see a significant number of patients who come in with DVT and post-thrombotic syndrome (PTS), as well as with venous leg ulcers, so we feel very comfortable managing the wide array of patients suffering from venous insufficiency and VTE. 

Could you expand upon how you go about managing patients with DVT? 

Our DVT management is multi-fold. The goal is to, first, relieve the patient’s symptoms, such as significant venous claudication or severe swelling that they find quite bothersome, or pain. Of course, we start with anticoagulation; however, a proportion of patients presenting with this pathology we feel benefit from intervention. Thinking further down the line, we want to avoid patients having significant sequelae of DVT, which, in up to 50% of patients with DVT, means PTS.2 Presently, these PTS patients are treated using the current standard of care, which is anticoagulation and elastic compression stockings. Even though they’re undergoing currently recommended treatments, these patients still develop long-term sequelae of PTS, so our goal here is to help mitigate the possibility of them developing these sequelae. 

Can you describe how the ClotTriever first made its way into your toolkit? 

Like a lot of other vascular specialists, I was using other devices on the market for the management of patients with DVT. I remember very vividly the first patient I treated with the ClotTriever System presented with phlegmasia. Even though I would consider our traditional treatment algorithm which was thrombolytic therapy, that would not be able to deliver an immediate resolution of the problem. What we needed was an immediate treatment for this patient who essentially had a surgical emergency. My hand was forced to try something that was immediate, single session and able to deliver a result without long infusion times. That case was around six years ago, and, frankly, we haven’t looked back since I started doing this type of treatment. 

How does the ClotTriever System differ from other modes of intervention for the treatment of DVT? 

Multiple variables of the system are beneficial to me. First, the ClotTriever is a single-session device. Bringing the patient back can be challenging, so a single-session device is important to me. Next, I don’t worry about the chronicity of the thrombus. Patients present within one or two days of discomfort, but we all know that the thrombus has probably been there longer. The symptoms may be acute, but the thrombus itself is likely sub-acute and even older. I have been using the ClotTriever BOLD Catheter to eliminate any guesswork on clot chronicity. Lastly, the unique device design allows me to remove wall-adherent thrombus to minimize residual vein obstruction. In terms of residual vein obstruction, creating more than just a channel with other thrombectomy devices is an important consideration regarding long-term outcomes. 

Can you outline ways in which the device has evolved your DVT practice? 

There is no associated ICU [intensive care unit] stay like there is when using thrombolytic therapy. There are no associated costs for pharmacologic therapy. There is no need for any capital equipment. Those were the benefits early on. To date, more than 50,000 ClotTriever cases have been performed. Additionally, there exists a plethora of data to support the device. Very aggressive efforts have been made to look at the data. The CLOUT registry is the largest study to assess mechanical thrombectomy to date, with interim two-year outcomes that showed 93% of limbs had none or mild PTS.3 Additionally, my experience—and histological analyses of ClotTriever cases— have not identified any cases where there has been venous valve or vessel wall damage.4 I’ve performed more than 200 DVT cases using the ClotTriever System and seen patients back with marked improvement in their discomfort and Villalta scores for PTS. I don’t think that would have been possible if we were ripping out valves or damaging the vein walls. 

What do you think the future holds for DVT treatment? 

For me, it’s important to be able to work with the groups investing in data. Unfortunately, the guidelines lag well behind what we see in practice. Of course, that is because a lot of data are necessary before guidelines can be created. Those data are forthcoming, however. The DEFIANCE randomized controlled trial (RCT)—currently the only RCT assessing DVT interventions—will be one such source. DEFIANCE, which compares iliofemoral DVT patients treated with the ClotTriever System versus anticoagulation only, should help support what we see day-to-day in our regular practice. 

CASE REPORT 

A woman in her early 60s presented with right leg pain and swelling. An ultrasound revealed unilateral right iliofemoral DVT, and the decision to intervene using the ClotTriever BOLD Catheter was made. 

Procedural overview 

The right popliteal vein was accessed with a micropuncture needle and wire under ultrasound guidance, and exchanged for a microsheath, ultimately upsizing to a short 10F sheath. A venogram demonstrated significant thrombus within the femoropopliteal segment, common femoral vein and extending into the external iliac vein. The lesion was crossed into the inferior vena cava (IVC). Next, pullback intravascular ultrasound (IVUS) from the IVC to the access site was performed to identify the extent of thrombus. A glidewire was advanced up into the right subclavian vein, and a vertebral catheter was advanced over it. Next, the glidewire was exchanged for a guidewire 7cm tip. A 19F dilator was used, followed by insertion of the ClotTriever sheath. The funnel was deployed under fluoroscopic guidance and the ClotTriever BOLD Catheter was advanced into the popliteal vein. The nitinol coring element and mesh collection bag were then deployed at the iliac vein, and the catheter was then retracted, capturing and removing significant acute thrombus. In total, four ClotTriever BOLD passes were completed. Completion IVUS showed complete thrombus removal. Completion venogram demonstrated brisk cephalad flow. Total procedure time was 35 minutes, while total device time was 10 minutes. There was estimated total blood loss of 20ml. 

Conclusion 

The patient’s pain resolved immediately postprocedure, with the swelling improving greatly. In follow-up, the swelling was resolved and the patient is doing well. 

References

  1. Dexter D et al. JSCAI. 2024.
  2. Kahn SR, et al. J Thomb Thrombolysis. 2016.
  3. Dexter D. Interim two-year outcomes from the fully enrolled CLOUT registry. AVF. 2024.
  4. Silver MJ, et al. Catheter Cardiovasc Interv. 2021.

The ClotTriever Thrombectomy System is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels; and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature, including deep vein thrombosis (DVT). Refer to IFU for complete indications for use, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. All trademarks are property of their respective owners. 

Vascular Specialist–March 2024

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Vascular Specialist–March 2024

In this issue:

 

IVUS use in claudicants not associated with improved outcomes, claims data show

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IVUS use in claudicants not associated with improved outcomes, claims data show
Caitlin Hicks

The use of intravascular ultrasound (IVUS) for the treatment of claudication doubled over a four-year period but there was “no clear relationship between IVUS use and improved patient outcomes,” a recently presented retrospective analysis of claims data showed.

Researchers found the rate of use of the diagnostic tool in peripheral vascular interventions went from 15.5% in 2018 to 29.2% in 2022 among Medicare beneficiaries undergoing index femoropopliteal interventions for claudication.

Use across all procedure types also increased over the time period, with the steepest rate of increase in cases treated using atherectomy.

Looking at site of service, the study showed that IVUS use in hospital settings nearly doubled (4.8% to 8.8%), while in ambulatory surgery centers (ASCs) and office-based labs (OBLs) IVUS was being used in 48.5% of all femoropopliteal interventions performed for claudication by 2022—up from 30.6% in 2018.

The data were delivered during the 2024 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Sun Valley, Idaho (Jan. 18–21).

Statistical analysis showed that the cumulative incidence of repeat interventions was “significantly greater when IVUS was used during the index femoropopliteal [procedure] than when it was not,” Sanuja Bose, MD, a postdoctoral research fellow in the Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins University in Baltimore, Maryland, told VESS 2024.

“Overall, IVUS was associated with greater conversion to chronic limb-threatening ischemia after adjusting for the baseline patient characteristics and clustering by physician.”

Senior author Caitlin Hicks, MD, Johns Hopkins’ associate vascular fellowship program director, later told Vascular Specialist IVUS has a “definite role” to play in settings such as the recanalization of chronic total occlusions “but I think that it’s frequently used more than that, and I don’t think it necessarily contributes any meaningful improvement to patient outcomes in all settings.”

CLOUT registry: Interim two-year rates of PTS ‘significantly lower’ than those in historical DVT studies

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CLOUT registry: Interim two-year rates of PTS ‘significantly lower’ than those in historical DVT studies
one-year
David Dexter

Rates of post-thrombotic syndrome (PTS) among deep vein thrombosis (DVT) patients treated with the ClotTriever thrombectomy system (Inari Medical) who are logged in the real-world CLOUT registry demonstrated “significant and sustained improvement” out to 24 months, according to interim two-year data recently delivered at the 2024 American Venous Forum in Tampa, Florida (March 3–6).

The rate of moderate-severe PTS at the two-year mark was reported as 7.3% among 228 patients included in the interim analysis, presenter David Dexter, MD, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, told AVF 2024 attendees. The overall rate of PTS in the interim results was 19.9%.

PTS rates reported in CLOUT are “significantly lower” than those from historical DVT studies such as ATTRACT and CAVA, which reported moderate-severe PTS rates ranging from 18–24%, he added.

The interim results are the largest prospective, multicenter two-year dataset in DVT since the ATTRACT trial. Patients had low incidence of independently adjudicated safety events related to re-thrombosis, with only 5% and 8.4% at 30 days and six months, Dexter reported.

“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile,” said Dexter. “And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients. The low PTS rate that continues to improve over time is a testament to the safety and effectiveness of wall-to-wall thrombus removal with ClotTriever.”

Single-centre analysis suggests improved longer-term outcomes with endarterectomy versus TCAR

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Single-centre analysis suggests improved longer-term outcomes with endarterectomy versus TCAR
Ali AbuRahma

A large, single-centre analysis has found that, despite parity between the two procedures in terms of perioperative clinical outcomes, carotid endarterectomy (CEA) was associated with a reduced rate of late stroke/death compared to transcarotid artery revascularisation (TCAR).

Writing in the Journal of Vascular Surgery (JVS), Ali AbuRahma, MD, from Charleston Area Medical Center/West Virginia University in Charleston, West Virginia, and colleagues also conclude that CEA produced a marginally lower rate of restenosis ≥80% at two years—although this difference did not reach statistical significance. The data were presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27).

The authors initially note that multiple registry studies—primarily ones conducted within the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative (VQI)—have compared early outcomes, and outcomes up to one year, between TCAR, CEA and carotid artery stenting (CAS). However, no large, single-centre studies have reported on late clinical outcomes between these procedures and, as such, they conducted a retrospective analysis comparing intermediate outcomes with TCAR versus CEA.

Their study analysed data collected from the TCAR Surveillance Project on patients at the Charleston Area Medical Center, with these data being compared and subsequently propensity matched against patients undergoing CEA. Patients in both groups were treated by the same providers across the same time period, the authors note.

The primary outcome of the analysis was a combination of perioperative stroke/death and late stroke/death rates, while secondary outcomes included combined stroke/death/myocardial infarction (MI), cranial nerve injury (CNI), and bleeding. Kaplan-Meier analyses were used to estimate patients’ freedom from stroke, stroke/death, and also rates of restenosis ≥50% and ≥80%.

Across 637 patients, a total of 646 procedures (404 CEAs and 242 TCARs) were analysed, with AbuRahma and colleagues finding no significant differences in indications for carotid intervention between these two groups—although TCAR patients had more high-risk criteria including hypertension, coronary artery disease, congestive heart failure, and renal failure.

The authors report that there was no significant difference between CEA and TCAR in terms of the rates of 30-day perioperative stroke (1% vs. 2%, respectively), stroke/death (1% vs. 3%), or major haematoma (2% vs. 2%). However, the rate of early CNI was found to be significantly higher with CEA (5%) versus TCAR (1%; p=0.0138). In addition, late follow-up analyses at two years revealed results favouring CEA over TCAR, as the former produced lower rates of stroke (1% vs. 4%, respectively; p=0.0273), stroke/death (8% vs. 15%; p=0.008), and restenosis ≥80% (0.5% vs. 3%; p=0.0139).

AbuRahma and colleagues’ propensity-matched analysis, under which 242 CEAs and 242 TCARs were included, found broadly similar perioperative outcomes regarding stroke rate (CEA, 1% vs. TCAR, 2%), stroke/death rate (CEA, 2% vs. TCAR, 3%) and CNI rate (CEA, 3% vs. TCAR, 1%). Once again, however, their later follow-up analysis generally favoured CEA, as demonstrated by a rate of stroke of 1%—compared to 4% with TCAR (p=0.0615)—and a rate of stroke/death of 8%—compared to 15% with TCAR (p=0.0345).

Finally, the authors also note a marginally smaller difference in the occurrence of restenosis ≥80% following propensity matching, as compared to their regular analysis, with rates of 0.9% associated with CEA versus 3% with TCAR (p=0.099). This difference was not deemed statistically significant, they add, and rates of restenosis ≥50% were not statistically significantly different between the two procedures either.

“In propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had somewhat lower rates of ≥80% restenosis at two years,” AbuRahma told NeuroNews, outlining the salient message from the paper. “The type of intervention, CEA versus TCAR, should depend on risk stratification—anatomical and/or physiological.”

ISC 2024 examines TCAR ‘explosion’ alongside advances in intensive medical therapy

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ISC 2024 examines TCAR ‘explosion’ alongside advances in intensive medical therapy
Seemant Chaturvedi and Caitlin Hicks

This year’s International Stroke Conference (Feb. 7–9) in Phoenix, Arizona, hosted discussions on the current state of play in carotid stenosis treatment—and, most notably, advances that may erode the dominance of long-established carotid revascularization procedures in the U.S.

Session moderator Larry Goldstein, chair of neurology at the University of Kentucky, Lexington, provided a fitting initial comment on the lack of up-to-date trial data evaluating different carotid disease treatments: “Looking around the room, some of you weren’t even born when these trials were done!”

As Goldstein noted, the trials in question—NASCET in the U.S. and ECST in Europe—were conducted and published some 30 years ago, and only included patients with symptomatic carotid artery stenosis.

“For some of you, this is almost ancient history—but, if you go to our national guidelines, this is all the grade A, level one evidence that we have,” he continued. “When the studies were done, they were internally valid, but time marches on, and things that we thought were true 40 years ago may not be true today.”

Dwindling need for revascularization?

This proved to be an appropriate segue into a presentation from Seemant Chaturvedi, MD, from the University of Maryland School of Medicine, Baltimore, Maryland, who began by stating that things have “dramatically changed” since the advent of those original trials in the 1990s. The succeeding decades have seen well-established medical therapies like antiplatelets, statins, blood-pressure control, physical activity and dietary modification joined by numerous modern options, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, bempedoic acid, semaglutide, and combination antithrombotic therapy.

Here, Chaturvedi touched on the various studies that have demonstrated the ability of these newer medications to safely reduce low-density lipoprotein (LDL) levels and ultimately minimize cardiovascular events. Evolocumab—an example of a PCSK9 inhibitor—and inclisiran have been tested and performed well in large-scale trials, while bempedoic acid serves as an alternative for patients who are unable or unwilling to take high-potency statins.

Chaturvedi then somewhat facetiously summarized “all of the data” evidencing the superiority of surgical revascularization over intensive medical therapy for asymptomatic carotid stenosis—presenting the audience with a completely blank slide.

“But, we do have some emerging evidence that, maybe, revascularization is not as good,” he continued, alluding to the fact that carotid endarterectomy (CEA) and medical therapy produced similar outcomes in the SPACE-2 trial, and highlighting the importance of data from the CREST-2 trial, which are expected in early 2026.

“On the symptomatic side, we also don’t really have much evidence that revascularization is much better than modern medical therapy [either]—there hasn’t been a large-scale study since 1991, and so there is a void in the current data,” Chaturvedi added. Once again, he drew attention to the relevance of ongoing studies in the area, including the SCORE registry.

“In 2024, we need to have very intensive medical therapy,” he summarized, also stating there is “no excuse” not to aim for lowering LDL levels to at least <70mg/dl in carotid stenosis patients—as per the target in CREST-2. However, he did note that he aims for LDL levels of <55mg/dl, if not lower, in his own practice. Starting medication alone is “not enough” in modern-day care, Chaturvedi continued, emphasizing the importance of administering treatment with certain goals in mind.

Lipoprotein (a), factor XIa inhibitors, colchicine, and agents that target vascular inflammation, are among additional medications “on the horizon” in carotid disease, according to Chaturvedi, who speculated that the neurovascular community is likely to hear more about each of these over the next 1–2 years.

“There is a plethora of new treatment options which have been proven to be associated with cardiovascular event reduction and, if we’re able to optimally use all of these agents, that should decrease the need for carotid revascularization.”

The third mode

Following this, Caitlin Hicks, MD, a vascular surgeon at Johns Hopkins Medicine in Baltimore, discussed another frontier that appears to have moved alongside CEA and carotid artery stenting (CAS) over the past decade: transcarotid artery revascularization (TCAR). Developed by Silk Road Medical via the Enroute stent system, TCAR’s intended benefits include avoiding the aortic arch, providing proximal protection, and improving particle capture.

TCAR received Food and Drug Administration (FDA) approval in 2015 for use solely in high-risk carotid stenosis patients, but with the caveat that physicians had to contribute clinical data—including perioperative and one-year outcomes—to the Vascular Quality Initiative TCAR Surveillance Project (VQI-TSP) in order to actually gain reimbursement for the procedure.

This has created a greater wealth of both comparative and non-comparative data on TCAR, and studies evaluating it have “exploded” over the past few years as a result, Hicks relayed. Broadly, these studies have suggested TCAR produces stroke/death rates, comparable to those seen with CEA out to one year, across asymptomatic and symptomatic patients alike. Additional studies demonstrating non-significant differences in rates of stroke/death/myocardial infarction between the two—specifically those involving standard-risk patients—ultimately supported an expanded indication of the procedure from the FDA in 2022.

Figures suggest TCAR has “taken off” in the USA over the past few years, with CEA and CAS declining slightly—a trend that is especially pronounced for high-risk carotid stenosis patients, in whom TCAR is now the predominant revascularization approach nationally. Hicks did also acknowledge that the 2023 Centers for Medicare and Medicaid Services (CMS) coverage expansion, under which CAS is no longer limited to certain lower-risk patients, will likely lead to an increased stenting uptake and TCAR “losing ground” in more high-risk patients. However, “on the flipside”, with TCAR also being covered by this expansion, physicians are no longer mandated to contribute to the VQI-TSP database, potentially making the procedure less expensive to accommodate and thus boosting uptake at smaller community hospitals in the USA.

Hicks then noted that “there has been very close oversight of the use of TCAR by industry”—although she feels this is likely to be “unsustainable” in the long term, especially if the procedure continues to expand and is taken up by multiple other specialties. She also highlighted the fact that data on TCAR remain limited, overall, as the majority come from the industry-sponsored ROADSTER studies as well as the VQI-TSP registry, which are helpful indicators of real-world patient outcomes, but certainly not equivalent to a randomized controlled trial (RCT).

“People always call for an RCT comparing TCAR to CEA—and/or transfemoral stenting,” she continued. “As much as I would love to see that happen, it almost certainly will not. It’s not financially viable. Silk Road Medical has seen a large market-share increase, and there’s really no reason for them to fund a study like that. So, unless something like that is funded by the government or another format, this will likely not be in our future.”

Nevertheless, Hicks feels data on longer-term outcomes are needed to help understand “where TCAR fits into our carotid revascularization armamentarium”.

Patient-centric decisions

“Ultimately, I think having patients see physicians that are able to perform all three procedures is probably the best bet, because we can really try to weigh up the risks and benefits, and have patient-specific decision-making,” Hicks commented.

In a subsequent discussion, Thomas Ford, MD, from UMass Memorial Health in Worcester, Massachusetts, said that, while an “ideal world” would see a single proceduralist offer all three of the aforementioned procedures, there is a certain “division of labour” in many centers whereby vascular surgeons often perform the majority of CEAs and TCARs, while interventionists perform a lot of non-invasive procedures like CAS.

Responding to Ford’s question on how best to navigate this, Hicks admitted it is “difficult, for sure”, but that the keys to success are the conversations had between vascular surgeons, interventional neuroradiologists, and stroke neurologists, where necessary.

“I certainly don’t think that there’s a perfect way,” she added. “The new carotid NCD [National Coverage Determination] calls for shared decision-making, with a discussion of all three carotid revascularization options prior to choosing one. There is no current, validated shared decision-making tool to use with patients, so that’s a little bit misaligned with what we have available in the clinical realm—but, I think, as that develops moving forward, at least being able to have a conversation about the three choices and then trying to steer the patient in the right direction is what we all need to aim for.”

The top 10 most popular Vascular Specialist stories of February 2024

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The top 10 most popular Vascular Specialist stories of February 2024

top 10In February, the most read stories from Vascular Specialist include a study of metformin and its potential as the first-ever medical treatment that can manage aneurysm disease; the SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) release the highly anticipated Office-Based Lab (OBL) Handbook; and a case series evaluation of aortoiliac endarterectomy, among several more. 

1.‘Get a Pulse on PAD’: Multi-society public awareness campaign launched

The Society for Vascular Surgery (SVS), in partnership with three other medical societies operating in the vascular disease space that form the PAD Pulse Alliance, is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD.”

2. SAVS 2024: A journey to the heart of DEI like no other

David L. Cull, MD, delivers a captivating presidential address, laying bare his own challenging journey as a vascular surgeon and the hidden lessons on diversity, equity and inclusion his life story may hold.

3. More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds

Amid the build-up to residency Match Day 2024, the Association of Program Directors in Vascular Surgery (APDVS) has delivered data from a VISIT (Vascular In-Person for Students in the Match Trial) pilot study that took place last year showing some 57% of medical students who took part changed their rank list of integrated vascular surgery programs based on post-virtual site visits to institutions on their radar.

4. Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’

The uncommonly performed aortoiliac endarterectomy—one of the open procedures on which the vascular surgical specialty was founded—provides acceptable durability in aortoiliac occlusive disease patients with smaller native vessels, especially among females, a 25-patient case series review performed at Louisiana State University (LSU) Health Sciences Center in New Orleans has shown.

5. Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty

A study comparing the extent of early infrapopliteal re­coil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrat­ed “technical feasibility” in measuring early recoil using standard angiography.

6. A proposal to save vascular surgery

Russell H. Samson writes in response to recent articles in the lay press suggesting vascular surgeons were performing unnecessary procedures, following a talk he gave at the 2023 VEITHsymposium.

In this article he begins: “At that meeting I provided data demonstrating which specialties are treating vascular patients and the rate of insurance denials dependent on provider specialty. I was originally reluctant. I had stopped writing editorials for Vascular Specialist because I had said all that I had on my mind. I was also concerned that, eventually, I would write a piece that readers would find so controversial that I would never be able to show my face in public again.”

7. How the best leaders ensure psychological safety at work

Bhagwan Satiani writes on his understanding of psychological safety, stating that this is when people feel safe expressing differing opinions and thoughts in the workplace. Although, he believes, psychological safety must be part of every organizational culture, it is critical for high-performing teams.

8. Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?

There is a global interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type-2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAAs). 

9. FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe

Andres Schanzer, MD, has hailed it “one of the most exciting changes” seen in imaging during the course of his career. Philips’ LumiGuide “human GPS” technology—which uses light reflected along an optical fiber inside a guidewire to generate three-dimensional (3D), high-resolution, color images of devices inside a patient’s body in real-time powered by Fiber Optic RealShape (FORS)—is now available to specialized hospitals in Europe and the U.S., the company has announced.

10. SOOVC releases handbook for outpatient care

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has released the anticipated Office-Based Lab (OBL) Handbook to guide practitioners and aid with safety and cost-effectiveness, as well as expand patients’ access to care. 

AVF 2024: Outgoing president addresses history, future direction of American Venous Forum

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AVF 2024: Outgoing president addresses history, future direction of American Venous Forum
Glenn Jacobowitz addresses AVF 2024 in Tampa, Florida

At the 2024 American Venous Forum (AVF) in Tampa, Florida (March 3–6), Glenn Jacobowitz, MD, professor of vascular and endovascular surgery at NYU Langone Health in New York City and 2023-24 AVF president, tackled the future direction of the society—and from where it has come.

Jacobowitz used his outgoing presidential address to outline plans to expand international outreach programs, increase diversity and equity amongst members, and focus on young venous specialists. He also stated that since it has been five years since the previous group retreat where the current AVF five-year plan was outlined, it is time to start looking ahead and what the next five years hold.

Jacobowitz participated in a retreat last year with former AVF President William A. Marston, MD, professor in the Division of Vascular Surgery at the University of North Carolina Hospitals in Chapel Hill, North Carolina, where there was a focus on making sure all persons have access to prevention and treatment options, improving on the current inequalities of venous care, and increasing access to understanding venous disease prevention and treatment.

Jacobowitz peered back into AVF history for help determining what its future should look like. “The AVF went through a brief time of financial stress and lower membership,” he told those gathered for the AVF 2024 address. “But our leaders identified a need to redefine our mission goals and align these goals in a way to expand our membership and diversify, and also restructure our management team and our strategic plan.

“We can’t have a myopic view of the world,” Jacobowitz said. The AVF has partnered with 35 international societies “to increase collaboration, improve management of venous disease globally, leading to information exchange and joint project proposals, including guideline summaries, collaborative research, and education,” he added.

The AVF now has educational offerings around the world, including early training programs, webinars, and planned symposia in South America, Europe, Egypt and China. There are also international webinars, the first of which was viewed in over 60 countries and had more than 1,000 registrants. The plan is to hold them every three months, Jacobowitz said.

Jacobowitz also mentioned that the AVF recently established around $200,000 in annual grants. Those include the AVF-Jobst Clinical Research Grant ($85,000), AVF-BSCI Translational Research Grant ($85,000), AVF-NIH/NHLBI Grant ($25,000), AVF Basic Science Research Grant ($15,000), and the AVF Janssen Fellowship ($50,000).

In the new year, there will be “increased focus on young venous specialists,” Jacobowitz stated. “We have a record number this year.” He continued by mentioning the importance of advanced practice providers (APP) and the need to engage more with them to “help mitigate the equities of care.”

Jacobowitz issued a call to action on equity of care. “It’s a complex problem, a large problem, but it involves the disease process … we need to develop programs over hurdles, understanding this and the geographically and economically underserved,” he said.

He concluded by saying the AVF will “lead the way in venous care in the U.S. and abroad through our own initiatives and through collaborative work with our global partners and industry. All the while we’ll maintain focus on research, mentorship, education and advocacy.”

Non-pneumatic compression device performed better than advanced pneumatic compression for lower extremity lymphedema

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Non-pneumatic compression device performed better than advanced pneumatic compression for lower extremity lymphedema
Dayspring data emerge in a breaking trials session at AVF 2024

A new study presented during the 2024 American Venous Forum (AVF) in Tampa, Florida (March 3–6), that compared a novel non-pneumatic compression device with an advanced pneumatic compression modality in the treatment of lower extremity lymphedema demonstrated “statistically significant disruption” in limb volume that favored the former.

The multicenter, randomized controlled crossover study’s primary endpoint was change in limb volume from baseline, change in quality of life using the LYMQOL validated quality-of-life scoring system, and treatment adherence during the study period, presenter Todd Berland, MD, director of outpatient vascular interventions at NYU Langone Health in New York, New York, told those gathered in a late breaking session at AVF 2024.

The patients in the study had an average of 58 years old, and a majority of them were White women. Of the cohort, there were 11 with primary and 60 with secondary lymphedema, 34 were unilateral and 37 bilateral, and they had an average of eight years since diagnosis.

Berland outlined the non-pneumatic technology at hand: the Dayspring (Koya Medical) device, a battery-powered without a foot portion, which allows users to walk, features components that “stretch and release, and fake or simulate a manual lymphatic massage experience,” he said. “Between the static compression that you get with the actual garment,” Berland continued, “the stretching and elongating phenomenon—and the fact that you can walk with the device, and really activate that calf muscle pump—may account for what we see here in this study, [where] we compare this device to commercially available advanced pneumatic plug-in-the-wall devices.”

“We had nine study sites with 121 patients consented,” he told AVF 2024. “There were 22 screening failures, leaving us with 99 patients.”

The team randomized patients to the non-pneumatic or advanced compression device, which patients then used for three months. “At the end of that three-month period, we checked quality-of-life and limb-volume measurements,” Berland said. “We then had them use nothing for one month, the washout period, to give us a new baseline. We rechecked limb volume and quality-of-life, and then the patients crossed over.”

After cross over, they used the opposite device that they were originally given for another three-month period. Measurements were taken of the patients’ lower extremities. Quality of life was also taken at the end of three months. Finally, patients were given a diary to record their thoughts of the devices throughout the study.

Results showed a “statistically significant disruption in limb volume favoring the Dayspring device,” Berland told the audience. “A 370mm volume reduction in this group compared to an 83mm reduction in advanced pneumatic compression.”

“When we look at the foot, there was actually no statistical significant difference here. Both devices and subgroups trended toward improved diameters and circumference of the foot,” he said.

The quality-of-life questionnaire also favored the Dayspring device, with the function, appearance and symptoms being rated as better than the advanced pneumatic compression device. Even when it came to how committed the patients in the study were, the Dayspring device had an adherence rate of 81% compared to the advanced pneumatic compression rate of 56%, Berland added.

Finally, when it came down to which of the two devices the patients preferred, “78% of patients preferred the Dayspring device compared to 22% for advanced pneumatic compression,” Berland said.

Adoption of AI into workflow associated with faster time to assessment of PE patients

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Adoption of AI into workflow associated with faster time to assessment of PE patients
Jacob Shapiro

An abstract presented at the 2024 American Venous Forum (AVF) annual meeting (March 3–6) revealed that, in the treatment of patients with pulmonary embolism (PE), the implementation of artificial intelligence (AI) software has been linked to a shorter time to assessment.

At the Tampa, Florida, meeting, Jacob Shapiro, MD, shared this and other key findings from a review of patients diagnosed with PE at a single center over a six-year period.

Shapiro, a resident at TriHealth in Cincinnati, Ohio, and colleagues outline in their abstract that the serious and potentially life-threatening nature of PE necessitates a “streamlined PE workflow with timely assessment and initiation of treatment” to potentially improve a patient’s chance of survival. They add that AI has been increasingly used in healthcare to improve clinical efficiency.

The authors detail that, in October 2022, TriHealth implemented an AI-powered parallel workflow tool designed to automatically detect and triage patients with suspected PE. The aim of the study, they share, was to evaluate the clinical impact of AI software on time to assessment, time to anticoagulation, and patient outcomes at the institution.

Shapiro et al reviewed 150 patients diagnosed with PE between January 2017 and July 2023, retrospectively collecting data on these patients prior to AI implementation and comparing it against those of PE patients following AI implementation. The researchers looked at scan-to-assessment time, scan-to-alert time—which they note was used as a surrogate for scan-to-assessment time following AI implementation assuming best practice—time to anticoagulation administration, Pulmonary Embolism Response Team (PERT) activations, and in-hospital mortalities.

Shapiro reported at AVF that scan-to-alert time in the post-AI group of 45 patients was “significantly faster” than scan-to-assessment time in the pre-AI group of 113 patients. He added that anticoagulants were administered faster for post-AI cases with PERT activation compared to cases without PERT activation, and that in-hospital mortalities decreased from 8.4% (pre-AI) to 2.2% (post-AI), with all mortalities occurring in cases without PERT activation.

“Adoption of AI into our workflow was associated with faster time to assessment of PE patients,” Shapiro and colleagues conclude in their abstract. They elaborate that, with an average AI alert time of under six minutes, AI “optimizes standard of care by promoting quicker triage.”

Furthermore, they note that the combined benefit of AI and PERT activation was highlighted by faster anticoagulation administration and decreased mortality in their sample. “These findings suggest a link between earlier anticoagulation and reduced risk of mortality,” they write.

Speaking ahead of AVF, Shapiro stated that “further research is needed to determine if long-term patient outcomes are impacted by this technology.”

On the learning curve with this AI software, Shapiro remarked that it is “very minimal.” He explains: “The interface for reviewing CT [computed tomography] scans is very intuitive and the chat feature is easy to navigate. The patient’s lab values are also automatically imported and obviously displayed.”

Shapiro commented that overreliance on AI could be a drawback of the technology. However, he emphasized his overall opinion that, as an adjunct to an expert reviewer, there are “no real downsides.” Specifically, he gives the example of the ability to look at scans in views other than axial (i.e. coronal or sagittal) as a benefit for reviewers.

On the wider endorsement of this software, Shapiro notes that it has already been widely adopted by neurosurgeons for strokes and that his institution has been using it for PE for over 18 months. “We are already seeing it integrated into clinical practice,” he says.

VESS 2024: Determining success in vascular surgery across the generations

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VESS 2024: Determining success in vascular surgery across the generations
Mark Conrad

Outgoing Vascular & Endovascular Surgery Society (VESS) President Mark Conrad, MD, used the 2024 VESS presidential address to illustrate how he got into vascular surgery, what determines success for different generations, what does and does not factor into building a career, and how he would advise those coming into the profession.

“It actually started at Henry Ford Hospital with Alex Shepard,” the chief of vascular surgery at St. Elizabeth’s Medical Center in Brighton, Massachusetts, told those gathered in Sun Valley, Idaho, for VESS’ annual winter meeting (Jan. 18–21). “My first two months as an intern were on vascular; it was the most horrible experience I can ever describe. Every time my pager went off, I got a shot of adrenaline that made me want to throw up, because it meant someone was dying, someone needed to be intubated, someone needed something else.”

Shepard wasn’t the only one to have a lasting impact on Conrad and his career. Former VESS President Emerick Szilagyi, MD, the Hungarian vascular pioneer, taught at Henry Ford in Detroit after working as a medical director at a rubber plantation in Brazil for the Ford Motor Company.

Szilagyi’s skepticism of technology around how its advancement could lead to a lack of fulfillment for surgeons in their jobs led Conrad to ponder technology’s role: does it lead to a lack of fulfillment and a lack of success? “It made me question, what determines success? Certainly, most of us think of success by outside factors … I think you’re judged based on your timeline, and I think that’s important,” Conrad stated. “Success based on a person’s timeline is an interesting concept, but it makes sense: we don’t look back at the failures of doctors such as Szilagyi, we look at their successes for the changes they helped create in the medical world.”

Conrad then looked ahead to the future of medicine, as Generation X doctors slowly give way to millennials. He mentioned how he and other Gen X doctors have tended to try to teach millennials to network the way they had been taught, but found that, “you see there are certain students that take over, they lead it, they pass it on, and it’s just this organic thing that happens. Maybe we need to step back and let the millennials do it their own way,” he told VESS 2024.

Closing, Conrad reflected again on one of those people who got him into vascular surgery—Szilagyi—and called upon his words. “The art of surgery is not yet perfect and advances now unimaginable are still to come. May you have the wisdom to live with them with grace and humanity,” Conrad recited to the crowd. He finished with a quote of his own: “We can’t imagine what’s going to occur in vascular surgery by 2074. As you progress through your career, don’t be derailed by outside influence. Be true to yourself.”

Frank J. Veith joins ViTAA Medical Solutions’ board of directors

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Frank J. Veith joins ViTAA Medical Solutions’ board of directors
Frank J Veith
Frank J Veith

ViTAA Medical Solutions has announced the appointment of Frank J Veith, MD, professor of surgery at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, Ohio, and New York University Medical Center in New York City, to its board of directors.

With a career spanning several decades, Veith has earned international acclaim for his contributions to vascular surgery, particularly in the areas of limb salvage, lung transplantation, and endovascular treatments. A press release details that his work includes performing the first endovascular aortic repair in North America, a milestone that has significantly influenced the direction and capabilities of modern vascular surgery. His leadership and expertise have also been instrumental in managing VEITHsymposium, one of the largest annual conferences regrouping vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists to learn the most current information about what is new and important in the treatment of vascular disease.

“We are honoured to welcome Dr Veith to our board of directors,” said Mitchel Benovoy, CEO of ViTAA Medical Solutions. “His unparalleled expertise, visionary leadership, and commitment to improving patient care align perfectly with ViTAA’s mission. We are confident that Dr Veith’s guidance will be invaluable as we continue to innovate in the vascular health industry.”

“I am honoured and excited to join the ViTAA board of directors and contribute to their mission of transforming vascular care,” said Veith. “I look forward to working alongside a team that is as dedicated to advancing the field of vascular surgery as I have been throughout my career.”

Endologix initiates postmarket study of the Detour system

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Endologix initiates postmarket study of the Detour system
PTAB using the Detour system
PTAB using the Detour system

Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study aimed at evaluating the real-world performance of the Detour system in patients undergoing treatment for long complex superficial femoral artery (SFA) disease.

The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO), a company press release notes.

The PTAB1 postmarket study evaluates the Detour system’s performance in patients with very long (TASC D) SFA lesions. The study plans to enrol up to 450 patients, with a focus on including at least 200 women and also features an imaging substudy. Recruitment will involve up to 200 sites, with five-year follow-up.

“The initiation of the PTAB1 postmarket study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease [PAD]. Through this study, we aim to further validate the Detour system’s innovative approach to overcoming complex PAD challenges,” expressed Matt Thompson, president and CEO of Endologix.

Thomas Maldonado

Thomas S Maldonado, the Schwartz-Buckley endowed professor of surgery in the Vascular Division at New York University Langone Medical Center (New York City, USA), underscored the significance of being the inaugural site to enrol a PTAB patient: “Our privilege of enrolling the first patient in the PTAB1 postmarket study underscores our commitment to advancing patient care in complex PAD. The Detour system offers a glimpse into a future where minimally invasive treatments could redefine our approach to extensive SFA lesions. We are optimistic about the contributions this study will make towards evolving patient treatment paradigms.”

EACTS and STS guidelines recognize aorta ‘as an organ in its own right’

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EACTS and STS guidelines recognize aorta ‘as an organ in its own right’

New guidelines from the European Association for Cardio-Thoracic Surgery (EACTS) and the Society of Thoracic Surgeons (STS) have, for the first time, recognized the aorta as “an organ in its own right.”

“Recognizing the aorta as an organ puts it on a par with the heart, lungs or brain. This is a big step,” says Martin Czerny, MD, from the Clinic for Cardiovascular Surgery at the University of Freiburg in Freiburg, Germany, chair of the writing committee responsible for putting the new guidelines together.

“The new guidelines clearly recommend bundling the treatment of the aorta in a separate speciality, naturally in close coordination with other specialities. We have been practicing this integrative approach at the Medical Center-University of Freiburg for a long time and I am delighted that our work is now also being recognized internationally,” said Czerny. “I am certain that this will improve the treatment of patients with aortic rupture and other serious diseases.”

Published simultaneously in the European Journal of Cardio-Thoracic Surgery and The Annals of Thoracic Surgery, the guidelines take into consideration the impact and risk of different diagnostic or therapeutic methods for the treatment of aortic disease, and are designed to serve as a support tool for physician decision-making in the treatment of diseases such as aortic aneurysm.

The aorta is responsible for transporting oxygen-rich blood from the heart to the rest of the body. In recent years, it has become increasingly clear that it also plays an important role in regulating blood pressure and blood flow velocity. In addition, it is involved in the production of certain hormones and has its own layer of smooth muscle cells that help to maintain its structure and function.

“Our understanding of the aortic organ is continually evolving, especially in regard to its pathophysiology, the timing for treatment and the application of current and the development of new therapeutic strategies. Aortic disease has emerged as a specialty with significant health economic relevance. Several components of this guideline already establish the foundational structure necessary to meet the needs of treating the aortic organ within a specialized centre by a dedicated interdisciplinary aortic team,” the document states.

FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe

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FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe
Phillips LumiGuide technology

Andres Schanzer, MD, has hailed it “one of the most exciting changes” seen in imaging during the course of his career. Philips’ LumiGuide “human GPS” technology—which uses light reflected along an optical fiber inside a guidewire to generate three-dimensional (3D), high-resolution, color images of devices inside a patient’s body in real-time powered by Fiber Optic RealShape (FORS)—is now available to specialized hospitals in Europe and the U.S., the company has announced.

The LumiGuide system enables doctors to navigate through blood vessels during endovascular procedures using light, instead of X-ray, and was first used to treat patients in late 2023 at Maastricht University Medical Center in Maastricht, The Netherlands, closely followed by the University of Alabama at Birmingham.

LumiGuide initially has been made available to aortic centers of excellence that perform complex aortic repairs in the U.S. and Europe, a Philips press release states. The radiation-free technology enables physicians to reduce their reliance on X-ray during complex aortic procedures that can take significantly more time, resulting in a higher radiation dose for patients and clinicians. LumiGuide can be used to see devices including off-the-shelf catheters from any angle and in multiple views, the company adds.

Following a limited release of FORS to nine aortic centers, more than 900 patients have undergone procedures using the technology, with one site conducting a historic cohort comparison showing a 37% reduction in complex aortic procedure time, and a 56% reduction in radiation exposure compared to X-ray.

As detailed in a presentation of the 2023 VEITHsymposium in New York City last November by Joost van Herwaarden, MD, of University Medical Center Utrecht in The Netherlands, the Limited Edition FORS technology—Food and Drug Administration (FDA) 501k-cleared in 2020—saw more than 800 completed cases by October of last year. The newly released LumiGuide includes workflow enhancements such as artificial intelligence (AI)-based automatic registration, along with visualization of a wider array of catheters, van Herwaarden pointed out

Geert Willem Schurink, MD, from Maastricht University Medical Center, Maastricht, The Netherlands, who performed the first procedure with LumiGuide, said: “This artificial intelligence-based semi-automatic registration is very quick and accurate, even in the presence of stent grafts. Especially, if there is a need to re-register the device being guided in the patient’s body during the procedure, it is extremely helpful.”

U.S. study highlights racial and ethnic disparities in the placement of ‘overused’ IVC filters

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U.S. study highlights racial and ethnic disparities in the placement of ‘overused’ IVC filters
IVC filters
IVC filter

A nationwide U.S. study, recently published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), showed that Black patients had the highest inferior vena cava (IVC) filter placement rate per 100,000 persons compared with white and Latino patients in the United States from 2016 to 2019.

“Given the known long-term complications and uncertain benefits of IVC filters, coupled with the 2010 US Food and Drug Administration [FDA] safety warning regarding adverse patient events for these devices, proactive measures should be taken to address this disparity among the Black patient population to promote health equity,” authors Jordan J. Juarez, MS,  (Philadelphia, USA) and colleagues remark.

Juarez, a medical student at Lewis Katz School of Medicine at Temple University, et al detail that they performed a retrospective review of National Inpatient Sample data to identify adult patients with a primary discharge diagnosis of acute proximal lower extremity deep vein thrombosis (DVT) from January 2016 to December 2019, including self-reported patient race and ethnicity.

The authors note that weighted multivariable logistic regression was used to compare IVC filter use by race and ethnicity. The regression model was adjusted for patient demographics, hospital information, weekend admission, and clinical characteristics.

Juarez and colleagues report in JVS-VL that, of 134,499 acute proximal lower extremity DVT patients included in the review, 18,909 (14.1%) received an IVC filter. Of the patients who received an IVC filter, 12,733 were white (67.3%), 3,563 were Black (18.8%), and 1,679 were Latino (8.95%). They relay that IVC filter placement decreased for all patient groups between 2016 and 2019.

After adjusting for the US population distribution, the investigators explain that the IVC filter placement rates were 11 to 12 per 100,000 persons for Black patients, seven to eight/100,000 persons for white patients, and four to five/100,000 persons for Latino patients. They share that the difference in IVC filter placement rates was statistically significant between patient groups (Black patients versus white patients, p<0.05; Black patients versus Latino patients, p<0.05; Latino patients versus white patients, p<0.05).

In discusssing their findings, Juarez et al look into possible reasons behind the uncovered disparities. “Although the reasons behind this racial and ethnic disparity need further investigation,” they write, “factors such as clinician bias related to concern for medication adherence could play a role.”

The authors also consider their results more generally in the context of IVC filter usage in the USA. They point to previously reported literature showing an implantation rate much higher in the USA than in Europe (three per 100,000 persons based on data from five large European countries). Against this background, they comment that higher placement rates in the Black community are “especially concerning” and “suggest that IVC filters are still overused in the USA”.

Focusing next on some of the limitations of their research, Juarez and colleagues underscore the possibility of unmeasured confounders not assessed and adjusted for in their multivariable regression analysis, among others.

“Future work should assess whether clinical bias for adherence to other treatments could be perpetuating this disparity in minoritized communities,” the authors write as a forward-looking concluding remark.

Mechanical thrombectomy demonstrates superior outcomes to anticoagulation in DVT patients, analysis of RCT and registry data shows

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Mechanical thrombectomy demonstrates superior outcomes to anticoagulation in DVT patients, analysis of RCT and registry data shows
Steven Abramowitz
Steven Abramowitz

Mechanical thrombectomy using the ClotTriever device (Inari Medical) for iliofemoral deep vein thrombosis (DVT) was found to be “associated with significantly” lower Villalta scores and a lower incidence of post-thrombotic syndrome (PTS) out to 12 months compared with treatment using anticoagulation, a propensity score matching analysis of a large randomized controlled trial (RCT) and registry data showed.

The study findings, led by first author Steven Abramowitz, associate professor of surgery at Georgetown University School of Medicine and chair of the Department of Vascular Surgery at MedStar Washington Hospital Center in Washington, DC, USA, were published online in the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL).

To assemble a propensity matched cohort, Abramowitz et al plumbed ATTRACT, the largest trial in the venous space to assess pharmacomechanical catheter-directed thrombolysis (pCDT) compared to anticoagulation, and the single-arm CLOUT registry, which included patients receiving mechanical thrombectomy with the ClotTriever.

A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching, the authors noted.

They found that there were fewer patients with any PTS at six months (19% vs. 46%; p<0.001) and 12 months (17% vs. 38%; p< 0.001) among patients receiving mechanical thrombectomy.

Abramowitz and colleagues discovered upon statistical modeling that, after adjusting for baseline Villalta scores, patients treated with anticoagulation had “significantly higher odds” of developing any PTS (odds ratio [OR] 3.1; 95% confidence interval [CI], 1.5–6.2; p=0.002), or moderate-to-severe PTS (OR 3.1; 95% CI, 1.1–8.4; p=0.027) at 12 months compared with those treated with mechanical thrombectomy. They further found that mean Villalta scores were lower through 12 months among those receiving mechanical thrombectomy versus anticoagulation (3.3 vs. 6.3 at 30 days; 2.5 vs. 5.5 at six months; and 2.6 vs. 4.9 at 12 months; p <0.001).

“Propensity score matching of patients in the ATTRACT and CLOUT studies showed that, despite more limited use of compression stockings, treatment with mechanical thrombectomy resulted in a significantly lower PTS incidence and improved Villalta scores compared with anticoagulation treatment,” the authors wrote. “Those treated with mechanical thrombectomy had 27% and 21% lower rates of PTS at six and 12 months, respectively, as well as significantly lower mean Villalta scores at 30 days, six months, and 12 months. Similarly, matched patients treated with anticoagulation were found to have 3.1 times the odds of developing PTS at 12 months in logistic regression modeling adjusting for baseline Villalta scores.”

The authors noted the inherent limitations of propensity score matched analyses like the one they conducted. “A comparison of different clinical studies using propensity score matching by its nature introduces the possibility of bias from factors that differ between studies that are either unknown or unable to be controlled for,” Abramowitz et al wrote.

They highlighted how a RCT comparing iliofemoral DVT treatment using contemporary mechanical thrombectomy or anticoagulation would address most of their study’s limitations.

“Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS following an acute DVT event,” the authors concluded.

Large administrative databases enter crosshairs as comparative analysis shows percutaneous mechanical thrombectomy as superior to CDT for acute PE

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Large administrative databases enter crosshairs as comparative analysis shows percutaneous mechanical thrombectomy as superior to CDT for acute PE
Photo by DIGITALE on Unsplash
Photo by DIGITALE on Unsplash

The pitfalls of large administrative databases came to the fore during the presentation of a propensity-match scoring analysis demonstrating that percutaneous mechanical thrombectomy (MT) was superior to catheter-directed thrombolysis (CDT) in patients diagnosed with acute pulmonary embolism (PE). Junji Taukagoshi, a vascular surgery resident at the University of Texas Medical Branch (UTMB) in Galveston, USA, presented the results from the retrospective analysis of patients drawn from the multi-institutional TriNetX network during the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) in Scottsdale, USA.

Taukagoshi and colleagues—including senior author Mitchell Cox, the vascular surgery program director at UTMB—showed that MT was associated with fewer 30-day perioperative complications, improved long-term pulmonary hypertension and right heart failure, and significantly fewer emergency room (ER) visits.

They performed the 1:1 propensity-match analysis with around 1,100 in each group who underwent the respective interventions within three days of a PE diagnosis from January 2017 to August 2023.

But the question of whether large administrative databases like TriNetX to produce the granularity of data can enable robust enough analysis quickly emerged when the study came under post-presentation scrutiny, with one questioner suggesting the research team perform sensitivity analysis to “potentially tease out these patients a little bit more precisely to make sure you don’t have a melting pot of individuals.”

Taukagoshi and Cox both acknowledged this limitation, with the latter describing both its benefits—large size, breadth and ease of use—along with the chief drawback that means “you can only get certain data from it.”

Taukagoshi detailed 30-day results show comparable mortality and number of blood transfusions. “However, MT was clearly superior when it comes to gastrointestinal bleed and intracranial hemorrhage. it is interesting that it was also superior with both lower rates of myocardial infarction and immediate post-procedural pulmonary hypertension. So, it looks like MT is the clear winner in the acute phase.”

Long term, MT continued to have better outcomes out to five years, Taukagoshi continued. “While mortality is not that much different, the incidence of chronic pulmonary hypertension and right heart failure are much improved in patients who had MT. They also had significantly fewer ER visits.”

Commenting further, he said 30-day data clearly showed MT as associated with “significantly fewer bleeding complications compared to CDT, which can be explained by thrombolytics,” alongside the lower incidence of MI and immediate postoperative pulmonary hypertension.

“Why is that?” he asked.

“We would speculate that more rapid clot clearance with MT might result in less myocardial strain and more rapid improvement in pulmonary hemodynamics.”

At five years, MT was also shown to be better, Taukagoshi added. “However, the overall incidence of chronic pulmonary hypertension is certainly higher than in previous studies. Clearly, our patient cohort had a high percentage of very significant high-risk PE events.”

So, is MT truly better? Taukagoshi asked, as he pointed to the limitations inherent in large databases. He further revealed that such data had persuaded his institution to shift away from thrombolysis toward MT in the majority of cases where interventions are required for massive or submassive PE.

“In the future, we would like to see if these results can be replicated with other large multi-institutional series or large datasets.”

Discussion points to lack of PE risk stratification information

Jean Panneton

Designated discussant Jean Panneton, a professor of surgery at Eastern Virginia Medical School in Norfolk, USA, led queries of the paper. He pointed to a lack of PE risk stratification information. “How do you believe that this may have impacted your results—[with] a propensity match that only matched for regular comorbidities, but nothing specific to the actual PE?”

In light of the administrative database source of the data and attendant Current Procedural Terminology (CPT) codes, Panneton questioned whether it was possible to know whether all of the interventions for suction thrombectomy or CDT were indeed “actually done for PE.”

“Could they have been possibly done for ischemic legs or for the 43% of patients with acute deep vein thrombosis [DVT] in that database?”

Jason Chin, a vascular surgeon at MedStar Health in Baltimore, USA, pointed out the different CDT regimens available and how that might have impacted results.

“It doesn’t seem like this database can parse that out,” he said. “I’m not sure if there is a code for ultrasound-assisted thrombolysis versus no-ultrasound assisted thrombolysis.”

Nitinol stents placed in iliac veins “not associated with prolonged back pain,” study finds

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Nitinol stents placed in iliac veins “not associated with prolonged back pain,” study finds

In a retrospective review of over 600 patients who underwent iliac vein stent placement, the development of back pain was found to be unrelated to stent type, diameter, length or covered vein territory.

Chloe Snow (Greenbelt, USA) and colleagues share this and other findings in a recent Phlebology paper. The review was a joint investigation by researchers at Greenbelt’s Center for Vein Restoration, to which Snow is affiliated, and the Center for Vascular Medicine, also in Greenbelt.

Snow et al write in their introduction that endovascular stenting is the standard of care for the management of symptomatic chronic venous obstruction. However, they note that the increased radial resistive force and longer lengths of nitinol stents often used have “led to questions over persistent postoperative back pain”. The purpose of this investigation, therefore, was to assess the incidence and severity of postoperative back pain associated with nitinol stents compared to Wallstents (Boston Scientific).

The researchers performed a retrospective review of data from the Center for Vascular Medicine, assessing patient demographics and preoperative, one-week, three-, six- and 12-month visual analog pain scores (VAS) for back pain, stent type, diameter, length, and vein locations.

In the period April 2014–November 2021, a total of 627 patients—comprising 412 women and 215 men—were assessed for the presence of postoperative back pain after an initial iliac vein stent placement. The authors detail that the stents utilized were Wallstents (n=114), Venovo (BD; n=342) and Abre (Medtronic; n=171). The most common nitinol stent diameter and lengths were 14mm, 16mm and 120mm, respectively, they add, noting a p-value of ≤0.03.

The Venovo venous stent was granted Food and Drug Administration (FDA) premarket approval in 2019. BD reported at the time that theirs was the first stent indicated to treat iliofemoral venous occlusive disease. The previous year, one-year results from the prospective, multicenter, single-arm VERNACULAR trial had been shared, demonstrating the safety and effectiveness of Venovo for the treatment of symptomatic iliofemoral venous outflow obstruction.

In 2020, Medtronic announced that the Abre venous self-expanding stent system had received FDA approval to treat venous outflow obstruction. The approval was based on 12-month results from the ABRE clinical study, which assessed the safety and effectiveness of the Abre stent in patients with iliofemoral venous outflow obstruction.

Results

Snow and colleagues report in Phlebology that the incidence of back pain at one week was 66%, occurring in 411 out of the 627 patients assessed in the review.

They add that VAS scores at one week and one, three and six months postoperatively were the following: Wallstents 2.6±3 (n=66), 1.7±2.6 (n=43), 0.7±2 (n=51), and 0±0 (n=27); Abre 3.5±3 (n=130), 3.8±3 (n=19), 1.2±2.5 (n=12), and 1±2 (n=5); and Venovo 2.5±3 (n=216), 2.4±3 (n=70), 0.9±2 (n=68), and 0.6±1.7 (n=49).

The authors state that there was no difference in the severity of back pain at any time point (p≥0.99) and that the development of back pain was unrelated to stent type, diameter, length or covered vein territory.

In their conclusion, Snow et al reiterate that postoperative back pain was observed in 66% of patients at one week, and that the average pain score at one week for the entire cohort was three, which declined to less than one at one month. Furthermore, they found that no difference in the severity of back pain between groups was observed at any time point, and that the development of back pain is unrelated to stent type, diameter, length or covered vein territory.

Consortium led by vascular surgeon-scientist secures $6.4 million funding to develop sustainable alternative to contrast CT imaging

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Consortium led by vascular surgeon-scientist secures $6.4 million funding to develop sustainable alternative to contrast CT imaging

The European Union Horizon Europe, with joint funding from UK Research Innovation, has awarded the NetZeroAICT Consortium €6 million ($6.4 million) in funding to develop a novel artificial intelligence (AI)-based computed tomography (CT) technology that has the potential to promote climate neutral and sustainable healthcare.

The international, transdisciplinary NetZeroAICT Consortium is headed up by Regent Lee, MBBS, a vascular surgeon scientist at Oxford University Hospitals NHS Foundation Trust and associate professor of vascular surgery at the University of Oxford in Oxford, England.

According to the multidisciplinary group—which further includes Vicente Grau, professor of engineering science at the University of Oxford—the new technology (CT Digital Contrast) can make CT scans “safer, faster, more equitable and more sustainable.”

Lee provided a high-level description of how the Technology works: the idea is to use AI to enhance non-contrast CT scans with the aim of getting the equivalent outcomes to a contrast scan. He elaborated: “When you do a contrast CT scan, you typically go through the scan twice. The first time, you have a non-contrast CT, and then, based on that non-contrast CT, the radiologist will calculate how tall you are, etc., and calculate the timing of the injection of the contrast. Next, the patient gets scanned a second time to get the contrast-enhanced CT. What we propose is that with AI, we would only require the first non-contrast CT scan. We can extract high-level information from the non-contrast CT scan using AI, overlay where contrast should be on the native non-contrast scan and display it as a digital contrast enhanced scan, without the need for the second scan.”

The funding received will allow the researchers to move Forward with development of the technology. Lee anticipates that the team will face some challenges along the way. He highlights, for example, that clinical acceptance may take time. “What we are proposing to do is quite radical,” he said. “Essentially we are proposing a complete change of how radiology services can be delivered, and there will be questions and reluctance amongst the clinicians to get used to this new way of looking at images.” He likened the task of launching the technology as “almost like trying to introduce a new language into the profession.” Lee also mentioned that patients may be fearful of using an entirely new method of imaging to treat them.

In a press release announcing the new funding, Lee commented on the wider significance of the consortium’s work: “The combined NetZeroAICT Consortium expertise will enable us to develop and deploy trustworthy ‘green’ AI software as a medical device with the ultimate goal to reduce the environmental footprint from CT imaging.

“European patients will have access to safer, faster, equitable and sustainable healthcare delivery while the healthcare systems strengthen their alignment with the European Green Deal. This is a new era of translational research. In addition to improving patients’ health, our aspiration is to improve planetary health for future generations.”

VAM 2024 pricing now available

VAM 2024 pricing now available

Pricing information for the 2024 Vascular Annual Meeting (VAM 2024) is now available. The event, scheduled in Chicago from June 19–22, is promoted as the year’s premier educational event for all vascular professionals. Organizers urge prospective attendees to secure funding from their institutions before the March registration launch.

VAM 2024 will reintroduce last year’s tiered registration model with an early registration period, a concept that was reintroduced to VAM for the 2023 conference. Early-bird registration will take place from March 20–April 10. After the April 10 deadline, prices will increase to the advance registration rate, which will last through June 17. An increased, on-site registration fee will be available to anyone who cannot register for VAM 2024 in advance.

The tiered registration model offers a significant discount for SVS members, which organizers say is consistent with other SVS education offerings. Individuals who register for the meeting before applying for SVS membership will be eligible to receive the refunded difference if the application is submitted. All membership applications are subject to approval. Visit vascular.org/Join to become a member.

Make a plan to secure your funding for VAM 2024 so you can register early and save. Visit vascular.org/VAM24Pricing to learn more.

New editorial team selected for Rutherford’s 12th edition

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New editorial team selected for Rutherford’s 12th edition

The SVS Executive Board has appointed the editorial team for the upcoming 12th edition of Rutherford’s Vascular Surgery and Endovascular Therapy. The team now includes Linda Harris, MD, Audra Duncan, MD, and Peter Henke, MD.

Duncan and Henke, alongside Harris, will work with 11th edition editors Tony Sidawy, MD, Bruce Perler, MD, to prepare the new editorial team for their upcoming tasks.

SVS President Joseph L. Mills, MD, expressed gratitude for the new appointments made to lead the title.

“The Publications Committee and Executive Board had a very difficult decision on its hands with three stellar proposals,” noted Mills. “All would do an outstanding job, and we thank them for their vision and interest in improving Rutherford’s. Drs. Harris, Duncan and Henke are uniquely positioned to take Rutherford to the next level.”

Speaking on behalf of the editorial team, Harris said: “We are excited and honored to have been selected to edit Rutherford’s 12th edition. We look forward to ensuring that it remains our ‘Vascular Bible’ for years to come.

“We expect to continue to innovate so that Rutherford’s is seen as the go-to book for all generations of learners.”

Rutherford’s 11th edition will come out during fiscal year 2025–26, when planning for the textbook’s 12th edition begins.

JVS group open-access papers

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JVS group open-access papers

The Journal of Vascular Surgery (JVS) editors announced the open-access articles available in the flagship title’s March 2024 issue.

The relevant papers are: “Creating hemodialysis autogenous access in children and adolescents” (vascular.org/JVShemodialysis); “Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia” (vascular.org/JVSsafety); “Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures” (vascular.org/JVSLearningCurve); and “Preoperative predictors of non-home discharge after F/BEVAR of complex abdominal and thoracoabdominal aortic aneurysms” (vascular.org/JVSpreoperative).

JVS-Venous and Lymphatic Disorders, now a fully open access peer review title within the JVS stable, is available at www.jvsvenous.org.

JVS-CIT releases special issue on genetic arteriopathy

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JVS-CIT releases special issue on genetic arteriopathy

The Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT) has published its latest virtual special issue, which covers genetic arteriopathy. This is the second special issue published in the journal. JVS-CIT currently plans to publish four per year.

JVS-CIT editors report that there are data showing manuscripts published in virtual special issues have a higher number of publications and are read more often.

The latest special issue theme is dedicated to the diagnosis of underlying aortopathy or arteriopathy etiology, and management of these conditions. The two guest editors are Sherene Shalhub, MD, of Oregon Health and Science University, and J.Westley Ohman, MD, of Washington University School of Medicine.

“Drs. Shalhub and Ohman are national thought-leaders in the management of genetic arteriopathies and were the key to making this issue possible,” said JVS-CIT Editor-in-Chief Matthew Smeds, MD. “They have been able to provide insight into the topic that would have otherwise been missing and helped put together a valuable resource for all vascular surgeons.”

The editorial board and guest editors of JVS-CIT spent six months recruiting content for the genetic arteriopathy issue. It contains 14 case reports and short communications. It can be found at vascular.org/JVSCITvsiGenetic.

JVS-CIT is currently recruiting manuscripts for the next two virtual special issues. The topics being studied include aortic dissections, guest edited by Firas Mussa, MD, and Bernardo Mendes, MD, and vascular trauma, guest edited by Mario D’Oria, MD, and Erica Leith Mitchell, MD. Release dates will be announced soon.

Audible Bleeding podcast expands horizons with new senior editor

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Audible Bleeding podcast expands horizons with new senior editor

In the fast-evolving landscape of medical education, podcasts have emerged as a powerful medium for disseminating knowledge and fostering community among professionals. Among these, Audible Bleeding has carved a niche as an auditory experience and formal publication dedicated to shaping the minds of early-career surgeons.

Founded in 2018, the podcast has seen remarkable growth, culminating in 204,841 downloads in 2023. It boasts an average of 561 unique daily listeners, indicating a steady and engaged audience within the surgical community. Popular Audible Bleeding sub-series include “Lost in Translation,” which explores how vascular surgeons and patients communicate, and Journal of Vascular Surgery (JVS) “Author Spotlights,” which discuss that month’s articles in the JVS journals.

Last year marked a pivotal moment for the podcast as Imani McElroy, MD, a member since 2021, became the senior editor. Currently a senior general surgery resident at Massachusetts General Hospital in Boston, McElroy’s passion for addressing healthcare disparities stems from her first hand experiences in San Francisco. Her research interests, spanning implementation sciences and examining racial/ethnic and gender disparities within healthcare and vascular surgery, align with the podcast’s commitment to equity.

I am excited to contribute to the educational mission of Audible Bleeding. We are currently working on streamlining procedures to ensure consistent, high-quality content. My goal is to foster collaboration, making Audible Bleeding a hub for knowledge exchange within the vascular surgery community,” said McElroy.

In 2024, the podcast will introduce two new sub-series to diversify its content. The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) will delve into developing a series of office-based lab (OBL) podcasts. In contrast, the “Managing, Organizing, and Navigating Investment Choices for Economic Success (MONIES)” sub-series will explore managing finances for medical professionals. These additions aim to cater to the audience’s diverse needs.

As McElroy steps into her role, Adam Johnson, MD, the podcast founder, expressed his confidence in the transition, stating: “I am thrilled to welcome Dr. McElroy as the senior editor. Her dedication to addressing disparities and robust research background make her the ideal leader for the podcast’s next chapter. I look forward to seeing the podcast flourish under her guidance.”

Listen to the Audible Bleeding on the podcast website, available at: www.audiblebleeding.com.

Budget neutrality and code valuation basics

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Budget neutrality and code valuation basics

So, what is budget neutrality and how does it affect physician payment? The Medicare Physician Fee Schedule (PFS) is a resource-based relative value scale (RVS) payment system, where relative value units (RVUs) are based on resource costs associated with physician work, practice expense and malpractice. The PFS has a budget neutrality requirement that has been in place since 1992. Budget neutrality is the federal mandate that requires an upward adjustment in expenditures in one area of the Medicare program to be offset by a downward adjustment in other areas. In the simplest terms, budget neutrality requires that the Centers for Medicare & Medicaid Services (CMS) make an overarching negative adjustment to the PFS to counterbalance any increases in PFS resources that CMS implements. This process occurs by implementing changes to the conversion factor (CF). The CF, a national dollar multiplier, is used to “convert” geographically adjusted Relative Value Units (RVU) to determine the Medicare-allowed payment amount for a particular physician service.

A significant budget neutrality adjustment went into effect in 2021 as a result of the revaluation of office/outpatient evaluation and management (E/M) codes within the PFS. However, coordinated advocacy efforts across the provider community resulted in Congress advancing legislation to mitigate the impact of the budget neutrality adjustment. They have taken similar action in each of the following years. Efforts to reverse the 2024 reduction in the PFS are still underway.

How are codes valued?

The American Medical Association (AMA) Relative Value Scale Update Committee (RUC) is an expert panel of physicians and healthcare professionals that makes recommendations to the federal government on the resources required to provide medical services. Medical services are described by Current Procedural Terminology (CPT) codes. CPT codes offer doctors and healthcare professionals a uniform language for coding medical services and procedures to streamline reporting, and increase accuracy and efficiency. CMS reviews RUC recommendations and determines the RVUs for CPT codes.

The AMA CPT panel meets three times per year in sequence with the RUC meetings. The CPT panel debates and approves new procedural codes, revises existing codes, and deletes obsolete ones. Typically, a code that has been revised or newly approved by the CPT panel will then be reviewed at the next RUC meeting for new or revised valuation.

Medical specialty societies such as the SVS—with 20% AMA membership and recognized by the AMA House of Delegates—nominate a specialty society member to advocate on behalf of their membership for appropriate values for medical services they provide.

These “RUC Advisors” present survey data to the AMA RUC panel. This panel is made up of physicians and other healthcare professionals.

There are 29 seats on the RUC. The majority of seats are filled by delegates from medical specialty societies. The RUC meets three times per year. Historically, greater than 90% of RUC recommendations were adopted by CMS, although that percentage fluctuates.

The survey data that the advisors present to the AMA RUC panel come from RUC surveys that the specialty societies disperse to the membership. The panel determines the questions and timeline for completion. The surveys include questions related to physician time, intensity, typical patients and pre-/postoperative care. The specialty society’s RUC advisor and coding committee review the data and prepare recommendations for the RUC panel.

Crucial role

Budget neutrality plays a critical role in these discussions; increasing the value of a particular code will result in a corresponding across-the-board decrease in reimbursement for all other procedures.

The exploration of topics such as budget neutrality and the valuation of CPT codes explains the crucial role these factors play in shaping healthcare reimbursement policies.

By highlighting how these processes occur, we hope to equip early-career vascular surgeons with the knowledge and insight necessary to actively engage in advocacy efforts and thereby contribute to the evolution of healthcare policies that directly impact their practice.

Natalie D. Sridharan, MD, and Nicolas J. Mouawad, MD, are both graduates of the SVS Advocacy Leadership Program.

“Where are you from? Where are you really from?”

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“Where are you from? Where are you really from?”

Vascular resident Saranya Sundaram, MD, shares a story of finding cultural understanding and community.

“It’s Sundaram, S-U-N…” I’m interrupted by a nurse asking me if I’d like to call anesthesia for an airway. I quickly nod and ask them to grab the crash cart.

“I’m sorry, you said… S-U-N-D-A-M?” the radiology resident repeats over the phone.

“No, I said S-U-N-D-A-R-A-M.” Another nurse asks me if this was the central line I wanted, and I give a thumbs up. They let me know they are still struggling to get another IV, but they could push the calcium through the remaining 16 gauge in the left arm. I tuck the phone against my shoulder and start grabbing the ultrasound, some flushes and gauze.

“I’m sorry, I still can’t find you. Can you spell it again?” he says a little louder over the phone, to get my attention. “It’s, what, S-U…” I try cutting him off, asking if there’s another way to look me up. I understand he needed my name for the wet read and thanked him for letting me know about the subdural on bed 11, but I had a man in the ICU a full minute into chest compressions, and I needed to get control of the room. He starts to argue, though I was saved by my intern who, after witnessing my frustrated expressions from across the room, grabbed the phone from me and promised to handle it. I thanked him quietly and refocused on the room.

I find myself back at this experience every once in a while. Sometimes, it’s while reflecting on my own, at home snuggled up with my dog, about the general absurdity of the situation. Yes, the absurdity that while running my first code as ICU chief, I was spelling my last name to a person who couldn’t be bothered to figure it out.

If I really thought about it, there wasn’t a clinic where I hadn’t gotten the I-know-you-aren’t-from-around-here-and-I’m-going-to-figure-you-out stare. And I had grown accustomed to the questions that followed— “Where are you from?” “Where are you really from?” And the occasional and bold, “You’re Indian right?”

In truth, Charleston wasn’t much different from the towns that I grew up in. My parents were deeply religious South Indians who just happened to settle on sleepy Carbondale, Illinois, as their opportunity for a life in America. Regardless, my parents had always been good at finding “the community,” even in places like Emporia, Kansas, where their children were born, or Grand Rapids, Michigan, where they grew up. It wasn’t until my later years that I realized my parents and Brother were the only aspect of “the community” I needed.

With thousands of miles now separating us, that quiet comfort of feeling seen and understood felt farther than it had ever been. But I’d like to think my time on research this year has allowed me a certain clarity. That out-of-place feeling is dealt more subtly outside of the hospital. And without the defense mechanism clinical efficiency had allowed me, I am forced to think about things as they happen and also pay more attention to how the people around me respond to similar situations.

Two of my co-residents have found ways to make themselves feel a little more at home, trying all the Vietnamese pho spots they happen upon or finding the best beef broccoli in Charleston at the back of a Chinese grocery store. And I realize now that spending time with them has always brought me closest to that feeling of community. Thinking back, things like the annual “Happy Diwali” phone calls from my program director were opportunities to be a part of “the community,” even if I didn’t realize it at that moment. It wasn’t until I was in the middle of a debriefing with one of my attendings, who happens to be one of a few Black female surgeons practicing in South Carolina, that it hit me—that feeling of “otherness” could be shared and understood across vastly different backgrounds.

I’ve started to lean into that clarity and the people who may not look like me but can understand me. The comfort that I have found from shared experiences has been life and outlook altering. Every once in a while, yes, I get that twinge of discomfort when I use a nickname at restaurants or spell my name over the phone. But I notice myself smiling more when I think about how much my co-residents or attendings would enjoy hearing about this new absurdity. And, for a moment, I realize that I have found my own sense of community.

Saranya Sundaram is a vascular surgery resident at Medical University of South Carolina in Charleston.

As temporal trends in hemodialysis access creation emerge, notion of AV fistula superiority comes under scrutiny

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As temporal trends in hemodialysis access creation emerge, notion of AV fistula superiority comes under scrutiny
Bright Benfor (left), Charmaine Lok (middle), and James J. Fitzgibbon (right)

The 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) hears three separate talks—two scientific papers and one from an invited guest lecturer—that separately and from different angles checked the pulse of the arteriovenous fistula (AVF)-first era.

Sandwiched neatly between two complementary dialysis access papers on the SAVS 2024 program, a prominent nephrologist and chair of the taskforce responsible for the 2019 update of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines delivered a point-by-point take down of the myths that she says surround the idea that AVFs are superior to arteriovenous grafts.

Charmaine Lok, MD, a professor at the University of Toronto in Canada, and medical director of the chronic kidney diseases and vascular access programs at Toronto General Hospital, was delivering the Scottsdale, Arizona-hosted meeting’s Jesse E. Thompson, MD, Distinguished Guest Lecture, the first non-surgeon to do so.

Taking attendees on a tour through the literature, she sought to debunk key aspects around why AVFs are accepted as superior to AV grafts, Lok challenged the argument that fistulas last longer than grafts. However, she said, the key data from which that assertion is derived do not compare all fistulas created vs. all grafts created. “They’re comparing fistulas that actually worked to all grafts,” she explained, making it a “flawed, biased analysis.”

After repeating the analysis, she found that after accounting for primary failure, there was no difference between fistulas and grafts—which was “true for both forearm and upper-arm fistulas.”

Lok added, “And when we looked at upper-arm access only, there was no difference between fistulas and grafts, whether or not we include or exclude primary failures.” Randomized controlled trial data tell a similar story, she said. In one, grafts “actually had superior survival [or lasted longer] compared to fistulas for both primary patency as well as secondary patency.”

Turning to the idea that fistulas have fewer complications, Lok pointed to a rare study in this area that focused on infection rates: among 200,000 patients, the investigators found that, between fistulas and grafts, the rate was the same, she said.

Moving on to the similar contention that fistulas require fewer interventions than do grafts, Lok drew on a study she said summarizes the evidence thus far: “Patency outcomes of fistulas and grafts is a trade-off between non-maturation and long-term outcomes,” she explained, also pointing to evidence from a study with follow-up out to six years showing that 50% of fistulas needed more interventions before use versus only 17% of grafts.

As for the proposition that AVFs lower costs, she pointed to evidence that demonstrated fistulas cost less only when the AVF maturation rate was greater than 82%. “We have already shown you that that is not happening—our fistula maturation rate was only about 40%,” Lok noted.

Finally, she rested on the idea that fistulas are associated with lower mortality when compared with grafts. She cited a study that demonstrated mortality risk was best with fistulas compared to catheters and grafts. Ultimately, Lok said, the higher mortality in those subjects was attributed to the higher comorbidity burden of patients receiving these access types. It boiled down to selection bias, she added.

Which led her to two ultimate questions: What do you think of fistulas now? she asked. Are they really that superior?

“It all depends on your point of view,” Lok said. “Fistula-first was a population-based perspective versus the patient perspective. Now, in this new era, we are looking at patient-centered care—and can you really apply a one-sized fits all to vascular access?”

AVFs in the forearm: Unchanged rates

At the podium immediately before Lok, James J. Fitzgibbon, MD, set the tone, as he presented data from a study on temporal trends in hemodialysis access creation in the fistula-first era among a patient cohort who were all recipients of first-time AVF and AV grafts in the upper-extremity.

The Brigham and Women’s Hospital, Boston, resident and colleagues set about answering the central question of whether rates of AVFs in the forearm are increasing. In short, they found that forearm fistulas constituted only a quarter of first-time accesses in the Vascular Quality Initiative (VQI) dialysis access database, with no significant increase seen across the 2012–2022 study period.

Upper-arm AVFs made up 57% of the 52,000 patients included in the retrospective cross-sectional analysis, with 15% upper-arm AV grafts and 1.5% AV grafts in the forearm. “There was no significant change in forearm AVFs across our study period,” Fitzgibbon told SAVS. “The only significant change we did find was there was a decrease in forearm AV grafts.”

Fitzgibbon and colleagues had a particular backdrop in mind as they conducted the analysis: the fistula-first approach described by Lok that was encapsulated in movements to promote autogenous access across the U.S., first with the “Fistula-First” initiative of 2005, and then the “Fistula First-Catheter Last” campaign it morphed into by 2015.

They looked at the impact of the latter by conducting an interrupted time series analysis of the rates of AVFs and AV grafts both before and after it was launched, but they did not detect a significant effect on the rates of AVFs or AV grafts after implementation. However, they did uncover significant increases in upper-arm AV grafts in women, elderly and Black patients, Fitzgibbon added.

“The goal of this project was to broadly report practice patterns across the U.S.,” he concluded. “This is by no means a comment on appropriateness of access; this is not trying to say that every patient should receive a forearm fistula, or is appropriate for a forearm fistula.”

Exploring appropriate access selection

Near the close of SAVS 2024, Bright Benfor, MD, a research fellow at Houston Methodist in Houston, Texas, stepped into the dialysis access fray with a study that compared surgeon choices of AVF to that recommended by an emerging app called “My Vascular Access.”

The program, which grew out of expert consensus and the KDOQI guidelines, is aimed at helping guide the right type of access for patients.

“Two days ago, we heard Dr. Lok talk a lot about the new KDOQI guidelines and how they focus more on a shift from fistula-first to the right access, for the right patient, at the right time, and for the right reasons,” Benfor told attendees.

With that in mind, Benfor and colleagues conducted a review of patients undergoing autologous AVF creation at Houston Methodist to determine how its surgeons’ choices between January and August 2021 held up against the app’s appropriateness rankings, ultimately asking, “Do we need it?”

They looked at 113 accesses performed during the study period. “We can see that there is a high number of radiocephalic fistulas that we created during that time, and we saw the number actually created were statistically significantly higher than the numbers that were recommended,” Benfor said. “Also, in other cases, the app recommended a graft be placed, but our surgeons went ahead and put in a fistula.”

Overall, 61% of the accesses were ranked as appropriate by the app, with 22% deemed inappropriate and 10% intermediate. “There is a significant mismatch between what the app is recommending and access actually created by the surgeons,” he concluded. “One thing we believe influences the choice of access is the level of expertise of the surgeon, which is not taken into account by an app.”

Vascular Verification Program green-lights first three outpatient centers

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Vascular Verification Program green-lights first three outpatient centers
Joseph L. Mills (left) and Anil Hingorani (right)

The American College of Surgeons (ACS) and the Society for Vascular Surgery (SVS) have verified the first three outpatient centers under the newly launched Vascular Verification Program (Vascular-VP), with initiatives that focus on ensuring the highest quality of vascular surgical and interventional care in both inpatient and outpatient settings.

The verified centers, namely Albany Medical Center Vascular Outpatient Lab in Albany, New York, Total Vascular Care in Brooklyn, New York, and Michigan Vascular Center in Flint, Michigan, have demonstrated their commitment to improving patient outcomes and delivering treatment, said Clifford Y. Ko, MD, director of the ACS division of research and optimal patient care.

“These three centers have, first as pilot sites and now as verified centers, established themselves as leaders in outpatient vascular care. They have paved the way for many more centers to join us in their journey to continuous improvement by using data and ACS standards and resources to deliver the best possible patient care,” said Ko.

The Vascular-VP, a collaborative effort between the ACS and SVS, offers two levels of participation, one for inpatient and one for outpatient centers. Built on a foundation of quality metrics, program resources, facility standards, and service provisions, the program emphasizes data collection and quality improvement activities. The shared standards across all levels ensure a comprehensive and standardized pathway for centers to enhance their vascular care infrastructure.

“This is a tremendous initiative and joint effort between the SVS and the ACS to address a very important issue in today’s healthcare landscape, as much care is now being delivered in the outpatient setting. These three verified centers are at the forefront of efforts to improve, monitor and optimize the outcomes of outpatient care for patients with vascular disease,” said SVS President Joseph L. Mills, MD.

To achieve verification, the three centers met the standards outlined in the Optimal Resources for Vascular Surgery and Interventional Care—Outpatient Standards framework. This set of standards addresses essential elements of vascular surgical care and quality, ensuring that verified centers maintain the highest standards in patient care.

“Participating in Vascular-VP brought together a lot of our resources, including nursing, vascular lab, office-based lab, front desk and others, to improve the care we are providing to the vascular patient,” said Anil Hingorani, MD, FACS, a vascular surgeon with Total Vascular Care. “These resources have helped set us apart from our competitors. It’s not just the quality or safety in this competitive market; you must be aware it’s a continuous cycle of looking at your results to find solutions and improvements to improve patient quality.”

Their Vascular-VP verification gives these centers the status of ACS Surgical Quality Partners, which signifies their commitment to continuous improvement, adherence to rigorous standards and dedication to delivering quality care. Patients seeking services at Surgical Quality Partner centers can trust that they are receiving care of the highest standards in surgical quality.

Both inpatient and outpatient centers interested in joining this initiative and continuing their vascular service quality improvement journey are encouraged to make an application online.

Learn more about the Vascular Verification Program at vascular.org/Verification.

Landmark BEST-CLI trial gains recognition as top cardiovascular advance in 2023

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Landmark BEST-CLI trial gains recognition as top cardiovascular advance in 2023
Alik Farber (left) and Matthew T. Menard (right)

The American Heart Association (AHA) has named the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial one of the top cardiovascular advances of 2023. This study—led by vascular surgeons Alik Farber, MD, and Matthew T. Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD—compared open and endovascular treatments for chronic limb-threatening ischemia (CLTI) and was aimed at exploring the effectiveness of each treatment modality.

“First and foremost, it brought surgery back into the discussion of CLTI care against a backdrop of a progressive decline in the use of surgical bypass and a dramatic escalation of the use of endovascular therapy,” commented Menard.

“Given the primary finding that surgery was more effective at preventing the main endpoint of major adverse limb events [MALE] or death, it was a wakeup call of sorts to the vascular surgical world in terms of the ongoing importance of surgery as a treatment option.”

Menard, from Brigham and Women’s Hospital, and his counterpart Farber, at Boston Medical Center, both in Boston, brought together their expertise in vascular and endovascular surgery to embark on a journey that spanned well over a decade. The duo initiated the idea for the BEST-CLI trial in 2007, during a break at the New England Society for Vascular Surgery annual meeting that year, recognizing the need to address the uncertainty surrounding the optimal treatment for CLTI patients. Rosenfield, from Massachusetts General Hospital, joined before the trial was approved and provided an interventionalist perspective to the project.

Farber said that neither he nor Menard had experience conducting clinical trials when they first conceptualized the idea. However, reaching out to the Society for Vascular Surgery (SVS) leadership proved crucial in securing the necessary support to turn their vision into reality.

The trial began enrolling patients in 2014 and concluded in 2019, though it encountered numerous challenges and roadblocks. Despite the complexities involved, Rosenfield acknowledged the enthusiasm within the medical community to answer the question of the optimal treatment for CLTI. To pursue the trial and provide impetus over the ensuing decade, the investigators confirmed the high degree of equipoise associated with the two standard-of-care open surgery and endovascular treatment strategies through a survey conducted early in the process. Involving over a thousand investigators across 150 sites worldwide, the trial required a substantial commitment to complete.

“The SVS has been critical, from the first outreach we undertook in 2009 to the support provided by every one of the SVS presidents since that time. They not only formally endorsed the trial,” said Farber, “they played a key role in our successful fundraising effort towards the end of the trial. They also helped us throughout the process by allowing us to showcase the trial in publications such as Vascular Specialist, within Society-sponsored webinars and at the SVS annual national meetings.”

The trial’s secondary findings, unveiled at the 2023 Vascular Annual Meeting (June 14–17) in National Harbor, Maryland, revealed that both open and endovascular procedures were equally safe for CLTI patients, and that, notably, the major adverse cardiovascular event (MACE) and mortality rates were similar between the two study arms. Farber stressed the study’s broader implications, noting its impact on raising awareness and interest in CLTI care, and in reinforcing a focus on CLTI globally, especially in the context of the increasing prevalence of diabetes.

“It’s the patient that suffers the most when we, as a community of physicians and caregivers, are unclear about best practices,” added Farber.

“We owe an incredible amount of gratitude both to the patients who were brave enough and generous enough to allow us to investigate this clinical problem through their experience, and to all the investigators, including many SVS members, who worked so hard to see the trial through to completion. The benefits of BEST will continue to be paid forward, as the wealth of generated data will serve as a foundation on which we as a community can base future efforts to better understand the numerous unanswered questions that remain in CLTI care.”

AAA and complex repair: ‘We need more evidence,’ says UChicago chief

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AAA and complex repair: ‘We need more evidence,’ says UChicago chief

A randomized controlled trial (RCT) of open repair versus endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms (AAAs), as well as head-to-head trials for additional information on EVAR and complex repairs, are warranted. This was the main conclusion of Ross Milner, MD, during a presentation he delivered as part of an “EVAR Developments” session at the recent Critical Issues America (CIA) annual meeting (Feb. 2–4) in Miami, Florida.

The professor of surgery and chief of the Section of Vascular Surgery at the University of Chicago Medicine in Chicago opened his talk with reference to a 2020 Journal of Vascular Surgery paper by Konstantinos Spanos, MD, and colleagues titled “A new randomized controlled trial on abdominal aortic repair is needed.”

In response to this need, Milner highlighted that Medtronic has launched three trials—HERCULES, ADVANCE and SOCRATES—the latter being the main focus of Milner’s talk at the CIA meeting. He homed in first on HERCULES. The purpose of this multicenter, global, randomized controlled post market trial, he shared, is to compare endosuture aneurysm repair (ESAR) to standard EVAR in the treatment of AAAs with wide proximal necks, and will be the first comparative trial to do so. He noted an enrollment goal of 300 patients at 40 sites across Europe and the U.S.

Milner then turned his attention to ADVANCE, which he said is the first EVAR head-to-head RCT looking at aneurysm sac regression outcomes between two devices. “The ADVANCE clinical study will progress the work of sac regression as a key early indicator of long-term outcomes,” he remarked. The study will “bring EVAR evidence into the current decade,” Milner added, and “empower physicians to make precise, evidence-based clinical decisions that improve patient outcomes.”

SOCRATES, meanwhile, will focus on treatment modalities for an especially complex group of AAA patients. Its purpose, Milner elaborated, is to compare the safety and performance of ESAR versus fenestrated EVAR (FEVAR) for the treatment of AAA patients with infrarenal aortic proximal neck lengths of 4–15mm and minimal proximal sealing zone lengths of 8mm.

“Hostile aortic necks can lead to a loss of proximal seal over time,” he said by way of background to the study, detailing that short necks are associated with increased risk of type Ia endoleak and secondary procedures. Milner noted that there are two treatment options available here: extending the sealing zone proximally or reinforcing the sealing zone. SOCRATES will compare the two.

The trial will be conducted at up to 40 sites in the U.S. and Europe, with Milner listing Austria, Belgium, France, Germany, Italy, The Netherlands, Spain and Switzerland as the European countries participating in the trial.

In terms of patient selection, Milner relayed that at least 204 patients are due to be randomized (1:1) and evaluated for non-inferiority. Patients will be treated by one of two methods: ESAR with Medtronic’s Endurant II/IIs with Heli-FX EndoAnchor implants, or FEVAR with either Cook’s Zenith fenestrated stent graft system or—in Europe only—Terumo’s fenestrated Anaconda equivalent.

“[SOCRATES] will be the first comparative trial of ESAR and FEVAR in the treatment of patients ineligible for standard EVAR due to challenging anatomical criteria but within the IFUs [instructions for use] of the two treatment modalities,” Milner summarized. He added that the trial is actively enrolling.

The latest update from the trial, Milner shared, is from August of last year, when the first U.S. patient was treated in the study by co-principal investigator BrantW. Ullery, MD, in Portland, Oregon.

“We need more evidence,” Milner said in his closing statement, looking at the field of AAA repair as a whole. Looking forward, he specified that an RCT of open repair as compared to EVAR—as well as FEVAR and branched EVAR (BEVAR)—is needed, and that head-to-head trials “will ideally provide additional safety and efficacy information for EVAR and complex repairs.”

Fifth edition of SVS leadership program reaches capacity

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Fifth edition of SVS leadership program reaches capacity

The fifth cohort in the society for Vascular Surgery (SVS) Leadership Development Program (LDP) reached capacity in early February due to limited space and high interest from members.

According to LDP faculty, the curriculum draws from the highest quality evidence-based model of leadership contained in the Jim Kouzes- and Barry Posner-penned book, The Leadership Challenge, with an intense focus placed on applying this knowledge into the world of real-life challenges.

Manuel Garcia-Toca, MD, Faisal Aziz, MD, Dawn M. Coleman, MD, Randall R. De Martino, MD, Kristina Giles, MD, and SVS Executive Director Kenneth M. Slaw, PhD, will lead the program.

“We all will have an opportunity to be leaders in some way shape or form as our careers evolve,” said LDP graduate Leigh Ann O’Banion, MD. “The LDP is a great way to learn from your colleagues and develop a foundational skill set that will be a valuable tool throughout your career!”

Garcia-Toca, who chairs the SVS LDP, added: “The direct correlation between effective leadership and improved patient outcomes makes this program beneficial not just for the surgeons themselves but also for the broader healthcare community they serve”.

A proposal to save vascular surgery

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A proposal to save vascular surgery

In response to recent articles in the lay press suggesting vascular surgeons were performing unnecessary procedures, Vascular Specialist medical editor, Malachi Sheahan, has asked me to write an editorial based on a talk I presented at the 2023 VEITHsymposium. At that meeting I provided data demonstrating which specialties are treating vascular patients and the rate of insurance denials dependent on provider specialty. I was originally reluctant. I had stopped writing editorials for Vascular Specialist because I had said all that I had on my mind. I was also concerned that, eventually, I would write a piece that readers would find so controversial that I would never be able to show my face in public again.

Well, here it is. I am going to come right out and say it in big, bold, black-and-white letters: “We need the insurance industry to save vascular patients and vascular surgeons.” To those few of you still reading, please stay with me. I am not suggesting that we continue the current system of prior authorization, since it is time-consuming, expensive, a nuisance for the provider and patient, and still does not guarantee quality care. Rather, I am going to propose a different system that I think has merit.

But first, here is some background as to how I came to the unfortunate conclusion that these companies could be the answer and not the problem. This will require that I detail some of the data that I addressed at the VEITHsymposium and my takeaway from the recent barrage of articles about unnecessary atherectomy. Further, how an American Board of Vascular and Endovascular Surgery (ABVES) aligns with my proposal, and why I keep urging that the Society for Vascular Surgery (SVS) change its name to the American College of Vascular and Endovascular Surgery (ACVES).

First, which specialty is responsible for most of vascular surgery in the United States? For the last two years I have been involved in developing and overseeing a major insurance carrier’s 100% outpatient Medicare Advantage prior authorization (PA) program involving 10 endovascular codes dealing with iliac, femoropopliteal and tibial arteries (Codes 37220–372230), and recently all vascular surgery. Medicare Advantage programs are now insuring more than 50% of all Medicare participants, so my experience has provided me a good overview of who is doing what and why. Cardiologists accounted for 48% of the requested PAs, with 42.6% from vascular surgeons, 8.3% from interventional radiologists, and 1% from general surgeons, thoracic surgeons, or nephrologists. There was a geographic variation with vascular surgeons, cardiologists, and interventional radiologists requesting, for example, 40%, 53%, and 6% PAs in Florida; 42.6%, 28.7%, and 28.7% in Texas; and 63%, 26%, and 11% in New York State, respectively. Irrespective of the variation, these data clearly show that, overall, vascular surgeons are probably doing less than half of the vascular procedures in the U.S. Now that the Centers for Medicare & Medicaid Services (CMS) has approved carotid stenting for asymptomatic patients, it is likely that cardiologists will take away even more procedures.

Diminishing voice

The fact that cardiology is now dominant has enormous repercussions. It diminishes the voice of vascular surgeons such that government entities, insurance companies, the lay press, and the public will turn to cardiologists and their societies for information, advice and treatment. This must have a negative impact on the viability of vascular surgeons’ practices and on patients’ health. Now, why do I say that it will affect patient health?

The answer to that also comes from my program, which has evaluated well over 20,000 requests for PA. Last year I presented a small sample of 1,488 PA requests (946 original PA, 172 peer-to-peer, and 370 appeals) for outpatient procedures from 20 states, with New York, Texas and Florida accounting for the majority. All PAs were evaluated predominantly by vascular surgeons or, on occasion, Board certified interventional cardiologists. Subsequent peer-to-peer discussions were performed by vascular surgeons. Let me assure you that this program was initiated because the company was convinced that abusive practices were causing harm not only to its bottom line, but also to its members’ (patients’) health and well-being. Since there is only one Local Carrier Determination (LCD 35998) dealing with non-cardiac stents, and since that LCD can only be used in six states for outpatient care, most insurance companies have developed their own documents outlining indications and appropriate use criteria. Some also use proprietary guidelines such as InterQual.1 For the most part, these are carefully researched, well-written attempts to curtail unnecessary procedures, yet ensure that necessary ones are authorized.

Our program predominantly used InterQual but also SVS appropriate use guidelines,2 as well as guidelines sponsored by the American College of Cardiology and American Heart Association.3 Overall denial rates were 44.8% for initial PAs, 45.8% for peer-to-peers, and 41% for appeals. Denials were more frequent for PA requests from cardiologists (56%) than interventional radiologists (47%) and vascular surgeons (30%). Admittedly, some denials were for lack of information or incorrect coding, but many were because patients were being rushed to the office-based lab (OBL) without attempts at conservative therapy. Some case scenarios attributed to cardiologists and interventional radiologists may shock even the most jaded reviewer. For example: a request to perform tibial atherectomy for claudication on a dialysis patient who one month previously had the peroneal artery perforated requiring two units of blood transfusion, fasciotomy, and resultant myocardial infarction; superficial femoral artery (SFA) and tibial atherectomy performed via pedal approach yet no prior or post attempt to treat proximal complete occlusion of the common iliac, external iliac and common femoral arteries; a patient with clearly defined significant femoropopliteal and tibial disease and a leg ulcer booked for an arteriogram but first having bilateral saphenous vein ablations thus destroying the potential for a tibial saphenous vein bypass; and now that we are reviewing all aspects of vascular surgery, an epidemic of PAs to treat “May-Thurner syndrome” affecting octogenarians with bilateral ankle swelling and congestive heart failure.

Since many of these latter requests are coming out of Florida, I suspect that May-Thurner syndrome must be caused by mosquito bites, as this would be the only way this epidemic could be explained. Further, radiologists are now offering endovascular embolization of genicular arteries to treat arthritis of the knee. In one case, the radiologist performed one of these procedures on a knee contralateral to a below-knee amputation and where the SFA was already showing evidence of atherosclerosis. What an amazing indictment that about half of all requests from these other specialists were denied.

Need I say more about how the expanded role of cardiologists will affect vascular patients? Well, if this is not sufficient, what about all the recent articles in the lay press? There is now an avalanche of material detailing the abusive use of atherectomy predominantly by cardiologists. However, as our PA program highlights, it is not just atherectomy but all the peripheral endovascular procedures.

‘Operate, Medicate and Dilate’

We must also recognize that, unfortunately, vascular surgeons accounted for 30% of the denials in this Medicare Advantage program. In a past editorial for Vascular Specialist, I made it abundantly clear that I believed that vascular surgeons, like the Knights of the Round Table (or more aptly, the rectangular table?) in the Arthurian legend, follow a chivalrous code of honor that guides us in placing a patient’s well-being ahead of financial reward. We ride out, catheter, stent and knife at the ready to defeat the malevolent atherosclerotic enemy. We proudly fly our banner proclaiming that only we “Operate, Medicate and Dilate.” We denounce other specialists involved in vascular care as Dark Knights whose evil intent is to plunder, their poor behavior induced by disparate payment schedules that favor dilating, rather than operating or medicating.

Yet, I am now chagrined to acknowledge that we too have knights who forsake their code of chivalry—vascular surgeons who value the attainment of wealth or prestige as their raison d’être. Perhaps a few examples of PAs requested by vascular surgeons will highlight that not all vascular surgeons follow appropriate guidelines: a stroke patient is wheelchair-bound and has no complaints relating to her legs but the duplex scan shows a “serious” SFA 80% occlusion that, if it occludes, can cause amputation; a request to treat an occluded anterior tibial artery at the same time as an SFA endovascular treatment for claudication, yet the posterior tibial and peroneal arteries are widely patent; an iliac angioplasty for claudication in a patient on home oxygen with limiting shortness of breath while being treated concomitantly for lung cancer; and four repetitive procedures within six months to treat recurrent right SFA occlusions with a patent popliteal and two-vessel runoff, yet no discussion of a surgical alternative? We need to make these “Dark Knights” aware of how their actions have a negative effect on the rest of us. Because, if left unchecked, castigation in the media and government action will punish all vascular surgeons and our legendary contributions to the management of vascular disease will fade from memory, just like Arthur and his knightly court.

Before I move on, let me speak to those of us who try to follow exemplary practice. Let us look deeply at our own experience and assess whether the following scenarios may be impacting what we do. In general, endovascular procedures are much easier to perform than open surgery, so a stent rather than a bypass. Complications may not be as devastating, so perhaps an inclination to intervene earlier in the disease process. As endovascular procedures replace open surgeries, new graduates and even older surgeons may begin to feel uncomfortable performing complex surgeries, so an angioplasty when a bypass may be preferable. Use a well-reimbursed new technology, though unproven, since it has a novel cache that can be advertised to referring physicians. Do some of these scenarios seem familiar?

Now let us return to the articles that were published in the New York Times and ProPublica since they are painting vascular surgeons with the same paint brush as cardiologists. It would take a highly educated layperson to realize that vascular surgeons accounted for very few of the 200 or so accused of overutilization since the word used most frequently is “vascular” not “cardiology,” and the authors often referred to the procedures as surgeries. So perhaps for the first time, the lay public is becoming aware of vascular surgeons, but surely this is not the way we had hoped? Let’s face it, the magician David Copperfield could not make vascular surgeons more invisible than we are now. Dr. Alan Dietzek, in his presidential address to the Society for Clinical Vascular Surgery,4 titled his first chapter, “The anonymity of our specialty,” and the following quotation remains true today. “Why are we still not recognized as the go-to physicians for the treatment of vascular disease? Why are we still fighting a battle for recognition that never seems to end? When will it change and how can we change it? Will our specialty survive?” Alan goes on to make an impassioned case for an American Board of Vascular Surgery (ABVS) independent from the American Board of Surgery (ABS), and he has remained committed to this quest.

I am suggesting that it rather be named the American Board of Vascular and Endovascular Surgery. Recently, cardiologists have approached the American Board of Medical Specialties (ABMS) requesting that their Board separate from the American Board of Internal Medicine, thus establishing a separate Board of Cardiovascular Medicine. If vascular surgery does not achieve its own board first, it will finally relegate vascular surgeons to being second-class purveyors of vascular treatment. Soon, I suspect the American College of Cardiology will adopt the name “American College of Cardiovascular Medicine.” That will be even more devastating; however, we cannot prevent it from happening. What we need instead is to immediately adopt a name change for the SVS. Some years ago, when the logo of the SVS was about to change, I suggested it was an opportune time to give up on the name Society for Vascular Surgery and rather become the American College of Vascular and Endovascular Surgery (ACVES). This has an imprimatur that will result in respect for its members and its messaging. It is more important now than ever before. Now, some will say it is too costly to change the name of the SVS and to have a separate ABVES. Stay tuned because my proposal will also pay for these changes. Together with the American Board of Vascular and Endovascular Surgery (ABVES), these renamed and new organizations will restore our preeminent position as the primary thought leaders and providers of vascular care.

If vascular surgery does not achieve its own board first, it will finally relegate vascular surgeons to being second class purveyors of vascular treatment

To summarize, it is apparent that cardiology is taking over much of the management of vascular surgery patients in the U.S. The quality of their care is suspect. However, we must admit that some vascular surgeons do not offer optimal care either. Part of the reason for cardiologists’ increasing supremacy is that vascular surgeons have failed to market who they are and what they do. By allowing the ABS to represent vascular surgeons, we have abrogated our ability to stand as a unique entity. The SVS has not been aggressive in marketing vascular surgeons and even the name of the Society does not assure that vascular surgeons are the go-to specialists for vascular interventions. Insurance companies are aware of an increasing number of unnecessary procedures and are ramping up prior authorization programs. Hence my proposal.

Program of spot-checks

I propose that the American College of Vascular and Endovascular Surgery, in conjunction with the ABVES, develop the following program. Member vascular surgeons agree to have 10 procedures a year spot-checked randomly by the carrier after the procedures have been completed. In return, participating physicians will not require PAs for their patient procedures and surgeries. The review will include actual images rather than just reports since the written word can manipulate the truth, but images do not lie. If patients had wounds or varicose veins, photographs would also be provided. The review will be performed by Board-certified vascular surgeons who have been rigorously trained by a program developed by the ABVES. The reviewers will be required to be thoroughly versed in Medicare rules as they apply to vascular surgery, the various LCDs and their jurisdictions, and appropriate use guidelines and peer reviewed manuscripts selected by the ABVES. Before being accredited as a certified reviewer, they will have to undergo a test developed and run also by the ABVES. The program will also assist in procuring and paying for state licensure where necessary. Appropriate insurance will also be provided. Importantly, these reviewers will be well compensated for their work. All would have to sign an agreement that they will not review a potential competitor, or someone closely affiliated. A peer-to-peer will be mandatory before any denial. The goal should be remedial education and not punishment. Denials will be reviewed by a second reviewer before a final determination. Denials will not be considered evidence of negligence but rather noncompliance with insurance standards. Vascular surgeons who provide appropriate care will not be required to undergo a similar review in the following year. Providers who fail such a review will undergo further spot checks at six monthly intervals until they are seen to comply with appropriate standards of care. Continuing abusive behavior may warrant exclusion from Medicare or the insurance carriers’ panel. The ACVES, being primarily responsible for this program, will market it to the various insurance carriers who, if they agree to participate, will pay a premium over the costs to be divided by the ABVES and the ACEVS.

The program has multiple benefits. The ACVES and the ABVES will be provided with a source of income that will keep these organizations solvent for the foreseeable future. Payers will see a significant reduction in the cost of provider oversight, a drastic reduction in the number of costly unnecessary procedures, and, by improving the health of their members, a further reduction in expenses. Vascular surgeons will not have to put up with time-consuming, expensive and frustrating PAs. Most importantly, they will be able to advertise to patients that they voluntarily agreed to a program of oversight and that their services have met the highest standard of peer review. Further, insurance carriers choosing providers for their panel will likely seek only those who are part of this program. This will guarantee that vascular surgeons are once again promoted as the appropriate providers of vascular services. Most importantly, the standard of care for vascular patients will be vastly improved. I am hopeful that eventually cardiology and interventional radiology will partner with us to improve the vascular health of the nation.

References

  1. InterQual. Evidence-Based Criteria/Guidelines. Utilization Management. InterQual. Change Healthcare
  2. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication. Journal of Vascular Surgery volume 76, issue 1, p 3–22 April 2022
  3. ACC/AHA/SCA/SIR/SVM 2018. Appropriate use criteria for peripheral arterial intervention. Journal of the American College of Cardiology volume 73 No2 2019
  4. Dietzek A. Vascular surgery is the best kept secret in medicine and my thoughts on how we can change that. Journal of Vascular Surgery Vol. 69 Issue 1 p 5–14 Published in issue: January, 2019

RUSSELL H. SAMSON is president of The Mote Vascular Foundation and past medical editor of Vascular Specialist.

Trial assessing AI-powered tissue microsensor technology in PAD begins enrollment

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Trial assessing AI-powered tissue microsensor technology in PAD begins enrollment

Sensome has announced enrollment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral arterial disease (PAD). Clotild was designated a breakthrough medical device for use in brain arteries by the Food and Drug Administration (FDA) in 2021.

The clinical trial, named SEPARATE, is designed to assess the artificial intelligence (AI)-powered Clotild sensor’s capability to detect various characteristics of blood vessel blockages in PAD patients. The first five patients have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium, and preliminary results are anticipated in mid-2024.

Koen Delosse

A key focus of the SEPARATE clinical trial—according to a Sensome press release—is to evaluate the Clotild sensor’s capacity in differentiating between soft and friable “fresh” clots, and organized “old” clots. This critical information empowers physicians to select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolization, and enhancing long-term treatment outcomes, the release adds.

“Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients,” said Koen Deloose, MD, head of the Department of Vascular Surgery at AZ Sint-Blasius Hospital and principal investigator of the SEPARATE clinical trial. “Sensome’s tissue microsensor technology could become a novel tool to characterize the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”

More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds

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More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds
David Rigberg appears at SAVS 2024

Amid the build-up to residency Match Day 2024, the Association of Program Directors in Vascular Surgery (APDVS) has delivered data from a VISIT (Vascular In-Person for Students in the Match Trial) pilot study that took place last year showing some 57% of medical students who took part changed their rank list of integrated vascular surgery programs based on post-virtual site visits to institutions on their radar. 

The headline finding emerged during the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27). 

“These VISIT data show that a visiting process with a locked ranking order list can really provide meaningful data to applicants—I say that in the context of 57% of them changing their rank lists following these visits,” said co-first author David Rigberg, MD, vascular surgery program director at the University of California, Los Angeles (UCLA), who was presenting on behalf of the APDVS executive council. 

The study was launched after the Association of American Medical Colleges (AAMC) released a position paper stressing the importance of diversity, equity and inclusion (DEI) practices, in-person interview affordability, and the environmental impact of interview travel in the wake of the COVID-19 pandemic-induced re-arrangement of the Match process landscape. 

COVID-19 yielded a transition to the virtual interview, but as the pandemic receded the AAMC continued to recommend the virtual interview process, Rigberg noted. 

In light of debate over whether or not to return to in-person interviews, or the potential for a third way involving a hybrid approach, through the VISIT pilot study the APDVS sought to answer the question: Do post-virtual interview site visits that take place after participating programs have already locked in their student rank lists provide benefit to applicants in the Match process? 

The study findings prompted incoming SAVS President Alan Lumsden, MD, chair of the Department of Cardiovascular Surgery at Houston Methodist in Houston, Texas, to emphasize the value of in-person visits, which, he said, “can’t be replicated by online interviews.” 

“To me, unfairness is asking a medical student to commit five years of their life to an institution, and the first day they walk through is for orientation,” he added. “The risk is more on the applicant side than it is on the institution side.” 

Some 21 of the 74 integrated vascular surgery residencies in the U.S. that took part in the 2023 National Resident Matching Program participated in the study, which involved a survey being disseminated to both the applicants and the institutions’ program directors. 

The post-virtual interview site visits took place within the month between programs locking their rank lists and students submitting their own ranking lists. The validated surveys were then later sent out, with the main question being probed whether in-person visits after virtual interviews impacted rank lists. 

“The answer was a resounding yes,” reflected Rigberg. Among the 57% who answered that they changed their rank lists, 37% increased a program’s rank after a visit. Another 10% said visits had no impact. 

“An additional 33% stated that although they did not change their rank list, [visits] affirmed their rank list, so they sent their rank list in with more confidence,” Rigberg said. 

The most common factor affecting decisions to change was esprit de corps—”so that relationship between attendings and trainees that you really have trouble seeing in a Zoom-type format,” added Rigberg. 

The survey results also demonstrated that 21% of programs would have—if they could—changed their rank lists following the in-person visits. 

“We don’t have granular data on whether this [movement] was up or down, but it is important to recognize the programs are locking themselves into something where they are getting information that they might not be able to act upon,” explained Rigberg. 

On the question of whether or not applicants would recommend a return to in-person interviews, the data showed a near 50-50 split among respondents, he continued, emphasizing that the medical students participating had decided they “wanted to visit in person and did so.” 

Among the program directors asked the same question, “interestingly enough, about 20% were kind of agnostic on it. Then there was a 37-37 split between ‘yes’ and ‘no’ about returning to in-person interviews. Again, there is some selection bias there as these are programs that wanted to have a program where they had some type of in-person visit,” Rigberg added. 

Vascular Specialist–February 2024

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Vascular Specialist–February 2024

In this issue:

‘Voices of Vascular’ campaign celebrates diversity for Black History Month

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‘Voices of Vascular’ campaign celebrates diversity for Black History Month

During Black History Month, the Society for Vascular Surgery (SVS) Foundation will shine a spotlight on the contributions of Black vascular surgeons through its “Voices of Vascular” campaign. This initiative is dedicated to recognizing the diverse voices within the SVS and promoting awareness of various cultures and communities.

The “Voices” campaign—whose presenting sponsor this year is Boston Scientific—spans multiple months, each dedicated to acknowledging different facets of diversity.

Following Black History Month in February, the campaign extends its focus to Women’s History Month in March, Asian American and Pacific Islander Heritage Month in April, Pride Month in June and National Hispanic Heritage Month from mid-September to mid-October. The goal is to engage members and the public in sharing crucial information about each highlighted group, fostering awareness and appreciation for their unique contributions.

Recognizing the campaign’s impact, the SVS and its Foundation received the Profile of Excellence Award from the American Association of Medical Society Executives (AAMSE) last September. This annual award program honors member organizations achieving excellence in areas such as diversity, equity, and inclusion (DEI), advocacy, communications, education, membership and leadership.

For Black History Month, the SVS has curated a series of profiles spotlighting the accomplishments and stories of Black vascular surgeons.

One featured professional for the 2023 initiative was Channa Blakely, DO, who was matched into vascular surgery in Galveston, Texas. Currently finishing up her residency at the University of Texas Medical Branch, Blakely recognized the implicit trust and understanding she shares with patients who look like her. As an African American woman in a surgical specialty, she emphasized the importance of her role in building connections with patients.

“I find that my patients express their pride and the comfort of me having a similar background to them. They often look at me for reassurance,” said Blakely.

The profiles aim to inspire the next generation of vascular surgeons and underscore the significance of diversity within the medical community. Daemar Jones, a fourth-year medical student at Texas Tech University Health Science Center School of Medicine, was featured for 2024 Black History Month. Jones, a 2023–24 social media ambassador for the SVS, emphasizes the impact of scholarships and donations to the Foundation that support physicians and students.

“Coming from me—a student who had all odds statistically [against him] as someone who’s not supposed to be here—if I get a Match acceptance, I aspire to advance my career academically and become an academic mentor. My goal is to be a resident with skills that impact my community. Those are the aspirations that drive me forward, and I am determined to break barriers and inspire the next generation,” said Jones.

The “Voices” campaign serves as a valuable resource for those interested in gaining insights into the multifaceted world of vascular surgery and the individuals shaping its future.

To learn more about “Voices of Vascular,” visit vascular.org/VoicesOfVascular.

SVS webinar aims to tackle upcoming changes to CMS reporting requirements

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SVS webinar aims to tackle upcoming changes to CMS reporting requirements

The SVS will host a webinar Feb. 29 to help equip members with insights on impending Centers for Medicare & Medicaid Services (CMS) reporting requirements that impact vascular specialists.

Jessica Simons, MD, chair of the SVS Quality Improvement Committee, emphasized vascular surgeons’ role at the intersection of high-quality patient care and the financial viability of their practices.

“The SVS Quality Measures and Performance Committee [QPMC] is actively engaged in developing vascular-specific Merit-based Incentive Payment System (MIPS)Value Pathways (MVPs) designed to optimize reporting and payment structures for our dedicated vascular specialists,” said Simons.

The webinar—“How Medicare Quality Requirements Will Impact Reimbursement”—aims to address the financial challenges posed by changes in reimbursement and government policies. Simons stressed the importance of adapting to current and future requirements to maintain high standards of care and ensure financial sustainability within the field.

CMS mandates that all healthcare providers, irrespective of their practice setting, submit quality measures through either MVP, MIPS or an Alternative Payment Model (APM). Effective reporting and compliance require the development of vascular-specific pathways as upcoming requirements have the potential to impact all SVS members.

In a collaborative effort, the SVS QPMC and the Quality Improvement Committee will provide insights during the webinar. Register for the webinar at vascular.org/QMPCwebinar

Make a ‘PLAN’ for CLTI by tuning into new webinar

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Make a ‘PLAN’ for CLTI by tuning into new webinar

An upcoming webinar is set to provide insights for healthcare professionals aiming to enhance their expertise in treating patients with chronic limb-threatening ischemia (CLTI).

Titled “Structured Decision-Making in the CLTI Patient: Understanding the PLAN,” the webinar’s goal is to delve into patient risk assessment, limb severity evaluation, and anatomic complexity considerations. Registration for the online session is now open and will be held at 6 p.m. CST on Feb. 27.

Organized through a grant from the Council of Medical Specialty Societies (CMSS), focused on fostering diagnostic excellence, the webinar seeks to explore the complexities of CLTI treatment through the lens of the PLAN algorithm (patient risk, limb severity, anatomic complexity).

According to webinar moderator Michael Conte, MD, professor and chief, Division of Vascular and Endovascular Surgery at the University of California, San Francisco, the webinar’s focus on the PLAN algorithm aligns with the global vascular Guidelines in CLTI, emphasizing the importance of a systematic approach to patient-centered decision-making.

For more information on the webinar, visit vascular.org/PLAN.

Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI

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Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI
Lewis B. Schwartz

Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed to treat de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI).

Using multiple, serial, intravascular scaffolds, the device’s patented FlexStep technology combines flexibility with support to open clogged vessels and sustain healthy blood flow while accommodating tortuosity and skeletal movement, the company states.

The system is formulated with sirolimus antiproliferative drug elution, with the bioresorbable scaffolds set up to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, and maintain durable patency while leaving no permanent implant behind. The device—designed for femoropopliteal intervention—is currently being tested in a first-in-human trial, EFEMORAL I, at investigative sites in New Zealand and Australia. Encouraged by early clinical results, Efemoral Medical is now developing an additional device for treating infrapopliteal arteries in patients with CLTI.

“Diseased human arteries are most simply, reliably, and successfully treated with drug-eluting, balloon-expandable stents,” said Lewis B. Schwartz, MD, co-founder and chief medical officer of Efemoral Medical. “However,” he continued, “it is extremely challenging to implant these permanent devices in the long and twisting arteries of the lower extremities. The EVSS uses a unique design of alternating, dissolvable, drug-eluting scaffolds that, for the first time, allows the long arteries of the legs to be treated with the same, effective, drug-eluting technology proven to be successful in multiple other vascular beds.”

SAVS 2024: A journey to the heart of DEI like no other

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SAVS 2024: A journey to the heart of DEI like no other
David L. Cull delivers the SAVS 2024 presidential address
David L. Cull, MD, delivers a captivating presidential address, laying bare his own challenging journey as a vascular surgeon and the hidden lessons on diversity, equity and inclusion his life story may hold.

Like nearly everyone else assembled, when Alan Lumsden, MD, took to the podium to deliver the customary presidential address preamble, he had little idea of the allegorical story that was to follow. Not even the program book quite captured what lay in store. “How my perspective on diversity, equity and inclusion has changed after I removed the log from my eye,” reads the entry under the presidential address in the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting guide. 

The title of the 2024 SAVS presidential address, a meeting highlight, of course suggested a diversity, equity and inclusion (DEI)-related topic, Lumsden—whose job it was as president-elect to introduce the sitting president—later shared. But what he and many others did not expect was the jaw-dropping tale of the lens with which 2023–24 SAVS President David L. Cull, MD, now looks at DEI through. Even for Lumsden, after he had just included in his introductory roast details of Cull’s early academic struggles, the presidential address caught him slightly off-guard. 

For, Cull revealed—bringing the true meaning of “the log from my eye” phrase into focus—he has considerable experience of the benefits of gaining acceptance: he has battled a learning disability his entire life. Until this moment, it had been a battle that took place privately, concealed from most of those professionally close to him. Yet that in itself carried the point, Cull told those gathered. The challenges he worked to overcome were hiding in plain sight. In turn, the idiosyncrasies to which his learning disability gave rise posed a different kind of challenge to his colleagues. A couple of years ago, this led to an epiphany for Cull: his story represented that of a DEI beneficiary. 

Cull, from the University of South Carolina School of Medicine in Greenville and formerly vice president of academic and clinical integration at Prisma Health, almost did not give the presentation. Tucked in his pocket as he followed Lumsden to the podium was an alternative address, there in case he decided to “bail” on the topic upon which he’d settled. As a Baby Boomer, a male and a surgeon, he has tendency not to share, he said. But the force of the moment, the divisiveness to which those three letters—DEI—can sometimes lead, helped compel him to overcome his discomfort. 

Raised in rural Virginia, Cull said he grew up inculcated with the mantra that “hard work and success were strongly linked,” and insulated from the cultural shifts that began taking place during his formative years. By the time he arrived in Greenville to start practice, he brought with him that sort of bias, he said, and that formed the bedrock of his views on DEI. 

“The segregated bubble in which I lived resulted in several biases which I carried with me to Greenville in 1997 when my vascular surgery practice began,” Cull said. “These biases dominated my perspective on DEI for the first decade in Greenville.” 

Until 2008. That’s when he first took part in DEI training as he entered the leadership of his institution’s Department of Surgery. Lots of reading, conversations with his adult children and their spouses, as well as roles in DEI initiatives eventually helped shift his views. 

Whereas before Cull held beliefs in keeping with the hard-work-yields-success mantra—such as people should fit and feel comfortable in a work environment, more women surgeons would harm the culture of surgery, LGBTQ discussions are uncomfortable and best avoided—now he’d evolved to adopt two core beliefs. “Systemic racism, sexism, and bias toward sexual orientation exist, and efforts to fix them are just and worthwhile,” he said. “And diversity strengthens businesses, organizations and our society.” 

These were intellectual decisions, not based on personal experiences, and many surgeons of his generation and gender might have embarked upon similar journeys, Cull reflected. At this point, skeptics might object and suggest his transformation “was more an indoctrination than an education,” he continued. 

Not long after his perspective on DEI reached a point of transformation, Cull also finally began to accept, within himself—if not publicly outside a small circle of close friends and partners—the fact he had a learning disability. Up to that point, he had developed a particular way of avoiding this explanation for his struggles. It had been long in the making: Cull was first diagnosed back during the latter part of his surgery residency at Wilford Hall Medical Center in San Antonio, Texas. 

During his presidential introduction, Lumsden trailed the early educational struggles Cull had encountered in elementary and middle school. “He studied a lot, but that was not reflected in his grades,” Lumsden quipped, revealing report cards with less-than-flattering scores. “With scores like this he was probably not exactly destined for surgery, but a big turnaround was made academically.” 

What Lumsden was not to know was the true nature and scale of the source of the issue. 

Following him, Cull revealed all, detailing the learning disability from symptom to diagnosis to aftermath. What he had was expressive and receptive language processing disorder. The disability meant he struggled to translate thought into speech. That explained the need to write down even basic instructions because of an inability to follow verbal instruction. An inability, for example, to present off-the-cuff on rounds, or respond to even basic questions for which he knew the answer. The poor grades early on. The necessity to work harder than his peers to attain required levels. 

Yet, at the point of diagnosis, he refused to accept that he had the disorder in question. “I considered a disability as uncorrectable, and if disclosed might be seen as an excuse for poor performance or something I was trying to use for secondary gain,” he told SAVS. “I found it more comfortable to accept I was on the lower end of the bell curve for intelligence compared to my colleagues.” 

That’s where that early grounding in rural Virginia re-entered the lexicon: you overcome those shortcomings with hard work because “hard work is highly valued in the surgery culture,” he said. “I held tightly to this less-intelligent narrative for most of my surgery career.” 

Despite at this point being unwilling to accept he had a learning disability, Cull had nevertheless already developed a retinue of techniques to help him adapt. Characteristics for which he would become well known were formed in this crucible. Extensive preparation. Meticulous planning. Never, ever procrastinating. Later, in leadership roles, he would similarly incorporate adaptive techniques aimed at thriving. “My partners would not recognize these techniques as adaptations to my disability because I had not disclosed my disability to them. Instead they would recognize them as endearing David Cull quirks,” he explained. 

The era prior to the endovascular revolution lent itself well to Cull’s abilities. During the late 1980s and 1990s, he said, “vascular surgery only required learning 10–12 operations, and the indications were well established. This narrow focus was a factor in me choosing vascular surgery, for it was a field I felt I could master.” 

The high case volume he experienced at Eastern Virginia Medical School during his fellowship allowed him to develop step-by-step instructions for every one of these operations. That lent him great confidence as he entered practice in Greenville and tackled the first few years of his career as a vascular surgeon. 

However, the specter of the endovascular revolution loomed. Ultimately, the complex range of catheters, wires, stents and balloons, as well as procedural bailouts, it yielded was not an arena to which Cull could re-tool his adaptive techniques in order that he could continue to thrive. “My partners would tell you that after considerable effort and time with them in the endovascular suite, I was never able to advance beyond the most basic endovascular skills,” he said. 

Instead, he found ways in which he could maximize his value to his group wherever he could, taking on “less appealing areas to my partners.” He found a home in the likes of vascular access and amputation, for instance, and thrived as a teacher. 

All of which leads up to this moment of public revelation. “It has taken me more than 25 years to accept I have a learning disability, and I have been successful at hiding this disability from everyone except a handful of close friends and colleagues,” he confided. “Even today I have difficulty disclosing this, because, for my entire career, I have been inculcated into a surgical culture that hasn’t seen diversity as a strength, rather as a weakness.” 

The year 2022 held an even deeper reckoning for the now retired surgeon. That was the year in which Cull realized his was a story of diversity and its benefits. In recent years, he recalled trying to explain to senior partners the characteristics of his disability that prevented him from being able to perform endovascular interventions. All he got in return were blank looks. After first being bothered by the response, he eventually came to realize they were unflinching because his value to the group had been long established. “They focused on what I could do rather than what I couldn’t do, and they accepted me as a full partner,” Cull noted. 

He drew on an example of how this inclusion played out in practice. Whenever he took vascular call and an emergency requiring an endovascular intervention reared its head, those same partners, if in town, always would be on deck to lend a hand, Cull said. “How I was treated by my partners is what a diverse, equitable and inclusive environment looks like. I was fortunate to have landed in a practice where I thrived and gained fulfillment from doing what Bill Marston called the routine work of vascular surgery.” 

Back on the subject of the title Cull chose for his presidential address, suggestive of a DEI topic but clearly representing something more, he explained how he settled on the particular wording. “The title came from the realization two years ago that my story is a diversity, equity and inclusion story, and I can use my experiences to gain insights into what it must be like in our profession and in our society to be a woman, a person of color, a member of the LGBTQ community or a disabled person,” he told SAVS as he came to the end of his address. “While my experiences have given me new insight, I can’t fully understand their life experience because I have had the advantage of being a White male who was able to hide his disability over a 30-year career—and was given the benefit of the doubt when I failed.” 

The top 10 most popular Vascular Specialist stories of January 2024

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The top 10 most popular Vascular Specialist stories of January 2024

top 10In January, the most read stories from Vascular Specialist include a U.S. Aortic Research Consortium analysis of F/BEVAR preoperative risk factors in AAAs/TAAAs; a reflection on lessons learnt one year on from BEST-CLI; Southern Vascular’s election of its first female president and more. 

1. The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented

A fifth of patients among a chronic kidney disease (CKD) cohort on hemodialysis—a rare subset pulled from a large repository of national data—were able to come off the treatment following renal artery stenting, a team of researchers from the University of Texas (UT) Southwestern Medical Center in Dallas has found.

2. University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project

Last October, the University Pittsburgh’s Clinical and Translational Sciences Institute hosted its 10th Pitt Innovation Challenge (PinCh), providing a total of $550,000 in prizes, with the top-three winners each receiving a $100,000 grand prize. PinCh 2023 announced that SVS member Nathan Liang, MD, and his co-founders Timothy Chung, PhD, and David Vorp, PhD, were awarded $100,000 for developing Aneurisk, an artificial intelligence (AI)-based tool designed to assess the risk and prognosis of patients with abdominal aortic aneurysms (AAAs), who share an update on their progress since winning.

3. U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs

A series of preoperative risk factors—including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

4. BEST-CLI: A year down the road

A dedicated session at the 2023 VEITHsymposium (Nov. 14–18) in New York City aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limb-threatening ischemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022. The trial’s principal investigators (PIs)—Boston-based vascular surgeons Alik Farber, MD, and Matthew Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD, also of Boston—share their thoughts and highlight some unanswered questions. 

5. First procedures announced in study of novel peripheral IVL system

FastWave Medical has announced the successful completion of enrollment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (IVL) technology. The prospective, single-arm study aims to assess the safety and performance of FastWave’s IVL system in patients with peripheral arterial disease (PAD) of the superficial femoral or popliteal arteries with moderate to severe calcium.

6. Southern Vascular elects first woman president-elect

The Southern Association for Vascular Surgery (SAVS) elected Margaret (Megan) Tracci, MD, to become its first ever woman president for the 2025–26 cycle.

Tracci, a professor of surgery at the University of Virginia in Charlottesville, will serve as SAVS president-elect during 2024–25. Tracci is a past president of the Virginia Vascular Society.

7. Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms

Gore has announced Food and Drug Administration (FDA) approval for the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), which the company states is the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

8. International collaboration unveils updated PAD guidelines in diabetic foot ulcers

The International Working Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) have jointly released updated guidelines for the diagnosis, prognosis and management of peripheral arterial disease (PAD) in individuals with diabetes mellitus and a foot ulcer.

9. Coding: Increasing complexity and lost RVUs—a drop in the ocean?

A vascular surgery team at Audie L. Murphy VA Medical Center in San Antonio, Texas, uncovers “staggeringly low” numbers of correctly coded billing for three commonly performed vascular procedures, raising concerns over cases with more complex coding.

10. Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system

Endologix recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system, effective since 1 January 2024.

Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’

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Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’
Shivik Patel

The uncommonly performed aortoiliac endarterectomy—one of the open procedures on which the vascular surgical specialty was founded—provides acceptable durability in aortoiliac occlusive disease patients with smaller native vessels, especially among females, a 25-patient case series review performed at Louisiana State University (LSU) Health Sciences Center in New Orleans has shown.

Results from the analysis, presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27), by Shivik Patel, MD, demonstrated freedom from major adverse limb events of 89% and 81% at two- and three-years post-procedure, while primary and secondary patency out to three years were 86% and 89%, respectively.

The patient sample, dating from 2006–2022, was 72% female with a mean age of 53.6 years. Overall survival was 94%. “Two patients had early postoperative thrombosis, and both of those patients had undergone procedures in an acute limb ischemia type of event,” explained Patel, formerly a vascular surgery resident at LSU and now an attending surgeon at WellSpan Health in York, Pennsylvania, in an interview with Vascular Specialist. “Among the patients who underwent the procedure in an elective circumstance, there was one instance of late reintervention that was needed., but, overall, this series shows pretty durable outcomes after three years.”

A subanalysis involving mean aortic and iliac diameter measurements further demonstrated that the patient cohort had smaller native vessels than the means of a general population, Patel continued.

“We went through all of the patients’ imaging and measured their juxtarenal aorta, their infrarenal aorta, distal aorta and bilateral iliac arteries, as we wanted to compare our group to standard population means for the age group,” he said. “We saw that our aortic diameters and iliac diameters were less than those means.”

Patel conceded study shortcomings, principally the lack of a control group. “Our study involved predominantly females, which could provide some bias in terms of having a mostly female sample, but I think it speaks to the benefit something like this procedure can have in the female population,” he added.

An aortoiliac endarterectomy case from the LSU series

Patel argued that given the surgery’s relatively uncommon use in practice, the 25-patient sample provides a “fairly robust” dataset with which to introduce numbers that suggest a role among a specific patient group.

“We have noticed, especially in my clinical experience, patients in whom we place stents in their smaller vessels, they are not going to have the durability, and, down the road, you’re going to be placing an aortobifemoral bypass,” he noted. “If you have a reason to avoid a large prosthetic graft, as in an aortobifemoral graft, or avoiding femoral incisions, this is a very durable procedure to do if you have isolated aortic and iliac disease, as long as the patient has acceptable operative risk, which if you’re planning on doing an aortic bypass, the risk is more or less in the same vein at that point.”

Patel sees his data set, for a procedure first performed in the early 1950s, and described in a 2006 Annals of Vascular Surgery paper as “almost a lost art,” as a moment for repose.

“This is an interesting opportunity for us to re-evaluate one of the traditional operative techniques that our specialty is founded on and to make sure we don’t forget about procedures like it,” he said. “They may come back to play a role, and aortoiliac endarterectomy is a surgery I think may re-emerge as a more popular option in patients with specific anatomic specifications.”

‘Get a Pulse on PAD’: Multi-society public awareness campaign launched

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‘Get a Pulse on PAD’: Multi-society public awareness campaign launched
SVS President Joseph L. Mills

The Society for Vascular Surgery (SVS), in partnership with three other medical societies operating in the vascular disease space that form the PAD Pulse Alliance, is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD.”

Alongside the Association of Black Cardiologists (ABC), the Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Interventional Radiology (SIR), the group aims to educate people on PAD risk factors and potential symptoms, as well as to encourage patients to advocate for their own health with their doctors.

The awareness campaign, taglined “Kick Off the Conversation,” kicked off as the PAD Pulse Alliance released survey data showing that 70% of Americans are unaware of the disease, contributing to 400 amputations performed each day in the U.S.

“The collaboration among these medical societies is a testament to the devastating impact PAD can have on people, families and whole communities if not diagnosed and treated early, and, importantly, early treatment usually consists of medication and lifestyle changes,” said SVS President Joseph L. Mills, MD. “We hope that care teams will continue to collaborate to ensure early and proper diagnosis with the ultimate goal of improving outcomes for patients.”

To help educate patients and give them the tools to start the conversation, the PAD Pulse Alliance published a website and patient toolkit at PADPulse.org.

Measuring plaque inflammation via SCAIL scores may improve carotid stenosis risk stratification

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Measuring plaque inflammation via SCAIL scores may improve carotid stenosis risk stratification

The use of a relatively novel scoring system, referred to as Symptomatic carotid atheroma inflammation lumen-stenosis (SCAIL), has produced favourable predictive qualities versus the Oxford carotid stenosis tool (OCST) and Essen stroke risk score (ESRS). According to researchers, the SCAIL score led to superior recurrent stroke predictions after minor stroke/transient ischaemic attack (TIA) and symptomatic carotid stenosis before revascularisation—as compared to these more established approaches—in a recent study involving three pooled, prospective cohorts of patients.

Writing in the European Stroke Journal, Sarah Gorey (Stroke Clinical Trials Network Ireland/University College Dublin, Dublin, Ireland) et al note that SCAIL led to discrimination “better than chance”, and provided added value for prognosis when used in conjunction with the clinically based ESRS system. These findings indicate that a combined assessment of stenosis and plaque inflammation on fluorodeoxyglucose positron-emission tomography (FDG-PET) imaging like the one utilised in SCAIL “may improve risk stratification in carotid stenosis”. The authors also stress the need for further studies to fully determine the role FDG-PET could play in evaluating plaque inflammation as a means for patient selection within randomised carotid revascularisation trials of the future.

Gorey and colleagues pooled three prospective cohort studies of patients with recent (<30 days), non-severe ischaemic stroke/TIA (modified Rankin scale [mRS] ≤3) and internal carotid artery stenosis ≥50%, and used these data to compare SCAIL—and its ability to predict ipsilateral stroke recurrence in symptomatic carotid stenosis—with both OCST and ESRS. The researchers detail that all of the included patients had carotid FDG-PET/computed tomography (CT) angiography and late follow-up data, with censoring at carotid revascularisation.

Across a total of 212 included patients, 16 post-PET ipsilateral recurrent strokes occurred in 343 patient years of follow-up—and occurred at a median timepoint of 42 days. Relaying their results, the authors state that baseline SCAIL predicted recurrent stroke with an unadjusted hazard ratio (HR) of 1.96 (confidence interval [CI] 1.2–3.22, p=0.007) and an adjusted HR of 2.37 (CI 1.31–4.29, p=0.004). In contrast, the HR for OCST was 0.996 (CI 0.987–1.006, p=0.49) and for ESRS was 1.26 (CI 0.87–1.82, p=0.23). The concordance (c-statistic) for each of the scoring systems evaluated in the study—with higher numbers indicating better discriminatory power—was 0.66 (CI 0.51–0.80) with SCAIL, 0.52 (CI 0.4–0.64) with OCST, and 0.61 (CI 0.48–0.74) with ESRS.

As per comparisons with ESRS alone, the addition of plaque inflammation measures (maximum standardised uptake value [SUVmax]) to ESRS gave rise to improved risk prediction outcomes when analysed both continuously (HR 1.51, CI 1.05–2.16, p=0.03) and categorically (p=0.005 for risk increase across groups; HR 3.31, CI 1.42–7.72, p=0.006; net reclassification improvement 10%). SUVmax plus ESRS was found to carry an adjusted HR of 1.57 (CI 1.04–2.36, p=0.03), and stratified recurrent stroke risks were low in 2.6% of patients, moderate in 5%, and high in 17.3%. However, Gorey et al report that their recurrent stroke prediction findings were unchanged by the further addition of carotid lumen stenosis measures—the other metric taken into consideration, alongside plaque inflammation, by SCAIL.

“The SCAIL score has demonstrated validity to predict early and late recurrent stroke,” the authors add. “In our study, SCAIL improved identification of patients with recurrent stroke when directly compared to established clinical risk scores. However, SCAIL correctly classified just over half of [the] patients in our study, and the addition of clinical variables in the ESRS provided only modest further improvements. Prediction models including measures of vascular inflammation—either alone or in combination with clinical risk factors—need to be further refined and validated before they can be applied in clinical practice for patient selection for carotid revascularisation.”

UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD

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UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD

Following a review, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such devices can be considered for the treatment of peripheral arterial disease (PAD), including intermittent claudication and critical limb-threatening ischemia (CLTI).

The MHRA had previously issued a statement in April 2022 on the use of paclitaxel drug-coated-balloons or drug-eluting stents in patients with CLTI which stated that they should only be used in patients where ‘the benefits may outweigh the risks’. The parameters for use outlined that exposure should be kept to a minimum, which referred to using the lowest dose device available and avoiding/reducing repeated exposure to a device. Furthermore, the 2022 guidelines noted that paclitaxel devices should not be used in the routine treatment of patients with intermittent claudication due to the reported risk of longer-term increased mortality.

The updated guidance has been issued following an extensive review of the most recent published literature alongside the MHRA’s request for the advice of the Interim Devices Working Group (IDWG) and other invited experts. The IDWG advised that the new studies did not support a statistically significant increased risk of harm associated with the use of paclitaxel-coated devices in patients with PAD, irrespective of disease type or severity.

In this update, the MHRA make reference to the 2023 evaluation of numerous randomized controlled trials and real-world studies which compared paclitaxel-coated devices versus control devices in a patient-level pooled analysis. Led by Sahil A. Parikh, MD, an interventional cardiologist at Columbia University Irving Medical Center in New York City, the analysis included a total of 2,666 participants with a median follow-up of 4.9 years. Their results showed that no significant increase in deaths were observed for patients treated with paclitaxel-coated devices, providing reassurance to patients, physicians and regulators on the safety of said devices.

Subsequently, the MHRA has removed its previous restrictions on indication, dose and repeated exposure for paclitaxel-coated devices for both intermitted claudication and CLTI.

Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty

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Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty
Serranator PTA serration balloon catheter

A study comparing the extent of early infrapopliteal re­coil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrat­ed “technical feasibility” in measuring early recoil using standard angiography.

The investigation, led by Venita Chandra, MD, of Stanford University in Stanford, California, as well as Michael Lichtenberg, MD, and Stefan Stahlhoff, MD, of Arnsberg Clinic in Arnsberg, Germany, was driven by the rising prevalence of peripheral arterial disease (PAD), and the rapidly developing arsenal of balloon devices imbued with new technologies, which are aimed at providing more effective treatment options. Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss in this patient population and is considered to be a contributing factor in early failure or later restenosis.

The findings were published online in the Journal of Endovascular Therapy in early December.

The Serranator (Cagent Vascular) balloon, which is designed to provide a controlled lumen gain while minimizing vessel injury when performing percutaneous transluminal angioplasty for PAD, was compared to plain balloon angioplasty. Chandra and colleagues—including first author Arash Fereydooni, MD, a Stanford vascular surgery resident—aimed to assess the ability to define and measure post-angioplasty recoil in infrapopliteal arteries, as well as to compare the two devices’ effect on recoil.

The multicenter, sequential comparative study enrolled patients with lesions of the infrapopliteal arteries who underwent alternating plain balloon angioplasty or serration angioplasty with the Serranator device. Capturing angiographic imaging pre-, immediately post-and 15-minutes following angioplasty, the study core lab measured and analyzed vessel recoil, final diameter stenosis and dissection grade.

A total of 36 patients were enrolled, with 39 infrapopliteal lesions treated. There were no significant differences concerning demographics or lesion characteristics between the Serranator (n=20) and plain balloon angioplasty (n=19) groups. Arterial recoil, defined as greater than 10% lumen loss at 15 minutes, occurred in 25% of Serranator-treated lesions compared to 64% in the plain balloon angioplasty group. The investigators also report that clinically relevant recoil, defined as greater than 30% lumen loss at 15 minutes, was present in only 10% of patients who underwent serration and in 53% of patients after plain balloon angioplasty.

The authors note that, although their study was undertaken to test the feasibility of measuring early arterial recoil, they were able to compare the performance of a serration balloon against plain balloons in a prospective, randomized fashion.

Fereydooni et al conclude that, to their knowledge, theirs is the “first demonstration” of a head-to-head core lab adjudicated angiographic outcome assessment of infrapopliteal artery recoil between a plain balloon and any specialty balloon. Situating their findings among concurrent research, the investigators highlight the consistency of their results with the earlier PRELUDE (Prospective study for the treatment of atherosclerotic lesions using the Serranator device) study conducted by Andrew Holden, MD, from the Auckland Regional Public Health Service in Auckland, New Zealand, which found one- and six-month patency rates to be 100% and 64%, respectively, between the Serranator and plain balloon angioplasty. Similarly, Fereydooni and colleagues also point to the single-center PRELUDE-BTK follow-on study, which reported an average final residual stenosis of 17% vs. 34% between the groups.

Fereydooni et al contend that a possible explanation for these favorable results may be due to the serration mechanism allowing for “more controlled and predictable delivery of radial force” compared with plain balloons.

Although their findings may add to a body of literature that favors serration angioplasty, Fereydooni and colleagues underline that their small sample size and the “preliminary nature” of their feasibility endpoints “[limit] the analysis power” for comparing serration and plain balloon angioplasty in specific patient anatomy.

Among other limitations, the authors add that the study protocol did not include an assessment of long-term outcomes of early arterial recoil and how this translates to long-term patency between the two devices. “It would be of interest to obtain three-dimensional data using intravascular ultrasound (IVUS) to better characterize changes in area and lesion morphology with SA [serration angioplasty],” they write.

Giving Tuesday brings in five-figure sum

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Giving Tuesday brings in five-figure sum

The SVS foundation celebrated another philanthropic success through its Giving Tuesday efforts, raising $20,000 in funds. Presenting sponsor W. L. Gore and Associates doubled the final funds through their match, further magnifying the donations. As a result, Giving Tuesday raised a total of $40,000 for vascular health.

SVS Foundation Chair Michael C. Dalsing, MD, said this day is a beacon of hope and charity, aligning with the true spirit of the holiday season. Notably, this season’s celebration extended to the Foundation’s “Celebration of Science” campaign, transforming into a months-long commemoration in honor of the Foundation’s mission.

“Anytime we have an infusion of funds to this level, it allows us to be more innovative and supportive of existing research grants and potentially to address new research opportunities,” said Dalsing. “It allows us to promote the health of our patients and gives us an opportunity to benefit them in an exponential manner by virtue of cutting-edge research.”

Giving Tuesday messaging, a Celebration of Science campaign component, was spread across multiple media outlets from the Foundation Board of Directors, sharing messages on reasons to donate to the Foundation. Dalsing even braved the social media world to spread the message to his colleagues.

Palma Shaw, MD, chair of the Industry Relations Advisory Committee, praised the donors for their generosity, expressing that the dedication exhibited by supporters on Giving Tuesday had been inspiring. Her goal within her role is to strengthen the relationship between the SVS and industry partners.

Donors can visit vascular.org/givingtuesday to learn how to join the celebration and support the Foundation’s ongoing work.

Redemption through perseverance

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Redemption through perseverance
Arthur E. Palamara, MD

In the late 1970s, a neurosurgeon at New York’s St. Luke’s Hospital operated on a beautiful, young, rising soprano who studied opera at a major New York conserva­tory. She was delightful, full of the joy of liv­ing, and orphaned at an early age to raise her teenage brother. Having already overcome significant adversity, her only impediment to a blossoming career and a happy life was a brain tumor. The tumor appeared benign, and its resection was considered routine. The neurosurgeon was top notch, capable and clinically at the top of his game. There was not much that could go wrong.

But as happens in the arcane realm of neu­rosurgery, things went terribly wrong. After the skull was opened and the surgeon began to remove the tumor, the brain increased in size and poured out of the brain cavity. The surgeon was devastated. He and the anesthe­siologist performed all of the maneuvers to shrink it back to size. It was of no use. More and more brain fungated from the skull. In a fit of absolute frustration, the surgeon gath­ered a fistful of brain tissue and disgustedly threw it against the wall. Despondent and defeated, the neurosurgeon turned to the resident assisting him and said: “She will not live. Close the skull as best you can.” Over­whelmed by a crushing sense of helplessness, he rushed hurriedly from the room.

It was my night to take care of patients and the neurosurgeon came to me. In a voice filled with anguish and despair, he bared his instruction. “Arthur, she may live a couple of days, but she will not survive. It would be best if you allowed her to die. There is no point in prolonging her suffering.”

An hour later, the patient arrived in the recovery room. Not culpable of any misdeed, her heart and lungs functioned perfectly. Her brain had betrayed her. I, in my innocence, could not let her die. I found I could not ne­glect her in her hour of need. I meticulously cared for her throughout the night with the concern of a shepherd guarding his injured lamb. I was too inexperienced and naive to do otherwise.

Persistence

For the next month, she became my charge. Her brother came in daily, cried, stayed for a while, and left. I performed every aspect of her care that required correction.

While her body stayed perfectly intact, she remained in a deep coma. Every morn­ing I would jab a large needle into her left femoral vein and withdraw blood to be sampled. Every afternoon I would make whatever adjustments were necessary. My patient and I endured the ridicule of more sanguine colleagues who laughed—but did not interfere—with this ritual. I admit that without her active mental interaction, I be­gan to think of her as a “thing” devoid of human qualities.

After more than a month, the neurosur­geon decided to try an operation, a ventric­ular-atrial shunt, to relieve the pressure in her brain. Since I was her de facto guardian, he allowed me—under his tutelage—to per­form the entire operation. I drilled a hole into her skull, inserted a long needle into the right lateral ventricle, and was rewarded with the presence of clear, white fluid. The needle was connected to a thin plastic tube inserted into a vein in her neck. Perhaps fu­tile, perhaps extravagant, the operation was at the very least, an attempt to remedy a ca­tastrophe. Sometimes the human condition demands an act of expiation.

The next morning, to our utter surprise, the patient woke up. She actually sat up in bed, talked to us and ate solid food. Because of her youth, her recovery was rapid. Her sole disability was dyslexia. Everything she attempted to read was backwards. Given the immensity of the alternatives, dyslexia was a small price to pay and no great impediment; her memory was sharp.

Six months later, on a Sunday afternoon, I was invited to her recital at Juilliard. She gave a concert where she sang beautifully. She possessed a superb, operatic voice, with great control, range and command. Her brother, her only relative, was in attendance. To me, it was a triumph of perseverance over adversity. Medically, it was probably a mira­cle. At the reception following her concert, I summoned up the courage to ask her: “Did you feel any of those needles that I stuck into your groin?”

“Yes,” was her response, “and they hurt like hell.” Some 45 years later, and still mind­ful of this acknowledgment, I never dehu­manize a patient.

The world of vascular surgery

Terri Schiavo was famously a patient in a veg­etative state confined to a nursing home in Tampa 18 years ago. She was in a coma for 10 years. She was unable to meaningfully in­teract with her environment. We really don’t know what Terri Schiavo could perceive.

My patient was in a coma for only a month. Yet Terri’s condition demanded answers as to a timeless question: what is life? More profoundly: how do we respond to individuals who don’t con­form to our definition of life? Do we have the right to terminate a life that we don’t find meaningful? Or are we simply imposing our biases on a defenseless human being? Our response says more about societal values than it does about a legislative or legal maelstrom.

This moral dilemma is even more con­flicting today over the subject of abor­tion. There is little doubt that both sides are sincere in their belief, while the gulf remains irreproachable.

Part of my training took place at Harlem Hospital in New York. Back in the 1970s, Harlem was part of the Columbia Presbyte­rian system. As interns, we did a one-month rotation on the vascular ward. In those days, vascular surgery at a large city hospital was largely an amputation service. While revas­cularization was sometimes attempted, it was rarely successful, which led to a number of multilevel amputations.

The huge floor was comprised of large rooms, each of which housed eight African American patients. They were all poor, all alone, and all suffering withered limbs with varying levels of amputations. Wounds would be dressed daily. Healing was slow and their hospitalizations were long. These patients were uniformly cheerful and bore their lot in life with grace and good humor. After dinner, they would go out on a balco­ny to smoke, then return to their room to watch—and good naturedly argue over—the Yankees or Mets game on a beat-up televi­sion with rabbit ears. After retiring for the night, they would repeat the same sequence the following day.

One afternoon after making rounds and frustrated by any lack of progress of any of the patients, I made a statement to the group: “I would rather be dead than live like those patients.”

Our African American attending turned to me with a calm, unemotional voice and said: “Doctor, these patients may not be a White, young doctor from New Jersey with aspirations of becoming a great surgeon, but they have achieved something you don’t yet have. They enjoy a roof over their head, three meals a day, entertainment, and emo­tional support for each other. Their expecta­tions may not be yours, but they have found contentment.”

In a slightly more forceful voice, he added: “You do not have the right to impose your values on them.”

Our medical landscape

Some people are slow learners. Some years ago, an elderly, very ill patient presented with a contained ruptured abdominal aortic aneu­rysm (AAA) and acute cholecystitis. It is an understatement to say he was sick and sep­tic. In true Crawfordian fashion, I repaired the aneurysm, closed the retroperitoneum, covered it with omentum, then removed the bulging, necrotic gallbladder. I drained ev­erything. He hung on for several weeks in the intensive care unit (ICU) experiencing multiple complications. He was returned to surgery several times, but the details have been forgotten.

Finally, one Saturday morning, he was again declining, some other problem having cropped up that could benefit from operative intervention. His overly supportive family was at his bedside.

As I explained the alternatives, his daugh­ter with whom I enjoyed a very good rela­tionship said:

“Whatever you think is best, doctor. We trust you.”

“We can try. Although he is very ill and may not survive,” I responded.

I walked towards the nurse’s station to book the case with the operating room. His hospital course replayed itself in my mind as I slowly acknowledged that he was not going to survive. I abruptly stopped. Retracing my steps, I re-entered the room.

The family looked at me expectantly. “I think I am operating for myself, not for your father’s benefit,” I explained. It is time to let him go. They cried and hugged me.

The story about the opera singer is true. The book is called Seizure. It was made into a television movie starring Leonard Nimoy.

As a doctor, I have fought death and illness for too many years to concede even one pa­tient. Unfortunately, I’m not sure that my reverence for the profession is shared by pri­vate equity firms that increasingly dominate our medical landscape.

Perhaps I am still imposing my values on others.

Arthur E. Palamara is a vascular surgeon practicing in Hollywood, Florida, for 44 years. He is active in county, state and national medical organizations.

SVS launches VESAP6 presales in January with discount

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SVS launches VESAP6 presales in January with discount

The SVS is set to launch the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) in April. The highly anticipated review resource became available for pre-sales Jan. 10, which will continue through March 26, allowing users access upon launch. VESAP is a digital aid for vascular surgeons in preparing for qualifying, certification and recertification examinations and to remain current in the specialty of vascular surgery and endovascular therapy.

Vascular and general surgery residents and fellows consistently report the utility of the program in their preparation for the Vascular Surgery In-Training Examination (VSITE) and American Board of Surgery In-Training Examination (ABSITE).

VESAP6 will come with over 600 questions, accompanied by detailed discussions and references. The resource can be used in learning mode, where users can review the correct answers, rationale and references; and exam mode, where the user will complete entire modules without seeing the answers, rationale or references, in hopes of passing with a score of 75% or higher to earn Continuing Medical Education Credit (CME).

VESAP6 has been allocated 97.5 CME credits. Pre-sales for VESAP6 will open with a 10% discount available on all individual purchases. Additionally, SVS members who take advantage of the presale will be entered into a lottery for complimentary registration for VAM 2024.

Visit vascular.org/VESAP to access more information on the resource.

SVS points to 2023 achievements, challenges in coming year

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SVS points to 2023 achievements, challenges in coming year
Joseph L. Mills (L) and Kenneth M. Slaw (R)

The Society for Vascular Surgery (SVS) reflects on a year marked by notable achievements on multiple fronts. In a communication to members in mid-December, Executive Director, Kenneth M. Slaw, PhD, underscored the organization’s growth, collaborative endeavors and key milestones attained in 2023.

“Our members’ dedication and collaborative efforts across various councils, committees and departments have propelled us forward. 2023 stands out as a year of significant achievements that our members can take pride in,” said Slaw. “As we look forward to 2024, the SVS remains steadfast in its commitment to championing quality and safety in patient care, the best science in the field, and advancing vascular surgery through meaningful collaboration, innovation, and, as a specialty, by letting the world know how special our members are as vascular surgeons.”

SVS takes to the Hill

  • Over 50 SVS leaders and staff participated in a Hill visit before the 2023 Vascular Annual Meeting (VAM) in Washington, D.C.
  • SVS members engaged with over 100 Congress representatives to advocate for immediate changes to Medicare payment policies, which led to initiatives to consider legislation, including a “Clinical Labor Bill”
  • The SVS plans to host an advocacy skill-building conference in 2025

Quality improvement goes national

  • The SVS successfully initiated the Vascular Verification Program with the American College of Surgeons, demonstrating achievement in both inpatient and outpatient standards programs
  • The SVS Patient Safety Organization (PSO)/ Vascular Quality Initiative (VQI) surpassed 1,000 subscribing practice sites and recorded over 1 million procedures in the VQI database
  • The VQI introduced the Smoking Cessation National Quality Initiative, highlighting the SVS’ commitment to addressing critical public health issues associated with vascular care
  • The SVS/PSO Fellowship in Training program was launched as part of ongoing efforts to enhance professional development and education
  • SVS mobilized dozens of member letters expressing concern for patient safety relative to the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) rule that will expand carotid stenting. The SVS is on record with CMS, expressing its concerns, and has offered solutions to minimize potential harm

Health reporters contacted the SVS numerous times, seeking comment and guidance regarding stories featuring poor patient outcomes.

“The role of clinical practice guidelines, appropriate use criteria (AUC), greater understanding of health and practice economics, and focus on substantial challenges and flaws in current CMS payment/incentive policies were all subjects of discussion,” said Slaw

“The SVS plans to strengthen its communications infrastructure as it anticipates more frequent and continued contact with media professionals in 2024 and beyond.”

Translation to transformation in clinical practice

  • The launch of the inaugural “Translating Guidelines into Practice” webinar attracted hundreds of SVS members. The course covered the translation of global chronic limb-threatening ischemia (CLTI) guidelines, Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) results and updated varicose veins clinical practice guidelines
  • The SVS secured a $100,000 educational grant from the Council of Medical Specialty Societies (CMSS) to support ongoing translational efforts
  • The SVS initiated a national compensation study and program for vascular surgery in response to member queries to address gaps in credible data

Emphasizing its ongoing commitment to office and outpatient care in the community, the SVS Section on Outpatient and Office Vascular Care (SOOVC) developed the Handbook on Outpatient Vascular Care, released at the end of 2023.

“Each month of the year brings new ideas, energy and opportunities, as well as new challenges and threats that make strategy and change a universal constant for the SVS,” said Slaw.

The pace of change has accelerated and has become its unique challenge. SVS leadership commits to continue evolving the Society to address new opportunities and challenges.”

Rolling with the changes

  • SVS membership reached a total of 6,400 diverse members
  • SVS Affiliate membership, encompassing over 500 vascular physician assistants, nurse practitioners, and advanced care providers, played a substantial role in shaping the future of vascular care delivery
  • Bylaw changes were ratified, concluding a multi-year journey to update SVS bylaws, explicitly focusing on modifying the composition of the Executive Board
  • During the 2023 Executive Board retreat in July, significant resources were committed to augmenting and accelerating branding efforts initiated in 2021, with the refreshed branding set to be unveiled in 2024

Advancements in education

  • The SVS achieved its highest attendance at the Vascular Research Initiatives Conference (VRIC), with over 130 registrants
  • The organization completed its second Complex Peripheral Vascular Intervention Skills Course and ongoing improvements in the Coding and Reimbursement Workshop
  • The SVS launched virtual coding courses in December
  • The sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) is set to launch in Spring 2024. A new audio supplement/companion for VESAP6 will be piloted, allowing learners to listen to case discussions
  • The launch of the fifth journal in the Journal of Vascular Surgery portfolio, Journal of Vascular Surgery-Vascular Insights, showcased open-access publishing models

The 2023 “Great Gatsby” Gala proved to be a resounding success, raising more than $200,000 to support the future of vascular health. The Vascular Health Step Challenge increased participation from last year, with participants collectively walking 44,000 miles and raised more than $100,000.

“As the year concludes, I encourage you join us in 2024 for the ‘Night at the Museum’ Gala at Chicago’s Museum of Science and Industry,” said Slaw.

SVS member volunteers have pressed forward to sculpt the future with numerous new task forces in 2023, including Pediatric Vascular Care, Patient Engagement, Innovation in Vascular Care, Clinical Trials and a proposed new Section for Senior Members.

SVS President Joseph L. Mills, MD, addressed achievements the Society will target in the new year.

“2024 will bring about a new set of challenges for our Society to overcome,” he said.

“The SVS reaffirms its unyielding commitment to advancing excellence and innovation in vascular health through education, advocacy, research and public awareness. Together, we will continue to emphasize quality and patient safety, push boundaries, foster innovative solutions, and empower our members with the knowledge and resources needed to excel in the dynamic field of vascular surgery.

“Our collective dedication will be the driving force behind the sustained success of the SVS and will continue to impact the evolving landscape of vascular healthcare favorably.”

First patient enrolled in HERCULES randomized trial comparing ESAR and EVAR

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First patient enrolled in HERCULES randomized trial comparing ESAR and EVAR
Michel Reijnen

The first patient has been enrolled into the HERCULES trial, which compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) in the treatment of abdominal aortic aneurysms (AAAs) with wide proximal necks. 

HERCULES is an investigator-driven trial led by Michel Reijnen, MD, a consultant vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands, and Konstantinos Donas, MD, head of the Department of Vascular and Endovascular Surgery at Asklepios Clinic Langen in Langen, Germany, in collaboration with Medtronic. Rijnstate Hospital is sponsoring the trial.

Patients will be randomly allocated 1:1 into ESAR and EVAR groups: the former arm will be treated with the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System, and the latter using the Endurant II/IIs stent graft system.

A total of 300 participants will be recruited worldwide at approximately 20 hospitals in Europe and another 20 in the U.S. They will be followed out to five years.

The primary endpoint of the trial will be the absence of type Ia endoleak, migration of the upper portion of the stent graft of ≥5mm (as compared to the one-month post-treatment CT scan), and aneurysm sac growth of ≥5mm (as compared to the one-month post-treatment CT scan).

Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?

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Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?
Ronald L. Dalman

There is a global interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type-2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAAs). 

The LIMIT trial, a prospective randomized, level one, placebo-controlled, blinded trial, sponsored by the National Institutes of Health (NIH), is designed to investigate whether metformin significantly prevents the enlargement of existing AAAs in non-diabetic people. 

“It is difficult to make an asymptomatic patient better. And so, you want a treatment that is not going to be very arduous, and not be very high risk. [It should be] relatively inexpensive, [and] easy to take, and metformin checks all those boxes,” explains Ronald L. Dalman, MD, from Stanford University in Stanford, California, at the 2023 VEITHsymposium in New York City (Nov. 14–18), who invites the U.S. vascular community to get involved in the trial. 

“If metformin works in this application, it may also work in secondary treatment after [a] patient has had endografting to reduce the need for secondary procedures for endoleaks, for graft migration, or aneurysm enlargement. It could be [used] in a variety of applications both as a de novo treatment, as well as an adjunctive treatment following surgery. Here is something that could be a complement to surgical management, both before, during or after surgical intervention,” adds Dalman, who is the Walter C. and Elsa R. Chidester professor and vice chair of surgery for clinical affairs at Stanford Medicine. He is also the inaugural executive editor for the Journal of Vascular Surgery suite of publications. 

There is some evidence available, albeit not without its limitations, to support the use of metformin in AAA management. A systematic review and meta-analysis of drug repurposing for the treatment of AAA—published online ahead of print the week following VEITH 2023 in the European Journal of Vascular and Endovascular Surgery (EJVES)—indicates that metformin and statins “may provide some effect in slowing AAA progression.” 

Authors led by Joachim Sejr Skovbo Kristensen, from Odense University Hospital and the University of Southern Denmark in Odense, Denmark, do acknowledge, however, that “no definitive evidence was found for any of the [12] investigated drugs in this study.” 

They posit that publication bias “may have influenced the positive findings,” and go on to stress that “further research is needed to identify effective medical treatments for AAA progression.” 

How the best leaders ensure psychological safety at work

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How the best leaders ensure psychological safety at work
Bhagwan Satiani

My limited understanding of psychological safety is when people feel safe expressing differing opinions, and thoughts in the workplace. Amy Edmondson, a pioneer in this area, defines it as “the belief that the environment is safe for interpersonal risk-taking.”1 Although psychological safety must be part of every organizational culture, it is critical for high-performing teams. Cues and actions to enable this behavior and impact organizational culture are the responsibility of the leader. High-innovation companies thrive on emotional energy compared to healthcare, where a high-safety environment—such as a hospital, for instance—relies on psychological safety. However, healthcare is also a combination of research, innovation and caring for human beings. This requires leadership to share their aspirations and push for a healthy balance of both. 

Why is psychological safety important in the workplace? Because it is key for people to perform optimally. A McKinsey & Company survey confirms that 89% of employees corroborate that their ability to voice their thoughts and feel safe is essential in the workplace. Gallup has calculated that doubling the percentage of employees who believe their opinion in the workplace counts from 30% to 60% resulted in a 27% reduction in turnover, a 40% reduction in safety incidents, and a 12% increase in productivity. Not surprisingly, it is also one of the strongest predictors of team performance. 

While the lack of such safety for employed physicians can be seen in any scenario, I have been most exposed to it in the academic environment. To assume that the impact of lack of such safety must only be on junior faculty or trainees is erroneous. Surprisingly, even senior tenured professors have expressed fear of speaking the truth in public, and often in meetings. I once had a chair express his fear of speaking out in front of a dean several years ago to me thus: “If anyone says anything to the contrary at a meeting, the dean will cut your b***s out.” Imagine how junior faculty must have felt. One can only assume that expressing an opinion counter to the leader in such an environment could result in ill-treatment in the form of compensation, further career advancement, recommendations and discretionally awarded titles. If senior professors are reluctant to speak up, newly hired or junior faculty will not risk their careers, leading to fear of speaking, a “yes” culture and stunted productivity. 

Most of us have encountered leaders who may be successful at soliciting ideas and driving change but lacking in spotting cues at meetings where no one feels free to disagree. Rather than psychological safety, there is a culture of silence. What makes employees feel safe and engaged at work and in teams? Some have described four progressing stages of feeling safe at work: safety to be included, to learn, to contribute and, finally, to feel safe in challenging the status quo.2 William Kahn, an expert on employee engagement in the context of psychological safety, has identified three conditions for optimum engagement: “feeling safe, meaningfulness and having access to the right energy and resources.” There are consequences of a culture where there is lack of such safety. Research shows that this culture leads to an 85% rate of project failure. 

Edmondson has offered an interesting two-by-two grid or matrix with performance standards (apathy and anxiety) on the x axis and psychological safety on the y axis (comfort and learning).1 She advocates for leaders to attempt to push people into the right upper quadrant or the learning zone. Learning, innovation, and productivity will proceed with psychological safety, she counsels. However, she warns that this one item is only a part of a range of leadership behaviors that accelerates high-performance teams. The obvious goal is for all team members to be in harmony with each other, able to speak and share ideas towards a common purpose, without fear of appearing inane or fearing reprisal. It is the leader’s job to remove any risk associated with speaking out. 

So, how should leaders advance a “speak up” culture in order to enable psychological safety? 

First, the leader must remember their role in a team. It is to facilitate, empower others, be a catalyst and model the desired behavior. This means having the awareness to be cognizant of the thoughts and feelings of others. Silence does not equal agreement. Then, asking themselves if the silence is a pattern or a “one-off ” behavior? Solutions for each are different. Are team members actively engaged in making eye contact with you and others? If you sense hesitation, encouragement with a self-deprecating anecdote of some kind may work. Or better still, mention one of your own shortcomings. If you are truly self-aware you know what they are or have heard it said about you. 

Second, if the leader senses silence during a discussion, ask for advice, not feedback. This is sometimes called the “feed-forward” technique. Feedback is often understood as either an “ask,” or after a decision has been made and interpreted as being judgmental. Using the word “advice” puts the onus on the other person, as well as being heard as being for the future rather than the past. A safe way to elicit advice is to admit that you are still pondering over the issue and that you are probably missing critical pieces of the matter. Not hearing people with a different mindset, leaders may be missing these pieces at a huge cost. 

Ron Carucci, co-founder and managing partner at Navalent, mentions two national disasters as examples where “employee voices” were not given importance because their opinions were either not solicited or ignored. These were the Challenger space shuttle in 1985 and the Columbia shuttle in 2003. Give people room to brainstorm out loud. Even if someone presents ideas or suggestions that lack substance, listen and understand the thought first, show empathy, and offer a counter idea, improving on their own statement by asking if they had considered it. People will generally remember what was decided at the meeting. It follows that if a certain position is accepted at a team meeting, progress must be reported at the next meeting. 

Third, every team needs a naysayer(s) or a contrarian. Sometimes uncomfortable? Yes. A facial expression or other tic may indicate disagreement but sometimes not. Ask for other viewpoints. To make a point, express a contrary view yourself to lead the discussion off. This allows others the freedom to express divergent opinions. 

Fourth, there is a risk that some team members may see the “safe” environment as a license to say whatever they want. Or, while all ideas may be welcome, many do not fit with the goals, mission, or task for the limited time at a team meeting. Remember, there is an “opportunity cost” associated with ideas/projects that do not sync with the goals and objectives of the team. Time and resources wasted on an unworthy project is time lost from a worthwhile one. After listening, gently steer the discussion away and remind everyone that although the idea was good, we can consider this for another time. 

Fifth, while I have seen good and bad leaders in a team environment, successful ones have two qualities that stand out. Calmness and confidence when their status or opinion is challenged. They do not get aggravated when the status quo is contested, and especially if team comportment or performance is deteriorating. Certainly, most team members will make errors. Give team members the freedom to fail as part of the team. Indeed, bring them up as learning opportunities, and avoid finger pointing. Emotions must be controlled. Focus on the error itself and how to avoid it in the future. This is where the fundamental pillar of leadership—self-awareness and knowledge of one’s own triggers—is so important for emotional regulation. 

Finally, consider a few steps that clearly demonstrate a team leader’s positive energy. People are loathe to report a problem with culture they see as incompatible with organizational values. The leader must encourage conversation about toxic behaviors in a secluded setting if necessary. Be generous with compliments. And please do not ask for advice from team members as you are close to walking out the door. I have seen this repeatedly. 

As I see it, providing psychological safety should be a part of all syllabi associated with developing physician leaders. Part of my learning has come from my own mistakes and being associated with our leadership program where I have watched groups go through the training, particularly during the team sessions. Although, data from McKinsey points to several other skills predictive of positive leadership, training in open dialogue skills, sponsorship, situational humility, and consultative behaviors (as in suggestion one and two) are especially important.3 McKinsey also reports that only 28% of leaders develop skills necessary to create psychological safety in team settings. We can do a whole lot better than that, right? 

References 

  1. https://amycedmondson.com/psychological-safety-%e2%89%a0-anything-goes/ 
  2. https://www.leaderfactor.com/post/why-are-some-leaders-afraid-of-psychological-safety) 
  3. https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-is-psychological-safety 

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor.

First patient treated in ZFEN+ fenestrated endovascular graft study

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First patient treated in ZFEN+ fenestrated endovascular graft study
Zenith Fenestrated+ endovascular graft

Cook Medical has announced the first patient treated in the clinical study of the Zenith Fenestrated+ endovascular graft (ZFEN+) in the U.S. The procedure was performed on Jan. 29, 2024, at the University of Texas Health (UTHealth) in Houston, Texas, by Gustavo Oderich, MD, global principal investigator.  

“We are ecstatic at UTHealth Houston to have treated this first ZFEN+ patient. This is a huge step forward in getting the first patient-specific device for complex abdominal and extent IV thoracoabdominal aneurysms with fenestrations. Rather than a one-size-fits-all approach, the ZFEN+ device design aims to optimize patient needs,” said Oderich.

The ZFEN+ clinical study is being conducted under an investigational device exemption (IDE) from the Food and Drug Administration (FDA). This clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith Universal distal body 2.0 graft (Unibody2), the investigational Bentley BeGraft balloon-expandable fenestrated endovascular aortic repair (FEVAR) bridging stent graft system, and the commercially available Zenith Spiral-Z abdominal aortic aneurysm (AAA) iliac leg graft (ZSLE).

The ZFEN+ clinical study will enroll patients in need of treatment of aortic aneurysms involving one or more of the major visceral arteries. Patients with juxtarenal, pararenal and extent IV thoracoabdominal aortic aneurysms meeting specific anatomical requirements may be included in the study. The ZFEN+ device is designed with fenestrations aligned to a patient’s unique anatomy and to extend the proximal margin of aneurysmal disease that can be treated endovascularly.

SVS seeks volunteers for open committee slots

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SVS seeks volunteers for open committee slots

The SVS is accepting applications for vice chairs and volunteers. SVS members in good standing can apply for up to two committee positions and serve for a one-year appointment term renewable for a maximum of three years based on evaluation of performance. 

This call for committee members comes with new eligibility terms for committee members and vice chairs. Any Early-Active SVS member in good standing can apply to serve. 

In November, membership votes made the change official. The Appointments Committee and Executive Board have expanded the pool of eligible vice chairs to include anyone who has served on a committee within the past six years. 

Once the application window closes, the SVS Appointments Committee will review all SVS committees, their leadership and assembled applications, analysing for gaps in knowledge, experience, practice type and diversity. Recommendations that come out of this process will be presented to the SVS Executive Board for approval. 

Eligible SVS members can apply for open positions from mid-January until late March. For questions about eligibility, email [email protected]. 

Mentor Match available for all SVS members

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Mentor Match available for all SVS members

The SVS has expanded its Mentor Match program, which is now available to all SVS members in good standing. The program aims to connect vascular surgery professionals with experienced mentors who can help them achieve goals. 

Mentor Match began in 2019 and was open to medical students and general surgery residents. The program allowed for future vascular surgeons to request a mentor who could provide guidance on their impending career. Between 2019 and 2023, over 200 individuals took advantage of the free program. 

The Society’s Membership Section leaders initiated the expansion of the program when they inquired about mentorship opportunities for their Section members in late 2023. In addition to allowing all members to become mentees, the Society will also enable more members to become mentors. 

Interested members can visit SVSconnect.vascular.org to learn more and sign up. 

SOOVC releases handbook for outpatient care

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SOOVC releases handbook for outpatient care
Anil Hingorani

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has released the anticipated Office-Based Lab (OBL) Handbook to guide practitioners and aid with safety and cost-effectiveness, as well as expand patients’ access to care. 

Anil Hingorani, MD, chair of SOOVC, emphasized the increasing prominence of outpatient vascular care, constituting over 50% of lower extremity angioplasties. The handbook aims to fill the existing resource void, offering guidance on starting and maintaining office-based labs (OBLs) and ambulatory surgery centers (ASCs), catering to new practitioners and those with established practices. 

“We don’t have many resources for how to manage this and develop and maintain these new types of practice models. This handbook is a resource meant to help a new practitioner or even a practitioner who already has an up-and-running OBL or ASC and assist them in maintaining these new paradigms,” said Hingorani. 

He highlighted the dynamic nature of the handbook, describing it as a live document that will evolve as the field progresses. This adaptability, made possible by its online format, enables timely updates and additions. Three new chapters have already been added since the initial version, reflecting the field’s rapid evolution. The handbook will have both an online and a print version for accessibility, with the online version available now. 

The handbook covers crucial topics for practitioners, including finance, research, anesthesia, equipment and accreditation. Hingorani said the chapters, designed to be concise and focused, feature formats such as bullet points, regular text, pictures and charts that are easy to understand. 

Addressing the timeline of the handbook’s creation, Hingorani mentioned that the process began about a year ago, with authors submitting chapters within a relatively short timeframe, facilitated by their familiarity with the subject matter. The SVS team played a crucial role in the editing process, ensuring the quality of the content. 

Hingorani mentioned the challenges practitioners face in the evolving field of outpatient vascular care, mainly focusing on financial considerations, regulations, and ensuring patient safety and quality care.“We want to make certain that these OBLs are financially solvent, and a lot of planning is done before you put the shovel in the ground,” said Hingorani. “Quite frankly, you want to ensure you have a financial plan. Fortunately, this handbook has chapters written by experts who know how to develop those. In medicine, we don’t train our trainees how to do that.” 

The handbook authors continuously contribute and provide updates to ensure the handbook remains a comprehensive and up-to-date resource. 

Regarding the future of the handbook, Hingorani mentioned the possibility of turning chapters into podcasts, leveraging the growing popularity of audio-based content. The aim is to make the content more accessible for practitioners. 

“This is an important contribution and advancement to the field that many of our practitioners are getting increasingly involved with, but more importantly for our patients, it’s quite important because they prefer an effective environment to perform these procedures.” 

For more, visit vascular.org/SOOVC. 

Viabahn VBX stent graft receives FDA approval

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Viabahn VBX stent graft receives FDA approval
GORE(R) VIABAHN(R) VBX Balloon Expandable Endoprosthesis
Viabahn VBX balloon expandable endoprosthesis

Gore has announced recent Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for the treatment of complex iliac occlusive disease.

“Our team is pleased to be the first commercial implanter of the new lower profile VBX stent graft,” said Darren Schneider, MD, chief of vascular surgery and endovascular therapy at Penn Medicine in Philadelphia. “Combined with the flexibility, strength and deployment accuracy I’ve always trusted with the device, the new lower profile will enable me to treat most of my complex cases with a 6 or 7F device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of my patients.”

Gore details in a press release that no changes to the stent design were made to achieve the lower profile. “By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides. Depending on the practice, physicians may be able to use the VBX stent graft with a broader set of patients, experience a lower risk of complications at the access site,” the company explains.

The lower profile device will be rolled out to the U.S. market over the coming months and is also being studied in the TAMBE trial of type 4 thoracoabdominal aortic aneurysms (TAAAs).

In January, Gore has announced that the first patients had been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease.

Endospan releases early TRIOMPHE IDE study results at Society of Thoracic Surgeons annual meeting

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Endospan releases early TRIOMPHE IDE study results at Society of Thoracic Surgeons annual meeting
Nexus system
TRIOMPHE
Nexus system

Endospan shared 30-day results from the first 22 patients enrolled in the TRIOMPHE investigational device exemption (IDE) study in a late-breaking presentation at the 60th annual meeting of the Society of Thoracic Surgeons (27–29 January, San Antonio, USA).

TRIOMPHE is a multi-arm, multicentre, non-randomised, prospective clinical study to evaluate the safety and effectiveness of Nexus in treating thoracic aortic lesions involving the aortic arch. The study will enrol 110 patients at up to 31 sites.

“We were pleased to see that in this high-risk patient population, the 30-day data for these first 22 patients showed a low mortality rate, no disabling strokes, paraplegia, or renal failure and short ICU [intensive care unit] and hospital lengths of stay,” said Bradley Leshnower, director of thoracic aortic surgery at Emory University School of Medicine (Atlanta, USA). “One year data are pending.”

A press release details that more than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extra corporal circulation and possibility of hypothermia, translating into reduced procedure and hospitalisation time.

“Nexus is designed for total endovascular arch repair to address the specific challenges of the aortic arch anatomy,” said Kevin Mayberry, Endospan CEO. “We are pleased to see that these early data align with the results achieved during the EU clinical study. These data suggests that NEXUS may provide surgeons with a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”

Southern Vascular elects first woman president-elect

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Southern Vascular elects first woman president-elect

The Southern Association for Vascular Surgery (SAVS) elected Margaret (Megan) Tracci, MD, to become its first ever woman president for the 2025–26 cycle.

Tracci, a professor of surgery at the University of Virginia in Charlottesville, will serve as SAVS president-elect during 2024–25. Tracci is a past president of the Virginia Vascular Society.

Alan Lumsden, MD, the Walter W. Fondren III Presidential Distinguished Chair of the DeBakey Heart & Vascular Center at Houston Methodist, is the 2024–25 SAVS president.

Lumsden took over from David L. Cull, MD, professor of surgery at the University of South Carolina in Greenville, at the SAVS business meeting, which took place Jan. 27, at the close of the association’s 2024 annual meeting in Scottsdale, Arizona (Jan. 24–27).

Beyond ‘do better’: New year reflections from a vascular surgery trainee

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Beyond ‘do better’: New year reflections from a vascular surgery trainee

The new year is a time for reflection. It is also an opportunity to rededicate, or if needed, reinvent ourselves. Vascular surgery training is long, at least five to seven years for most of us. Most of our reflection happens as we progress from one academic year to the next, and often our self-feedback loop is stuck on do better, go faster, publish more. In the midst of surgical training, we regularly internalize our failures but often fail to savor our victories.

This year, I’m trying something new. In business, SWOT (strengths, weaknesses, opportunities and threats) analysis is the gold standard to evaluate performance, reprioritize and reallocate resources, and set future goals. As a current second-year research resident, soon to start year six of seven of vascular surgery training, I’m sharing my own SWOT with you. 

Strengths 

Leadership, organization, communication: After a recent busy call weekend (during research time, we cover one shift per month as the acting “chief ” resident), operating all night and then rounding on 25 new patients, my attending texted me: “Great work this weekend, chief ! You’ll do well when you come back given your natural attention to detail. Thank you for your help.” 

Weaknesses 

I have many. First, the Vascular Surgery In-Training Examination (VSITE). Each year, I am determined to do all the Vascular Education and Self-Assessment Program (VESAP) and Vascular Surgery Surgical Council on Resident Education (VSCORE) questions, review Anki flashcards, and score higher than just average on the in-service exam, but to no avail. This year, I’m buddying up with a friend in the general surgery program, and we’ve scheduled weekly study sessions on zoom for accountability. I’m also using Dr. Thomas Creeden’s The Vascular Surgery Review Book. Second, lower extremity distal bypass and upper extremity thoracic outlet syndrome exposures. No matter how many times I review the anatomy, it doesn’t click for me. This year, I am using the Complete Anatomy 3D human body atlas app while I read. Third, taking on too many projects. Research time has been a blessing in many ways, but it is also an easy time to over-commit to seemingly disparate research and writing projects and lose sight of what you actually set out to accomplish during the two years. 

Opportunities 

Anatomy and simulation courses and training. With the continued concerns regarding open surgical training volume, doubling down on program-initiated, regional, or national courses seems like a no-brainer. 

This past fall, our program had its first cadaver lab where we worked in teams of senior/junior trainees to cover all the major vascular dissections. I also attended the Midwestern Vascular Surgical Society (MVSS) simulation course, which covered everything from lower extremity bypass to ruptured endovascular aneurysm repair (EVAR), and ZFEN (Zenith Fenestrated AAA endovascular graft) to transcarotid artery revascularization (TCAR). Other courses on my list to attend are the Louisiana State University Fundamentals of Vascular Surgery Symposium, Top Gun skills competition at the Society for Clinical Vascular Surgery (SCVS) annual meeting, Houston Methodist open aortic training course, and the Weill Cornell Big Apple Bootcamp skills course. 

Threats 

Burnout and letting self-care fall to the bottom of my list. While I don’t think I have personally experienced burnout, I know that making sure to schedule yoga classes, meal prep, and family time on my calendar (just like all my other work commitments), makes me feel better and more whole. If you are clinical right now, this is hard. But even just fitting in a 15-minute high-intensity interval training video with my coffee in the morning before heading to the hospital, or after getting home from a long day before dinner, can shift my mood entirely. 

This year, rather than resolutions, I would encourage you to write out your SWOT analysis and maybe even share it with someone else. Hearing a co-resident’s struggles, and then sharing your own, is a powerful way to connect and combat burnout. Don’t let one bad day, week, or month define you. Vascular surgery also doesn’t define you, but it’s a large part of who we are, who we have chosen to become. It is also a path of continuous evolution. Just when you’ve mastered one skillset, it’s time to feel uncomfortable again. This holds true through every transition, from intern to second year, second to third year, third year to research time, and research years back to the last two clinical chief years. 

So, as I get close to starting up “Heartbreak Hill” with just a little more than two years left in training, I am reminding myself of why I chose and love vascular surgery: our patients have complex disease requiring our creativity and resilience, and yet they accept the redo-redo-redo procedure and remain grateful. We have lifelong relationships with our patients, and we are still the only surgical specialty I know to receive holiday cards and gift baskets from our patients and their families. We are the firefighters of the hospital, the service other surgeons call when they need help. We foster a culture of innovation and research. We are a close-knit community of approximately 3,000 vascular surgeons, who all seem to know each other, somehow. 

Shernaz Dossabhoy, MD, is a vascular surgery resident at Stanford University in Palo Alto, California. 

Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms

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Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms
Gore Excluder TAMBE

Gore has announced Food and Drug Administration (FDA) approval for the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), which the company states is the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

A press release details that U.S. physicians have had limited options for treating patients with aortic aneurysms involving the visceral branch vessels, with the current standard of open surgical repair being complex and associated with a high rate of mortality and morbidity. It continues that existing options for a minimally invasive approach are limited to products not designed for this purpose or custom-built devices—when and if the patient’s anatomy qualifies them—which can delay treatment due to manufacturing time.

“Until now, endovascular treatment options were limited as alternatives to open surgical repair,” said Mark A. Farber, MD, national principal investigator. “TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.”

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PAAA) of the aorta using an endovascular approach in which the physician guides the device through arteries in the groin and arm via small incisions. Using established imaging techniques, the physician deploys the device to seal off the aneurysm, allowing blood to flow directly through the endoprosthesis.

TAMBE has four built-in, pre-cannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen. It is expected to become available in June 2024.

ESVS 2024 clinical practice guidelines on the management of abdominal aortoiliac artery aneurysms—what’s new?

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ESVS 2024 clinical practice guidelines on the management of abdominal aortoiliac artery aneurysms—what’s new?
Anders Wanhainen and Isabelle Van Herzeele
Anders Wanhainen and Isabelle Van Herzeele
The updated European Society for Vascular Surgery (ESVS) 2024 clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries, have been published online this month in European Journal of Vascular and Endovascular Surgery, and will be in print next month. Here, Anders Wanhainen, MD, from Uppsala, Sweden, and Isabelle Van Herzeele, from Ghent, Belgium—chair and co-chair of the guideline writing committee, respectively—highlight some important updates from the new document for vascular specialists and policymakers alike.

The ESVS 2024 guidelines document on the management of abdominal aortoiliac artery aneurysms was developed over a three-year period by a writing committee comprising of 16 aortic experts from 12 European countries. By summarising and evaluating the currently best available evidence, 160 recommendations for the evaluation and treatment of patients have been formulated and graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C to mark the level of evidence (LoE). Compared to the previous 2019 version, 59 recommendations are completely new, 49 have been revised, and only 52 recommendations have not been changed. Importantly, only 10/160 (6%) recommendations are based on Level A evidence, while 112 (70%) recommendations are supported by Level C evidence or based on consensus, illustrating lack of evidence in the aortic field. 

Screening and management of small AAAs 

Because of changing epidemiology, with the decreasing prevalence of abdominal aortic aneurysm (AAA), a thorough re-evaluation of the screening recommendations has been made. Although screening of high risk groups remains highly recommended (Class I, Level A), the target groups have not been included in the recommendations, but should be made depending on local conditions, such as prevalence of the disease, life expectancy and healthcare structure.  

People who have first-degree relatives with AAA, with other peripheral aneurysms or organ transplant recipients are established high-risk groups that should be subject to screening. Older men, especially those with a history of smoking, also remain a suitable target group in many settings. But in populations with extremely low smoking prevalence, the incidence of AAA is so low (<1%) that the value of screening can be questioned. There is also lack of support for screening women and people with cardiovascular disease. 

The importance of cardiovascular risk factor management in patients with small AAAs has been strengthened. Based on a comprehensive analysis of the available evidence it is not considered to be justified to restrict the use of fluoroquinolone antibiotics in patients with AAA as was previously suggested by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Similarly, this guideline advises against restricting exercise and sexual activity in patients with AAAs. 

Indication for repair 

In line with the evidence, a clear negative recommendation is now issued for the repair of AAA <55mm in men and <50mm in women. The diameter threshold for when repair can be considered is maintained at 55mm for men and 50mm for women; however, the recommendations have been downgraded due to the lack of supporting high quality evidence. Furthermore, in line with recent data, it is clarified that the diameter threshold for considering repair should preferably be based on the ultrasound (US) measurement, while computed tomography angiography (CTA) for treatment planning is only recommended when the diameter threshold has been met on US. 

Given the natural history of iliac artery aneurysms with slow growth rates and the very low risk of rupture below 40mm in diameter, the writing committee considers it justified to raise the recommended diameter threshold for surgical repair to 40mm. There are no data to suggest any gender differentiation of the indication for repair. Nevertheless, it may be reasonable to take gender and body size into account, in the same way as for AAA. 

Elective AAA repair 

Due to the rapid technological and medical development, the existing RCTs comparing open surgical repair (OSR) and endovascular aneurysm repair (EVAR) are partly outdated and thereby not entirely relevant for today’s situation. It is therefore necessary to also include more recent case series and register studies in the overall evaluation. Thus, despite data from multiple RCTs and meta-analyses, representing the highest level of evidence, the existing level of evidence was rated as mediocre (Level B). Overall, evidence suggests a significant short-term survival benefit of EVAR over OSR, with similar long-term outcome up till 15 years of follow-up. Thus, the impetus towards EVAR as the preferred treatment modality for AAA in most patients is retained in the 2024 guideline.  

Following reports of failing devices in EVAR, this guideline advocates the use of devices with proven durability, and advises against EVAR outside the manufacturer’s instruction for use (IFU) in the elective setting. Long-term follow up in prospective registers of updated devices based on established platforms is recommended as before, however with the increased requirement for 10 years of durability data.  

Due to the lack of evidence of a clinically relevant benefit, routine pre-emptive coiling of side branches or non-selective aneurysm sac embolisation before EVAR is not recommended, and in OSR of AAA routine use of antimicrobial coated grafts to prevent aortic graft infection is not recommended.  

The previously preferred endovascular approach for iliac aneurysms has been amended. Neither technique is generally considered superior to the other, but instead the choice of surgical technique (open or endo) for iliac aneurysm repair should be based on patient and lesion characteristics. 

Ruptured AAA repair 

The benefit of EVAR for rAAA has been demonstrated in RCTs and large cohort studies, which is why the recommendation for EVAR as the first option in rAAA remains as Class I, whereas it is considered justified to upgrade the LoE to Level A. 

The recommendation of using aortic balloon occlusion for proximal control is downgraded due to the uncertainty of its effect, while the recommendation for vacuum assisted open abdominal closure has been upgraded, with the addition of mesh traction. Other news includes the need for proper stent graft oversizing, anticoagulation in the emergency setting, management of colonic ischaemia, and treatment of aorto-caval fistula. 

EVAR follow-up 

An updated recommended follow-up algorithm after standard EVAR has been included. All patients are recommended for early post-operative CTA imaging (within 30 days), to assess the presence of endoleak, component overlap and sealing zone length.  

Patients stratified as low risk of complications (no endoleak, anatomy within IFU, without high risk features (proximal neck diameter <30mm and angulation <60°, and iliac diameter <20mm), adequate overlap and seal of ≥10mm proximal and distal stent graft apposition to arterial wall) should be considered for low frequency imaging follow-up during the first five years.  

Patients deemed at high risk (presence of type 2 endoleak [T2EL], insufficient overlap or seal <10mm, anatomy outside IFU, large proximal neck (>30mm), ectatic iliac fixation zones (>20mm) or extreme angulation (>60°) and EVAR failures (direct endoleak [type 1 or 3 endoleak], obvious degradation of seal zones with impending endoleak, or aneurysm sac growth > 10mm) should instead be managed more actively with intensified and/or additional imaging or consideration of treatment.  

Several new and updated recommendations on the management of endoleaks are presented and a suggested diagnostic step up for occult undetermined endoleaks is described, where the option of conversion to open surgical repair (OSR) with stent graft explantation is highlighted. 

Complex AAA 

The coverage of complex AAAs has been expanded significantly to reflect advances in technology since 2019 and now covers the management of juxta- and pararenal AAAs as well as suprarenal AAAs and type 4 thoraco-abdominal aortic aneurysms (TAAAs). Treatment recommendations have been updated based on an increasingly comprehensive body of knowledge, including preliminary data from the most recent UK Complex aneurysm study (UK COMPASS trial). Endovascular repair with fenestrated and branched endografts is considered to have some benefit and is advocated in patients with high surgical risk and complex anatomy.  

Further updated recommendations have been issued on preservation of renal function, prevention of spinal cord ischaemia, and new technologies, such as off the shelf branched devices, physician modified fenestrated endografts (PMEGs), and in situ fenestration. Parallel graft techniques should only be considered as an option in the emergency setting, or as a bailout, and ideally be restricted to ≤2 chimneys. The use of new techniques and concepts for treatment of complex AAAs is not recommended in routine clinical practice, and should be limited to studies approved by research ethics committees after obtaining patient’s informed consent, until adequately evaluated. Of note, this includes the use of endostaples to treat short- neck AAAs with standard EVAR devices. 

Centralisation 

The firm evidence of a volume-outcome relationship of surgical repair in general, and AAA repair in particular, makes it necessary and justifiable with a continued centralisation of AAA repair. The recommended minimum yearly caseload has been upgraded to at least 30 standard AAA repairs per centre (no less than 15 of each OSR and EVAR), and a consensus recommendation on a minimum yearly caseload of 20 complex AAA repairs has been added. Rare and complex conditions, such as aortic graft infections, mycotic aortic aneurysms and patients with genetic syndromes should only be managed in highly specialised centres.  

Conclusion 

We encourage everyone to carefully read the new ESVS aortic guidelines in its entirety. We realise that it is an extensive document but it offers more recommendations of clinical importance and a comprehensive supporting text summarising the literature and motivating our positions. We hope you will find it relevant and useful for your practice.  

Anders Wanhainen, MD, is professor and chair of vascular surgery at Uppsala University in Uppsala, Sweden.

Isabelle Van Herzeele, MD, is associate professor of vascular surgery in the Department of Thoracic and Vascular Surgery at Ghent University in Ghent, Belgium.

Coding: Increasing complexity and lost RVUs—a drop in the ocean?

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Coding: Increasing complexity and lost RVUs—a drop in the ocean?
A vascular surgery team at Audie L. Murphy VA Medical Center in San Antonio, Texas, uncovers “staggeringly low” numbers of correctly coded billing for three commonly performed vascular procedures, raising concerns over cases with more complex coding.

Not long after becoming chief of vascular surgery at Audie L. Murphy Memorial Veterans Hospital—one of the larger of the Veterans Affairs institutions in the U.S.—in the past year, Alissa Hart, MD, started to look at her team’s productivity, and identified a problem. Despite car­rying out a brisk load of complex vascular cases for a VA setting like hers, there appeared to be a problem in terms of the level of relative work value units (RVUs) being captured by the center’s coding service. So she went “down the rabbit hole.” What she found astounded her.

“Only 42% were coded correctly, so the majority weren’t coded cor­rectly,” Hart tells Vascular Specialist. “These are simple cases. The TCARs [transcarotid artery revascularizations] were actually coded pretty correct­ly, but the other two—EVARs [endovascular aneurysm re­pairs] and fenestrated EVARs (FEVARs)? This isn’t even a pedal access atherectomy with stent placement, or some­thing along those lines.

“What I realized, when we looked at this in general, I went back and started trying to re-code my own cases, and there was a point where we did five EVARs in a month—which is pretty good for a VA—and only two of them were coded with a code that had RVUs attached to them.”

Based on her initial discovery, Hart and colleagues—including presenting author Luke Perry, DO, a first-year vascular sur­gery fellow at UT San Antonio—carried out a retrospective study of the total number of cases, those coded correctly, total number of RVUs, and the number of RVUs actually captured for TCARs, EVARs and FEVARs carried out at their center across a five-year period. The data are set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) in Scottsdale, Arizona.

Total RVUs completed were 1,764.42 but only 1,196.82 were captured, SAVS 2024 will hear. “When I started looking at this, and look­ing at our productivity numbers, I thought, ‘How is this possible?’” Hart recalls. “We’re doing atherectomy cases, doing TCARs, EVARs and FEVARs, and all these things that a tertiary-level center would do at a VA. I was quite proud of our department. So having just come from private practice, where I had started to get more familiar with how outpatient-based labs code, and how many RVUs you can get out of a single procedure, I started looking at the way our coding was coming back from our central­ized coders. That led me down a rabbit hole where I started to realize that, not just the VA but other organizations as well, are using coders that are primarily used as outpatient coders to code surgical packages.

“For vas­cular surgery, in addition to complex cod­ing, you also have all these modifiers that really increase your RVUs. If a coder is not really sure how to do that properly, we’re doing all this work and we’re not getting the productivity value out of that, or the bonus value for our surgeons. We’re constantly being told you’re not productive enough and our system is trying to find ways for us to cut costs, when the reality is, if they would spend the time and put the energy into coding, then they could justify our existence as is—and probably provide us with more resources.”

With Hart being on the younger side— 34, she reveals—on becoming a chief all of sudden she realized she hadn’t really been prepared, either in her residency or during a stint in private practice, how to improve productivity or, for instance, justify the sal­aries of new hires.

There is also a vascular identity within hospital systems as well as resource alloca­tion dimension to consider. “Vascular sur­gery should get the resources that it needs based on the services it provides,” Hart says. “Some of our cases, we are back-up for cardiology, or we are back-up for inter­ventional radiology when they have access complications.

“To make sure vascular surgery gets the recognition and the resources that it de­serves to provide both surgical back-up and radiological assistance to so many different departments is really important.”

The next step in this line of study will see Hart and colleagues delve deeper into their more complex endovascular cases in order to ascertain the extent of incorrect coding issues. “We’re trying to find out what that looks like now because one of the other is­sues that I’ve found in my department in my particular system is that we don’t get RVUs

Alissa Hart

associated with reading vascular labs,” she explains. “What I’ve learned in the complex­ity of the bureaucracy in the federal govern­ment, your [productivity] scores are only as good as the data put in.”

So now Hart’s team will look to in­corporate that data with their operat­ing room coding in

order to determine what is being missed—“not just with vascular lab readings, but also on the ra­diological interpretation, ultrasound guidance, all those things for those CPT [Current Procedural Terminology] code modifiers, and see how many RVUs we’re losing.”

SVS announces on-demand coding courses are now available

To expand coding educational resources, the Society for Vascular Surgery (SVS) and long-term partner KarenZupko and Associates Inc. (KZA), a consulting and education firm, plans to release a series of on-demand courses quarterly that will examine the intricacies of coding for vascular surgery. The first course launched in December 2023.

Each fall, the SVS hosts an in-person Coding and Reimbursement Workshop, but the need for additional resources was clear, stated SVS Advocacy Council Chair, Megan Tracci, MD. “Coding is a critical part of running a successful practice for all vascular surgeons and we’re in need of resources, but they’re scarce,” she explained. “The SVS is working to ensure our members have access to the information they need.”

The first course focuses on surgical modifiers in vascular surgery. Modifiers tell the payor what happened in surgery and, more importantly, how they impact on reimbursements. The course dives into the most common modifiers and how they are used accurately in vascular surgery scenarios. New courses will drop throughout 2024.

The courses will provide American Academy of Professional Coders continuing education credits. Vascular surgery professionals and their office staff can access the first on-demand course by visiting vascular.org/codinginquiries.

Midterm CARAS study results show cerebral ischaemic event incidence “should not be underestimated”

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Midterm CARAS study results show cerebral ischaemic event incidence “should not be underestimated”

The final publication of midterm results from the observational CARAS study suggest that cerebral ischaemic event (CIE) incidence in asymptomatic carotid stenosis patients “should not be underestimated”, so say authors Rodolfo Pini (University of Bologna, Italy) and colleagues, relaying these findings in the Journal of Stroke and Cerebrovascular Diseases.

The authors further conclude that plaque progression and contralateral stenosis are among factors that may serve as primary predictors of CIEs, as per the results of their midterm analyses—which were initially presented at last year’s Vascular Annual Meeting (VAM; 14–17 June 2023, National Harbor, USA).

“Carotid endarterectomy [CEA] in patients with asymptomatic carotid stenosis remains a subject of debate,” Pini and colleagues initially state. “Current recommendations are based on randomised trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of CIEs. This study presents a midterm analysis of results from an ongoing, prospective, observational study of [asymptomatic carotid stenosis] patients to assess their CIE risk in a real-world setting.”

CARAS is a prospective, observational study of a cohort of asymptomatic patients with >60% carotid stenosis—as per criteria from the original NASCET trial—identified in a single duplex ultrasonography vascular laboratory. Short life expectancy and absence of signs of plaque vulnerability are among the factors cited by the authors for patients in the study not being considered for CEA.

The study’s primary endpoint is to assess CIEs ipsilateral to asymptomatic carotid stenosis, including strokes, transient ischaemic attacks (TIAs), and amaurosis-fugax, along with plaque progression rate and patient survival.

Patient enrolment took place from January 2019 to March 2020, with a sample size of 300 patients being targeted and a five-year follow-up scheduled. CARAS ultimately included a total of 307 patients (average age, 80 years; 55% male), of whom 61 (20%) had contralateral stenosis >60% and some 77% were on best medical management.

At a mean follow-up of 41 months, seven ipsilateral strokes and nine TIAs occurred, resulting in a total of 14 CIEs, Pini and colleagues report. They also note that two patients experienced both stroke and TIA during the follow-up period. And, as per a Kaplan-Meier analysis, the four-year CIE rate was 6%, with an annual CIE rate of 1.5%.

Disclosing further detail on their midterm results, the authors relay that 58 patients (19%) had a stenosis progression that was associated with a higher four-year estimated CIE rate compared to patients with stable plaque (10.3% vs. 3.2%, p=0.01). Similarly, contralateral carotid stenosis >60% was associated with a higher four-year estimated CIE rate (11.7% vs. 2.9%, p=0.002). A multivariate cox analysis revealed that these factors were independently associated with a high CIE risk, with hazard ratios of 3.2 and 3.6, respectively.

“The midterm results of this prospective study suggest that the incidence of CIE in [asymptomatic carotid stenosis] patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs,” Pini and colleagues conclude.

University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project

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University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project
The Aneurisk founders are in the front row (seated from left to right): Nathan Liang, David Vorp and Timothy Chung. The Aneurisk team (standing left to right) are Pete Gueldner a PhD student, lead software developer Chris Niles, and Micah Guffey, director of operations

Last October, the University Pittsburgh’s Clinical and Translational Sciences Institute hosted its 10th Pitt Innovation Challenge (PinCh), providing a total of $550,000 in prizes, with the top-three winners each receiving a $100,000 grand prize. PinCh 2023 announced that SVS member Nathan Liang, MD, and his co-founders Timothy Chung, PhD, and David Vorp, PhD, were awarded $100,000 for developing Aneurisk, an artificial intelligence (AI)-based tool designed to assess the risk and prognosis of patients with abdominal aortic aneurysms (AAAs). 

The grand prize teams presented their proposals to a panel of judges at the Petersen Events Center, where six finalist teams and 10 “elevator pitch” finalists showcased their ideas to address critical health issues. The Aneurisk technology aims to reduce adverse patient outcomes and surveillance costs by providing clinicians with a tool to project growth and likely outcomes upon diagnosis. 

With their collective backgrounds in clinical medicine, biostatistics, biomechanics, artificial intelligence and machine learning, the team collaborated to utilize a retrospective dataset from UPMC to develop a machine-learning model that predicts patient outcomes after approximately five years. 

“The results of our prototype algorithm got us really excited,” said Liang, a vascular surgeon at the University of Pittsburgh Medical Center (UPMC) and assistant professor of surgery and bioengineering at the University of Pittsburgh. “There is a potential opportunity to use our technology for treating or, at the very least, understanding these aortic aneurysms better. It became clear that this was a technology that could become something, and that’s where we were encouraged by the Pitt Innovation Institute to spin out a startup company.” 

Aneurisk focuses on utilizing AI to assess the risk of AAA patients. The patent-pending technology has the potential to revolutionize the field by providing a preliminary prediction of aneurysm behavior, offering clinicians valuable insights for treatment decisions, said Liang. Work on the technology goes back over five years and led to the recent incorporation of the company in February 2023. Since they started working together, the team has received more than $1 million in funding for research and development. 

Chung highlighted the importance of engaging with potential end-users during the development phase. The team spent six weeks contacting vascular surgeons across the country and other potential customers to gauge interest and refine their hypothesis and technology approach. The team expressed their gratitude for the responses received from SVS members who took the time to speak about common pain points in managing patients with AAAs. 

“We have developed AI tools to accelerate image-based analyses, all while modeling clinical outcomes. Acceleration is critically important in offering point-of-care solutions for identifying which patients are at higher risk,” said Chung. 

“The power of the machine-learning approach we are taking is that the prediction algorithm will be trained using many types of data and will determine which types and which specific parameters are critical in forecasting future aortic aneurysm enlargement or even eventual outcomes. We now know that biomechanics—specifically the balance between wall stress and strength—is important in considering the current risk of aneurysm rupture, but what other factors—and combinations of factors—can predict future rupture accurately now? What groups of parameters can predict future growth or time to critical size for the aneurysm? When fully constructed and clinically validated, Aneurisk will be able to do this on a patient-specific basis,” explained Vorp. 

The Aneurisk team is now seeking additional funding to transition their technology from a proof-of-concept to a practical tool clinicians can use for patients. “I’ve been doing this long enough to know that many people promise a lot, but not everyone follows through. We’re trying to ensure that we’re offering something that meets the needs of patients and our fellow vascular surgeons,” said Liang. 

International collaboration unveils updated PAD guidelines in diabetic foot ulcers

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International collaboration unveils updated PAD guidelines in diabetic foot ulcers
New guidelines cover

The International Working Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) have jointly released updated guidelines for the diagnosis, prognosis and management of peripheral arterial disease (PAD) in individuals with diabetes mellitus and a foot ulcer. 

The guidelines were developed using GRADE (Grading of Recommendations, Assessment, Development and Evaluations) methodology and were supported by several systematic reviews organized by Vivienne Chuter, MD, professor of podiatry at the University of Newcastle, Australia. The aim is to provide consistent, multidisciplinary and inter-societal recommendations applicable to clinicians everywhere. 

SVS President Joseph Mills, MD, affiliated with Baylor College of Medicine in Houston, who co-chaired the writing committee along with Rob Fitridge, MD, of the University of Adelaide, Australia (IWGDF) and Rob Hinchliffe, MD, of the University of Bristol, England (ESVS), shed light on the significant developments. 

“This collaboration, with extensive input from multiple specialties, represents a critical step forward in addressing diabetes-related foot complications across the globe,” Mills said. 

Building upon the 2019 IWGDF guideline, the updated guidelines cover a spectrum of crucial aspects of diabetic foot care. The writing committee, consisting of 18 experts from various disciplines, including vascular surgery, angiology, interventional radiology, vascular medicine, endocrinology, epidemiology and podiatry, worked collaboratively to develop recommendations that span the entire continuum of care. 

The guidelines were jointly published in the Journal of Vascular Surgery, the European Journal of Vascular and Endovascular Surgery and Diabetes/Metabolism Research and Reviews. 

The guidelines include five critical recommendations for diagnosing PAD in individuals with diabetes, both with and without a foot ulcer or gangrene. Additionally, the guidelines offer five recommendations for prognosis, aiding in estimating the likelihood of healing and amputation outcomes in those with diabetes and a foot ulcer or gangrene. 

A comprehensive set of 15 recommendations focuses on PAD treatment, prioritizing individuals for revascularization, selecting appropriate procedures and post-surgical care. The writing committee, conscious of potential gaps in current evidence, also highlighted key research questions for further exploration. 

Mills stressed the importance of these guidelines in improving patient care and reducing the burden of diabetes-related foot complications. “By becoming familiar with and following these recommendations, healthcare professionals can enhance their ability to provide better care to individuals with diabetes, ultimately improving outcomes,” he said. 

Mills indicated that the international, multidisciplinary approach to developing these guidelines reflects a concerted effort to address the diverse needs of patients with diabetes around the world. 

“As healthcare professionals begin to implement these updated recommendations, we hope to substantially diminish the burden of diabetes-related foot complications, reduce preventable, major limb amputations and improve outcomes for individuals worldwide,” said Mills. 

First procedures announced in study of novel peripheral IVL system

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First procedures announced in study of novel peripheral IVL system
A FastWave first-in-human case

FastWave Medical has announced the successful completion of enrollment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (IVL) technology.

The prospective, single-arm study aims to assess the safety and performance of FastWave’s IVL system in patients with peripheral arterial disease (PAD) of the superficial femoral or popliteal arteries with moderate to severe calcium. Principal investigators Miguel Montero-Baker, MD, a vascular surgeon from Houston Methodist Hospital and HOPE Vascular & Podiatry Clinic in Houston, Texas, and Venkatesh Ramaiah, MD, a vascular surgeon from HonorHealth Vascular Group and Pulse Cardiovascular Institute Scottsdale, Arizona, conducted the procedures successfully in collaboration with the hosting investigator, Antonio Muñoa, MD, of San Lucas Hospital in Tuxtla Gutiérrez, Mexico.

Montero-Baker stated: “I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform. Their team has rapidly developed an easy-to-use system to address existing technological gaps, marking a significant milestone in achieving the company’s near-term goals.”

FastWave’s IVL platform is designed to treat calcific artery disease by fracturing calcium deposits using a balloon catheter that delivers shockwaves. The company’s peripheral IVL technology offers a user-friendly design with a highly deliverable, low-profile, rupture-resistant balloon that generates durable and predictable circumferential ultrasonic pressure, the company says in a press release.

“Calcium poses significant therapeutic challenges in treating peripheral artery disease, and many of the existing modalities are not optimal for addressing medial and deep plaque,” stated Ramaiah. “FastWave’s peripheral IVL technology is a promising advancement in calcium modification, and I am excited by the procedural success in these initial cases.”

New Florida vascular chief sets vision aimed at improving outcomes through multidisciplinary collaboration and innovation

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New Florida vascular chief sets vision aimed at improving outcomes through multidisciplinary collaboration and innovation
Jean Bismuth and Murray Shames

This advertorial is sponsored by Tampa General Hospital.

Early on, Jean Bismuth, MD, acquired a passion for vascular surgery from a world-class source. Back in his Danish homeland, he was drawn into the specialty as an intern by pioneering vascular surgeon and former European Society for Vascular Surgery (ESVS) President Henrik Sillesen, MD. Under Sillesen at the University of Copenhagen, he quickly acquired a keen awareness for how innovation drives the vascular field forward and the part it plays in improving patient outcomes. Add into the mix a keen sense for the important role played by multidisciplinary teamwork, and key elements of Bismuth’s approach to vascular surgery come into focus.

As Tampa General Hospital (TGH) and the University of South Florida (USF)’s new chief of vascular surgery, those core values are set to perform an important function. TGH’s Heart & Vascular Institute (HVI)—of which the Division of Vascular Surgery is a central plank—is growing and evolving. Long-standing vascular chief Murray Shames, MD, was appointed TGH chief of staff and USF chair of surgery. So Bismuth takes over at a critical juncture.

“It was clear to do justice to the growing division and the HVI that we needed to bring in a new leader—somebody with experience, an excellent clinical reputation, an innovator with an established research portfolio, and a commitment to our education mission for our residency program,” says Shames, who has been connected to TGH for three decades and division chief since 2017. “Dr. Bismuth brings national and international recognition to the division and the Department of Surgery. It was important that we find somebody with that experience who we could trust with a division that means a lot to me personally from an emotional and career development perspective. I have been part of USF and TGH for 30 years and so it was important to pass that baton to an established leader who would take it to the next level, beyond what I have been able to do.”

At TGH, the HVI service line model has evolved from a legacy academic department into its current guise: more collaborative and multidisciplinary.

For his part, Bismuth, in post two months now, is clear about the direction of travel. “What is necessary to make the TGH HVI successful? It’s really innovation in care,” he says. Bismuth doubles up as the HVI Vascular Center of Excellence medical director. He has wasted little time setting his vision in motion.

“The willingness here to have an open mind about how to build and how to structure this model so that the three units that belong under the HVI are successful is actually imperative,” Bismuth reflects. “One of the things we want to do is innovate in the therapies we deliver. Already, I have been reaching across platforms. Part of the vision is to demonstrate that there is a mission across borders. We have to break down these barriers between the specialties. Working across specialties really has defined my career.”

Bismuth came to Tampa from Houston. There, he was an associate professor of surgery at Houston Methodist, landing in Texas to complete his fellowship. Initially expecting to move back to the East Coast soon after finishing his training, Bismuth stuck around. Houston holds significant vascular surgical history, the home base of luminaries such as Michael DeBakey, MD, and E. Stanley Crawford, MD.

He credits much of his technical acumen to his time there, crediting a somewhat unlikely source for his education. “My grounding in terms of skill came primarily from one of my cardiac mentors there, Dr. Michael Reardon ,” he says. “A lot of the techniques I use today, they come from him. It’s a little ironic that cardiac surgery taught me vascular surgery!”

That pioneering spirit of Houston vascular surgery sharpened a natural gravitation toward innovation and collaboration. “It’s a big center there,” Bismuth explains. “It opened some doors for me, particularly with respect to my attributes. I work well across specialties. We had the good fortune of having a structure around the Heart and Vascular Center, which really allowed us to work well across specialties, so much so that I would say that probably 90%—if not more—of all my research were collaborations with cardiology in particular, and also cardiac surgery. It made for a very fruitful interaction. From an innovation standpoint, because it’s such a large medical center, it attracts a lot of medical startups, and I worked with a lot of new companies during my time there.”

Bismuth covers the full range of vascular disease but has particular clinical and research interests in aortic dissection, peripheral arterial disease (PAD) and central venous pathologies. That innovative spirit found early purchase during his days in Houston, where the specter of aortic dissections initially stumped him.

“Initially, I didn’t understand aortic dissections, and I don’t mean technically but from an imaging standpoint—they really perplexed me, by how they behaved and how they evolved,” he says. “As I worked across specialties, with cardiology, we started to develop specific imaging techniques for better understanding of these dissections.”

In the immediate term, Bismuth has his sights set on defining how the TGH HVI vision will translate on the ground in Tampa for the community at large. Longer term, he wants TGH to be an extension of what is a rapidly growing city. “It’s about being at the forefront of the trials, making sure industry is interested in bringing trials to Tampa,” he says. “I also think it is important that we have physician-driven innovation. And we have a unique structure in that we have CAMLS [Center for Advanced Medical Learning and Simulation], a fantastic 30,000-square-foot training location that almost nobody else in the country has. We have a common vision here in making Tampa an education destination.”

For Shames, stability has been a defining facet of his TGH department since he first landed 30 years ago. “We have not had a lot of turnover at the helm of vascular surgery here during my time, and I’m looking forward to a long career and legacy that Dr. Bismuth is going to leave behind,” he says.

“Tampa itself is evolving,” adds Bismuth. “Its expansion and what it promises is second to none. Migration to Tampa is huge. There is a general sense of innovation in the whole city.”

First patients enrolled in VBX FORWARD clinical study

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First patients enrolled in VBX FORWARD clinical study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Gore Viabahn VBX balloon expandable endoprosthesis

Gore has announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) to bare metal stenting for patients with complex iliac occlusive disease

The trial aims to enroll an estimated 244 patients across 40 sites in the U.S.AustraliaNew Zealand and Europe, randomizing them 1:1 to the VBX stent graft group or the control group (BMS) and conduct follow-up visits through five years from the initial procedure.

“Treating complex iliac occlusive disease often comes with significant challenges, including tortuous anatomy and calcified lesions with the potential for rupture,” remarked Melissa Kirkwood, MD, professor and chief of vascular surgery at the University of Texas Southwestern Medical Center in Dallas, Texas, and study steering committee member. “The outcomes of this important trial will help determine whether the VBX stent graft, with its unique and versatile design, plays a meaningful role in addressing these challenges.”

A Gore press release details that the VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. It states that recently published long-term follow-up of patients treated with the stent graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device through five years.

Vascular Specialist–January 2024

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Vascular Specialist–January 2024

In this issue:

  • Coding: Increasing complexity and lost RVUs—a drop in the ocean? 
  • The utility of renal stenting in hemodialysis patients: one in five found to come off dialysis after being stented
  • SVS points to 2023 achievements, challenges in coming year
  • Guest editorial: How the best leaders ensure psychological safety at work 
  • Aortic Research Consortium: F/BEVAR risk factors and one-year mortality 

 

U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs

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U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs
Adam Beck

A series of preoperative risk factors—including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

That is the key finding from one of the latest papers to come out of the U.S. Aortic Research Consortium (U.S. ARC) of investigational device exemption (IDE) trials set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27).

The 10-center, more than 3,000-patient research conglomerate aims to use the data generated to create a risk stratification calculator to help inform a preoperative decision-making process that balances risk of aneurysm rupture if no intervention takes place, and mortality risk at one year if the disease is operated upon, Adam Beck, MD, a U.S. ARC investigator and vascular surgery division director at the University of Alabama at Birmingham in Birmingham, Alabama, told Vascular Specialist ahead of the SAVS 2024 meeting.

“The typical discussion when we are in clinic talking to patients about whether or when they should repair their aneurysm always focuses on the risk of rupture,” he said. “And that risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture. That was the idea behind this one-year mortality risk. So, you can say, ‘This is the risk of doing nothing, and here is the risk of doing something,’ in the setting of the patient’s overall state of health and quality of life.”

Operative mortality can be very low—from 1–2%—depending on the extent of the aneurysm and complexity of the repair, Beck observed. “But the mortality when you go out to a year can be much higher than that. So, something is happening to these patients after they get repaired. It’s not rupture of their aneurysm. Many of them are dying of their other medical comorbidities.” 

The U.S. ARC researchers looked at the full range of preoperatively available risk factors—gender, race, age, coronary disease, CHF, emphysema, cerebrovascular disease, diabetes, renal disease, hypertension, as well as both smoking and preoperative functional status. They were stratified by Crawford extent of their aneurysm: one complex AAA (juxtarenal/suprarenal) and two separate TAAA groups—one comprising Crawford type IV and V and the other the particularly high-risk extent I–III group, Beck explained.  

“The things that we found that were predictive of one-year mortality in a multivariable Cox regression was if they were a current smoker, if they had CKD, CHF, a very large aneurysm (greater than 7cm), more advanced age (75-plus), extent I–III TAAAs, patients with known COPD, and those who were anemic at baseline,” he said.

“The aneurysm size is a tough one. That one always falls out in an analysis like this: the bigger your aneurysm, the higher your risk of one-year mortality. It’s an interesting thing because the bigger your aneurysm, the more likely we are to offer you a repair—even in the setting of higher-risk patients, because we’re weighing that risk-benefit with rupture.”

During SAVS 2024, the research team will break down what the risk looks like in their predictive model by increasing risk factors. The risk calculator the U.S. ARC investigators hope to generate would enable individual patient data to be plugged in to gauge their one-year mortality risk.    

“Hopefully this could be something that will allow you to discuss with the patient in clinic and say, ‘Here is your risk of rupture, and here is your risk of mortality at one year. I think that it makes sense to proceed with your repair.’ Or you could say, ‘It really doesn’t make sense at your current size for us to put you at the risk of the operation,’” explained Beck. “This could also help you with your discussions about smoking cessation. If we could show patients on our phones apps and say, ‘This is your risk of mortality at a year with you being a current smoker. If I take this risk factor out, here is your risk factor at one year, and it will be a sizable difference.’ I think that will really help that discussion with the patient and our clinical decision-making.”

Further down the road, U.S. ARC is set to continue building on its body of work with additional analyses in areas such as target-vessel outcomes based on type of stent graft used, the impact of aortic aneurysm sac behavior after repair, the impact of renal insufficiency on outcomes, and the impact of endoleaks on mortality. The group has also recently completed a pilot study for a randomized controlled trial (RCT) for prophylactic spinal drains in patients with extent I–III TAAAs. The latter particularly excites Beck owing to his long-standing interest in preventing spinal cord ischemia as a complication of complex aortic aneurysm repairs.

Another recent development saw U.S. ARC include aortic arch procedures in its registry. “A few of the centers are capturing data for their endovascular aortic arch reconstructions,” Beck noted. “This is still in its infancy, but we’ll have some consortium data to publish in the next year or two, once we have more patients.”

Despite being only about six years old, U.S. ARC is having a big impact on evolving the arena of complex repair of TAAAs and AAAs, Beck said. “In our group, we have each changed our practices based on our publications,” leading to quality improvement, he added. “I’m biased because of my personal academic interests, but I think if we can actually get a [large, nationwide] RCT going for spinal cord ischemia, that would be one of the biggest contributions that we could make to the aortic surgery world. It will take a few years to enroll the number of patients we will need, so successfully initiating the trial may be one of our next big landmarks.”

The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented

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The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented
J. Gregory Modrall

A fifth of patients among a chronic kidney disease (CKD) cohort on hemodialysis—a rare subset pulled from a large repository of national data—were able to come off the treatment following renal artery stenting, a team of researchers from the University of Texas (UT) Southwestern Medical Center in Dallas has found.

The findings—set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27)—have been hailed as being potentially the best evidence available in the field of renal stenting for decades to come, among a patient population so few in number that a randomized controlled trial (RCT) would almost never be viable, senior investigator and vascular surgeon J. Gregory Modrall, MD, a professor of surgery at UT Southwestern Medical School, told Vascular Specialist ahead of SAVS 2024.

“I have worked in the area of renal artery stenting for a number of years, but we have always focused on patients who had CKD and were not yet on dialysis,” Modrall explained.

When working on a larger study, using the TriNetX clinical database, he realized an opportunity had presented itself because of the repository’s sheer size. “It has a very large number of patients who were already on dialysis when they got stented,” said Modrall. “I realized that this presented a unique opportunity to address something that the literature is completely lacking.”

Among 173 patients who met inclusion criteria, Modrall and colleagues show that 33 (19.1%) were rescued from dialysis after stenting and were categorized as responders. At 30–90 days post-stenting, the median eGFR (estimated glomerular filtration rate) for responders was 51.6 ml/ min/1.73 m2 and remained stable over a median follow-up of 1.1 years. Survival was superior for responders, compared to non-responders, they found.

“We looked at patients who were on recent dialysis or current dialysis at the time of the renal artery stenting,” Modrall explained. “We defined recent stenting as within 60 days. The goal was to avoid inclusion of patients who maybe had dialysis six months ago but were no longer on it.

“Many of us in this field have had the sense there may be a small subset who can come off dialysis if stented at the right time but we have never had any data to guide us in patient selection, so, by and large, providers have just decided if patients are already on dialysis then they’re not going to stent that patient.

“What we found was that there is a subset that will come off dialysis—it’s about 19% of stenting patients came off in this cohort.”

Modrall and his team established that there were three basic predictors: duration of pre-stenting dialysis <79.5 days, diabetes and smoking. Two were dominant, he said. “Diabetes was a negative predictor.”

Those two dominant variables within the cohort alone “predicted 83–84% of the outcomes accurately,” Modrall continued. “So, we think that’s pretty solid data that suggest that we should be looking especially at those two variables in choosing the patients for stenting.”

With no RCT ever likely to be carried out in this subset of patients because the number who were stented in any given institution while already on dialysis are so few up to now, the data from his SAVS paper “might be the best we have for decades,” reflected Modrall.

“I personally wouldn’t stent every patient who was recently on dialysis, had renal artery stenting and was not a diabetic, because we have got to look at other factors like long-term survival, ability to tolerate the procedures, etc., but I think that is a good starting place and a lot more than we had before this study began,” Modrall added.

“It’s always going to be a difficult decision and it’s something that should be made in conjunction with a nephrologist, the patient and after looking at life expectancy and the patient’s ability to tolerate the procedure. With good education, the patient should be very active in making that decision. The chances are not high, one in five, but if we can take you off dialysis, it will have a huge impact on your life going forward.”

The ongoing larger study on which Modrall and colleagues are working revealed that patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73m2) are the only sub-groups with a significant probability of improved renal function after renal stenting, with the rate of decline of preoperative eGFR over the months prior to stenting a powerful discriminator of patients who are most likely to benefit.

Those results, delivered during SAVS 2023 in Rio Grande, Puerto Rico, last January, bore the ultimate aim of creating a prediction tool. At the time, Modrall pointed out that the predictors highlighted were “putative,” or “candidate predictors,” that have not been validated in a prospective series. “The next step is to take the data from this study, combine it with two of our prior studies, and in doing so we will have close to 1,800 patients with renal artery stents,” he said at the time. “That represents the single largest dataset of renal artery stenting patients in existence to my knowledge.”

Modrall and his team explained how they had hoped to leverage the enlarged dataset to create an outcome prediction tool that clinicians can use in practice. He envisaged a desktop- or phone-based application into which a patient’s parameters could be input in order to establish a probability of improved renal function.

“It turns there are variables that we haven’t defined,” he said prior to SAVS 2024. “The predictive capacity is better than we have now, but it is not as high as I’d like to see it. We are continuing to work on that.

“If I cannot get to a predictive capacity with this database that I think is sufficient, the next step would be to take a machine-learning approach to try to identify variables that maybe we haven’t even considered before.”

BEST-CLI: A year down the road

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BEST-CLI: A year down the road
Alik Farber presents data from BEST-CLI for the first time in November 2022

A dedicated session at the 2023 VEITHsymposium (Nov. 14–18) in New York City aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limb-threatening ischemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022.

The trial’s principal investigators (PIs)—Boston-based vascular surgeons Alik Farber, MD, and Matthew Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD, also of Boston—invited a multidisciplinary panel of opinion leaders from both the U.S. and Europe to share their thoughts and highlight some unanswered questions. 

‘We don’t cure these people’ 

First to comment was vascular surgeon Peter Schneider, MD, from the University of California San Francisco in San Francisco. “One thing I think is worth calling out is the change over one year,” he began. Schneider recalled that, during a 2022 VEITHsymposium session on BEST-CLI, “everybody was worried in some way” about what was going to happen next. A year later, however, he pointed out that “that’s melted away completely.” This change in opinion, in Schneider’s view, is testament to the leadership of the three PIs. 

Schneider’s main point was that BEST-CLI has contributed to a recognition that CLTI treatment is “much more complicated” than revascularization alone, predicting that the field is “going to become more like cancer treatment.” He continued: “These people have cancer. It was clear to all of us how sick they are, but now it will be clear to a much broader audience” 

Vascular surgeon and SVS President Joseph Mills, MD, from Baylor College of Medicine in Houston, expanded on Schneider’s point. “This cancer analogy works really well,” he said. “We don’t cure these people, and what we want to do is try to put them in remission for as long as possible.” Here, Mills advocated the use of endpoints that look at disease-free survival and wound-free period, suggesting they are probably the most useful for assessing long-term outcomes. “We should start looking at what’s better for [patients’] long-term care and not even one- or two-year results, but what happens over the lifespan of that patient,” he said. 

Antiproliferative therapy key 

Interventional radiologist Robert Lookstein, MD, from Mount Sinai Health System in New York, echoed Schneider’s sentiment that “the discourse [around BEST-CLI] has become more constructive than deconstructive” over the course of the past 12 months, in large part thanks to the trial leadership. 

He was keen to stress, however, that it is “obviously concerning” BEST-CLI reached different outcomes to BASIL-2, presented in April 2023. “It should be recognized they’re studying different populations,” he noted. Lookstein also highlighted the fact that there were very few women and underrepresented minorities enrolled in these two trials, urging caution with regard to extrapolating the results to these specific demographics. 

Lookstein’s pointed to the importance of antiproliferative therapy. He referenced a retrospective analysis presented earlier in the session by vascular surgeon Michael Conte, MD, from the University of California San Francisco, that suggested the endovascular arm of BEST-CLI “would probably have better outcomes” had the endovascular protocol been standardized with the level one evidence available on antiproliferative therapy and the infrainguinal circulation. “We have massive amounts of data [showing] that [antiproliferative therapy] is superior to non-antiproliferative therapy,” he stressed, asking why—against this backdrop of evidence— any vascular specialist would withhold this technology from their patients. 

Rosenfield, from Massachusetts General Hospital, pointed out that if he were to place a bare metal stent in a coronary vessel, “that would almost be malpractice nowadays.” 

Menard, of Brigham and Women’s Hospital, also picked up on Lookstein’s point, saying that one of the very important current challenges is that of “how to get the best endo[vascular] and the best surgery out there.” 

Lookstein added: “I think it behooves all of us to either lobby the guidelines or to speak out.” He mentioned the “profound” data presented by Conte on the impact of antiproliferative therapy on patency. “I firmly believe drug-coated balloons and stents must be considered the standard of care at this point.” 

Put the patient first 

Vascular surgeon Elizabeth Genovese, MD, from Penn Medicine in Philadelphia, noted the endovascular-first nature of her clinical expertise, which stemmed from the fact that she had worked for five years in the southeast of the U.S., where her patients had been “very medically complex and often poor surgical candidates.” 

Once BEST-CLI was published, Genovese stated that she moved to offering a more “patient-first” approach. Now, she relayed, her practice is framed around the question of which patients fall into the BEST-CLI cohort that does well with bypass first compared to an endovascular-first approach. “These are the patients who not only have good vein, but that tend to be on the healthier spectrum of the patient population; these are the patients that I didn’t necessarily see in the first five years of my practice,” Genovese noted. “But simultaneously, the patients in the open cohort had a fairly high anatomic complexity,” she added, referencing that over 60% of patients had infrapopliteal targets and 51% of the endovascular arm required tibial interventions. “What this study has done for us is made us realize that, in the right patient population, in more complex anatomic patients, bypass first remains still a really good and durable option,” Genovese summarized. 

Responding, Rosenfield stressed that “we need to be better about case selection for all of our techniques.” 

No more silos 

Interventional cardiologist Carlos Mena-Hurtado, MD, from Yale School of Medicine in New Haven, Connecticut, remarked that—for him and his institution—BEST-CLI had been “incredibly important” because “it made us come out of silos and it made us understand […] that CLTI is more than simply just revascularization.” He stressed that, while there is “a lot of work to do,” it is important not to put blame on each other. “I think we need to create the spaces where we can come together and discuss how best to [treat these patients],” he said. 

“The single most important thing that I learnt from the trial was the fact that when we had a patient with CLTI come into our facility, we would be forced to look at [the case] together,” Mena-Hurtado added. “We continue that practice up until today, and I think it has made not only our outcomes better, but our patients better.” 

‘There’s more work that needs to be done’ 

Vascular surgeon Maarit Venermo, MD, from Helsinki University Hospital in Helsinki, Finland—who noted that her center was the first site outside the U.S. to join the trial—pointed to the “huge number” of future studies in the works, which she believes will inform decisions around which treatment is best for which subgroups of CLTI patients. “Also, there will be a population who don’t benefit from endo[vascular] or surgery,” she added, stressing the importance of taking this into account when making clinical decisions. 

Farber, of Boston Medical Center, also encouraged audience members to look ahead to what is next, stressing that BEST-CLI and BASIL-2 are just the start. “No matter what your views are on [BEST-CLI] or BASIL-2 […], the exciting thing is that we have data coming in this space, which did not have a lot of data [before],” he said. Farber said more work needs to be done, with the “top priority” now to “harmonize” BEST-CLI and BASIL-2 using patient-level data. “It’s an exciting time,” he added. 

No increased risk of complications found with transradial access for carotid artery stenting

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No increased risk of complications found with transradial access for carotid artery stenting
Santiago Ortega-Gutierrez

Carotid artery stenting (CAS) delivered via transradial artery access has demonstrated no increased risk of stroke, death, myocardial infarction, transient ischaemic attack, or access site complications, as compared to the more traditional transfemoral approach. That is the concluding finding of a recent Stroke: Vascular and Interventional Neurology publication from Santiago Ortega‐Gutierrez (University of Iowa Hospitals and Clinics, Iowa City, USA) and colleagues.

“The transradial approach shows promise as an alternative method for CAS, offering potential benefits without increased risk of complications,” the authors write. “However, further studies are needed to confirm these findings.”

Ortega-Gutierrez and colleagues initially aver that transfemoral arterial access, while still the most widely used and preferred method for CAS, is associated with “inherent limitations and potential complications”, primarily related to access. The authors further state that positive results and experiences within interventional cardiology have seen transradial displace transfemoral access, becoming the primary approach for many cardiovascular procedures.

“Consequently, exploring transradial artery access as a potential option [due to innovative advances in large bore catheters] becomes crucial in optimising patient outcomes and procedural success rates,” they add, also noting that there are limited data comparing the approach and its outcomes to transfemoral access in CAS.

As such, the authors conducted a systematic review and meta-analysis of the existing literature in this space. From an electronic search of four databases, randomised and non-randomised studies alike involving CAS via transradial or transfemoral approaches were included. Overall, six studies comprising a total of 6,917 patients featured in their analyses. Some 602 of these patients (8.7%) underwent transradial access for the procedure, while 6,315 (91.3%) received transfemoral access.

Ortega-Gutierrez and colleagues’ subsequent meta-analysis showed “no significant difference” between the two access approaches in terms of stroke occurrence, with strokes being observed in 1.7% of patients in the transradial group and 1.9% in the transfemoral group (odds ratio [OR], 0.98). Furthermore, no significant differences were detected regarding death (1% vs. 0.9%, respectively; OR, 0.95), myocardial infarction (0.2% vs. 0.3%; OR, 1.53), transient ischaemic attack (0.4% vs. 1%; OR, 0.46), or access site complications (2.2% vs. 1%; OR, 0.97).

These findings align with other, previously published meta-analyses of the data in this area, according to the authors. However, in contrast to those analyses, the present study employed a Grading of recommendation, assessment, development, and evaluation (GRADE) approach to assess the certainty of the evidence—with the hope of providing “a more comprehensive and robust evaluation of the safety of CAS to better inform decision‐making”.

“Although these results indicate the potential viability of the transradial approach as an alternative to the traditional transfemoral access for CAS, the relatively small number of studies, considerable heterogeneity [in outcome definitions] among them, and the low certainty of evidence, highlight the need for caution in relying on these findings,” Ortega-Gutierrez and colleagues write. “The clinical decision‐making process should therefore be guided by a personalised approach that considers individual patient characteristics and anatomical considerations. Further studies, including RCTs [randomised controlled trials] with larger sample sizes, are warranted to confirm and refine these findings, and to guide clinical decision‐making in the selection of the optimal access approach for CAS.”

FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system

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FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system

Endovascular Engineering (E2) has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its ENGULF US pivotal trial.

The study will evaluate the safety and effectiveness of the Hēlo thrombectomy system in treating pulmonary embolism (PE). The approval of the IDE follows the successful completion of the company’s 25-patient feasibility study.

“We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study. This significant achievement sets the stage for definitive results in the ENGULF pivotal trial. The Hēlo thrombectomy system represents a significant leap forward in pulmonary embolism treatment, and I am enthusiastic about investigating its full potential in the upcoming phase of the study,” said Jay Giri (University of Pennsylvania, Philadelphia, USA) the national principal investigator (PI) for the ENGULF feasibility study.

“We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Hēlo thrombectomy system’s role as a transformative force in the treatment of pulmonary embolism,” said Andrew Klein (Piedmont Heart Institute, Atlanta, USA), the national PI for the ENGULF pivotal study.

Mike Rosenthal, CEO of E2, commented: “The positive results from our feasibility study give us confidence as we enter the pivotal phase. The Hēlo system introduces a differentiated technology with the potential to advance PE treatment options. Embarking on our ENGULF pivotal trial is a significant step, further validating the system’s safety and efficacy. It advances our efforts toward introducing this innovative technology to the market, ultimately helping patients with PE.”

SCAI, SIR, SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable

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SCAI, SIR, SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable
ivus
IVUS imaging

Proceedings from an expert consensus roundtable that discussed the benefits of intravascular ultrasound (IVUS) in lower extremity revascularization procedures were released today in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of Vascular and Interventional Radiology (JVIR), and Journal of Vascular Surgery-Vascular Insights.

The roundtable focused on the current challenges in diagnosing and treating lower extremity revascularization, knowledge and data gaps, and the potential role of IVUS in addressing these challenges. Experts shared their insights and experiences from the fields of interventional cardiology, interventional radiology, and vascular surgery. The expert consensus meeting was convened by SCAI and co-sponsored by: the American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), Society of Interventional Radiology (SIR), Society for Vascular Medicine (SVM), and Society for Vascular Surgery (SVS).

“Improvements in outcomes following peripheral vascular intervention have lagged compared to other endovascular treatments, such as percutaneous coronary intervention. Both clinical experience and evidence support the greater use of peripheral IVUS to reduce adverse events and extend the patency of our lower extremity revascularization procedures. By gathering experts from different specialties, we aimed to foster collaboration and exchange ideas to improve patient care for peripheral IVUS,” said Eric A. Secemsky, MD, lead author of the proceedings document and Director of Vascular Intervention, Beth Israel Deaconess Medical Center. “The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

Lower extremity revascularization is a critical procedure used to restore blood flow to the legs and feet in patients suffering from peripheral arterial disease (PAD) and deep venous pathology. It is estimated that millions of people worldwide are affected by these conditions, which can lead to severe pain, non-healing wounds, and even limb loss if left untreated. Although angiography is the dominant imaging modality in revascularization, it has inherent limitations. IVUS is a minimally invasive imaging technique that allows physicians to visualize the inside of blood vessels in real-time. It provides detailed information about the vessel wall, plaque composition, and blood flow characteristics, enabling more accurate diagnosis and treatment planning.

During the roundtable, participants highlighted the potential of IVUS in guiding revascularization procedures, such as angioplasty and stenting, to optimize outcomes for patients. They also emphasized the need for further research and evidence to support the integration of IVUS into routine clinical practice.

“Vascular diseases are complex conditions requiring team-based care, research and information sharing to ensure that patients have access to appropriate, quality care for their condition,” said SIR President Alda L. Tam, MD. “Ongoing collaboration among these specialties is paramount to improving outcomes for patients worldwide.”

The roundtable concluded with a commitment to ongoing interdisciplinary collaboration and knowledge sharing among physicians. Participants agreed that treatment standards, formal training programs and global quality metrics remain needed to improve patient care.

The considerations and consensus views shared in “Intravascular ultrasound use in peripheral arterial and deep venous interventions: Multidisciplinary expert opinion from SCAI/AVF/AVLS/SIR/SVM/SVS” represent the opinion of the consensus committee members.

Why should SVS members respond when they receive an invitation to complete an RUC survey?

Why should SVS members respond when they receive an invitation to complete an RUC survey?

The Society for Vascular Surgery (SVS) is an active participant in the American Medical Association (AMA)/ Specialty Society Relative Value Scale Update Committee (RUC) process. A very important component of the RUC process is the RUC survey. 

The rules related to conducting an RUC survey are governed by the RUC. The specialty societies conduct the surveys, analyze the data and use those data to advocate for fair physician work relative value units (RVUs). 

RUC surveys are conducted when new CPT (Current Procedural Terminology) codes are approved by the AMA’s CPT Editorial Panel or when the Centers for Medicare & Medicaid Services (CMS) and/ or the AMA RUC identify a service as potentially misvalued. 

RUC surveys are completed online and must be completed independently without coaching or assistance, with the exception of clarification from specialty society staff. 

An RUC survey of physician work solicits information about: physician time required to perform the service; mental effort and judgment; technical skill and physical effort; and psychological stress. 

Respondents are asked to indicate whether the typical patient described in their survey is their typical patient for that procedure. However, regardless of whether the patient described is the respondent’s typical patient, the respondent should complete the survey based on the described typical patient. 

Demographic information about the person completing the survey is collected to assist with data analysis. The survey includes a reference service list of codes for currently performed procedures and their corresponding RVUs. Respondents will estimate how much time it takes to perform the surveyed procedure and the number and level of postoperative visits. 

Respondents will be asked to compare the mental effort and judgment, technical skill or physical effort, and psychological stress of the surveyed code to the reference procedure. 

In the final step, respondents are asked to estimate a relative physician work RVU for the surveyed procedure based on responses to all the previous questions. 

Members, your voice needs to be heard. Next time you receive an invitation in your email to complete an RUC survey, please take the time to complete it. Contact [email protected] with questions. 

Wayne Causey, MD, is a member of the SVS Coding Committee. 

Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system

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Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system
PTAB using the Detour system
Detour
Percutaneous transmural arterial bypass using the Detour system

Endologix recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system, effective since 1 January 2024.

The TPT payment was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries. TPT will provide hospitals with additional device reimbursement when the DETOUR system is used for eligible cases in the hospital outpatient setting. Details on the TPT, code C1604, can be found in the January 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS), accessible on the CMS website and the Endologix website.

Percutaneous transmural arterial bypass (PTAB) with the Detour system, a US Food and Drug Administration (FDA) Breakthrough Device, received premarket approval in June 2023. Endologix states that PTAB offers a novel approach to treating complex peripheral arterial disease (PAD). The company details that Detour enables physicians to bypass lesions in the superficial femoral artery, by using conduits routed through the femoral vein via a transmural passage, to restore blood flow to the leg. According to Endologix, this approach is effective for patients with long lesions (20–46cm in length), those who have already undergone failed endovascular procedures, or those who may be suboptimal candidates for open surgical bypass.

“Being awarded the TPT designation marks an important milestone in our reimbursement strategy and the commercial launch of the Detour system for treating patients with complex PAD. At Endologix, our core mission is to deliver healthcare innovation to improve the lives of patients with vascular disease. With the support from CMS for qualified patients, we eagerly anticipate more patients to benefit from PTAB,” said Matt Thompson, president and CEO of Endologix.

The company advises that the Detour system is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200–460mm in length with chronic total occlusions (100–425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The Detour system, or any of its components, is not for use in the coronary and cerebral vasculature.

VAM travel scholarships open doors for underrepresented medical students

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VAM travel scholarships open doors for underrepresented medical students
A scene from the VAM 2022 Residency Fair in Boston

The Society for Vascular Surgery (SVS) Resident and Student Outreach Committee (RSOC) is accepting applications through Jan. 8, 2024, for the Diversity Medical Student Travel Scholarship. The award aims to provide aspiring vascular surgeons from underrepresented racial and ethnic minorities with the opportunity to attend the 2024 Vascular Annual Meeting (VAM) in Chicago. 

Scholarship recipients will receive financial assistance for travel expenses and complimentary registration for VAM. In addition to scientific sessions, VAM will offer medical student sessions, a mock interview session, a Residency Fair, SVS Connect@VAM and the VAM Mentoring Program. 

Carlo Angello Sánchez Montaño, MD, a previous scholarship recipient, shared his experience as the only Mexican resident from his program to receive the award for VAM 2023. He emphasized the significance of the opportunity, expressing his gratitude for the chance to connect with professionals and participate in the Vascular Health Step Challenge at VAM. 

Applicants currently enrolled as medical or pre-med students must have an active SVS account before submitting their applications. Although not eligible for the monetary travel award, local applicants are encouraged to apply for complimentary registration by selecting “local student/resident” on the application form. 

“My advice to future applicants is never to surrender, do your best, be a good person and pursue what you’re passionate about. If you don’t get selected the first time, don’t lose faith,” said Sánchez Montaño. 

Learn more at vascular.org/DiversityVAMTravel. 

VAM 2024 also includes the General Surgery Resident/Medical Student VAM Travel Scholarship for aspiring vascular surgeons. This scholarship includes a financial award for travel expenses and complimentary VAM registration for medical and pre-med students, as well as general surgery residents. Local applicants can apply for complimentary registration. Learn more at vascular.org/VAMTravelScholarship. 

Meanwhile, several SVS and SVS Foundation Awards and Scholarships are now available for 2024. 

SVS awards 

James S.T. Yao Resident Research Award: Apply by Jan. 10, 2024: This award motivates early-career physicians to pursue research in vascular disease and translational therapies. The recipient receives $5,000, a one-year complimentary subscription to the Journal of Vascular Surgery and the opportunity to present his or her research at VAM (vascular.org/YaoRRA). 

SOOVC Presentation Award and SOOVC Research Seed Grant: Apply by Jan. 15, 2024 for two SVS Section on Outpatient and Office Vascular Care (SOOVC) opportunities to engage in clinical research within office-based labs (OBLs) or ambulatory surgery centers (ASCs). 

The SOOVC Presentation Award (vascular.org/SOOVCPresentationAward) recognizes three outstanding projects, offering recipients the chance to present their research and receive recognition. Additionally, the SOOVC Research Seed Grant (vascular.org/SOOVCResearchGrant) provides three grants of $10,000 each, renewable for a second year, to support data analysis for actionable insights, quality improvement and patient care. 

Excellence in Community Practice Award: Apply by Feb. 1, 2024 for this award (vascular.org/CommunityPracticeAward), which honors a practicing vascular surgeon who has demonstrated exceptional leadership within their community. 

Lifetime Achievement Award and Medal for Innovation in Vascular Surgery: Nominate by March 1, 2024 for these honors. The Lifetime Achievement Award (vascular.org/LifetimeAward) is the highest accolade bestowed by the SVS. It recognizes an individual’s outstanding and sustained contributions to the profession and the Society, and exemplary professional practice and leadership. 

The Medal for Innovation in Vascular Surgery honors individuals whose transformative contributions have had a profound impact on the practice or science of vascular surgery. 

SVS Foundation awards 

Apply by March 1, 2024 for the SVS Foundation Clinical Research Seed Grant (vascular.org/ClinicalResearchGrant) to encourage clinical investigation in vascular disease. There is a Feb. 1, 2024, deadline for the Student Research Fellowship (vascular.org/studentfellowship), which supports laboratory and clinical vascular research by undergraduate and medical school students. 

Trainees should apply by Jan. 10, 2024, for the Vascular Research Initiatives Conference (VRIC) Trainee Award can receive this award (vascular.org/VRICTraineeAward). VRIC fosters collaboration and encourages interest in research among aspiring academic vascular surgeons. 

Vascular Specialist’s top stories of 2023

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Vascular Specialist’s top stories of 2023

top 10Which stories captured the attention of the vascular community over the course of the past year? Read our summary of the trending articles from across Vascular Specialist in 2023. Let us know your highlights by leaving a reply at the foot of the page with your comments.

1. Coding: New CPT codes for percutaneous arteriovenous fistula creation

Back in February, Sunita Srivastava, MD, and David Han, MD, worked through the 2023 Current Procedural Terminology (CPT) code set and the two new codes governing arteriovenous (AV) fistula creation in the upper extremity.

2. SVS responds to New York Times article on overuse of vascular interventions

In July, SVS President Jospeh Mills, MD, penned a response to the swirling coverage in the mainstream media of inappropriateness in vascular care.

3. Likes, dislikes and reposts: The new age of the vascular surgery influencer

Early in the year, Jean Bismuth, MD, and Jonathan Cardella, MD, tackled the thorny topic of vascular surgeons’ use of social media, starting their piece with the searing opener: “The brave new world of social media, with its TikToks and Kar­dashians, has now invaded our once-sane specialty.”

4. From the editor: Sex, lies, and carotid stents

In our October issue, Malachi Sheahan III, MD, Vascular Specialist medical editor, entered the debate around the Centers for Medicare & Medicaid Services (CMS) decision to expand coverage for carotid artery stenting. He dealt, in part, with the issue of practitioner competence in the treatment of asymptomatic carotid disease, writing: “Vascular surgeons matriculate into the workforce with documented technical and educational experience in the treatment of carotid disease. For other specialties? Not so much.”

5. Surmodics provides regulatory update related to FDA premarket approval application for SurVeil

Surmodics announced in January how it had received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB). In the letter, the FDA indicated that the application was not currently approvable, while providing specific guidance as to a path forward. The device received approval in July.

6. Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief

In April, we interviewed Alan Lumsden, MD,  the Walter W. Fondren III Presidential Distinguished Chair at Houston Methodist’s DeBakey Heart & Vascular Center in Houston, Texas, on an emerging program at Houston Methodist that aimed to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery.

7. Letter to the editor: The vascular influencer

W. Michael Park, MD, from University Hospitals in Cleveland, Ohio, responded to the earlier editorial penned by Jean Bismuth, MD, and Jonathan Cardella, MD, focused on social media use by vascular surgeons. “The voices of non-academic surgeons are given a platform to broadly share their experience,” he retorted in his piece. “If legitimately good people are dissuaded from participating, only the cheap suits will remain.”

8. Vascular surgery added as named specialty to influential national hospital rankings 

In July, it emerged that U.S. News & World Report was about to rename the specialty formerly known as “Cardiology & Heart Surgery” to include vascular surgery in its national rankings of the best hospitals in the country.

9. Envision, private equity and patient care: Substituted values 2.0

Back at the start of the year, Arthur E. Palamara, MD, a vascular surgeon in Hollywood, Florida, crafted a commentary on the specter of private equity in healthcare.

10. CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

In October, we reported on the final CMS decision to approve the coverage expansion for carotid stenting. National Coverage Determination (NCD) 20.7 essentially confirmed the expansion outlined in a July proposed decision memo.

Government Grand Rounds: How SVS members can contribute to actively support advocacy efforts

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Government Grand Rounds: How SVS members can contribute to actively support advocacy efforts

While advocacy consistently maintains a top spot among the list of priorities for SVS members, there remains a degree of uncertainty among many in the vascular surgery community regarding how to actively support SVS advocacy-related programs, the spectrum of available activities, and methods for measuring success throughout the process. 

In response to this need, the SVS advocacy team introduced a new column dedicated to shedding light on the actions of Congress and regulatory agencies and their direct implications on vascular surgery. The Government Grand Rounds series was designed to address these uncertainties, aiming to propel the SVS towards its objective of fostering a robust culture of engagement across the entirety of our SVS membership. 

Through the series, the emphasis was placed on highlighting the significance of the various tools we can utilize across our advocacy efforts. Looking back at that advocacy toolkit, we see the importance of advocacy from a multitude of perspectives. 

Protect: Advocacy in vascular surgery aims to protect patient access to necessary procedures. 

Engage: Engaging with the full range of healthcare policymakers and professionals is pivotal in advocating for vascular surgery. 

Educate: Vascular surgery advocacy focuses on educating decision makers about the importance of the vascular surgical specialty. 

Serve: Advocacy in vascular surgery is about serving the community by ensuring access to quality care and resources for vascular health. 

Advance: Advocacy initiatives in vascular surgery strive to advance and enhance patient outcomes and overall vascular care. 

Reform: Advocates in vascular surgery work to reform healthcare policies to ensure equitable access to vascular treatments and procedures. 

Promote: Vascular surgery advocacy seeks to promote awareness of the vascular specialty. 

Amplify: Advocacy in vascular surgery amplifies the voices of medical professionals and patients, advocating for better resources and understanding. 

Build: Vascular surgery advocacy aims to build collaborative networks among medical practitioners to improve standards and innovation in the field. 

Change: Advocacy efforts in vascular surgery are committed to driving systemic changes that improve patient care, treatment options and overall vascular health outcomes. 

Government Grand Rounds will continue into next year, to serve as a vehicle to drive the SVS towards its primary goal: cultivating that vibrant culture of engagement throughout its extensive membership. This strategic initiative aimed to not only resolve doubts but to galvanize participation, uniting members under a common cause of advancing vascular surgery. 

For more information about how the SVS advocacy programs help protect vascular surgeons and the patients you serve, visit vascular.org/advocacy. 

Andrew Kenney is a member of the SVS advocacy staff. 

Corner Stitch: On the vascular trainee opportunities on the conference calendar

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Corner Stitch: On the vascular trainee opportunities on the conference calendar
technology
Christopher Audu
Christopher Audu, MD, surveys the 2024 meeting landscape, highlighting prime opportunities for trainees to showcase their research.

It is abstract submission, and this month I wanted to highlight a few national meetings that are “trainee friendly” for getting your work presented as a podium talk or poster presentation. This list is not exhaustive but hopefully gets you thinking about applying. 

Vascular and Endovascular Surgical Society (VESS) 

We did a deep exposé on this organization in the December 2020 issue. A premier vascular meeting, the VESS winter conference is always in January and always at a ski resort, making it very popular. There is programming for trainees from the medical student, to the resident and fellow level. In addition, there is always great science presented. A very welcoming society, if you miss the winter conference, watch out for the spring edition—that’s always paired with the SVS Vascular Annual Meeting (VAM). 

Society for Clinical Vascular Surgery (SCVS) 

This is another society that has programming for students, residents and fellows. The meeting is usually in the late winter/ early spring—in March—and is usually somewhere warm. Be on the lookout for the SCVS Top Gun Competition, where you can go head-to-head with your colleagues in friendly battle. 

Pacific Northwest Endovascular Conference (PNEC) 

Don’t be fooled by the name, this is a meeting of vascular minds that invites faculty from all over the country to participate. Usually in Seattle, and hosted by the University of Washington, this meeting also has a friendly competition where programs can send a team to compete in a variety of vascular simulations. In addition, it is a great place to present some newer work. 

Academic Surgical Congress (ASC) 

This meeting is not exclusively focused on vascular surgery, but it does accept papers discussing vascular conditions. This is a great conference for students and trainees to get on for podium presentations. The meeting usually is in close temporal proximity to VESS—in February. 

American Venous Forum (AVF) 

Have you done work looking at venous pathology? This is the premier national meeting to present your work either in talk or poster format. The AVF is usually at a resort and often seeks trainee input. While there is no dedicated trainee programming, the organizers actively seek out trainee involvement. 

Charing Cross (CX) International Symposium 

This is an international meeting, set in London, England, and is usually in April. It’s a unique-style symposium that focuses on controversies in vascular surgical management in an effort to develop a consensus. While not entirely exclusive to vascular surgeons, it serves as a great meeting to hear the latest and reconsider what may be dogma based on practice patterns at your institution. 

Vascular Research Initiatives Conference (VRIC) and Vascular Discovery (AHA) 

This is a gathering for anyone conducting basic science vascular research. VRIC is often the day before the American Heart Association (AHA) Vascular Discovery meeting, and usually in April or May. It’s a wonderful opportunity to present groundbreaking work in a friendly environment. There is a poster competition and select abstracts will be recognized and awarded. For the budding basic scientist-vascular surgeon, this is a must-attend meeting that will allow you to meet other like-minded surgeon-scientists. 

Vascular Annual Meeting (VAM) 

This is always a big hit, and is the premier vascular surgery meeting in the U.S. With excellent programming aimed at medical students, residents/fellows, and a general audience, this meeting provides ample opportunity to learn, network and gain exposure to current practices in vascular surgery. As a trainee, if there’s only one meeting you can make, this one is probably it. 

In addition to those listed above, there are a number of other meetings and conferences that are great for educational and learning purposes, although the talks at these are usually in the form of invited lectures given by attendings rather than through abstract submission. These include, but are not limited to, VIVA (Vascular Interventional Advances), The VEINS (Venous Endovascular Interventional Strategies), VEITHsymposium and the Strandness Symposium. 

In the end, these are all opportunities to meet and re-meet expert vascular surgeons as we progress on this journey towards becoming competent vascular surgeons ourselves. I look forward to seeing you on a podium somewhere as you share your awesome work! 

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

Yao family and SVS Foundation establish James S.T. Yao Resident Research Award

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Yao family and SVS Foundation establish James S.T. Yao Resident Research Award
James S.T. Yao

In a tribute to the late James S.T. Yao, MD, PhD, a luminary in the field of vascular surgery, the Yao family and the SVS Foundation announced the renaming of the Resident Research Award to the James S.T. Yao Resident Research Award. 

The renaming of the award serves as a testament to Yao’s unwavering commitment to the advancement of vascular surgery, said Yao’s wife, Louise. The contribution from Louise and their three children—Kathy, a surgeon; John, a musician; and Pauline, a museum curator—ensures that his legacy continues to inspire future generations. Yao resided in Wilmette, Illinois, and had a longtime association with Northwestern University. 

“He was a great believer in research and writing papers,” reminisced Louise. “I see other people like him and my daughter, who is also in medicine and has many of those traits.” 

The award supports emerging medical professionals exploring vascular disease biology and innovative translational therapies. It recognizes unpublished, original scientific work in manuscript form that demonstrates publication quality. The recipient presents the research in a plenary session at the SVS Vascular Annual Meeting (VAM). 

“The Resident Research Award was my first opportunity to present the work of our team to a large audience, including many of my heroes, including Dr. Yao, from papers I had read,” said Luke Brewster, MD, a 2005 recipient of the award. 

Louise recalled her husband’s regard for the Foundation and how “he thought so highly of this organization and the things they did to help young people get into the field.” 

Yao, known as Jimmy, passed away on Dec. 20, 2022. His career began with his medical education at the National Taiwan University Medical School in Taipei. He continued his journey with a surgical residency at Cook County Hospital in Chicago and earned a doctorate in London, England. From 1988– 2007, he served as the Magerstadt Professor of Surgery and chief of vascular surgery at Northwestern University. 

His work led to the development of the ankle-brachial index (ABI), a quick and simple test for peripheral arterial disease that is now standard practice. His contributions included formalizing protocols for noninvasive vascular studies and founding the Society for Noninvasive Vascular Technology in 1977. Throughout his career, Yao wrote 200 textbook chapters and 50 academic books. He established the first blood flow laboratory in Chicago, initiated a vascular fellowship training program and held various leadership positions in vascular surgery organizations, including serving as SVS president in 1993. 

“[Dr. Yao] wrote over 300 manuscripts; he probably influenced every aspect of vascular surgery based on their case series,” said Michael C. Dalsing, MD, SVS Foundation chair and one of Yao’s former trainees. “But with all his success, he never forgot who he was—truthful, dedicated, humble and intellectually fearless.” 

Through his leadership in the SVS History Project Work Group, Yao demonstrated his commitment to preserving the history of vascular surgery by conducting interviews with more than 85 prominent figures in the field. In 2007, he received the SVS Lifetime Achievement Award. 

The recipient of the resident award renamed in his honor receives a $5,000 award and a one-year subscription to the Journal of Vascular Surgery. 

“The award deals with research that looks at the basic mechanisms of how vascular disease pathophysiology presents, or an innovative spin on treatment and how it sets the basis of how we look at disease or vascular health. It’s an innovative process, which is always very important if science is going to move forward,” said Dalsing. 

For more information on the award, visit vascular.org/YaoRRA. Submissions for 2024 are due Jan. 10, 2024. 

Nominations open for 2024 SVS Excellence in Community Practice Award

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Nominations open for 2024 SVS Excellence in Community Practice Award
Patricia Furey (right) pictured with Robert Molnar

The Society for Vascular Surgery (SVS) is calling for nominations for its Excellence in Community Practice Award, which recognizes outstanding leadership within the community by a practicing vascular surgeon who has made sustained contributions to patient care and community well-being. 

Patricia Furey, MD, one of last year’s recipients, highlighted the inspiration it provides. 

“This award is extremely important for many of us who are in community practice, so I was very pleased to receive the award and very grateful, and I think it’s inspiring because we have a lot of wonderful community surgeons that wouldn’t even think of nominating themselves,” she said. 

Nominees must have a minimum of 20 years as a practicing vascular surgeon, with at least five years as an SVS member to qualify. 

The selection process considers evidence of the nominee’s impact on vascular care and community health, such as leadership in a community-based practice. 

The 2024 nomination period is now open, with nominations due by Feb. 1, 2024. Any SVS member can nominate a candidate by submitting a nomination form and supporting documentation. Self-nominations are also accepted. 

Nominations will be carefully reviewed by the SVS Community Practice Section, which will determine the award recipient. 

Robert Molnar, MD, a 2022 award recipient, underscored the importance of recognizing community practice surgeons, who constitute nearly 50% of the SVS membership, he said. 

To make inquiries or to obtain more information on the award and nominations, visit vascular.org/CommunityPracticeAward. 

First patient treated in ARISE II study of ascending stent graft

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First patient treated in ARISE II study of ascending stent graft
Ascending stent graft in place

Gore has announced the first patient implantation of the company’s ascending stent graft in the ARISE II trial, describing this as an exciting step in the development of treatments for pathologies involving the ascending aorta using endovascular repair rather than traditional open surgery.

On Dec. 1, national principal investigator Eric Roselli, MD a cardiac surgeon at the Cleveland Clinic in Cleveland, Ohio, performed the case at Cleveland Clinic alongside study investigators fellow cardiac surgeon Patrick Vargo, MD, and vascular surgeon Frank Caputo, MD. The patient was identified as a candidate for the study after presenting with a fusiform aneurysm of the ascending aorta and aortic arch.

The ARISE II study is the first multicenter pivotal study approved by the Food and Drug Administration (FDA) investigating the use of a minimally invasive endovascular device to treat the ascending aorta. The study investigates the treatment of isolated lesions as well as chronic and residual type A dissections involving the ascending aorta. The Gore ascending stent graft is designed for investigational use in combination with the Gore Tag thoracic branch endoprosthesis.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” said Roselli.

The ARISE II study will investigate how an endovascular stent graft, delivered via catheter, may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair. Endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, but no endovascular device is currently approved for the ascending aorta.

“Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery,” said Caputo.

Personalized postoperative anticoagulation needed to curb lower-limb amputations

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Personalized postoperative anticoagulation needed to curb lower-limb amputations

Dua“We’re going to see more and more amputations if we don’t figure out the right post procedure thromboprophylaxis regime ASAP,” Anahita Dua, MD, warned during a lecture on innovative approaches to preventing amputation at the Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (Nov. 22–24). 

Diabetes is a significant and growing problem for the vascular community, the associate professor of surgery at Harvard Medical School and vascular surgeon at Massachusetts General Hospital in Boston began. She explained to the audience: “Because our diabetic drugs are doing their job and the way we take care of these patients is getting better, they are living longer so we are seeing more of these patients.” 

At the Dublin, Ireland, meeting, Dua noted that this rise in prevalence will be accompanied by a parallel increase in the number of associated complications, specifically “complications we, as a society, may not have dealt with before”. She highlighted one that is a particular cause for concern: the microvascular dissemination of the foot. And, to make matters worse, “we have nothing to help these ‘no-option’ patients,” she said. 

Dua’s talk—titled ‘Going out on a limb to save a life and a limb’—first focused on deep venous arterialization (DVA)—a new technique that, according to the presenter, “is kind of taking the world by storm”. 

She first addressed some misconceptions. “There are going to be a couple of guys in the audience who are going to turn to their friend and say ‘we did this in the 80s’. No, you didn’t—I promise. You did some version of something that was called this in the 80s, but things have changed because technology and medicine have changed,” she said.  

So, this is not a new concept, the presenter stressed, noting in fact that there are reports of attempts from 1881. Following a “big breakthrough” in the 1970s, however, she remarked that the technique fell out of favor “because it didn’t really work in the way it was meant to.” There were various reasons for this, according to Dua. “We were plagued by a lack of technology, lack of buy-in and lack of patients.”  

The presenter highlighted some data on the new and improved iteration of this technique, first mentioning the PROMISE II trial, for which she was an investigator. While amputation-free survival was the primary endpoint, Dua focused on the limb salvage rate, which was 76% in patients who otherwise may have had no other option but an amputation.  

This is where the presenter turned the audience’s attention to another study—CLariTI—designed to illuminate the ‘real-world’ amputation rate in the U.S. The presenter reported that, in this study of 180 patients at 22 sites across the country, up to 73% who underwent an amputation did not have a diagnostic angiogram, while 54% had no revascularization attempts. “We need to make sure that across the country all of these patients are getting the same level of care,” Dua stressed. 

The presenter continued that in patients who were told they had no conventional options for salvage and/or had undergone two failed attempts at revascularization, the limb salvage rate was 48% at one year—so, “about a coin toss,” as Dua put it. The pooled results from PROMISE I and PROMISE II, however, which the presenter reiterated focused on DVA, revealed a higher limb salvage rate of 73%.  

“I really think that that is the future, or the only thing we have, frankly, right now, for patients that are coming in with microvascular dissemination of the foot and no other options,” Dua opined, based on these data.  

Anticoagulation: “One size fits all doesn’t work” 

Despite the progress made for these patients technique-wise, Dua told the audience that the issue of postoperative anticoagulation is hindering outcomes. “What do we do immediately after we’ve done this amazing, futuristic surgery?” she asked. “We put them on ‘one-size-fits-all’ thromboprophylaxis because we have little idea what we’re doing.” This result is suboptimal outcomes with up to 20% of patients needing reintervention from stenosis or thrombosis in the first six months post procedure.  

Dua advocated moving away from a “one-size-fits-all” approach, talking through some of the work she is currently conducting on this in her lab at Massachusetts General Hospital.

She noted that, based on her research, a patient’s platelets need to be inhibited by 30% to get a reasonable decrease in thrombosis. In order to get to this number, she explained, every patient will take different medications. “What we should be doing is testing the blood, determining whether or not you hit a particular level, and then treating accordingly,” she said. 

The presenter mentioned, for example, that men and women require different treatment. “We are undertreating women, even though we think we’re treating them the same. Because of course our studies have not included that many women, so we haven’t seen this.” The answer? “We need to personalize it,” according to Dua. 

The presenter noted that her work in this field has been published in the Journal of the American Heart Association (JAHA), but the task now is to translate the data into practice. In this regard, Dua referenced an ongoing trial she is conducting called TEG-MED. Dua and her team have formed an anticoagulation algorithm based on the 30% figure highlighted in their previous research. The aim now is to work out which patient needs what medication to get to that figure, remarking again that “every patient is slightly different”. 

“The future for these patients is very bright,” Dua said in her concluding remarks. “We’re figuring out the coagulation story, we’re starting to understand that there are patients that can be helped with deep venous arterialization and we’re accepting this new technology, and I really feel that—over time—we don’t have to even say we’re going out on a limb to save a limb, because it’s just going to become our standard of care.” 

JVS-VL to be open access beginning in January

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JVS-VL to be open access beginning in January
JVS-VL goes open access from January 2024

The Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) will move from a subscription model to one of open access—freely available online—on Jan. 1, 2024. JVS-VL is the journal for both the SVS and the American Venous Forum (AVF) and is celebrating its 10th year of publication. 

The change is part of the larger overall adjustment to eliminating paywalls in scientific journals and making research accessible to all, said JVS-VL Editor-in-Chief Ruth L. Bush, MD, JD. Publishers make such decisions in part based on the number of print subscriptions versus electronic ones, as well as submission volume and impact factor. JVS-VL had already changed to electronic-only as of January 2023, as only 3.3% of AVF and SVS subscribers had a print subscription. 

“I think this reflects changing habits and demographic changes,” Bush said of the move. “It’s about people’s choices and how they interact with the literature. And it’s environmentally friendly.” 

“Open access removes restrictions and the science is available to everyone, not just those behind a privileged paywall,” she said. “Anyone with internet service can access the science.” 

Bush and other editors have been accepting articles that will be part of the new open-access system since mid- August. The final non-open-access articles were published in November’s JVS-VL. 

Under the new model 

Readers will have immediate access to cutting-edge research from around the country and the world. Reviewers will see no change, continuing to “read articles critically, improve manuscripts and then make them available to the public.” 

Authors will see both advantages and disadvantages, said Bush. Articles will be disseminated much more rapidly to the public and the science community. “As soon as an article is reviewed and accepted, after copyediting, it’s available to anyone around the globe,” Bush said. “We are accelerating the pace at which knowledge is available and, hopefully, positively influence citation behavior.” 

However, under open access, authors pay an article processing charge, which, Bush acknowledged, may anger or concern some prospective contributors and could be a major barrier. 

“However, we have in place various ways to help with the processing fee,” Bush said. “Reach out and ask.” Readers are asked to email [email protected] for more information. 

In addition, many academic institutions have so-called “transformative agreements” with Elsevier, publisher of the JVS publications, to cover the charge. Her own institution in Texas covers a portion of the charges, as do many others, Bush said. 

SVS members receive a 20% discount on the fee, and both the SVS and the AVF will subsidize the processing charge for authors of manuscripts accepted for the 2024 AVF annual meeting’s plenary sessions. Bush also pointed out that a fee split between five or six co-authors, even if it’s a total fee of $1,600, reduces the per-person fee to a more manageable level. 

Open access also means the ability to reach out to people from other countries to be able to publish their work. “We’ll be more global,” said Bush. 

JVS-VL is already truly a global journal, and a top-tier one for publications dedicated to venous and lymphatic disorders, she said. In 2022, 25% of articles came from China, and 35% from the U.S, with the balance from around the world. 

“Whether the move is positive or negative, it’s where we are,” said Bush. “I am someone who fully believes, if we want our science to be appreciated, then everyone should have access to it.” 

Learn more about open access, fees and more at www.jvsvenous.org. 

SVS members pitch in to help patients kick the smoking habit

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SVS members pitch in to help patients kick the smoking habit
The toolkit is aimed at helping strengthen surgeons’ existing “quit smoking” messaging

SVS members are taking advantage of the new Smoking Cessation Toolkit and resources from the Vascular Quality Initiative (VQI), adding them to existing programs and giving new life to their quest to get their patients to kick the nicotine habit and improve their health. 

The SVS Patient Safety Organization (PSO) launched the national smoking cessation initiative, CAN-DO (Choosing Against Combustible Nicotine Despite Obstacles) in June during the VQI Annual Meeting held in conjunction with SVS’ Vascular Annual Meeting. 

CAN-DO includes several components to increase smoking rates: physician and patient toolkits; including smoking cessation variables in the SVS PSO VQI’s arterial registries; and updating information on smoking cessation on the SVS website. 

Toolkit elements that physicians and surgeons may find useful include: 

  • A quick guide to treatment options 
  • Information on counseling via text messaging 
  • Use of smartphone apps and web-based services 
  • Resource documents 
  • Information on quit lines 
  • Patient-facing information doctors can distribute 
  • Billable smoking cessation codes 

The patient toolkit, meanwhile, includes links to many resources on quitting smoking. 

“As vascular surgeons, we are tasked with helping our patients navigate through some of their most challenging and life-changing moments in their lives,” said Gary Lemmon, MD, associate medical director for the SVS PSO. “It is up to us to advise them as to their best chance of success and quality-of-life improvement. Smoking cessation assistance is integral to that success.” 

Cassius Iyad Ochoa Chaar, MD, an associate professor of surgery at Yale University in New Haven, Connecticut; Yale postdoctoral research fellow Dana Alameddine, MD; and Peter Henke, MD, the section chair of vascular surgery at University of Michigan Health in Ann Arbor, Michigan, all are taking advantage of the toolkit to help strengthen their existing “quit smoking” messaging. 

“This extensive toolkit is very, very helpful and user-friendly,” said Chaar. “We can incorporate the various phrases and strategies included and get all our providers to engage with them. If someone doesn’t want to prescribe medications, he or she can incorporate other elements VQI wants to encourage, such as counseling and nicotine replacement therapy.” 

Their experiences with predecessor programs and, after reviewing the resources included in the new VQI initiative, led them to stress how an upcoming major inpatient surgery and its recovery provide a great opportunity to deliver the “quit smoking” message. Patients by and large will have to quit smoking while in the hospital, plus multidisciplinary teams are available who can reinforce the message from different angles. They also emphasized the importance of “systemizing” the effort by making sure it is part of the hospital system. “If you have to opt out, rather than opt in, that’s helpful,” said Henke. “Statewide, in Michigan, it became part of the discharge summary.” 

The surgeons also noted how smoking cessation requires the emphasis the toolkit and initiative have created. The group also stressed that the tools in the toolkit are easily adoptable to different practices and physicians. 

Surgery and recovery provide an optimal time to deliver the “quit smoking” message, said Chaar. 

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“We can basically reinforce the message on a daily basis—and we do that,” he continued. The patients also become “plugged into” the hospital smoking cessation program. Prior research shows that a lack of connection can impede patient follow-up, but inpatients receive both that link and that follow-up. “We’re able to sometimes provide them with medications, and we’ve given them nicotine patches in the hospital, so when they leave, we give them their best shot at stopping.” 

Said Henke: “Surgery, particularly an aneurysm or bypass or similar major operation, is a major life event. They’ve had to quit smoking while they’re in the hospital—for weeks of hospitalization—so if they’ve stopped and then they’re smoking sporadically, perhaps you can transition them to a nicotine patch and varenicline. They have a higher quit rate as well, as compared to a patient who may have a one-day procedure.” 

Chaar said the anti-smoking effort stretches across all medical teams that deal with smokers. “At every hospital we deliver the same message about smoking but from different angles,” he said. For example, cardiologists can point to cardiac disease, neurologists about strokes, and vascular surgeons about the many diseases smoking worsens. Oncologists can speak to the different cancers that can result.” 

Yale physicians and providers are incorporating suggested thought phrases and incorporating the elements VQI wants to capture regarding counseling and treatment for patients into electronic health records, Chaar said. “So, we’re able to be early adopters and we can track this in our own institution and our health system, and also contribute to the nationwide initiative as well,” he said. 

Yale has been very active in the smoking cessation movement, said Chaar. “It’s terrible for people with vascular disease and we’ve been trying to look at novel ways to help them quit.” 

Michigan has been active too. “We were early adopters of this,” said Henke, who practices in that state. Michigan’s statewide quality collaborative created a cessation intervention initiative several years ago, in the wake of the VAPOR clinical trial results that covered the feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons. The trial concluded that “implementation of a brief, surgeon-delivered smoking cessation intervention is feasible for patients with peripheral arterial disease. A larger trial will be necessary to determine whether this is effective for smoking cessation.” 

The state added a fairly robust set of resources following the VAPOR trial. The new VQI toolkit, Henke said, adds impetus and heft to the state’s efforts. The initiative included nicotine replacement therapy, a referral to the telephone quit-line, and physician-delivered advice along the lines of “Smoking is harmful, it’s important to quit and how can we help you accomplish that?” 

The quit-line has proved fairly successful, he said, noting that referrals to such help lines are part of the VQI toolkit. 

Smoking cessation needs such emphasis engendered by the toolkit and initiative, Henke said, adding he hopes VQI and SVS leadership make this a top priority. 

“Vascular surgeons almost more so than those in another field, see the ramifications and results of smoking,” he said. “We see amputations, death, aneurysm growth—all so smoking-related. We’re really at the front lines of this public health program.” 

“The tools in the toolkit are easily adoptable,” he said. “And this is a super important message. It’s not as headline-striking as a new device, but it decreases amputation and death, heart attacks and strokes. It’s a no-brainer in one sense. But it’s hard to keep it in the forefront, when other topics grab headlines.” 

The toolkit, pointed out Chaar, includes not only phrases and strategies physicians can use to help their patients stop smoking, but also information on the billing component of delivering such advice and resources. “That’s important for physicians’ and surgeons’ practices,” he said. 

More information is available at www.vqi.org/quality-improvement/quality-improvement-tools. 

Ego, logistics, money: Overcoming barriers to a successful wound care program

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Ego, logistics, money: Overcoming barriers to a successful wound care program
Vincent Rowe at VIVA 2023

Proper integration of primary care physicians (PCPs) in the multidisciplinary care of vascular wounds is going to play an increasingly important role as the popularity of the team approach spreads, according to a leading voice in the treatment of peripheral arterial disease (PAD).

“I think the key is making sure we get to the patients early,” said Vincent Rowe, MD, chief of vascular surgery at the University of California Los Angeles (UCLA) in Los Angeles, in an interview with Vascular Specialist at VIVA 2023 (Oct. 30–Nov. 2), in Las Vegas. “We need to provide education so patients can understand how they can prevent these wounds, but we also need to educate the PCPs. Do we keep these patients in our care for a while, or do we send them back and hope that nothing else happens again? Those are going to be some of the keys in how we manage these patients.”

Rowe had just given a talk on patient-specific decisions and how to determine appropriate timing, resources and management of vascular wounds. He told Vascular Specialist how his institution had approached the multidisciplinary team approach to vascular wound care—one that involves the likes of podiatry, physical therapy, cardiology and interventional radiology in addition to vascular surgery and wound care specialists.

“I think [the multidisciplinary approach] is gaining popularity,” he said. “It’s making a difference in terms of how we manage the patients—and saving limbs. But sometimes different things get in the way: ego, logistics, and sometimes even money can all be barriers to having a successful program for these patients. I think at our center the biggest barrier was logistics in terms of space—and also ego. We were able to overcome these by meeting together, trusting each other and moving forward together, and we had a successful program.”

Once patients with vascular wounds reach such programs, reflected Rowe, these teams tend to successfully array resources to provide appropriate treatment. “But I think it is going to be [determining] the role of the other specialties like the PCPs—how are they going to be integrated? And we also need to educate the patient.”

Society for Vascular Surgery addresses latest mainstream media reports on atherectomy

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Society for Vascular Surgery addresses latest mainstream media reports on atherectomy

The Society for Vascular Surgery (SVS) has issued a statement addressing the latest reports published by ProPublica on atherectomy use in the U.S.

The nonprofit investigative news outlet published three articles in its latest round of investigations looking into Medicare claims data.

The SVS informed members that it was aware of the latest ProPublica coverage and remains concerned that such articles, “while addressing an important issue of potential overutilization and statistical outliers, can also stoke unnecessary fear in the patient population and may contribute to a well-documented under-diagnosis issue, fostering downstream negative outcomes which can be prevented with earlier diagnosis and treatment.”

The statement continued, “It is important to note that in this series of articles the overwhelming majority of providers consistently seem to be practicing in accordance with vascular care guidelines, and this deserves acknowledgement.”

The Society pointed to previous “strong” positions it has taken regarding quality standards in the provision of vascular care. The SVS statement stressed that it would continue to advocate “that all providers of vascular care should practice in accordance with quality care and patient safety guidelines, enroll in a registry that meets or exceeds the standards of the VQI [Vascular Quality Initiative], and engage in quality improvement initiative.”

The SVS leadership will continue to review the articles, the statement added, with a more in-depth response to be released in the coming days. The Society also plans to work closely with societies in the interventional cardiology and interventional radiology worlds—the Society for Interventional Radiology (SIR) and the Society for Cardiovascular Angiography & Interventions (SCAI)—on a joint response.

Carotid stenting rebuttal: Those who live in glass houses…

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Carotid stenting rebuttal: Those who live in glass houses…
Christopher J. White
Christopher J. White, MD, responds to a recent editorial by Malachi Sheahan III, MD, that took a critical look at the decision by the Centers for Medicare & Medicaid Services (CMS) to expand coverage for carotid artery stenting (CAS). 

I’m grateful for the opportunity extended by Dr. Sheahan to respond to his very entertaining, and acerbic commentary in “Sex, lies, and carotid stents.” While I don’t agree with much of the opinion expressed, I enjoyed reading his well-done piece. Allow me to offer some constructive criticism, correct some misstatements and clarify my rationale for supporting the recent CMS decision to reimburse for CAS on par with carotid endarterectomy (CEA). 

First, in our spirited debates over optimal approaches to managing carotid artery disease, we must assume our surgical colleagues have good intentions and sincerely want to offer their patients the best opportunity for good clinical outcomes. Alas, some vascular surgeons appear to be influenced by an ulterior, self-serving motive designed to protect their “turf.” Thus, the goal of achieving the best patient outcome, the “raison d’etre” of our profession, becomes collateral damage. 

In many areas of medicine, there are clinical conditions treated by multiple specialties from different training pathways and backgrounds. It is generally accepted that multispecialty teams are the best solution to turf battles, offering better perspective and more balanced patient guidance than that of individual specialties who are siloed in their views. Carotid artery disease is but one example of a condition managed by clinicians from multiple disciplines: the neurosciences (neurology and neurosurgery); radiology; surgery (general and vascular); and cardiology.

The Multispecialty Carotid Alliance (MSCA), so vilified by Dr. Sheahan, is made up of a diverse group of physicians with representation from each of these specialty groups (many of whom have held leadership positions within their various specialty societies), and along with many others supported the decision by CMS to reimburse for carotid stenting. The rationale for the MSCA’s support for carotid stenting reimbursement is detailed in a letter to CMS.1 The simple contrast of a multispecialty group (which, by the way, included vascular surgeons) supporting carotid stent reimbursement versus the single specialty of vascular surgery (represented by the SVS) in opposition is revealing. Which group would have the patient’s best interest in mind versus protecting their specialty’s turf? 

The most blatant misstatement made by Dr. Sheahan was asserting a lack of training and preparation of interventional cardiologists to manage patients with carotid artery disease. In February 2023, the most recent advanced training statement on interventional cardiology was published with multiple mentions of “carotid” and “cerebrovascular” management in a very detailed and robust training document.2 This begs the question: why single out cardiologists when specialists from the neurosciences and radiology are also very much engaged in managing patients with carotid artery disease? Are their respective training programs up to par? Isn’t the best solution a multidisciplinary approach, not one dictated by a single specialty represented by the SVS? 

Dr. Sheahan’s failure to discuss transcarotid artery revascularization (TCAR)—included in the CMS coverage decision for stenting—is telling. TCAR was developed and championed by vascular surgeons and is rarely if ever performed by cardiologists. Yet, Dr. Sheahan’s concern for high-quality care failed to mention the glaring gaps in evidence regarding the efficacy of TCAR versus alternative procedures. With the earliest publications of this technique dating back to 2004, there are now 20 years of experience with this procedure. Yet, as of today, no prospective randomized trials have been performed. In stark contrast, carotid stenting is one of the most studied clinical procedures of all time, with dozens of randomized trials supporting its use. Yet, vascular surgeons happily offer their patients TCAR without any comparative evidence of benefit. For shame! It appears that the occupants of vascular surgery’s “glass house” have started a rock-throwing fight. 

Finally, my rationale for supporting CMS reimbursement for carotid stenting is to allow a flexible, informed and individualized approach. Of those patients with carotid artery disease likely to benefit from revascularization, some will be better served with surgery, some better treated with carotid stenting, and many who are candidates for either procedure and should be offered an informed choice. 

Remember, the National Institutes of Health (NIH) has determined that there is equipoise for carotid surgery and carotid stenting. In sponsoring CREST-2, a randomized clinical trial, they adopted a parallel-arm approach comparing carotid surgery with medical therapy to medical therapy alone, and carotid stenting plus medical therapy to medical therapy alone. Patients are enrolled in this trial by investigators who discuss treatment options with the patient. The patient, with physician counsel, is allowed to choose either the surgery arm or the stent arm. Sounds like a great example of patient-centered care. I rest my case. 

Thank you, Dr. Sheahan, for the opportunity to participate in this discussion. 

References 

  1. MCAS response: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=311&fromTracking=Y&. 2023. 
  2. Bass TA, Abbott JD, Mahmud E, et al. 2023 ACC/AHA/ SCAI advanced training statement on interventional cardiology (coronary, peripheral vascular, and structural heart interventions): A report of the ACC Competency Management Committee. J Am Coll Cardiol. 2023;81: 1386–1438. 

Christopher J. White is the medical director of the Centers of Excellence and Service Lines at Ochsner Health in New Orleans, Louisiana. 

SVS receives CMSS grant to advance diagnostic excellence

SVS receives CMSS grant to advance diagnostic excellence

The Society for Vascular Surgery (SVS) has received a $100,000 grant from the Council of Medical Specialty Societies (CMSS) to promote diagnostic excellence across the medical field. 

The CMSS, a coalition of 53 specialty societies representing over 800,000 physicians, has recognized the importance of enhancing capabilities in healthcare and has committed resources to support innovative projects in this area. The SVS proposal, “Advancing diagnosis and staging for early detection and treatment of peripheral arterial disease [PAD] to prevent amputation,” is one of 11 grant recipients. 

The grant plays a significant role in the SVS’ commitment to improving patient care, said SVS Director of Clinical Guidelines and Quality Practice Reva Bhushan, PhD, who helped secure the grant. 

“Vascular surgeons and their care teams play a key role in screening and managing PAD patients. This grant will allow the SVS to promote the use of diagnostic, staging and quality-of-life tools for patient assessment to prevent chronic limb-threatening ischemia [CLTI] and amputation,” said Bhushan. 

CMSS projects focus on three categories of conditions known to cause a disproportionate share of preventable harm due to suboptimal diagnosis: cancer, cardiovascular disease and infection. 

The grant program, administered by CMSS and funded by the Gordon and Betty Moore Foundation and The John A. Hartford Foundation, assists medical specialty societies in promoting analytical excellence for clinicians and patients. “Diagnostic excellence is fundamental to the health and well-being of all people, especially older adults who often have multiple chronic conditions complicated by frailty,” said Terry Fulmer, PhD, RN, president of The John A. Hartford Foundation. 

“With the generous support of our funders, 20 specialties are actively engaging their members in diagnostic excellence,” said CMSS CEO Helen Burstin, MD, MPH. 

“The legacy of the CMSS grant program will be greater awareness, attention and action to prevent avoidable diagnostic harm across medicine.”

Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel

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Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel
Human Acellular Vessel

Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

A press release details that the BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

“Submitting the BLA to the FDA is a pivotal milestone in achieving our goal of providing regenerative human tissues to injured patients, at commercial scale,” said Laura Niklason, chief executive officer of Humacyte. “I want to thank the patients and medical professionals who participated in our clinical studies, and our Humacyte team for their tremendous effort and dedication in completing the BLA submission for this first-in-class product candidate.”

The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. Humacyte has requested priority review of the application and, if granted, the review should be completed within six months of the filing acceptance date. In May 2023, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma. In addition, the HAV was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel, such as traumatic injuries.

Humacyte details that the HAV, a bioengineered tissue, is under investigation as an infection-resistant, universally implantable conduit for use in vascular repair. “Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to improve outcomes and reduce complications for patients. The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need,” a press release reads.

Humacyte claims that the HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for haemodialysis, and peripheral arterial disease.

The company advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Less vain and more vein: Evaluating the perceptions of venous disease amongst the vascular surgery community

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Less vain and more vein: Evaluating the perceptions of venous disease amongst the vascular surgery community
3d rendered illustration of the male vascular system
Part of the venous system

Our biases permeate the fabric of our very being, as they weave their way into our training and practice. It is clear that complex aortic work is definitely in vogue and “in,” and, well… treating veins gets a bad rap. While training, our staff perpetually complained about not only treating venous disease but not having the patience to sit and listen to these “complex” patients. Current vascular surgery training paradigms focus significantly on arterial disease, and training programs rarely focus on venous disease management as part of the core curriculum.

It comes as no surprise that if those teaching the next generation of vascular specialists are not enthusiastic or motivated and possibly even deterring the pursuit of treating venous disease, the next generation will face similar sentiments. It is clear that not all vascular systems are created equal, but why? 

The management of venous disease is imperative, as it has been reported to be twice as prevalent as coronary heart disease and five times more prevalent than peripheral arterial disease (PAD). More than 25 million adults in the U.S. suffer from chronic venous insufficiency, with more than 6 million having advanced venous disease.2 Further, venous disease cost of care is estimated to range from $3 to $10 billion annually.2,4 However, there seems to be a discrepancy in its perceived importance among vascular surgery specialists. 

It has been proposed that there exists a lack of adequate, specific and practical training throughout the academic curriculum presented to future vascular surgeons, which has led to the view that venous pathology, compared to arterial conditions, is of secondary nature. 

In addition to this, themes such as less technical challenge, lower morbidity/mortality risk, ease of lifestyle, less institutional support for research or clinical programs, and fewer funding opportunities were highlighted as reasons for the existence of this perception in a survey on the topic Furthermore, the terms “ego” and “prestige” were mentioned when describing rationales for arterial work being more important than those in the field of venous disease.1 

Vascular surgeons continue to be the largest provider for venous disease care in both medical and surgical specialties.3 More than 17% of all medical and surgical venous care providers do not have active board certification. Therefore, it behooves our specialty to uphold best practices in venous disease and continue to better understand the venous disease population. Our versatility in open and endovenous surgical management provides our specialty the skillset to care for venous disease when compared to other specialties. 

Another important and complex layer involved in this perception of venous and arterial work differing in value is gender bias and disparity. There is a significant lack of literature in venous disease compared to arterial disease regarding healthcare disparities. 

Racial/ethnic, gender and socioeconomic disparities impact venous disease similarly to arterial disease, driving how we approach our patients’ care. Chronic venous insufficiency can involve a difficult disease pattern superimposed with various risk factors that vascular surgeons must navigate in a similar way as they do with arterial diseases. 

It cannot go unsaid that vascular surgery is a male-dominated specialization and that, interestingly enough, the perception that venous diseases are of less importance stemmed mainly from younger female respondents. It is difficult to disseminate clearly why this may be the case, but the survey data suggest that this disparity in perception paves the way for a key new body of research. An in-depth analysis of existing and potentially inherent gender-based values as drivers for framing systemic perceptions in vascular surgery could be a valuable step in reducing gender bias within the field. 

Above all, the scarce exposure of trainees to the array of levels of venous interventions that exist seems to have driven and deeply embedded this perception that venous work is less of a challenge, and, in turn, of less interest to vascular specialists. As vascular surgery residents and fellows have reported feeling deficient in venous training, this is logically a root cause in the lack of value it has been historically attributed. 

One could argue it is ironic, as venous diseases pathologies are often complex, even more so than arterial ones, yet lack of attention to this nature during training is a recurring theme. A shift in this perception, however, is necessary. Potential avenues for improving such a deficit could include various mandates with regard to trainee exposure to venous pathologies and interventions, as well as the inclusion of continuing education initiatives, similar to that of advanced aortic training and formal limb salvage. Addressing and reducing the gender bias in existing perceptions may also pave the way for a more equitable view of both venous and arterial work. 

References 

  1. Kiguchi MM, Drudi LM, Jazaeri O, Smeds MR, Aulivola B, MacCallum K, et al. Exploring the perception of venous disease within vascular surgery. JVS: Venous and Lymphatic Disorders. 2023:11(5);1063–1069. 
  2. Kim, Young, et al. Defining the human and healthcare costs of chronic venous insufficiency. Seminars in Vascular Surgery. Vol. 34, no. 1, Mar. 2021, pp. 59–64. DOI.org (Crossref), https://doi.org/10.1053/j.semvascsurg.2021.02.007. 
  3. Gabel, Josh, et al. Who is treating venous disease in America today? Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 7, no. 4, July 2019, pp. 610–14. DOI.org (Crossref), https://doi.org/10.1016/j.jvsv.2019.03.009. 
  4. O’Banion, Leigh Ann, et al. A review of the current literature of ethnic, gender and socioeconomic disparities in venous disease. Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 11, no. 4, July 2023, pp. 682–87. DOI.org (Crossref), https://doi.org/10.1016/j.jvsv.2023.03.006. 

Sarah Wells, MS, is a clinical research assistant at Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal, Canada; Eric Pillado, MD, is an integrated vascular surgery resident at Northwestern Medicine in Chicago; and Laura Marie Drudi, MD, is an assistant professor of surgery at CHUM. 

‘There is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing’

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‘There is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing’
Anne Abbott addresses VEITH 2023. Thomas Brott (seated) is pictured at the far right
The recent move to expand Medicare coverage of carotid stenting formed the basis of a recent debate over the wisdom of the decision taken by the Centers for Medicare & Medicaid Services (CMS). Two heavyweights in the stroke arena went head-to-head, sparring over whether the decision should have been taken at all. 

Two luminaries in the field of stroke prevention weighed in on opposite sides of a still-raging debate over whether the recent decision by CMS to expand Medicare coverage for carotid artery stenting (CAS) was the right move to make amid conflicting opinion on what the weight of the scientific evidence says on carotid revascularization interventions. 

Thomas Brott, MD, a professor of neurology at the Mayo Clinic in Jacksonville, Florida, and a principal investigator of the ongoing and keenly followed CREST-2 (Carotid Revascularization Endarterectomy vs. Stenting Trial-2) study, and Anne Abbott, MD, a neurologist at Central Clinical School, Monash University, in Melbourne, Australia, took up opposing positions during the 2023 VEITHsymposium back-and-forth in New York City (Nov. 14–18). 

Brott took up that position that, “Since TCAR [transcarotid artery revascularization] already has it, reimbursement for transfemoral and transbrachial carotid stenting should be expanded to include asymptomatic patients.” Abbott pushed back strongly, arguing, “There should be no reimbursement for CAS or TCAR in asymptomatic or symptomatic [patients].” 

Brott took issue with recent published writings from Abbott in which she stated that stenting near the transaortic root causes more procedural stroke, death and heart attacks than does carotid endarterectomy (CEA); that there is no randomized trial evidence of patient benefit from any carotid procedure compared with current standards of non-invasive care alone; that crucially needed trials such as CREST-2 to assess procedural efficacy will be exceedingly difficult if not impossible to complete; and that the CMS funding changes “will open the floodgates.” 

Regarding Abbott’s point on unfavorable outcomes in stenting vs. CEA near the transaortic root, “where she emphasizes randomized trial evidence,” Brott contended that “that’s not true for CREST; that’s not true for ACST-2 [Asymptomatic Carotid Surgery Trial-2]; it’s not true for ACT-1 [Asymptomatic Carotid Stenosis]; and it’s not true for the combined analysis of CREST and ACT-1—all randomized trials.” 

Brott turned to Abbott’s assertion of no randomized trial evidence of patient benefit from any carotid procedure compared to current standards of non-invasive care. “These are 70-year-old patients on average, and you can see here 10-year ipsilateral stroke [rates],” he said, pointing to a slide illustrating relevant data. “Six percent in CREST, 6% in ACST-2. Remember, these patients came in with risk factors for stroke, high-grade stenosis, and that is 0.6% per year in this patient population. In the United States, for a random population in that age group, any stroke is 0.6% per year. This is an achievement.” 

Brott continued: “What about current standards of non-invasive care? With people that have high-grade carotid stenosis and all the attendant risks of that disease, we do not know. And that is why the medical arm is actually the experimental arm in CREST-2.” 

Brott also addressed Abbott’s statement that crucially needed trials will be difficult, if not impossible, to complete. “CEA enrollment in CREST-2 is complete,” he argued. “With CAS enrollment, we have only got about 80 or so patients to go.” Finally, he focused on Abbott’s claim over the CMS funding changes and increased usage. “Atherosclerosis is getting less and less common,” he retorted. “We are seeing fewer and fewer patients. We don’t know what is going to happen, but the changes in medical care are decreasing the numbers of patients with asymptomatic carotid stenosis.” 

Stepping up to the VEITH 2023 debate podium after Brott, Abbott hit back, standing behind her recent writings with which Brott took issue. “In a major coup for bad medicine, U.S. Medicare has just announced it finds coverage for carotid stenting is reasonable and necessary for beneficiaries with symptomatic carotid stenosis of at least 50%, or asymptomatic stenosis of at least 70%,” she told the gathering. “This is greatly expanded coverage, including to average-surgical-risk patients. Further CMS—or third-party—accreditation or certification are no longer required. Facilities will now be responsible for their own procedural standards and training. Formal shared decision-making with beneficiaries has been encouraged. Facility oversight committees are encouraged to apply published guidelines.” 

She called the move “a major breach of U.S. Medicare’s duty of care to the public—and there are many reasons for this.” First, Abbott said stenting “does cause more harm” than CEA. “In randomized trials, stenting caused more 30-day periprocedural stroke, death and heart attack in symptomatic patients, and in a meta-analysis of randomized trials stenting caused more 30-day periprocedural stroke and death in asymptomatic patients,” she continued. “Stenting was worse with risk-factor long-term stroke rates, and registry stroke shows similar, if not worse, results with stenting compared to endarterectomy.” 

Furthermore, Abbott argued that “there is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing. Guidelines worldwide are outdated and encourage procedural overuse. Procedural outcomes are highly dependent on operator expertise, and removal of externally applied standards will encourage harm.” 

Abbott also addressed the case of TCAR. “It has not been compared to endarterectomy,” she said, “and its efficacy has not been assessed and compared to non-invasive care alone, so there is no procedural indication and, in fact, there is no current procedural benefit for any carotid artery so-called revascularization procedure compared to current standards, particularly of best practice non-invasive care alone.” 

At the debate conclusion, the VEITH 2023 audience overwhelming voted to back the arguments put forward by Abbott. 

Need for ‘clear, well-defined guidelines’ in patient selection for surgical implantation of baroreflex activation therapy devices identified

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Need for ‘clear, well-defined guidelines’ in patient selection for surgical implantation of baroreflex activation therapy devices identified
The Barostim device

The emergence of a baroreflex activation therapy device for heart failure patients is drawing in the assistance of the open surgical expertise of vascular surgeons in the arena of the carotid bulb— and drawing attention to a need for “clear and well-defined guidelines.” 

Discussion was stirred after the delivery of a case experience from the University of Miami, Florida, during the 2023 Eastern Vascular Society (EVS) annual meeting (Sept. 7–9) in Washington, D.C., in which presenter Christopher Chow, MD, a vascular surgery resident at the institution, raised the possibility of a randomized controlled trial comparing the Barostim device (CVRx) to a sham therapy. 

Chow described the University of Miami experience working with his institution’s heart failure-cardiology team who identify patients who would benefit. 

He reported successful intraoperative therapy among all patients treated, many of whom returned home the same day. “Patients by and large tolerate the procedure without significant complications,” he told EVS 2023. “Discomfort associated with device activity is actually a common complaint, known as extraneous stimulations. It’s been described as stimulations of the nerves around the carotid bulb.” They can take the form of headaches and a painful buzzing sensation in the chest, Chow added. 

The baroreflex activation therapy device is an implantable pulse generator designed to deliver continuous electrical stimulation to carotid baroreceptors through a lead sewn into the adventitia of the carotid bulb, with a subsequent increase in parasympathetic outflow and a reduction in symptoms of heart failure, Chow said. 

“There have been some early studies that it may be beneficial,” Chow said. “The implantation of the device is very neatly suited for the skillset of vascular surgeons. It requires a small carotid cutdown at the carotid bulb through ultrasound identification and then sewing of the lead onto the adventitia of the bulb.” 

But Chow emphasized a need for clearer guidelines. 

“Further research is definitely needed, such a randomized controlled trial—we would suggest a sham device therapy,” he said. “Vascular surgeons are very keen on generating this data. We should continue working with heart and cardiovascular teams to find the best practice guidelines for Barostim therapy.” 

Under audience questioning, Chow underscored the point: “In general, I would say there is really no clear and well-defined guidelines about who would actually benefit from this therapy, and that is actually one of the aims of this discussion—to try to foster that conversation,” he said. 

The baroreflex activation technology is relatively new but is gaining traction, Chow observed, with work already starting on a percutaneous approach. “You can imagine what that may imply for future carotid interventions,” he added.

Bylaws referendum approved by SVS voting members

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Bylaws referendum approved by SVS voting members

The voting members of the SVS have approved amendments to the Society bylaws following a referendum that closed on Nov. 20. The proposed changes were focused on two areas: adjustments to membership privileges for early-career members and adjustments to the composition of the SVS Executive Board. 

A total of 453 voting members participated, exceeding by a factor of three the quorum requirement of 150 votes (5% of voting members). A two-thirds majority of those voting is required for ratification of bylaw changes. 

On the question of changes regarding early-career membership, the referendum passed with 92.72%. On Executive Board composition, it passed with 81.24%. 

“The approval of these amendments reflect the ongoing interest and commitment of our members to advancing the SVS and ensuring that our membership and governance structures align with the evolving needs of our dynamic medical community,” said SVS President Joseph Mills, MD. 

The voting, which began on Nov. 6, asked members to consider and ratify proposed amendments that had been formally approved by the SVS Strategic Board of Directors. 

The amendments are aimed at accelerating engagement of early-career vascular surgeons within the SVS and fostering diversity of perspective. The bylaw changes go into effect immediately regarding early-career membership revisions. 

For Executive Board composition, the changes will begin to apply for 2024–2025, which will include potential expansion of the number of candidates in officer elections from the current two, to a maximum of four; and expansion of the appointed members of the board from three to five, and making each position “at-large,” selected on the basis of merit, qualifications and identified gaps in expertise on the Executive Board. 

A review of the changes is available at vascular.org/2023BylawsRef. For answers to any questions regarding the referendum, email [email protected].

SVS makes fresh call for active participation in compensation survey

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SVS makes fresh call for active participation in compensation survey
Keith Calligaro

The Society for Vascular Surgery (SVS) has made a fresh call for members to participate in a compensation survey, a collaboration with Phairify, that aims to provide vascular surgeons with tailored insights into compensation, practice and productivity data relevant to their specialty and practice situations, helping them make informed career decisions. 

The SVS seeks a 20% response rate from its members to ensure the survey’s scientific validity. 

“Ensuring a robust response rate from SVS members is crucial for the scientific credibility of the compensation survey,” said Keith Calligaro, MD, chair of the SVS Compensation/Phairify Committee that developed the survey. “The data obtained will not only benefit individual vascular surgeons, but will also contribute to a comprehensive understanding of compensation and practice trends within our specialty. Your participation is key to the success of this initiative,” he said. 

Phairify, a web-based data collection and visualization platform, offers free access to SVS members. Members can complete an anonymous 15-minute survey that allows them to filter and access compensation, productivity and practice data specific to the specialty. The survey provides members with a better understanding of their compensation and productivity through data comparisons with their peers. Members can participate by visiting vascular.org/CompensationStudy2023. 

“Over the last few years, many SVS members have noted that when vascular surgeons apply for a job somewhere—whether after completing a fellowship or a mid-career move—they are not sure what to expect in terms of financial compensation. This survey will help in terms of dealing with future employers, what to expect and maybe even what to ask for,” Calligaro previously stated when assessing the importance of the survey

Changing course: The natural history of tibial claudication comes under scrutiny as interventions for ‘relatively benign’ disease trend upward

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Changing course: The natural history of tibial claudication comes under scrutiny as interventions for ‘relatively benign’ disease trend upward
Michael Conte

In the end, reflected Michael S. Conte, MD, “it’s not the evidence.” The leading vascular surgeon and peripheral arterial disease (PAD) expert made the bold statement during the recent 2023 VEITHsymposium (Nov. 14–18) as he pointedly asked a room full of colleagues: what is behind the trend that appears to show tibial interventions for intermittent claudication are growing? 

The question of whether or not the practice carries a reasonable risk or, rather, if the risks “exceed the benefits” has long lingered, the chief of vascular and endovascular surgery at the University of California San Francisco (UCSF) told the New York City gathering. 

Ultimately, the preponderance of the data, Conte said, suggests the latter. 

So what of those reasons behind the recent trend? 

Conte, finding his rhythm, first turned to datasets outlining pattern of use. 

Vascular Quality Initiative (VQI) data from 2003–2018 demonstrated that about 11% of claudication interventions involved infrapopliteal arteries, with isolated infrapopliteal interventions or combined interventions associated with a higher risk for major amputation compared to femoropopliteal interventions alone, he said. “This finding was particularly true in patients with diabetes,” Conte added. 

Then to some of the factors potentially responsible: One research group looked at the influence of a competitive marketplace and found that working in an area with high market competition seemed to be associated with a higher rate of using tibial interventions—particularly atherectomy—for claudication patients. “I guess, if you have a lot of competition around you, you may be prone to be more aggressive in the patients that you treat; these data seem to imply that competition in the area affects the utilization of tibial interventions in claudicants,” Conte said. 

He moved onto Medicare data from 2017–2019. “Now you can see the numbers are a little bit different: 28% of all claudication interventions involved infrapopliteal arteries, and of these more than a third were isolated infrapopliteal and about a third were multiple tibial arteries,” Conte continued. “This pattern was more prevalent in patients who are Black, Hispanic and who had kidney disease.” He delved deeper, pointing to evidence showing that the providers who were associated with higher use were more likely to be early-career interventionalists or surgeons, in the western half of the U.S., in higher volume practices, more often based at ambulatory surgery centers (ASCs) or office-based labs (OBLs), and more commonly interventionalists versus vascular surgeons. 

Conte then turned to recent VQI-VISION (Vascular Implant Surveillance and Interventional Outcomes Network) data on patients who received infrapopliteal interventions, presented at last year’s VAM. 

“You can see looking downstream that the risk of conversion to chronic limb-threatening ischemia [CLTI] was significantly higher among patients who underwent tibial interventions versus patients who had isolated femoropopliteal interventions for claudication—and the risk of needing repeat interventions was significantly higher, suggesting that patients getting these procedures are being placed at greater risk for deterioration of their disease and multiple additional procedures,” he explained. 

As the data pile up, and many have questioned the wisdom of such interventions, Conte asked: “Are we really doing the right thing?” 

“This alarming trend, from 11% to more recently around 30% of peripheral vascular interventions in the U.S. involving a tibial artery for claudication, suggests we may be at risk of changing the natural history of a relatively benign disease,” he summarized. 

Conte went further. A systematic review that looked at 11 studies covering current conservative management and intervention, and 16 studies probing peripheral vascular interventions or open surgery for claudication “found that there were consistently higher rates of major amputation or repeat intervention associated with revascularization, and particularly with tibial interventions,” he said. 

What of the guidelines and appropriate use criteria (AUC) in the arena of treatment for intermittent claudication? It’s a mixed bag, said Conte. While the Society for Vascular Surgery (SVS) guidelines from 2015 recommend against endovascular therapies for isolated infrapopliteal disease for claudication “because it is of unproven benefit and possibly harmful,” other bodies, such as the Society for Cardiovascular Angiography & Interventions (SCAI), suggest that “this practice may be occasionally or rarely appropriate,” Conte said. 

The recent SVS AUC for intermittent claudication, a multispecialty collaboration, saw unanimous agreement that the risks outweighed the benefits regarding revascularization for infrapopliteal disease, he added. 

So, to Conte’s original question: what explains the increasing use of tibial interventions for claudication? “It certainly is not the evidence that it is helping people, because the evidence is simply not there to support this concept of full revascularization for claudication, with treatment of every lesion in sight on the angiogram,” Conte elaborated. 

The data suggests other practice-level factors may be at play, he reflected: economic incentives and the current reimbursement framework; elevated use in ASCs and OBLs; strong associations with atherectomy; higher use among certain types of providers; meetings where live case demonstrations focus on technical elements of the interventions rather than their appropriateness. 

“I guess that some providers believe that the short-term risk of these interventions is low, and the downstream harms are not tangible at the time, so they have convinced themselves they may be providing a benefit,” Conte concluded. 

“That’s certainly not a basis for evidence-based practice, and with growing signals of harm, the vascular community needs to address the overuse and misuse of interventions that will erode the public trust.” 

Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE

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Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE
AlphaVac system

Patient enrollment is now complete in the APEX-AV trial evaluating the safety and efficacy of the AlphaVac F1885 (AngioDynamics) multipurpose mechanical aspiration system for the treatment of acute intermediate-risk pulmonary embolism (PE).

APEX-AV is a single-arm investigational device exemption (IDE) study involving 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the U.S. The primary efficacy endpoint of APEX-AV is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of major adverse events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.

AngioDynamics initiated the study in partnership with the Pulmonary Embolism Response Team (PERT) Consortium. It is led by co-principal investigators William Brent Keeling, MD, associate professor of surgery at the Emory University School in of Medicine in Atlanta and immediate past president of Tthe PERT Consortium, and Mona Ranade, MD, assistant professor of interventional radiology at the David Geffen School of Medicine at the University of California, Los Angeles.

“Data from the APEX-AV study expands the current body of literature on the safety and efficacy of mechanical thrombectomy and broadens the PE treatment options, particularly in this space,” said Ranade.

The AlphaVac F1885 system is cleared for the removal of thromboemboli from the venous system. APEX-AV was designed to provide safety and efficacy data for a clearance specific to PE.

Vascular Specialist–December 2023

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Vascular Specialist–December 2023

In this issue:

  • Changing course: The natural history of tibial claudication comes under scrutiny as interventions for “relatively benign” disease trend upward 
  • Our guest editorial this month looks at perceptions of venous disease in the vascular surgery community 
  • VEITH 2023 plays host to lively debate over CMS decision to expand coverage of carotid artery stenting 
  • Comment & Analysis: Christopher White, MD, rebuts a recent editorial from our medical editor Malachi Sheahan III, MD, entitled, “Sex, lies and carotid stents” 

 

The top 10 most popular Vascular Specialist stories of November 2023

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The top 10 most popular Vascular Specialist stories of November 2023

top 10 In November, the most read stories from Vascular Specialist include a reassessment of which carotid revascularization treatment modality is best after the recent Centers for Medicare & Medicaid Services (CMS) coverage expansion; updated analyses from the VOYAGER PAD clinical trial; Bhagwan Satiani, Vascular Specialist associate medical editor, considers time-management techniques and tools; and Peter Schneider provides insight on 36-month data from Surmodics’ TRANSCEND clinical trial.

1. New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

For Scott Berman, MD, patient responses when confronted with an explanation of the extent of their asymptomatic carotid disease tend to be quite stark. They are either so petrified of having a stroke that they express clearly that they want to be operated on as a matter of urgency, the Tucson, Arizona-based vascular surgeon explains, or else they are steadfastly against surgery under any circumstance.

2. The pulmonary arterial tree—it is time we branch out

Nicolas Mouawad, MD, chief of vascular surgery at McLaren Health System in Bay City, Michigan, urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.

3. Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio

Patients undergoing computer-assisted vacuum thrombectomy with the Indigo Aspiration System (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

4. Carotid disease: Getting to the right decision

The recent move by the CMS to expand coverage for carotid artery stenting brought with it the requirement for a shared decision-making interaction between physicians and patients as they establish which carotid revascularization treatment modality is best for their disease. Currently, a validated tool does not exist—but investigators at Dartmouth Hitchcock Medical Center are working on research aimed at changing that.

5. VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations

New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (Nov. 11–13) in Philadelphia.

6. Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports

A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium.

7. Can you count the ‘monkeys’ on your back?

Bhagwan Satiani, Vascular Specialist associate medical editor, considers time-management techniques and tools and how a “high-level approach to separate the chaff from the wheat may start with things such as your own goals, organizational objectives followed by a variety of individual objectives”.

8. SVS announces leadership development program for vascular surgeons

Now set to welcome its fifth cohort, the SVS Leadership Development Program (LDP) continues to help vascular surgeons across the U.S. and Canada to hone their leadership skills.

Manuel Garcia-Toca, MD, chair of both the Leadership Development Committee and LDP, said he believes the seven-month program can revolutionize the leadership skills of vascular surgeons, empowering them to make a remarkable impact both in their field and beyond. The program will begin April 11, 2024.

9. Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems

A 14-year effort to achieve departmental status for vascular surgery at a large healthcare system in Southern California resulted in significant gains for the specialty within the organizational apparatus, according to an administrative case report on an effort finalized last year.

10. TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB

Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics’ TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).

Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports

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Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports
Solutio
anesthesia
Solutio catheter

A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium

The investigational Solutio catheter (MedVasc), which contains both a bent needle for tumescence deployment through the vessel wall into the perivascular space and endothermic fiber for ablation treatment, produced a median score of 5 (0–24) on the visual analogue scale (VAS) in nine consecutive patients in Sweden, Michael Åkesson, MD, an interventional radiologist and developer of the device, told the New York City gathering (Nov. 14–18). 

He hailed the catheter as a safe and feasible solution resulting in a single puncture as opposed to several. 

Traditionally, Åkesson observed, patients find the anesthesia part of the ablation treatment process unpleasant, with VAS pain scores often varying from 20–60. 

Results from the FIH study showed two “mild” device deficiencies and no serious adverse events. Patients—eight women and one man—underwent treatment by a single vascular surgeon. They were recorded as having a great saphenous vein median length of 41cm. 

“The subject with the 24 VAS score reported that the pain came from the puncture site area in the lower leg,” Åkesson, a researcher attached to Lund University in Lund, Sweden, told VEITH 2023. “The surgeon suspected this was caused by a dissection while accessing the vein. He generally considered the catheter to be safe and easy to use, but with a short learning curve. Two minor device-related defects were reported—low flow rate in the long needle and catheter with high friction while pushing the needle out of the catheter. Both problems will be resolved with the prototype.” 

During the four-week follow-up period following treatment, no serious adverse events emerged and no signs of bleeding were reported, Åkesson added. 

VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations

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VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations
Marc Bonaca

New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (Nov. 11–13) in Philadelphia.

The randomized, double blind VOYAGER PAD trial enrolled more than 6,500 patients in 34 countries who had peripheral arterial disease (PAD) and had undergone lower extremity revascularization.

Patients were randomly assigned to receive either rivaroxaban (Xarelto, Janssen) or a placebo in addition to daily aspirin. The research team reported in a late-breaking clinical trial presented at ACC.20/WCC that VOYAGER PAD met its primary endpoint, with a 15% statistically significant reduction in the risk of a first major adverse limb or cardiovascular event (MALE or MACE) seen in patients who received rivaroxaban compared with those who received the placebo.

Fragile patients with PAD can be at a heightened risk for MALE, defined as a composite of acute limb ischemia (ALI) and major amputation. In the first of the two analyses presented by Mario Enrico Canonico, MD, from the University of Colorado Anschutz Medical Campus in Aurora, Colorado, fragile patients were defined as being older than 75 years, weighing less than 50kg, or having a baseline estimated glomerular filtration rate (eGFR) less than 50 mL/min/1.732.

Rivaroxaban plus aspirin (2.5mg twice daily plus aspirin 100 mg once daily) was shown to be effective in reducing the occurrence of MALE in both fragile and non-fragile patients, compared to aspirin alone. In fragile patients treated with rivaroxaban plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo. In non-fragile patients, 7.9% of patients treated with rivaroxaban plus aspirin experienced a MALE compared to 9.7% of patients treated with placebo.

The second analysis examined the role of rivaroxaban plus aspirin on myocardial infarction (MI) in patients with PAD with and without concomitant coronary artery disease following lower extremity revascularization (LER).

Following LER, patients with PAD are four times more likely to experience acute limb ischaemia, or a rapid decrease in lower limb blood flow, which is often associated with long hospitalisations and high incidences of amputation, disability, and death unless appropriate treatment is given.

Patients with PAD are also at a heightened risk of MACE, defined as MI, ischaemic stroke, or cardiovascular death. In this analysis, 14.1% of patients with PAD and coronary artery disease treated with rivaroxaban plus aspirin experienced a MACE versus 17.6% of patients treated with placebo (aspirin alone). In patients with PAD only, 11% of patients treated with rivaroxaban plus aspirin experienced a MACE versus 9.8% of patients treated with placebo. Overall, rivaroxaban plus aspirin showed a consistent benefit in reducing MACE in patients with and without coronary artery disease.

“These analyses reinforce the consistency of the favorable benefit-risk profile of Xarelto plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as ‘fragile’ are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments,” said Marc Bonaca, MD, also from the University of Colorado Anschutz Medical Campus. “We hope the ongoing wealth of data coming from VOYAGER PAD presented at AHA offers clinicians the information they need to support shared decision-making in prescribing Xarelto plus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex.”

In August 2021, the Food and Drug Administration (FDA) approved an expanded PAD indication for Xarelto to include patients following a recent LER due to symptomatic PAD. Xarelto acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation.

VRIC submissions are now open

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VRIC submissions are now open

Researchers may now submit abstracts for the SVS Vascular Research Initiatives Conference (VRIC), to be held in conjunction with the American Heart Association’s annual Vascular Discovery meeting.

The conference, which emphasizes basic and translational vascular science, will take place all day May 15, 2024, at the Hilton Chicago, 720 S. Michigan Ave., in Chicago.

VRIC registration will open in early 2024. Learn more and get the abstract submission link at vascular.org/VRIC24.

SVS 2024 dues renewal deadline approaches

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SVS 2024 dues renewal deadline approaches

SVS members are reminded to act promptly before the year’s end to ensure uninterrupted access to their 2024 membership benefits.

Renewals are due on or before the close of the year on Dec. 31. SVS members can pay their dues now by logging on at vascular.org/invoices.

Renewal guarantees the continuation of all the benefits associated with the Society, including reduced or no-cost access to all Journal of Vascular Surgery peer-review publications, exclusive entry to the SVS Education Portal, reduced rates for the Vascular Annual Meeting (VAM) and other educational courses and workshops, access to the SVS Branding Toolkit, and more.

For any questions, email [email protected].

TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB

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TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB
Peter Schneider
Peter Schneider

Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics’ TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).

The TRANSCEND trial is a prospective, multicentre, single-blind randomised controlled trial to assess the safety and efficacy of the SurVeil drug coated balloon (DCB; Surmodics) versus the IN.PACT Admiral DCB (Medtronic) for treatment of superficial femoral and proximal popliteal artery lesions. A total of 446 patients were randomised to either the low-dose paclitaxel (2.0µg/mm2) SurVeil DCB (n = 222) or the high-dose (3.5µg/mm2) paclitaxel IN.PACT Admiral DCB (n=224) at 65 sites in the USA, Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand.

The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularisation (CD-TLR). Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs. 85.9%). The primary safety endpoint is freedom from device- or procedure-related death within 30 days and above-ankle amputation or CD-TLR within 12 months, which also demonstrated comparable outcomes between SurVeil DCB and IN.PACT Admiral DCB (91.8% vs. 89.9%). Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025.

Data demonstrate the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy while delivering a substantially lower drug dose, a Surmodics press release reports. Both the SurVeil and IN.PACT Admiral DCBs utilise coatings with the antiproliferative drug paclitaxel. However, the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5μg/mm2) than the SurVeil DCB, which has a 2.0μg/mm² drug load.

Patient outcomes are being collected at one, siz, 12, 24, 36, 48, and 60 months. Intermediate-term (36-month) secondary outcomes included CD-TLR, major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events.

A total of 352/363 (96.97%) patients completed their 36-month visit.

Surmodics states that the SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continues to demonstrate similar outcomes at intermediate-term follow-up of 36 months compared with the high-dose IN.PACT Admiral DCB in the treatment of patients with symptomatic peripheral arterial disease (PAD) caused by stenosis of the femoral and/or popliteal arteries. Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR (20.3% vs. 19.5%; p=0.897), major TLA (0.0% vs. 0.5%; p=1), thrombosis at the target lesion (0.6% vs. 0.0%; p=0.475), and historical major adverse events (MAEs; 28.6% vs. 28.5%; p=1).

“The TRANSCEND 36-month data continue to demonstrate safe and effective performance of the SurVeil DCB. SurVeil DCB is a best-in-class, high-quality treatment option for our PAD patients utilising a next-generation surface coating with a lower dose of paclitaxel compared to IN.PACT Admiral DCB,” said Schneider.

SVS announces leadership development program for vascular surgeons

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SVS announces leadership development program for vascular surgeons

The 2023 cohort of the Leadership Development Program gathered in Washington D.C.

Now set to welcome its fifth cohort, the SVS Leadership Development Program (LDP) continues to help vascular surgeons across the U.S. and Canada to hone their leadership skills.

Manuel Garcia-Toca, MD, chair of both the Leadership Development Committee and LDP, said he believes the seven-month program can revolutionize the leadership skills of vascular surgeons, empowering them to make a remarkable impact both in their field and beyond. The program will begin April 11, 2024.

He encouraged participants to “build lifelong relationships, have some fun and invest in your future and the profession’s future,” while earning continuing medical education (CME) credit.

The LDP, developed primarily for vascular surgeons with five to 10 years of experience, offers an immersive learning experience, emphasizing evidence-based leadership models. The curriculum draws from authors Jim Kouzes and Barry Posner’s The Leadership Challenge.

A significant change in the program from previous years is its commitment to flexibility, recognizing the demanding schedules of vascular surgeons, said Garcia-Toca. On-demand didactic presentations, live online faculty-led discussions, mentoring and a 1.5-day in-person workshop have replaced the traditional webinars.

“This format change allows participants to engage with the material more effectively and in a manner that best suits their busy lives. The program’s goal is to empower participants to reach their full potential as leaders, not only in their medical practices but also in their communities and other areas of their lives,” said Garcia-Toca.

The core faculty for the cohort includes Manuel Garcia-Toca, MD, MS; Faisal Aziz, MD; Dawn M. Coleman, MD; Randall R. DeMartino, MD; Kristina Giles, MD; and SVS Executive Director Kenneth M. Slaw, PhD. Participants will have until Dec. 2, 2024, to claim credits or earn their certificates.

For more information on registration, visit vascular.org/LDP5.

SVS Foundation gears up for Giving Tuesday

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SVS Foundation gears up for Giving Tuesday

As the holiday season comes into focus, the SVS Foundation is preparing to celebrate science and honor our vascular heroes on Giving Tuesday, a time dedicated to philanthropy and giving back to the community.

Giving Tuesday is celebrated annually on the Tuesday following Thanksgiving—Nov. 28 this year. It stands as a beacon of hope and charity consistent with the true spirit of the holiday season, said Foundation Chair Michael C. Dalsing, MD. For the SVS, this year the celebration will expand past the day, leading to a month-long celebration following Giving Tuesday, in honor of the Foundation’s history.

The Foundation has achieved personal milestones in medical research, grants, awards and fundraising initiatives throughout the year, said Dalsing. They include its Voices of Vascular campaign to highlight the diverse voices within the SVS, the Foundation’s yearly Gala and the Vascular Health Step Challenge, a campaign to raise funds for and awareness of peripheral arterial disease (PAD).

“Giving Tuesday is not just a day; it’s a chance to make a significant difference in the lives of those who rely on our assistance and expertise. We are dedicated to furthering our mission and fostering a community that cares,” said Dalsing.

The Foundation’s efforts have propelled research initiatives, enabled the distribution of crucial grants, recognized outstanding contributions through awards, and facilitated innovative projects that promise to improve the lives of countless individuals.

“Every donation, regardless of size, contributes to our broader mission,” said Dalsing. “Whether you’re a longtime supporter or new to our cause, your contribution is invaluable and greatly appreciated.”

Donors can visit vascular.org/Donate to learn how to join the celebration and support the Foundation’s work.

SOOVC award initiatives offer opportunities to advance outpatient vascular care

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SOOVC award initiatives offer opportunities to advance outpatient vascular care
Anil Hingorani, MD,

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has opened applications for its Presentation Award and Research Seed Grant, allowing practitioners to contribute to an ever-changing outpatient and office-based vascular care sector.

The Presentation Award recognizes the work of vascular surgeons who have completed research projects in an office-based lab (OBL) or an ambulatory surgery center (ASC) setting. The award is open to active SVS members and will allow three recipients to present their research findings at the SOOVC session during the 2024 Vascular Annual Meeting (VAM). Anil Hingorani, MD, chair of SOOVC, highlighted the significance of these awards, stating, “This is an opportunity to focus on procedures being done in the outpatient setting. These procedures are more cost-effective and efficient, and patients prefer them, making it a win-win situation.”

The three recipients of the 2023 Presentation Award were Michael A. Curi, MD, Keerthi Harish, MD, and Pavel Kibrik, MD. Their projects demonstrated the evolving landscape of vascular care.

Research Seed Grant recipients receive a $10,000 grant to fund analysis of research data for actionable insights, quality improvement and enhanced patient care. The 2023 Research Seed Grant recipients were Michael Curi, MD, Robert G. Molnar, MD, Heather Waldrop, MD, and Christina Cui, MD.

“These abstracts can be related to quality and safety, patient experience, billing, or anything that influences the patient’s journey in an OBL or ASC. It doesn’t have to be solely focused on procedures,” said Hingorani on the broad scope of research areas within the initiatives.

He encouraged all practitioners, from early-career physicians to students, nurse practitioners, physician assistants and nurses, to apply. In addition to promoting diversity and inclusivity, Hingorani stressed the importance of involving community practitioners and those working in lower socioeconomic areas. The deadline to apply is Jan. 15, 2024. Recipients will be announced at VAM 2024, which is set for June 19-22.

Learn more at vascular.org/SOOVCPresentationAward and vascular.org/SOOVCResearchGrant.—Marlén Gomez

VAM abstract submissions window opens

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VAM abstract submissions window opens
Andres Schanzer

VAM program chair Andres Schanzer, MD, makes a call for cutting-edge new science for next year’s meeting in Chicago.

Researchers who want to present new science at the 2024 Vascular Annual Meeting (VAM) are encouraged to prepare their abstracts for Nov. 15, when submissions open, to take advantage of the eight-week submission window.

“What we’re looking for is innovative new topics, new areas of research that haven’t yet been presented or published elsewhere, representing the very front edge of evolving knowledge and technology across the field of vascular surgery,” said Schanzer, SVS Program Committee Chair. Abstract submissions will close Jan. 10, 2024.

Schanzer emphasized the significance of the abstract submission process in setting the stage for VAM. Organizers post guidelines and policies in the submission instructions to serve as a blueprint for researchers and professionals preparing to submit their work.

The 25-member committee, under Schanzer’s leadership, evaluates all abstracts to present top research for the meeting. Schanzer highlighted relatively recent changes to the program, including the division of scientific content in the mornings and concurrent educational sessions in the afternoons, in order to ensure diversity and quality.

Schanzer assigns several specialized teams of content experts to tackle the multitude of submissions. Each group focuses on all submissions in that given category to score them. The teams are responsible for updating the larger committee on their rankings and leading a discussion for the submissions in their content area.

He said the broad expertise of the committee helps promote the full spectrum of vascular surgery research, all of it appropriately reviewed blindly and considered for inclusion. Despite the increasing number of submissions, there is no fixed target for abstract acceptance.

Learn more at vascular.org/VAM24Abstracts.

SVS Foundation step challenge helps place lens on ‘under-appreciation’ of country’s PAD problem

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SVS Foundation step challenge helps place lens on ‘under-appreciation’ of country’s PAD problem
Vikram Kashyap hits the trails during the Step Challenge

“We have a critical problem in America, which is the under-appreciation of peripheral arterial disease [PAD],” says Vikram Kashyap, MD, on his first time par­ticipating in the SVS Foundation’s Vascular Health Step Challenge, which concluded in September.

Kashyap, a member of the SVS Foundation board of directors, was one of more than 500 individuals globally who came together in September for a month-long initiative to promote vascular health and raise awareness and funds for the Foundation’s mission. The annual SVS Foundation challenge concluded with participants walking a collective 44,000 miles and raising $100,000.

It corresponded with National PAD Awareness Month, aiming to help encour­age individuals to maintain an active and healthy lifestyle. Participants pledged to walk 60 miles throughout the month, symboliz­ing the 60,000 miles of blood vessels in the human body.

Kashyap notes that this symbolic jour­ney aimed to underscore the importance of maintaining a healthy vascular system and emphasizes the critical role vascular sur­geons play in keeping those systems in opti­mal condition. “I think this is the first step,” he says. “No pun intended. I hope we can use this momentum and continue to grow in the years ahead.”

This year’s challenge introduced the “Pay-it-Forward” initiative, asking registrants to help ensure patient participation in the chal­lenge. More than 70 Pay-it-Forward dona­tions were received.

The Step Challenge also garnered sponsor­ship support, with a 77% increase compared to the previous year. Sponsors included or­ganizations in the medical and healthcare industry, including presenting sponsor Ad­vanced Oxygen Therapy, Inc.; W. L. Gore & Associates; Medtronic; 3M; the Way to My Heart organization; and the Society for Vascular Nursing.

As part of his efforts, Kashyap visited several walking destinations throughout September, including his new hometown of Grand Rapids, Michigan; Traverse City, Michigan; Los Angeles; Central Park in New York City; and Columbus, Ohio.

He emphasized that the challenge does not require an “all-or-nothing” mentality. The Foundation aims to use monies raised to provide necessary treatments and improve the quality of life for those in need, while also driving innovations in vascular care.

Change: A driving force behind SVS advocacy initiatives

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Change: A driving force behind SVS advocacy initiatives
Mounir Haurani

Change is a constant in life, and advocacy is no exception. The healthcare landscape is always evolving, and the SVS Advocacy Council is working to maintain a voice in the decision-making process. The council is committed to driving change that will improve the lives of vascular surgeons and their patients. By working to influence government policy, the Advocacy Council can make a real difference in the practice of vascular surgery and the care patients receive.

To create meaningful change, the SVS has identified several pieces of legislation that the Advocacy Council believes will result in impactful changes in federal policy that will drive positive outcomes for vascular surgeons and patients. Members identified several bills to help:

  • R. 3674, the “Providing Relief and Stability for Medicare Patients Act of 2023”
  • R. 2474, the “Strengthening Medicare for Patients and Providers Act”
  • R. 1202/S. 704, the “Resident Education Deferred Interest (REDI) Act”
  • R. 2389/S. 1302, the “Resident Physician Shortage Reduction Act of 2023”
  • R. 731/S. 220, the “Workforce Mobility Act of 2023”
  • R. 4261, the “Amputation Reduction and Compassion (ARC) Act”

There are many ways members can get involved in driving this change, such as getting acquainted with grassroots advocacy. There are few advocacy tools more powerful than direct engagement between a constituent and a member of Congress. Engaging with your federal lawmakers helps to amplify SVS’ legislative priorities on Capitol Hill because elected officials want to hear from their constituents about the issues that are important to them. Your representative and senators are not experts in vascular care and need to hear from you about policies that impact your practice and patients. The SVS offers several opportunities for members to get involved in grassroots advocacy. For instance, sign up as a REACH 535 key contact, where you become the bridge between SVS legislative priorities and your elected officials. You can also participate in Voter Voice activities. Meanwhile, members can also support the SVS Political Action Committee (PAC).

Mounir Haurani, MD, is vice chair of the SVS Government Relations Committee.

The pulmonary arterial tree—it is time we branch out

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The pulmonary arterial tree—it is time we branch out
Nicolas Mouawad, MD
Nicolas Mouawad, MD, chief of vascular surgery at McLaren Health System in Bay City, Michigan, urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.

With more than 1 million cases of deep vein thrombosis (DVT) and/or PE diagnosed each year in the U.S. alone,1 the management of patients with venous thromboem­bolic disease (VTE) is a critical public health concern.2 So much so that in 2008, the U.S. Surgeon General declared a formal call to action against VTE. Despite an initial mod­est increase in awareness, it has been the recent COVID-19 pandemic that truly erupted a flurry of VTE therapies and catapulted this pathology from the sidelines to center-stage. Although DVT and PE are a continuum of the same disease state, untreated acute PE has a mortality of 30%.3 The sever­ity of impact is primarily based on the embolic burden and the resultant effect on the right ventricle (RV), in addition to underlying comorbid conditions. The vicious cycle com­mences with acute increases in pulmonary arterial pressure secondary to the embolic obstruction which increases right ventricular afterload, increasing RV myocardial oxygen con­sumption and impairing RV contractility. This in turn affects the left side manifest by decreased cardiac output that can eventually lead to cardiogenic shock and death.

Pulmonary embolism response teams (PERTs) have emerged as an effort to battle the crisis of pulmonary em­boli. Akin to “doctor-heart” for ST-elevation myocardial infarctions (STEMIs) and code stroke activations, the PERT is a multidisciplinary team focused on early triage, assessment, risk stratification and rapid coordination of an organized re­sponse to mobilize resources as necessary for PE care. These traditionally have been composed of interventional medical specialties with surgical counterparts as backup. The role of the vascular surgeon in the management of PEs varies widely and is based on their interest, their comfort (particularly nav­igating the heart), geography and the institutional politics.

The main issue in my opinion is that it feels outside of our “comfort zone” to be in the thorax. Whether surgically or by endovascular means, the thorax has historically been a black box—a void—for the vascular surgeon. From an in­terventional perspective, it is a domain of cardiothoracic surgery, interventional cardiology and interventional radiol­ogy, among some others. Furthermore, dedicated training paradigms have not been established for formal education in navigating the heart and the pulmonary vasculature for vascular surgeons. Most of us who are involved in PE care learned it from our interventional colleagues, training cours­es, or “on the job.” But why do we not take a more active role in this disease process? After all, we are vascular spe­cialists very comfortable in diseases of the arteries, veins and lymphatics, whether medical, minimally invasive or maximally open.

And who gets an intervention? Unfortunately, risk strat­ification of patients with PE remains in development. The most common system separates them into low risk, inter­mediate risk, and high risk. An in-depth evaluation of cost, resource utilization, risk and safety profiles, as well as clinical efficacy, such as HI-PEITHO, PEERLESS II, STORM-PE, PE-TRACTS, among others, are currently underway to help answer many of these questions.

For those that qualify for intervention based on current­ly used criteria, vascular access is obtained in the standard fashion with ultrasound guidance. Caval venography is per­formed to ensure no anatomic abnormality, thrombosis or clot in transit. The right heart is then catheterized—I am a fan of the angled pigtail more so than a balloon-tipped catheter such as the Swan-Ganz as I feel its shape mirrors the anticipated trajectory. For each one of my PE interventions, a full right heart catheterization is performed. A comfort with waveform analysis traversing right atrium, right ventricle and into the main pulmonary artery is paramount. These are standard displays in a cardiac catheterization laborato­ry, although not usual in the operating suite, so depending on your site of care, it is important to equip your lab with the ability to transmit and display these data. Clearly this will help monitor critical patient vitals and also assist in evaluating the effectiveness of some interventions. The procedure is then completed in the standard fashion.

Just as we have adopted many new dis­ruptive technologies for the management of our patients, the pulmonary vascula­ture is an extension of the vascular tree we are trained to treat. I submit that it is time we branch out in the pulmonary arterial tree and become comfortable navigating the heart. We are trained for quick decision-making in high-stakes situations. It is time to dust off our old physiology textbooks and revisit right heart pressures, pulmonary vascular resistance and dynes/sec!

A multidisciplinary group is imperative for the manage­ment of patients with PE—and for a successful PERT—and vascular surgeons should get out of their comfort zone and play an active role in this patient population and pathology. We have a duty to our trainees to develop training paradigms to tackle all components of vascular disease and offer a fa­miliarity and applicability of endovascular concepts while addressing barriers to implementation. Through continued awareness, education, and support, we can help cement vas­cular surgery as an integral component of comprehensive PE care and focus on improving PE patient outcomes.

References

  1. Lutsey PL, Zakai NA. Epidemiology and prevention of venous thromboembolism. Nat Rev Cardiol. 2023 Apr;20(4):248–262. doi: 10.1038/s41569-022-00787-6. Epub 2022 Oct 18. PMID: 36258120; PMCID: PMC9579604.
  2. US Department of Health and Human Services. Surgeon General’s call to action to prevent deep vein thrombosis and pulmonary embolism 2008. http://www.surgeongeneral.gov/topics/deepvein.
  3. Bˇelohlávek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and non-thrombotic pulmonary embolism. Exp Clin Cardiol. 2013 Spring;18(2):129–38. PMID: 23940438; PMCID: PMC3718593.

Nicolas Mouawad is chief and medical director of vascular and endovascular surgery at McLaren Health System in Bay City, Michigan.

Twelve-month first-in-human data from Xeltis’ aXess haemodialysis vascular conduit trial presented at VEITHsymposium 2023

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Twelve-month first-in-human data from Xeltis’ aXess haemodialysis vascular conduit trial presented at VEITHsymposium 2023
Frans Moll
Frans Moll

Xeltis has announced “highly encouraging” 12-month results from its first-in-human (FIH) aXess vascular conduit trial. The data were presented by Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands) at this year’s VEITHsymposium (14–18 November, New York, USA).

At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit. According to Xeltis, these results represent a significant improvement over current standard of care. This performance builds on the six-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal. To date, more than 3,500 dialysis sessions have been conducted across the six centres in Belgium, Italy, Latvia and Lithuania.

aXess is a restorative conduit which enables the creation of a new, long-term living vessel for haemodialysis vascular access. The aXess FIH trial is a single-arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in patients older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for five years. A separate pivotal trial of aXess is underway, enrolling up to 110 patients across up to 25 sites in nine EU countries, with over 40 patients already implanted.

The full data were presented by Moll in a presentation entitled ‘Novel application of polymer technology to create endogenous tissue with host collagen and endothelium compatible with flowing blood: One-year clinical results of the aXess graft’.

Moll and member of Xeltis’ medical advisory board said in a press release:“The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG [arteriovenous graft], such as early cannulation and no maturation needed, with the long-term advantages of AVF [arteriovenous fistula], including better patency rates, a reduced need for intervention and low infection rates.”

Eliane Schutte, CEO of Xeltis commented: “The outstanding 12-month data from our FIH study highlights aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to haemodialysis patients worldwide.”

Randomized trial set to elucidate value of image fusion technology for aortic repair

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Randomized trial set to elucidate value of image fusion technology for aortic repair
technology
Rachel Clough

An ongoing UK National Institute for Health and Care Research (NIHR)-funded randomized controlled trial seeks to illuminate the value of an image fusion guidance technology for endovascular aortic repair.  

In a presentation on the trial at this year’s VEITHsymposium (Nov. 14–18) in New York City, Rachel Clough, MD, a consultant vascular surgeon at King’s College London in London, England, first outlined the issue at hand. While endovascular devices are available to treat complex aortic disease using a combination of branches and fenestrations, she said, challenges arise when positioning these devices in three-dimensional spaces. 

“We currently use high-contrast and high-spatial resolution CT [computed tomography] angiography to both plan these procedures and to design these custom-made devices,” Clough said. Until recently, however, she noted that there was “no direct link” between these preoperative image data and intraoperative two-dimensional fluoroscopy images. 

To remedy this, Clough detailed that a new technology—Cydar Maps (Cydar Medical) image fusion guidance—was designed in order to accurately and in real time automatically overlay preoperative CT, volume-rendered aortas onto intraoperative fluoroscopy data. 

The presenter noted that Cydar Maps is now a cloud-based product that incorporates three phases—planning, navigation and review. The benefits of a cloud-based system, Clough relayed, include the fact that it is always updated, enables remote planning and review of cases, and provides a platform for sharing data with other organisations or device companies.  

Furthermore, Clough said, the technology has the benefit of being able to aggregate data in an effort to develop data-driven clinical decision support. “During the planning, navigation and review phases, the data are pooled and then analytics can be used to try to predict outcomes,” the presenter explained. She continued that a particular patient could be matched to similar previous patients, and not just necessarily in one centre, but across multiple centres, after which predictions of outcomes based on different device type usage could be provided. 

Data-wise, Clough shared that the technology has been demonstrated in independent case-control series in both the UK and the USA to result in reduced radiation and procedure times in both standard and complex endovascular repair. In fenestrated cases, she added, it has also been shown to reduce the amount of iodinated contrast agent used. The presenter further noted a sustained reduction in radiation exposure for the operator after just 10 cases. 

Integration into healthcare systems, however, will require further data. “We need to demonstrate that [Cydar Maps] provides similar operator benefit and similar or lower overall costs compared to comparators, as the UK is a value-based healthcare system,” Clough stated. She noted that the UK National Institute of Health and Care Excellence (NICE) has a digital evidence framework that requires a high-quality randomized trial for any technology designed to guide treatment. 

Against this backdrop, Clough and Tom Carrell (co-creator of Cydar Maps) applied for funding to NIHR for a randomized controlled trial to investigate the technology’s value. The funding was granted, and the investigators subsequently set up a prospective, multicenter, two-arm randomized controlled trial recruiting patients with abdominal aortic aneurysm (AAA) and thoracoabdominal AAA trial in 10 sites across the UK.  

“[The trial] is designed to capture real-world practice, so it is deliberately relatively simple,” Clough commented. “We screen patients at MDT [multidisciplinary team meetings] or in clinic and collect routine clinical data and CT imaging data, as would be usual practice,” the presenter elaborated. A quality-of-life questionnaire (the 10-question EQ5D) is really the only additional element needed for the trial. 

Clough continued that patients will be randomized in a 1:1 fashion, with the aim being to recruit a total of 340 patients. Clinical, technical and cost-effectiveness data will be collected to evaluate the technology. 

The presenter closed with a progress report, detailing that 213 patients—just over 60% of the cases required—have been enrolled so far. “We are pleased that, on the whole, sites are recruiting patients well,” she remarked, noting that around 80% of all eligible patients that are screened are being recruited to the trial.  

“Health technology has the potential to drive efficiency and cost savings, but its value must be demonstrated,” Clough stressed in her conclusion. “Cydar Maps has been shown to provide benefit compared to standard treatment in smaller studies for both complex and simple endovascular aortic repair, and we hope this NIHR-funded trial will provide data of sufficient quality for submission to NICE for evaluation, to understand the true value of this technology.” 

Impact of the CMS proposed rule on the QPP for 2024

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Impact of the CMS proposed rule on the QPP for 2024

This summer the center for medicare and Medicaid Services (CMS) published its annual Physician Fee Schedule and Proposed Rule for calendar year 2024, and on Nov. 2 the Final Rule was published. The proposed rule included several proposals within the Quality Payment Pro­gram (QPP) that would impact vascular surgeons. The fol­lowing article reviews highlights and the SVS responses.

One active area for CMS is the development of Mer­it-Based Incentive Payment System (MIPS) Value Pathways (MVPs). MVPs are viewed as the gateway for providers to transition into Alternative Payment Models (APMs). Their development for vascular conditions was covered in a recent Vascular Specialist article.

In the proposed rule for 2024, CMS proposed five new MVPs, which would bring the total to 12 optional MVPs for physician reporting. CMS also proposed to increase public comments during MVP development by soliciting feedback for 30 days following submission and making changes with­out input from the society or stakeholder that submitted the MVP if CMS deems those changes are appropriate. The agency also proposed to solicit recommendations for MVP updates annually. While the SVS appreciated CMS’ plan for public outreach, we argued that the persons and/or specialty societies who developed an MVP should be able to view and respond to public comments once received, as they will have a more nuanced view regarding how the proposed changes would impact the MVP and might create unintended con­sequences. The SVS also recommended that CMS provide a one-year lead time regarding the clinical areas under consid­eration for condition, specialty or procedure-based MVPs.

Subgroup reporting will become an option for MVP par­ticipants, which the SVS believes is important for broadening specialists’ reporting options and for the development of MVPs. The SVS emphasized the need for a transparent sign-on and a sufficient transition period for providers choosing to report via subgroups.

In the MIPS Quality Performance Category, CMS proposed maintaining the 30% weight of the final MIPS score but in­creasing the data completeness measure from 70% to 75% beginning with the 2024 performance year. The SVS noted that this increased reporting requirement was counter to CMS’ goals of reducing administrative burden within the MIPS program, particularly at a time when data and care integration are challenged and the costs of doing so are borne by physicians and their practices. Additionally, until more valid claims or easy-to-access electronic health measures are made available, it seems unfair to increase this requirement.

Under statute, the MIPS Cost Performance Category will continue to have a 30% weight. CMS proposed to establish a maximum cost improvement score of one point out of 100. The SVS recognized the flexibilities that CMS put in place to hold physicians harmless from undue MIPS penalties during the COVID-19 pandemic and asked that CMS continue to allow for hardship exemptions. The SVS also asked that CMS consider a maximum cost improvement score of at least five bonus points.

CMS proposed maintaining the 15% weight for the Im­provement Activities (IAs) category and proposed four ad­ditions and five removals of IAs. The SVS encouraged de­velopment of methods for IA credit awards for performing activities that overlap with similar Quality, Cost and Promot­ing Interoperability (PI) measures.

CMS proposed that PI category remain at 25% of the over­all MIPS score. CMS suggested requiring a yes/no response for Public Health and Clinical Data Exchange measures, with the requirement to submit level of active engagement. CMS also proposed to make the Query of Prescription Drug Monitoring Program (PDMP) a required measure. The SVS opposed the PDMP requirement, as many physicians and health systems remain incapable of interconnecting with PDMP systems. The SVS also strongly urged CMS to recon­sider its proposal to tie physicians’ PI category success to the “all or nothing” approach proposed for Public Health and Clinical Data Exchange objective requirements.

There are many other components of the rule that cannot be covered here. For a more detailed review and/or the final SVS comment letter, visit the CMS Final Rule fact sheet at vascular.org/24FeeSkedFactSheet.

References

  1. Vascular Specialist June 2023 Volume 19 Number 06: vascular.org/June23VascularSpecialist
  2. Proposed rule: vascular.org/ProposedRulefor24
  3. SVS comment letter: vascular.org/2024PaymentPolicyResponse
  4. QPP Fact Sheet: vascular.org/2024QPPProposedRuleFactSheet

CAITLIN HICKS is vice chair and EVAN LIPSITZ the chair of the SVS Quality Performance Measures Committee.

Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease

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Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease
Ramon Varcoe
SWING
Ramon Varcoe presented the new data at VEITHsymposium 2023

Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year’s VEITHsymposium (Nov. 14–18) in New York City.

The SWING trial is a 35-patient prospective, multicenter, single-arm feasibility study to evaluate the safety and performance of the Sundance sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING trial enrolled patients with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2–4mm, and a total lesion length of ≤230mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study patients will be followed for 36 months post index procedure.

The primary safety endpoint is defined as the number of patients with a composite of freedom from major adverse limb event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is the rate of late lumen loss at six months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING trial were achieved.

Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major reintervention was reported among the 35 trial patients. The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularizations) at six months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. Primary efficacy data show late lumen loss of 1mm (±0.79mm) across 35 lesions at six months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure.

Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularisation associated with deterioration of Rutherford clinical classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population. The Rutherford clinical classification describes seven categories of peripheral arterial disease, including both the patient’s clinical symptoms as well as objective findings, and is used to assess disease progression.

Andrew Holden

“The two-year safety and performance results of the SWING trial continue to show promise for the Sundance sirolimus DCB in treating below-the-knee disease in a challenging CLTI [chronic limb-threatening ischaemia] patient population where options are currently limited,” said Andrew Holden, MD, from Auckland City Hospital in Auckland, New Zealand, co-lead investigator, in a Surmodics press release.

“We need to continue to strive for better treatments for treating infrapopliteal disease,” added co-lead investigator Ramon Varcoe, MD, from Prince of Wales Hospital in Sydney, Australia, who presented the new data at VEITHsymposium 2023. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

On gratefulness as a vascular surgery trainee

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On gratefulness as a vascular surgery trainee

I enjoy listening to podcasts. In addition to my usual rotation through Audi­ble Bleeding and Behind the Knife, I’ve found insight in listening to Hidden Brain. A recent episode centered on the concept of grati­tude, where it was highlighted how quick we are to dismiss the good things that happen to us and perseverate on the negative, inconve­nient or unsavory parts of our day—both for ourselves and those around us.

In training, this is sometimes expressed in complaint form. We complain about how difficult residency is; how certain residents/attendings/consulting specialties treat us. We find it cathartic to air out these grievanc­es, all the while forgetting that once upon a time, this present state of being a trainee, was a dream—a position achieved through very hard work.

So, then, why should we be grateful?

There are a number of benefits, I think, that accrue from gratitude as a resident. Most important is the sense of being situ­ationally aware and outward-focused. This allows for a growth mindset.

Such a framework sets the tone for becom­ing better—in skill and knowledge—at our job as surgical trainees. Challenges become opportunities; roadblocks become chances. For me, this means seeing my call status, not as a “black cloud,” but as an opportunity for learning. I’m not always successful at this, but it is an aspirational goal.

Another benefit that I identified from past chief residents and fellows is that the grateful ones were often superlative leaders. Because simply acknowledging the difficulties of pro­viding care for patients at various levels— from the intern on the wards, to the OR staff setting up—is encouraging and uplifting. Fre­quently, this attitude would translate into a certain work ethic in the team and a cultural ethos that had patient care as the top priority. It’s nice to be noted for the hard work being put into quality patient care.

Finally, gratitude comes best through seemingly small acts that can become a habit. For instance, a congratulatory fist bump to a co-trainee, saying “well done” when some­thing goes well, or even just taking the time to listen to the patient’s concerns, are all acts of being grateful for the opportunity to learn from the best clinical teachers—our patients.

This Thanksgiving month, as many con­template gratefulness, on the wards, in the operating room, or in the angiography suite, I hope we are imbued with a sense of added gratitude to be living what was once a dream for all of us.

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

Can you count the ‘monkeys’ on your back?

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Can you count the ‘monkeys’ on your back?

HappinessPeriodically, when under pressure at work, and sometimes at home, I would think about what I could do to free up more time for myself and the family. How I could pri­oritize or drop tasks that were unimportant. There were and are many books and articles advising us how to prioritize assignments. Over time, most of us have devised an imperfect system to deal with non-urgent tasks. A high-level approach to separate the chaff from the wheat may start with things such as your own goals, organizational objectives followed by a variety of individual objectives. However, the day-to-day pesky problems added to our calendar continue to test our time-management skills.

Time-management techniques and tools have progressed from handwritten notes and checklists to paper and now electronic calendars. Many years ago, Stephen Covey postulated that we are managing ourselves, not just our time, and that our goal should be prioritizing relationships and results. His book, called The 7 Habits of Highly Effective People, is one of the best time management books I have read. Since this was written in 1990, many of my younger colleagues may not have read it. Besides discussing how to cultivate the seven habits, the book has practical advice about separating tasks by urgency and importance in a time management matrix. The two-by-two grid with four quadrants has “important” and “not important” on the y axis and “urgent” and “non urgent” on the x axis. This matrix also goes by the “Eisenhower matrix.” If you are still struggling with time management, it may be worth using this simple tool.

While the grid was helpful in prioritizing tasks one has already accepted, I soon realized that the advice was useful after I had already committed and taken on many of these management tasks. This is where the “monkeys” arrived into my life.

I came across an article in Harvard Business Review in 2011 about tasks or “monkeys” in relation to time management problems for managers.1 The source of this metaphor is uncertain. Speculation ranges from Sinbad the Sailor in Arabian Nights carrying a person or an ape across water who would then not leave, to denoting lugging a load of anger or even carrying the burden of drug or alcohol addiction. In general terms, the idiom means dealing with a difficult-to-resolve task or problem, but in practical terms it connotes a task or burden that has been transferred to you, willingly or not.2

An older “Grady” physician like me (alumnus of Grady Hospital in Atlanta, part of Emory University and Morehouse) quoted George Michael as singing, “Watch out! Baby who’s that? Don’t look now—there’s a monkey on your back!” and reminded readers of that idol of yesteryear Peter Gabriel, who, while made up as a shaman, sang, “Don’t you know you’ve got to shock the monkey?”3 Gabriel’s context was not about animal cruelty or People for the Ethical Treatment of Animals (PETA), but about jealousy, which can trigger animal-like behavior. I think he may have been onto something. The constant scratching and emotional toll of one or more monkeys on our backs for months or years may in fact lead us to overreact and act like wounded spirits—not due to jealousy but helplessness.

The ex-Grady doc discusses management time at work in three practical categories: boss-imposed, system-imposed and self-imposed time. At work, the monkeys are usually boss or system-imposed varieties.

While monkeys have many species, for discussion purposes, our monkeys come in three varieties: those that are invited in, others who we unintentionally invited in and feed for a while, and those that are forced on us who live on our backs till we get rid of them.

Then there are those monkeys who are unwittingly invited through emails or phone calls. If you are known to be a “giver,” according to psychologist Adam Grant, chances are you are highly susceptible to this dialogue. The shifting, or giving of a task (“monkey transfer”) may go like this: “I have heard you are an expert in… so, can you help me make sense of this? It will only take a few minutes… (take your pick: chapter, abstract, manuscript, statistics)?” Full disclosure: I have shamelessly used this tactic too.

Or: “I just need to pick your brains for a few minutes about… since our mutual acquaintance Dr. Y told me you helped her with…’ I am guilty of this too, but only after helping someone several times, which then forces me to switch to becoming a “matcher” so I can seek reciprocity.

The uninvited monkeys are a different problem. These are friends of friends, or relatives of relatives, who forward their images or reports. Outside of work, it’s the same pattern. In my experience as a “retired” physician, most of them are invited in. Sometimes, the transfer is so well done that I am not aware that I invited them in. I am guessing others may also have read this Harvard Business Review article and know how to seamlessly transfer the monkey(s)! Some weeks, I am dealing with the health issues of at least two to three relatives, good friends or acquaintances across the globe. Most of us gladly accept these demands, but the pace picked up after my retirement. Please do not get me wrong: I derive satisfaction from being able to assist in whatever way I can, whether it is getting someone a quicker appointment, a second opinion, or guiding them to the right physician. Any person I can direct to appropriate care, I count as a victory. It is when a five-minute informal advice changes to making a medical decision for someone who ends up asking the usual question: “What would you do if you were in my place?” One must be careful here as the “monkey” is now in transfer mode and ready to make the jump to your back.

It is a cliché, but prevention is the best medicine for this very underestimated time waster. My advice is, unless you are looking to impress your boss, or do not wish to spend any time at home, be on “monkey alert” so you can spot the incoming transfer prior to it leaving the transferor. If the creature has already started jumping through neutral space, the game is lost. Most often, it starts with an attempt to make it a mutual problem with statements like, “How should we deal with this?” The monkey is now in neutral territory or, as the authors put it, “the monkey in each case begins its career astride both their backs,” and then makes the leap.1

If you do not prevent the transfer, plot carefully about getting rid of the monkey. But where does the creature finally go? Your options are convincing someone that the monkey belongs to them, to punt it upstairs with the task resolved, boot it down to a subordinate, or ignore it hoping the other side forgets. Based on experience, the last option is your best one. Another piece of advice offered is to “pet the monkey” while it is in someone else’s lap, or on their shoulder/back, and solicitously show some empathy while changing the topic and discouraging transfer.

William Oncken, Jr. and Donald L. Wass have a few useful rules for managers struggling to deal with the “care and feeding of monkeys.”1 First, one either feeds them or gets rid of them, but does not continue to deal with them through vague language. Next, do not spend more than 15 minutes on a single monkey, and feed them only face-to-face or by telephone—and only with an appointment. They suggest avoiding being at your desk too long since that is where your computer and phone are. This is also where monkeys are waiting to switch parties. Much easier to be elsewhere since you do not have your calendar with you, or are busy in the clinic or the OR. Finally, they advise an assigned feeding time and to pre-determine the degree of effort you wish to put in it. Better still, you could offer some time next Wednesday at 5 p.m. to hear more about the potential transfer. Chances are they have forgotten, and you will not get the call. But if you do, they probably really need your help.

Alas, some of these rules are hard for we “retirees,” as people assume we sit around all day waiting to welcome the monkey. My best advice is to beware of this type of “transfer.” After you have received a monkey or two, you will know which people are anxious to make their own load lighter.

References

  1. Management Time: Who’s Got the Monkey? https://hbr.org/1999/11/management-time-whos-got-the-monkey
  2. https://www.idioms.online/monkey-on-your-back/
  3. http://www.gradydoctor.com/2013/09/dont-look-now-theres-monkey-on-your-back.html

BHAGWAN SATIANI is a Vascular Specialist associate medical editor.

Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems

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Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems
Jeffrey Hsu presents at VEITH 2023

A 14-year effort to achieve departmental status for vascular surgery at a large healthcare system in Southern California resulted in significant gains for the specialty within the organizational apparatus, according to an administrative case report on an effort finalized last year.

Jeffrey Hsu, MD, the regional chief of vascular surgery at Kaiser Permanente Southern California, charted the course of departmentalization at his institution amid resistance from general surgery and organization-level bylaw changes necessary to define a transition process during a 2023 VEITHsymposium (Nov. 14–18) session in New York City.

The process originated after a general consensus was reached among the healthcare system’s vascular surgeons in 2008 that they needed their own department due to issues around inadequate representation for the specialty, lack of administrative control over vascular surgery resources, and “a general sense of recognition and identity for the specialty,” Hsu told attendees.

After changes to the Kaiser Permanente bylaws were defined and approved, it became apparent vascular surgery met all the criteria required to become a department.

“In 2016, vascular surgery was granted divisional status by the executive leadership,” explained Hsu. “However. operationally this had little effect, and the majority of vascular surgery chiefs wanted to continue to pursue department status. In 2017, vascular surgeons in our organization collectively decided to transition from a division to a department. Through a lengthy process of negotiations and discussions, we were finally able to achieve in unanimity. In 2021, we were able to gain the support of the general surgery department to proceed.”

Finally, in 2022, the Kaiser Permanente board of directors “unanimously voted to form the department of vascular surgery,” added Hsu.

The stakes couldn’t be higher, he observed.

“It stands to reason that specialty representation at all levels of healthcare organizations will become increasingly important as we move toward value-based systems, increased administration and more corporate control of healthcare,” Hsu said. “Vascular surgery’s place in the organizational structure is an important factor to consider.”

He listed the benefits witnessed in the year since the department was formed. Surgical service line operations now include vascular surgery decision-making, Hsu said. Collegiality with general surgery “remains strong and unharmed,” and “the medical school has established vascular surgery clerkships and appointed vascular surgery preceptors.” Surgical residents are given increased exposure and longer rotations in vascular surgery, and vascular surgery chiefs are now invited to all surgical leadership meetings, both regionally and locally, Hsu added.

“This report demonstrates that departmentalization of vascular surgery is possible in large healthcare organization,” he concluded. “So I ask our colleagues who take leadership positions in your organizations who are faced with mounting administrative challenges—it is my hope that you will consider departmentalization as a viable option.”

NIH-funded research on the use of AI in vascular surgery: A decade in the making

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NIH-funded research on the use of AI in vascular surgery: A decade in the making

Vascular surgeon-scientist Elsie Gyang Ross, MD, recently secured coveted funding through the National Institutes of Health (NIH) Research Project Grant Program (R01)—a rare feat for one so young having managed to achieve the career landmark before the age of 40.

Here, the associate professor of surgery at the University of California San Diego tells Vascular Specialist how she got started researching the use of artificial intelligence (AI) in vascular surgery, where it could improve care and how the $3 million-plus NIH funding will be used to build AI models that can predict peripheral arterial disease (PAD) in diverse patient populations.

“Not just at one hospital, but across the country,” she says, explaining the scope of her work. “And to see if these models—when we put them in the clinician’s hands—will actually change care.”

Video attributions

Footage attribution:
Hyperlapse Media/stock.adobe.com

Music:
Quirky-tension-investigation-(sleek-sneak)/performed by Apollo Audio/FineTune Music/stock.adobe.com

SVS executive director elected to executive council of Council of Medical Specialty Societies

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SVS executive director elected to executive council of Council of Medical Specialty Societies
Kenneth M. Slaw

The Society for Vascular Surgery (SVS) Executive Director Kenneth M. Slaw, PhD, has been elected to executive council of the Council of Medical Specialty Societies (CMSS).

The Council of Medical Specialty Societies (CMSS) is an organization of 53 boarded medical specialties representing over 800,000 specialty physicians in the U.S. whose mission is to “advance the expertise and collective voice of specialty societies in support of physicians and the patients they serve.” Its vision states that “working together, specialty societies advance healthcare for patients and physicians.”

CMSS is a highly effective collaborative body that brings all of the medical specialty societies together to work on common issues, challenges, and national initiatives, Slaw tells Vascular Specialist. “CMSS has established cross-society policies for ethics, relations with industry, diversity, equity and inclusion [DEI], and takes formal advocacy positions when essential to foster and protect specialty medicine,” he says.

Staff executives in specialty societies meet across numerous professional peer groups to share best practices and optimize education, marketing, communications, governance, legal, industry relations, registries and quality improvement.

Additionally, CMSS has received numerous grants from the Centers for Disease Control and Prevention (CDC) and private foundations in the past several years to accelerate progress in the areas of diagnostic quality, health equity, and many other areas of interest, Slaw points out. The SVS was recently awarded a $100,000 grant from CMSS to foster diagnostic excellence in chronic limb-threatening ischemia (CLTI).

“I am proud and honored to do all I can to accelerate the movement of specialty societies and CMSS to face a litany of future challenges” notes Slaw. “Vascular health and healthcare span the lifespan and interact with dozens of other medical specialty physicians and societies. Serving CMSS will tighten these important relationships for SVS and help improve care for patients.  SVS will have a front row seat and active role in addressing the future of healthcare.”

Slaw is in his eighth year as executive director of the SVS, and has served specialty societies in a senior or executive role for more than 35 years.

Vascular Specialist–November 2023

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Vascular Specialist–November 2023

In this issue:

  • Carotid revascularization: Getting to the right decision
  • SVS reveals proposed changes to Society bylaws
  • Meta-analysis: The complete patient-level dataset on paclitaxel and death that helped sway FDA 
  • PE care: The pulmonary arterial tree—is it time to branch out? 
  • Obituary: Roger M. Greenhalgh, SVS International Lifetime Achievement Awardee, dies aged 82 

New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

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New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

This advertorial is sponsored by Silk Road Medical.

Scott Berman and Stacey LeJeune

For Scott Berman, MD, patient responses when confronted with an explanation of the extent of their asymptomatic carotid disease tend to be quite stark. They are either so petrified of having a stroke that they express clearly that they want to be operated on as a matter of urgency, the Tucson, Arizona-based vascular surgeon explains, or else they are steadfastly against surgery under any circumstances. 

That’s why Berman sees patient-reported outcomes as a crucial component to factor into certain areas of his treatment decision-making. So, a recent patient satisfaction survey—which demonstrated those carotid disease patients who underwent transcarotid artery revascularization (TCAR) recovered more quickly than those who received carotid endarterectomy (CEA)—confirmed what already seemed intuitive. 

“As soon as we started doing TCAR, we could see early on that these patients were recovering a lot more quickly than CEA patients,” says Berman, of Pima Heart & Vascular, a study author who contributed a tranche of patients to the survey. “The overall experience seemed to be better.” 

The survey, conducted across nine medical centers, drew 304 responses (161 TCAR; 143 CEA) from 64 patients across a total of 13 questions on post-procedure pain, lifestyle limitations and activity ability. A hospital staff member at each of the nine participating hospitals conducted the surveys over the phone once per week for four weeks. 

Berman contributed 10 patients—five each for TCAR and CEA. “It really reinforced what we had observed—that TCAR patients seemed to have a less eventful recovery after revascularization than endarterectomy patients,” he says. “The overall experience has seemed to be better with TCAR, and the early results with this survey support that.” 

Among the key findings, the study—which was completed Silk Road Medical—established that patients who were treated with TCAR experienced less pain over all time periods than those who underwent CEA. TCAR patients also reported significantly less facial numbness, swallowing issues, facial drooping and voice changes over time than their CEA counterparts. Furthermore, TCAR patients reported more ease in completing ordinary tasks 48 hours to one week post-procedure. 

“Even in my subset, we were able to see that there was statistical significance in many areas, including pain control and returning to activities,” notes Stacey LeJeune, MD, of Surgical Associates and a community hospital vascular surgeon in Wausau, Wisconsin, another author involved in the patient satisfaction study. 

Carotid revascularization patient satisfaction survey data

LeJeune contributed 20 patients to the survey—10 for each procedure. 

“As someone who does a lot of carotid surgery, both endarterectomy and TCAR are overall felt to be relatively safe. Patients tend to do well, and the majority go home the next day. But this study is very interesting because it gets the patients’ perspective on the little things that matter to them during their recovery. I was greatly surprised by the one-week post-procedure results regarding patients returning to driving their car.” 

The relevant data from the survey show that 71.4% of TCAR patients reported having driven their car at the one-week post-procedure mark versus just 25% of CEA patients responding that they had done so. 

Berman drills further into what the data mean for patients in their day-to-day lives in the days after treatment. 

“Globally, patients seemed to recover quickly,” he reflects. “if you look at the actual numbers: less pain, less trouble moving, able to drive. Return of normal voice, lack of numbness, no facial droop. With all of these things, they really reinforced what we had already observed.” 

Berman sees such patient-reported outcome measures as sitting at the vanguard of surgeons and interventionalists being better healthcare spending stewards. 

“We have to make sure that the treatment we provide is actually helping the patient, and making them feel better,” he says. 

“There are some things that are a little objective—if a patient has a giant aneurysm, we don’t operate on them to make them feel better; we operate on them to prevent death. Claudication is the classic example of when we try to improve a patient’s lifestyle, so we certainly should be able to measure whether or not lifestyle improved as a result of our treatment.” 

Carotid disease sits somewhere in between the aortic aneurysm and claudication analogy, Berman explains. “We certainly want to improve or reduce the risk of stroke, but that risk of stroke impacts how people conduct their life.” 

LeJeune, meanwhile, looks at patient satisfaction through the lens of appropriate patient selection. 

“Through my experience performing TCAR on my own patients, and also teaching the procedure to many colleagues, it’s clear to see how much faster, smoother and less invasive this procedure is, particularly for those who have the right anatomy,” she explains. 

“Patient selection is key to good outcomes, and I think that we are going to continue to see positive outcomes for these patients—both standard risk and high risk— as we move forward. As a surgeon my priority is a good clinical outcome, but if we’ve proven that that is equivalent, it then gets down to time, cost and patient satisfaction. In a world where patient satisfaction is very important for a lot of reimbursement type of issues, I think patient-reported outcomes are very important.” 

Berman points toward the future direction of the survey and how it had dovetailed with his experience investigating patient-reported outcomes in the claudication arena. 

“With claudication, there are a lot of validated surveys of patient-reported outcomes,” he observes. “There are none for carotid disease.” Berman says the challenge now is to take “a robust questionnaire” and put it through the rigors of statistical validation. 

“Vascular surgeons in general are very data driven, and quick to challenge data to make sure it’s been collected appropriately,” he adds. “That’s the next step but this is an important first step.” 

Which is only going to become more important in light of recent events regarding Centers for Medicare & Medicaid Services (CMS) moves to incorporate patient preference: “I think it’s important to have this kind of data from patients to make informed decisions,” says Berman. 

For LeJeune, bolstering patient enrollment is key to strengthening the survey data going forward. As the authors look at the survey as it currently stands, the results point to a truism, she adds. 

“Having this good subset of patient responses is supporting what we know already, but as clinicians sometimes understimate—the part of a patient’s healing where we assume they are doing well. We see them back a few weeks later and don’t appreciate these nuances. 

“This study has teased out some of that, showing how much faster TCAR patients feel better and recover in the short-term.” 

Cyclical-pressure Topical Wound Oxygen therapy emerges as a proven wound-healing device for diabetic foot ulcers, showing great promise in venous leg ulcers

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Cyclical-pressure Topical Wound Oxygen therapy emerges as a proven wound-healing device for diabetic foot ulcers, showing great promise in venous leg ulcers
Enrico Ascher and Natalie Marks

This advertorial is sponsored by AOTI.

Enrico Ascher, MD, and Natalie Marks, MD, currently combine for close to 60 years of vascular surgery practice experience in New York City’s 3 million-strong populous borough of Brooklyn. Between them they see a steady stream of patients with various types of acute and chronic wounds—arterial, venous and mixed etiology nonhealing ulcerations not being properly treated. 

Over the years, Ascher, a vascular surgeon with the Vascular Institute of New York, has established a wound care center, built expertise in the wound-healing space and developed hyperbaric oxygen therapy experience, seeking to fill a void in appropriate therapy for a sick population of patients with peripheral arterial disease (PAD). 

More recently, Ascher and Marks, a vascular medicine and board-certified wound specialist in the same practice, have developed a “small but impressive” experience with Topical Wound Oxygen (TWO2) therapy in treating not only diabetic foot ulcers (DFUs) but also venous leg ulcers (VLUs). Ascher says the home-based TWO2 therapy—which combines supplemental oxygen with non-contact cyclical compression and humidification through a single-use extremity chamber system—is emerging as an effective alternative with independently proven advantages involving cost, simplicity and patient comfort. 

He points to a recent systematic review of randomized controlled trials (RCTs) he says confirmed RCT evidence showing that topical oxygen therapy increased the likelihood of DFU healing compared to controls. 

“We have a small experience—but significant in our initial interpretation—of the outcome of this therapy,” Ascher explains. “We did 29 limbs with patients who absolutely would not heal with anything, and for months we followed these patients. When we tried this new methodology, most of them did well.” 

Introducing two cases in which TWO2 was used to treat two patients with VLUs, Ascher expresses hope similar evidence will emerge showing effectiveness in the healing of ulceration with a venous etiology. 

Case no. 1 

Ascher and Marks describe the case of an 82-year-old male patient who first presented to their practice in 2021 with recurrent lower-leg circumferential ulceration, seo-sanguinous discharge, severe itching, inflammation and venous stasis. 

“He had some venous procedures in the past—he had had his veins closed, a stent placed in the iliac vein, several sessions of foam sclerotherapy of varicose veins—to decrease swelling in his leg and to promote healing,” explains Marks. “He had been going to different specialists, but was getting worse. We also found that in addition to his venous insufficiency, he had vasculitis, and we tried topical and oral steroids. After starting TWO2 at home, in five months— there were a couple of hiccups in the middle to do with coverage issues—we were able to heal his wound completely, and it stayed healed.” 

Case no. 2 

Turning to a second case—that of an 84-year-old female who presented with a large lower leg ulcer of venous etiology in the setting of recurrent cellulitis—Ascher and Marks outline a lingering wound that had worsened over weeks. 

The patient, who was housebound, had comorbidities that included hypertension and hyperlipidemia, and had sought treatment through her primary care doctor. Her symptoms included progressive swelling, skin hyperkeratosis and peeling, itching, dermatitis changes and increased discharge. 

“After she came here, we were wrapping her with compression dressings,” says Marks. “Then, after gaining coverage approval for TWO2 within a week, in just four weeks of oxygen therapy at home, the wound healed and has not recurred since.” 

Home-based care 

Ascher highlights TWO2’s simplicity. “This is a methodology that is much simpler, less complicated, less burdensome to the patient and actually very comfortable,” he says. “The patient is sitting in their home watching TV, listening to some music or reading a book, and they put a boot on over existing compression dressings.” 

Among its advantages, he lists how it helps reduce edema with the non-contact cyclical compression, addresses infection resistance, and aids the production of good collagen in the wounds, resulting in wound coverage with healthy tissue. “There is evidence it also can increase angiogenesis,” Ascher adds. The topical mode of oxygenation to the tissue is delivered with a partial pressure of approximately 800mmHg. 

Contrasting TWO2 with hyperbaric oxygen therapy, Ascher reflects that some had trouble tolerating the hyperbaric machine. “But most of the complaints were that they had to spend two hours inside the chamber, and some were claustrophobic. So TWO2 has been shown, so far mostly by our podiatry colleagues, in the literature that it is an alternative for these patients, and maybe for more patients if they want to have this kind of comfort with equally or almost equally good results.” 

Marks notes how patients interact with the device, an extremity chamber, or boot, which extends up to and above the knee. “We have seen meaningful results in terms of patient comfort and willingness to stick with the treatment,” she says. “They see the results with each treatment as the wound gets a little bit better looking—less pain, less swelling, less discharge. So they persist because they see constant and gradual improvement.” 

Combined with the evidence provided in the meta-analysis, Ascher says the “small but impressive experience” from his own practice encourages him to push on with TWO2 as a component feature of his wound-healing armamentarium. “I think we will try to treat these ulcers by fixing the cause of the ulceration: If it is an infection, we have to clean the wound—maybe administer antibiotics. If it is of arterial origin, we have to improve the circulation. If venous, we have to fix the vein issue as best we can. Then we give a chance for the ulcer to heal. If it does not heal, then I think that is the time to provide the option of having topical oxygen therapy.” 

Marks also highlights a cost-savings dimension. “TWO2 provides not only patient comfort, healing of the wound and decreased chances of complications, I think financially it makes a lot of sense,” she says. “Give a little bit of extra resource up front for this topical oxygen therapy but provide faster healing, instead of having all of these wasted resources.” Ascher points to what chronic wounds cost the U.S. in dollar terms: “Anywhere from $50 to $60 billion,” he concludes. “It’s a big problem and has been forgotten for years. Only now, fortunately, people are much more tuned into it.” 

Carotid disease: Getting to the right decision

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Carotid disease: Getting to the right decision
Brianna Krafcik at NESVS 2023
The recent move by the Centers for Medicare & Medicaid Services (CMS) to expand coverage for carotid artery stenting brought with it the requirement for a shared decision-making interaction between physicians and patients as they establish which carotid revascularization treatment modality is best for their disease. Currently, a validated tool does not exist—but investigators at Dartmouth Hitchcock Medical Center are working on research aimed at changing that. 

Now that the decision has been made to expand Medicare coverage for carotid artery stenting to include patients who have symptomatic carotid stenosis ≥50% and asymptomatic ≥70%, the stage has been set. 

Yet, as Brianna M. Krafcik, MD, a vascular surgery resident at Dartmouth Health in Lebanon, New Hampshire, reflects, just over a year ago, long before the controversial move went under the spotlight, she and colleagues failed to garner much attention when they submitted a review paper that looked at the decision aids available to carotid stenosis patients considering intervention versus medical therapy. 

Now there is a need. A shared decision-making interaction has been mandated in CMS’ final decision memo. Amid the vacuum, the work of Krafcik and colleagues is suddenly taking center stage. This includes a paper recently presented at the 2023 New England Society for Vascular Surgery (NESVS) annual meeting in Boston (Oct. 6–8) that lays down some foundational pieces in the process toward creating such a tool—one that can be used across the multiple specialties treating carotid stenosis patients, and incorporate all options, including transcarotid artery revascularization (TCAR), approved in 2015 and not part of prior decision aids. 

“When we did the review paper—which is currently submitted for publication—more than a year ago, we only found four studies that looked at decision aid instruments with any kind of scientific method,” Krafcik explains in an interview. “I think that review paper shows that even those four instruments that have been studied, anecdotally and in the literature, it has been shown that they are pretty underutilized both by vascular surgeons and also interventional radiologists—for interventionalists who are working in carotid disease there is almost nothing. Medicare is asking for a decision aid that doesn’t exist, so the stage is set to create such an instrument.” 

The latest research from the Dartmouth group, led by Krafcik and senior author Jesse A. Columbo, MD, an assistant professor of surgery at Dartmouth, looks to plug a gap in qualitative data regarding patient understanding of carotid disease. 

They found that there is a “complicated interplay between patient values, understanding of the procedures, and preferred level of involvement in medical decision-making” that contributes to a patient’s ultimate decision. They carried out longitudinal perioperative semi-structured interviews with 20 carotid stenosis patients eligible for both carotid endarterectomy and transcarotid artery revascularization (TCAR)—10 for each procedure. 

“In the patient surveys, the most important source of information regarding the procedures was the vascular surgeon followed by any written materials they may have received, while TV or videos were generally less important,” Krafcik told NESVS 2023. “When patients were asked about their feelings towards shared decision-making, most would like to discuss all treatment options with the physician and make a decision together. However, only approximately 70% of patients agreed that they understood their carotid disease and the treatment options available. Patients reporting on factors important to them when considering procedures in general felt the surgeon’s experience with the procedure and the presence of long-term outcomes data were very important, while the length of the operation and size of the incision were less important.” 

Concluding, Krafcik and colleagues said in the present era of multiple treatment options, “patients should be presented with all available information when discussing carotid revascularization. A shared decision-making discussion consistent with the patients’ values and level of desired involvement improves patient satisfaction and compliance.” 

Krafcik tells Vascular Specialist the Dartmouth team are currently working with social scientists, the Vascular Quality Initiative (VQI) and other organizations in order to try to create a pilot instrument that can be studied “in an iterative way.” “From there, once we have a prototype, then we can study it for usability, accessibility and feasibility so it can then be scaled up to a multicenter study that takes into account different regions, education level and sociodemographic factors. That’s the long-term plan,” she added. 

Importantly, Krafcik explains, the goal is to create a decision feed that will have “buy-in” across the different specialties treating carotid stenosis. “If a patient were to see a cardiologist and be given this decision aid, and based on the information says, ‘I actually would prefer an open carotid endarterectomy,’ that the cardiologist would be OK saying, ‘Then, I’ll refer you to a vascular surgery colleague.’ I think now that more providers are going to be doing these procedures, our decision aid should encompass and have buy-in from all of the different specialties.” 

Krafcik says two things in particular from the study struck her— the impact that the surgeon has on patients and that not every patient wants to participate in shared decision-making or wants to participate in the same way. “A lot of the patients would, when I asked them to explain the procedure in their own words, reiterate what their surgeon told them,” she relates. “When asked why they decided, they said it seemed like their surgeon felt that this one was better than the other.” Preoperative conversations are time-limited, Krafcik adds, “so understanding first how involved the patient wants to be, how much info they want, and how they prefer to receive it is helpful in guiding the discussion, because there is not really a one-size fits-all preoperative discussion.” 

DETOUR1 and DETOUR2 pooled analysis of bypass system reveals primary rate of 68.1% through 24 months

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DETOUR1 and DETOUR2 pooled analysis of bypass system reveals primary rate of 68.1% through 24 months
Sean Lyden

Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.

The Detour system offers a novel approach to treating complex peripheral arterial disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery (SFA), by using conduits routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20–46cm in length).

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multicenter, international studies. Inclusion criteria and prespecified endpoints were similar. Both studies utilized imaging core lab and independent adverse event adjudication. Endpoints included freedom from major adverse events (MAEs) through 30 days, symptomatic deep vein thrombosis (DVT), and length of stay. For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).

The results from the 275 pooled patients were presented at VIVA 2023 (Oct. 30–Nov. 2) in Las Vegas by one of the study’s principal investigators, Sean Lyden, MD, chair of vascular surgery at the Cleveland Clinic in Cleveland, Ohio.

The presented results included the following:

  • Primary patency, defined as freedom from TVR, was 79.1% at one year and 68.1% through two years
  • Freedom from MAEs through 30 days was 97.8%
  • Clinical success rate was 92.9%, 96%, and 95.3% at 30 days, one year and two years, respectively
  • Symptomatic DVT was 3.3% and pulmonary embolism (PE) rate was 0%, respectively through the two-year time point
  • Average length of hospital stay was 1.3 days.
  • Ninety-four percent of the patients had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm

“These results not only demonstrate the clinical utility of this therapeutic strategy in managing long complex femoropopliteal lesions but also highlight that PTAB with the Detour system achieves similar results to open surgical prosthetic femoropopliteal bypass without the need for general anesthesia, long length of stay, and high rate of complications. We eagerly await more comprehensive data from broader real-world settings to further corroborate these findings,” stated Lyden.

Use of IVUS reduces patient risk of MALE or death by up to 28%: Data support consensus views on importance of advanced visualization for peripheral vascular disease interventions

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Use of IVUS reduces patient risk of MALE or death by up to 28%: Data support consensus views on importance of advanced visualization for peripheral vascular disease interventions

This advertorial is sponsored by Philips.

The benefits of utilizing intravascular ultrasound (IVUS) in peripheral vascular interventions has been widely demonstrated in the literature. In nearly every vascular bed studied, we have seen an improvement in overall outcomes. Over the last several years, clinical data in support of IVUS has exploded, including the first-ever randomized controlled trial (RCT) of the modality that demonstrated its use has changed treatment plans in 79% of arterial cases.1

In addition, an analysis of over 500,000 patients demonstrated that IVUS improved outcomes with a 27% reduction in major adverse limb events (MALEs).2 The use of IVUS in the venous vasculature has also demonstrated clinically significant improvements in outcomes. A real-world analysis of IVUS use in the treatment of venous disease demonstrated a 28% risk reduction for repeat intervention, hospitalization or death.3

These data build on the VIDIO (Venogram vs. IVUS for diagnosing iliac vein obstruction) study findings, which like the arterial RCT, demonstrated IVUS changed treatment plans in nearly 60% of venous cases,4 identifying patients with severely symptomatic central pelvic vein occlusive disease that would have been missed with other routine imaging. With these compelling data in mind, a group of 40 cross-specialty physicians published a consensus paper regarding the use of IVUS in peripheral interventions, where they agreed that the use of IVUS was strongly recommended in all interventional phases of both arterial and venous procedures.5 

With advanced visualization tools like IVUS, we can get a 360-degree view inside the vessel, allowing us to accurately assess the severity of disease and create a specialized approach to treatment. 

Case review: Arterial example 

Here, we present a case of a patient with severe ischemic rest pain and an ankle-brachial index (ABI) of 0. The patient was a prior smoker who had multiple prior interventions for critical limb ischemia (CLI) and tissue loss. In 2021, the patient had a second femoral-to-tibial artery bypass and was lost to follow-up. 

On angiogram, there was redemonstration of superficial femoral artery and popliteal artery stent occlusion, and chronic occlusion of both the anterior tibial and posterior tibial target bypasses. There was no arterial reconstitution of viable open or endovascular target vessels in the foot. 

Deep venous arterialization (DVA) was performed using the Pioneer Plus catheter for IVUS-guided arterial re-entry (see Figure 1). Visualization of the popliteal artery re-entry target by IVUS allowed for rapid crossing from the posterior tibial venous access site (see Figure 2). 

The use of covered self-expanding stents and percutaneous balloon angio-and venoplasty formalized the iatrogenic arteriovenous fistula. Post-intervention IVUS using the Reconnaissance .018 OTW IVUS catheter verified appropriate luminal gain and aided identification of incomplete venous valvular disruption in the foot (see Figure 3). Target areas of venous outflow were addressed with repeated venoplasty. At one-month follow-up, the patient reported marked symptomatic improvement, and non-invasive duplex imaging showed DVA patency. 

Venous example 

Here, we present a case of a 65-year-old Caucasian female with a three-year history of left leg swelling, heaviness and achiness, which improved with elevation. 

She had no history of prior deep vein thrombosis (DVT), venous interventions, peripheral artery occlusive disease, leg trauma, congestive heart failure or chronic kidney injury. The symptoms improved overnight while in bed, and returned the next day. She woke up in the morning free of these symptoms, but, by evening, she was quite uncomfortable. On physical exam, she had erythema in the gaiter distribution of the lower- and mid-calf circumferentially, with skin induration and edema of the calf. She had no open wounds. She had no visible varicose veins. 

On left lower-extremity venous duplex ultrasound exam, the patient had no significant infrainguinal superficial vein disease. There was significant multi-segmental deep vein reflux, with a reflux time of >1 second. There was no acute DVT, nor any evidence of deep vein scar to indicate a prior DVT. 

Evaluation of the central veins in the pelvis with venogram revealed no focal iliac vein stenosis or filling defect, and there were no cross-pelvic or lumbar collaterals noted. IVUS with the Visions .035 system was performed, identifying a severe cranial external iliac vein (EIV) stenosis (73%), compared to the normal suprainguinal caudal EIV, due to a non-thrombotic iliac vein lesion (NIVL). Normal suprainguinal caudal EIV and severe cranial external iliac vein stenosis (see Figures 4 and 5). 

Post-angioplasty and stent, there was no residual stenosis (Figure 6). On follow-up exam one week later, the stent was widely patent on duplex ultrasound, and the patient remarked, “I can see my ankle again!” 

The heaviness, achiness and erythema resolved during the following weeks. Through five years of follow-up, she had no recurrence of her symptoms or physical findings of chronic venous hypertension and insufficiency. 

References 

  1. Allan R, Puckridge P, Spark J, et al. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions. J Am Coll Cardiol Intv. 2022 Mar, 15 (5) 536–546. https://doi.org/10.1016/j.jcin.2022.01.001 
  2. Divakaran S, Parikh SA, Hawkins BM, et al. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC Cardiovasc Interv. 2022;15(20):2080- 2090. doi:10.1016/j.jcin.2022.07.050 
  3. Divakaran S, Meissner MH, Kohi MP, et al. Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries. J Vasc Interv Radiol. 2022;33(12):1476-1484.e2. doi:10.1016/j.jvir.2022.08.018 
  4. Gagne PJ, Tahara RW, Fastabend CP, et al. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017;5(5):678-687. doi:10.1016/j.jvsv.2017.04.007 
  5. Secemsky EA, Mosarla RC, Rosenfield K, et al. Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions. JACC Cardiovasc Interv. 2022;15(15):1558-1568. doi:10.1016/j.jcin.2022.04.034 

Steven D. Abramowitz, MD, is a vascular surgeon in Washington, D.C. Abramowitz has been compensated for his services for Philips’ further use and distribution. Paul J. Gagne, MD, is a vascular surgeon with the Vascular Care Group in Darien, Connecticut. Gagne has been compensated for his services for Philips’ further use and distribution. 

PROMISE II 12-month data show durable outcomes with the LimFlow system in no-option CLTI patients

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PROMISE II 12-month data show durable outcomes with the LimFlow system in no-option CLTI patients

One-year results from the PROMISE II US pivotal trial demonstrate the durability of outcomes of transcatheter arterialisation of the deep veins (TADV) using the LimFlow system (LimFlow) and that the procedure is safe and reproducible.

Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) recently presented the new data for the first time at VIVA 2023 (30 October–2 November, Las Vegas, USA). He reported a limb-salvage rate of 69% at 12 months, among other key results, in patients who have chronic limb-threatening ischaemia (CLTI) with no suitable endovascular or surgical revascularisation options. 

Clair, who served as co-principal investigator of the trial alongside Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), noted that the new data are an extension of the six-month PROMISE II results that were presented at VIVA 2022. Following publication of these results in the New England Journal of Medicine (NEJM), the US Food Administration (FDA) approved the LimFlow system in September of this year.

At 20 centres without roll-ins across the USA, 105 no-option CLTI patients were enrolled in a non-randomised manner. All enrolled patients had Rutherford class 5 or 6 disease and were deemed by an independent committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow.

The median age of the patient cohort was 70 years, two-thirds were male, and one-quarter were Hispanic or Latino. Most patients presented with pre-existing comorbidities, including diabetes, hypertension, dyslipidaemia, and a history of intervention on the index limb. All patients presented with a non-healing ulcer or frank gangrene and were classified as either Rutherford class 5 or 6.

Clair revealed at VIVA that, at one year, limb salvage was maintained in 69% of patients. “You can see—and this has been noted before—a drop-off through the first three months, but those who were able to keep their limbs to that point usually did significantly well over time,” he commented.

In addition, the presenter shared that the average wound area was 0.2cm2 at 12 months. “You are talking about minimal wounds that these patients had when they did have remaining wounds,” he said. Clair also noted an average pain score (scale 0–10) of 1.4 at 12 months, representing a “significant reduction” from an average of 5.3 at enrolment. More than half of patients were classified as Rutherford class 0 at one year.

In addition, Clair reported pooled results from PROMISE I and PROMISE II. “The PROMISE I trial did not include dialysis patients and did not include COVID deaths, but other than that these two trials were very similar,” he remarked. In the pooled analysis, the presenter noted an overall survival rate of 85%, a limb-salvage rate of close to 75%, and a 63% rate of amputation for this population.

“In conclusion, the [US] FDA has approved this product with the six-month data that have been published in the [NEJM], and these 12-month data extend upon that and show that this is a durable, sustainable outcome,” Clair summarised. He added that the outcomes are consistent even with new users. “The procedure is reproducible and generalisable—most operators in PROMISE II had essentially no experience with this technique—and I continue to believe that as we gain experience with this, over time we will learn more and do better as we move forward.”

“I am very proud to be able to present this information and happy with where we are headed with this complex group of patients,” he said in closing.

The top 10 most popular Vascular Specialist stories of October 2023

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The top 10 most popular Vascular Specialist stories of October 2023

Last month, the most popular stories from Vascular Specialist included The Centers for Medicare & Medicaid Services (CMS) confirmation of carotid artery stenting coverage expansion; data on a “next generation” inferior vena cava (IVC) filter retrieval device presented at the annual meeting of the New England Society for Vascular Surgery (NESVS); and recent study data supporting the findings of the BEST-CLI trial results. 

1. From the editor: Sex, lies, and carotid stents

Malachi Sheahan III tackles the nascent debate over carotid stenting (CAS) vs. endarterectomy (CEA) amid a CMS decision over proposed expanded coverage for CAS.

2. CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in a July proposed decision memo.

3. Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

Roger Malcolm Greenhalgh, MD, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on Oct. 6. He was 82. At the time of his death, he was emeritus professor of surgery at Imperial College in London and head of its Vascular Surgery Research Group.

4. NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report

An inferior vena cava (IVC) filter retrieval device dubbed the next-generation in removal of the venous thromboembolism-fighting tools could substantially cut procedural times and radiation exposure, according to data emerging out of in vivo testing at Yale University.

5. Vascular branding: Determining a vascular surgeon’s value

A vascular surgeon’s value includes far more than direct revenues from procedures performed, said SVS member Robert Tahara, MD, recently. He told surgeons to remember not only these direct revenues, but also the help a surgeon provides other specialties in the hospital, as well as legal savings from “near misses—rarely considered and certainly rarely acknowledged.”

6. CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting BEST-CLI results

A recently published study has shown that lower limb bypass surgery offered a significantly higher probability of amputation-free survival and wound healing compared with endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This and other key findings from the study are reported in the European Journal of Vascular and Endovascular Surgery (EJVES).

7. Enrollment of first patient in Neuroguard carotid stent system trial announced

Contego Medical has announced enrollment of the first patient in the prospective, multicenter PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access.

8. George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies

George S. Lavenson Jr., lovingly referred to as “Doc” by his many friends, died Saturday, Aug. 19, 2023, on the beautiful island of Maui, Hawaii, where he chose to share a life in majestic Lahaina with his loving wife, Judy. He was 91. George leaves behind four children, Mark, Jim, Patricia and Dean, and three grandchildren, Kelsey, Luke, and Oliver.

9. Survey suggests venous work less valued than arterial interventions

The majority of more than 300 vascular surgeons who responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease. Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, D.C., and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

10. SVS varicose vein guideline webinar set for Oct. 10

A virtual roundtable on Oct. 10 will cover the new Society for Vascular Surgery (SVS) varicose veins guidelines. Set for 6–7:30 p.m. CDT, the session will address the latest in the diagnostic evaluation of patients with the venous condition using duplex scanning.

Researchers report 30-day outcome data for pair of investigational carotid stenting systems

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Researchers report 30-day outcome data for pair of investigational carotid stenting systems
William Gray delivers Neuroguard data at VIVA 2023

Thirty-day results from two trials assessing the performance of investigational carotid artery stenting systems—the Neuroguard and the CGuard—were recently presented at VIVA 2023.

Stenting with the CGuard embolic protection carotid stent system (InspireMD) in patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had a death (all-cause mortality), any stroke or myocardial infarction rate of 0.95% from procedure through 30 days of follow-up, reported D. Christopher Metzger, MD, an interventional cardiologist at OhioHealth in Columbus, Ohio, at the Las Vegas meeting (Oct. 30–Nov. 2).

The C-GUARDIANS U.S. investigational device exemption (IDE) pivotal trial looked at 316 patients from July 2021–June 2023 who were prospectively enrolled in the single-arm study performed at 24 sites in the U.S. and Europe. The primary endpoint was a composite of either incidence of major adverse events including death (all-cause mortality), any stroke or myocardial infarction through 30 days post-index procedure; or ipsilateral stroke from day 31 to day 365 post-procedure.

InspireMD anticipates reporting primary endpoint results from C-GUARDIANS—which the company stated may support a premarket approval (PMA) application to the Food and Drug Administration (FDA)—in the second half of 2024.

In the PERFORMANCE II prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) system, the reported 30-day stroke rate was 1.31% in the intention-to-treat analysis and 0.98% in a per-protocol analysis, with no major strokes or contralateral strokes, and all patients returning to baseline neurologically within 30 days, William Gray, MD, the system chief of cardiovascular disease at Main Line Health in Philadelphia, told VIVA 2023.

The Neuroguard (Contego Medical) PERFORMANCE II single-arm study is assessing the device among 305 patients at 40 clinical sites in the U.S. and Europe. At one-year follow-up (all stroke within 30 days, and ipsilateral stroke between day 31 and 12 months), the reported stroke rate was 1.68% in the intention-to-treat analysis and 1.35% in a per-protocol analysis, Gray added. No major strokes or neurological deaths occurred in the study.

In addition to the PERFORMANCE II study—in which the Neuroguard was placed via transfemoral or transradial access—the PERFORMANCE III study is currently enrolling patients to evaluate the same stent placed via direct transcarotid access, Contego Medical reported.

LimFlow announces agreement to be acquired by Inari Medical

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LimFlow announces agreement to be acquired by Inari Medical
Vein becoming artery with LimFlow crossing stent
agreement
Vein becoming artery with LimFlow crossing stent

LimFlow announced today that it has entered into a definitive agreement to be acquired by Inari Medical.

A press release details that, under the terms of the agreement, LimFlow will receive US$250 million in cash at closing and be eligible to receive up to US$165 million in additional payments based on certain commercial and reimbursement milestones, for a total potential transaction value of up to US$415 million. The transaction is expected to close in the fourth quarter of 2023.

LimFlow’s acquisition by Inari Medical is expected to increase patient access to its LimFlow system for transcatheter arterialisation of the deep veins (TADV), which is designed to re-establish blood flow in deep veins for “no-option” chronic limb-threatening ischaemia (CLTI) patients who have no other suitable endovascular or surgical treatment options and are facing major amputation.

US Food and Drug Administration (FDA) approval for the LimFlow system was received in September 2023 based on successful outcomes seen in the PROMISE II pivotal trial, recently published in the New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment. LimFlow details that its system is the first and only FDA-approved device for TADV and previously received Breakthrough Device designation from the FDA.

“We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering,” said LimFlow CEO Dan Rose. “Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission. Together, we eagerly anticipate advancing our shared vision of addressing crucial unmet needs in the realm of vascular disease.”

LimFlow investors include Sofinnova Partners (through its Crossover Strategy), Bpifrance, Balestier (an affiliate of M&L Healthcare Investments), Longitude Capital, Soleus Capital and Inari Medical. LimFlow was incubated by MD Start and co-founded by Martin Rothman and Tim Lenihan.

“The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio,” said Drew Hykes, CEO of Inari. “We see the CLTI market as poised for durable growth, driven by compelling technology, outstanding clinical results, and multiple opportunities for expansion As a minority investor and board observer in LimFlow since early 2022, we have seen firsthand the life-changing impact this technology has on patients, as well as how complementary our two businesses are.”

Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio

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Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio
Ido Weinberg

Patients undergoing computer-assisted vacuum thrombectomy with the Indigo Aspiration System (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

“The STRIKE-PE dataset is very encouraging as it confirms the promise of computer-assisted vacuum thrombectomy to restore blood flow quickly, safely and effectively while also showing promising, prompt and lasting improvement in patient outcomes,” said Ido Weinberg, MD, a vascular medicine specialist at Massachusetts General Hospital in Worcester, Massachusetts, who presented the data during a late-breaking science session at the Vascular Interventional Advances (VIVA) 2023 annual meeting (Oct. 30–Nov. 2) held in Las Vegas.

The interim analysis—comprising 150 patients of a real-world, multicenter study at up to 55 global centers aimed at eva

luating 600 subjects with acute PE symptoms of ≤14 days and a RV/LV ratio ≥0.9—demonstrated that mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours post-thrombectomy. Four patients experienced MAEs within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased, Weinberg informed VIVA 2023.

In terms of secondary outcomes out to 90 days, Weinberg said the dyspnea scale significantly improved from presentation to discharge and from presentation to the three-month follow-up marker. Additionally, the six-minute walk test distance significantly improved from discharge to 90-day follow-up.

“STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety,” Weinberg concluded. “At 90-day follow-up, treatment with computer-assisted vacuum thrombectomy with the Indigo Aspiration System improved patients’ functional capacity.”

STRIKE-PE will follow patient outcomes out to one year.

SVS launches expansion of coding resources

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SVS launches expansion of coding resources

The SVS has announced an expansion of its coding-related information and help in response to increasing member demand. The new resources will assist vascular surgeons in navigating medical coding and billing complexities, in line with the Society’s ongoing commitment to provide valuable tools and knowledge in vascular surgery.

On the SVS website, members can review a list of frequently asked questions and answers explicitly tailored to vascular surgery coding. The FAQs will evolve over the next year, with monthly updates.

The SVS and long-term partner Karen Zupko and Associates Inc. (KZA), a consulting and education firm, will launch a series of quarterly on-demand educational courses that will examine the intricacies of coding for vascular surgery. 

The SVS will release the first of these courses later this month. The new courses are an addition to the annual SVS in-person Coding and Reimbursement Workshop held each fall.

The SVS Coding Committee can assist members who encounter specific coding inquiries or issues that require individualized support. Members can review the resources and submit questions at vascular.org/CodingInquiries.

The course, he said, was designed by vascular surgeons for vascular surgeons. 

CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting BEST-CLI results

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CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting  BEST-CLI results

A recently published study has shown that lower limb bypass surgery offered a significantly higher probability of amputation-free survival and wound healing compared with endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This and other key findings from the study are reported in the European Journal of Vascular and Endovascular Surgery (EJVES).

The research group, led by Jean-Baptiste Ricco, MD, PhD, professor of vascular surgery at CHU de Poitiers in Poitiers, France, aimed to compare the long-term efficacy of lower limb bypass with that of endovascular treatment in patients with CLTI.

Ricco and colleagues conducted a retrospective, multicenter study with propensity analysis to evaluate the outcomes of patients with CLTI who underwent first-time infrainguinal bypass or endovascular treatment. In the methods section of their paper, the authors elaborate that the retrospective cohort study design was employed using hospital charts of patients treated between January 2015 and December 2021 in four European vascular centers—three in France (the University of Poitiers, the University of Clermont-Ferrand and the University of Toulouse) and one in Italy (the University of Rome, Sapienza). 

They detail that the primary outcome was to compare amputation-free survival rates between the two propensity score matched groups. The secondary outcome was to compare wound healing within the first six months. Major adverse events were compared according to the type of revascularization, Ricco et al note.

The authors share that, overall, 793 patients fulfilled the eligibility criteria, from whom 236 propensity score matched pairs were analyzed. They specify that the 236 bypass procedures included 190 autogenous bypass grafts (80.5%), 151 (64%) of which were infrapopliteal. The mean follow-up was 52 months.

Ricco and colleagues add that, among the 236 endovascular treatment procedures, the target lesion was the femoropopliteal segment in 81 patients (34.3%), the femoropopliteal and infrapopliteal segments in 101 patients (42.8%), and the infrapopliteal segment in 54 patients (22.9%). 

The investigators report in EJVES that amputation-free survival was significantly better in the bypass group at five years (60.5±3.6%) compared with the endovascular treatment group (35.3±3.6%), citing a p value of 0.001.

Furthermore, they reveal that major amputation occurred in 61 patients (25.8%) in the bypass group and 85 (36%) in the endovascular treatment group (hazard ratio 0.66, 95% confidence interval 0.47–0.92; p=0.14). 

In other results, Ricco et al share that the probability of healing was significantly better in the bypass group at six months compared with the endovascular treatment group (p=0.003) and that the median length of stay was shorter for the endovascular treatment group (four days) than for the bypass group (eight days) with a p value of 0.001. Finally, they detail that urgent reintervention and readmission rates were high and did not differ significantly between the groups.

In the discussion section of their paper, Ricco and colleagues acknowledge some study limitations. They write, for example, that this was a retrospective study and, “despite propensity score matching, the possibility of unmeasured confounders cannot be excluded”. They also recognize that disparities in state funding of French and Italian university hospitals did not allow conduct of a cost analysis of the endovascular therapy and bypass groups.

Also in their discussion, Ricco and colleagues touch upon the significance of the outcome measures used in the study. Amputation-free survival and ischemic wound healing rates are two outcomes of “primary importance” for CLTI patients, they state. “Most previous studies have focused on survival, limb salvage, or amputation-free survival, but these outcomes cannot determine whether, and after how many weeks, wound healing is achieved in patients with CLTI. In this study, amputation-free survival and wound healing together made it possible to assess the effectiveness of revascularization,” the authors elaborate.

The investigators also consider the context of the recently published BEST-CLI trial, which they note provides “substantial clarity” about the midterm outcome—2.7 years median follow-up—showing a lower incidence of a major adverse limb event or death in bypass patients compared with the endovascular treatment group. The authors write, “The present research supports these results with 80.5% of autogenous bypasses made possible by systematic pre-operative DUS assessment of saphenous veins and arm veins, together with the deliberate choice of a bypass inflow located downstream from the common femoral artery in 62.3% of patients with a combination of SFA angioplasty above a distal origin graft allowed the patient to be offered autogenous grafting to a distal target.”

They highlight several similarities and differences between the BEST-CLI and the present study. For example, they note that both included the use of up-to-date endovascular techniques such as drug-coated balloons or drug-eluting stents, citing figures of 62% and 60.6%, respectively. On the other hand, they note that mean follow-up was a point of difference between the two studies, with follow-up being 52 months for the present study compared to 32 months for BEST-CLI.

In their conclusion, Ricco et al stress that their results provide “strong positive evidence” that patients receiving bypass surgery for CLTI have a “significantly higher probability” of amputation-free survival and wound healing compared with patients treated with an endovascular procedure. They reiterate that the rate of urgent reintervention and readmission remains high for individuals receiving either procedure. 

For Diabetes Month, diabetes resources for SVS members, patients

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For Diabetes Month, diabetes resources for SVS members, patients

November is National Diabetes Month. Because SVS members treat patients with the condition—and its complications—the Society has numerous educational resources available. 

“Diabetes and Vascular Disease” is one of nearly 10 patient education fliers produced by the SVS Foundation as part its awareness and prevention mission. Available at vascular.org/PatientFliers, it outlines what the disease is, its effects, where it can lead in terms of additional health problems, treatment, preventive care and more. 

Other patient education fliers may also be of interest to diabetes patients, such as those on carotid artery disease, cholesterol and physical activity, vascular health and smoking, all of which come into play for people with diabetes. 

Each flier is English and Spanish and includes a link to the SVS “Find a Specialist” web page. A second set of fliers that can be customized with a member’s contact information and then printed, is available at vascular.org/BrandingToolkit.

Visit vascular.org/Diabetes for an overall look at diabetes and vascular disease. This page provides numerous resources for patients and families on how diabetes affects vascular health, including on keeping feet healthy, FAQs about diabetes, the benefits of walking and information from other medical societies, including the American Podiatric Medical Association. It also provides links to diabetes-related illnesses and related resources for physicians. 

Akura thrombectomy system for PE appears safe and demonstrates reduction of RV/LV ratio in first-in-human study

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Akura thrombectomy system for PE appears safe and demonstrates reduction of RV/LV ratio in first-in-human study
Jay Mathews
Akura
Jay Mathews

Results from a first-in-human, prospective, single-arm study of the Akura Medical thrombectomy system (Akura Medical) for pulmonary embolism (PE) were revealed this week at The VEINS 2023 (28–30 October, Las Vegas, USA).

Presenter Jay Mathews (Manatee Memorial Hospital, Bradenton, USA) detailed that the study enrolled five patients at two sites in Tbilisi, Georgia, in March and April 2023 to evaluate the safety and performance of percutaneous mechanical thrombectomy using the Akura Medical thrombectomy system. The Akura system is a low-profile system that combines targeted clot removal with a platform capable of providing objective data on haemodynamics to help clinicians understand the relationship between thrombus removal and alleviation of pulmonary artery pressures.

The key inclusion criteria included medically eligible patients aged >18 years with clinical symptoms consistent with acute PE or sPESI (simplified PE Severity Index) ≥1, with symptom onset ≤14 days, proximal PE confirmed by computed tomography angiography (CTA), a stable heart rate <130 bpm prior to procedure, and systolic blood pressure ≥90 mmHg, with a right ventricular/left ventricular (RV/LV) ratio >0.9. Five patients were enrolled, treated, and followed through seven-day follow-up.

The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature. The average procedure time from anaesthesia start to closure was 117±50 minutes, with an average fluoroscopy time of 30±21 minutes (range, 13–68 minutes). Total blood loss was 247±80mL on average, with 189±120mL of contrast used per procedure. After 48 hours, the RV/LV ratio decreased by 0.35 from 1.29±0.15 to 0.94±0.12 (p<0.05; 26.85% reduction). Through seven-day follow-up, there were no deaths, device-related major bleeding, or device-related adverse events.

Mathews concluded that the Akura thrombectomy system for PE appears safe, and preliminary evidence shows that this platform technology leads to a significant reduction in RV/LV ratio and thrombus burden.

No relationship found between DW-MRI lesions and long-term stroke risk following carotid revascularisation

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No relationship found between DW-MRI lesions and long-term stroke risk following carotid revascularisation
Gert J de Borst

A secondary analysis of existing clinical trial data has indicated that new ischaemic brain lesions detected via diffusion-weighted magnetic resonance imaging (DW-MRI) following carotid artery revascularisation—either with carotid artery stenting (CAS) or carotid endarterectomy (CEA)—do not appear to have a relationship with long-term stroke risks.

“The results from our analysis do not support the role of ischaemic brain lesions discovered on [DW-MRI] after carotid revascularisation procedures as risk markers for long-term recurrent stroke or TIA [transient ischaemic attack],” authors Gert J de Borst (University Medical Center Utrecht, The Netherlands) et al write, concluding their report in the journal Stroke. “However, as new periprocedural [DW-MRI] lesions seem to be a marker for early recurrent cerebrovascular events, future randomised studies are needed to evaluate whether the effect of treatment on these lesions corresponds to the effect of treatment on procedural stroke before surrogacy can be validated.”

The researchers initially posit that five-year follow-up findings from the randomised International Carotid Stenting Study (ICSS) indicate an increased risk of recurrent stroke or TIA following a CAS procedure, but that the trial failed to demonstrate any association between DW-MRI lesions and recurrent stroke/TIA risks following CEA.

“The establishment of the longer-term clinical relevance of the [DW-MRI] lesions after carotid revascularisation procedures is essential in the process of implementing a universally accepted surrogate outcome,” De Borst and colleagues note. “Today, thus far, there are no data describing adverse events in [DW-MRI]-positive patients beyond five-year follow-up. Therefore, in this study, we intended to determine the long-term cerebrovascular outcome in [DW-MRI]-positive compared with [DW-MRI]-negative patients after carotid revascularisation procedures.”

The authors report that their study—a secondary, observational, prospective cohort analysis—included 162 patients with symptomatic carotid stenosis who were previously randomised to CAS or CEA in ICSS, and were subsequently included in the ICSS MRI substudy. They further relay that the primary composite clinical outcome of their analysis was the time to any stroke or TIA during follow-up. Patients with new DW-MRI lesions on post-treatment MRI scans (DWI+) were compared with patients without new lesions (DWI–), De Borst et al add.

For the 162 patients included in the ICSS-MRI substudy between January 2004 and October 2008, 110 general practitioners (GPs) ultimately provided long-term follow-up data for the present study. Discussing the baseline characteristics of this patient population, De Borst et al note that those in the DWI+ group were more often treated with CAS, while total cholesterol at randomisation was higher in the DWI− group.

Relaying their results, the authors state that the median follow-up time was 8.6 years, and that Kaplan-Meier cumulative incidence for the primary outcome after 12.5 years of follow-up was 35.3% in DWI+ patients and 31.1% in DWI− patients. With respective hazard ratios of 1.5 and 1.3, univariable and multivariable regression analyses did not show significant differences between these two patient cohorts, they add. Separate analyses, specifically relating to CAS and CEA, showed that the higher primary outcome rate in DWI+ patients across the entire cohort was mainly caused by events in the CAS group.

“In the ICSS MRI substudy, both the presence and count of [DW-MRI] lesions were associated with recurrent stroke/TIA occurring after the post-treatment scan, with most events seen in the first six months after treatment,” De Borst and colleagues write. “The results of the present study showed that this association was no longer present after 12.5 years of follow-up. In addition, the analyses with [DW-MRI] counts were largely influenced by the small number of patients with high [DW-MRI] lesions, which lost the association with the clinical outcomes after bootstrapping the HR CIs [hazard-ratio confidence intervals].

“This supports the hypothesis that [DW-MRI] lesions are caused by thromboembolic material or atherosclerotic plaque debris during and after the carotid revascularisation procedure, and therefore might be used as surrogate markers of early recurrent stroke/TIA but not for long-term ischaemic events.”

Six-month outcomes from phase-one trial of anti-inflammatory drug to assess benefit in acute DVT patients demonstrate ‘promise’

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Six-month outcomes from phase-one trial of anti-inflammatory drug to assess benefit in acute DVT patients demonstrate ‘promise’
David J. Dexter during The VEINS 2023

The open-label phase of the DEXTERITY-AFP trial investigating the Bullfrog microinfusion device—which involves the perivenous injection of the anti-inflammatory drug dexamethasone to improve patency and post-thrombotic syndrome (PTS) six months after thrombus removal in symptomatic deep vein thrombosis (DVT) patients—has shown positive results.

That’s according to late-breaking data revealed during The VEINS 2023 meeting (Oct. 28–30) in Las Vegas by David J. Dexter, MD, co-principal investigator and a vascular surgeon at Sentara Healthcare in Norfolk, Virginia.

From a trend standpoint, Dexter told attendees, the 20-patient cohort, fully enrolled with six months of follow-up, showed a 5% rate of any PTS and currently no patients through 12 months with moderate-to-severe PTS.

The femoropopliteal segment study is moving in its second phase during which 60 patients will be enrolled 1:1 to receive the perivenous steroid or saline injections in a dual-blinded randomized controlled trial (RCT), and is considered the first known trial to investigate local drug delivery intended to reduce venous inflammation associated with DVT.

Of the total 21 patients initially enrolled in the first phase, one withdrew after one-month follow-up. In terms of safety, there were no device (Mercator MedSystems) or drug-related serious adverse events observed. The primary efficacy endpoint—clinically relevant loss of primary patency—will be examined as combined with the RCT phase, the investigators revealed. Of the 21 patients followed at one month, 19 (90.5%) had fully compressible and two had partially compressible common femoral veins. Other key secondary endpoint data for the 20 participants with in-window, six-month follow-up included reduction from baseline to six months in average Villalta score (7.3 to 1.6) and 10-point pain score (3.2 to 0.5).

“Iliofemoral DVT continues to have poor outcomes,” Dexter told The VEINS 2023. “Femoropopliteal DVT has been neglected because we have really poor therapeutic outcomes yet they compromise more than half of DVT cases we see. Inflammation appears to be linked to vein wall scarring and PTS. Dexamethasone appears to show really promising results both in pre-clinical studies as well as in our single-arm, early-phase data. The biomarker work, the compressibility work and the Villalta score all show really favorable early outcomes.”

One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever

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One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever
David Dexter
David Dexter

David Dexter (Sentara Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry this week at The VEINS 2023 (28–30 October, Las Vegas, USA).

Long-term, prospective outcome data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking. The CLOUT (ClotTriever Outcomes) registry is a prospective, multicentre study evaluating patient outcomes for proximal lower extremity DVT treated with the ClotTriever system (Inari Medical).

CLOUT is the largest mechanical thrombectomy study in the field of DVT, said Dexter, and although positive results have been previously published, this is the first report of one-year outcomes for all available patients. Patients in CLOUT were aged ≥18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment failure for the current DVT event, or contraindications to thrombolytic therapy. A total of 310 patients completed the one-year follow-up visit.

One year after mechanical thrombectomy, moderate-to-severe post-thrombotic syndrome (PTS; Villalta score ≥10) was observed in 8.8% of treated limbs. The overall PTS rate (Villalta score ≥5) was 19.3%. Venous patency, as measured by the presence of flow with normal or partial compressibility on duplex ultrasound, was observed in 94.2% of cases. Additionally, significant improvements from baseline in revised Venous Clinical Severity Score, Numeric Pain Rating Scale score, and EQ-5D questionnaire score were demonstrated.

In the real-world, all-comer CLOUT registry, one-year outcomes demonstrate a low rate of PTS following treatment with the ClotTriever system, which was complemented by patient-centric improvements in symptom relief and quality of life. Study follow-up through two years is ongoing.

Dexter stated that these favourable clinical outcomes highlight the need for randomised controlled trial data comparing mechanical thrombectomy with standard of care anticoagulation treatment. The recently initiated randomised controlled DEFIANCE trial will compare the ClotTriever system to anticoagulation for the treatment of symptomatic iliofemoral DVT.

New varicose vein management guidelines released

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New varicose vein management guidelines released

The SVS, in collaboration with the American Venous Forum (AVF) and the American Vein and Lymphatic Society (AVLS), has un­veiled part two of the clinical practice guidelines for the manage­ment of varicose veins of the lower extremities. Building upon the foundation laid by part one, which was published online in Octo­ber 2022, this latest installment offers evidence-based guidance to healthcare professionals and patients navigating the complexities of varicose vein care.

The new guidelines, endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine, were published in the Journal of Vascular Surgery-Venous and Lymphatic Disorders in September, and are set to become a trusted resource for medical practitioners and individuals seeking effective varicose vein management strategies, according to co-primary author of the guideline writing group, Peter Gloviczki, MD.

SVS clinical practice guidelines are rooted in an evaluation of scientific literature, weighing the likely benefits and potential harms of various treatments.

The guideline writing group utilizes systematic reviews to distill key recommendations from the vast body of available evidence, ensuring that these guidelines remain both current and reliable.

Gloviczki emphasized the trustworthiness of the guidelines, stating, “These guidelines offer the most current and reliable source of information for both patients and healthcare providers.”

The guidelines address critical issues concerning the management of lower-extremity varicose veins, using the PICO (patients, interventions, comparators and outcomes) framework to provide evidence-based answers to crucial questions.

Part I focused on the role of duplex ultrasound scanning in evaluating varicose veins and treating superficial truncal reflux. Part II delves into several aspects, including the prevention and management of varicose vein patients with compression, treatment with venotonic drugs and nutritional supplements. It also covers the evaluation and treatment of varicose tributaries, superficial thrombophlebitis, venous aneurysms and the management of complications associated with varicose veins and their treatment.

The guidelines place emphasis on incorporating contemporary endovascular venous interventions, both thermal and non-thermal procedures, aligning them with compression therapy and pharmacological treatment for managing varicose veins.

The document encompasses a wide range of recommendations spanning parts I and II, ungraded consensus statements, pragmatic implementation notes and best-practice directives. It provides guidance for the appropriate management of patients with symptomatic lower-extremity varicose veins.

“When evaluating patients for varicose veins and conducting duplex ultrasounds, it is important that all physicians use the CEAP (Clinical-Etiological- Anatomical-Pathophysiological) classification system.

All patients with varicose veins C2 disease should have duplex ultrasound evaluations to evaluate the reflux in the saphenous veins and other superficial veins. This exam should be performed with the patient standing, whenever possible,” said Gloviczki.—Marlén Gomez

SVS submits comment letter on Medicare fee schedule to CMS

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SVS submits comment letter on Medicare fee schedule to CMS

In September, the Society for Vascular Surgery submitted a detailed comment letter to the Cen­ters for Medicare and Medicaid Services (CMS) in re­sponse to a proposed rule that could mean a 3–4% cut in Medicare payments.

The letter responds to CMS’ Calendar Year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule (MPFS). SVS members are urged to address lawmakers on the issues, via grassroots advocacy. Pre-written messages are available at vascular.org/Grassroots.

Depending on practice setting, vascular surgeons face a 3 to 4% cut based on current Medicare policies proposed in the MPFS rule.

These cuts result from a reduction in the temporary update to the conversion factor under current law and a negative budget-neutrality adjustment stemming in large part from CMS moving forward with implementation of separate pay­ment for add-on code G2211 to account for visit complexity associated with certain office/outpatient evaluation and management visits. The code was initially proposed three years ago, but implementation was delayed as a result of an aggressive advocacy campaign led by surgical societies, including the SVS.

In addition, payment reductions for many vascular sur­geons are compounded by the third year of CMS’ phased-in implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule.

“Systemic issues such as the negative impact of the Medi­care physician fee schedule’s budget neutrality requirements and the lack of an annual inflationary update will continue to generate significant instability for health care clinicians moving forward, threatening beneficiary access to essential health care services,” the letter includes.

The SVS, in collaboration with medical specialty societies, is continuing to work to mitigate the scheduled cuts and advance policies to stabilize the payment system in the short term and reform the system for the future.

To that end, the SVS supports legislation to provide an inflationary update for the MPFS (H.R. 2474) and is leading the effort that brought forth the introduction of legislation to provide targeted relief for codes most impacted by the clinical labor update policy (H.R. 3674).

The SVS is also seeking further delay of the G2211 code implementation via both regulatory and legislative initiatives.

Read the letter to CMS at vascular.org/CMS.9.23.

The ‘modern’ VA has made great strides with patient outcomes and satisfaction scores

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The ‘modern’ VA has made great strides with patient outcomes and satisfaction scores

Data can be granular and clarifying. Conversely, data without appropriate context can lack nuance—like a paint-by-numbers portrait using only one crayon.

A recent article publivenshed by Becker’s Hospital Review, and promoted by the medical network Doximity, listed the top 10 hospitals with the lowest and highest rate of 30-day readmission based off data from the Centers for Medicare & Medicaid Services’ (CMS) Care Compare Website.1 Eight of the nine hospitals with the highest re-admission rate (I know it was supposed to be 10 but I didn’t write it; blame ChatGPT) are part of the U.S. Department of Veterans Affairs (VA) system.

This information has been in the press lately because facilities in the VA system are now being included in the CMS Overall Hospital Quality Star Ratings. The metric is based off five categories: mortality, safety of care, readmission, patient experience, and timely and effective care. Five stars is the maximum a facility can attain based on its aggregate score.

The dataset from CMS’ Care Compare website encompassed readmissions from July 1, 2018, through June 30, 2021. However, the data in the article were isolated to July 2020 and June 2021: a heterogenous time pre- and post-COVID-19 vaccine filled with quarantining people who refused to go to the hospital.

In the United Kingdom, deaths at home rose by almost a third in 2020 while in-hospital deaths fell, except those related to COVID-19.2

It is difficult to glean accurate data on readmissions during this time. Furthermore, readmission at VA facilities occur due to manifold reasons: including housing uncertainty, mental health and lack of resources.

The main offender listed in the Becker article was the VA Pittsburgh Healthcare System (VAPHS). What the article doesn’t mention is that since that time, the Pittsburgh VA has implemented the Surgical Safety Net as championed by the Interdisciplinary Medical Preoperative Assessment Consultation and Treatment Clinic Impact team.3 This is a multidisciplinary clinic comprised of Anesthesiology, Care Management and Social Work Services, Office of Primary Care, Physical Medicine and Rehabilitation, and Surgery.4

The team used a prediction model to identify high-risk veterans for readmission after surgery. Members then used a nurse-navigator preoperatively to counsel patients and their families on what to expect perioperatively, as well as calls on post-discharge days two, five, 14 and 30. The Department of Physical Medicine and Rehabilitation (PRM) worked with prehabilitation for the patient. A telehealth team taught the patient and the family to use virtual devices, and provided hotspots if the family had no internet access. There was now 24/7 access postoperatively for the veteran that he or she knew how to use.4

VAPHS dropped its readmission rate from 11.2 in October 2019 to 8.4 in October 2022. This program was selected as the winner for the VA’s 2022 Shark Tank competition. It is in trials at select sites across the country.

This article cherry-picks only readmissions from the list of components for the star system. Other factors, such as mortality and patient experience, have long been analyzed by the VA, especially in relationship to surgery. The American College of Surgeons’ National Surgical Quality Improvement Program for the VA has been used to improve risk-adjusted surgical outcomes.5

The VA has many metrics, such as SAIL (Strategic Analytics for Improvement and Learning Value Model), that it uses to grade its facilities. Started in 2012, SAIL uses 27 quality measures and two measures of overall efficiency and capacity to monitor such factors as acute-care mortality, access to care and employee satisfaction.6

While historically not receiving the best press, the “modern” VA has made great strides with patient outcomes and satisfaction scores.

Many recent articles have found that patients cared for by the VA have equal to—if not better—outcomes than those cared for in the civilian world.7

To that very point, Becker’s Hospital Review published an article on July 26 reporting that 67% of the VA facilities eligible received four or five stars in the latest batch of CMS data.8 What a difference 27 days make.

References

  1. https://www.beckershospitalreview.com/rankings-and-ratings/10-hospitalswith-highest-lowest-rate-of-unplannedreadmissions.html
  2. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/articles/deathsathomeincreasedbyathirdin2020whiledeathsinhospitalsfellexceptforcovid19/2021-05-07
  3. https://news.va.gov/120638/castingsurgical-safety-net-reduce-readmissions/
  4. https://marketplace.va.gov/innovations/preventing-post-operative-readmissionswith-surgical-safety-net
  5. ha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003; 348:2218–2227.
  6. https://www.gao.gov/assets/700/699359.pdf
  7. Blegen M, Ko J, Salzman G, et al. Comparing Quality of Surgical Care Between the US Department of Veterans Affairs and Non-Veterans Affairs Settings: A Systematic Review. Journal of the American College of Surgeons. 237 (2): p 352–61.
  8. https://www.beckershospitalreview.com/rankings-and-ratings/67-of-va-hospitals-receive-4-or-5-star-cms-ratings-for-patient-safety.html

AMIT CHAWLA is a member of the SVS Veterans Affairs Vascular Surgeons Committee. Chawla is chief of vascular surgery at Southeastern Louisiana Veterans Healthcare System in New Orleans.

Government Grand Rounds: Opportunity knocks as Congressional ‘busy season’ beckons

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Government Grand Rounds: Opportunity knocks as Congressional ‘busy season’ beckons

With the congressional “busy season” upon us, the SVS is gearing up for big tasks ahead on the legislative and regulatory fronts. Having stepped into the role of chair of the SVS Advocacy Council this past June, I have to start by highlighting the generosity of our members and the ser­vice of surgeon-volunteers who have provided an incredibly strong foundation to build on for the work that lies ahead.

Mark Mattos, MD, and Peter Connolly, MD, led our politi­cal advocacy efforts (via the SVS Political Action Committee [PAC] Steering Committee) to achieve a new fundraising record during the last election cycle. This is due to all the donors who have provided invaluable resources to ensure that vascular surgery’s voice is heard on all of the matters important to our members. Already, incoming PAC Chair Yazan Duwayri, MD, is working with the advocacy staff to deploy these funds for maximum impact, including combin­ing forces across specialties where there is common cause. In the upcoming year, we will build on the excellent grass­roots efforts of the past year in establishing our “grass-tops” reach 535 program and supporting these volunteers in developing lasting relationships with members of Congress.

Some great opportunities are also on the horizon as Con­gress starts to ask long-overdue questions. A recent “Request for Information” issued in September by the House Ways and Means Committee notes, “Patients across America are facing increasing healthcare facility closures, travel distances and wait times, driven by a shrinking healthcare workforce, healthcare consolidation and patchwork financing models. This access challenge is uniquely difficult for patients and families living in rural and underserved areas in America.” See the request at vascular.org/RuralHealthCareRFI.

This is preaching to the choir—who knows these challeng­es better than vascular surgeons and patients? The committee “is seeking broad stakeholder input … with an emphasis on solutions to reshape our nation’s healthcare system and bring new access to care in rural and underserved areas.” We are working to answer that, building on the work of the Population Health Task Force with the establishment of an SVS Health Policy Research Consortium to marshal what our researchers have learned about vascular deserts and access challenges in both rural and urban areas, and to enlist our own best minds to fill gaps in the data needed for the strongest, best-informed advocacy.

As the conversation about reform moves forward, from sustainable funding to more efficient and humane delivery, the SVS will also be working to build alliances to help physi­cians and patients speak with the single voice needed to rise above the cacophony of interested parties. This holds true for reform at the congressional level and certainly for the upcom­ing task at the Relative Values Scale (RVS) Update Committee (RUC) of examining how lower-extremity interventions are valued—one in which SVS members can appreciate the foun­dation of expertise and credibility laid by leaders like Robert Zwolak, MD, Sean Roddy, MD, and Matthew Sideman, MD, and carried forward by Sunita Srivastava, MD, and David Han, MD, on the SVS Coding Committee.

And last, but not least, advocacy looks forward to hearing from SVS members about how we can help you where you are and about your interests and priorities. For instance, we hear from surgeons across the country that prior authori­zation practices and denials are becoming more onerous, seemingly by the day. The SVS has always worked to analyze and respond to these trends and to work hand-in-hand with members needing support in payer relations. The Society is exploring avenues to most effectively combat barriers to timely, high-quality care. Visit vascular.org/AdvocacyQues­tion, or contact [email protected].

Margaret C. Tracci is chair of the SVS Advocacy Council.

SVS unveils proposal outlining changes to Society bylaws

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SVS unveils proposal outlining changes to Society bylaws

Voting members of the SVS will have the opportunity to consider a bylaws referendum, with key amendments related to membership and the composition of the SVS Executive Board.

The voting follows the SVS Strategic Board of Directors’ formal approval of the Executive Board’s proposals. Voting will begin Nov.6 and run through Nov. 20.

Key amendments include Article III changes, which involves providing enhanced privileges for Early Active members. Approval will “codify” the establishment of “Early Active” membership in the SVS for those who have completed their training but are not eligible for Active membership. This has been piloted over the past year with great success and support. Early Active members will be able to serve on committees and vote in SVS elections. Currently, only Active and Senior SVS members may vote.

There are also changes to Articles V and VII concerning the composition of the Executive Board. Approval will alter the composition of the Executive Board so it aligns with current best practices for medical societies to establish “competency-based” models of governance that provide greater diversity of perspective for decision-making and governance, as well as provide for greater flexibility and agility to address evolving needs over time. The composition of the EB would change in two distinct ways:

The first change increases the size of the Executive Board from nine to 11 members. Currently, the nine members include six elected officers (three elected, and three acceding from previous election) and three appointed members determined by their committee positions: chair of the SVS Community Practice Section, chair of the Program Committee and a representative from the Strategic Board of Directors. Under the proposal, two additional non-officer members would be added, with all five serving as “at-large” members, on staggered terms. These members would be selected and appointed by the EB, following consultation with the Nominating Committee and Strategic Board of Directors, based on identified priority gaps in expertise or perspective. At-large members will be required to have been SVS members in good standing for at least five years.

The second change will alter the nominating process for SVS officers (vice president, secretary and treasurer). The Nominating Committee will have the flexibility to bring forward a minimum of two, and maximum of four candidates for each vacant officer position. This will provide opportunity to expand diversity of choice amongst highly qualified candidates and permit the voting membership to choose. Additionally, the Executive Board and the Strategic Board of Directors will actively compile existing competencies in their respective memberships, identify gaps of needed perspective and expertise and share these findings with the Nominating Committee.

A review of the changes is available at vascular.org/2023BylawsRef. For answers to any questions, email [email protected].

Alert! Pay SVS 2024 member dues by Dec. 31.

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Alert! Pay SVS 2024 member dues by Dec. 31.

SVSSVS members must act before the end of the year to avoid interruption of their 2024 membership benefits. Members can pay their dues on or before Dec. 31 to support the SVS mission and advance vascular health.

Membership renewal includes continued access to all membership benefits, including all Journal of Vascular Surgery publications at reduced or no cost, access to the SVS Education Portal, reduced rates to VAM and more.

Members can pay their dues at vascular.org/invoices; login is required. While paying their dues, members can also donate to the work of the SVS Foundation.

Additionally, members also can update their SVS profiles, including adding mobile numbers to receive infrequent text alerts on critical society communications, such as dues renewals and election notices when updating their SVS profiles.

For questions, email [email protected].

Applications open for awards, grant

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Applications open for awards, grant

Applications open this month for the SVS Excellence in Community Practice Award and the Sub-Section on Outpatient & Office Vascular Care (SOOVC) Research Seed Grant and Presentation Award.

The Excellence in Community Practice Award honors members who have exhibited outstanding leadership within his or her community as a practicing vascular surgeon. Criteria include a minimum of 20 years as a practicing vascular surgeon and minimum of five years as an SVS member.

Applicants/nominees must present evidence of leadership in a community-based practice, such as implementation of services or innovations to advance community health, partnerships or collaborations with organizations in the community, and contributions that elevate the stature of the specialty of vascular surgery in the community.

Learn more at vascular.org/CommunityPracticeAward. Applications close Feb. 1.

The SOOVC Presentation Award recognizes vascular surgeons who have completed clinical research projects in an office-based lab (OBL) or ambulatory surgery center (ASC). Three recipients will be selected for the award.

The Research Seed Grant supports research in an OBL or ASC practice, providing vascular surgeons with funds for a data analyst to analyze research data for actionable insights, quality improvement and patient care. Three recipients will be selected, and each will receive a $10,000 grant.

Visit vascular.org/SOOVCResearchGrant and vascular.org/SOOVCPresentationAward. Applications close Jan.15.

REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment

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REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment
EkoSonic
EkoSonic
EkoSonic

Data from the REAL-PE study were presented this week at TCT 2023 (23–26 October, San Francisco, USA) demonstrating that patients treated for pulmonary embolism (PE) with the Ekos endovascular system (Boston Scientific) had lower rates of adverse events, including statistically significant lower rates of major bleeding, within seven days following their procedure compared to the FlowTriever system (Inari Medical).

According to Boston Scientific, the analysis is the largest comparative study to use near real-time health system-based electronic health record (EHR) data to understand clinical practices and outcomes related to PE.

A press release details that, while treatment for PE has historically included anticoagulant medication, the use of new interventional therapies—such as the EKOS system—is increasing. The EKOS system uses a combination of ultrasound energy and a low thrombolytic drug dose to restore blood flow in patients with PE and other occlusions in the peripheral vasculature.

The REAL-PE study reviewed data from Truveta, a data and analytics company that provides EHR data from more than 30 US health systems and 100 million patients, including lab values, comorbidities, images, demographics and clinical outcomes, as well information about the performance of specific medical devices. In the REAL-PE analysis, 2,259 patients who experienced PE and received interventional treatment with either the EKOS system or the FlowTriever system between 2009 and 2023 were identified, and safety events associated with both devices were compared.

“In the past decade, there have been a number of advances in interventional therapies for the treatment of PE, but gaps in clinical evidence still exist when it comes to determining the optimal modality for each patient’s unique needs,” said Peter Monteleone, an interventional cardiologist with Ascension (Austin, USA) and principal investigator of the REAL-PE study. “The REAL-PE study provides comprehensive data and unprecedented insight into the real-world performance of specific interventional devices, which can help physicians make more informed clinical decisions.”

Major bleeding events in the REAL-PE study were based on definitions derived from established clinical criteria and guidelines, with statistically significant lower rates within seven days of the procedure consistently found in the cohort of patients treated with the EKOS system:

  • A rate of 12.4% for patients treated with the EKOS system vs. 17.3% for those treated with the FlowTriever system (p=0.0018), using the International Society on Thrombosis and Haemostasis (ISTH) definition, and;
  • A rate of 11.8% for patients treated with the EKOS system vs. 15.4% for those treated with the FlowTriever system (p=0.0190), using the Bleeding Academic Research Consortium type 3b (BARC3b) definition.

Medical coding data in the analysis also demonstrated that intracerebral haemorrhage within seven days following the procedure occurred statistically significant less frequently among patients treated with the EKOS system (0.3% vs. 1.3%, p=0.005). All other studied safety events also trended in favour of the EKOS system, including in-hospital mortality (2.6% vs. 3.7%) and all-cause 30-day readmission rates (5.1% vs. 5.4%). Median lengths of hospital stay were comparable at 3.6 days for both groups.

“Electronic health record data of this scale provides in-depth information about larger, more diverse patient populations, while also accounting for multiple variables including complex medical histories or comorbidities that often exclude patients from clinical trials,” said Michael R Jaff, chief medical officer and vice president, clinical affairs, technology and innovation, peripheral interventions, Boston Scientific. “While data from clinical trials and registries will always play an important role in healthcare, access to the breadth of data such as that used in the REAL-PE study has the potential to better inform and accelerate clinical decision-making and, ultimately, improve patient care.”

To date, Boston Scientific shares, the EKOS system has been used to treat more than 100,000 patients with PE globally, and the next-generation Ekos+ endovascular system received US Food and Drug Administration 510(k) clearance in 2022.

Thrombolex announces new insights from the RESCUE trial with the Bashir endovascular catheter

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Thrombolex announces new insights from the RESCUE trial with the Bashir endovascular catheter
Bashir endovascular catheter
Bashir endovascular catheter

Thrombolex has announced never-before-reported major reductions in obstruction in all of the segmental pulmonary arteries (PA), based on independent core lab data analysis of 107 patients from 18 sites in the USA, with acute intermediate-risk pulmonary embolism (PE), using the Bashir endovascular catheter and small doses of tissue plasminogen activator (tPA).

The National Institutes of Health (NIH)-sponsored RESCUE trial also showed unsurpassed efficacy and safety in this patient population compared to recently published studies with other US Food and Drug Administration (FDA)-cleared devices, Thrombolex reports in a press release. These new data have just been published in the Journal of the American College of Cardiology (JACC): Advances online.

The RESCUE trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PM-CDT) therapy using the Bashir endovascular catheter to administer recombinant tPA (r-tPA) in small doses (7mg for unilateral and 14mg for bilateral PE over five hours) resulted in a 71.1% (40.5% to 11.7%; p<0.0001) reduction in the number of segmental PA branches with total or subtotal occlusions at 48 hours, using contrast-enhanced chest computed tomography angiography. Proximal PA branch total or subtotal occlusions decreased by 61.3% (28.7% to 11.0%; p<0.0001). The reduction in segmental artery occlusions correlated significantly with the reduction in right ventricular/left ventricular (RV/LV) ratio (P=0.0026) whereas that in the proximal PA did not (p=0.173).

Gregory Piazza, associate professor of medicine, Harvard Medical School (Boston, USA) and chairman of the RESCUE Data Safety Monitoring Board noted: “A growing body of literature supports the hypothesis that reperfusion of the distal pulmonary vasculature is a critical therapeutic target, influencing right ventricular recovery, symptom relief, and gas exchange.”

“The critical finding in the present study is that by using the Bashir endovascular catheter and small doses of tPA we are able to markedly reduce segmental and main pulmonary arterial occlusions. Assessment of segmental artery patency after catheter-based therapies of acute PE may be critical to understanding the long-term benefits of these therapies and should be part of all future clinical trials in acute PE,” said Brian G Firth, chief scientific officer, Thrombolex.

Vam 2024 gala set for chicago’s museum of science and industry

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Vam 2024 gala set for chicago’s museum of science and industry
Pictured at the 2023 Gala are Leigh Ann O’Banion (top), and (bottom, left to right) Anna Boniakowski, Bernadette Aulivola, Dawn Coleman and Misty Humphries

During the vascular annual meeting that celebrates science and research, the SVS Foundation’s annual Gala will take place in a museum that also honors science. “A Night at the Museum—A Celebration of Science” is set for Friday, June 21, 2024 at Chicago’s world-famous Museum of Science and Industry.

Chairs of the 2024 Gala are Michael Dalsing, MD, chair of the SVS Foundation; Bernadette Aulivola, MD, member of the SVS Foundation Board of Directors; and Leigh Ann O’Banion, MD, co-chair of the 2023 Gala.

Tickets for this annual event, which typically sell out quickly, will go on sale in March. Included in the evening are transportation to the museum, live and silent auctions, plated dinner, dancing to a DJ, and much more. “Guests will be able to visit the exhibits on the main floor, which is where the event will be located,” said O’Banion. That includes the museum’s “Yesterday’s Main Street,” the Coal Mine, “Numbers in Nature: A Mirror Maze” and exhibits on “The Great Train Story” (in the Transportation Gallery), “Science Storms,” “Extreme Ice,” “Earth Revealed,” and more. “I practice in Chicago and am no stranger to this fantastic museum,” said Aulivola. “I’m thrilled that we’ve secured this location for our upcoming Gala and I cannot wait to show it off to our Gala attendees. I am certain that this will be an incredibly fun event for all.”

For information contact Catherine Lampi at [email protected].

Corner Stich: Bridging knowledge gaps and meeting new demands of vascular surgical training

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Corner Stich: Bridging knowledge gaps and meeting new demands of vascular surgical training
Christopher Audu and Scot Stanulis

This month in Corner Stitch, we highlight a trainee-centric study presented at the 2023 Midwestern Vascular Surgical Society (MVSS) annual meeting held in Minneapolis, Minnesota (Sept. 7–9). With the rise of Entrustable Professional Activities (EPAs) and the diminishing number of open aortic cases being performed across the country, this study from the group at Southern Illinois University provides an idea of how we may begin bridging these knowledge gaps and meeting the new educational demands coming to surgical training. For this, Christopher Audu, MD, interviews vascular surgery resident Scot Stanulis, MD, who presented his work on “Video-based self-assessment is an effective method of open surgical education for vascular surgery trainees.”

CA: In your study, your group evaluated open surgical skills using cadavers. Can you share the origin story for this idea? What prompted a cadaveric simulation study?

SS: An important topic in vascular surgery education at the moment, with the advent of integrated residencies and as the proportion of endovascular procedures increases, is that our residents may be exposed to fewer open vascular cases in their training. We wanted to start looking at solutions to this problem, and as we already have a great relationship with our surgical simulation lab, we thought this would be a natural start. The surgical literature, particularly in general surgery, shows promise for integrating more simulation into resident education, and we wanted to see if we could step it up a notch by including complete operations from skin-to-skin, and to see if video recordings, along with faculty and self-assessment, could increase the educational value.

CA: Bravo on taking on a really cool project to meet the need for open skills. How did you go about procuring permission from your anatomy department for this simulation? Is this something any residency can do to improve their resident/fellow open skills?

SS: Luckily, we already have a great relationship with our anatomy department, and many surgical subspecialties at our institution use the surgical simulation lab for cadaveric-based education. For standardization purposes, we needed to request cadavers that had not already underwent dissection in the operative field for a carotid endarterectomy (CEA), and we needed to ensure we could set up a live video-feed with overhead cameras. We were able to work with our simulation lab faculty to solve these pretty quickly. If a residency program does not already have access to cadavers, this would be a bigger obstacle to overcome; however, cadaveric education is an important part of robust simulation education, even outside of our project, and we would recommend any program strive to include some form of cadaveric education in their curriculum.

CA: In the paper you presented, you focused on carotid endarterectomies. What were the areas that the juniors improved in the most? Needle handling? Draping? Steps of the procedure?

SS: For our first exploration in video-based simulation, we chose CEAs for a few reasons: it is a procedure that all our residents had some exposure to; it has well-established, replicable steps, which aids in standardization; and it encompasses a broad range of vascular surgical skills.

In our experience with CEA, we found that the junior residents improved the most in the initial parts of the procedure, including draping and positioning, incision, and initial dissection and exposure. Additionally, there were some specific steps; for example, the PGY1 was able to clamp in the correct order the second time around; and the PGY2 improved at identifying each nerve during dissection. Our senior residents nearly aced our evaluation forms from the first attempt, so there was not much room for improvement—meaning we need to challenge them with more stringent evaluation criteria or a more difficult operation.

CA: That makes sense. What was your observed correlation between areas identified by the resident and those identified by the faculty? Can you infer anything about how a resident is able to assess their own growth?

SS: Residents and faculty were generally congruent on objective measures like “clamping order,” but for subjective measures like “overall proficiency” or even “proper nerve exposure,” we found more of a difference. We did see some improvement in resident self-assessment ability across sessions, but at this point it is clear that a junior resident will need faculty feedback to properly assess their operative performance, at least until they further develop their skill of self-assessment.

CA: That is very interesting. Did the improved residents notice greater autonomy in the operating room (OR) for carotid cases?

SS: At our program, our residents do already get a fair bit of autonomy, and it is hard to say how much that improved from this one experience, particularly as our experience was blinded and the faculty did not get to see an individual resident’s improvement to then grant more autonomy. However, residents did say that they felt more confident and prepared going into their next CEA, and we do believe that this preparation can make it so residents get more out of their real cases once they have overcome some of the learning process in simulation.

CA: I see. So, one unintended benefit of this is improving resident/trainee confidence, which then translates into OR proficiency. How do you envision the platform being used for other vascular cases? Did your faculty find this a helpful exercise in their assessment of residents?

SS: I think the real benefit for this type of experience is augmenting surgical education in operations that our residents will see less often. Providing residents with confidence and foundational skills in open abdominal cases will be invaluable as we see a trend of residents reporting fewer of these cases in the endovascular era.

Faculty did report that it was useful to see the general weak points of residents so they could better direct teaching in the OR, but our experience was set up more for resident learning, and we did not assess if faculty improved at teaching or assessment.

CA: Right on. I suppose faculty evaluation of their teaching can be a future project. What open vascular operation are you going to do next?

SS: The next operation we will evaluate will be an open abdominal aortic aneurysm (AAA) repair. We chose this because we want to challenge our senior residents more, and see if this model holds up with a more complex operation. Challenges include keeping a larger operative field in the camera view, creating reasonable standardized evaluation forms, and increased time requirements in the simulation lab. If this model works for both a CEA and an open AAA, I don’t see many reasons that would prevent it from being used for a multitude of other open vascular surgery cases.

CHRISTOPHER AUDU is the Vascular Specialist resident/fellow editor. He is a resident at the University of Michigan in Ann Arbor, Michigan.

Highlighting original work by women: Peer-review title blazes new trail in vascular surgery

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Highlighting original work by women: Peer-review title blazes new trail in vascular surgery

The September issue of Annals of Vascular Surgery featured 37 original, peer-reviewed scientific papers whose lead authors and researchers are women vascular surgeons. Here, editor Caitlin W. Hicks, MD, discusses the mechanics of getting the publication out, coming amid recent trials and tribulations in the vascular space that saw her come under personal attack.

The work had been more than a year in the making, so to see the final title reach the point of release filled those behind the Annals of Vascular Surgery special issue, “Original Work by Women,” with a sense of accomplishment. Hicks said the mere fact the entire edition is fully open access has attracted positive feedback, but, for her, something else stands out as a particular achievement. “The biggest highlight is just the fact we were able to get so many articles with first and last women authors, which given the number of female vascular surgeons is relatively small, and the articles still underwent standard, strict peer review, is probably the most exciting and impactful component,” she tells Vascular Specialist. Solidifying the point, Hicks reveals that somewhere in the region of about 30% of the articles received for inclusion in the issue were rejected.

Reaching the point where such a dedicated women’s issue is possible didn’t occur in a vacuum, Hicks observes. The Medbikini fiasco that kicked off in 2020 lit a fire, she says. “There was sort of an influx of women stepping up to say ‘We’re here,’” she continues. “I think since then, we’ve seen a real presence of women in all aspects of vascular surgery, which is really exciting. This issue doesn’t really come out of the blue. It feeds off of that progress we have made in recent years.”

Strides toward better representation of women vascular surgeons in leadership positions continue to be made, Hicks says, with vascular surgery currently “bottom heavy in the societies because, out of training, we’re seeing 50/50 men vs. women, but 15 years ago it was not that way.” The Women’s Vascular Summit, started by Linda Harris, MD, out of Buffalo, has also planted roots in recent years. “We continue to push forward and continue to champion the leaders that we have in our women’s group, and then create our own opportunities,” Hicks explains. “What has come out of the [SVS] election findings over the last couple of years has increased focus on the role of women in the vascular surgery space. Linda Harris has had a meeting for a few years now, and that group is going to codify into a women’s vascular society, which I think is exciting.”

Lately, just as the Annals issue was heading for publication, on a personal level Hicks had to confront a backlash to her contributions to the public conversation that followed the NYT exposé on inappropriateness in vascular care. “I have done a lot of research in this space, and the motivation behind my research is to improve patient care, so when you do things for the right reasons and you get personally attacked, it’s always challenging,” she reflects. “There was definitely a component of ageism in the posts,” adding, “It’s always hard to know, but I do believe if I had been a male I wouldn’t have gotten that type of attack.”—Bryan Kay

Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders

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Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders

Julie A. Freischlag, MD, used her turn as honorary guest lecturer at the 2023 Midwestern Vascular Surgical Society (MVSS) annual meeting to make a pitch for vascular surgeons to step up to the plate as hospital and institutional leaders—because that is “who you are,” she told the gathering in Minneapolis, Minnesota (Sept. 7–9).

“I would challenge you as vascular surgeons to go and run things,” she said. “Surgeons are really, really good at running things. You make decisions with very little data, and go do it on a Friday night. You make mistakes; things bleed and clot; and you strive to go fix it. You walk into that operating room every day with high hopes.”

Many CEOs and the types of C-suite operators involved in the likes of mergers and acquisitions, on the other hand, walk into the room with “a whole different thought,” Freischlag said. Often, they assume things are going to fail, and “they may not always tell the truth.”

That’s the opposite of the archetypal vascular surgeon, she continued. “What you need to do is get in those rooms and lead those processes, because that is who you are. You make good decisions, are able to own up to your mistakes, and you actually care—about your patients, teams, families and where you are going.”

Freischlag’s lecture was built around the theme of “Daring to do hard things.” Detailing snapshots from her own journey—which, in addition to a lofty career trajectory, also included road bumps such as a divorce—she highlighted themes of resilience, diversity, mentorship and bravery in leadership.

She placed a particular emphasis on the importance of diversity in surgery, referencing the recent publication of the special women’s issue of Annals of Vascular Surgery, for which she was invited to write the introduction.

To illustrate the point, Freischlag detailed her first open aneurysm repair, in San Diego in 1987, when she was just 32 years old. The 82-year-old patient, who presented with a 6cm aneurysm, was due to undergo the procedure when Freischlag walked into the room to a less than rapt wider audience. “Her family was aghast,” she recalled. “Who is this kid, they were thinking,” although the actual patient herself had no reservations, underwent the operation, and came out the other side, Freischlag said. The tale ended with Freischlag receiving two gifts from the lady and her family: a cross-stitched handkerchief crafted by the patient, along with an inscribed gold bracelet marking out the gratitude of the family. Freischlag cherishes the keepsakes still, explaining: “I was the most diverse vascular surgeon anybody saw doing that work back in the 80s— doing her procedure and trusting me, just like our patients trust us in our clinical trials. It’s really important that that continues to happen in all shapes and forms.”

Meanwhile, inclusive leadership means “you take somebody with you wherever you go. If you haven’t introduced one of your students, residents or fellows to somebody at this meeting, shame on you,” Freischlag implored. “You need to take them by the arm, introduce them to leadership, let them present … Watching them grow to do it even better than you did is a wonderful feeling, and it makes the world a better place.”

Leadership is a journey, Freischlag added. It is about helping those around you, but, just like in her case, “it isn’t always easy.” As the COVID-19 pandemic demonstrated, she said, “you get interrupted.”

TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries

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TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries
L-r: Ramon L Varcoe, Britan G DeRubertis and Sahil A Parikh

Results of the LIFE-BTK randomized controlled trial have just been presented at TCT 2023 (Oct. 23–26) in San Francisco. The data show that, in patients with chronic limb-threatening ischemia (CLTI) due to infrapopliteal artery disease, an everolimus-eluting resorbable scaffold was superior to angioplasty at one year with respect to the primary efficacy endpoint. 

Ramon L. Varcoe, MBBS, from Prince of Wales Hospital and University of New South Wales in Randwick, Australia, shared this and other key findings at TCT on behalf of co-principal investigators Brian G. DeRubertis, MD, from New York Presbyterian–Weill Cornell Medical Center in New York, and Sahil A. Parikh, MD, from Columbia University Irving Medical Center, also in New York. The trial results were simultaneously published in the New England Journal of Medicine (NEJM). 

Parikh shares his thoughts on the significance of these results with this newspaper: “This trial is the first of its kind to demonstrate superiority of a technology for below-the-knee [BTK] intervention along a relatively long time point for this patient population.” He describes the effects of the technology as durable and notes they are “continuing to diverge” at the 12-month time point. “It is a highly clinically significant result.” 

Peter Schneider, MD, from University of California San Francisco in San Francisco, provides some context, noting that LIFE-BTK follows multiple failed trials in the BTK segment. “The key thing I think is that we do not have the tools we need to treat BTK disease. Yes, catheter-based treatments for limb salvage are quite good, they performed well in both the BEST-CLI and BASIL-2 trials, but it is still somewhat limited in terms of the number of options we have,” he says. “We have had a number of failed trials below the knee—three failed [drug-coated balloon] trials and one failed drug-eluting stent trial—and the fact that we now have a successful trial is really I would say wind in the sails of this whole effort to try to improve the tools and the approaches that we have for BTK disease.” 

In this multicenter, randomized controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive an everolimus-eluting resorbable scaffold (Esprit BTK; Abbott Vascular) or angioplasty. 

The primary efficacy endpoint was freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at one year. The primary safety endpoint was freedom from major adverse limb events at six months and perioperative death. 

The authors report in NEJM that the primary efficacy endpoint was observed—by which they mean no events occurred—in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; p<0.001 for superiority). This is “a highly statistically significant result,” Parikh remarks in conversation with this newspaper. 

Parikh adds that the primary safety endpoint was “statistically indistinguishable between the two groups.” Writing in NEJM, the investigators elaborate that this endpoint was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0).  

Finally, the investigators relay in their NEJM report that serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. 

Lessons learned 

Parikh, an interventional cardiologist, notes that resorbable scaffold technology has “significantly improved” since the early iterations used in the coronary arteries. He expresses his hope for use of this technology in the peripheral vessels: “I would like to make clear that this is a new iteration of this technology,” he says. “The scaffold thickness is substantially less, it is in fact comparable to the contemporary drug-eluting coronary stents that we now use, with a thickness of less than 100 microns.” 

Parikh adds that the lesion lengths that can be treated now are much longer. “In fact, in this trial, the lesions that were treated were up to 17cm, with overlapping scaffolds,” he shares. 

According to Parikh, the success of current resorbable scaffold technology is a testament to lessons learned from past versions. “It is a similar technology to predecessors, but has benefitted from the experience that we have learned from other trials, and what we have learned is that fastidious implantation technique, adequate sizing, and appropriate pharmacotherapy are really the mainstays of treatment, and they are probably critically important to all vascular interventions, but specifically using a drug-eluting resorbable scaffold.” 

He urges caution when comparing use of resorbable scaffolds in different vessels, although notes that “in this specific instance, the technology has proven itself to be superior in a randomized controlled clinical trial.” 

Based on the positive findings from LIFE-KTK, Parikh is hopeful for the future of treatment in patients with CLTI due to infrainguinal disease: “We are extremely excited about the prospect of this technology being part of our armamentarium.” 

On whether the results will change practice, Schneider opines that “this is a tool that all of us are going to want to have on our shelf.” However, he advises that interventionalists “keep in mind that a randomized controlled trial […] is not the same as an everyday algorithm of when to use and in which patients and in which situation.” The next step, according to Schneider, should be to develop that algorithm.  

Questions remain, he says, including “is this something we are going to be using every day, or something we are going to be using once in a while in specific situations?” and “that is the part that I think we need to go forward and figure out.”

TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA

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TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA
patient-level
L-r: Sahil Parikh, Peter Schneider and William A Gray

Data from a patient-level meta-analysis—a factor in the Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (Oct. 23–26) in San Francisco.

The analysis led investigators to conclude that there is no association between mortality risk and paclitaxel-coated device exposure or dose, and should provide reassurance to patients, physicians and regulators on the safety of paclitaxel-coated devices, they say.

The release of the data, which has also been published today in The Lancet, draws a line in the sand over the question of the safety of paclitaxel, which is used in peripheral interventions to prevent restenosis, after data  from a summary-level meta-analysis put forward in 2018 pointed to an increased risk of death at two and five years following the use of paclitaxel-coated devices in the femoropopliteal artery.

William A. Gray, MD, of Lankenau Heart Institute in Wynnewood, Pennsylvania, told TCT attendees that the analysis provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices and represents the most complete patient-level analysis to date, or likely to be available in the future.

Gray presented the findings on behalf of an independent physician steering committee, comprising Sahil Parikh, MD, from Columbia University Irving Medical Center in New York, Peter Schneider, MD, from University of California San Francisco in San Francisco, Christopher Mullin, MS, and Tyson Rogers, MS, both from North American Science Associates (NAMSA) in Minneapolis, Minnesota, who were enlisted by the regulator and industry to dig into the final and updated patient-level datasets and address limitations of prior paclitaxel meta-analyses. Funding for the study came from BD, Boston Scientific, Cook, Medtronic, Philips, Surmodics and TriReme Medical, though the funders of the study had no role in its design, data analysis, data interpretation, or writing of the report, but did provide patient-level data for the analysis, which was independently conducted.

The use of paclitaxel-coated devices for the treatment of PAD dropped by as much as 50% due to changes in practice patterns worldwide, Gray said, which was in response to the FDA’s 2019 statement that use of paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. This change in position came after a meta-analysis from Konstantinos Katsanos, MD, from University of Patras in Patras, Greece, et al had first raised the specter of a mortality risk. FDA removed the red flag in July this year, stating that “additional data from the pivotal randomized controlled trials (RCTs) ha[ve] become available” in a letter to healthcare providers in which it set out the decision.

Gray presents the findings at TCT 2023

To inform this decision, Gray and his co-investigators analyzed randomized trials that evaluated FDA-approved paclitaxel-coated devices versus uncoated devices for the treatment of femoropopliteal artery disease, looking primarily at the mortality risk on an intention-to-treat basis, with key secondary analyses including dose/mortality and covariate interactions.

Data from 10 trials were included, encompassing 2,666 participants over a median follow-up of 4.9 years. One-year follow-up was available in 98.7% of evaluable participants and five-year follow-up in 95%, which Gray noted represents an additional 3,355.5 patient years since a 2020 analysis by VIVA Physicians, in which investigators identified an absolute 4.6% increased mortality risk associated with paclitaxel-coated devices, albeit demonstrating a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

Results of the latest analysis presented by Gray and published in The Lancet demonstrated an overall hazard ratio (HR) for the intention to treat population of 1.14 (95% confidence interval [CI] 0.93–1.40). In post-hoc analyses assessing the proportional hazards assumption, there was no evidence the assumption was violated. HRs for individual studies ranged from 0.32 to 1.52, and there were no studies in which the CI did not include the null value of 1. The HR for the as-treated analysis was 1.13 (0.92–1.39). Furthermore, the as-treated crossover analyses also did not show a significant difference in deaths between the paclitaxel-coated and control groups, with an HR of 1.07 (0.87–1.31) when late crossovers were censored, and 1.04 (0.84–1.28) in the time-varying analysis of late crossovers. Examination of late crossover using iterative parameter estimations also failed to detect a significant effect on deaths.

In their report of the findings in The Lancet, investigators describe their dataset as “very likely to be the most complete and thoroughly vetted dataset to emerge regarding paclitaxel-coated devices and death, given the likelihood that randomized trials against control devices will no longer have clinical equipoise for effectiveness, and the substantial coordination efforts for data collection, analysis and multilateral consensus will be difficult to recapitulate.”

They also praise the collaborative and thorough efforts of many clinicians, industry sponsors, and regulators over several years that enabled this research.

“The most important takeaways are that: number one, we [have] learned a tremendous amount about how future studies should be planned, so that we do not go down a blind alley again to be fooled by a summary level meta-analysis,” Schneider tells this newspaper, reflecting on the takeaways from the research.

“The second thing is that this was a tremendous effort to resolve this problem, and that included collaboration like we have never had before between physicians of different specialties in different parts of the world, with industry and with regulatory bodies all over the geography, but especially with FDA, [which] has been extremely collaborative and has been all about problem solving since the beginning of this issue.”

“Here we have probably the most complete dataset that will be feasible from the randomised controlled trials,” comments Parikh. “We looked at the overall percentage of patients identified with vital status at five years, and it was 95% of the total cohort of almost 2,700 patients. I think it will be hard to find a more complete dataset at this level of detail.”

More importantly, adds Parikh, was the opportunity to conduct crossovers analyses.

“We are identifying exposure to paclitaxel in any way, to the maximum extent possible, and, with each subsequent iteration of the analysis, our findings showed a closer and closer point estimate to no hazard at all, to unity,” he says. “That really emphasizes that going the extra mile to identify every exposure to paclitaxel, in this case most often with a contralateral limb intervention or reintervention, was the appropriate approach to adjudicate paclitaxel exposure and its risk.”

TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA

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TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA
patient-level
L-r: Sahil Parikh, Peter Schneider and William A Gray

Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (23–26 October, San Francisco, USA).

The analysis led investigators to conclude that there is no association between mortality risk and paclitaxel-coated device exposure or dose, and should provide reassurance to patients, physicians and regulators on the safety of paclitaxel-coated devices, they say.

The release of the data, which has also been published today in The Lancet, draws a line in the sand over the question of the safety of paclitaxel, which is used in peripheral interventions to prevent restenosis, after data  from a summary-level meta-analysis put forward in 2018 pointed to an increased risk of death at two and five years following the use of paclitaxel-coated devices in the femoropopliteal artery.

William A Gray (Lankenau Heart Institute, Wynnewood, USA) told TCT attendees that the analysis provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices and represents the most complete patient-level analysis to date, or likely to be available in the future.

Gray presented the findings on behalf of an independent physician steering committee, comprising Sahil Parikh (Columbia University Irving Medical Center, New York, USA), Peter Schneider (University of California San Francisco, San Francisco, USA), Christopher Mullin and Tyson Rogers (both North American Science Associates [NAMSA], Minneapolis, USA), who were enlisted by the regulator and industry to dig into the final and updated patient-level datasets and address limitations of prior paclitaxel meta-analyses. Funding for the study came from BD, Boston Scientific, Cook, Medtronic, Philips, Surmodics and TriReme Medical, though the funders of the study had no role in its design, data analysis, data interpretation, or writing of the report, but did provide patient-level data for the analysis, which was independently conducted.

The use of paclitaxel-coated devices for the treatment of PAD dropped by as much as 50% due to changes in practice patterns worldwide, Gray said, which was in response to the FDA’s 2019 statement that use of paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. This change in position came after a meta-analysis from Konstantinos Katsanos (University of Patras, Patras, Greece) et al had first raised the spectre of a mortality risk. FDA removed the red flag in July this year, stating that “additional data from the pivotal randomised controlled trials (RCTs) ha[ve] become available” in a letter to healthcare providers in which it set out the decision.

To inform this decision, Gray and his co-investigators analysed randomised trials that evaluated FDA-approved paclitaxel-coated devices versus uncoated devices for the treatment of femoropopliteal artery disease, looking primarily at the mortality risk on an intention-to-treat basis, with key secondary analyses including dose/mortality and covariate interactions.

Data from 10 trials were included, encompassing 2,666 participants over a median follow-up of 4.9 years. One-year follow-up was available in 98.7% of evaluable participants and five-year follow-up in 95%, which Gray noted represents an additional 3,355.5 patient years since a 2020 analysis by VIVA Physicians, in which investigators identified an absolute 4.6% increased mortality risk associated with paclitaxel-coated devices, albeit demonstrating a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

Results of the latest analysis presented by Gray and published in The Lancet demonstrated an overall hazard ratio (HR) for the intention to treat populationof 1.14 (95% confidence interval [CI] 0.93–1.40). In post-hoc analyses assessing the proportional hazards assumption, there was no evidence the assumption was violated. HRs for individual studies ranged from 0.32 to 1.52, and there were no studies in which the CI did not include the null value of 1. The HR for the as-treated analysis was 1.13 (0.92–1.39). Furthermore, the as-treated crossover analyses also did not show a significant difference in deaths between the paclitaxel-coated and control groups, with an HR of 1.07 (0.87–1.31) when late crossovers were censored, and 1.04 (0.84–1.28) in the time-varying analysis of late crossovers. Examination of late crossover using iterative parameter estimations also failed to detect a significant effect on deaths.

In their report of the findings in The Lancet, investigators describe their dataset as “very likely to be the most complete and thoroughly vetted dataset to emerge regarding paclitaxel-coated devices and death, given the likelihood that randomised trials against control devices will no longer have clinical equipoise for effectiveness, and the substantial coordination efforts for data collection, analysis and multilateral consensus will be difficult to recapitulate”.

They also praise the collaborative and thorough efforts of many clinicians, industry sponsors, and regulators over several years that enabled this research.

“The most important takeaways are that: number one, we [have] learned a tremendous amount about how future studies should be planned, so that we do not go down a blind alley again to be fooled by a summary level meta-analysis,” Schneider tells this newspaper, reflecting on the takeaways from the research.

“The second thing is that this was a tremendous effort to resolve this problem, and that included collaboration like we have never had before between physicians of different specialties in different parts of the world, with industry and with regulatory bodies all over the geography, but especially with FDA, [which] has been extremely collaborative and has been all about problem solving since the beginning of this issue.”

“Here we have probably the most complete dataset that will be feasible from the randomised controlled trials,” comments Parikh. “We looked at the overall percentage of patients identified with vital status at five years, and it was 95% of the total cohort of almost 2,700 patients. I think it will be hard to find a more complete dataset at this level of detail.”

More importantly, adds Parikh, was the opportunity to conduct crossovers analyses.

“We are identifying exposure to paclitaxel in any way, to the maximum extent possible, and, with each subsequent iteration of the analysis, our findings showed a closer and closer point estimate to no hazard at all, to unity,” he says. “That really emphasises that going the extra mile to identify every exposure to paclitaxel, in this case most often with a contralateral limb intervention or reintervention, was the appropriate approach to adjudicate paclitaxel exposure and its risk.”

Survey suggests venous work less valued than arterial interventions

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Survey suggests venous work less valued than arterial interventions
3d rendered illustration of the male vascular system
Venous disease is perceived to be of less value

The majority of more than 300 vascular surgeons who responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease. Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, D.C., and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. 

The authors note that biases and gender disparities influence career pathways in medicine, with vascular surgery being no exception. They continue that, despite venous disease comprising an estimated 1–3% of total healthcare expenditures, its value among vascular surgeons is ill defined. It was the aim of the present study to address this, by investigating the factors that influence vascular surgeons’ current perceptions of superficial and deep venous disease treatments. 

Kiguchi et al share that an anonymous survey was distributed electronically to practicing vascular surgeons in December 2021, with respondents stratified by gender and practice breakdown. They detail that a venous-heavy practice was defined as one with venous work comprising ≥25% of the total volume. 

The investigators note that a total of 315 practicing vascular surgeons responded to their survey, with a majority of 81.5% from the U.S. The respondents had a mean age of 46.6±9.6 years, the authors detail, and almost two-thirds (63.3%) identified as men. 

In terms of race and ethnicity, Kiguchi and colleagues state that 63% of respondents identified as White (non- Hispanic), 17.1% Asian or Asian Indian, 8.4% Hispanic, Latinx, or Spanish, 1.6% Black. The remaining 9.9% selected ‘unknown’ for this category. 

Nearly half of respondents (47%) shared that their practice setting was academic, compared to 26.5% private practice, 23.3% hospital employed, and 3.2% ‘other’. 

The investigators also note that the female respondents were “significantly” younger than their male counterparts (p<0.0001). In addition, they had fewer years in practice (p<0.0001) and were more likely to perceive a gender bias within a career encompassing venous disease compared with the male respondents (p=0.02). 

Of the 315 participants in the survey, Kiguchi et al relay that 143 (45.4%) had a venous-heavy practice, with no differences found in age or gender between the venous-heavy and venous-light practices. They continue that those with a venous-heavy practice had significantly more years in practice statistically (p=0.02), had sought more venous training after graduation (p<0.0001), were more likely to be in private practice (p<0.0001), and were more likely to desire a practice change (p=0.001) compared with those with a venous-light practice. 

Kiguchi and colleagues report that, overall, 74.3% of respondents indicated that venous work might be less “valued” than arterial work in the field of vascular surgery. On multivariable regression, they detail, the predictors for the perception of venous work being less valued were female gender (odds ratio 2.01, 95% confidence interval 1.14–4.03) and completion of a vascular surgery fellowship (odds ratio 2, 95% confidence interval 1.15–3.57). 

In their conclusion, Kiguchi et al state that vascular surgeons perceived the management of venous disease to be of less value than that of arterial disease, particularly by women and fellowship-trained vascular surgeons. “The prevalence of venous disease, as measured by its proportion of the U.S. healthcare budget, cannot be overstated,” the authors state. As a result, they stress that “efforts to elevate the importance of chronic venous disease within the scope of vascular surgery practices are essential to ensure patients are provided with appropriate specialty care.” 

NESVS 2023: Cambria takes over as New England SVS president

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NESVS 2023: Cambria takes over as New England SVS president
Sean Roddy, left, and Robert Cambria

Robert Cambria, MD, recently took over as president of the New England Society for Vascular Surgery (NESVS). He was passed the presidential baton by Sean Roddy, MD, during the NESVS 2023 annual meeting, held in Boston (Oct. 6–8).

Cambria is a vascular surgeon at Northern Light Health/Eastern Maine Medical Center in Bangor, Maine. Roddy is a professor of vascular surgery at Albany Med Health System in Albany, New York.

At the same meeting, Jessica Simons, MD, was elected as NESVS president-elect, and will become the first-ever female NESVS president in 2024. Simons is a professor of surgery at UMass Chan Medical School in Worcester, Massachusetts.

Prepare to submit research for VAM 2024

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Prepare to submit research for VAM 2024

Organizing a Vascular Annual Meeting (VAM) takes a whole lot of time and a whole lot of long-range planning. 

Thus, members of the SVS Postgraduate Education Committee (PGEC) have already evaluated the 90 submitted proposals (an SVS record) for educational sessions at VAM 2024. And Program Committee members, who select the scientific abstracts, are looking ahead to the November opening of the abstract-submission site. 

Researchers can submit abstracts for possible inclusion from Nov. 15 through Jan. 10, 2024. 

“The science is a critical part of the Vascular Annual Meeting,” said Program Committee Chair Andres Schanzer, MD. “While VAM of course offers opportunities for participants to get together for meetings, exhibits, dinners, catching up with friends and casual events, the scientific and educational sessions continue to be a main highlight. We received the most PGEC submissions in the history of the meeting and hopefully will do the same with the upcoming scientific abstract submissions.” 

Many VAM sessions feature abstract presentations, including the large-scale plenary sessions; the International Young Surgeons and International Poster competitions; the International Fast Talk and International Forum scientific sessions; the Vascular and Endovascular Surgery Society (VESS) presentations; the “How I Do It” video session; and the Poster Competition. 

VAM 2024 will be held June 19–22 at McCormick Place in Chicago. Educational sessions will run across all four days. 

Multicenter study points to favourable safety and efficacy of radial access for peripheral interventions

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Multicenter study points to favourable safety and efficacy of radial access for peripheral interventions
Mehdi Shishehbor

New research examining the safety and efficacy of using radial access for peripheral artery interventions has found that radial access allows early ambulation and same-day discharge with no serious adverse events.

These are the conclusions of a study published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), conducted by a team of researchers from eight prominent U.S. medical centers, aimed at examining the safety and feasibility of radial artery access for complex endovascular lower extremity interventions.

Peripheral artery interventions are commonly performed to treat vascular conditions that obstruct blood flow to the lower extremities, though traditionally these procedures have used a femoral artery access approach. In recent years, there has been increasing interest in using radial access, which involves accessing the arteries of the wrist or forearm, as an alternative approach.

From June 2020 to June 2021, 120 patients at eight centers were enrolled. The mean age of the patient population was 68.7 years and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%) and tibial (19.5%) vessels.

The primary efficacy endpoint, procedural success, defined as the successful completion of the procedure without conversion to femoral access and without radial access complications peri-procedure, was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25%) patients required one or more additional access to facilitate crossing and/or to complete the planned treatment (five femoral, 10 tibial, and 17 pedal). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and three hours 30 minutes; respectively, with 93.3% same day discharge. At 30 days, 97.2% of patients had ultrasound-confirmed radial access patency.

The findings of the study also demonstrate that radial access for peripheral artery interventions was associated with favorable safety profiles. Notably, the incidence of access site complications and major adverse cardiovascular events was significantly lower compared to the traditional femoral access approach. The results also showed comparable procedural success rates and long-term clinical outcomes between the two approaches.

Additionally, radial access was found to have the potential to be a safe and effective alternative for performing peripheral artery interventions. The researchers believe that the wrist and forearm offer several advantages over the traditional femoral access site, including improved patient comfort, reduced bleeding complications, and faster ambulation. Further research and clinical trials are warranted to validate these findings and establish radial access as a mainstream approach in this field, the study’s authors note.

“This study contributes to the growing body of evidence supporting the use of radial access for peripheral artery interventions,” stated Mehdi Shishehbor, MD, from University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio, lead author of the study. “As medical professionals continue to explore different approaches, advances in technology and techniques are expected to further enhance the safety and efficacy of these procedures. With its potential to improve patient outcomes and satisfaction, radial access may revolutionize the field of peripheral artery interventions.”

Writing in the conclusion to their paper, the study’s authors note that their research shows the safety and efficacy of the radial access approach for treating complex, multilevel peripheral arterial disease. “Radial approach allowed same day discharge for most patients with no serious adverse events,” Shishehbor et al write. “Future randomized trials should examine the clinical and cost effectiveness of this approach compared with femoral access for patients with peripheral arterial disease.”

NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report

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NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report
Valentyna Kostiuk

An inferior vena cava (IVC) filter retrieval device dubbed the next-generation in removal of the venous thromboembolism-fighting tools could substantially cut procedural times and radiation exposure, according to data emerging out of in vivo testing at Yale University. 

The Articulating Atraumatic Grasper is the brainchild of Cassius Iyad Ochoa Chaar, MD, associate professor of vascular surgery at Yale in New Haven, Connecticut, and colleagues, with in vitro and in vivo testing data presented at the 2023 American Venous Forum in San Antonio, Texas, earlier this year. 

The grasper got a fresh airing during the 2023 annual meeting of the New England Society for Vascular Surgery (NESVS) in Boston (Oct. 6–8), during which presenting author Valentyna Kostiuk, a Yale medical student and aspiring vascular surgeon, showed attendees how an advanced technique currently used in practice was deployed to retrieve a tilted filter in a patient, compared to a similarly positioned filter in a porcine model that was captured using the emerging grasper. In the case of the former, the procedural time was 55 minutes. During the example taken from in vivo testing, the procedural time was 11 minutes. 

The data show great promise for the novel retrieval device to improve the efficiency of IVC filter removal procedures, Kostiuk told NESVS 2023. 

So far, in vitro testing—which involved IVC filters being anchored to the inner wall of a flexible tube simulating the IVC and a high-contrast backlit camera view simulating 2D fluoroscopy projection during retrieval in the operating room—has demonstrated comparable retrieval times between the grasper and a standard-of-care snare device to remove a retrievable IVC filter in a centered configuration. However, the grasper device was also effective to remove permanent filters in both centered and tilted configurations that could not be retrieved using a standard snare device. Additionally, Ochoa Chaar and colleagues found that grasper removal of a centered permanent filter required “significantly less time”—29 seconds vs. 79 seconds when compared to the snare removal of a retrievable filter in a centered configuration. 

In the case of in vivo testing in a porcine model, six tilted infrarenal IVC filters were retrieved with the grasper via the right jugular approach. Comparison analysis between animal and patient procedures was performed for total procedure time, and both retrieval and fluoroscopy time. 

They showed that all IVC filters were retrieved using the grasper with no adverse events. The total procedure and fluoroscopy times were reduced by more than 50% in the pig group compared to the 12-patient match group—“significantly shorter,” the Yale researchers report. “Moreover, in the patient group, 16.7% of retrievals required advanced endovascular techniques and one IVC filter could not be retrieved [success rate= 91.7%], while all the IVC filters were successfully retrieved in the animal model without the use of additional tools.” 

Kostiuk, speaking to Vascular Specialist after delivering her video presentation at NESVS 2023, highlighted the potential advance of the grasper over current standard of care in IVC filter removal. “Standard removal devices we have right now consist of a snare, so in order to remove the filter, you need to have the hook available to be captured by the snare loops,” she said. 

The more advanced current technique—involving a wire loop and a snare—that was used in the case of a 27-year-old patient with a 9-degree tilted configuration who featured in her NESVS presentation further elucidates where practice currently stands, Kostiuk explained. 

“You have one big wire loop already holding the filter, and one snare device with multiple loops, to try to capture the hook,” she said. “The problem is, if you have a filter with significant lateral tilt, the filter can abut the IVC wall, and it is really impossible to capture the hook using the snare only. Such complex configuration requires the use of a wire loop to reposition the IVC filter and make its hook more accessible to be captured by the snare device. Thus, the use of multiple devices—snares and wire loops—during advanced endovascular retrievals significantly prolongs the total procedure and fluoroscopy time, and is associated with complications.” 

The advantage of the grasper, on the other hand, lies in a novel design consisting of two unique features: the articulating arm with lateral movements that allow the grasper device to be directed to the tilted IVC filter in any configuration; and a pair of grasping jaws that can grasp the filter hook or neck—particularly useful for filters with extreme lateral tilt or hook abutment to the IVC wall, Kostiuk explained. “Even if the hook is embedded in the IVC wall, or if the filter has been there for years and the hook is covered with scar tissue and not available to be captured by a snare and wires, you can still use the grasping jaws to engage the neck of the filter and to capture the filter,” she said. “The hook is not that critical anymore.” 

Kostiuk emphasized the in vivo case featured in the NESVS video: “This procedure took 11 minutes in the pig, while the other procedure that we showed in the patient, using the wire loop and the snare—it took 55 minutes,” she said. “That is five times the amount of time to capture the filter. This also means much more radiation. So, we make it significantly safer for the patient—and faster for the vascular surgeons carrying out these procedures.” 

The Yale researchers are currently carrying out market analysis with a view to advancing development of the grasper device as they look to perform clinical studies to evaluate its safety for use in patients. 

Vascular branding: Determining a vascular surgeon’s value

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Vascular branding: Determining a vascular surgeon’s value
Robert Tahara

A vascular surgeon’s value includes far more than direct revenues from procedures performed, said SVS member Robert Tahara, MD, recently. He told surgeons to remember not only these direct revenues, but also the help a surgeon provides other specialties in the hospital, as well as legal savings from “near misses—rarely considered and certainly rarely acknowledged.” 

The total will add up to considerably more than the direct revenues usually cited, he told attendees at the 2023 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM). His presentation was part of the SVS Community Practice Section’s special educational session, “Recognizing, Enhancing and Promoting the Value of the Vascular Surgeon.” 

The presentation covered a variety of financial topics, including whether to get a master of business administration degree, a surgeon’s ancillary value, incorporating the use of advanced practice providers and more. 

The SVS for many years has sought to determine a vascular surgeon’s true value to his or her institution, Tahara said. An SVS Valuation Work Group produced “The Value of the Modern Vascular Surgeon to the Healthcare System,” report, which includes many of the details he planned to discuss. Tahara recommended surgeons read the report, which was published in February 2021 (visit vascular.org/PowellReport). 

In terms of revenues, “Direct revenue is usually the only number physicians ever talk about,” he said. However, indirect (or enabling) revenue, from helping other specialties, and “near-miss” revenue, also are important. 

The indirect revenue is that derived “from what we enable other non-vascular services to keep in the institution,” which can lead to increases in the case mix index (CMI). A higher CMI value indicates the hospital has treated more complex, resource-intensive cases, and the hospital may be reimbursed at a higher rate for such cases. “The CMI bump in indirect revenue is poorly accounted for and highly variable,” he said. In analyzing his work at his own facility, his work “added $650,000 a year.” 

Tahara also highlighted the “near-miss value, the amount of money that we just saved that hospital by scrubbing in and over-sewing that big rip in the aorta or iliac. I get about one a year,” he said. In one such case, he said, he determined his work saved $300,000 in institutional legal fees, $100,000 in legal fees for him, and $130,000 for the patient. 

With wrongful death settlements averaging $1 million, attorneys estimated that because of this patient’s age, had the “save” not occurred, a settlement in this case would have been $5 million instead. 

“This is not a trivial amount of money and never gets accounted for. Your ‘near-miss value’ is never acknowledged, but the value is substantial,” Tahara said. 

He recommended all surgeons log every near-miss, to assist when building data packages for compensation negotiations. “At least once a year you save one of these patients,” he told attendees. 

CMI and near-miss contributions nearly double a surgeon’s financial value, Tahara said. “Do your homework before negotiating with your hospital about anything,” he told the crowd. 

He summarized a vascular surgeon’s financial value: the direct revenue of $886,000; enabling revenue of $640,000; the CMI bump of $650,000; and the total from saved near-miss cases ($450,000 in legal fees plus approximately $1 million for a wrongful death settlement totaling $1.45 million). This brings a vascular surgeon’s full-time equivalent value to more than $3.62 million. “It adds up to almost double what’s quoted in the literature,” he said. 

“It is critically important that the value that a vascular surgeon brings to an institution or facility is not unrecognized,” said Robert Molnar, MD, chair of the SVS Community Practice Section. “Vascular surgeons are the hub of the wheel, and we provide the essential base needed for any hospital system to offer multispecialty care.” 

Registered VAM attendees can view the section’s session, held from 1:30–3 p.m. EDT on Friday, June 16, at vascular.org/OnlinePlanner23. 

SVS Foundation Board of Directors welcomes two new members to its leadership team

SVS Foundation Board of Directors welcomes two new members to its leadership team
Edith Tzeng and Palma Shaw

The SVS Foundation’s Board of Directors announced the appointment of two new board members, Edith Tzeng, MD, and Palma Shaw, MD, at the board’s fall meeting in September. Tzeng was approved as the new chair of the Foundation Development Committee. 

Tzeng is the University of Pittsburgh Medical Center chair, professor of surgery and chief of vascular surgery at the Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. She brings to the board her dedication to advancing vascular surgery research and education, focusing on the problems of blood vessels healing after injury, bypass or angioplasty, and the translational potential of nitric oxide and carbon monoxide for vascular healing. 

“I am deeply honored to lead the Development Committee. Together with our dedicated team, we will continue to work diligently to support the Foundation’s mission and to further enhance the future of vascular surgery through research, disease prevention, community outreach and inclusivity,” said Tzeng. 

Shaw, recently appointed chair of the Foundation’s Industry Relations Committee, comes to the board following a bylaws change that provides a board seat for that committee chair. She is a professor of surgery at the State University of New York Upstate Medical University program and a member of the division of vascular surgery at Upstate Medical Center in Syracuse, New York. Her clinical expertise includes aortic surgery, peripheral and venous intervention, diabetic foot management and wound care. 

“I am thrilled to join the SVS Foundation board as the chair of the Industry Relations Committee. I look forward to working closely with our industry partners to advance the field of vascular surgery and improve patient care,” said Shaw. 

The Foundation’s board is committed to funding the future of vascular health through its four pillars: research and innovation, community vascular care and patient education, disease prevention, and diversity, equity and inclusion.

Vascular Health Step Challenge emerges as beacon of awareness and action

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Vascular Health Step Challenge emerges as beacon of awareness and action

This September, 533 people put their feet to the ground to raise awareness about peripheral arterial disease (PAD) as part of the SVS Foundation’s Vascular Health Step Challenge. The challenge raises funds and awareness, with participants pledging to walk 60 miles throughout the month, a symbolic journey that mirrors the 60,000 miles of blood vessels in the human body. 

The annual initiative emphasizes the importance of vascular health and promotes healthy vascular habits. Funds raised during the challenge will support the future of vascular surgery and fulfill the Foundation’s mission. 

New this year was the “Pay it Forward” initiative, allowing registrants to cover the $60 sign-up fee for low-income patients, ensuring their participation in the challenge. 

The challenge saw a 77% increase in sponsorship compared to 2022. Sponsors include AOTI, Gore, Medtronic, 3M, the Way to My Heart organization, and the Society for Vascular Nursing (SVN). 

Participants in the Step Challenge have more than just the goal of a healthier vascular system to strive for; prizes await. Those who achieve the 60-mile target will receive a backpack, and those who raise $600 or more will receive a Stanley drink cup. Team members that meet the $6,000 team goal will be able to sport a Step Challenge cap, and the top individual walker and fundraiser each will receive an outdoor blanket. 

By Sept. 19, the campaign had already met its walker goal, at that point with 525 registered participants. In 2022, 457 walkers collectively raised over $80,000. Halfway through this year’s challenge, donations raised were at $60,000, and firmly on track to reach its target.

Visit vascular.org/Step23. 

SVS webinar covers insights learned from experiences of mass-casualty disasters

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SVS webinar covers insights learned from experiences of mass-casualty disasters
an “SVS Presents” webinar in August that focused on disaster preparedness

A mass shooting in Las Vegas. A bombing at the finish line of the Boston Marathon. A shooting at a Fourth of July parade. Healthcare workers may not be on the actual front line of disasters, but they’re definitely in the pipeline for the aftermath, when victims flood hospital emergency and operating rooms. 

The question is, are those doctors, nurses, surgeons—and the institutions—ready? 

Two trauma surgeons relayed their medical centers’ experiences with mass-casualty incidents during an “SVS Presents” webinar in August that focused on disaster preparedness. The webinar looked at mass casualties and how such incidents may affect the vascular surgery community. Moderator April Boyd, MD, PhD, chair of the SVS Education Committee, said SVS members told SVS leadership, in a needs assessment survey, that they want educational programs on leadership, particularly leadership in crisis. 

Susan Briggs, MD, is an acute care and trauma surgeon and director of the International Trauma and Disaster Institute at Massachusetts General Hospital in Boston and discussed the 2013 Boston Marathon bombing. Deborah Kuhls, MD, is a trauma surgeon and medical director of University Medical Center’s Trauma Intensive Care Unit. She relayed the experiences at University Medical Center in Las Vegas following the 2017 shooting during the Route 91 Harvest music festival on the Las Vegas Strip. 

Three people were killed in the bombing and hundreds were injured, including nearly 20 who lost limbs. In the shooting and its aftermath, 60 people died and more than 850 were wounded. 

“Disaster medical care is not the same as conventional medical care,” Briggs said. That’s in terms not only of the severity of the injuries but also how likely a patient is going to survive, as well as the available resources. 

In the acute phase, providers are working on “minimally acceptable, not maximally acceptable, care due to the large number of victims,” she said, adding, “Both are difficult lessons. 

“The key principle in a mass casualty event is that the critical patients with the greatest chance of survival and the least expenditure of time and resources are treated first.” 

Vascular surgeons who partner with other physicians and surgeons frequently are invaluable members of a disaster preparedness team, both doctors said. Vascular trainees would be invaluable as well. 

“They can work with other surgeons of any specialty,” said Kuhls. “They have special skills.” 

Briggs said, “Vascular surgeons are surgeons first. They can help with almost any operation. More and more we’re getting away from titles and functional capabilities and helping each other. We utilized vascular surgeons in almost every case with trauma surgeons.” 

In the 2017 Las Vegas shooting, the shooter fired 1,100 rounds of military-grade ammunition in 13 minutes, toward more than 22,000 people at a multi-day concert on the Las Vegas strip. “We went from zero to 40 patients that were very critical within five minutes. Some had already died,” said Kuhls. 

Because Las Vegas is a tourist destination used to hosting huge events, disaster training in different scenarios, particularly among the trauma centers, occurs at least quarterly, she said. 

The shooting taught hospital leaders that “hospitals themselves need to be prepared, and not just individual healthcare workers,” said Kuhls. The Disaster Management Emergency Preparedness Course focuses on the institution as a whole, including how entire hospitals should go about doing drills and being prepared. 

Both Briggs and Kuhls relayed other lessons learned during the respective events, which are available on the video recording. 

The webinar was a collaborative effort of the SVS Education and Leadership Development committees, plus the Young Surgeons and Women’s sections. It can be viewed at vascular.org/MassCasualtiesWebinar. SVS members may watch at no charge; non-members will pay $35. 

CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

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CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in a July proposed decision memo.

In a communique to its members today, the Society for Vascular Surgery (SVS) said the final decision contained “few substantive changes from what was proposed in July.”

CMS outlined in the decision memo, dated Oct. 11, that it had found “coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary with the placement of a Food and Drug Administration [FDA]-approved carotid stent with an FDA-approved or cleared embolic protection device” for Medicare patients who have symptomatic carotid stenosis ≥50% and asymptomatic carotid stenosis ≥70%.

In the July proposed decision, the federal agency detailed an expansion that would significantly broaden coverage for carotid stenting, expanding Medicare coverage to individuals previously only eligible for coverage in clinical trials, removing the limitation of coverage to only high-surgical-risk individuals, and removing facility standards and approval requirements.

“While this outcome was anticipated, the SVS remains concerned,” the SVS said in its statement to members. “The SVS Executive Board will convene next week to thoroughly discuss and will issue a formal statement soon thereafter.”

Rates of stroke, death and myocardial infarction post-TCAR do not differ by patient sex

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Rates of stroke, death and myocardial infarction post-TCAR do not differ by patient sex
Vikram Kashyap

While sex disparities regarding the outcomes of carotid revascularization have “long been a concern,” new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid artery revascularization (TCAR)—one of the most prominent approaches used to treat carotid artery stenosis.

Writing in JVS on behalf of the ROADSTER trial investigators, Vikram Kashyap (Frederik Meijer Heart and Vascular Institute at Corewell Health, Grand Rapids, Michigan) and colleagues report “exceptionally low” rates of stroke, death and myocardial infarction (MI) derived from prospective TCAR trial data. They further note that these low rates “do not differ by patient sex”.

Previously, several studies of carotid revascularization have demonstrated increased frequencies of postoperative death and stroke for female patients after either carotid endarterectomy (CEA), or transfemoral carotid artery stenting (CAS). In addition, adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases, the authors relay.

In prospectively analyzing results from the ROADSTER 1, ROADSTER 2 and ROADSTER Extended Access TCAR trials, Kashyap and colleagues’ objective was to investigate post-TCAR outcomes stratified by patient sex. They hypothesized that the results would be similar between males and females.

All included patients had verified carotid stenoses meeting the criteria for carotid intervention (≥80% in asymptomatic and ≥50% in symptomatic patients), and were included based on anatomical or clinical high-risk criteria for carotid stenting. The researchers’ primary outcomes were a combination of stroke/death (S/D) and stroke/death/MI (S/D/M) at 30 days, while secondary outcomes were the individual components of stroke, death, and MI.

Kashyap and colleagues included a total of 910 patients for analysis, roughly two thirds of whom were male (n=604; 66.4%). They note that female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%), and were more often of Black/African American ethnicity (7.5% vs 4.3%), as compared with their male counterparts.

“There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria,” the authors disseminate. “General anaesthetic use, stent brands used and procedure times did not differ by sex—although flow reversal times were longer in female patients, [and] more contrast [was] used in procedures for female patients.”

In addition, both the 30-day rates of S/D (2.7% male vs 1.6% female) and S/D/M (3.6% male vs 2.6% female) were similar between the two groups of sex-stratified patients. The researchers also found that these key outcome measures did not differ when patients were stratified by symptom status either. Comparable findings were identified in terms of secondary outcomes—including stroke rates at 30 days—too.

“Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR] 4.19) and S/D/M (OR 2.78), as was symptomatic presentation with increased odds for S/D (OR 2.78),” Kashyap and colleagues aver in conclusion.

SVS varicose vein guideline webinar set for Oct. 10

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SVS varicose vein guideline webinar set for Oct. 10
Painful varicose and spider veins on active womans legs, self-helping herself in overcoming the pain. Vascular disease, varicose veins problems, active life concept
The roundtable will address the latest in the diagnostic evaluation of patients with varicose veins

A virtual roundtable on Oct. 10 will cover the new Society for Vascular Surgery (SVS) varicose veins guidelines. Set for 6–7:30 p.m. CDT, the session will address the latest in the diagnostic evaluation of patients with the venous condition using duplex scanning. 

The assembled faculty will use case vignettes to design treatment strategies and demonstrate how to put the recommendations from the evidence-based clinical practice guidelines into practice. 

Lead author of the guidelines, Peter Gloviczki, MD, will introduce subject matter and provide an overview. 

Other topics and presenters are: diagnostic evaluation of vein incompetence, by Mark H. Meissner, MD; compression therapy for varicose veins, by Andrea T. Obi, MD; drug therapy for varicose veins, by Monika L. Gloviczki, MD; percutaneous endovenous ablations of saphenous veins, by Jose Almeida, MD; thrombotic complications of endovenous ablations, by Peter F. Lawrence, MD; and treatment of superficial thrombophlebitis, by Suman M. Wasan, MD. 

Learn more and sign up at vascular.org/VVpart2Roundtable. 

From the editor: Sex, lies, and carotid stents

From the editor: Sex, lies, and carotid stents
Malachi Sheahan III

First, a disclaimer. This commentary is woefully short of sex-related content. Not even the wholesome gender-based outcomes stuff. So, if that key term brought your internet search here, feel free to press on with your illicit journeys my friend. Now, let’s get to the lies. 

In 2008, Christopher White, MD, then chair of the Department of Cardiology at the Ochsner Clinic Foundation, published an editorial accusing vascular surgeons of various crimes and misdemeanors in the nascent debate over carotid stenting (CAS) vs. endarterectomy (CEA). Eloquently titled “Liar, liar, pants on fire,” the article begins, “At the most recent Society of Vascular Surgery [SVS] meeting, held in a secret location, deep in a mountain bunker, shielded against critical and independent thinking, surgeons regaled themselves with tales of science fiction, disguised as scientific data, and told to make the endovascularly challenged among them feel safe and secure from the ‘bogeyman’ of carotid artery stenting.” Now, before everyone can post their Spidermen-pointing-at-each-other memes, I will acknowledge the inherent hypocrisy in calling out another medical editor for utilizing hyperbole and provocative titles. So let’s get to the substance of his argument. 

The two abstracts that drew White’s ire utilized national databases and showed that CEA demonstrated dramatic benefits over CAS in terms of stroke, mortality and cost. White points out the limitations of the studies, including the lack of independent neurological evaluations to document stroke. He states, “In reporting the superiority of CEA compared to CAS without any qualification, should we give the authors the benefit of the doubt that they are not sophisticated enough to comprehend the inherent ‘bias’ that invalidates their intended comparison, or have we caught them red-handed in an attempt to purposely deceive their audience?” While bemoaning the lack of a limitations section makes me suspect that White does not know how abstracts work, the request for an exam by an independent neurologist seems fair. 

So, surely when he published a study in the same issue of this journal, making the provocative claim that carotid artery stenting is safe in the very elderly (>80 years), he held himself to the same lofty standard? After all, the lead-in phase of CREST had just shown a 12% risk of stroke with CAS in octogenarians. White and colleagues, however, reported only a 1.8% risk of stroke in this same age range, even though half were performed without embolic protection. It seems that independent neurologists don’t grow on trees, though, and White’s group often employed vascular medicine physicians from his institution to perform these evaluations, despite no clear evidence that they are either independent or adequately trained to assess for stroke. So perhaps White’s group did achieve these outlier results, or perhaps, as he stated in his editorial, the underreporting of complications is a dirty little secret that is “very difficult to prove without an independent audit.” 

White also disputes the finding of higher hospital costs associated with CAS. He states that “the biased data reported in this abstract fly in the face of thousands of reported CAS patients with audited independent data who have had short hospital stays and lower or comparable procedure costs.” I wonder then what he thought of the excellent 2011 analysis by W. Charles Sternbergh, MD, which found that CAS was 40% more costly than CEA and did not provide better clinical outcomes or a reduction in length of stay. I am certain White is aware of this study, as the data came from his own institution. 

Over the past 15 years, a plethora of new data has arrived with a series of randomized controlled trials (RCTs). While many used perplexing endpoints (the inclusion of myocardial infarction [MI] seems the logical equivalent of considering ambiance while comparing delivery pizzas), and most were underpowered to detect a statistically significant difference in the risk of stroke, a clear trend emerged. CREST-1 (4.1% vs. 2.3%), ACT-1 (2.8% vs. 1.4%), ICSS (7.7% vs. 4.1%), SAPPHIRE (3.6% vs. 3.1%), SPACE-1 (6.5% vs. 5.1%), EVA-3S (9.2% vs. 3.5%), and ACST-2 (3.6% vs. 2.1%) all demonstrated a persistently increased incidence of 30-day stroke with CAS over CEA. Only CAVATAS was an outlier (7.2% vs. 8.3%), although only 504 patients were randomized. 

I was certain that White and his fellow stent enthusiasts would be happy that these new data have brought some much-needed clarity. Surely we can all agree that a good degree of caution must be employed when performing transfemoral carotid stent procedures, particularly in asymptomatic patients where the treatment efficacy is razor-thin? Well reader, I regret to inform you that I was wrong. Last year, the Centers for Medicare & Medicaid Services (CMS) accepted a formal request from the Multispecialty Carotid Alliance to consider greatly expanding coverage for carotid stent procedures while also removing several safeguards currently in place. Although “The Alliance” may sound like the bad guys from a mid-tier Liam Neeson movie, in reality, they are a collection of neurologists, surgeons and interventionalists, including White, who seemingly formed solely to petition CMS to reconsider percutaneous carotid stent coverage. 

Medicare began coverage for CAS procedures in 2001 for those performed within investigational device exempt (IDE) studies. In 2005, this expanded to high-risk patients who are symptomatic with greater than 70% lesions, which is essentially where it stands now. Currently, outside of clinical trials, no asymptomatic patients are covered. The last CMS coverage reconsideration for CAS occurred in 2009. According to the Alliance, special interest groups intervened and successfully restricted access to CAS. These “special interest groups” were the SVS, the American Association of Neurological Surgeons, and the American Academy of Neurology. 

The Alliance now requests that CMS expand CAS indications to all asymptomatic lesions >70% and all symptomatic lesions >50%. They also request the removal of all facility standards, calling them obsolete. Privileging and credentialing standards, in their plan, will be up to local hospitals. Similarly, all quality assurance would be left to the local peer-review level, eliminating the requirement for participation in a quality registry. Libertarian principles like these are usually better in theory than practice. Allowing folks to police themselves often leads to things like emotional support leopards on domestic flights. Where the evidence does not support expanding CAS indications, the Alliance is quick to find fault. They refer to the stroke/death outcomes in SPACE, EVA-3S, and ICSS as “unacceptable by 2021 standards.” They criticize the inexperience of the CAS operators and the technology and techniques employed at the time. The Alliance would have us believe that EVA-3S was performed in the 1500s by a bunch of French peasants launching stents at unsuspecting patients with trebuchets. 

In critiquing the International Carotid Stenting Study (ICSS), presumably because of its 7.7% CAS stroke rate, the Alliance notes that two operators caused five of the strokes despite enrolling only 11 patients. Even though the operators were suspended, the Alliance points out that the strokes were included in the final analysis. To this, I would reply that these practitioners were only removed because the study was carefully monitoring outcomes. How many more real-world strokes are we going to see if guardrails such as registries are removed, as the Alliance recommends? In their submission to CMS, the Alliance states that there are four modern RCTs comparing CAS to CEA in asymptomatic patients. They opine that all have shown comparable outcomes for periprocedural complications, as well as rates of ipsilateral stroke. In reality, none of the protocols were powered to detect a statistically significant difference in stroke outcomes. 

The Asymptomatic Carotid Trial (ACT-1) randomized 1,453 patients out of an intended 1,658. The study reported a stroke rate of 2.8% in the stent group and 1.4% in CEA group. Stent-Protected Angioplasty vs. Carotid Endarterectomy-2 (SPACE-2) planned to enroll 3,640 patients but only randomized 513. There were three groups: CEA with best medical therapy (BMT), CAS with BMT, and BMT alone. The five-year cumulative incidence of any ischemic or hemorrhagic stroke was 5.3% in the CEA group, 9.8% with CAS, and 6.5% with BMT. The CAS group also demonstrated the highest (4.4%) five-year cumulative ipsilateral ischemic stroke rate (2% CEA, 3.1% BMT). The Asymptomatic Carotid Surgery Trial-2 (ACST- 2) randomized 3,625 patients. The 30-day stroke rates were higher with CAS (3.6% vs. 2.4%, p=0.06) but did not achieve significance. At five years, the composite risk of ipsilateral stroke or death was 5.5% for CAS and 3.6% for CEA. The Stenting vs. Endarterectomy for Treatment of Carotid-Artery Stenosis (CREST) trial randomized 2,502 patients and did find a significantly higher risk of periprocedural stroke with CAS (4.1% vs. 2.3%, p=0.01). Of course, CREST famously used a combined stroke, MI, and death primary endpoint, which did not demonstrate a significant difference between the modalities. So even though all four modern asymptomatic carotid trials showed a higher incidence of stroke with CAS, the Alliance assures us not to worry. Why? Well, we are better now. Smarter. We have a greatly improved understanding of the anatomic and clinical characteristics that increase risk for CAS. In fact, they even provide them. 

So fans of precision medicine take note: Criterion #1— vasculopathy. Vascu-what now? In fact, of the high-risk characteristics provided by the Alliance, the majority are vague definitions like atherosclerotic arch, complex great vessel anatomy and carotid tortuosity. The Alliance correctly touts the importance of patient selection and operator experience in asymptomatic patients, yet they would like to remove all of the guardrails. 

So clearly, to offer safe treatment to patients with asymptomatic carotid disease, the practitioner must be technically experienced as well as a content expert. Where will this expertise be gained? Interest does not translate to competence. Vascular surgeons matriculate into the workforce with documented technical and educational experience in the treatment of carotid disease. For other specialties? Not so much. The words “cerebrovascular” and “carotid” appear a total of zero times in the ACGME Program Requirements for Graduate Medical Education in Interventional Cardiology. If CMS follows the recommendations of the Alliance, only one thing is certain. More transfemoral stents will be placed in asymptomatic carotid lesions in Medicare patients by interventionalists under less regulation. The Alliance states that this is in the best interests of patient care. Who is lying now? 

Malachi Sheahan III, MD, is the chief medical editor of Vascular Specialist. His opinions do not reflect SVS policy or positions.

Enrollment of first patient in Neuroguard carotid stent system trial announced

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Enrollment of first patient in Neuroguard carotid stent system trial announced
Sean Lyden, co-national principal investigator of the PERFORMANCE III trial

Contego Medical has announced enrollment of the first patient in the prospective, multicenter PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access.

The study is a follow-on to the fully enrolled PERFORMANCE II study of the Neuroguard IEP system, which was conducted to evaluate the stent placed via percutaneous transfemoral or transradial access. Both PERFORMANCE II and PERFORMANCE III are being conducted under an investigational device exemption (IDE) through the Food and Drug Administration (FDA).

“We look forward to studying the Neuroguard IEP direct system and determining its potential as a new option for patients with carotid artery stenosis,” said Sean Lyden, MD, chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio, co-national principal investigator of the PERFORMANCE III trial.

According to a company press release, the Neuroguard IEP and Neuroguard IEP direct systems leverage Contego’s IEP technology, a “unique” platform with a microfilter integrated on the delivery catheter, designed to provide added safety where it matters most—during stent placement and balloon dilation. The microfilter captures the micro-emboli that other protection mechanisms do not, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients, the release adds.

The Neuroguard IEP direct system also includes a novel, single-access point blood flow reversal system specifically designed for direct transcarotid access. The system is a three-in-one catheter with the stent, balloon and microfilter all in one device, minimizing catheter exchanges and improving treatment efficiency. In addition, Neuroguard utilizes FlexRing stent technology, which Contego says provides the best properties of both open- and closed-cell stents while leveraging the proven, long-term material performance of nitinol.

Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

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Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

Roger Malcolm Greenhalgh, MD, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on Oct. 6. He was 82. At the time of his death, he was emeritus professor of surgery at Imperial College in London and head of its Vascular Surgery Research Group.  

Professor Greenhalgh, born in Derbyshire, was not from a medical background. His parents were very entrepreneurial in their different ways, and his grandfather, Fred Poynton, broke the world record in road walking over 20 miles in 1924. He went to Ilkeston Grammar School, a state school with entry by scholarship only. There he followed the advice of his headmaster, John Hewitson, that he should consider medicine as a career. He was the first in his family to attend university. Within a term of arriving at Clare College, Cambridge, his medical tutor, Dr. Gordon Wright, predicted that Roger would be a surgeon. At St. Thomas’s Hospital in London, he qualified as a doctor and was allowed to move up the surgical ladder with a rotation to learn research methods at the Hammersmith Hospital after his surgical training at St. Thomas’s. During this time, he discovered a love of vascular surgery. The pioneer vascular surgeon, Peter Martin, inspired him by saying that he would go on to solve problems that he could not. Whilst in training, in 1974, he won the prestigious Moynihan Fellowship of the Association of Surgeons of Great Britain & Ireland. The £1,000 stipend enabled him to visit many worldwide vascular centers of excellence using the connections of his mentors, including Martin, Frank Cockett and Professor Gerry Taylor.  

Roger joined the surgical consultant staff as senior lecturer at Charing Cross Hospital in 1976, less than 10 years after being a medical student. His career did not follow a conventional path by moving from the St. Thomas’s system to St. Barts and, finally, to Charing Cross. He went on to become professor of surgery, head of the university department and dean of the Charing Cross & Westminster Medical School for four years, between 1993 and 1997, during which time he oversaw a merger with Imperial College London. His junior at St. Bart’s and then secretary of the Vascular Society of Great Britain and Ireland (VSGBI), Professor Bruce Campbell, said to Professor Greenhalgh, who was the millennium president of the Vascular Society from 1999–2000: “You always do your own thing, you know you do.” 

Michael DeBakey (far left), Karin Greenhalgh and Roger Greenhalgh in 1989

Professor Greenhalgh’s long and distinguished research career started with an interest in hyperlipidemia when he was a resident, during which he attempted to elucidate the role played by serum lipids and lipoproteins in arterial disease as lead author of a 1971 paper published in The Lancet. His research, with more than 300 original published papers, spanned all areas of vascular surgery: venous, carotid, peripheral and aortic. His most significant contributions came from his early adoption of the rigor of prospective randomized trials to address the gray areas in vascular disease management. He led more than a dozen trials in the field of aneurysm management to promote level-one evidence in clinical practice, including the UK Small Aneurysms Trial (UKSAT) and the UK endovascular aneurysm repair (EVAR 1 and 2) trials. UKSAT was the first trial to show that there was no long-term survival benefit of early elective open repair of small abdominal aortic aneurysms. The 15-year follow up of the EVAR 1 and 2 trials were published in The Lancet in 2016 showing EVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. Professor Greenhalgh was also the principal investigator of the mild to moderate intermittent claudication (MIMIC) trials, which finally proved the adjuvant benefit of angioplasty over supervised exercise and best medical therapy in patients with stable mild and moderate intermittent claudication.   

Inspired by the impact of these many landmark trials, Andrew W. Bradbury, the Sampson Gamgee Professor of Vascular Surgery at University of Birmingham, England, and principal investigator of the randomized controlled BASIL trials, wrote to Professor Greenhalgh: “Your achievements are greater than anyone alive or dead.” Professor Bradbury recently presented first-time results from the BASIL-2 trial at the 2023 Charing Cross (CX) International Symposium during a session chaired by Professor Greenhalgh. 

Professor Greenhalgh founded the Charing Cross series of international symposia and annual books in 1978 when he was 37 years of age. This started as a small, focused symposium, with topics such as smoking and arterial disease, held at the Charing Cross Hospital. The earliest symposia had just 100–200 delegates but were always accompanied by a book covering the main presentations and discussions. The CX Symposium has grown exponentially and has been forced to move to much bigger venues to cope with the increasing popularity of the meeting, which peaked at over 4,000 in-person attendees in the years immediately before the COVID-19 pandemic. Pioneers such as Michael DeBakey, Denton Cooley, Jesse Thompson, John Mannick, John Bergan, Jimmy Yao, Ted Diethrich, Juan Parodi and Frank Veith have all graced the podium. Tom Fogarty spoke of his catheter and Andreas Grüntzig spoke of his angioplasty in the 1980s. Julio Palmaz gave news of EVAR at CX 1990. CX continues to provide top-class vascular education and critical discussion of cutting-edge developments in the management of vascular disease. Professor Greenhalgh presided over the 45th symposium earlier this year. Many speakers feared his acerbic wit and the tolling of the bell if they strayed overtime.  

Princess Anne attends the CX Symposium in 1982

Professor Greenhalgh, who was quick to embrace digital methods of transmission, recently spoke from the state-of-the-art CX Vascular studio in London to detail the global interest in the Charing Cross brand of education. In 2023, the symposium saw registrations from 2,500 in-person attendees and an additional 7,000 people participated digitally, tuning in mainly from China. He was always in his element at the CX podium, his secret passion for the theatre on full display, enjoying the cut and thrust of discussing the current, hot-button issues in the vascular field with global experts. Age did not wither nor custom stale his delight in unpicking an argument to get to the core of the matter, always endeavoring to outline the research and education required to drive the topic forward. In the days before his passing, Professor Greenhalgh’s passion for the quality of the CX Symposium program burned brightly right to the very end as he worked on the CX 2024 version in the Hammersmith Hospital’s De Wardener ward intensive care unit.  

Professor Greenhalgh played a pivotal role in the creation of the European Society for Vascular Surgery (ESVS) and the establishment of its journal. The ESVS was launched at CX in 1987 and Professor Greenhalgh wrote the constitution. He was founder and chairman of the editorial board for the European Journal of Vascular and Endovascular Surgery (EJVES) from 1987–2003. He became the first ESVS European honorary member because of his role in the ESVS foundation. He also played a major role in the development of surgical training and standards across Europe through his role as president of the European Board of Surgery for the European Union of Medical Specialists (Union Européenne des Médecins Spécialistes—UEMS) from 1998–2002 and the European Board of Vascular Surgery (2002–2006). The European Board of Vascular Surgery honored Professor Greenhalgh as Honorary Life President in recognition of his founding role. 

His brilliant surgical skills were recognized by innumerable international surgical societies as well as the White House Medical Unit for the support he provided during the visit of President George H. W. Bush to London in 1991. More recently, Professor Greenhalgh became a company director, founding BIBA Medical with his son, Stephen, in 1994. Professor Greenhalgh was editor-in-chief of the company’s foremost medical publication, Vascular News, from its inception in 1999–2023, overseeing a total of 100 editions of the newspaper in this time. He captured his experiences in the roles of surgeon, professor and company director in his 2011 autobiography, Born to be a Surgeon. 

Roger Greenhalgh receiving the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in 2018 from Enrico Ascher

Professor Greenhalgh received recognition for his lifelong contributions to vascular surgery from multiple prestigious groups, including most recently, an honorary Fellowship of the American College of Surgeons in October 2018 and the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in June 2018 after being nominated by the ESVS. Enrico Ascher, of New York University in New York City, who presented the award and is a past president of the SVS, said of Professor Greenhalgh at the time: “He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person. As a person who is totally committed to his profession, to his family, to his friends, to his peers. He thinks first about them, and not about himself. That is what makes him a moral leader, and what sets him apart.” 

Writing in EJVES following Professor Greenhalgh’s receipt of this award, his long-time research partner, Professor Janet Powell, of Imperial College in London, England, described him as a “brilliant” clinician with a “long and distinguished” research career, as well as highlighting his prowess as an educator and mentor, noting that “medical students and junior doctors have queued for the opportunity to work in his team.” She also hailed him as a “legendary figure” whose wit, humor and charm “have made him many friends across the world.” 

Professor Greenhalgh had many sporting skills and interests. He rowed in international regattas with future Olympian, Peter Thomas, at stroke whilst he was captain of boats as a medical student at St. Thomas’s Medical School. He remained a strong supporter of the Imperial College Boat Club and even had a boat named after him. His love of skiing saw him create the Association of International Vascular Surgeons (AIVS), which was used to forge international professional friendships and the AIVS continues to this day under the chairmanship of Mark A. Adelman. He was supported throughout by his Austrian wife, Karin, whose ability to speak multiple European languages and communicate with people from all cultures, proved invaluable.  

Roger Greenhalgh was married to Karin Maria (née Gross), who died in April 2020 from COVID-19. They were happily married for over 55 years and her constant support was integral to his success. He was at his most relaxed amongst his family. He is survived by his two children, Stephen (Lord Greenhalgh) and Christina, and three grandchildren Sebastian, Francesca and Marcus, of whom he was immensely proud. 

The Professor Roger M. Greenhalgh book of condolence can be found here: https://www.memorialstory.com/memorials/8cb0e8f5-acc6-49b4-8ffa-ebe3047d2cba/roger-malcolm-greenhalgh. Please post your messages, stories and photos to commemorate his life and legacy.

Behind the procedure: Removing in-stent thrombosis with the RevCore Thrombectomy Catheter

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Behind the procedure: Removing in-stent thrombosis with the RevCore Thrombectomy Catheter
Rishi Roy

This advertorial is sponsored by Inari Medical.

For patients with in-stent thrombosis (IST), one of the most critical unmet needs has been an effective method to remove acute-to-chronic material. Here, Rishi Roy, MD, a vascular surgeon at Advanced Vascular & Vein Associates in Flowood, Mississippi, discusses his experience with the first mechanical thrombectomy device to be able to do so—the RevCore thrombectomy system.

RevCore is a minimally invasive, over-the-wire device indicated to treat thromboemboli in the peripheral vasculature, including venous stents. It includes a catheter with an expandable element for venous stent treatment. It also has a reinforced catheter shaft for precise movements and a diameter-control knob for adjusting the element to treat vessels 6mm-plus and venous stents from 10–20mm. 

Prior to RevCore, how did you treat in-stent thrombosis? 

Previously I would take a multimodal approach using suction thrombectomy, along with balloon venoplasty, or even a non-compliant balloon. The goal was to get some lumen gain, to restore some outflow to decompress the limb. 

How does this new device work? 

RevCore makes it possible to extract thrombotic material from an occluded stent. The diameter of the coring element can be increased or decreased manually to accommodate the size of the vessel . You engage or disengage with the stent, as needed, and you can be more aggressive as you work through the material that caused the occlusion. 

How do you size the catheter and capture liberated clot? 

When sizing the element in the stent, low and slow is key. There is a tactile feel to the device when “revving,” and it’s important to note resistance level. Some resistance is good—too much means the element is likely oversized and should be decreased by turning the external diameter-control knob to the minus sign on the handle. An important consideration for these cases is to have another device placed in the inferior vena cava (IVC) to capture the cleared material. 

When do you know that RevCore worked? 

Immediately postprocedure, I can gauge whether the device worked when I visualize blood flow on imaging. Because the device is new, I have an intensive follow-up protocol and, working with a wound care group, even closer follow-up is possible. I generally see the patient back in four weeks. After that, we see them at three and six months, and then every six months. If over a two-year period we don’t see recurrent stenosis, and the patient is comfortable, we could get it down to once a year. 

What anticoagulation regimen do you give these patients? 

I send them out on either a novel oral anticoagulant (NOAC) or Coumadin. You know, people often ask me, “Which do you prefer?” My honest answer is I prefer whatever the patient can afford. Because if they can’t afford a NOAC, then they’re not going to take it, and we’re back at square one. 

How do you think RevCore will change the treatment pathway? 

RevCore allows us to consider intervention sooner for patients who are suffering from symptoms related to IST. Some had stents placed when they were in their 20s or 30s, and when these stents are put in, they’re in forever. Now it’s decades later, and they have recurrent IST with chronic material that requires reintervention every three-six-eight months for symptom relief. Now, if we can debulk and get back to the original stent diameter, that patient will require close follow-up every six months or so, but they may be able to go for a couple of years between interventions. Fewer interventions also means decreased anesthesia time, operative time, chance of adverse events and morbidity. If we can decrease the number of cases because we’re able to remove IST in a single procedure, that’s a game changer. 

Case report: Complete thrombus extraction after severe right EIV stent stenosis 

Patient history 

A man in his mid-50s presented with ulceration and swelling in his right foot with the intention to transfer care. Several months prior, a right external iliac vein (EIV) to right common femoral vein (CFV) stent had been placed. A venous duplex ultrasound study showed proximal stent occlusion and non-occlusive venous thrombosis in the left proximal femoral, popliteal, posterior tibial, and gastrocnemius vessels, as well as thrombosed varicosities. Right lower extremity venography and intravascular ultrasound (IVUS) performed two-and-a-half weeks later confirmed 65% stenosis of the left EIV stent (image A). An in-hospital mechanical thrombectomy and balloon angioplasty procedure was planned. 

Procedural overview 

The patient was positioned supine and ultrasound guidance was used to access the right CFV. A J-wire was advanced into the IVC. An 8F sheath was placed and a venogram showed stenosis within the right EIV stent (B). Similarly, access was gained to the left CFV, and a J-wire was advanced into the IVC. An 11F sheath was placed and a venogram confirmed there was no stenosis in the selected segments. 

A FlowTriever catheter (Inari Medical) was advanced over a stiff wire to the infrarenal segment of the IVC, and two of the catheter’s XL disks were deployed. From the right side, a stiff wire was advanced to the IVC via a Bern catheter (Boston Scientific), followed by an Amplatz wire. The catheter was removed, and then a 16F sheath was placed. 

IVUS was performed in the IVC, revealing that the stent extended into the very distal IVC; no stenosis was seen. IVUS of the right common iliac vein (CIV) showed overlapping stents but no stenosis. A venous ultrasound probe inserted to the level of the right EIV showed 50–60% stenosis. IV heparin was administered. 

The RevCore catheter was advanced over the Amplatz wire to the right EIV, and the coring element was deployed within the stent in an unexpanded state. The coring element was then slowly enlarged and rotated, loosening the material within the stent. RevCore was then withdrawn and cleaned. A Triever16 Curve catheter (Inari Medical) was advanced and suction thrombectomy performed, removing a combination of subacute and chronic thrombotic material (C). Balloon venoplasty of the stented portion of the right CFV, EIV and CIV was performed with an 18mm noncompliant balloon. 

Additional passes with the Triever16 Curve catheter were conducted along the right iliac segments and within the IVC, removing thrombotic material that had been captured by the FlowTriever XL disks. Thrombus capture with either FlowTriever XL disks or the Protrieve sheath is critical to the RevCore procedure. Blood was returned to the patient using FlowSaver. 

A final IVUS showed nearly 100% lumen gain, restoring the right EIV to CFV in-stent diameter to 16.4 mm (D). A final venogram demonstrated appropriate flow through the right CFV, EIV, CIV and IVC, and resolution of the stenosis within the right EIV (E). The FlowTriever disks and all other devices were removed, and manual pressure was held. 

Total procedure time: 40 minutes. Estimated blood loss: <50mL. The patient tolerated the procedure well. He was discharged on dabigatran the following day. At four-week follow-up, stent patency was maintained per venous duplex ultrasound, and the patient’s right lower extremity pain and edema had improved. Progress was also seen in a previously non-healing ulceration of the right foot. 

He will continue wound care and daily medication and return every six months for repeat imaging. 

Conclusion 

Use of the novel RevCore system (F) allowed for thorough extraction of in-stent thrombosis and complete lumen restoration post-thrombectomy, with sustained patency and symptom relief at follow-up. The results show promise for improving quality of life in patients who had exhausted their treatment options previously. 

Vascular Specialist–October 2023

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Vascular Specialist–October 2023

In this issue:

  • Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise
  • Eastern Vascular: New data chart underrepresentation of women at the head of national clinical trials
  • Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders
  • From the Editor: Malachi Sheahan III, MD, on sex, lies and carotid stents 

 

EVS 2023: New data chart underrepresentation of women at the head of national clinical trials

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EVS 2023: New data chart underrepresentation of women at the head of national clinical trials
Valentyna Kostiuk

The underrepresentation of women vascular surgeons in national clinical trial leadership formed the central theme of data coming out of a new study that probed all clinical trials in five main areas of vascular disease between 1997 and 2003. 

Delivered before the 2023 Eastern Vascular Society (EVS) annual meeting in Washington, D.C. (Sept. 7–9), investigators revealed that female vascular surgeons constituted 10.3% of all investigators leading clinical trials, with solo female principal investigators (PIs) making up just 9%. Additionally, only 5% of women vascular surgeons were solo PIs on industry-sponsored trials, and women were also less likely to lead interventional compared to non-interventional treatment trials, EVS 2023 heard. 

The data were presented by Valentyna Kostiuk, a medical student from Yale School of Medicine in New Haven, Connecticut, who opened her talk with a baseline remark: “Female vascular surgeons constitute about 15% of the workforce, but remain underrepresented in vascular societies and NIH [National Institutes of Health] funding. Additionally, female patients are more likely to be enrolled in clinical trials if they are led by female investigators.” 

To evaluate representation, the Yale study group looked at all national PIs, their specialties and their presenting gender. When comparing vascular surgeon PIs to non-vascular surgeon PIs, female investigators constituted 10.3% in the vascular surgeon group compared to 19.9% of investigators in the non-vascular surgical group, Kostiuk said. 

They looked at 114 clinical trials focusing on abdominal aortic aneurysms (AAA), analyzing 101: these were led by 125 vascular surgeons, of which 8.8% were women. Similarly, 138 carotid disease trials were identified, with 122 analyzed. This revealed that 38 were led by vascular surgeons, with 13.2% of them women. Another 100 hemodialysis access trials yielded 86 for analysis. These were led by 52 vascular surgeons (9.6% women). In the venous space, 26 thrombectomy and stenting trials showed 30 vascular surgeon as PIs, with 15.4% of them women. Finally, 536 peripheral arterial disease (PAD) trials yielded 432 for analysis, with 169 headed up by vascular surgeons (10.7% women). 

“Overall, out of all the investigators, for five major vascular conditions, 10% of them were female investigators,” explained Kostiuk. “On subgroup analysis, we looked at clinical trials led by solo PIs, and 9% of these PIs were women. Additionally, women were less likely to lead clinical trials investigating interventions compared to non-interventional treatments. For industry funding, we identified 11% of investigators as women for non-industry sponsored clinical trials as compared to 8% for industry sponsored trials. Out of this 8%, 5% were solo female investigators.” 

Kostiuk concluded by pointing toward the 10.3% figure, which constituted the representation of women vascular surgeons in national clinical trial leadership. “This study identifies a specific issue with diversity and inclusion in our specialty,” she said. “It represents an opportunity for growth and improvement, and also encourages vascular societies and industry sponsors to define pathways for women to lead clinical trials.” 

In response to a query from the EVS audience, Kostiuk said the Yale research team will now look to break down whether the numbers are improving over time or remain stagnant. “The numbers are low and could be improved.” 

Last month, Vascular Specialist reported on the issues surrounding gender representation at the head of clinical trials and female patient enrollment. One of the starkest portraits of the scene was painted by leading vascular surgical voice Melina R. Kibbe, MD, in an interview. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” stated the dean at the University of Virginia School of Medicine in Charlottesville, Virginia, as she reflected on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. 

George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies

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George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies
George S. Lavenson Jr.

George S. Lavenson Jr., lovingly referred to as “Doc” by his many friends, died Saturday, Aug. 19, 2023, on the beautiful island of Maui, Hawaii, where he chose to share a life in majestic Lahaina with his loving wife, Judy. He was 91. George leaves behind four children, Mark, Jim, Patricia and Dean, and three grandchildren, Kelsey, Luke, and Oliver. 

As a vascular and general surgeon, George worked tirelessly up until his last days educating and advocating for screening seniors for stroke prevention. When not at his desk researching and writing, George enjoyed reading, cooking, photography, jazz, flying, surfing, cycling, and driving his bright candy-apple red Miata, or cruising on his yellow Harley Davidson motorcycle around the island. 

Born in Tacoma, Washington, on Jan. 29, 1932, George graduated from the University of Washington in 1954, and the University of Washington School of Medicine in 1957. He completed his residency in general surgery at Tripler Army Medical Center in Honolulu in 1965. George went on to complete a vascular surgery fellowship at Walter Reed Army Medical Center in 1968 under the mentorship of Col. (retired) Norman Rich. 

George served as a surgeon in the Vietnam War with the 24th Evacuation Hospital in Long Binh in 1968 and 1969, and was one of the pioneers of Doppler ultrasound to assess blood flow and viability in injured extremities on the battlefield. As an active-duty Army surgeon at the time, stationed at William Beaumont Army Medical Center in El Paso, Texas, George presented this first-of-its-kind experience as a study and manuscript from the podium at the International Society of Cardiovascular Surgery (ISCVS) in Philadelphia in June 1971. The paper was accepted two weeks later and published in Archives of Surgery (now JAMA Surgery) later that fall. Traveling to Philadelphia as an Army officer in 1971 and presenting this paper in uniform amidst the intense anti-war sentiments of the country at the time was undoubtedly an act of courage itself, not to mention the groundbreaking clinical results from their downrange experience using Doppler ultrasound. 

Later in life, George returned to active duty during the Persian Gulf War with the 44th Evacuation Hospital in Saudi Arabia. Despite his civilian practice and then distance traveled when he lived in Lahaina, George had an unwavering commitment to military surgeons and trainees. 

He showed up. George rarely missed the annual December meeting of the Military Vascular Surgery Society in Bethesda, Maryland. He made in-person visits to Walter Reed and the Uniformed Services University to see faculty, residents, and students. And, since Frank Veith, MD, started them at the VEITHsymposium in 2005 or 2006, George never missed sessions that are a tribute to military surgery. 

For a decade-plus, as military surgeons were enduring deployments and caring for the injured during the Iraq and Afghanistan wars, George was present to discuss cases, provide his perspectives and, most importantly, his encouragement. Nothing epitomized George’s commitment to military surgery more than his volunteering to participate in the Society for Vascular Surgery Senior Visiting Surgeon Program, which included him spending time at Landstuhl Regional Medical Center in Germany during the height of the wars. After 20 years of service as an Army officer, George never abandoned the needs of military personnel, volunteering his trauma surgical and critical care skills at various times and in various locations. 

Most recently, during the COVID-19 pandemic, George volunteered to participate in the Department of Defense’s global pandemic response teleconferences. George joined remotely during the spring of 2020 from his home in Lahaina, astutely pointing out the similarities between COVID-related pulmonary dysfunction and lessons he and his generation had learned from managing Da Nang lung in the combat-injured in Vietnam five decades earlier. George was enthusiastic in conveying his wartime critical care experience, and his perspective as to how today’s Military Health System might optimize management of pulmonary failure amidst the pandemic. 

In addition to his years of military service, George had a busy clinical practice in Visalia, California, for 30 years, serving as chair of the Department of Surgery from 1978–1983. 

Amongst George’s proudest achievements in civilian medicine was development of a cost-effective stroke prevention screening protocol involving the “LAV Scan” after his own name. George’s innovation and lifelong advocacy for stroke prevention was recognized and honored by the Western Vascular Society as recently as last year. On his deathbed on Aug. 17, George wrote his final statement: 

  1. Carotid artery disease is the leading immediate cause of strokes. 
  2. Some 80% of cases in carotid artery disease are asymptomatic prior to the stroke that it causes. 
  3. The only possible means of reducing strokes in a large epidemiology scale is to find asymptomatic carotid disease so that a stroke can be managed preventively by screening senior populations for asymptomatic carotid disease. 
  4. Controls for proper application can be applied. 
  5. How to screen seniors: The only way to find carotid artery disease is to screen seniors, which can be done with a LAV Scan. 

George’s presence was a constant for decades and he will be greatly missed. But rest assured George’s legacy lives. Rest in peace George. Mahalo. 

Online condolences: www.NormansMortuary.com. Donations in George’s honor can be made to The Red Cross Maui Disaster Relief Fund. 

MVSS 2023: Human Acellular Vessel proves ‘safe, effective bypass conduit’ in complex CLTI cohort

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MVSS 2023: Human Acellular Vessel proves ‘safe, effective bypass conduit’ in complex CLTI cohort
Sebastian Cifuentes reports results from a recent study of the Human Acellular Vessel in a cohort of CLTI patients

An investigator-sponsored clinical study conducted at the Mayo Clinic in Rochester, Minnesota, of the investigational Human Acellular Vessel (HAV) in patients with chronic limb-threatening ischemia (CLTI) was presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting in Minneapolis, Minnesota (Sept. 7–9). 

Delivered by Sebastian Cifuentes, MD, from the Department of Vascular and Endovascular Surgery at the Mayo Clinic, the researchers concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. 

The presentation reported the outcomes of 29 patients—with a mean age of 71 who had no available vein to use as a bypass graft—who underwent HAV implantation. Of these patients, 97% had previously experienced unsuccessful revascularization procedures on the extremity and 21 (72%) had tissue loss or gangrene. Based on the state of this disease, this patient group had a 30–50% one-year risk of amputation. Notably, surgery in 22 (76%) patients necessitated a tibial artery target, a surgical procedure involving the fusion of two 42 cm long HAVs to achieve the required bypass length. The Mayo team, led by Todd Rasmussen, MD, reported that the operations to implant the HAV achieved a 100% technical success rate, without any HAV-related major adverse events reported. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 72%. The limb salvage rate was 86%, corresponding to only a 14% amputation rate. 

“In a complex cohort of patients with CLTI and no autologous options, the HAV is a safe and effective arterial bypass conduit,” Cifuentes reported at MVSS 2023. “This experience using the Food and Drug Administration (FDA) Expanded Access Program provides real-world data that can inform regulatory deliberations and future trials of the HAV. Further studies will evaluate the HAV as a first-line bypass conduit to define patency and limb-salvage potential in less severe cases of CLTI.” 

The HAV, a bioengineered tissue, is under investigation as an infection-resistant alternative for revascularization. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to reduce discomfort and complications for patients. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and PAD, Humacyte, the company behind the product, reports. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. 

Meanwhile, Humacyte also recently announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. A company press release reported that the single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the FDA during the fourth quarter of 2023. 

The V005 trial was a single-arm study conducted in the U.S. and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. 

MVSS president outlines why vascular surgery is special and how ‘people need to know what we do’

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MVSS president outlines why vascular surgery is special and how ‘people need to know what we do’
Jeffrey Jim at MVSS 2023

Outgoing Midwestern Vascular Surgical Society (MVSS) President Jeffrey Jim, MD, used his recent presidential address to call upon vascular surgeons to spread the word far and wide—from Main Street to hospital C-suites—of what marks out vascular surgery as the truly “special” specialty. 

Jim struck on familiar themes during the talk at the 2023 MVSS annual meeting in Minneapolis, Minnesota (Sept. 7–9): the uniqueness of vascular surgery as a comprehensive provider of vascular care; the roots of the “vascular firefighter” analogy; and the value of the specialty to a hospital system. He prefaced with a slight apologia that the content of his talk might lean pollyannaish, but his core purpose was unwavering: that “vascular surgery is the best”—and here is why… 

What do patients do when they need medical help? “Call a medical doctor,” Jim expanded. “When a medical doctor needs help, who do they call? They call a surgeon. When a surgeon needs help, who do they call? A vascular surgeon.” He delved into the necessity of vascular surgical presence in the context of case mix indexes so complicated, they cannot function without vascular being called in. Vascular surgery is the best, Jim told his audience—“and how can we keep it that way?” 

So how should vascular surgeons go about doing so? 

“We know [all this],” Jim continued, “but we need to spread the word. For the longest time we have been hiding out—walking in, walking out. We need to own vascular disease in the community.” 

If that means heading out into the community to give a rudimentary talk about what vascular disease is, “you need to do it,” he implored. If the setting is a dinner with other healthcare providers, ditto, Jim said. “We need to let them know. We are the ones with the complete toolbox. We need to collaborate and explain what we do and how we can help them.” 

Top of mind, too, should be letting leadership figures and hospital administrators in on the vascular story, “because I think we are very undervalued,” he commented. “People barely know what we do.” 

It can play out along tired conversation lines, Jim outlined: “Are you in the cath lab? Are you doing open? Are you doing endo? 

“We are much more than that,” he emphasized. “We are there to make sure we promote a safe environment, and we let them go ahead and do other service lines. We let them do other cases that otherwise they are not going to be able to do, because we are there to back them up. You need to take ownership and make sure people in your hospital system know that.” 

Vascular surgeons also need to become the leaders of quality in vascular care, Jim said. “We may be small in number, but we are really knowledgeable. We happen to have very diverse experience of what we do. We need to look at patient outcomes and experience.” 

Cost-effectiveness, too, requires vascular leadership, he pointed out—and independent of specialty. “We can’t just sit there and have arguments with people that we are better because we are vascular surgeons, or you’re not as good because you’re not. We need to talk about who is actually giving better cost-effective care.” 

Jim also called out the special nature of vascular surgery in terms of how it plows an innovation trail. In that particular vein, he highlighted the Midwest region of the U.S. as particularly fertile ground. 

“I think there is something unique about the healthcare system in the Midwest,” he said. “We have gigantic hospitals. Not that they don’t have big hospitals at UCLA, Stanford, LSU, but we have really big hospitals everywhere. We take care of a lot of surrounding areas, rural areas, and, because of that, I think we have the ability to get high, significant clinical volumes that you might not always get in the big populated city.” 

Ergo, the opportunities to advance vascular care by innovation abound. 

In his own case, Jim has become known for his special interest in carotid disease and his work with Silk Road to train vascular surgeons in the use of transcarotid revascularization (TCAR). “One of the things I am really proud of is when I go teach the course, I don’t care whether you do the procedure,” he said. “But if you are, I want to make sure you do it right— that’s what vascular surgeons do.” 

Expiation, Karl Wallenda, Oppenheimer and us

Expiation, Karl Wallenda, Oppenheimer and us
Arthur E. Palamara

On March 22, 1978, Karl Wallenda went up on a high wire in Puerto Rico strung between two high-rise buildings. There was no safety net. The winds were blowing hard. A crowd was massed below, awaiting the event. As a seasoned circus performer, he knew that a star never disappoints the crowd. Even at the risk of his own death. He was the founder of the world-renowned family circus troupe called The Great Wallendas, famous for performing daredevil acts without a safety net. 

In 1962, The Great Wallendas began forming their “human pyramid,” a stunt they had been performing for many years. As they made their way to the wire, the pyramid collapsed. Two family members were killed and one was paralyzed. Karl, the patriarch of the family, managed to catch one performer with his legs, saving his life. Karl ultimately fell, broke his ribs, but miraculously survived. Although he continued to perform, the memory of that tragic day haunted him incessantly. 

On that day in 1978, standing ringside at Madison Square Garden, I was watching Tito Gaona, renowned aerialist for the Barnum and Bailey Circus, attempt his quadruple somersault. He was a master in his own right, performing the triple somersault so effortlessly that it became boring. He came out of the rotation easily, but his catcher, his cousin Laio Murillo, could not hold on, and Tito fell to the net. As show time approached, they tried four times and gave up. 

Tito and his cousin went to their dressing room to change into their costumes. The ringmaster could be heard in the background starting the show. “Ladies and Gentlemen, and children of all ages…” bellowed in the distance. The show had begun. Tito and his cousin came into the doctor’s office, a few paces from the Madison Square Garden arena, waiting for their event. The office was a hangout for entertainers, security guards, executives and whoever passed by to chew the fat, and often to receive a vitamin B shot, which they thought was universally curative. A cheap black-and-white television, perched on the desk, droned mindless blather. As Tito and his cousin entered, programming was interrupted to announce a tragedy that had just occurred in Puerto Rico: the great Karl Wallenda had fallen to his death. 

We stood there in stunned silence. The reporter described the scene and attempted to attribute cause. “Karl should have never been up there in the first place; the wire had not been set properly; the winds were too high; he was too old.” He was a great performer for the ages, he continued. 

After several minutes of reflection, Tito broke the silence remarking: “Karl has finally paid for his sin.” It was a statement that seemed incongruous with those offered by the television reporter a few moments earlier. The group standing around the TV performed similar tricks and risked their lives nightly. Clearly their protective confidence had been penetrated by Karl’s death. 

Afraid to break reverence of the moment, I mindlessly blurted, “What sin?” 

Tito replied, “Karl never dropped his pole. Doing so, he may have killed spectators below. But, had he done that, he could have pulled himself back onto the wire and saved himself. He knew it was time to pay for his sin”: the human pyramid that had killed members of his family, for which he had never forgiven himself. 

Self-reproach takes many forms. 

Oppenheimer—both the film and the individual—is a complex depiction of existential choices faced by imperfect men at critical junctures in human history. “Oppie,” as he was called by his friends, was a Jewish scientist and an expert in quantum physics, tasked with the responsibility of creating the atom bomb. He was selected because of his intense desire to avenge the death of Jews in the Nazi concentration camps. J. Robert Oppenheimer was offered the responsibility of creating a weapon so powerful it would redefine warfare. It would also instill existential fear. Like Prometheus, who brought both salvation and fiery destruction to humanity, this weapon would bring hope for ending the war in Japan—but bore the potential of causing cataclysmic destruction to end humanity. 

“Could this bomb vaporize the atmosphere?” Oppenheimer was asked. 

“We don’t know, but almost zero probability,” was his reply. Almost zero? Is that the best we can do? 

Back then, as Oppenheimer discovers the purpose of the project is to bomb two Japanese cities and end the war, he becomes increasingly despondent. Aware that the 200,000 Japanese casualties will be comprised of combatants and innocents alike, he vigorously opposes creating the far more lethal hydrogen bomb. Rich in symbolism, he names the site for the first detonation, Trinity. 

Oppenheimer has now become the angel of death. Unlike Prometheus, his liver will not be eaten daily by an eagle sent as punishment by Zeus, but his conscience will perpetually search for moral relief. Prometheus’ liver regenerated at night. Oppenheimer woke every day to face the same self-reproach. President Harry S. Truman offered him respite by saying that he didn’t make the decision to drop the bomb and kill those people: “I did! “You only made it!” In that confrontational meeting, an exasperated Truman yelled at his Secretary of War, Henry L. Stimson, to “get that cry-baby out of here!” He was referring to Oppenheimer. 

As a means of seeking vindication, he appealed to a committee arranged to decide if Oppenheimer should continue his leadership of the Atomic Energy Commission. The committee was ostensibly centered on national security and support for the even deadlier hydrogen bomb. Its real purpose was to get rid of Oppenheimer, a troubled human who realized what he had released into the world. 

Before Oppenheimer’s appearance, he bellowed to his wife, “They [the people] must hear this.” The hostile meeting was a surrogate for his anguish. Members of the committee were selected to prevent his continued leadership since he realized that further development of weapons of mass destruction would only hasten mankind’s demise. Anticipating the committee’s decision, his wife said: “They will never give it to you.” What she meant was: they will grant you neither the chairmanship, nor forgiveness. 

Predictably, he was rejected. 

How does this apply to vascular surgery? Some years ago, my partner and I performed an open aneurysm repair on a healthy 60-year-old male. The patient worked out every day and was a prominent lawyer in the community. The operation went along flawlessly: the graft was sewn in and the retroperitoneum closed. Heparin was reversed with protamine with no issue. Vital signs were stable. My partner scrubbed out to enter post-op orders. The anesthesiologist asked if I wanted to return the cell-saved blood. Although we had not lost much, I reasoned that it was his blood and would make his recovery that much easier. I agreed and the perfusionist spun down the blood and began the infusion. At that moment, disaster struck. 

His blood pressure and saturation fell to zero. We immediately performed a transesophageal echocardiogram. The images were staggering. Both atria and ventricles were filled with clot, as were the pulmonary artery and aorta. The patient had suddenly clotted his vascular system for no apparent reason. We thought of extracorporeal membrane oxygenation (ECMO), but there was literally nothing to be done. 

We called around the country seeking information or if anyone had ever experienced a similar complication. A professor at Emory in Atlanta suggested antiphospholipid antibody syndrome or preformed anti-heparin antibodies. Our hospital did an investigation and came up with nothing. We met with the widow multiple times and tried (but failed) to give her an explanation. 

Understandably, the wife obtained the best malpractice law firm in the area. When I received the intent-to-sue letter, I did something I had never done before and called the attorney. I told him that I had no idea why that patient clotted his heart, that I had never seen that happen before, and that I hoped to never see it again. I told him of the research that we did and that, if his experts had any insight, to please share it. We never heard from him again. 

The renowned Boston vascular surgeon, Alan Callow, used to say that the ghosts of our failures parade around our bed at night. Yet, every patient we place on the operating table is put at risk. It takes a special person to accept this heavy responsibility, and we all carry the emotional burden of our failures. How we seek expiation is a matter of personal accommodation. A resident who worked with Dr. Charles Bailey, a pioneer in pediatric cardiac bypass surgery in the 1950s, told me that Bailey lost his first 74 patients. The resident approached Dr. Bailey, asking: “Dr. Bailey, don’t you think we should stop?” Bailey responded: “No! We are close!” The 75th patient survived. 

I’m not sure that many of us would have had the callousness to continue after losing 74 patients, nor would it even be possible today. But we surgeons all face similar responsibilities and bear the weight of our failures. And somehow, we return to the operating room the next day wizened, but humbled. To survive, we either develop emotional callousness, or realize that the good we do for most patients outweighs our failures. Or both. 

Before he accepted the leadership of the atom bomb project, Albert Einstein asked Oppie: “Do you think you will be able to handle the consequences?” Oppenheimer did not answer. 

As each practitioner seeks their own reconciliation, we acknowledge that our choice is not an easy profession—replete with gratification but often humbling. 

Arthur E. Palamara, MD, is a vascular surgeon in Hollywood, Florida. 

The top 10 most popular Vascular Specialist stories of September 2023

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The top 10 most popular Vascular Specialist stories of September 2023

top 10Last month, the most read stories from Vascular Specialist included data releases from the recent Midwestern Vascular Surgical Society (MVSS) using direct revascularization of segmental arteries to prevent spinal cord ischemia; a reflection on the crucial role of vascular nurses during Vascular Nurses Week and a multi-society update on new guidelines for the management of varicose veins of the lower extremities.

1. When women are PIs: A story foretold on the vascular frontlines

“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. “We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virgina, as she reflects on two decades of missed opportunities.

2. Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures

This commentary—authored by Anne Abbott, PhD, MBBS, Lawrence Schott, MD, Lan Gao, MMed, PhD, Hrvoje Budincevic, MD, PhD, Rishad Faruqi, MD, Tatjana Rundek, MD, PhD, Jean-Baptiste Ricco, MD, PhD, Saeid Shahidi, MD, and Gert J. de Borst, MD, PhD—consists of a multinational, multispecialty, multidisciplinary updated evidence review and policy advice.

3. Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears

A vascular surgery team from the University of Southern California (USC) in Los Angeles demonstrated the feasibility of multidisciplinary direct revascularization of segmental arteries to prevent spinal cord ischemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk patients with complex thoracoabdominal aortic aneurysms (TAAAs).

4. Vascular Nurses Week shines spotlight on vital role in patient care and innovation

Vascular Nurses Week—Sept. 10–16—serves as a reminder of the role vascular professionals play in patient care, education and research. Kristen Alix, MS, ANP-BC, AGACNP-BC, CVN, a vascular nurse since 1997 and the president of the Society for Vascular Nursing (SVN), emphasizes that this celebratory week is about more than receiving recognition.

5. Multi-society guidelines on varicose vein management published

The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities.

6. SAVS makes travel scholarship applications call for 2024 meeting

The Southern Association for Vascular Surgery (SAVS) has put out a call for applications from medical students and general surgery residents for 20 travel scholarships now available to attend the 2024 SAVS annual meeting.

7. MVSS 2023: Aulivola takes over Midwestern Vascular reins

Bernadette Aulivola, MD, the division director of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois, took over as president of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the MVSS annual business meeting held in Minneapolis, Minnesota, on Sept. 8.

8. SVS urges members to take part in compensation survey—and bolster results

Organizers behind an SVS-commissioned financial compensation survey are calling on more members to fill out the short list of questions so that they can break a key 20% response-rate target and begin to publish data gleaned from participants.

9. FDA approves LimFlow system for ‘no-option’ CLTI patients

The Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).

10. Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma

Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.

EVS 2023: Putting artificial intelligence to use in vascular practice

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EVS 2023: Putting artificial intelligence to use in vascular practice
Reid Ravin

The potential for large language-learning models like ChatGPT to take over tedious writing tasks such as emails and parts of PowerPoint presentations—or even be put to use to help collate Current Procedural Terminology (CPT) code data—was put to attendees of an artificial intelligence (AI) and social media issues session at the recent Eastern Vascular Society (EVS) annual meeting (Sept. 7–9) in Washington, D.C. 

Reid Ravin, MD, an attending vascular surgeon at ChristianaCare in Newark, Delaware, outlined the advantages of the generative technology, highlighting such AI technology’s ability to understand and generate human language using advanced mathematics and deep neural networks, with “essentially the entire internet fed into them.” 

Highlighting a pertinent use in daily vascular practice, he illustrated how he uses ChatGPT to circumnavigate CPT code acquisition. When searching for codes via Google, either the search engine gets the code wrong or “you end up on a site behind a paywall,” Ravin said. 

In the case of ChatGPT, “the entire internet lives inside of it.” Ravin demonstrated for EVS 2023 an example: for the past three procedures he carried out, he used the model to list the operations and work them up into a chart alongside a list of their relative value units (RVUs). 

He also pointed out Aidoc, an AI-powered triage and notification system, which he said interfaces with electronic medical records to detect patients with specific pathologies. 

Ravin also pointed to potential dangers, such as in the case of systems like Aidoc, which could end up “pulling out patients that really don’t need screening—and people who end up getting procedures they don’t need.” 

WVS 2023: President emphasizes importance of ‘tolerance’ in vascular specialty

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WVS 2023: President emphasizes importance of ‘tolerance’ in vascular specialty
Wei Zhou

Outgoing Western Vascular Society (WVS) President Wei Zhou, MD, used her presidential address to put out a call for the vascular specialty to embrace tolerance in order that it thrives amid rising cases of physician burnout and the mounting pressures of practice. 

She was speaking during the 2023 WVS annual meeting held in Koloa, Hawaii (Sept. 9–12). “As a specialty we face many challenges,” she told her audience. “Some reflect differences in cultural background, training experience and personal priorities.” 

Zhou, an immigrant from China, shared a personal experience, which involved a case in which she suffered illness while at work, dating from her time as an intern. “I tried to stay strong for the team and minimize my illness, scrubbing for a long pancreatic case,” she remembered. Eventually, Zhou threw up into her surgical mask about four hours into the case. As she was walking out of the operating room to clean herself up, she explained, the surgeon on the case declared before the surgical team that Zhou was “pregnant.” “He did not ask, he just assumed that pregnancy is the reason for nausea in a young woman,” she said. “On that day I lost my respect for that surgeon.” Zhou asked the WVS attendees to realize that “we are different,” and “we need to figure out other people’s perspectives.” 

“To keep an honest discussion, we also need to explore our own points of view. Oftentimes, we can find more things in common than differences,” she added. That means empathy, Zhou continued. 

“We don’t look like each other, sound like each other or act like each other. Being tolerant is not always easy. It requires us to accept our own limitations, look past our differences and accept each other’s flaws—and accept uncertainty.”

JVS-VL peer-review title launches virtual special issue on diversity topics

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JVS-VL peer-review title launches virtual special issue on diversity topics

The Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) has launched its first virtual special issue on diversity, equity and inclusion (DEI) in vascular surgery. 

“DEI issues have come to the forefront and affect multiple aspects of the care we render our patients every day,” said Anil Hingorani, MD, JVS-VL associate editor and DEI officer. “This peer-reviewed collection is meant to be a living set of articles focused on DEI, and more articles will be added in the future.” 

Hingorani likened the virtual issue to print supplements of previous years, which “really drill down into a topic important to vascular surgery and really get into the weeds. This is a modern version.” 

DEI issues are “sort of the elephant in the room,” pointing out many parts of the country will be majority non-white in the foreseeable future, he said. “As diversity spreads across the nation, we all need to be aware of this.” 

In healthcare, diversity packs an impact, Hingorani continued. “It directly affects how patients present, how they’re diagnosed, treatment algorithms and support. Everything we do is affected by the patient’s identity.” 

The collection currently includes four articles: “Race, sex and socioeconomic disparities affect the clinical stage of patients presenting for treatment of superficial venous disease”; “Black or African American patients undergo great saphenous vein ablation procedures for advanced venous disease and have the least improvement in their symptoms after these procedures”; “Importance of sensitivity to patients’ individual background in venous care”; and “A review of the current literature of ethnic, gender, and socioeconomic disparities in venous disease.” The fourth article is available via open access at vascular.org/JVSVL-DEIdisparitiesReview. 

Each takes a slightly different tack. “It’s not just patient outcomes and presentations; DEI affects a lot more than patient-centered outcomes,” said Hingorani. 

Four more, presented at the 2023 American Venous Forum and Society for Clinical Vascular Surgery (SCVS) meetings, are in the process of being added to the site. 

The journal website permits JVS-VL to “bring together the best and most recent articles—top-notch, state-of-the-art ideas from around the world,” Hingorani said. The work to update the site, as opposed to a print journal, is simple, he added. It’s all part of the transition to open access and the online world, he said. “It’s something that’s happening, and I think it will continue. This is part of that process.” 

Editors are always looking for new articles, he said, as he invited researchers to submit their work. Those who are submitting papers are excited about the new initiative. “There is a lot of enthusiasm to have a focus on DEI issues,” Hingorani said. 

Visit www.jvsvenous.org/DEIinvascularsurgery to read the collection. 

SVS History Digital Archive Task Force calls for notabilia

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SVS History Digital Archive Task Force calls for notabilia

The SVS History Digital Archives Task Force is soliciting contributions as it aims to present a curated collection to SVS members and the medical community. The initiative came from the SVS Executive Board earlier this year as members saw a need to foster a comprehensive digital repository of the specialty. 

Task Force Co-Chairs Jerry Goldstone, MD, and Craig Miller, MD, have outlined a list of topics of potential interest. These include historical figures, technological advancements, scientific discoveries and novel procedures of significant clinical impact. Miller emphasized that members with primary-source items are encouraged to submit. 

“One of the things we’re doing right now is assembling documents that we’ve created ourselves … We aim to assemble these items to create a cohesive narrative. This is a project that should be ongoing. Moving forward, what is present will become past. As another generation comes along, there are things that will turn out to be of historical significance.” Submit at vascular.org/DigitalArchive. 

Amplifying advocacy: SVS tool for vascular influence on the federal stage

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Amplifying advocacy: SVS tool for vascular influence on the federal stage
Sean Lyden

In the dynamic arena of healthcare advocacy, the Society for Vascular Surgery (SVS) stands as a champion, harnessing the power of amplification to thrust the voices of vascular surgeons into the forefront of federal decision-making. Over the past year, the SVS has orchestrated three compelling “Week of Action” campaigns, underscoring the Society’s commitment to advancing legislative priorities on Capitol Hill and invigorating advocacy participation within its membership. 

Recognizing the evolving landscape of advocacy, the SVS has embraced a multi-pronged approach to the “Week of Action,” aimed at advancing the interests of vascular surgery. 

Grassroots campaigns: Embracing the strength of collective voices, SVS empowers its members to actively participate in grassroots campaigns via the “Voter Voice” platform. This digital rallying cry amplifies the concerns of vascular surgeons, magnifying their impact on pivotal issues. By channeling the diversity and energy of its membership, the SVS cements its position as an influential force. 

Supporting candidate and incumbent lawmakers through the SVS Political Action Committee (PAC): the SVS not only raises its voice, but also invests in the future of advocacy for vascular surgery. The SVS PAC serves as a pivotal tool, bolstering the campaigns of lawmakers who champion healthcare policies aligned with the SVS’ overarching mission. Through backing candidates who resonate with the principles of vascular surgery, the SVS proactively shapes a legislative landscape conducive to the field’s growth. 

Traditional legislative advocacy and lobbying: Capitol Hill has borne witness to the presence of SVS representatives as they advocate for policies that resonate with the core of vascular surgery. Through deliberate engagements with federal lawmakers, the SVS ensures that the intricacies and concerns of vascular surgeons are not only acknowledged but also deeply understood. This timeless approach remains a cornerstone of the SVS’ advocacy efforts, forging relationships that pave the way for well-informed decision-making. 

Amplification transcends mere volume: The SVS has wielded this principle to increase our level of influence, ensuring that the aspirations and concerns of vascular surgeons are heard at the federal level. The “Week of Action” campaigns further underscore the SVS’ dedication, showing how a collective voice can serve as an agent of transformation. 

As the SVS charges ahead, the tool of amplification remains a central pillar of its advocacy strategy. With every campaign, each engagement, and participation of its members, the SVS fortifies its position as a resounding voice, propelling change in the healthcare landscape and securing a positive future for vascular surgery. 

To learn more about SVS advocacy efforts, or catch up on previous “Week of Action” campaigns, visit vascular.org/advocacy. 

Sean Lyden, MD, is a member of the SVS Advocacy Council. 

Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears

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Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears
Anand Ganapathy

A vascular surgery team from the University of Southern California (USC) in Los Angeles demonstrated the feasibility of multidisciplinary direct revascularization of segmental arteries to prevent spinal cord ischemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk patients with complex thoracoabdominal aortic aneurysms (TAAAs) following a retrospective review of fenestrated or branched endovascular aneurysm repairs (F/BEVARs) over a five-year period, attendees of the recent Western Vascular Society (WVS) annual meeting (Sept. 9–12) were told.

The early work, which involves 12 patients undergoing either an endovascular or open approach, was hailed by audience member Benjamin W. Starnes, MD, chief of vascular surgery at University of Washington Medicine in Seattle, who said, “This is a new idea. I applaud the courageousness of our colleagues at USC for pursuing this.”

USC integrated vascular surgery resident Anand Ganapathy, MD, who presented the study results, told WVS 2023, held in Koloa, Hawaii, that nine patients were treated endovascularly, with a total of 11 segmental arteries incorporated. Ganapathy outlined how seven were revascularized using a directional cuff sewn directly onto a physician-modified graft that was extended with self-expanding Viabahn stents; two of the arteries were treated using stented fenestrations; and the remaining two—located along the seal zone—were tackled using unbridged, large fenestrations without covered branched stents. The other three patients received an extra-anatomic bypass.

Extents I and II were the most common type of TAAA among the patient group, Ganapathy continued. Procedural details for endovascular repair of the aneurysms demonstrated an average of 4.3 target vessels (2–6) treated, with a technical success rate of 83%. Failures (two patients) involved a bridging stent to a renal artery “that was dislocated from the fenestration and not recoverable” and a malalignment of an unstented fenestration to an intercostal artery “maintained with an uncovered stent.” Nine patients had successful prophylactic spinal drain placement. The three patients who underwent open repair of their segmental arteries received their bypass an average of three days prior to the F/BEVAR procedure.

Ganapathy reported no mortality at 30 days post-procedure. Two patients—one who had a staged extra-anatomic bypass, the other an unstented fenestration—incurred spinal cord ischemia that “resolved completely by discharge.” Both had prophylactic spinal drain placement. Average follow-up was 472 days. Three of the 14 targeted segmental arteries occluded during follow-up, Ganapathy added. Occluded branches involved one extra-anatomic bypass and two directional cuffs. “They occurred beyond one year without causing spinal cord ischemia,” he said.

Ganapathy concluded: “Spinal cord ischemia remains a serious complication of F/BEVAR, despite current mitigation strategies. Our initial experience demonstrates feasibility of endovascular and extra-anatomic bypass for segmental revascularization in select patients. Further work is planned to improve patient selection through anatomic and dynamic assessment of spinal cord perfusion patterns, as well as the safety and efficacy of segmental artery revascularization procedures through a multidisciplinary, collaborative effort across expertise from a growing list of specialists. Our vision is that someday this might be serve as another adjunct to the current spinal cord ischemia mitigation protocols.”

Karthikeshwar Kasirajan, MD, a clinical professor of vascular surgery at Stanford University, who was the designated discussant of the paper at WVS, summarized the study’s headline findings, outlining how the novel techniques had been employed in 3.8% of F/BEVAR patients reviewed during the study period. Some 11% of the endovascular group and 33% of the open group developed transient paraplegia, he said. Kasirajan commented: “In my opinion, it should be noted that stent grafts have a lower instance of paraplegia when compared to open repairs in general. This is despite the fact that length of coverage is often more extensive as to require landing zones that are much more extensive than open repairs. Additionally, during open repairs we can reimplant intercostals. This cannot be done during stent grafts [implantation], hence intercostal revascularization may not be the holy grail in the prevention of paraplegia.”

Alan Lumsden, MD, chair of the Department of Cardiovascular Surgery at Houston Methodist in Houston, Texas, congratulated the USC team on the ground-breaking nature of their work, asking Ganapathy and colleagues to drill down on any guidelines they follow to determine which patients should receive the novel approach.

Senior author of the study, Sukgu Han, MD, co-director of the Comprehensive Aortic Center at USC’s Keck Hospital, said: “Patient selection is everything. There’s probably more value from putting this protocol together with people from different specialties, maybe actually in the characterization of the spinal perfusion and individual variability. Because, so far, really the only surrogate marker we are looking at, in really very few select patients, is the size and assumption that that carries dominant collateral to the spinal cord.”

VasQ AVF creation device receives FDA clearance

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VasQ AVF creation device receives FDA clearance
VasQ external vascular support

Laminate Medical Technologies has announced their flagship device, the VasQ external vascular support, has been cleared by the Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a breakthrough technology, was cleared based on a de novo review of the 144 patient VasQ U.S. pivotal study, as well as a track record of safety and effectiveness of use in multiple studies from outside the U.S.

As recently published in the Journal of Vascular Surgery, VasQ patients in the VasQ study met the primary endpoint of improved primary patency (freedom from intervention plus adequate flow for hemodialysis) at six months. No serious adverse event associated with the device was reported over the two year study.

Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study, reported statistically superior rates of functional success (confirmed use of the AVF for dialysis), and reduced need for additional procedures. The result was central venous catheters (CVC), the primary source of hospitalization due to infection in dialysis patients, were able to be removed in 80% of the patients within the first year as compared to 62% of unsupported fistulas as reported by the National Institute of Health’s United States Renal Data System.

Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Hospital Systems in Raleigh, North Carolina, stated, “I, along with other study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections.”

VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula. The device was designed to provide structural reinforcement of the mobilized vessels now freed from its native supporting tissue as well as guides a more stable arterial flow profile as it transitions into the vein. Magnetic resonance imaging as well as computational fluid dynamic models have supported the proposed mechanistic benefits of the VasQ design that have led to consistent beneficial clinical outcomes in multiple studies.

New clinical data support AI solution for improved PE detection and care coordination

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New clinical data support AI solution for improved PE detection and care coordination
Viz.ai

Viz.ai has announced new clinical data supporting advancements in pulmonary embolism (PE) detection. Two studies have demonstrated the real-world clinical efficacy of Viz.ai’s PE module to quickly and accurately identify PE and associated right heart strain, accelerate care coordination, and improve healthcare workflow efficiency, the company reports. 

The first study—”Automated PE clot detection and RV/LV ratio measurement using AI [artificial intelligence]-based deep learning algorithms: A preliminary validation study”—evaluated the performance of Viz PE and Viz right ventricle/left ventricle (RV/LV) algorithms. The study found that, across 100 retrospectively collected chest computed tomography pulmonary angiogram (CTPA) images, Viz PE demonstrated a sensitivity of 91.1% and specificity of 100%. Furthermore, the study revealed a significant positive correlation between algorithmic and manual calculation of RV/LV ratio.

“Our preliminary findings underscore the remarkable performance of Viz PE and Viz RV/LV,” said Parth Rali, MD, associate professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University in Philadelphia. “We are excited to partner with Viz.ai and pioneer investigator-initiated research that will reveal the impact of AI technology in revolutionizing patient care.”

The second—”The use of artificial intelligence technology in the detection and treatment of pulmonary embolism at a tertiary referral center”—demonstrated how Viz PE directly improves patient wait times for evaluation, the company commented. Adoption of Viz.ai’s technology significantly reduced time to consult on average from four hours to six minutes, leading to faster diagnosis and initiation of treatment. When combined with multidisciplinary evaluation by an existing pulmonary embolism response team (PERT), time to radiology report was reduced by 109 minutes, showcasing the potential combined benefits of AI technology and the PERT model of care on PE care and management.

“The integration of AI technology into our PE workflow has significantly shortened the time-to-consult, helping us to promptly evaluate and triage these potentially unstable patients,” said Jacob Shapiro, MD, a vascular surgery resident at TriHealth in Cincinnati, Ohio. “This advancement has the possibility to reshape the landscape of PE management.”

‘Voices of Vascular’ attracts national recognition with diversity award

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‘Voices of Vascular’ attracts national recognition with diversity award
Voice of Vascular

“Voices of Vascular,” an initiative to highlight the diverse voices within the SVS, has earned the Society and the SVS Foundation a Profile of Excellence Award from the American Association of Medical Society Executives (AAMSE). 

Catherine Lampi, the Foundation’s director of development, accepted the award on behalf of the Society, in the “diversity, equity and inclusion” (DEI) category, at the AAMSE conference, which took place in mid-July. 

The annual awards program recognizes member organizations that have achieved excellence in one of several categories: DEI, advocacy, communications, education, membership and leadership. 

Voices of Vascular honors several months of diversity throughout the year, including Black History Month in February; Women’s History Month in March; Asian American and Pacific Islander Heritage Month in April; Pride Month in June; and National Hispanic Heritage Month, which runs from Sept. 15 through Oct. 15. 

During each of the given months, the SVS and the Foundation share important facts about the groups to spread awareness. The campaign also involves posting profiles of SVS members and, on occasion, patients too. 

“Every person has a story,” said Foundation Chair and Immediate Past President Michael Dalsing, MD. “Voices of Vascular shares our members’ stories and experiences, not only as a vascular surgeon, but also as a member of a particular group. The initiative has proved very popular and insightful.” 

During June, Pride Month, Eric Pillado, MD, an integrated vascular surgery resident at Northwestern University in Chicago, shared his life’s story. 

“I think the future of vascular involves Pride Month, making sure all our patients, regardless of their background, are included, and the future of vascular surgery involves providers of various backgrounds being included in our specialty.” 

Visit Voices of Vascular at vascular.org/VoicesofVascular. 

Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures

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Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures
This commentary—authored by Anne Abbott, PhD, MBBS, Lawrence Schott, MD, Lan Gao, MMed, PhD, Hrvoje Budincevic, MD, PhD, Rishad Faruqi, MD, Tatjana Rundek, MD, PhD, Jean-Baptiste Ricco, MD, PhD, Saeid Shahidi, MD, and Gert J. de Borst, MD, PhD—consists of a multinational, multispecialty, multidisciplinary updated evidence review and policy advice, which was published on the U.S. Centers for Medicare & Medicaid Services (CMS) website on Aug. 8, 2023. This review and policy advice was prompted by CMS’ proposed decision to fund “free-for-all” carotid artery “stenting” procedures in any American aged at least 65 years, on certain disability benefits and/or with end-stage renal failure who is determined as having at least “50” or “70%” carotid stenosis (despite no accurate and reproducible method of classifying degree of carotid stenosis). This manuscript is based on a longer group submission posted on the CMS website in February 2023. 

We classify the types of misinformation being used to errantly push U.S. Medicare to expand reimbursement indications for carotid artery stenting (CAS) and a new hybrid procedure known as transcarotid arterial revascularization (TCAR). This is already an environment with too many unnecessary carotid procedures done in the name of stroke risk reduction. Founding members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (FACTCATS) explained in 2012 why reimbursement indications for CAS should not be expanded.1,2 The fundamental reasons were higher risks with CAS (stroke, death and myocardial infarction) compared to carotid endarterectomy (CEA) and declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods. The situation has not changed, except that the excessive hazards with stenting are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven. Once again, we advise that expanding reimbursement indications for carotid procedures “would have serious negative health and economic repercussions for the USA and any other country that may follow such inappropriate action.”1

Introduction 

Since 2005, CMS has limited carotid stenting (CAS) reimbursement indications to individuals considered at high-risk from carotid surgery (carotid endarterectomy, CEA) who are symptomatic with >70% carotid stenosis and to other high-CEA-risk patients if used in appropriate studies (those with 50-70% stenosis if symptomatic or >80% stenosis if asymptomatic).3 High-CEA-risk is defined by CMS as having major comorbidities and/or anatomic risk factors (including current life-threatening cardiac conditions).3 The definition is open to interpretation. CMS also created minimum standards upon which CAS coverage (reimbursement) is dependent.3

As per the January 2023 online CMS announcement,4 a “multispecialty alliance” (the “Alliance”) asked that CMS:

  • Expand CAS reimbursement indications to all individuals with >70% asymptomatic carotid stenosis and any symptomatic person with >50% stenosis (including those not considered high-CEA-risk)
  • Eliminate the minimal standards for facility requirements
  • Leave coverage for any CAS procedure (including TCAR) not described by the CMS National Coverage Determination (NCD) to the discretion of the local Medicare Administrative Contractors

Founding members of FACTCATS published evidence reviews and advice to U.S. Medicare in 2012 and 2013 outlining why reimbursement indications for CAS should not be expanded.1,2 The main reasoning then was the higher risk of stroke and death with CAS compared to CEA, as well as declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods (risk factor identification and amelioration using lifestyle interventions and medication). The situation has not changed, except that the excessive hazards with CAS are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven.5–10

CMS reimbursement indications were not expanded following the 2012 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.5 The results have been greatly limited access to procedural “carotid revascularization” by non-surgically trained practitioners, the saving of up to several million older Americans from unnecessary, excessively dangerous carotid procedures, the saving of up to at least 60 billion American healthcare dollars and an excellent global health policy example.5,11 This analysis is a cut-down version of our updated evidence review and policy advice for CMS that was publicly posted Feb. 10, 2023, with 71 co-signatories.

The Alliance used an online letter to CMS and a 2022 review article as the case for ‘new evidence’ supporting expansion of reimbursement indications for CAS, TCAR and any other procedure they may consider under the umbrella of CAS in the future.4,12,13 However, the case for expansion consists of misinformation favoring procedural over-use and lacks a cost-effectiveness analysis. We have classified the most important forms of misinformation encouraging procedural overuse into four types: factual errors (untrue statements), fact distortion (a fact is conveyed then misconstrued), omitted information (omission of information relevant to clinical decision making) and speculation. We would like to emphasize that we are not targeting individuals, rather we are addressing misinformation. Further, this misinformation is common in the medical literature.

Factual errors

  1. CAS is not equivalent, or noninferior, to CEA as claimed12,13

CAS is more dangerous for patients than CEA. In every adequately powered randomized trial comparison, CAS (when used for primary or secondary stroke risk reduction) was associated with approximately 1.5–2 times as many peri-procedural strokes or deaths as CEA.5 Several individual randomized trials of symptomatic patients showed a statistically significant higher periprocedural rate of stroke or death from CAS compared to CEA (including the International Carotid Stenting Study [ICSS], the Carotid Revascularization Endarterectomy vs. Stenting Trial [CREST-1], and the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis [EVA-3-S] trial).5 Registries and administrative databases have also consistently shown higher periprocedural rates of stroke or death with CAS compared to CEA.2,5,14

By contrast, no individual randomized trial of CAS versus CEA in patients with asymptomatic (or recently asymptomatic) carotid stenosis has been sufficiently powered for this comparison because of low event rates and, hence, the requirement for larger study samples.5,15,16 Underpowered trials involving asymptomatic patients include the 2nd Asymptomatic Carotid Surgery Trial (ACST-2), published in 2021.17,18 However, all individual randomized trials of asymptomatic, or recently asymptomatic patients, with more than 200 subjects have shown trends towards more periprocedural stroke or death with CAS than CEA. For example, in ACST-2, the odds ratio (OR) for 30-day peri-procedural death or stroke with CAS versus CEA was 1.35 (95% confidence interval [CI] 0.91–2.03). The comparison reached statistical significance in a 2019 meta-analysis of randomized trials (eight trials and 3,467 patients: OR 1.64, 95% CI 1.02–2.64)15 and borderline significance in a 2020 meta-analysis of randomized trials (seven trials and 3,378 patients: OR 1.72, 95% CI 1.00–2.97).16

In randomized trials, myocardial infarction was generally less common with CAS than CEA. However, where published, in randomized trials of CAS versus CEA involving symptomatic and/or asymptomatic patients, peri-procedural stroke (mostly caused by CAS) was overall 4.6 times more common than clinically defined myocardial infarction.19 Further, periprocedural death was 34% higher with CAS and periprocedural stroke, death, and clinically defined myocardial infarction were 1.6 times more common after CAS than CEA.5,19 The difference in this latter, triple-composite outcome measure reached statistical significance in meta-analyses involving symptomatic patients.5,15,16

There are still insufficient randomized trial data to adequately power this triple-composite comparison for asymptomatic patients.5,15,16 However, randomized trial results indicate that it is highly likely that if CAS is rolled out into routine practice (involving many more asymptomatic patients than in trials with/or without lower procedural standards) it would cause significantly more strokes, deaths and myocardial infarctions than CEA. That would be clinically and economically highly significant.5

Further, in adequately powered randomized trial comparisons, rates of periprocedural stroke or death and later ipsilateral stroke have been higher with CAS compared to CEA for as long as patients have been followed up.5 Rates of new ipsilateral stroke beyond the periprocedural period were generally similar with each procedure. This indicates that patients who have a periprocedural stroke tend to live long-term with their stroke. Meanwhile, those that die in the periprocedural period do not recover. Therefore, compared to CEA, the harm from CAS is durable.5 Differing results have been reported with respect to ‘protection devices’ for lowering the CAS-associated risk of stroke or death.5 Further, severe carotid re-stenosis is more common after CAS than CEA and CAS tends to cost more.20,21 Complications (apart from stroke and death) that are more likely with, or particular to, CAS compared to CEA include hemodynamic instability (severe hypotension or bradycardia, including the need for a permanent pacemaker) and retroperitoneal haemorrhage.5

  1. Age is not the only risk factor for harm from CAS as claimed12,13

In randomized trials, CAS has not been shown to be more beneficial than CEA or non-invasive medical intervention alone in any subgroup of patients. Particularly vulnerable to stroke from CAS compared to CEA are:

  • The most senior patients (aged >70 years). Randomized trial comparisons in younger patients have been underpowered, probably because of lower event rates and less representation5
  • Those who are most recently symptomatic (especially within the previous 7–14 days, which is when best practice CEA is most likely to be beneficial)5,22
  • Women. However, men are also at higher risk of stroke or death from CAS compared to CEA5
  • Those with certain carotid anatomical features, such as longer, angulated, or tandem lesions5
  • Those who have CAS in low volume centers or outside trials5
  • Regression of carotid plaque has been seen from non-invasive medical intervention alone, in contrast to what was claimed12,13

Studies have shown that statin and ezetimibe therapy can cause carotid plaque regression and content stabilization.23-28 Moreover, statins, ezetimibe and PCSK9 inhibitors reduce the risk of stroke and other arterial disease morbidity and mortality whether or not individuals undergo a carotid artery procedure.29–31

Fact distortion

  1. Inappropriate dismissal of ‘minor’ or ‘nondisabling’ strokes in attempt to justify CAS12,13

The most severe or fatal periprocedural strokes are usually defined as being associated with a modified Rankin score of >3.5 Fortunately, severe strokes are less common than milder strokes. A well-recognized method of falsely claiming equivalence between CAS and CEA is to ignore milder strokes.19 However, this distorts the facts in two ways. Firstly, so-called ‘minor’ strokes may impose significant disability and reduced quality of life and should not be discounted.32,33 Secondly, past randomized trials of CAS versus CEA were underpowered to compare the peri-procedural rate of the most severe strokes. Therefore, it is incorrect to claim that CAS and CEA are similar with respect to causing severe strokes.5

  1. Inappropriate use of periprocedural myocardial infarction to justify CAS12,13

As explained above, in all adequately powered randomized trial comparisons, CAS was associated with significantly more periprocedural stroke, death and clinically defined myocardial infarction than CEA.15,16,19 However, because myocardial infarction was often more frequent with CAS than CEA in randomized trials, including it in a primary outcome measure with stroke and death means the adverse outcomes are more evenly distributed between CEA and CAS. Therefore, larger sample sizes are required to show statistically significant procedural differences. As explained above, this has been achieved in meta-analyses of randomized symptomatic patients.15,16 Underpowered triple-composite outcome comparisons camouflage the statistically significant higher periprocedural rate of stroke or death with CAS compared to CEA. “No statistically significant difference” is often due to underpowering, and this is demonstrated with meta-analyses involving larger subject numbers.5,15,16,19

  1. Inappropriately using the SAPPHIRE trial to justify CAS in high-CEA-risk patients12,13

The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial was inappropriate to determine a role for carotid artery procedures in individuals considered at high-CEA-risk because it lacked a non-invasive-treatment-only option.34 Performing randomized trials of only procedures and concluding that a procedure is best, or indicated, constitutes procedural bias.19,35 Outcomes with non-invasive treatment alone have not been measured in these patients. Further, high-surgical-risk medical comorbidities (such as unstable angina, congestive cardiac failure and advanced age) identify individuals with high rates of procedural complications and not likely to live long enough to benefit from a carotid artery procedure.36-40 Interestingly, patients deemed high-CEA-risk using CMS criteria do not appear better off with CAS compared to CEA.41

The SAPPHIRE trial had other major limitations for applicability in clinical practice. It included myocardial infarction in the primary outcome measure (the pitfalls of this are described above). Further, myocardial infarction was unusually defined as a “creatinine kinase level >2 times the upper limit of normal with a positive myocardial band (MB) fraction.”34 However, elevated cardiac enzymes are not necessarily indicative of significant heart damage, are not rare after non-cardiac surgery, and are perhaps more common after CEA than CAS.42-44 Further, the SAPPHIRE sample size was very small (334, 70% asymptomatic) with only 17 total 30-day periprocedural strokes or deaths (OR for CAS versus CEA: 0.9, 95% CI 0.3–2.3) and 55 total strokes or deaths by one year (OR for CAS versus CEA: 0.6, 95% CI 0.3–1.1). The trial was underpowered, particularly with respect to analysis of asymptomatic and symptomatic patients separately. As far as we know, the SAPPHIRE trial is the only randomized procedural trial of high-CEA-risk patients.12,13 SAPPHIRE’s limitations, and unknown outcomes with current best practice non-invasive treatment alone, underscore the lack of evidence supporting a procedural approach in “high-surgical-risk” individuals and an outstanding over-reliance on SAPPHIRE in health policy and guidelines.45

  1. Inappropriately using outdated and overreaching guidelines to justify CAS12,13

It is inappropriate to cite outdated procedural standards (such as a 30-day periprocedural stroke or death rate <2–3% for asymptomatic carotid stenosis patients or <6% for stroke or TIA patients with carotid stenosis) to encourage ongoing routine use of carotid artery procedures, let alone reimbursement expansion. The randomized trials upon which such guidelines and standards are based are long outdated due to ongoing advances in non-invasive stroke prevention.5,45 Further, prevailing guidelines encourage carotid artery procedures for many more patient subgroups than have ever been shown to benefit (see below).5,45

  1. Patient choice in treatment decisions12,13

The Alliance repeatedly referred to patient choice, or preference, as a reason to expand reimbursement indications. Patient preference, and informed consent, are prerequisites for any medical intervention.46 This is usually the last “bastion” in protecting patients.46 However, patient preference strongly depends on the way information is presented (or omitted). This has already been demonstrated with decision-making in asymptomatic carotid stenosis patients.47 This demonstrates the importance of how physicians talk to patients. Meanwhile, “shared decision-making” could be a way of making patients take responsibility for treatment that, rather than help, is more likely to harm them.

Omitted information

  1. Implications of improved non-invasive risk reduction12,13

The efficacy of any carotid procedure in stroke risk reduction can only be established using sufficiently powered comparisons against current best practice non-invasive medical intervention alone (healthy lifestyle habits and appropriate medication). This point was consistently missed by the Alliance. Mention was made in the 2022 review of very low (approximately 1%) annual stroke rates in asymptomatic carotid stenosis patients leading to new trials (CREST-2 and the 2nd European Carotid Surgical Trial [ECST-2]) comparing procedures to non-invasive treatment alone.13 In the Alliance letter of request, “expanded” non-invasive medical intervention was deemed “experimental,” instead of the gold standard against which all procedures should be compared.5,12

The ‘Alliance’ advocating for expansion of CAS reimbursement neglected to explain an evidence base showing that stroke rates have dropped by >50-65% with non-invasive care alone in asymptomatic and symptomatic individuals with carotid stenosis, and other cerebrovascular disease populations, since all past randomized trials of CEA versus non-invasive treatment alone.5,7,8,48–53 The Alliance did not mention that these outstanding achievements with non-invasive care mean that there is no current evidence of patient benefit from any carotid procedure. However, there are ongoing reported rates of periprocedural stroke or death of >1–6%.14 Even if procedural stroke and death rates of consistently zero were possible, this is insufficient to justify carotid procedures in the absence of a clinically significant benefit compared to current best-practice non-invasive care alone.5,54

  1. Degree of 50–99% asymptomatic carotid stenosis does not justify a procedure12,13

The Alliance cited a recent Oxford Vascular Study publication describing how patients with 80–99%, compared to 50–79%, asymptomatic carotid stenosis had a higher ipsilateral stroke rate.12,13,55 However, they did not explain that the highest average annual ipsilateral stroke rate seen in that study approximated only 3%, not high enough to ensure a procedural benefit if Asymptomatic Carotid Atherosclerosis Study (ACAS) results are used as an indicator.51,54,56 Furthermore, they neglected to explain that the non-invasive stroke prevention treatment used in that study (and particularly in the associated meta-analysis studies) was suboptimal. Therefore, it is highly likely that the 3% average annual ipsilateral stroke rate is higher than that achievable with current best practice non-invasive care alone.54

  1. TCAR has not been shown to be as safe as CEA or more effective than non-invasive care12,13

Even with large numbers of registry patients, there is no clear evidence that TCAR is as safe as CEA in terms of the risk of stroke or death, at least in standard-surgical-risk patients.32,57–61 TCAR (like CEA) appears to be safer than CAS in the Vascular Quality Initiative (VQI) registry 57–59 However, definitive interpretation of TCAR studies is impossible because of underpowering, lack of randomization, mismatch in patient comorbidity loads, combined patient symptomatic status, predominance of asymptomatic patients, retrospective interrogation and lack of comparison with current best practice non-invasive care.9,10,61,62 CEA remains the safest carotid revascularization procedure and should still be considered in selected symptomatic patients.5,10 However, patients and their carers need to understand that the evidence for an overall CEA benefit compared to non-invasive care alone was collected decades ago and needs re-evaluation.5,63

  1. Differentiating ‘asymptomatic’ and ‘symptomatic’ and those shown to benefit12,13

The Alliance request expansion of reimbursement in “selected candidates.” However, no details are provided about how to select patients. Definitions are not given for asymptomatic or symptomatic patients or for categorizing degree of carotid stenosis.12,13Further, the Alliance omitted to explain the patient subgroups ever shown to have an overall benefit from a procedure (only CEA) compared to non-invasive treatment alone in randomized trials.48–51,64 The overall CEA benefit was small (approximately 1%/year for asymptomatic/recently asymptomatic carotid stenosis patients and up to approximately 3.2%/year for symptomatic patients with ipsilateral carotid stenosis).5 Further, patients had to satisfy all trial selection criteria, have a life expectancy of at least 3–5 years and fit into one of the four following groups:5

  • Men aged <75–80 years with 60–99% asymptomatic (or recently asymptomatic) carotid stenosis (defined using conventional intra-arterial angiography or ultrasound and North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria)51,64
  • Symptomatic Women with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA)65
  • Symptomatic Men with 50–69% stenosis (defined using conventional intra-arterial angiography and NASCET criteria) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA65
  • Symptomatic Men with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 3 months of their last same-sided non-severe stroke or TIA. However, the CEA benefit fell rapidly over this time and was highest within the first 2–3 weeks65

There has never been evidence of procedural efficacy for any other subpopulation of carotid stenosis patients. Further, evidence for the groups defined above is outdated. A “lean to” approach with respect to procedural reimbursement (or “access”) in other subpopulations is inappropriate, given the large numbers of additional implicated patients, and especially when there is evidence of net harm.5 Prevailing policy should be reevaluated with appreciation of the health and economic importance of appropriate “exnovation” and independent monitoring of outcomes with all treatment modalities (procedural and nonprocedural).5,66 Further, it needs to be recognized that a randomized trial is not always needed to answer clinical question. For example, if ipsilateral stroke rates associated with carotid arterial disease are clearly sufficiently close to zero with non-invasive care alone, then randomized procedural trials are not required.5

  1. Categorizing degree of stenosis (and risk) has changed, and is fraught with error12,13

The dominant method of measuring carotid stenosis in previous randomized trials was catheter-based digital subtraction angiography and the NASCET criteria for stenosis.67 Ultrasound was used to some extent in ACAS and was used in ACST-1 (the 1st Asymptomatic Carotid Surgery Trial).51,64 However, most arterial imaging is now non-invasive. Furthermore, there is inherent error with each imaging modality and correlation is far from perfect.5,68,69 Concerningly, angiography using magnetic resonance imaging and computed tomography, and “real world” operators, tend to overestimate carotid stenosis severity, encouraging procedural overuse.70–72 Changes in imaging methodology for categorizing degree of carotid stenosis and measuring risk, along with major advances in noninvasive care and the lack of enforcement of procedural standards outside trials, are major reasons why the original randomized trials of CEA versus non-invasive intervention alone are outdated and/or non-applicable, and the Alliance requests are inappropriate.5,73–75

Speculation

It is speculation that outcomes with CAS may improve.12,13 This speculation is not relevant to funding decisions currently under discussion. In fact, the evidence base indicates that CAS (at least by the transaortic route) should be avoided.

Conclusions

In summary, rather than expansion, the evidence base clearly demonstrates that it is time for exnovation when it comes to reimbursement indications for carotid artery procedures.66 There are many reasons, and any reason alone could lead to net patient harm:5

  1. Prevailing guidelines advocate for carotid procedures on many more subgroups than have ever been shown to benefit.
  2. CAS is more dangerous than CEA, and TCAR has not been shown to be as safe as CEA.
  3. Procedural complication rates, when measured, are usually higher in practice than in trials.
  4. There is no current randomized trial evidence of carotid procedural benefit for any patient subgroup compared to current best practice non-invasive care alone. Further, all patients should receive current best practice non-invasive care. Plus, randomized trials are not required to answer every clinical question. For example, if ipsilateral stroke rates are clearly sufficiently close to zero with non-invasive care alone, then randomized procedural trials in such patients are unnecessary and may be unethical.
  5. Methods of categorizing carotid stenosis have changed and lack reproducibility.
  6. Routine procedural reimbursement blocks new, critically needed research (such as CREST-2 and the Stent-Protected Angioplasty in Asymptomatic Carotid Artery Stenosis vs. Endarterectomy [SPACE-2] trial) to assess carotid procedural efficacy against non-invasive care alone.5,76
  7. Healthcare system sustainability in the U.S. (and elsewhere) is threatened by rising costs, including from poor quality care.77,78

CMS, and other payers of health services, are key in protecting patients and healthcare resources. This is particularly pertinent in an environment already compromised by misinformation and self-serving practices.35,79,80 Overuse of carotid artery procedures is a global problem driven by entrenched misdirected incentives.5,81,82 It can be overcome by redirecting wasted resources to effective interventions, new research, and establishing outcomes-based, rather than activity-based, medicine.5,83 Patient welfare focused medicine requires putting aside pressure from those likely to gain directly or indirectly, in terms of funds and/or popularity, and objectively sorting the scientific facts. Further, it means insisting on independently maintained clinical standards which ensure healthcare excellence, free from conflict of interest, and which protect patients from harmful or unproven treatment.

References

  1. Abbott AL, Adelman MA, Alexandrov AV, Barnett HJ, Beard J, Bell P, Bjorck M, Blacker D, Buckley CJ, Cambria RP, et al. Why the United States Center for Medicare and Medicaid Services (CMS) should not extend reimbursement indications for carotid artery angioplasty/stenting. Eur J Vasc Endovasc Surg. 2012;43:247-251.
  2. Abbott AL, Adelman MA, Alexandrov AV, Barber PA, Barnett HJ, Beard J, Bell P, Bjorck M, Blacker D, Bonati LH, et al. Why calls for more routine carotid stenting are currently inappropriate: an international, multispecialty, expert review and position statement. Stroke. 2013;44:1186-1190.
  3. US Centers for Medicare & Medicaid Services (CMS). National Coverage Determination [NCD] for Percutaneous Transluminal Angioplasty [PTA] 20.7. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=201&ncdver=10.
  4. US Centers for Medicare & Medicaid Services (CMS). Percutaneous trans-luminal angioplasty (PTA) of the carotid artery concurrent with stenting: National coverage analysis. CAG–00085R8. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=311. 12th January, 2023.
  5. Abbott A. Extra-Cranial Carotid Artery Stenosis: An Objective Analysis of the Available Evidence. Front Neurol 2022 Jun 21;13:739999
  6. Yang C, Bogiatzi C, Spence JD. Risk of Stroke at the Time of Carotid Occlusion. JAMA Neurology. 2015;72:1261-1267.
  7. Shahidi S, Owen-Falkenberg A, Gottschalksen B, Ellemann K. Risk of early recurrent stroke in symptomatic carotid stenosis after best medical therapy and before endarterectomy. Int J Stroke. 2016;11:41-51.
  8. Fisch U, von Felten S, Wiencierz A, Jansen O, Howard G, Hendrikse J, Halliday A, Fraedrich G, Eckstein HH, Calvet D, et al. Risk of Stroke before Revascularisation in Patients with Symptomatic Carotid Stenosis: A Pooled Analysis of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2021;61:881-887.
  9. de Borst GJ. Transcarotid Artery Stenting: Hype or Hope? Stroke. 2022;53:108-110. doi: 10.1161/STROKEAHA.121.036464
  10. de Borst GJ. Transcarotid arterial revascularisation. BJS. 2023;110:127–128.
  11. Abbott AAL. Healthy lifestyle habits and appropriate medication: Modern breakthroughs in reducing risk of stroke and other arterial disease complications. Veithsymposium Bulletin. June, 2022: https://www.veithsymposium.org/pdf/articles/vei/61.pdf.
  12. Brott T, Clair DG, Gray W, Heck D, Jovin T, Lyden S, Metzger C, Rosenfield K, Roubin G, Sachar R, et al. Formal Request for Reconsideration of National Coverage Determination (NCD) 20.7, 2022: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id311.pdf..
  13. White CJ, Brott TG, Gray WA, Heck D, Jovin T, Lyden SP, Metzger DC, Rosenfield K, Roubin G, Sachar R, et al. Carotid Artery Stenting: JACC State-of-the-Art Review. Journal of the American College of Cardiology. 2022;80:155-170.
  14. Paraskevas KI, Kalmykov EL, Naylor AR. Stroke/Death Rates Following Carotid Artery Stenting and Carotid Endarterectomy in Contemporary Administrative Dataset Registries: A Systematic Review. Eur J Vasc Endovasc Surg. 2016;51:3-12.
  15. Batchelder AJ, Saratzis A, Ross Naylor A. Overview of Primary and Secondary Analyses From 20 Randomised Controlled Trials Comparing Carotid Artery Stenting With Carotid Endarterectomy. Eur J Vasc Endovasc Surg. 2019;58:479-493.
  16. Muller MD, Lyrer P, Brown MM, Bonati LH. Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis. Cochrane Database Syst Rev. 2020;2:CD000515.
  17. Abbott AL, Wijeratne T, Zeebregts CJ, Ricco JB, Svetlikov A. Is stenting equivalent to endarterectomy for asymptomatic carotid stenosis? Lancet. 2022;399:1115-1116.
  18. Halliday A, Bulbulia R, Bonati LH, Chester J, Cradduck-Bamford A, Peto R, Pan H, for the ACST-Collaborative Group. Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy. Lancet. 2021;398:1065-1073.
  19. Abbott AL, Brunser AM, Giannoukas A, Harbaugh RE, Kleinig T, Lattanzi S, Poppert H, Rundek T, Shahidi S, Silvestrini M, et al. Misconceptions regarding the adequacy of best medical intervention alone for asymptomatic carotid stenosis. J Vasc Surg. 2020;71:257-269.
  20. Eslami MH, McPhee JT, Simons JP, Schanzer A, Messina LM. National trends in utilization and postprocedure outcomes for carotid artery revascularization 2005 to 2007. J Vasc Surg. 2011;53:307-315.
  21. Cole TS, Mezher AW, Catapano JS, Godzik J, Baranoski JF, Nakaji P, Albuquerque FC, Lawton MT, Little AS, Ducruet AF. Nationwide Trends in Carotid Endarterectomy and Carotid Artery Stenting in the Post-CREST Era. Stroke. 2020;51:579-587.
  22. Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G, Carotid Stenting Trialists C. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. J Vasc Surg. 2013;57:619-626 e612; discussion 625-616.
  23. Ainsworth CD, Blake CC, Tamayo A, Beletsky V, Fenster A, Spence JD. 3D ultrasound measurement of change in carotid plaque volume: a tool for rapid evaluation of new therapies. Stroke. 2005;36:1904-1909.
  24. Makris GC, Lavida A, Nicolaides AN, Geroulakos G. The effect of statins on carotid plaque morphology: a LDL-associated action or one more pleiotropic effect of statins? Atherosclerosis. 2010;213:8-20.
  25. Migrino RQ, Bowers M, Harmann L, Prost R, LaDisa JF, Jr. Carotid plaque regression following 6-month statin therapy assessed by 3T cardiovascular magnetic resonance: comparison with ultrasound intima media thickness. J Cardiovasc Magn Reson. 2011;13:37.
  26. Bogiatzi C, Spence JD. Ezetimibe and regression of carotid atherosclerosis: importance of measuring plaque burden. Stroke. 2012;43:1153-1155.
  27. Kakkos SK, Nicolaides AN, Charalambous I, Thomas D, Giannopoulos A, Naylor AR, Geroulakos G, Abbott AL, Asymptomatic Carotid S, Risk of Stroke Study G. Predictors and clinical significance of progression or regression of asymptomatic carotid stenosis. J Vasc Surg. 2014;59:956-967 e951.
  28. Du R, Cai J, Zhao XQ, Wang QJ, Liu DQ, Leng WX, Gao P, Wu HM, Ma L, Ye P. Early decrease in carotid plaque lipid content as assessed by magnetic resonance imaging during treatment of rosuvastatin. BMC Cardiovascular Disorders. 2014;14:83.
  29. Raman G, Kitsios GD, Moorthy D, Hadar N, Dahabreh IJ, O’Donnell TF, Thaler DE, Feldmann E, Lau J. Management of Asymptomatic Carotid Stenosis: Technology Assessment Report. 2012.
  30. Paraskevas KI, Mikhailidis DP, Veith FJ. Statins induce regression of carotid artery stenosis: Fact or fiction? Int J Card. 2016;220:680.
  31. Giugliano RP, Pedersen TR, Saver JL, Sever PS, Keech AC, Bohula EA, Murphy SA, Wasserman SM, Honarpour N, Wang H, et al. Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis. Stroke. 2020;51:1546-1554.
  32. Abbott A. Words of Caution Regarding Safety Comparisons Between Transcarotid Artery Revascularization, Carotid Endarterectomy, and Carotid Stenting. JAHA. 2022;11:e027402.
  33. Brott TG, Hobson RW, 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. New Eng J Med. 2010;363:11-23.
  34. Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. New Eng J Med. 2004;351:1493-1501.
  35. Abbott AL. Bias in the use of randomized trials for carotid stenosis management. Gefasschirurgie. 2015;20:252-257.
  36. Wallaert JB, De Martino RR, Finlayson SR, Walsh DB, Corriere MA, Stone DH, Cronenwett JL, Goodney PP. Carotid endarterectomy in asymptomatic patients with limited life expectancy. Stroke. 2012;43:1781-1787.
  37. Conrad MF, Kang J, Mukhopadhyay S, Patel VI, LaMuraglia GM, Cambria RP. A risk prediction model for determining appropriateness of CEA in patients with asymptomatic carotid artery stenosis. Ann Surg. 2013;258:534-538; discussion 538-540.
  38. Wallaert JB, Cronenwett JL, Bertges DJ, Schanzer A, Nolan BW, De Martino R, Eldrup-Jorgensen J, Goodney PP, Vasc Study Grp New E. Optimal selection of asymptomatic patients for carotid endarterectomy based on predicted 5-year survival. J Vasc Surg. 2013;58:112-118.
  39. Melin AA, Schmid KK, Lynch TG, Pipinos, II, Kappes S, Longo GM, Gupta PK, Johanning JM. Preoperative frailty Risk Analysis Index to stratify patients undergoing carotid endarterectomy. J Vasc Surg. 2015;61:683-689.
  40. Pandip V, Lee A, Zeesham M, Goshima K, Tan TW, Jhajj S, Trinidad B, Weinkauf C, Zhou W. Effective frailty syndrome on outcomes of patients with carotid stenosis. J Vasc Surg. 2020;71:1595-1600.
  41. Schermerhorn ML, Fokkema M, Goodney P, Dillavou ED, Jim J, Kenwood CT, Siami FS, White RA, Committee SVSO. The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry. J Vasc Surg. 2013;57:1318-1324.
  42. Motamed C, Motamed-Kazerounian G, Merle JC, Dumerat M, Yakhou L, Vodinh J, Kouyoumoudjian C, Duvaldestin P, Becquemin JP. Cardiac troponin I assessment and late cardiac complications after carotid stenting or endarterectomy. J Vasc Surg. 2005;41:769-774.
  43. Blackshear JL, Cutlip DE, Roubin GS, Hill MD, Leimgruber PP, Begg RJ, Cohen DJ, Eidt JF, Narins CR, Prineas RJ, et al. Myocardial infarction after carotid stenting and endarterectomy: results from the carotid revascularization endarterectomy versus stenting trial. Circulation. 2011;123:2571-2578.
  44. Moghadam-Kia S, Oddis C, Aggarwal R. Approach to asymptomatic creatinine kinase elevation. Cleveland Clinic Journal of Medicine. 2016;83:37-42.
  45. Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, Cao L, Fu Q, Wijeratne T, Leung TW, et al. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015;46:3288-3301.
  46. Abbott AL. Management of Patients with Asymptomatic Carotid Stenosis May Need to Be Individualized: A Multidisciplinary Call for Action. Journal of Stroke. 2022;24:160-162. doi: https://doi.org/10.5853/jos.2021.03034
  47. Silver B, Zaman IF, Ashraf K, Majed Y, Norwood EM, Schuh LA, Smith BJ, Smith RE, Schultz LR. A randomized trial of decision-making in asymptomatic carotid stenosis. Neurology. 2012;78:315-321.
  48. Hobson RW, 2nd, Weiss DG, Fields WS, Goldstone J, Moore WS, Towne JB, Wright CB. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. New Eng J Med. 1993;328:221-227.
  49. Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, Rankin RN, Clagett GP, Hachinski VC, Sackett DL, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. New Eng J Med.1998;339:1415-1425.
  50. European Carotid Surgery Trialists’ Collaborative Group t. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998;351:1379-1387.
  51. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995;273:1421-1428.
  52. Abbott AL. Symptomatic Patients and Stroke Risk Before Carotid Endarterectomy or Stenting. Eur J Vasc Endovasc Surg. 2021. Nov;62(5):825
  53. Chang RW, Tucker LY, Rothenberg KA, Lancaster E, Faruqi RM, Kuang HC, Flint AC, Avins AL, Nguyen-Huynh MN. Incidence of Ischemic Stroke in Patients With Asymptomatic Severe Carotid Stenosis Without Surgical Intervention. JAMA. 2022;327:1974-1982.
  54. Abbott A. Asymptomatic carotid stenosis and stroke risk. Lancet Neurol. 2022;20:698-699.
  55. Howard DPJ, Gaziano L, Rothwell PM, Oxford Vascular Study. Risk of stroke in relation to degree of asymptomatic carotid stenosis: a population-based cohort study, systematic review, and meta-analysis. Lancet Neurol. 2021;20:193-202.
  56. Abbott AL. Medical (nonsurgical) intervention alone is now best for prevention of stroke associated with asymptomatic severe carotid stenosis: results of a systematic review and analysis. Stroke. 2009;40:e573-583.
  57. Columbo JA, Martinez-Camblor P, Stone DH, Goodney PP, O’Malley AJ. Procedural Safety Comparison Between Transcarotid Artery Revascularization, Carotid Endarterectomy, and Carotid Stenting: Perioperative and 1-Year Rates of Stroke or Death. JAHA. 2022;11:e024964.
  58. Zhang GQ, Bose S, Stonko DP, Abularrage CJ, Zarkowsky DS, Hicks CW. Transcarotid artery revascularization is associated with similar outcomes to carotid endarterectomy regardless of patient risk status. J Vasc Surg. 2022;76:474-481 e473.
  59. Cui CL, Dakour-Aridi H, Lu JJ, Yei KS, Schermerhorn ML, Malas MB. In-Hospital Outcomes of Urgent, Early, or Late Revascularization for Symptomatic Carotid Artery Stenosis. Stroke. 2022;53:100-107.
  60. Liang P, Cronenwett JL, Secemsky EA, Eldrup-Jorgensen J, Malas MB, Wang GJ, Nolan BW, Kashyap VS, Motaganahalli RL, Schermerhorn ML. Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk. JAMA Neurol. 2023;80(5):437-444.
  61. Chaturvedi S. Transcarotid Artery Revascularization for Stroke Prevention-Multiple Elephants in the Room. JAMA Neurol. 2023;80(5):435-436
  62. Malas MB, Dakour-Aridi H, Kashyap VS, Eldrup-Jorgensen J, Wang GJ, Motaganahalli RL, Cronenwett JL, Schermerhorn ML. TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project. Ann Surg. 2022;276:398-403.
  63. Perez-Troncoso D, Epstein D, Davies AH, Thapar A. Cost-effectiveness of carotid endarterectomy in symptomatic patients. Brit J Surgy. 2023;110:193-199.
  64. Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004;363:1491-1502.
  65. Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ. Sex difference in the effect of time from symptoms to surgery on benefit from carotid endarterectomy for transient ischemic attack and nondisabling stroke. Stroke. 2004;35:2855-2861.
  66. Bekelis K, Skinner J, Gottlieb D, Goodney P. De-adoption and exnovation in the use of carotid revascularization: retrospective cohort study. BMJ. 2017;359:j4695.
  67. Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, Warlow CP, Barnett HJ. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003;361:107-116.
  68. Beach KW, Leotta DF, Zierler RE. Carotid Doppler velocity measurements and anatomic stenosis: correlation is futile. Vasc Endovascular Surg. 2012;46:466-474.
  69. Gornik HL, Rundek T, Gardener H, Benenati JF, Dahiya N, Hamburg NM, Kupinski AM, Leers SA, Lilly MP, Lohr JM, et al. Optimization of duplex velocity criteria for diagnosis of internal carotid artery (ICA) stenosis: A report of the Intersocietal Accreditation Commission (IAC) Vascular Testing Division Carotid Diagnostic Criteria Committee. Vasc Med. 2021;26:515-525.
  70. Townsend TC, Saloner D, Pan XM, Rapp JH. Contrast material-enhanced MRA overestimates severity of carotid stenosis, compared with 3D time-of-flight MRA. J Vasc Surg. 2003;38:36-40.
  71. Horev A, Honig A, Cohen JE, Goldbart A, Dizitzer Y, Star M, Gomori JM, Zlotnik Y, Ifergane G, Borodetsky V, et al. Overestimation of carotid stenosis on CTA – Real world experience. J Clin Neurosci. 2021;85:36-40.
  72. Jareczek F, Farrell MB, E. L, Sila CA, Terry J, Sacks D, Kalapos P, Simon S, Crockroft KM. Over estimation of percent stenosis by physician operators may lead to carotid stent over utilisation. Available at: https://www.ahajournals.org/doi/10.1161/str.54.suppl_1.133. 2023 International/conference oral abstract #133. 2023.
  73. Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019;18:559-572.
  74. van Dam-Nolen DHK, Truijman MTB, van der Kolk AG, Liem MI, Schreuder F, Boersma E, Daemen M, Mess WH, van Oostenbrugge RJ, van der Steen AFW, et al. Carotid Plaque Characteristics Predict Recurrent Ischemic Stroke and TIA: The PARISK (Plaque At RISK) Study. JACC Cardiovascular Imaging. 2022;15:1715-1726.
  75. Abbott AL. Imaging the Carotid Artery: Counterpoint-Why Luminal Stenosis Remains the Most Important Imaging Feature in 2022. American Journal of Roentgenology. 2023;220:345-346.
  76. Eckstein HH, Reiff T, Ringleb P, Jansen O, Mansmann U, Hacke W, Investigators S. SPACE-2: A Missed Opportunity to Compare Carotid Endarterectomy, Carotid Stenting, and Best Medical Treatment in Patients with Asymptomatic Carotid Stenoses. Eur J Vasc Endovasc Surg. 2016;51:761-765.
  77. 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds, 2023: https://www.cms.gov/oact/tr/2023.
  78. Kruk ME, Gage AD, Arsenault C, Jordan K, Leslie HH, Roder-DeWan S, Adeyi O, Barker P, Daelmans B, Doubova SV, et al. High-quality health systems in the Sustainable Development Goals era: time for a revolution. Lancet Glob Health. 2018;6:e1196-e1252.
  79. The Council of Canadian Academies (CCA). Fault Lines. Ottawa (ON): Expert Panel on the Socioeconomic Impacts of Science and Health Misinformation, CCA, 2023. Available at: https://cca-reports.ca/reports/the-socioeconomic-impacts-of-health-and-science-misinformation/.
  80. Berwick DM. Salve Lucrum: The Existential Threat of Greed in US Health Care. JAMA 2023;329:629-630.
  81. Venermo M, Wang G, Sedrakyan A, Mao J, Eldrup N, DeMartino R, Mani K, Altreuther M, Beiles B, Menyhei G, et al. Editor’s Choice – Carotid Stenosis Treatment: Variation in International Practice Patterns. Eur J Vasc Endovasc Surg. 2017;53:511-519.
  82. Sorber R, Holscher CM, Zarkowsky DS, Abularrage CJ, Black JH, 3rd, Wang GJ, Hicks CW. Increased Regional Market Competition is Associated with a Lower Threshold for Revascularization in Asymptomatic Carotid Artery Stenosis. Annals Vasc Surg. 2022;87:164-173.
  83. Abbott AL, Budincevic H. Carotid stenosis management: Getting the genie back in the bottle. HJVEVS. 2023;4:84-85.

Anne Abbott is a neurologist in the Department of Neuroscience at Central Clinical School, Monash University, in Melbourne, Australia. She has received several grants for independent research on the topic of stroke prevention. However, she was not academically funded at the time of creating this manuscript. She is also the founding member of FACTCAT. All authors, and most co-signatories, are FACTCAT members. The views of particular FACTCATs do not necessarily reflect the views of others. Lawrence Schott, MD, is a retired neuroradiologist, in Ireland and was the medical officer (2000–2013) for the Coverage and Analysis Group (CAG), Office of Clinical Standards and Quality (OCSQ), at CMS, and the lead medical officer, Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), Management of Carotid Atherosclerosis, Jan. 25, 2012. Lan Gao, MMed, PhD, is a senior lecturer in health economics at the Institute for Health Transformation, School of Health & Social Development, Deakin University, in Melbourne, Australia. Hrvoje Budincevic, MD, PhD, is head of the Stroke and Intensive Care Unit and deputy dead of the Department of Neurology at Sveti Duh University Hospital, in Zagreb, Croatia. Rishad Faruqi, MD, is clinical associate professor of surgery (affiliate) at Stanford University and clinical associate professor of surgery (affiliate) at University of California, San Francisco (UCSF). Tatjana Rundek, MD, PhD, is professor of neurology in the Department of Neurology at Miller School of Medicine in Miami, Florida. She holds National Institutes of Health (NIH) grants that are unrelated to this manuscript. Jean-Baptiste Ricco, MD, PhD, is a vascular surgeon in the Department of Vascular Surgery at the University Hospital of Toulouse and University of Poitiers in France. Saeid Shahidi, MD, is a senior consultant in vascular surgery, chief consultant in supra aortic disease, research chief physician in vascular surgery, and associate professor at the University of Copenhagen and Zealand, Department of Cardiology and Vascular Surgery at Zealand University Hospital in Roskilde, Denmark. Gert J. de Borst, MD, PhD, is head of the Department of Vascular Surgery at University Medical Centre of Utrecht, the Netherlands. 

Co-signatories: Anne Abbott (Neurologist, Australia); Mohamad AbdalKader (interventional neuroradiologist, U.S.); Yogesh Acharya (vascular surgeon, Ireland); Nishath Altaf (vascular surgeon, Australia); Pier Luigi Antignani (angiologist, Italy); Omar Ayoub (neurologist, Saudi Arabia); Hernan Bazan (vascular surgeon, U.S.); Peter Bell (vascular surgeon, United Kingdom); Ruth Benson (vascular surgeon, New Zealand); Aleš Blinc (cardiologist/vascular physician, Slovenia); Alejandro Brunser (neurologist, Chile); Hrvoje Budincevic (neurologist, Croatia); Jonathan Cardella (vascular surgeon, U.S.); Robert Chang (vascular surgeon, U.S.); Alun Davies (vascular surgeon, United Kingdom); Gert J. de Borst (vascular surgeon, the Netherlands); Rishad Faruqi (vascular surgeon, U.S.); Aaron Gaekwad (neurologist physician trainee, Australia); Lan Gao (health economist, Australia); Hannah Gardener (epidemiologist, U.S.); Richard Genova (registered vascular technologist, U.S.); George Geroulakos (vascular surgeon, Greece/United Kingdom); Athanasios Giannoukas (vascular surgeon, Greece); Harry Gibbs (general & vascular medicine physician, Australia); Peter Gloviczki, (vascular surgeon, U.S.); Anders Gottsäter (vascular physician, Sweden); Guillaume Goudot (vascular physician, France); Jose Gutierrez (neurologist, U.S.); Vassilis Hadjianastassiou (vascular surgeon, United Kingdom); Kimberley Hammar (PhD candidate & resident [emergency medicine], Sweden); Robert Harbaugh (neurosurgeon, U.S.); Eitan Heldenberg (vascular surgeon, Israel); Caitlin Hicks (vascular surgeon, U.S.); Michal Juszynski (vascular surgeon, Poland); Stavros Kakkos (vascular surgeon, Greece); Anthony Kam (neuroradiologist, Australia); Zubair Kareem (neurologist, U.S.); Tien Khoo (internist [general & acute] medicine, Australia); Stefan Kiechl (neurologist, Austria); Timothy Kleinig (neurologist, Australia); Michael Knoflach (neurologist, Austria); Simona Lattanzi (neurologist, Italy); Kaitlyn Lillemoe (neurologist, U.S.); Ian Loftus (vascular surgeon, United Kingdom); Fedor Lurie (vascular surgeon, U.S.); Jonas Malmstedt (vascular surgeon, Sweden); Devender Mittapalli (vascular surgeon, United Kingdom); Wesley Moore (vascular surgeon, U.S.); Bibombe Patrice Mwipatayi (vascular surgeon, Australia); Achim Neufang (vascular surgeon, Germany); Branimir Nevajda (neurologist and stroke specialist, United Kingdom); Alexander Oberhuber (vascular surgeon/endovascular specialist, Germany); Jean Panneton (vascular surgeon, U.S.); Malay Patel (vascular surgeon, India); David Pelz (neuroradiologist, Canada); Fernando Picazo Pineda (vascular surgeon, Australia); Bartlomiej Piechowski-Jozwiak (neurologist, United Arab Emirates); Holger Poppert (neurologist, Germany); Alkoredi Fatai Radji (neurologist, France); Jean-Baptiste Ricco (vascular surgeon, France); Peter Ringleb (neurologist, Germany); Jenni Robertson (consumer representative & stroke survivor, United Kingdom); David Robinson (vascular surgeon, Australia); Sara Rostanski (vascular neurologist, U.S.); Tatjana Rundek (neurologist, U.S.); David Saloner (arterial/biomedical imaging specialist, U.S.); Felix Schlachetzki (neurologist, Germany); Lawrence Schott (neuroradiologist, Ireland); Saeid Shahidi (vascular surgeon, Denmark); Joseph Shalhoub (vascular surgeon, United Kingdom); Francesco Spinelli (vascular surgeon, Italy); Daniel Staub (angiologist, Switzerland); Francesco Stilo (vascular surgeon, Italy); Tim Stokes (consumer representative & survivor of stroke misdiagnosis, Australia); Sherif Sultan (vascular surgeon, Ireland); Costas Thomopoulos (cardiologist, Greece); Raffi Topakian (Neurologist, Austria); Francesco Torella (vascular surgeon, United Kingdom); Olise Uyagu (general medical practitioner, Australia); Claude Vaislic (vascular surgeon, France); Fred Weaver (vascular surgeon, U.S.); Martin Veller (vascular surgeon, South Africa); Maarit Venermo (vascular surgeon, Finland); Alex Vesey (vascular surgeon, United Kingdom); Tissa Wijeratne (neurologist, Australia); Joshua Willey (neurologist, U.S.); Mary-Ann Williams (consumer representative & stroke survivor, Australia); Roz Williamson (allied health, Australia); Kim Wootton (consumer representative & stroke survivor, Australia); and Wei Zhou (vascular surgeon, U.S.).

WVS 2023: Western Vascular Society presidency passes from Zhou to Fujitani

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WVS 2023: Western Vascular Society presidency passes from Zhou to Fujitani
Roy M. Fujitani takes over as WVS president from Wei Zhou

Roy M. Fujitani, MD, president of the University of California, Irvine (UCI) Medical Center medical staff, took over as Western Vascular Society (WVS) president at the conclusion of the WVS annual meeting recently held in Koloa, Hawaii (Sept. 9–12).

He accepted the mantle from outgoing WVS President Wei Zhou, MD, chief of vascular and endovascular surgery at the University of Arizona in Tucson.

Zhou delivered her presidential address on the on the importance of tolerance in vascular surgery in order for the profession to thrive.

SVS-ACS Vascular Verification Program marks release of new standards for outpatient vascular centers

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SVS-ACS Vascular Verification Program marks release of new standards for outpatient vascular centers
The Vascular-VP—a joint SVS-ACS effort—now offers verification for both inpatient and outpatient vascular centers

The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have released new standards for outpatient vascular centers to help them provide optimal care and treatment of patients receiving vascular surgical and procedural care.

These new standards, outlined in the Optimal Resources for Vascular Surgery & Interventional Care—2023 Vascular-VP Outpatient Standards manual, are part of the Vascular Verification Program (Vascular-VP), launched earlier this year by the SVS and the ACS. These standards provide the requirements necessary for outpatient vascular centers to achieve and maintain verification for their vascular programs.

“Outpatient facility verification by this program demonstrates to patients, referring physicians, regulators, and payors that high quality, high value, vascular care is being delivered. Participants who successfully complete the verification process will be setting the standard for vascular care in their community,” said William Shutze, MD, chair of the Vascular-VP Outpatient Work Group and a vascular surgeon with Texas Vascular Associates in Plano, Texas.

Vascular-VP, which now offers verification for both inpatient and outpatient vascular centers, leverages the strengths and expertise of the SVS and ACS to provide a program that provides an evidence-driven, standardized pathway for instituting and growing a quality improvement and clinical care infrastructure within a center’s vascular program.

The release of this new set of standards within Vascular-VP encourages sites to put the same emphasis on quality in outpatient settings that is applied to inpatient settings, as more surgical services are directed to outpatient centers.

These new Vascular-VP outpatient standards detail elements of vascular surgical care and quality across nine domains, including:

  • Institutional commitment
  • Program scope and governance
  • Resources for facilities, equipment, services, and personnel
  • Clinical care
  • Data abstraction and analysis
  • Quality improvement

By participating in the Vascular-VP program and complying with these standards, outpatient vascular centers can develop the tools necessary to provide safe, effective, patient-centered, timely, efficient and equitable care to all vascular patients.

Together, the SVS and ACS sought to evaluate and improve the quality of care for vascular patients with the following elements: program-specific standards; infrastructure needed to meet such standards and deliver high-quality, high-value care; data collection and analysis; and verification site visits to ensure proper implementation and maintenance of these components

Centers interested in becoming verified and continuing the quality improvement journey of their vascular service are encouraged to apply online.

SAVS makes travel scholarship applications call for 2024 meeting

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SAVS makes travel scholarship applications call for 2024 meeting
In this high angle view, a group of medical students stand in their classroom. They look up and smile for the camera.

The Southern Association for Vascular Surgery (SAVS) has put out a call for applications from medical students and general surgery residents for 20 travel scholarships now available to attend the 2024 SAVS annual meeting.

Applicants must be either a medical student in years 1–3 or a general surgery resident in PGY years 1–3 who are interested in vascular surgery and able to attend the meeting from Jan. 24-27 in Scottsdale, Arizona, the Society announced. Ten of the twenty scholarships are reserved for women and underrepresented minorities.

The scholarships are worth $1,000, with the application deadline Oct. 18.

Mock oral examinations designed to prepare candidate members and vascular fellows for the Vascular Qualifying Examination are again taking place at the meeting and set for Jan. 24. The application deadline is Nov. 1 at 11:59 p.m. (EDT).

The meeting will also play host once more to a Simulation Skills Competition. Admission will be based on order received, giving priority to represent as many different vascular training programs as possible, the Society stated. Each participant will perform a carotid patch, open aortic anastomosis and thoracic endovascular aortic repair (TEVAR). The application deadline is Nov. 1, also at 11:59 PM (EDT).

VRIC 2024 set for May 15

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VRIC 2024 set for May 15

The 2024 Society for for Vascular Surgery (SVS) Vascular Research Initiatives Conference (VRIC), which concentrates on basic and translational vascular science, will take place from 7 a.m.–6 p.m. CDT on May 15, 2024, at the Hilton Chicago in Chicago. Researchers may submit abstracts from Oct. 25 through Jan. 10, 2024.

VRIC is held in the same place and in conjunction with the American Heart Association’s Vascular Discovery Scientific Sessions, set for May 15–18. Hopeful presenters may submit their abstracts for both meetings in one streamlined process.

Top-scoring VRIC abstracts submitted by trainees will be considered for the Vascular Research Initiatives Conference Trainee Award, which includes the opportunity for the authors to present their work at the conference.

The SVS Basic and Translational Research Committee organizes VRIC, which encourages thoughtful discussion among a variety of attendees, including trainees, vascular surgeon-scientists and other scientists with an interest in advancing vascular science and treatments. Highlights of the program includes abstract sessions, a scientific translational panel, poster presentations and the Alexander W. Clowes Distinguished Lecture, named for the late Clowes, an SVS member and a renowned surgeon-scientist and mentor.

More information will be published within the next few weeks.

Popliteal artery lesions: Two-year results from European DCB catheter registry announced

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Popliteal artery lesions: Two-year results from European DCB catheter registry announced
Passeo-18 Lux

“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” said Frank Vermassen, MD, chief of vascular and thoracic surgery at UZ Gent in Ghent, Belgium. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB [drug-coated balloon]-only approach.”

Vermassen was speaking as Biotronik announced the two-year results from the BIOLUX P-III BENELUX all-comers registry, which he presented as principal investigator during the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (Sept. 9–13), held in Copenhagen, Denmark.

The prospective, international, multicenter post-market registry evaluated the safety and efficacy of the Passeo-18 Lux DCB catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents.

BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, The Netherlands, and Luxembourg with Rutherford 2–5 disease and at least 2cm of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%. At 24 months:

  • Freedom from clinically driven target lesion revascularization (CD-TLR) was 81.6%
  • Freedom from major target limb amputation was 98%
  • Freedom from all-cause of death was 89.4%
  • Significant improvement of Rutherford classification was observed for 88.1% of the patients

When women are PIs: A story foretold on the vascular frontlines

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When women are PIs: A story foretold on the vascular frontlines
“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virginia, as she reflects on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. Her statement is far from isolated—underpinned by a growing body of research which addresses key gender inequities in study leadership and participation. Vascular Specialist spoke to prominent names across the global vascular space on their experiences as a PI, meditations on the barriers to access, and the vital work needed to improve diversity across the board. 

Mounting data from recent research has spurred widespread review of women’s progression in the vascular field to date. In particular, focus has been placed on how the gender of PIs has affected the balance of male and female participants enrolled in trials. Conducted in April this year, Kibbe et al evaluated 1,427 clinical trials published in the Journal of the American Medical Association (JAMA), The Lancet, and the New England Journal of Medicine (NEJM), from January 1, 2015, to December 31, 2019, to determine if women’s enrollment in research correlated with the gender of first and/or senior authors. Their results showed a positive correlation between female enrollees and female first and senior authors (51.7% vs. 48.3%, p≤0.0001)—an association which endured in subset analyses by funding source, phase, randomization for study participants, drug and/or device trial, and geographic location. 

Kibbe et al’s results uncover a deficit in both leadership and enrollment which poses crucial challenges to obtaining accurate research outcomes for women and underrepresented minorities (URMs). Adding detail to this, Kathleen Ozsvath, MD, president-elect of the Eastern Vascular Society (EVS), from St Peters Health Partners in Albany, New York, tells Vascular Specialist of the fundamental anatomical differences, presentation to care, and symptom manifestation—such as acute myocardial infarction, she adds— that differ between women and men in vascular treatment. Ozsvath notes that “these differences are yet to be better understood,” a statement echoed by Caitlin Hicks, MD, associate fellowship program director at Johns Hopkins in Baltimore, Maryland, who says that gender-based differences have “only just” begun to gain attention in vascular surgical outcomes, “despite being present for decades.” 

Considering the results of her review, “no,” is Kibbe’s resounding response when reflecting on whether current journal and society efforts are sufficient in promoting diversity and inclusion. Hicks observes the SVS’ “concerted effort over the last few years to improve equity in a wide range of vascular-related initiatives,” but there remains, she adds, a “persistent gender gap in clinical trial PIs,” despite how “critically important” rectification of enrollment inequities is. Moreover, Palma Shaw, MD, professor of surgery at the State University of New York in Albany, New York, and president-elect of the International Society for Endovascular Specialists (ISEVS), delineates that “opportunities for women’s advancement differs in each society, but regional vascular societies have been more progressive”—although when looking nationally, progression is “much slower.” Shaw continues: “Some journals have made an intentional effort to increase the number of female and underrepresented minorities as reviewers and editors. The #Medbikini movement triggered a much-needed change.” 

A watershed dressed in a bikini 

In 2020, #Medbikini marked a watershed, exposing the deepening inequities that have been slow to change. The hashtag arose after an abstract, entitled “Prevalence of unprofessional social media content among young vascular surgeons,” published in the Journal of Vascular Surgery (JVS), was shared online. Labeling bikinis “inappropriate attire,” the study warned that posting pictures wearing one could be viewed as “potentially unprofessional.” This ignited a viral response on Twitter and Instagram under the hashtag #Medbikini, seeing women and men across specialties post themselves in bikinis or casual attire in shared criticism of biased targeting of women in vascular surgery. 

The virality of the movement undoubtedly reflected back an uncomfortable truth for vascular societies and institutions, which began installing strategies to support women and URMs seeking equal opportunities in research and clinical progression. In 2019, Kim Hodgson, MD, then SVS president, established the SVS Diversity, Equity and Inclusion (DEI) Task Force. Late in 2020, as the Task Force was morphing into a committee, leaders asked members to complete a census to survey demographics and member priorities. 

In a review of the dedicated DEI session named Building Diversity and Equitable Systems in Vascular Surgery at the 2022 Vascular Annual Meeting (VAM) given by Imani E. McElroy, MD, from Harvard University, in Cambridge, Massachusetts and Carla C. Moreira, MD, from Brown University in Providence, Rhode Island, “shockingly low attendance” by both members and leaders was reported, leaving the few attendees feeling as if they had “witnessed a fumble at a one-yard line.” The subsequent social media backlash drew a brief statement from the SVS committing to continued prioritization of DEI principles to address shortcomings. 

This year, at VAM 2023, the E. Stanley Crawford Critical Issues Forum raised continued concerns over workforce maldistribution relating to the SVS’ DEI declaration, which states support of “a diverse workforce with equal opportunities.” Addressing the panel, Rana Afifi, MD, associate professor of vascular surgery at McGovern Medical School, University of Texas Health Houston in Houston, Texas, maintained how data presented by former SVS president Michel S. Makaroun, MD, from the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania—whose talk concerned insufficient numbers in the workforce pipeline—do not represent her. 

After graduating from her residency-fellowship outside of the U.S., Afifi was told after “PGY-11 years” to repeat her residency when seeking a path toward U.S. Board certification, she related from the VAM floor. Afifi asserted that others too must be “struggling,” and “are broken because they feel inadequate,” highlighting key “problems” in the handling of DEI matters relating to the vascular workforce. 

Slow progress to seniority 

“Times are changing with an interest and awareness of DEI,” Ozsvath asserts, punctuating her optimism with the fact that women are still “a fraction of the membership within vascular societies” today. This detail sits amid an international rise in the number of women in the vascular field, yet runs parallel to a wealth of new research which reports how this increase does not translate to equitable gender distribution in roles of high-level seniority or decision-making in both academia and clinical care. 

A retrospective review conducted in 2021 by Misty D. Humphries, MD, of UC Davis Health in Sacramento, California, et al—including Julie A. Freischlag, MD, the first and still only ever woman SVS president, and CEO of Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina—found that between 1999–2009 and 2010–2019, the mean percentage of women who presented abstracts at five U.S. regional and national societies “increased significantly” from 10.9% to 20.6%. However, increases in the number of women as senior authors and committee chairs remained statistically insignificant throughout both early and late periods. Humphries et al commented that efforts to recruit women into the field of vascular surgery, and support for their professional development, are “facilitated” by women in leadership roles. Speaking to Vascular Specialist, Freischlag emphasizes that the progression of women and people of color to these positions is “key” to more accurate enrollment and results in clinical research. 

In Europe too, the unequal representation of women pervades. “It’s a male community,” Marianne Brodmann, MD, head of clinical research in the division of angiography at Medical University of Graz in Graz, Austria, tells Vascular Specialist, “especially in the endovascular and [vascular] surgical [space].” Weighing in, Janet Powell, MD, professor of vascular biology and medicine at Imperial College in London, England, and co-investigator in the widely endorsed WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial, says that Europe’s advancement in this arena is “further behind” that of the U.S., which boasts the likes of Linda M. Harris, MD, who, to Powell, represents a “leading light in making life easier for women [in clinical research].” Harris set up the Women’s Vascular Summit, an annual meeting dedicated to reviewing how vascular disease presents and is treated in women. 

However, for Powell, “better representation” of women only gained significant ground around nine months ago, while the inclusion of people from minorities and lower socioeconomic groups has not yet been addressed, she adds. In particular, Powell raises concerns over the underenrollment of women and URM groups in the recent BASIL-2 and BEST-CLI trials for the management of chronic limb-threatening ischemia (CLTI). Women made up just 28% and 19% of participants in the trials, respectively, while 72% and 91% of enrollees were white. In Powell’s words, this reveals how contemporary enrollment disparities are perhaps “worse in Europe” currently, but shows a global need to urgently re-evaluate enrollment processes. 

Industry responsibility and stimulating change 

For Harris, who is a professor of vascular surgery at the University at Buffalo in Buffalo, New York, and a past president of the EVS, slow progression of diversity in PI positions and leadership roles in the vascular field is “multifactorial.” 

“Some of it is seniority, but much of it is relationships cultivated with industry in a previously more nepotistic system,” she tells Vascular Specialist. “Breaking in as a PI, especially for women, is the hard part. Once established, it is much easier to continue work with industry, and sponsorship helps immensely—or having partners from the same or different institutions.” 

However, cultivating these relationships with limited experience of the process may be “hard,” Hicks opines, and “initiative typically falls on the woman,” rather than on the industry partner’s outreach efforts. “Our industry partners need to play a role in this— many vascular trials are industry sponsored and, therefore, medical device companies need to recognize and acknowledge the lack of women PIs included in prior trials, and make a conscious effort to include women moving forward,” Hicks says. 

The rise in research concerning gender equity within vascular specialties in recent years has created a wealth of visible evidence. Hopes abound that industry and institutions will now do more. However, in a male-dominated field, fears exist that research of this nature could spark a backlash and/or result in researchers being ostracized. A study carried out by Matthew R. Smeds, MD, et al, titled “Gender disparity and sexual harassment in vascular surgical practices,” found—through an anonymous survey sent to vascular surgery faculty members at 52 training sites in the U.S. — that 32% of respondents believed that harassment most commonly occurred in surgical specialties that are historically male-dominated due to purposeful ignorance of hierarchy/ power dynamics in the field. Of the study’s conclusions, perceptions of workplace gender disparities “differed significantly” between the genders. 

Better strategies are needed 

Research such as this makes clear that alignment on gender inequities among vascular professionals must be present to affect change—in Ozsvath’s words “awareness of this deficit will encourage industry to find more diverse PIs” and support DEI initiatives more broadly. Positively, initiatives are being taken up by more institutions to improve gender disparities, such as the Athena Swan Charter—a framework used globally to support the advancement of women in higher education and research. “The initiative is taken very seriously and is supported by annual Athena Swan lectures,” Powell notes of her institution in the UK. 

For women in the vascular field, deciding to pursue academic progression can be “complex,” Harris explains, as, for women beginning down this career path, most are “also at an age when they often have young children.” Although this “does not preclude them from running studies or being academic surgeons, the work-life balance issues are still different and more complex for women than for men based on assessments of division of labor for home obligations,” she states. Yet, Harris believes that this is “starting to change” as the younger generations “[embrace] more of a work-life balance for all.” 

When speaking to Vascular Specialist, all interviewees coalesced around the idea that women’s representation in academic and clinical leadership, as well as in research enrollment, must be addressed collectively to accelerate progression to gender equity. Most vitally, through better representation, Powell says, women who have previously been “underrepresented and underserved” in clinical research can be more accurately assessed and treated with improved knowledge of their crucial vascular variations. 

For Shaw, the positioning of women in these roles and the targeted enrollment of women need to be “deliberate and established at the time of the proposal for the trial.” This approach must include women from “diverse backgrounds,” Ozsvath says, “so we can better understand how these patient populations differ in presentation and what best treatment options exist specific to them.” By measuring the impact of women’s vascular differences, including “size, biologic responsiveness, hormonal issues, social determinants and trust issues,” Harris finishes, “we will be successful in moving the needle in our understanding and care of women vascular patients.” 

 

Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma

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Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma
Human Acellular Vessel
Human Acellular Vessel
Human Acellular Vessel

Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.

A press release reports that the single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the US Food and Drug Administration (FDA) during the fourth quarter of 2023.

The V005 trial was a single-arm study conducted in the USA and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. Trauma injuries are commonly contaminated, and therefore patients are at a high risk of infection. As a single-arm study, the comparators for the HAV results were benchmark outcomes for treatment with synthetics grafts based on a systematic literature search. The principal means of evaluation was comparability of secondary patency (blood flow) at 30 days, with primary patency (blood flow without intervention) also evaluated. Secondary comparisons comprised of improvement in rates of amputation and rates of infection at 30 days. A total of 69 patients were enrolled in the V005 trial, of which 51 had vascular injury of the extremities and comprised the primary evaluation group for the study.

The V005 trial was a success, Humacyte reveals, and the principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2% for the extremity patients (89.9% for total patients) compared to 81.1% historically reported for synthetic grafts. Primary patency for total HAV patients and for extremity patients was 81.2% and 84.3%, respectively, although no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications. For the secondary comparison of amputation rates, the HAV demonstrated an improvement with a rate of 9.8% for extremity patients (10.1% for total patients) compared to 20.6% historically reported for synthetic grafts. For the secondary comparison of infection rate, the HAV demonstrated an improvement, with a rate of 2.0% for the extremity patients (2.9% for the total patients) compared to 8.9% historically reported for synthetic grafts. There were no unexpected safety signals for the HAV in this study. An expanded presentation of the results of the V005 trial is expected to be made at the upcoming VEITHsymposium (14–18 November, New York, USA).

“We are elated that the V005 results support our expectation that the HAV may improve the treatment and outcome of patients suffering major traumatic Injuries,” said Laura Niklason, chief executive officer of Humacyte. “We are pleased to reach this major milestone, and thank the medical professionals, patients, advisors and our own team members who contributed to the success of this clinical trial. We now look forward to moving to completion of our BLA filing and planned commercial launch.”

Humacyte is currently preparing a BLA for use of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and saphenous vein is not feasible to the FDA before the end of the year. In May 2023, Humacyte’s 6mm HAV received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for urgent arterial repair following extremity vascular trauma, which provides a basis for priority review of the BLA by the FDA. Based on guidance from the FDA, Humacyte plans to pursue a traditional BLA approval which may eliminate the requirement for a post-approval confirmatory study.

The FDA has advised Humacyte to include patient outcomes from a humanitarian programme conducted in Ukraine in its BLA submission. As a result, the company is also reporting preliminary results for the 16 extremity patients from Ukraine who provided consent for use of their results. For this population, 30-day secondary patency for the HAV was 93.8% compared to 81.1% historically reported for synthetic grafts. The rate of amputation for the HAV was 0.0% compared to 20.6% historically reported for synthetic grafts. The rate of infection for the HAV was 0.0% compared to 8.9% historically reported for synthetic grafts.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

SVS launches national smoking cessation initiative

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SVS launches national smoking cessation initiative
The SVS PSO has launched a national smoking cessation initiative

The Society for Vascular Surgery’s Patient Safety Organization (SVS PSO) has formally launched a national smoking cessation initiative. It includes tools and resources to help physicians, surgeons and other healthcare professionals to help their patients kick the smoking habit.

CAN-DO (Choosing Against combustible Nicotine Despite Obstacles) includes three components to increase smoking quit rates: physician and patient toolkits; inclusion of smoking cessation variables in the SVS PSO Vascular Quality Initiative’s arterial registries; and updating smoking cessation information on the SVS website (vascular.org), which is completed. 

Vascular Specialist first reported on the initiative during the 2023 Vascular Annual Meeting (VAM).

“Getting our patients to quit smoking is probably the most important thing we can do, probably even more than any surgery we would talk about,” said Matthew Edwards, MD, a vascular surgeon with Wake Forest University School of Medicine in Winston-Salem, North Carolina.  

A press release details toolkit elements that physicians and surgeons will find useful, including a quick guide to treatment options, information on counseling via text messaging, use of smartphone apps and web-based services, a dictionary of electronic cigarettes and vaping products, resource documents, patient-facing information doctors can distribute and billable smoking cessation codes that will permit reimbursement.  

The Patient Toolkit, meanwhile, includes links to many resources on quitting smoking.   

Simply asking a patient, “Do you smoke?” is insufficient, said Gary Lemmon, MD, SVS PSO associate medical director, urging surgeons and doctors to extend the conversation to the “3 A’s”:  

  • The Ask: Ask if the patient wants to quit and when the patient smokes that first cigarette of the day
  • The Assist: Offer liberal use of nicotine replacement therapy and medications but tell the patient not to use e-cigarettes as a crutch while also smoking
  • The Advice: Refer patients to professional counseling, apps and other tools 

This targeted intervention is proven to improve success in smoking cessation, Lemmon said. “Smoking is the leading cause of preventable death and disability, 10 times more than the premature deaths from all wars fought by the U.S.,” said Lemmon. It is a major cause of cardiovascular disease and more than 90% of cancer of the lungs and other organs. Moreover, secondhand smoke increases the risk of death and disability to those who do not smoke, he said.  

Both SVS and the American Heart Association advise patients to quit smoking before surgery. 

Lemmon and Betsy Wymer, SVS PSO director of quality, noted that new technologies have multiplied the number of tools available to help people quit. “Most adults try to quit six times before being successful,” said Wymer. She and Lemmon urged surgeons to stress, “It is never too late to quit.”  

Learn more at www.vqi.org/smoking-cessation/. 

FDA approves LimFlow system for ‘no-option’ CLTI patients

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FDA approves LimFlow system for ‘no-option’ CLTI patients
Vein becoming artery with LimFlow crossing stent
PROMISE II
Vein becoming artery with LimFlow crossing stent

The Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).

LimFlow’s FDA approval follows New England Journal of Medicine publication of results from the PROMISE II multicentre prospective study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute in Cleveland, Ohio, which found that the therapy enabled most patients treated to keep their leg and experience wound healing.

Mehdi Shishehbor, DO, president of UH Harrington Heart & Vascular Institute, and Angela and James Hambrick chair in Innovation, as well as lead author and co-principal investigator of the study, said: “LimFlow is a unique alternative to major amputation, providing hope to hopeless cases. The results from this study are excellent, and expanding LimFlow’s availability beyond the hospitals participating in the clinical study has the potential to save many more limbs and lives.”

A press release details that LimFlow takes a new approach to treating patients who are facing major amputation because they have no other suitable treatment options, such as traditional bypass surgery or endovascular revascularization, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein into an artery. This shift rushes blood back into the foot.

Mehdi Shishehbor

The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialization of the deep veins (TADV) using LimFlow therapy. All patients had non-healing wounds on their feet and were facing inevitable amputation before the procedure. At six months post-procedure, the rate of limb salvage was 76%. Within the same time period, 76% of patients had completely healed or healing wounds. Freedom from all-cause mortality was 87% at six months.

“Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said Shishehbor. “At UH Harrington Heart & Vascular Institute, we are proud to have led the research that showed the FDA that LimFlow works, so that patients have another option to keep their leg and improve their quality of life.”

MVSS 2023: Aulivola takes over Midwestern Vascular reins

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MVSS 2023: Aulivola takes over Midwestern Vascular reins
Jeffrey Jim passes the gavel over to his successor as MVSS president, Bernadette Aulivola

Bernadette Aulivola, MD, the division director of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois, took over as president of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the MVSS annual business meeting held in Minneapolis, Minnesota, on Sept. 8.

Aulivola took over from Jeffrey Jim, MD, the 2022–23 MVSS president, who is chair of vascular and endovascular surgery at Allina Health Minneapolis Heart Institute in Minneapolis.

Patrick Muck, MD, chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio, who previously was an MVSS councilor, is the new president-elect of the Society for 2023–24.

The MVSS’ 47th annual meeting took place in Minneapolis from Sept. 7–9.

EVS 2023: Ozsvath assumes Eastern Vascular presidency

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EVS 2023: Ozsvath assumes Eastern Vascular presidency
The EVS saw the presidential mantle pass from Peter Faries to Kathleen Ozsvath in Washington, D.C.

Kathleen Ozsvath, MD, a vascular surgeon at St. Peters Health Partners in Albany, New York, took over as president of the Eastern Vascular Society (EVS) during the 37th EVS annual meeting that took place in Washington, D.C. from Sept. 7–9.

Ozsvath assumed the mantle following the Society’s business meeting on Sept. 8, before which the 2022–23 EVS President Peter Faries, MD, chief of vascular surgery at Mount Sinai in New York, delivered his parting presidential address before the assembled attendees.

 

FDA clears AAA-SHAPE trial for IDE approval

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FDA clears AAA-SHAPE trial for IDE approval
Impede embolisation plug, expanded

Shape Memory Medical recently announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

A press release details that AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) will enroll 180 patients with infrarenal AAAs across 40 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.

The investigational device, Impede-FX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially-available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

The AAA-SHAPE pivotal trial is preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and The Netherlands. This early experience was recently described by Andrew Holden, MD, et al in the Journal of Vascular Surgery: Cases, Innovations, and Techniques.

“The AAA-SHAPE early feasibility studies have been key to validating the procedural techniques and best practices that we will leverage in the pivotal trial,” said Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, and principal investigator of the AAA-SHAPE pivotal trial. “We are excited to initiate this widely-anticipated trial in the U.S. and abroad.”

Joining Schermerhorn as co-principal investigators are Virendra Patel, MD, chief of vascular surgery at New York Presbyterian/Columbia University Irving Medical Center in New York, and Ross Milner, chief of the Section of Vascular Surgery and Endovascular Therapy at the University of Chicago Medicine in Chicago.

“We used to consider both aneurysm regression and stability as indicators of a successful EVAR outcome. However, contemporary data reveals that stable sacs are not as benign as once thought and that any failure of the sac to regress is associated with higher long-term mortality,” said Patel. “Shape memory polymer is a meaningful advancement in AAA repair and has the potential to address these unmet needs.”

Milner added: “I commend [Shape Memory Medical] on the decision to pursue a randomized controlled trial. This head-to-head study will offer the level 1 evidence the vascular community will seek to determine the potential role of shape memory polymer in the management of AAA patients.”

Multi-society guidelines on varicose vein management published

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Multi-society guidelines on varicose vein management published
Peter Gloviczki

The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations, which update the 2011 SVS and AVF guidance on the topic, were published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL)

The new document focusses on the following topics: 

  • Evidence supporting the prevention and management of varicose vein patients with compression
  • Treatment with drugs and nutritional supplements 
  • Evaluation and treatment of varicose tributaries 
  • Superficial venous aneurysms 
  • The management of complications of varicose veins and their treatment 

The publication—authored by Peter Gloviczki (Mayo Clinic, Rochester, USA) and 19 other members of a multispecialty guideline writing committee—follows last year’s release of part one of the guidelines, which addressed duplex scanning and treatment of superficial truncal reflux.  

Gloviczki and colleagues outline in their introduction the reason behind the two-part publication of the updated guidelines. They note that all recommendations in part one were based on a new, independent systematic review and meta-analysis that “provided the latest scientific evidence to support updated or completely new guidelines on evaluation with duplex scanning and on the management of superficial truncal reflux in patients with varicose veins”. However, the authors recognised “several additional important clinical issues” needed to be addressed, despite many having varying levels of scientific evidence associated with them. For this reason, when a systematic review was not available, the writing committee based ungraded statements on a comprehensive review of the literature, combined with unanimous consensus of the expert panel. 

Alongside a series of recommendations, the writing committee highlight “several” knowledge gaps on the natural history, evaluation, prevention and treatment of patients with varicose veins, highlighting their top 20 recommendations for future research. The most important three they identify are comparative studies of polidocanol endovenous micro-foam versus physician-compounded foam for treatment of varicose tributaries, comparative studies of polidocanol endovenous micro-foam versus other techniques of thermal and non-thermal ablation of incompetent superficial truncal veins, and best metric of axial reflux to determine ablation of superficial truncal veins. 

The guideline document can be accessed in full on the JVS-VL website: https://www.jvsvenous.org/article/S2213-333X(23)00322-0/fulltext 

Vascular Nurses Week shines spotlight on vital role in patient care and innovation

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Vascular Nurses Week shines spotlight on vital role in patient care and innovation
Vascular Nurses Week is Sept. 10–16

In a world in which both medical breakthroughs and technological advancements seem to dominate the healthcare landscape, it’s easy to overlook the unsung heroes who work tirelessly to ensure that patients receive the specialized care they need. Vascular Nurses Week—Sept. 10–16—serves as a reminder of the role vascular professionals play in patient care, education and research. 

Kristen Alix, MS, ANP-BC, AGACNP-BC, CVN, a vascular nurse since 1997 and the president of the Society for Vascular Nursing (SVN), emphasizes that this celebratory week is about more than receiving recognition. It’s also a platform for education, advocacy and a call to raise awareness about vascular health. 

Alix’s interest in vascular nursing stems from the challenges posed by this specialty. “The vascular patient as a whole is a big medical puzzle for people to solve,” she said. “Such patients present a variety of comorbidities, including hypertension, cardiac disease, renal disease or diabetes, not to mention the complicated social challenges. The vascular nurse is an individual contributor to the patient’s success before, after and sometimes during the surgery.” 

Alix noted that vascular nursing is a vocation not for the faint of heart, as it places vascular nurses at the forefront of patient care. 

Founded in 1982, the SVN emerged as a society that formally acknowledged vascular nursing as a specialized field. 

The society is not composed solely of nurses, but incudes a diverse assembly of providers, researchers and leaders, spanning the spectrum of healthcare contributors. 

“My attraction to vascular nursing stems from the critical thinking and the creativity needed to help solve the patient’s issue,” she said. 

As Vascular Nurses Week neared, Alix and the SVN invited everyone to take a moment and express appreciation for the dedication, compassion and expertise of these healthcare professionals. Throughout the celebratory week, the SVN urges individuals to amplify the message by sharing the hashtag #IAMSVN across social media platforms. 

The SVN also advocates for individuals to consider offering the gift of membership to their nurse practitioners and nursing teams. 

To give the gift of membership and join in this movement, visit www.svnnet.org/page/ GIFTOFMEMBERSHIP. 

SVS urges members to take part in compensation survey—and bolster results

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SVS urges members to take part in compensation survey—and bolster results
Keith Calligaro

Organizers behind an SVS-commissioned financial compensation survey are calling on more members to fill out the short list of questions so that they can break a key 20% response-rate target and begin to publish data gleaned from participants. Any member completing the survey can learn the results, but the goal is to inform the entire membership of the results, they emphasized. 

Keith Calligaro, MD, chair of the SVS Compensation Task Force that developed the survey, highlighted the potential value of the data the survey is designed to produce: robust demographic statistics around vascular surgeon salaries and employment conditions. Calligaro also sought to allay confidentiality concerns expressed by some members related to the information they provide in the survey, which is being carried out in partnership with Phairify, a medical profession-focused data collection platform. 

“Over the last few years, many SVS members have noted that when vascular surgeons apply for a job somewhere—whether after completing a fellowship or a mid-career move—they are not sure what to expect in terms of financial compensation. This survey will help in terms of dealing with future employers, what to expect and maybe even what to ask for,” he explained. 

“We want to emphasize this is confidential information. There is no way anyone can find out which individual is filling out the survey. That’s been one concern we have heard about. People are concerned their responses will somehow be public information, which is not true.” 

The point of the survey is to ask questions in key areas around annual salaries, Calligaro said. “What is your annual salary? How old are you? Salaries might vary on age. How many years have you been in clinical practice? Do you identify as a man or a woman? Where do you work? If you work in Philadelphia, do you get paid less or more than if you work in a small hospital in Iowa? 

“There are about 25 questions, which are very basic and preliminary. We also created templates for those wishing to learn more about particular issues, such as being on call or serving as a medicolegal expert. If you fill out that template, you get access to the results.” 

The crux is this, continued Calligaro: “Twenty percent of the members have to fill out the survey before we can publish anything and allow all members to know the results.” 

In essence, in order for the SVS to publish any type of results, a 20% completion rate is required for scientific validity in the publication environment—and filling out the list of questions should take no longer than 10–15 minutes, Calligaro added. 

Phairify is working on the logistics to have office hours available to help each individual completing the survey access the data, the SVS pointed out. Once the process is ready, the Society will make an announcement. 

“Our members get inundated with surveys, and we understand that,” Calligaro said. “However, the latest figure we have is that only 10% of members have completed the survey, and we’re trying to build that up to at least 20%. If so, then I see the number of participants exploding because then we can start showing the results to all of the members.” 

The survey was launched at VAM 2023, which took place at National Harbor, Maryland, in June. Members can participate by visiting vascular.org/CompensationStudy2023. 

Members of the Compensation Task Force include Calligaro as chair; Bernadette Aulivola, MD; Ali Azizzadeh, MD; Sara Duson, MD; Geetha Jeyabalan, MD; Judith Lin, MD; Joseph Lombardi, MD; Dan McDevitt, MD; Richard Powell, MD; Matthew Smeds, MD; Mark Kristiansen, co-founder and CEO at Phairify; G. Randall Green, MD, of Phairify; Reva Bhushan, SVS director of clinical guidelines and quality practice; Carrie McGraw, SVS manager of quality improvement and practice; and Jim Wadzinski, SVS assistant executive director. 

Vascular Specialist–September 2023

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Vascular Specialist–September 2023

In this issue:

  • When women are PIs: A story foretold on the vascular frontlines
  • SVS members rally to respond to CMS carotid stenting coverage expansion proposal
  • Guest Editorial: Arthur E. Palamara, MD, onExpiation, Karl Wallenda, Oppenheimer and us” 
  • SVS calls on members to participate in financial compensation survey—and help bolster results 
  • Elections: The SVS Executive Board breaks down the demographics

 

CMS: Proposed reduced conversion factor would cut vascular surgeon reimbursements

CMS: Proposed reduced conversion factor would cut vascular surgeon reimbursements
For CY2024, CMS has proposed a conversion factor of $32.75

The Centers for Medicare & Medicaid Services (CMS) in mid-July released two payment-related proposed rules—the highly-anticipated calendar year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule (MPFS) and the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. The SVS will submit comments for both proposed rules by the Sept. 11 due date. 

For CY2024, CMS has proposed a conversion factor—a critical component for calculating Medicare payments—of $32.75, a decrease of approximately 3.4% from the CY2023 conversion factor. Preliminary SVS analysis, in addition to the impact charts provided in the proposed rule by CMS, indicate that vascular surgeons, depending on practice setting, face a 3–4% cut based on current Medicare policies proposed in the MPFS rule. 

These cuts result from a reduction in the temporary update to the conversion factor under current law and a negative budget neutrality adjustment, stemming in large part from CMS moving forward with implementation of separate payment for add-on code G2211 to account for visit complexity associated with certain office/outpatient evaluation and management care. G2211 was initially proposed three years ago, but implementation was delayed as a result of an aggressive advocacy campaign led by the surgical societies, including the SVS. 

In addition, payment reductions for many vascular surgeons are compounded by the third year of CMS’ phased-in implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule. 

CMS is proposing an update to OPPS for hospitals that meet the quality reporting requirements by 2.8%. The update is based on the projected inpatient hospital market basket percentage increase of 3%, reduced by a 0.2 percentage point for productivity adjustment. 

The SVS is aware of the significance of the policies outlined in these rules—particularly the additional Medicare payment reductions vascular surgeons face and the potential impacts on patient care and access. 

There is broad agreement thats the Medicare physician payment system is broken and that physicians/surgeons are reeling due to yearly budget neutrality adjustments and the fact that the MPFS is the only fee schedule lacking an annual inflationary update. 

The SVS, in collaboration with medical specialty societies, is continuing to work to mitigate the scheduled cuts and advance policies to stabilize the payment system in the short term and reform the system in the long term. 

To that end, the SVS supports legislation to provide an inflationary update for the MPFS (H.R. 2474) and is leading the effort that brought forth the introduction of legislation to provide targeted relief for codes most impacted by the clinical labor update policy (H.R. 3674). The SVS will also seek further delay of the G2211 code implementation via the comment period on the rule, and legislative relief with an additional delay. Visit the SVS Advocacy Center to urge your lawmakers to support these important bills. 

The SVS is analyzing both rules and will submit extensive comments to CMS. In addition, the Society will continue to collaborate with other surgical and medical specialty societies to amplify our message on Capitol Hill for Congress to address these cuts before the end of the year. 

The SVS is also working in earnest to identify long-term solutions that will provide stability and equity across the Medicare physician payment system. SVS members should be prepared to engage in these ongoing advocacy efforts through the remainder of the year. 

Megan Marcinko is SVS director of advocacy. 

Submit ideas for VAM 2024 educational sessions

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Submit ideas for VAM 2024 educational sessions
SVS PGEC Chair William Robinson

Organizers of VAM 2024 want members to consider what the modern-day vascular surgeon needs to know for optimal patient care and professional success. What’s the latest in the venous disease space? What are helpful tips and tricks in open surgery and endovascular intervention? How about new information on in the world of peripheral arterial disease (PAD)? What are the optimal practice management strategies? 

The SVS Postgraduate Education Committee (PGEC) is requesting proposals for Educational Sessions for VAM 2024. All proposals for the 2024 meeting are welcome and must be submitted by Aug. 23. Those whose proposals are selected for inclusion in the VAM program will be expected to collaborate with the PGEC on the development and delivery of the proposed sessions, and then co-moderate the session at VAM 2024, which takes place June 19–22, 2024, in Chicago, with educational sessions spread over all four days. 

“Each and every year, we want VAM to deliver the most cutting-edge, innovative, high-impact information to address the patient care and professional needs of those who care for vascular disease,” said PGEC Chair William Robinson, MD. 

“To do this, we need to mobilize the considerable enthusiasm and expertise of all of our members. So, we ask all interested members to submit proposals on the most important and current information and issues they believe impact vascular surgeons today. 

“The majority of the educational sessions come from these proposals, so it’s a great way to get involved and contribute to the impact of the Vascular Annual Meeting.” 

Educational Sessions are aimed at covering a breadth of subjects—both clinical and non-clinical—deemed important and timely to the ongoing education of SVS members and other attendees. 

These segments of the VAM agenda—which makes up close to 50% of programming each day of the meeting—occur in varying size, meet the educational needs of different age groups and practice settings, and take on formats such as small-group interactive lectures, case-based courses, and hands-on and innovative/non-didactic approaches. 

PGEC members judge proposals blindly through an online platform, followed by an unblinded selection meeting. Proposals scoring above a certain threshold are typically considered for inclusion in the VAM program, sometimes with suggestions for further development based on the overall content needs and related requirements. 

To see the formal call for submissions as well as to find the link to the submission guidelines, visit vascular.org/VAM24CallForProposals. Meanwhile, to view recordings of the sessions from VAM 2023, which took place in National Harbor, Maryland, in June, visit the VAM Online Planner at vascular.org/OnlinePlanner23.

SVS members rally to respond to CMS carotid stenting coverage proposal

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SVS members rally to respond to CMS carotid stenting coverage proposal
SVS members rallied to submit comments on controversial CMS carotid stenting coverage proposal

Nearly one-third of the public comments submitted to the Centers for Medicare & Medicaid Services (CMS) on a controversial proposed coverage decision affecting carotid stenting were from SVS members. 

“We could not have been more pleased with our members’ response to a proposal that we, as a Society, believe will negatively impact patient care, result in unnecessary procedures, and increase the number of strokes across the vascular patient spectrum,” said SVS President Joseph Mills, MD. 

Of approximately 760 responses, at least 237 were initially identified as being from SVS members, he said. “There may well be even more.” 

In July, CMS released a proposed decision that would significantly broaden coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The proposal would expand Medicare coverage of the procedure to individuals previously only eligible for coverage in clinical trials, remove the limitation of coverage to only high surgical risk individuals, and remove facility standards and approval requirements. The proposal adds shared decision-making with the patient prior to the procedure and allows Medicare Administrative Contractors (MAC) discretion for all other coverage of carotid artery PTA concurrent with stenting not otherwise addressed in the national coverage determination. 

Comments were due by Aug. 10. In the weeks prior to that, SVS leaders wrote the Society’s formal comment and embarked on a careful campaign to solicit members to add their voices to the discussion. “We focused on patient safety, because we believe it is at risk if NCD 20.7 is finalized without our issues addressed,” Mills said. 

A CMS decision is expected on or before Oct. 6. In its formal response, SVS made three recommendations. 

First, mandate utilization of a standardized “shared decision-making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders. 

“Shared decision-making is a vital component of allowing patients to receive a carotid treatment plan that best aligns with their wishes and values. Unfortunately, currently there is no validated carotid decision tool that captures the options offered in contemporary practice that are the subject of this NCD,” the Society said. 

Second, revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. “These elements are critical for ensuring a high degree of patient safety,” the Society commented. 

Third, revise the proposed decision memo to include a definition of a “qualified physician” with demonstrated core competency standards relating to carotid stenting. “CMS should work with relevant stakeholders to develop the core competency standards.” 

In its conclusion, the response states the SVS believes the coverage expansion is “premature and jeopardizes patient safety.” If CMS finalizes the proposed expansion of coverage, the letter states, the “finalized memorandum should reflect the outlined recommendations.” 

“SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate use criteria (AUC) documents, PSO-VQI Registry and other major initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with these tools and to utilize them. SVS will continue to develop these resources and make them available.” 

Mills pointed out that, among other concerns, clinical trial data from the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) trial have yet to be released, and such a major expansion of coverage should not be implemented until data have been released and analyzed. 

“Our primary focus remains, as it always has been, patient safety,” he said. “We are not anti-stent in the appropriate patient and setting. The sheer number and depth of responses from our members demonstrate the firm commitment of SVS members to quality and safety in the care of patients with vascular disease.” 

A sample of SVS members who contributed individual comments before the deadline for public submissions passed follows: 

  • Edward Gifford, MD, Hartford HealthCare, Hartford, Connecticut: “As a young vascular surgeon, I feel this proposed decision does not do enough to monitor for the safety of patients after removing previous guardrails for carotid artery stenting. I feel that transfemoral stenting (TF-CAS] has a role in carotid stenosis. However, on the whole, our threshold to intervene on asymptomatic disease has only increased as medical therapy advances.” 
  • Katharine McGinigle, MD, University of North Carolina at Chapel Hill: “Before the new level 1 data is available, I do not think that it is appropriate to change practice patterns. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD 20.7 is premature and jeopardizes patient safety.” 
  • Robert Molnar, MD, Michigan Vascular Center, Flint, Michigan: “Not only is [NCD 20.7] premature, given the pending CREST-2 trial, which specifically will address the outcomes of TF-CAS with best medical therapy, but it completely removes common sense safeguards needed to allow for all-inclusive TF-CAS.” 
  • Elsie Gyang Ross, MD, University of California San Diego (UCSD): “With the expansion, we will likely see new outpatient ‘stroke prevention centers’ whereby a number of specialists who can navigate to the carotid and place a stent will do so, without the true consideration of patient risk. It is an unfortunate byproduct of healthcare today in the U.S.” 
  • Ali Azizzadeh, MD, Cedars-Sinai Medical Center, Los Angeles: “Since the level 1 evidence regarding the use of TF-CAS, particularly in standard-risk patients, is evolving, it seems that it is too premature to jump to approval of TF-CAS, even in high-risk patients, and I would disagree with the decision memo.”

Read about the proposed decision at vascular.org/CarotidNCD. Read the formal response at vascular.org/NCDResponse. 

Empowering vascular surgery to promote five pivotal healthcare bills before Congress

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Empowering vascular surgery to promote five pivotal healthcare bills before Congress
In the dynamic landscape of healthcare, the promotion of positive change requires more than just clinical expertise

Welcome back to Government Grand Rounds, a campaign aimed at expanding vascular surgeons’ understanding of—and comfort with—the SVS’ many advocacy tools. In the dynamic landscape of healthcare, the promotion of positive change and the advancement of our profession require more than just clinical expertise. 

As highlighted throughout this campaign, advocacy plays a critical role in shaping the future of vascular surgery. By focusing on grassroots activations and leveraging the power of our collective voice, we can promote essential initiatives and drive impactful change. 

The SVS is currently promoting five pivotal bills. By rallying behind these legislative initiatives, we can pave the way for transformative improvements in patient care and the landscape of vascular care. Together, we can use our power to promote and champion these crucial bills. 

  • H.R. 3674, the Providing Relief and Stability for Medicare Patients Act: Legislation to increase the non-facility/office-based practice expense relative value units negatively impacted by the Centers for Medicare & Medicaid Services’ clinical labor policy for the next two years 
  • H.R. 2474, the Strengthening Medicare for Patients and Providers Act: Legislation to provide annual inflationary updates, based on the Medicare Economic Index, for Medicare physician services, similar to updates received by other healthcare providers 
  • H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act: Legislation to allow borrowers in medical or dental internships or residency programs to defer student loan payments without interest until the completion of their programs 
  • H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act: Legislation to provide 14,000 new Medicare-supported graduate medical education positions over seven years 
  • H.R. 731/S. 220, the Workforce Mobility Act: Legislation to free physicians from non-competes (except in limited circumstances), providing them with an option to work for a competitor and/or more easily transition from one practice type to another 

These opportunities serve as catalysts for change and empower vascular surgeons to actively promote their profession. 

By leveraging these avenues, SVS members can play a pivotal role in shaping policies, driving awareness, and elevating the vascular specialty. To promote these bills, head to vascular.org/advocacy/grassroots-advocacy and send messages to specific lawmakers. 

Interested in learning more? Staying informed is of paramount importance in the realm of advocacy, and the SVS’ DC Update newsletter serves as a vital resource for vascular surgeons who are passionate about driving change. 

This monthly newsletter provides a comprehensive and timely overview of legislative developments, policy updates, and advocacy opportunities, empowering surgeons to stay at the forefront of the advocacy landscape. 

Members who have not received the DC Update newsletter because of preferences they have set in the communications database can send an email to [email protected] for help. 

Andrew Kenney is a member of the SVS’ Washington, D.C. office. 

Coding and complex PAD: Register today for two SVS courses

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Coding and complex PAD: Register today for two SVS courses
Participants learn complex PAD techniques at the 2022 CPVI Skills Course

Limited spots remain open for two popular SVS courses coming in October: the Complex Peripheral Vascular Interventions (CPVI) Skills Course on Oct. 1–2 and the Coding and Reimbursement Workshop (with optional half-day evaluation and management coding workshop) on Oct. 16–17.

Treating patients with peripheral arterial disease (PAD) is the largest clinical area for vascular surgeons in the U.S. Thus, being well-versed in treatment, innovations and techniques is vital. The course includes didactic and case-based learning, plus seven hours of hands-on training. Learn more and register here.

Proper coding is essential to reimbursement – and in the vascular surgery world, it’s also complicated. The workshop will provide a comprehensive review of current coding and reimbursement information, including critical updates to those who want to be well versed in vascular coding. The course is geared to both vascular surgeons and staff who perform the coding. Learn more and register here.

Step off Friday for SVS Vascular Health Step Challenge

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Step off Friday for SVS Vascular Health Step Challenge

The month of September begins Friday and with it, the SVS Foundation’s Vascular Health Step Challenge.

The initiative challenges participants to walk 60 miles—representing the 60,000 miles of blood vessels in the human body—throughout the month, which is National Peripheral Arterial Disease (PAD) Awareness Month.

The challenge amplifies the importance of vascular health while also promoting health vascular health habits. The Foundation will use funds raised to fund the future of vascular surgery and fulfill the Foundation’s mission.

According to estimates, more than 12 million people in the United States suffer with PAD, caused by buildup of plaque in the lower extremities, which narrows the arteries and causes them to become stiff. In the most severe cases, PAD can lead to amputation. 

Exercise therapy—such as walking—is a first-line response to PAD, and numerous studies have confirmed the health benefits of putting one foot in front of the other. The SVS Foundation lists a number of walking benefits on its Step Challenge information page, vascular.org/FoundationStep23. And a recent meta-analysis of 17 studies study showed people who walk at least 4,000 steps a day can lower their risk of death from any cause. Those who walk only 2,337 steps a day lower their risk of death from cardiovascular disease. 

Beyond mere bragging rights are prizes: a Sport backpack for those who meet the 60-mile goal; a Stanley drink cup for those who raise $600; a Step Challenge hat for team members who meet the $6,000 team goal; and an outdoor blanket for the top individual walker and fundraiser. 

New this year is a “Pay it Forward” initiative in which registrants offer to pay the $60 sign-up fee for low-income patients. Sponsors for this year’s Step Challenge are: AOTI, Gore, The Way to My Heart organization, Medtronic, 3M and the Society for Vascular Nursing (SVN).

First US patient enrolled in SOCRATES short neck AAA trial

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First US patient enrolled in SOCRATES short neck AAA trial
AAA

The first U.S. patient has been treated as part of the SOCRATES trial (Short neck AAA randomized trial—ESAR and FEVAR), which compares the safety and performance of endosuture aneurysm repair (ESAR) with fenestrated endovascular aneurysm repair (FEVAR) for the treatment of abdominal aortic aneurysms (AAAs) with a short neck.

The maiden procedure performed Stateside was carried out by Brant Ullery, MD, the medical director of vascular and endovascular surgery at Providence Heart and Vascular Institute in Portland, Oregon, who is a SOCRATES trial co-principal investigator.

The randomized, postmarket, head-to-head study was designed to determine whether clinical outcomes of ESAR and FEVAR are equivalent in the treatment of infrarenal AAAs with a core lab-measured short proximal neck length of 4–15mm and minimal infrarenal sealing zone of 8mm, the trial’s sponsor, the Foundation for Cardiovascular Research and Education (FCRE), states.

Organized globally by FCRE in collaboration with Medtronic as funding partner, it randomizes patients 1:1 to either ESAR with the Endurant II/IIs stent graft system (Medtronic) and Heli-FX EndoAnchor system (Medtronic), or FEVAR with the Zenith Fenestrated AAA endovascular graft (Cook Medical) or Anaconda fenestrated stent graft (Terumo).

SOCRATES is slated to enroll approximately 204 patients at up to 40 sites globally. The prespecified safety endpoint is freedom from major adverse events through 30 days. The composite effectiveness endpoint is technical success at index procedure, freedom from type IA or type III endoleaks, freedom from aneurysm-related mortality, and freedom from secondary reinterventions through 12 months.

Heli-FX has FDA clearance for distribution in the U.S. and CE Mark approval for distribution in Europe. Zenith Fenestrated is available in the U.S. and Europe, and Anaconda is available outside the U.S.

Speaking on the design of SOCRATES at this year’s Leipzig Interventional Course (LINC 2023) in Leipzig, Germany, in June, Ullery’s co-principal investigator Giovanni Torsello, MD, from St Franziskus Hospital in Münster, Germany, expanded on the intentions of the trial, which he stated is the “first comparative” study to compare ESAR and FEVAR.

Torsello told LINC attendees how hostile aortic neck can lead to “loss of proximal seal over time,” noting how short necks are associated with increased risk of type IA endoleak and secondary procedures, ultimately asking: “How should we treat our patients with a short neck?”

Which is where SOCRATES seeks to step in.

“If we can build the first comparative trial in the treatment of such patients, and we can learn more about the fate of those treated in these ways, it will be a fantastic trial,” Torsello said.

The extension of trial enrollment to the United States from its initial European starting place would “make a great contribution to this prospective study,” he added.

The price of a cup of coffee

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The price of a cup of coffee
Adam Tanious
In the wake of the coverage of inappropriate vascular interventions in the mainstream press, guest editorialist Adam Tanious, MD, tackles the thorny issue of interactions with industry “reps”—particularly among younger surgeons. 

Many of us in the surgical community have had an emotional response to the recent New York Times article describing the questionable practices of some of the members of our medical community.1 Against this backdrop, as I look to tackle the subject of interactions with our industry partners as surgeons/ interventionalists, a few disclosures: 

  • I have many positive relationships with my industry representatives 
  • I have never received any form of payment from any industry partner
  • I have just completed my MBA, taking specific courses in sales and marketing

Next, I’d like to define our terms. When I say industry, I am referring to both the publicly-traded and privately-held companies that make and manufacture devices that sparked a revolution in minimally invasive surgery we have been enjoying over the past two decades. More specifically, I am referring to the device representatives at the local level who are responsible for knowing their devices and make themselves available to assist surgeons/interventionalists in using these devices correctly to achieve the best outcomes for patients.2,3 

For those newer to the world of industry, there are two main people you will work with at the local level as it pertains to industry: your local device representative and your “clinical” representative. A device representative is, by and large, a sales representative. They are required to have expert knowledge of their device and are expected to meet certain sales targets, with one key goal of expanding the sales in their respective territories. A “clinical” is a local representative who carries expert knowledge of the device or product in question, and is immediately available to clinicians to help with proper use and troubleshooting of said device in a clinical setting. They are not held to the same “targets” as their sales representative counterparts. However, based on which company you are discussing, there is likely a mutualistic relationship between a territory’s clinical and sales representatives (collectively referred to here as “reps”).2–4 

Let us delve into the relationship our specialty has with industry and how it affects surgeons in their day-to-day practices—with a particular focus on being a young surgeon/interventionalist. 

The relationship starts during training. Depending on your training institution, you are exposed to various interactions between your attendings and their industry colleagues. Reps are always excited and engaged when meeting trainees. These interactions usually happen over a much-needed cup of coffee bought by your reps. What proceeds is, hopefully, a very fruitful and positive relationship whereby your rep teaches trainees about the device they represent and its nuances, and appropriate instructions for use. Throughout our course as trainees, we become very familiar with our reps, and often engage them regarding cases where their device is going to be used. 

As a trainee, I did not appreciate at the time how much the way my attendings interacted with their reps influenced the way that I interact with reps as a young attending. This is something not discussed enough from an educational standpoint. We as attendings need to realize that trainees are watching not just how we operate or interact with the operating room (OR) and hospital staff—they are also looking to us for guidance on interacting with our industry partners. As a young intern and junior resident, I remember being incredibly quiet and simply observing the interactions of everybody in the room when reps and attendings were together. Even though I had grown up in a household raised by a rep in the world of finance, seeing this interaction in the field of medicine still did not add up—for profit companies side-by-side with physicians. 

After graduation 

Fast-forward to when trainees are ready to graduate: I recall this time in my life vividly as it is something you’ve been anticipating for the better part of a decade. Once you have decided on where you will go to practice, the inevitable invitations for a “handoff dinner” start to arrive from your local reps who are familiar with those at the location of your future job. These dinners are lovely and really a time to interact with people in a new city where you may have never lived. These dinners offer an opportunity to put a face to the name behind the person you will likely be calling on in the middle of the night during some aortic emergency, when you still have yet to figure out the hospital system, or the inner dynamics of the OR. Additionally, in most job settings you will need to be calling on your reps for a large portion of cases, as you may not have the necessary product available at your hospital to perform your desired procedure. 

While these practices may sound questionable to a layperson reading this article, everyone must understand that these interactions go hand-in-hand with our ability as a medical community to provide patients with a “minimally invasive” option for surgery. There are very few patients who, when presented with both an open and minimally invasive surgical option, opt for the maximally invasive option. Our relationship with industry is often necessary to provide the care that patients want. 

Additionally, reps have access to resources above and beyond what educators are given to help teach and train the next generation of surgeons and interventionalists. Industry has the power to help fund conferences and educational seminars where experts are allowed to teach their clinical knowledge to a large forum of future practitioners. I can personally attest that these are invaluable teaching and training opportunities that individual training programs just cannot be expected to provide.2 

Rep ‘support’ 

Now comes the hard part of being an attending—and the hard part of this article. What happens during the cases where industry representatives are not needed but can help “facilitate” cases? Reps often offer to be present for cases to “support” the case. This typically happens when you are treating a particular category

of disease that has a multitude of treatment options (i.e., peripheral arterial disease). Stated plainly, having a rep present for a case where you have multiple device options to choose from to effectively treat your patient has the strong potential to sway your decision.2–5 

My question to everyone reading is this: should we put ourselves in a position to be swayed? 

When I have predetermined the need of a particular product for a given case, I will always call upon a trusted rep with many years of experience to be present. Reps see their product used several times a day, every day of the week. It would be wrong of me to assume that level of experience with any device, as our jobs call for us to be experts in many different types of procedures, using an array of different products. As a junior attending, newly managing so many different aspects of the OR environment, why would I not welcome additional expertise that is available to me when I have predetermined a specific tool I plan on using anyway? 

What we as practitioners must understand is the strategy to sales. Anyone with a knowledge of sales and marketing should understand that, more often than not, sales reps sell themselves, not just their product.2–6 While I truly believe that it is in the nature of every rep I have worked with to be extremely helpful and engaged in the OR, we must also realize that this is a sales tactic. The more buy-in we are given by reps during a case, the more we are likely to use their product. This extends to the cup of coffee and the meals bought for us before, between, or after cases.3,4,6 Taking it a step further, there will always be more aggressive reps who try to “actively” sell you on their product. It has happened to me personally. 

This is not to say that the majority of device reps I have worked with try to actively sell during a procedure. In fact, many of the device reps I work with are the first to pull other competitors’ products during a case if it will serve the patient best. What I am saying is that there is an interaction that occurs that has meaningful outcomes for all parties involved. More importantly, it may be harder to anticipate these interactions as freshly minted attendings than we give credit to during our training of future surgeons. 

Who belongs in the OR? 

As I have grown as an attending, my ability to recognize the nuances of these interactions has evolved rapidly. Additionally, having senior partners who have good relationships with reps has also helped. Moreover, there is an earned confidence that comes with being the primary decision-maker responsible for a patient’s care that cements the relationship between physician and rep. 

My goal here is not to provide an answer for young attendings about how to interact with industry. Rather, my aim is to start a conversation. What I think we as practitioners need to be better about is controlling who belongs in the OR. While it is not possible to know every potential problem we will run into during a case, as practitioners we should be better about deciding what tools and devices we anticipate using for specific pathologies, and ensure that, no matter who is present during a case, that our plan for our patient is not swayed by individuals who are ultimately hired to support a particular product. 

More importantly, we as attendings should be actively engaged in teaching our trainees about all the tools we use, and be a sounding board for our trainees about the merits and pitfalls of these devices in conjunction with our industry colleagues. We must provide clear guidelines around the interaction between medicine and industry for the younger, more susceptible minds among us. 

So, will I continue to have device representatives present for various cases? Yes. Will I plan on the particular device I want to use for each case before deciding on which rep to call? As often as possible, yes. Do I want my trainees to interact with and learn from my reps? Absolutely—with an attending present. If an industry representative asks whether they can come to my next case “to support me,” will I let them? I can honestly say that, in this regard, I am on the fence. 

References 

  1. Thomas K, Silver-Greenberg J, Gebeloff R. They Lost Their Legs. Doctors and Health Care Giants Profited.pdf [Internet]. New York Times. 2023. 
  2. Chung KC, Kotsis SV, Berger RA, Ummersen GV. The Relationship Between Industry and Surgery. J Hand Surg 2011;36(8):1352–9. 
  3. O’Connor B, Pollner F, Fugh-Berman A. Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 2016;11(8):e0158510. 
  4. Lively C. The Dual Role of the Medical Device Representative. Voices in Bioethics 2020. 
  5. Grundy Q, Hutchison K, Johnson J, et al. Device representatives in hospitals: are commercial imperatives driving clinical decision-making? J Méd Ethics 2018;44(9):589–92. 
  6. Moed BR, Israel HA. Device Sales Representatives in the Operating Room: Do We Really Need or Want Them? A Survey of Orthopaedic Trauma Surgeons. J Orthop Trauma 2017;31(9):e296–300. 

Adam Tanious is an assistant professor of surgery in the Division of Vascular Surgery at Medical University of South Carolina in Charleston. 

Shockwave L6 catheter expands treatment options for large-vessel cases

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Shockwave L6 catheter expands treatment options for large-vessel cases

NOTE: This video is ONLY available to watch in selected countries and geographies

The benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter—designed for use in large, calcified vessels (available in 8-12 mm diameter sizes), —were highlighted recently during a case-based roundtable discussion at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17).

Karan Garg, MD (New York City) was joined by Misty Humphries, MD (Sacramento, California) and Mathew Wooster, MD (Charleston, South Carolina) to explore how the new device has changed their practice and treatment approach in larger vessels.

To illustrate use of the device in clinical practice, Humphries shared a case where Shockwave L6 was used to treat a calcified iliac artery to enable delivering of a large bore device.  A  73-year-old man presented with a 7cm type 4 thoracoabdominal aneurysm and Humphries noted that physician-modified grafts are often used to treat these patients and that a percutaneous method is preferable, though she stressed that this requires a large device.

One alternative in cases such as this would be using a conduit, although Humphries highlighted that this is far from ideal, citing additional case time and increased blood loss. Essentially, she said, using a conduit makes a case “really challenging”.

For cases such as the one highlighted by Humphries, Garg remarked that the L6 is a “clear improvement” on the Shockwave M5+, an earlier, smaller-diameter device from Shockwave Medical—noting that it can be more effective at treating vessels with larger diameters.

Humphries reported a “great result” from the case using the L6, with the left common iliac (used for access) opened with no remaining stenosis.

Based on her clinical experience, Humphries advised users to oversize the device by 10% for optimal results. “This is not something to be afraid of,” she said, stressing that good wall apposition is key to breaking up calcium.

On a more general note, Garg admitted that while he was a “very slow adopter” of the L6 technology, he now holds the opinion that “once you start using it, you can’t get enough of it,” referencing his use of the technology in tibial vessels. “I find it very effective in that space”.

Similarly, Wooster noted that the L6 has expanded practitioners’ ability to get percutaneous access to the common femoral artery in patients who otherwise would have required a surgical cut-down. In addition, he shared that there are “really strong data” available showing benefit in these patients.

The Shockwave L6 catheter is available in the US-only.

This video is sponsored by Shockwave Medical.

Part 1: Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

Endovascular stablization system for infrarenal AAAs gains FDA Fast Track designation

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Endovascular stablization system for infrarenal AAAs gains FDA Fast Track designation

Nectero Medical announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) of maximum diameter 3.5–5cm. The company states that it is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness.

The designation allows for more frequent meetings with the FDA to ensure appropriate data collection in support of drug approval, enables eligibility for accelerated approval and priority review, and supports rolling review, where individual sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted once completed rather than waiting for the entire application to be reviewed, the company stated in a press release.

The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAA. It is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation.

Nectero Medical noted that the procedure does not require any specialized tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST system may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.

Venous stenting and the IVC: ‘Persistent problems’ in the setting of post-thrombotic syndrome

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Venous stenting and the IVC: ‘Persistent problems’ in the setting of post-thrombotic syndrome
Peter Gloviczki

The question of “persistent problems” with venous stenting among post-thrombotic syndrome (PTS) patients emerged as a key talking point during the recent Deep Venous Stenting Summit that took place during VAM 2023 in National Harbor, Maryland (June 14–17).

The issue was raised by venous disease titan Peter Gloviczki, MD, professor and chair emeritus of vascular surgery at the Mayo Clinic in Scottsdale, Arizona, after a talk by Erin Murphy, MD, director of Sanger Heart & Vascular Institute’s venous and lymphatic program in Charlotte, North Carolina, drilled into the management of stent complications—pondering whether to recanalize, explant or bypass.

Prior speaker, Mark D. Iafrati, MD, a professor of vascular surgery at Vanderbilt University Medical Center in Nashville, Tennessee, had in a prior talk on best medical treatment and surveillance protocols already provided the data behind Gloviczki’s point—published in 2013 in the Journal of Vascular Surgery by Seshadri Raju, MD, a vascular surgeon at the Rane Center in Jackson, Mississippi, and colleagues showing 90–100% patency in the setting of non-thrombotic disease and 74–89% in PTS at three to five years, outcomes which he said hold up today.

“Dr. Raju’s results are excellent, but let’s face it, about one-in-four post-thrombotic patients has problems with stents, and there are persistent problems,” Gloviczki commented from the floor during a question-and-answer session at the close of the summit. “One, for instance, is if you have a lesion very close to the IVC [inferior vena cava].

“We really don’t have a beveled stent in this country,” he continued, referring to the CE-marked sinus-Obliquus device. “Even the dedicated stents extend, at least in part, in these patients into the vena cava. So, I wanted to ask Erin if you still use the technique of combined stenting and have you had problems with the penetration of the wall by the Z-stent?”

Murphy related her early experience navigating venous dedicated stents to her intended landing spot.

“With the newer stents, I had a little bit of trouble at first trying to get them to land right at the cava and treat the cranial disease right there to the point where I almost went back to combined stenting with Z-stents,” she explained. “I’ve since fairly-well perfected landing them without jailing the other side. They are strong enough that, even if the artery is right there, they don’t collapse like the Wallstent does—it pushes the artery off, and I have not had recurrence.”

It is a different story among already-stented patients who land in Murphy’s practice, she continued. “I do see quite a bit of universal jailing of the other side. Most patients who I see in my practice that have already been stented, [the other side] is jailed. We are still pretty early—with the old stents it took us 10–15 years to say that it is a problem. I do think we have seen a couple of contralateral [deep vein thromboses] to the new stents, so I do think it will happen. And if it inadvertently happens, I encourage those patients, or If I see somebody sent [my way], I encourage them to be on low-dose anticoagulation.”

In terms of Z-stents, Murphy elaborated that she had not encountered them outside the IVC, explaining: “Typically, the ones that I’ve done in the past were inside—three quarters of them—the Wallstent, so that kind of prevents [penetration], but in the cases where they are unsupported, I have seen them outside the cava. I have not had complications from them.”

Gloviczki further pondered the specter of the external iliac vein. “We never talk about it but most of the time we stent into the external iliac vein, and mostly we do so because some of the common iliac veins are so big, but practically every time we jail the internal iliac vein, and I wonder if in the long run this is not going to be an issue.”

Murphy referred to the use of Wallstents in this setting over the years. “I don’t recall seeing a consequence of that,” she noted. “The internals are so well collateralized, but maybe we’re just not looking.”

Fellow panelist Lorena DeMarco-Garcia, MD, chief of vascular surgery at Plainview Hospital, Northwell Health in Syosset, New York, who spoke on stenting for non-thrombotic iliac vein lesions (NIVLs), concurred, saying: “The pelvic floor drains contralaterally and that is it. But I’m sure we are probably eventually causing future ostium occlusion, for sure.”

Congress considers incremental steps towards Medicare payment reform

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Congress considers incremental steps towards Medicare payment reform
Capitol Hill

There is no doubt that the Medicare payment system needs reform. At this moment, the SVS is aiming to inspire reform through all facets of effective advocacy. This takes place incrementally by raising Congressional awareness of the issues that physicians face. 

Following its enactment in 2015, Congress has not conducted rigorous oversight of the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) law. But that changed this summer with the Energy and Commerce Committee Subcommittee on Oversight and Investigations convening a hearing in June titled “MACRA Checkup: Assessing Implementation and the Challenges that Remain for Patients and Doctors.” The hearing’s intent was to give members of Congress the opportunity to hear from experts, evaluate the implementation of the law and better understand what challenges remain. 

In addition, Congressional committees with jurisdiction over healthcare matters are conducting hearings to examine the drivers of escalating healthcare costs, including consolidation and price transparency. The House Energy and Commerce, and Ways and Means committees, and the Senate Finance Committee, have held hearings on healthcare system consolidation resulting from hospital mergers, and corporate and private equity acquisition of independent physician practices. Witnesses have discussed how this practice of consolidation has demonstrated increased healthcare spending without corresponding improvements in quality of care. 

Inadequate physician payments and the instability of the Medicare physician fee schedule are factors that have led to health system consolidation. For some independent physician practices, an employment arrangement through merger with a hospital system is the only viable financial option to remain in business. 

There are many flaws in the Medicare physician fee schedule that need to be addressed so physicians receive predictable, sustainable payment. While solving these issues will necessitate a broad approach to physician payment reform, the SVS has led the Clinical Labor Coalition to advocate for the introduction of legislation providing payment relief to clinicians who provide specialty care using high-cost supplies and equipment in community-based independent practices. 

The Providing Relief and Stability for Medicare Patients Act (H.R. 3674), introduced by Reps. Gus Bilirakis (R-12- FL), Tony Cardenas (D- 29-CA), Greg Murphy (R-3-NC) and Danny Davis (D-7-IL), mitigates the reduction in payments for office-based specialty procedures due to budget neutrality and the update in clinical labor costs that the Centers for Medicare & Medicaid Services (CMS) began in 2022 and is phasing in over a four-year period. 

H.R. 3674 will provide two years of targeted relief for specialist providers who have been most adversely affected by the update of the clinical labor costs by increasing the non-facility practice expense relative value units (PE RVUs) for those procedures performed in an office-based setting that need an expensive medical device or piece of medical equipment. 

Although the SVS continues to pursue systemic physician payment reform, passage of H.R. 3674 will provide some modest relief from payment cuts that are eroding patient access to vascular care and the viability of the community-based vascular practice. This seemingly small step is a crucial piece of an effort to influence massive reform of how healthcare is funded at the federal level. 

These efforts over time can help raise awareness of the issues our specialty and physicians face, and along the way inspire reform to a more sustainable and competitive system. 

For more information on how the SVS inspires reform at the federal level, visit vascular.org/advocacy or contact [email protected]. 

Jill Rathbun is a member of the SVS Washington, D.C., office. 

First patient treated in global strategic collaboration involving Cydar Maps technology

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First patient treated in global strategic collaboration involving Cydar Maps technology
Cydar Maps
Cydar Maps

Cydar Medical has announced the successful treatment of the first patient in a strategic collaboration with Medtronic. The collaboration, which spans 40 sites across the U.S., UK and Europe, involves the integration of the company’s Cydar Maps software with Medtronic’s services and case support, with the aim of improving patient care and the efficiency of medical professionals by introducing unique artificial intelligence (AI) solutions into the clinical environment.

The first patient in the pilot program was treated using Cydar Maps at Edward Hospital  in Naperville, Illinois, by vascular and endovascular surgeon George Pontikis, MD.

Cydar Maps is the first product from Cydar’s AI technology platform and, according to the company, transforms the way information is provided to clinicians undertaking image-guided minimally invasive surgery (MIS) simplifying complexities within operating theaters at leading hospitals across the globe.

The company explains that Cydar Maps generates a 3D map of patient soft tissue to support and integrate preoperative planning, intraoperative guidance and postoperative review of endovascular MIS, using AI to update the map throughout the patient journey. Cydar Maps has been shown to offer a number of benefits, a company press release reports, including halving the radiation exposure for patients and the clinical team, simplifying the clinical workflow and increasing clinician confidence, which in turn can significantly reduce procedure times.

The pilot program is also expected to inform the ongoing development of Cydar Maps, which will include predictive analytics to support optimized procedure planning based on the use of AI to compare patient anatomy and procedure outcomes from a global data set.

Pontikis said: “This cutting-edge technology empowers us with the ability to navigate complex vascular procedures with greater precision—ensuring optimal outcomes for our patients. We are honored to be a part of this innovative program and are eager to contribute to the advancement of endovascular aortic surgery.”

Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

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Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

NOTE: This video is ONLY available to watch in selected countries and geographies

Experts gathered at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) to discuss the latest innovation from Shockwave Medical—the Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter (available in 8-12 mm diameter sizes), for use in calcified large-vessel interventions.

Karan Garg, MD (New York City, USA) was joined by Misty Humphries, MD (Sacramento, USA) and Mathew Wooster, MD (Charleston, USA) to explore how the new device has changed their practice and treatment approach in larger vessels.

According to Humphries, the larger Shockwave L6 catheter “opens up the ability to do thoracic endografting and aortic endografting for patients with calcified vessels”.

Wooster added that, while the Shockwave M5+, worked and was a “great” device, the L6 simplifies certain procedures. He explained: “Instead of having to use a small Shockwave balloon that’s truly undersized and then come back with a standard balloon in order to get up to a large enough diameter for our large-bore device, you do it in one step, and it just makes things much more efficient.”
To demonstrate the benefits of the new L6 in clinical practice, Wooster shared with the group a case that showed “how the L6 can really impact our care, and change the pathways that we have available to us”.

The case involved a 70-year-old man with a 5cm juxtarenal aneurysm, subacute ischemia, and a nearly occluded common femoral artery. Sharing the outcomes, Wooster detailed that the L6 device ensured the common femoral artery was “almost pristine” following treatment.

Commenting on the case, which Wooster said he was “fully expecting to fail,” Humphries highlighted the impressive trackability of the L6, with Garg remarking on the “well-executed” nature of the treatment.

The Shockwave L6 catheter is available in the US-only.
This video is sponsored by Shockwave Medical.

Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium

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Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium
Human Acellular Vessel
Human Acellular Vessel

Clinical outcomes of Humacyte’s investigational Human Acellular Vessel (HAV) were presented at the Military Health System Research Symposium in Kissimmee, Florida (Aug. 14–17), following a year-long humanitarian program in Ukraine. The bioengineered, implantable human tissue-based device was provided to five hospitals on the frontlines of the Ukrainian war to treat traumatic vascular injuries beginning in June 2022.   

War injuries in Ukraine have led to tens of thousands of amputations, many of which occur because blood flow cannot be restored after the injury, the company outlined in a press release. As of July 2023, the HAV has been used to treat 19 patients in the eastern European country suffering from a range of traumatic vascular injuries, including gunshots, shrapnel, blasts and industrial accidents.

Clinicians reported that the rate of success in treating patients with the HAV was high, Humacyte reported, with an observed 30-day HAV patency (presence of blood flow) of 95%. At 30 days after treatment with the HAV, the limb salvage rate was 100%, meaning no amputations occurred in patients treated with the bioengineered vessel. In addition, there was 100% patient survival and no cases of infection of the HAV. There was one patient whose HAV had to be removed due to shrapnel-related bleeding.

“The novel bioengineered, off-the-shelf HAV provides time to the surgeon and patient,” said Oleksandr Sokolov, MD, a Ukrainian vascular surgeon and HAV implanter in the humanitarian program. “It has the potential to be a significant advancement in treating life-threatening combat vascular injuries.”

Humacyte’s humanitarian program was initiated in May 2022, when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv and Kharkiv, in response to Ukrainian surgeon requests. Humacyte worked closely with the Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for the program. The company then subsequently trained Ukrainian surgeons by video conference on how to implant the HAV.

The HAV, a regenerative medicine product candidate, is designed to provide surgeons with a universally implantable, bioengineered human vessel. It is intended to be available to the surgeon immediately and provide a potentially life- and limb-saving option in circumstances where synthetics are not indicated and autologous vein is not feasible. Designed to be off-the-shelf, the HAV has the potential to save valuable time and reduce complications like amputations and tissue loss, Humacyte pointed out. Additionally, the HAV is comprised of the same tissue that makes up natural human vessels, thereby having the potential to repopulate with the patient’s own cells.

Clinical results suggest that the HAV is durable and highly infection-resistant, and therefore may be well suited for treating the contaminated wounds created by major wartime blast and shrapnel injuries, Humacyte said in the press release.

The new data from the frontlines in Ukraine will be included as part of Humacyte’s Biologics License Application (BLA) to the FDA, which is planned for the fourth quarter of 2023, the company said. The planned BLA will build on results from Humacyte’s pivotal trial studying the HAV in treating patients with vascular injury in the extremities, which recently completed enrollment. The HAV also received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation in May 2023 for urgent arterial repair following extremity vascular trauma.

The HAV has accumulated over 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. It is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Child-bearing age ‘should not be a contraindication to venous stenting’

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Child-bearing age ‘should not be a contraindication to venous stenting’

pregnancyIn a recently published study, dedicated venous stents performed well through pregnancy and postpartum, and a protocol including the use of low-dose antiplatelets in combination with anticoagulation at either a prophylactic or therapeutic dose depending on the patient’s risk profile appeared safe and effective.

Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), authors Laurencia Villalba (Vascular Care Centre, Wollongong, Australia) and Theresa A Larkin (University of Wollongong, Wollongong, Australia) share that the aim of their study was to assess the performance of dedicated iliac venous stents during subsequent pregnancy and postpartum, including stent patency and stent integrity, as well as incidence of venous thromboembolism (VTE) and bleeding complications.

The investigators outline in their introduction that, while venous stenting has become the preferred method of treatment for non-thrombotic iliac vein lesions, post-thrombotic lesions, and lesions found after thrombus removal in the setting of an acute iliofemoral deep vein thrombosis, “concern remains about stenting women of child-bearing age”. They explain that this is because pregnancy is a hypercoagulable state, and the gravid uterus can potentially compress the stent and/or the inflow vessels and thus compromise patency. Villalba and Larkin add that the current literature on the performance of venous stentings during pregnancy comprises only six studies to date, including 66 patients and 74 pregnancies with most stents assessed being Wallstents (Boston Scientific).

This was a single-site, prospective cohort study. Villalba and Larkin detail that women of child-bearing age who had received dedicated iliac venous stents were included in a surveillance program and then, for any subsequent pregnancies, followed the same pregnancy care protocol. They explain that this included an antithrombotic regimen of 100mg aspirin daily until gestation week 36, and subcutaneous enoxaparin at a dose dependent on risk of thrombosis. Going into more detail, Villalba and Larkin specify that low-risk patients, those stented for non-thrombotic iliac vein lesions, received a prophylactic dose of 40mg/day from the third trimester, while high-risk patients, those stented for thrombotic indication, received a therapeutic dose of 1.5mg/kg/day from the first trimester. All women underwent follow-up with duplex ultrasound assessment of stent patency during pregnancy and six weeks postpartum, the authors note.

The authors report that, among 10 women who had received dedicated iliac venous stents for either a non-thrombotic or thrombotic indication, and 13 post-stent pregnancies—during which a dedicated protocol for stent thrombosis prevention was followed—there was a 100% patency rate, no bleeding complications, and no VTE during pregnancy or puerperium. Only one stent was permanently deformed /compressed by the gravid uterus, but it was a Vici stent that had been “balloon fenestrated” at the time of insertion due to concerns of contralateral caging, so it had lost its structural integrity.

In the discussion of their findings, the investigators write that the main limitation of their study is its small sample size. In addition, they acknowledge that it is still unknown whether multiple pregnancies could affect stent structure over time, despite three patients having two pregnancies each.

Villalba and Larkin also highlight the study’s key strengths, including the fact that patients were followed up prospectively, and that the investigators followed a protocol including serial imaging, multidisciplinary input and a tailored antithrombotic regime.

“Dedicated iliac venous stents perform well during subsequent pregnancy with no stent occlusion or fracture,” Villalba and Larkin conclude. They state in closing that child-bearing age “should not be a contraindication to venous stenting,” though they also stress that studies reporting on a larger sample size of patients are necessary.

Study finds no correlation between IVC filter placement position and device complications

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Study finds no correlation between IVC filter placement position and device complications
IVC filter
Scott Grubman

Researchers report that inferior vena cava (IVC) filter placement position relative to the level of the most inferior renal vein was not associated with differences in IVC thrombosis in a recent single-centre cohort study.

Additional key findings from the study include a low incidence of other filter-related complications, including migration, fracture, and caval wall penetration, and no occurrence of device-related mortality. These conclusions were recently shared online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

Authors Scott Grubman (Yale University School of Medicine, New Haven, USA) and colleagues write that indwelling IVC filters can cause complications, including penetration into surrounding structures, migration, and thrombosis of the vena cava. They add that, while computational fluid dynamics suggest juxtarenal placement of IVC filters decreases the risk of thrombosis, this has not been explored clinically.

Against this background, Grubman et al communicate that it was their aim in the present study to examine the effect of filter placement position on long-term device complications with an emphasis on IVC thrombosis. “We hypothesised that IVC filters placed further caudal to the renal veins were more likely to develop long-term thrombosis,” they write.

In order to investigate their hypothesis, the researchers document that they conducted a retrospective review of the medical records of patients receiving IVC filters at a single tertiary centre between 2008 and 2016. They note that they excluded patients missing follow-up or procedural imaging data.

“The placement procedure venograms were reviewed, and the distance from the filter apex to the more inferior renal vein was measured using reported IVC filter lengths for calibration,” Grubman and colleagues detail in JVS-VL, sharing their study methods. They add that they patients were divided into three groups according to the tip position relative to the more inferior renal vein: group A (at or superior), group B (1–20mm inferior), and group C (>20mm inferior). The researchers then compared patient and procedural characteristics and outcomes between the three groups, with the primary endpoints being IVC thrombosis and device-related mortality.

Grubman et al state in the results section of their paper that, of the 1,497 eligible patients, 267 (17.8%) were excluded from the present study. They write that the most common placement position was group B (64%), and that the mean age was lowest in group C (59.5 years), followed by groups A (64.6 years) and B (62.6 years), with a p value of 0.003. The team convey that no statistically significant differences were found in the distribution of sex or the measured comorbidities.

The authors continue that group C was the most likely to receive jugular access (group C, 71.7%; group A, 48.3%; group B, 62.4%; p<0.001) and received more first-generation filters (group C, 58.5%; group A, 46.6%l group B, 52.5%; p=0.045).

Sharing their key findings from the study, Grubman and colleagues report: “The short-term (<30-day) and long-term (≥30-day) outcomes, including access site haematoma, deep vein thrombosis, and pulmonary embolism, were uncommon, with no differences between the groups.” They add that cases of symptomatic filter penetration, migration, and fracture were rare (one, one, and three cases, respectively).

The authors further highlight that, although a pattern of increasing thrombosis with more inferior placement was found, the difference between groups was not statistically significant (group A, 1.5%; group B, 1.8%; group C, 2.5%; p=0.638).

Grubman et al also relay that no cases of device-related mortality occurred, and that all-cause mortality after a mean follow-up of 2.6±2.3 years was 41.3% and did not vary significantly between the groups (p=0.051).

Finally, the authors state that multivariate logistic regression revealed that placement position did not predict for short- or long-term deep vein thrombosis, pulmonary embolism, IVC thrombosis, or all-cause mortality after adjustment for the baseline patient characteristics.

In their conclusion, Grubman and colleagues summarise: “IVC filters have low rates of short- and long-term complications, including IVC thrombosis. The placement position did not affect the occurrence of device complications in this study.”

The authors acknowledge some limitations of their study, including those “common to a retrospective medical record review”, such as inconsistent information entry into the medical records, missing or incomplete records or procedural imaging studies, potential bias from loss to follow-up, and the potential for uncaptured, non-randomised confounding variables.

In addition, Grubman et al recognise that the study “likely lacked a sufficient sample size to limit type II errors when comparing the rates of the more uncommon complications between groups” and note that “larger studies would be helpful to further elucidate the relationship between filter position and the occurrence of rare adverse events”.

Learn coding intricacies at October workshop on reimbursement

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Learn coding intricacies at October workshop on reimbursement
Sean Roddy

The SVS will host the SVS Coding and Reimbursement Workshop this fall, providing a comprehensive program designed to equip vascular surgeons and their support staff with essential knowledge and competence in appropriate billing and coding procedures. 

Over the course of the workshop, scheduled for Oct. 16– 17, attendees will receive a review of coding practices, recent changes to the current procedural terminology (CPT) and Medicare, the proper application of modifiers for streamlined reimbursement, and the impact of Medicare’s Global Surgical Package on billing and reimbursement. 

Workshop director Sean Roddy, MD, provided an overview of what attendees can anticipate during the workshop, which includes an optional half-day workshop on evaluation and management (E&M) codes. The workshop will address the intricate and distinctive aspects of vascular surgery coding that distinguish it from other medical specialties. 

“Vascular surgery has some nuances that are different from other specialties, and it is important to get the vascular lab coding correct for the ultrasounds and procedures. Endovascular procedures can be confusing on what codes you bill, so we try to clarify that with examples,” said Roddy. 

Participants can expect to receive the most up-to-date information directly from vascular surgeons who are deeply involved in the creation and valuation of codes, ensuring the most accurate and reliable recommendations. Roddy emphasized the significance of this educational event, highlighting the direct impact Medicare has on the specialty. 

“We have decreasing revenue from Medicare, which uniquely impacts vascular surgeons since up to 70% of our patient population has Medicare. Accurate coding and good documentation are crucial to optimizing our revenue for all payers, reducing denials, optimizing accounts receivable, and increasing our revenue,” said Roddy. 

The workshop demonstrates SVS’ commitment to empowering medical professionals with the tools they need to provide the highest quality of care possible, according to Roddy. 

Medical professionals interested in attending the educational course are encouraged to register early. It will be held at the OLC Education and Conference Center at SVS headquarters, 9400 W. Higgins Road in Rosemont, Illinois. 

It is designed for vascular surgeons and their office staff, including practice managers, nurse practitioners, physician assistants, nurses, surgery schedulers, coders, and others who seek to improve and expand their knowledge of accurate coding and reimbursement for vascular surgery. 

Course leaders point out the event is ideal for vascular trainees and surgeons as the level of the content is intermediate to advanced. 

Attendees can earn a maximum of 3.75 AMA PRA Category 1 Credit(s) for the optional evaluation and management (E&M) coding workshop and 10.00 AMA PRA Category 1 Credit(s) for the Coding and Reimbursement Workshop. 

The optional workshop will be held from 8 a.m.–12 p.m. Oct. 16, while the main workshop sessions will follow from 1–5 p.m. the same day and from 7:30 a.m.–4:30 p.m. on Oct. 17. 

More information about the courses and the preliminary agenda can be found at vascular.org/coding23. 

Your SVS: Executive Board sets course for year

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Your SVS: Executive Board sets course for year
SVS President Joseph Mills

Phase II of a national branding campaign for vascular surgery and three new task forces are just two of several initiatives the SVS’ Executive Board highlighted for further action during its recent board retreat.

The SVS Strategic Board meets each January to review the Society’s strategic plan and develop priorities for the coming year. Each July, the Executive Board meets to accelerate implementation of those key priorities that were identified by the Strategic Board. The Executive Board met July 27–29 under the leadership of SVS President Joseph Mills, MD, and took action to move multiple priorities forward:

  • Granted approval for and agreed to provide resources for phase II of a major national branding campaign for vascular surgery
  • Established a Bylaws Subcommittee to deliberate, carefully consider and recommend any further changes regarding selection and election of SVS officers and Executive Board members
  • Established three new task forces to fast-track development: a Research Clinical Trials (RCT) Task Force to foster and accelerate new trials; an Innovation Task Force to provide education and resources to help member entrepreneurs; and a Patient Engagement Task Force to optimize patient engagement in the work of the SVS
  • Agreed to develop a new, dedicated Advocacy/Health Policy Leadership Conference
  • Approved methodology and terminology to move forward with appropriate use criteria (AUC) for management of carotid artery occlusive disease
  • Established a private practice peer review process to augment the upcoming launch of the Vascular Verification Outpatient Program

The board will continue to keep members informed across SVS communication channels, including Pulse, Vascular Specialist, social media, SVSConnect and email, and will seek volunteers to contribute to these efforts.

“The Strategic Board was preceded by a half-day meeting of major stakeholders to consider the status and progress of diversity, equity and inclusion within the SVS,” said Mills.

“Branding, advocacy, appropriate use and outpatient peer review represent just a few of the key topics we discussed and the paths forward that we initiated. We will keep members informed and engaged as we move forward, seeking feedback, contributions and broad participation from our SVS membership.”

UCLA-SVS review course is this month

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UCLA-SVS review course is this month

Time is running out to plan attendance at the annual course, A Comprehensive Review and Update of What’s New in Vascular and Endovascular Surgery, to be held from Aug. 23–26 at the Beverly Hilton, in Beverly Hills, California. 

The course is a joint effort of the Division of Vascular and Endovascular Surgery at the University of California, Los Angeles (UCLA) and the SVS. Besides an in-depth review of the specialty, it also provides basic didactic education for vascular residents and fellows in training. Many attendees find it offers a good review before the Vascular Surgery Board (VSB) exams. 

The course recognizes four major pillars of vascular surgery practice: conventional open operations, catheter-based interventions (endovascular surgery), medical management and diagnostic imaging and noninvasive testing. 

For more information, including the schedule, visit vascular.org/UCLAReviewCourse23. 

Corner Stitch: Supplementing our formal learning as vascular trainees

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Corner Stitch: Supplementing our formal learning as vascular trainees
Christopher Audu

As a vascular surgery trainee, there are multiple aspects of vascular surgery that I’ve had the opportunity to learn about. And to be honest, I’m still learning. 

To that end, the SVS has put a great deal of effort in providing multiple opportunities to supplement our formal curriculum and cater to various academic and clinical interests through a number of short courses or fellowships. As trainees, I find that these are invaluable to fill gaps in the curriculum that may not exist at individual institutes. 

In this issue of Vascular Specialist, the SVS VQI Fellowship-In-Training (FIT) program is highlighted. This program was developed to support the curation of a cadre of trainees (general surgery, vascular surgery, cardiology, etc.) in the scientific pursuit of analysis of clinical data. I imagine that this pipeline of fellows will be important to shaping future policy in the world of vascular surgery. 

Another program supported by the SVS and aimed towards trainees is the Journal of Vascular Surgery (JVS) internship— now in its third year. This program is developing a pipeline of conscientious reviewers who will bring a diverse and nuanced approach to journal manuscript reviews to elevate the quality of work published in the JVS journals. 

Interested in the business of vascular surgery—including how coding, reimbursements and policy are intertwined? Then the annual SVS Coding & Reimbursement Workshop is for you. This 1.5-day course provides an extensive review of coding and critical updates. In addition to becoming savvy in coding and billing for cases/procedures, it helps to shine a light on the importance of policy reforms that affect billing codes and reimbursements for vascular surgery services. 

But academic pursuits are not the only domain where the SVS has developed programming. In this issue, there is a highlight on the Complex Peripheral Vascular Intervention (CPVI) Skills Course in which participants will be exposed to didactic and hands-on-training on the innovative aspects of interventions for peripheral arterial disease (PAD), including endovascular, open and hybrid options. This is a course for vascular surgeons, developed by vascular surgeons. It’s a quick two-day course at the SVS office headquarters. 

Another course with a similar flavor, although not formally supported by the SVS, is the Advanced Practical Exposures in Vascular Surgery (APEX) held at the St. Louis University hospital every fall. This course provides an invaluable hands-on experience to less commonly encountered exposures in the neck, chest, abdomen and lower extremities. The highlight of the course is the “How I Do It” didactic sessions prior to the cadaver exercises. 

And of course, there is the UCLA/SVS course that provides a comprehensive review of vascular surgical techniques. Held every August in Los Angeles, this three-day course is invaluable to the graduating vascular trainee and is often subsidized for trainee attendance. 

In addition, there are multiple opportunities to engage in courses offered through the likes of local regional societies and VAM. If there were any course I’d like to see developed, it is one that focuses on vascular trauma. I think that could be helpful to identify best practices for this vulnerable patient population. Nevertheless, as a trainee, I’m glad that these opportunities exist to plug knowledge gaps that exist in every program—and I hope that you too are able to partake in some of these courses. 

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor. He is an integrated vascular surgery resident at the University of Michigan in Ann Arbor, Michigan. 

Breaking ground: A trial to improve the care of uncomplicated type B aortic dissection

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Breaking ground: A trial to improve the care of uncomplicated type B aortic dissection
The IMPROVE-AD trial will enroll its first patient by the end of the year

Because high-quality evidence from large, prospective multicenter trials on the best treatment of uncomplicated type B aortic dissection (uTBAD) is scarce, SVS members Firas F. Mussa, MD, a professor of vascular surgery at UT-Houston in Houston, Texas, and Panos Kougias, MD, chair of the Department of Surgery at SUNY Downstate Health Sciences in New York City, are moving forward with a large randomized trial to address this unmet need. Other principal investigators are Manesh Patel, MD, Seekanth Vemalapalli, MD, and Sean O’Brien, PhD, from Duke Heart Center, Duke University and Duke Clinical Research Institute (DCRI) in Durham, North Carolina, the award recipient institution. Sherene Shalhub, MD, head of vascular surgery at Oregon Health Sciences University in Portland, Oregon, will lead the patient engagement. 

This prospective, pragmatic, randomized clinical trial, entitled IMPROVE-AD (Improving outcomes in vascular disease—aortic dissection), will enroll its first patient by the end of the year. 

Acute aortic dissection is the most common life-threatening aortic emergency, with 30–40% classified as uTBAD. The current standard-of-care consisting of optimal medical therapy with surveillance is appropriate in the majority of such dissections. However, recent data suggest early thoracic endovascular aneurysm repair, known as TEVAR, could be beneficial for some patients, said Mussa. In fact, the trial’s primary hypothesis is that the latter therapy will be superior. 

The trial will assess clinical outcomes in patients with subacute uTBAD undergoing either upfront TEVAR plus medical therapy vs. medical therapy with surveillance for deterioration. 

IMPROVE-AD is funded by the National Heart, Lung and Blood Institute (NHLBI) to enroll and randomize 1,100 patients at 60 sites in North America. It expected to last seven years and generate the sought-after quality evidence to guide daily clinical practice and future SVS guidelines. 

Panos Kougias and Firas F. Mussa

Treatment of aortic dissection is a top SVS clinical research priority in aortic disease. Writing a letter of support to Mussa, SVS Immediate Past President Michael Dalsing, MD, said, “… it is our belief that this trial addresses a significant and timely question related to the care of patients with acute type B aortic dissection as there remains clinical equipoise when considering available treatment options at the time of initial presentation. When completed, your trial will provide strong evidence that will guide clinical practice in a safe and rational manner.” 

Mussa has worked on the project for almost a decade, and, over the past several years, with support from other vascular surgeons, has refined the design and organization of the trial. “Until today, I wake up and think of the trial design, endpoint, ancillary studies, enrollment and how to get people engaged,” said Mussa. 

Personnel at the 60 sites will collect baseline history, dissection-related data and in-hospital outcomes. Duke Clinical Research Institute will collect medical events. 

To be included, uTBAD patients must be more than 21 years old and have no history of aortic intervention. The condition is defined as dissection without involvement of the aorta at, or proximal to, the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity). Patients will be randomized within 48 hours to six weeks, stratified by the presence of one of the high-risk features upon presentation. 

Site investigators will determine all subsequent care (including additional testing, medications/procedures), with the exception of aortic interventions. Such interventions will be allowed for: acute complications (rupture and/ or malperfusion, embolization, or aortoesophageal/aortotracheal fistula), aneurysmal degeneration of more than 55cm, significant aortic growth of more than 5mm over a six-month period, or persistent pain and/or hypertension during index admission. All participants will have their blood pressure monitored remotely, with follow-up administered through the use of a centralized call center with physician adjudication of relevant cardiovascular and aortic events. 

“In addition to determining the optimal treatment that leads to the best short-and long-term benefit, we also want to address other questions, including the impact of high-risk dissection features on outcomes,”said Kougias. “Also, we should aim to further understand what patients want; what are their priorities? That’s a critical part of what we should be asking.” 

The trial’s primary endpoint is the composite of all-cause death or major aortic complications. Secondary endpoints are quality of life, cardiovascular hospitalizations, cardiovascular death and components of the primary endpoint. 

The trial is sponsored by UT Health Houston, SUNY Downstate Health Sciences University, and Duke Clinical Research Institute. An IMPROVE-AD informational meeting held during VAM 2023 in June drew a crowd of surgeon-scientists and clinicians who wanted to learn more and become involved in the trial. 

Meeting attendees had many suggestions and thoughts, including on the “diagnosis-to-intervention” timeframe, with most selecting the six-week mark as the endpoint for intervention to be included in the trial. 

An attendee suggested the trial should include a parallel patient engagement plan to make sure patient voices are heard. Many indicated they are willing to enroll their patients. “Every one of you has a patient who would qualify,” Mussa pointed out to those in attendance. “My ‘ask’ of you is to please connect them with us.” He also asked surgeons to participate in the analysis and outcomes. 

IMPROVE-AD investigators also have proposed several ancillary studies pending further funding. 

Patrice Desvigne-Nickens, MD, from the NHLBI, stressed the importance of the shared partnership with the institute for the trial. “We really want this to go forward and succeed,” she said. 

The trial has several unique features, she explained, including that it is pragmatic. “It will enroll every eligible patient and really answer vital questions for surgeons,” she said. “Medicine is a random distribution of what the physician decides to do.” 

Determining systematically what is best in practice is a better way to make decisions, she added, encouraging all the surgeons in attendance to participate, either by enrolling patients or participating in analysis. “Your participation is really key,” Desvigne-Nickens concluded. 

VQI Fellows in Training program marks one year

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VQI Fellows in Training  program marks one year
FIT introduces residents and fellows in vascular surgery and medicine to the SVS PSO

The Vascular Quality Initiative (VQI) Fellows in Training (FIT) program is a success, said leaders as they provided a one-year review. 

FIT introduces residents and fellows in vascular surgery and medicine to the SVS Patient Safety Organization (PSO). Fellows worked closely with their mentors to participate in VQI regional meetings. They also participated in quality charter development, the quality improvement process and research initiatives using VQI data. FIT is run in collaboration with the Association of Program Directors in Vascular Surgery (APDVS). 

Adam Johnson, MD, a vascular surgeon at Duke Health in Durham, North Carolina, briefly reviewed the first year of the program during the recent VQI Annual Meeting in June. During the session, founding VQI Medical Director Jack Cronenwett, MD, announced the recipients of the second-year scholarship that bears his name. 

Year one included 16 mentors and 16 fellows representing 10 of the VQI’s 18 regions, said Johnson. Over the year, the fellows have submitted projects to research advisory committees, with refinement following review and data analysis. Some of the projects were included in the poster presentations at the annual meeting. Mentors were “very satisfied” with the projects overall, and trainees were “very or somewhat satisfied” with the program, Johnson said. 

Leaders added virtual meetings, to which mentors will be added this coming year; formalized the curriculum and made it more readily available; and helped provide local leadership in the aftermath of a few mentor changes. For year two, organizers will promote engagement via presentations by fellows at regional meetings, he said. 

The five scholarship winners will continue work with the program, receiving individual funding to continue their research and/or work more closely with VQI staff and committees. Scholarships are awarded in either the research or quality categories. 

Quality 

For 2023–24, the FIT fellows and mentors in the quality category are: Hanna Dakour Aridi, MD, from Indiana University Health-Methodist in Indianapolis—mentored by Michael Murphy, MD—who has studied postoperative day-one discharge, which is used as a quality-of-care indicator after carotid revascularization. Her project involved reviewing records of 122,560 elective carotid interventions in the VQI to identify drivers of increased length of stay. 

Christine Kariya, MD, from the University of Vermont Medical Center in Burlington, Vermont—mentored by Danny Bertges, MD—is working to incorporate patient-reported outcome measures (PROMs) into the electronic medical record (EMR) and VQI registries. 

Research 

In the research category, Caronae Howell, MD, from University of Utah Hospital and Clinics/The University of Arizona—who is mentored by Benjamin Brooks, MD—is studying racial and ethnic disparities in revascularization options for chronic limb-threatening ischemia (CLTI), with a study designed to compare anatomic patterns of disease and limb-salvage outcomes among patients from racial and ethnic groups undergoing first-time revascularization for lower-extremity CLTI. 

Brianna Krafcik, MD (mentor Phil Goodney, MD), from Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, is using the carotid endarterectomy and carotid stenting VQI modules to compare indirect quality-of-life measures such as length of stay, new neurologic events, frailty, and new medications between carotid endarterectomy and transcarotid artery revascularization (TCAR). 

Lastly, Ben Li, MD, from Toronto General Hospital in Toronto, Canada—mentored by Graham Roche-Nagle, MD—is developing machine learning algorithms to predict outcomes following major vascular surgery using the VQI database. He used VQI data to develop robust machine-learning models that accurately predict outcomes following carotid endarterectomy.

SVS members get ready for second annual vascular health awareness event

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SVS members get ready for second annual vascular health awareness event
The annual walking initiative benefits the SVS Foundation

September’s Vascular Health Step Challenge is fast-approaching, and SVS members are preparing to step up to meet it. 

The challenge benefits the SVS Foundation, which asks people to walk 60 miles—representing the 60,000 miles of blood vessels in the human body—throughout September. Funds raised will help the Foundation amplify the importance of vascular health while also promoting healthy vascular health habits throughout the country. 

Participants all receive a Step Challenge T-shirt and can walk individually or as part of a team. Those who registered by Aug. 5 will receive their T-shirts by Sept. 1, the start of the campaign. 

September is National Peripheral Arterial Disease (PAD) Awareness Month, making it the perfect time to highlight the benefits of walking and overall vascular health. Walking is a front-line therapy for PAD, a chronic disease in which plaque builds up in the arteries to the legs. Vascular surgeons deal with PAD routinely and, thus, are the perfect advocates for walking, said SVS Foundation Chair Michael Dalsing, MD. And, as vascular surgeons are, by nature, highly competitive, they’re typically up for such a challenge. 

For example, in asking several of 2022’s top fundraisers why they put their shoes to pavement last year, answers included the importance of walking—and beating another surgeon. 

Adam Beck, MD, walked and donated for two reasons, he said: “To support the SVS and to try to encourage others to walk as well through competition and to beat Dr. [Leigh Ann] O’Banion.” He noted, “(I lost, no surprise).” 

O’Banion, who walked as part of “Team FAB,” laughed at his response, saying her two reasons were: “I am committed to advancing the care of patients with PAD in disadvantaged and rural patient populations, and I am the most competitive person ever and was so proud to be part of a FABulous group of surgeons who kicked some butt!” 

O’Banion’s 27-member team raised the most funds, a healthy $12,970. 

Said Jesus Matos, MD: “I walked and donated because I wanted to be a role model to all of our patients. Exercise is the most powerful medicine for all chronic illnesses and the best predictor of longevity,” he said, adding, “Walk with me, 2023.” 

Laurel Hastings, MD, was also part of “Team FAB.” “I walked to support programs that fund community outreach, bringing awareness to PAD, and to give Leigh Ann O’Banion a formidable competitor,” she said, adding with a smile emoji, “See fundraising results please.” (Let the record show she was the top individual fund-raiser, beating O’Banion by $60.) 

Surgeons are undoubtedly planning their competitions for this year. 

The Vascular Step Health Challenge entry fee is $60. New this year is a “pay -it-forward” registration to help cover the participation fee for low-income vascular patients. 

The program takes place on the Charity Footprints platform. During registration, participants can link their fitness tracker to the platform to automatically log steps throughout the month of September. Eligible trackers are Apple Watch, Fitbit, Garmin, Google Fit, Misfit and Strava. Those people who don’t have eligible trackers can enter their steps manually, or connect via their smartphone. 

Pay-it-forward participants, as of July 20, are: James Persky, Edward Gifford, Bethany Slater, Yong Daniel, Kate Shuman, Rhuseet Patel, Kimberly Thomas, William Shutze, Kathryn Bowser, Dejah Judelson, Simpledeep Banipal and Bill Maloney. 

SVS responds to CMS proposed coverage expansion for carotid stenting

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SVS responds to CMS proposed coverage expansion for carotid stenting

The Society for Vascular Surgery (SVS) and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) have submitted a formal response to the Centers for Medicare & Medicaid Services (CMS) regarding its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

In a letter dated 4 August, Joseph L. Mills, MD, SVS president, on behalf of the SVS executive board, and Jens Eldrup-Jorgensen, MD, medical director of the SVS PSO, state that the SVS and its affiliated PSO “remain concerned” with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7. They go on to submit a series comments for consideration in advance of the CMS issuing a final decision memorandum. These include the negative impact on patient safety, the premature nature of the decision given that CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial] is still underway, the impact to the elderly patient population, the “substantial and lengthy” learning curve for transfemoral carotid artery stenting (TF-CAS), and the lack of a registry participation requirement.

Due to these concerns, Mills and Eldrup-Jorgensen write that they “urge CMS to revise its proposed decision memo relating to NCD 20.7” and set out a series of recommendations. These are as follows:

  • Recommendation 1. Mandate utilization of a standardized “Shared Decision Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.
  • Recommendation 2. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. These elements are critical for ensuring a high degree of patient safety.
  • Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Mills and Eldrup-Jorgensen conclude: “The SVS believes the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations. SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate care documents, PSO-VQI Registry and Initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with and to utilize them. SVS will continue to develop these resources and make them available.”

Read the full response here.

WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study completes enrolment

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WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study completes enrolment

Merit Medical has announced that it has completed enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty (PTA) for treatment of stenosis/occlusion in the venous outflow circuit in patients undergoing hemodialysis. 

Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access is required for patients undergoing hemodialysis. However, progressive stenosis and/or occlusion of blood vessels where the AVF and AVG are located can prevent delivery of hemodialysis, which can have life-threatening consequences. WRAPSODY was developed to help physicians treat patients with stenosis/occlusion in the vessels used for hemodialysis.

The WAVE study enrolled 244 patients with AVFs and 113 patients with AVGs across sites in Brazil, Canada, the UK, and the USA. Merit intends to collect safety and efficacy outcomes throughout the study follow-up period. Merit anticipates filing primary outcomes with the US. Food and Drug Administration (FDA) for premarket approval (PMA) after six months post-enrollment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.

SCVS president becomes chair of American Board of Surgery

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SCVS president becomes chair of American Board of Surgery
M. Ashraf Mansour

The American Board of Surgery (ABS) has named Society for Clinical Vascular Surgery (SCVS) President M. Ashraf Mansour, MBBS, as its 2023–24 chair. He was nominated to the ABS by the Association of Program Directors in Vascular Surgery (APDVS) in 2016.

“It is a great honor to serve as the American Board of Surgery chair this year,” said  Mansour. “I am very proud of all the accomplishments of the Board since I joined in 2016, from governance redesign to leading by example on diversity, equity, and inclusion.”

The Vascular Surgery Board (VSB), which administers the Qualifying and Certifying Exams required for board certification in vascular surgery, is part of the ABS.

“Achieving board certification is a milestone in every surgeon’s career,” said Mansour. “Being a diplomate of the American Board of Surgery tells the public that this surgeon has successfully completed surgical training and went through a rigorous certification process.”

Mansour is the chief of vascular surgery at Corewell Health in Grand Rapids, Michigan, and professor of surgery at Michigan State University. Born in Cairo, Egypt, he attended medical school at the Cairo University School of Medicine. After completing a general surgery residency at the University of Colorado Health Sciences Center in Denver,  Mansour served in the United States Army Medical Corps. He then completed a vascular surgery fellowship at Southern Illinois University in Springfield.

Mansour previously served as vice chair of the VSB from 2018–2019. He is also a past president of the Midwestern Vascular Surgical Society (MVSS).

Light-activated drug-coated balloon granted FDA approval for clinical study

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Light-activated drug-coated balloon granted FDA approval for clinical study

Alucent Biomedical has announced that the Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a U.S. clinical study of AlucentNVS, a light-activated, drug-coated balloon catheter technology.

AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow. AlucentNVS is also designed to retain the natural functionality and flexibility of the vascular wall, while avoiding traditional complications of inserting permanent implants.

AlucentNVS is currently being evaluated in two feasibility trials in Australia and Poland, also examining its use in treating peripheral artery disease (PAD) and promoting the maturation of arteriovenous fistulas (AVF) for patients requiring hemodialysis. Enrollment in those trials is expected to conclude by the end of 2023.

Vascular Specialist–August 2023

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Vascular Specialist–August 2023

In this issue:

  • SVS responds to New York Times exposé on overuse of vascular interventions 
  • Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
  • Vascular surgery added as named specialty to influential national hospital rankings
  • Guest Editorial: Adam Tanious, MD, ruminates on how to navigate industry rep exchanges 
  • uTBAD: A new randomized trial aimed at improving the lives of aortic dissection patients 

 

‘Vascular surgery should be a key member of pulmonary embolism response teams’

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‘Vascular surgery should be a key member of pulmonary embolism response teams’
The VAM pulmonary embolism session panel featuring Dennis Gable (seated, third from left)

“PERT care is the coalition of the willing,” quipped Dennis Gable, MD, a vascular surgeon at Texas Vascular Associates in Plano, Texas. He was referring to team-based care for pulmonary embolism (PE) patients and how, unlike acute stroke intervention and ST-elevation myocardial infarction (STEMI) care, PE lacks a clear owner specialty in the setting of pulmonary embolism response teams (PERTs), which represent multidisciplinary care characterized by easy accessibility, rapid response and individualized consensus-driven treatment. Gable was making the case that vascular surgeons are well poised to assume the mantle of a pivotal role during Management of Pulmonary Embolism: Fundamentals and Advances, a special session that took place during the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17).

“There is no specialty that has really stepped up and said we are going to own the right heart and lung, and a lot of people don’t want to deal with PE altogether—they want to send that to the specialty centers of which we are growing in number,” he told attendees.

PE is a problem whose scope is significant, with many centers lacking the ability to treat this patient population, Gable observed. The importance of “team” in PERTs is paramount, he emphasized. “That entails not only vascular surgery, which is an important part of this and a key member, but also cardiology, interventional radiology, your ER [emergency room] physicians, pulmonary critical care and CT [cardiothoracic] surgery.”

Based on his team’s institutional experience, the establishment of a PERT was associated with “significantly higher utilization” of catheter-directed interventions, less major bleeding events and reduced in-hospital and 30-day mortality, Gable said. “Overall, our data suggest a definite advantage for a full multidisciplinary team to treat these patients.”

Data from 2016 demonstrated that vascular surgery involvement in PERTs was not among the top contributors to PE care teams. Gable said he was not aware of more recently published data mapping out the specialty’s current role but believes it likely now is the second or third top contributor.

He contrasted this with an allusion to CT surgery’s diminished role in cardiac catheterization: “Our CT colleagues, when cardiac catheterization came out, they were so busy with development and initiation of cardiac surgery, they gave up the cardiac catheterization to cardiology primarily,” Gable explained. “They took a role of standby operator backing up the interventionalists—but currently that is no longer existent in most centers.”

“PERTS have demonstrated the value for patient survival and decreased utilization of critical care resources,” Gable concluded. “Vascular surgeons have demonstrated expertise in this arena and treatment space. Vascular surgery is, and should be, a key member of the PERT team. And, to maintain branding as a vascular specialist and for our specialty overall, should remain and strive to be leaders in the area.”

Elsewhere, Gable also referenced the emerging role of artificial intelligence (AI) in PE care, and how machine learning can shave considerable time off the process of determining management for individual patients. AI algorithms allow treatment determinations to be established in “a more rapid fashion,” he noted.

SVS urges members to make voices heard on CMS carotid stenting coverage expansion

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SVS urges members to make voices heard on CMS carotid stenting coverage expansion

The SVS has created a template to help members transmit comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed major adjustments in National Coverage Determination (NCD) 20.7, which covers carotid artery stenting (CAS).

The CMS proposal would adjust coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting by expanding coverage to individuals previously only eligible for coverage in clinical trials and to standard surgical risk individuals by removing the limitation of coverage to only high-surgical-risk individuals.

It also would remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing CAS; and allow Medicare Administrative Contractor (MAC) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

The proposed decision was released July 11, opening a 30-day comment period that ends at 11:59 p.m. Aug. 10. The SVS-provided template for individual comments reads as follows:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardize patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. These elements are critical for ensuring a high degree of patient safety.

Recommendation 2. Mandate utilization of a standardized “Shared Decision-Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If, however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Comments by individuals—or on behalf of a practice—should be submitted at vascular.org/CarotidNCD. At the close of the comment period, CMS will review each submission in advance of finalizing changes to NCD 20.7.

The SVS and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) remain concerned with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7 and are in the process of creating its formal response.

SVS leaders want members to be aware of the issue and of some of the important topics the Society will raise during the comment period. They also encourage members to make their voices heard. The template highlights several critical points that will be featured in an upcoming SVS/PSO formal comment submission.

The proposed adjustments are a result of a formal request to CMS from the Multispecialty Carotid Alliance (MSCA) in late 2022 to reconsider NCD 20.7. In it, the MSCA urged CMS to update NCD 20.7 to cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis greater than or equal to 70%, and in patients with symptomatic carotid artery stenosis greater than or equal to 50%; remove the requirement that patients are at high risk for carotid endarterectomy as well as facility and operator requirements; and leave coverage for any CAS procedure not described in the NCD to MAC discretion.

With that request, CMS opened an initial public comment period than ran from Jan. 12 to Feb. 11. During this period, the SVS and the PSO/VQI both submitted formal responses opposing reconsideration.

‘FDA’s mission to bring safe and effective vascular surgery devices to market remains steadfast’

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‘FDA’s mission to bring safe and effective vascular surgery devices to market remains steadfast’
The Vascular and Endovascular Devices Team (VEDT) in the Food and Drug Administration (FDA) Office of Cardiovascular Devices appreciates the Vascular Specialist editorial board’s offer to provide an update to the vascular community to enhance regulatory transparency and communication. In this commentary, Ronald M. Fairman, MD, Gordon Bryson, Carmen Gacchina Johnson, PhD, and Andrew Farb, MD, cover COVID-19’s impact on the team’s work, pre- and post-market data collection, physician-sponsored investigational device exemption (PS-IDE) studies, and ongoing collaborations to support timely access of innovative devices to U.S. patients. The authors are responding to a report—“Getting medical devices to market: The future might not be now, says regulatory expert”—carried in the April issue of Vascular Specialist

The COVID-19 pandemic broadly impacted the vascular community, notably numerous challenges to initiating new and conducting ongoing medical device studies. One important example was the difficulty investigators and device manufacturers faced maintaining subject follow-up compliance to collect complete and meaningful information in support of future device marketing applications. Despite the challenges during this time, sustained collaboration between FDA review staff and study sponsors helped assure access to innovative vascular surgery devices (e.g., ascending, aortic arch, descending thoracic and thoracoabdominal aortic devices). 

Two recent examples include FDA approval of the first frozen elephant trunk platform, and the first single-branch thoracic endoprosthesis for endovascular repair of descending thoracic aortic lesions that maintains blood flow into the left subclavian artery. Despite the challenges posed by COVID-19, the Office of Cardiovascular Devices worked diligently with industry sponsors to ensure novel, safe and effective devices reached the U.S. patients. In addition, there are multiple actively enrolling studies at U.S. sites for devices placed in the ascending aorta, aortic arch and thoracoabdominal aorta to treat diverse aortic pathologies.   

Given the limitations in maintaining patient follow-up compliance during the COVID-19 pandemic, as well as experience with prior studies (e.g., challenges in longer-term data collection, strict selection criteria in studies not reflecting real-world device use), and in consideration of our commitment to commercialize life-saving new therapies in a timely manner, VEDT re-evaluated our approach to post-market studies. Applying the appropriate pre-market and post-market data collection balance facilitates timely patient access to important new technology without undermining patient safety. As such, there have been new efforts to identify areas for improvement in post-market data collection.

On Nov. 3, 2021, the FDA held a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to obtain advice and recommendations on the long-term safety and effectiveness of endovascular aneurysm repair (EVAR). This meeting included industry sponsors, investigators, patient advocate organizations, and physician experts. After the panel meeting, the FDA issued a letter to healthcare providers in February 2022 and has been involved in dedicated efforts to gain alignment with stakeholders on ways to strengthen post-market data collection, which are intended to allow for a better understanding of long-term outcomes with EVAR devices, help identify safety signals, and potentially support labeling expansions. 

Independent of these post-market activities, it is important to address concerns regarding PS-IDEs evaluating the performance of devices in the thoracoabdominal aorta. These PS-IDEs typically study commercially available devices that are physician-modified or used for a new intended use, or devices that are commercially available outside of the U.S. If physician modification of a commercial aortic device or use of a commercial device for a new indication is being done on a routine basis, we continue to recommend an IDE should be submitted.    

We recognize that there are patients with complex life-threatening aortic pathologies, and PS-IDEs are an option that has been utilized to allow access to new devices or approved devices for new indications, particularly for treatment of thoracoabdominal aortic aneurysms. PS-IDEs have helped advance device design, management of bridging stent instability, patient selection, management, and prevention of spinal cord ischemia. PS-IDEs have also refined strategies to reduce radiation exposure, improve imaging, and guide accessory device use. The results of many of these studies have been published in the Journal of Vascular Surgery (JVS) and presented at the SVS’ Vascular Annual Meeting (VAM). VEDT currently has over 30 approved PS-IDEs, and the number has been growing annually.    

There are some regulatory concerns regarding PS-IDEs that can impact the availability of new beneficial therapies for patients. Typically, PS-IDEs are of limited size and scope and do not collect the definitive data needed for device approval (a reasonable assurance of safety and effectiveness). Further, PS-IDEs may have little or no industry support, such that non-clinical testing and manufacturing requirements are not met to support a marketing application. As a result, although PS-IDEs can provide important insights into device performance, the devices studied (and their physician modifications) remain investigational, and the devices are not available to treat many U.S. patients with the target clinical condition.

To address this issue, we are collaborating with investigators and manufacturers on physician-sponsored and industry-sponsored feasibility and pivotal IDE studies that will support device approval so that new safe and effective devices are available to all U.S. patients.    

There has been communication with industry and physician sponsors to discuss the future of PS-IDEs and alignment on plans to bring these life-saving aortic devices to market in a timely manner. These plans include the following: 

  • The FDA continues to consider access to devices through PS-IDEs as long as adequate information is provided to support the IDEs (e.g., non-clinical information, individual investigator experience). When there is significant interest in device access, efforts are underway to pursue manufacturer-sponsored studies and/or marketing applications in a timely manner. 
  • Device manufacturers and the FDA are working together to limit the number of PS-IDEs so as not to create situations that would in effect constitute commercializing an investigational device.   
  • Stakeholders are collaborating to determine if existing data is adequate to support pivotal studies or marketing applications. 
  • The FDA is encouraging physicians treating patients with unmet clinical needs to engage in pivotal studies for next-generation devices. 

As illustrated in the above framework, the FDA remains committed to promoting timely access to safe and effective devices. The FDA remains supportive of PS-IDEs when appropriately justified, and we would like to assure the community that there have been no measures to halt existing PS-IDEs provided the results are encouraging. We are regularly accessible to practicing physicians to discuss unmet needs of their patients and how we may work together to address them, and we encourage engagement with the FDA on such proposals through the Q-submission process.

We are also currently working with the SVS on updates to the PS-IDE template for treatment of complex aortic pathologies. We encourage physicians who may pursue a PS-IDE to obtain the template from the Society ([email protected]) as it provides a clear outline, pre-populated content, and suggestions for providing study-specific information.  

We acknowledge there are increasing numbers of well-trained physicians with experience and sophisticated skills treating patients with complex aortic pathologies using investigational or modified devices. Yet, after leaving their training programs where they may have used devices under an IDE, physicians may experience limitations to access investigational devices and techniques for endovascular treatment of complex cases. The FDA does not encourage physician modifications of commercialized endovascular grafts but notes that the routine practice of physician modification of devices should be conducted under an IDE. 

VEDT is hopeful that the need for physician-modified devices will be substantially decreased as device manufacturers pursue clinical studies for devices meeting patient needs and as devices currently under study come to market with data to support a reasonable assurance of safety and effectiveness.          

In summary, the FDA Office of Cardiovascular Devices is focused on supporting and enhancing patients’ timely access to safe and effective cardiovascular devices. The FDA’s mission, enthusiasm, and the commitment of VEDT to advance medical device innovation to bring safe and effective vascular surgery devices to market—thereby supporting and improving public health—remain steadfast. We seek efficient clinical studies and commercialization of innovative technology addressing unmet needs for U.S. patients, and we are engaged with external stakeholders to navigate paths to achieve these goals. Continued stakeholder collaboration on pivotal studies, marketing applications, and robust post-market data collection plans are critical to get devices to market to address unmet needs.  

We are dedicated to working with all stakeholders in order to bring life-saving and innovative devices to the U.S. market to benefit patients.   

It was a pleasure for many VEDT reviewers to participate in the recent VAM 2023 and engage with many of you. We look forward to the ongoing collaborations. Thank you again for this opportunity to reach out to the broader vascular community with this update. 

Disclaimer: This article reflects the views of the authors and should not be construed to represent the FDA’s views or policies. Ronald M. Fairman, MD, is the FDA’s VEDT medical officer and a former SVS president. Gordon Bryson is an FDA biomedical engineer; Carmen Gacchina Johnson, PhD, the organization’s assistant director for vascular and endovascular devices; and Andrew Farb, MD, its chief medical officer in the Division of Cardiovascular Devices.

The top 10 most popular Vascular Specialist stories of July 2023

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The top 10 most popular Vascular Specialist stories of July 2023

In the previous month, Vascular Specialist delivered a range of leading commentary from the Society for Vascular Surgery (SVS) in response to the New York Times investigation on inappropriateness in vascular care; the anticipated Food and Drug Administration (FDA) update on excess mortality risk for paclitaxel-coated devices; a review of protocols addressing hypersensitivity reactions after cyanoacrylate varicose vein treatment; and rumination from the E. Stanley Crawford Critical Issues Forum on the pipeline of sources feeding the vascular surgery ranks.

1. SVS responds to New York Times article on overuse of vascular interventions

In an official Society response, SVS President Joseph Mills, MD, tackles recent coverage in the mainstream media of inappropriateness in vascular care.

2. Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices

In a letter to healthcare providers dated July 11 2023, the FDA communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data and analyses.

3. The numbers are in: VAM 2023 adds up to another SVS classic

The 2023 SVS Vascular Annual Meeting (VAM) was heralded another big success with nearly 1,400 vascular professionals moves the needle with program innovations, slew of new science and jam-packed agenda.

4. FDA approves study of ZFEN+ for treatment of aortic aneurysms

The FDA has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).

5. Second edition of VSITE review text released

The second edition of a hit trainee-created textbook primarily aimed at those taking the Vascular Surgery In-Training Exam (VSITE) has hit the shelves.

6. Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline

This year’s E. Stanley Crawford Critical Issues Forum zeroed in on the pipeline of sources feeding the vascular surgery ranks. Incoming SVS President Joseph Mills, MD, assembled an expert panel to look at many of the key issues at the heart of efforts to address workforce-related concerns.

7. Surmodics receives FDA approval for the SurVeil drug-coated balloon

Surmodics announces the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). A company press release notes that the SurVeil DCB may now be marketed and sold in the USA to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation.

8. Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment

Despite being considered “generally safe,” cyanoacrylate can cause local reactions in up to 25% of patients, disproportionately affecting women, Asian race and thin patients with a body mass index of <22. This was the conclusion drawn by Eduardo Silva, MD, from Coimbra Hospital and University Center in Coimbra, Portugal, in his presentation at this year’s European Venous Forum (June 22–24) in Berlin, Germany.

9. SVS seeks volunteers to write position paper

SVS members have until July 31 to apply to serve on a new SVS writing group to develop a position paper on the scope of work of vascular surgery practice in diagnosing and treating vascular disease. Volunteers should have expertise and interest in this topic area.

10. Study finds similar rates of VTE in both flying and non-flying surgical patients

Uncertainty underlying the magnitude of risk posed by long distance air travel in venous thromboembolism (VTE) patients has created the need for a deeper, systematic dive into the guidelines and resources providers should be turning to when managing their pre-flight VTE patients.

Newest JVS peer-review title appoints editor-in-chief

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Newest JVS peer-review title appoints editor-in-chief
Anahita Dua

The Journal of Vascular Surgery (JVS) has announced the appointment of Anahita Dua, MD, as the editor-in-chief of the Journal of Vascular Surgery-Vascular Insights (JVS-VI), the newest title in the JVS stable.

Dua, an SVS member, is an associate professor of surgery at the Massachusetts General Hospital (MGH) and Harvard Medical School in Boston. She has authored more than 180 peer-reviewed papers and has edited five vascular surgery medical textbooks. Dua also runs a National Institute of Health (NIH)-funded coagulation lab at MGH and a vascular surgery practice focusing on complex peripheral artery disease (PAD) and limb salvage. Her appointment became effective today (Aug. 1).

“It’s crucial to provide fellow vascular professionals with the most up-to-date data to make well-informed decisions in their daily practice,” Dua told Vascular Specialist. “I believe this position allows me to be part of shaping the landscape of vascular surgery by delivering high-quality data through an evidence-based journal that focuses on the ‘other’ crucial parts of success in vascular surgery in 2023, including aspects such as quality, research, DEI [diversity, equity and inclusion] efforts, innovation, administration/business, and health policy.”

JVS-VI launched in early January, coinciding with the renewal of the SVS’ publishing contract with Elsevier. In response to the changing landscape of academic publishing, JVS-VI was introduced as an online-only, open-access (non-subscription) journal, allowing for broader accessibility to the latest research and developments in the field.

Ronald Dalman, MD, executive editor of the JVS group, was editor-in-chief for JVS-VI upon its creation. However, recognizing the need for a dedicated editor to lead the journal, he noted how the its success depended on someone with a vision and passion.

“Establishing a dedicated editor-in-chief for this journal became our goal, and during the interview process, it became clear that Dr. Dua’s compelling vision made her an excellent fit for the role,” said Dalman.

The JVS editorial team integrated the journal into its portfolio of publications to capture exceptional work that other journals might have overlooked. Dua believes that JVS-VI will ensure that significant topics receive the recognition they deserve.

Under Dua’s leadership, the JVS-VI editorial team will give priority to high-quality research manuscripts that generate hypotheses and provide background information, along with review articles, single-center quality improvement projects and discussions on practice management, business, ethics topics, commentaries, and historical vignettes.

Dua emphasized that the move towards open access ensures that a wider audience can access crucial research discoveries globally without charge immediately upon publication, fostering collaboration, creativity and equity within the vascular surgery field.

“This journal is dedicated to modern vascular surgeons practicing in 2023 faced with not only ensuring optimal surgical technique but also maintaining the other parts of vascular surgery practice—quality, logistics, education, research—that support excellent patient outcomes,” she said.

“We aim to address various aspects of vascular surgery in this day and age, and I feel a great responsibility to our readership to present quality articles that discuss these topics. I’m very excited to bring fresh new ideas to our portfolio, starting with a diverse editorial board with national and international representation.”

Read JVS-VI at www.jvsvi.org.

Financial viability, appropriate use and patient safety in the operation of outpatient facilities

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Financial viability, appropriate use and patient safety in the operation of outpatient facilities

The number of office-based facilities has been increasing steadily over the past several years—and more vascular surgeons may be considering becoming involved in operating such centers.

To help vascular surgeons consider the various details involved, the SVS Subsection on Outpatient and Office Vascular Care (SOOVC) held a special membership section session on The Business of Running an OBL (office-based lab) during VAM 2023 in June. 

Among the standout presentations included, Neil Poulsen, MD, from Cardiovascular Care Group in Springfield, New Jersey, delivered a talk entitled “The financial viability of the OBL” during the session. 

Top of mind, the number of office-based facilities increased 49% from 2002–2012, he told those gathered. OBLs provide ease and access to care, improved patient satisfaction, and excellent outcomes; they limit hospital exposure; and they increase efficiency, Poulsen pointed out. 

In light of recent coverage of overuse of certain procedures, Poulsen said, his presentation assumed “appropriate use by trustworthy/ethical practitioners practicing evidence-based medicine.” 

In terms of financial viability, the first step is to identify the three stakeholders: the patients, practitioners and the overall medical system, he continued. “If one is out of balance, the whole system falls apart,” Poulsen said. 

As for safety, he cited research showing that among 6,021 procedures in a particular OBL, there were no office-based mortalities, major bleeds, acute limb losses, myocardial infractions, strokes or hospital transfers within 72 hours, and a 0.5% rate of minor complications. “We do have the evidence that use of OBLs is equal to procedures performed in hospitals,” Poulsen said. 

As far as providers, an OBL practice can offset continuing declines in the professional fees for vascular interventions, allow for a more patient-centered practice model, avoid the headaches of dealing with operating room turnovers and access to block time as well as hospital policies, allow for referrals that may have gone to competing practices, and provide a new and increased revenue stream for the vascular practice. 

Research from 2020 highlighted 2017 fees for certain procedures, including a balloon angioplasty for which the physician was reimbursed $482. The hospital reimbursement was $4,592, but the provider in the outpatient facility received not only $482 in physician reimbursement but also $2,288 for the facility reimbursement, for a total of $2,770. 

Other research showed significantly increased revenues in one center, with physician reimbursement for a thrombectomy in an outpatient setting nearly quadruple that performed in a hospital. “In 12 months of procedures in [this] OBL, revenues increased approximately $1.3 million,” he said. Total reimbursements for a group of procedures (with both the provider and facility fees) was nearly $1.7 million, compared to $368,897 for the provider reimbursement alone. Of course, revenues must be weighted against the increased responsibility of owning and operating an OBL, he said, with set-up and building costs that could reach $500,000 to $1 million. Other costs involve investors, staffing, supplies and acquiring patients. 

The healthcare system as a whole saves money as well. The success of the outpatient practice model is directly related to its ability to provide high-quality patient care while reducing waste spending, and the transition also helps to conserve hospital and inpatient resources, Poulsen said. 

Data from his own group showing 1,741 procedures in a single OBL over 12 months showed hospital-based fees of $2.9 million and OBL fees of nearly $2.5 million. The Medicare system saved $462,443, or 18%, he said. Highlighting code 36902 (fistulagram with percutaneous transluminal angioplasty [PTA]), with 443 performed in a year the medical system saved 38% by having the procedures performed in an OBL. 

His group realized increased revenues of $2,453,652, compared to $376,199 for the hospital-based procedures. 

Poulsen concluded by stating that the success or failure of an OBL depends on optimizing outcomes for all stakeholders. OBLs provide a safe, efficient and effective environment for patient care, he continued, and the transition of care from the hospital setting to the OBL is associated with a significant reduction in overall healthcare costs. The financial success of an OBL is driven by the ability to limit expenses while providing high-quality, safe and evidence-based patient care, Poulsen added. 

“You’ll note I didn’t say anything about improving revenue,” he told attendees. “The revenue is going to come,” Poulsen emphasized. “Don’t go out of your way to improve revenue only. You want to limit your costs and provide appropriate patient care.” 

Comments sought on CMS proposed coverage expansion for carotid stenting

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Comments sought on CMS proposed coverage expansion for carotid stenting

SVS members are encouraged to submit comments—due Aug. 10—to the Centers for Medicare & Medicaid Services (CMS) on its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

The SVS and the SVS Patient Safety Organization (PSO) are preparing comments to CMS. Members can submit remarks at vascular.org/CarotidNCD. These will focus on the issue that these changes are premature and will jeopardize patient safety, the Society reported.

“We should be informed by data from the conclusion of CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial],” the SVS said in a statement. “While we support shared decision-making, a validated tool does not currently exist. To evaluate the impact of this change, the continued collection of registry data needs to be part of any change to NCD20.7.

“We need clear definition for ‘Qualified Physician’ and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting.”

New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs

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New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs
RAW Mapping

The characterization of aortic tissue by means of three key biomechanics-based biomarkers bundled into a compound Regional Areas of Weakness (RAW) Map showed “very good performance” as part of an artificial intelligence (AI)-based prediction of faster than average growth for a population of abdominal aortic aneurysm (AAA) patients under serial monitoring, according to a new study published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).

The retrospective study was conducted into 36 AAA patients undergoing surveillance by electrocardiographically (ECG)-gated computed tomography angiography (CTA) at the University of Calgary in Alberta, Canada, by a team of researchers led by vascular surgeon Randy Moore, MD, and Elena Di Martino, PhD, a professor of biomedical engineering, using the emerging ViTAA Medical Solutions technology, which aims to provide an algorithm-driven route to precision care.

The RAW Mapping assessment of aortic weakness incorporates time-averaged wall-shear stress, in-vivo principal strain and intraluminal thrombus thickness. “The use of features based on the functional and local characterization of the aortic tissue resulted in a superior performance in terms of faster than average growth prediction when compared to models mostly based on geometrical assessments,” the research team concluded from the published analysis.

The technology deploys an AI model to predict accelerated aneurysmal growth, with the current study looking at RAW Mapping’s ability to predict growth and AAA evolution within a year. Future work will focus on expanding the investigation and growth prediction over a longer surveillance period, the investigators reported. Further research will also aim to broaden the applicability of the methodology to different imaging modalities and protocols used to monitor AAAs.

“The ability to access functional information related to tissue weakening and disease progression at baseline for individual aortas has the potential to benefit patient monitoring, risk stratification and treatment selection, and optimize precision-based aortic care,” the researchers added.

Vascular surgery added as named specialty to influential national hospital rankings 

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Vascular surgery added as named specialty to influential national hospital rankings 
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021

U.S. News & World Report has renamed the specialty formerly known as “Cardiology & Heart Surgery” to include vascular surgery in its national rankings of the best hospitals in the country. 

The category will now be called “Cardiology, Heart & Vascular Surgery,” the media company announced ahead of the Aug. 1 publication of its 2023–2024 Best Hospitals rankings and ratings.

“The specialty formerly known as Cardiology & Heart Surgery has been renamed Cardiology, Heart & Vascular Surgery, in recognition that vascular specialists take the lead on some cases that have consistently been included in the specialty’s outcome measures,” write Ben Harder, managing editor, and Min Hee Seo, senior health data scientist. “In certain contexts, U.S. News will use the shorthand Heart & Vascular to refer to Cardiology, Heart & Vascular Surgery.”

Recognition has long been sought for vascular surgery as a separate specialty within the rankings.

In 2020, the question of its inclusion was raised by then incoming SVS President Ronald L. Dalman, MD, and given a prominent spot in that year’s E. Stanley Crawford Critical Issues Forum, which took place during SVS ONLINE, the COVID-enforced digital replacement for VAM 2020. Dalman invited Harder to be part of the forum panel.

“One of the challenges for our members in the U.S. at the current time is the U.S. News & World Report rankings do not recognize vascular surgery as a separate specialty,” Dalman told Vascular Specialist at the time. “They have cardiology, cardiac surgery, neurological surgery, general surgery.”

“This move recognizes vascular surgery as an important specialty,” said SVS Executive Director Kenneth M. Slaw, PhD. “The SVS worked with U.S. News to enact this change, and as we move forward, we will continue to engage with the publication to offer suggestions to help with continued improvement of the rankings in the newly named domain.”

Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair

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Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Human Acellular Vessel
Humacyte
Human Acellular Vessel

Humacyte today announced completion of enrollment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair.

A press release details that the HAV is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase II/III vascular trauma trial are intended to support a BLA filing with the US Food and Drug Administration (FDA), planned for the fourth quarter 2023.

The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level I trauma centers in the U.S. and Israel. The primary efficacy assessment will be based on a 30-day HAV patency (presence of blood flow) in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in literature. Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results. The company currently expects to complete these activities and report top-line results from the trial before the end of the third quarter 2023.

“We believe that the HAV could revolutionize the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” said Laura Niklason, CEO of Humacyte. “The completion of the target enrollment in Humacyte’s Phase II/III vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science. Our regenerative medicine technologies create dramatic new therapies—with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available.”

Humacyte’s HAV is a universally implantable, bioengineered human artery that is designed to overcome the challenges associated with traumatic injuries, the company states. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is available off the shelf, the HAV can ultimately save valuable time and potentially reduce complications like amputations and tissue loss. Because the HAV is comprised of the same tissue that makes up natural human vessels, it has the potential to repopulate with the patient’s own cells. Clinical results suggest that the HAV is highly infection resistant and therefore is well suited for treating the contaminated wounds created by major traumatic injuries. Importantly, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients.

The V005 study is intended to support Humacyte’s BLA filing with the FDA for treatment of extremity vascular trauma when a synthetic graft is not indicated and when an autologous vein is not feasible. The completion of V005 enrollment comes on the heels of Humacyte receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV in vascular trauma in May 2023. The RMAT designation allows for close collaboration between Humacyte and the FDA, and increases the chance for a priority review of a BLA after it is filed. At the time of V005 target enrollment, a total of 68 patients had received the HAV in the V005 trial, of which 51 had vascular trauma of the extremity and comprise the primary efficacy analysis.

In addition to the V005 trial, Humacyte notes that the HAV is also being used in Ukraine under a humanitarian aid program that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favorable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair

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Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Human Acellular Vessel
Humacyte
Human Acellular Vessel

Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair.

A press release details that the HAV is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase II/III vascular trauma trial are intended to support a BLA filing with the US Food and Drug Administration (FDA), planned for the fourth quarter 2023.

The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level I trauma centres in the USA and Israel. The primary efficacy assessment will be based on a 30-day HAV patency (presence of blood flow) in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in literature. Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results. The company currently expects to complete these activities and report top-line results from the trial before the end of the third quarter 2023.

“We believe that the HAV could revolutionise the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” said Laura Niklason, CEO of Humacyte. “The completion of the target enrolment in Humacyte’s Phase II/III vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science. Our regenerative medicine technologies create dramatic new therapies—with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available.”

Humacyte’s HAV is a universally implantable, bioengineered human artery that is designed to overcome the challenges associated with traumatic injuries, the company states. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is available off the shelf, the HAV can ultimately save valuable time and potentially reduce complications like amputations and tissue loss. Because the HAV is comprised of the same tissue that makes up natural human vessels, it has the potential to repopulate with the patient’s own cells. Clinical results suggest that the HAV is highly infection resistant and therefore is well suited for treating the contaminated wounds created by major traumatic injuries. Importantly, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients.

The V005 study is intended to support Humacyte’s BLA filing with the FDA for treatment of extremity vascular trauma when a synthetic graft is not indicated and when an autologous vein is not feasible. The completion of V005 enrolment comes on the heels of Humacyte receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV in vascular trauma in May 2023. The RMAT designation allows for close collaboration between Humacyte and the FDA, and increases the chance for a priority review of a BLA after it is filed. At the time of V005 target enrolment, a total of 68 patients had received the HAV in the V005 trial, of which 51 had vascular trauma of the extremity and comprise the primary efficacy analysis.

In addition to the V005 trial, Humacyte notes that the HAV is also being used in Ukraine under a humanitarian aid programme that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favourable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for haemodialysis, and peripheral arterial disease.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

SVS Foundation adds two surgeons to board of directors

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SVS Foundation adds two surgeons to board of directors
Bernadette Aulivola and Vikram Kashyap

The Society for Vascular Surgery (SVS) Foundation has announced the appointment of Bernadette Aulivola, MD, and Vikram Kashyap, MD, to its board of directors. Both will serve two-year terms and, with the board’s collective knowledge and experience, will further bolster the Foundation’s ongoing success in driving advancements and impacting the field of vascular surgery.

Assuming the position of board chair is Michael C. Dalsing, MD, SVS immediate past president. Joining him are SVS officers Joseph Mills, MD (president); Treasurer Thomas Forbes, MD; President-elect Matthew Eagleton, MD; and SVS Research Council Chair Raul Guzman, MD. Other board members include Ulka Sachdev, MD, Peter Nelson, MD, Geetha Jeyabalan, MD, and Anil Hingorani, MD.

An SVS Foundation press release notes that Aulivola, a vascular surgeon, professor and director of the Division of Vascular Surgery and Endovascular Therapy at Loyola University Medical Center in Maywood, Illinois, brings a wealth of experience in diagnosing and treating vascular diseases. She has made significant contributions to the field, particularly in venous disease and aortic aneurysms, and her research endeavors have resulted in numerous publications in medical journals.

Kashyap is a vascular surgeon and the Frederik Meijer chair of the Meijer Heart and Vascular Institute, as well as the vice president for Cardiovascular Health at Corewell Health in Grand Rapids, Michigan. With several decades of experience, Kashyap has co-authored more than 200 articles and book chapters, focusing on research areas such as atherosclerosis, thrombosis and cerebrovascular disease.

The Golden Larva syndrome: Is it real?

The Golden Larva syndrome: Is it real?
Bhagwan Satiani
Failure is part of the process that leads to success. Occasional failures may sting but we must recognize the adage that failure is a “bruise, not a tattoo.”

I knew a mid-career faculty member some years ago who was rapidly progressing up the leadership ladder until they were not. There were no apparent personal or health issues, or any other roadblocks, but gradually, over a period of six to 12 months, the brakes went on. There were some inexplicable decisions, beyond just humility or caution, which made me wonder if professional advancement was even a priority. 

My experience with a few underachieving physicians has been more in the academic sphere than the private-practice world. Although there were some private practitioners who wished to climb the administrative ladder, most were focused on patient care, some academic work, and activities outside work. 

Academic physicians have specific targets, such as promotion, climbing the administrative ladder, and moving up the national and international specialty society hierarchy. These steps are linked with financial rewards and professional recognition. The behavior of underachieving, resulting in a failure to advance, is seen in many professions, including sports and business, and is said to be part of the “Golden Larva syndrome.” 

Robert F. Kennedy is supposed to have said, “Only those who dare to fail greatly can ever achieve greatly.” In a business, entrepreneurial and leadership context, failing is part of the process that leads to success. Famous founders of companies like Google and Apple are cited. New, successful writers are a good example. They ask themselves, “Can I succeed again?” And fear failure. 

Similarly, the fearful leader may freeze and be unable to make any decisions. Carried to an extreme, an irrational fear of failure or atychiphobia occurs often in perfectionists. Fear of failure can sometimes be crippling. Paulo Coelho, the writer, is reputed to have said: “There is only one thing that makes a dream impossible to achieve: the fear of failure.” If enough self-doubt creeps in, most will either not attempt a “stretch” goal, or, if they do, they make it known that their expectations are low. 

Self-doubt is common before we develop enough self-awareness and discover our own capabilities. However, achievements are not always under our control. In my case, I know that there were some events beyond my control, such as timing, bias, or cultural upbringing, where boasting about accomplishments was considered gauche. My deliberate choice of family time versus work and travel was also a factor. It was never a fear of failure. Later, there were health issues that would have prevented me from being competitive and successful, but I wonder if there was, at times, a touch of the Golden Larva syndrome. 

The behavioral hodgepodge of underachievement, negative thinking, sometimes self-sabotage, fear of failing, or even fear of success, falls under the Golden Larva syndrome. Educator and psychoanalyst Manfred Kets de Vries describes one extreme when there is self-sabotage as being akin to a caterpillar that does not fulfill its potential, and therefore fails to flourish into a butterfly.1 People possess the promise of a bright future, but get in their own way and hinder their ability to thrive. Hence, the term Golden Larva syndrome. This includes manifestations such as imposter syndrome and Peter Pan syndrome. 

Imposter syndrome is the most well-known and was first described in 1978 by psychologists Pauline Rose Clance and Suzanne Imes in professional women.2 They initially described women as feeling like frauds and lacking confidence, but later determined that the syndrome occurred in both sexes equally. People with imposter syndrome doubt their abilities, don’t like attention, feel unworthy or less deserving of any success, and give credit to factors other than themselves. Success may also be avoided because one feels unfit or fearful of being under the spotlight in society and taking the place of more deserving people. Some consider this is “success phobia,” part of an ever-increasing number of phobias. There is no joy if and when success does come. Psychologists say that the syndrome is not a medical diagnosis but viewed as “cognitive distortions,” or biased on irrational thoughts and beliefs that we choose to self-reinforce over time.2 

There are some who think that imposter syndrome is an excuse to cover up systemic failures. Ruchika Tulshiyan and Jodi-Ann Burey believe it is a result of bias and exclusion, and that women especially are made to feel that it is a lack of self-confidence that causes them to fail rather than system or organizational issues.3 

Another reason why some may self-sabotage is a reluctance to grow up and take on responsibilities, otherwise known as Peter Pan syndrome. Dan Kiley described this phenomenon in his book, The Peter Pan Syndrome: Men Who Have Never Grown Up. This is also not a medical diagnosis, but a term psychologists use to describe adults, most often males, who decline to shoulder responsibilities and are unable to have healthy personal relationships. In another book, Men Who Never Grow Up, Dan Kiley describes these men as unable to “grow up.” Other traits include a fear of loneliness, a tendency of being self-centered or narcissistic, and impulsive behavior. 

As surgeons, we sometime fail even after performing a “perfect” operation, and although cumulatively these failures take a toll, few of us feel like failures ourselves and stop helping our patients.4 In a clinical context, I know I have had, at one time or another, a fear of failing but in the context of causing harm to patients. We fight through this. We have faith in our training and experience. But the most valuable asset we have are the people around us who believe in us and our abilities, at home and work. 

Given a difficult surgical problem, we have the luxury of leaning on colleagues and members of our society to seek other opinions. I have never had anyone refuse to assist me or decline a call for help when I needed another opinion. Nor have I ever declined to help, including desperate calls from the operating room. This is another reason why we can reach out to members of our society, as extended family, to give our patients the very best care that they deserve. 

Occasional failures do sting, but family, faith, friends, work-related teams and, yes, our colleagues are powerful antidotes. As the poet and writer John Sinclair said: “Failure is a bruise, not a tattoo.” Healers need other healers to take care of each other. We should try this more often. 

References 

  1. De Vries KMFR. Breaking the Cycle of Self-Sabotage: How to Overcome the “Golden Larva Syndrome.” https://knowledge.insead.edu/career/breaking-cycle-self-sabotage-how-overcome-golden-larva-syndrome 
  2. Saymeh A. What is imposter syndrome? Learn what it is and 10 ways to cope. https://www.betterup.com/blog/what-is-imposter-syndrome-and-how-to-avoid-it#:~:text=Imposter%20syndrome%20 is%20the%20condition,phony%22%20and%20doubting%20 their%20abilities 
  3. Tulshyan R, Burey JA. Stop Telling Women They Have Imposter Syndrome. https://hbr.org/2021/02/stop-telling-women-they-have-imposter-syndrome?ref=charterworks.com 

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor. 

Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system

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Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system

NecteroNectero Medical today announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy of the Nectero endovascular aneurysm stabilisation treatment (EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm.

“We believe the Nectero EAST system has the potential to address a significant unmet clinical need and improve outcomes in AAA patients who currently have no proven treatment options. Nectero EAST aims to be the first therapy to stabilise growth of small- to mid-sized AAAs,” commented Jack Springer, president and chief executive officer of Nectero Medical. “The IND clearance and initiation of a landmark pivotal study reflect our continuing commitment to bringing transformative therapies to improve the lives of patients with aneurysmal disease.”

The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAAs and is comprised of a dual-balloon delivery catheter and stabiliser mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and potentially reduce the risk of further degradation. A press release details that the procedure does not require any specialised tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions.

“I am really encouraged by the initial data of the Nectero EAST system to potentially slow the growth of AAA and thereby minimise the likelihood of rupture and/or need for major intervention,” commented Dan Clair (Vanderbilt University Medical Center, Nashville, USA), co-principal investigator for the stAAAble study. “If proven safe and efficacious at stabilising AAA growth, the Nectero EAST system has the potential to transform the lives of thousands of patients with aneurysmal disease.  We are honoured to be one of the centre to participate in this groundbreaking study that is likely to have a pronounced impact on the future management of AAA patients.”

The IND submission was supported by a prospective, first-in-human study of 21 patients treated outside the USA. Early Phase I clinical results were recently published in the Journal of Vascular Surgery and showed that a single, localised PGG administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAA. The stAAAble study will be conducted largely in the USA and is expected to initiate enrolment in the next few months.

Endologix announces first patients treated with the Detour system

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Endologix announces first patients treated with the Detour system

Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since Food and Drug Administration (FDA) approval of the system was granted.

PTAB with the Detour system treats complex peripheral arterial disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg. This approach is effective for patients with long lesions (20–46cm in length), those that have already undergone failed endovascular procedures, or those that may be suboptimal candidates for open surgical bypass, the company states.

For the rollout, Endologix collaborated with two healthcare systems known for clinical excellence. PTAB using the Detour system was first performed at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and at Salinas Valley Health Medical Center.

SVS coding workshop coming in October

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SVS coding workshop coming in October

The SVS’ 2023 Coding and Reimbursement Workshop will help participants learn about accurate coding and reimbursement for vascular surgery. The intensive two-day program will review essential topics such as recent Current Procedural Terminology (CPT) code and Medicare changes. 

An optional workshop on evaluation and management (E/M) codes is being offered to provide participants with a deeper understanding of E/M codes, which are crucial for accurately documenting patient encounters and determining appropriate reimbursement. 

The optional workshop will be held from 8 a.m. to 12 p.m. on Oct. 16. The main course will be conducted from 1 to 5 p.m. on Oct. 16 and from 7:30 a.m. to 4:30 p.m. on Oct. 17. 

Both the CPVI Skills Course and the Coding and Reimbursement Workshop will be held at the OLC Education & Conference Center, 9400 W. Higgins Road, Rosemont, Illinois. Visit vascular.org/coding23. 

Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline

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Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline
The 2023 Crawford panel

This year’s E. Stanley Crawford Critical Issues Forum zeroed in on the pipeline of sources feeding the vascular surgery ranks. Incoming SVS President Joseph Mills, MD, assembled an expert panel to look at many of the key issues at the heart of efforts to address workforce-related concerns. 

The panel captured three main areas of focus: the root sources of future vascular surgeons, the existing workforce, and the distribution of that workforce. Lee Kirksey, MD, from the Cleveland Clinic in Ohio, looked at outreach to high school and college students and Malachi Sheahan III, MD, from Louisiana State University in New Orleans, dealt with efforts to attract medical students and residents in training. Dawn M. Coleman, MD, from Duke University Medical Center in Durham, North Carolina, addressed vascular surgeon wellness, followed by Laura Marie Drudi, MD, from Centre Hospitalier de l’Universite de Montreal in Canada, on burnout solutions. The panel was rounded out by former SVS President Michel S. Makaroun, MD, on workforce supply or maldistribution, and Peter R. Nelson, MD, from the University of Oklahoma in Tulsa, on measures to improve the workforce crisis. 

Lee Kirksey on the early years… 

“Not everyone is capable of, or wants, to be a physician. I know it’s hard for us in this room to believe that, but not everyone wants to be a physician or vascular surgeon. However, there is a broad range of healthcare ecosystem jobs that provide family-sustaining wages and opportunities for a rewarding career. Much investigation is needed to better understand the student- and family-perceived barriers in pursuing health science careers. We think we know, but when we talk to parents we actually are probably missing the point. And in every community, whether it is urban, indigenous American, rural, White, Black or brown, there are motivated caregivers and communities whom we serve, and they hold surgeons in such high regard, they are waiting for us to take a leadership role in galvanizing the resources and continuing to address the important issue of shaping a multi-dimensional, diverse healthcare workforce.” 

Malachi Sheahan III on medical education and training… 

“It is time to establish ourselves as the expert on vascular disease at the medical school level. If we don’t, there are other specialties very interested. In a [2016] editorial by the leaders of the American Heart Association and the American College of Cardiology, they say they need an American Board of Internal Medicine-certified specialty focused on patients with peripheral arterial disease [PAD] because their care has been undermined. So if we don’t establish ourselves as the expert, other people will.” 

Dawn M. Coleman on surgeon wellness… 

“Physician burnout is a public health crisis. Frankly, it is a workforce crisis for us. It is a chronic condition in which your perceived demands outweigh perceived resources. There are staggering personal and professional repercussions of physician burnout. In 2019, burnout was reclassified as an occupational phenomenon by the ICD-11 classification of diseases. And there are also staggering personal and professional ramifications that are associated with work-related stress—which is a precursor for burnout—that have really impressive medical sequelae, including cognitive dysfunction, increased risk of heart disease, type-2 diabetes, fertility challenges, sleep disruptions, insomnia, isolation, etc. Moral distress matters, which can intersect with burnout, and I am positive all of us feel this at some point.” 

Laura Marie Drudi on burnout solutions… 

“Addressing physician burnout and well-being requires a multi-level, multi-pronged approach that involves both individual and organizational factors. Although burnout is rooted in the environment and systems in which we work, I do believe we have to first turn inwards to fill our own cup before we serve others. For those of you who are experiencing burnout and feel isolated, you’re not alone. Through support, connection and engagement, I am confident we will make progress in this space together.” 

Michel S. Makaroun on workforce supply… 

“In the last three years, approximately 170 vascular certificates have been issued every year, but we are still far behind the interventional radiologists and interventional cardiologists. So, is the funnel looking a little bit better? It is. We are now producing about 58 new vascular surgeons per year, but it is still inadequate. I will leave with you with this statement from a paper about the county-level maldistribution. ‘Although encouraging vascular surgeons to practice in underserved areas would be an ideal solution, it is not pragmatic.’ Developing alternatives is essential to get new methods of providing vascular care to geographically isolated populations.” 

Peter R. Nelson on prophylactic measures to address the workforce crisis… 

“We really need to work toward regional systems for efficient education, communication and delivery of multidisciplinary team healthcare. Patients want access to vascular healthcare close to home. They don’t want to come to Tulsa or Oklahoma City to get care. Vascular surgeons can and should lead in these efforts by recruiting vascular surgeons to work in these underserved areas with support from the tertiary referral centers—but, more importantly, to think broadly of how we define workforce, empower other physicians who are already in those communities—primary care providers, podiatrists, general surgeons, cardiologists—to feel more comfortable and confident taking care of vascular disease.”

SVS responds to New York Times article on overuse of vascular interventions

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SVS responds to New York Times article on overuse of vascular interventions
SVS President Joseph Mills
In an official Society response, SVS President Joseph Mills, MD, tackles recent coverage in the mainstream media of inappropriateness in vascular care.

There have been several recently published articles by respected news media outlets highlighting the deeply concerning issue of the overuse of invasive procedures to treat peripheral arterial disease (PAD). The front-page New York Times article (Sunday, July 16, 2023), first-authored by Katie Thomas, serves as the exclamation point. The Society for Vascular Surgery (SVS) appreciates the efforts of the NYT to call attention to the inappropriate use of interventions in an effort to raise patient awareness, promote quality and advocate for safety in the delivery of vascular care.

The SVS has more than a 75-year history of setting the standards of care, quality and safety for patients with PAD. Founded in 1946, and comprising more than 6,000 members, the SVS mission is to advance excellence in vascular healthcare through education, advocacy, research and public awareness. Our mission and code of ethics focus on doing what is best and most appropriate for the care of patients with vascular disease, despite the challenges created by a struggling healthcare delivery system and problematic regulatory/reimbursement policies. We are troubled to see reports of patient harm because of the violation of the fundamental ethos of all physicians and surgeons to “first do no harm.” However, we are also concerned that such articles will cause patients to mistrust the healthcare system and delay seeking appropriate and timely care for limb- and sometimes life-threatening PAD.

It is essential for the public, affected patients and their family members, to understand there is only one primary specialty in medicine comprehensively educated, trained and tested to provide the full spectrum of evidence-based care to vascular patients, ranging from medical management to minimally invasive procedures, to open surgery. That specialty is vascular surgery.  The vast majority of SVS members are vascular surgeons, board-certified by the Vascular Surgery Board (VSB) of the American Board of Surgery (ABS), who practice daily with integrity and are dedicated to appropriate and ethical care. Unfortunately, there are outliers practicing far beyond the pale who stretch ethical boundaries and deviate from the best available science and evidence-base. Within the NYT article, regarding the procedure highlighted, it was noted that “from 2017–2021, about half of Medicare’s atherectomy payments—$1.4 billion—have gone to 200 high-volume providers.”  It should be noted that none of the physicians detailed in this NYT story is a board-certified vascular surgeon or SVS member. As the article also documents, after failed attempts at limb salvage by other practitioners, patients end up in the vascular surgeon’s care only as a last resort, sometimes far too late to save a precious limb.

The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology, are providing high-quality, evidence-based care with safety and the best patient outcomes in mind. Appropriate and safe vascular care can be delivered in both outpatient and hospital settings.

Unfortunately, as in all professions and trades (albeit more disturbing in the healthcare arena), there are outliers who overstep the bounds of ethics, appropriateness and quality, perhaps driven by other motivations, including notoriety or financial gain. This is a complex issue that requires the examination not only of the events detailed in this story, in which several patient experiences with the physicians that provided their care were highlighted, but of the underlying healthcare economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.

The issue of overuse in medical care is not a new one. Scientific, peer-reviewed articles written by SVS members and vascular surgeons were among the first to call attention to potential patient harm resulting from the aggressive overuse of interventions for patients with PAD largely brought about by regulatory and reimbursement coverage decisions that financially incentivized such therapy. These studies documented a dramatic increase in atherectomy procedures primarily performed in an outpatient setting with extremely high-volume users (outliers) more likely to be non-vascular surgeons treating patients early after a diagnosis of claudication. As one example of a highly reimbursed procedure of unproven value, roughly 50% of Medicare reimbursements for atherectomy went to just 200 high-volume providers.

The article also alludes to the potential for the development of improper relationships between industry and healthcare practitioners as one factor that may drive inappropriate use or overuse of drugs and devices for financial gain. A detailed discussion of this issue is not possible here, but there is no doubt that the medical industry of drug and device manufacturers is essential to the provision of healthcare and innovation in therapy. Many widely available and highly useful drugs and devices (stents, endovascular grafts, etc.) have been developed by ethical, scientific collaboration between practicing physicians and surgeons and the healthcare technology industry. As do most other medical societies, the SVS has a policy on conflict of interest and conflicts of commitment.

These ethical principles underpin and guide all we do, not only as a medical organization, but also as individual practitioners. The needs of the patient should always come first; no procedure should be recommended or performed in any patient if it is not primarily and solely for the benefit and best interests of that patient.

The SVS has been the leading national organization in defining quality and safety standards for the provision of comprehensive vascular care, particularly for PAD. There are an estimated 10–12 million people in the U.S. who have PAD, so it is important to educate patients and the public about PAD and how it should be treated. The disease is caused by the build-up of plaque deposits in the walls of arteries due to a combination of risk factors, including diabetes, smoking, hypertension, hyperlipidemia, increased age and genetics. PAD is a broad spectrum of disease; in general, it is a marker for cardiovascular disease and the most common complication to develop in affected patients is not limb loss, but rather heart attacks and stroke. Thus, all patients with PAD should have best medical therapy and control of their risk factors to the extent possible. There are three stages of PAD: asymptomatic, claudication (leg cramping or pain with walking) and chronic limb-threatening ischemia (CLTI=non-healing wound or gangrene).

Only the latter has a significant risk of limb loss, and even in CLTI patients, the risk depends upon the stage of disease. Through the publication of research studies, evidence-based guidelines and appropriate use criteria documents, the SVS has consistently promulgated the principle that the best care for the majority of patients with PAD—particularly those who are asymptomatic—is to promote exercise (walking) and to manage the PAD medically by modifying correctable risk factors such as elevated lipids, diabetes, smoking and hypertension.

PAD is common, particularly in older people, but not all leg pain is directly related to PAD—even in those who have the disease. For example, arthritis, gout, musculoskeletal and spinal problems can all cause leg and foot pain. Even for patients who have pain with walking from PAD, the majority are best treated initially with risk-factor control, walking therapy to promote collaterals, and muscle adaptation to exercise and occasionally medicines specific for vascular leg pain brought on by walking (since fewer than 5% of patients with claudication progress to a limb-threatening PAD stage). Vascular surgeons are uniquely trained and positioned to understand the full context and spectrum of PAD and all of the available treatment options. As such, it has been the position of the SVS that a first intervention for PAD patients—even a “minimally invasive procedure”—should be done only when absolutely necessary, as once completed, it may “accelerate the clock” and speed the progression of vascular disease and its complications.

Invasive procedures for claudication may improve function and quality of life but patients should be selected carefully, and the interventions tailored to be both safe and likely to produce meaningful benefit. The SVS practice guidelines have proposed a threshold of at least two years of likely durability for an intervention performed for claudication. There is a disturbing trend of overly aggressive treatment, with recent studies demonstrating nearly 30% of patients are receiving interventions on below-the-knee arteries, despite no evidence they would benefit and mounting evidence it may accelerate their disease. Moreover, the article highlights the growing frequency of multiple, repeated procedures that is emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous.

There are patients with PAD (perhaps 5–8%) who suffer from or progress to the most advanced PAD stage, that of CLTI. This condition is more prevalent in people with diabetes. Preventing amputation in such patients hinges upon early and accurate diagnosis, followed by an individualized treatment plan targeted to the patient’s risk, goals and stage of disease. Such a plan is best carried out with the involvement of a vascular surgeon, and frequently includes other specialists, such as podiatrists. The SVS spearheaded and published classification systems to assess risk of limb loss, an anatomic staging system and global guidelines for evidence-based care to save limbs and prevent amputations. Although many CLTI patients require intervention, endovascular therapy is only one option, and a good number of patients fare better with surgical bypass. Vascular surgeons are the only specialists trained to offer both options, when needed. Patients deserve to be fully informed when making decisions about invasive treatments.

Vascular surgeons have also pioneered tracking patient outcomes. To this end, the SVS established its Patient Safety Organization (PSO) to monitor outcomes of patient care, which now includes 1,007 participating centers, and has collected the outcomes of more than 1 million vascular interventions within its Vascular Quality Initiative (VQI) registries. In addition, in collaboration with the American College of Surgeons, the SVS recently launched it Vascular Verification Program, setting standards of quality across vascular care settings. Vascular surgeons are actively engaged in and leading the effort to promote shared decision-making and patient education around PAD care, including the message that while an abnormal ankle brachial index (ABI)—a noninvasive measure of blood flow to the leg/foot—or the symptom of claudication can be important warning signs, the best therapeutic response is most often best medical therapy, not the “quick fix” of an intervention performed unnecessarily or prematurely.

As reported in another recent article by ProPublica, SVS feels strongly that the public at large and the vascular patient population should be educated and have access to all the resources they need to make the best choices for their care, including being provided with an explanation of the natural history of their condition, the expected outcomes of medical and interventional therapy, and understanding the differences between a variety of types of providers who perform some vascular procedures compared to board-certified vascular surgeons who provide the full spectrum of vascular care.

The SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate care documents, PSO-VQI registry and initiatives such as the Vascular Verification Program. All practitioners in vascular practice are encouraged to become familiar with and to utilize them. The SVS will continue to develop these resources and make them available.

The SVS encourages patients to check and verify the credentials of their providers before agreeing to a plan of vascular care. We also encourage second opinions. Finally, in their efforts to cover health news, the SVS urges media professionals to be diligent in presenting healthcare and medical information that is fully balanced, as coverage could lead to patient distrust and delays in necessary care with potentially adverse consequences.

Joseph Mills is president of the SVS. He was writing on behalf of the SVS Executive Board.

The numbers are in: VAM 2023 adds up to another SVS classic

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The numbers are in: VAM 2023 adds up to another SVS classic
VAM 2023 by the numbers
Landmark meeting (June 14-17) with nearly 1,400 vascular professionals moves the needle with program innovations, slew of new science and jam-packed agenda. 

With more content presented than ever before, a family-friendly Wednesday night gathering, the inaugural Frank J. Veith Distinguished Lecture, a hugely successful gala and the vascular surgery community more than happy to be together, the 2023 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) was heralded as another big success. 

“Overall, it was really well-received,” declared Andres Schanzer, MD, chair of the SVS Program Committee, which oversees the scientific content at the meeting. “People really enjoyed themselves,” he said. 

“The quality and impact of the science was really high. It was diverse across the whole array of vascular surgery procedures and medical management.” 

And, not only was the science and research important, “but I think people really enjoyed the opportunity to connect with colleagues. People are enjoying interacting with each other in a meaningful way around vascular surgery,” Schanzer continued. 

“And most importantly, we are being as inclusive as possible with the hope that our meeting participants look more like the patients we take care of.” 

Some of the highlights of VAM 2023 by the numbers include: 

  • Nearly 2,300 total attendees
  • More than 800 abstracts submitted 
  • Fifty-two abstracts at eight plenaries 
  • Twenty-one educational sessions 
  • Four SVS special section sessions 
  • Hands-on learning for the Physician Assistant Section 
  • Five international sessions 
  • A total of 271 posters 
  • Eleven abstracts presented simultaneously with publication in the Journal of Vascular Surgery 
  • The move of officer voting into VAM’s first few days 

This year’s meeting also included a number of new initiatives and events, which proved quite popular, Schanzer said. 

Attendees enjoyed an opening night, family-friendly SVS Connect@VAM: Building Community party that was open to all, with food, games and activities. With a successful debut, it will return in 2024 and afterwards as an annual event, Schanzer said. 

The inaugural Veith lecture, announced at the close of VAM 2022—which focused on the results of the BEST-CLI trial—drew a healthy crowd, as did several other BEST-CLI-focused content. 

Organizers moved the championship round of the Poster Competition to the plenary room on Saturday morning, leading to a robust audience and more recognition for the 10 finalists. 

Highlighting sessions that included topics related to diversity, equity and inclusion, plus including “invited discussants” for many of those sessions, also was well-received. 

The Program Committee and Postgraduate Education Committee are reviewing the feedback obtained via the VAM 2023 evaluation, Schanzer said. 

“So, if you have not completed the evaluation please do so no later than July 14. It is critical we hear from you so we can continue to meet your educational needs going forward,” he added. 

Second edition of VSITE review text released

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Second edition of VSITE review text released
The second edition was released at the end of June 2023

The second edition of a hit trainee-created textbook primarily aimed at those taking the Vascular Surgery In-Training Exam (VSITE) has hit the shelves.

The Vascular Surgery Review Book, authored by Thomas Creeden, DO, a resident from the University of Massachusetts in Worcester, Massachusetts, was first released a year ago and quickly saw soaring sales.

The latest edition features updates on technical steps for the majority of routine vascular surgery procedures—including bailout techniques—as well as detailed descriptions and explanations of sizing/designing of custom fenestrated and branched aortic grafts.

Also new are summaries of high-yield societal guidelines, new chapters covering areas such as ascending aortic management and distal lower-extremity bypass, and a section on the recently published results from landmark chronic limb-threatening ischemia (CLTI) trials, BEST-CLI and BASIL-2.

Late last year, as sales soared, Creeden said the textbook had also reached many medical students, vascular surgery interest groups (VSIGs), and even the device industry.

By December, the title had registered as one of the top-selling books on Amazon within the vascular and thoracic surgery category, with copies selling in 14 countries, he detailed.

Creeden’s original driving force was to create a high-yield reference text that would be fundamentally easier and quicker to work through than traditional vascular surgery textbooks when preparing for the VSITE, along with exams like the vascular boards.

SVS seeks volunteers to write position paper

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SVS seeks volunteers to write position paper
SVS seeks volunteers for new position paper

Society for Vascular Surgery (SVS) members have until July 31 to apply to serve on a new SVS writing group to develop a position paper on the scope of work of vascular surgery practice in diagnosing and treating vascular disease. Volunteers should have expertise and interest in this topic area.

The paper will address the following:

  • Discussing the vascular surgery service line and the scope of work based on basic core and sub-competencies of a vascular surgeon
  • Defining a vascular surgeon in each category and various positions
  • Setting the upper limits of what is considered appropriate in terms of time utilization and expectations
  • Defining the appropriate and adequate support structure needed to provide 24-hour vascular care at an institution
  • Maximizing the utility and value of healthcare professionals on the team, with focus on developing recommendations for optimizing the role of advanced practice providers (APP)
  • Presenting recommendations on how to deal with workforce shortages to optimize efficiency to prevent burnout

This is a one-year commitment, with volunteers expected to participate in monthly meetings, review papers and help with writing the position paper. After review, the paper will be published in the Journal of Vascular Surgery (JVS).

Those interested in participating should complete the online application—which must include a brief statement (200 words or less) regarding their experience and interest in this topic—and their CV by July 31. Applicants will be requested to fill out relevant conflicts of interest (COI) per the SVS’s COI Policy.

Study finds similar rates of VTE in both flying and non-flying surgical patients

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Study finds similar rates of VTE in both flying and non-flying surgical patients

air travelUncertainty underlying the magnitude of risk posed by long distance air travel in venous thromboembolism (VTE) patients has created the need for a deeper, systematic dive into the guidelines and resources providers should be turning to when managing their pre-flight VTE patients.

Jessie Shea (Imperial College London, London, U.K.) took to the stage at the recent European Venous Forum (22–24 June, Berlin, Germany) to deliver the findings of a recent systematic review and meta-analysis of VTE risk in surgical patients with recent air travel.

“A number of studies have shown a positive correlation between VTE risk and long-haul air travel, with incidence rates of up to 5% in patients with concurrent risk factors and an estimated 10–30% of patients with VTE dying within 30 days of incidence,” Shea detailed.

With surgical tourism on the rise, Shea explained that patients opting to endure long-distance flights to seek surgical intervention could be lacking the resources necessary to guide safe air travel. In 2017 alone, there were an estimated 1.4 million US medical tourists, creating a significant need for peri-operative travel guidelines to inform patients of potential risk.

To address the potential risk, Shea et al‘s systematic review and meta-analysis was designed by pulling all available literature about VTE risk in surgery when flying versus surgery at home. To conduct the analysis, the study design collected reporting of incidence of VTE in patients undergoing surgical intervention who had recently engaged in air travel versus those who had not.

Shea detailed that limiting factors for the study included risk of detection or recall basis, heterogeneity in thromboprophylaxis applied, variation in flight characteristics and duration, and impact of other associated VTE risk factors in participating patients.

The presenter concluded that the study found similar rates of VTE in both flying and non-flying surgical patients maintained across subgroup analysis of both preoperative and postoperative air travel, air travel greater than four hours in length and surgery associated with high VTE risk.

“The most important thing is to use a full risk assessment to identify each individual patient’s risk and also take into account the length of surgery,” she said in her closing remarks. “Looking at our study, it would suggest that there is no increase for VTE, but obviously our conclusion is limited by the quality of the evidence.”

Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices

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Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
FDA has issued new guidance for the use of paclitaxel coated devices in peripheral arterial disease
paclitaxel update issued by FDA
The FDA has issued new guidance for the use of paclitaxel coated devices in peripheral arterial disease

In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data and analyses.

This update signals a lowering of the red flag raised in a 2019 letter from the Administration—published in response to a meta-analysis that indicated a late mortality signal—warning that treatment of PAD with paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. 

Alongside the letter, the US FDA has updated its recommendations for healthcare providers regarding the use of paclitaxel-coated balloons and stents for PAD. As well as removing reference to the possibility of increased mortality with these devices, the amended guidance softens the language around the monitoring of patients who have been treated with paclitaxel-coated stents and balloons, stating that healthcare providers should continue ‘routine’ rather than ‘close’ monitoring of these patients, as had previously been stated. 

The safety of paclitaxel—used in peripheral interventions to prevent restenosis—was called into question by data put forward in 2018 by Konstantinos Katsanos (University of Patras, Patras, Greece) et al that pointed to an increased risk of death at two and five years following the use of paclitaxel-coated balloons and paclitaxel-eluting stents in the femoropopliteal artery. 

The FDA responded, notifying healthcare providers in early 2019 about a late mortality signal in patients treated for PAD in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. Their most recent update on the topic, prior to that shared on July 11, 2023, was posted in August 2019. 

In its new update, the FDA notes that “additional data from the pivotal randomised controlled trials (RCTs) has become available,” and that the Administration has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation. 

The FDA references the fact that device manufacturers collaborated in an updated meta-analysis, which included “additional studies, more complete vital status information, and longer-term follow-up compared to prior studies”. Patient follow-up in these studies ranged from two to five years, the Administration notes, and led it to conclude that the updated RCT meta-analysis “does not indicate that the use of paclitaxel-coated devices is associated with a late mortality signal”. 

Furthermore, the FDA states that it also reviewed additional analyzed of the risk for late mortality, including the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the US Veterans Health Administration study and the Medicare SAFE-PAD study. “None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a risk for late mortality associated with paclitaxel-coated devices,” the FDA communicates, adding that longer-term follow-up in several of these studies is ongoing. 

VESAP5 expires July 14

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VESAP5 expires July 14

The SVS’ fifth edition of the Vascular Education and Self- Assessment Program (VESAP5) expires at 9 a.m. CDT July 14 and with it, the possibility of claiming continuing medical education credits. 

Learners can earn credits and obtain certificates until then. Vascular surgeons and trainees can utilize the online program to prepare for qualifying, certification and recertification exams in vascular surgery and to keep up-to-date in the field. 

The VESAP5 program was released on July 16, 2020. Those who purchase the VESAP5 comprehensive package—now at up to 50% off—before the expiration date will have access to a non-CME version from July 17 of this year through July 17, 2024. 

The educational content will remain accessible even after the CME expiration. Learn more at vascular.org/VESAP5. 

Vascular Specialist–July 2023 VAM Review Edition

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Vascular Specialist–July 2023 VAM Review Edition

in this issue:

    • The numbers are in: VAM 2023 adds up to another SVS classic 
    • Guest Editorial: The Golden Larva Syndrome: Is it real? asks Bhagwan Satiani, MD
    • Comment & Analysis: Congress considers incremental steps towards Medicare payment reform 
    • Presidential Address: Michael C. Dalsing charts a course from rural America to the vanguard of a revolutionary surgical specialty
    • Vascular Leaders: SVS honors two vascular surgeons with Lifetime Achievement Award 

Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment

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Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment
Eduardo Silva

Despite being considered “generally safe,” cyanoacrylate can cause local reactions in up to 25% of patients, disproportionately affecting women, Asian race and thin patients with a body mass index of <22. This was the conclusion drawn by Eduardo Silva, MD, from Coimbra Hospital and University Center in Coimbra, Portugal, in his presentation at this year’s European Venous Forum (June 22–24) in Berlin, Germany.

Cyanoacrylate, the speaker first noted, has gained popularity in recent years for the treatment of varicose veins, due to its “minimally invasive” procedural nature and its ability to be performed in an outpatient setting. However, concern has grown in parallel to cyanoacrylate’s uptake, since increasing reports of “phlebitis-like reactions” have led some to question its safety.

These kinds of reactions have been later associated with type IV hypersensitivity, Silva explained, observing that symptoms can range from local itching, erythema, pain and swelling—typically resolving within a few days—although “severe” reactions have been reported.

Elaborating further on the typical presentation of this kind of hypersensitivity, Silva emphasized that type IV hypersensitivity often has a delayed onset, developing days to months after exposure to cyanoacrylate. Warning against expecting an immediate reaction, he made clear that “most of these will be between two to three days after the treatment.” Silva explained that these reactions occur in response to antigens produced by the subject to foreign substances that he has previously been exposed to, which, upon new exposure, triggers an “inflammatory cascade mediated by T cells.”

Using this information as the foundation of their study, Silva et al conducted a literature review using Embase and PubMed databases, evaluating the incidence and symptoms of suspected hypersensitivity reactions and their relation with phlebitis-like adverse events following cyanoacrylate varicose vein treatment.

Identifying 17 studies which reported severe complications, they highlighted 1,208 patients that had undergone cyanoacrylate varicose vein treatment, amounting to 1,631 treated veins. In total, 13 veins had to be excised in nine patients. Among these patients, the majority were female (65.8%), with a mean age of 52 years.

Looking closely at less severe reactions to cyanoacrylate treatment, Silva and his team noted 250 patients who had developed some form of adverse reaction after administration, the most common reaction being thrombophlebitis or phlebitis-like reactions (4–25.4%), however he asserted that “most complications were mild and self-limited”.

Building a portfolio of risk factors, the speaker noted that the presence of suprafascial saphenous vein location (<1cm underneath the skin), as well as larger veins (>8mm), were associated with adverse reactions to cyanoacrylate. Although Silva concluded that population characteristics and procedural factors “did not seem to influence the risk of developing hypersensitivity.”

After critically reviewing the literature, Silva concluded his presentation by asking the question: “Who should we test?” He asked if it should it be everyone? Patients with a known acrylate allergy? Or patients at risk of previous exposure? First, he considered patch testing all patients pre-procedure, stating that this “can be very useful to identify patients that might be at risk of developing hypersensitivity,” though he warned that “exposing everyone to [patch testing] may actually be causing first exposure and sensitizing the patient.”

Secondly, revealing a trick question, Silva eliminated patients with a known acrylate allergy completely, stating that these patients “should not be treated [with cyanoacrylate] at all.” Looking at his third option, he concluded that patients at risk of previous exposure should be considered for testing, although “many patients do not know they have been previously exposed,” posing difficulties for healthcare providers.

Providing a clear overview of their findings, Silva conveyed that cyanoacrylate is “a safe treatment,” but discussion needs to address the differences between phlebitis-like reactions and “classic” thrombophlebitis. Finally, he emphasized the importance of “developing protocols to identify and reduce hypersensitivity reactions,” and urged physicians to consider referral to clinical allergists “when in doubt”.

The top 10 most popular Vascular Specialist stories of June 2023

The top 10 most popular Vascular Specialist stories of June 2023

Last month, Vascular Specialist garnered readers’ attention with an array of commentary on the BEST-CLI and BASIL-2 trials; the medical editor’s interview with vascular surgery’s ‘living legend’ Frank J. Veith, MD; the news of the death of Past SVS President Kenneth Wayne Johnston; and a report of a Vascular Annual Meeting (VAM) breakfast session on the role of vascular surgeons in the pulmonary embolism (PE) treatment paradigm.

1. More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients

Misty Humphries, MD, MAS, associate professor of surgery at UC Davis in Sacramento, California, gives Vascular Specialist the lowdown on recent findings that intravascular lithotripsy (IVL) may be able to expand transcarotid artery revascularization (TCAR) into patients with traditionally prohibitive calcific disease.

2. ‘Nobody believed us’: Vascular giant on overcoming skeptics

Malachi Sheahan III, MD, Vascular Specialist’s medical editor, speaks to living legend and limb-salvage pioneer Frank J. Veith, MD, on the contents of his hard-hitting new book, The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia, ahead of the inaugural named lecture established in his honor taking place at last month’s VAM.

3. BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance

The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J. Veith Distinguished Lecture at VAM 2023 in which they laid bare the blood, sweat and tears shed on their journey to complete the landmark study.

4. SVS mourns death of Past President Kenneth Wayne Johnston

The Society for Vascular Surgery (SVS) mourns the death of Kenneth Wayne Johnston, an SVS member, former president and recipient in 2009 of the SVS’ highest honor, the Lifetime Achievement Award.

5. Novel drug candidate for slowing AAA growth demonstrates safety in humans

According to Stephen Cheng, MBBS, MS, chair of the Department of Surgery at the University of Hong Kong, the first-in-human study findings suggesting that the local delivery of a glucose-derived compound in small- and medium-sized AAAs is safe merit further evaluations within randomized controlled trials.

6. BASIL-2 and BEST-CLI: A tale of two limb trials

Michael S. Conte, MD, is chair in Vascular Surgery at the University of California San Francisco (UCSF), and he weighs in on some of the key questions surrounding the BASIL-2 and BEST-CLI trials.

7. Crawford panel focuses on challenges of vascular workforce crisis

This year’s VAM E. Stanley Crawford Critical Issues Forum looked at ways to address the pipeline of sources feeding the vascular surgery pool of talent, yielded an illuminating perspective on the looming workforce crisis currently occupying leaders in the field.

8. VQI@VAM: Social media helps promote safe technique, study finds

A social media campaign promoting educational videos proved efficient and cost-effective, and similar campaigns will be useful for quality improvement projects directed toward medical trainees.

9. The essential ‘need’ for vascular surgeons in PE treatment paradigm

Vascular surgeons who are SVS members from pulmonary embolism response teams (PERTs) or busy PE programs from six large hospitals and systems discussed advances in care and the role that vascular surgeons play in the current PE landscape at a breakfast session at VAM last month.

10. Special VAM session underscores ‘complementary’ nature of open and endovascular strategies in CLTI patients

A dedicated session at VAM 2023 saw speakers and delegates gather to debate, analyse and consider the implementation of the BEST-CLI and BASIL-2 randomized-controlled trials (RCTs). There was general agreement that the strategies are complementary, and that “picking the right thing for the right patient at the right time” should take precedence.

Surmodics receives FDA approval for the SurVeil drug-coated balloon

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Surmodics receives FDA approval for the SurVeil drug-coated balloon
Kenneth Rosenfield

Surmodics has announced the receipt of Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).

A company press release notes that the SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤180mm in length) in femoral and popliteal arteries having reference vessel diameters of 4mm to 7mm. The SurVeil DCB received CE mark certification in the European Union in June 2020.

“I am excited that the Surveil DCB will be available to treat patients in the USA,” said Kenneth Rosenfield, MD, an interventional cardiologist at Massachusetts General Hospital in Boston, co-principal investigator of the TRANSCEND clinical trial.

“The Surveil DCB is the next generation DCB as established by results from the TRANSCEND trial which is the only head-to-head pivotal study that has been conducted versus the market-leading DCB. The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years post-treatment with a substantially lower drug dose.”

FDA approves study of ZFEN+ for treatment of aortic aneurysms

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FDA approves study of ZFEN+ for treatment of aortic aneurysms
Photo by Dwight C. Andrews/McGovern Medical School at UTHealth Office of Communications Dr. Gustavo Oderich - CV Surgery
Gustavo Oderich

The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).

The clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the Bentley InnoMed BeGraft balloon-expandable fenestrated endovascular aortic repair (FEVAR) bridging stent graft system (BeGraft) for the endovascular treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

The ZFEN+ is predicated on the commercially available Zenith fenestrated abdominal aortic aneurysm (AAA) endovascular graft, but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease. For patients with complex aortic disease, the only currently established treatment option is open surgical repair.

The ZFEN+ clinical study is a prospective, multicenter, single-arm study that will include sites in the U.S. and Europe. At this time, the FDA has approved enrollment of the first 30 patients. Ultimately, Cook intends to enroll 102 patients in the pivotal study. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant reintervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.

“The ZFEN+ endovascular graft will meet a significant need for our patients,” said Gustavo Oderich, MD from the University of Texas Health Science Center at Houston in Houston, Texas, who is the global principal investigator of the study.

“There are not many options to treat complex aortic aneurysms other than open repair or off-label use of devices. Even long after off-the-shelf devices become available, the ZFEN+ will offer a tailored approach specific to the patient anatomy. The ZFEN+ clinical study will provide a benchmark for safety and effectiveness of a less invasive option to treat complex abdominal aortic aneurysms.”

VAM 2023 attendees have their say on the impact of BEST-CLI and BASIL-2 trials

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VAM 2023 attendees have their say on the impact of BEST-CLI and BASIL-2 trials

As the vascular community continues to unpack the key learnings from two of the biggest trials to date in chronic limb threatening ischemia—BEST-CLI and BASIL-2—attendees of the 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) told Vascular Specialist how they see the two landmark trials shaping practice in years to come.

SVS mourns death of Past President Kenneth Wayne Johnston

SVS mourns death of Past President Kenneth Wayne Johnston
Kenneth Wayne Johnston

The Society for Vascular Surgery (SVS) mourns the death of Kenneth Wayne Johnston, an SVS member, former president and recipient in 2009 of the SVS’ highest honor, the Lifetime Achievement Award. 

Barry Rubin, MD, chair and program medical director for the Peter Munk Cardiac Centre for the University Health Network in Toronto, writing with other colleagues, called Johnston “one of Canada’s preeminent and gifted academic surgeons … Dr. Johnston was a visionary leader, educator, researcher and tireless advocate for vascular surgery who cared for his patients with kindness and compassion. His surgical skills were outstanding and always carefully applied and he was a patient teacher of clinical skills to a large cohort of residents and fellows. Dr. Johnston’s work ethic was legendary, and he led by example, always contributing, learning and exploring new areas of research to apply to patients with vascular disease. He continuously questioned current dogma and used the scientific approach to develop new diagnostics and therapies and instilled this quest in the trainees who were privileged to work with him. Dr. Johnston set very high standards for himself and strove each day to meet them – we and many others were deeply influenced by watching Dr. Johnston reach those standards and are much better today because of it.”

In the U.S., Johnston played a critical role in brokering the merger of the two American vascular societies to become the SVS, overcoming strong resistance to the merger at the time. He served as vice president and then president, in 2008, leading the development of SVS’ first strategic plan. He received SVS’ Lifetime Achievement Award in 2009, to recognize his outstanding and sustained contributions to the profession of vascular surgery and to Society itself. He is the only Canadian to ever have received this most prestigious award. He was also Vascular Specialist‘s first-ever medical editor.

Said SVS Treasurer and colleague of Johnston, Thomas Forbes, MD: “Wayne was the penultimate vascular surgeon, scholar, leader and educator. More importantly he was a loving family man and trusted mentor, colleague and friend. We all looked to him for his sage advice and wisdom. He will be sorely missed but we’ll all try to continue his legacy, locally, nationally and internationally.”

Johnston was a pioneer and driving force in the establishment of the Canadian Society for Vascular Surgery 40 years ago and served as both its secretary and president. Today, the Society is internationally recognized and is Canada’s most important forum for supporting professional education, research and standards of care related to the prevention, diagnosis and treatment of vascular conditions, said Rubin.

At the University of Toronto, Johnston established the Division of Vascular Surgery and was its inaugural chair, a position he held for more than 20 years. As a teacher and mentor, he established the first vascular surgery training program in Canada and trained a generation of vascular surgeons, many of whom he inspired to go on to have distinguished careers in academic and community medicine. A strong proponent of multidisciplinary approaches to research, he supervised 43 masters and doctoral-level engineers.

Johnston played a major role in setting the standards for accreditation of training in vascular surgery that were adopted by the Royal College of Physicians and Surgeons of Canada. He co-edited the seventh and eight editions of Rutherford’s Vascular Surgery, the standard, definitive medical reference text for a range of health professionals including vascular surgeons, interventionalists and vascular medicine specialists worldwide, and was the first and only Canadian to do so. For seven years he was editor- in-chief of SVS’ peer-reviewed scientific journal, the Journal of Vascular Surgery, and was the first Canadian to be honored with this responsibility.

As a clinical scientist, Johnston’s research greatly improved the care of patients with vascular disease, and his vascular research lab was one of the first in North America. His impact on the understanding and treatment of patients with vascular disease was unparalleled. Dr. Johnston published seminal papers detailing the results of the world’s first major prospective study of patients that established the role of balloon angioplasty of the arteries of the legs in treating patients with impaired circulation, preventing disabling pain and amputations. His research changed the way that patients with blocked arteries are treated and this procedure is now recognized internationally as the treatment of choice.

In the late 1980s and early 1990s, Johnston led the first and largest Canadian-based multicenter study of abdominal aortic aneurysms in the world. The study results had a significant impact on the selection and treatment of patients with abdominal aortic aneurysms and continue to be used to identify patients at increased risk of major surgery who would benefit from new and less invasive approaches. Remarkably, Johnston had 34 years of continuous funding from the Canadian Institute for Health Research for his research into the development and use of ultrasound.

In 2018, Johnston was invested as a Member of the Order of Canada, one of the country’s highest civilian honors. “Dr. Johnston left an indelible mark on us, and we are privileged to have known, been trained by and worked with him for so many years. He will truly be missed,” said Rubin.

Johnston is survived by his wife Liz Cain, his daughter Andrea (Andrew) and son Matthew (Paloma) and grandchildren Mercer, Maren, Myles and Piers. Wayne was predeceased by his wife of almost 50 years, Dr. Jean Turley.

His funeral will be July 5 in Toronto. Memorial contributions may be made to to the Princess Margaret Cancer Foundation or to the Dr. K. Wayne Johnston Memorial Fund.

Risk of cancer-related VTE recurrence ‘significantly lower’ using NOACs compared with low molecular weight heparin

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Risk of cancer-related VTE recurrence ‘significantly lower’ using NOACs compared with low molecular weight heparin
Female nurse assisting patient undergoing renal dialysis in hospital room

Delivering results and recommendations from a systematic review and meta-analysis of novel oral anticoagulants (NOACs) versus low molecular weight heparin (LMWH) in the prevention of venous thromboembolism (VTE) recurrence in cancer patients, Patricia Noreen Bueno, MD, from St Luke’s Medical Center in Quezon City, Philippines, asserted that the risk was “significantly lower” when using NOACs, but “careful consideration” must be employed when choosing an anticoagulant.  

Presenting on the first morning of this year’s European Venous Forum (June 22–24) in Berlin, Germany, Bueno began by situating their chosen field of study, highlighting the prevalence of VTE as a common complication in cancer patients, and its association with higher morbidity and mortality.  

“Traditionally,” she noted “LMWH has been the standard [preventive measure] in this population, however NOACs or oral anticoagulants have emerged as a potential alternative due to their convenience and ease-of-use.”  

In their analysis, Bueno and her team looked at randomized controlled trials (RCTs) that included NOACs in patients with cancer-associated VTE, defining their primary outcome as VTE recurrence. To do so, they initiated a comprehensive search of clinical trials available on PubMed, Cochrane, Google Scholar and Gray literature, using RevMan 5.4 to perform their critical appraisal.  

Identifying eight RCTs including 4,741 patients—2,408 who received NOACs and 2,337 who received LMWH—Bueno et al specify that NOACs were administered orally, while LMWH were required to be administered subcutaneously by a healthcare professional.  

“Our analysis showed that risk of cancer-associated VTE recurrence was significantly lower in patients treated with NOACs, compared with LMWH [risk ratio 0.64; 95% confidence interval 0.52–0.80; p<0.0001; I2%],” Bueno said, however making clear that the safety of NOACs is not significantly superior to that of LMWH. Adding to their results, Bueno also noted that all-cause mortality showed no statistical difference between the two groups.  

Showing consistency with prior meta-analyses performed in this area, Bueno conveyed that their review “[reflects] the benefits of NOACs’ pharmacokinetics and pharmacodynamics, including their short half-life, rapid onset/offset of action, and few drug-drug interactions”.  

As an offshoot to their current study, Bueno then moved on to give detail to two subanalyses they performed using the present patient population, first looking at risk of major bleeding based on location of cancer and use of either NOACs or LMWH, and secondly, looking at the type of NOAC used, namely apixaban, rivaroxaban or edoxaban.  

Elucidating the results of the former subanalysis, Bueno et al defined groups by gastrointestinal (GI) and non-GI location of cancer, finding no statistical significance between groups when using NOACs or LMWH. She continued, however, stating that in GI studies they found “an increased risk of major bleeding when [patients were] treated with NOACs.” This, she posited, may be due to cancer location and the presence of other pathologies such as ulceration, and “highlights the importance of closely monitoring symptoms and signs of bleeding in patients with GI malignancies while undergoing treatment with anticoagulants.” 

Concerning the latter subanalysis, Bueno gave a brief review of available NOACs and their attributed risk factors—overall emphasizing the “careful consideration” that must be maintained by clinicians when choosing an appropriate anticoagulant—particularly for patients with pre-existing bleeding risk factors.  

Overall, Bueno and her team observed that anticoagulation therapy with NOACs is “effective and safe” in preventing cancer-associated VTE recurrence. Although they acknowledge that the current preference is LMWH for patients with GI malignancies who have a high risk of bleeding, they hope that their review may “aid clinicians” in their decision-making and spur further clinical trials.

Vascular Verification Program registers first four hospitals in US—including UCSF

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Vascular Verification Program registers first four hospitals in US—including UCSF
Michael S. Conte

UC San Francisco Medical Center (UCSF) is among the first four hospitals in the U.S. to be verified as part of the American College of Surgeons’ (ACS) Vascular Verification Program (Vascular-VP), a quality program recently launched in partnership with the Society for Vascular Surgery (SVS).

To receive verification as a “Comprehensive Inpatient Vascular Program,” UCSF demonstrated a commitment to improving outcomes and care for patients receiving vascular surgical and interventional care in an inpatient setting.

Vascular-VP leverages the strengths and expertise of the ACS and SVS to provide an evidence-driven, standardized pathway for instituting and growing a quality improvement and clinical care infrastructure within a hospital’s vascular program.

“The Vascular Verification Program helps strengthen a hospital’s safety and continuous improvement culture to enhance patient outcomes with greater reliability and standardization of care. As one of the first hospitals to receive this verification, UCSF Health has shown its commitment to providing the highest quality care for vascular patients,” said Clifford Y. Ko, MD, director of the ACS Division of Research and Optimal Patient Care.

To become verified, UCSF Health met the standards outlined in the Optimal Resources for Vascular Surgery and Interventional Care (2023 Inpatient Standards), which addresses elements of vascular surgical and interventional care and quality. These standards span from the outpatient clinic to the operating rooms, recovery areas, intensive care units, laboratories and interventional suites.

“We are proud to partner with the ACS and the SVS in this important new program, which exemplifies the culture of surgical quality improvement that drive us every day in our operating rooms, clinics, and wards,” said Julie Ann Sosa, MD, chair of the Department of Surgery at UCSF.

“Modern care of vascular patients requires teamwork and expertise. This designation recognizes the deep commitment of our leadership, faculty, and staff to optimal care of the vascular patient through all phases of their care,” added Michael S. Conte, MD, co-director of the Heart and Vascular Center and chief of vascular and endovascular surgery at UCSF.

As a Vascular-VP verified hospital, UCSF Medical Center also becomes an ACS Surgical Quality Partner. Being a Surgical Quality Partner signifies a hospital’s dedication to consistently improving procedures and approaches, while maintaining a critical eye on process at every step. The Surgical Quality Partner designation lets patients know UCSF Health is dedicated to quality and relentless self-improvement and has been verified or accredited by the ACS. Patients can trust that the care they receive at Surgical Quality Partner hospitals adheres to the most rigorous standards in surgical quality. UCSF Health is an ACS Surgical Quality Partner by participating in Vascular-VP.

“We welcome UCSF Health into the ACS Quality Programs. They have shown their commitment to delivering the highest quality care, evaluating that care in a rigorous fashion, and dedicating themselves to continuous improvement,” said ACS Executive Director  and CEO Patricia L. Turner, MD.

Assessing the needs of young vascular patients

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Assessing the needs of young vascular patients
Dawn Coleman
vascular
Dawn Coleman

In the past 18 months, a joint taskforce studying the needs of pediatric vascular patients has made great strides, conducting a needs assessment, identifying top priorities and planning resources for surgeons of these young patients. The next step—a meeting this month for interested members from both the Society for Vascular Surgery (SVS) and the American Pediatric Surgical Association (APSA). SVS members Dawn Coleman, MD, and John White, MD, co-lead for the SVS; Regan Williams, MD, and David Rothstein, MD, co-lead for APSA.

The meeting titled the Pediatric Vascular Surgery Development Group was held on Thursday June 15, 2023 at the Gaylord National Resort and Convention Center, with interested SVS members at­tending live during the SVS Vascular Annual Meeting (VAM) and APSA members attending virtually. All four co-leaders anticipate the group will hereafter begin to meet quarterly.

It’s the first-of-its-kind get-together at an annual meeting to gather both vascular and pediatric surgeons. Since its formation in late 2021, the task force has conduct­ed a thorough needs assessment and prioritized four pillars of critical care: blunt and penetrating vascular trauma, iatrogen­ic trauma, hemodialysis access and ECMO (extracorporeal membrane oxygenation) life support.

Trauma isn’t the No. 1 issue in pediatric vascular patients, but it is one of the most common and, importantly, it’s often a time-sensitive challenge, according to Coleman. “Delays in care can compromise the long-term and functional outcomes of children, in addition to immediate life and limb threat,” she said. “Thus, it’s a high-impact focus for our team.”

Many more invasive procedures on the heart and kidneys occur now than 10 and 20 years ago, said White. “Patients will have complications from these procedures, and we need to be prepared to address them.” ECMO has been used more frequently with children recently, especially during COVID-19, but also for the wide variety of respiratory dis­orders children acquire. “Its usefulness in children has been proven and it requires vascular cannulation. So we, again, need to explore best techniques,” White added.

Williams and Rothstein said the task force grew out of several themes. For one, general surgery residents (and con­sequently graduating pediatric surgery fellows) have progres­sively less and less exposure to vascular surgery, particularly open surgery. As a result, practicing pediatric surgeons, es­pecially early-career ones, have little experience in vascular surgery operations. Additionally, vascular surgery diseases are rare in pediatric surgery but opportunities for collabora­tion with vascular surgeons abound. “The best care for our pediatric patients is often provided in a collaborative fashion and we can improve this collaboration by defining areas of common ground, breaking down administrative barriers and measuring our outcomes,” they said.

In the works are supplements from each organization’s journals that will include a set of descriptive disease-specific articles and access to a physician toolkit. Task force members want to accelerate developing best practices for these critical domains already identified and eventually expand into other areas and engage stakeholders from other disciplines.

New analysis probes BEST-CLI trial against real-world setting data

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New analysis probes BEST-CLI trial against real-world setting data

SCAIA new analysis of chronic limb-threatening ischemia (CLTI) treatment outcomes was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Ses­sions (May 18–20) in Phoenix.

Since the initial results of the BEST-CLI trial found surgery superior to endovascular revascularization, questions have lingered. The new analysis, led by Eric Secemsky, MD, sought to analyze a broader clinical population via the Medicare population. The endpoint used for the patient group was a composite of major adverse limb events (MALE) and death.

A total of 66,153 patients were included—10,125 autologous grafts, 7,867 non-autologous and 48,161 endovascular. Compared to BEST-CLI cohort 1, patients were older, more often female and had a greater burden of comorbidities. Endovascular operators were less likely to be surgeons (55.9% vs. 73% in BEST-CLI) and more likely to be interventional cardi­ologists (25.5% vs. 13.0%). The risk of death or MALE was higher with surgery (56.6% autologous vs. 42.6% BEST-CLI cohort 1; 51.6% non-au­tologous vs. 42.8% BEST-CLI cohort 2) but similar with endovascular. Of those receiving endovascular treatment, major interventions occurred less frequently compared to the trial (10% real-world vs. 23.5% cohort 1; 8.6% real-world vs. 25.6% cohort 2).

Primary patency after venous stenting best in NIVL patients, study finds

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Primary patency after venous stenting best in NIVL patients, study finds

A recent study concludes that non-thrombotic iliac vein lesion (NIVL) patients have better primary patency after venous stenting than patients with venous thrombotic disorders. Olivier Espitia, MD, from CHU de Nantes in Nantes, France, and col­leagues report this main finding from a multicenter cohort study in the European Journal of Vascular and Endovascular Surgery (EJVES).

The authors detail that it was their aim to assess primary stent patency predictive factors in three groups of patients with history of lower limb vein thrombosis: NIVL, acute deep vein thrombosis (aDVT) and post-thrombotic syndrome (PTS).

The investigators included consecutive patients from January 2014 to December 2020 from seven hospitals. The team reported the anticoagulant and antiplatelet therapy strategies employed after venous stenting and compared these between the three patient groups. In their results, Espitia et al state that the study included 377 patients in total, comprising 134 in the NIVL group, 55 in the aDVT group and 188 PTS patients, and that medi­an follow-up was 28.2 months.

The authors report in EJVES that primary paten­cy was statistically significantly higher in the NIVL group (99.3%) compared with the PTS group (68.6%; p<0.001) and the aDVT group (83.6%; p=0.002). In addition, the researchers note that PTS patients received a statistically significantly greater number of stents and had more stents below the inguinal ligament.

Finally, Espitia et al report that discontinuation of antiplatelet therapy at the last assessment was 83.6% for NIVL, 100% for aDVT, and 95.7% for the PTS group (p<0.001). Discontinuation of anticoagulation therapy was 93.2% for NIVL, 25% for aDVT, and 70.3% for the PTS group (p<0.001). “The only predictor of worse primary patency in the aDVT group was long-term anticoagulation before stenting,” they write.

Bias and the silver bullet: Gender partiality seen within AI algorithms for AAA identification

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Bias and the silver bullet: Gender partiality seen within AI algorithms for AAA identification
Sharon Kiang
AI
Sharon Kiang

Artificial intelligence (AI) has become a central focus within various spheres, from commerce to medicine—including applications in patient care. Sharon Kiang, MD, talks to Vascular Specialist about the specter of bias and how a “hybrid” approach between AI and human specialty may be the best solution going forward.

Sharon Kiang, MD, considers it the “silver bullet” clinical perception of AI. In the Loma Linda University School of Med­icine associate professor’s reckoning, it’s no mere nebulous metaphor but the underpin­nings of her latest research into disease pre­diction models, and the gendered biases they found within their foundational algorithms.

“Originally, we weren’t looking at bias. We were just looking to see if the aortic model, using machine learning and AI algorithms, could predict and understand the progres­sion of disease and, if possible, therefore pre­dict outcomes,” Kiang tells Vascular Specialist. Operating on the assertion that human error and a “human-bound limitation of resourc­es” confound patient care today, Kiang’s team believe that AI could alleviate a portion of manual “yearly factors,” which can take up significant time.

Kiang has not long since finished present­ing some of her latest findings at the 2023 Women’s Vascular Summit (April 28–29) in Buffalo, New York, where she extrapolated on the advent of AI’s more frequent deploy­ment, and the greater ease with which its limitations can be seen. “We started reading about how bias is unintentionally put into algorithms, and so went to look at our own data to see if there are biases there,” she says. Kiang selected gender as their specified bias variable, in part because disparities within post-intervention clinical outcomes in fe­male aneurysm patients have already been reported. “We wanted to see if our machine was able to fix that and equalize its ability to learn,” Kiang explains.

Kiang told the Women’s Vascular Summit about how she and col­leagues investigated gendered bias in convolutional neural networks, or deep learning, for abdominal aor­tic aneurysm (AAA). Their findings revealed that the machine was un­able to overcome this bias and could not identify aneurysms in females as it could in males. “This may be that female aortas are smaller,” Kiang notes, so limiting the ma­chine’s accuracy. Offering further explana­tion, she stated that their data may have also been “flawed,” creating bias in the algorithm, or that it may not accurately represent “the question being asked of the machine.”

Although she hypothesized that a perfect algorithm could theoretically be designed— blinded to race, gender, financial, and geo­graphical disparities, so in essence a “blinded unicorn algorithm”—Kiang states that ques­tions arise about whether this would make it a “useful” algorithm at all. Where the “bal­ance” lies, she continues, is in a realistic AI architecture that can support these variables in a “representative” and “fair” way.

But, time is of the essence. “AI moves fast” Kiang asserts, observing that her growing body of research is developing closely along­side that of organizations with predomi­nantly financial motives, who are keen to “keep pushing.” Apart from a brief diversion to comment on the novel and rapid devel­opment of ChatGPT—“Dude, we haven’t even discussed the ethical implications of [ChatGPT], right?”—Kiang’s viewpoint remains focused on the positive change AI can effect in the care of humans globally. “It sounds Ivory Tower-ish, but my mind is cen­tered on the benefit to populations—not just at a specialty level, or even at a hospital level, but at a national, global level,” Kiang says.

AI does not come without limitations, Ki­ang makes clear; however, apprehension has most commonly been “driven by fear.” “On a superficial level people suggest that they will be out of a job, and I be­lieve that’s unfounded,” she says, high­lighting the only legitimate fear might be for support staff whose job could be performed more efficiently by AI. “I’m not here to say we should not advance technology so that people can be less efficient in the care that they provide pa­tients. But neither am I saying we should build Skynet and drive the human race out of need,” she adds.

A “hybrid” approach between AI and human specialty may be the best solution, Kiang proposes, a “human understanding of relationships” filling the gaps where AI is most lacking. But a “critical mass” of peo­ple who believe in the positive function of AI is needed, she continues. “If you don’t have that buy-in, you will have a lopsided relationship that isn’t truly a hybrid model. In this case, you will have executive bean-count­ers who don’t know anything about boots-to-the-ground patient care, leaning on AI predictions. I can see that as a problem mov­ing forward.”

Kiang describes her experience of the complex contemporary reception to AI, de­tailing how audiences are becoming more “receptive” to her ongoing AI research com­pared with previous years.

“We are hitting while the iron is hot right now, and it’s very hot,” she says. Kiang be­lieves people are now more “open-minded, or are being forced to be.” Emphasizing the importance of “clean” messaging when pre­senting research on this technology, Kiang says she aims to continue demonstrating the realistic clinical applications of AI that have the potential to better patient care in the future.

Advocacy exists to serve: Surgeons, patients and our mission

Advocacy exists to serve: Surgeons, patients and our mission
Margaret C. Tracci
advocacy
Margaret C. Tracci

One of the most gratifying aspects of working to advocate for surgeons is that, at its heart, this is completely trans­parent and is done simply to serve. Serve what? To serve surgeons, by supporting their ability to flourish in practice, pushing back against the seemingly endless accumulation of regulatory and other encumbrances, and focusing a light on surgeon well-being.

To serve our patients, by advocating for the highest quality care and tackling impediments to access. To serve our mission, by raising public and patient awareness of the role of vascular surgery and highlighting the importance of research, care innovation and the healthy growth of the vascular surgeon workforce.

Over the years, the Society for Vascular Surgery (SVS) has built a robust infrastructure to serve its members through advocacy, supported by both surgeon volunteers on its com­mittees and councils and by an expert professional staff, based both in Rosemont, Illinois, and Washington, D.C. The Policy and Advocacy Council works closely with policy and ad­vocacy staff to facilitate communication and coordination among its member committees, across councils, with the Strategic Board.

The Council’s committees include: Government Relations, which takes the lead on federal legislative and regulatory issues; Coding, which plays a critical role through the Amer­ican Medical Association’s Relative Value Scale (RVS) Update Committee (RUC) and beyond in the valuation and reim­bursement of vascular services; the PAC Steering Commit­tee, which raises and disburses funds to support all advocacy efforts; the VA Vascular Surgeons Committee, representing the unique position and perspective of the U.S. Department of Veterans Affairs (VA) surgeons and veterans; and the Per­formance Measures Committee, doing duty across councils to ensure alignment.

What does coordination and collaboration of advocacy across the SVS mean? This means that the policy and pri­orities of the entire society are drawn from the expertise of the councils and committees and the values of our vascular surgeon members. The Clinical Practice Council, for ex­ample, has helped define our advocacy agenda through the recommendations developed by the Wellness Committee, the insight into the impact of current payment policies of­fered by the Section on Outpatient and Office Vascular Care (SOOVC), and the initial work of the Population Health Task Force. Once policy and priorities are set, the SVS continues to serve through its three advocacy pillars: grassroots, political and legislative advocacy.

Our professional staff is continually working to move our priorities forward in D.C. And as Andrew Kenney wrote a few months ago, this operation is infinitely stronger with the support of surgeons engaging our legislators through in-per­son meetings, letters, calls, and social media in a grassroots campaign. So when you think of advocacy, know that SVS advocacy truly exists to serve. To get involved, reach out at [email protected].

Margaret C. Tracci is the chair of the SVS Advocacy Council.

Changing gears: A guide to cruising back to the operating room

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Changing gears: A guide to cruising back to the operating room
Kenneth Tran

For surgeons-in-training, professional development time (colloquially known as “the research years”) is a welcome break from the rigors of surgical residency. A time to rest, reflect, and embark on new growth opportunities. A reprieve from the 6:00 a.m. (or earlier) morning rounds, mid­dle of the night calls from the emergency department, and discerning gaze from our attendings. However, inevitably, the time comes to get back into clinical gear to fin­ish the job that you started (residency). Cue the nervous jitters and sweaty palms. This is a universal feeling nearly all of us have felt before returning to patient care after a long hiatus. Rest assured, the first three years of your surgical training have prepared you well for your return—but there are a few things you can do to make the transition back as smooth as possible.

Trip down memory lane

Like all things in surgery, the devil is in the de­tail. While the basics of clinical care, such as determining operative candidacy or periop­erative management, are likely old hat, little things will certainly have escaped your mem­ory. This is especially true in the operating room (OR). Which side of the anastomosis is easier to sew first for a below-knee bypass? What sheath size does this device need again? How does attending X like their cases draped and positioned? Revisiting old case logs and surgical notes from years past may be helpful to jog your memory of these minute details. This is also a good time to dust off the old anatomy and operative technique textbooks. Like riding a bicycle, technically performing both open and endovascular cases “comes back fast.” However, a few afternoons of deliberate practice with a set of Castrovie­jos, 6-0 Prolene, some expired PTFE grafts and your favorite Spotify playlist is a nice way to get back into the swing. Likewise, for endovascular cases in particular, a proac­tive visit to the endovascular device storage room to get re-acquainted with the names of commonly used wires, catheters and sheaths is beneficial.

Showing your age

One of the joys of vascular surgery is the sheer pace of innovation in our field, with a never-ending stream of new devices and techniques to master. Coming back from research, I found myself encountering new acronyms that I had never heard of before. What is a DVA exactly? Is the TBE the same as TAMBE? Seemingly overnight, TCAR be­came a widely adopted procedure that I was now expected to be facile with. A quick meet­ing with your friendly neighborhood device representatives is helpful in this regard. They often can share with you the newest updated endograft configuration booklets, which are invaluable for case planning. A few months prior to starting back, you may also find it useful to listen in on your division’s weekly case conferences to get a grasp on current clinical algorithms. For example, our vascu­lar lab and limb salvage program had adopt­ed pedal acceleration time as a new surrogate marker for foot perfusion, which may affect which patients are offered intervention.

It’s all about the team

Returning from research years often coin­cides with transitioning from being a junior to senior resident. In your new role, man­aging a cadre of interns, junior residents and advanced practice providers becomes supremely important. Cases need to be appropriately and fairly assigned, consults evaluated and staffed efficiently, and patient concerns and dispositions thoroughly ad­dressed. These tasks cannot be performed without a well-functioning team. I personal­ly found team management was one of the most difficult aspects of my final years of residency. This aspect of training was sel­dom discussed, nor do we often have formal education or coaching to improve our “soft skills”—which are arguably right up there with gaining operative skill in order to be an effective surgeon. If they can spare the time, grabbing coffee to chat with the cur­rent chief residents on service is immensely helpful in this regard. Your colleagues can give you a primer on any new workflow changes, service logistics or other aspects of patient care that have changed since you were last on service. Leaning into your new role as chief resident is a daunting task, but is without a doubt a rewarding and beneficial experience as you embark on your journey to independent practice.

The week before you start

One of my friends told me that he channeled his nerves into preparation. For him, that meant rounding with the team a few days before he was to start running the service. This helped get him back into the wake-up schedule, and he got to know the patient on service and their plan. He was also able to pick the mind of the chief resident he was taking over from. He got to meet the support staff. He also cites the benefit of knowing the operative schedule so that he could prep for the cases. Finally, he says he went down to the hybrid room on a quiet afternoon and reminded himself of “what the buttons did.”

The first month back is going to be stress­ful. There’s just no way around it, but I hope this column helps someone make that tran­sition back a little smoother.

Kenneth Tran is a vascular surgery resident at Stanford University, California.

Physical pain a risk factor for vascular surgery trainee burnout, survey reveals

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Physical pain a risk factor for vascular surgery trainee burnout, survey reveals

burnoutA recent survey has indicated that physical pain is “prevalent” among vascular sur­gery trainees and represents a risk fac­tor for burnout. Eric Pillado, MD, MBA, a vascular surgery resident at Northwestern University Feinberg School of Medicine in Chicago, shared this conclusion during the second SVS-VESS Scien­tific Session at this year’s Vascular Annual Meeting (VAM). 

Pillado detailed that 527 trainees completed a confidential, voluntary survey, administered after the Vascular Surgery In-Training Examination (VSITE), representing an 82.2% response rate. He revealed that 38% reported moderate-to-severe discomfort/pain after a full day of working, among whom 73.6% reported using ergonomic adjustments and 67% over-the-counter medications. Pillado also communicated that more women tended to report moderate-to-severe pain than men (44.3% vs. 34.5%, p<0.01).

After adjusting for gender, training level, race/ethnicity, mistreatment, and lack of operative autonomy—which the authors describe in their abstract as a proxy for loss of meaning in work— moderate-to-severe pain (odds ratio [OR] 2.52, 95% confidence interval [CI] 1.48–4.26) and using physiotherapy as pain management (OR 3.06, 95% CI 1.02–9.14) were determined to be risk factors for burnout.

In light of these findings, the presenter suggested in his conclusion that programs “should provide ergonomic education and adjuncts, such as posture awareness and microbreaks during surgery, early and throughout training”.

Pillado presented this work on behalf of senior author Dawn M. Coleman, MD, chief of the division of vascular and endovascular surgery at Duke University Medical Center in Durham, North Carolina, and the Vascular Surgery SECOND trial steering committee.

The Big Interview: Pioneering surgeon recounts career as new VAM lectureship is birthed

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The Big Interview: Pioneering surgeon recounts career as new VAM lectureship is birthed

Vascular Specialist medical editor Malachi Sheahan III, MD, sits down with Frank J. Veith, MD,  to discuss his new book, The Medical Jungle, ahead of the maiden named Vascular Annual Meeting (VAM) lecture created in the former SVS President’s honor. The Frank J. Veith Distinguished Lecture took place last week, and was focused on BEST-CLI. Here, they talk through his career highlights, including his journey as a limb-salvage pioneer.

VAM attendees chime in on BEST-CLI and BASIL-2

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VAM attendees chime in on BEST-CLI and BASIL-2

VS@VAM journalist Will Date and videographer Jean-Philippe Bensoussan caught some VAM 2023 foot traffic outside the BEST-CLI and BASIL-2: Debate, Analysis and Implementation session last week to get their take on the two trials and how it has impacted their practice.

William Shutze

First up, SVS President and vascular surgeon William Shutze, MD with Texas Vascular Associates in Plano, says he is staying a familiar course.

“These are two really amazing, important trials that just came out this year that have profoundly affected the care of vascular patients. And it’s very exciting that the results have been published.

“At the same time, even though the overarching conclusions appear to be different, the way that I have interpreted these trials is it’s reinforced a lot of my own personal biases in the care of vascular patients. “I strongly favor bypass surgery for patients that are healthy and have a good quality vein. However, for patients that fall outside of those parameters, it demonstrate the superiority of endovascular techniques and limb salvage.”

Nicolas Mouawad

Nicolas Mouawad, MD, chief of vascular and endovascular surgery at McLaren Bay Region in Bay City, Michigan, says the two trials offer much food for thought.

“The long-awaited BEST-CLI and then BASIL-2, which I saw when they gave the information at Charing Cross,. I must say it really has confirmed and validated my current practice. We want to keep [intervention] as minimally invasive as possible, but if you have single-segment great saphenous vein in complex patients with CLTI, then I generally would offer a bypass.

“BEST-CLI is really an opportunity to compare best surgical therapy versus endovascular care. However, with BASIL-2 coming out, this has given us a little bit of a different perspective from what we saw in BEST-CLI. Unfortunately, I think it keeps the waters a little bit muddied, but for me in my current practice, it really just validates what I currently do.”

Lee Kirksey

Lee Kirksey, MD, vice chair of vascular surgery at Cleveland Clinic in Cleveland, Ohio, peripheral arterial disease (PAD) care is about offering the most appropriate care for the individual patient.

“What BASIL-2 as well as BEST-CLI really highlight is the importance of looking at this heterogeneous group of patients with PAD in a more granular fashion. We know that systemic risk of the operation, the patient’s anatomic complexity, the lesion complexity—all of these things should influence and impact how we manage the patients.

“I really look at BEST-CLI and BASIL-2 as highlighting the importance that we need to tailor therapy to the patient in front of us, using all the best available grading classifications, the GLASS scale for anatomic complexity, the WIfI scale in terms of the patient presentation, and then select the appropriate therapy. Really, it endorses the need for team based care so that we have expertise within endovascular therapy, expertise within open surgical bypass. Sometimes there will be some hybrid component of those therapies and we offer the most appropriate therapy for that patient in front of us.

Vincent Rowe

For University of California Los Angeles (UCLA) chief of vascular surgery Vincent Rowe, MD, a BEST-CLI site investigator, diagnosis and screening come to the fore.

“For me, the most important lesson was the outcome the outcome of the patients. I knew that patients with lower extremity disease had a high rate of mortality at four to five years. I didn’t realize it was this high— and even in those treated with endovascular therapy. So that was shocking to me. And I believe it means we’re going to need to try to diagnose these patients earlier. I think we should start screening these patients. I think it will save lives. And then I also believe that it will really help us be able to combat that low survival rate.

“To know that a patient that I operate on either with a stent or a bypass has a low probability of being there in follow up at five years makes me work even harder because, even though they may not be there in five years, I want them there with their leg until they close their eyes.”

Frailty status beats WIfI score as mortality predictor in all-comer CLTI study

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Frailty status beats WIfI score as mortality predictor in all-comer CLTI study
WIfI score
John Houghton

A study presented during Plenary Session 3 at last week’s Vascular Annual Meeting (VAM), concluded that the Wound, Ischemia, and Foot Infection (WIfI) stage is predictive of major amputation at one-year follow-up in patients with chronic limb-threatening ischemia (CLTI), while frailty status is a better predictor of mortality. The researchers also found that, at baseline, WIfI classification is associated with both frailty and disability but not quality of life (QoL).

Submitting and presenting author John Houghton, MD, a National Institute for Health and Care Research (NIHR) academic clinical lecturer at the University of Leicester in Leicester, England, opened his talk by noting that the WIfI classification system has been widely adopted in CLTI management; however validation has predominantly been among patients undergoing revascularization. The present study, therefore, aimed to investigate the association of WIfI stage with baseline frailty, disability, and QoL, in addition to one-year major amputation and survival, in all-comers with CLTI.

Outlining the study methods, Houghton noted that the research team performed a single-center prospective cohort study of patients aged ≥18 with CLTI, who were enrolled in the study between May 2019 and March 2022. He noted that frailty, disability and QoL assessments were performed at baseline, with an interim analysis of one year outcomes performed in January 2023.

The presenter continued that amputation incidence was calculated for WIfI stages, and individual WIfI score combinations with ≥5 patients, and presented as percentages with 95% confidence intervals (CI).

Houghton, who presented this study on behalf of senior author Rob Sayers, professor of vascular surgery at the University of Leicester, and colleagues, detailed that a total of 432 patients were included in the research. He shared that 52 patients (12%) classified as WIfI stage 1, 112 (25.7%) stage 2, 107 (24.8%) stage 3, and 93 (21.5%) stage 4. There were 69 patients (16%) who had incomplete WIfI scores.

Sharing key results with the VAM audience, Houghton reported that increasing WIfI stage was associated with increasing prevalence and severity of frailty (p=0.003), and greater disability (p<0.001). He added that QoL scores, however, were similar for each WIfI stage.><0.001). He added that QoL scores, however, were similar for each WIfI stage.

In addition, the presenter revealed that major amputation incidence at one-year follow-up was 2% (95% CI, 0–11) for WIfI stage 1, 7% (95% CI, 4–14) for stage 2, 8% (95% CI, 4–15) for stage 3, 20% (95% CI, 13–30) for stage 4, and 16% (95% CI, 9–27) in those patients with incomplete WIfI scores. It was specified that amputation incidence for individual WIfI scores was largely consistent with stage classification.

Houghton further reported that increasing WIfI stage was independently associated with one-year major amputation (sub-distribution hazard ratio [SHR], 1.99; 95% CI, 1.33–2.97, p=0.001), and was also associated with one-year mortality (HR, 1.31; 95% CI, 1.03–1.67; p=0.029). Frailty (clinical frailty score ≥5; HR, 2.18; 95% CI, 1.26–3.76; p=0.005) and non-operative management (HR, 4.42; 95% CI, 2.63–7.41; p<0.001), the presenter stated, were found to be the strongest predictors of mortality at one year.><0.001), the presenter stated, were found to be the strongest predictors of mortality at one year.

“These results from the Leg ischemia management collaboration (LIMb) study provide further validation of the utility of the WIfI score in classifying patients with CLTI by risk of major amputation at one year,” Houghton told VS@VAM ahead of his presentation.

“These data are particularly useful as all not all patients presenting with CLTI require, or are suitable for, revascularization but most of the published data on the WIfI score come from patients undergoing intervention. The LIMb patient cohort is a representative sample of CLTI patients and nearly 25% of patients included were initially managed conservatively. The finding that both frailty and disability were associated with increased WIfI stage highlights both the vulnerability of this patient population and the potential benefits of successful revascularization, but the lack of association of WIfI score with quality of life is counter-intuitive and warrants further exploration.”

SVS diversity celebration at VAM 2023

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SVS diversity celebration at VAM 2023
Doctors and medical staff wearing surgical masks, they are standing together, coronavirus prevention concept

The Society for Vascular Surgery celebrates all of its members at the inaugural Celebration of Diversity Reception at the Vascular Annual Meeting (VAM) 2023.

In previous years, many specific groups held smaller receptions while at VAM, including young surgeons, women and many others, including alumni groups. For this year, SVS organizers decided to instead combine many into one.

“In the past, the Women’s Networking Reception was held as an extension of the ‘Women’s Committee,’ a designation that preceded the current Women’s Section,” said Audra Duncan, MD, one of the founding members and current chair of the Women’s Section.

“The reception became so popular, that it was typically difficult to enter the packed room at the venue. So, the reception evolved into larger and larger rooms, and the invite list became broader to capture the wide audience that was interested in attending,” she said.

“It is breath-taking to see the large audience at this reception compared to the handful of us in a room 20 years ago, and to know we are gathering with so many other VAM members.”

Optimizing the clinical environment: ‘Mitigating Barriers to Inclusion and Advancement in Academic Surgery’ presented at VAM 2023

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Optimizing the clinical environment: ‘Mitigating Barriers to Inclusion and Advancement in Academic Surgery’ presented at VAM 2023
Raghu L. Motaganahalli

America’s face is changing, becoming more diverse and with more women and immigrants in the country, medicine and the vascular surgery specialty.

Raghu L. Motaganahalli, MD, of the Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, presented both the barriers and pathways to success in “Mitigating Barriers to Inclusion and Advancement in Academic Surgery: International Medical Graduate (IMG) Perspective. His presentation was part of an educational session on “Optimizing the Clinical Environment: Learning & Practicing with Intent and Inclusion” Thursday afternoon at the Vascular Annual Meeting (VAM) 2023 last week.

“I am an immigrant vascular surgeon and believe we add value to our specialty,” he said straightforwardly, at the start of his presentation. The US includes more than 2.8 million foreign-born healthcare workers from a wide range of countries. Top countries of birth are the Philippines, Mexico, India, Jamaica and Haiti.

In 2021, US-born doctors represented 60.1% of residents and fellows in ACGME-accredited programs; DOs made up 16.9% and international medical graduates made up nearly 23%. IMGs in 2021 represented 17.5% of the vascular surgery workforce.

Some challenges in getting hired include concerns about standardized training, including school reputation and accreditation; perceived language and cultural barriers and visa requirements, he said.

Both systemic intervention and individual actions can help mitigate exclusion. IMGs who want to advance in academics should “choose the right environment, surround yourself with people who want you to succeed and supplement your environment with the necessary resources to succeed.”

SVS honors two with Lifetime Achievement Award

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SVS honors two with Lifetime Achievement Award
Left to right: Julie Freischlag, Michael C. Dalsing, Enrico Ascher
SVS
Left to right: Julie Freischlag, Michael C. Dalsing, Enrico Ascher

The Society for Vascular Surgery (SVS) honored two surgeons—instead of the traditional one—with its highest honors, the Lifetime Achievement Award at the Vascular Annual Meeting (VAM) last week.

It’s only the third time the Society has done so in the award’s history, said Michael C. Dalsing, MD. He presented the honorees: Enrico Ascher, MD, professor of surgery at NYU Langone School of Medicine, and Julie Freischlag, MD, formerly dean of Wake Forest University School of Medicine and now chief academic officer of Advocate Health. Freischlag was SVS’ first—and still only—woman president.

Both Ascher and Freischlag are “exceptionally deserving of this prestigious distinction,” said Dalsing. SVS will profile the two recipients in the July issue Vascular Specialist.

‘Vigilant’ surveillance and low threshold for further interventions ‘crucial’ following rescue of prior EVAR with PMEG

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‘Vigilant’ surveillance and low threshold for further interventions ‘crucial’ following rescue of prior EVAR with PMEG
PMEG
Senior author Marc L. Schermerhorn

The findings of a recent study on reinterventions and sac dynamics after fenestrated endovascular aneurysm repair (FEVAR) with a physician-modified endograft (PMEG) for index aneurysm repair and following prior EVAR led researchers to conclude that “vigilant” surveillance and a low threshold for further interventions are “crucial.” The finding relates to PMEG for rescue of prior EVAR with loss of proximal seal.

Nicholas J. Swerdlow, MD, a vascular surgery fellow at Beth Israel Deaconess Medical Center in Boston, shared these findings during Plenary Session 4 last week at the 2023 Vascular Annual Meeting (VAM) on behalf of senior author Marc L. Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center, and colleagues.

Swerdlow et al note in their study abstract that, while the high frequency of reinterventions after FEVAR with a PMEG has been well-studied, the impact of prior EVAR on reinterventions and sac behaviour following these procedures remains unknown. In the present study, therefore, the researchers analyzed three-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal.

The investigators analyzed 122 consecutive FEVARs with PMEGs at a tertiary care center that was submitted to the Food and Drug Administration (FDA) in support of an investigational device exemption (IDE) trial. They excluded patients with aortic dissection, type I–III thoracoabdominal aneurysms, non-elective procedures and prior aortic surgery other than EVAR, for a final cohort of 92 patients.

Patients were divided into those who underwent PMEG for index aneurysm repair (index-PMEG) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (rescue-PMEG).

Swerdlow shared with the audience that, of the 92 patients included in the analysis, 55 (60%) underwent index-PMEG and 37 (40%) underwent rescue-PMEG. He added that rescue-PMEG patients were older—78 years (interquartile range [IQR] 75–83) vs. 73 years (69–78), p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics.

The presenter reported that perioperative mortality was 1.8% for index-PMEG and 2.7% for rescue-PMEG (p=0.8) and that, at three years, overall survival was 83% for index-PMEG and 72% for rescue-PMEG (p=0.08).

In addition, he noted that freedom from reintervention was significantly higher for index-PMEG than rescue-PMEG, specifically 79% vs. 45% at three years (p<0.001).

Swerdlow then shared sac dynamic findings. He revealed that, at three years following index-PMEG, aneurysm diameter was stable in 58% of patients and decreased in 42% of patients, with no cases of sac expansion.

At three years following rescue-PMEG, however, he noted that aneurysm diameter was stable in 31% of patients, decreased in 31% of patients and increased in 38% of patients (p=0.05).

The presenter stated in his conclusion that FEVAR with PMEGs for index aortic repair and rescue of prior EVAR with loss of proximal seal are “two distinctly different entities.” He summarized that, following FEVAR with a PMEG for index aneurysm repair, less than a quarter of patients had undergone reintervention at three years and sac expansion was “rare.”

At three years following PMEG rescue of prior EVAR with loss of proximal seal, however, it was observed that over half of patients had undergone reintervention and over a third had ongoing sac expansion, which led Swerdlow to underscore the importance of “vigilant” surveillance and a low threshold for further interventions in this group of patients.

Ahead of Swerdlow’s presentation, Schermerhorn shared some thoughts on the study findings with VS@VAM: “I have changed my practice now to reline the entire graft whenever I do a rescue PMEG. I believe that many of these patients have undetected type 3 endoleaks that lead to sac expansion and subsequent loss of the proximal seal.

“Extending the seal proximally fixes the 1a leak but does not address the original cause of sac expansion for the subgroup that had original expansion due to type 2 or 3 endoleak and we need to be alert to this possibility. I have now performed sacotomy on four patients for presumed type 2 endoleak with sac expansion (two of whom had prior rescue PMEG) and found fabric tears that were not detected by [computed tomography angiography], duplex, or angiography.”

Two-year DETOUR2 study results presented at VAM 2023

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Two-year DETOUR2 study results presented at VAM 2023
Sean Lyden

Endologix has announced the 24-month results of the DETOUR2 study, presented at VAM 2023, the annual meeting of the Society for Vascular Surgery (SVS), by one of the study’s principal investigators, Sean Lyden, MD,  chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio.

Percutaneous transmural arterial bypass (PTAB) with the Detour system, recently received premarket approval Approval from the Food and Drug Administration (FDA). The system enables physicians to percutaneously bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg. The Detour system is comprised of the Endocross device and Torus stent grafts.

The DETOUR2 study enrolled 202 patients in the U.S. and Europe. The 24-month results from the study indicated that 96% of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm. Technical success was achieved in 100% of treated patients and the primary safety endpoint was surpassed with a 30-day major adverse event (MAE) rate of 7%

The freedom from clinically driven target lesion revascularization (CD-TLR) at 24 months was 76.7%, and secondary patency was 82.3%. The freedom from symptomatic deep vein thrombosis (DVT) was 96.5%, and freedom from major lower limb amputation was 98.5% at 24 months.

“The two-year results from the DETOUR2 Study are encouraging and demonstrate PTAB using the Detour system offers good patency rates in long superficial femoral artery (SFA) lesions. As noted in the conclusion of the presentation, the two-year data mimics those of surgical bypass without the need for general anesthesia, long length of stay, and high risk of complications. We look forward to continuing to study the Detour system,” said Lyden.

SVS announces new vice president and treasurer following 2023 election

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SVS announces new vice president and treasurer following 2023 election
Keith Calligaro and Thomas Forbes

The Society for Vascular Surgery (SVS) has announced the latest additions to its officer roll following the 2023 elections for Society vice president and treasurer. 

Keith Calligaro, MD, of Pennsylvania Hospital and a professor of clinical surgery at the University of Pennsylvania School of Medicine in Philadelphia, was elected vice president for 2023–24, meaning he enters the presidential line of succession to become president in 2025–26.

Thomas Forbes, MD, surgeon-in-chief and James Wallace McCutcheon Chair of the Sprott Department of Surgery at the University Health Network in Toronto, assumes the role of SVS treasurer after winning the electoral contest.

The results were announced during the SVS Annual Business Meeting held at the conclusion of the 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland.

Incoming SVS President Joseph Mills, MD, told members in a Society mailer the election saw a record number cast ballots.

“The election opened in Mid-May, and we left no stone unturned to stress the importance of voting to all voting-eligible members, which resulted in a record turnout with 939 votes (30% of eligible voters),” he wrote. “In the 2022 election, just over 600 voting eligible members voted, resulting in a 50% increase in one year. Thank you to all members who chose to cast their vote.

Mills also thanked the other candidates who ran for the two positions for their candidacies: Kellie Brown, MD, professor of surgery in the Division of Vascular and Endovascular Surgery at the Medical College of Wisconsin in Milwaukee, who ran for vice president; and Palma Shaw, MD, professor of surgery at State University of New York in Syracuse.

“Each of them is a strong leader within the society and their institutions, and I look forward to continuing to work with them within SVS,” Mills commented. “There’s no doubt we will continue to see great things from them.”

Nephrologist insights for vascular surgeons at hemodialysis access session

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Nephrologist insights for vascular surgeons at hemodialysis access session
Female nurse assisting patient undergoing renal dialysis in hospital room

Friday afternoon in Potomac D will see VAM play host to a series of presentations on access for hemodialysis that will offer education on arteriovenous fistulas (AVFs), grafts (AVGs) and maturation—as well as strategies for managing their failure.

The session will be moderated by Maureen Sheehan, MD, of Wake Forest University Medical Center, North Carolina, and Thomas Huber, MD, from the University of Florida in Gainesville, and is titled “Creation and Complications: Current Strategies in Hemodialysis Access.” Split into two sections, the 90-minute program will focus first on access creation, with Vandana Dua Niyyar, MD, President of the American Society of Diagnostic and Interventional Nephrology (ASDIN), offering up an interventional nephrologist’s angle on the creation of dialysis access.

Speaking to VS@VAM, Huber—among those behind the program—said: “The hope was that we could get someone from the outside that could share their perspective. We’ve tasked [Niyyar] with telling us what vascular surgeons need to know from a nephrologist’s perspective.”

Next up will come Theodore Yuo, MD, of the University of Pittsburgh Medical Center, who will explore endovascular AVF (endoAVF), before Libby Weaver from the University of Virginia Health System will talk AVG materials and Yana Etkin, MD, Zucker School of Medicine at Hofstra/Northwell, Long Island, New York, will explore access maturation strategies.

Following a 15-minute panel discussion, the second half of the session will get underway with a talk on the management of failing AVGs and AVFs from Jeffrey J. Siracuse, MD, from the Boston School of Medicine in Boston. Management is the name of the game in this whole second sequence of talks—with management of everything from high-flow AV access the focus of Samuel S. Ahn of TCU & UNTHSC School of Medicine, Fort Worth, to the management of access emergencies rounding out the session in a talk from Huber himself.

Detailing his talk, Huber told VS@VAM that he will turn the spotlight on “aneurysms and pseudoaneurysms that are not recognised and treated definitively.”

‘Excellent’ limb salvage rates for trauma bypass performed by vascular surgeons

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‘Excellent’ limb salvage rates for trauma bypass performed by vascular surgeons
Clement Darling, MD

Revascularization for extremity trauma can be performed with excellent limb salvage rates, though poor compliance with long-term surveillance raises some cause for concern.

These are among the primary messages presented from a study detailing the experience and outcomes of a rural, level one, trauma center performing upper- or lower-extremity revascularization in trauma patients over a 20-year timespan, in which investigators sought to identify bypass failure modes and surveillance protocols.

Vascular surgery resident Misak Harutyunyan, MD, presented the analysis during this morning’s Plenary Session 7 (8:00–9:30 a.m.) in Potomac A/B, on behalf of the Albany Medical College vascular team, including senior author Jeffrey Hnath, MD, and submitting author R. Clement Darling, MD. The Albany team posits that long-term outcomes in civilian trauma patients requiring upper- or lower-extremity revascularization has been poorly studied, secondary to limitations of certain large databases and the nature of the patients in this specific vascular subset.

Their dataset offers up insights from 223 revascularizations performed between January 2002 and June 2022. Of these patients 161 (72%) had lower and 62 (28%) upper extremities. The Albany team reports an operative mortality rate of 4.5% (n=10), all involving lower-extremity revascularization. Thirty-day non-fatal complications included immediate bypass occlusion in 11 patients (4.9%), wound infection in 7 (3.1%), graft infection in 6 (2.7%), and lymphocele/seroma in 5 patients (2.2%). All major amputations (13, 5.8%) were early and in the lower extremity bypass group, the study’s authors report. Late revisions in the lower- and upper-extremity groups were 14 (8.7%) and 2 (3.2%) respectively.

Although the study’s authors are set to report that revascularization for extremity trauma can be performed with excellent limb salvage rates, demonstrating long-term durability with low limb loss and bypass revision rates, they also sound a note of caution over poor compliance with long-term surveillance. “The poor compliance with long-term surveillance is concerning and may require adjustment in patient retention protocols,” they will state, adding, however, that “emergent returns for bypass failure are extremely low in our experience.”

Improved fistulas and cost-effectiveness promised in plenary 5 abstract presentation

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Improved fistulas and cost-effectiveness promised in plenary 5 abstract presentation
Ellen Dillavou
Ellen Dillavou, MD

Friday morning’s Plenary Session 5 (8:00–9:30 a.m.) is set to feature new data on an external support device that may deliver more functional arteriovenous fistulas (AVFs) while also offering an improvement in cost-effectiveness. Presenting an abstract on research into the VasQ device will be Ellen D. Dillavou, MD, of WakeMed Hospital in Raleigh, North Carolina.

The study explored the support device’s ability to improve functional success in AVF over a 24-month period. Dillavou is set to deliver “the first complete report of the U.S. pivotal comparative study results”, alongside a cost-effectiveness analysis. Over the study, she will detail, 144 patients were enrolled—90% of them receiving a brachiocephalic and 10% a radiocephalic fistula. Some 782 patients treated by the same surgeons without the VasQ device immediately before enrollment in the trial were identified as a comparative group, with their Medicare claims data utilized for comparison. Statistical comparison was then performed between the groups with regards to primary patency—defined as freedom from intervention—as well as functional success (continuous use for dialysis after 30 days) and post-creation reintervention. Payor cost was taken into consideration alongside each of these outcomes.

“Primary failure of 7.9% for VasQ AVF patients compared favorably to the 22% to 32.2% reported in contemporary U.S. meta-analyses,” the study authors report, while the cumulative patency for the VasQ device of 76.7% (95% confidence interval [CI]: 67.7–83.4%) was found to be “superior to contemporary meta-analyses,” which the authors say report between 53.7% to 63% for standard AVFs. There was a “nearly 50% reduction in access interventions” with the device at six months, which the authors argue led to the annualized cost reduction they found of US$7,764.19 per patient year.

Last hours to bid on Gala Auction items

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Last hours to bid on Gala Auction items

A night of grandeur, reminiscent of the parties hosted by the fictional character Jay Gatsby, awaits attendees on tonight (Friday) at the “Great Gatsby Gala,” benefiting the SVS Foundation.

Gala tickets are sold out, but bidding will continue for everyone regardless of VAM or Gala attendance. More than 50 items are available, including weekend excursion packages. The Gala Silent Auction will close at 8 p.m., allowing individuals from around the globe to participate.

Presidential handover at VAM 2023

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Presidential handover at VAM 2023

The annual business meeting (for members only).

The results of the just completed SVS election of officers (vice president and treasurer) will be announced at the meeting, which will also feature reports from officers and others, presentation of awards and the passing of the gavel—and the SVS presidency—from Michael C. Dalsing, MD, to Joseph Mills, MD. The meeting, from 12–1:45 p.m. Saturday, closes out VAM 2023.

Future research needed to ‘optimize’ use of imaging technologies during aortic procedures

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Future research needed to ‘optimize’ use of imaging technologies during aortic procedures
Carlos H. Timaran, MD and Francis Caputo, MD
Carlos H. Timaran, MD and Francis Caputo, MD

Imaging technologies in the aortic space will be a key feature of Saturday’s Plenary Session 8 (11:15 a.m. to 12:30 p.m.) in Potomac A/B, with speakers set to share data on Philips’ Fiber Optic RealShape (FORS) technology and Centerline Biomedical’s IntraOperative Positioning System (IOPS).

Valeria Mejia-Martinez, BS, a medical student at the University of Texas Southwestern Medical Center in Dallas, is due to deliver a presentation on target vessel catheterization with FORS using upper extremity versus transfemoral access for fenestrated/branched endovascular aneurysm repair (F/BEVAR).

Mejia-Martinez et al note in their study abstract that traditionally, and due to length constraints, FORS has been used primarily for transfemoral (TF) access, with the purpose of the present study being to report the feasibility and benefits of using FORS during F/BEVAR—including cannulation times of target vessels and radiation measures—comparing upper extremity (UE) versus TF access.

In order to achieve their study objective, the research team conducted a single-center retrospective study with prospectively collected data. They included data from 74 patients who underwent F/BEVAR with FORS guidance for target vessel catheterization during an 11-month period. Among 370 navigation tasks reported, the researchers note that 350 (94.6%) were performed with FORS.

The presenter is due to share at VAM the result that technical success was 90.3% and that mean time required to deem the catheterization as a failure was 8.4±5 minutes. She will also communicate that UE access, steerable sheath, and FORS catheters were used in 54.3%, 17.7% and 13.7% of cases, respectively.

Mejia-Martinez will conclude that F/BEVAR with FORS technology is feasible using both UE and TF access and facilitates artery catheterization with acceptable technical success and potentially reduced radiation. However, she will stress that further experience is required to “optimize the use of FORS during F/BEVAR”.

Speaking to VS@VAM ahead of the presentation, senior author Carlos H. Timaran, MD, MS, professor in the division of vascular and endovascular surgery at the University of Texas Southwestern Medical Center, shares his opinion on what is next for FORS: “Cost, potential use with all imaging platforms and expanded availability of guidewires and catheters are the key steps forward in the development and widespread application of this technology.”

Later in the session, Nicholas G. Hoell, MD, integrated vascular resident at the Cleveland Clinic in Cleveland, will speak on the use of electromagnetic IOPS as a 3D imaging adjunct in EVAR based on the results of a safety and feasibility study.

On behalf of senior author Francis J. Caputo, MD, associate professor and program director at the Cleveland Clinic, Hoell will share the results of a study that aimed to demonstrate the safety and efficacy of the electromagnetic-based IOPS in providing guidance for accurate wire and catheter navigation as an adjunct to fluoroscopy during thoracic endovascular aortic repair (TEVAR), FEVAR and EVAR.

Hoell will detail that 30 patients with aortic aneurysms suitable for TEVAR, FEVAR and EVAR were enrolled across two sites in the U.S. from 2020 to 2022.

He is set to reveal that technical success was achieved in 100% of patients with IOPS providing adjunctive 3D guidance for wire and catheter manipulation during aortic navigation and branch vessel cannulation, with zero serious and non-serious adverse events attributable to the IOPS system at seven-day follow-up.

Hoell will conclude at VAM that the electromagnetic-based IOPS is safe and effective in providing adjunctive 3D guidance for wire and catheter manipulation in infrarenal and fenestrated endovascular abdominal aortic aneurysm repair. She will, however, underline the fact that future research is needed to investigate the potential for IOPS to reduce radiation exposure to patient and operator, reduce contrast usage, and reduce operative time while providing better visualization of complex anatomy.

Caputo told VS@VAM ahead of the presentation: “It is imperative that we find alternative imaging modalities to fluoroscopy. This study is a first step in showing the IOPS is safe and effective as an adjunct to traditional fluoroscopy. Future studies must demonstrate the ability to perform endovascular procedures alone with IOPS as well as the ability to have the tools to navigate tough anatomy.”

Study shows performance on the vascular qualifying examination does not predict performance on the certifying examination

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Study shows performance on the vascular qualifying examination does not predict performance on the certifying examination
Libby Weaver, MD
Libby Weaver, MD

A national cohort study of vascular trainees taking the Vascular Qualifying Examination (VQE) and the Vascular Certifying Examination (VCE) found performance during the former is “not predictive” of first-time pass achievement in the latter—but, the findings highlight the “[necessary]” identification of trainee competency measures that may predict certification examination failure.

Speaking to VS@VAM ahead of her presentation on Saturday, Libby Weaver, MD, from University of Virginia Health System in Charlottesville explained that their results may have stemmed from the two examinations testing distinct competencies.

Given board certification is associated with better quality of care, and that training programs must demonstrate high rates of first-attempt pass by their graduate candidates to maintain accreditation, Weaver noted this result indicates we must “find a marker to better identify candidates at risk [of failure]”.

In a follow-up study looking at Accreditation Council for Graduate Medical Education (ACGME) Milestone ratings—a means of formative assessment of trainees—Weaver et al convey how these are seen to be a “highly predictive” indication of ability to pass board certification examinations. Specifically, medical knowledge and patient care competencies strongly predict performance on VQE, whereas interpersonal communication skills emerge as strongly predictive of VCE performance. This suggests we are “certifying well-rounded vascular surgeons and maintaining a high-quality standard within our specialty”, Weaver noted.

To this end, Weaver intends on furthering this research against a backdrop of the emerging evidence which has found a correlation between board certification and quality of care.

The current study’s senior author Brigette Smith, MD, University of Utah Health, Salt Lake City, is presently researching how Milestone ratings ultimately predict quality of care, ensuring outcomes in practice are reflective of assessment of trainees. “If we are able to make that connection it would be a huge advancement in surgical education,” Weaver commented.

Novel drug candidate for slowing AAA growth demonstrates safety in humans

Novel drug candidate for slowing AAA growth demonstrates safety in humans
Stephen Cheng, MD

The local delivery of a glucose-derived compound in small- and medium-sized abdominal aortic aneurysms (AAAs) has been deemed safe, with “promising” early efficacy data indicating its potential in stabilising or slowing AAA sac growth. According to Stephen Cheng, MBBS, MS, chair of the Department of Surgery at the University of Hong Kong, these first-in-human study findings—which he will present today at VAM 2023 during Plenary session 6 (10–11 a.m.) in Potomac A/B—merit further evaluations within randomized controlled trials.

“The main message is that this is a group of patients where, currently, there are no effective treatments to slow the growth of [abdominal aortic] aneurysms,” Cheng tells VS@VAM. “And, therefore, the idea of using a drug that is delivered only once inside the aneurysm sac sounds attractive— especially if it leaves nothing behind and all the future treatment options are left open.”

The multicenter study in question saw patients with an AAA (diameter <5.5cm) recruited to receive a one-time, local administration of 25ml of 1,2,3,4,6-pentagalloyl glucose (PGG) solution via transfemoral access. The study’s primary endpoints were technical success and safety—determined by the occurrence of major adverse events at 30 days. Cheng et al have reported a 100% rate of technical success, and found that the only safety-related concern was that four of the 21 enrolled patients showed a transient elevation of liver enzyme levels. However, these levels returned to normal within 30 days and triggered no clinical symptoms.

“When we talked to the pharma scientists, who are really looking at the molecular aspects of why these drugs work, the answer was that PGG is largely metabolized in the liver,” Cheng adds. “This is a way that the liver responds to any [raised level] of glucose in the metabolism pathway. That is the explanation that has been given to us, but we have seen no adverse effects in the patients. It will certainly be an area we will be closely monitoring as to how patients behave afterwards but, so far, they are all fine and the one patient who did have a very high enzyme level returned to normal in about a month’s time.” With this being a first-in-human study, Cheng is quick to point out that any conclusions drawn from the results regarding efficacy of the PGG solution in slowing AAA growth are preliminary.

Nevertheless, as per their secondary endpoint of freedom from aneurysm sac enlargement, the researchers report average AAA diameter changes from baseline of 0.2mm, 1.1mm, 2mm and 0.8mm at six, 12, 24 and 36 months, respectively. Follow-up computed tomography angiography (CTA) data further indicated average volume changes of 2.5%, 9.6%, 24.3%, and 11.6%, respectively—and, at 12 months, none of the aneurysms had grown by more than 5mm in diameter, while only three had a volume growth >10%.

Prior studies have indicated that the average rate of AAA sac growth is around 3–3.5mm per year, according to Cheng. He states that this figure was used as a target in the present study, adding that the treatment threshold in Caucasians is an aneurysm diameter of 5.5cm and, “if we can slow the growth by 50% [to about 1.7mm], then we can push back the threshold for intervention from five years to 10 years, and that would bring expected benefits”.

“But, I must reiterate that this is a first-in human study of a relatively small number of patients,” he adds. “The main focus was on patient safety rather than long-term aneurysm sac [growth].”

BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance

BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance
Alik Faber, MD and Matthew Menard, MD

The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J. Veith Distinguished Lecture yesterday morning in which they laid bare the blood, sweat and tears shed on their journey to complete the landmark study.

The headline findings that emerged out of the trial—that both open and endovascular procedures were equally safe, and that chronic limb-threatening ischemia (CLTI) patients deemed suitable for either approach who had an adequate great saphenous vein experienced better overall clinical outcomes after open bypass surgery—sparked rancor in the interventional and surgical communities.

Yet, Alik Farber, MD, and Matthew Menard, MD, used the maiden Veith Lecture to shine a light down a path toward further advances in end-stage peripheral arterial disease (PAD) care. The pair used the platform to tell the story of their journey in order that others might take the leap of faith they did to tackle “impactful questions in science,” Farber told VAM 2023 attendees.

They first got together to develop the idea for a trial to compare open vs. endo treatment for CLTI in 2007. “It really was the blind leading the just as blind,” quipped Menard. As Farber described, personally he had very little experience in clinical trials at the time. “There was a lot of insecurity,” he said. “Were we really the right people to do this?” he recalled thinking back then.

Upon receiving positive feedback from within the vascular surgery ranks, Farber related, they began the National Institutes of Health (NIH) application portion of their journey.

At first blush, as they prepared to go down the NIH route, they thought vascular surgeons should do the trial owing to the fact they carry out both procedural modalities.

Despite their arguments, the application failed. Yet, they persevered. They responded to the criticisms. Other specialties were included. More funding was secured. Some of that rancor seen in the aftermath of the release of their findings late last year emerged back then over trial design too. But eventually, the specialties united, and they got NIH grant approval.

They had many difficulties along the way. “This trial was extremely difficult to enroll,” said Farber. “There were multiple curveballs.” The Katsanos meta-analysis. COVID-19. Running out of money.

They got there, presenting at the American Heart Association and publishing the results in the New England Journal of Medicine. “We hope our story encourages others to pursue their research ambitions, even in the face of obstacles, self-doubt and judgment of others,” said Farber.

Menard paid tribute to the man for whom the new VAM lecture is named: Frank Veith, MD. “It is impossible to [over]estimate how much of a maverick Frank has been, and the enormity of what he has contributed to the field,” he said. Menard sees a kindred spirit in Veith in the sense of how the limb-salvage pioneer looks at the foot. Menard, too, likes to try the less conventional. “But one thing I haven’t done, and Frank did it a long time ago: he did a prosthetic bypass to the foot,” said Menard. “It worked. Here’s another thing that Frank did: 13 prior failed procedures—he did a bypass from the common iliac artery to the peroneal artery. And it worked.”

Veith was also an endovascular believer before most had cottoned on to its potential, he said. Menard’s point was centered on progress in CLTI made over the decades. That extends to turf battles—endo vs. open. “Hopefully, never more,” he said. “Turf battles in the vascular community have been, and still are distracting, destructive, highly counter-productive and of very little service to our patients. I charge the audience to sincerely bring to their part to fight an entirely new battle: that is to move beyond this 25-year-old paradigm of endo vs. open.”

Vascular Specialist@VAM: Conference Edition 3

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Vascular Specialist@VAM: Conference Edition 3

In this issue:

  • BEST-CLI investigators implore a move beyond endo vs. Open ‘battle’ in the name of scientific advance
  • Presidential address: ‘The annual meeting is only part of our story’
  • Special VAM session underscores ‘complementary’ nature of open and endovascular strategies in CLTI patients
  • Lifetime Award: Pair of former SVS presidents gain accolade 

 

Generational divide: Do baby boomers and millennials see eye-to-eye on vascular surgery training needs?

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Generational divide: Do baby boomers and millennials see eye-to-eye on vascular surgery training needs?
Rodrigo Garza-Herrera
generational
Rodrigo Garza-Herrera

Older-generation vascular surgeons are keen to hone their endovascular skills, while the younger generation are looking to develop their capacity to treat aortic pathologies—but sur­geons at all stages in their career favor hands-on learning to continue their development.

These are among the key findings of a multi-generational survey of Mexican vascular surgeons, intended to gain a greater understand­ing of the training and developmental needs of the country’s growing vascular community.

“We are a facing a change in Mexico, where an increase in the number of vascular surgeons is needed, so the response has been to open more hospital programs and more available positions,” Rodrigo Garza-Her­rera, MD, representing the Mexican Society for Vascular Surgery, told VAM 2023 delegates at Thursday morning’s International Chapter Forum Educa­tional Session.

Garza-Herrera explained that the number of vascular surgeons prac­ticing in Mexico is expected to expand rapidly in the coming years, from around 1,100 now to more than 1,600 by 2026. Consequently, the millennial generation—those born between 1980–1996—will make up a greater proportion of the workforce by the end of the decade, in­creasing from 43% at the current count, to an estimated 63% in 2026.

To understand whether these demographic changes will impact the training needs of its vascular community, the Mexican Society has surveyed all of the vascular surgeons practicing within the country, and the results of the survey have informed the development of new training initiatives and programs. The work has also shone a light on some important differenc­es—and similarities—spanning the generational divide.

In total, 356 individuals took part in the survey, pre­dominantly male (74%) and mainly from the millennial generation (46%), followed by generation X (34%) and those from the baby boomer generation (20%).

The survey suggests that there is a far greater proportion of women entering Mexico’s vascular surgery field, with men outnumbering wom­en 8:1 in the boomer generation, compared to 1.6:1 in among the mil­lennials, a trend that Garza-Herrera said he “hopes to see continuing.”

Surgeons were also polled on their academic needs, with seven key fields identified for them to prioritize their areas of strength and weak­ness, including: venous pathology, open arterial surgery, endovascular therapy, vascular access, aortic disease, vascular anomalies and advanced wound care.

Venous pathology was reported as the biggest strength in 41% of participants, whereas the greatest weakness was vascular malforma­tion, chosen by 52% of respondents—an area that was particularly pronounced among millennials, 63% of whom selected this criteria.

The survey asked participants to identify the areas where they felt the greatest need for improvement, to which 54% felt that they need to improve their endovascular skills, and 32% felt that an increased com­petence in treating vascular malformations is needed.

“Baby boomers showed the highest need for improving endovascular skills and millennials showed the highest need to improve their capaci­ties in the treatment of aortic pathology,” Garza-Herrera commented, pointing out a generational difference highlighted through the survey responses.

Results from the survey, which was conducted in 2020, have already shaped training initiatives being put into practice in Mexico.

Special VAM session underscores ‘complementary’ nature of open and endovascular strategies in CLTI patients

Special VAM session underscores ‘complementary’ nature of open and endovascular strategies in CLTI patients
complementary
Kristina A. Giles takes the podium at VAM 2023

A dedicated session at VAM 2023 saw speakers and delegates gather to debate, analyse and consider the implementation of the BEST-CLI and BASIL-2 randomized-controlled trials (RCTs). There was general agreement that the strategies are complementary, and that “picking the right thing for the right patient at the right time” should take precedence.

First to speak were Alik Farber, MD, MBA, professor of surgery and radiolo­gy at Boston University, and Matthew T. Menard, MD, associate professor of sur­gery at Brigham and Women’s Hospital in Boston, who shared key findings from the BEST-CLI trial.

They concluded that the BEST-CLI trial “supports a complementary role for open and endovascular revascularization strate­gies and highlights the need for expertise in both for optimal care of these patients.”

The next step? According to Farber and Menard, this will be to figure out which patients are best treated with surgery and which with endovascular therapy.

The focus then moved to BASIL-2, with Andrew Bradbury, MD, MBA, professor of vascular surgery at the University of Birmingham in Solihull, England, sharing main findings from this trial. He addressed the question, will BASIL-2 change practice in the UK? To this he said that in around 50% of patients it is not “obvious” that in­frapopliteal vein bypass or best endovascu­lar therapy is preferable and so there is “no strong [multidisciplinary team meeting] recommendation” on the subject.

Next on the agenda was a debate, during which Michael S. Conte, MD, professor and chief of the division of vascular and endovascular surgery at the University of California San Francisco was tasked with arguing that patients with chronic limb-threatening ischemia (CLTI) who have adequate saphenous vein should be treated with bypass.

Before getting started, he modified the debate question to read: “Patients with CLTI who are acceptable surgical candidates, and who have adequate great saphenous vein, should be offered bypass surgery as an initial treatment strategy.” His closing message was in line with that posed before him, that endovascular and open are complementary therapies. “It’s time for our field to mature and develop an evidence-based framework akin to [coro­nary artery disease],” he stressed, urging delegates to “stop the simple-minded ‘open vs. endo’ debate.” The important thing is “picking the right thing for the right patient at the right time,” he said.

Delivering the counterview, Brian G. DeRubertis, MD, of Weill Cornell Medi­cine in New York, contended that “almost all” patients with CLTI who have adequate saphenous vein should be treated with bypass. He argued that this was an “easier stance” as—he put forward—an endovas­cular-first treatment strategy “has become the standard of care for the majority of pa­tients with CLTI over the last 15 years.” He underlined the fact that recent randomized controlled trials “demonstrate an import­ant and preferred role for surgical bypass in some patients with CLTI,” noting however that trial results “do not suggest this is true for most patients.”

“We have yet to determine exactly which patients warrant a bypass-first approach.”

Following the debate, Vincent L. Rowe, MD, professor of clinical surgery at the University of Southern California Los Angeles, spoke on “how best to capture meaning” from the two trials.

One of the points Rowe made in his conclusion was that the death rates in both trials were “very high” and that a deeper dive on what was causing these deaths is warranted. “Is there some type of risk factor that we can find that’s causing all of these deaths to occur in these patients?”

Addressing the question “what is BEST for CLTI?” Misty D. Humphries, MD, MS, associated professor of surgery at the Uni­versity of California-Davis in Sacramento, weighed up the pros and cons of both an administrative database and a randomized trial. Concluding, she argued that observa­tional studies are “not going anywhere,” but stressed that there “may be saturation without changes in data fields.” Random­ized trials, on the other hand, cost “lots of money, but eliminate bias.” Alongside these concluding thoughts, Humphries included a picture on the slide, highlighting a ques­tion that was in keeping with one of the overarching themes of the session: “Can’t we all just get along?”

Finally, Kristina A. Giles, MD, division chief of the department of surgery at Main Medical Center in Scarborough, Maine, addressed the topic of implementing BEST-CLI and BASIL-2, sharing “what will be easy and what will not.”

Scrutinizing the data, realizing that the trials are complementary, and realizing that open and endovascular methods are com­plementary will be “easy,” she said, while noting that one of the harder aspects of implementation will include the challenges associated with vein mapping everyone before an angiogram, among others.

Moderator Joseph L. Mills Sr., MD, of the Baylor College of Medicine in Hous­ton, opened the discussion with a question on bias. Conte remarked here that “bias comes in lots of forms” and brought up a “major bias” in real-world practice that is the economic and workflow bias. “A lot of people are working in places where doing surgery is inconvenient for their workflow and potentially forgotten.”

Various panel and audience members brought up coronary disease in CLTI pa­tients. Touching on a point he made during his presentation, Rowe averred that “death was most likely caused by a coro­nary event,” with Mills also stating that “we need to pay more attention to coro­nary disease.”

In this vein, Menard commented that one of the tasks ahead for the trial inves­tigators is to look at both trials closely, stressing that “shockingly, we don’t know what our patients are dying from, that’s step one.” complementary

Presidential address: ‘The annual meeting is only part of our story’

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Presidential address: ‘The annual meeting is only part of our story’
Michael C. Dalsing

Friday morning will see Michael C. Dalsing, MD, MBA, deliver what is an annual hallmark of the VAM program—the SVS Presidential Address. 

From 11:00 a.m.–12:15 p.m. in Potomac A/B, Dalsing will chart his personal journey from “small-town boy with some big dreams” to president of the SVS, as well as the history of the Society and that of the vascular surgery specialty in general, all the while delivering the salient message that “the Annual Meeting is only part of our story.” 

Rural America will be the opening scene for Dalsing’s address. This is where he grew up, with parents who were “deeply affected by World War II and the Depression,” his mother— who, Dalsing will say, would have travelled widely given the chance—“convinced that education would open doors to the world.” 

Against this backdrop, Dalsing moved away to attend college, majoring in biology and expecting to be a scientist, before making “potentially one of the most consequential decisions of [his] life” and taking the Medical College Admissions Test (MCAT), thus launching a long and celebrated career in vascular surgery. 

Alongside his personal and professional journey to SVS president, Dalsing will deliver a sweeping history of vascular surgery, and outline how the twists and turns of certain decades were pivotal in defining vascular surgery as the distinct specialty that it is today, as well as some of the challenges that it presently faces. 

In the 1940s, he will say, vascular surgery was “coming of age.” In the 1970s and early 1980s, training, certification, and defining the specialty took “center stage,” and the endovascular revolution of the 1990s and 2000s, he will continue, saw a vascular surgery field that was “changing fast.” 

The president, who is professor emeritus in the Division of Vascular Surgery at Indiana University School of Medicine in Indianapolis, will reflect on his current position within the vascular surgery field, paying honorable mention a “long list” of individuals who have influenced his career over the years. He will also describe the “immense joy” at seeing the next generation of vascular surgery residents and fellows serve their communities as “compassionate and skilled vascular surgeons,” in addition to being “exceptional people.” 

Dalsing’s talk will argue that vascular surgery is “unique” as a specialty, in that it involves the care of a patient from initial contact to the end of their life. As a result, specialists “must master several dissimilar skillsets requiring years of training.” 

The specialty is, however, a “hidden gem,” Dalsing will say, which he highlights as a problem. 

“In general, people do not know what we do,” meaning the specialty risks being “overlooked as a needed partner in discussions about our patients’ care.” 

And this is all in the context of an aging population and its “increasing demands,” being served by a “finite” number of providers. 

This is where the SVS comes in, Dalsing will state, with its role extending far beyond the calendar highlight that is VAM. “SVS is literally reinventing itself as it evolves and moves forward to integrate dozens of new innovative ideas currently under consideration for implementation. This process happens year over year. We are coming of age as a mature organization,” he will tell attendees. 

And who but the SVS will advocate for the interests of vascular surgeons? Dalsing will ask. “No one!” He will stress that the SVS is a small group that “must speak with a strong and unified voice to be heard,” all in the interest of vascular patients, as well as members’ wellbeing. 

“We are the champions of quality vascular care. We must embrace this role and encourage those who want to be on the vascular team,” Dalsing will say. 

He will express his belief in the need to market to the general population—a seemingly “unattainable” goal by his own admission, but one he feels is the “endgame” if there is a desire to be recognized as the “undisputed champions of quality vascular care.” 

He will define the scope, the added value the specialty brings, and a general impression of the players involved. The next steps? According to Dalsing, “defining the rules of engagement and tactics to be used for success” with education as a “centerpiece” of this effort. 

Carotid revascularization capable of improving mood in depressed patients with carotid atherosclerosis

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Carotid revascularization capable of improving mood in depressed patients with carotid atherosclerosis

A prospective study has demonstrated that carotid intervention can improve mood in depressed patients with advanced carotid disease, in addition to enabling cognitive improvements irrespective of baseline depression.

These findings were presented during the Plenary Session 1: William J. von Liebig Forum at VAM 2023 by Bahaa Succar, MD, a postdoctoral research fellow at the University of Arizona in Tucson.

Speaking to VS@VAM, Succar said: “This study provides valuable information regarding the use of carotid interventions, particularly for patients with asymptomatic carotid artery stenosis. Since stroke and mortality rates are relatively low for carotid interventions and best medical therapy, mood and cognitive assessments could offer an additional perspective to help clinicians tailor the treatment approach when counselling a patient.”

Outlining the backdrop to their work, the researchers note that the impact carotid interventions may have on neurocognitive function in patients with advanced carotid atherosclerosis has not yet been fully elucidated. In addition, little is currently known about the impact carotid interventions can have on mood.

As such, they set out to investigate this phenomenon in a “well-defined cohort of patients”, prospectively recruiting a total of 158 people undergoing carotid revascularization. Screening for depression was performed preoperatively, and at one, six and 12 months post-intervention using the long form of the geriatric depression scale (GDS) questionnaire. The cohort was divided into ‘depressed’ and ‘non-depressed’ based on preoperative GDS scores >9 and ≤9, respectively. Patients also received other neuropsychometric tests to assess memory and executive function concurrently at the designated timepoints—with scores being adjusted against age and education to generate scaled comparisons.

Succar reported the following results at VAM 2023: At baseline, depression (GDS >9) was observed in 49 subjects (31%), whereas 109 (69%) were not depressed (GDS score ≤9), and the average preoperative GDS scores were 15 and 4 in the depressed and non-depressed groups, respectively. A “significant improvement” in average GDS scores was observed within the depressed group at one month (13), six months (13.2) and one year (11.6) post-intervention compared to preoperatively, whereas the non-depressed group had similar postoperative GDS scores at all timepoints compared to baseline.

“Improvements in mood are only among those who had baseline depression,” the researchers conclude. “Further studies with larger sample sizes are warranted to investigate the association between depression, carotid disease, and carotid intervention.”

The global burden of CLTI: ESVS President points toward need for new global vascular guidelines

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The global burden of CLTI: ESVS President points toward need for new global vascular guidelines
Asha Malan, Palma Shaw, Philippe Kolh
Asha Malan, Palma Shaw, Philippe Kolh

Early-bird VAM 2023 attendees yesterday gained broad insight into the issues facing vascular surgeons around the world, with the tone set from the opening talk on the World Federation of Vascular Societies (WFVS) Educational Session docket.

Looking at the global burden of chronic limb-threatening ischemia (CLTI) and the joint guidelines that steer practice, Philippe Kolh, MD, from the University Hospital of Liege in Belgium and current president of both the European Society for Vascular Surgery (ESVS) and the WFVS, told attendees: “We need a new version of these guidelines.”

Kolh was talking through the global burden, patterns and management of CLTI patients across the globe. He set the scene for the core argument behind his message on what the latest survey data show. “The caseload is highly variable,” he said.

“The proportion of CLTI patients need­ing primary amputation was very large across centers, with the lowest proportion in the U.S. and the highest in India and South Africa—that probably also reflects the type of care that we can provide to our patients with CLTI.

“In Asia and South Africa, the majority use the GLASS [the Global Limb Anatomic Staging System] rating; in other regions, the minority of the reporting centers use GLASS.

“A similar pattern (and discrepancy) was seen with the risk calculator: the majority in Asia and South Africa use it. The WIfI (Wound, ischemia and foot infection) system is used by the majority in most countries except, quite strangely, the U.S., where 50% of centers reported no use of WIfI.”

Assessing how much is this snapshot representative of the global picture, Kolh proffered. “We’ll see in the next survey,” he said.

“Endovascular-first strategy was the most common strategy in India and South Africa. In other countries, the majority reported that endovascular-first is not their approach for CLTI.

“For bypass surgery, in addition to great saphenous vein [GSV], synthetic graft is the preferred conduit in many centers, while for below-the-knee bypass with a GSV is preferred.

When there was no GSV, the contralat­eral vein was the preferred conduit in all countries when above-the-knee bypass is in question. When below-the-knee bypass is needed in cases of no conduit, surprisingly [an] endovascular approach is the most preferred alternative. No center reported arm veins as an option.”

Further, said Kolh, drug-eluting technol­ogy is accepted in both femoropopliteal and crural artery segments, and arm veins are used in about 40% of centers.

He then turned to costs. “There was a huge variation in procedural cost across countries and centers,” Kolh reported. “The percentage of patients who bear out-of-pocket [costs] is quite different. It varies from less than 10% [in the majority of centers] to up to 80% [in India/Asia].”

Meanwhile, Kolh provided feedback based upon the impact of the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial, and how it had altered surgeon practice. “About half of replies indicate that the BEST-CLI trial has changed their practice,” he revealed. “If the answer was ‘no,’ the reason most often given was that they already were doing their practice according to the results.”

Concluding, Kolh said there was “huge variation” in patterns of CLTI treatment across the globe.

The WFVS session—the second to be hosted at VAM—saw each member society of the organization represented in person, said moderator Palma Shaw, MD, the WFVS secretary-general.

One of those—the Vascular Society of Southern Africa (VASSA)—produced an insight on the state of vascular surgery training in Africa, and the challenges faced on the continent.

Asha Malan, MD, a VASSA executive committee member, provided stark data. The South African population of approx­imately 60 million is currently served by nearly 65 [vascular surgeons]—“even though this does reflect an approximate 50% increase over the last decade.”

This compares to France, with a similar population of 67 million, where there are 10 times this number of vascular surgeons, she said. “To make matters worse,” Malan went on, of that 65 number, “only 13 of us are currently employed in the public sector, carrying 80% of the burden of disease.”

Because of the shortage of general surgeons in South Africa, vascular surgery is still considered a subspecialty of general surgery, she said, with the consequence that vascular surgery training requires a further two years after five years of general surgery training completion.

Training is offered at seven centers, Malan added, with a currently enrolled rate of 14 trainees. “However, due to the lack of funding for training programs,” just two-to-four vascular surgeons qualify annually, resulting in a net loss, she pointed out.

“South Africa needs to re-evaluate the need for revision of specialized vascular surgical care,” Malan concluded.

SVS-VESS@VAM 2023: Observational study addresses ‘ongoing debate’ around intervention in asymptomatic carotid patients

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SVS-VESS@VAM 2023: Observational study addresses ‘ongoing debate’ around intervention in asymptomatic carotid patients
Alessandro Gregio, MD
Alessandro Gregio, MD

Alessandro Gregio, MD, a vascular surgery trainee at the University of Bologna in Bologna, Italy, presented midterm results from the Carotid asymptomatic stenosis observational study during the first of two SVS-VESS (Vascular and Endovascular Surgery Society) Scientific Sessions yesterday afternoon.

“Whether to intervene or to follow [asymptomatic] patients with best medical therapy is an ongoing matter of debate,” said Gregio, noting that he and colleagues performed a prospective observational cohort study to add data to the discussion. Out of 366 patients enrolled in the study, 306 completed follow-up.

Gregio, who was presenting the study results on behalf of senior author Mauro Gargiulo, MD, and colleagues, concluded that the 48-month risk of ipsilateral transient ischemic attack or stroke was 6% in a real-world scenario. He added that adherence to best medical therapy is high in this population, and also that plaque progression and contralateral stenosis are risk factors for neurological events during follow-up.

The researchers will follow patients out to five years, the presenter noted.

Cross-specialty approach to embolization ‘provides the best care for patients’

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Cross-specialty approach to embolization ‘provides the best care for patients’
Shang Loh, MD
embolization
Shang Loh, MD

Shang Loh, MD, is chief of vascular surgery and endovascular therapy at Penn Presbyterian Medical Center in Philadelphia and professor of clinical surgery at the University of Pennsylvania. Ahead of the Embolization for Vascular Surgeons: Techniques, Tips and Tricks lunch session Wednesday (12:30–1:30pm in Maryland A), he spoke to VS@VAM about the embolization-related challenges vascular surgeons can come up against in their practice, and how cross-specialty partnership is key for maximizing the quality of this type of therapy.

VS@VAM: Would you be able to outline the embolization procedures that fall into the vascular surgery wheelhouse?

SL: I don’t think that any embolization procedure is necessarily out of the wheel­house for a vascular surgeon if they have the desire to learn the skills. However, traditionally, the majority of embolization work falls into the following categories: primary treatment of aneurysms such as splenic, mesenteric, and pseudoaneurysms; adjuncts to aortic aneurysm treatment including embolization of branch vessels and accessory vessels; endoleak treatment; chronic dissection management; venous disease; arteriovenous (AV) or venous mal­formations; trauma and bleeding.

VS@VAM: What does your vascular surgery practice focus around, particularly from an embolization perspective?

SL: My practice involves all areas of vas­cular surgery but primarily on the arterial side. My practice is mostly focused on aor­tic diseases but I also do aneurysm work in other areas, as well as peripheral and cere­brovascular work. I perform all my own embolizations except for venous disease and AV/venous malformations. Trauma is handled mostly by interventional radiology (IR) at our hospital but I will perform my own trauma embolizations if I am already involved in their care. The majority of my embolization work revolves around adjunct treatments for aortic aneurysms (such as branch or accessory ves­sel occlusion), emboliza­tion for type II endoleaks, embolizations for aortic dissections, and emboli­zation as primary treat­ment for other peripheral aneurysms. I also teach courses, along with Dr. Darren Schneider, on various techniques for embolizations of type II endoleaks and speak about embolization techniques.

VS@VAM: What are some of the challenges that vascular surgeons may face when doing these procedures?

SL: One of the main challenges is acquiring the proper skill set. This is heavily depen­dant on prior training with older surgeons not necessarily having been trained in this. As a corollary, surgeons starting out in the embolization realm may find challenges in getting the proper inventory in place— and having the right imaging equipment. However, the focus of sessions such as Wednesday’s is to help bridge that gap and allow them to incorporate these elements into their practice if they desire. The other main challenge is that other specialties, such as interventional radiology, perform similar procedures. It is critically important to discuss this from a multidisciplinary perspective in order to determine every­one’s role in treating the different types of patients. I strongly believe in cross-specialty participation in embolization and believe a partnership provides the best care for patients.

VS@VAM: In your experience, what does this cross-disciplinary approach to caring for patients who require an embolization entail?

SL: As I previously mentioned, I strongly believe in a partnership with a cross-specialty approach to emboli­zation. This skill set is present in a few different specialties. The most important step is to have representation from all the specialties at the table and to formal­ly outline areas that are treated by one specialty versus areas treated by more than one. This can also include how patients will be referred. It is also important to decide how the emergency cases will be handled and whether there should be a shared call schedule for these. This is most important in the trauma setting. This removes any confusion when referring patients and when patients need emergent treatment.

Trainees and students anticipate VAM experience

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Trainees and students anticipate VAM experience
Top; Left to Right: Marinna Tadros, Arshia Javidan, Jessica Rea, Bottom; Left to Right: Daema Jones, Kundanika Lakkadi, Jordan George

VAM brings together not only vascular surgeons but also res­idents, fellows and medical students keen to glean as much vascular education as possible. VS@VAM caught up with a selection of aspiring surgeons to find out how their conference was going so far—and what they hope to gain from it.

  •  “I’m looking forward to meeting the leaders in the field, getting to see and learn about interesting research, new technology and learning more about vascular surgery out­side of the limited clinical setting that I had during rotations this past year.” Jordan George, third-year medical student at Meharry Medical College, Nashville, Tennessee.
  •  “Internships and sponsorships are the two key things that have helped me … so I really look to my mentors and spon­sors I’ve met at VAM to guide me in my next steps.” Jessica Rea, MD, resident at Baylor College of Medicine, Houston.
  • “I’m looking forward to networking and getting to know more vascular surgeons and, all in all, getting more vascular exposure through some of the topics presented at VAM.” Marinna Tadros, MD, applying for vascular surgery resi­dency at the University of Arkansas at Little Rock, Little Rock, Arkansas.
  •  “I come from a school that doesn’t have a vascular program so just getting exposed to that is what I’m really looking for­ward to.” Daemar Jones, scholarship recipient, fourth-year medical student at Texas Tech University Health Sciences Center, Lubbock, Texas.
  • “I hope to meet people with similar interests and back­ground in vascular surgery and to connect with mentors in the field, while getting advice on how someone very early in his or her career can proceed.” Kundanika Lakkadi, med­ical student at University of Queensland-Ochsner Clinical School, New Orleans.
  • “As a Canadian trainee, to be able to get a sense of the broader vascular surgery landscape and being able to net­work with our colleagues is what I most look forward to. I’m looking forward to the “Emerging Issues and Contro­versies in Vascular Trauma” session; I think it will be very interesting.” Arshia Javidan, MD, resident, University of Toronto, Toronto, Canada.

Learn the who, the when and the what of treating deep vein thrombosis

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Learn the who, the when and the what of treating deep vein thrombosis

deep vein thrombosisBetween additional available therapies, multiple new devices now on the market and evolving re­search supporting thrombus removal, Patrick Muck, MD, and Madhavi Meka, MD, anticipated an informative session on deep vein thrombosis (DVT) at lunchtime Wednesday.

The two surgeons co-moderated Bringing What’s New in Deep Venous Thrombosis Treatments to You in 2023, from 12:30–1:30 p.m. in Potomac C. The American Venous Forum (AVF) is collaborating with the SVS on both this program and Deep Venous Stenting Summit: Tips and Tricks for Success, from 1:30 to 3 p.m. Friday in the same location.

“Attendees will leave with thrombus removal strategies, coupled with several new DVT therapeutic options in their armamentariums,” said Muck. “Dr. Meka and I view this session as one to help to guide vascular surgeons on who to treat, when to treat and what device to use.”

Topics and speakers for the session included “Deep Venous Thrombosis Interventions: Who Do We Treat and Why,” with Alessandra Puggioni, MD; the many therapeutic DVT options available, presented by Angela Kokkosis, MD; tips and tricks for aggressive thrombus removal, with William Marston, MD; and “IVC (inferior vena cava) thrombosis: What works,” with Glenn R. Jacobowitz, MD.

Deep vein thrombosis is a “hot topic,” said Muck. “It’s an area of vascular surgery practice that’s growing, and it’s really an exciting session.”

Meka agreed. “There has been a paucity of literature over the past few years regarding thrombectomy/thrombolysis of large veins,” she said.

“In the past, the emphasis for treatment of acute iliac and venacaval thrombosis was on clot resolution using cathe­ter-directed thromboslysis with percutaneous mechanical thrombectomy adjuncts such as Angiojet, EKOS and Trellis Thrombolysis systems. Prolonged infusion of lytics comes with the risk of hemorrhage, particularly intracranial. With emerging technology for enbloc clot removal (AngioVac, Inari, QuickClear, Penumbra, Jeti) infusion of lytics is becom­ing obsolete. The session intends to discuss some of these available techniques and gadgets.”

The presentations by Marston and Jacobowitz represent exciting topics. “There is more research now and more tools to choose from, along with information on which tool works where,” he said.

VAM 2023: Vascular Quality Initiative launches national smoking cessation drive

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VAM 2023: Vascular Quality Initiative launches national smoking cessation drive
Betsy Wymer and Gary Lemmon

The SVS Patient Safety Organization (SVS PSO) has launched a national smoking cessation initiative. 

SVS PSO Associate Medical Director Gary Lemmon, MD, and SVS PSO Director of Quality Betsy Wymer introduced the program during SVS PSO’s Vascular Quality Initiative’s (VQI) Annual Meeting Wednesday.

CAN-DO (Choosing Against Combustible Nicotine Despite Obstacles) joins two existing national initiatives on discharge medications and sac diameter reporting, with imaging, in connection with endovascular aneurysm repair (EVAR).

“Smoking is the leading cause of preventable death and disability, 10 times more than the premature deaths from all wars fought by the U.S,” said Lemmon. It’s a major cause of cardiovascular disease and more than 90% of cancer of the lungs and other organs. Moreover, secondhand smoke increases the risk of death and disability to those who do not smoke themselves.

CAN-DO includes three components to increase smoking quit rates: including smoking cessation variables (preop smoking in elective procedures only, and smoking cessative for elective, urgent and emergent cases) in VQI’s arterial registries; physician and patient toolkits; and revising the smoking cessation section on the SVS website, to make it more patient-centered and increase its visibility.

VQI currently captures some variables, but the new initiative expands upon them to include smoking status, history and demographics prior to surgery and in post-op care and long-term follow-up. Simplicity is stressed. “We’re trying to minimize the burden” on VQI members in terms of the additional variables, Wymer said.

The physician toolkit includes many elements physicians and surgeons will find useful, including results and efficacy from a clinical trial of a brief smoking cessation intervention, a “visual dictionary” on electronic cigarettes and vaping products, an educational library of useful resource documents, the patient-facing document housed on the SVS site and, importantly in a billable world, billable smoking cessation codes.

“We can receive reimbursement for talking to patients about quitting smoking,” said Lemmon. He discussed key phrases and elements to be included to meet the threshold for reimbursement.

The patient toolkit, meanwhile, includes links to many resources on quitting smoking.

Patient education is another important component, said Wymer. In the U.S., 30.8 million adults smoke cigarettes, 3.08 million middle and high school students use tobacco products, one in four people who don’t smoke are exposed to second-hand smoke and more than $240 billion a year goes to treat smoking-related diseases.

Moreover, tobacco companies target specific populations, including people of lower income, and spend $9.1 billion in marketing annually in the U.S. “There are nearly five times more tobacco retailers per square mile in neighborhoods with the lowest income compared to neighborhoods with the highest income,” she said.

Lemmon also noted that simply asking a patient, “Do you smoke?” is insufficient. Surgeons and doctors should instead extend the conversation to the “3 As”: ask if the patient wants to quit and when the patient smokes that first cigarette of the day; assist by offering liberal use of nicotine replacement therapy and medications but also add that the patient should not combine e-cigarettes as a crutch while also smoking; and give advice by referring patients to professional counseling, apps and other tools.

Other useful information includes a quick guide to treatment options, including nicotine patches, lozenges, nasal spray, gum and inhaler, and the use of counseling via text messaging, smartphone apps and web-based services.

Wymer and Lemmon also stressed the deleterious effects of smoking on health: increased risk for peripheral artery disease, plaque building in arteries. Smoking narrows, and thus damages, blood vessel walls, it increases blood pressure and heart rate; affects cholesterol and increases triglyceride levels, a type of fat found in the blood. Both SVS and the American Heart Association advice patients to quit smoking before surgery.

Learn more at www.vqi.org/smoking-cessation.

Risk assessment models “no better than coin toss” for predicting bleeding in patients considered for VTE pharmacologic prophylaxis

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Risk assessment models “no better than coin toss” for predicting bleeding in patients considered for VTE pharmacologic prophylaxis

A study of two risk assessment models (RAMs) for predicting the bleeding risk in patients considered for pharmacolog­ic prophylaxis to prevent venous thrombo­embolism (VTE) has found that though an increasing risk score correlated with higher bleeding rates, both models had a low pre­dictive ability for major bleeding post-ad­mission.

This was the conclusion of Hilary Hays­sen, MD, who presented the findings of the analysis of more than 1.2 million patients undergoing both surgical and non-surgical interventions during Wednesday’s William J. von Liebig Forum in Potomac A/B at the Vascular Annual Meeting (VAM).

Half of all VTE events are associated with hospitalization, Hayssen told delegates, ex­plaining that hospital-associated pulmonary embolism (PE) is a leading preventable cause of death. Pharmacologic prophylaxis reduc­es the incidence of PE but can cause bleed­ing, meaning that there is a need to balance the risk of VTE against the risk of bleeding when considering this avenue of treatment.

There are two current risk assessment models to evaluate bleeding risk in those be­ing considered for pharmacologic prophy­laxis, the IMPROVE and Consensus models. Hayssen and colleagues assessed the predic­tive ability of each model for bleeding within 30, 60 and 90 days post-admission, compar­ing the performance of the two models in patients admitted at all 1,298 Veterans Health Administration (VHA) facilities nationwide between January 2016 and December 2021.

In total, data were analysed from 1,228,448 patients, 26.5% (n=324,959) of whom un­derwent surgical procedures, and 73.5% (n=903,489) non-surgical interventions. To review the two scores, researchers calculated the IMPROVE and Consensus scores using medical record data, which enabled them to assess the predictive ability of the models for bleeding at 90 days in both surgical and non-surgical patients.

A total of 5.6% of patients had major bleeding, as defined by the International So­ciety on Thrombosis and Hemostasis (ISTH), within 90 days post-admission, occurring in 5% of the surgical patients, and 5.8% of non-surgical patients. A total of 68,372 bleed­ing events occurred within 90 days of admis­sion, and 29% of events occurred between 31 and 90 days, Hayssen reported.

In terms of the performance of the two models, Hayssen reported that higher scores were associated with higher bleeding rates. Results showed that the IMPROVE scores ranged from 0 to 22, while Consensus scores ranged from -5.60 to -1.21.

However, she reported that the ability of either RAM to predict 90-day bleeding, cal­culated by computing the areas under the respective receiver operating-characteristic curves (AUC) was “no better than a coin toss” (AUCs: IMPROVE 0.61, Consensus 0.59), a finding that was similarly low at 30 and 60 days post-admission. The predictive ability for either score was consistent across both surgical and non-surgical patients.

“In this validation study evaluating these two bleeding RAMs for patients being con­sidered for pharmacoprophylaxis, we found that increasing scores were associated with increasing bleeding rates, but that the scores actually had low predictive ability for 90-day bleeding in a general hospitalized setting,” Hayssen offered in her concluding remarks.

“The bleeding RAMs possibly are not ready for general implementation in a hos­pital setting. More validation studies and more evaluation of the components of these models is needed to improve predictive abil­ity to evaluate these models in conjunction with our more commonly used VTE risk as­sessment models.” In the discussion that fol­lowed the presentation, Hayssen was asked by session moderator Michael Dalsing, MD, what factors could improve the two scores.

“It is a combination of adding risk factors that are not included,” she commented, not­ing that one of the risk models has 11 risk factors and the other has seven. It could be possible, she said, to include risk factors that are related but also possibly removing risk factors that are not related.

“When we looked at the prevalence of the factors in the bleeding group and the non-bleeding group, there were [factors] that were possibly, in isolation, considered more protective based upon their incidence in the two groups. So, while we haven’t evaluated which risk factors may be more important, that is definitely an aim of future research that we have.”

Opening ceremony heralds ‘power’ of VAM attendance

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Opening ceremony heralds ‘power’ of VAM attendance
SVS President Michael Dalsing, MD

SVS President Michael Dalsing, MD, officially opened the 2023 Vascular Annual Meeting (VAM) yesterday morning, telling attendees at the early morning Opening Cere­mony: “For 76 years, vascular surgeons have been developing and integrating ideas, tenacity and collaboration across this meeting— and unless this is your very first VAM, you understand first-hand the power that comes with attending VAM.”

For those for whom VAM 2023 is their first meeting, the cur­rent moment is a wonderful one within the specialty, Dalsing said—“full of innovation, friendship and scholarship.” He hailed a bustling program of new science and special sessions, including the Frank J. Veith Distinguished Lecture, which takes place today (9:30–10 a.m.) in Potomac A/B.

Dalsing was followed at the podium by Andres Schanzer, MD, SVS Program Committee chair, who highlighted the “radical de­parture” from the meeting’s historical approach to postgraduate education content. “We have moved away from invited sessions to a submission of education proposals,” he said. The move, led by William Robinson, MD, Postgraduate Education Committee chair, is no longer “friends inviting friends to give talks with many of the same faces on the podium all week long,” but “entirely created by you and your peers.”

VAM 2023: Bring your Twitter ‘A’ game

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VAM 2023: Bring your Twitter ‘A’ game

Who enjoys Twitter as part of their daily routine? The Society for Vascular Surgery Social Media Subcommittee plans a challenge during the Vascular Annual Meeting that’s right up their alley.

The #VAM23 Twitter Challenge, “You’re So Vein,” will test the prowess of all the Twitter users in attendance. In “Vein,” participants must meet challenges presented via Twitter with #VAM23. Participants’ tweets must be tagged with @VascularSVS and use #VAM23.

The challenge opened Wednesday and closes at 4 p.m. Friday. The first three people to complete all challenges will receive a $100, $75 and $50 VISA gift card, respectively.

Winners must claim their prizes at the meeting.

Twitter profiles will need to be “public” during VAM so committee members can monitor results.

Questions? Send a tweet to @VascularSVS! Participants can also stop by SVS Central, outside the Exhibit Hall, to ask questions.

VAM 2023: Vascular trauma session to highlight the current role of endovascular therapy

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VAM 2023: Vascular trauma session to highlight the current role of endovascular therapy
Sherene Shalhub, MD,

A focused session on vascular trauma yesterday took a deep dive into emerging issues and controversies in the field.

Moderated by Sherene Shalhub, MD, of Oregon Health & Science University, Portland, Oregon, and Rishi Kundi, MD, of the R Adams Cowley Shock Trauma Center, Baltimore, Maryland, at­tendees can expect a series of presentations and discussions geared towards building a comprehensive update on the management of vascular injury.

The current role of endovascular therapy is a key theme running through the core of the session, moderator Shalhub tells VS@VAM, pointing out a number of the important learning points attendees can expect to be covered by the course.

“Endovascular and hybrid techniques are increasingly dominant in the treatment of vascular trauma, and in some cases are the standard of care,” adds Kundi, touching on the significance of the session. “Vascular surgeons should work to not only familiarize themselves with vascular trauma surgery, but to seize the opportunity that trauma presents. There is nobody better to lead the discussion of vascular injury than vascular surgeons.”

Elina Quiroga, MD, opens the session with a presentation on thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI)—taking the audience through what we know now that wasn’t known five years ago. Following Quiroga, Kathryn E. Bowser, MD, will give attendees an overview of the principles of blunt arterial injury management.

Among other key learning objectives, Shalhub pinpoints that attendees of the session should take away an understanding of the state-of-the-art in both the open surgical and medical management of arterial injuries. In this arena, Anna Romagnoli, MD, addresses controversies in peripheral arterial vascular injuries— taking in both endovascular and open surgical approaches.

Another area of focus in the session, according to Shalhub, is a review the management of major venous injuries, with a particular focus on those to the inferior vena cava. This is a topic covered in depth by Adenauer Goes Jr., MD, whose presentation touches on injuries to the inferior vena cava and iliac veins.

VAM 2023: Earn credits, contact hours at VAM, VQI@VAM and SVN meetings

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VAM 2023: Earn credits, contact hours at VAM, VQI@VAM and SVN meetings

SVS VQIAttendees at the society for Vascular Surgery Vascular Annual Meeting, the Vascular Quality Initiative meeting—VQI@VAM—and the Society for Vascular Nursing Annual Conference all can receive credits or project hours for their participation in the meetings.

The Accreditation Council for Continuing Medical Education (ACCME) has accredited SVS to provide CME for physicians. VAM has been designated for a maximum of 27 AMA PRA Category 1 Credit(s)™. VAM also includes a self-assessment component. Claim by July 17.

VAM 2023: Great Gatsby Gala announces after-party

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VAM 2023: Great Gatsby Gala announces after-party

SVSKeep the party going at the Great Gatsby Gala after-party. New this year, enjoy two additional hours of Prohibition-era festivities by purchasing a ticket for $150. Gala tickets do not include access to the after-party.

Also, get “Glam” before the Gala: The SVS Foundation is pleased to offer a limited number of hair and make-up sessions ahead of the Gala. Treat yourself to a pre-Gala makeover and champagne. Learn more and book your appointment by emailing crobb@ vascularsociety.org.

VAM 2023: Gala offers early check-in option for guests

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VAM 2023: Gala offers early check-in option for guests

Quell your anticipation for the upcoming Great Gatsby Gala by skipping the registration lines Friday evening and heading straight to the night’s festivities. This year, the SVS Foundation offers guests early check-in for a no muss/no-fuss experience.

Registrants should already have received an email with check-in instructions, from [email protected] (check your spam folder!). Emails were sent to the registrant’s address. Those who did not receive the email and need it resent should contact kbrewer-smith@ vascularsociety.org.

Guests must provide their cell numbers for updates and have a credit card number on file. This information will link guests’ registrations with their attendance. Those who do not want to provide their information will need to check on the day. Early check-in expires at 2 p.m. Friday.

Prediction model offers new option for forecasting AAA growth

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Prediction model offers new option for forecasting AAA growth
headshot of Anirudh Chandrashekar
Anirudh Chandrashekar, MD

A predictive model incorporating 3D shape features such as aneurysmal flow lumen and outer wall structure extracted from computed tomography (CT) imaging can improve the ability to predict the growth of abdominal aortic aneurysms (AAAs).

This is according to research presented during yesterday morning’s William J. von Liebig Forum by Anirudh Chandrashekar, DPhil, of Stony Brook Medicine, Stony Brook, New York, who tells VS@VAM that the research has the potential to add to existing metrics for predicting aneurysmal growth, used to inform surveillance intervals and timing for surgical intervention.

Alongside senior author Regent Lee, PhD, from University of Oxford, England, Chandrashekar and colleagues set out to develop a means of predicting aneurysm growth beyond the current gold standard—namely assessment of the diameter of the aneurysmal sac. “What we wanted to do was to devel­op a prediction paradigm to individualize the follow-up and risk factor management for these patients,” Chandrashekar comments. “This may better inform the timing of surgery down the line.”

The first arm of the project saw the researchers develop a deep learning process to extract and categorize geometric features of the aneurysmal sac that may be associated with AAA-growth, including curvature of the sac and surface irregularity.

The latest step of their research, which will be presented here at VAM, looks at both the lumen and outer aneurys­mal wall, and how these correlate with AAA growth. “The methodology is extremely novel, and this is the first time we are incorporating the lumen in this whole decision model,” says Chandrashekar.

To test their model, the researchers have conducted a ret­rospective analysis of serial CT images taken during sur­veillance in 192 patients with infrarenal AAAs, categorising patients into either “slow” or “fast” cohorts based upon the progression of their aneurysm.

Chandrashekar will report that integrating the lumen and outer wall structure as unique components within the 3D sta­tistical shape model captured the lumen-thrombus interface, marking this as superior to max diameter, undulation index and radius of curvature in the prediction of AAA growth phenotype, with a p-value of <0.001.

“We can take a CT image, isolate the aneurysm section, extract out the aneurysm shape and extract measurements from the defined shape to a level that is clinically acceptable, and we can do this automatically,” says Chandrashekar of the top line messages of the research.

“Secondly, we are able to improve on already published metrics to predict aneursymal growth, by incorporating not only the aneurysmal sac, but also how the flow lumen interacts with the surrounding thrombus and the surround­ing aneurysmal wall,” he adds, commenting that this is “ex­tremely novel in itself.”

Further work has been conducted to validate the model in an independent cohort of patients, which “excitingly,” according to Chandrashekar, shows that the growth model still holds to be predictive.

“Going on from there the next step is to try to establish a prospective study, a longitudinal study following aneurysm patients over time, extracting out additional clinical metrics, for example blood pressure, medication regimen and all those metrics that you would obtain in a randomized con­trolled study, to see whether this model truly is effective.”

Senior author Regent Lee told VS@VAM: “I congratulate Dr. Chandrashekar in spearheading this international col­laborative project and for delivering refinement of our AAA growth prediction model as an independent postdoc­toral researcher.”

“The results presented here further highlight the concept of CT image-derived indices as ‘standalone’ biomarkers to predict AAA growth. With appropriate regulatory approvals, this can be further field vali­dated at scale by utilizing existing data already stored in the clinical picture archiving and communication systems (PACS) archives. We look forward to hearing from col­leagues who are interested to participate in such collaborative studies.”

Make those VAM steps count: Compete to be the meeting’s top walker

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Make those VAM steps count: Compete to be the meeting’s top walker

Any past VAM attendee knows he or she will put in a lot of steps on the way to educational sessions, the Exhibit Hall, receptions, plenaries and dancing the night away at the Gala.

This year those steps will count for more than just good health, with a competition to become VAM’s “Top Walker.” Register for the upcoming 2023 SVS Foundation’s Vascular Health Step Challenge and participate in two exciting chal­lenges with just one registration.

“What better way to get people excited about stepping up to improve vascular health than during our annual meeting, where people are already logging thousands of steps?” asked SVS Secretary William Shutze, MD, an enthusiastic stepper himself.

Registration for the VAM Step Challenge, held from June 14 to 17, includes automatic registration for the Foundation’s second annual Vascular Health Step Challenge.

The Step Challenge – walking 60 miles to represent the 60,000 miles of blood vessels in the human body – is held throughout September, National Peripheral Arterial Disease (PAD) Awareness Month. This month-long campaign urges patients and supporters to get moving in order to improve their vascular health.

In 2022, the Foundation raised more than $90,000 from more than 450 walkers, walking both individually and in teams. Proceeds helped the Foundation amplify the impor­tance of vascular health and promote healthy vascular health habits in communities across the country. “Last year was our inaugural challenge and we were pleased and proud of the outcome,” said Shutze. “We’re aiming higher this year, to raise more money and help more people develop the walking habit and improve their health.”

New this year is a “Pay-it-Forward” plan. Participants can register themselves and fund the $60 registration for a low-in­come PAD patient to participate in the challenge as well. Top walkers and Pay-it-Forward registrants may be recognized at VAM 2023 and on SVS social media accounts.

VAM attendees can register at vascular.org/Step23 or at “SVS Central,” which will be located just outside the Exhibit Hall on the lower level. SVS Central will be open from 12 to 5 p.m. Wednesday, 10:30 a.m. to 6:30 p.m. Thursday and from 9:30 a.m. to 5 p.m. Friday. Following VAM, registration will be open at vascular.org/Step23.

VAM 2023: ‘What I wish I knew before retirement’ talk gives insight into adaptation and emeritus life

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VAM 2023: ‘What I wish I knew before retirement’ talk gives insight into adaptation and emeritus life
Peter Gloviczki

Reflecting on the positives and negatives of retirement, Peter Gloviczki, MD, from the Mayo Clinic, previously in Rochester, Minnesota, now in Scottsdale, Arizona, and editor-in-chief emeritus of the Journal of Vascular Surgery (JVS) regaled attendees of his “Lessons learned: What I wish I would have known before I retired” as part of the Transition to Retirement session on Day 1 of VAM 2023.

The annals of Gloviczki’s clinical practice show a brimming career spanning all areas of vascular surgery—arterial, venous and lymphatic—while having performed over 10,000 surgeries throughout his time with Mayo Clinic. He stood as the past president of the Society for Vascular Surgery, American Venous Forum, International Union of Angiology, World Federation of Vascular Societies, Society for Clinical Vascular Surgery, among others. His name is included in 501 peer-reviewed publications, he has authored or co-authored 250 book chapters and eight textbooks, and he has 26,874 citations to his name, plus he has just received an honorary doctorate title at the University of Padua, Italy—the list could continue.

Gloviczki’s presentation detailed his life after retirement, denoting areas of major change in areas such as professional activities, personal life, healthcare, income and residency, describing the tectonic shifts these can bring for a physician accustomed to the busy fluctuations of healthcare. Placing emphasis on loss, he described the lack of access to clinical and patient data, and isolation from a team, be it surgical or research. He added that retirement means a certain detachment from your previous institution, asserting that “emeritus status is not equivalent to being a full member of an institution”.

Looking at the glass half-full however, he paused on the positive changes that occur in your personal life after retirement. Extending a new lease of agency, Gloviczki portended that getting up when you would like and being home for lunch top the list for retirement bliss: “Your home is your castle, cafeteria, lounge, call-room and office.” Although, he ambiguously warned that being home much more may affect relationships with family members, leaving plausible room for the VAM 2023 audiences’ individual interpretation.

Customary to many who have retired from lengthy careers in healthcare, Gloviczki described the procedures, patients, daily team interactions and the distancing from community that is felt. He did, however, caveat this with a reminder that there is “more work inside your house than [one] could have ever imagined” and weight can be gained “fast”—the latter perhaps being dependent on the former. More light-hearted discussions aside, Gloviczki brought awareness to the difficult questions that retirement can pose. What health, dental and eye-glass insurance should you buy? Should you take a lumpsum or monthly installments? What is the best time to start receiving Social Security? These are all among the dilemmas faced by retirees, and as Gloviczki noted with inflation rising and individual retirement account (IRA) decreases of more than 10%, making confident decisions can be a minefield.

Tailoring his final remarks to his personal experience, Gloviczki detailed the tribulations he faced changing residence during retirement. Working full-time in a hospital did not prepare him for the “freezing cold” Minnesota, nor did his prolific involvement in vascular surgery prepare him for “how long it takes to dig a swimming pool” after his definitive retirement and subsequent move to Arizona. He added that to top off the resounding joy that is retirement, “not all animals will make you feel less lonely” throughout—Arizona being home to a generous swath of scorpions and rattlesnakes.

VAM 2023: Endovascular thermal septotomy for chronic post-dissection aortic aneurysm

VAM 2023: Endovascular thermal septotomy for chronic post-dissection aortic aneurysm

Aidin Baghbani-Oskouei, MD, and Gustavo S. Oderich, MD, from the University of Texas Health Science Center at Houston, Texas, detail the endovascular thermal septotomy technique for chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs), which featured as a video presentation at the end of the William J. von Liebig Forum yesterday at the Vascular Annual Meeting (VAM) 2023.

Aortic dissection often results in chronic aneurysmal degeneration due to progressive false lumen expansion. Thoracic endovascular aneurysm repair (TEVAR) and other techniques of vessel in­corporation—such as fenestrated-branched or parallel grafts—have been increasingly utilized to treat chronic post-dissection aneurysms. Even in patients with severe true lumen compression, or when vessels originate from the false lumen, this poses technical difficulties.

In these cases, the limited space from a compressed true lumen may result in inadequate stent-graft expansion or restrict the ability to reposition the device or ma­nipulate catheters. Reentrance techniques may be used selectively to assist with target vessel catheterization. Thermal electrocau­tery septotomy is a novel technique that has evolved from the cardiology experience with trans-septal or trans-catheter aortic valve procedures. This technique has been applied in select cases to facilitate the cre­ation of proximal and distal landing zones, to disrupt the septum in patients with an excessively compressed true lumen or with vessels that have separate origins from true and false lumens.

At VAM, we present a video that details the technical pitfalls of thermal electrocau­tery septotomy in a patient with chronic post-dissection aortic aneurysm. The pa­tient presented with isolated enlargement of the iliac artery and modest enlargement of the descending thoracic aorta (3.8 cm). To decrease the risk of spinal cord injury, we recommended endovascular repair of the infrarenal aortic enlargement with left internal iliac preservation using iliac branch endoprosthesis (IBE). The septotomy pro­cedure was used as an adjunct technique to create a suitable proximal landing zone in the infra-renal aorta.

The procedure requires a standard percu­taneous approach using perclose technique. Access is established into the true and false lumen and confirmed with intra-vascular ultrasound (IVUS). A 6F Oscor steerable guiding sheath is positioned in the intended area of septotomy, which due to excessive angulation was at the level of the celiac axis (CA). A 35-mm Amplatz Goose Neck Snare kit is advanced via the ipsilateral approach into the false lumen and opened opposite to the steerable sheath to facilitate orienta­tion during guidewire crossing of the dis­section septum. The orientation between the steerable sheath and snare is confirmed under fluoroscopy in the anteroposterior, lateral, and oblique views. Once the orien­tation is optimized, a 0.018 NaviCross cath­eter and 0.018 Astato hydrophilic guidewire are prepared by removing the guidewire coating and connecting the guidewire to the electrocautery. With the electrocautery set on cut mode at 80 Watts, the guidewire is gently advanced across the dissection membrane without difficulty and promptly snared. The through-and-through guide­wire is retracted along with the NaviCross catheter to allow the creation of a 5mm trapeze-shaped area which is denuded from the coating and readvanced into position.

A second 0.018 NaviCross catheter is advanced via the other end of the 0.018 Astato guidewire to protect structures from thermal injury, allowing only the 5-mm trapeze segment to be exposed. The Astato guidewire is again reconnected to the electrocautery and septotomy is performed extending to the distal end of the septum membrane in the external iliac artery. The septotomy is guided by fluoroscopy and confirmed with IVUS. Once the septotomy was completed, the infrarenal EVAR was performed in standard fashion using Gore Excluder Conformable with bilateral iliac limb extensions and a left Gore IBE device.

This adjunctive technique is useful to facilitate endovascular repair in patients with subacute or post-dissection aneu­rysms but has not been used in the acute setting where the friable membrane may be more prone to disrupt or detach from the aortic wall.

CEA associated with less reintervention than stenting in first six months-study

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CEA associated with less reintervention than stenting in first six months-study
Jordan R. Stern, MD,

A durability study that looks at reintervention risk among patients treated with carotid endarterectomy (CEA) versus carotid artery stenting (CAS) proce­dures established that CEA demonstrated the lowest risk up to six months after sur­gery. A subgroup analysis between stenting procedures—transfemoral stenting versus transcarotid artery revascularization (TCAR)—further showed the latter stent­ing modality was superior after six months.

The data was delivered during Ple­nary Session 2 yesterday (9:45–11 a.m.) in Po­tomac A/B by first author Shaunak Adkar, MD, a vascular surgery resident at Stanford Medicine in Stanford, California.

The point was to understand the as-yet lesser-understood nature of procedural durability, explains senior author Jordan R. Stern, MD, clinical associate professor of vascular surgery at Stanford, in an inter­view with VS@VAM ahead of this year’s meeting. “We don’t really know about the durability of each of the procedures,” he says.

The study team used the Vascular Quali­ty Initiative (VQI), matching it to Medicare claims via the Vascular Implant Surveil­lance and Implantation Network (VISION) database.

They identified patients who had prima­ry carotid revascularization from Decem­ber 2016 to December 2019. The primary outcome was ipsilateral reintervention, while secondary outcomes included stroke and mortality. After propensity match­ing, patients who underwent CEA and CAS were compared within six months following the index procedure, and from six months to three years separately. A separate propensity-matched analysis was then performed to compare transfemoral stenting and TCAR.

“Like many endovascular procedures, we had a presumption that reintervention may be significantly higher among stenting-type procedures versus endarterectomy—anal­ogous to lower-extremity or aortic work,” explains Stern.

“When we looked at reintervention, which was what we were primarily inter­ested in, we found a difference between endarterectomy and all stenting. CEA was superior up to six months, but that was not maintained in the long run. Over time, the reintervention rates merge and it’s no longer statistically significant.

“In terms of TCAR versus transfemoral stenting, I had the presumption that things would be equal,” Stern continues. “A stent is a stent, and, once you get through the perioperative risk of transfemoral stenting, I thought that, probably in the long run, the stents would be equally durable.

“But, actually, we did not find that—we found that TCAR was associated with a lower risk of reintervention than transfem­oral stenting. That was after six months. So CEA is better than all stents within six months, and TCAR is better than transfem­oral stenting after six months.”

The data were based on some 27,944 patients undergoing CEA (n=21,256) or CAS (n=6,688). After propensity match­ing, 4,705 patients were compared in each group.

They showed an increased risk of reinter­vention within six months for CAS, with a hazard ratio (HR) of 1.97 (confidence inter­val [CI] 1.11–3.50; p<0.05), but not beyond (HR: 1.08; CI: 0.62-1.89; p=0.79).

For Stern, the findings paint a broad picture, between well-defined perioperative outcomes and reintervention risk.

“For me personally, transfemoral stenting has been relegated to a secondary procedure because of the perioperative stroke risk,” he says.

“I think, then, that when I’m looking at durability, if reinterventions are lower with CEA within the first six months, that would probably push me towards CEA even more than I already am. The finding of TCAR be­ing lower than transfemoral stenting I think provides more evidence that TCAR is a superior procedure in most ways compared to transfemoral stenting.”

Ultimately, says Stern, “what we really want to know is what is good for patients long-term.”

To that end, further analyses carried out by the research team uncovered additional findings set to be elaborated upon during the VAM talk today.

“In the unmatched set, transfemoral stenting was an independent predictor of reintervention,” Stern reveals. “And we did an additional analysis of TCAR versus CEA, since those seem to be the superior modalities, and did not find a difference.”

Back on the core analysis, presenting author Adkar, on behalf of Stern and colleagues is set to tell VAM 2023: “CEA portends a lower risk of reintervention than CAS, particularly within the first six months after intervention. We also confirm prior data suggesting lower rates of ipsilat­eral stroke and death with CEA compared to CAS.

“On subgroup analysis of stenting modalities, TCAR had a lower rate of rein­tervention than transfemoral stenting. CEA appears to be the most durable carotid re­vascularization strategy, with TCAR being more durable among stenting procedures.”

Special invited research presentations offered at VAM

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Special invited research presentations offered at VAM
Katherine Gallagher, MD,
Katherine Gallagher, MD,

VAM traditionally includes presentations from specially invited translational researchers that are performing cutting-edge work focused on vascular disease. All are held during plenary sessions.

“These presentations inform the larger VAM audience about cutting-edge translational science performed by our members and, very importantly, how that research can, will and does translate to the care of the vascular patient,” said Katherine Gallagher, MD, chair of the Basic and Translational Research Committee.

“Our vascular surgeon-scientists look to the future as they evaluate molecular mechanisms and gain valuable information from human tissues and animal models. Research today could lead to breakthroughs in the coming years, and it’s important to tell our members about treatment possibilities from the exciting research that is going on,” she said.

“No one is more interested in identifying new treatments for vascular disease than vascular surgeons, who know and deal with these problems in our patient population.”

The 10-minute presentations include seven minutes of information followed by a three-minute discussion period led by a moderator. “We are thrilled to showcase this year’s presenters,” she said. They are:

  • “The endothelial cell is the superhero of the vascular system,” by Kathryn L. Howe, MD, PhD, University of Toronto, Toronto, Ontario, Canada; Discussant, Dr. Andrea Obi; 10:37–10:47 a.m. Wednesday, during Plenary 2
  • “Cellular mechanisms of tissue repair in the ischemic limb,” Kevin Southerland, MD, Duke University Medical Center; Discussant, Dr. Gale L. Tang; 8–8:10 a.m. Thursday, during Plenary 3
  • “The effect of physical activity on aneurysm and dissection: Insights from animal models,” by Areck Ucuzian, MD, PhD; University of Maryland School of Medicine; Discussant, Jean Marie Ruddy, MD; 8–8:10 a.m. Friday, during Plenary 5

Study weighs up total transfemoral and upper extremity approaches for F/BEVAR

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Study weighs up total transfemoral and upper extremity approaches for F/BEVAR
Gustavo Oderich, MD

In a prospective, non-randomized study, researchers found that a total transfemoral approach was associated with lower rates of cerebrovascular events and improved outcomes compared to an upper extremity approach during fenestrated/branched endovascular aneurysm repair (F/BEVAR).

Thomas Mesnard, MD, research fellow at the University of Texas Health Science Center at Houston, is due to share this finding with the VAM audience this morning (11:45–11:52 a.m.) during Plenary Session 4, which takes place in Potomac A/B.

The authors detail in their abstract that this study was conducted over the course of nine years, from 2013–2022, and included 541 patients (70% male; mean age, 74±8 years) treated with F/BEV­AR. They specify that an upper extremity approach was used in 366 (68%) patients and transfemoral access in 177 (33%) patients.

Mesnard will report that the use of a transfemoral approach was associated with lower fluoroscopy time (p=0.001), lower operative time (p<0.001), similar cumulative air kerma (p=0.2), and similar technical success (p=0.96) as compared to an upper extremity approach. Mortality occurred in 1% of all patients, with no significant difference between groups (p=0.67).

Furthermore, he will share that patients treated by an upper extremity approach had significantly higher rates of major adverse events (18% vs. 8%, p=0.006) and more cerebrovascular events (3% vs. 0%, p=0.035).

Mesnard will present these findings on behalf of Gustavo S. Oderich, MD, professor of surgery and chair of vascular and endovascular surgery at the University of Texas Health Science Center at Houston, and colleagues.

Speaking to VS@VAM ahead of the presentation, Oderich comment­ed on what procedures in this space might look like in the future: “Transfemoral access allowed us to reduce the risk of stroke and complications. This has been possible with the development of steerable sheaths. It is likely that, with the introduction of smaller-profile stents and better sheaths, the procedure will be simplified even further.”

Onco-vascular session set to offer ‘clinical pearls’ in ‘new’ area of vascular surgery

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Onco-vascular session set to offer ‘clinical pearls’ in ‘new’ area of vascular surgery

Randall DeMartino, MD, is Division Chair of Vascular and Endovascular Surgery at the Mayo Clinic in Rochester, Minnesota, and a co-moderator of a session dedicated to onco-vascular surgery, taking place today from 3:30–5 p.m. in National Harbor 12/13. A series of presentations will feature case reviews as well as discussion of how to achieve the best outcomes in vascular reconstruction for oncology patients. DeMartino previewed the session for VS@VAM ahead of time.

“The goal of the session is to describe the landscape of cases that aren’t as typical in vascular training,” DeMartino begins, outlining how in recent years, vascular surgeons have been taking on increasing numbers of cases from oncology colleagues for tumors involving vascular structures and performing reconstruction post-resection. “We want to be able to help” in affording patients the better chance at survival that resection can provide, he emphasizes, while noting how this is a “new” field for many vascular surgeons. The growing case numbers he and other vascular surgeons have been seeing is what prompted his interest in holding the session at this year’s VAM, DeMartino adds.

There is a significant need for multidisciplinary collaboration in order to deal with these complex cancer cases, he continues, citing urology and orthopedics as among the departments he works with. “We find ourselves [working] all over the body,” he summarizes, pointing out that vascular surgeons “are the experts in helping the patients maintain limb or organ function through the vasculature.”

The session will cover multidisciplinary collaboration and the importance of good communication among the specialties involved in a particular case; which imaging modalities to use; how to approach patients who have had previous surgeries or whose tumor has been irradiated; how to set up and prepare mentally for emergency cases; and how best to follow up with different patients.

Educational opportunities abound at VAM 2023

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Educational opportunities abound at VAM 2023
Christopher Audu

Ok, so day one has lived up to the hype. From hearing about amazing research endeavors to listening to lively discussions on the latest treatment options for vascular patients, it has been very invigorating.

Day two is equally packed. One of the advantages of an internationally recognized meeting, such as VAM, is the opportunity to interact with, and learn from, international colleagues on the advances in and challenges to vascular surgery in their respective environments. These can range from coffee break conversations to the formal sessions organized by the society. Check out the International Educational Forum today, where there’ll be opportunities to learn about vascular surgery in various geographical contexts.

One of the reasons the vascular field is so fascinating is that we can treat even young patients who need vascular care. Look for the Pediatric Vascular Surgery development group session in the afternoon. I anticipate there’ll be presentations on the surgical treatment of renovascular hypertension in the pediatric population, in addition to novel approaches and considerations for mid-aortic syndrome.

Another vascular surgical area that is exciting to see develop is vascular oncology. Tomorrow afternoon there’ll be an exciting session on the onco-vascular surgeon. What does this mean? How do we aid our surgical oncology colleagues when malignancies need to be removed? How should we think about vascular reconstruction in the setting of tumor burden? These are questions on my mind, and as a trainee, this, and the pediatrics sessions, present a valuable opportunity to learn about conditions whose treatment may not be available at every training institution.

I hope you are able to take full advantage of the chances to fill knowledge gaps, meet new friends and see old ones at SVS VAM 2023. Thanks to the organizers for putting together a stellar program.

Christopher Audu is the Vascular Specialist resident/fellow editor

Analyses offer a deeper dive into BEST-CLI trial data

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Analyses offer a deeper dive into BEST-CLI trial data
Matthew Menard and Michael Conte

As the vascular community continues to digest key insights from the BEST-CLI randomized controlled trial (RCT), attendees of Plenary Session 3 at the Vascular Annual Meeting (VAM) 2023, taking place 8:00–9:30a.m. Thursday morning in Potomac A/B, will be offered a deep dive into the trial’s vast dataset in the form of two new secondary analyses.

BEST-CLI is the largest trial to date comparing revascularization treatment strategies in patients with chronic limb-threatening ischemia (CLTI). The primary results, reported to great interest by investigators in late 2022, showed that both surgical bypass and endovascular strategies are safe and effective, but in those with adequate single-segment great saphenous vein (GSV), it was found that surgery is likely to be the more effective revascularization strategy for a patient who is suitable for either of these approaches.

The two latest analyses, presented here at VAM, come from Matthew Menard, MD, comparing rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI following endovascular or open revascularization, and from Michael Conte, MD, focusing on reintervention-related endpoints.

“On Thursday, Dr Menard and I are presenting two of the pre-planned secondary endpoint analyses from the trial, which are important for the vascular community to further digest the impact of initial treatment selection on key clinical outcomes in CLTI patients,” Conte tells VS@VAM in an interview prior to taking to the podium.

“As with any large trial, primary publication can only get so much of the message across, and there is a lot more still planned in the coming months—including looking at subgroups of patients and other important secondary endpoints like these.”

Menard comments that the CLTI patient population is “complicated,” and each individual patient represents a unique treatment challenge, adding that there has been a great need for high-quality data to guide treatment decisions in the space.

“I think the vascular community has appreciated the effort it took to complete the trial and has welcomed the information,” he says.

“As we further unroll the many secondary analyses and additional outcomes, as well as the salient details on the patients that were enrolled into the trial and their anatomic profiles, I think the full impact of BEST-CLI will only continue to grow.”

In the analysis presented by Menard, clinical failure is defined as a composite of all-cause death, above ankle amputation, major reintervention, and degradation of wound, ischemia, and foot infection (WIfI), while hemodynamic failure comprises a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to initially increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion.

The study’s time-to-event analyses were by intention-to-treat assignment in both trial cohorts—those with suitable single-segment GSV, and those lacking suitable single-segment GSV—using multivariate stratified Cox regression models.

Multivariate analysis

In the abstract published ahead of the presentation, it is reported that in the cohort of patients with suitable single-segment GSV there was a significant difference in time to clinical failure, hemodynamic failure, and resolution of presenting symptoms in favor of the open surgical approach.

Among those lacking suitable single-segment GSV, there was a significantly lower rate of hemodynamic failure, also favouring the open approach, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis also reveals that assignment to open surgery was associated with significantly lower risk of clinical and hemodynamic failure in both cohorts, and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates.

“My own belief is that there is much more to the story than how technically successful our initial revascularization effort is at restoring adequate perfusion to the ischemic foot,” Menard tells VS@ VAM, placing the findings firmly into context. “CLTI is quite analogous to cancer, and a hallmark of the disease is lingering wounds, persistent pain, and unfortunately, frequent recurrent symptoms.

“The current presentation suggests that for patients who were considered candidates for both open and endovascular treatment options, open surgical bypass is more effective at providing a sustained level of clinical and hemodynamic benefit. This result was seen in both patients that had a single segment of saphenous vein, which is the ideal surgical scenario, and those that did not.

“For those that did have optimal vein, the initial CLTI symptoms resolved more quickly, and the rate of recurrent symptoms over the course of the follow-up period was significantly lower.”

Conte, meanwhile, focuses his presentation on the reintervention-related study endpoints, looking at rates of both major reintervention, any reintervention and the composite of any reintervention, amputation or death, by intention-to-treat (ITT) assignment in both trial cohorts. The analysis also makes a comparison between treatment arms in each cohort using a stratified Cox model adjusted for prespecified baseline covariates.

“This analysis is really a deeper dive into the overall burden of reinterventions experienced by patients in the trial, and beyond the primary ITT comparisons we delve into what some of the predictive factors are for patients needing reinterventions,” says Conte of the aims of the study.

“We do not have anything quite like this existing in the literature—prospectively collected data in over 1,800 CLTI patients who were revascularized and followed for several years,” he comments.

“There are key observations that need to be brought to the forefront in terms of the nature of reinterventions, the cumulative number of reinterventions that were required, the timings of those reinterventions and how they differed between endo and open. This is important information for how to inform and follow CLTI patients in everyday practice, no matter what [approach] you pick.”

In the study’s abstract, the investigators report that in the trial’s cohort 1, assignment to initial open treatment was associated with a significantly reduced incidence of major limb reintervention, any reintervention, or the composite of any reintervention, amputation or death. The findings are similar in cohort 2 for major reintervention or any reintervention.

In both cohorts, limb reinterventions were notably higher for patients assigned to endovascular treatment, as opposed to open surgery.

“Secondary reinterventions in CLTI are common—and are more common with endovascular strategies compared to bypass with a good vein,” says Conte of the results. “Despite more than double the total number of major reinterventions, patients randomized to endo in BEST-CLI still experienced 27% more major amputations compared to those in the open arm with good vein.

“Thus, there are real downstream costs to these treatment failures, and not all limbs are recoverable by a secondary attempt. We should use the available evidence on patient risk, anatomic complexity, and severity of limb threat to select the best revascularization treatment up-front, and inform CLTI patients about these inherent trade-offs.

“It’s past time to end the tiresome “open-versus-endo” debate and embrace the complementary nature of these options for each individual patient.”

VAM 2023: SVS descends on Capitol Hill

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VAM 2023: SVS descends on Capitol Hill
SVS members attend Congress during VAM 2023

Nearly 50 SVS members took advantage of VAM’s location near Washington, D.C., visiting Capitol Hill Tuesday to discuss legislation related to vascular surgery with members of Congress and their staffs. 

The meetings were constituent-driven, with members talking with elected officials (and their staffs) from their home districts/states. 

“The primary purpose of our trip to the Hill was to establish relationships that help the Society and its members become resources for lawmakers and help educate them on the issues important to the specialty and the patients we serve,” said incoming SVS Advocacy Council Chair Margaret Tracci, MD. “We want them to ask, ‘What do the vascular surgeons think?’” 

Progress in advocacy is made through the development of key relationships with members of Congress and their staffs, particularly those who work on healthcare legislation, said Executive Director Kenneth Slaw, PhD. 

“The presence of 50 vascular surgeons and staff on the Hill could not be more timely or meaningful in that relationship-building process,” he said. “During the nearly 100 meetings, participants talked about the need to ensure that there is a viable and vibrant workforce of vascular surgeons.” 

The day ended “with great momentum, and on a particularly positive note when several influential members of Congress who have been key allies for surgeons visited, offering encouragement and a pledge to continue to work with the SVS to address issues critical to vascular surgeons and patients,” said Tracci. 

Slaw concurred. “It was a very successful and productive day and reinforces that SVS and members have a regular presence on Capitol Hill going forward,” he added. 

Advocacy at VAM 

During Wednesday’s advocacy session, “Member Perspectives on Advocacy—Myths, Facts and Reasons Why all SVS Members Should Engage,” SVS panelists delved into the changing trends in advocacy across different generations and shared ways to make a lasting impact at all levels of engagement. 

Leading the interactive session were Margaret Tracci, MD, current vice chair and incoming chair of the SVS Advocacy Council, and Matthew Sideman, MD, current council chair. 

Tracci’s presentation on “Elements of effective advocacy” highlighted advocacy’s role in shaping the future of vascular surgery. She emphasized the importance of active member participation, dispelled common myths surrounding advocacy and provided reasons why every SVS member should engage in advocacy efforts. 

Sideman provided an overview of SVS’ advocacy and policy priorities. He emphasized the need to advocate for policies that ensure optimal patient care, access to innovative treatments and adequate resources for vascular surgeons. 

Sideman will soon pass the torch to Tracci as council chair and offered remarks on his time on the council. 

“I’m most encouraged by our increased participation and awareness among the Society. One specific issue we’ve been able to address was the clinical labor update that resulted in a $3.5 billion shift in significant hardships for people who run their own practices. We’ve worked tirelessly on that and, leading a coalition, we have focused on legislation to provide relief. I would’ve liked to have seen that passed into law before my time ends, but I’ll pass the reins to Tracci,” said Sideman. 

The panel discussion used the Slido live Q&A platform to allow attendees to share their thoughts, concerns and suggestions about advocating for vascular surgery. Many questions and comments focused on the Capitol Hill visit nearly 50 SVS members had attended the day before. 

All the presenters emphasized the need for collective action and urged attendees to become active advocates for the specialty of vascular surgery. 

VAM will feature a Friday breakfast educational session from 6:45–8 a.m., highlighting more of SVS’ advocacy-related efforts. It will give participants an overview of the foundations of SVS’ advocacy and policy work, “SVS Advocacy in Action: Work Being Done, Issues on the Horizon and How to Become Involved.” 

VAM 2023: Slew of special SVS section sessions set for Thursday

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VAM 2023: Slew of special SVS section sessions set for Thursday
Special sections cater to interest groups across the SVS

The SVS includes five special sections for different member groups, including physician assistants, women, young surgeons, surgeons in community practice and the Subsection on Outpatient and Office Vascular Care (SOOVC).

With each section session quite popular during the 2022 VAM, all sections will hold dedicated educational sessions during this year as well. SOOVC and the Women and PA sections take place from 1:30–3 p.m. Thursday. PAs continue from 3:30–5 p.m. 

SOOVC 

SOOVC will concentrate on the “Business of Running an OBL (office-based lab),” as well as comparing costs of OBLs vs. ambulatory surgery centers (ACSs), financial viability, daily management, and maintaining an OBL with decreased payments. 

Section leaders also will present the recipients of the section’s first-ever awards. The SOOVC Presentation Award recipients are: 

  • Michael A. Curi, MD; “Arteriovenous fistula creation and care in a dedicated office-based practice is superior to hospital-based care” 
  • Keerthi Harish, MD; “Prior authorization processes in the office-based laboratory setting are administratively inefficient and threaten timeliness of care” 
  • Pavel Kibrik, MD; “Success rate and factors predictive of redo endothermal ablation of small saphenous veins” 

The SOOVC Research Seed Grant recipients are: 

  • Michael Curi, for the award above 
  • Robert Molnar, MD; “Assessing the currently accepted indications for outpatient fistulogram performance and developing a quality improvement plan to establish a treatment algorithm for patients with hemodialysis (HD) dysfunction” 
  • Heather Waldrop, MD, and Christina Cui, MD; “Potential cost savings by moving appropriate cases to an office-based angiography suite” 

Women’s Section 

The Women’s Section will concentrate on “Financial Literacy for the Vascular Surgeon.” Talks include “It’s never too soon: Early planning for your financial future”; “Navigating business plans for vascular surgery practice”; “Understanding your contract”; “Financial planning for mid- and late-career surgeons: An advisor perspective”; “Consulting with industry: Collaboration or conflict?”; and “Negotiating salary: Tips to minimize the pay gap.” 

Physician Assistants Section 

Following a rousing session of “Jeopardy Cases over Cocktails” on Wednesday, the PAs continue their collaboration with the Society for Vascular Nursing today. From 12–1 p.m., the two groups will hold a lunchtime panel discussion with PAs Ricardo Morales, Erin Hanlon and Abby Keen, and nurses Katherine Hays, Gabriell Grayson and Stacy Hosenfeld. Audience members should bring their questions. 

“This will focus on discussing our different roles and responsibilities,” said Holly Grunebach, PA-C, section chair. “We function very similarly within the vascular team. Our training is different but our interactions with the patient are the same. There is a lot of collaboration.” 

PAs then have an afternoon of education, with sessions from 1:30–3 and 3:30–5 p.m. in Maryland A. The line-up includes a review and discussion of vascular oddities and vascular imaging. Participants will view comparisons of ultrasound images highlighting the area of disease both before and after repair with such tools as a patch, stent, bypass and more. 

SVS members will lead three hands-on simulations, highlighting the use of two closure devices to close arteriotomy sites after angiograms. The third will offer hands-on learning of performing an ultrasound of the carotid artery, plus discussion of the results. 

“We think we’ve planned a fantastic afternoon of learning for our members,” said Grunebach. “We started out our planning with thinking about what we really found useful from last year and went from there.” 

This is the only PA group that is for PAs in vascular surgery, Grunebach pointed out. “It’s hard to find something this specialized and it’s what I really like about it. We’re of like minds and function in similar practices. The section is very valuable.” 

Crawford panel focuses minds on challenges facing vascular surgery workforce numbers

Crawford panel focuses minds on challenges facing vascular surgery workforce numbers
Laura Marie Drudi and Michel S. Makaroun

Yesterday’s E. Stanley Crawford Critical Issues Forum, which looked at ways to address the pipeline of sources feeding the vascular surgery pool of talent, yielded an illuminating perspective on the looming workforce crisis currently occupying leaders in the field.

Speaking from the VAM 2023 audience after the six-strong panel concluded their talks, Rana Afifi, MD, from McGovern Medical School, University of Texas Health Houston, introduced herself to the panel of experts assembled by organizer President-Elect Joseph Mills, MD, as a non-Board-certified vascular surgeon—and as someone not eligible for the U.S. Board. “I graduated from my residency-fellowship outside of the U.S., and came for super-fellowship in the U.S.,” she told them, describing the many “obstacles and problems” she has encountered on her path toward Board eligibility. “I was told after PGY-11 years: Repeat. Repeat your residency.”

Despite the challenges, Afifi continued, she found a way forward and is now practicing, but pointed out she is not represented in the statistics produced by former SVS President Michel S. Makaroun, MD, from the University of Pittsburgh Medical Center, whose talk honed in on the question of insufficient supply or maldistribution in the workforce pipeline. 

“I’m pretty sure there are a lot of others who are struggling—who either leave, are frustrated, are broken because they feel inadequate, or they compete for spots for people in the U.S.,” Afifi elaborated. 

She addressed a need for “more creative” solutions in efforts aimed at finding an alternative pathway for people who graduated from residency outside of the U.S. “Have we reached out as a vascular society to other societies to see if they have found solutions that can create more spots?” 

Responding, Makaroun said he completely agreed with the need for creativity in the search for more surgeons to bolster the workforce. “I believe you are a member of the SVS and you are counted in the group that is called ‘early-active,’” he continued. “The people who are not Board-eligible are still part of those statistics, so we are not ignoring you. But I totally agree with you that we need to look for other opportunities to have support for our workforce.” 

The Crawford Forum is developed by the incoming SVS president to address long-range issues deemed critical to the specialty, with Mills focusing the theme on the complexity of the issues contained within the workforce pipeline. He titled the forum, “The State and Future of Our Specialty— Extending, Repairing and Maintaining the Vascular Surgery Pipeline.” 

Mills deems the challenges multifaceted, saying: “The pipeline is not one line. It has multiple connections that come from multiple places and go to multiple places.” 

The panel captured three main areas of focus: the root sources of future vascular surgeons, the existing workforce, and the distribution of that workforce. Lee Kirksey, MD, from the Cleveland Clinic in Ohio looked at outreach to high school and college students and Malachi Sheahan III, MD, from Louisiana State University in New Orleans, dealt with efforts to attract medical students and residents in training. Dawn M. Coleman, MD, from Duke University Medical Center in Durham, North Carolina, addressed vascular surgeon wellness, followed by Laura Marie Drudi, MD, from Centre Hospitalier de l’Universite de Montreal in Canada, on burnout solutions. The panel was rounded out by former SVS President Makaroun, on workforce supply or maldistribution, and Peter R. Nelson, MD, from the University of Oklahoma in Tulsa, on prophylactic measures to improve the workforce crisis. 

Vascular Specialist@VAM–Conference Edition 2

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Vascular Specialist@VAM–Conference Edition 2

In this issue: 

  • Opening Ceremony heralds ‘power’ of VAM attendance
  • Von Liebig Forum: Significant life and limb gains for claudicants who stop smoking before lower-extremity bypass
  • PAD: Sex-related disparities in lower-extremity revascularization 
  • VESS@VAM: Carotid stenting observational data 

 

Sex-related disparities in lower-extremity revascularization outcomes brought into focus

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Sex-related disparities in lower-extremity revascularization outcomes brought into focus
cap
Keyuree K. Satam

Women are more likely to undergo reintervention after lower extremity revascularization for peripheral arterial disease (PAD) compared to male patients with similar limb salvage and survival outcomes despite having fewer comorbidities, findings of a retrospective analysis presented during the William J. von Liebig Forum at VAM 2023.

Keyuree K. Satam, MD, an incoming vascular surgery intern at Stanford Hospital presented the findings of the analysis, outlining that prior research has suggested that women are more likely to undergo these repeat procedures than men.

The current study analysed patients who had a revascularization procedure for PAD between 2013 and 2020 at a tertiary care center, looking at comorbidities, perioperative, and long-term outcomes by sex, as well as the rate and frequency of reintervention. The study team carried out Kaplan-Meier analyses for major adverse limb event (MALE)-free survival.

The study included 1,987 patients undergoing lower extremity revascularization, of whom 37% (n=736) were female. The female patients included were more likely to be older (70.5 years vs. 69.2, p=0.015) and Black (18% vs. 12.3%, p=0.003). Male participants were more likely to have a higher prevalence of comorbidities including coronary artery disease (59.3% vs. 45.6%, p<0.0001), diabetes (60.2% vs. 51.9%, p=0.0003), and chronic renal insufficiency (20.1% vs. 15.8%, p=0.016).

The speaker shared that patients in the study had a total of 2,647 reinterventions, with females having a significantly higher rate of ipsilateral reinterventions compared to males (2.0±1.5 vs. 1.7±1.4, p=0.05) and a higher proportion of ≥3 reinterventions (9.5% vs. 6.6%, p=0.035). Kaplan-Meier curves showed no difference between males and females regarding MALE-free survival.

Satam noted that perioperative complications were similar for male and female patients, except for those resulting in a return to the operating room, which was higher among males (17.7% vs. 13.9%, p=0.029). After a mean follow-up of three years, there was no difference in major amputation, reintervention rate, MALE, or mortality.

Endothelial cell granted superhero status in invited research presentation

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Endothelial cell granted superhero status in invited research presentation
Kathryn L. Howe

“The endothelial cell is the superhero of the vascular system,” Kathryn L. Howe, MD, PhD, FRSCS, a vascular surgeon-scientist at the University of Toronto in Toronto, Canada, argued during an invited research presentation in Plenary Session 2 at VAM 2023.

Howe detailed that the endothelial cell acts as a “gateway to health and disease,” forming an interface between blood and tissue and governing the function of vessels and also the organs they supply. They are also a “rich source of biomarkers” and a “powerful therapeutic agent,” the presenter added.

“I would like to put forward the case that there is a parallel between Superman and the superpowers that we see of the endothelial cell,” Howe went on to say in Potomac A/B.

Howe listed three key arguments in support of this statement, signposting first the idea that both Superman and endothelial cells are considered guardians. While Superman has the ability to act like a shield, the presenter said, the endothelial cell—as a structural divide between the vessel lumen and the vessel wall—could be a therapeutic target but also a delivery module.

Both are also “more than they appear,” Howe continued. “In the case of Superman, he is more than a mild-mannered reporter,” she stated, likening this to the fact that endothelial cells are more than a single layer of cells, but in fact are “heavy orchestrators of cell-cell communication”.

Finally, the presenter contended that both have crucial roles, elaborating that they respond to their environment and can shift identity. “In the case of Superman, this is in the form of super skills; for endothelial cells, this is in the form of cell plasticity and changing their identity.”

Just like Superman, however, Howe pointed out that endothelial cells have a kryptonite. Smoking, sleep habits, diet, sedentary activity, diabetes, obesity, dyslipidemia and hypertension are “all factors that undermine the power of the endothelial cell,” the presenter stressed.

So, what can vascular surgeons do? To this question, Howe had a clear answer: “We can deliver exceptional vascular care by promoting endothelial health for all.”

Significant life and limb gains for claudicants who stop smoking before lower-extremity bypass

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Significant life and limb gains for claudicants who stop smoking before lower-extremity bypass
Rohini J. Patel
Rohini J. Patel

Long-term overall survival (OS) and amputation-free survival (AFS) are outcomes that rebound in claudicants who quit smoking prior to elective surgery—and they mirror those of never smokers. But patients who don’t kick the habit have significantly worse outcomes, lighting up the question: should stubbing out for good be “a requirement” before intervention?

That was the message from Rohini J. Patel, MD, who presented data during the William J. von Liebig Forum at VAM 2023 on long-term outcomes in the smoking claudicant after elective lower extremity bypass. The findings were published simultaneously in the Journal of Vascular Surgery (JVS).

Patel, a general surgery resident physician at the University of San Diego, San Diego, California, noted that patients and vascular specialists must grasp that structured smoking cessation should be a more prominent part of vascular office visits before and after lower extremity bypass and can “even be considered a requirement prior to elective procedures in claudicants”, a group that represents a unique non-emergent vascular patient population that can require lower extremity bypass.

Smoking is known to increase complications, including poor wound healing and coagulation abnormalities, and have cardiac and pulmonary ramifications, said Patel. “Across specialties, elective surgical procedures are commonly denied to active smokers. Given the base population of active smokers with vascular disease, smoking cessation is encouraged but is not required the way it is in general surgery,” she explained.

The research team queried the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network (VISION) database over a 16-year period to tackle the question of how actively smoking claudicants fare after elective lower extremity bypass. They then carried out two separate propensity score matches on patient records that included 609 (10%) never smokers, 3,388 (55.3%) former smokers, and 2,123 (34.7%) current smokers who underwent bypass for claudication. One analysis examined the outcomes of former smokers and compared these to outcomes achieved in patients who had never smoked. The second analysis contrasted outcomes between current smokers and former smokers. The primary outcome measures included five-year OS, limb salvage (LS), freedom from target lesion reintervention (FTR) and AFS.

Health gains don’t shift unless claudicants quit smoking

There were no differences recorded with respect to any of these measures between 497 well-matched pairs of former smokers and those who had never smoked. The second analysis, which focused on ascertaining outcome differences between 1,451 well-matched pairs of current and former smokers, found that there was no difference in LS or FTR, but revealed “a significant increase in OS and AFS” in former smokers compared with current smokers, suggesting that giving up smoking reaps rewards in terms of both limb and life preservation.

“Our study found that former smokers have better OS and AFS when compared to current smokers, while former smokers mimic never smokers at five-year outcomes for OS, LS, FTR and AFS,” Patel averred.

Patel states: “This study emphasizes that we as providers must spend more time and effort working with patients to quit smoking prior to elective lower extremity bypass in claudicants.”

Limitations of the study include that the database contained no information on the duration or intensity of smoking among the study population, and there were no available data on the rate of recidivism or the cause of death among those studied.

According to senior author Mahmoud Malas, MD, chief of Vascular and Endovascular Surgery at UCSD: “Previous studies have shown that smoking cessation might not necessarily affect an immediate outcome in patients. We have found through this VISION database that even quitting one month prior to surgical intervention can change long-term outcomes. Former smokers do better than current smokers and former smokers mimic the results of patients who have never smoked. As vascular surgeons, we need to play a more active role in these discussions with patients in the clinic.”

In discussion that followed the presentation, Patel was asked to comment on whether she felt that the length of time from smoking cessation could be an additional avenue of study, in particular if that information could be conveyed to patients to arrive at a specific length of time that may confer a benefit.

“We just looked at the actual smoking status,” responded Patel, adding that if this could be linked to variables such as days since patients have quit smoking “that would be a great next step to see if there are some intervals such as six or eight weeks that provide the best drop off”.

Patel was also asked when smoking status should play a role in advising patients that they simply cannot undergo surgery. “With my general surgery residency training, I was used to telling patients that we would not operate on them for elective cases and so I wanted to look at this in the vascular world,” she responded. “I thought that claudicants represented a good population that could be intervened on because they don’t have acute limb ischemia and their life versus limb moment is not right now.

“If I was a practicing vascular surgeon and I could decide—I would really try to get my patient to try to stop smoking, wait at least 30 days, maybe do a nicotine test in preop and see if they did actually stop smoking before doing an elective bypass.”

VAM is ‘in the room where it happens’

VAM is ‘in the room where it happens’
Margaret C Tracci
Margaret C Tracci

To borrow from the hit musical “Hamilton,” VAM 2023 takes place right near Washington, D.C., the seat of power, and “the room where it happens.” While the song refers to a particular room and a particular deal, “it,” can also refer to the art of the deal and the place where lawmakers make decisions that impact the country.

“Because of our Washington, D.C., loca­tion, advocacy and government relations have a much larger presence at this year’s VAM than is typical,” said Margaret C. Tracci, MD, vice chair (and soon chair) of the Society for Vascu­lar Surgery’s Advocacy Council. The council oversees the work of four committees, in­cluding the Coding, Government Relations, Political Action Committee Steering and VA Vascular Surgeons committees.

“Fifty of us are going to the Hill (Capitol Hill) Tuesday to meet with lawmakers and staff. This is an incredible opportunity to drive home to legislators our issues with Medicare reimbursement, the extensive cuts our mem­bers have endured in the past several years and they will be facing going forward and the fact that the system is, essentially, broken,” she said. SVS members won’t just present prob­lems but will also offer solutions to some of these issues, Tracci said.

SVS has been busy in the advocacy sphere recently, spearheading the introduction of H.R. 3674, the “Providing Relief and Stability for Medicare Patients Act,” in collaboration with its Clinical Labor Coalition.

The legislation is designed to mitigate cuts to office-based specialists for a targeted group of services for two years, thereby helping to avoid significant disruptions in patient ac­cess to care while overall concerns regarding the future of Medicare physician payments are addressed.

SVS is partnering with prominent members of both the House Energy and Commerce, and Ways and Means committees in introduc­ing this critical legislation. “Using this biparti­san and dual-committee approach provides a strong foundation for the Society’s continued work to secure additional support for the bill and identify opportunities for advancement,” said Tracci.

The council asks SVS members to contact their lawmakers to urge them to co-sponsor H.R. 3674. The proposal will be a topic of conversation with lawmakers Tuesday, Trac­ci said.

VAM itself will feature two separate edu­cational sessions highlighting the full breadth of SVS’ advocacy-related efforts: Member Perspectives on Advocacy—Myths, Facts and Reasons Why all SVS Members Should Engage, takes place from 12:30–1:30 p.m. Wednesday, June 14, while Tracci will first present the Elements of Effective Advocacy, followed by Advocacy Council Chair Mat­thew Sideman, MD, providing a primer of sorts on SVS’ advocacy and policy priorities.

A panel discussion will follow. Using the Slido live Q&A platform, audience members will be able to ask questions and provide com­ments to the panel in real time, which could well revolve around the visit to Capitol Hill the previous day.

A Friday breakfast session, from 6:45–8 a.m., will give participants an overview on the foundations of SVS’ advocacy and policy work, SVS Advocacy in Action: Work Being Done, Issues on the Horizon and How to Be­come Involved.

Sean Lyden, MD, and Peter Connolly, MD, will moderate. Both are heavily involved in SVS advocacy and government relations activities.

Presentations will include Lyden discussing “Tell it to me straight: What does ‘Advocacy’ mean for SVS.”

Then Mounir Haurani, MD, will present “If You’re Not at the Table, You’re on the Menu: Why SVS Needs a Culture of Advo­cacy Engagement,” followed by payment reform with Tracci. Mark Mattos, MD, co-chair with Connolly of the SVS PAC Steering Committee will present “Advocacy Ways and Means: The Important of SVS PAC.”

Advocacy can include downtime as well! Anyone who has contributed to the SVS Po­litical Action Committee may attend a casual PAC Steering Committee-sponsored recep­tion from 6:30 to 7:30 p.m. Wednesday, June 14, at the Harbor Social Restaurant, located in the Gaylord National Resort and Conven­tion Center.

Safety benefits mean TCAR may be preferable approach in radiation-induced carotid stenosis

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Safety benefits mean TCAR may be preferable approach in radiation-induced carotid stenosis

SVSA study set to be presented at VAM (14–17 June, National Harbor, USA) has found that the long-term outcomes of transcarotid artery revascularization (TCAR) are “not significantly affected” by prior head and neck radiation. Owing to substantially increased risks of mortality with transfemoral carotid artery stenting (CAS), as well as both stroke and mortality with carotid endarterectomy (CEA), researchers believe TCAR “may be the preferred treatment modality for patients with radiation-induced carotid stenosis.”

Bala Ramanan, MBBS, MS, a vascular surgeon at University of Texas (UT) Southwestern Medical Center in Dallas, will deliver these findings from a study that sought to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques—TCAR, CAS and CEA—based on patients (≥65 years old) in the Society for Vascular Surgery’s (SVS) multicenter Vascular Quality Initiative (VQI) linked to the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) database.

Primary endpoints in the study were three-year death, stroke and reintervention rates, from a total of 1,244 patients with prior radiation and 54,925 without prior radiation, the researchers performed propensity matching on 1,223 patients (CEA=655; TCAR=292; CAS=287).

Ramanan et al found no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events, across all three procedures— although the prior-radiation group had higher rates of cranial injury (3.7% vs. 1.8%) and 90-day readmission (23.5% vs. 18.3%) after CEA.

Prior radiation significantly increased mortality risks after CEA and CAS, and the three-year risk of stroke associated with CEA was also significantly higher in radiated patients compared to non-radiated patients. Prior radiation did not, however, significantly affect death or stroke in patients undergoing TCAR. The researchers also found that prior radiation did not impact the rates of short-and long-term reintervention after any of the three procedures.

“We plan to look at our institutional data to get more granular results regarding the long-term outcomes of patients undergoing revascularization procedures for radiation-induced carotid stenosis,” Ramanan told VS@VAM. “However, since this is a relatively uncommon issue, we may need to pool data from multiple institutions to validate the results of the study.”

Base revascularization strategy on effectiveness in restoring adequate and durable limb perfusion, BEST-CLI subanalysis advises

Base revascularization strategy on effectiveness in restoring adequate and durable limb perfusion, BEST-CLI subanalysis advises
subanalysis
Jeffrey Siracuse

The results of a subanalysis of the BEST-CLI trial found that patients with chronic limb-threatening ischemia (CLTI) who were deemed suitable for open lower-extremity bypass surgery “have similar periprocedural complications following either open or endovascular revascularization.”

The finding led researchers to assert that choice of revascularization strategy should be based primarily on effectiveness in restoring adequate and durable limb perfusion.

Submitting and presenting author Jeffrey J. Siracuse, MD, of the Boston University School of Medicine in Boston, is due to pres­ent the results of this study during the first SVS-VESS (Vascular and Endo­vascular Surgery Society) Scientific Session at VAM 2023, which is due to take place 1:30–3 p.m. on Wednesday June 14 in Potomac C.

In the study abstract for their subanalysis, Siracuse et al note that perioperative morbidity is a “major deciding factor” for choosing a revasculariza­tion method for CLTI. It was the objective in this study, they communicate, to assess systemic perioperative complications in the BEST-CLI trial.

By way of context, the authors write that the BEST-CLI trial was a prospective ran­domized trial comparing open and endovas­cular revascularization strategies. They detail that there were two cohorts, with cohort 1 including patients with adequate single-seg­ment great saphenous vein (SSGSV) and co­hort 2, those without SSGSV.

Data from the trial were analyzed for ma­jor adverse cardiovascular events (MACE)— defined as a composite of myocardial infarction, stroke and death— non-serious (non-SAE) and serious adverse events (SAE) 30 days after revasculariza­tion. The investigators share that they used a per-protocol analysis, which in this case was intervention received without crossover.

Siracuse and colleagues relay that there were 1,367 (662 open, 705 endovascular) patients in cohort 1 and 379 (188 open, 191 endovascular) in cohort 2 who met their in­clusion criteria. Sharing the results in their study abstract, the authors report that 30-day mortality was low—1.5% in cohort 1 (open 1.8%; endo­vascular 1.3%) and 1.3% in cohort 2 (2.7% open; 0% en­dovascular).

They add that the rate of MACE in cohort 1 was 4.98% for open vs. 3.3% for endovas­cular (p=0.12) and in cohort 2 was 4.3% for open and 1.6% for endovascular (p=0.16). The authors specify that on multivariate analysis, there was no difference in 30-day mortality MACE for open vs. endovascular for either cohort 1 (hazard ratio [HR] 1.49, 95% confidence interval [CI] 0.85–2.62, p=0.17) or cohort 2 (HR 2.25, 95% CI 0.49– 10.4, p=0.3).

Acute renal failure was found to be similar by inter­vention, Siracuse et al state, detailing that the rates in cohort 1 were 3.6% for open vs. 2.1% endovascular (HR 1.6, 95% CI 0.85–3.12, p=0.14) and cohort 2, 4.2% vs. 1.6% (HR 2.86, 95% CI 0.75–10.8, p=0.12). In addi­tion, they note that venous thromboembolism (VTE) rates were low, with cohort 1 at 0.7% (open 0.9%; endo­vascular 0.4%) and cohort 2 at 0.3% (open 0.5%; endo­vascular 0%).

Other results from the subanalysis include the fact that patients with non-SAE in cohort 1 were 23.4% for open and 17.9% for endo­vascular (p=0.06), and in co­hort 2 were 21.8% for open and 19.9% for endovascular (p=0.71). Furthermore, the investigators share that pa­tients with SAE in cohort 1 were 35.3% for open and 31.6% for endovascular (p=0.57), and cohort 2 were for 25.5% open and 23.6% endovascu­lar (p=0.72). Siracuse and colleagues detail that the most common etiologies for non- SAE and SAE were infectious, procedural complications, and related to underlying peripheral vascular disease.

Global perspectives take center stage in second annual WFVS session at VAM

Global perspectives take center stage in second annual WFVS session at VAM
Palma Shaw
WFVS
Palma Shaw

“The intellectual exchange of information and a better understanding of unique global perspectives has brought the leading societies closer,” Palma Shaw, MD, MBA, secretary general of the World Federation of Vascular Societies (WFVS) says of the success of this international organization ahead of its second annual Educational Session to be held at VAM 2023, due to take place on Wednesday June 14 (6:30–7:30 a.m.) in Maryland A.

In an interview with VS@VAM ahead of the session, Shaw, of Upstate Medical University in Syracuse, New York, states that the key role of the WFVS is to “help form a bridge” between its various partner societies from across the globe. The organization’s goals, she continues, include “fostering international scientific discourse for the purpose of the understanding of vascular disease” and “shar­ing knowledge in the development of effective therapies and interventions to treat vascular disease and strategies for training vascular specialists” for the benefit of vascular patients worldwide.

The VAM audience will hear from representatives of all member societies. On behalf of the Society for Vascular Surgery (SVS), Wei Zhou, MD, of the University of Arizona in Tucson, Arizona, is due to speak on tailoring carotid end­arterectomy (CEA), transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS) to improve clinical and cognitive outcomes.

“Although multiple randomized controlled trials and the most recent SVS carotid guideline endorse CEA over medical therapy in patients with carotid artery stenosis,” she tells this newspaper, “studies have shown that aggressive risk factor modification is just as effective in stroke prevention in asymp­tomatic patients.” Meanwhile, she notes that there has been a rapid increase in TCAR adoption in the US, and that TF-CAS continues to be widely accepted with stent innovation.

Speaking on behalf of the Latin American Association for Vascular Surgery (ALCVA), Nelson De Luccia, MD, of the University of Sao Paulo in Sao Paulo, Brazil, will focus on the topic of hybrid operations for aortic arch aneurysms. He describes this treatment option to VS@VAM as a “less invasive and effective solution” for many patients with aortic arch aneurysms at a time when total endovascular solutions are not yet available on a regular basis.

Mark J. Jackson, MD, MBBS, of Gold Coast Hospital in Southport, Australia, will be giving a presentation on behalf of the Australia and New Zealand Society for Vascular Sur­gery (ANZSVS) looking at challenges for the provision of vascular surgical services in remote Australia.

“The ANZSVS has proposed a model for a more reliable and sustainable vascular service in Australia’s remote re­gions,” he shares in an interview prior to VAM. However, he notes multiple jurisdictions and organizational barriers make this a “challenging” task.

On behalf of the Asian Society for Vascular Surgery (ASVS), Stephen W. K. Cheng, MBBS, MS, of the Univer­sity of Hong Kong will give some insights from endo­vascular repair of the arch using custom-branched endografts. “Endovascular treatment of diseases of the arch, like aneurysms, dis­sections, and infections, had been the pinnacle of chal­lenge in vascular surgery,” he says. “The WFVS session will be a good opportunity to showcase our results and share tips and tricks specific to pathology and anatomy of this region.”

Elsewhere in the session, Philippe H. Kolh, MD, PhD, of the University of Liege in Liege, Belgium—who is current president of the WFVS—will be speaking on behalf of the European Society for Vascular Surgery (ESVS). VAM del­egates will also hear from Nihar Pradhan, MBBS, MS, of Apollo Health City in Hyderabad, India, representing the Vascular Society of India (VSI); Takahiro Suzuki, MD, of the University of Miami in Miami, Florida, representing the Jap­anese Society for Vascular Surgery (JSVS); and Asha Malan, MD, of the Universitas Academic Hospital in Bloemfontein, South Africa, representing the Vascular Society of Southern Africa (VASSA).

Integrated vascular surgery program features may optimize trainee wellness and decrease attrition

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Integrated vascular surgery program features may optimize trainee wellness and decrease attrition

Today’s program at the 2023 Vascular Annual Meeting (VAM) will feature the presentation of an abstract by R. Debbie Li, MD, Loyola University Medical Center, Chicago, on the divergent perceived experiences of the shared learning environment by vascular and general surgery residents.

The research, led by Dawn M. Coleman, MD, Duke University Medical Center, Durham, North Carolina, and Malachi Sheahan III, MD, on behalf of the Vascular Arm of the SECOND Trial was carried out in the belief that “an enriching learning environment is integral to resident wellness” per the abstract. The study team aimed to identify differences in the experience of vascular and general surgery residents with a view to finding “practical levers for change” in improving resident wellness and addressing rates of attrition.

Li and colleagues conducted a convergent mixed-methods study which included the use of cross-sectional surveys following the 2020 ABS In-Training Examination (ABSITE) and Vascular In-Training Examination (VSITE). This survey looked at eight domains of the learning environment and resident wellness, while multivariable logistic regression models were used to compare thoughts of attrition between postgraduate year (PGY) 1–3 residents in general and vascular surgery across 57 institutions. Focus groups were also conducted at last year’s VAM.

In total, 205 vascular residents and 1,198 general surgical residents responded, with general residents found to be more likely to experience mistreatment and consider leaving their program. Coleman, Li and colleagues highlight the qualitative data they collected, stating: “Vascular trainees expressed that early specialization and a smaller, more invested faculty allows for an apprenticeship model” that facilitates “frequent feedback, and thus early skill acquisition” as well as “closer relationships with co-residents and faculty.” This relationship in turn allowed vascular trainees to be more comfortable in reporting mistreatment.

These differences, the study authors suggest, may be the result of “intrinsic features of the integrated training paradigm that are not easily replicated” by larger surgical training programs. Li et al say they are “thrilled” with these results, and propose in conclusion that “optimization of differential aspects of the learning environment is crucial to continue to enhance the next generation of our surgical workforce.”

VAM 2023: Learn at lunchtime

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VAM 2023: Learn at lunchtime
Learn over lunch at VAM 2023

The Society for Vascular Surgery has added four lunchtime learning sessions to the VAM opening day. 

Topics are both clinical and non-clinical, ranging from planning for retirement, embolization tips and tricks, new deep vein thrombosis treatments and a session on the importance of advocacy from member perspectives. 

All sessions are Wednesday from 12:30–1:30 p.m. and will include box lunches for attendees. 

All are also part of the non-plenary educational sessions that are an important part of VAM. “We have something for everyone, at every career stage,” said Will Robinson, MD, chair of the Postgraduate Education Committee, which develops these sessions. “All these programs are terrific—they’re innovative and they’re current.” 

Embolization for Vascular Surgeons: Techniques, Tips and Tricks (Maryland A) will cover an overview of a surgeon’s “embolization arsenal,” management of type II endoleaks, visceral artery aneurysms and embolization in trauma, followed by a panel discussion. 

Case studies submitted by vascular residents will be a part of Bringing what’s New in Deep Venous Thrombosis Treatments to You in 2023 in Potomac C. The session, in cooperation with the American Venous Forum, will cover patient selection issues, the many options for deep venous thrombectomy therapies, tips and tricks for aggressive thrombus removal and what works when it comes to IVC thrombosis. 

With the pronounced aging of the vascular surgery workforce, help with Transition to Retirement: What I Wish I Would have Known takes on new importance. Topics include ways to wind down, including opportunities beyond the operating room, staying fit despite ergonomic challenges while aging, financial considerations, including transitioning from growth to an income stream, asset protection and whether a surgeon has enough assets to call it quits. The session will be in National Harbor 4/5. 

Two stalwart SVS supporters for advocacy will provide Member Perspectives on Advocacy—Myths, Facts and Reasons Why all SVS Members Should Engage in Potomac D.

Study finds carotid stent fracture rate to be negligible but long-term research needed

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Study finds carotid stent fracture rate to be negligible but long-term research needed
Neeta Karani, MD

Presenter Neeta Karani, MD, from Bronson Healthcare, Kalamazoo, Michigan, is set to elucidate findings that consider the incidence of carotid stent fractures and their impact on carotid stent durability during Plenary Session 2 (9:45–11 a.m.) in Potomac A/B at the Vascular Annual Meeting (VAM) 2023. 

Research from Karani and colleagues—including senior author Robert Molnar, MD, from Michigan Vascular Center—comes against the backdrop of the recent approval of transcarotid artery revascularization (TCAR) for asymptomatic patients by the Centers for Medicare and Medicaid Services (CMS), which, by proxy, has increased the number of carotid artery stenting (CAS) procedures being performed today. Subsequently, Karani, alongside coauthor Subbaiah Perla, a professor of statistics at Oakland University in Rochester, Michigan, identified a number of carotid stent fractures in their practice, and so set about investigating the prevalence of this condition and its influence on the efficacy of CAS.

Conducting a prospective trial, the researchers enrolled 200 patients who had undergone CAS between January 2002 and November 2021. Karani et al then evaluated these patients for stent fractures via anterior-posterior (AP) and lateral cervical X-rays. These X-rays were independently reviewed by three vascular surgeons, who, upon complete consensus, identified those patients who had definitive stent fractures. Additionally, Karani and colleagues applied a modification to their study that allowed for a second X-ray to be obtained at a later date to assess the potential for late fracture development in their patient cohort.

Their primary outcome measure was defined as the incidence of carotid stent fracture, followed by a secondary measure which was an evaluation of the clinical implications associated with the condition upon confirmed identification.

In the 200 patients who consented and were enrolled in the study, a total of 227 stent procedures were performed over the duration of Karani and her team’s investigation. In the first wave of X-rays obtained by the team, they identified 18 stent fractures, amounting to a stent fracture rate of 7.9%. Karani will go on to report that 103 patients additionally received a second/delayed X-ray, which amounted to a total of 117 X-rays obtained. In these patients, a further six stent fractures were discovered for a delayed fracture rate of 5.6%.

The total number of fractures found by the researchers amounted to 24, representing an overall stent fracture rate of 10.6%. Karani et al will explain that, of those with stent fractures, duplex assessment in the follow-up period pinpointed only one severe case of recurrent stenosis that required intervention—further designating a 4.2% reintervention rate for their patient cohort.

Karani is set to expand on the study’s conclusions which found that, among patients who had undergone CAS placement, a total stent fracture rate of 10.6% was identified, with a total delayed fracture rate of 5.6%. “While we have identified that carotid stent fractures do occur, the follow-up duplex examinations revealed minimal restenosis, with only one reintervention required. Our study indicates that the CAS fracture rate is approximately 10% and the clinical sequelae appear to be negligible,” Karani is set to explain in her presentation.

Furthermore, Karani and her team posit that their research intends to emphasize the need for further prospective studies with long-term outcomes that acknowledge the increased occurrence of carotid stenting in the treatment of patients today.

In doing so, they seek to highlight that future research in this arena should draw particular attention to stent fractures and reintervention rates as matters of pointed importance.

VAM 2023: SVS Connect@VAM social event is tonight

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VAM 2023: SVS Connect@VAM social event is tonight

As part of its ongoing commitment to foster collaboration and strengthen the vascular community, the SVS will host the inaugural SVS Connect@VAM: Building Community Wednesday evening, to close out the first day of VAM. This event allows attendees a unique opportunity to connect, relax and recharge in a festive atmosphere with colleagues, friends and family. Dress style is strictly casual. 

Thanks to the sponsorship of Terumo Aortic and Philips, the event—which SVS leaders hope becomes an annual one—is free. However, because space is extremely limited, attendees are strongly encouraged to reserve their spots early by visiting vascular.org/ SVSConnectVAMBuildingCommunity. 

From 7–9 p.m., attendees will gather on the lawn of the Gaylord National Resort and Convention Center, on the banks of the Potomac River. SVS Connect@VAM will feature interactive activities, food stations, games and entertainment designed to create an environment of camaraderie and fun for attendees and their families. 

Email [email protected] with any questions. 

‘First’ study to identify endothelial cell-cell communication via bidirectional secretion of extracellular vesicle cargo wins SVS Foundation award, place on VAM stage

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‘First’ study to identify endothelial cell-cell communication via bidirectional secretion of extracellular vesicle cargo wins SVS Foundation award, place on VAM stage
Sneha Raju
Award-winning vascular resident talks about the science behind her work, which her mentor says is “moving the needle on every front.” 

University of Toronto surgeon-scientist trainee Sneha Raju, MD, has been awarded the SVS Foundation Resident Research Award for 2023 for her work on a “new paradigm” of endothelial cell-cell communication and its invaluable implications for atherosclerotic plaque development. Her work delves into the “critical” bidirectional interface that endothelial cells (ECs) inhabit, in the hopes that manipulating the mechanism might lead to mitigation of disease progression. 

Created to encourage early-career physicians to become involved in basic science research, the annual award centers on explorations of the biology of vascular disease and potential translational therapies. Abstracts are submitted by the applicant alongside an SVS senior collaborator, and on winning, are given the opportunity to present their research at VAM. Said to be “moving the needle on every front” by her mentor and collaborator Kathryn L. Howe, MD, PhD, at the University of Toronto, Toronto, Canada, Raju is set to present her research during the first plenary—William J. von Liebig Forum session—on Wednesday June 14, 8–8:10 a.m. in Potomac A/B). 

The research is founded on a central tenet—ECs can release extracellular vesicle (EV)-encapsulated miRNAs and proteins to mediate cell-cell communication. Seeking to expand on this, Howe and Raju hypothesized that EC-EV release is altered by activation state and drives functional changes in surrounding cells via bidirectional release. 

In conversation with VS@VAM prior to her presentation, Raju reflects on how the research was borne out of a deficit in knowledge surrounding plaque burden and its progression. Approaching Howe who runs a laboratory focused on endothelial communication and carotid disease, Raju found that their interests blended, and they began investigating this question through an endothelial and vesicle perspective, specifically looking at the bidirectional interface where these cells communicate. 

Kathryn L. Howe

“The idea in both of our minds,” Howe tells VS@ VAM, “is that atherosclerosis does not form overnight—it is not a single moment in time, it takes decades to form. So, if you envision a cell that has lived at this interface for a time where it is constantly irritated or activated by non-laminar or turbulent flow, you can imagine how it may be constantly sensing and communicating back this distressed environment response.” With this information, Raju alongside Howe investigated what drives atherosclerosis and plaque build-up in target zones, considering what influences shifts in cell activation state from stable to vulnerable to rupture. 

These activation states, Raju describes, can be “happy” or “angry”, denoting the either quiescent or inflammatory vesicle packages the EC contains. “We wanted to see how the EC modulates vesicle release in conditions that are quiet and happy—and in conditions where we have made them angry, as is seen in patients who have vascular diseases like atherosclerosis,” Raju outlines. Interestingly, when relevant cells are treated with EC-derived vesicles, they found that vesicles were able to modulate or change conditions in cells found in both the vessel wall and the blood, raising new questions on the mechanism behind this. 

“We were the first to show that ECs can load specific cargo and secrete it in both the apical and basolateral directions”, Raju says, their findings uncovering the “critical interface” ECs reside in. “Not only are they able to sense what is going on in the environment, but they are able to change the vesicular cargo” said Raju, which can then induce the happy or angry cell activation states. Importantly, they also found that ECs can polarize vesicle release bidirectionally, which may specifically govern functional changes in circulating and resident vascular cells. 

“This has broad-ranging applications” Raju states, “although it builds on a fundamental principle of vascular biology—we know that these ECs are secreting vesicles that are going into the vessel wall and communicating with cells there. If we can find a way to harness and change that communication to make it happier, then we can hopefully circumvent, reverse or rescue some of the negative cell-cell communication happening in disease states to mitigate plaque progression.” 

Making continued progress, Raju is interested in exploring this from a biomarker perspective so that she can get ahead of plaque progression before a patient becomes symptomatic. “As vascular surgeons we operate on patients who have symptomatic carotid atherosclerosis which leads to stroke.” However, without a “good biomarker” to indicate plaque progression in asymptomatic patients, predicting and preventing later clinical events can be difficult. 

Understanding the communication between ECs and progression to rupture or stroke formulates the translational aspect to Raju’s research, which is a key element in the Resident Research Award’s parameters. To explore this, Raju’s team have been collecting carotid plaques and plasma to see if this information can be corroborated with their patient cohort. From a therapeutic perspective, Raju states, they want to better understand the mechanism by which ECs are releasing vesicles in a basolateral direction and driving the biology of the disease, so that they can design therapeutics or small molecules that can “inhibit or enhance” the mechanism and find ways of reverting it into a quiescent phenotype. “I think we have unearthed a basic biological tenet that can be applied to several vascular pathologies, which is promising,” Raju concludes. “Beyond a vascular surgical viewpoint, it could also be applied to other areas such as cerebral aneurysms or cancer biology.” 

On winning the award, Raju reflects on the “motivation and inspiration” gaining this recognition has instilled: “It is great that the committee thought this work deserving of the award, I am very grateful for this international platform to showcase my research and establish international collaborations with fellow vascular surgeons and scientists to advance some of these questions together.” 

On her involvement in research projects of the future, Raju details that in the year before she returns to residency, she hopes to dedicate time to the translational side of the current research. “I hope to stay involved in this project as it progresses and develops, and use this skill set to ask vascular biology related questions as a future surgeon-scientist in my own independent lab—that would be the dream.” 

Looking ahead to Raju’s presentation at VAM 2023, Howe believes it is an exciting chance to “lift the lid” on the progressions being made in research and “bring this into the space of the clinician.” 

VAM 2023: President-elect zeroes in on complexity of issues within vascular surgery pipeline

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VAM 2023: President-elect zeroes in on complexity of issues within vascular surgery pipeline
This year’s Crawford Forum panel

The Vascular Annual Meeting (VAM) E. Stanley Crawford Critical Issues Forum this year probes the problems and the challenges facing the vascular surgery workforce pipeline. The opening day highlight—the domain of the incoming SVS president, Joseph Mills, MD—seeks to unravel the multi-faceted, multi-directional nature of the issues contained within this complex structure. 

Joseph Mills describes it as having become something of an overused, one-dimensional trope. For the SVS president-elect, who takes over as president at the close of VAM 2023, the pipeline is far more complex than that: The issues surrounding, feeding into, emerging out of— and, potentially, clogging up—the vascular surgery workforce pipeline are myriad and far more difficult to pin down than to a simple, singular pipe. “The pipeline is not one line,” the professor and chief of vascular surgery at Baylor College of Medicine in Houston, Texas, tells VS@VAM. “It has multiple connections that come from multiple places and go to multiple places.” 

That’s why Mills planned this year’s Crawford Forum—traditionally the preserve of the incoming Society president to focus on the direction of vascular surgery—with a title reflecting one of the specialty’s most existential issues: The State and Future of Our Specialty—Extending, Repairing and Maintaining the Vascular Surgery Pipeline. The session will take place in Potomac A/B today (11 a.m.–12:15 p.m.). 

The Forum’s panel captures three main areas of focus: sources of future vascular surgeons, the existing workforce, and the distribution of that workforce. To that end, Mills hand-picked six speakers to deal with the issues at hand. Lee Kirksey, MD, from the Cleveland Clinic in Ohio looks at outreach to high school and college students and Malachi Sheahan III, MD, from Louisiana State University in New Orleans, deals with outreach to medical students and residents in training. And while Dawn M. Coleman, MD, from Duke University Medical Center in Durham, North Carolina, will address vascular surgeon wellness, Laura Marie Drudi, MD, from Centre Hospitalier de l’Universite de Montreal in Canada, will discuss solutions for burnout in vascular surgery. Meanwhile, former SVS President Michel S. Makaroun, MD, from University of Pittsburgh Medical Center, is set to hone in on the question of insufficient supply or maldistribution in vascular surgery, as Peter R. Nelson, MD, from the University of Oklahoma in Tulsa, rounds out the panel with a talk on prophylactic measures to improve the workforce crisis. 

‘It’s complicated’ 

Mills wants his colleagues to grasp the complexity of the issues facing the vascular surgery workforce. That is what his lineup of speakers and their topics are set up to elucidate. “The pipeline meme has become a bit of a tired one,” he says. “The pipeline that people traditionally think about—that there are not enough people coming into the pipeline; we need more people to pour out the end of the pipeline—I think it’s much more complicated than that. It’s an interconnected network of pipes, which is how I want to think about this whole problem.” 

It’s as the title portends, Mills continues: “Extending, repairing and maintaining the pipeline; so it’s not just a matter of getting more people in so we can get more people out. It’s how we treat the people inside the pipeline to prevent them from clogging or from leaking out of the pipeline. And then how do we supply—think about an irrigation network supplying water to farmland. We have a maldistribution of vascular surgeons, and probably an insufficient supply also, although those two things interact.” 

The first two talks—concerning recruitment—are about sparking interest. And it purposely goes beyond what might be thought of as the traditional realms of trainee origin, Mills says. “For years, we took all our trainees from a general surgery program. As the specialty split off, it became obvious we needed to reach out to medical students.” 

But to get the right mix, the specialty needs to reach even further back into the pipeline—even middle school students—to try to develop broad interest in medicine, Mills explains. “If you believe—and most of us do—that patients like to see doctors who are like them and understand them, then if you don’t recruit people from smaller and unrepresented communities, and you don’t recruit people who look like your patients, you’re going to perpetuate inequitable access to and distrust in our healthcare delivery system.” 

Then there are concerns around maintenance of the existing workforce, and the specter of wellness, burnout and moral injury. That means keeping vascular surgeons in the pipeline so that they don’t retire too early because they get “burned out” amid some of the automated aspects of modern practice, says Mills. “There probably are too few vascular surgeons and a large proportion of us are over 55. If we start retiring earlier, and a large number of our specialists are over 55, that’s going to accentuate the lack of vascular surgeons. What will happen is other specialties will try to fill the gap.” 

The other two talks ponder whether there are enough vascular surgeons currently practicing, or if they “are just in the wrong places,” Mills says. “My own take is that it is both.” His theme of a workforce pipeline is not meant to be “the tired” analogy of: “You’ve got to pour more people through to get more people out of the end.” The questions, then, center on: “Are we attracting people from diverse backgrounds,” Mills concludes. “And if we do that, can we solve some of the distribution problems? Texas is an oil state. Pipelines burst and corrode. And they get obstructed. So how do you maintain what you have and, by design, even extend service to areas and people that aren’t being served.”

More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients

More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients
Misty Humphries

Earlier this year, researchers debuted single-center experiences indicating that intravascular lithotripsy (IVL) may be able to expand transcarotid artery revascularization (TCAR) into patients with traditionally prohibitive calcific disease. With a multicenter case series now further suggesting IVL’s utility, but also revealing potential safety concerns versus conventional TCAR or carotid endarterectomy (CEA), principal investigator Misty Humphries, MD, MAS, associate professor of surgery at UC Davis in Sacramento, California, gives Vascular Specialist the lowdown on these findings.

VS: Could you very briefly outline the motives behind this research?

MH: TCAR has been shown to be highly effective and safe, but there are still anatomic exclusion criteria—specifically, severe calcification. There are also many patients who are just not a candidate for traditional CEA for various reasons. The use of IVL has the potential to open TCAR technology up to more patients.

VS: How do these more recent, multicentric findings build on your publication from earlier in the year?

MH: With our initial presentation, we discussed how we do the procedure. That presentation was our own institutional data. When we analyzed our own experience, we had no complications, and the technology appeared safe. But, in this larger, multicenter cohort, we see a risk of transient ischemic attack (TIA) post-procedure that was not present. Multicenter studies like this demonstrate what can happen when technology is expanded to more practitioners of various skill levels.

VS: Why was freedom from stroke/TIA selected as the study’s primary safety endpoint?

MH: Stroke and TIA are the two outcomes patients care about most. We saw this with the CREST trial data that were analyzed. All of my research is patient-centered and, for me to use technology, I want to know that it is safe—not just for what providers care about, but for what patients care about as well.

VS: What were the key safety and efficacy findings of the study?

MH: IVL combined with TCAR seems to be highly effective, allowing full stent expansion. The safety of the combined treatment needs to be studied in a prospective trial. There are not a significant amount of known data on the risk of stroke and TIA in patients with severe calcium after carotid artery stenting (CAS) because these patients are typically excluded from trials. The best data we have were presented at the Society for Clinical Vascular Surgery (SCVS) meeting earlier this year. In a review of Vascular Quality Initiative (VQI) patients who underwent TCAR and CAS, patients with severe calcium had a higher risk of stroke/TIA than those who did not. This tells us that it is the disease process, and we need to learn more about this.

VS: How significant is it that a technical success rate of 100% was achieved?

MH: Technical success of 100% means we can do the procedure. The real question is how to do the procedure effectively and safely. I do not think we know that yet.

VS: How concerning is the increased stroke/TIA rate versus conventional TCAR or CEA—would the benefits of IVL plus TCAR still outweigh these risks?

MH: Studies that break out results based on the degree of calcium are lacking because these patients are excluded from TCAR trials. The VQI data presented at SCVS 2023 show that patients with higher degrees of calcium have increased stroke rates with TCAR and CAS. I truly believe that heavily calcified patients are better served with CEA, but there are some patients that cannot undergo CEA and, in those patients, IVL with TCAR is an answer. We are just exploring how to do this procedure in the best way for patients. We also need to do a prospective trial where we control for all factors, such as Plavix (clopidogrel) resistance, and procedural or postprocedural hypotension.

Vascular Specialist@VAM–Conference Edition 1

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Vascular Specialist@VAM–Conference Edition 1

In this issue:

  •  President-elect zeroes in on complexity of issues within vascular surgery pipeline
  • ‘First’ study to identify endothelial cell-cell communication via bidirectional secretion of extracellular vesicle cargo wins SVS Foundation award, place on VAM stage 
  • Advocacy: VAM 2023 is in the room where it happens! 
  • TAAA video: Endovascular thermal septotomy 
  • Reintervention: Carotid endarterectomy more durable out to six months 

The essential ‘need’ for vascular surgeons in pulmonary embolism treatment paradigm

The essential ‘need’ for vascular surgeons in pulmonary embolism treatment paradigm
Charles B. Ross

The specter of pulmonary embolism (PE) as a common and lethal disease process—with mortality of massive PE static at about 50% for decades while rapid advances were made in stroke and STEMI care—forms the backdrop to a VAM 2023 breakfast session taking place on Friday.

With the introduction of new and refined management strategies and interventional options for PE, says session moderator Charles B. Ross, MD, chief of vascular and endovascular services at Piedmont Heart Institute in Atlanta, outcomes are changing at an accelerated pace for the better.

With these advances in mind, vascular surgeons who are SVS members from pulmonary embolism response teams (PERTs) or busy PE programs from six large hospitals and systems will discuss advances in care and the role that vascular surgeons play in the current PE landscape in the breakfast session. The session—Management of Pulmonary Embolism: Fundamentals and Advances—is from 6:45–8a.m.

One key talk delves into the importance of a multidisciplinary team for treatment of patients with pulmonary embolism that includes vascular surgery, and how it offers the best opportunity for improved patient outcomes. The addition of artificial intelligence in PE diagnosis, as well as the necessary role of vascular surgeons in PERT care form some of the central themes set to be discussed by Dennis R. Gable, MD, a vascular surgeon at Texas Vascular Associates in Plano, Texas. His talk will lead off the program from 6:45–6:55a.m.

Fundamentally, Dr Gable tells VS@VAM, venous thromboembolism (VTE), including PE, has always been considered a “peripheral vascular” diagnosis and, “we, as peripheral vascular specialists, need to be involved in this treatment paradigm and pathophysiology.”

Gable is set to hone in on what he describes as the necessity of vascular surgery as a key component of PERTs—multispecialty entities which incorporate interventional cardiology, vascular surgery, cardiothoracic surgery, pulmonology, critical care, hematology and heart failure specialists, among others.

Gable will explain how the leadership and providers of interventional management of PE varies from hospital to hospital, with vascular surgeons deeply involved at some centers—but minimally involved at others. This heterogeneity concerns Gable. One of the points of discussion is this: “If you do not participate in PE care, it may in the long run cause us as a specialty more harm by diminishing our role in overall VTE management,” he explains. “It eliminates us from being involved with these patients and the ability to maintain a voice in their care.”

On the emerging role of artificial intelligence (AI) in vascular surgery, Gable will introduce the concept of how AI can shave considerable time off the process of determining management for individual patients. “If you get a scan that shows a central PE, rather than having the information go back to ER doctors or the referring physicians—and then them having to make a call, get everybody together and eventually get a PERT team consult—with AI, when a PE is seen on imaging, there is an automatic PERT alert including images and stratification data sent out to the PERT team on call,” he says.

“You can make a diagnosis, put a plan together, discuss with members of the PERT team in real time, expedite consensus decision-making and treatment logistics far more efficiently.”

Relax, recharge at VAM 2023 opening day social event

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Relax, recharge at VAM 2023 opening day social event

SVSThe opening day at the society for Vascular Surgery’s Vascular Annual Meeting (VAM) starts with an educational session for the World Federation of Vascular Societies (WFVS), moves on to the Opening Ceremony, followed by a very full day of abstract and education sessions, meetings, industry symposiums and more.

With VAM Wednesday (June 14) packed full of important vascular topics, what better way to unwind and to celebrate the kick-off of this epic four-day gathering of vascular professionals than with fun?

New this year is the first SVS Connect@VAM: Building Community, a free, blockparty-style and family-friendly networking event that will include food and beverages, games, entertainment and activities. The event is sponsored by Terumo Aortic and Philips.

“People will have spent the day moving from place to place to place, all to catch as many of the sessions we’re offering as they can,” said Andres Schanzer, MD, chair of the SVS Program Committee, which plans much of VAM’s educational content.

“We’re introducing this event—and we want it to become a new tradition—to encourage everyone to take a breath, or seven, and relax and recharge. Bring the family if they’re along for the trip. Bring yourself!”

“It’s strictly casual,” he emphasized. “Save the fancy clothing for Friday’s ‘Great Gatsby’ Gala on Friday night,” he said. “We want people to focus on kicking back and visiting with some of the people they haven’t seen since last year’s VAM. The emphasis is on family and fun.”

Though the event is free, tickets are required and may be obtained when registering for VAM. Those already registered can include “Connect” tickets at vascular.org/VAM23reg.

Visit ‘SVS Central’ for headshots

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Visit ‘SVS Central’ for headshots

SVSThe Society for Vascular Surgery (SVS) will once again offer the 2023 Vascular Annual Meeting (VAM) attendees the opportunity to receive free headshots.

These professional headshots are a valuable addition to any professional’s career portfolio. The headshot booth will be open from 10a.m. to 2p.m. on Thursday and Friday of VAM 2023, close to “SVS Central,” the Society’s own member resource. Both will be just outside the entrance to the Exhibit Hall.

“We urge all of our members who don’t have an up-to-date professional photo to stop by and have their photos taken,” said SVS Communications Committee Chair William Shutze, MD. “A photo helps demonstrate your professionalism, either of you alone, or as part of your practice or division.”

VQI@VAM: Quality takes center stage at VQI meeting, initiative making much out of zero

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VQI@VAM: Quality takes center stage at VQI meeting, initiative making much out of zero
VQI
Jens Eldrup-Jorgensen

Over the past several months, the Society for Vascular Surgery’s Vascular Quality Initiative (VQI) hit some important milestones, including registering procedure number 1,000,000 in its database, enrolling center number 1,000, as well as 100-plus quality charters initiated in 2022. There are also the 10,000-plus new procedures added to the clinical registry every month.

In short, VQI has collected a lot of zeros. But it’s about more than collecting: it’s about how the members of the VQI use these zeros to become quality improvement heroes.

This year’s VQI@VAM—the VQI’s annual meeting—will celebrate those zeros. But the meeting is about so much more than nothing, said VQI Medical Director Jens Eldrup-Jorgensen, MD.

The meeting will be held from 12 to 5p.m. Tuesday June 13, followed immediately by the VQI Poster Networking Reception until 6:30p.m., and from 8a.m. to 5p.m. Wednesday (June 14). Highlights of this year’s VQI@VAM include the launch of a new national initiative, the announcement of scholarships for vascular fellows pursuing quality improvement projects, an update on that program, announcement of VQI participation awards, and the popular reception on Tuesday evening.

VQI launched the Fellows in Training (FIT) initiative in 2022 and will graduate its first set of graduates during the meeting. FIT is a 12- to 18-month program for individuals completing their medical residencies or fellowships in any vascular disease-focused specialty, such as vascular surgery, cardiology, radiology or vascular medicine.

It fosters an understanding of quality processes and metrics through mentorship in the VQI. The program is a collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology (ACC) and the Society for Vascular Medicine (SVM).

Gary Lemmon, MD, an integral part of FIT, will announce the winners of the Jack Cronenwett Scholarship, permitting these recipients to continue for a second year. The update and awards will be from 11:15 to 11:40a.m. Wednesday (June 14). The scholarships are named for Cronenwett not just because of everything he means to vascular surgery and quality initiatives, but also because he has already mentored so many physicians, said Eldrup-Jorgensen. “It’s a part of his career that should be publicized and applauded. It’s not just his work with quality, but because of the excellent mentor he was to generations of current excellent vascular surgeons.”

Cronenwett, in fact, will meet with the first group of FIT Scholarship Award winners Thursday morning (June 15). He founded the New England Vascular Study group which led to the creation of VQI, and received the Lifetime Achievement Award at VAM 2016. Eldrup-Jorgensen is saving FIT program highlights for Adam Johnson, MD, chair of the FIT Committee, to discuss at the meeting, but said assessments of the program from participants and mentors indicated the experience was beneficial. “The true indication that it really did work was when so many people applied for the Year Two scholarship,” he said.

On the Wednesday morning of the meeting, Lemmon will announce a new major initiative on smoking cessation. Prior to that presentation, Cassius I. Ochoa Chaar, MD, will discuss “A Comprehensive multidisciplinary inpatient-based approach to smoking cessation for patients with vascular disease” at 10 a.m. Wednesday. Priscilla Callahan Leone of the Food and Drug Administration (FDA) follows as a guest speaker from 10:08 to 10:28 a.m.” Lemmon will present more on the initiative until 10:45 a.m.

“Smoking cessation is of primary importance to patients, particularly vascular patients, who are particularly affected by smoking,” said Eldrup-Jorgensen. He and SVS Patient Safety Organization Director of Quality Betsy Wymer will introduce a patient toolkit physicians can use to help their patients quit smoking. Underscoring the topic’s importance, VAM 2023 includes smoking cessation in two abstract presentations.

VQI@VAM’s Tuesday sessions include panel discussions on a variety of topics as well as drilling into semi-annual regional reports. Wednesday sessions are designed for physicians, nurses, data managers, quality improvement professionals and administrators.

View the full meeting agenda at vascular.org/OnlinePlanner23. Organizers point out that VQI@VAM requires a separate ticket from VAM registration.

VQI@VAM: Social media helps promote safe technique, study finds

VQI@VAM: Social media helps promote safe technique, study finds
The “No Guess with Access” quality improvement campaign included an instructional video

A social media campaign promoting educational videos proved efficient and cost-effective, and similar campaigns will be useful for quality improvement projects directed toward medical trainees.

That’s the message from “A social media campaign to promote safe technique in femoral access,” which will be presented during the Vascular Quality Initiative (VQI) annual meeting from 11:05–11:15 a.m. Wednesday in National Harbor 2/3, site of the 2023 Vascular Annual Meeting (VAM).

Cassius I. Ochoa Chaar, MD, MS, of the Division of Vascular Surgery and Endovascular Therapy at Yale University School of Medicine, and Joshua J. Huttler, BA, and MD candidate, also of Yale University School of Medicine will present the campaign and its conclusions.

The effort grew out of an objective to “standardize access protocol and reduce access-relating bleeding complications,” according to the authors. Issues included department differences in femoral access technique and a cadaveric groin dissection study that showed significant anatomic variation in anatomy.

The team created the “No Guess with Access” quality improvement campaign, which included surveys, posters, teaching sessions, the Yale School of Medicine newsletter, an instructional video on “optimal femoral access corrects anatomical error” and the social medica campaign on Twitter and YouTube.

The “No Guess with Access” training video was posted on YouTube; links on social media publicized it, calling the video “an essential training video for all endovascular specialists for safe femoral access techniques.” The social media campaign included 16 weeks of paid advertising on Twitter, targeting health care professionals, specifically medical trainees.

BEST-CLI vs. BASIL-2: Different questions yield different answers

BEST-CLI vs. BASIL-2: Different questions yield different answers
Malachi Sheahan III
Medical editor Malachi Sheahan III, MD, takes a look at seemingly conflicting results from the landmark BEST-CLI and BASIL-2 trials, and asks what they really reveal.

This past April, BASIL-2 chief investigator Andrew Bradbury, MD, presented trial results at the Charing Cross (CX) International Symposium in London. The authors concluded that an endovascular-first approach to patients with critical limb-threatening ischemia (CLTI) who required an infrapopliteal intervention was associated with better amputation-free survival. These findings seem to be a direct contradiction to the bypass-first approach supported by the BEST-CLI study. So what do we do when two major trials report conflicting data? That’s right, start a Flame War on Twitter. But before we bury the interventionalists in memes, let’s look at what these studies may actually be telling us. 

BASIL-2 was an open-label, pragmatic, multicenter, randomized trial performed mainly in the United Kingdom. The primary outcome was amputation-free survival, which was higher in the endovascular treatment group than the bypass cohort (hazard ratio [HR] 1.35, p=0.037). But what drove this disparity? There was no difference in major amputation rate between the endo and open groups (18% vs. 20%) over the study period. Therefore, the difference in outcomes was mainly derived from the lower mortality in the endo patients (45% vs 53%). 

Intuitively, one would think that the higher mortality in the open group would be associated with the risk of general anesthesia and the increased morbidity of surgery. The 30-day morbidity and mortality, however, were not statistically different between the treatment modality groups. What then drove this difference in survival? First, it should be noted that overall survival was fairly dismal, as one would expect from an aging population with severe peripheral vascular disease. It is often easy to get lost in the canyon between statistical significance and clinical significance. My back of the napkin math tells me that as few as five more deaths in the endo group over the study period might have robbed the endpoint of its statistical “significance.” Looking at the two groups, they seem pretty well matched, but the raw prevalence of previous myocardial infarction (24% vs. 13%) and previous dialysis (6% vs. 3%) were higher in the bypass cohort. Could this have been enough to generate a few more late deaths? 

It is also important to note that in this intent-to-treat analysis, only 145 of the 172 patients in the bypass group underwent surgery. Since the difference in outcomes was mainly driven by late mortality, a look at the survival in each group of those actually receiving the treatment would be helpful. 

Interestingly, the BASIL-2 results also seem to contradict a previously published subgroup analysis from the BASIL-1 trial, which suggested better outcomes with vein bypass than angioplasty in infrapopliteal revascularization. 

Cohort 1 of the BEST-CLI trial was comprised of CLTI patients with an adequate saphenous vein who were randomized to either an endovascular- or surgery-first strategy. The study concluded that an initial surgical approach led to a lower risk of major adverse limb event or death. Cohort 1 enrolled more than four times as many patients as BASIL-2 and had many crucial differences in design. Participants were required to be good operative risks. The patients were younger and demonstrated more gender and ethnic diversity. Infrapopliteal revascularization was a requirement for BASIL-2 but only performed in about 60% of the BEST-CLI cohort 1. Perhaps most importantly, the primary measured outcome of BEST-CLI was a combined freedom from death, major amputation, and major reintervention, while BASIL-2 focused on amputation-free survival. Both BASIL-2 and BEST-CLI found significantly higher reintervention rates in the endo groups. So where to go from here? Luckily, the BEST-CLI and BASIL-2 investigators have a data-sharing agreement in place that should elucidate many of these questions in the future. Patient-level data and more detailed anatomic information are needed to provide any true guidance to the ideal therapy for CLTI. 

Also, a disclaimer. These trials employed complex statistical modeling. This passage from the BASIL-2 manuscript made my eyes glaze over: “Binary secondary outcomes measured at a single timepoint were analyzed using a mixed effects log-binomial model to generate an adjusted risk ratio and risk difference (with an identity link function).” So, to paraphrase Michael Scott, I know exactly what I’m doing, but in a much more real sense, I have no idea what I’m doing. To this end, I have asked Michael Conte to provide a “smart guy” commentary to complement my own in this issue of Vascular Specialist. 

While we await further analysis, should we employ an endo- or open-first strategy for CLTI? The answer is likely neither. The best approach is one suited to the individual patient. Of course, one could then argue that the best physician for this problem is one who can expertly offer either treatment paradigm. But I’ll leave that for the Twitterati. Don’t @ me. 

‘Nobody believed us’: Vascular giant discusses overcoming skeptics to make specialty-defining breakthroughs

‘Nobody believed us’: Vascular giant discusses overcoming skeptics to make specialty-defining breakthroughs
Frank J. Veith, MD
Malachi Sheahan III, MD, Vascular Specialist’s medical editor, speaks to living legend and limb-salvage pioneer Frank J. Veith, MD, on the contents of his hard-hitting new book, The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia, ahead of the inaugural named lecture established in his honor taking place at this month’s Vascular Annual Meeting (VAM).

Frank Veith needs little introduction to the world of vas­cular surgery, either in the United States or anywhere around the globe. He is one of the profession’s pio­neers. A vascular working life that started more than a half century ago, Veith’s book—memoir-cum-manifes­to—covers the highlights from the start, middle and later parts of his career. VAM will see the birth of its fulcrum: The Frank J. Veith Distinguished Lecture was announced during VAM 2022 in honor of the former SVS president’s near-career-long dedication to the avoidance of amputation, and will focus on the recently published BEST-CLI trial. The talk is to be delivered by trial principal investi­gators, Alik Farber, MD, and Matthew Menard, MD, and will look at the journey that resulted in BEST-CLI’s evidence, and what lies beyond it for the treatment of CLTI.

The Medical Jungle by Frank J. Veith

Veith devotes a significant portion of The Medical Jungle to limb salvage, as well as topics ranging from his early work in lung trans­plantation, his involvement in North America’s first-ever endovas­cular aneurysm repair (EVAR), to the question of vascular surgery as an independent specialty and his philosophy on the mentorship of trainees. Here, he tackles these themes and more in a frank exchange, which is an edited version of a video interview that features as a VAM 2023 special on the Vascular Specialist website.

MS: Dr. Veith, in your book, you describe yourself as extremely shy as a student and early trainee. How do you account for the evolution in your personality?

FV: That’s a great question. I don’t know how to answer. I still consider myself pretty shy. You know, I don’t jump up and ask questions at meetings, and stuff like that. I had to be a little more forceful and outgoing. With practice, you get better at public speaking, but I would always get nervous when I would give a talk, particularly at a big meeting. But somehow, you get through it. And if you prepare, things usually go pretty well.

MS: For vascular surgeons of my generation, it’s really fascinating to see how much we were involved with transplant surgery in the early days. Can you describe how you got interested in transplant surgery—and as a profession, did we drop the boat on this?

FV: Well, it was very simple. I trained at the Brigham with Franny Moore and Joe Murray, who were pioneers in kidney transplan­tation and, to some extent, in liver transplantation … But I also wanted to be in an area that was somewhat unconquered and that got me into lung transplantation, which really had not been done with any degree of success. So we started out by trying to figure out why [lung transplantation] hadn’t been successful. Because it was just another organ that involved some vascular surgical techniques [in order] to do the transplant.

MS: You describe very well in the book how you looked to differ­entiate yourself—and you really took to limb salvage early on. Can you describe how that came about?

FV: It was, of course, when I went to Montefiore, which was, in New York City, really a second-rate, or somewhat second-rate, institution in the Bronx. It was not glamorous, like Cornell, Co­lumbia, Mount Sinai, NYU [New York University]. I wanted to do the normal stuff, aneurysms, carotid, etc., and we didn’t have many of those cases for a variety of reasons. We did have an abun­dance of poor patients with threatened limbs—with gangrene or ulceration—who were faced with amputation, and the thinking of the day was, well, “If they have such a limb-threatening lesion, they need a below-knee amputation and ‘rapid rehabilitation.’” We found that that didn’t work. So we started with great care and concern, obviously, to challenge the thinking of the day, which was not to do reconstructive vascular surgery for limb salvage. We found that if we were very careful with our tech­niques, using some of the methods that I’d learned to do—AV [arteriovenous] fistulas, micro and semi-micro anasto­moses—that many of these limbs could be saved. We were able to save more than 90% of the patients who presented to us with a threatened limb.

MS: You were also one of the early ad­vocates—maybe the first—for EVAR for ruptured aneurysms. Can you tell us a bit more about that?

FV: We actually did the first-ever EVAR outside of Argentina. That was a stroke of good fortune. As I say, I had always been interested in endovascular tech­niques because I’d become very friendly with Barry Katzen, a well-known interventional radiologist. Be­cause of our friendship and my early support for him, he used to invite me to his interventional meetings. So I was exposed to the benefits of those endovascular techniques. And I was a very early believer, despite many of my colleagues not being believers in angioplasty, stenting, and so forth. I was always interested in the idea of doing EVAR because we had a lot of very sick aneurysm patients who didn’t do well with an open aneurysm repair. When that became available, we embraced it. Remarkably, we were very lucky that the procedure proved to be a big success. The patient— who was totally inoperable and with very bad heart and lung dis­ease—got better. He was up and sitting in a chair reading Playboy the next day. For me, that was an epiphany. I said, “God, if we don’t—as vascular surgeons—learn how to do these techniques, we’re going to be out of a job and become extinct.” … Of course, nobody believed us again. It was very discouraging. But then, with time, after about four or five years, and persistence in presenting our work, and because of our unbelievable successes in these very difficult patients, other vascular surgeons started to embrace the technology.

Veith was pioneering limb-salvage techniques when no one else seemed to believe they could work, he says

MS: You were an early proponent of collaboration with interventional radiology. And during your SVS Presi­dential Address, collaboration was one of your three missions for our specialty. You say later that we failed. Why do you think things happened that way?

FV: Human nature. The book highlights a lot of the frail­ties, or bad traits, of human nature that you don’t think are going to apply in medicine. I mean: lust for power, control, self interest, greed and, sometimes, jealousy. We’re certainly as separate as neurosurgery or orthope­dic surgery, or gynecology, and, yet, that barrier has not yet been breached. I’m not fighting it anymore, but I think, sooner or later, we have to come into accordance with other countries. Vascular surgery should be a totally separate specialty. Why? Because we sort of are: we don’t do general surgery anymore. We may cover for them, but we really are separate because we’re different. Our techniques are different. And we certainly need the separation from interventional cardiology and interventional radiology that will allow us to compete with them on a level playing field. Because interventional cardiology, who are very talented and very much support­ed by institutions, outnumber us by about five to one.

MS: Your ideas were in many ways the father of the Heart and Vascular Center concept.

FV: Yes. We tried to do that. [But] either a chairman of radiology, or perhaps the chairman of surgery, and other places, didn’t want to let go of their patient loads, etc. One of the recommendations that I made, way back in 1996, was that we have vascular centers that were independent of medicine and surgery, and radiology, and could function as isolated centers. That just didn’t work in many cases. In a few places it worked, but, in most cases, either a surgeon or medical specialist, or interventionalists, wanted to be dominant. We felt that that is not going to work—that you have to share leadership, you have to share financial rewards, and you have to teach each other without being threatened. And that, of course, is not easy.

MS: Turning toward the creation of the VEITHsymposium and your ideas in developing it—what was lacking in terms of vascular gatherings at that time? What was the niche you were trying to fill with the symposium?

FV: I had great good fortune because the meeting was started as a very small meeting by Dr. Henri Haimovici, who was a prominent vascular surgeon, very academically oriented, and very smart in writing and speaking. It was a tiny meeting. It had maybe 10 or 12 faculty and less than 100 attendees. It was in a fleabag hotel in New York. So when I became chief [at Montefiore], I inherited that meeting. Again, we were lucky. It was in New York, which was easy to get to. We embraced industry from the beginning, which no one else was doing at that time. Coming up with the idea of the short talk—again, good luck, more than good thinking—was so I could get more faculty on the program. And, gradually, we grew to the point where it became a major international vascular meeting. We also embraced—from the very beginning—inter­ventional radiologists and cardiologists because they had a lot to contribute.

MS: One of your other goals for the specialty outlined in your Presidential Address—which I think you have falsely characterized as having failed—was independence for vascular surgery. I think that what I hear from you is you don’t understand how much you actually won, and how different things are than when you start­ed. It is difficult for people of a certain generation to know how subservient we were to general surgery, especially in the 1970s, 80s and 90s ,when we were basically not even a subspecialty of general surgery at times.

FV: We did make some inroads. I mean, we got residencies that were zero and five—vascular surgery residency. But the prob­lem now is in many institutions—and I’ve been in two of them, or maybe three actually, because you can include the Cleveland Clinic—vascular surgery doesn’t [have independence] because it’s not a separate specialty. It doesn’t have a seat at the table where resources are doled out. You have to go through your general sur­gery chairman, or your cardiac surgery chairman, in order to get a sign off on what you want to do—and we really are a separate specialty. We’re certainly as separate as neurosurgery or orthopedic surgery, or gynecology, and, yet, that barrier has not yet been breached. I’m not fighting it anymore, but I think, sooner or later, we have to come into accordance with other countries. Vascular surgery should be a totally separate specialty. Why? Because we sort of are: we don’t do general surgery anymore. We may cover for them, but we really are separate because we’re different. Our techniques are different. And we certainly need the separation from interventional cardiology and interventional radiology that will allow us to compete with them on a level playing field. Because interventional cardiology, who are very talented and very much supported by institutions, outnumber us by about five to one. 

MS: This brings us to the topic of energy. With all of the things you’ve achieved, I think what we all want to know is: where do you get your energy? 

FV: It’s luck and genes. I mean, the two things that you obviously have, and I was greatly fortunate to have, was pretty good health. And if you don’t have your health, you don’t have your energy. If I get tired now, everything sort of stops. So you have to keep at it. That’s your genes and your parents, and you can’t do anything to pick them. And then commitment to want to do stuff that matters. 

MS: The last section of the book is on mentorship. I think I’m probably one of the last American vascular surgeons who you did not train. What do you think is the key to mentoring our trainees? 

FV: Some of it is luck. I always picked people who wanted to go into academics, and then I would beat them unmercifully to publish stuff, and they used to joke about it and belittle me for it. But the other thing is to treat people at all levels well and as equals. You’ve got to pay people well. You split the income pretty much—as bad as that can be in vascular surgery. Sometimes, you split the good cases and you put your trainees as first authors on papers, even though you may end up writing the paper. And, they sort of get the bug. Nobody is going to remember what I did in 10 or 20 years. But hopefully the people that I train know that I helped them get to where they are—that’s a good legacy, because they’ll be around for a long time. It goes against human nature, but you’ve got to be forcefully unselfish. Because, in the end, it comes back to benefit your interest a lot more if you support people than if you exploit them. 

BASIL-2 and BEST-CLI: A tale of two limb trials

BASIL-2 and BEST-CLI: A tale of two limb trials
BASIL-2
Michael S. Conte, MD

Optimal treatment of patients with chronic limb-threatening ischemia (CLTI) has been an ongoing debate within the vascular community, fueled by growing numbers of patients, evolving technologies, provider bias, and a lack of high-quality evidence.

Few randomized controlled trials (RCTs) have focused on this patient population. Now, within a six-month period, the primary results of the long-awaited BEST-CLI and BASIL-2 RCTs have been reported. At the top level, their results seem wholly discordant with respect to limb-based versus survival outcomes. A deeper dive into the designs of these two trials, their populations and outcomes reported to date is needed to interpret their meaning.

The BEST-CLI trial was funded by the U.S. National Heart, Lung and Blood Institute and involved 133 centers in the U.S., 12 in Canada, and five in other countries. It was designed to compare the effectiveness of endovascular intervention versus open bypass surgery among CLTI patients with infrainguinal occlusive disease who were deemed acceptable candidates for either treatment. The study was conducted as two parallel RCTs based on preoperative assessment of an adequate great saphenous vein (GSV) for bypass. The primary endpoint was major adverse limb event (MALE)-free survival, defined in accordance with the published SVS Objective Performance Goals (MALE: major amputation or major reintervention [new open bypass, major open graft revision, thrombectomy or thrombolysis]). A total of 1,434 subjects were randomized in cohort 1 (adequate GSV) and 396 in cohort 2.

Analyzed by intention-to-treat (ITT), patients assigned to open surgery in cohort 1 (median follow-up time 2.7 years) experienced significantly lower rates of MALE or death (32% relative risk [RR]), major amputation (27% RR), any major reintervention (65% RR), and less than half the total number of major reinterventions in the treated limb over time.3 These findings were robust across virtually all pre-defined patient subgroups. In cohort 2, there was no significant difference in the primary endpoint after a median of 1.6 years of follow-up. Importantly, perioperative mortality, long-term survival, and overall major adverse cardiovascular event (MACE) rates were not different by assigned treatment in either cohort. The BEST-CLI investigators concluded that both procedures were equally safe, and that CLTI patients deemed suitable for either approach who had an adequate GSV experienced better overall clinical outcomes after open bypass surgery.

BASIL-2 was funded by the UK National Institute of Health Research and involved 39 centers in the UK, one in Sweden and one in Denmark. It was designed to compare the effectiveness of endovascular intervention versus open bypass with vein among CLTI patients requiring treatment of infrapopliteal (IP) disease, with or without a more proximal infrainguinal intervention. Patients had to be deemed suitable for either procedure, with an anticipated life expectancy of at least six months. The primary endpoint was major amputation-free survival (AFS). Among 345 patients enrolled and followed for a median of 40 months, those assigned to bypass surgery experienced a 35% greater incidence of major amputation or death. This result was driven entirely by excess long-term mortality in the surgical group.

The BASIL-2 investigators concluded that while limb-based outcomes were similar, patients treated by an endovascular-first strategy were more likely to be alive with an intact limb compared to those who underwent surgery first.

What gives with these seemingly opposite results?

Let’s start with similarities between the two RCTs. Both trials were designed to compare revascularization strategies among patients deemed suitable for either, with equipoise determined locally by site investigators. Immediate technical success rates reported for endovascular interventions were strikingly similar (85% in BEST-CLI, 87% in BASIL-2). Approximately 70% of subjects in both trials had diabetes. More than 70% in both trials were treated with an antiplatelet agent, and similar proportions were treated with a statin. Both trials had to deal with the major impacts of a COVID pandemic on healthcare delivery and clinical research. And once again these trials highlight that, despite concerted efforts at guideline-based medical therapy, mortality rates in CLTI approximate 10% or more per year. However, differences in the designs, enrolled populations, treatments received and trial execution are all likely related to the disparate outcomes reported. Key characteristics of the two RCT cohorts, most importantly the anatomic complexity of disease treated, remain incompletely described at this time.

Comparison of the populations is important for understanding both the contrasting results and the generalizability of each trial. BEST- CLI was more than five times the size of BASIL-2 and had broader inclusion criteria. BEST-CLI enrolled more women (28% vs 18%) and more non-white (28% vs. 9%) subjects. The BASIL-2 study population was defined as requiring an IP intervention. In BEST-CLI an IP procedure was performed in just over half of all subjects, and only a minority had treatment of IP disease alone (16% in cohort 1). The severity and management of femoropopliteal disease in BASIL-2 is unclear and likely different from BEST-CLI. Patients in BASIL-2 were older (72 vs. 67 yrs), and, notably, those randomized to open surgery had a higher prevalence of prior MI (24% vs. 13% for the endo arm). Together with the six-month life expectancy entry criterion for BASIL-2, these factors may explain worse long-term survival among surgical patients in BASIL-2. Perioperative mortality after bypass surgery was twice as high in BASIL-2 (6% vs 1.7% in BEST-CLI cohort 1).

Both RCTs were “pragmatic” and, thus, an array of endovascular and open interventions were applied. Befitting the infrapopliteal design of BASIL-2, there were twice as many bypasses originating from the popliteal artery in BASIL-2 (41%) versus cohort 1 of BEST-CLI (16%). Data reported to date on endovascular devices and techniques are hard to compare but plain balloon angioplasty was the most common procedure below the knee in both trials. In BEST-CLI, vascular surgeons performed 73% of endovascular interventions, compared to BASIL-2 where interventional radiologists performed 84%. These differences reflect the healthcare systems of the United Kingdom and U.S. in relation to vascular care.

AFS is an important outcome in CLTI but is dominated by mortality rather than limb events, and does not reflect the burden of reinterventions and unresolved or recurrent symptoms that are experienced. As such, it is an insensitive measure of the quality of limb revascularization. Just as in coronary disease RCTs, need for repeat revascularizations and other major limb events are highly relevant to compare treatment strategies. BASIL-2 was likely quite underpowered for limb-specific outcomes, a problem amplified by extending follow-up time rather than enrolling more new subjects to reach a targeted number of events, since most MALEs occur within the first year. Reinterventions in CLTI are largely driven by ongoing symptoms during follow-up surveillance.

The impacts of the COVID-19 pandemic on healthcare delivery and trial execution in these trials were likely disparate. BASIL-2 investigators noted that face-to-face follow-up assessments were substantially affected after March 2020. In looking at some of the published top-line results, major amputation rates were higher in both arms of BASIL-2 (20% open and 18% endo vs. 10.4% and 14.9%, respectively, in BEST-CLI cohort 1); reintervention rates were lower in the endovascular arm of BASIL-2 (32% vs. 43% in BEST-CLI cohort 1); and mortality after open bypass was significantly worse in BASIL-2. It is presently unclear if these differences between study outcomes reflect the patients enrolled, the care delivered, or both.

All RCTs have limitations of which generalizability is paramount. CLTI patients are heterogeneous in systemic risk, severity of limb threat, and anatomic complexity of occlusive disease. The “endo-first vs. open-first” debate is and has always been an oversimplification, and a disservice to this clinical complexity. The results of BEST-CLI clearly demonstrate advantages of surgical bypass in a subset of CLTI patients. To better understand the relative effectiveness of these complementary strategies, trials and registries need to incorporate staging such as WIfI (Wound, ischemia and foot infection) and GLASS (Global Limb Anatomic Staging System) in their design and reporting. We anticipate much further and more granular data in regard to important patient subsets in these trials, as well as secondary endpoints and economic analyses. It remains for the trial investigators to further unravel the puzzle by comparing like-to-like patients and identifying predictive factors for outcomes. The good news is that we now have a large trove of high-quality data in CLTI from these two RCTs, thanks to the great efforts of the investigators, the sponsors, and most importantly the patients who volunteered to participate. These data will undoubtedly advance evidence-based practice in CLTI and improve future study designs in this arena.

Michael S. Conte is Edwin J. Wylie, MD, Chair in Vascular Surgery at the University of California San Francisco (UCSF).

VAM 2023 beckons

VAM 2023 beckons

Our annual gathering is almost here. After months of planning, our premiere educational event in vascular surgery, the Vascular Annual Meeting (VAM), opens June 14. Every president before me has said nothing can top this year’s event—and yet, somehow, year after year, we do. This year is no exception, writes SVS President Michael C. Dalsing, MD.

VAM 2023 is finally here, months of planning and hard work are almost complete. The Program Committee, headed by Andres Schanzer, MD, and the Postgraduate Education Committee, with Will Robinson, MD, at the helm, have put in countless hours selecting top-notch abstracts and developing clinical and non-clinical educational sessions for your knowledge and inspiration. Diversity, equity and inclusion (DEI) topics are incorporated into each session to highlight discussion within the very fabric of the meeting.

From talking with both Schanzer and Robinson, I know that each and every attendee will be able to leave VAM with information they can use immediately in their practices and/or careers. It could take the form of research results, how-tos on performing particular procedures, thoughts on the road to retirement or practice management tips and tricks. We once again have sessions for a variety of career stages and interests. Each SVS membership section and subsection—physician assistants, women, young surgeons, those in community practice and those operating in an office-based lab—is hosting sessions of particular interest to the section members. Plus:

  • Special sessions aimed at international members
  • Our always-interesting E. Stanley Crawford Critical Issues Forum, this year on the vascular surgery workforce pipeline
  • A session on transitioning to retirement
  • Maximizing various facets of vascular care in attendees’ practices
  • Events for medical students and residents
  • The inaugural Frank J. Veith Distinguished Lecture, named for our former president, and to focus on limb salvage
  • A special session on the results of two landmark clinical trials: BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischemia) and BASIL-2 (Bypass versus angioplasty in severe ischemia of the leg)
  • Sessions covering the full range of vascular disease 
  • A career fair for anyone who is contemplating a change of direction 
  • Collaboration with both the Society for Vascular Nursing (SVN) and the Vascular Quality Initiative (VQI), also both holding their annual meetings during VAM 2023 

In addition, we’ve added a family-friendly event for Wednesday evening, SVS Connect: Building Community, for people to get together, renew old acquaintances and meet new colleagues. We have also arranged a Celebration of Diversity Reception on Thursday. 

And, in a change from past years, the last presentation in every plenary session will feature a video on a particular procedure or repair. 

There’s so much more on the schedule than I can mention here. For information on the full VAM 2023 lineup, visit vascular.org/OnlinePlanner23. 

And I hope to see many of you in National Harbor, Maryland, next month. 

Yours, 

Michael C. Dalsing, MD  

SVS President 

FDA seeks to ‘modernize’ clinical trials with new draft guidance

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FDA seeks to ‘modernize’ clinical trials with new draft guidance
FDA
New draft guidance for clinical trials has been issued by the FDA

The Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials.

In a statement, the regulator said that the updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products, with an aim to be “more agile without compromising data integrity or participant protections”.

The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.

“A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” said FDA commissioner Robert M Califf, MD. “These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”

GCPs ensure the safety of trial participants, as well as the integrity of the data generated from trials. Over the years, the clinical trial enterprise has been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilization of technology, data sources and innovations in design and conduct. The COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches, FDA’s statement adds.

“These draft recommendations were developed with the aim to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve,” said M Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy. “We hope these recommendations, once finalised, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”

ElZarrad led the ICH Expert Working Group in developing the ICH E6(R3) draft guideline. Academic clinical trial experts from various ICH member countries also played an important role in informing the work of the expert group.

This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements.

The draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalising the ICH guideline.

‘Sonolysis is back’ after safely reducing endarterectomy stroke risk in randomized trial

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‘Sonolysis is back’ after safely reducing endarterectomy stroke risk in randomized trial
David Školoudík presenting at ESOC 2023

Positive results from a clinical trial involving a novel therapeutic procedure known as sonolysis—deployed during a carotid endarterectomy (CEA)—were presented at the recent European Stroke Organisation Conference (ESOC; 24–26 May, Munich, Germany).

“The randomised clinical trial confirmed the results of pilot studies that sonolysis using diagnostic 2-MHz probe is safe and significantly reduces the risk of stroke, transient ischaemic attack [TIA], and silent brain infarctions detected using brain MRI [magnetic resonance imaging],” said David Školoudík (University of Ostrava, Ostrava, Czech Republic), principal investigator for SONOBIRDIE—the trial in question. “In clinical practice, this could mean not only an increase in the safety of CEA, but also an expansion of indications for this procedure.”

As an ESO press release details, CEA is a well-established approach in the treatment of carotid artery stenosis, but carries stroke risks both during and immediately after the procedure that are “not negligible”, meaning methods for reducing said risks are needed.

Transcranial Doppler (TCD), which uses ultrasound beams with a specific frequency, is a non-invasive procedure that has been shown to have some potential effect on accelerating spontaneous or induced reopening of otherwise occluded arteries. In the multicentre, randomised, double-blinded, sham-controlled SONOBIRDIE trial, this novel therapeutic approach—also referred to as sonolysis—was evaluated for safety and effectiveness in reducing risks of stroke, mini-stroke or any infarction detected on brain imaging during CEA.

Patients from 16 European centres were recruited between 2015 and 2022. All of these patients had severe internal carotid artery stenosis (≥70%) with a clinical indication for CEA and were aged 40–85 years. They were randomised either to sonolysis or to a sham procedure. Neurological exams and MRI were performed both before and after CEA to detect any stroke, TIA or death within 30 days. Overall, the study recruited 1,004 patients with a mean age of 68 years, 31% of whom were women.

According to Školoudík, members of the SONOBIRDIE data and safety monitoring board “unanimously recommended” stopping the trial early due to “clear evidence” of effectiveness in November 2020—at which point 507 patients had been randomised to the sonolysis group and 497 had been randomised to sham treatment.

As per interim analyses, the investigators found that sonolysis during CEA was associated with a “significant reduction” in risks of stroke, TIA or death at 30 days, with rates of this composite primary endpoint being 2.2% in the sonolysis group versus 7.6% in the sham treatment group. The same trend was seen for both symptomatic strokes (1.8% vs 7.5%) and new ischaemic lesions on MRI (8.6% vs 17.4%), Školoudík also detailed.

Multivariate analyses presented by Školoudík revealed that female gender appeared to be the only baseline characteristic associated with an increased risk of a negative outcome with sonolysis, while atrial fibrillation and anticoagulation were not linked to a significant difference between the two groups (sonolysis and sham treatment).

The concluding finding of SONOBIRDIE—the fact that periprocedural stroke and TIA risks were safely and effectively reduced in the trial using a diagnostic 2-MHz probe—led ESOC session moderator Carlos Molina (Vall d’Hebron Hospital, Barcelona, Spain) to remark that “sonolysis is back”.

The results drew similarly positive comments on social media, with Ashkan Shoamanesh (McMaster University, Hamilton, Canada) quipping: “sonolysis re-emerges from the ashes with the SONOBIRDIE trial meeting its primary outcome […]”. On Twitter, Zoi Netou-Kandylidou (Accident Hospital Berlin, Berlin, Germany) echoed Molina’s sentiment that ‘sonolysis is back’, adding: “fans of ultrasound, rejoice”.

The top 10 most popular Vascular Specialist stories of May 2023

The top 10 most popular Vascular Specialist stories of May 2023

Last month, Vascular Specialist most piqued reader interest with a commentary from the editor-in-chief on why he supports the decision by the Southern Association for Vascular Surgery (SAVS) to replace its emblem; a guest editorial examining whether physicians nowadays can experience both a sense of wellness and purpose in their profession; news from a UK vascular meeting where delegates heard of the optics challenges venous disease is up against; and a report of a newly published ‘biopsychosocial roadmap’ for peripheral arterial disease (PAD) treatment.

1. A vascular mission: Defying assumptions in the fight against amputation in disadvantaged areas

Lyssa Ochoa, MD, is the founding vascular surgeon behind the SAVE Clinic in San Antonio, geared in its entirety towards targeting the Texas city’s most socially and economically disadvantaged areas against the backdrop of some of the state’s most eye-watering rates of diabetes-related amputation. She answers some of Vascular Specialist’s questions.

2. We can honor the past without living in it

Malachi Sheahan III, MD, peels back the layers on why a decision by the SAVS to replace its signature emblem is the right one.

3. Happiness, well-being and culture are key ingredients for seeking ‘eudaimonia’

“Practicing medicine is certainly a ‘purpose’, but the quest for ‘deep wellness’ has been lost over time and instead we are left with burnout […] What does this mean for the modern physician, particularly for those employed by large organizations or groups?”—Bhagwan Satiani, MD, examines this question.

4. Reinterventions after physician-modified endovascular grafts ‘non-detrimental’ to long-term survival

For the treatment of juxtarenal aortic aneurysms, reinterventions after physician-modified endovascular grafts are non-detrimental to long-term survival. This is one of the main findings of a recently published study by Ayumi Tachida (University of Washington School of Medicine, Seattle, USA) and colleagues.

5. CX 2023: Venous, we have a perception problem

Venous disease care has a problem with optics in the context of growth in the number of venous procedures and the spectre of inappropriate care, the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) heard.

6. New ‘biopsychosocial’ roadmap set out to address PAD treatment and mental health impacts

Published in the Journal of The American College of Cardiology, researchers have put forward a “biopsychosocial” PAD management roadmap, offering solutions to current care “obstacles” to better attend to both behavioral and social health needs throughout vascular treatment.

7. Interim data find ‘no evidence of benefit’ for carotid revascularization additional to optimized medical therapy

Interim results from the ECST-2 randomized controlled trial (RCT) have shown no evidence that carotid stenosis patients with a low-to-intermediate stroke risk, treated with optimized medical therapy, will benefit from additional carotid revascularization via carotid endarterectomy (CEA) or carotid artery stenting (CAS).

8. Letter to the editor: The virtue of a social media presence for surgeons in the internet era

Vincent Noori, MD, shares why he “[believes] we are fortunate to have a social media presence in the internet era, where surgeons can still stay connected and learn from each other in an ever-evolving field, despite being miles apart”.

9. Primary patency after venous stenting best in NIVL patients, study finds

A recent study concludes that non-thrombotic iliac vein lesion (NIVL) patients have better primary patency after venous stenting than patients with venous thrombotic disorders.

10. Cook Medical treats first patient in first-in-human clinical trial for venous valve

Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency.

Vascular surgery moves to assess trainees’ competence with EPAs

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Vascular surgery moves to assess trainees’ competence with EPAs
Brigitte Smith

For surgeons, “EPA” means not the “Environmental Protection Agency” but “Entrustable Professional Activity”—and they’re going to change surgery training. A pilot rollout for vascular surgeons will begin in select centers in the fall with Vascular Surgery Board (VSB) implementation expected to begin in July 2024. 

The American Board of Surgery (ABS) announced the move to competency-based assessment of surgical trainees in February 2022, introducing the ABS EPA Project. The project for general surgery residency programs, for instance, is set to launch in July. 

It’s a slightly different version of the Norwegian concept of “entrustment” as a “core way of thinking about when a healthcare professional is ready to be unsupervised,” Brigitte Smith, MD, tells Vascular Specialist. 

Smith, associate professor of vascular surgery and program director for the vascular surgery fellowship at the University of Utah in Salt Lake City, is leading work to develop the concept of an EPA program for the Association of Program Directors in Vascular Surgery (APDVS). APDVS directors reviewed the program and discussed pilot site recruitment at the APDVS Spring Meeting in March. 

Smith said supervisors generally assess performance in terms of medical knowledge, test scores, technical skills and a numerical threshold of procedures and/or years of training. 

However, more than 20 years ago, from Europe came the idea of assessing trainees thusly, said Smith: “Do I trust you to do this task independently or do you still need supervision?” It provides a more holistic and intuitive workplace-based assessment to assure graduates are ready to treat patients. 

Physicians frequently do this with trainees, she said. “Without really thinking about it, they make a judgment about whether trainees can do a consult by themselves, whether they can be left in the operating room (OR). You can think of it as, ‘Are they ready to do things by themselves?’” 

EPA development for vascular surgery began nearly two years ago, in June 2021. The VSB of the ABS and the APDVS hope to launch a pilot of approximately 20 programs this fall, which will give developers a chance to identify hiccups and refine the program as it evolves. 

Vascular surgery’s EPAs will include proficiency in 15 observable areas of work as the minimum bar for trainees before they would be entrusted to work on their own before graduating from residency or fellowship, Smith said. 

“It’s the absolute floor, or minimum bar to complete training and practice vascular surgery,” she said. General surgery, meanwhile, includes 18 EPAs. According to the ABS, each EPA includes a description, essential functions, scope and expected behaviors. The Board has created entrustment scales to assess EPAs as follows: 

  • Limited participation 
  • Direct supervision 
  • Indirect supervision 
  • Practice ready 

Smith said she foresees hesitance to change a system many perceive is working, and that the “I walked uphill in the snow both ways” adage applies to medicine. Some physicians may think, “I was fine; I was ready to operate; ergo our system is fine, it’s not broken, don’t fix it.” 

However, medicine has changed dramatically in even the past decade, with an older population that is living longer and experiencing more complicated health problems, and hospital systems focused on length of stay. 

“The learner 20, 30 years ago wasn’t being pushed for a quick discharge; he or she could treat the same patient for a longer period of time, could order blood work and other procedures to figure things out,” she said. “The attention on cost, efficiency, and safety that’s prominent now, and important, has nonetheless changed the experience for trainees. They don’t operate by themselves as much.” 

Assessments should change to meet changing circumstances, she said. “We need to be accountable to the public that trainees can meet this minimum bar of competence. At the same time, trainees will have a definitive set of expectations to work toward.” 

EPAs attempt to address this need. “Holistically, can we trust this person to care for patients with aortic aneurysm disease? Can we trust them to see the patient, work them up, consider the whole range of care, deliver care and operate?” notes Smith. 

The ABS is partnering with the Society for Improving Medical Professional Learning (SIMPL) to create the technology platform for the EPA project, including the mobile platform, data storage and reporting structures. “We’re trying to make it really user-friendly so there’s no reason not to do these,” Smith said. 

Currently, assessment typically takes place potentially quite a bit after interactions with trainees. 

“The idea with the EPA is that the supervisor is on the app and completing the assessment within 72 hours of the interaction,” Smith explained. “As soon as the resident is done with the consult, you do the EPA. It’s less prone to recall bias and more accurate.” 

Increased frequency of assessment will mean a larger dataset—data assessment points that happened in real time—that will help with judgments on a trainee’s competencies and also help program directors refine the system, she said. 

An unknown is what happens if a trainee isn’t ready. Smith estimated that maybe just a small percentage of trainees would not be ready “on time” and perhaps need a few more months of focused training in a particular area. That, in turn, brings on such questions as who will pay the trainee’s salary in the event of extended training. 

“Overall, I’d say the vast majority of people will finish on time. Some will be ready early,” she said. “If they’re not, it will be focused remediation and support to ensure competence.” 

But making sure trainees are patient-ready is the important point, she added. To be sure, patient safety is the fundamental focus. 

Nobody likes change, she acknowledged. And most people perceive this new system as being more work and want to know what existing evaluations can be jettisoned. 

“Hopefully this will take the place of a few things over time, such as end-of-rotation evaluations” Smith said. 

“But ultimately, we owe it to our patients to assure them that before trainees leave the supervised environment to treat patients independently, they’ve demonstrated and we’ve documented competence.” 

Vascular Specialist–June 2023 VAM special

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Vascular Specialist–June 2023 VAM special

In this VAM 2023 preview issue:

  • The Vascular Annual Meeting (VAM) beckons: “Our annual gathering is almost here. After months of planning, our premiere educational event in vascular surgery opens June 14,” writes SVS President Michael C. Dalsing, MD (p. 1 and 14)
  • BASIL-2 and BEST-CLI: A tale of two limb trials: Michael S. Conte, MD, opines in an invited commentary piece (p. 1 and 4)
  • Vascular surgery moves to assess trainee competence with Entrustable Professional Activities (EPAs) (p. 1 and 8)
  • The Big Interview: Frank J. Veith, MD, goes in-depth in conversation with Malachi Sheahan III, MD, about his book ahead of an inaugural VAM lecture named in his honor (p. 11)

 

Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit

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Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit
Mazin Foteh

This advertorial is sponsored by Shockwave Medical.

Mazin Foteh, MD, contrasts the benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy Catheter alongside those of its sister device, the Shockwave M5+ Peripheral Intravascular Lithotripsy Catheter.

The Shockwave L6 device is a purpose-built IVL catheter, perfectly designed for complex iliac occlusive disease. Calcified plaque blockages in this region are distinctly different from lesions elsewhere in the arterial system. These are much larger blood vessels, which are often thick and heterogeneously calcified. Although the Shockwave M5+ IVL catheter was instrumental in introducing this technology to an underserved space, in some scenarios it lacked the size and energy profile to compete with this degree of calcium. The most important feature of the Shockwave L6 catheter is its larger diameter offerings (8, 9, 10 and 12mm). 

Today, we can appropriately match the Shockwave balloon catheter to the vessel and optimize outcomes. Secondly, the compact emitter placement is instrumental in providing a uniform energy profile across the length of the balloon. There are a total of three paired emitters, which fire in groupings of two. This translates to consistent sonic output without diminishment at the ends. 

The Shockwave M5+, on the other hand, delivers peak pressure at the center electrode. In practice this equates to improved case efficiency, as we are no longer trying to center the electrode at the most dense area of plaque. Finally, all of the Shockwave L6 catheters can be delivered over an 0.018” wire and in 7/8F sizes. Tracking over a larger wire removes resistance and sets a platform for additional therapies such as stents. 

To date, the endovascular treatments for calcified iliac plaques have centered on the “crack and pave” technique, which harnesses barotrauma as the mechanism of action. The Shockwave L6 catheter allows a rethinking of this method, now relying purely on low-pressure inflations and the delivery of sonic pressure waves to the hardened calcium. 

This results in a much gentler, worry-free technique, causing calcified lesions to yield in a manner that is without the risk of rupture. Additionally, if stenting is necessary, we can rest assured that optimal luminal gain can be achieved. This particular arterial bed is very frequently laden with calcium deposits, therefore the need for new techniques is present. 

Shockwave’s new IVL catheter

The Shockwave L6 catheter is the first technology to address this need and may one day challenge the notion that all iliac blockages require a stent. My practice is centered around large-bore devices for endovascular aneurysm repair (EVAR), thoracic EVAR (TEVAR), and fenestrated EVAR (FEVAR). Iliac stenosis and poor access are quite common in this population. 

Prior to the Shockwave L6, we were forced to create a runway for delivery. This meant advanced and expensive techniques such as endovascular and open surgical conduits. These procedures can add cost, but also morbidity. I can now successfully treat most iliac lesions in this setting with the Shockwave L6 alone. 

The Shockwave M5+ was an excellent precursor to the Shockwave L6 catheter. Its longer length certainly provided a nice platform to treat multi-segment disease, especially in the external iliac as well as the fem-pop distribution. However, its energy profile differs greatly from the Shockwave L6, with the maximal energy coming from the center electrode. This feature affects the way the balloon is used, generally requiring significant overlap of the inflations and sometimes even trying to center the middle emitter on the peak plaque. 

Furthermore, it is somewhat limited in its applicability in larger vessels, simply based on the balloon size. I find that for medium-sized vessels with moderate calcium burden that this balloon is favored. Whereas for focal, dense plaque in larger vessels, the Shockwave L6 is the catheter of choice. My experience with this system has taught me that appropriate balloon sizing is the single-most important predictor of a successful outcome. 

Case 1: The Shockwave L6 device in the setting of FEVAR and complex iliac stenosis 

An 82-year-old man with a history of coronary artery disease (CAD), hypertension, hyperlipidemia, and peripheral arterial disease (PAD) presents with rest pain as well as a large pararenal abdominal aortic aneurysm (AAA). 

His computed tomography angiography (CTA) revealed very dense and highly diseased iliac vessels with calcium deposition along most of the bilateral common iliac distribution. 

The minimum luminal diameter (MLD) of the common iliac arteries measured roughly 4.5mm; however, the healthy reference vessel diameter (RVD) was 9.5mm. He would require a fenestrated repair of the AAA along with complex iliac stenosis treatment, and extensive bilateral common femoral endarterectomies. 

Further, we were concerned we would not be able to advance the 19F fenestrated graft. The endograft was prepared, and then both femoral arteries were exposed. We attempted delivery of the endograft via the right common iliac access. This failed. We then attempted delivery on the contralateral side. Despite multiple attempts, we made little progress. A 10x30mm Shockwave L6 catheter was selected, and a total of 150 pulses were delivered to each iliac artery at just 4atm. This not only allowed for the delivery of our FEVAR graft but also the full unrestricted expansion of the endograft limbs in the common iliac arteries. 

At the completion of the AAA, we took extra time to perform endarterectomies of the deep femoral arteries. His completion CT scan revealed a good seal of the AAA, patency of the renal fenestrations and unrestricted flow to the bilateral femoral arteries.

Case 2: The Shockwave M5+ tackles 90% stenosis of the distal SFA 

The patient is a 75-year-old man with a history of hypertension, hyperlipidemia, CAD, chronic kidney disease and diabetes mellitus, who presents with a non-healing wound of the right lower extremity for three months. 

He had undergone diagnostic work—his ankle-brachial index (ABI) was found to be 0.73 with a toe pressure of 50mmhg, and a duplex ultrasound revealed a densely calcified superficial femoral artery (SFA) stenosis of 90%. 

He was taken to the cath lab and underwent a right lower-extremity arteriogram. This confirmed a 90% stenosis of the distal SFA, with normal three-vessel run off. 

Due to the heavy calcium, we opted for a Shockwave M5+ 6x60mm and delivered 200 pulses to the lesion. There was no appreciable residual stenosis at the completion of the procedure, and his post-procedure ABI improved to 1. 

This is a great example of how IVL can be used as a standalone therapy without the need for adjunctive treatment. 

Mazin Foteh is director of aortic therapy and innovation and co-director of the Aortic Clinic at Baylor Scott & White Health in Plano, Texas. He is a paid consultant to Shockwave Medical. The views expressed are those of the author and not necessarily those of Shockwave Medical. 

Shockwave M5+, Shockwave M5, Shockwave S4 and Shockwave L6 Safety Information In the United States: Rx only. Indications for Use—The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature. 

Contraindications—Do not use if unable to pass 0.014” (M5, M5+, S4) or 0.018” (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries. 

Warnings—Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the device—Use the generator in accordance with recommended settings as stated in the Operator’s Manual. 

Precautions—use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician—Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. 

Adverse effects–Possible adverse effects consistent with standard angioplasty include–Access site complications –Allergy to contrast or blood thinner– Arterial bypass surgery—Bleeding complications— Death—Fracture of guidewire or device—Hypertension/Hypotension—Infection/sepsis—Placement of a stent—renal failure—Shock/pulmonary edema—target vessel stenosis or occlusion—Vascular complications. Risks unique to the device and its use—Allergy to catheter material(s)— Device malfunction or failure—Excess heat at target site. 

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com. SPL-68917 Rev. A. 

SVS Foundation announces 2023 student fellowship awards

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SVS Foundation announces 2023 student fellowship awards

The Society for Vascular Surgery (SVS) Foundation has announced the winners of the 2023 Student Research Fellowship Awards.

The award is for undergraduate college and medical school students registered at universities in the United States and Canada. Its intent is to introduce the student to the application of rigorous scientific methods to clinical problems and underlying biologic processes important to patients with vascular disease.

Michelle Bach, University of Texas at Austin Dell Medical School
Sponsor: Pedro Teixeira, MD
Project Title: “Amplify amputees: Health literacy and patient reported outcomes and clinical outcomes in non-traumatic major lower limb amputees”

Christian Barksdale, Medical University of South Carolina
Sponsor: Jean Marie Ruddy, MD
Project Title: “Defining the mechanosensitive threshold of serum and glucocorticoid inducible kinase-1 (SGK-1) in the murine abdominal aorta”

Nitishkumar Bhatt, Toronto General Hospital, University Health Network
Sponsor: Kathryn Howe, MD
Project Title: “Automated and interpretable deep learning for carotid plaque analysis using ultrasound”

Emely Tatiana Carmona, University of Pittsburgh
Sponsor: Nathan L. Liang, MD
Project Title: “Association between patient neighborhood deprivation index, long-term mortality outcomes, and loss to long-term follow-up after an elective abdominal aortic aneurism repair”

Haley Cirka, University of Massachusetts Chan Medical School
Sponsor: Tammy Nguyen, MD
Project Title: “The effect of type-2 diabetes on macrophage differentiation in non-healing diabetic foot ulcers”

Aria Harding, University of Florida College of Medicine, North Florida/ South Georgia VAMC
Sponsor: Scott T. Robinson, MD
Project Title: “The impact of e-cigarette exposure on skeletal muscle function in peripheral arterial disease”

April Huang, University of Califorinia San Francisco
Sponsor: Adam Oskowitz, MD
Project Title: “Immune cell profiling in photodynamic therapy: A novel treatment for abdominal aortic aneurysm”

Baqir Jamal Kedwai, University of Rochester Medical Center
Sponsor: Doran Mix, MD
Project Title: Determination of the Natural History of Aortic Dissection Tissue Mechanics using Non-invasive Elastography

Junsung Kim, University of Chicago
Sponsor: Luka Pocivavsek, MD
Project Title: “Using machine learning to predict post-EVAR complications from aortic shape”

Hong Quang Le, University of Virginia
Sponsor: K. Craig Kent, MD
Project Title: “The therapeutic implications of methionine restriction in post-thrombotic syndrome through attenuation of vein wall fibrosis and inflammation post-deep vein thrombosis”

Renxi Li, The George Washington University
Sponsor: Bao-Ngoc Nguyen, MD
Project Title: A comprehensive guide to the angiogenic niche during early acute skin inflammation using single-cell RNA sequencing

Max Zhu, Boston University Chobanian and Avedisian School of Medicine
Sponsor: Jeffrey J. Siracuse, MD
Project Title: “The impact of neighborhood social disadvantage on presentation and management of first-time hemodialysis access surgery patients”

SVS webinar discusses BEST-CLI and early impacts on practice

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SVS webinar discusses BEST-CLI and early impacts on practice

A recording of the inaugural “SVS Presents” virtual educational session, on the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial and its effect on vascular surgery, is now available.

More than 150 people joined the webcast, which discussed the results from BEST-CLI. The trial aimed to pinpoint the best treatment for patients with peripher­al arterial disease (PAD) associated with CLI, or chronic limb-threatening ischemia (CLTI); the webcast also dove into what the results mean for the vascular surgery community.

Trial principal investigators, and SVS members Alik Farber, MD, and Matthew Menard, MD, took part. Caitlin Hicks, MD, and Vincent Rowe, MD, moderated. Polling on two questions took place before the webcast, with 81 attendees responding. Surgeons reported on their paradigm for treating CLTI prior to the trial results and whether the results have since changed their practices. Approximately 46% of the respondents reported they performed endovascular therapy first prior to publication of BEST-CLI, while 6% reported they performed open revas­cularization first. Some 68% reported that the decision depended on other patient factors, and 75% reported that they performed open revascu­larization first if an appropriate great saphenous vein (GSV) conduit were available.

Trial results showed surgical bypass with adequate single-segment GSV is a more effective revasculariza­tion strategy for a patient with CLTI who are deemed to be suitable for either an open surgical or endovas­cular approach. They also found that both strategies are safe and effective.

When asked if the BEST-CLI trial results have changed their prac­tices, 28% of respondents replied that they had, 31% said that they hadn’t, and 41% said their decision was pending.

At the conclusion of the webinar, attendees were re-polled about the changing landscape of CLTI care. The majority (61%) of respondents reported “more patients will receive open surgery” based on the results of the trial, 4% reported endovas­cular interventions will take over as first-line therapy despite the trial results, and 35% reported there would be no major changes.

Visit svsondemand.vascular.org to view the recording.

Interim data find ‘no evidence of benefit’ for carotid revascularization additional to optimized medical therapy

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Interim data find ‘no evidence of benefit’ for carotid revascularization additional to optimized medical therapy
Paul Nederkoorn presenting at ESOC 2023

Interim results from the ECST-2 randomized controlled trial (RCT) have shown no evidence that carotid stenosis patients with a low-to-intermediate stroke risk, treated with optimized medical therapy, will benefit from additional carotid revascularization via carotid endarterectomy (CEA) or carotid artery stenting (CAS).

Nevertheless, Paul Nederkoorn (Amsterdam UMC, Amsterdam, The Netherlands)—who presented these late-breaking findings at the European Stroke Organisation Conference (ESOC; 24–26 May, Munich, Germany)—noted that a longer clinical follow-up is now required. The aforementioned interim results were observed at two years, with ECST-2 set to continue following patients for a total of five years.

In an attempt to provide an update to the original European carotid surgery trial (ECST), which was published in the late 1990s and found CEA to be effective in symptomatic patients with carotid stenosis >80%, ECST-2 hypothesized that there would be no benefit from additional carotid revascularization alongside optimized medical therapy in patients who have carotid stenosis ≥50% and a low-to-intermediate risk of stroke. Nederkoorn stated during his presentation that, in the decades following the ECST and NASCET RCTs, medical management—the comparator in both trials—has improved “significantly”.

ECST-2 was designed as a multicenter, prospective RCT with blinded-outcome adjudication, and saw patients randomized to either immediate carotid revascularization plus optimized medical therapy or optimized medical therapy alone. Patients were considered eligible if they had an asymptomatic or symptomatic carotid stenosis ≥50% and an estimated five-year stroke risk <20%, calculated using the Carotid Artery Risk (CAR) score. Recruitment was halted after the inclusion of 428 patients, Nederkoorn reported.

For the composite endpoint defined for these interim results—the two-year rate of any stroke, myocardial infarction (MI) or periprocedural death—Nederkoorn and colleagues found a hazard ratio of 0.96 with optimized medical therapy alone in comparison to optimized medical therapy plus revascularization (95% confidence interval [CI] 0.53–1.76). The speaker noted that there was “a sign of more harm” initially with revascularization, signified by a higher rate of stroke, MI or periprocedural death in the first few months following randomization, but that these rates converged later on and Kaplan-Meier analyses ultimately showed no significant difference between the two groups at 24 months.

While the numbers involved were “very small, precluding valid conclusions,” Nederkoorn reported no differences across any of the predefined subgroups in ECST-2—including between symptomatic and asymptomatic stenoses. There was, however, a slight trend towards optimized medical therapy being associated with a greater treatment effect in patients with an increased risk of ipsilateral stroke (CAR score >10%).

From this interim analysis of the ECST-2 intention-to-treat population, the investigators concluded that there is no evidence patients with stenosis ≥50% and a low-to-intermediate stroke risk will benefit from carotid revascularization in addition to optimized medical therapy.

As well as emphasizing that, despite this finding, further follow-up is both warranted and planned in ECST-2, Nederkoorn stated that a complete, two-year analysis including evaluations of silent infarcts on magnetic resonance imaging (MRI) is now scheduled too. Also, the results of an MR plaque-imaging substudy from ECST-2 will soon be available, which Nederkoorn said is a “crucial tool” within a novel prediction rule that is still to be designed but may elucidate future stroke risks and treatment decisions in this domain of patients.

A subsequent discussion at ESOC 2023 saw Seemant Chaturvedi (University of Maryland School of Medicine, Baltimore, USA) posit that the medical therapy given in the trial’s comparator arm could have been optimized “even further” in accordance with some current guideline recommendations, potentially improving that group’s outcomes to a still-greater extent—a point that Nederkoorn agreed with.

FLAME, FLASH and ongoing PEERLESS trials collect ‘compelling’ data for FlowTriever device

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FLAME, FLASH and ongoing PEERLESS trials collect ‘compelling’ data for FlowTriever device
FlowTriever thrombectomy device
FlowTriever thrombectomy device

Speaking on the FLAME, FLASH and PEERLESS trials that each collected data on the FlowTriever (Inari Medical) device for the treatment of pulmonary embolism (PE), Ripal Gandhi, MD, Miami Cardiac & Vascular Institute & Miami Cancer Institute, Miami, elaborated on the presiding safety and efficacy that is consistent throughout the research, and how these studies may shape future guidelines to better standardize the PE care pathway for physicians and patients.

Presenting at the 2023 International Vein Conference (April 27–29, Miami), Gandhi began by foregrounding the central focus of this work, stating that PE is the third leading cause of cardiovascular death worldwide, which often renders anticoagulation insufficient for patients with intermediate- or high-risk PE and/or long-term complications. Although several thrombotic therapies are known to be effective, Gandhi noted that there is a risk of bleeding, meaning not all patients are deemed eligible. As a knock-on effect of this, more devices have been brought to market to treat these patients, such as the FlowTriever device.

Speaking to Vascular Specialist about his presentation at IVC, Gandhi briefly discussed the main aims of the three studies and their results. First concerning the FLAME trial—the largest interventional trial done in high-risk PE patients  Gandhi noted—he explained that the study was intended to enroll more participants but was concluded early after meeting the prespecified interim analysis criterion.

Principal investigator for the FLAME trial James Horowitz, MD, NYU Grossman School of Medicine, New York, and his team found that large-bore mechanical thrombectomy with the FlowTriever system in patients with high-risk PE was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments. In the FlowTriever arm, a mortality rate of 1.9% was recorded, compared to 29.5% in the context arm.

“It had to be [concluded prematurely]—the study was stopped at 50 patients because the results were so compelling. With the 17% endpoint in the FlowTriever arm versus 63.9% in the context arm, this was lower than the performance goal of 32%—much lower”, said Gandhi, commenting on FLAME’s results.

Turning his attention to the FLASH registry—the “largest interventional study ever done in PE”—  Gandhi explained how the analysis drew from an 800-patient, prospective, multicenter, real-world registry. Led by Caitlin Toma, MD, University of Pittsburgh School of Medicine, Pittsburgh, the researchers’ main objective was to assess the safety and effectiveness of large-bore thrombectomy in an all-comer patient population through to six months.

Their primary endpoints were defined as any composite of major adverse events (MAE) within 48 hours. Their results showed a 1.8% MAE rate, with no device-related deaths. “This was quite remarkable,” Gandhi opined. “However, one of the most important things to look at is all-cause mortality at 30 days in this patient population, which was only 0.8%.”

“[In the FLASH registry] most of the patients did not require an intensive care unit day—as an interventionist the thing that is most gratifying when treating a patient who is very sick, is seeing immediate changes in their hemodynamic parameters on the table,” Gandhi described. “In treating patients with large bore thrombectomy, we see immediate changes in pulmonary artery pressures, improvement in their cardiac index and heart rate, and to see that in real-time is quite remarkable. It is extremely valuable.”

Briefly sketching out the intent for the currently ongoing PEERLESS trial, led by Wissam Jaber, MD, Emory University, Atlanta and Carin Gonsalves, MD, Thomas Jefferson University, Philadelphia, Gandhi averred that it is the “first and only” head-to-head randomized clinical trial comparing large-bore thrombectomy—via the FlowTriever system—with catheter-directed thrombolysis in PE patients.

“We happen to be one of the enrolling sites,” Gandhi said, noting that enrolment is currently at its halfway point. “[PEERLESS] is one of several randomized clinical trials that are being done in this space right now and this is an important one, however we definitely need more research.”

Amongst the research emerging for the treatment of PE, Gandhi makes clear that better standardized care pathways are the “goal”, although it will not “happen overnight”. “In most of our hospitals we have rapid care pathways for patients who present with ST elevation myocardial infarction or stroke, but we should have similar pathways for patients presenting with high-risk PE”. Gandhi emphasized the invaluable nature of trials such as these in helping to “guide” physicians in the future, and to inform them on how best to manage these patients.

Urban residents have smaller risk of mortality from chronic limb-threatening ischemia

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Urban residents have smaller risk of mortality from chronic limb-threatening ischemia

A new study using data from millions of patients hospitalized across the U.S. has determined whether population density and associated urban versus suburban versus rural environments predispose patients with peripheral vascular disease for chronic poor blood flow in their lower extremities. The findings were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (May18–20) in Phoenix.

Advanced and chronic peripheral arterial disease can significantly increase a patient’s risk for all-cause mortality including myocardial infarction (MI), stroke, and heart failure. The study aimed to identify the role that sociodemographics, including population density in a patient’s hometown affect outcomes including mortality from chronic limb-threatening ischemia (CLTI).

In the study, deidentified patient data from the National Inpatient Sample (NIS) from 2001–2013 were queried. Inclusion criteria included a diagnosis of CLTI. Data were analyzed using SPSS software in a binary logistic regression model, a p value <0.001 was considered statistically significant, and samples were standardized for comparison using predicted probabilities.

Of the 100m+ patients in the NIS, there were 1,907,089 patients identified with CLTI. Patients living in an urban setting with a population greater than one million people were found to be at a statistically significant decreased risk of mortality from CLTI (odds ratio [OR]=0.647, p<0.001). Females were also at a statistically significant decreased risk of mortality (OR=0.846, p<0.001). There was no statistically significant increase in mortality among different age groups, races, insurance carriers, median household income, or elective admission status (p<0.001).

“We now know that we need to ambulate our patients and encourage aggressive physical activity earlier and more frequently, especially for men,” said Harsh Jain (Montefiore Health System, New York), lead author of the study. “This is a very low cost, low barrier to adoption that has significant ramifications including improved mortality for millions of people, decreased burden on healthcare resources, and millions of dollars in healthcare spending. Furthermore, men should be more vigilantly monitored when diagnosed with peripheral vascular disease, as they seem to fare worse regardless of where they are across the nation.”

Based on the findings, researchers suggest that patients with CLTI should be encouraged to maintain an active lifestyle and engage in vigorous exercise regimens earlier in their disease course to prevent progression and decrease their risk of mortality.

Advance: Navigating the policy and political processes on Capitol Hill

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Advance: Navigating the policy and political processes on Capitol Hill
SVS
Capitol Hill

The underlying processes associated with advocacy—whether legislative, regulatory or political—are arduous and complex. As a result, measures of “success” are often characterized by progress within the process, or in other words, to advance a given initiative even if additional work is still required.

Admittedly, this innate feature of advocacy-related efforts can be frustrating and may beg the question, “why bother?” To best answer this inquiry, we start from the beginning. “Advocacy” is defined as the act or process of supporting a cause or proposal. The Society for Vascular Surgery (SVS) engages in expansive advocacy efforts with an overarching goal to support its members and the patients they serve. To achieve this goal, the SVS monitors and engages in issues relating to workforce and physician wellness, easing regulatory burdens, and payment/reimbursement (to name a few). However, each of these example issue areas generates its own web of opportunities for engagement via both the legislative and regulatory processes. The existence of these opportunities brings us back to the notion of progress within the process.

While our end-goal is the enactment of SVS-supported policies, the complexities of advocacy work often result in, or require, multi-year efforts. As result, shorter-term strategies are often driven by efforts to advance an initiative within the process. For a new piece of legislation, this might mean establishing a robust group of bipartisan cosponsors or securing a committee hearing. In the regulatory realm, we might focus on meeting with critical stakeholders from relevant agencies or delaying the implementation of a policy that we believe needs adjustment. While these aren’t “finish-line” objectives, they are critical steps in the process and denote a successful byproduct of our ongoing advocacy efforts. These days, even the most passive observer of advocacy-related issues is likely aware of the heightened partisanship that is generating an especially difficult policy-making environment on Capitol Hill. While frustrating, it makes the SVS’ efforts to expand our advocacy footprint even more important.

By engaging in these initiatives—responding to Voter Voice “Calls to Act,” contributing to SVS Political Action Committee (PAC) or joining our grassroots key contact network—you will help us advance our priorities through the legislative and regulatory processes. Together, we can make a difference. To learn more, visit vascular.org/advocacy.

Megan Marcinko is the SVS director of advocacy.

We can honor the past without living in it

We can honor the past without living in it
Malachi Sheahan III, MD
Malachi Sheahan III, MD
Malachi Sheahan III, MD, peels back the layers on why a decision by the Southern Association for Vascular Surgery (SAVS) to replace its signature emblem is the right one.

Imagine you are considering moving to a country where you will be an ethnic minority. For example, suppose I am contemplating a position at a hospital in Ghana. I would spend a lot of time thinking about how my family and I would fit in with the cultures of that nation. How would we be perceived by its population? Suppose, in my research, I came across these quotes from the head of the hospital’s board of directors:

“These characteristics tend to confirm the lowly status of the white man in the scale of human evolution, and to establish closer analogies with primitive anthropoids than exist between these and other races of mankind.” “The degenerative tendencies of the white race revealed by statistics, are due, essentially, to the influence of unfavorable hygienic surroundings; to unfavorable social (including moral) environment; to all the causes which lead to a bad heredity, vice, dependency, and degradation, and which are acting simultaneously upon this ethnologically inferior and passive race which is struggling for existence with our superior and dominant population.”

What if their chair of anesthesia had authored a paper with the following passage: “Confining ourselves to the salient peculiarities of surgical interest, we shall insist, with all observers, on the lessened sensibility of the white nervous system to pain and shock. It is also believed—and my personal experience confirms this impression—that the tactile sensibility as revealed by the aesthesiometer is lessened. This would appear to be associated with a histological difference in the development and shape of the tactile papillae of the skin. This diminished peripheral sensibility is in harmony with the inferior organization of the white race. Diminished sensibility is not peculiar to whites, but common to all primitive races. Livingston was one of the first to call attention to the fact that white people can undergo the most painful operations with apparent indifference. This combination of circumstances—i.e. a naturally diminished peripheral sensibility, coupled with a more passive condition of the mind—makes the white man a most favorable subject for all kinds of surgical treatment with or without preliminary anesthesia.” What should I think? Maybe there’s some flexibility in the base pay? Of course, I would not join a place where the figureheads view me as inferior. Yet these quotes are not from some mythical figures in Ghana, but have been taken almost directly—except for reversing the races—from the writings of Rudolph Matas, whose face adorns the seal of the Southern Association for Vascular Surgery (SAVS).

This, however, is about to change. In his 2023 SAVS Presidential Address, William D. Jordan, MD, acknowledged a concern “that our image among many young surgeons is negatively impacted by having his likeness on our seal. Many of us have great respect for the work he has done, but some have expressed concerns about parts of his academic work that was offensive and not respectful to disadvantaged groups of the day.” President Jordan then called on members of the society to help design a new seal and “turn our eyes to the future.”

This clash between past and present is certainly not unique to our field. Perhaps the most public and possibly illuminating debate came over the presence of Confederate monuments in the United States. Defenders of the statues often cite their role in preserving history. A look at the actual timeline of their construction points to a more dubious purpose.

The American Civil War exacted a disastrous toll on the population of the South. Approximately 20% of Southern White men of military age were killed. Almost every family lost at least one member. In the decades after the war, numerous memorials were built to remember the dead. These were placed in solemn areas for contemplation, such as cemeteries. Starting around 1890 and peaking in the early 1900s, a new type of monument began to appear. Giant stone statues of Confederate leaders like Generals Robert E. Lee and Thomas “Stonewall” Jackson were erected. Now, instead of places for reflection, the monuments were positioned in public areas, such as town squares, courthouses, and state capitols. Rather than mourning the dead, the purpose of the new statues was clearly a validation of Confederate values during the Jim Crow segregation era. They seemed unequivocally designed and located to intimidate and discourage Black Americans from asserting their rights. Need more evidence? Ask Senator John Sharp Williams from Mississippi. At a 1927 dedication ceremony for a statue of Jefferson Davis, Senator Williams proclaimed that “[t]he cause of White Racial Supremacy, which . . . is not a ‘Lost Cause.’ It is a Cause Triumphant. . . The white man’s family, life, his code of social ethics, his racial integrity—in a word his civilization—the destruction of which in the slave states was dreaded . . . are safe.” See? These racists wanted to make it so clear that the Confederate statues represented White Supremacy that they just straight up handed out receipts.

Decades later, a new surge of Confederate imagery appeared as a backlash to the Civil Rights Movement. Georgia redesigned its state flag to include the Confederate symbol in 1956, and in 1961, South Carolina began to fly the rebel battle flag at its capitol building, where it would remain until 2015. Also undermining the claim that these monuments were constructed to preserve the local history of the South is that they were erected in 31 states. The Confederacy only consisted of eleven.

It is important to recognize and celebrate the achievements of historical figures. Still, we must maintain a critical perspective and acknowledge the full context of their lives and actions. We should strive to learn from the past while recognizing the limitations and biases inherent in our understanding. We can admire Thomas Jefferson’s accomplishments without ignoring his status as a slave owner. The latter should be scrutinized and studied as an example of the dangerous potential of the duality of man. Location and context are critical. Immortalizing individuals with giant marble statues seems more the domain of authoritarian regimes than advanced democracies.

Some argue that judging historical figures through the standards of today is unfair and term it presentism. There is ample evidence that as we become more easily connected to others through technology, our empathy grows. Princeton philosopher Peter Singer calls this our expanding moral circle. Social media also brings quick and global judgment to perceived bad behavior. It’s hard to be a jerk in private these days. As @maplecocaine posted, “Each day on twitter there is one main character. The goal is to never be it.” We take it as a point of fact that knowledge improves with time, so why wouldn’t morality?

We probably just need to be more careful about who we idolize. Most of history’s “greats” had serious character flaws. Winston Churchill hated Indians and sent the Black and Tans to ravage Ireland. Mother Theresa glorified poverty and told the unfortunate to accept their suffering. What about Gandi, John Lennon, or Albert Einstein? Racist, abuser, and chauvinist. At least to some.

While idolizing historical figures can provide inspiration and motivation, it can also lead to a distorted view of history and prevent critical examination of the past. We may be less likely to hold these individuals accountable for their actions or to acknowledge the harm that they caused. This can perpetuate a culture of impunity, where those in positions of power are immune from scrutiny or consequences.

Other scientific communities have also had to re-evaluate the honors they have bestowed on historical figures. The Association of American Medical Colleges (AAMC) recently decided to rename its prestigious Abraham Flexner Award. Flexner was responsible for a report in the early 1900s that revolutionized medica training. Unfortunately, the report also contained a myriad of racist and sexist ideas, and led to the closure of most of the historically Black medical schools in the US. Even the world of botany has been affected. Carl Linnaeus, the developer of the genus and species classification system, had his name attached to the Entomological Society of America’s annual competition. Unfortunately, Linnaeus used his system to classify humans by variety and assigned more positive traits to those with lighter skin tones. In removing the name, the society’s president, Dr. Alvin M. Simmons, stated, “A name can be replaced, but each entomologist brings a unique and valuable contribution to our society that is irreplaceable.” A valid point. Why make a divisive figure the symbol of your society?

So, what of Dr. Rudolph Matas? He is perhaps the most significant surgeon to come from my adopted home of New Orleans. Am I advocating for his erasure from our history? His cancellation? Absolutely not. As the head of the Tulane University and Louisiana State University (LSU) vascular programs, I am as much the caretaker of his legacy as any. I strongly recommend that all surgeons take the time to learn about this innovative and trailblazing man and his remarkable life. Sir William Osler, MD, hailed him as the “Father of Vascular Surgery.” The definitive account of his life: Rudolph Matas: A Biography of One of the Great Pioneers in Surgery was written by Isidore Cohn, MD, the father of my former chair of surgery at LSU. I would also enthusiastically endorse John Ochsner’s 2001 Journal of Vascular Surgery article “The complex life of Rudolph Matas.” Although here, his poor wife has to bear the indignity of having her portrait labeled “Fig. 8. Adrienne Matas in the early time of her weight gain.”

We must reconcile our desire to preserve the past while projecting symbols of inclusion. When a prospective member of SAVS looks at the seal and sees Rudolph Matas staring back, what do they think? Is he wearing sunglasses? Projecting Matas as the singular emblem of our society sends the message that this man, above all others, represents our ideals. A task, perhaps, too heavy for any solitary man or woman to carry.

I strongly believe in the wisdom that can be gained through studying our predecessors. Nearly every editorial I have written has looked to the past to provide context for our present. Surgeons must find a way to make our history relevant and illuminating to the next generation. Naming awards and creating symbols accomplish neither. I am certain this will engender some discussion, and not all of it favorable (please folks, it’s “you’re” a woke jackass). Clearly, some will see this as an attempt to erase history. But if that is your opinion, what is your vision here? Would you go to work for my mythical hospital in Ghana? Matas’s opinions on race may seem harmlessly antiquated, but what about when they are directed at you? When we start debating “was it racist for the time?”, we all lose.

Progress and tradition will battle without end. Our symbols and conventions must be able to endure the scrutiny of time. As Dr. Jordan said, rather than focus on the divisive errors of the past, surgeons should work together to produce solutions for our common future.

Insights from largest chronic limb-threatening ischaemia study to inform quality of care improvements

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Insights from largest chronic limb-threatening ischaemia study to inform quality of care improvements

Data from a cohort of one million patients with chronic limb-threatening ischaemia (CLTI) were recently presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA). Using data from Medicare, the cohort, CLIPPER (Chronic limb threatening ischaemia process performance), found one out of six patients with CLTI died within their first year of diagnosis and 50% survived at five years.

Using data from Medicare, the CLIPPER cohort was created to develop and test process measures for CLTI, which could ultimately be used to measure and improve quality of care.

Using inpatient and outpatient claims data from patients with fee-for-service Medicare from 2010 to 2019, a coding algorithm was used to identify patients with CLTI. To qualify for a CLTI diagnosis, patients had either 1) one diagnostic code for peripheral arterial disease and one diagnostic code for ulceration, infection, or gangrene on the same inpatient or outpatient claim, or 2) one CLTI-specific diagnostic code, as well as a procedure code indicating arterial vascular testing within six months before or after the qualifying CLTI diagnostic code(s).

The cohort comprised 1,130,065 patients diagnosed with CLTI between 2010 and 2019. Mean age of the cohort was 75±5.8 years; 48.4% were women and 14.6% were Black. Within 30 days of CLTI diagnosis, 20.4% of patients underwent percutaneous or surgical revascularisation. Within six months, 3.3% of patients underwent major amputation; 16.7% of patients died at one-year follow-up and 50.3% at five-year follow-up.

“CLTI is an incredibly deadly disease if not treated quickly after diagnosis, but we know very little about how hospitals perform with respect to treatment,” said lead author Alexander Fanaroff (University of Pennsylvania, Philadelphia, USA). “Comprehensive process measures are needed for patients in order to advance care and improve the chance of survival. Our hope is that this study is a first step toward developing better process measures.”

The authors note they plan for the CLIPPER data to be used for future studies on CLTI, including developing process measures that can be captured from administrative claims data, and measuring their association with limb outcomes and corresponding racial, ethnic, socioeconomic, gender-based, and geographic variability.

JETi registry provides “remarkable results” for peripheral thrombectomy system

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JETi registry provides “remarkable results” for peripheral thrombectomy system
Abbott's Jeti peripheral thrombectomy system
Jeti peripheral thrombectomy
Abbott’s Jeti peripheral thrombectomy system

Presenting “remarkable results” from the JETi registry—a prospective, multicenter, observational study which collected real-world data on the safety, performance and clinical benefits of the JETi peripheral thrombectomy system—speaker Mahmood K. Razavi, MD, relayed the positive outcomes seen with the “powerful” Jeti device  (Abbott) to audience members at the 2023 International Vein Conference (April 27–29, Miami).

Of their main objectives, the research team set about analyzing JETi outcomes in patients with deep venous thrombosis (DVT), to ultimately determine if iliocaval and iliofemoral DVT in a single session is feasible. Speaking to Vascular Specialist, Razavi explained that “Jeti was one of the earlier devices that came into market that had the capability for single-session treatment of patients—so this was the basis of our intention-to-treat analysis, to evaluate the effectiveness, outcomes and feasibility of the device for this purpose.”

Treating 53 limbs in 47 patients, Razavi stated that around a fifth—21%—had symptoms longer than 14 days, placing them in the sub-acute category. Their primary efficacy endpoint was acute procedural success defined as the establishment of unobstructed flow from the limb in a single session. Another “critical” secondary endpoint Razavi highlighted was the evaluation of haemoglobinuria due to the Jeti’s differing mechanism of action in comparison to other devices such as the AngioJet (Boston Scientific) device. “People often confuse the [Jeti] mechanism of action with Angiojet. They are different. Jeti can be described as a hydrodynamic thrombectomy device, although this is not commonly a used term” Razavi explained.

The Jeti system is designed to deliver a stream of high-pressure saline via a pump to the distal tip of the catheter, while aspirating thrombotic material. The saline jet acts to macerate the clot inside the catheter and prevent clogging. Hence no intravascular clot maceration and no haemoglobinuria.

Razavi, describing their findings, stated that re-establishment of unobstructed flow after a single session was seen in 89% of patients with Jeti alone at a mean procedure time of 90 minutes. Overall, complete flow was reestablished in 94% after Jeti combined with stenting. Iliocaval thrombosis was present in 12 patients included in this cohort, their clot extending into the inferior vena cava (IVC). Furthermore, in nine of these 12 the researchers found the clot to be behind an IVC filter—“this meant that the entire infrarenal IVC was thrombosed and yet we achieved these kind of results—it was somewhat surprising to us.”

Breaking their results down further, Razavi stated that in these patients prior to stenting, flow restoration with Jeti alone was seen in 86% of patients with a clotted IVC (100% after stenting), 75% in iliofemoral (92% after stenting) and 100% of the isolated femoropopliteal patients, respectively. “This is a very different aspiration system, [Jeti] was far more efficacious than we anticipated,” Razavi opined.

Although their team did not evaluate long-term clinical outcomes, they did assess 30-day Jeti-related efficacy via ultrasound, a measure which Razavi averred has been correlated with long-term patency and the development of post-thrombotic syndrome, as seen in the ATTRACT trial. Referring to the rate of clot absence during ultrasound follow-up, in the common femoral it was 87.2%, and in the femoral vein, 71.7%.

“Not only was this a highly effective treatment in 90 minutes, but the mid-term outcomes were also fairly good and comparable to other studies such as the ClotTriever outcomes [CLOUT] registry” Razavi continued. “At the time this system became available there were multiple studies that had been published and none could consistently achieve single-session thrombectomy in patients with iliofemoral DVT, let alone iliocaval,” said Razavi. “We had made the observation that this is a very efficacious system—but can we successfully treat DVT in a single session? Is Jeti a superior system as compared to devices that were used before? It would be a game-changer if we could treat iliocaval and iliofemoral DVT in a single session with mid-term patency rates similar to thrombolysis.”

Of his concluding thoughts, Razavi hopes that the team’s experiences throughout this trial will help European and US practitioners alike choose “more carefully as to what works and what does not”, and to “go with the system that is proven to work without causing vessel wall injury”, which may perhaps mean taking up and employing an unfamiliar device and system.

VAM 2023 meeting underscores commitment to DEI

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VAM 2023 meeting underscores commitment to DEI

DEIDiversity, equity and inclusion (DEI) have been a focus for the Society for Vascular Surgery (SVS) and continue to grow in importance. VAM 2023 organizers are committed to making sessions and content more diverse, equitable and inclusive. “This year we are striving to make this the most diverse, equitable and inclusive VAM ever,” said Andres Schanzer, MD, Program Committee chair. “We are distributing DEI-focused science and educational presentations throughout the entire program, all day, every day.”

DEI Committee members will serve as discussants. Schanzer and DEI Committee leaders Vincent Rowe, MD, (chair) and Rana Afifi, MD, (vice chair),highlighted the sessions as well as the specific discussants who will review the DEI aspects of the presentation. Several educational sessions also will include DEI topics and themes.

As of May 2, the scientific and educational sessions at VAM 2023 are:

◆ Plenary 1 (William J. von Liebig Forum), 8 to 9:30 a.m. Wednesday; “Comparative analysis of reinterventions after lower-extremity revascularization between the sexes” (Discussant: Kwame Amankwah, MD).

◆ International Young Surgeons Competition, 3:30 to 5:00 p.m. Wednesday; “What Specific Factors Has the Medicaid Expansion Influenced or Affected Regarding the Management and Surgical Outcomes of Patients with Peripheral Arterial Disease?”

◆ Plenary 3, 8 to 9:30 a.m. Thursday (two abstracts); “Black patients have worse outcomes after lower-extremity revascularization: A propensity-matched analysis of comorbidities and socioeconomic factors” (Discussant: Olamide Alabi, MD) and “Socioeconomic status not associated with worse outcomes after open lower-extremity revascularization” (Discussant: Carla Moreira, MD).

◆ International Forum Scientific Session, 7:15 to 8:00 a.m. Friday, “Carotid endarterectomy performed in asymptomatic females is not associated with increased perioperative and long-term complication rates in comparison with males”.

EndoAVF found usually less cost effective compared with sAVF

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EndoAVF found usually less cost effective compared with sAVF
Bianca Mulaney, MD

The Society for Clinical Vascular Surgery (SCVS) 50th Annual Symposium (25–29 March, Miami) hosted a series of abstract presentations. Among them was one by Bianca Mulaney, MD and colleagues including Elizabeth George, MD, Stanford University, Stanford, on the cost effectiveness of endovascular arteriovenous fistula (endoAVF) creation when compared with surgical AVF (sAVF) creation.

Mulaney began her presentation by telling the SCVS audience that around US$2.8 billion is estimated to be spent on vascular access and its complications each year in the USA, which she said amounts to “a significant cost burden” as well as “a significant portion of the vascular surgeon’s caseload”. Though endoAVF has demonstrated lower rates of complications such as steal syndrome in some studies, “the clinical and financial impact of endoAVF remains uncertain”, according to Mulaney. It is this uncertainty that the study she led aimed to resolve.

“The one way we can get at this question, in the absence of concrete data from a randomised controlled trial (RCT), is a cost-effectiveness analysis aimed at forecasting the outcomes of the two approaches,” Mulaney said.

The parameters for her cost-effectiveness analysis came from a systematic review she conducted to obtain data on technical success of the procedures along with maturation, patency, and utility values, as well as data from the Medicare 2022 fee schedule for costs associated with the two procedures. She presented a decision tree linked to a probabilistic cohort state-transition model comparing endoAVF and sAVF outcomes over five years. Further outlining the study authors’ methods, the abstract states that they used “a five-year time horizon, an annual discount rate of 3% for costs and utilities—measured in quality-adjusted life years (QALYs)—and the common willingness-to-pay (WTP) threshold of US$50,000.”

Setting out the study’s findings, Mulaney stated clearly that endoAVF was found not to be cost effective when compared with sAVF. “Although endoAVF increases QALYs by the equivalent of about one-and-a-half months of extra life for the average patient with ESRD,” she added, “it comes at a significantly greater cost.” Comparing endoAVF (per capita US$30,129 costs, 2.19 QALYs; 65% patent at five years) with sAVF (per capita US$12,987 costs, 2.11 QALYs; 66% patent at five years) generated an incremental cost-effectiveness ratio (ICER) of US$227,504 per QALY gained.

However, Mulaney specified that a series of one-way sensitivity analyses revealed that, when several variables reached certain thresholds, endoAVF did become cost effective. When the endoAVF maturation rate is greater than 90%, for instance, it became cost effective compared with sAVF. Other examples include when the initial cost of sAVF creation exceeds endoAVF by at least US$600, the additional QALYs gained from endoAVF exceeds 0.12 QALYs/year and when sAVF maturation rate is beneath 65%.

The abstract presented by Mulaney ascribes endoAVF’s inferior cost effectiveness when modelling five-year outcomes to the “four times higher up-front cost for endoAVF creation as well as a relatively low initial maturation rate for endoAVF”. Mulaney expanded on this, putting forward the suggestion that an RCT is “definitely warranted” to further examine when endoAVF may be more cost effective. Responding to audience questions, Mulaney highlighted maturation rates as something which the study found to be having a particular impact on cost effectiveness. She called on device companies to improve device capabilities to increase maturation rates. Looking forward, she also said she would welcome future studies examining the differences between specific endoAVF devices.

Correct coding for IVUS during venous and arterial interventions

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Correct coding for IVUS during venous and arterial interventions

ivusThe use of intravascular ultrasound (IVUS) can provide helpful information for assessment of pre- and post-intervention vascular status and, thus, is an important part of the management of patients with arterial and venous disease. IVUS can provide information about lesions not evident with angiography or standard ultrasound. Correct coding of IVUS depends on anatomic considerations in addition to accurate documentation of the procedure and findings.

For Current Procedural Terminology (CPT) 2016, the surgical and interpretation components of IVUS were combined into two new bundled codes for reporting IVUS in the initial noncoronary vessel (37252) and each additional noncoronary vessel (37253). IVUS codes may be reported in addition to any angiographic or interventional procedure codes when treating peripheral arteries and/or veins.

Certain principles of documentation and vascular nomenclature will help inform the use of and number of units of IVUS that may be reported for any given intervention; specifically, one unit of service for each IVUS procedure for each vessel (vessels are defined in Appendix L of the CPT codebook). In other words, separate coding for a pre- and post-intervention IVUS examination is not permitted. The number of units of IVUS reported is based on the number of vessels studied and includes all work necessary to perform the procedure. While it is possible to code for each vessel studied, when a lesion spans two different vessels those two vessels are considered a single vessel. For example, a stenosis involving the external iliac vein that continues into the common iliac vein would be coded as one vessel. This is based on CPT codebook guidelines for characterizing anatomic definitions of vessels and applies to IVUS and other procedures.

Documentation must support the number of units of IVUS reported. Each vessel, with laterality specified, needs to be included in the documentation. In addition, the physician must describe the IVUS findings for each vessel before and after any intervention. Quantification of percentage stenosis is always helpful as documentary support for the intervention and the use of IVUS.

As is always the case, the clinical indications for the procedure should support the use of IVUS technology in each vessel that is being studied. When performed, IVUS is included in IVC (inferior vena cava) filter placement, repositioning and removal, and foreign body retrieval and should not be separately reported with these procedures.

Physicians who use advanced technologies such as IVUS to improve outcomes for their patients should be reimbursed accordingly. The guidance provided is designed to facilitate the documentation and coding for use of this technology.

There may be situations where questions arise regarding the proper documentation and coding for more complex lesions and anatomic features. For help, email [email protected].

Happiness, well-being and culture are key ingredients for seeking ‘eudaimonia’

Happiness, well-being and culture are key ingredients for seeking ‘eudaimonia’
happiness
Bhagwan Satiani, MD

Although researchers describe eudaimonia as the practice of virtues like courage, wisdom, good humor, moderation and kindness, some have translated the writings of Greek philosopher Aristotle to mean achieving deep wellness and purpose. Certainly, if Aristotle says so, it must be true! Practicing medicine is certainly a “purpose,” but the quest for “deep wellness” has been lost over time and instead we are left with burnout for which we hope that wellness and resilience programs can lead us to happiness and eudaimonia. What does this mean for the modern physician, particularly for those employed by large organizations or groups? And is a healthy culture essential for happiness and well-being?

Bruce L. Gewertz, MD, a senior member of our society, expressed his thoughts on the importance of happiness and joy in a very thoughtful piece titled “Life, surgery, and the pursuit of happiness.”1 The Dalai Lama agrees. He explains that Buddhism believes that joy is humanity’s elemental nature and, therefore, our goal should be to return to it.

Most of us associate happiness with success. In truth, success likely follows happiness. Research studies show a direct relationship between life satisfaction and successful business outcomes.2 In turn, McKinsey has shown that employees life satisfaction greatly depends on their relationships with management. The share of satisfaction on the job depends 39% on interpersonal relationships and the share in interpersonal relationships at work depends 86% on relationship with management.3 The study also pointed out that 75% of those surveyed said that the most stressful aspect at work was their immediate boss leading to a toxic culture.4

In a survey by the Katzenbach Center, 84% of respondents pointed to culture as critically important. However, less than half reported that companies did a good job of managing culture in that it was not a priority initiative.5

Culture reflects the values of an organization and, if a “healthy” culture, ambiguous as it may be, is one of their values, it is seen as emphasizing employee satisfaction. In the longer term, we know that happier employees tend to be 12–20% more productive.

Furthermore, unhealthy “microstresses” from a culture of little autonomy, excessive workload, and mismatched values are setting people up for burnout.

A culture of well-being at work, to include not just the usual policy prescriptions such as evaluation of workloads, working hours, family-friendly policies etc., but an emphasis and monitoring of a healthy interpersonal organizational milieu is essential for people to thrive. It also helps to identify areas of moral distress and cognitive dissonance. A 2022 study showed that 66% of physicians perceived that their organizations do not prioritize physician well-being.6

Being mortals, we all struggle with being happy. Add to that a workplace with a culture that is driven by some leaders who are unaware or overlooking the impact of culture on employee happiness and burnout. There is therefore a continuous loop of damaging culture, unhappiness and burnout. By now we are aware of the conditions, including long work hours that lead to burnout in physicians, especially vascular surgeons who work some of the longest hours. A review of 47 multinational studies of physicians found that longer work hours were a strong predictor of burnout.7 It is also true that burnout is more correlated with a lack of enjoyment or fulfillment at work. However, deep happiness and hard but meaningful work, even with longer hours, makes us more resilient and able to deal with stress.

The work ethic responsible for hard work and efficiency has transformed itself into an “overwork culture,” which exists in many if not most institutions and practices driven by productivity incentives leading to financial rewards. A challenge to the ‘pursuit of happiness’ has been the push by employers, including academic institutions to enshrine productivity incentives in employment contracts. It may succeed in the short term until we experience time poverty and even ‘“famine”—a collective cultural failure to effectively manage our most precious resource, time.”8 The bet is that working harder to earn more will make physicians happier. An institutional culture of pushing working harder may make physicians (and the institution of course) richer but counteracts simultaneous efforts to prevent burnout. I have mentioned previously that “time affluence” is at a low and some claim there is ‘famine’ based upon a Gallup survey of 2.5 million Americans showing that 80% declared insufficient time each day to accomplish what they wanted to do.

Purpose or meaningful work is the second component of eudaimonia. That does not necessarily mean profitable work. If sage leaders constantly model the purpose, rather than profit alone, organizations thrive and grow 5–7% more than the market.9 In 2014, CEO Satya Nadella affirmed Microsoft’s purpose

as to “…empower every person and every organization on the planet to achieve more.” So, purpose, strategy and culture have often been identified as the triad leading to success, which means better relationships, kindness, and psychological safety among other elements.

Finally, in an increasingly VUCA (volatility, uncertainty, complexity, and ambiguity) world with increasing workloads and physician shortages the most critical parts of the eudaimonia equation are being overlooked. A balance between working harder, i.e.,  increased productivity and physician well-being is surely needed. Now. Ahora!

References

  1. https://pubmed.ncbi.nlm.nih.gov/19620538/.
  2. https://www.shawnachor.com/project/harvard-business-reviewthe-value-of-happiness/.
  3. Tallas T, Schaninger B. The boss factor: Making the world a better place through workplace relationships.
  4. https://www.physicianleaders.org/articles/doi/10.55834/plj.6849841215.
  5. https://www.strategyand.pwc.com/gx/en/insights/2011-2014/cultures-role-organizational-change.html.
  6. 2022 Well-Being in Healthcare: Trends & Insights.
  7. E Amoafo, N Hanbali, A Patel, P Singh. What are the significant factors associated with burnout in doctors? Occup Med (Lond) 2015 Mar;65(2):117-21. doi: 10.1093/occmed/kqu144. Epub 2014 Oct 16.
  8. https://hbr.org/cover-story/2019/01/time-forhappiness.
  9. https://hbr.org/2019/08/181-top-ceos-haverealized- companies-need-a-purpose-beyondprofit.

BHAGWAN SATIANI, MD, is a Vascular Specialist associate medical editor.

Medical therapy gains highlight need to reassess carotid surgery

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Medical therapy gains highlight need to reassess carotid surgery
Alun Davies, MD

“The time has definitely come to look at the evidence, and redo these studies,” posited Alun Davies, MD, from Imperial College London in London, England, putting forward his argument that the NASCET and ECST clinical trials “need to be reconducted” at this year’s Charing Cross (CX) Symposium (April 25–27) in London.

Much of Davies’ argument centred on the fact that best medical therapy—the comparator arm against which carotid endarterectomy (CEA) was assessed, and found to produce clinical benefits in carotid artery stenosis patients, in both of these studies—is “significantly better than it was” at the time.

“We are relying on evidence from 1992, and I would say the playing fields have completely changed,” he noted. After outlining discrepancies between the North American NASCET and European ECST trials regarding how internal carotid artery stenosis was defined—with ECST having a higher threshold for severity—Davies said NASCET observed a 3.3% stroke/death rate at one month in its medical therapy arm, compared to roughly 5–6% with CEA. Recent research has shown that targeting a patient’s cholesterol, and initiating best medical therapy more quickly, can reduce adverse event rates by up to 80% early on, said Davies. He theorized that stroke/death incidence could now be as low as 0.7% with today’s best medical therapy.

Attendees preparing for VAM 2023 education, networking

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Attendees preparing for VAM 2023 education, networking

VAMMore than 880 vascular professionals are preparing to pack their bags in preparation for the 2023 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM).

The specialty’s premiere educational event of the year takes place June 14 to 17 at the Gaylord National Resort and Convention Center in National Harbor, Maryland, just outside of Washington, D.C.

VAM opens with an educational session for the World Federation of Vascular Societies at 6:30 a.m. June 14 and ends with the conclusion of the Annual Business Meeting—complete with officer reports, a luncheon, presentation of awards and the results of the 2023–24 officer election at 1:45 p.m. In between will be presentation of the latest science in vascular disease from 120-plus abstracts, more than 25 other educational sessions, the graduation of the latest cohort of the Leadership Development Program, industry exhibits and sessions, two named lectures, poster competitions, events for international members and much more.

The VAM Online Planner makes it a snap to plan ahead—visit vascular.org.OnlinePlanner23. It includes the full schedule from Tuesday, with the Vascular Quality Initiative’s VQI@VAM beginning that afternoon, through Saturday, with details on nearly every session and abstract. Schedules include not only the VAM schedule but also those for the VQI meeting and the Society for Vascular Nursing Annual Conference, both held in conjunction with VAM. The planner also includes a listing of authors and invited faculty, information on credits and certificates, exhibitors, sponsors and registration information. Participants soon will be able to mark certain sessions as “favorites,” with that information transferred to the mobile app when it launches a few weeks before the meeting.

Filters let users quickly find specific sessions of interest, and icons highlight for which tickets are required or that will include the topics of diversity, equity and inclusion. A few highlights (all times Eastern Daylight Time) include:

◆ The E. Stanley Crawford Critical Issues Forum on “The State and Future of Our Specialty—Extending, Repairing and Maintaining the Vascular Surgery Pipeline,” starting at 11 a.m. Wednesday

◆ The inaugural Frank J. Veith Distinguished Lecture, on BEST-CLI, 9:35 a.m. Thursday

◆ The Michael Dalsing, MD, Presidential Address, beginning at 11 a.m. Friday with an introduction by President-Elect Joseph Mills, MD

◆ A Career Fair, from 9 a.m. to 3 p.m. Friday, for those who want to explore career options

◆ The Roy Greenberg Distinguished Lecture at 10:45 a.m. Saturday, with Michael Murphy, MD

The SVS’ new tiered registration rates are now at the “advance rate,” and will remain so until June 12. On June 13, rates increase to the “on-site” rate. Learn more and
register at vascular.org/VAM.

Mix and mingle at SVS Connect@VAM

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Mix and mingle at SVS Connect@VAM

The 2023 Society for Vascular Surgery’s Vascular Annual Meeting will end its first full day on Wednesday with an outdoor networking event—food and drink, games, entertainment, artist demonstrations and more—for attendees and their families.

The inaugural SVS Connect@VAM: Building Community is set for 7 to 9 p.m. EDT June 14 on the Potomac Terrace at the Gaylord National Resort and Convention Center. “We want our attendees to balance their VAM experience,” said Andres Schanzer, MD, chair of the SVS Program Committee, which plans much of VAM’s sessions. “Besides education, there is also connecting with others and taking the time to recharge. Seeing friends and making new friends is a huge part of VAM. We want to double down on that experience.”

Due to the generous help from VAM sponsors, Terumo Aortic and Philips, admission to the event is free. Space is limited, so it’s a good idea to reserve your spot early. All attendees are welcome to bring family members. The festivities will include food stations, games, entertainment, and other activities that will remind attendees of a summertime block party. “People may not have a chance earlier than Wednesday to connect with their friends and colleagues,” said Schanzer. “This will provide a great opportunity to do so.

Visit vascular.org/VAM to add “Connect” tickets to existing
reservations, or to register for VAM.

Five-year results of the LEOPARD trial published in the Journal of Vascular Surgery

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Five-year results of the LEOPARD trial published in the Journal of Vascular Surgery
LEOPARD
AFX2 system

Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study’s findings showed that there was no significant difference in aneurysm-related outcomes between patients randomized to the AFX endograft system, with anatomical fixation, and commercially available endografts with proximal fixation.

“The publication of these final five-year results in JVS reinforces the performance of our AFX2 endovascular AAA [abdominal aortic aneurysm] system in the treatment of patients with [AAAs],” said Matt Thompson, president and CEO of Endologix. “We are proud to have conducted the first randomized controlled trial comparing commercially available endografts, and we remain committed to providing the highest quality clinical evidence that underpins our life-changing vascular therapies. Importantly, the comparable performance results from the LEOPARD study between AFX/AFX2 and other endografts align with a recent publication that was authored on behalf of the Society for Vascular Surgery’s Patient Safety Organization and used linked registry claims data.”

LEOPARD was a prospective, randomized, multicentre trial that enrolled 455 patients across 56 US centres. Two hundred and thirty five patients were included in the AFX/AFX2 arm and 220 patients in the comparator arm.

The primary endpoint was freedom from aneurysm-related complications (ARC), a composite endpoint consisting of perioperative death, aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysm-related reintervention.

The results presented included:

  • Freedom from ARC at five years was:
    • 63.8% in AFX/ AFX2 device cohort
    • 55.5% in comparator endografts
  • There was no clinically significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type 1 and type 3 endoleaks between the two cohorts
    • The type 3 endoleak rate for the AFX/AFX2 device cohort was 1.5% at five years and was not statistically different from the comparator devices
    • The type 2 endoleak rate reached a statistically significant lower rate at 21.2% at five years for the AFX2 cohort than the rate of 31.6% seen with the comparator devices

CX 2023: Statins save lives after aortic repair regardless of dose

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CX 2023: Statins save lives after aortic repair regardless of dose
Kevin Mani
statins
Kevin Mani

Statin treatment after aortic repair is associated with improved long-term survival, while dose does not matter. This was the key message from a first-to-podium presentation delivered by Kevin Mani (Uppsala University, Uppsala, Sweden) at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK). The CX audience showed their support for this conclusion, with 89% agreeing with the statement ‘Statins save lives’ during discussion time.

Mani began by underlining the fact that abdominal aortic aneurysm (AAA) is a cardiovascular disease that shares risk factors with atherosclerotic cardiovascular disease (ASCVD). According to the American Heart Association (AHA), the presenter detailed, AAA is in fact classified as one of the ASCVDs.

“AAA patients have a higher mortality than the general population due to cardiovascular disease,” Mani noted, adding that statin treatment is associated with improved survival in patients with ASCVD.

The presenter detailed that current European Society for Vascular Surgery (ESVS) guidelines on the management of abdominal aortoiliac artery aneurysms, published in 2019, suggest that patients with AAA should have blood pressure control, statins and antiplatelet therapy. “This is a class IIa recommendation with level b evidence,” the presenter specified, which he said indicates that “probably all patients” with AAA should have statin treatment.

The AHA guidelines, Mani highlighted, split statin treatment into high dose and moderate to low dose. “The suggestion is that patients with ASCVD including those with AAA should have high-dose statin treatment,” the presenter shared with the Kensington 1 audience. “However,” he said, “the evidence for what dose should be given to AAA patients is non-existent, and the vascular surgical guidelines do not recommend a specific dose for AAA patients.”

To address this gap in the literature, Mani and colleagues conducted a national study assessing the potential benefit of statin treatment in AAA patients and whether dose has an effect. The team used four national registries and then cross-matched these to identify all AAA repairs performed in Sweden between the years of 2006 and 2018, the presenter explained. The team then assessed statin treatment by combining patient data and the national prescribed drug registry, looking at outcomes in terms of death, cause of death and rehospitalization, also using national registries.

Mani detailed that the researchers performed three analyses, the first looking at 90-day mortality for patients who had statin treatment preoperatively, the second assessing statin versus no statin treatment postoperatively, and the final one examining high-dose versus low-to-moderate-dose statin treatment postoperatively, considering overall survival, aortic-related survival and freedom from cardiovascular events. Propensity score matching was used to ensure that the groups were comparable in terms of baseline comorbidities and characteristics.

The presenter revealed that approximately 60% of the 11,000 patients who underwent AAA repair in the national study had statin treatment prior to undergoing repair. Postoperatively, he added, half of the patients had continuous statin treatment 80% of the time after the operation. In both instances, the rates were higher among men compared to women.

Looking at perioperative mortality, Mani reported that this was the same in the group on statin treatment versus no statin treatment and was equal for the endovascular aneurysms repair (EVAR) and open repair cohorts, with an overall 90-day mortality of just under 3%.

The presenter also shared the finding that patients on statin treatment had an improved survival in the long term, and that overall survival was “significantly improved” in a propensity score-matched group of patients with or without continuous statin treatment after AAA repair. Aortic-related survival was improved with statin treatment, he stated, as was freedom from cardiovascular events, if the patients were on statin treatment.

Finally, the team assessed the high-dose statin group versus the low-to-moderate-dose group. “There was no effect of the dose of statins, neither on overall survival nor on aortic-related survival or cardiovascular events,” he communicated. “These were equal, irrespective of dose.”

“In conclusion,” the presenter summarised, “statin treatment is beneficial in AAA patients with improved long-term survival, as well as improved freedom from aortic-related complications and cardiovascular events.” However, he added the caveat that there is no support in the study for high-intensity statin treatment after AAA repair, and that perioperative mortality was not affected by statin treatment.

In subsequent discussion, panellist Janet Powell (Imperial College London, London, UK) asked whether the study results are independent of low-density lipoprotein (LDL) cholesterol levels. Mani responded that the team does not have such data. However, he highlighted the fact that the AHA recommendation for high-dose statins for patients with AAA below the age of 75 is irrespective of their LDL levels. “Clearly, this is an area where we need to work more on how we achieve the adequate effect of statins by looking at LDL levels,” he remarked, considering future research in this space.

Corner Stitch: Navigating the technology landscape as a vascular trainee

Corner Stitch: Navigating the technology landscape as a vascular trainee
Christopher Audu, MD

I vividly recall sitting in the back of the conference room as a medical student and marvelling at the various approaches that could be used to solve vascular problems during the weekly “indications conference.” Every Monday morning, the creativity displayed at this conference to solve difficult problems served as a major draw for me into the field of vascular surgery, even though, to be honest, some of it went over my head at the time. During these hours, the senior residents and fellows seemed to have all the answers, and the attendings had no shortage of tips and tricks up their sleeves!

Fast forward a few years, and now self-expanding stents, balloons (drug-coated and plain), steerable sheaths, atherectomy devices, intraluminal lithotripsy, Fiber Optic RealShape (FORS) technology, laser fenestration, percutaneous fistula creation devices, transcarotid stent placement with flow reversal are but a few of the technologies that are commercially available to change the landscape of options that we offer our patients. I find it truly amazing that most of these were not in routine use when I was a medical student just a few short years ago! Recently, the PROMISE II trial was published in the New England Journal of Medicine highlighting the advantages of venous transcatheter arterialization technology for end stage chronic limb threatening ischemia. This, I suspect, will likely spawn a new industry around this technology. It’s exciting to be a trainee in these times of technological advancement!

However, with these options comes a paradox of choice. Walk through the vendor displays at any vascular meeting and it can sometimes be paralyzing the number of device options available. This is especially important because not all of our training have the same access to these devices. So the question becomes: How should we bridge these knowledge and practice gaps? Even better yet, how should we think about each of these technologies as we go through training?

I’m no expert but I have been thinking of this lately, remaining fully aware that I am a product of my training institution, and that I won’t be exposed to everything out there. In talking with my attendings and peers, I’ve distilled a method to approach this problem:

Read and case plan with attendings

Taking an active role in case planning is essential. I try to come up with my plan for treating a patient’s pathology (as if I were the attending) before I read the attendings’ plan in their notes and then discuss their approach with them. Clinic can be critical for this knowledge exchange. I’ve discovered that the operating room is not the place to come up with your initial plan.

Utilize the other human resources

In addition to planning with attendings, read and be familiar with the instructions for use (IFU) of the devices that you encounter. Pick the brains of the radiology technologists/nurses, and device representatives—many of whom rotate through other hospitals and are chock-full of tips and tricks to get out of trouble. I find the device representative who gives an honest appraisal of the strengths and weaknesses of their product most valuable.

Deliberate exposure

It’s impossible to use every device during training—even in the most “early-adopter” health systems. I’ve found that most device reps are ready to do a quick in-service with resident/fellow teams to show how their device works and how it adds to the vascular surgeon’s toolbox.

It’s important during these sessions to also speak to the device’s limitations, and in what patient population in shouldn’t be used in. On this note, if you can, go to conferences and learn.

Keep an open mind

I’m not an “early adopter” but philosophically, it’s important to keep an open and inquisitive mind. My ultimate goal is to be able to select the best device that helps the patient in front of me. At the end of the day as the surgeon, I assume the majority of the responsibility for the operation and its outcome. Therefore, in my mind, these are tools to aid our patient and we should be exposed to as much as we can during training.

Journal—and work the back table

This next one, I heard at a conference from Dr. Venita Chandra of Stanford University: During the senior years of training, keep a log of devices you like—and why. It’ll serve you well as an attending, especially as you may be the pioneer of a new technology within the hospital system you take a job in. On that note, during training, spend some time working the back table as a senior learner. It is important to know how to prep the devices and troubleshoot malfunctions.

It’s a given that over the next 10 years, technology for vascular disease will continue to advance. In the journey towards becoming competent, confident, and compassionate vascular surgeons we have to always think about the best option for the patient in front of us.

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

New analysis of chronic limb-threatening ischaemia patients places BEST-CLI trial into context within real-world setting

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New analysis of chronic limb-threatening ischaemia patients places BEST-CLI trial into context within real-world setting
CLTI
Study lead Eric A Secemsky

A new analysis of chronic limb-threatening ischaemia (CLTI) treatment outcomes was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA), a press release reports.

Following the initial results of the BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischaemia) trial in 2022, which found surgical intervention superior to endovascular revascularisation, questions remained regarding how inclusive the enrolled patient population was, how reflective the specialty of the physicians who performed the procedures are compared to the broader breakdown of US specialists performing peripheral procedures, and whether outcome rates are similarly observed in clinical practice among Medicare beneficiaries.

The BEST-CLI trial compared two CLTI treatment options, endovascular revascularisation and surgical bypass to understand which approach leads to better outcomes. While the study found surgical revascularisation to be superior, the generalisability of this study to the clinical population with CLTI has not been evaluated.

The new study sought to analyse a broader clinical population by identifying all Medicare beneficiaries between 2016–2019 and aged 65–85 years with a diagnosis of CLTI who underwent endovascular or surgical revascularisation. Revascularisation was stratified by endovascular, autologous graft, and non-autologous graft. The endpoint was a composite of major adverse limb events (MALE) and death.

A total of 66,153 patients were included in this study (10,125 autologous graft; 7,867 non-autologous graft; 48,161 endovascular). Compared to BEST-CLI Cohort 1, patients were older, more often female and had a greater burden of comorbidities. Endovascular operators for the study population versus BEST-CLI were less likely to be surgeons (55.9% vs. 73.0%) and more likely to be interventional cardiologists (25.5% vs. 13.0%). The risk of death or MALE in this cohort was higher with surgery (56.6% autologous grafts vs. 42.6% BEST-CLI Cohort 1; 51.6% non-autologous grafts vs. 42.8% BEST-CLI Cohort 2) but similar with endovascular (58.7% real-world vs. 57.4% Cohort 1; 47.0% real-world vs. 47.7%). Of those receiving endovascular treatment, major interventions occurred less frequently compared to the trial (10.0% real-world vs. 23.5% Cohort 1; 8.6% real-world vs. 25.6% Cohort 2).

“For critical limb ischaemia, the key is ensuring timely access to vascular care. Although the BEST-CLI trial is important, it does not fully capture the full range of CLI patients, including older patients with greater comorbidities,” said Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), the study lead, in a SCAI press release. “The findings from our study point to the need to individually tailor revascularisation strategies based on patient risks, benefits and preferences.”

The authors note that older CLTI patients may not experience the same benefit with bypass surgery as observed in BEST-CLI where at the time, fewer Medicare patients were enrolled in the trial.

A vascular mission: Defying assumptions in the fight against amputation in disadvantaged areas

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A vascular mission: Defying assumptions in the fight against amputation in disadvantaged areas
Lyssa Ochoa presents during the 2023 Houston Aortic Symposium

Lyssa Ochoa, MD, is used to the assumptions. One: ”What a nice program you have.” Another: “It must be so nice that you can give away all of this charity care.” 

Ochoa is the founding vascular surgeon behind the SAVE Clinic in San Antonio, geared in its entirety towards targeting the Texas city’s most socially and economically disadvantaged areas against the backdrop of some of the state’s most eye-watering rates of diabetes-related amputation. 

Her answers to these types of questions are to point out that she is not operating a program.

Rather, her work in these communities is her entire practice. SAVE—which stands for San Antonio Vascular and Endovascular—is a comprehensive private practice. As for that other assumption? “I don’t do charity care,” Ochoa says sharply. 

Ochoa, a native of the Rio Grande Valley in the borderlands of south Texas where she grew up seeing the same kind of health disparities which she now helps tackle in the city, is turning heads in the vascular community lately for her work in underserved communities. Recently, she has given revealing presentations on aspects of how she goes about her practice. At both the Houston Aortic Symposium (March 16–18) and the Society for Clinical Vascular Surgery (SCVS) Annual Symposium (March 25–29) in Miami, the themes of Ochoa’s talks—respectively “pioneering equitable vascular care” and “the path less traveled in private practice”—spurred those kinds of assumptions and questions. Many of those puzzled by it settle on the ultimate question of: “How does she manage to pull this off?” 

Making the numbers work 

She is, to be sure, a private-practice surgeon. The numbers still have to work—a bottom line marshaled by both Ochoa and her husband, also the SAVE Clinic business administrator. Which means she must fulfill a certain volume of work. But that isn’t to say Ochoa is not on a vascular mission. 

The need she describes is great: “We are in the most economically segregated city in the nation. Literally you can draw a line across the middle of San Antonio, and lifespan can vary up to 20 years. It is a very clear line.” 

Ochoa started out in private practice in the city as part of a large single-specialty group of vascular surgeons. Fairly quickly, Ochoa realized the practice culture was not a good fit for her goals as a surgeon. Yet it was here that she first struck on what would become the object of her future work. While there, Ochoa was assigned to the south side of the city, and what she saw, and the realizations her experiences spawned, helped fuel a career-defining move. 

“I had already established a practice in those areas, mainly because none of the other surgeons wanted to go there, and they were happy to let me go there myself,” she explains. “It was when I began to see that disparate care … I would see over and over again how the patients—depending on which hospitals they were at—they got treated differently. 

“Of course, when the patients came in on the south side, they were definitely sicker. They were younger. I was seeing patients in their early 30s who suffer from complications of type-2 diabetes, of amputation, being blind, on dialysis, heart attacks, strokes. It was just so profound for me when I experienced that—even different than when I trained in Houston in the county system. I knew that something was wrong and couldn’t figure out why.” 

Then she started to learn about the particular history of San Antonio. Of its manifestations of segregation. Red-lining. Non-investment in areas populated by minorities. 

“If you look at a red-line map of San Antonio, it is the same healthcare outcomes for COVID deaths, for diabetic amputations and all the other social determinants of health,” Ochoa says. “I now understood. It was that light-bulb moment for me of why we have such horrible outcomes and things are not changing. It’s because these whole neighborhoods, these whole communities, have a lack of investment in education, healthcare literacy, in food deserts, safe places to walk and play, access to the internet. They just don’t have that.” 

It is one thing to identify a problem and to begin to understand it, but quite another to devote an entire practice to its remedy. The decision to do so was fraught. At first, Ochoa wasn’t sure if she would be capable of pulling off all of the mechanics and finer points of starting a private practice from the ground up. Especially as she would be entering a vascular surgical practice environment dominated by the group she was leaving behind. That’s where the business acumen of her husband came into its own. A business plan. A business loan. The business nitty gritty. 

Ultimately, for Ochoa, it boiled down to the volume question. “How many patients do I have to see? How many surgeries do I have to do? How many endovascular procedures do I have to do?” she recalls saying. “I need to know I’m going to be financially viable and I’m not just going out there blind, hoping and praying that it is going to work. I also told him that I wanted to make sure that when we calculate what that was, that I am practicing evidence-based vascular surgery.” 

Conservative estimates eventually gave way to a confidence in Ochoa that she was on a viable track. “When I got that number, I had been doing that easily already,” she relates. “I knew that if I could get just as busy as I was in the other group that we would be fine.” 

In the interim, business planning went into full flow. An existing space was acquired for the practice in the south side of San Antonio. And Ochoa went on a fact-finding mission across the country to hoover up private-practice wisdom from other solo practitioners who broke out on their own. 

Today, the SAVE Clinic is buttressed by a main center and eight satellite clinics. The satellites operate on a time-share basis, made possible by a 15-passenger bus that is loaded with imaging equipment, techs, medical students, and even front desk staff, in order to meet vascular patients confronting the on-the-ground realities of social determinants of health where they are. 

Growth of the practice was quick, more than had been anticipated. Some of this owed to the fact that there were few alternative vascular surgery options in the market, Ochoa explains. For the SAVE Clinic, the result was one overstretched vascular surgeon. “My error in judgment would have been to start looking for another surgeon sooner,” she says chuckling. The hours, though, were no joke. She took 24/7 call for three and a half years. 

It wasn’t easy, Ochoa concedes, but her mission is clear. She wants to do vascular surgery in these areas in a particular way— not by competing but by offering something completely different to the other practice option in town. “We may both do vascular surgery,” Ochoa says, “but I am really focusing on how I help address the social determinants of health with my patients and within the communities. And that means addressing transportation issues—I go to them. Wrapping them around with resources to help them get their medications. To help them get resources for mental health. To help them if they don’t have insurance.” 

It is also multidisciplinary, looping in podiatry and primary care providers, for instance, to ensure care is a team sport. “We are here for more than just vascular surgery,” says Ochoa. 

The SAVE Clinic has been around for around five years now, growing from just eight members of staff to a current workforce of 37, including one additional full-time and two part-time physicians. They also outgrew their original location, moving into a new 10,000-square-foot building— complete with two operating rooms—a year and a half ago. 

This new space also plays into Ochoa’s team-sport vision for healthcare in these communities. “The reason we built the surgery center is not because I can do a lot of surgery on the south side—I usually need hospitals,” she points out. “But it now creates a space for other specialists to come in, to come to this area of town, to provide the care that [the people here] don’t have.” 

Setting an example 

The question then might be less about how this type of practice can be done, but rather why it should be. Ochoa makes clear she became a physician through luck and opportunity. So she takes a collaborative approach, working with stakeholders such as local politicians and academic medical centers. “I have been able to use my practice as a vehicle for advocacy for this area of town—for these populations,” she says. “People opened doors for me, and it is now my obligation to do the same. If I want future physicians and healthcare workers to do the work that we are doing, then I have to be a part of that training paradigm.” 

That means working with everyone from high school students to medical students and beyond in order to “build the future healthcare force that is going to do this kind of work, and believes that it is possible we can do it the right way and benefit a community—and that it is a financially viable way to do things,” Ochoa says. 

And that notion that, somehow, she must be carrying out charity care? It looms at the coalface of actually making sure patients get the treatment they need. “Part of the way it works is I’m where the need is,” Ochoa continues. “There are many, many patients that need help in this area. We are of the mindset that we will adjust and be flexible, and we will figure out how to make things work. An example: In my area of town, we have about 30% of unfunded [patients]. That’s what the numbers show. We still have a lot of Medicare and Medicaid, which pays just fine, but I will see my unfunded patients in the hospital, which is where they end up. And none of these hospital systems—we have just one 87-bed hospital to take care of over half a million people on the south side of San Antonio, by the way—pay me to take care of unfunded patients.” 

Which is where the team effort kicks in once more—in order that not only is care delivered but the model remains financially viable. “I take care of them at that instant for that episode of care, and that I do for ‘free,’ so to say,” Ochoa explains. But what she also does is pair those patients with what she calls her “navigator,” whose deep-diving role involves finding a funded solution for them in the long term. “She knows the health insurance plans and the resources in San Antonio very well,” Ochoa elaborates. “She will sit with that patient, figure out what their finances are, what their needs are, and every single person I have sent to her has been able to find a marketplace plan or Medicare or Medicaid, or some of the non-profits to help get them care.” 

Once an insurance provider is secured, the theory follows that Ochoa then has a reimbursement source going forward. “I don’t consider that charity care because I’m just putting in a little bit of effort in the beginning—which we all should—to help the patient get what they need, and then I’m reimbursed for their care,” she says. “And once a vascular patient, always a vascular patient, so they become lifelong patients of mine.” 

Sometimes the how and the why questions of the SAVE Clinic and Ochoa’s efforts co-mingle. And, sometimes, the interlocutors can be closer to home. Much closer. “My father was once, like, ‘What are you doing? You’re just banging your head against a wall.’ I’ve had one of my mentors say, ‘Why are you doing this? This is going to kill you.’ I say, ‘No, actually, the opposite.’ 

“What does get frustrating for me as a physician is when I work and take care of these people, and the people who became physicians, who trained to take care of patients—they don’t do their job, and I have to fight them to take care of patients. That’s frustrating, because we are all physicians. That’s why we became doctors—to take care of those who are suffering and figure out a way to help them.” 

The road ahead 

What Ochoa founded in the SAVE Clinic was a way to pair her training and education with a passion for trying to make a difference. So, to that original assumption, hinting at the impossibility of it all, she has a question and an answer: “Is it really possible by doing it the right way? Yes.” 

To those who may follow, she says this: Doing the right thing for patients for the right reasons, and practicing the specialty the way it was meant to be practiced, will ensure, in the end, things will work out. “I hope that, with what I am doing, I leave people behind me; that I’ve opened doors for them, laid a path for them, inspired them, educated them to come in and do the same. Even if I don’t move the number on diabetic amputations, I’m hoping that, through all those interactions, I leave some kind of legacy of hope—and that I’ve tried.” 

New ‘biopsychosocial’ roadmap set out to address PAD treatment and mental health impacts

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New ‘biopsychosocial’ roadmap set out to address PAD treatment and mental health impacts
mental health
Kim G Smolderen and Carlos Mena-Hurtado

A recent proposal has called for “whole-person, multidisciplinary interventions” after an interrogation of the interplay between lower extremity peripheral arterial disease (PAD) and mental health impacts. Published in the Journal of The American College of Cardiology, researchers have put forward a “biopsychosocial” PAD management roadmap, offering solutions to current care “obstacles” to better attend to both behavioral and social health needs throughout vascular treatment.

Posing significant public health concerns, Kim G. Smolderen, clinical psychologist, and Carlos Mena-Hurtado, interventional cardiologist, from Yale University in New Haven, Connecticut, et al note that PAD affects roughly 8.5 million individuals in the USA and 220 million globally. Individuals of workforce age have become a growing area of concern, however, due to an increase in PAD-related hospital admissions presenting with critical limb ischemia, the “most severe” form of the disease.

With PAD, multimorbidity is “common,” which includes both mental and physical health conditions that the authors assert disproportionately affect underrepresented groups and younger people. “Younger patients are most likely to present with mental health conditions and modifiable cardiovascular risk factors with a behavioral component” Smolderen and Mena, founders of the Vascular medicine outcomes (VAMOS) lab at Yale, et al state. They note that these can include obesity, smoking and poor dietary habits.

Rooted in “maladaptive” health behaviors, the authors believe these conditions are directly undermining cardiovascular health and disease management. This link can be seen between depression and anxiety in the context of endovascular and surgical revascularization, which are associated with increased mortality, major amputation and higher costs.

The “PAD experience,” including the clinical and financial burden of the comorbid conditions linked with PAD, have received “little consideration,” Smolderen, Mena and colleagues opine. This lack, they believe, is driving the need to “expand the PAD care paradigm” to a biopsychosocial one, which acknowledges the contribution of both behavior and psychosocial factors on disease management and outcomes. “The substantial societal cost of healthcare for patients with PAD, including the need to close the gaps for observed disparities and health inequities in PAD, requires a broader perspective of PAD care,” the researchers convey.

Their roadmap identifies four domains that, once addressed, can redesign vascular specialty care services to attend to the behavioral and social health needs of all patients.

Identifying first a “fundamental problem” in the way physical and mental health are divided when providing care, the authors pinpoint the “major advocacy efforts” that are needed across professional organizations serving populations of PAD. Their recommendations begin at trainee level across disciplines and specialties, defining “core competencies” which reduce stigma and “unawareness” around mental illness and its effects on PAD.

Second, they outline the evolution of highly technological and procedural care which has been “valued disproportionately” over preventative and psychosocial care in the context of reimbursement and code availability—which the authors note are both presently absent from cardiovascular speciality care. To rectify this, they believe payment reform is needed, allowing for “codes and compensation for integrated care models” which should be piloted to integrate quality metrics of care delivery, including mental health screening and treatment tracking in such a manner to affect payment of services.

Thirdly, Smolderen, Mena and colleagues emphasize that despite several evidence-based interventions stemming from high-level randomized controlled trial evidence across cardiovascular populations, there is a prevalent “lack of awareness” among health administrators regarding the “scope of practice” of allied mental and behavioral health physicians in the context of chronic disease. They believe adopting a formal approach to assessing behavioral health could be a solution for this, assigning “routine components of care” and “expanding system capacity to address health disparities and behavioral health conditions.”

As an extension of their solution, they assert that “interprofessional team-based training” that promotes “a climate of mutual respect and shared values, moving away from a hierarchical system of care delivery and delineating roles” be established. Furthermore, Smolderen, Mena, et al state that investments in program building and coordination for vascular patients must be made, as well as the promotion of integrated care for diverse and uninsured populations, to “broaden access” and remove barriers to PAD care.

Their fourth and final area of proposed reform concerns integrated behavioral care practice guidelines for PAD management, and the formation of better evidence-based workflows derived from comparative effectiveness and implementation research—which they currently believe to be “lacking.”

“Funding budgets for research,” the authors state, “is needed to generate evidence for implementation models of integrated care delivery, tailored to the PAD context”.  Smolderen, Mena et al conclude that research is needed to address “clinical, operational and financial” outcomes—which includes decreased cost of care for comorbid patients—relevant to multiple stakeholders. To this end, they believe quality efforts at a national level will help to “benchmark data” for PAD care, “integrating social determinants of health, and tracking the use of integrated care services for vascular populations.”

Reinterventions after physician-modified endovascular grafts ‘non-detrimental’ to long-term survival

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Reinterventions after physician-modified endovascular grafts ‘non-detrimental’ to long-term survival
Senior author Sara Zettervall

For the treatment of juxtarenal aortic aneurysms, reinterventions after physician-modified endovascular grafts (PMEGs) are non-detrimental to long-term survival. This is one of the main findings of a recently published study by Ayumi Tachida (University of Washington School of Medicine, Seattle, USA) and colleagues.

The authors note in their Journal of Vascular Surgery (JVS) paper that the frequency and impact of reintervention on mortality after PMEGs in unknown. It was the aim of the present study, therefore, to describe reinterventions after PMEG for the treatment of juxtarenal aneurysms and their effect on survival.

Tachida et al used 11 years’ worth of data (2011–2022) from a prospective investigational device exemption clinical trial in their study. The trial in question—officially titled ‘Physician-modified endovascular grafts for the treatment of elective, symptomatic or ruptured juxtarenal aortic aneurysm: an investigator-initiated study’—is being led by Benjamin Starnes (University of Washington, Seattle, USA), who is also a co-author of the JVS paper. The trial aims to enrol 300 participants with an estimated completion date of January 2035.

On the Clinical Trials webpage for the study, it is mentioned that not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair, with the reasons for exclusion noted to predominantly involve a lack of a suitable proximal aortic neck. “Solutions to this problem involve multi-branched or ‘fenestrated’ endografts, which are being assessed in other clinical trials,” the study description continues. However, it is highlighted that grafts in these trials require between six and 12 weeks to manufacture and deliver to the investigational site.

“We seek to evaluate the safety and efficacy of PMEG using a US Food and Drug Administration [FDA]-approved, off-the-shelf device in order to increase the applicability of these technologies to more patients and thus save more lives,” the description reads.

In the study reported in JVS, reinterventions after PMEG were categorised as open or percutaneous and major or minor by Society for Vascular Surgery reporting standards according to high or low magnitude based on physiological impact. The investigators also categorised reinterventions by timing, as well as those interventions which occurred within one week of PMEG. They compared survival between patients who did and did not undergo reintervention and between reintervention subcategories.

Writing in JVS, Tachida and colleagues relay that a total of 170 patients underwent PMEG in the 11-year study time period, 50 (29%) of whom underwent a total of 91 reinterventions (mean reinterventions/patient, 1.8). They report that freedom from reintervention was 84% at one year and 60% at five years. The authors specify that reinterventions were most often percutaneous (80%), minor (55%) and low magnitude (77%), with the most common reintervention being renal stenting (26%). They also note that there were 10 early reinterventions within one week of PMEG and that two aortic-related mortalities occurred after reintervention.

There were no differences in survival between patients who underwent reintervention and those who did not, Tachida et al also communicate in the results section of the paper. However, they continue, survival differed based on the timing of reintervention.

Tachida and colleagues further share that, after adjusted analysis, reintervention within one week of PMEG was associated with an increased risk of mortality both compared with late reintervention (hazard ratio [HR], 11.1; 95% confidence interval [CI], 2.7–46.5) and no reintervention (HR, 5.2; 95% CI, 1.6–16.8).

Study finds no correlation between TEVAR timing and uncomplicated type B aortic dissection outcomes

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Study finds no correlation between TEVAR timing and uncomplicated type B aortic dissection outcomes
timing
Adam W Beck

With proper patient selection, short-term outcomes of thoracic endovascular aortic repair (TEVAR) in acute uncomplicated acute type B aortic dissection (uTBAD) are similar irrespective of the timing of treatment after dissection. This is according to a study recently published in the Journal of Vascular Surgery (JVS).

Authors Adam W Beck (University of Alabama at Birmingham, Birmingham, USA) and colleagues write in their introduction that the timing of TEVAR after the onset of uTBAD “remains controversial”. The objective of the present study, against this backdrop of contention, was to evaluate the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) post-approval study (VQI PAS) data for the impact of TEVAR timing for uTBAD on early and late outcomes. These included mortality, procedural complications, and long-term reintervention.

The investigators note that the VQI PAS used for this analysis includes a total of 606 patients. Those patients with uTBAD—who were defined as those without rupture or malperfusion—exclusive of cases categorised as emergency (n=206), were divided into groups defined by the SVS/Society of Thoracic Surgeons reporting guidelines based on the timing of treatment after the onset of dissection. The three groups were: treatment within 24 hours (n=8), between one to 14 days (n=121) and between 15 to 90 days (n=77). The researchers used univariate and multivariable analysis to determine differences between timing groups for postoperative mortality, in-hospital complications and reintervention.

Demographics and comorbid conditions were “very similar” across the three TEVAR timing groups, Beck et al detail. The authors state that there were some “notable differences” between the groups, including higher prevalence of baseline elevated creatinine (>1.8mg/dL)/chronic end-stage renal disease and designation as ‘urgent’ in the <24-hour group, as well as a higher rate of preoperative ß-blocker therapy in the one- to 14-day group.

The authors report that postoperative stroke, congestive heart failure and renal ischaemia were more common in the <24-hour group without an increase in mortality. Unadjusted 30-day mortality across the groups, they continue, was lowest in the early TEVAR group (0%, 3.3% and 5.2%; p=0.68), as was the one-year mortality (0%, 8.3% and 18.2%; p=0.06). However, they add the caveat that these results were not statistically different at any time point.

Furthermore, Beck and colleagues reveal that reintervention out to three years was not different between the groups, and that multivariable analysis demonstrated the need for a postoperative therapeutic lumbar drain to be the only predictive risk factor for mortality (hazard ratio=7.595, 95% confidence interval: 1.73–33.337, p=0.007).

In the conclusion of their study, Beck et al acknowledge that patients with uTBAD treated within 24 hours were unusual (n=8) and the group was “too small for valid statistical comparison”. They add that these patients “likely represent a high-risk subgroup, which is manifested in a higher risk of complications”.

Although there was a “trend” toward improved survival in the acute (one- to 14-day) phase, the researchers summarise that outcomes did not differ compared with the subacute (15- to 90-day) phase with relation to early mortality, postoperative complications, or one-year survival. They state in closing: “These data suggest that the proper selection of patients for early TEVAR can result in equivalent survival and early outcomes.”

Efforts to move towards routine patch closure or eversion endarterectomy among all carotid surgeons “warranted”

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Efforts to move towards routine patch closure or eversion endarterectomy among all carotid surgeons “warranted”
Magnus Jonsson

A nationwide cohort study of over 9,000 patients shows that the “controversial” practice of arteriotomy closure for carotid endarterectomy (CEA) is associated with an increased risk of ipsilateral stroke and “should be avoided”. Instead, authors Magnus Jonsson (Karolinska University Hospital, Stockholm, Sweden) and colleagues argue, endarterectomy should be performed with either routine patch closure or using the eversion technique. Despite these findings, the authors underline the fact that primary closure “remains common practice” among some surgeons.

The study—recently published as an Editor’s Choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES)—also shows that the long-term durability of different patch materials is equivalent, and that bovine pericardium and eversion have a lower risk of late infections.

Jonsson et al note in their introduction that current European guidelines recommend both eversion CEA and conventional CEA with routine patch closure, rather than routine primary closure. However, they add, “many surgeons prefer selective patching and there remains much controversy about the relative benefits of the different surgical techniques and patches for CEA”. The aim of the present study was to evaluate the short- and long-term outcomes after CEA based on surgical technique and patch material.

The investigators detail that there are several available patch types on the market at present. “Dacron, vein and polytetrafluoroethylene (PTFE) have been used for a long time,” they state, adding that bovine pericardium has been used in more recent years. “Bovine pericardium may have the advantage of greater resistance to late infections and smaller haematomas than other patch types, but there are few long-term follow-up studies comparing pericardium with other patch materials,” the authors comment.

The researchers conducted a registry-based study on all primary CEAs performed for symptomatic carotid artery stenosis in Sweden from July 2008 to December 2019, which numbered 9,205 in total. This was cross-linked with data from the Swedish stroke registry, Riksstroke, and chart review for evaluation of any events occurring during follow-up, they detail. The primary endpoint was ipsilateral stroke <30 days and secondary endpoints included reoperations due to neck haematoma and <30-day ipsilateral stroke, >30-day ipsilateral stroke, all stroke >30 days and all-cause mortality.

Reporting the results of their study in EJVES, Jonsson and colleagues reveal that 2,495 patients underwent eversion CEA and 6,710 conventional CEA for symptomatic carotid stenosis. They found that the most commonly used patch material was Dacron (n=3,921), followed by PTFE (n=588) and bovine pericardium (n=413).

Furthermore, Jonsson et al relay that a total of 1,788 patients underwent conventional CEA with primary closure, and that 273 patients (3%) had a stroke within 30 days of intervention.

They also share the finding that that primary closure was associated with an increased risk of ipsilateral stroke and stroke or death within 30 days: odds ratio 1.7 (95% confidence interval [CI] 1.2–2.4, p=0.002); and 1.5 (95% CI 1.2–2), respectively. During follow-up, which was a median of 4.2 years, the investigators report that 592 patients had any form of stroke and 1,492 died. “There was no significant difference in long-term risk of ipsilateral stroke, all stroke or death depending on surgical technique or patch material,” the authors communicate.

“There was an increased risk of ipsilateral stroke <30 days in patients operated on with primary closure compared with eversion CEA and patch angioplasty,” Jonsson and colleagues summarise in their conclusion, adding that there was no difference between primary closure, different patch types or eversion after the perioperative phase.

Strengths and weaknesses

In the discussion of their findings, the authors stress that the results of their study “should be interpreted within the context of the strengths and limitations associated with retrospective analysis of prospectively collected registry data”. Focusing first on the latter, they note that “the high validity” of the Swedevasc registry—with its almost 100% coverage for all carotid procedures performed in Sweden—and the possibility for cross linkage of data based on unique personal identifiers to assess long-term survival and stroke outcome “result in high generalisability and low loss to follow-up in this study”.

On the other hand, given the study assessed carotid procedures performed over a 10-year period, Jonsson and colleagues acknowledge that “changes in practice over time may be a confounder affecting results for factors not captured by the registry”. The authors elaborate that this may include changes in medical management of patients prior to surgery—including preoperative thrombolysis or antiplatelet therapy—as well as changes in periprocedural routines, such as use of different techniques for cerebral monitoring during carotid surgery.

In addition, the researchers recognise that the Swedevasc registry did not include data on arteriotomy length, width of internal carotid artery, type of anaesthesia and intracerebral vessel, and as a result, “these variables were not corrected for”.

Primary closure “remains common practice” by some

Considering the wider importance of their research, the authors write that their study “underlines the variation in surgical techniques used for CEA in Sweden,” underscoring the fact that up to 20% are operated on with primary closure without patch.

Jonsson et al reiterate in their conclusion that, due to its association with an increased risk of postprocedural stroke, the technique “should not be used”. In addition, they note the current report underlines the fact that selective primary closure “remains common practice” by some surgeons, and stress that “further educational efforts to move towards routine patch closure or eversion endarterectomy among all carotid surgeons are warranted”.

Primary patency after venous stenting best in NIVL patients, study finds

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Primary patency after venous stenting best in NIVL patients, study finds
Abre

A recent study concludes that non-thrombotic iliac vein lesion (NIVL) patients have better primary patency after venous stenting than patients with venous thrombotic disorders. Olivier Espitia (CHU de Nantes, Nantes, France) and colleagues report this main finding from a multicenter cohort study in the European Journal of Vascular and Endovascular Surgery (EJVES).

The authors detail that it was their aim to assess primary stent patency predictive factors in three groups of patients with history of lower limb vein thrombosis: NIVL, acute deep vein thrombosis (aDVT) and post-thrombotic syndrome (PTS).

The investigators included consecutive patients from January 2014 to December 2020 with history of lower leg vein stenting from seven hospitals in the study. They note that all patients received an iliac or common femoral venous stent and had at least a six-month follow-up available with stent imaging. The team reported the anticoagulant and antiplatelet therapy strategies employed after venous stenting and compared these between the three patient groups.

In their results section, Espitia et al state that the study included 377 patients in total, comprising 134 in the NIVL group, 55 in the aDVT group and 188 PTS patients, and that median follow-up was 28.2 months (interquartile range 16, 47). The authors report in EJVES that primary patency was statistically significantly higher in the NIVL group (99.3%) compared with the PTS group (68.6%; p<0.001) and the aDVT group (83.6%; p=0.002).

In addition, the researchers note that PTS patients received a statistically significantly greater number of stents (p<0.001) and had more stents below the inguinal ligament (p<0.001).

Finally, Espitia and colleagues relay the findings that discontinuation of antiplatelet therapy at the last assessment was 83.6% for NIVL, 100% for aDVT, and 95.7% for the PTS group (p<0.001). Discontinuation of anticoagulation therapy at the last assessment, they add, was 93.2% for NIVL, 25% for aDVT, and 70.3% for the PTS group (p<0.001). “The only predictor of worse primary patency in the aDVT group was long-term anticoagulation before stenting,” the authors highlight.

CX 2023: Venous, we have a perception problem

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CX 2023: Venous, we have a perception problem
Erin Murphy at CX 2023
problem
Erin Murphy at CX 2023

Venous disease care has a problem with optics in the context of growth in the number of venous procedures and the spectre of inappropriate care, the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) heard.

The conversation thread emerged in a question from Stephen Black (Guy’s and St Thomas’ Hospital, London, UK), posed to presenter Erin Murphy (Sanger Heart and Vascular Institute, Atrium Health, Charlotte, USA), who had just presented possible solutions that can be targeted at not only discouraging inappropriate venous care but also encouraging appropriately administered procedures.

Having trained and carved out a career as a venous specialist, said Black, if he were to suddenly decide “to now go and do a coronary angiogram and stent, I would get absolutely obliterated”. So, he asked Murphy: “Why is it that it is so easy for people who have never trained in veins just to crack on and treat veins without any consequences?”

Murphy pointed to a problem with misperception—”that this is an easy patient subset to treat, and I think those of us who are in this room treating these patients know that there is actually very complex decision-making [involved] in order to get the right outcomes for our patients,” she said. “We need to change that perception.”

Murphy had outlined several ways she sees of helping to curb the problem, building on a talk Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) gave last year. They included defining appropriate care through research initiatives, consensus statements and guideline data; educating and disseminating such data; holding practices accountable for decisions to carry out inappropriate care; and establishing correct financial incentives.

The biggest of these challenges currently involves educating a sprawling array of providers who treat venous disease patients, Murphy said. Are the right doctors treating the venous disease population? Vascular surgeons, for instance, “have no requirement in their board certification to be treating venous patients,” Murphy said, asking whether they are well-enough trained in the venous area. “Coming out of training, they have done about 40 venous cases overall.” Similarly, for interventional radiology, the situation is not any better, she reasoned. “Cardiology has no required training. So, what we do?”

The answer might be dedicated providers who undertake training and fellowship requirements specific to venous disease, as well as specific board certification, and accreditation. “This is in progress,” Murphy pointed out to the CX 2023 audience. “This is probably a direction that we need to go.”

In terms of accountability, she queried whether the venous space should be auditing for decision-making when people are trained appropriately. “We have seen when we identify practices that are doing things outside the norm,” Murphy explained, drawing attention to example of practices carrying out more ablations per patient compared to the average practitioner treating venous disease, “when we notified the practice of their outside-the-box numbers, they actually self-corrected to an extent.” The implication here is that they had been educated, she added.

Underdiagnosis and undertreatment probably affect more patients than overtreatment, particularly over time,” Murphy said. “So, we do not want to disincentivise. But a multimodal effort to address inappropriate care is needed, and, probably, educating providers is our number one thing.”

Study finds anatomic positioning and physical activity type can cause device fatigue in the iliac and iliofemoral veins

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Study finds anatomic positioning and physical activity type can cause device fatigue in the iliac and iliofemoral veins

stent deformationA recent multicentre, prospective study has found that stent deformations are greater in the common iliac vein with higher levels of hip flexion, as well as in iliofemoral veins with hyperextension at the superior ramus of the pubis.

Their results suggest anatomic positioning and physical activity type/level can cause device fatigue which must be considered for “careful” anatomic placement, activity modification and future device design and evaluation.

Central to their investigation, lead study author Christopher P Cheng (Stanford University, Stanford, USA) and colleagues set about characterising deformations of venous stents implanted into common iliac veins (for non-thrombotic iliac vein lesions) and iliofemoral veins (for deep vein thrombosis) due to hip movements commensurate with everyday activities such as walking, sitting, and stair-climbing.

Patients who were treated with iliofemoral venous stents were recruited from three centres and imaged with two orthogonal two-dimensional (2D) projection X-rays. Stents in the common iliac veins and iliofemoral veins crossing the hip joint were imaged in 0°/30°/90° and -15°/0°/30° hip positions. Subsequently, using the X-ray images, the researchers constructed three-dimensional (3D) geometries of the stents for each hip position and diametric, employing these to quantify bending deformations between those positions.

Of their results, Cheng et al note that 12 patients who received iliac vein stents experienced approximately two-fold more local diametric compression with 90° hip flexion, compared to 30° flexion. Continuing, they state those with iliofemoral vein stents crossing the hip joint experienced “significant” bending in the hip hyperextension (-15°) but not with hip flexion. Furthermore, Cheng and colleagues observed that in both anatomic locations, maximum local diametric and bending deformations were in proximity to one another.

The researchers’ observations conclude that stents implanted in the common iliac and iliofemoral veins exhibit greater deformation during high hip flexion and hyperextension, respectively, and iliofemoral venous stents interact with the superior ramus of the pubis during hyperextension.

Reflecting on this correlation, Cheng et al believe that device fatigue may be influenced by the type and extent of patient physical activity, alongside anatomic positioning. To this end, they underscore the potential benefits of activity modification and invite caution when planning an implantation strategy on a case-by-case basis. Additionally, they posit that the proximity of maximum diametric and bending deformations means that simultaneous multimodal deformations need to be considered for device design and evaluation.

Corner Stitch: Spotlight on VESS 2023

Corner Stitch: Spotlight on VESS 2023
Christopher Audu, MD and Nallely Saldana-Ruiz, MD
Christopher Audu, MD and Nallely Saldana-Ruiz, MD

This month, Corner Stitch highlights one of the papers recently presented at the Vascular and Endovascular Surgery Society (VESS) 2023 winter meeting in Whistler, British Columbia, Canada (Feb. 23–26). Nallely Saldana-Ruiz, MD, a senior vascular surgery fellow at the University of Washington in Seattle, and colleagues studied the trainee experience in open aortic reconstruction in the modern endovascular era—a topic on the minds of many trainees that sometimes influences how senior medical students rank programs. Here, she tells Christopher Audu, MD, what they found.

CA: Congrats on presenting at VESS 2023! Can you give us a synopsis of the study you presented?

NSR: Thank you. Presenting at VESS 2023 was truly a great experience. We were honored with the opportunity to share our work. Vascular surgery is a rapidly evolving field. While trainees around the country are exposed to many procedures during their years of training, some literature has demonstrated a wide variation in trainee experience and comfort with common procedures, including infrapopliteal revascularizations and in treating abdominal aortic aneurysm (AAA) disease.

We noted a paucity of data on the trainee experience with complex aortic surgery, and wanted to understand what the complex thoracoabdominal aortic disease trainee experience was for recent vascular surgery graduates. We collected anonymous survey data from U.S. vascular surgery trainees who graduated in 2020. We wanted to get a better understanding of their experience during training, as well as learn about their current practice and any desire for additional training. Our study adds the unique perspective of early-career vascular surgeons and is strengthened by the anonymous nature of the survey. This allowed participants the opportunity to freely share their experience and how that experience may have shaped their current practice patterns.

The limitations of the study include the small number of participants and the overall response rate. While it is certainly possible that the data can be biased by those who chose to answer the survey, we believe the responses provide a valuable insight into the early-career surgeon experience.

CA: What anecdotes or observations prompted this study?

NSR: The impetus for the study came from reading recent data, which demonstrated a wide variation in trainee experience with infrapopliteal bypasses and endovascular procedures. In their 2018 paper “Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training,” McCallum et al demonstrated a significant variation in trainee experience and comfort with treating infrapopliteal arterial disease.

They suggest that a quarter of vascular surgery trainees were receiving insufficient exposure to infrapopliteal open and endovascular procedures. Their study found that 27% of vascular surgery trainees performed 10 or less infrapopliteal vein bypasses, while 29% performed 10 or fewer infrapopliteal endovascular procedures. Given these data and the paucity of data on the experience of trainees with treating complex aortic disease, we were compelled to ask the questions.

CA: From your analysis, what does your team think is the “number needed to learn” for trainees to feel comfortable treating complex aortic disease as junior attendings?

NSR: It is important to recognize that we never stop learning, even as we transition out of our trainee roles. It is also essential to acknowledge that the “number needed to learn” will vary from trainee to trainee. Learning is different from mastery, and if you ask five different surgeons the same question you will certainly get five different answers. Still, I think it likely takes anywhere between five to 10 cases before you feel comfortable with attempting to independently manage the pathology. For thoracoabdominal aortic aneurysm (TAAA) disease, learning how to approach and care for patients is challenging on many fronts.

As an early-career surgeon, we will be faced with the complexities of decision-making and planning, all while carefully considering our patient’s physi­ology, anatomy, and fitness. Thus, “learn­ing” is truly a long-term endeavor that is never complete.

CA: What do you propose that trainees who don’t have that sort of TAAA volume do to gain a certain level of comfort with this option—especially the open component?

NSR: The thoracoabdominal aortic disease training at the University of Washington is robust, and as trainees we are very fortunate to have such opportunities. Still, there is great benefit from cadaveric and simulation courses around the country for all trainees. Learning through simulation and didactics in a controlled environment, such as through courses like “The Big Apple Bootcamp,” the “Moore course,” and the open aortic train­ing course at Houston Methodist Hospital, gives trainees unique exposure to the technical and clinical aspects of manag­ing thoracoabdominal disease. However, I believe that there is no substitute for doing cases with those who manage and treat pa­tients with thoracoabdominal disease often.

CA: Should the Association of Program Directors in Vascular Surgery, SVS or other vascular surgical societies make this a priority and sponsor open or simulation courses to help address this training gap?

NSR: Simulation and access to additional training should be supported. Additionally, some of the most beneficial aspects of partic­ipating in simulations and didactics center on the learning that occurs through interaction. So much of our clinical growth comes from

learning the intricacies of treating complex pathology through the experience of others. These are skills that cannot be mastered with independent simulation alone. In fact, one of the key findings of our study was that the vascular gradu­ates who continued to treat com­plex aortic disease in their practice were doing so with the participation of their partners. This highlights that as young surgeons we continue to learn from our mentors and colleagues.

CA: In your estimation, what was the most surprising finding from your study?

NSR: One thing we found most surprising was that while most trainees reported doing a low number of complex open and endovas­cular aortic cases during their training, many were performing them in practice. When we looked closer at the data, we noted that most of our trainees were doing these cases with partners. Early-career surgeons working closely with senior partners in early practice is not surprising at all, and our data helped us to understand that our current training par­adigm is one in which we continue learning from others.

CA: I have a feeling you may have already alluded to it, but what is the biggest takeaway you’d like our readers to gain from this work?

NSR: Continuing to learn in the years fol­lowing our formal trainee period is a critical part of our lifelong learning process. Still, because we found that the experience with the management of open and endovascu­lar complex aortic disease treatment var­ied among trainees in our study, additional training in the form of simulation, dedicated courses, or “super fellowships” can provide effective educational adjuncts.

Addition­ally, regionalization and the high-volume center—which provides dedicated care to patients with specific disease pathologies— may also afford the interested trainee the opportunity to learn a certain skillset in the form of visiting rotations and externships.

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

Contribute to PAC in April: Be honored at VAM in June

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Contribute to PAC in April: Be honored at VAM in June

This year’s VAM will include an “enhanced” Society for Vascular Surgery Political Action Committee (SVS PAC) contributor display, which will recognize SVS PAC donors from both 2022 and 2023. Deadlines for recognition for 2023 are April 15 for groups and April 30 for individuals.

The SVS will recognize practices that achieved 100% SVS PAC contributor participation within their groups in 2022 and those that achieve 100% 2023 participation in advance of the April deadline.

Members who believe their practices qualify for either 2022 or 2023 should email [email protected] to share the name of their practice and their colleagues’ names. Members who plan to make an SVS PAC contribution for 2023, and who do so by April 30, will have their names included on the 2023 SVS PAC contributor list at VAM.

Letter to the editor: The virtue of a social media presence for surgeons in the internet era

Letter to the editor: The virtue of a social media presence for surgeons in the internet era
vincent noori
Vincent Noori, MD

Dear editor,

I recently read an article in Vascular Specialist regarding the new age of the “vascular surgery influencer” that dis­cussed how the world of social media has invaded our “once-sane” specialty. While I assume the article was meant to raise awareness of the overuse of social media platforms and how it can violate HIPAA rights, it felt like a personal attack to all who use social media for vascular surgery and neglected all the positive attributes that these platforms have to offer.

I have been in practice for just over two years now. I am by no means an expert vascular surgeon. I am no complex aortic special­ist. I am your everyday vascular surgeon. Over the last two years, I have experienced, like all new vascular surgeons, successes—but also failures. While there are many successful revascularizations, the cases that have stuck with me more have been the defeats. All surgeons have these experiences.

We all like to discuss the topic of burnout and our mental health, and we all share our opinions on the matter, but it is not often that we have a good resource to manage these things. For me, social me­dia is my resource. It is an outlet where I can share my stories, and share my victories. And I have also discovered that I do like a little validation, or a “pat on the back.” They are a reminder that while this specialty is exhausting and filled with tribulation, victories do occur, and they are nice to share with people. Because one thing I have learned as an attending is that I do not always have people with whom to share this.

As a trainee, I was always surrounded by my colleagues in our call room. Our vent sessions—sharing our successful cases and our fail­ures—were a daily occurrence. It was a great place to learn as well: impromptu M&M conference was held every lunchtime. I miss that collegiality as an attending. While I am fortunate to have two great partners who are very supportive, at the same time they have their own lives. We do not often sit in a call room and discuss our cases. We have families to go home to. And at the end of the day, the last thing we want to discuss when we go home is vascular surgery.

So, for me, social media is that outlet. It is my “call room” that I visit to find colleagues to share my successes and have them con­gratulate. It is also the place I can share my failures with those who understand and can benefit from my mistakes, and where I can learn from others. I believe we are fortunate to have a social media presence in the internet era, where surgeons can still stay connected and learn from each other in an ever-evolving field, despite being miles apart. I believe there is a role for validation; there is solace to know that we are not alone when we face those specialty hardships.

Of course, there are issues of overuse and HIPAA compliance, which are important matters. As with any tool, these outlets can be misused, and we should know their limitations. However, that does not mean we should abandon social media completely. Instead, should we not embrace the future of our specialty, and help guide its presence in social medial? I doubt I am the only one out there who seeks a little validation from time to time.

Vincent Noori, MD 

Mercy Medical Center, Baltimore 

Vascular Specialist–May 2023

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Vascular Specialist–May 2023

In this month’s issue:

  • BASIL-2 points towards endovascular-first revascularization strategy in CLTI patients (p. 1 and 3)
  • A vascular mission: Defying assumptions in the fight against amputation in disadvantaged areas (p. 1 and 5)
  • Research on aortic size index as a predictor of AAAs in men vs. women highlights importance of evidence-based practice (p. 1 and 7)
  • From the Editor: We can honor the past without living in it, says Malachi Sheahan III, MD (p. 2 and and 4)
  • Your SVS: Officer candidates announced for 2023 elections (p. 4)

 

FDA approves dissection and transection indication expansion for RelayPro stent graft system

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FDA approves dissection and transection indication expansion for RelayPro stent graft system
dissection
RelayPro C NBS

Terumo Aortic announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of dissection and transection in the U.S.

A Terumo Aortic press release notes that RelayPro delivers uncompromised clinical performance in the lowest commercially available profile and is indicated for all pathologies of the descending thoracic artery; aneurysm, penetrating atherosclerotic ulcers, transection and dissection. RelayPro offers unparalleled accuracy, proven efficacy and durability as well as the widest range of sizes, tapering and configurations on the market, designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels, the release continues.

This approval follows the results from recent studies on RelayPro Dissection (RelayPro-D) and RelayPro traumatic injury (RelayPro-T).

The Pro-D study was a prospective, multicenter pivotal trial conducted in 22 U.S. centers and enrolled 56 patients with acute, complicated type B aortic dissection. Approximately two thirds of the subjects had dissection extension to the iliac arteries. The primary endpoint of all-cause mortality at 30 days was 1.8% and demonstrated a clear early survival benefit. Patients will be followed for five years.

National principal investigator of the Pro-D study, Peter Rossi (Medical College of Wisconsin, Milwaukee, USA), said: “The fully covered, non-bare stent (NBS) configuration of RelayPro was most used in the pivotal trial, highlighting the clinical value of this platform, and a full 86% of procedures were percutaneous. I am very encouraged by the one-year outcomes of this pivotal study which will be published soon now that approval of this new generation device has been granted; also, it is heartening that our dissection patients will have this additional option.”

The Pro-T study was a prospective, multicenter pivotal study that enrolled 50 patients in 16 U.S. centers. The purpose of the study was to assess the performance of RelayPro for the treatment of transection. The primary endpoint of the trial was all-cause mortality at 30 days was 2% with follow-up continuing for five years.

National principal investigator of the Pro-T study, Benjamin W. Starnes (University of Washington, Seattle, USA) commented: “We are looking forward to having this latest-generation device available for all thoracic indications. A low-profile device will be particularly useful for trauma patients who are typically younger and with smaller access vessels. Eighty per cent of the procedures in this study were percutaneous, highlighting a distinct value of the RelayPro stent graft system.” The approval of RelayPro-T also introduces a 22mm diameter option.

The RelayPro thoracic stent graft received CE mark approval in 2017 and FDA approval in 2021 for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).

The top 10 most popular Vascular Specialist stories of April 2023

The top 10 most popular Vascular Specialist stories of April 2023

In April 2023, Vascular Specialist readers were drawn to an interview dissecting the role robotics play, and can play in the future, in vascular surgery; a report of a new study that trialled the explantation of mature arteriovenous fistulas (AVFs) from patients with venous outflow obstruction; and a conversation with two members of the Society of Black Vascular Surgeons on the advocacy, mentorship and networking their society does.

1. Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief

An emerging program at Houston Methodist aims to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery, Alan Lumsden, MD, tells Vascular Specialist.

2. Computational model found to predict early aortic abdominal aneurysm rupture

In Physics of Fluids, researchers from the Indian Institute of Technology Varanasi and Indian Institute of Technology Kanpur published a computational model of the cardiovascular system in order to predict early abdominal aortic aneurysm rupture and monitor patients’ blood vessel conditions.

3. Award-winning paper finds F/BEVAR ‘feasible and safe’ in patients with failed aortic repairs

Andrea Vacirca, MD, revealed how, despite prior records which demonstrate that fenestrated-branched endovascular aortic repair (F/BEVAR) is “feasible and safe” in patients with failed aortic repairs, few studies have outlined the “granular data” to support this claim, which his team aimed to provide through their analysis.

4. SVS announces officer candidates for 2023 election

The 2023 Society for Vascular Surgery (SVS) Nominating Committee has announced the candidates for the 2023 officer election. For the full candidate biographies and statements—and to register for a May 17 “Meet the Candidates” event—visit the SVS website.

5. A call to arms: Reuse of mature venous conduits urged

“Recycle that vein!” is the appeal from the authors of a new study that trialled the explantation of mature arteriovenous fistulas (AVFs) from patients with venous outflow obstruction in one extremity and translocation of them to the contralateral extremity.

6. Intentional mentorship and pushing beyond representation

Chicago medical student Maria Paz, BS, discusses intentional mentorship—and why she believes it matters. 

7. Creating an AI-based tool to help clinicians perform precision AAA analysis

Vascular surgeon Randy Moore, MD, believes the route to a world of precision care for individual abdominal aortic aneurysm patients—involving aortic wall strength-mapping technology developed over the course of the last 15 years, allied to an artificial intelligence (AI)-powered algorithm—is drawing nearer.

8. Society of Black Vascular Surgeons builds bridges, connects international dots

A decade ago, if he were asked to name 10 Black vascular surgeons, says one African American vascular chief, he could have come up with six or seven. Vincent Rowe, MD, and Edwin Kendrick, MD, discuss the importance and work of the Society of Black Vascular Surgeons.

9. BASIL-2 points towards endovascular-first revascularization strategy in CLTI patients

In the BASIL-2 trial of 345 patients with chronic limb-threatening ischemia (CLTI), a best endovascular treatment-first revascularization strategy was associated with better amputation-free survival than a vein bypass-first strategy in those who required an infrapopliteal repair.

10. On 45th anniversary, CX Symposium chairman credits Chicago vascular surgical tandem for enduring success

Roger Greenhalgh, MD, tells how the brilliance of a meeting set up by John J. Bergan, MD, and James S. T. Yao, MD, inspired him to create something similar back in London, England, where the then-young vascular surgeon, soon-to-be surgery department chair, would birth the CX Symposium at Charing Cross in 1978. 

Xeltis presents six-month first-in-human data on aXess graft

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Xeltis presents six-month first-in-human data on aXess graft

Xeltis has presented “highly-encouraging” six-month data from its first-in-human (FIH) aXess vascular graft trial at the 13th Congress of the Vascular Access Society (VAS; 27–29 April, Porto, Portugal).

A press release outlines that six-month data from the FIH trial found that the aXess vascular access graft for haemodialysis demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary patency). At six months, a 0% infection rate and low re-intervention rates were reported, resulting in a highly favourable safety profile. Haemodialysis was successfully performed through the graft, and compared to current standard of care measures, which typically show lower rates of patency combined with a greater risk of infection or rejection, aXess demonstrated “extremely promising” results.

The full data will be presented by Matteo Tozzi (University of Insubria, Varese, Italy) in a presentation entitled “aXess Vascular GraftFIH trial 6-month outcomes” at the VAS conference.

Tozzi, who is principal investigator in Xeltis’ FIH clinical trial, said: “These six-month data are very promising in terms of patency and infection rates and suggest that aXess has great potential to be a game-changing alternative to existing vascular access options, which have a number of significant shortcomings. Xeltis’ vascular access implants, which harness the power of the body’s natural healing processes, could play a vital part in significantly improving the lives of patients requiring haemodialysis.”

The aXess FIH trial is a single-arm, non-randomized FIH feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects who are older than 18 years with end-stage renal disease, and who are deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after initial procedure, with full study follow-up visits to be conducted at five years. The aXess pivotal trial is currently enrolling up to 110 patients across up to 25 sites in nine EU countries.

Cook Medical treats first patient in first-in-human clinical trial for venous valve

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Cook Medical treats first patient in first-in-human clinical trial for venous valve
Paul Gagne

Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar, MD, a vascular surgeon at Clinica de la Costa in Barranquilla, Colombia.

The valve’s safety and efficacy are now being tested in a global, multisite clinical trial. The global principal investigator of the study is Paul Gagne MD, a vascular surgeon and an associate clinical professor of surgery at New York University’s School of Medicine. In addition to being a practicing surgeon and interventionalist, a press release notes that Gagne brings significant experience in performing clinical trials of minimally invasive vascular medical devices.

Cook Medical and Cook Advanced Technologies developed a valve that functions similar to the way the veins naturally work. The artificial valve is a novel proprietary design that mimics native venous valves.

“After extensive ultrasonic and venographic evaluation of venous anatomy, we placed the Cook Medical venous valve in the leg vein. The deployment took a few minutes and the patient had local anesthesia. It was a team effort to manage this complex case, resulting in the first clinical use of this venous valve,” said Alviar.

The clinical trial will continue to evaluate safety, efficacy, wound healing, leg pain, and disability levels over the next five years.

Help fund future of vascular health by serving on SVS Foundation Board of Directors

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Help fund future of vascular health by serving on SVS Foundation Board of Directors

The Society for Vascular Surgery (SVS) Foundation seeks applicants to fill a pair of two-year terms on the Foundation Board of Directors. The term starts in June and ends in June 2025. Applications are due May 12.

The Foundation seeks candidates with leadership skills, connected networks for raising funds and a natural affinity for cultivating relationships. Applicants also should possess integrity, credibility and a passion for improving the vascular health of patients and the public.

Members of the Foundation’s Board of Directors act as an envoy to help obtain philanthropic and corporate sponsorship. Directors support the Foundation’s work and provide mission-based leadership and support.

That mission is to optimize the vascular health and well-being of patients and the public through support of research that leads to discovery of knowledge and innovative strategies, as well as education and programs, to prevent and treat circulatory disease.

The SVS Foundation is committed to funding the future of vascular health through research and innovation, patient education, disease prevention and diversity, equity and inclusion.

Read more about the member position description here. Apply here.

Government Grand Rounds: Educating through advocacy

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Government Grand Rounds: Educating through advocacy
Anahita Dua

Since the initial launch of the Cancer Moonshot in 2016, the cancer community has made tangible progress towards ambitious goals, including accelerating scientific discovery in cancer, fostering greater collaboration and improving data-sharing. 

Just last year, U.S. President Joe Biden announced a re-ignition of the Cancer Moonshot, highlighting new goals, including reducing the cancer death rate by half within 25 years and improving the lives of people with cancer and cancer survivors. 

Cancer is a scourge on society, but we as vascular surgeons know that mortality rates in patients with critical limb ischemia (CLI) are higher than all cancers combined. 

So how is it that cancer as a disease process has reached the lips of the highest legislators in our society, while peripheral artery disease (PAD) is still essentially an unknown entity? 

The answer lies in our need to educate through advocacy. In the 1970s, both patients and physicians passionate about eradicating cancer made a concerted effort to lobby government representatives to support passage of legislation that increased National Institutes of Health (NIH) spending, rallied bipartisan support, and ultimately landed successes such as passage of the National Cancer Act of 1971. The latter intended “to amend the Public Health Service Act so as to strengthen the National Cancer Institute in order to more effectively carry out the national effort against cancer.” 

Because of these actions, cancer therapies have exploded onto the scene, and the public and our government understand the basics of the disease process and the need to support actions to manage it. This understanding of what is needed and how to achieve it has resulted in significant support through funding and education to ambitiously plan to rid the world of cancer through scientific discovery. 

We vascular surgeons now need to turn this tactic towards our patient population. Our patients are dying from cardiovascular diseases that have undiscovered genetic underpinnings and treatments that need to be studied and financially backed. 

We must understand that our legislators cannot be expected to be passionate about supporting bills when they do not fully understand the relevant clinical outcomes and how policies can impact the vascular population. 

It is our job to use advocacy to educate our lawmakers about the serious problems in the vascular surgery world so they can get behind the solutions that are best for our patients. For example, in some parts of the country, 50% of the amputations that take place for CLI occur without an angiogram! 

Wouldn’t it be nice if our lawmakers understood the relationship between an angiogram and potential limb salvage, and then advocated for a bill that said Medicare won’t pay for an amputation unless an angiogram is performed in a patient without sepsis? And wouldn’t it be nice if our lawmakers understood the labor and skill we put into an angiogram, and the subsequent distal tibial bypass, so we vascular surgeons can be appropriately reimbursed for our work? This is where education through advocacy can truly steer positive change for the next generation of patients and vascular surgeons. 

So, I implore you, my fellow vascular surgeons, please support the breadth of SVS’ advocacy programs—including the SVS Political Action Committee (PAC), grassroots advocacy via REACH 535, and whatever other opportunities are available—as these combined efforts are our strongest tools for educating our lawmakers about the diseases that kill our patients and the importance of our specialty. 

Without the right legislation in place, we will make little to no progress, as dollars will be funneled to other groups that do make the effort to educate. We have to make our own case; no one will do it for us. We owe this to our patients who need us to advocate for them on the national stage. 

For more information on how to help educate with the SVS’ advocacy programs, visit vascular.org/advocacy or contact [email protected]. 

Anahita Dua, MD, is an associate professor of surgery in the division of vascular and endovascular surgery at Massachusetts General Hospital/Harvard Medical School in Boston. 

Navigating the red tape: A case for hybrid ORs in the VA

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Navigating the red tape: A case for hybrid ORs in the VA
Courtney Morgan

The United States military has access to the most cutting-edge equipment to perform its duties, so we should expect nothing less for its veterans. As vascular surgeons, we all appreciate the importance of high-functioning, cutting-edge equipment. Over the past decade, hybrid operating rooms (ORs) have become more commonplace and are becoming the norm rather than the exception to be able to provide comprehensive vascular care in an efficient manner.1 

Any institution that has been involved in the acquisition of a hybrid OR system understands the complex process involved. Multiple stakeholders, including representatives from specialties expecting to utilize the equipment—OR leadership, hospital finance, acquisition committees and biomedical engineering—need to work together to determine the optimal operating system to best serve patients’ needs that will fit within the confines of the physical space and budget. 

This can be a particularly overwhelming challenge within the Department of Veterans Affairs (VA) system due to the increased level of bureaucracy involved. Like any institution, the utility of a hybrid OR must first be established locally. This often involves cooperation between services that will utilize the system besides vascular surgeons, such as neurosurgeons, interventional radiologists, cardiologists, pulmonologists and nephrologists, to name a few. 

In addition to vascular surgery, the progression of structural heart programs and transcatheter aortic valve procedures has largely driven this need and may create additional utilization when determining expected volume. Once the need for a hybrid OR system has been established within a specific VA medical center, approval through the Veterans Integrated Service Network (VISN) budget is required. 

Even with the support of the VISN, the high cost of hybrid room technology and intricate construction required for installation pushes this acquisition into the classification of High-Cost High-Technical (HCHT), and must go through the VA National Acquisition Center (NAC). The application considers all aspects of the project, including clinical justifications, finance, impact of veterans’ wait time, and how this all fits into strategic planning. 

Moreover, in selecting the specific hybrid system, because the purchaser is the federal government, additional layers of scrutiny are required to ensure open and fair competition among vendors. Once the system and construction budget is approved, additional time for construction and installation should be anticipated. Multidisciplinary collaboration for shared use of cardiac catheterization labs or interventional radiology suites may be required to continue to provide clinical services during a prolonged construction phase. 

Conquering the alphabet soup of government acquisition approval is well worth it in the end, and many high-complexity VA facilities already have hybrid ORs. Early adopters have been utilizing their hybrid ORs for nearly 20 years, providing equally complex endovascular aortic repairs to their partnering academic institutions.2 The direct impact on care of a hybrid OR for veterans is easily appreciated, but just as important is the impact on training the next generation of vascular surgeons, with more than half of VA vascular surgeons providing direct teaching to vascular surgery trainees.2,3 

Unfortunately, the lifetime of a hybrid OR is not indefinite, and several of the early hybrid ORs in the VA system are undergoing—or have already undergone—upgrades and replacement that are equally as involved as installing a new system. Just as the U.S. military is constantly evaluating its technology to ensure access to the optimal equipment, we as vascular surgeons should continue to advocate for the best equipment within our VAs to optimize care for veterans and enhance training. When undertaking such a planning project, start early and anticipate a lengthy, involved process. 

References 

  1. Spenkelink IM, Heidkamp J, Fütterer JJ, Rovers MM (2022) Image-guided procedures in the hybrid operating room: A systematic scoping review. PLOS ONE 17(4): e0266341. https://doi.org/10.1371/journal.pone.0266341 
  2. Flannagan CP, Gasper WJ, Caring for the veteran, training the surgeon: The role of the VA in vascular surgery training. Vascular Specialist. 2021 Aug 23 
  3. Longo WE, Cheadle W, Fink A, Kozol R, DePalma R, Rege R, Neumayer L, Tarpley J, Tarpley M, Joehl R, Miller TA, Rosendale D, Itani K. The role of the Veterans Affairs Medical Centers in patient care, surgical education, research and faculty development. Am J Surg. 2005 Nov;190(5):662-75. doi: 10.1016/j.amjsurg.2005.07.001. PMID: 16226937. 

Courtney Morgan, MD, is a member of the VA Vascular Surgeons Committee. 

Research on aortic size index as predictor of AAAs in men vs women highlights importance of evidence-based practice

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Research on aortic size index as predictor of AAAs in men vs women highlights importance of evidence-based practice
Blake Murphy

Seeking a better understanding of why women with ruptured abdominal aortic aneurysms (AAAs) have worse outcomes when compared with men, a new study champions adherence to “evidence-based practice” to challenge gender disparities within vascular surgery, in pursuit of sustained conversation about these differences within policy and research spaces.

Presented at the 2023 Women’s Vascular Summit in Buffalo, New York (April 28–29), lead author Blake Murphy, MD, an integrated vascular surgery resident from the University of Washington in Seattle, spoke to Vascular Specialist in the hopes that their research will prompt better awareness of health disparities within institutional practices over time.

“In the past five years, we have seen more frequent conversations about where our blind spots are—not only on a societal level but also within medicine—in how we treat and interact with patients who look different to us, or who come from different backgrounds,” Murphy said. “So I hope [our research] adds to the growing body of literature that promotes guideline-based practice for people of different races, ethnicities and genders and orientations.”

Clarifying the route they took to researching this area, Murphy began by referencing an earlier iteration of their current study in which they reviewed a AAA rupture database built between 2002–2018.

They found discrepancies between the amount of endovascular aortic repairs (EVARs) performed between men and women, with around 40% of women receiving EVARs after initial AAA presentation, compared with 55% received in men. Finding no significant difference in post-operative outcomes, Murphy noted that sex-related disparities in AAA diameter normalized when aortic size index was calculated.

Informing their next line of research, Murphy and her team sought to explore physical anatomical differences and the higher rates of rupture despite smaller AAA diameters. Using data from the University of Washington’s Harborview Medical Center—which is one of five level 1 trauma centers in the WWAMI region that includes Washington, Wyoming, Alaska, Montana and Idaho—Murphy emphasized the breadth of acute presentations they were able to access, as the institution covers such an expansive region.

Using the Society for Vascular Surgery (SVS) guidelines—published in 2009, which recommended an EVAR-first approach to treating ruptured AAAs—Murphy and her team found that the variations in how men and women were offered endovascular interventions were normalized.

Interrogating their results and any limitations, Murphy underlined the importance of acknowledging the “technological changes” that occurred between 2002–2018, such as the adoption of electronic medical records (EMRs). She explained the difficulties this technological hurdle posed when retrieving anatomical data which, if successfully accessed, may have better informed their current conclusions given that “one of the common arguments is that women are not offered endovascular intervention in these settings because of anatomic limitations.”

Murphy and her team have not been deterred by these blind spots, but instead use them to fuel further investigation. “This is a jumping off point for iterations about how to inform practice and specific examination of anatomical characteristics,” Murphy stated. “This research provides a pointed opportunity for not just our own practice, but vascular surgical practice in general,” she added, emphasizing the “incredible importance of industry collaboration” in the rapidly advancing space.

Reflecting on the importance of the Women’s Vascular Summit as an invaluable opportunity to “come together” as women in vascular surgery to discuss research, Murphy thanked her mentor Sara Zettervall, MD, associate program director at the University of Washington Montlake Campus, who is currently co-investigating for two investigational device exemptions (IDEs) within the complex aortic space at Harborview and the University of Washington Medical Center. “She is one of the people who are building an incredible research pipeline at the university, with tremendous support from our faculty in general,” said Murphy. “We certainly have plans to iterate on our current research, so you’ll certainly be seeing more from us.”

Wrapping up her presentation, Murphy acknowledged the fast-paced evolution of vascular surgical practice throughout the 21st century, and how, in a specialty so swiftly advancing, it is within healthcare specialists’ “ability” to “tackle disparities that we see in medical practice” and to continue to engage in “robust discussion” and consistent reevaluation to eliminate them.

Women’s Vascular Summit 2023: The ‘changing’ landscape of AAAs in women

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Women’s Vascular Summit 2023: The ‘changing’ landscape of AAAs in women
Indrani Sen

Since conducting an initial U.S. population-based study of gendered abdominal aortic aneurysm (AAA) trends spanning 40 years, Indrani Sen, MBBS, an assistant professor of surgery in the Mayo Clinic Health System, has used her research as a launchpad to delve into the specific differences women experience seeking diagnosis and treatment. The details of the study were presented at the 2023 Women’s Vascular Summit (April 28–29) in Buffalo, New York.

Breaking new ground, Sen’s previous research—led by Manju Kalra, MBBS, a professor of vascular surgery from the Division of Vascular and Endovascular Surgery at the Mayo Clinic in Rochester, Minnesota—used the Rochester Epidemiology Project to collect population-based data, finding that aneurysms are diagnosed and treated in women almost a decade later than in men.

“In the study, we essentially found that women whose aneurysms were not repaired had the highest aneurysm-related mortality—rupture was significantly higher in these women,” Sen reflected in conversation with Vascular Specialist ahead of her Women’s Vascular Summit presentation. “We also found that aneurysms are diagnosed at a smaller size in women, but eventual rupture rates did not differ. This led us to question if aneurysms in women should be repaired at a smaller size.”

Driving Sen to investigate further, her new research scrutinizes the clinical causes behind why women experience a delay to diagnosis and treatment, and to identify the root cause of this. “Reports have said that women lose the ability to have their aneurysms repaired due to aging and developing advanced arterial disease or other comorbidities that take prominence,” Sen elaborated. “This then means they are no longer eligible for aneurysm repair. As the population ages, this is a trend across the board, with patient diagnosis coming much later. But as this study demonstrated, this is specifically in women.”

Importantly, their recent research raises various questions surrounding AAA screening for women, which has historically been viewed as cost-ineffective due to the greater incidence of disease among men. Sen emphasized this fact too, making clear that AAA is still a “disease in men,” with complex aneurysms being more frequently seen in women, said Sen. Yet, she noted the diagnostic landscape for women is “certainly changing.”

Addressing issues with incidental aneurysm detection, which is most commonly how women are diagnosed with AAA, Sen’s research recognizes the cross-section of challenges which make diagnosis and treatment difficult in women—one of which is the presence of comorbidities that make women “reluctant” to undergo treatment, she stated. “It is often not the surgeon saying we can’t do it, but the patient.”

Outlining initial steps that could be taken to overcome this challenge, Sen asserts that greater awareness of screening and extended guidelines that include women who have a history of smoking and a family history of aneurysm are needed.

Having presented the first iteration of this research at a previous conference, Sen—when asked about its reception—stated their information seemed new to the audience, which was supported by a subsequent poll. The majority of participants—both vascular and otherwise—voted that women do not refuse aortic aneurysm repair, which makes visible the gaps in contemporary awareness where her team’s current research fills, she added.

Vascular community split over ‘death’ of traditional carotid stenting

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Vascular community split over ‘death’ of traditional carotid stenting
Peter Schneider (L) debates with Domenico Valenti
Peter Schneider, left, debates with Domenico Valenti

A debate between two prominent carotid interventionists—Peter Schneider, MD, professor of vascular and endovascular surgery at University of California San Francisco in San Francisco, and Domenico Valenti, MD, professor of vascular surgery at King’s College London in London, England—on the Wednesday of the 2023 Charing Cross (CX) International Symposium (April 25–27) in London revealed that the vascular community is currently divided over the benefits of transcarotid artery revascularization (TCAR), as compared to percutaneous carotid artery stenting (CAS).

Schneider kicked off the debate by arguing in favor of TCAR, initially outlining some of the limitations of percutaneous CAS that prior studies have demonstrated—for example, unwanted events relating to manipulation of the aortic arch as well as incomplete particulate capture. He went on to query if there is a “better way” to treat carotid artery disease, positing that TCAR may offer a solution that overcomes these limitations.

Once again referring to the current literature in this space, he noted that TCAR can enable greater neuroprotective capabilities; improved safety in symptomatic patients and octogenarians; and carries a more efficient learning curve, versus percutaneous stenting.

After reiterating the “unresolved challenges” CAS faces, including those relating to the aortic arch and particulate capture, Schneider concluded that prospective TCAR studies and his own experiences have shown both safety and efficacy with the procedure, demonstrating outcomes that are “competitive” with carotid endarterectomy (CEA) and “substantially better” than percutaneous stenting.

Offering a riposte to these assertions, Valenti stated that TCAR—in essence, at least—has been around for many years, and is therefore not the “disruptive technology” within carotid interventions it is sometimes presented as, also claiming that his opponent and other TCAR advocates have been “mesmerized” by the existing data.

Homing in on said data, Valenti challenged positive conclusions drawn from the results of the ROADSTER 2 trial, noting its non-randomized nature, low proportion of symptomatic patients and, “more importantly,” lack of stratified data on delay to treatment. Additionally, he told attendees that findings from the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative (VQI) are also limited by selection biases, gaps in the data, and the fact they come from a non-randomized trial.

Finally, Valenti noted that CAS has been subject to far more “intense scrutiny” than TCAR to date—for example, in the CREST, ICSS and SPACE randomized controlled trials (RCTs). And, while he commented that TCAR may yet prove useful in certain patients, they are yet to be identified, and the lack of RCT-derived evidence supporting it means the “death” of percutaneous stenting is not imminent.

A subsequent audience poll produced a very close result, but ultimately saw more CX 2023 attendees concur with Valenti’s closing gambit that “TCAR is not about to send CAS to oblivion,” as 52% voted against the statement that “TCAR is better than percutaneous carotid stenting.”

BASIL-2 points towards endovascular-first revascularization strategy in CLTI patients

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BASIL-2 points towards endovascular-first revascularization strategy in CLTI patients
Andrew Bradbury delivers BASEL-2 results at CX 2023

A question from Manj Gohel, MD, from Cambridge University Hospitals in Cambridge, England, on what the 2023 Charing Cross (CX) International Symposium audience should take back to their multidisciplinary team meetings from the first-time presentation of BASIL-2 led chief investigator Andrew Bradbury, MD, from the University of Birmingham in Birmingham, England, to deliver the stark message: a patient who needs a below-the-knee revascularization with or without a femoropopliteal revascularization is likely to do better if they are treated with a best endovascular-first strategy rather than a vein bypass-first approach. 

In the BASIL-2 (Bypass versus angioplasty for severe ischemia of the leg) trial of 345 patients with chronic limb-threatening ischemia (CLTI), a best endovascular treatment-first revascularization strategy was associated with better amputation-free survival than a vein bypass-first strategy in those who required an infrapopliteal repair—with or without a more proximal infrainguinal procedure. This result was largely driven by fewer deaths in the best endovascular treatment group. Bradbury, of the University of Birmingham, presented this key finding during a Podium First presentation yesterday morning. The results were simultaneously published in The Lancet. 

“It all seems to be pointing towards attempting an endovascular procedure first and then if that does not work, doing something else—which could be more endovascular,” Bradbury said in response to Gohel, who was asking a question from the floor of CX 2023 (April 25–27) taking place in London, England. Alternatively, he added, this could be the point at which the vascular specialist switches over to a bypass approach. BASIL-2, however, “lends quite a lot of weight” to an endovascular-first revascularization strategy, “with all the caveats that we have to consider.” 

Bradbury, delivering the data for the first time during day one of CX 2023, revealed that 63% of patients randomized to a vein bypass-first strategy of treatment underwent a major amputation or died during follow-up, compared to just 53% of those allotted to a best endovascular-first approach—BASIL-2’s primary outcome measure (adjusted hazard ratio 1.35, 95% confidence interval [CI] 1.02–1.08, p=0.037). 

“Essentially this means that, in this cohort, a vein bypass revascularization strategy resulted in a 35% increased risk of amputation or death during the follow-up compared with a best endovascular-first revascularization strategy,” Bradbury told the CX audience. 

Median survival for the whole cohort was 3.8 years—3.3 years for the vein bypass group and 4.4 for the endovascular arm, he said. “The significant difference we have observed in favor of best endovascular therapy with amputation-free survival is very largely driven by the fact that there were more deaths in the vein bypass group—53% of vein bypass patients and 45% of best endovascular therapy patients,” Bradbury continued. “There is no significant difference of 30-day mortality but you can see that the median survival of the two groups is quite different.” 

CLTI is the “severest manifestation” of peripheral arterial disease (PAD) and presents as ischemic pain at rest or tissue loss, or both, the authors detail in The Lancet. Against this backdrop, Bradbury and colleagues were comparing effectiveness of a vein bypass-first with a best endovascular treatment-first revascularization strategy in terms of preventing major amputation and death in patients with CLTI. 

“It is important to emphasize that the best way of analyzing this trial, which is the way our statistical colleagues have done it, is on the intention-to-treat population; however, for completeness they have done some sensitivity analyses, and this includes a per protocol analysis, which includes only patients who were adherent—that is, they received the allocated intervention they were randomized to,” Bradbury explained at CX. “They also performed an as-treated analysis, which is based upon the first revascularization that the patient actually received following randomization, and as you can see here they both trend towards reduced amputation-free survival in the vein bypass-first group.” 

The BASIL-2 co-investigators, namely statistician Catherine Moakes, MSc, senior nurse Gareth Bate, PGDip, and academic lecturer Matthew Popplewell, MD, all of Birmingham, and Lewis Meecham, FRCS, from the University Hospital of Wales in Cardiff, Wales, also presented during the session on the journey from BASIL-1 to BASIL-2, a hypothesis-generating prospective cohort study, methodology, study limitations and future work, among other topics. 

BASIL-2 was an open-label, pragmatic, multicenter, phase 3, randomized trial performed at 41 vascular surgery units in three countries: the United Kingdom (n=39), Sweden (n=1) and Denmark (n=1). The central site was the University of Birmingham. “Eligible patients were those who presented to hospital-based vascular surgery units with [CLTI] due to atherosclerotic disease and who required an infrapopliteal, with or without an additional more proximal infrainguinal, revascularization procedure to restore limb perfusion,” they state in The Lancet. 

Bradbury and colleagues randomly assigned participants 1:1 to receive either vein bypass or best endovascular treatment as their first revascularization procedure through a secure online randomization system. The Lancet paper details that participants were excluded if they had ischemic pain or tissue loss considered not to be primarily due to atherosclerotic PAD. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries, the authors communicate, while most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. 

Patients were followed up for a minimum of two years, Bradbury et al write, with data collected locally at participating centers. In England, Wales and Sweden, the authors note, centralized databases were used to collect information on amputations and deaths. They add that data were analyzed centrally at the Birmingham Clinical Trials Unit. 

The primary outcome of amputation-free survival was defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30 days after first revascularization. 

Between 22 July 2014 and 30 November 2020, the triallists enrolled and randomized 345 patients with CLTI—65 (19%) women and 280 (81%) men with a median age of 72.5 years (62.7–79.3). The patients were randomly assigned to either the vein bypass group (172 [50%]) or the best endovascular treatment group (173 [50%]). 

Bradbury detailed at CX that major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group. The relevant mortality numbers were 91 (63%) among the vein bypass group and 77 (53%) in the endovascular arm. 

In both groups, the authors write, the most common causes of morbidity and death— including that occurring within 30 days of their first revascularization—were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group). They add that the number of cardiovascular and respiratory deaths were not mutually exclusive. 

In the discussion section of their paper, Bradbury et al consider how their findings compare to those from the BEST-CLI trial, which were presented for the first time last November. “At first glance,” they remark, “our results appear to conflict with the BEST-CLI trial.” However, they note that there were “many differences” between the two trials, including the primary endpoint. “Our clinical experience suggests that few patients with [CLTI] are deemed suitable and have an optimal vein for infrapopliteal bypass,” Bradbury and colleagues comment, adding that future work is required to determine whether the patients enrolled in BASIL-2 are more like the patients with a non-optimal vein in the BEST-CLI trial. 

During the panel discussion following the BASIL-2 presentations at CX, Andres Schanzer, MD, chief of vascular surgery at the UMass Memorial Medical Center in Worcester, Massachusetts, asked Bradbury and colleagues to cast the findings against the backdrop of BEST-CLI. Moakes, who was the statistician for BASIL-2, explained that the team are planning to conduct an individual patient data meta-analysis to answer questions around any relevant differences between the two trials. 

‘A trial of two strategies’ 

Also during the discussion, the panel touched on the evolving landscape of endovascular treatment, with moderator Andrew Holden, MD, director of interventional radiology at Auckland City Hospital in Auckland, New Zealand, asking Bradbury and colleagues whether they had noted a significant change in endovascular practice in the period between BASIL-2 and its eponymous predecessor. 

Bradbury noted in his interpretation of the data that “there is a much greater willingness now that if you do an endo[vascular], and you are not happy with it, the interventional radiologists will go back and have another go, whereas what we tended to see, I think, in BASIL-1, was that if endo[vascular] did not work, [treatment would] quickly go over to bypass. I think that is the difference.” 

Moderator Dittmar Böckler, MD, professor of surgery at the University of Heidelberg in Heidelberg, Germany, urged the audience to keep in mind the various options that remain open when undertaking an endovascular-first approach. Greenhalgh underscored the point. “It also came out with BEST-CLI that the quality of the vein is important,” he said. “It is very, very crucial that whatever you do first, it does not have to be the last word.” 

Böckler said vascular specialists “need to learn from this trial which patient deserves which treatment”. It is not a case of surgery versus endovascular therapy, but rather a case of learning from the data, he added. Bradbury concurred. “It is a trial of two strategies,” he said. “That was what BASIL-1 was. It is quite a difficult concept to get across. We are not comparing a vein bypass with an endovascular treatment. We are in a sense—but what we are saying is, ‘What do you do first?’ If you have got equipoise, if you are really on the fence, and you do not know which to do, this trial suggests fairly strongly, I would suggest, that in this subgroup of patients, that you should go endo[vascular] first.” 

VAM 2023: Gala organizers seek auction donations

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VAM 2023: Gala organizers seek auction donations

The “Great Gatsby Gala” Committee is turning its attention to gathering auction items to entice bidders in both the Live and Silent auctions. 

The sky’s the limit, organizers say—anyone up for donating rides in a hot-air balloon, for example? In the past, members have donated weekend or even week-long stays at vacation homes across the country, in the mountains, and along the water. There even have been trips offered on other continents. In 2022, multiple people donated stays of five-to-seven days at their vacation homes or timeshares, raising more than $30,000 in donations. 

All proceeds benefit the Society for Vascular Surgery (SVS) Foundation. The Gala, with its Roaring Twenties-inspired theme, harkening the days of F. Scott Fitzgerald’s 1925 classic, The Great Gatsby, will take place Friday, June 16, during VAM 2023. 

Though the Gala’s Live Auction will be available only to ticket-holders, anyone, anywhere, can bid on the Silent Auction prizes, via computer. Those items will be available in early June, ahead of the Gala itself, with bidding closing during the event. Artwork from Chris Robb and a gift card to Enrico Cuini already have been donated. To donate items for the auctions, email [email protected]. 

Showcasing a ‘rewarding field’: student-trainee program at VAM deals with full spectrum of vascular surgery

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Showcasing a ‘rewarding field’: student-trainee program at VAM deals with full spectrum of vascular surgery

Besides being able to attend the scientific and educational sessions at the Vascular Annual Meeting (VAM), medical students and general surgery residents have an entire program devoted specifically to their career stage. 

The VAM Resident and Student Program includes: 

  • An introduction to vascular surgery, for pre-medical and medical students interested in learning more about the field of vascular surgery, 6:45 to 8 a.m. Thursday, June 15 
  • Succeeding as a vascular surgery residency applicant, for medical students who are planning to apply or who have already matched into vascular surgery residency training, 6:45 to 8 a.m. Thursday, June 15 
  • Succeeding as a vascular surgery fellowship applicant, for general surgery residents who are considering or plan to pursue vascular fellowship training, 6:45 to 8 a.m. Thursday, June 15 
  • A mock interview session, to prepare students and general surgery residents for vascular surgery training program interviews, 6:30 to 8 a.m. Friday, June 16 
  • A Residency and Fellowship Fair, from 1:30 to 3 p.m. Friday, June 16 
  • A welcome reception specifically for medical students and general surgery residents, from 5:15 to 6:15 p.m. Wednesday, June 14 
  • Mentor Mentee match, pairing students and general surgery residents with a vascular surgeon for on-site mentorship that often continues on in subsequent months and years 

Students and residents also enjoy highly discounted rates to attend VAM, ranging from $50–$100 for SVS member medical students to $375–$525 for SVS member residents. The exact fee depends on the registration date, which includes three zones. 

In addition, with the support of a faculty member, trainees are encouraged to submit cases for an education session set for Friday, June 16, called “Endovation II.” 

“The Resident and Student Outreach Committee (RSOC) carefully plans this program to showcase our specialty and the Society. VAM serves as an introduction to vascular surgery to those considering vascular surgery as a career choice; they can get an in-depth look at the research, technology and clinical cases that make vascular surgery a rewarding field of practice.

Also, students and residents have the opportunity to meet and network with peers, vascular trainees and faculty already practicing in this rewarding specialty,” said Bernadette Aulivola, MD, committee chair. “Over the years, it’s proved highly successful. Some of our most active SVS members became committed to vascular surgery after attending VAM as a student or resident.” 

It’s not just the programming, she said. Former attendees specifically mention the welcoming atmosphere and camaraderie amongst vascular surgeons at all levels, from newly minted surgeons to those with decades of experience. Aulivola also pointed to the depth and breadth of knowledge that is showcased at VAM, including cutting-edge research presented at the plenaries. 

Learn more at vascular.org/VAM.

First implant of custom-made thoracoabdominal hybrid device in North America announced

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First implant of custom-made thoracoabdominal hybrid device in North America announced
Thoracoflo device

Terumo Aortic announced the first North American implant of a custom-made hybrid device, Thoracoflo.

A press release noted that the device is used to treat patients with thoracoabdominal aortic disease using a less invasive surgical technique than traditional open surgical repair.

This thoracoabdominal repair procedure using Thoracoflo was carried out by Randy Moore, MD, from the University of Calgary in Calgary, Canada. Moore and colleagues were supported by Sabine Wipper, MD, from University Hospital Innsbruck in Innsbruck, Austria. Terumo Aortic details that Moore was able to access the device through the Health Canada Special Access program.

The lead center in Europe for this hybrid procedure, the company states, is the University Heart Center in Hamburg, Germany, under the direction of Sebastian Debus, MD.

Moore commented: “This unique hybrid graft was designed through Terumo Aortic’s custom device program, specifically for the patient we were treating. With no other device with similar technology currently available globally for thoracoabdominal aortic repair, the Thoracoflo graft is designed to reduce the risk of complications associated with thoracotomy and extracorporeal circulation. This is the first time the device has been implanted in North America; it was easy to implant, and the procedure was uneventful and straightforward. The patient is recovering well with no complications postoperatively.”

Terumo Aortic relays that Thoracoflo incorporates a combination of Terumo Aortic’s Gelweave woven polyester grafts and ring-stent technology to address the patient’s specific anatomy.

A call to arms: Reuse of mature venous conduits urged

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A call to arms: Reuse of mature venous conduits urged

“Recycle that vein!”—that was the appeal from the authors of a new study that trialled the explantation of mature arteriovenous fistulas (AVFs) from patients with venous outflow obstruction in one extremity and translocation of them to the contralateral extremity. Led by Guillermo A. Escobar, MD, program director of the vascular surgery fellowship and residency at Emory University in Atlanta, the small study’s abstract was put to the audience at the Society for Clinical Vascular Surgery (SCVS) 50th Annual Symposium (March 25–29) in Miami, and presented by Brandi Mize, MD, an Emory vascular surgery resident.

The authors note that unresolvable venous obstruction in cases of a patent AVF brings extremity dysfunction and pain, traditionally followed by the ligation and disposal of a mature vein. This leads to “prolonged dialysis catheter dependence” as a new vein is sought for maturation or a prosthetic is used. They say it can be “especially devastating” when there is not an appropriate alternative vein for access as catheter dependence leads to further central stenosis. Escobar et al sought to establish whether the translocation of even “potentially aneurysmal or thrombus-laden” AVFs was an effective treatment for the swelling associated with venous obstruction as well as a means of providing “early, autologous access” to reduce patients’ dependence on dialysis catheters. They asked: “Why ligate a >10mm autologous conduit?”

The authors removed matured AVF in patients with venous outflow obstruction and repaired them ex vivo if needed. The repairs consisted of thrombectomy, endarterectomy, resection/plication of aneurysms with end-to-end reanastomosis, or any combination. Following this, they were then reimplanted in patients’ contralateral extremities to form a new AVF.

They evaluated four patients facing occluded central or extremity outflow veins despite multiple attempts at endovascular resolution. “All patients had complete resolution of their original symptoms,” Escobar et al state. All went from experiencing “severe swelling, pain and a disfigured extremity”—even with “elephantiasis and ulceration of the arm”—to having a functional access following the procedure, with a mean time to use of 44 days (median 37) and as early as 20 days in their study, though Escobar et al add that earlier access is likely “feasible in as little as 14 days.” Primary patency was a mean of 315 days (median 300). Though three of the four needed repair or partial resection of AVF aneurysms before the implantation of their fistula in the contralateral extremity, only one required reintervention in the form of angioplasty of outflow vein without interruption of dialysis.

In their conclusion, the authors state: “Translocation of mature venous conduits to new sites seem very successful even if they require repair/resection of aneurysmal portions.” They note that “surgical times are long”, as the harvest, repair and reimplantation takes a mean time of almost 8hrs. The procedure also demands “meticulous technical skill” for the repair and anastomosis of what they call “a very mismatched vein to a radial artery,” but they say that it appears to offer resolution of symptoms and the creation of a functional, autologous access.

“In addition, there is short catheter dependence compared to traditional approaches of ligation, recreation and awaiting unpredictable AVF maturity,” they add. Speaking to Vascular Specialist, they suggest the findings offer a “paradigm shift” away from ligating mature AVF and instead “recycling” them: “We believe that discarding usable, autologous venous conduits should be discouraged despite the technical challenges.”

Surmodics announces successful first patient use of Sublime radial access microcatheter

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Surmodics announces successful first patient use of Sublime radial access microcatheter
The Sublime microcatheter

Surmodics has announced that Ankur Lodha, MD, an interventional cardiologist at the Cardiovascular Institute of the South in Lafayette, Lousiana, and Pradeep Nair, director of the institute’s vein program, were the first physicians to use the company’s Sublime radial access microcatheter. 

The Sublime microcatheter is in limited market evaluation, a press release notes. The full suite of Sublime microcatheters will be launched in 2024. The Sublime portfolio will include the industry’s first suite of 0.014”, 0.018”, and 0.035” high-performance peripheral microcatheters.

“For peripheral as well as coronary interventions, radial access is safer than femoral access and much preferred by patients,” said Lodha. “I am pleased to report that the Sublime microcatheter performed exceptionally well during our first uses of the device in treating peripheral arterial disease [PAD].”

“The lack of long-length, high-performance catheters for peripheral procedures has slowed adoption of radial access for treatment of lower-extremity artery disease,” added Nair. “Sublime microcatheters will fill a major gap in the peripheral-intervention toolkit, including for procedures from access sites other than the wrist.”

Available in five lengths from 65 to 200cm and compatible with 0.014”, 0.018”, and 0.035” guidewires, the press release details that the Sublime microcatheters Surmodics’ Pristyne hydrophilic coating for lubricity to optimize device trackability through vessel tortuosity. The device’s dual stainless steel, locked-braid layers work in unison to optimize torque control, push transmission, and deliverability to distal target lesions, the company adds.

The microcatheters are available in straight or angled tip configurations. The Sublime 0.014” and 0.018” microcatheters can be telescoped through the 0.035” Sublime microcatheter to provide additional back up support when navigating extreme tortuosity or heavily stenosed lesions, the press release continues.

FDA approves IDE for pivotal study of high-intensity focused ultrasound platform

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FDA approves IDE for pivotal study of high-intensity focused ultrasound platform
Sonovein HD

The Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application for the VEINRESET multicenter pivotal study that will evaluate Sonovein high-intensity focused ultrasound (HIFU) treatment for varicose veins, it has been announced.

Antonios Gasparis, MD, director of the Center for Vein Care at Stony Brook University in Stony Brook, New York, recently reported the first U.S. assessment of the echotherapy platform, showing 100% technical feasibility at three months.

Sonovein treats primary insufficiency of great saphenous veins (GSVs) by concentrating therapeutic ultrasounds to an internal focal point from outside of the body, according to investigators.

The pivotal study will be conducted at four centers in the U.S. and Europe, with Steve Elias, MD, director of the Center for Vein Disease at Englewood Hospital in New Jersey, acting as principal investigator in the U.S.

“We believe that this key study will confirm the positive findings of the FDA feasibility study, completed just two months ago, and will ultimately allow us to commercially address the U.S. market,” said Yann Duchesne, executive chairman of Theraclion, the company behind Sonovein, in a press release.

VAM educational sessions set to cover gamut of clinical and vascular practice matters

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VAM educational sessions set to cover gamut of clinical and vascular practice matters
William Robinson at VAM 2022 in Boston

With sessions covering a wide swath of topics important to vascular surgeons, including many proposed by Society for Vascular Surgery (SVS) members themselves, participants at the 2023 SVS Vascular Annual Meeting (VAM) are sure to find valuable information on both clinical and non-clinical topics important to the professional lives of vascular surgeons. 

That’s the word from William Robinson, MD, chair of the SVS Postgraduate Education Committee (PGEC), which plans the educational sessions at VAM. The meeting takes place June 14–17 at the Gaylord National Resort and Convention Center in National Harbor, Maryland, just outside Washington, D.C. 

“Our committee has striven to achieve a really good mix of topics,” he said of the 17 clinical and eight non-clinical sessions that comprise the educational sessions. “We have something for everybody, irrespective of where they are in their careers. We also try to mix clinical information with sessions related to education, practice management, advocacy for our specialty and professional well-being. In all of them, we strive for programs which are innovative and current, and try to use inventive and interactive formats to increase engagement.” 

The PGEC evaluated—blindly—63 proposals submitted by members in the fall of 2022. Committee members ultimately selected 18 proposals, and then worked with the submitters to develop the educational sessions. Those represent a large portion of PGEC programming. The remainder of the sessions cover clinical topics highly desired based upon feedback from SVS members, but which have not been addressed in three to four years. 

Throughout the meeting, sessions will cover what Robinson calls “updates and innovations in the meat and potatoes of vascular surgery,” such as hemodialysis, acute limb ischemia, venous disease and arterial intervention, while mixing in specialized and more focused topics. 

For example, the schedule includes a session on the “onco-vascular surgeon,” on vascular surgeons’ assistance in cancer operations. “This highlights the role vascular surgeons play in assisting multiple other specialties, of which cancer surgery is just one area,” said Robinson. 

“Every year, we consider what topics need particular emphasis based on current practice trends, important data and member feedback,” he said. This year, such sessions will cover venous disease, two of them offered in collaboration with the American Venous Forum, one on iliocaval stenting, and a second on “what’s new in deep venous thrombosis treatments.” 

In addition, a session is planned that takes a deeper dive into the BEST-CLI and BASIL-2 trials. 

The PGEC also works with the four SVS sections—Young Surgeons, Community Practice, Women’s, and Sub-Section on Outpatient & Office Vascular Care (SOOVC)—to develop educational programs sponsored by each. Topics include financial literacy (Women’s Section), the business side of running an outpatient facility (SOOVC), tips for surgeons in their first five years of practice (Young Surgeons Section), and a session on recognizing, enhancing and promoting the vascular surgeon’s value (Community Practice Section). Physician assistants will have separate educational sessions, including a luncheon and “Cases Over Cocktails” with the Society for Vascular Nursing. 

The educational sessions organized by the sections proved popular last year, said Robinson. 

“They allow a particular membership group to identify what large portions of SVS members think are important. It therefore gives all of our members an opportunity for a voice in the meeting content, and helps ensure this content is applicable and important to a diverse group of members,” he said. 

View the VAM Online Planner for detailed information on all presentations at vascular.org/OnlinePlanner23. 

May Vascular Research Initiatives Conference program takes shape

May Vascular Research Initiatives Conference program takes shape
Depiction of fibroblast cells

With an emphasis on cells—structural and immune—the program for the May 10 Vascular Research Initiatives Conference (VRIC) in Boston next month is taking shape. 

VRIC will be held at the Boston Marriott Copley Place in Boston, in conjunction with the American Heart Association’s “Vascular Discovery 2023: From Genes to Medicine.” The AHA sessions will be held May 10–13 at the venue. 

The conference emphasizes discussions of research of basic and translational vascular science, in a thoughtful atmosphere intended to motivate participants to discover solutions to important problems affecting vascular patients. VRIC brings together vascular surgeon-scientists, vascular biologists and other cardiovascular physicians researching vascular disease, and trainees working in the cardiovascular disease space. The 2023 theme is “Structural and Immune Cells in Vascular Disease.” 

Four abstract sessions will focus on venous disease and novel devices; vascular regeneration, stem cells and wound-healing; atherosclerosis and the role of the immune system; and aortopathies. 

Esther Lutgens, MD, will deliver the Alexander W. Clowes Distinguished Lecture, established in 2017 to honor the late SVS member and surgeon-scientist who had a big hand in shaping the conference over the years. Her topic is “Co stimulatory immune checkpoints in atherosclerosis: Novel immunotherapeutic targets to combat atherosclerotic cardiovascular disease.” 

Lutgens is a renowned molecular biologist and professor of cardiovascular medicine at the Mayo Clinic in Rochester, Minnesota. The day’s agenda also includes the Translational Panel. Chiara Giannarelli, MD, will focus on deep phenotyping of human atherosclerosis, and Bhama Ramkhelawon, PhD, will discuss structural triggers of macrophages in aortic aneurysms. 

“This is going to be an outstanding conference with a focus on vascular discovery. We had a near record number of abstracts submitted this year, many of which were by trainees performing exceptional research that will one day advance our understanding and treatment of cardiovascular disease,” said Katherine Gallagher, MD, chair of the SVS Basic and Translational Research Committee, which plans VRIC. 

“I don’t think anyone will leave VRIC 2023 anything but inspired, and hopefully the knowledge gained here will lead investigators to other pathways of inquiry.” 

Areck Ucuzian, MD, will present his research into “The benefits of moderate aerobic exercise on maintaining vessel structure in mouse models of aortopathy,” as part of his SVS Foundation Mentored Clinical Scientist Research Career Development Award. 

Four vascular trainees were selected as recipients of the SVS Foundation VRIC Trainee Award; their abstracts were scored among the highest of those submitted. They will present their work at the conference: 

  • Sharika Bamezai, BA, a Sarnoff Research Fellow at Stanford University School of Medicine and a medical student at University of Michigan Medical School, “Safety and efficacy of pro-efferocytic nanoparticles to treat atherosclerosis in a porcine model.” Her mentor is Nick Leeper, MD 
  • Tyler Bauer, MD, a general surgery resident at University of Michigan Medical School, “Inflammatory macrophages dictate fibroblast function via epigenetic reprogramming in diabetic wounds.” Mentor: Katherine Gallagher, MD 
  • Rodrigo Meade, BS, a research fellow at Washington University in St. Louis, “Fatty acid synthase targeting reduces aortic atherosclerosis and inflammation.” Mentor: Mohamed Zayed, MD 
  • Humraaz Samra, MBBCh, an integrated vascular surgery resident at Indiana University School of Medicine, “Allogeneic mesenchymal stromal cells significantly increase type 1 regulatory T cells, decrease effector Th17 cells and decrease aneurysm volume in a dose-dependent fashion in patients with small abdominal aortic aneurysms—Results of the phase I Aortic aneurysm repression with mesenchymal stem cells (ARREST) trial.” Mentor: Michael P. Murphy, MD 

A poster competition and cocktail reception also are included. For more information on the conference and to register, visit vascular.org/VRIC23. 

Intentional mentorship and pushing beyond representation

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Intentional mentorship and pushing beyond representation
Maria Paz
Chicago medical student Maria Paz, BS, discusses intentional mentorship—and why she believes it matters. 

When I started medical school, I never imagined that the most difficult part would be convincing myself that I deserved to be there. I remember at my first interview being separated at lunch to hear a presentation about diversity efforts at the institution. When I rejoined the rest of the students, I remember being asked where I went and one of my fellow interviewees telling me how lucky I was to be a minority. Suddenly, it felt like no one believed I was worthy of being there, least of all myself. I wish I could say this was an isolated experience. From that day forward, I felt as though I had to prove to everyone around me that I deserved the opportunities I had actually earned.

Even my advisors at the time would make comments about how much easier it was for me as a Hispanic woman—how my MCAT could be lower, my application less impressive. They even went so far as to say that scholarships would be given to me, and residency spots handed over easily. It didn’t matter that I had worked for five years building a resume worth accepting. My grades, efforts, and dedication were diminished to a singular box I had to check when I applied. While my other classmates were able to start their medical school journey with the joy and excitement of finally achieving their dream, I was left with self-doubt and imposter syndrome that would take me years to unlearn, or at the very least develop effective coping mechanisms for. 

The first time I met with my research mentor, she offered me the opportunity to help write a chapter for a textbook about disparities in surgery. I remember immediately feeling like I had to warn her that I would probably underperform. I wanted to set the expectations low for when I inevitably disappointed her. Years of striving to please advisors and admissions committees left me paralyzed with the fear of failure. She stopped me in the middle of yet another self-deprecating comment and said, “Stop worrying, you will be great.” Her singular vote of confidence was a startling contrast to the comments I had received in the past.

This was my first experience with what I now consider intentional mentorship. Intentional mentorship goes beyond representation. Instead of simply serving as an example, these mentors use their lived experiences and backgrounds to relate to their students and actively foster a meaningful relationship. The actions that differentiate intentional mentors from the rest often require little effort, like the words of affirmation I received during that first research meeting.

As medical students, we crave praise because we are so deprived of it. Words of affirmation are often so sparingly handed out but can have a lasting impact. Luckily, my mentors were not only intentionally telling me when they were impressed, but also did it vocally in front of other physicians and members of the team. Over time, their positive encouragement started to be louder than the negative self-talk to which I was so accustomed to listening. I stopped the self-deprecating comments and my mindset shifted from a fear of disappointment to an excitement about my untapped potential. 

Despite the confidence boost from my mentors, the realities of academic surgery continued to reveal themselves, including the significant financial investment required to progress in your training and, ultimately, your career. I never expected my vascular research mentors to recognize these barriers because they were so far removed from the life and budget of a student. Yet again, they all exceeded my expectations in their understanding and compassion for my circumstances when it came to presenting our research at a national conference. Whenever they could, they allocated funds from their own section budgets to help offset the cost of travel or help with registration fees. When this wasn’t possible, they were intentional about helping me look for travel grants, reminding me about scholarship application deadlines, and writing me recommendation letters for financial aid. They sought out every opportunity they could to help me, even nominating me for awards that not only added to my resume but gave me very real financial stability. I had underestimated the difference it could make to have people looking out for me professionally. All these small acts not only provided me with tangible aid but also helped me believe in myself. 

Then came my clinical rotations. I was immediately filled with anxiety about performing well on my vascular rotation. It was one of the only opportunities I would get to impress the section during my surgery clerkship. It would also be the first time I would interact with my mentors clinically, and again I was struck with the fear that I would disappoint. After two years of working with them in a research capacity, I was terrified they would regret investing in me if I didn’t “perform” well in the operating room. The night before I started on the service, I was cc’d on the weekly section email that included the faculty and trainees. At the very end of the email, it read “Perhaps everyone is already aware, but we have a medical student joining the team tomorrow, Maria Paz. She is interested in Vascular Surgery so let’s show her a good time.”

Those few lines probably took her less than five minutes to write, but it made all the difference in my experience on the rotation. People knew to expect me, and that someone they all admired believed in me. I truly think this led to opportunities that I wouldn’t have received otherwise. The fellow trusted me to assist with a chart review project he had been too busy to start, the attendings gave me extra learning opportunities during the procedures, and I began to really picture myself as a vascular surgeon. So many of my peers felt like they could never admit to their mentors when they were struggling. Especially given that those same physicians would be the ones reviewing their residency applications or writing their recommendations, it wasn’t an option to openly discuss issues like mental health or burnout.

I had so many questions about a career in surgery. How do I balance this dream and all the other things I want out of life? What kind of mother will I be? How do I stay healthy during this journey? The only thing I never had to question was that I could turn to the mentors in my life for help finding answers. Women in medicine who agreed to mentor me truly meant it, and would never judge me for struggling. Maybe without realizing it, these relationships gave me a framework for how I want to be once I finally achieve all my dreams. I know that when a medical student comes to me one day, I will be intentional about every interaction. I will remember the small things that made all the difference, and strive to show them exactly how to treat their future students. The cycle will continue, and all these small acts will add up to real and significant changes in medicine. 

I now realize the power of someone believing in me, which is multiplied when it originates from mentors that you look up to. I hope that sharing more of these experiences will provide physicians with real and actionable examples of ways to be more intentional about mentorship. Improving representation in the surgical workforce must begin with helping students believe they can succeed in this field. I believe that intentional mentorship could make all the difference in recruiting diverse students into a field they historically felt simply wasn’t for them. 

Maria Paz is a medical student at the University of Chicago Pritzker School of Medicine. 

The BeBack crossing catheter: A ‘game-changer’ in endovascular PAD practice

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The BeBack crossing catheter: A ‘game-changer’ in endovascular PAD practice
Andrej Schmidt

This advertorial is sponsored by Bentley.

Crossing chronic total occlusion (CTO) lesions is a challenging procedure. The BeBack crossing catheter—Bentley’s first product to be available in both Europe and the United States following the company’s acquisition of Upstream Peripheral Medical Technologies’ GoBack catheter in September 2022—offers a new solution in this space. In this interview, Andrej Schmidt, MD, a senior interventionalist at University Hospital Leipzig in Leipzig, Germany, who was one of the first to use the catheter, shares his clinical experience with the BeBack, noting how it has been a “game-changer” in his endovascular peripheral arterial disease (PAD) practice. 

What does your PAD practice look like, and what do you think are the most difficult aspects to overcome when treating CTO lesions? 

The University Hospital Leipzig is one of the larger centers in Germany for the endovascular therapy of peripheral arterial occlusive disease, and we receive a lot of very complex cases—many of them failed in other hospitals. These are very often patients with severely calcified infrainguinal disease, but also complex iliac total occlusions. 

Could you talk us through your first experience with the BeBack catheter? 

We were struggling with a CTO of the common iliac artery in an abdominal aneurysm patient, and failed to get through the CTO coming from retrograde, cross-over and antegrade using an arm-access. Nothing worked until, eventually, we used the BeBack catheter via the retrograde approach. With this, device passage through the CTO back into the aorta succeeded immediately. This experience was an eye-opener for us. 

Can the BeBack also be used as a support catheter? 

In addition to its main purpose as a crossing catheter for complex, calcified CTOs, the BeBack indeed can be used as a support catheter, since it is quite stable and stiff. This feature is very helpful in difficult total occlusions. It also can be used as a re-entry catheter—for example during a recanalization of a CTO of the femoropopliteal segment. In the typical situation of being stuck subintimally, unable to pass the guidewire back into the true lumen distal to the CTO, the BeBack reliably helps to re-enter the distal patent segment of the artery. 

How is the BeBack part of your recanalization strategy? 

This depends on the type of lesion and the problem encountered during the intervention. For example, a typical femoropopliteal CTO is usually approached from antegrade. In case of inability to penetrate the guidewire into the CTO, either due to dense fibrosis of the proximal cap or severe calcification, the BeBack catheter is used as a crossing device by pushing the adjustable needle just a little bit out of the tip of the 4F catheter. More frequent, however, is the situation that the guidewire passes the CTO subintimally, and reconnection to the patent lumen, distal to the CTO, fails. As mentioned, the BeBack catheter is then used as a re-entry-device by protruding the curved inner needle further out of the tip of the catheter. Different to other re-entry devices is that the BeBack is 4F compatible, instead of 6F, and introduction into calcified, tight lesions may be easier. Yet, it can be used over a 0.018” guidewire, which is often the guidewire of choice in difficult CTOs, improving stability and success compared to 0.014” guidewires. 

Another situation in which the BeBack is our device of choice is a reocclusion of the femoropopliteal segment with previous spot-stenting. Usually, the guidewire passes subintimally, and entering into the occluded lumen of a stent within a longer CTO is not possible. In this situation, the BeBack—indeed reliably and fast—allows the guidewire to enter into the proximal end of the occluded stent and to finalize the procedure successfully. 

Below the knee, we mainly use the 2.9F BeBack device, although the 4F device also is used in the proximal third of the calf for penetrating through calcific CTOs, or for re-entering after subintimal guidewire passage. In some cases of severely calcified infrapopliteal lesions, it can happen that the guidewire passes easily intraluminally through a stenosis, but no balloon would follow due to the tightness and calcification of the lesion. In this situation, the 2.9F BeBack is inserted over the guidewire and, with the needle slightly protruded from the tip of the catheter, it is drilled into the problematic plaque. This technique, mimicking the Japanese technique of transcutaneous plaque-piercing, is very successful in facilitating introduction of balloons into the lesion and finalizing the procedure. 

Has the BeBack changed your practice, and, if so, how? 

For many years, we and other centers have helped to develop techniques to improve the success rate in difficult peripheral CTOs. The retrograde and bidirectional approach became standard in case of inability to pass a CTO from antegrade. However, in some cases it can be anticipated that establishing a retrograde access will be cumbersome or time consuming. In these cases, we now prefer the BeBack to keep the intervention simple. Furthermore, a bidirectional recanalization can be time consuming and may even fail. In this situation, the BeBack helps to speed up, and may even be the only way to finalize the procedure successfully. 

During CTO recanalizations, do you think that sometimes physicians start to switch from one technique to another too late? 

Not infrequently, physicians try different guidewires and different catheters many times in order to pass a difficult CTO, or re-enter back into the patent distal lumen. This increases the risk of protruding the dissection distal to the CTO, destroying healthy segments, which sometimes worsens the clinical situation. Furthermore, radiation dose and the amount of contrast medium increase. Complications correlate with the duration of the procedure. The retrograde approach and the BeBack catheter together are our technique and technology of choice in order to shorten the procedure time. 

How much time—or how many attempts—would you give yourself with conventional techniques before using the BeBack crossing catheter? 

It depends on the complexity of the lesion. If we see a chance to be successful using an antegrade approach, we may proceed for some minutes. In very complex lesions, where it can be anticipated that a conventional approach has a high risk of failure or may take time, we switch to the BeBack catheter within a minute. 

Case images

If a colleague were to ask you about the BeBack, how would you describe it? 

The BeBack is a reliable crossing and re-entry device. It is very slim (2.9F or 4F), yet very stable and can easily be used not only in larger diameter arteries like iliacs, but also in small arteries—even via a retrograde pedal access through a 2.9F sheath. Furthermore, it is possible to use the catheter over 0.014” and stable 0.018” guidewires, the latter of which is usually the wire of choice in more complex lesions. Due to the BeBack’s straightforward design, it is easy to position and reposition the device, and control the depth and direction of the 360-degree adjustable needle from the tip of the catheter. It is helpful in quite a large variety of difficult situations, and handling the BeBack is easy to learn. 

SVS member named 2023 Presidential Leadership Scholar

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SVS member named 2023 Presidential Leadership Scholar
Anahita Dua

Society for Vascular Surgery (SVS) member Anahita Dua, MD, has been named a Presidential Leadership Scholar for 2023. 

She is one of 60 scholars in this eighth annual class. Dua is an associate professor of surgery at Massachusetts General Hospital and Harvard Medical School in Boston. 

Presidential Leadership Scholars are “making a difference in the world by applying lessons in leadership learned from the presidential experiences of Presidents George W. Bush, Bill Clinton, George H.W. Bush and Lyndon B. Johnson,” according to program leaders. 

“I am honored to be a part of this program that teaches leadership skills utilized by our past presidents of Bush, Clinton and Johnson and their administrations to make the world a better place,” said Dua of her honor. 

Her project focuses on decreasing amputations rates among Americans through targeted legislative changes “that would optimize the multidisciplinary team approach to limb salvage, making it both standardized and accessible.” 

Her intent is to address limb amputation—one of the most detrimental and costly outcomes of diabetes—and its prevalence amongst minority groups. 

The scholars will travel to each participating presidential center to learn from former presidents, key officials of their administrations, business and civic leaders, and leading academics. Dua and the other scholars will study and put into practice varying approaches to leadership and exchange ideas to help strengthen their impact. 

SVS announces officer candidates for 2023 election

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SVS announces officer candidates for 2023 election
SVS vice presidential candidates Kellie Brown and Keith Calligaro

The 2023 Society for Vascular Surgery (SVS) Nominating Committee has announced the candidates for the 2023 officer election. They are:

  • For SVS vice president, succeeding to president-elect, and then president: Kellie Brown, MD, and Keith Calligaro, MD
  • For SVS treasurer, a three-year term: Thomas Forbes, MD, and Palma Shaw, MD

Voting is under way for and will continue through 2 p.m. CDT Thursday, June 15.

This is the first year that voting not only takes place for such an extended period of time, but also during the SVS Vascular Annual Meeting (VAM). Up for election this year are the offices of SVS vice president and treasurer.

Voting is a privilege restricted to Active and Senior members in good standing, who may vote only once and cannot change their vote once recorded. Members not in good standing can pay their 2023 dues at vascular.org/invoices.

SVS members had a chance to “Meet the Candidates” at a town hall May 17. Candidates’ biographies and answers to specific questions are at vascular.org/23_24Candidates.

“We hope that by extending the voting period and offering it during VAM, with hundreds of members in attendance, more people will take advantage of the chance to let their voices be heard,” said Nominating Committee Chair Kim Hodgson, MD. “It’s our members’ opportunity to impact the future direction of our Society.”

Leaders hope more than 1,000 members cast votes this year.

Election results will be announced during the Annual Business Meeting at 12 to 1:45 p.m. Saturday, June 17, at VAM.

Candidates for SVS treasurer, Thomas Forbes and Palma Shaw

In December 2022, SVS members approved proposed changes to the bylaws that changed the composition of the SVS Nominating Committee. The committee size remained at seven members but the diversity of perspective was expanded. Committee members are:

  • Past President: Ronald Dalman, MD
  • Member-at-Large: Gilbert R. Upchurch Jr., MD
  • Strategic Board Member: Linda Harris, MD
  • Community Practice Section: Geetha Jeyabalan, MD
  • DEI Committee: Rana Afifi, MD
  • Young Surgeons Section: Chelsea Dorsey, MD

On 45th anniversary, CX Symposium chairman credits Chicago vascular surgical tandem for enduring success

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On 45th anniversary, CX Symposium chairman credits Chicago vascular surgical tandem for enduring success
The first CX Symposium took place in 1978

The occasion of a seminal meeting held in Chicago by former Society for Vascular Surgery (SVS) Presidents John J. Bergan, MD, and James S.T. (Jimmy) Yao, MD, played a central role in the formation of the world-renowned Charing Cross (CX) International Symposium, which this year marks its 45th edition. 

The year was 1976, and Roger M. Greenhalgh, MD, CX founder and chairman, had not long returned from a tour of the world’s major vascular surgery centers, when he was invited to attend the Bergan and Yao meeting at Northwestern University. The brilliance of that educational meeting, said Greenhalgh, inspired him to create something similar back in London, England, where the then-young vascular surgeon, soon-to-be surgery department chair, would birth the CX Symposium at Charing Cross in 1978. 

“John Bergan was a master of education,” remarked Greenhalgh. “I tried to do what he and Jimmy Yao did. Jesse Thompson, from Dallas, came to the first CX meeting in 1978, which was focused on progress in stroke research. Even now, we have an acute stroke session, but the first was entirely about that area.” 

Every year since, Greenhalgh recalls, he has been invited to the U.S. “and learned from the giants,” drawing particular attention to Houston, “the mecca of vascular surgery,” and its most famous cardiovascular son, Michael E. DeBakey, MD, with whom he had spent time the year prior to attending the Northwestern meeting. “Nothing after that equalled that amazing experience,” he said. “There was no comparison between the quality of care there seen anywhere else in the world.” 

CX Chairman Roger M. Greenhalgh (left) is pictured with Michael E. DeBakey at the 1989 edition of CX

Thus, the CX cornerstone was laid. Over the years, the symposium was the setting for key moments in vascular surgery history. The European Society for Vascular Surgery (ESVS) was convened at the meeting in 1988, with DeBakey involved in prompting vascular societies of Europe to form a pancontinental group, Greenhalgh noted. 

In the same decade, Andreas Grüntzig, MD, attended CX to talk about his version of a new balloon angioplasty system, and the symposium was an incubator for the development of key randomized-controlled (RCT) trials, such as the UK Small Aneurysm Trial, EVAR 1 and 2, and IMPROVE. 

In keeping with this long-standing tradition for being a theater for presentation and discussion of landmark advances in vascular care, this year will see CX play host to delivery of the first results from the much-anticipated BASIL-2 (Bypass versus angioplasty in severe ischemia of the leg-2) trial. They will be revealed by chief investigator Andrew Bradbury, MD, from the University of Birmingham in Birmingham, England, in the presence of representatives of the BEST-CLI (Best endovascular versus best surgical therapy for patients with critical limb ischemia) trial. A roundtable discussion is planned to include invited commentary from Eleni Whatley, from the U.S. Food and Drug Administration (FDA), and the British Secretary of State for Health, Steve Barclay. “At the moment of speaking, publication of the results will take place in The Lancet, which is a huge moment for CX,” he said. “We have had 45 years of a very global CX, and the tradition continues.” 

Looking ahead, Greenhalgh believes one of the most pressing issues facing the vascular world is that of patients with a “hurting leg” not being seen by a professional in a timely manner. “My personal interest, not as yet proven, is a suspicion that patients whose legs hurt are at risk of amputation, and it is the responsibility of the vascular profession to do something about it,” he said. 

Greenhalgh says he is not talking about patients who are referred to vascular specialists, but instead “the people who are not yet patients, whose legs hurt,” and who might not get advice from a doctor “simply because they think it is the aging process and they do not need to.” He continued: “They live in such an environment where they somehow do not get the advice that would enable them to have something done that would save their legs.” 

He references “interesting data” on the subject from Naseer Ahmad, MBChB, from Manchester Royal Infirmary in Manchester, England, which “would seem to suggest that in parts of the population where there is poverty, or inadequate facilities, that these are the areas in which the ‘hurting leg’ does not get the attention it should.” Suggesting what can be done to address this, Greenhalgh stresses that it is important to throw light upon this issue “in order to be able to get more people to get more timely intervention and have their leg saved.” 

On the occasion of the 45th anniversary of CX, Greenhalgh ponders what is coming next for the meeting. In particular, he emphasizes the importance of future planning to ensure the concept of CX—education, innovation and evidence—continues. 

To that end, he has recently appointed three new co-chairs to the CX leadership team who will work alongside him to deliver the CX program going forward: Dittmar Böckler, MD, medical director of the Clinic for Vascular and Endovascular Surgery at University Hospital Heidelberg in Heidelberg, Germany; Andrew Holden, MD, director of interventional radiology at Auckland City Hospital in Auckland, New Zealand; and Erin Murphy, MD, director of the Venous and Lymphatic Institute at Sanger Heart and Vascular, Atrium Health in Charlotte, North Carolina. “We are covering the globe and all vascular subjects,” Greenhalgh said of the new leadership team. “There will be every opportunity for the CX concept to continue if that is considered to be worthwhile doing.” 

The CX anchor points to what he sees as one of the central pillars of the CX brand: its multidisciplinary appeal. “If you have an interest in—and are managing patients with—vascular disease,” he says, “there is something for you at CX.” This multidisciplinary approach is particularly important for the education of the next generation, Greenhalgh believes. “It is important to get as much experience alongside as many people as you can, so that you become a compendium of all those people that you have learned from,” he added. 

Society of Black Vascular Surgeons builds bridges, connects international dots

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Society of Black Vascular Surgeons builds bridges, connects international dots
Vincent Rowe speaks during VAM 2022 session in Boston

A decade ago, if he were asked to name 10 Black vascular surgeons, says one African American vascular chief, he could have come up with six or seven. 

Today after being part of the creation and formation of the Society of Black Vascular Surgeons (SBVS), Vincent Rowe, MD, thinks he could list “60, 70, 80” vascular surgeons who are Black. That’s a far cry from 10 years ago, when he thinks could perhaps name just “six or seven.” At a basic level, that’s what the Society has done for him personally, said the chief of vascular surgery at the University of California, Los Angeles (UCLA). “It’s made me feel like I have a lot of colleagues with similar interests, and who have similar challenges to those I have had to face in this profession.” 

The SBVS was formed in spring of 2021, after an exploratory meeting in late 2020 discovered enthusiasm and interest in creating such a group, said Edwin Kendrick, MD. It “promotes fellowship amongst members through networking, mentorship and professional development. … [and] has a core mission of education, research, advocacy and provider pipeline development to advance health equity. The Society seeks to support policies that improve care and overall outcomes by addressing health[care] disparities in underserved patients.” 

“Each one of us saw a need,” said Rowe, noting that just 2% of SVS membership is African American. “We felt it necessary to form a collegial networking environment for ourselves, future trainees and colleagues. There’s kind of a dearth of networking systems.” 

Kendrick said he has always had “an urgent call to make an impact on improving the pipeline for people entering healthcare.” In 2017 and 2018, he read a report about challenges Black doctors were facing in California. He touched base with Rowe with the idea of trying to create additional opportunities in healthcare for Black physicians in the state. 

Rowe began contacting people around the country to gauge interest and discovered “a lot of people who felt they wanted to feel connected,” said Kendrick, who is president of a health equity and technology company. Both men’s visions had a lot of overlap. Kendrick’s long-standing interest was in what he wanted to do for Black physicians, whereas he, Rowe said, was more focused on vascular surgeons specifically. 

In late 2020, they met for the first time, and over the next months began forming a potential group. The Society was formed in May 2021, and thanks to the dedication of a diverse board, chaired by Kenneth Simon, MD, the SBVS has continued to flourish and slowly grow. The Society started small, with perhaps 20 to 30 members, but now counts approximately 140 people. “The most revealing and beautiful thing is that the talent pool is so diverse and so strong,” said Kendrick. 

“We have a mix of everything in terms of interests—advocacy, entrepreneurship, general surgery, mission work, mentoring, research, a complete coverage of all these different talents.” 

It remains a work in progress, both said. They want to be sure not to overreach, but they have ambitions for future projects. 

And connections are being formed, to unexpected results. Rowe said he met a surgeon who has been practicing for 20-odd years in West Virginia who regularly travels to Nigeria to train vascular surgeons. A few months ago, Rowe met another doctor who was going to Nigeria. Rowe put the two in contact, and they plan to connect and possibly expand that work. 

“We’re doing a lot of this, putting people together because of our network,” Rowe said. “Without it, these two people wouldn’t have connected—and I did not know either one of them a year ago.” 

Both Rowe and Kendrick said they feel the SBVS works in parallel with SVS. Their first in-person gathering was at the Vascular Annual Meeting (VAM), and they plan a reception at this year’s meeting outside Washington, D.C. They noted both 2022 vice presidential candidates talked with their members. “We outvoted our percentage,” in terms of demographics, noted Rowe. “Blacks make up 2% of SVS membership and we were 4% of the vote.” 

SVS leaders also have made a concerted effort to add diversity to its committees and task forces, which has led to more engagement between SVS and its Black members. One SVS member, in fact, reached out to Rowe to seek a recommendation for an SBVS member to put on a particular task force. 

The new SBVS, they noted, is helping build the support required to bring people together, to work to improve healthcare in general and mentor Black surgeons in particular, and to advocate for increased opportunities. It also wants to address the existence of healthcare disparities. Rowe wants SVS members to “remember we are parallel. We’re trying to accomplish some of the same things together. Don’t be afraid to utilize some of our expertise. 

“Reach out,” he added. “I know many of our members would say they don’t have a bridge to get involved with SVS. Without that bridge, it’s hard to get places. All of us will help to get people involved where they can and help them get that opportunity.” 

Interested parties can learn more about the SBVS at blackvascular.org. 

Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief

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Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief
Houston Methodist surgeons perform robotic surgery to remove an IVC filter
An emerging program at Houston Methodist aims to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery.

The first ah-ha during a talk at a national meeting being given by one of the foremost vascular surgeons in the U.S. The second came back at home base. The theme common to both? That major vascular operations and complications were being carried out by other specialties engaged in robotics-assisted surgery. 

“I was at the Society for Clinical Vascular Surgery [SCVS] one year, and was watching a robotic left renal vein transposition—that’s a very sophisticated operation—by Sam Money, at that time the chief of the Mayo Clinic at Scottsdale,” says Alan Lumsden, MD, the Walter W. Fondren III Presidential Distinguished Chair at Houston Methodist’s DeBakey Heart & Vascular Center in Houston, Texas. “And then he said: ‘I didn’t do this operation, the urologist did it.’” 

Alan Lumsden

Then, back home in Houston, Lumsden was called to assist with a bleeding complication during a pelvic procedure being carried out by a gynecologist. When he arrived, the specialist—performing the procedure robotically—asked Lumsden if he could resolve some bleeding from an iliac artery using the robot. His response was in the negative. “I can’t do that,” he recalls saying. The gynecologist, unperturbed, then told him she would take care of the situation herself. “And I was dismissed,” he says. “Here is a major vascular operation being done by a urologist, and a major complication, that is normally in our bailiwick of repairing, now being done by the gynecologist.” 

These experiences led to a realization—and a resolution. “We, in vascular surgery, have missed the boat on this,” says Lumsden. So he set about building a vascular robotics program.

Of late, that program has been gaining some interested glances from around the country following dissemination of a video from the popular Houston Methodist DeBakey CV Education YouTube channel via social media. The video features an inferior vena cava (IVC) filter removal procedure performed robotically. The surgery was led by his colleague, Charudatta Bavare, MD, who in a DeBakey Heart & Vascular Center grand rounds from September 2022, proposed robotic vascular surgery as an “underexplored frontier,” raising the possibility that the open and endovascular era of the specialty may segue “into robotic vascular surgery in the future—that is the hope.” 

Charudatta Bavare

Lumsden, who recently became president-elect of the Southern Association for Vascular Surgery (SAVS), stresses his role as “enabler” in this quest. For a long time, one of the challenges that held back vascular surgery was a lack of laparoscopic training, he points out. But these days, even many newer general surgeons “are now bypassing laparoscopic surgery and going straight to robotic,” he notes. “So this need for laparoscopic skills is not an absolute requirement to become a robotic surgeon.” 

Lumsden sees his role as one of “pushing this along,” continuing: “You have got to learn the basics before you start taking on the big stuff. Charu[datta] Bavare is one of my mid-level partners, trained as a general surgeon, worked in the community in laparoscopic surgery, vascular surgery, general surgery—he had to go to what we call an underserved community—and he has got all the skills. If he can’t make this work, nobody can make it work.”

In Houston, Bavare started out on “relatively trivial cases,” explains Lumsden. Cases that perhaps do not require a robot, he says. “But you have to get up to speed in a safe environment. And you have to get your team up to speed.” From procedures such as laparoscopic peritoneal dialysis placement and revisions, Bavare moved on to the likes of median arcuate ligament syndrome, and, now, the IVC filter removal. “We have a lot of people here who are sophisticated in robotics, all of whom are interested in helping us do this,” Lumsden relates. “There are these little pieces we need in other specialties that we are actively trying to seek out and grab, and pull this toward the vascular surgery community.” 

Lumsden looks back to the man for whom his center is named, Michael E. DeBakey, MD, and his innovation of the Dacron graft, as he looks forward. “To this day, that is probably the single-most durable procedure that has been described for repairing the aorta.” The problem with that was a “not-so-hot” delivery system, which the endovascular revolution sought to remedy. “What we’ve essentially done is given up durability for a delivery system. And that means stent grafts,” he says. 

“If you look at other specialties—urology, general surgery—when they went minimally invasive, they went laparoscopic or robotic. They did the same procedures that have been proven for 20, 30 years. They didn’t invent a whole new specialty called endovascular surgery the way we bought into it.” 

Vascular Specialist–April 2023

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Vascular Specialist–April 2023

In this issue:

  • SVS, American College of Surgeons (ACS) launch new quality verification program (p. 1 and 3)
  • SCVS 2023: Endovascular-first or -only approach to all CLTI patients ‘is not evidence-based care’ (p. 1 and 6)
  • On occasion of 45th anniversary, CX Symposium chairman credits Chicago vascular surgical tandem for enduring success (p. 1 and 6)
  • Guest editorial: Maria Paz, BS, on intentional mentorship— and why it matters (p. 2 and 4)
  • Society of Black Vascular Surgeons builds bridges (p. 12)

 

SVS Vascular Quality Initiative passes milestone 1,000th-center mark

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SVS Vascular Quality Initiative passes milestone 1,000th-center mark

The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry recently announced it has achieved another milestone, with more than 1,000 centers enlisted in VQI registries. This achievement will strengthen vascular care, improve outcomes and underscore the value of real-world data in analyzing outcomes and reducing resource utilization, a press release reports.

The SVS VQI is a clinical registry dedicated to improving the care of vascular patients through a data-driven approach to healthcare. In late 2022, the organization achieved a significant milestone by surpassing one million procedures collected in its database. Since its inception, the SVS VQI claims, clinical data gathered from participating centers has dramatically impacted patient care, leading to scientific discoveries that have changed the way in which care is delivered, improving outcomes and saving thousands of lives.

“Improving quality is a high priority for everyone in the medical community. This long list of SVS VQI participating centers reflects their commitment to quality. By collecting detailed clinical and procedural data that is usable and actionable, the SVS VQI is a critical tool that provides invaluable insight to providers and device manufacturers. We are all committed to improving patient care and the data provides a path,” said Jens Eldrup-Jorgensen, MD, medical director, SVS Patient Safety Organization.

Since 2011, when the SVS VQI was formed, VQI registries have achieved growth in participation and engagement. In 2022 alone, 100 quality charters have gotten underway. Other major milestones include:

  • More than 600 articles published in peer-reviewed journals using SVS VQI data
  • Eighteen regional groups formed and meeting biannually to discuss outcomes and quality improvement projects
  • More than 250 physician volunteers contributing to registry design and operations.
  • More than 6,000 participating physicians from multiple disciplines engaged in using the SVS VQI
  • More than 4,000 data managers, hospital managers and other professionals participating in the SVS VQI
  • Numerous collaborations with other organizations, including the American College of Cardiology (ACC), American Venous Forum (AVF), American Heart Association (AHA), Society for Vascular Medicine (SVM), Vascular Access Society of the Americas (VASA), Society for Vascular Ultrasound (SVU) and many regional vascular societies, governmental regulatory agencies, device manufacturers and payers
  • Fourteen VQI registries established, each collecting demographic, clinical, procedural and outcomes data from more than one million vascular procedures performed in the USA, Canada, Puerto Rico and Singapore

On average, more than 10,000 new procedures are added to the clinical registry each month. The wealth of data in the registry enables providers to track their performance and compare it against regional and national benchmarks.

The SVS VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a partnership between the SVS VQI and Medical Device Epidemiology Network (MDEpiNet) that directly supports the mission of the SVS VQI to improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information. VISION links SVS VQI registry data to Medicare claims to generate novel registry-claims linked datasets. The datasets combine the clinical detail from the SVS VQI with long-term outcome variables derived from Medicare claims.

Another major initiative launched in 2022 is the SVS VQI Fellowship in Training (SVS FIT) program. Individuals completing their medical residencies or fellowships in any vascular disease-focused specialty (e.g., vascular surgery, cardiology, radiology, vascular medicine) may participate in the 12- to 18-month program. It fosters an understanding of quality processes and metrics among vascular residents and fellows through mentorship in the VQI, in collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology and the Society for Vascular Medicine.

SVS VQI registries are powered by the Fivos Pathways platform, a secure, cloud-based solution for data collection and analysis. Using Pathways, SVS VQI participating providers can utilize real-time reporting to benchmark performance, while device manufacturers can develop custom projects that leverage registry data to accelerate device development, evaluation, or approval.

To learn more, visit https://www.vqi.org.

Initial case series indicates lithotripsy can help TCAR expand into high-risk patients

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Initial case series indicates lithotripsy can help TCAR expand into high-risk patients
Kathryn DiLosa takes to the SCVS 2023 podium

Lithotripsy may hold the key to enabling more carotid artery disease patients who require calcification treatment to undergo stent placement via a transcarotid artery revascularization (TCAR) procedure, as per single-center experiences presented at the recent Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Miami (March 25–29) by Kathryn DiLosa, MD, a University of California (UC) Davis, Sacramento, vascular surgery resident, alongside principal investigator Misty Humphries, MD, interim chief of the division of vascular surgery at UC Davis.

In cases of circumferential or eccentric calcification, TCAR is precluded and carotid endarterectomy (CEA) often becomes the preferred approach—however, in patients considered “high risk” due to their anatomy or prior surgeries, for example, “another alternative exists,” the speaker said.

Detailing the use of intravascular lithotripsy (IVL) prior to a TCAR procedure, DiLosa noted that predilation angioplasty may be required to allow passage of a lithotripsy balloon, and the balloon “should be sized to fully oppose the vessel wall, but not extend past the intended coverage area.”

She further stated that lithotripsy technologies have been used in the treatment of kidney stones previously, and are now shifting into the endovascular space.

The speaker also reported a 100% rate of technical success with this approach at her institution, across a total of seven patients, with comparable procedural and flow-reversal times to standard TCAR, and no observed complications within 30 days of the procedure. “However, a larger cohort [of patients] is still needed to confirm safety,” DiLosa said.

Responding to an audience query on how lithotripsy is able to successfully break up calcium without leading to embolization—a concern she admitted to having initially herself—DiLosa added that “all of the available literature has demonstrated that it is able to fracture the calcium, within the wall, without it embolizing from the wall.”

Briefly touching on the available literature regarding pre-TCAR lithotripsy, she stated that case studies—but no significant case series—are available at this point, although she and her colleagues are currently compiling a multi-institutional cohort including more than 50 patients.

“This is definitely for a specific patient population—those who cannot tolerate endarterectomy, but that would need the benefit of calcification [treatment],” DiLosa concluded.

Trainees: Cases sought for three VAM sessions   

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Trainees: Cases sought for three VAM sessions   

Vascular trainees and medical students are invited to submit their best cases for three sessions at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) this year. Case submissions are due April 26.

They are (all times Eastern Daylight Time):

“Bringing What’s New in Deep Venous Thrombosis Treatments to You in 2023!” It will be held from 12:30 to 1:30 p.m. Wednesday, June 14. The submitter for the case with the highest score will be offered the chance to present a five-minute presentation during the session.

“The Onco-Vascular Surgeon: Case Reviews and Strategies to Guide to Optimize Vascular Reconstruction in Oncology,” 3:30 to 5 p.m. Thursday, June 15.

“Endovation II: Innovative Strategies for Complex Aortic Disorders,” 1:30 to 3:30 p.m. Friday, June 16

Organizers have outlined specifics of what they seek in cases in all three sessions. Visit vascular.org/2023Call4Cases for full details and to submit cases.

SVS-ACS verification program: Key former SVS president predicts need for additional reviewers

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SVS-ACS verification program: Key former SVS president predicts need for additional reviewers
The SVS and ACS recently launched the Vascular Verification Program, an ACS Quality Program

Former SVS President Anton Sidawy, MD, hopes the launch of the Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) “Vascular Verification Program (Vascular-VP)”  leads to the “flood gates” opening with applications.

“We’re going to need reviewers as we move forward,” to augment the more than 15 already trained, said Sidawy, the vascular regent serving on the Board of Regents of the ACS who led the effort to create the Vascular-VP.

Program reviewers undergo formal training and follow the “surgery dogma” of “see one, do one, teach one,” he explained. For example, he worked with the ACS first, then participated and, finally, led a visit with another trainee.

Those interested in becoming a reviewer can email Carrie McGraw at [email protected].

Creating an AI-based tool to help clinicians perform precision AAA analysis

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Creating an AI-based tool to help clinicians perform precision AAA analysis
Randy Moore speaks at the Houston Aortic Symposium 2023

For University of Calgary, Alberta, Canada, vascular surgeon Randy Moore, MD, the route to a world of precision care for individual abdominal aortic aneurysm (AAA) patients—involving aortic wall strength-mapping technology developed over the course of the last 15 years, allied to an artificial intelligence (AI)-powered algorithm—is drawing nearer. Right now, says the associate professor of vascular and endovascular surgery, the decision to treat AAAs is based on a single diameter measure derived from population-based information. “That is flawed,” he implored. “And this hasn’t changed in over half a century.” 

Moore was speaking during the 2023 Houston Aortic Symposium (March 16–18), held in Houston, Texas, where he delivered insight into RAW (Regional Areas of Weakness) Maps and its aim to provide a precision medicine solution for AAA patients. “When we look at size alone as a measure for patients at risk of aortic aneurysm disease, we ignore all these other things that are critical to our decision-making,” he told those gathered for a talk on the ViTAA Medical Solutions technology. Moore is the company’s medical director and a co-founder, and it is on his clinical experience that early testing of the tool’s effectiveness is based. 

Moore emphasized the core principle behind AI in clinical work: analyzing large amounts of data, recognizing patterns, and predicting outcomes from pattern-recognition algorithms. “In our center, for the past 15 years, we have developed a number of algorithms that allow us to link actual tissue strength to risk in terms of wall strength analysis,” he said.

The ViTAA solution he proposes uses a RAW mapping score of aortic wall tissue integrity so that clinicians can talk through with patients the risk associated with their condition. “We knew our mapping technology was very effective at identifying wall strength and weakness,” he said. “But is that map a useful tool to allow for forward prediction—not just a map in real time but the ability to move ahead and provide the clinician with a tool?” 

An initial pilot study of 36 patients showed a statistically significant correlation between ViTAA’s RAW Maps and aortic growth over time. “We could, from a single ViTAA analysis, identify or predict risk in that patient moving forward up to 12 months with a statistically significant outcome,” Moore said. “We knew the mapping tool was good, but we wanted to understand how the addition of artificial intelligence would unlock, not just that mapping technique, but the predictive value moving forward.” 

That’s where the ViTAA Aortic Model comes in, he continued. This involves the use of patient imaging—which the system “flattens out,” gathering 3,000 coordinates of the aorta—and comparisons between different aortic scans at “exactly the part of the aortic wall we want to address.” The model enables serial investigations, Moore said, and using explainable AI—unroofing the concept of black-box AI—clinicians can then see what’s being measured and modified for auditable purposes.

“Our vision is that with the AI we have combined with the mapping technology, we are going to be able to provide the clinician with a go-forward view of a patient’s down-the-road behavior, which can then inform current real-time decision-making.”

Of course, the AI algorithm requires datasets from which to learn, Moore conceded. As with human facial recognition technology that generates people who do not exist, artificial patients, too, can be created. “Why would we do this?” asked Moore.

In order to generate a large enough dataset so that the researchers can get the answers they need in a short period of time, he said. “You can generate human aortic characteristics without actually including any backtraceable, real patient data. How does this work? You take real patient data, feed it in, and a generative adversarial network then creates this synthetic dataset that you can learn to train your AI.” 

Moore pointed to a concrete use case his team developed. “In our initial 16-patient pilot study looking at the strength of the aortic neck, we were able to identify a statistically significant relationship to a weak neck and subsequent type 1a endoleak. But if you look at the dataset, it was heavily weighted toward endoseal, with a small number of endoleaks. To make that learning set more applicable, we then created a synthetic database with 5,000 patients, with equipoise between the two groups. That took six minutes on a laptop.” After an analysis probing the synthetic database’s validity, the researchers found that it still produced what is considered a “very excellent” predictive rate. 

Moore and colleagues are now focused on validating the model through a North American multi-site registry and a number of research-use only sites accumulating datasets on aortic pathology. “The future of precision aortic care ain’t what it used to be as some of these tools continue to roll out.” 

Tackling health insecurity ‘from the top down and the bottom up’

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Tackling health insecurity ‘from the top down and the bottom up’
Rana Afifi at SCVS 2023

The feeling of being “uncertain, anxious and vulnerable” defines a creeping health insecurity problem riddling parts of the U.S. patient population—demographics who are underserved and at higher risk of outcomes such as amputation. And they can be a barrier to obtaining healthcare, according to Rana Afifi, MD, an associate professor of vascular surgery at McGovern Medical School, University of Texas Health Houston. Afifi was speaking during an invited presentation on strategies that can be used to tackle health insecurities during the 2023 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Miami (March 25–29).

“There [are] plenty of data in the literature [showing] that there is a significant increase in the number of publications that show the relationship between social determinants of health and outcomes,” she told attendees. “However, what is lacking is the data regarding how we do any strategies to improve, implement or actually have any intervention…”

Afifi spoke of health policy reforms that “incentivize healthcare systems to respond to social determinants of health and improve population health as a strategy for reducing excessive costs.” She also focused on strategies already available that can be applied locally. Afifi dealt with health security issues as they relate to such areas of life as housing, finance, transportation and food. “You can work with food banks,” Afifi said. “There have been studies showing their role in care for patients and mitigating some of the health insecurities at risk for this.”

She turned to the example of the SAVE (San Antonio Vascular and Endovascular) Clinic in San Antonio, Texas, founded and run by vascular surgeon Lyssa Ochoa, MD, as a case in point. Ochoa based her work on identifying the zones where, for example, there are high amputation rates and low socioeconomic status—high-risk populations, observed Afifi. “That’s basically where she based her outreach clinics,” she said. Her network is equipped with vascular care-equipped mobile units that head out into the heart of these communities, “assisting with some of the transportation options.”

Ochoa and her team also partner with community healthcare workers to navigate wider needs, such as screening and trust-building. Going forward, the health insecurity issue necessitates a cultural change, and needs to be addressed at multiple levels, Afifi added. “The way to address it is from the top down and the bottom up at the same time—we can’t just wait for policy to change.”

Award-winning paper finds F/BEVAR ‘feasible and safe’ in patients with failed aortic repairs

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Award-winning paper finds F/BEVAR ‘feasible and safe’ in patients with failed aortic repairs
Andrea Vacirca F/BEVAR
Andrea Vacirca, presenting the SCVS 2023 Peter B. Samuels Award-winning research

Presenting award-winning new research, Andrea Vacirca, MD, a research fellow at The University of Texas Health Science Center in Houston (UTHealth Houston), revealed how, despite prior records which demonstrate that fenestrated-branched endovascular aortic repair (F/BEVAR) is “feasible and safe” in patients with failed aortic repairs, few studies have outlined the “granular data” to support this claim, which his team aimed to provide through their analysis.

Vacirca was speaking during the opening scientific session at the 2023 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Miami (March 25–29), where he picked up the Peter B. Samuels Award for work looking at early and midterm outcomes of F/BEVAR in patients with or without a prior history of EVAR or open repair. And he set a course for his team’s main conclusions, first highlighting  the “increasingly utilized” F/BEVAR’s “high” technical success and “low” mortality rates in the study population.

Vacirca and colleagues had set out to compare these outcomes of EVAR on complex abdominal aortic aneurysm (AAA) and thoracoabdominal aortic aneurysms (TAAAs) in a prospective, non-randomized analysis of clinical data from 502 enrollees. They reviewed outcomes in 376 patients with no previous aortic repair (controls), 54 who had prior EVAR (group one) and 72 with prior abdominal open repair (group two).

The researchers reported on 30-day mortality and MAEs, patient survival and freedom from aortic-related mortality (ARM), secondary interventions, any type II endoleak, sac enlargement (≥5mm), and new-onset dialysis.

Their results showed that EVAR was performed on average 7±4 and 12±6 years after the prior EVAR and abdominal open repair, respectively, with a complex AAA extent in 29% (143) of patients and TAAA in 72% (359) of patients. Breaking this down, Vacirca remarked that patients with prior open repair more frequently experienced TAAA, which were also “more extensive” when compared with the other two groups. However, freedom from Type II endoleak and sac enlargement greater than 5mm, was “significantly lower” in patients with prior EVAR, Vacirca told SCVS 2023.

Continuing, he remarked that these abdominal open repair patients were younger at index procedure, and showed “lower” survival and freedom from new-onset hemodialysis which—when prompted on why the latter had occurred during audience discussion—raised a “very important” question for Vacirca and his team. “We evaluated this aspect—if new-onset dialysis was related with lower survival in group two. But we found that only four patients experienced this, and so we associated lower survival with more extensive aortic disease.”

Overall technical success, mortality, and MAE rates were 96%, 1%, and 28% respectively, Vacirca outlined, though patient survival after 30-month follow-up was “significantly lower” in patients with prior open repair and was reported to be 45% at five years, consistently falling  behind the other two groups.

“These procedures carry many technical challenges,” Vacirca stated, their data tentatively weighing up F/BEVAR and open repair for these complex patients. Allowing their research to speak for itself, Vacirca and his team offered an insight into their working practices, describing their hybrid operating room. “Our technique has evolved over the years […] We prefer a total femoral approach, without prophylactic drain whenever possible. We often request a preloaded system, and we now move to use the unibody fenestrated bifurcated devices, and we often double stent vessels coming from the suprarenal fixation devices,” Vacirca explained, making clear that procedural methods must continually be revaluated, and a hybrid approach adopted to provide the best treatment pathway for each individual in this complex patient population.

The top 10 most popular Vascular Specialist stories of March 2023

The top 10 most popular Vascular Specialist stories of March 2023

In March 2023, the Vascular Specialist stories grabbing readers’ attention were a response to a February letter addressing vascular surgeons’ use of social media; an interview with an advocate for more carefully considered use of venous stents; the publication of the PROMISE II trial results; and a letter from the SVS President, urging members to work more closely together to further the specialty’s common goals.

1. Letter to the editor: The vascular influencer

W. Michael Park, MD, responds to Jean Bismuth, MD, and Jonathan Cardella, MD, “[agreeing] with their point that many of these posts are made by mediocre practitioners who display only the best and curated images” but expresses his “[discomfort] with the feeling that [he] may be one of those people being castigated for over-exposure on social media”.

2. ABCs for the treatment of lower-extremity acute DVTs

Ashish Gupta, MD, shares his deep vein thrombosis (DVT) ABCs—A is for “anticoagulation” for not more than six months of duration; B is for “Be active, Be ambulatory”; and C is for “Consider compression stockings or ace wraps”.

3. Corner Stitch: What I wish I had known in vascular training

From the vantage point of six months into his first attending position, J. Aaron Barnes, MD, pens his best pieces of advice for newly matched vascular trainees—”I wish I had known as a trainee that I would eventually understand the method to the madness.”

4. Venous stenting: ‘We need to evaluate use, appropriateness and clinical indication’

In an interview with Vascular Specialist during the recent American Venous Forum (AVF) meeting (San Antonio, Texas, Feb. 22–25), Karem Harth, MD, said the increase in use of venous stents was “not surprising but did highlight a number of areas in need of evaluation”.

5. SVS, ACS launch quality verification program

The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have launched the “Vascular Verification Program (Vascular-VP),” an ACS Quality Program developed in partnership with the SVS.

6. Results from PROMISE II pivotal trial published

Results from the PROMISE II pivotal trial investigating transcatheter arterialization of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischemia (CLTI) patients have been published in the New England Journal of Medicine (NEJM).

7. Distal embolic protection linked to significantly better outcomes in carotid stenting

Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection during carotid stenting.

8. Four decades of AAAs in the US: Rare epidemiological study establishes women are diagnosed and repaired 10 years later than men

Abdominal aortic aneurysm (AAA) diagnosis and repair occurs among women almost 10 years later than in men—with similar age-adjusted mortality. The finding is part of a rare U.S. population-based study of AAA trends, spanning nearly 40 years.

9. Bioprosthetic venous valve: ‘We want to know that this is really working’

A key investigator in efforts to tackle chronic venous insufficiency (CVI) with an bioprosthetic venous valve replacement talks about progress being made with surgical and endovascular versions of the device—and surgical community skepticism.

10. From the SVS president: Supporting one another

Michael C. Dalsing, MD, Society for Vascular Surgery (SVS) President considers the importance of “[rededicating] ourselves to supporting one another, focusing in a unified manner to address the very real challenges that surround us”.

Former SVS President William Abbott, 1997–98, dies at 86

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Former SVS President William Abbott, 1997–98, dies at 86
William Martin Abbott

William Martin Abbott, MD, former president of the Society for Vascular Surgery (SVS), died peacefully in his home Jan. 9 after a brief illness. He was 86.

Abbott grew up in San Francisco and graduated from Stanford University and Stanford Medical School. He completed his surgical training at Massachusetts General Hospital (MGH) and served in the Navy during the Vietnam War.

As one of the early true surgeon-scientists, he embarked on an extensive laboratory effort while maintaining and practicing the high standards of clinical vascular surgery at the MGH. His myriad contributions to his specialty resulted in his appointment by then Chair of Surgery W. Gerald Austen, MD, as the first chief of vascular surgery at the MGH, a position he held for 22 years and subsequently his SVS presidency in 1998. Abbott’s investigative work was at the intersection of multiple scientific disciplines. His research and clinical contributions touched upon all of the salient advances that have allowed vascular surgery to evolve to its highly regarded stature as a surgical and interventional specialty addressing some of the most complex human diseases.

Abbott worked on the development of experimental and autologous vascular grafts, as well as the biologic and physiological determinants of graft behavior, allowing clear scientific underpinnings to predict how vascular grafts should be engineered or constructed to optimize their behavior in the human vasculature. He married clinical observations to cutting-edge work in the cell biology of vascular interventions and for many years headed a multidisciplinary National Institutes of Health-funded lab as well as served on numerous NIH study sections which he found to be a wonderfully collegial and intellectually stimulating experience. In collaboration with labs and universities around the world, the MGH scientific effort in vascular disease was a huge attractant for other scientists and surgeons interested in the evolving specialty of vascular surgery.

Abbott published in the area of noninvasive diagnosis and new radiologic techniques for surgical selection and planning. As chief of vascular surgery, he was at the cusp of the endovascular revolution ensuring that the MGH vascular division was a cornerstone investigator as the era was launched. The division’s reputation today as a globally leading endovascular center expands on his legacy and initial engagement at the forefront of change.

Abbott was also an instrumental contributor to the policies and educational advances that have made vascular surgery a prominent field. He advocated for the responsible adoption of new techniques, the expansion of scientific and multidisciplinary approaches to vascular disease to ensure higher quality patient care and the establishment of vascular surgery as an independent specialty with its own boards and accreditation. The MGH vascular fellowship was formally established on his watch, gaining prominence for the training and further education of vascular surgeons. Many of the division’s visiting surgeons and fellows to the MGH were or became leaders in their own right in their respective countries. The vascular fellowship established by Abbott has remained one of the eminent vascular fellowships in the world, producing many future chiefs of vascular surgery, and chairs of surgical departments.

With vision and prescience, Abbott’s view of the practice of medicine went well beyond the scope of vascular surgery. Throughout his career he spoke to the issues of quality assurance, time for reflection and excellence in work as well as in personal life balance. He was an early and fierce advocate for examining indications and outcomes in the treatments for vascular disease. In his post-surgical life, his intellectual curiosity and desire to contribute to his community found him in the role of a counselor for those suffering from substance-abuse, and he tackled this role and responsibility with as much fervor and joy as he did throughout the earlier part of his professional life as a surgeon.

Abbott is remembered by all of his friends as a shining intellect, a visionary leader of surgeons, an educator and mentor, and an individual for whom the right values, decency and integrity were paramount. His legacy is found within the walls of the MGH, and around the world.

He is survived by his wife, Cynthia (Davison), his son, William W. Abbott, and his wife, Katherine of Barrington, Rhode Island, and their two daughters, Annabelle and Allison. He is also survived by his daughter, Sarah L. Abbott of Westminster, Colorado, and her son, Morgan. There will be a celebration of life in the spring of 2023.

Jonathan Gertler, MD, is a former associate professor of surgery at Harvard Medical School and Massachusetts General Hospital. This is an edited version of an obituary originally written for Massachusetts General Hospital. It is reprinted with permission.

SCVS 2023: DAPT linked to better post-TCAR outcomes versus other drug regimens

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SCVS 2023: DAPT linked to better post-TCAR outcomes versus other drug regimens
Hanaa Dakour-Aridi presents her team’s latest findings on DAPT use in TCAR patients during SCVS 2023

Recent data presentations have revealed reduced risks of stroke and mortality among transcarotid artery revascularization (TCAR) patients who receive dual antiplatelet therapy (DAPT)—both preoperatively and at discharge—as compared to other drug regimens. Researchers believe these findings underscore the importance of compliance to DAPT regimens before and after a TCAR procedure.

At the 2023 Society for Clinical Vascular Surgery (SCVS) Annual Symposium (March 25–29) in Miami, Hanaa Dakour-Aridi, MD, a vascular surgery resident at Indiana University School of Medicine in Indianapolis, presented the results of a study evaluating post-TCAR discharge regimens in patients within the Vascular Quality Initiative (VQI) registry.

The data revealed that 19.2% of patients in the VQI are not discharged on dual antiplatelets after stent placement via TCAR—9% receive a “triple therapy” involving DAPT plus anticoagulation, 5.8% are given single antiplatelet therapy (SAPT) plus anticoagulation, and 4% are directed to take either SAPT or a single anticoagulant.

“We demonstrated that patients discharged on a combination of single antiplatelets with anticoagulation witnessed increased [rates of] 30-day stroke, high-grade restenosis, and one-year mortality and stroke/death,” Dakour-Aridi noted during SCVS 2023. “The use of a single antiplatelet or single anticoagulant after TCAR was associated with increased 30-day and one-year stroke/death risks. However, there was no significant association between triple therapy and 30-day stroke/death outcomes [following multivariate analysis adjustments].”

Highlighting the limitations of the present study, she touched on the absence of indications for antiplatelet regimens on discharge—increasing the likelihood of selection bias—as well as limited data at follow-up (52% at 30 days and 45% at one year), and the unknown risk of bleeding with triple therapy.

Nevertheless, Dakour-Aridi concluded that “[…] these findings reinforce our prior study on the importance of compliance to DAPT after TCAR, as well as the need for further follow-up studies to evaluate the appropriateness of TCAR in different patient populations”.

Dakour-Aridi and her colleagues also recently published a similar study in the Journal of Vascular Surgery (JVS), with the key difference being that, here, they examined the association between preoperative antiplatelet regimens—DAPT vs. other regimens—and in-hospital outcomes after TCAR. This research ultimately produced similar results, as DAPT demonstrated improved clinical outcomes, including reduced in-hospital stroke and mortality risks, compared to other medication regimens in carotid artery disease patients undergoing a TCAR procedure.

Computational model found to predict early aortic abdominal aneurysm rupture

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Computational model found to predict early aortic abdominal aneurysm rupture
abdominal aortic aneurysm
AAA development and ruptured stage (left) and simulated results (right)

In Physics of Fluids, by AIP Publishing, researchers from the Indian Institute of Technology (BHU) Varanasi and Indian Institute of Technology Kanpur made a computational model of the cardiovascular system in order to predict early abdominal aortic aneurysm (AAA) rupture and monitor patients’ blood vessel conditions.

The team investigated the effect of realistic, patient-specific AAA shapes on the hemodynamics of pulsatile Newtonian fluids in an aortofemoral artery under normal and diseased conditions.

An AAA causes the wall of a person’s aorta, the largest artery in the body, to weaken and bulge outward. If left untreated, it can continue to grow and eventually rupture, which can lead to life-threatening bleeding.

According to some estimates, up to 80% of patients who experience a ruptured AAA will die before they reach the hospital or during surgery. But early intervention can prevent rupture, improve outcomes, and avoid death.

Predicting the risk of AAA rupture involves a combination of imaging studies, such as ultrasound, computed tomography (CT) scans, and magnetic resonance imaging (MRI), and hemodynamics, as well as clinical factors such as age, sex, smoking history, and family history of AAA.

“If an AAA is detected early, treatment options such as surgical repair or endovascular stent grafting are available to prevent rupture,” said the authors. “These treatments are both effective at reducing the risk of rupture and improving survival rates.”

Using image-based computational blood dynamics, the researchers mimicked specific health conditions and investigated various hemodynamic parameters. Their patient-specific geometric models of a human aortofemoral artery were constructed from three-dimensional (3D) medical imaging data. To solve the blood flow governing equations under the pulsating conditions caused by the heart’s beating, they used finite element-based simulations.

The team found that aneurysm size alters the blood flow velocity distribution. In addition, flow separation occurs during systolic deceleration, and the vortex begins to travel in the aneurysm sac. Among other complex dynamics, this may influence the blood circulation of lower extremities.

“In the future, such computational work will help in development of digital twins of the cardiovascular system,” said Sumit Kumar, PhD, lead author of the study.

Digital twins are virtual patient representations that receive real-time updates on a variety of data variables and help doctors better forecast disease and choose the best course of therapy.

SCVS 2023: DAPT shows higher survival rate in patients with low WIfI scores, study indicates

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SCVS 2023: DAPT shows higher survival rate in patients with low WIfI scores, study indicates
C.Y. Maximilian Png presents during SCVS 2023

A retrospective cohort study presented at the 2023 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Miami (March 25–29) has found lower-extremity bypass patients who received dual antiplatelet therapy or anticoagulation (DAPT/AC) postoperatively had a higher 30-day survival rate.

“We have limited contemporary evidence to support increasing antithrombotic therapies after bypass,” C.Y. Maximilian Png, MD, a vascular surgery resident at Massachusetts General Hospital stated, providing background for their research in conversation with Vascular Specialist on his return from presenting the data at SCVS. The authors set about identifying optimal antithrombotic management of patients after lower-extremity bypass through a restriction analysis of wound, ischemia and foot infection (WIfI) scores.

At a single hospital system, Png and colleagues extracted data from infrainguinal bypass procedures completed between January 2018–2021, assigning preoperative WIfI scores to each individual case through the associated documentation. Excluding patients with wound scores of two or three, ischemia scores of zero or one, or foot infection scores of three, Png’s study singularly concerned patients at “[low] risk” of a negative outcome, such as major amputation, who may “theoretically benefit the most” from increased therapy, he said.

Based on the type of antithrombotic regimen on discharge, demographics, comorbidities, type of bypass, 30-day rates of graft occlusion, major amputation, mortality and major adverse limb events (MALEs) were analyzed. “The WIfI scoring system has already been clinically validated and associated with amputation risk,” Png said. “The next challenge is to figure out how to get the most out of this valuable tool, and we thought one use of it could be to help differentiate patients who would benefit from increased anti-thrombotic medication therapy.”

Including 191 procedures in the study, Png et al found 66 (34.6%) patients were discharged on single antiplatelet therapy (SAPT), compared with 125 (65.5%) who were discharged on either DAPT or AC. The only difference that the authors identified between the two groups was a higher prevalence of atrial fibrillation in the DAPT/AC group.

At 30 days, Png and colleagues observed no significant difference in postoperative reintervention or graft occlusion rates, however the DAPT/AC group had a significantly lower rates of mortality (2.2% vs. 9.1%, P<0.05), major amputation (1.6% vs. 7.6%, P <0.05) and MALE. Reflecting on their Kaplan-Meier analysis, the authors determined that MALE-free survival were higher amongst DAPT/AC patients compared with the SAPT group.

Despite drawing this conclusion from their analysis, Png made clear that their results cannot be generalized to the rest of the PAD population, as this work was done in a select group of patients. And although they illuminate an alternate treatment path which diverts from the contemporary hesitance to prescribe DAPT or AC therapies postoperatively, Png said, more research must be done.

“If you ask any researcher if more research should be done, we’ll always say yes. Our study has several limitations, including selection bias and its lack of granularity regarding the types of antiplatelet and anticoagulation medications, but if you’re to get anything out of our study it’s that there truly is no one-size-fits-all solution.”

Getting medical devices to market: The future might not be now, says regulatory expert

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Getting medical devices to market: The future might not be now, says regulatory expert
Dorothy Abel, pictured during CIA 2023

The development of medical devices in the vascular space faces increasing challenges amid moves afoot at the Food and Drug Administration (FDA), according to a leading regulatory expert in the field.

Among the developmental vehicles currently caught in the crosshairs are physician-sponsored investigational device exemption (PS-IDE) studies, Dorothy Abel, the former FDA official responsible for leading evaluation of vascular and endovascular surgery devices, recently told the 2023 Critical Issues America (CIA) annual meeting (Feb. 10–11) in Miami.

She was giving the CIA keynote address, tackling the subject of endovascular grafts across the decades, their evolution and what lies in store for device development down the road.

Throughout, Abel, currently vice president of regulatory strategy at medical device research organization NAMSA, emphasized the importance of collaboration during the process of shepherding new products toward commercialization.

Developers should work together across the spectrum of interested parties—manufacturers, testing facilities, regulatory agencies—to establish the best bench-testing and animal study protocols, and what needs to be gleaned from the clinical setting, to get to requirements centered on a risk-based rationale for testing, she said.

This might entail looking at “what does the device need to be able to do; what can go wrong if it does not do that, what type of testing do we need to help us believe that it is going to do what it is supposed to do,” explained Abel, who cofounded the FDA’s early feasibility studies program.

She contrasted the difference in standards between what is required in the European Union (EU) and the U.S. “In the U.S., it is kind of a guidance—it helps FDA understand what should be done,” Abel said. “But in the EU, they take it very seriously,” she added. “If it is written in a standard as something that needs to be done, you are going to have to do it in order to get the device to market.”

Abel posed the overarching question—“Is the future now?”—of the medical device development landscape, answering herself: “I am kind of hoping that it is not.” Her reasoning? Those challenges that potentially limit PS-IDEs.

“The FDA has recently shut down the opportunity for doing some sponsor-investigator IDEs,” Abel said. “We do not know yet what their thinking is; whether that is going to apply to all IDEs in this space; or if it is going to be focused on particular manufacturers, or types of devices. But, it is a little bit concerning, because we want to make sure people continue to study these devices responsibly.”

Right now, the FDA is focused on devices from a protection standpoint, with the agency often taking a skeptical view of new technology, Abel observed. “What is even more concerning, to go along with that skepticism, is there is a little less communication. They have almost doubled the size of postmarket studies as compared to the premarket studies in the most recent approvals, and it is not clear exactly what their fear is.”

The focus needs to be on patients, she said. “I am afraid that has gone away a little bit. Because there is so much focus on safety, they are not thinking about, ‘We need better things to take care of our patients in general.’”

From another angle, Abel highlighted how blame is apportioned when things go wrong.

“Sometimes we are asking the wrong questions,” she said, referring to the example of ruptures occurring in patients fitted with endovascular devices. “Why did they have the ruptures? Were they not being followed? Is it really the endograft’s fault? Is it your fault? Is it the patient’s fault? But the FDA automatically goes, ‘It is the manufacturers who need to collect more data to figure out what is going on because we have these ruptures.’”

Investors and developers too are not beyond criticism, Abel continued. “Bad things can happen to potentially ruin good devices, and some of those bad things come from assumptions,” she said.

In order to ensure a successful future in the device development field, Abel returned to the concept of collaboration. And that also includes patients, she said. In the past, Abel recalled, “we kind of fell short. We did not have the patients involved early on. I think we need the patients involved.”

Shooting for the stars is laudable, she said, but “be happy to take some baby steps—they keep you moving forward.” Also be realistic, Abel advised. “Often we see timelines driven by investors.” And, whenever possible, be conservative, she added. “If you have a way to test something in a less risky population, why not do that first so you can de-risk the future.

“The goals are to solve problems, improve lives, reduce harm. In order to avoid that, you want to know about the field that you are playing in. You need to know about regulatory, patient safety, study design, technology adoption. This is not for the faint of heart.”

Learning not only from mistakes, but also successes is important, Abel concluded. In the case of the latter, she drew attention to one in particular: “I think one of the big successes in endografts has been the sponsor-investigator studies. We have learned so much—I know it is over 30 years—but it is a relatively short amount of time when you think about medicine and the complexity of what is being done. And, cooperation is key.”

Results from PROMISE II pivotal trial published, reinforcing ‘ transformational value’ of deep vein arterialization in no-option CLTI patients

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Results from PROMISE II pivotal trial published, reinforcing ‘ transformational value’ of deep vein arterialization in no-option CLTI patients
LimFlow deep vein arterialization
LimFlow deep vein arterialization

Results from the PROMISE II pivotal trial investigating transcatheter arterialization of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischemia (CLTI) patients were today published in the New England Journal of Medicine (NEJM).

The publication confirmed an amputation-free survival rate of 66% at six months, which exceeded the trial’s primary endpoint target of 54%, as reported by co-principal investigator Daniel Clair, MD, professor and chair in the Department of Vascular Surgery at Vanderbilt University in Nashville, Tennessee, at the 2022 Vascular Interventional Advances (VIVA) meeting (Oct. 31–Nov. 3) in Las Vegas.

PROMISE II—multicenter, prospective and single-arm—included 105 patients with CLTI, the most severe form of peripheral arterial disease (PAD). The pool bore a median age of 70, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino.

Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%), the researchers report in NEJM. At six months, 66.1% of the patients had amputation-free survival. “Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan–Meier analysis),” they write. “Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.”

Patients enrolled in PROMISE II “were representative of real-world patients,” including those with dialysis-dependent chronic kidney disease (CKD) and Rutherford class 5 or 6 wounds—groups “routinely excluded” from vascular device studies, the triallists noted in the discussion section of their paper.

Prespecified subgroup analyses indicated a difference between the 19 patients with dialysis-dependent CKD—who had amputation-free survival of 36.8%—and the 86 patients who did not (72.7%), the authors report. Similarly, the mortality rates among these groups of patients were 36.2% (dialysis dependent) and 8.6%, they show.

“Results of a prespecified subgroup analysis were aligned with those of previously published outcomes indicating an increased risk of death after peripheral arterial revascularization procedures among patients who were undergoing dialysis,” they write. “Although the incidence of limb salvage was similar between patients who had dialysis-dependent chronic kidney disease and those who did not, mortality appeared to be greater in the population with dialysis-dependent disease. The decision to offer transcatheter arterialization of the deep veins to patients with dialysis-dependent chronic kidney disease should take into consideration life expectancy and patient preferences.”

The LimFlow transcatheter arterialization system is designed to reestablish blood flow in deep veins for end-stage CLTI patients who have exhausted all other treatment methods and face major amputation of their lower limb. Trial subjects will be followed out to three years.

“The publication of PROMISE II in the New England Journal of Medicine reinforces the transformational value of [transcatheter arterialization of deep veins] for a patient population in great need,” stated Mehdi Shishehbor, DO, PROMISE II’s other co-principal investigator, who is president of the Harrington Heart and Vascular Institute, University Hospitals, in Cleveland and lead author of the NEJM paper. “The introduction of this therapy provides the possibility of limb salvage for a no-option CLTI population previously consigned to primary amputation, potentially reducing the suffering, mortality, and economic burden in this ever-growing segment of patients.”

“These results establish [transcatheter arterialization of deep veins] as a real alternative to major amputation for patients facing inevitable limb loss from no-option CLTI,” added Clair. “This therapy will enable us to redefine the concept of a ‘no-option’ CLTI patient by giving us a treatment that offers patients limb salvage and hope.”

The LimFlow system—an investigational device in the U.S.—attained a CE mark for use in the European Union in 2016.

DAPT linked to better post-TCAR outcomes versus other drug regimens

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DAPT linked to better post-TCAR outcomes versus other drug regimens
Hanaa Dakour-Aridi (L), S Keisin Wang
Hanaa Dakour-Aridi

Dual antiplatelet therapy (DAPT) has demonstrated improved clinical outcomes, including reduced in-hospital stroke and mortality risks, compared to other medication regimens in carotid disease patients who undergo stent placement via a transcarotid artery revascularization (TCAR) procedure.

This is the key concluding message put forward by Hanaa Dakour-Aridi, MD, an integrated vascular surgery resident at Indiana University School of Medicine in Indianapolis, S. Keisin Wang, MD, an assistant professor of vascular and endovascular surgery at McGovern Medical School at UTHealth in Houston, and colleagues in a recent Journal of Vascular Surgery (JVS) publication.

The authors queried all patients who underwent TCAR within the Vascular Quality Initiative (VQI) from September 2016 to June 2022 to determine the association between antiplatelet choices and outcomes. They did this against the backdrop of DAPT being the preferred medication regimen in post-TCAR patients, “despite a dearth of quality data,” in an effort to define the risks carried by different antiplatelet approaches.

“Patients maintained on DAPT were compared with those receiving alternative regimens consisting of single antiplatelet [therapy], anticoagulation, or a combination of the two,” Dakour-Aridi, Wang and colleagues note. “A 1:1 propensity-score match was performed with respect to baseline comorbidities, functional status, anatomic/physiologic risk, medications and intraoperative characteristics. In-hospital and one-year outcomes were compared between the groups.”

The authors report that a total of 29,802 procedures were included in their study population, with 82.7% receiving DAPT and 17.3% receiving an alternative antiplatelet regimen. Propensity-score matching generated 4,876 unique pairs across which they performed their analysis.

Compared with patients on DAPT, in-hospital ipsilateral stroke rates were “significantly higher” among those receiving other types of antiplatelet therapy (1.1% vs 1.7%, respectively). And, while there was no statistically significant difference between the two groups regarding mortality—0.5% with DAPT and 0.6% without—a composite of stroke/death was more likely in patients receiving an alternative regimen (2.4%) rather than DAPT.

S. Keisin Wang

Furthermore, Dakour-Aridi, Wang and colleagues found that immediate stent thrombosis was more common in the ‘alternative’ group of patients, and a non-significant trend towards increased rates of returning to the operating room was observed as well.

“Conversely, the incidence of perioperative myocardial infarction was lower in the alternative regimen group [than with DAPT],” the authors posit, highlighting rates of 0.4% and 0.7%, respectively. “At one year after the procedure, we observed an increased risk of mortality but not stroke in patients treated with an alternative medication regimen.”

Dakour-Aridi, Wang and colleagues ultimately convey that their propensity score-matched analysis found an increased risk of both in-hospital stroke and one-year mortality in TCAR recipients who were treated with an alternative approach to DAPT. And, although patients on triple therapy experienced the same rate of major adverse cardiovascular events (MACE) as DAPT, bleeding events were not available in the VQI, the authors also note.

“Further studies are needed to elucidate the drivers of DAPT failure in patients undergoing TCAR to improve outcomes for carotid stenting patients,” they conclude.

SCVS 2023: Endovascular-first or -only approach to all CLTI patients ‘is not evidence-based care’

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SCVS 2023: Endovascular-first or -only approach to all CLTI patients ‘is not evidence-based care’
Michael S. Conte, the SCVS 2023 Distinguished Visiting Professor

Michael S. Conte, MD, one of the foremost experts in the field of peripheral arterial disease (PAD), took attendees of the 2023 annual meeting of the Society for Clinical Vascular Surgery (SCVS) in Miami on a journey through the decades of evidence-based revascularization for limb-threatening ischemia, telling those gathered that the recently published “landmark” BEST-CLI trial evidence should lead to a shift in the current practice landscape where open bypass surgery is “under-offered and under-utilized.”

Conte, chair, professor and chief of vascular and endovascular surgery at the University of California San Francisco (UCSF), was delivering the SCVS 2023 (March 25–29) Distinguished Visiting Professor address, devoting a significant portion to the recent publication of the BEST-CLI (Best endovascular versus best surgical therapy for patients with CLTI) randomized-controlled trial (RCT) data, and what its results means for the treatment of chronic limb-threatening ischemia (CLTI) going forward.

Conte posed the ultimate question: What are the take-home messages in the world of CLTI treatment post-publication of the BEST-CLI results.  “I think it is really clear,” said Conte. “That an endo[vascular]-first, or, even more strikingly, endo-only approach, to all patients with CLTI is simply not evidence-based care. And Centers of Excellence must be skilled in both techniques of revascularization.

“Furthermore, informed decision-making with patients in this field should include the results of this evidence, and suitable patients should be offered the option of open bypass surgery, which I suspect is being under-offered and under-utilized in current practice. I think this trial should make that begin to change.

“It’s not surprising—it shouldn’t be surprising to us—that there are trade-offs between effectiveness and invasiveness. This is common in medicine and surgery, and, as I showed you, it is common in coronary artery disease. We need to embrace it and accept it. But I would suggest to you that one of the differences between coronary disease and vascular disease is that, as vascular surgeons doing both of these things, we have the opportunity to make these decisions. That could be either an advantage or burden, because we all have settled into our ways and our workflows, and maybe unwilling to change what we currently do in practice.”

Conte then returned to an overarching message he also delivered at a BEST-CLI session hosted at the 2022 VEITHsymposium that took place in New York in November. “I would suggest to you that centers doing less than 20% bypass in CLTI should really probably take stock about whether this is the best treatment for these patients,” he said.

Results from BEST-CLI showed that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularization strategy for patients with chronic limb-threatening ischemia (CLTI) who are deemed to be suitable for either an open or endovascular approach, the investigators reported. In patients without a suitable single-segment saphenous vein, both surgical and endovascular strategies were found to be effective in treating patients with CLTI, leading the investigators to conclude that there is “a complementary role for both revascularization strategies in these patients.”

BEST-CLI was a “landmark effort by [principal investigators] Alik Farber, Matt Menard and many others,” he said. Their passion and dedication “cannot be overstated in making this a reality over almost a decade, with much more to come from this trial.”

The work exhibited vascular surgeons taking the lead, he continued, “designing and executing science that is practice-changing science,” and “that needs to be recognized,” Conte added. It involved the BEST-CLI researchers taking lessons learned over the 20- to 30-year time span covering the development of evidence-based revascularization that he outlined in his address, he said, rolling them into the design of the trial.

Conte, having summarized BEST-CLI’s headline results and delved into characteristics of its two cohorts to underscore his point, also noted the trial’s limitations—a theme of focus among its skeptics. “Any trial can only begin to answer certain questions, and raises many others,” he said. “I think it is currently the standard, landmark trial in our field from which we can launch forward with true evidence-based guidelines and approaches.”

Short neck AAAs: ‘Choosing what is best for the patient’

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Short neck AAAs: ‘Choosing what is best for the patient’
Ross Milner takes the CIA 2023 podium

Navigating cases of abdominal aortic aneurysm (AAA) with short neck anatomy poses a serious challenge to vascular surgeons, but the list of potential options available to carry out repairs are numerous—and decision-making can be optimized by using a bespoke algorithm.

That was the message delivered by Ross Milner, MD, chief of vascular surgery and co-director of the Center for Aortic Diseases at the University of Chicago Medicine, in a session on endovascular aneurysm repair (EVAR) controversies at the 2023 Critical Issues America (CIA) annual meeting in Miami (Feb. 10–11).

Milner outlined the four core pathways open to surgeons when they are confronted with short necks—defined as greater than 4mm and less than 10mm: open repair, fenestrated EVAR (FEVAR) or physician-modified endografts (PMEGs), off-label chimney EVAR (ChEVAR), and endosuture aneurysm repair (ESAR).

In short, he said, the treatment ultimately elected should be dictated by the individual patient.

“I think in the past you’ve seen a lot of talks that are designed as debates between one of these techniques, and we commonly joke  about different techniques not working well,” he told CIA 2023. “The reality is, when you’re looking at each one of your patients, and you’re sitting in the office, and trying to make a decision, I think we incorporate all of these options.”

Milner uses his algorithm, or decision tree, in order to help establish which approach is going to best serve the patient in front of him. This includes figuring out the patient’s physiologic risk, the level of urgency of a procedure, durability based on risk profile/age, the direction of the renal arteries and the state of the aortic arch anatomy.

“When I look at the anatomy, the things I look at from an anatomic standpoint are: how do the renal arteries come off the aorta?” he said. “At least in my hands, I find that for chimney approaches, downward-going renal arteries are easier. For upward-going, fenestrated is easier. But again, in different people’s hands, it’s probably different. I also look at the anatomy of the neck and the tortuosity. If you’re going to think about ChEVAR, you look at the aortic arch.”

Open repair can be valuable in the right set of patients, Milner continued, but is “highly invasive” and “the risk of renal failure with open surgery is greater than with complex EVAR, and likely leads to worse outcomes.”

In his practice, Milner and colleagues do not perform procedures with PMEGs but rather on-label FEVARs. “It’s FDA approved, it’s all transfemoral, it’s indicated for 4mm neck, but it can be limited by anatomy, and sometimes the device just can’t be made,” he explained.

ChEVAR, meanwhile, has performed “relatively well” for his team in the treatment of complex anatomy. “Its limitations are gutter leaks and stroke risk,” Milner said.

Then there is short neck ESAR, he added, which incorporates EndoAnchors with an Endurant stent-graft. Overall, said Milner, his decision tree breaks down to, first, physiologic risk. “If it’s low, consider open surgery,” he said. “If high, go with an endovascular approach. For FEVAR, I look at iliac access, the direction of the renals, the neck tortuosity, the urgency of the procedure; for ChEVAR, again, iliac access, the direction of the renals, neck tortuosity and the aortic arch anatomy; for ESAR, calcification and thrombus, and reverse taper of the neck.”

Responding to skepticism over the ESAR procedure, Milner acknowledged controversy centers on a central question: ”What is the true neck? And all of us know that a 4mm neck is exceptionally challenging to use EndoAnchors on. I know that this is written as an indication, but that is hard to do,” he said, concluding: “Many options exist; choose what is best for your patient.”

Pay SVS dues to receive SVS benefits, including VAM discount 

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Pay SVS dues to receive SVS benefits, including VAM discount 
SVS President Michael C. Dalsing, pictured at the podium during VAM 2022

With registration for the 2023 Vascular Annual Meeting (VAM) right around the corner, those people who have not paid their SVS 2023 dues have a good incentive to do so quickly. Members receive a discount on not only VAM but also other SVS educational courses.

Other benefits include standing to vote in SVS elections (Active and Senior categories only), access to the Journal of Vascular Surgery, the SVSConnect online community, branding tools and more. Pay dues at vascular.org/Invoices. 

If non-members apply for membership by May 1, they could receive the membership discount for VAM, which is subject to application approval. Dues must be paid prior to the meeting to receive the member rate; the rate difference will be refunded after the meeting. 

First US patient enrolled in Gore Viafort vascular stent pivotal study

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First US patient enrolled in Gore Viafort vascular stent pivotal study
Viafort stent

W L Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, randomized, multicenter, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction. 

The first US patient was enrolled by Kush Desai, MD, at Northwestern University Feinberg School of Medicine in Chicago. “It is exciting to have enrolled the first US patient, an important milestone for venous occlusive disease treatment,” stated Desai. “With no device options indicated, or frankly designed for both IVC and iliofemoral venous disease, implanting the Gore Viafort vascular stent in patients represents a significant step forward in research and ultimately management of these complex patients.”

A company press release notes that the Gore Viafort vascular stent, which has received Breakthrough Device designation from the Food and Drug Administration (FDA), utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wire, sinusoidal-wound nitinol frame. The Gore Viafort vascular stent IVC study is evaluating the device in a treatment range of 10–28mm diameter for iliofemoral veins and the IVC. The study is being conducted in the U.S. under an approved investigational device exemption (IDE).

Getinge receives FDA premarket approval for the iCast covered stent system

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Getinge receives FDA premarket approval for the iCast covered stent system

Getinge‘s iCast covered stent system has received premarket approval from the Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

The iCast covered stent system, sold outside the U.S. under the brand name Advanta V12, has been used by clinicians for 20 years and is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with clinical data published in more than 550 articles.

Act now to keep CME credits, SVS urges members

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Act now to keep CME credits, SVS urges members

Society for Vascular Surgery (SVS) members should act now so they do not lose earned continuing medical education (CME) credits.

The American Board of Surgery (ABS) has changed its processes for CME credits, which affects their upload as well as meeting certification requirements. It also requires that, after July 1, members provide certain information in order for the SVS to transfer credits earned from SVS activities to the ABS.

To be sure existing credits have transferred correctly, members are asked to confirm the credits by April 1, says Lisa Cohen, SVS director of education.

Beginning July 1, all CME credits will be automatically transferred to the ABS through the Accreditation Council for Continuing Medical Education (ACCME) Program and Activity Reporting System (PARS). On that same date, ABS will retire its manual reporting feature, which permits individuals to self-claim their CME credits directly with the ABS.

While the SVS is committed to making the process as seamless as possible, SVS is still aligning its systems to meet the new requirements.

The SVS has established a process for moving credits, with a timeline established for manual transfers. Detailed information, including critical steps in the process, as well as guidance, is available at vascular.org/NewCreditProcess.

“As this is an evolving process, SVS will post the timing of credit transfers to ABS on the web page for each activity,” adds Cohen. “If credits are missing, contact [email protected] as soon as possible so staff can resolve issues before the June 30 deadline. Confirm credits at vascular.org/ABSCreditSite.”

Study highlights need for ‘continuous comparative assessments’ to guide endograft treatment decisions

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Study highlights need for ‘continuous comparative assessments’ to guide endograft treatment decisions
endograft
Senior author Ramon L. Varcoe

A recent study comparing outcomes of endovascular aneurysm repair (EVAR) patients has reported no statistically significant differences in mortality or secondary rupture rates between standard Cook, Medtronic and Gore endografts, suggesting similar safety in a real-world setting.

Michael O. Falster, PhD, a senior research fellow from the Centre for Big Data Research in Health in Sydney, Australia, Ramon L. Varcoe, MBBS, a vascular surgeon from Prince of Wales Hospital, also in Sydney, Australia, and colleagues report this and other outcomes from a large population-based observational study in the European Journal of Vascular and Endovascular Surgery (EJVES).

Another key finding was that rates of subsequent aneurysm repair were higher for endografts other than Cook devices, but only statistically significant for Medtronic devices.

In order to compare rates of all cause death, secondary rupture and secondary intervention in their retrospective cohort study, Falster, Varcoe et al used linked clinical registry (Australasian Vascular Audit [AVA]) and all payer administrative data from patients undergoing EVAR for intact abdominal aortic aneurysm (AAA) between 2010 and 2019 in New South Wales, Australia.

The authors identified 2,874 eligible EVAR patients, with a median follow-up of 4.1 years and a maximum follow-up of 9.5 years.

Writing in EJVES, Falster, Varcoe and colleagues report similar mortality rates for patients receiving different devices, ranging between 7 and 7.3 per 100 person years. In addition, they reveal that there was no statistically significant difference between devices in secondary rupture rates, which ranged between 0.4 and 0.5 per 100 person years.

Furthermore, Falster, Varcoe et al note that patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person years) than patients receiving Cook devices (0.8 per 100 person years). This finding, the authors write, remained in the adjusted analysis, but was only statistically significant for Medtronic devices (hazard ratio [HR] 1.57, 95% confidence interval [CI] 1.02–2.47; HR 1.73, 95% CI 0.94–3.18, respectively).

“Major endograft devices have similar overall long-term safety profiles,” the authors summarize in their concluding statement. However, they add, there may be differences in rates of secondary intervention for some devices. “This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy,” Falster, Varcoe and colleagues posit.

According to the authors, this population-based study is one of the largest to compare outcomes of EVAR patients receiving contemporary endografts from different manufacturers.

In the discussion of their findings, the investigators note that there are no studies that have randomized patients to endograft type to evaluate long-term mortality and secondary intervention rates. Given this absence, Falster, Varcoe et al suggest, observational studies “have a place” in providing “complementary” evidence for postmarket outcomes and are “well positioned to address the evidence gap around emerging technologies”.

The key strength of the present study, the authors claim, was the use of linked clinical registry and population-level administrative data. “This study is one of the largest to have explored outcomes for patients receiving different endografts, and also one of the only studies to have examined a contemporary cohort of patients to directly compare outcomes of endografts in current use,” Falster, Varcoe et al add.

The authors underscore “a need for ongoing surveillance of patient outcomes to compare and evaluate different devices used in clinical practice” to ensure those grafts are “providing the highest levels of safety and efficacy, with identification of those that are not”. Falster, Varcoe and colleagues opine that the history of endovascular surgery is “littered with examples of underperforming endografts,” which after evaluation were “identified and managed by either temporary pause for device modification or withdrawal from the commercial market entirely”.

The investigators stress that regulators such as the US Food and Drug Administration are “acutely aware” of the importance of postmarket data to assess the safety of device and encourage surveillance programs. The present study, Falster, Varcoe et al claim, “demonstrates that linkage of clinical registry and administrative data can strengthen the evidence to help fill the inevitable gaps which occur when [randomized controlled trials] do not exist or are unethical to perform”. They continue: “Increased capacity within clinical registries to identify specific endograft devices, as well as indication for device choice, will further enable this comparative work.”

Considering the limitations of their work, Falster, Varcoe and colleagues note that the drawbacks of administrative data are “well known,” referencing the fact that the present linkage rate of 82.7% between the AVA and administrative datasets means that findings “may not be representative of all EVAR patients in [New South Wales]”.

The investigators stress that their results must be “interpreted with some caution” given the small number of patients receiving some endografts, the relative scarcity of some of the endpoints (e.g. aneurysm rupture) and that the bias which may result from individual surgeons’ subjective device selection methods and the potential for unmeasured confounders has not been eliminated from the study.

“Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices,” Falster, Varcoe et al write in their closing remarks.

STEVECO trial calls into question randomization in the venous stenting field

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STEVECO trial calls into question randomization in the venous stenting field
Jorinde van Laanen at EVC 2023 cropped 2
STEVECO
Jorinde van Laanen at EVC 2023

Recruitment proved to be a major challenge for the STEVECO (Stent versus conservative treatment in patients with deep venous obstruction) randomized controlled trial (RCT), prompting discussion on how best to randomize patients in future trials, the ethics of doing so, and possible alternatives to RCTs.

Jorinde van Laanen, MD, from Maastricht University Medical Center in Maastricht, The Netherlands, presented results of the STEVECO trial at this year’s European Vascular Course (March 5–7) in Maastricht.

While venous stenting is “basically common practice” and supported by various guidelines, the presenter noted, the problem is that the evidence available on venous stenting is limited. Most reports focus on stent safety and patency, with only three studies—according to a literature review van Laanen referenced—reporting on quality of life. “Are we really helping the patients? Are the clinical symptoms improving?” she questioned.

The STEVECO trial, sponsored by Optimed, was designed as a multicenter, randomized study. Van Laanen detailed that patients had to be treated conservatively for one year before they could be included in the trial, which had a primary outcome of VEINES-QoL/Sym score at 12 months and secondary outcomes of general quality of life, clinical improvement and stent patency.

“The trial had a lot of challenges,” van Laanen remarked, with randomization of patients being the most notable. She explained that patients present to the Maastricht centre after tertiary referral because they have been struggling with symptoms for a long time. “These patients have already been treated conservatively and are sent to expert centers for treatment, so they want a treatment, an intervention,” the presenter continued. When the investigators tried to randomize patients—with the possibility that they would be assigned to the conservative arm for at least one more year—she noted that patients often refused to participate.

As a result of this and other challenges, van Laanen detailed that the investigators stopped recruitment at 63 patients out of a target of 130, with 21 in the control group and 42 in the intervention group.

At EVC, the presenter reported an eight-point VEINES-QoL score advantage for the stent group at one year, as well as a six-point VEINES-Sym benefit.

In terms of secondary outcomes, she revealed no significant difference in general quality of life—as assessed by the EQ5D questionnaire—and a significantly diminished pain score (11 points) in the stented group. Finally, she detailed a significant reduction in venous clinical severity score (VCSS) but not in Villalta score.

The patency results, van Laanen added, were comparable to other studies, with a primary patency of 91% and secondary patency of 97%.

The presenter stressed that there are some key questions that must be asked going forward. “How should we do this in the future?” van Laanen asked the audience at EVC. “If we really want to prove stenting is better than conservative treatment, how are we going to include patients in an RCT when we are all doing the treatment all of the time?”

Randomization: Ethics and alternatives

“You need to be applauded for trying this,” panelist Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England, remarked in the discussion following van Laanen’s presentation on the STEVECO trial. He stressed that recruiting for a venous RCT is not an uncommon problem, noting BEST-PTS is “struggling” and C-TRACT is “in danger of being terminated.” He also referred to past trials, highlighting that ATTRACT and CAVA both took 10 years to recruit.

Considering what investigators need to do differently in the future, van Laanen suggested that “maybe the only option” would be to offer stenting exclusively to patients who participate in an RCT. Alun Davies, MD, from Imperial College London, expressed his support for this idea, telling the audience it is “exactly what happened in the UK” with the EVAR 1 and EVAR 2 trials. “The only way you could get a device was by actually going into the trial,” he said.

Black remarked that the ethics of randomized trials are “quite difficult,” expressing the opinion that “we need to find alternatives to RCTs.” These trials are “exceptionally difficult to run” and “exceptionally expensive,” he said, adding that he is not sure the narrative that an RCT is the only level of acceptable evidence is completely correct.

Looking ahead, he underlined the potential of artificial intelligence (AI) and other new technologies in looking at large datasets. “There are opportunities there to run studies that provide you with exactly as robust a level of evidence, without having to randomize patients,” he explained. “I suspect the only way we are going to get around ethics is really looking at study design in a more robust fashion.”

‘Time matters’: New study finds novel EHR workflow improves timeliness in vascular care

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‘Time matters’: New study finds novel EHR workflow improves timeliness in vascular care
John Iguidbashian

A novel, order-initiated workflow facilitated by the electronic health record (EHR) has been shown to improve timeliness of care for vascular surgery patients, decreasing time to operation and working to standardize and automate the consultation process. 

Presented at the 2023 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Whistler, British Columbia (Feb. 23–26), by University of Colorado general surgery resident John Iguidbashian, MD, senior author Jeniann Yi, MD, spoke to Vascular Specialist about why streamlining consultation operations is paramount for the “acute and urgent” cases vascular healthcare professionals often handle. 

Implemented at a single institution, the team’s order-initiated workflow automated notifications to providers of consult requests, communication of patient data, patient additions to consultants’ lists, and tracked consult completion. The investigators subsequently compared consultation timelines pre- and post-implementation. 

When prompted on their reasoning in evaluating this process, Yi, an assistant professor of surgery at the University of Colorado in Aurora, Colorado, fleshed out the prevalent “issues” they had been encountering with the system, stating that “there was no clear understanding” in the process. She noted a criticism they had encountered which suggested that the system may remove the human element of providing patient information. However, Yi countered this by affirming that, particularly in critically ill patients, if the complete order was initiated and the workflow subsequently expedited, then healthcare professionals are able to trigger those essential, in-person conversations faster. “It removes a lot of steps and mindless work from of the process,” Yi said. 

The authors evaluated 278 inpatient and emergency department vascular surgery consultations (158 pre-implementation, 120 post-implementation); 41 and 38 consults required surgery pre- and post-implementation, respectively. Among their results, viewable consult notes were available 31.77 minutes earlier than pre-implementation, while attending attestations outlining final treatment plans were added 205.65 minutes sooner post-implementation. 

Yi asserts that by using their novel workflow they were able to more easily track recommendations so that actions could be initiated for patient recommendations sooner, and potentially expedite them to lower levels. 

Although their results show positive evidence to support the EHR—also known as the electronic medical record (EMR)—as a tool, practitioners expressed “mixed feelings” toward it, Yi explained. When asked about the audiences’ reception of their presentation at VESS, however, Yi stated that discussions centered around how the existing process can be “adapted” to solve “conflicts within existing workflows” as to not pile on additional “[burdensome]” admin. 

Emphasizing an area in which their research proves essential, Yi observed that the vascular subspecialty—which frequently includes acute care surgery—is a key area where streamlined workflow processes would benefit most: “Time matters, especially in human intervention—the sooner they receive treatment, the better their outcomes are. To save time is the goal and at the heart of it, it’s about being able to provide prompt treatment for these patients in need of urgent care.”

Analysis finds no difference in TCAR outcomes between academic, community hospitals

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Analysis finds no difference in TCAR outcomes between academic, community hospitals
TCAR procedure

A new study found no difference in perioperative outcomes and incidence of adverse events at follow-up after transcarotid artery revascularization (TCAR) between academic and non-teaching community institutions. Presented at the 2023 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Whistler, British Columbia (Feb. 23–26), lead authors Samuel Leonard, MD, and Shihuan K. Wang, MD, of UTHealth in Houston, Texas, spoke to Vascular Specialist and situated their research within contemporary vascular practice. 

Outlining their two-pronged research aim, Leonard began by elucidating their initial objectives, noting that they wanted to compare patient cohorts between community versus academic hospitals, as well as outcomes in patients who underwent TCAR at these institutions. 

Building on this, Wang explained the relatively recent and “[quick]” adoption of TCAR—after the Food and Drug Administration’s (FDA) approval of reverse flow carotid stenting in 2015—which has influenced an “exponential” rise in the volume of TCAR procedures being carried out, he asserted. Due to wider availability, Wang continues, TCAR is no longer limited to academic institutions but is being performed in smaller hospitals, setting the stage for the investigation the authors conducted. 

The researchers carried out a retrospective review of prospectively maintained system-wide databases from UTHealth, Houston, and IU Health, Indianapolis, Indiana, evaluating TCAR procedures performed between 2015–2022. 

Patients were stratified based on the setting of surgical intervention, such as academic with trainees or non-teaching community hospital with only staff surgeons. Relevant demographics, medical conditions, anatomical characteristics, intra- and post-operative courses, and adverse events were captured for statistical analysis. 

Identifying 729 patients who underwent TCAR, the authors found no significant difference in perioperative stroke at 30-day follow-up, however, they did note disparities in performance metrics between institutions. Procedures carried out at academic hospitals took longer, although Leonard points out that this may be attributable to the complexity level of the cases they receive. 

Nonetheless, the “comparable” results for TCAR, regardless of care location, show that you do not necessarily need the “big box of resources” to have desirable outcomes, as Wang phrased it. 

“We’re not saying everyone should be getting [TCAR], we certainly don’t have the data for that”—both authors agreed that advocation is not their intent—”the gold standard continues to be carotid endarterectomy (CEA),” Wang clarified. 

Additionally, when recalling the questions put to the authors at VESS 2023, Leonard posited that their advocacy for TCAR was tangibly “on the audience’s mind,” reiterating that the investigators continue to abide by the Society for Vascular Surgery (SVS) guidelines, which continue to recommend CEA for carotid disease. 

Quashing any hint of upheaval, the absence of any industry supported trial or study evaluating TCAR data which shows clinical equipoise between TCAR and CEA, meant there “wasn’t too much uproar from the audience,” Leonard explained. 

On a sobering note, Wang added: “It’s a new technology, there is limited evidence, and the pendulum is swinging toward TCAR a little too aggressively right now and I do worry about that.” Making clear that CEA still takes precedence, TCAR, he stated, will remain an “alternative” until clinical trials shed more light on its efficacy. 

As Wang continued, he stated their results emphasize a broadening of resources, “opening up options” for patients, noting that particularly for elderly or very unwell patients, navigating a large academic hospital may not be feasible, and attending a smaller, local institution may be advantageous. “A lot of these patients prefer, if possible, to get procedures done at a smaller place that’s just as good, and then drive, two, three blocks away to the Big Mega Mart—this data reassures patients a little bit,” he said. 

Echoing Wang’s sentiment, Leonard concluded by expressing their continued efforts to build the database to extract “other salient points” in the future.

SVS, ACS launch new quality verification program

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SVS, ACS launch new quality verification program
Anton Sidawy, R. Clement Darling III, and Michael C. Dalsing

The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have launched the “Vascular Verification Program (Vascular-VP),” an ACS Quality Program developed in partnership with the SVS.

The newly launched inpatient program reviews not just safety processes against standards created by vascular surgeons, but also emphasizes the importance of using clinical data for tracking outcomes and supporting quality improvement specific to vascular care. It covers the perioperative continuum of care, from pre-hospital to post-discharge care.

“We created this program to ensure quality and quality improvement in vascular care in both the inpatient and outpatient settings,” said SVS President Michael C. Dalsing, MD. “Our own members asked for this program, particularly for outpatient settings, which may have little or no oversight. They understand the importance of standard policies and procedures imbedded wherever care is provided to ensure safety and promote quality.”

The verification process ensures that an applicant program:

  • Has the appropriate infrastructure for the procedures performed
  • Follows clinical pathways to ensure care is in line with evidence-based clinical guidelines when available
  • Monitors outcomes, emphasizing the importance of clinically relevant, risk-adjusted, nationally-benchmarked data
  • Submits all needed information to reviewers who will assess all required aspects of the program for verification
  • Undergoes a verification visit to ensure all standards are complied with and performs case review to ensure that there are internal quality processes in place to ensure safe and appropriate care of patients afflicted with vascular disease is provided

ACS has a long-standing experience in a wide array of quality verification programs to include cancer, trauma, bariatric surgery, pediatric surgery, to name a few. All these programs use the same structure used in the new Vascular-VP. This structure is based on four pillars:

  • Standards based on peer-reviewed published data and expert consensus
  • Appropriate infrastructure based on the standards designed for the program
  • Data for monitoring outcomes and quality improvement support, using reliable, clinically relevant, benchmark data
  • External peer-review team to verify compliance with the standards

“It was a win-win to work with the College for the vascular program,” said Anton Sidawy, MD, who, as the vascular regent serving on the Board of Regents of the ACS and past president of the SVS, led the effort to create the Vascular-VP. This is not the first time that the SVS sought such a program to ensure vascular centers are reviewed for quality.

“With the ongoing shift in reimbursement for our services from volume to value, who best to define quality and value than us—vascular surgeons and the professional organization representing us, the Society for Vascular Surgery?” Sidawy said.

Vascular diseases and issues covered in the program include, but are not limited to, thoracic-aortic, abdominal aortic, carotid artery disease, peripheral artery disease (PAD), arteriovenous hemodialysis access, and superficial and deep venous disease.

Those centers that meet the current inpatient standards will be “Verified” at one of two levels: a “comprehensive inpatient vascular center,” or “verified inpatient vascular center.”

Eight pilot programs—four inpatient and four outpatient—have already gone through the pilot phase of the verification process, including both the inpatient and outpatient components of Albany Medical Center in Albany, New York, under the direction of R. Clement Darling III, MD, chief of vascular surgery at the institution, and himself an SVS past president. He called the process “invaluable.” That includes ascertaining that Albany Medical “had the components we always thought we did. We found out we need to do better in some areas and actually begin implementing procedures in other areas.”

Administrators at Albany Medical Center found it eye-opening to see how much work goes into a successful vascular program, Darling said, including “how comprehensive the infrastructure needs to be to care for these incredibly complex patients. It showed them what infrastructure we need from the hospital to provide the best care for our patients.”

Going through the process “made us better and helped us take better care of our patients,” Darling said, and urged other vascular centers to undertake the verification process.

The process also ensures the longitudinal care for which vascular surgeons are known for providing. “Our care doesn’t end in the OR [operating room],” said Darling. “Every move has to be documented and evaluated; this process lets us follow our patients to make sure we’re providing the best care for them.”

“As the program launches, more institutions are waiting in the wings, including my own in Indianapolis, Indiana,” added Dalsing.

He believes the new initiative will provide several benefits, including improvement in quality of care for patients, enhanced learning throughout the institution, and external credibility to regulators. “We set the standards and we’re reviewing the data,” said Dalsing. “This will help everyone understand that ‘quality vascular care’ should be the goal of every center that takes care of patients with vascular disease, and that this program is the tool to help us realize this goal.”

Sidawy, Darling and Dalsing all emphasized advantages for not only patient care but also potential improvements to vascular programs.

Those involved examine the entire process, such as: “What other support staff do we need? How can we maximize utilization of all the components in the system—not as just a vascular unit but also a vascular system that has significant impact on other specialties, such as orthopedics, oncology, spine, and cardiology?” Darling said. “We are an integral horizontal component for many high-end specialties. This process really documents the importance and impact of a vascular surgery system on the hospital system.”

As the program continues, those who already have gone through the process will be able to share information and experiences with other vascular surgeons embarking on verification. “Much of the information we used in putting together our data could be shared as to what protocols were important,” Darling said. “This gives us a consistency and accountability across the country for expert vascular care.”

Dalsing, Darling, and Sidawy stressed that quality and quality improvement are at the heart of the Vascular-VP, the only program available that establishes and verifies a programmatic approach to quality in vascular care.

In the end it comes down to ensuring quality, said Dalsing. “SVS is all about quality. It is our North Star.”

Facilities involved in pilot site visits

Pilot sites involved in the verification program were, for inpatient: Albany Medical Center; Baylor Scott & White Heart Hospital in Plano, Texas; the University of California, San Francisco Vascular Program; and Keck Hospital of University of Southern California.

Outpatient sites were Albany Medical Center; Michigan Vascular Center; Nashville Vascular and Vein Center in Tennessee; and Vascular Institute of New York/Total Vascular Center in Brooklyn, New York.

SVS members involved in the pilot site visits are, respectively, R. Clement Darling III, MD, William Shutze, MD, Michael Conte, MD, and Fred Weaver, MD, for inpatient facilities and Darling, Robert Molnar, MD, Patrick Ryan, MD, and Anil Hingorani, MD, for outpatient facilities.

Bioprosthetic venous valve: ‘We want to know that this is really working’

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Bioprosthetic venous valve: ‘We want to know that this is really working’
Surgical implantation of the bioprosthetic VenoValve
A key investigator in efforts to tackle chronic venous insufficiency (CVI) with an bioprosthetic venous valve replacement talks about progress being made with surgical and endovascular versions of the device—and surgical community skepticism. 

Jorge Ulloa, MD, has not long since produced the latest data from a first-in-human (FIH) trial for emerging stainless-steel frame-based surgical implant, the VenoValve device, intended to treat patients with C5–C6 disease on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification scale. 

He is talking on the sidelines of the 2023 annual meeting of the American Venous Forum (AVF) in San Antonio, Texas (Feb. 22–25), where he has just presented the latest update on what the 36-month data from the FIH is showing. 

Jorge Ulloa

Those results for the investigational device continue to be promising, Ulloa says, but the U.S. pivotal trial, the SAVVE study, or Surgical anti-reflux venous valve endoprosthesis, is also approaching a crucial tipping point, he tells Vascular Specialist. “We’re getting into 40-plus patients, more than half of what is required by the Food and Drug Administration [FDA],” he explains. “We’re at 24 sites. The goal is to end up with 75 cases. That data needs to be analyzed in order to know that the experience we had with the small number [of FIH patients] we got in Colombia, which was 13 at the beginning and now eight under the last cut of the follow-up, is replicated. That is the position we are in right now.” 

Attention is turning, too, to the early stages of a catheter-delivered version of the valve, Ulloa says. The Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia, vascular surgeon has, of course, been at the vanguard of the early research efforts around the surgical valve replacement. He will play a similar role as the FIH trial of the endovascularly delivered bioprosthetic gets underway, also in Colombia. 

“This endovascular approach, which is a miniaturization of the valve—the same one that we placed and have been placing in Colombia and the U.S.—in order to accommodate it in a catheter and allow it to be placed, involves a different process in that it goes under nitinol, the material of stents. It will go into a catheter and then be delivered via the popliteal vein, and then deployed at the femoral vein level, in the very same way that we are doing so far with the open and surgical approach. 

“The advantages of this are that, of course, delivery is an endovascular process— the morbidity of the surgical approach goes almost toward zero—we don’t make incisions, we don’t do dissections, we don’t have to deal much with bleeding.” 

If all goes to plan, the TAVVE (Transcatheter anti-reflux, venous valve endoprosthesis) FIH trial will commence within a couple months, potentially with up to 20 subjects, Ulloa adds. 

Yet, he is aware of skepticism over results recorded thus far among some within the vascular surgical community. “There have been a series of attempts for the last 60 years or so, with the first report of a prosthetic valve going back to the 1960s,” he says. “The first implantation in the human body was sometime around the late 1980s, early 1990s. The number of cases was very low, and the follow-up was very short and not very promising. Therefore, I understand, we all understand, that there is going to be a whole field of skeptical surgeons.” 

Rather, Ulloa argues the medical landscape is more conducive to success now. “Materials are way better than they were 20, 30, 40 years ago,” he continues. “The surgical approaches are better now. We understand physiology way better. We can assess the behavior of a valve right after and during the surgery, and right after the surgery we can check it and can see it; we can measure it, we can get a lot of physiological data out of each and every one of the patients or cases. Also, the numbers we got are a little higher than the historical average, and the follow-up we got [in the FIH VenoValve trial] is the longest we’ve got in history—the longest we had before was six months.” 

The valve, Ulloa says, is not going to be perfect, nor cure the underlying problem—“but it will manage the problem, and will improve the quality of life, and the data is supporting all those ideas.” He points to decreased reflux, reduced pain and healed ulcers. “Of course, we have to continue the follow-up to see what is going to happen, and continue to add numbers.” 

There might be no more skeptical a group than those investigating the device themselves, Ulloa says. “We want to know that this really working, we want to see how it is working, we want to assess each and every measurement that we can, and that’s what we have been doing so far with it. Yes, probably we are approaching the end of the road, and we are getting into the field of a lifelong problem that has been facing vascular surgeons—really difficult to manage—which is the post-phlebitic syndrome. For the first time, it has real possibility of treatment that will, at least for three years, see a dramatic improvement in symptoms and dramatic increase in quality of life.” 

Letter to the editor: The vascular influencer

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Letter to the editor: The vascular influencer
W. Michael Park
Dear editor, 

Reading “Likes, dislikes and reposts: The new age of the vascular surgery influencer,” by Drs. Jean Bismuth (@jeanbismuth) and Jonathan Cardella (@yalevascular), they rightly point the spotlight on the trend of some vascular surgeons posting cases on social media for the purposes of self-promotion, virtue signaling, and influencing. 

I can agree with their point that many of these posts are made by mediocre practitioners who display only the best and curated images, but I felt uncomfortable with the feeling that I may be one of those people being castigated for over-exposure on social media. They warn the readers of the dangers of misinformation fed to an uninformed public, but overlook the potential of social media for education and community. Being a vascular surgeon who has been on social media for over 15 years, there are reasons why I am here which are not explained by this article. 

Be the lede 

My journey started with hacking Google searches. My first job out of fellowship was a faculty position at my medical alma mater, Columbia P&S. The PR department asked everyone to compose a blurb for a web page and after searching on Google on how to rise in a Google search, I wrote out a paragraph full of the right verbiage to maximize my relevance on search. It wasn’t very difficult in 2002 to do this. Searching “vascular surgeon in New York” on Google after posting that info page consistently brought me up to the top five links, ahead of whole departments and many big names. I did over 400 cases my first year out, and I really felt if I could make it there, I could make it anywhere. 

Bury the lede 

Unfortunately, like many vascular surgeons in New York, I got named in a lawsuit, and like many young surgeons with limited means and large loans to pay off, I couldn’t fight it and took the advice of hospital lawyers and settled. After that lawsuit, a Google search would return an article by the law industry PR around 2007, and I was at that point very busy in private practice in Iowa. It was so discouraging seeing that as the only thing speaking for me. I decided that I had to take an active part in shaping the message around me, to not let my Google search profile be defined by that article. 

I decided to write and figured a few articles every week over a year would bury that article behind many better articles. I began to blog about something I am both horrible at but aspire to greatness in—golf (www.golfism.org). Writing about myself and my struggles in golf and being a young father and husband was how I found my voice. It was during this period I found my best pieces were when I gave something of myself. 

After finding my author legs, I began writing about vascular surgery, something I’m pretty good at but aspire to greatness in, on a personal blog (docparkblog, on Apple’s defunct cloud service). After a year, the blog got only 30-50 hits a day, at most 100. By internet standards, that’s low, and I kept my day job. After giving a talk at Midwest Vascular to an audience of about 50 mildly interested surgeons, that 30–50 engaged readers on my blog a day felt pretty good. A hundred was amazing. Medscape eventually tapped me for blogging on their site. My blog there, “The Pipes Are Calling,” was rated among the top five most-read medical blogs in the world when I shut it down in 2011. 

The influencer 

This social media presence generated influence -I was asked to participate in prominent research trials like PIVOTAL, CVRx, and CREST and others despite being in private practice. This is common now, but rare 15 years ago. The blogging did bury the lede. It eventually generated misunderstanding in the hospital administration at that time in 2011 and I was asked to stop blogging, at least until they could figure out what this internet thing was about. In 2012, I joined the Cleveland Clinic, I huddled with their social media department and came up with ironclad rules: 

  1. All accounts were to have the header that posts and articles were my own opinion and not of my employer 
  2. All patients sign a media release for posting of case histories and images 

After launching www.vascsurg.me in 2013, I chose to focus on technique and opinion. I used my LinkedIn and Twitter accounts to promote my articles. I always communicate in my authentic voice, although over the years, I’ve toned down the irony which is frequently misunderstood. In moving to my current hospital, University Hospitals, the first thing I did was arrange for a social media release and confirm what I was doing was okay. In reading the article by Drs. Bismuth and Cardella, in 2023, misunderstanding is still at the core of arguments against the use of social media. 

The worst 

I have seen egregious examples of bad behavior on social media by physicians, as mentioned in the article. On my Twitter stream, I’ve seen people put stents in subclavian veins for thoracic outlet compression and wait for praise, which they get from similarly ill-informed people who don’t realize I see patients like this several times a year with swollen arms and faces. While I was in Abu Dhabi, someone put stents in a patient from the common femoral to popliteal artery, and received accolades for “minimally invasive skills” from all corners of the globe, only for me to remove the stents a month later and perform fasciotomies on the same patient—a middle-aged claudicator! There, I couldn’t post a rebuttal to the original case presentation because of local social media laws. Despite the word getting out, the surgeon only doubled down on his minimally-invasive fantasies. About the same time, I witnessed a relatively famous person self-implode on Twitter while accusing vascular surgeons of butchery (his words) by supporting open surgery over head-to-toe interventions. He got crushed by the general disapproval of his misrepresentation and personal bullying of a vascular surgeon, and then disappeared from social media. Evaporated. Good. We all have to do better. 

The best 

I have also seen patients with rare diseases such as median arcuate ligament syndrome reach out and connect with each other and with physicians about diseases that aren’t taught in medical school or residency training on social media. There are Facebook groups, Twitter hashtags, and sub-Reddits—rich communities of people who have to make serious decisions about their lives, many with limited access to specialists in their far-flung burgs and precincts. I think the fear is that bad decisions will be made based on bad information, but even in the highest, most rarified medical institutions, patients may get misguidance, have a complication, a poor outcome, in-person which can be worse than a social media interaction. If we value patient autonomy, access to the best information needs to be available. Social media lowers the barriers to access, for bad or good. Yes, it can do a whole lot of bad, but also an immense amount of good. 

Keeping it real 

The authors are correct in that people will prefer to promote themselves rather than air complications and bad outcomes. The American surgical M&M process is an amazing and cherished tradition and protected process. It has no place in social media. Most surgeons also take the view that social media presence doesn’t lengthen your CV, it doesn’t bill. The many cheap suits of medical social media, the hawkers, the hucksters, the fragile egos, will always be there on Twitter and LinkedIn. 

But other functions such as access and broad dissemination of information, experience, and opinion, are legitimate and critical. Comparatively few people get the message from a closed academic conferences and traditional modes of dissemination are slow. Most of the best social media posts are, as the authors mention, case reports. They fail to mention case reports under “open access” cost about $500 to publish. 

The peer review process, which I participate in, results in sometimes glacial turnaround times with papers landing often a year or more after presentation at a conference. I also learned from my time in private practice that these barriers block the voices of many legitimately great surgeons whose remarkable talents are only shared locally. I also learn from my time in academic practice that too many departments are not multiplicities of talents, but shops built around single personalities, who may declare that having never seen something, it cannot exist—to the detriment of those with unseen problems. Social media is the great leveler for patients and surgeons. It brings needed exposure to young surgeons building practices, while connecting people searching for solutions to people who may have a clue. The voices of non-academic surgeons are given a platform to broadly share their experience. If legitimately good people are dissuaded from participating, only the cheap suits will remain. As always, caveat emptor, et primum non nocere. 

W. Michael Park, MD

University Hospitals, Cleveland 

Viz.ai receives FDA 510(k) clearance for abdominal aortic aneurysm AI algorithm

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Viz.ai receives FDA 510(k) clearance for abdominal aortic aneurysm AI algorithm
Viz.ai platform

Viz.ai recently announced it has received Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA, the company claims.

“There are an estimated 1.1 million Americans living with a AAA. The majority of these patients are asymptomatic and many are unaware of their disease until a rupture occurs. This is a catastrophic medical emergency, resulting in over 10,000 deaths each year,” said Philip M. Batista, MD, from Cooper University Health Care in Camden, New Jersey. “This algorithm is a powerful new tool for healthcare professionals to more readily identify and capture individuals with AAA and, importantly, automatically refer those at imminent risk for rupture.”

“I look forward to the new aortic platform here at TriHealth, as its implementation will allow for enhanced identification, triage and team member communication, resulting in the best possible care for our aortic patients,” said Patrick Muck, MD, from TriHealth Heart Institute in Cincinnati, Ohio. “We have been using the Viz software for the detection of suspected pulmonary embolism over the last several months and have seen improvements in patient care across our institution.”

Viz AAA uses artificial intelligence (AI) to automatically search for the presence of a AAA from computed tomography angiography (CTA) from any scanner in a hospital network, a press release details. The new AI algorithm and clinical workflow solution will be a part of the Viz Aortic Module, an AI solution designed to accelerate treatment decisions for all aortic pathology.

Viz.ai notes that the software can be integrated into existing hospital workflows, allowing physicians to quickly and easily identify patients who may have a suspected AAA and take appropriate measures to prevent a rupture.

ABCs for the treatment of lower-extremity acute DVTs

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ABCs for the treatment of lower-extremity acute DVTs
Ashish Gupta

Ashish Gupta, MD, outlines his ABCs for confronting and treating patients with acute deep vein thrombosis (DVT) of the lower extremity, and how he developed his dictums. 

A is for “anticoagulation” for not more than six months of duration. Rationale: At the six-month mark, if the patient is still on anticoagulation, there has to be a reassessment and discussion between patient and healthcare personnel over whether the patient really needs further treatment with anticoagulation. The American Society of Hematology (ASH) guidelines define the treatment period as “initial management” (first five to 21 days), “primary treatment” (first three to six months), and “secondary prevention” (beyond the first three to six months). The guidelines favor shorter courses of anticoagulation (three to six months) associated with a transient risk factor. The guidelines suggest indefinite anticoagulation for most patients with unprovoked DVT associated with a chronic risk factor. 

B is for “Be active, Be ambulatory.” Rationale: Many people are told to take it easy, such as limit their walking and stay on bed rest. Both are myths. Both the American College of Chest Physicians and American Physical Therapy Association (APTA) guidelines recommend early ambulation for patients with acute DVT. 

C is for “Consider compression stockings or ace wraps.” Rationale: Requirement for compression will be dependent on extent and location of DVT. Per ASH, select patients benefit from compression stockings to help with edema and pain associated with acute DVT. 

ABCs background 

It is a well-established science that for general treatment of acute DVTs, three to six months of standard anticoagulation, early ambulation, and compression stockings for certain scenarios are recommended. 

However, after 17 years of solo private practice in a community setting, I find that these dictums are not being followed the majority of the time. 

As vascular surgeons are not the first-line people in treating and diagnosing the majority of DVTs, my personal experience has been that many patients in a wide variety of scenarios are not taken off their anticoagulation (rather they are led to believe that they have to stay on them forever). 

Instead of early ambulation, they are told to limit their ambulation post-diagnosis, and only few get their compression stockings prescribed when indicated. Another of my observations has been that patients have an inherent feeling of security against DVTs when they are taking blood thinners indefinitely. And when told that you can get off it, they look at you with suspicion and doubt. 

Furthermore, I have seen many patients (who have DVT as one of their many diagnoses) admitted in long-term acute care facilities (LTACs) and nursing homes who keep getting their anticoagulation for beyond six months, despite rebounding between hospitals and back to their LTACs and nursing homes. It’s practically impossible for innumerable rotating physicians, consultants, and emergency room physicians to stop their anticoagulation as they don’t have a total picture of the patient. And their mindset is also: why rock the boat! It is easier to keep the anticoagulation rather than take patients off. 

New PCP 

Then we also have those patients who move to another city and establish care with a new primary care provider (PCP). And if they have been on anticoagulation with the initial physician, the new PCP continues the same anticoagulation regimen. 

On a personal front, I have had several patients over the years who have been on warfarin for several years for a remote DVT (supra- and infrapopliteal), and now they don’t have veins from which to draw blood. When admitted to hospital, they end up getting central lines as they don’t have any peripheral venous access. Also, people with chronic DVT diagnoses found during hospital admissions keep being treated with anticoagulation. 

Then there are those several patients who have been on direct oral anticoagulants (DOACs) that don’t require blood testing, but they are paying a lot of money unnecessarily for their medications. They frequently mention that they can’t afford these expensive medications, and ask whether I have samples for them. Finally, how can we forget those patients who get into bleeding complications that are catastrophic. It is obvious that unnecessary anticoagulation is a major risk that patients take while pharmaceutical companies reap their profits. 

As March is national DVT Awareness Month, I have been thinking about how to make the treatment algorithm simple for all. This includes patients, their family members, medical students, residents, fellows, practicing doctors (PCPs, hematologists, cardiologists, pulmonologists, internists, vascular surgeons, interventional radiologists), nurse practitioners, physician assistants, and anyone who comes in contact with DVTs. And what better way than using a simple acronym? In the spirit of global awareness and education, I came up with a simple catchy phrase/triad: “Dr. Ashish Gupta’s ABCs for treatment of lower-extremity acute DVTs.” 

This acronym is by no means discriminating between treatment of supra- and infrapopliteal DVTs, as some do treat infrapopliteal DVTs, on a case-by-case basis, with anticoagulation and/or with follow-up venous duplex for evaluation of propagation. Even if someone is treated for infrapopliteal DVT, their anticoagulation should be stopped by six months at the latest, if not sooner. The hope is to make this acronym a framework for all involved in the treatment of DVTs in order to raise awareness of the ABCs, and not simply over treat. 

I strongly believe that implementation of this acronym will help all involved remember easily how to manage DVTs, empower patients and caregivers, and will avoid unnecessary use of anticoagulation, avoid costs, and reduce major complications that can come from diagnosis of DVT. The implications during DVT Awareness Month of this acronym can be exponentially beneficial and fruitful in terms of best practices, where not only healthcare providers, but even patients and their family members can remind themselves at six months whether they need anticoagulants anymore. 

Ashish Gupta is a board-certified vascular and endovascular surgeon practicing in Wyandotte, Michigan, as a solo private practitioner since 2005. 

From the SVS president: Supporting one another

From the SVS president: Supporting one another
Michael C. Dalsing

The Society for Vascular Surgery (SVS) has a vision that is unwavering. We desire quality vascular care for all patients by providing our members with the information and tools they need to provide best care. We believe the goal is the right care, by the right provider, at the right time, and in the right place for each patient. 

Over the last few months, there has been much debate amongst members regarding quality and appropriateness of care across various healthcare settings. This has been stimulated by recent research conducted, published, and presented by colleagues from Johns Hopkins University, as well as other work published by academic surgeons in the recent past. Before going any further I would like to make two points absolutely clear and unequivocal: 

  • SVS is 100% supportive, and a champion, for all of its members working hard to provide quality care of patients regardless of site of service. Championing the “right care-right provider-right time-right place” mantra requires the SVS, and all of us, to embrace and continue to improve care for patients wherever it is delivered. 
  • SVS has always embraced as one of its highest core values, that we follow best science and best evidence to inform and improve our specialty. This means we question, challenge and debate to be sure, but in the interest of strengthening evidence that will help us to take better care of our patients. 

It is with these principles in mind that, on Feb. 24, representatives from academic and private practice, along with SVS leadership, had a productive meeting to address the ongoing issues and perceptions that resulted from recent publications and presentations. We openly discussed any misunderstandings and sought to find a constructive path forward. 

A primary issue was the discovery of strong correlations within the Medicare database that demonstrated a signal of inappropriate care by extreme outliers. In some cases, these outlier occurrences were found more likely associated with the office-based lab (OBL) setting. Importantly, most outliers were not vascular surgeons. Some members of the vascular surgery community working in the OBL setting interpreted the conclusions and discussions of this correlational data as a general accusation of providing inappropriate care for personal gain. 

On our call, it quickly became very clear that everyone wanted the best care possible for our vascular patients. The Medicare database research did point out signals of concern that should worry all of us, that are deserving of more research, and must be addressed through policy, education, and quality improvement. Everyone agreed that the OBL can and does provide an accessible, affordable, patient-friendly setting with vascular surgeons who provide excellent patient care. It was further observed that the other part of the story has been lost in the controversy. The vast majority of vascular surgeons in all practice settings are meeting or exceeding practice guidelines and appropriate use criteria (AUC) recommendations to provide quality care. Other specialty providers seeking to expand their role in vascular interventions and care fall short of this metric much more often. Even so, we need to address any issues within our own community to be “the best we can be for our patients.” 

Research from our SVS members provides us with the information we need to consider as potential challenges and opportunities to improve patient care. Some research utilizing “big data” and/or retrospective data highlights “associations” that alert us to potential issues that need to be addressed. These data raise important questions and help inform our discussions around quality care. We discussed that the data and its interpretation are not always well aligned, can be overstated, and how open discussion around this is important. 

In addition, what is lacking from the current administrative databases is direct information on the “cause and effect” of clinical questions. During our meeting, there were plans made for our academic vascular surgeon researchers and private practice surgeons to collaborate on pertinent questions that need to be answered—some around the cost of care delivery, with research methodologies that are sufficiently robust to conclusively answer “cause-and-effect” questions. 

This most recent debate and dialogue has resulted in improvements in the peer-review process of the Journal of Vascular Surgery. Although the editors have previously strived to diversify the reviewer database, there have been few reviewers who were community practice vascular surgeons and/or who worked in OBLs, until now. The editors are grateful for those who have volunteered to review papers, and to write commentaries explaining the nuances of OBL practice and economics.

The OBL can and does provide an accessible, affordable, patient-friendly setting

From a clinical perspective, we all understand that there is work to be done. There are outliers providing care that deviates from current best or even acceptable practice. The SVS has no direct (legal) knowledge of local vascular care delivery and cannot police these issues for our members. We can provide the tools to do the best job we can for our patients. The SVS leaders, and the members present at this meeting, do stand behind quality vascular care as outlined in our clinical practice guidelines and AUC documents. Clinical vascular care is an art influenced by the science available. Clinical guidelines and AUC documents provide the current best science we have for the art that must be practiced. The SVS provides this information to our members as rapidly as possible. 

Perhaps the most important and potentially influential exemplar is the national launch of the new American College of Surgeons (ACS)-SVS Vascular Quality Program (“ACS-VP: A Quality Program with the Society for Vascular Surgery”). If you care about quality and patient safety, I encourage all SVS members to participate in this “vascular center of excellence” program, built around quality improvement.  

Vascular surgery is a unique specialty with its many sites of service to provide care for our patients. Much of vascular care can be provided outside of a hospital; the OBL setting can provide vascular care in a more accessible, less costly and convenient manner for some of our patients.  This relatively new site of service has some unique payment aspects that need clarification. In the Medicare database, Medicare-allowed charges for care are reported. However, these data do not account for all aspects of care, including rent, ancillary service/products (including payment of associate staff), supplies, devices, insurance, and the physician payment so important to consider in the OBL setting. How the cost of care delivery is reimbursed is a question many seem to struggle with if SVSConnect comments are any indication.  To add one more way to improve understanding of how this works and to promote an informed readership, a reporting standards document on the cost of care delivery in research publications is in the works.  

The OBL site of service currently has few requirements in place to ensure patient safety and quality vascular care. Some in the OBL space already have instituted robust measures to provide the oversight and metrics needed for best patient care. The SVS leadership and members working in the OBL site of service believe such oversight and quality improvement measures are important to ensure a safe patient experience that will improve over time. We recommend the use of the ACS-SVS Vascular Quality Program to benchmark care in this new site of service. In addition to patient safety, it is our hope that it provides the infrastructure for quality care improvement and OBL-specific research.  

I would be remiss if I did not also make a few comments regarding social media. It is important to stress that every SVS member has the right to post whatever they wish on social media. 

The SVS’ own guidelines, published by its then-Young Surgeons Committee, now a section, provide important insight and strategy on how to leverage social media for positive gain rather than negative effect.1 All SVS members should refer to these guidelines as a resource in their use of social media. I ask our members to be mindful about respecting their peers on private platforms such as SVSConnect. 

Let’s take this opportunity to rededicate ourselves to supporting one another, focusing in a unified manner to address the very real challenges that surround us. Only by working as a team can we hope to rapidly advance vascular care. 

Becoming a vascular surgeon is a unique and impactful choice made by all of us. Our professional compass is aligned in intangible ways—we need to embrace our common goals and propel our specialty forward. 

Reference 

  1. Gifford ED, Mouawad NJ, Bowser KE, Bush RL, Chandra V, Coleman DM, et al. Society for Vascular Surgery best practice recommendations for use of social media. J Vasc Surg 2021;74:1783-91. 

Michael C. Dalsing, MD, is the current SVS president. 

SCVS 2023: Four decades of AAAs in the US: Rare epidemiological study establishes women are diagnosed and repaired 10 years later than men

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SCVS 2023: Four decades of AAAs in the US: Rare epidemiological study establishes women are diagnosed and repaired 10 years later than men
Indrani Sen and Manju Kalra

Abdominal aortic aneurysm (AAA) diagnosis and repair occurs among women almost 10 years later than in men—with similar age-adjusted mortality—the 2023 Society for Clinical Vascular Surgery (SCVS) annual meeting in Miami (March 25–29) is set to be told. The finding is part of a rare U.S. population-based study of AAA trends, spanning nearly 40 years, carried out by researchers at the Mayo Clinic in Rochester, Minnesota, underscoring already established evidence showing that incidence of ruptured AAAs and aortic-related mortality have decreased significantly in the population over time. 

The epidemiological analysis was conducted by first-named author Indrani Sen, MBBS, an assistant professor of surgery in the Mayo Clinic Health System, senior researcher Manju Kalra, MBBS, a professor of surgery in Mayo’s division of vascular and endovascular surgery, and colleagues. They used the Rochester Epidemiology Project—which captures population-based data, not merely hospital-based datasets—to track changes over the four-decade-long study period (1980–2017), a stretch of time that includes the coming of the endovascular revolution at the turn of the century, and the institution in 2007 of AAA screening for men at the age of 65 who have ever smoked. 

The study included 1,537 patients, 75% of them male and with a median age of 74 years. Diagnosis of AAA was made at presentation with rupture in 95 patients, the research team found—with 75% presenting before and 66% after Medicare established ultrasound screening criteria. “Overall, only 16% AAAs were detected on screening, 23% after 2007, with no significant change per year,” they report. “Patients with incidentally detected AAAs were older, had larger AAAs, more likely female, and to present with rupture, but had similar incidence of progression to and type of repair.” 

Overall survival in AAA patients was 94%, 72% and 34% at one, five and 15 years—“significantly lower than age and sex-matched controls throughout the study,” Sen et al established. 

“Traditionally, it has been believed that based upon single-center series, VQI registry studies, hospital-based data, that outcomes in women are poorer than in men,” says Kalra in an interview with Vascular Specialist ahead of SCVS 2023. “Traditionally, aneurysms have been picked up much less frequently in women than in men. We also know that the actual incidence is lower per 100,000 [patient years], which is what we have confirmed yet again with this population-based study.” 

Sen points to the finding around the disparity involving female diagnosis and repair as breaking new ground in this area of AAA. “All the rest of the findings are supportive data for a lot of trends we already see, but nobody has ever actually put it down on paper that aneurysms are diagnosed and repaired in women almost a decade later than men with similar age-adjusted mortality,” she says. “What additionally came to light from this study was that, even though the screening guidelines came in over a decade ago, incidental detection is still the commonest [avenue].” 

They now have a new baseline to address these issues, Sen continues. She points to newly initiated research in the UK set to look into AAAs in women. The multinational collaboration of researchers received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for the WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial. It aims to answer the question: Should women have their aneurysms repaired electively using endovascular aneurysm repair (EVAR) at smaller diameters than men to improve their survival and quality of life? Imperial College London in London, England, is co-ordinating the study, but it will include collaboration with vascular surgeons from Canada, Denmark, The Netherlands, and Sweden, as well as the U.S. 

The investigators behind WARRIORS have noted that the rationale and need for this trial, which seeks to recruit nearly 1,200 women, stems from the poor outcomes suffered by women with AAAs. Although women contribute 15–20% of total AAA burden, and one-third of ruptures, they have been significantly underrepresented in trials which guide current AAA repair, the WARRIORS investigators detailed, adding that women have smaller arteries, a four-fold higher rupture risk, and lose eligibility for EVAR at smaller AAA diameters. 

“We have learnt that women worry a lot about their AAA, and modeling has suggested that repair of AAA at 4cm for women might result in improved quality of life and reduced overall cost,” the WARRIORS investigators recently commented. “These potential benefits as well as reduction in aneurysm-related mortality, would need to be balanced against the operative risk of early repair.” They state that these areas of uncertainty, regarding the optimal strategy for AAA repair in women, are what the trial seeks to answer. 

The Mayo epidemiological study provides timely data pointing to the fact that these and similar questions regarding aneurysms in women are relevant, Sen adds. The need for a population-based study to highlight these was great, Sen and Kalra relate. 

“We don’t have good natural history data, or epidemiology, of aortic aneurysms in the U.S.,” remarks Sen. “Everything that we use, we take from studies performed in Europe and Australia. Among the few studies performed in the U.S., one of them was from this same Rochester epidemiology data—which was in the 1980s. Since the 80s, the two major changes that have happened are the introduction of endovascular repair, which has become the commonest way of repairing these AAAs, and the introduction of a screening protocol for men.” 

The questions that the research team were looking to answer were: Do advances in screening really work? How comprehensive is the adoption of the program, and who is being screened? “Are we identifying more aneurysms in women as a side effect?” adds Sen. “A lot has changed in clinical practice, and the outcomes of this are being reported using large hospital-based treatment datasets.” The impact of these developments and changes at a population level was not known, Kalra chimes in, nodding toward the questions around potential benefits of early detection of these aneurysms in women, “although data exists that screening for them has been shown not to be cost-effective.” She says the chief finding was actually something of a surprise. “It’s not that women do poorly with AAA repair, it’s because they are nearly a decade older by the time you are fixing them,” adds Kalra. 

As they concentrate their efforts on this particular area of the dataset, Sen informs of future efforts and analysis to get to the bottom of factors that lead to later diagnosis and repair of aneurysms in women. 

Vesteck completes first-in-human use of several Suture-Tight devices

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Vesteck completes first-in-human use of several Suture-Tight devices

Vesteck scientific advisory board members along with key opinion leaders from around the world have successfully completed the first three in-human cases with the Suture-Tight catheter, a press release reports.

Dai Yamanouchi (University of Wisconsin, Madison, USA) and Dainis Krievins (Paul Stradins Clinical University Hospital, Riga, Latvia) successfully performed the first two endovascular aneurysm repair (EVAR) procedures utilising the Suture-Tight catheter in Riga, Latvia.

In the first two patients, the Suture-Tight device was used to secure a commercially available EVAR graft to the aorta during the initial implant. Most importantly, Vesteck relays, the devices performed as intended and both patients were discharged from the hospital and home the very next day.

Yamanouchi comments: “In my opinion, the Vesteck device is a game-changer in the endovascular repair of aortic aneurysms. With its ability to secure stent grafts to the aortic wall, it addresses a critical unmet clinical need. This should be particularly important in preventing Type I endoleaks at the initial stent graft implant and treating late Type I endoleaks after EVAR, where the current solutions fall short. I am thrilled to see this innovative technology make its way to their FDA [US Food and Drug Administration] 510K clinical trial and look forward to seeing the resulting data, supporting improved patient outcomes.”

Krievins remarks: “This appears to be a good solution, to have endovascular fixation like a surgical suture. Thus, possibly preventing AAA [abdominal aortic aneurysm] endografts from migration, providing good seal and improving endograft durability in the long term.”

Vesteck’s chief medical consultant, Sean Lyden (Cleveland Clinic, Cleveland, USA) together with Bao Bui (CHUS Hospital Fleurmont Sherbrooke, Sherbrooke, Canada) helped a third aortic aneurysm patient in Montreal, Canada, by quickly and safely securing the endovascular graft to the aorta at the time of initial implant.

“I was very excited to participate in a procedure using this new device for the first time in North America,” said Lyden. “Endovascular specialists are in need of additional tools like this to help our EVAR/TEVAR [thoracic endovascular aortic repair] patients.”

Bui stated after the case: “The Suture-Tight catheter will inevitably change the landscape of EVAR/TEVAR by providing a secure attachment of the endograft to the neck of aortic aneurysms, eliminating long-term neck dilatation, secondary migration and leaks.”

Vesteck CEO, Joe Rafferty asked: “Are you sensing a theme here, with these comments from global endovascular key opinion leaders? The Vesteck Suture-Tight catheter is a much-needed tool, addressing a significant unmet patient need. This is a very exciting milestone. Vesteck has now become a clinical stage company, actively helping aortic aneurysm patients around the world.”

Florida hospital targets lingering disparities in limb salvage with region’s first multidisciplinary Limb Preservation Program

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Florida hospital targets lingering disparities in limb salvage with region’s first multidisciplinary Limb Preservation Program
Charles J. Bailey (right) and members of the Tampa General Hospital Heart & Vascular Institute team recently opened a new satellite facility

This advertorial is sponsored by Tampa General Hospital.

Operating in Tampa, Florida, Charles J. Bailey, MD, and his partners in the Division of Vascular Surgery at the University of South Florida see their fair share of preventable amputations. In a region of the Sunshine state with an ethnically and socioeconomically diverse population, he treats patients from many of its most disparately hit communities, among a demographic whose healthcare outcomes and rates of major lower-extremity amputation often diverge from the national mean. 

This is the challenge embraced by the team he leads in the Limb Preservation-Peripheral Arterial Disease (PAD) Program within the Tampa General Hospital (TGH) Heart & Vascular Institute (HVI)-Vascular Center of Excellence, to provide not only the highest quality evidence-based vascular care but to also create a team and program focused on addressing the disparities in healthcare delivery and outcomes in his own community.

That’s why a new satellite clinic in the Tampa area—the first of its kind in the region—has Bailey excited at the potential for his multidisciplinary team to make a true impact on limb salvage and rates of major lower-extremity amputations. The need for cross-specialty care is key, he emphasizes.

“The care of patients with advanced peripheral arterial disease (PAD), chronic limb-threatening ischemia (CLTI) in the form of rest pain or non-healing wounds really requires an integrated, collaborative, evidence-based approach to give a patient the best chance of limb salvage and an amputation-free survival,” says Bailey, director of the HVI-Vascular Center of Excellence and medical director of the Limb Preservation-PAD Program.

Charles J. Bailey

“Our team of surgeons and specialists embrace the newest research and technology and work as partners to provide a treatment plan as unique as each patient. The LPP clinic will represent the first off-campus satellite clinic for the Heart & Vascular Institute and offers a novel level of care to our medical community. Many non-traumatic amputations are preventable, and programs like ours have proven to reduce amputation rates and improve healthcare-related quality of life for PAD patients.

“Caring for a patient at risk for amputation is not simply about improving blood flow, caring for a wound, or ensuring the right antibiotics or medical risk factor management is being provided.  Each piece of the puzzle is unique, though intimately connected to those around it. Forming a multidisciplinary clinic gives us the ability to treat our patients uniquely and with enhanced efficiency.”

Bailey and his colleagues at the TGH HVI-Vascular Center of Excellence figure among the leading experts in the treatment of PAD its the end-stage form of the disease, CLTI. The team, explains Bailey, is acutely aware of the need for such a satellite clinic in the Tampa area in order to tackle some of the most challenging outcomes associated with CLTI. He points to peer-reviewed research showing that multidisciplinary care improves amputation-free survival1 and reduces rates of major limb amputation.2

“A risk factor for PAD and a common catalyst for amputation in our community is diabetes,” notes Bailey. “According to the Centers for Disease Control and Prevention (CDC), 154,000 lower-extremity amputations are done each year in the U.S. for adults who are diabetic. Within this number is a glaring example of the disparities in our healthcare system. As compared to non-Hispanic White Americans, Black Americans are up to four-times—and Latinx are over 50%—more likely to suffer a major lower-extremity amputation.

“Preventing an amputation is not solely a vascular, podiatry, or wound care problem, it is a public health crisis. Early disease detection and management, medical education to both patient and practitioners, and improving access to high-quality vascular care is essential. The very roots and foundation of Tampa is intertwined with the Latinx community, so creating an off-campus satellite clinic was mission-critical.

“We are taking our multidisciplinary program and the goals of limb salvage—and reducing healthcare disparities—directly into the community that needs us. Tampa General Hospital sits on an island, and ‘moving off the island,’ is proof that coordinated multi-specialty care can be provided outside of the traditional academic medical center confines, and we see this as a necessary step in our commitment towards being present and active in addressing the public health needs of all. The Limb Preservation-PAD Program is truly the first and only of its kind in the Tampa Bay area to provide such a multidisciplinary, integrated, evidence-based approach to the management and care of patients with complex PAD,” adds Bailey.

References

  1. Jayer Chung, MD, J. Gregory Modrall, MD, Chul Ahn, PhD, Lawrence A. Lavery, DPM, and R. James Valentine, MD. Multidisciplinary care improves amputation-free survival in patients with chronic critical limb ischemia. J Vasc Surg 2015;61:162-9.
  2. Alyssa M. Flores, BS, Matthew W. Mell, MD, MS, Ronald L. Dalman, MD, and Venita Chandra, MD. Benefit of multidisciplinary wound care center on the volume and outcomes of a vascular surgery practice. J Vasc Surg 2019; 70:1612-9.

Shockwave Medical announces US launch of new peripheral IVL catheter

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Shockwave Medical announces US launch of new peripheral IVL catheter
Shockwave’s IVL system

Shockwave Medical announced the full U.S. commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the Food and Drug Administration (FDA).

A press release details that the Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries.

“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” said Frank Arko, MD, from Sanger Heart and Vascular Institute in Charlotte, North Carolina.

“The characteristics of the new catheter allow physicians to optimize IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the U.S. each year. The Shockwave L6 catheter may also be beneficial when IVL is utilized to facilitate transfemoral access for large-bore procedures like TAVR [transcatheter aortic valve replacement], TEVAR [thoracic endovascular aortic repair] and EVAR [endovascular aortic repair] to minimize the risks of rupture and dissection.”

Vascular Specialist–March 2023

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Vascular Specialist–March 2023

In this issue:

  • Four decades of AAAs in the U.S.: Rare epidemiological study establishes women are diagnosed and repaired 10 years later than men (p. 1 and 4)
  • From the SVS president: Supporting one another (p. 1 and 6)
  • Guest editorial: The ABCs for lower-extremity acute DVTs (p. 2)
  • AVF 2023: VS interviews bioprosthetic valve FIH trial investigator (p. 10)

 

SVS member elected to RUC committee

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SVS member elected to RUC committee

SVS member David Han, MD, has been re-elected to the American Medical Association (AMA) Relative Values Scale (RVS) Update Committee (RUC). Han’s two-year term runs from March 2023 and ends in February 2025. 

This is the third time Han will serve in that capacity. He currently is vice chair of the Society for Vascular Surgery (SVS) Coding Committee and will continue as the vice chair of the AMA RUC Practice Expense Subcommittee. 

The RUC is the multispecialty committee that makes relative value recommendations for new, revised and potentially misvalued services to the Centers for Medicare & Medicaid Services (CMS). CMS considers input from the RUC Relative Value Units (RVUs) when making payment decisions. 

Han will serve on the committee as one of a handful of members from surgical subspecialities; most seats are held permanently by major national medical specialty societies. The committee provides input to CMS. 

“Many other specialty societies have permanent seats on the committee. We, as a small subspecialty, do not; instead, our members can be elected on a rotating basis with other small subspecialties,” said Matthew Sideman, MD, chair of the SVS Advocacy Council. 

Sideman said Han supports the SVS’ mission of advocacy and payment reform. He is professor of surgery and chief of the division of vascular surgery at SSM Health St. Louis University in St. Louis, Missouri. 

Fellow SVS member, and longtime SVS coding expert, Robert Zwolak, MD, serves in a leadership role on the RUC. He was named in late 2020 as the AMA alternative representative to the RUC and alternative vice chair. His three-year term began in March 2021. 

“Dr. Han will be and has been a valuable asset to the RUC Committee,” said SVS President Michael C. Dalsing, MD. “He understands the complexity, processes, and nuances involved in coding and all the other elements that go into reimbursement rates, which are an integral part of the medical world we live and practice in.” 

“I am grateful for working with such a talented team of individuals who work tirelessly on behalf of our specialty to ensure that vascular surgeons are fairly valued for the work we do,” said Han. 

“I truly stand on the shoulders of giants with regards to the team as well as those who have come before me. I hope that I can play a similar role in helping the next generation continue to advocate for the highest quality and most sustainable and equitable care.”

Corner Stitch: What I wish I had known in vascular training

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Corner Stitch: What I wish I had known in vascular training
J. Aaron Barnes

Welcome newly matched vascular surgery residents into the fold! I am just over six months into my first attending position after completing my residency training at Dartmouth. While nothing reminds you of how much you don’t know or haven’t seen like being an early career attending, I suppose I am now in a position to reflect back on what I wish I knew or did differently in training. This is certainly not an exhaustive list, but I write this in the hopes that current trainees and those who just matched into vascular surgery are able to find something that resonates with them. 

You are a product of your environment 

“Gentle, gentle!” This was a phrase that had been said to me—and at me—countless times and at many different volumes throughout my training by a specific attending. I did not fully appreciate the extent to which this phrase was burned into my psyche until I noticed I was often muttering it to myself alone while operating as a new attending in Alaska. This is just one small example of how we become products of the environment in which we train. 

From quirky idioms to highly specific operative techniques, we are shaped by those who train us. Some of the things we learn are obvious—techniques are taught, knowledge is conferred through didactics—while others are subtle. How an attending explains long-term stroke risk in clinic, establishes and maintains a relationship with a referring provider, or speaks with a family after a poor outcome, are not taught but rather observed. I wish I had paid more attention to how my attendings practiced and navigated these crucial yet less obvious aspects of being a vascular surgeon as a trainee. 

The things that are ‘mindless’ can be anything but 

The night before I performed my first lower-extremity bypass as an attending, I pored over the patient’s chart and history, reviewed the diagnostic studies and pre-operative imaging, studied the anatomy, confirmed we had all necessary equipment available, and made contingency plans in case things went awry. I arrived the morning of surgery feeling ready. This confidence all came crashing down when the circulator asked me what drapes I wanted to use. It took longer than I want to admit to recall the default drape configuration from residency. Fortunately, I was able to pull the information from the recesses of my mind, and the case was soon underway. This instance, plus a few others that can be described as less than glamorous, made me wish I had paid closer attention to the seemingly mundane things like draping and room setup as a trainee. 

Go back to go forward 

As in many training programs, I had my pick of cases as a chief resident. My weeks were filled with open aortic cases, complex endovascular aortic aneurysm repairs (EVARs), carotid endarterectomies, transcarotid artery revascularizations, and a smattering of lower-extremity bypasses. Towards the end of my training, though, I was given the opportunity to perform various less complex procedures such as venous ablations, arteriovenous fistula creations, and straightforward peripheral bypasses without the assistance of an attending scrubbed in. These experiences were invaluable. Those “intern-level” cases are part of my current practice and I needed to freshen up on them. I needed to learn to operate alone, as I do many of my cases without an assistant today. While I am thankful for the experiences I did have, I wish I would have made more of an effort to seek out those autonomous experiences with simple cases earlier and more frequently in my training. 

There is a method to the madness

The transition from trainee to attending is a little bizarre. Seemingly overnight your role in the surgical hierarchy flips, and you suddenly have more say over your schedule, your cases, and your patients’ care. Now that I am a bit more removed from training, I can look back and see the gradual transition from trainee to attending. I can now appreciate so many aspects of my training program. Case conference forced me to come up with case plans, defend their indications, and have back-up plans. Sizing and ordering devices for EVARs in residency prepared me to do so confidently in the middle of the night as an attending for a rupture. Morbidity and mortality conferences taught me to critically examine my complications and identify areas to target to improve outcomes. In the moment and taken individually, these and many other aspects of training, can be seen as mundane. When taken as a whole, these tasks shape us into vascular surgeons. I am not sure it is possible to truly appreciate the entirety of training when you are in the midst of it, but I wish I had known as a trainee that I would eventually understand the method to the madness. 

J. Aaron Barnes, MD, is a vascular surgeon at Alyeska Vascular Surgery, in Anchorage, Alaska. 

Government Grand Rounds: Culture of engagement

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Government Grand Rounds: Culture of engagement

Welcome back to Government Grand Rounds, where the Society for Vascular Surgery (SVS) Advocacy Council discusses how sustained advocacy engagement is important for all SVS members. 

While “advocacy” continues to rank high among SVS member priorities, many remain unsure how to support SVS advocacy-related programs, what activities are available and how to measure success along the way. This series aims to answer those questions through the many useful tools of advocacy. Last month, the Council shared the importance of perspective and examined how advocacy can be used as a tool to protect. But how do we use that tool and what are the driving factors behind that tool’s effectiveness? One of the key drivers of success in advocacy is engagement. 

Many have probably heard of the term “grassroots” before, but what exactly does that mean in the context of advocacy? Grassroots is often defined as “the basic level of society or of an organization” or something that is “basic, fundamental.” In advocacy, we use this term to describe the efforts that every-day citizens go through to help shape the government, often through sending letters to Congress, protesting in public spaces or organizing their own awareness campaign. These efforts are the bread and butter of what it means to advocate. 

The SVS engages in grassroots activities through a few programs, designed to connect SVS members with their lawmakers to create tangible channels for vascular surgeons to personally advocate on issues that significantly impact the specialty. The REACH 535 program establishes a concrete mechanism for the SVS to amplify its advocacy efforts by ensuring we can quickly engage with the 535 decision-makers on Capitol Hill. This engagement with lawmakers is what drives change. (Visit vascular.org/REACH535form to sign up for REACH 535.) To create a strong foundation for grassroots advocacy, the SVS needs to establish a culture of engagement. This culture looks like taking the opportunity to engage with lawmakers via Voter Voice, signing up for REACH 535, and donating to the SVS PAC. When we work together to strengthen our collective voice, we simultaneously expand our impact on Capitol Hill. 

These facets of engagement, when done together, help to amplify the entirety of the effort. One letter sent may not change the course of a bill, but organized, collective action from thousands of vascular surgeons could permanently alter the trajectory of a proposed policy or pending piece of legislation. For more information on how to engage with the SVS’ advocacy programs, visit vascular.org/advocacy or contact [email protected]. 

Andrew Kenney is SVS advocacy coordinator. 

SVS launches web-based perioperative care guide

SVS launches web-based perioperative care guide
The guide web portal

The Society for Vascular Surgery (SVS) has launched its “Management Guide on the Perioperative Care of Patients with Vascular Disease,” a multidisciplinary resource for care of patients with vascular disease who require an intervention. 

The American Society of Anesthesiologists, the Society for Vascular Medicine and the Society for Vascular Nursing all helped develop the guide, supported through an unrestricted educational grant from Janssen Pharmaceuticals, Inc. 

The resource provides information on the medical and non-medical management of vascular patients in the perioperative period: 1) 30 to 90 days before intervention, 2) during the intervention, and 3) 30 to 90 days post-intervention. 

With mobile-responsive design and easy, intuitive navigation, it is ideal for on-the-go use by busy members of the entire vascular team, from trainees, to surgeons, anesthesiologists, internists, vascular nurses and allied health members. 

It covers the procedures and conditions that encompass the most common vascular disorders. Each section outlines factors for each stage. Pre-operative care for abdominal non-aortic pathology, for example, lists such factors as patient history, including specific elements to assess for certain conditions; physical examination; imaging; medical management and lifestyle changes; risk stratification and risk assessment; preoperative lab tests recommended; and medication adjustments to make prior to intervention. 

The guide then provides similarly detailed information and recommended steps for the intraoperative and postoperative phases. 

To develop the guide, the SVS brought together experts who represent key members of the perioperative team, including vascular surgeons, anesthesiologists, vascular medicine specialists, vascular nurses and physician assistants. “We don’t intend that this new guide replace any of the documents and protocols or local practices,” said Rabih Chaer, MD, chair of the authoring group. 

Instead, as stated in the guide’s introduction, “It provides guidance that can be used by individual institutions to build their own perioperative management protocols and design educational programming, and complements the Enhanced Recovery After Surgery (ERAS) guidelines that the SVS is developing. The document will help facilities address comorbidities and other risk factors that can affect postoperative outcomes and reduce the use of redundant and/or unnecessary tests.” 

It’s more of a complete 360-degree view of the care of patients who need a vascular intervention, involving all aspects and all team members involved in that care, he said. “The procedure is important, of course,” he said. “But all aspects of perioperative care—from medication compliance to follow-up care—are critical to ensure successful outcomes. This is one of our first official resources that articulates the entire patient experience.” 

View the guide, which also includes conclusions, the definitions of approximately 125 terms from abdominal aortic aneurysm to Vitamin-K antagonist, and more than 160 references, at vascular.org/PMG. Users can also download the guide at the site. 

Venous stenting: ‘We need to evaluate use, appropriateness and clinical indication’

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Venous stenting: ‘We need to evaluate use, appropriateness and clinical indication’
Karem Harth

An analysis of venous stent usage trends in the United States from 2014 through 2021 showed a “significant increase” in stents per day placed over time, despite high-profile recalls of two dedicated venous stents from the market.

Those were among the observations of Karem Harth, MD, associate professor of surgery and director of the Center for Comprehensive Venous Care at University Hospitals in Cleveland, Ohio, who led the investigation, which looked at the total eight-year period of the study and three distinct timeframes within it: before Food and Drug Administration (FDA) approval of dedicated venous stents; from FDA approval through to the date of the first recall; and the period after the recall. Harth delivered the results at 2023 annual meeting of the American Venous Forum (AVF) held in San Antonio, Texas (Feb. 22–25).

In an interview with Vascular Specialist during the AVF meeting, she said the increase in usage was not surprising but did highlight a number of areas in need of evaluation.

“In our data, we looked at a large consortium of hospitals through the TriNetX database, and we looked at clinical indications for venous stenting throughout time, and how venous stent use increased and changed over the FDA period of approval,” she explained. “We found that there was a significant increase in stenting since FDA approval, which is not surprising because this therapy is exciting and long awaited.

“But what we also found was that the top three diagnoses included acute deep vein thrombosis [DVT], NIVLs or non-thrombotic iliac vein lesions, as well as mild chronic venous insufficiency [CVI], which came as a surprise to us when we looked at this data, and that trend remained over time.”

After analyzing venous stent usage rates both overall and across the three time periods by demographics, indications for stenting, and overall mortality, significant differences were identified in terms of gender, race and overall mortality (p < 0.05), Harth said.

In addition to the increase in stent usage overall (p<0.00001), on multivariate regression analysis Harth and colleagues recorded an increase from the period prior to FDA venous stent approval to the period afterward until the first stent recall among more white and female patients (p<0.005), as well as in both acute and chronic DVT patients (p<0.01).

Meanwhile, in the same timeframe the trend showed decreased usage in patients with NIVLs, CVI with no inflammation, and CVI with inflammation. From the second time period (FDA approval–first recall) to the third (after the recall), no changes occurred across indications for stenting (p >0.05), Harth told AVF 2023. Risk factors in the first and second periods for overall mortality at more than two years post-stenting included age, male sex and chronic DVT, NIVL, and CVI with ulceration, while African-American race was a risk factor in the period prior to venous stent approval, she added.

Harth concluded her podium presentation by stating that “significant increases in venous stenting occurred after U.S. FDA approval and remained unchanged after FDA recall.” Indications are broad and “may not all be appropriate use of venous stenting,” she said, highlighting the need for further work to understand the venous stent landscape, usage and to minimize unnecessary stenting. Further, Harth stated that “there is a need to understand barriers to access to these therapies among underrepresented groups.”

Afterward, she told Vascular Specialist: “I think this data points to a need to evaluate how these stents are being used, the appropriateness for use, the clinical indication and how it may or may not align with our current criteria. It also showed that there were some disparities in terms of who has access to these stents, with mostly white women undergoing stenting.”

Distal embolic protection linked to significantly better outcomes in carotid stenting

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Distal embolic protection linked to significantly better outcomes in carotid stenting
Sophie Wang (L), Patric Liang
Sophie Wang, MD (L), Patric Liang, MD

Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection during carotid stenting, and supporting the notion that, “if a filter cannot be placed safely, an alternative approach to carotid revascularization should be considered”.

Sophie Wang, MD, Patric Liang, MD, both Harvard Medical School in Boston, and colleagues deliver this message in a recent Journal of Vascular Surgery (JVS) publication detailing a retrospective, propensity score-matched cohort analysis of tfCAS patients in the Vascular Quality Initiative (VQI) across a 16-year period.

“Transfemoral carotid stenting without use of embolic protection is associated with a significant increase in in-hospital stroke/death compared with tfCAS performed with distal filter placement,” the authors write. “Failed attempted filter placement is associated with worse outcomes after tfCAS, but stroke/death rates are no different than those seen in patients in whom a filter was never attempted.

“These findings support the current guideline recommendation for routine use of distal embolic filters during tfCAS. However, the proportion of non-protected tfCAS performed annually is increasing, and there is significant variability in routine filter usage across physicians and centers in the VQI.”

In an effort to assess in-hospital outcomes in patients undergoing tfCAS with and without embolic protection using a distal filter, Wang, Liang and colleagues identified all patients undergoing this procedure in the VQI from March 2005 to December 2021—excluding those who received proximal embolic balloon protection. As well as creating propensity score-matched cohorts of patients who underwent tfCAS with and without attempted filter placement, they performed subgroup analyses of patients with ‘failed’ versus ‘successful’ filter placement, and ‘failed’ versus ‘no attempt’ at filter placement.

In-hospital outcomes were assessed using log binomial regression, adjusted for protamine use, the authors detail. Their outcomes of interest were composite stroke/death, stroke, death, myocardial infarction (MI), transient ischemic attack (TIA), and hyperperfusion syndrome.

Among 29,853 patients who underwent tfCAS, 28,213 (95%) had a filter attempted for distal embolic protection and 1,640 (5%) did not. After propensity-score matching, 6,859 patients were identified.

In comparison to cases in which a filter placement was attempted, no attempted filter was associated with a significantly higher risk of in-hospital stroke/death (6.4% vs 3.8%)—constituting a more than two-fold increase in stroke/death risk, as per the analysis’ key outcome of interest. Similar trends were observed regarding stroke (3.7% vs 2.5%) and mortality (3.5% vs 1.7%) too.

In a secondary analysis of patients who underwent a failed attempt at filter placement—versus successful filter placement—failure was associated with worse outcomes (stroke/death: 5.8% vs 2.7%; stroke: 5.3% vs 1.8%, respectively). However, Wang, Liang and colleagues observed no statistical difference in outcomes in patients with failed versus no attempted filter placement (stroke/death: 5.4% vs 6.2%; stroke: 4.7% vs 3.7%; death: 0.9% vs 3.4%) after adjusted analysis.

“Distal embolic protection confers a benefit in stroke/death rates following tfCAS compared to unprotected stenting,” the authors conclude, putting forward their ‘take-home message’ in JVS. “Failure to place a filter should prompt exploration of alternative carotid revascularization approaches.”

Algorithm predicts females have higher risk for kidney damage after aneurysm repair

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Algorithm predicts females have higher risk for kidney damage after aneurysm repair

kidneyWhen receiving treatment for abdominal aortic aneurysm (AAA), female patients have a higher risk for kidney damage after endovascular repair, a Michigan Medicine study finds.

Researchers from Michigan Medicine designed an algorithm that can be used prior to endovascular AAA repair to identify risk for kidney damage. They tested the algorithm using data from over 7,000 patients through the Blue Cross Blue Shield of Michigan Cardiovascular Consortium database.

The risk prediction algorithm, according to findings published in Annals of Vascular Surgery, demonstrated that women receiving endovascular aneurysm repair had 1.4 times higher odds of developing acute kidney injury after aneurysm repair.

“While we have seen higher risk of acute kidney injury in female patients who have undergone coronary stenting or renal stenting, this is the first time we are seeing a higher risk after endovascular abdominal aortic aneurysm repair,” said senior author Peter Henke, MD, vascular surgeon and director of the University of Michigan Health Frankel Cardiovascular Center in Ann Arbor, Michigan.

Patients with reduced glomerular filtration rate, an indicator of kidney disease, had 4.7 times higher odds of developing acute kidney injury after aneurysm repair. Those with larger aneurysms were also at increased risk. These findings are less surprising than the higher odds of kidney injury in women, investigators say, given patients’ decreased renal function at baseline and the possible prolonged procedures and intraoperative contrast loads that come with larger aneurysms.

The Michigan Medicine research team hopes to implement the algorithm in clinical practice to provide at-risk patients with optimisation before an operation.

“Kidney injury after surgery can be benign, but for some patients it leads to permanent renal failure and, in some instances, dialysis,” said Drew Braet, MD, first author and vascular surgery resident at U-M Health. “This algorithm shows that we can use easily attainable factors prior to surgery that may help identify patients at risk of complications during their surgery and, thus, ensure we are optimizing these patients accordingly. If we can protect patients and decrease their risk of permanent renal failure, then we have truly provided them a benefit.”

VAM 2023: Early-bird registration opens

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VAM 2023: Early-bird registration opens
Andres Schanzer

Meeting registration and hotel reservations opened March 15 for the Society for Vascular Surgery (SVS) 2023 Vascular Annual Meeting (VAM). This year’s premiere educational event for all vascular professionals will be June 14–17 at the National Resort and Convention Center in National Harbor, Maryland, just outside Washington, D.C.

Early-bird registration pricing will be in effect for the first three weeks of registration, through April 5. Advance pricing is then in effect until June 13, when on-site registration opens. On-site pricing remains in effect through the close of the meeting on Saturday, June 17.

This year, participants must register for the meeting itself before making hotel reservations.

SVS members receive a substantial discount on VAM registration. Non-members can apply for membership by May 1 to receive—subject to SVS Executive Board approval—the member discount. Dues must be paid prior to VAM to receive the member registration rate. The rate discount will be refunded after the meeting. See vascular.org/JOIN for more information.

Visit vascular.org/VAM and then click registration information link for admission specifics.

VAM 2023 encompasses four full days of education, networking and learning, and two days of industry exhibits. Topics range from hard science to the vascular surgery workforce, quality care and improvement, planning for retirement, a discussion of clinical trial results and much more. Each plenary session also will include a video demonstrating a complex surgical procedure.

This year’s VAM includes some new features. The meeting will feature SVS’ first annual social event, SVSConnect@VAM: Building Community, is set for 7 to 9 p.m. Wednesday. It’s a family-friendly event to bring not only health care professionals but also their families together, said Andres Schanzer, MD, chair of the SVS Program Committee, which oversees much of VAM’s education programming, said, “We want to celebrate our membership and the diversity of our membership.”

The inaugural Frank J. Veith Distinguished Lecture takes the stage from 9:30 to 10 a.m. Thursday, tackling the topic of the BEST-CLI trial: Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia, results of which were announced in November 2022. Veith has long had an interest in peripheral arterial disease (PAD) and, in particular, limb salvage, which will be the focus of this named lectureship, announced at the close of VAM 2022. The speaker is still to be announced.

A celebration of diversity will be hosted by the Diversity, Equity Inclusion Committee and the SVS’ Women’s and Young Surgeons sections, from 6:30 to 7:30 p.m. Thursday.

Of course, educational sessions will cover a wide range of subjects with a mix of clinical and non-clinical topics. Some programs will focus on embolization and aortic dissection, wound care, trauma, hemodialysis access, optimizing vascular reconstruction in oncology, worst cases, clinical learning and the practice environment, to planning for retirement and advocating for vascular surgeons in the federal government. After a successful inaugural year in 2022, each SVS membership section will hold a session of interest to their particular members.

Two sessions, one on deep venous thrombosis and the second on deep venous stenting, will be presented in collaboration with the American Venous Forum.

“Every year we pride ourselves on offering an expansive variety of topics to match the wide-ranging interests of our diverse membership and their practice settings,” said Schanzer. “Every attendee will be able to take home information he or she can put into use immediately, or that will provide food for thought down the road.”

View the VAM Schedule-at-a-Glance (subject to change) at vascular.org/SAG23 to get a jump-start on planning VAM 2023. All times are Eastern Daylight Time.

EU ministers approve changes to MDR transition timetable

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EU ministers approve changes to MDR transition timetable

The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).

Producers of medical devices will have until Dec. 31, 2027, for higher risk devices and until Dec. 31, 2028, for medium and lower risk devices to meet the legal requirements.

The extension of the transition period will be granted under certain conditions, ensuring that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic.  However, challenges in the implementation of the legislation led to concerns about a potential shortfall in the availability of certain devices, which prompted a rethink in the timetable for the regulation as proposed by the European Commission in December.

Today’s adoption of the resolution by EU Council members, comprising ministers from each of the EU’s member states, means that the decision to extend the implementation period will enter into force on the day of its publication in the Official Journal of the EU.

“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” Acko Ankarberg Johansson, Sweden’s minister for healthcare, was quoted saying.

MedTech Europe, which represents the continent’s device manufacturers, has welcomed the adoption of the amended transitional provisions, which it said will help mitigate the immediate risk that medical devices across all areas of medicine, which are still on the EU market, would no longer be available after May 2024.

“The amendment of the Medical Devices Regulations’ transitional provisions is a needed step forward to help ensure that more medical devices remain available to patients and healthcare systems across Europe. This decision grants Notified Bodies more time to complete certification of more than 500.000 medical devices and accelerates efforts to certify innovative devices in the pipeline,” says Oliver Bisazza, CEO of MedTech Europe.

As soon as the amendment comes into force, MedTech Europe said that alongside its members it will work toward its implementation according to the new provisions and extended deadlines.

“In that regard, it is important that all stakeholders have an aligned and clear interpretation of the amendment, including the process for submitting applications to Notified Bodies, and how the extended validity of certificates can be concretely demonstrated,” the organization’s statement adds.

New VOYAGER PAD analysis confirms consistent benefit of low-dose rivaroxaban plus aspirin following lower extremity revascularization

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New VOYAGER PAD analysis confirms consistent benefit of low-dose rivaroxaban plus aspirin following lower extremity revascularization
Marc P Bonaca
VOYAGER
Marc P Bonaca

Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischemia and a 15% reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT).

The data were presented at the American College of Cardiology’s 72nd annual scientific session (ACC.23), hosted in New Orleans, Louisiana, March 4–6.

The new findings reinforce the benefits of the Xarelto (rivaroxaban; Janssen Pharmaceutical Companies of Johnson & Johnson) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following lower extremity revascularization in patients with peripheral arterial disease (PAD).

“These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularization for symptomatic [PAD],” said lead study author of the VOYAGER PAD analysis, Marc P. Bonaca, MD, of the University of Colorado Anschutz Medical Campus in Aurora, Colorado. “We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularization regardless of whether or not DAPT is utilized.”

Those treated with Xarelto plus aspirin after lower extremity revascularization saw a 33% reduction in acute limb ischemia, with a trend toward greater benefit observed early (≤30 days hazard ratio [HR]=0.45; 95% confidence interval [CI] 0.24–0.85) vs. late (>90 days HR=0.75; 95% CI 0.60–0.95).

Xarelto plus aspirin was more effective than antiplatelet therapy alone in preventing acute limb ischemia after lower extremity revascularization (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was HR 2.01 (range 0.9–4.47) and from days 91 up to three years was HR 1.28 (range 0.82–1.99), neither of which were statistically significant.

Janssen Pharmaceutical Companies of Johnson & Johnson note in a press release announcing the new results that the Xarelto vascular dose is the first and only approved anticoagulant for PAD.

‘Voices of Vascular’ series celebrates Women’s History Month

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‘Voices of Vascular’ series celebrates Women’s History Month

The contributions of the Society for Vascular Surgery’s women members take center stage this month as part of the SVS Foundation’s “Voices of Vascular” series. 

The “Voices” series is designed to help celebrate the diversity in the vascular surgery specialty. It debuted in February, Black History Month, and will continue throughout the year. In March, “Voices” will highlight profiles of women, their lives, their road to becoming vascular surgeons and their views of the vascular surgery specialty. The March celebration is in collaboration with the SVS’ Women’s Section. 

Audra Duncan, MD, section co-chair of the SVS Women’s Steering Committee, explained why such efforts matter. “More than half of our incoming medical students are women. SVS recognizes this trend and is committed to recruiting and promoting young surgeons to represent the future of surgery, by embracing diversity and equity, including gender equity,” said Duncan.

“Several studies support that patients may have better outcomes when they can be taken care of by physicians of similar gender, race or ethnicity, so it is critical that the face of the SVS reflects the diversity of the populations we care for in order to achieve the best outcomes for our patients.” 

In addition, Boston Scientific, the campaign’s presenting sponsor, will match all gifts to the SVS Foundation up to $10,000 through March 31. That means a gift goes two times as far to support Women in Vascular— past, present and future. Donors can double their impact today by visiting give.classy.org/WHM2023. 

Patient education is an important part of the campaign, and includes information on how vascular disease impacts women differently and how to inform women about the common signs of vascular disease to promote health and change outcomes. 

ACC 2023: Large bore mechanical thrombectomy reduces adverse outcomes in high-risk PE patients

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ACC 2023: Large bore mechanical thrombectomy reduces adverse outcomes in high-risk PE patients
Mitchell Silver
Mitchell Silver

Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the American College of Cardiology (ACC) 2023 Scientific Sessions (4–6 March, New Orleans, USA) indicate.  

These were among the results of the FLAME study, a prospective, non-randomised study of interventional treatment in high-risk PE, a patient population with a historical mortality rate of 25-50%, which were presented at ACC 2023 by Mitchell Silver (OhioHealth Heart and Vascular, Mansfield, USA).  

The study collected data on patients treated with the FlowTriever and on those treated with other therapies in a context arm. The primary endpoint measured a composite of meaningful in-hospital clinical outcomes, including mortality, major bleeding, clinical deterioration, and escalation to an alternate therapy.  

Silver reported that FLAME was stopped early after meeting the pre-specified interim analysis criterion at 50 FlowTriever patients. Sharing the results of the study, Silver noted that the endpoint was met in the FlowTriever arm, in which a mortality rate of 1.9% was recorded, compared to 29.5% in the context arm. In all, the composite primary endpoint occurred in 17% of patients in the FlowTriever arm, compared to 63.9% in the context arm. 

“The remarkably low mortality seen with FlowTriever demonstrates the benefit of rapidly identifying PE patients and getting them to an interventionalist for assessment,” Silver was quoted as saying in a press release issued shortly after the presentation of the results at ACC 2023. “It is time for our hospital systems to develop standardized care pathways for PE, similar to what has been done in other major cardiovascular diseases such as heart attack and stroke.” 

“High-risk PE persists as one of the deadliest cardiovascular diseases,” James Horowitz (NYU Grossman School of Medicine, New York, USA), FLAME national principal investigator was also quoted in the same release. “Outcomes have remained unchanged for decades. The FLAME data shows that [the] FlowTriever is an important new treatment option that offers a dramatic improvement in survival.” 

Apply for Brandeis health policy program by March 15

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Apply for Brandeis health policy program by March 15

Society for Vascular Surgery (SVS) members have until March 15 to apply for a scholarship to attend the Executive Leadership Program in Health Policy and Management at Brandeis University.

The week-long program for physicians and surgeons will be June 4–10 at Brandeis University, near Boston. With the American College of Surgeons, the SVS sponsors an $8,000 scholarship to defray costs to attend the program.

The program focuses on healthcare policy and reform as well as solutions to improve the quality, cost-effectiveness and efficiency of health care service delivery.

Applicants must be members in good standing of both the SVS and ACS, and must be at least 30 years old, but not yet 60, on the date the completed application is filed.

Learn more at vascular.org/Brandeis23.

RESCUE trial shows reduction in segmental and main pulmonary artery occlusions

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RESCUE trial shows reduction in segmental and main pulmonary artery occlusions

Robert A. Lookstein, MD, who is executive vice chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital in New York today presented the results of a subanalysis of Thrombolex’s National Heart, Lung and Blood Institute (NHLBI)-sponsored RESCUE trial during the late-breaking trial session at the Society for Interventional Radiology (SIR) annual scientific meeting meeting (March 4–9, Phoenix, AZ).

The core laboratory analysis of this investigational device exemption (IDE) trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PMCDT) therapy using the Bashir endovascular catheter from Thrombolex led to a significant reduction in segmental arterial occlusions (71%; p<0.0001), which correlated with the reduction in right ventricular to left ventricular (RV/LV) ratio (p= 0.0026). There was also a significant reduction in main pulmonary artery (PA) occlusions (61%; p<0.0001) but this did not correlate significantly with the reduction in RV/LV ratio. This reduction in occlusions of not only the main PAs but also the segmental arteries explains why the overall reduction in PA obstruction as assessed by the refined Modified Miller Index is greater with the Bashir endovascular catheter than that which has been reported in contemporary thrombectomy or thrombolysis trials for the treatment of acute pulmonary embolism (PE).

The magnitude of effect of these other treatments on segmental arterial occlusions has not previously been reported.

The RESCUE trial is a prospective, multicenter trial evaluating the Bashir catheter in 109 patients with intermediate-risk acute PE at 18 sites in the US. The Bashir catheter was used to deliver 7mg of recombinant tissue plasminogen activator (r-tPA) into each PA over a five-hour infusion period. The primary efficacy endpoint was the core lab-assessed change in the computed tomography angioplasty (CTA)-derived mean RV/LV diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events, including major bleeding, at 72 hours. The median device placement time was 15 minutes and length of hospital stay, 2.8 days.

“The RESCUE trial demonstrated rapid resolution of obstruction in the main, and especially segmental, arteries, with less than a 1% major bleeding rate. It is imperative that future PE trials assess the reduction in obstruction in more distal PAs since it has been shown that both the degree of residual PA obstruction and reduction in pulmonary vascular volumes, presumably due to reduced PA inflow, are significant predictors of late PE-related mortality. This novel approach with the Bashir catheter and low-dose tPA represents a major advance in the treatment of acute PE,” said Lookstein.

“We are pleased to be able to share this important new information from our RESCUE trial and thank all those who made this possible, especially our physician-investigators and their patients. We would also like to thank the National Institutes of Health and the Commonwealth of Pennsylvania Department of Health for their support,” said Brian G. Firth, chief scientific officer of Thrombolex and principal investigator of the NHLBI-funded grant to Thrombolex.

‘SVS Presents’ provides enhanced learning opportunities

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‘SVS Presents’ provides enhanced learning opportunities

The Society for Vascular Surgery (SVS) will debut “SVS Presents” April 12, a monthly webinar series that provides an evening of educational programming for members. 

“Presents” is in response to a key finding from the 2021 Educational Needs Assessment and the 2022 SVS Member Survey, which indicated online education opportunities as a top member priority. 

During the COVID-19 pandemic, the SVS produced more than 40 webinars in 2020 alone. Through the educational needs assessment, members stated their interest for the SVS to continue to offer online education, but to condense the offerings to once a month. 

“‘SVS Presents’ aims to consolidate the offerings to an identifiable time, hopefully decreasing ‘Zoom meeting fatigue,’” said Education Council Chair Linda Harris, MD. “We are also trying to better engage various committees, councils and membership sections to decrease the work and increase the audience for all presentations.” 

The first presentation, on April 12, from 7–8 p.m. (CDT), will focus on the trial results released in late 2022 on the BEST-CLI trial. The second, May 3, will introduce the 2023–24 candidates for Society president and treasurer to SVS members prior to the start of voting. Future topics include advocacy, leadership development, quality practice and guidelines. 

“SVS Presents” will take place either the first or second Wednesday evening of every month, excluding January and June due to holidays and preparation for the Vascular Annual Meeting (VAM). Some months will have several hours of programming while others will offer just one hour. This year will be a pilot year to measure interest and increase engagement from all SVS member segments. Planners hope to expand programming and encourage committees to utilize this specific day each month for educational content. 

In the effort to standardize SVS educational programming, leaders hope to increase opportunities to participate in the activities. Webinars will be the focus at first, with hopes to offer other educational opportunities, such as releasing video content or micro-learning opportunities, or even hosting the Society’s popular TweetChats. 

AVF 2023: Results from first US trial of Sonovein delivered

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AVF 2023: Results from first US trial of Sonovein delivered
Antonis Gasparis

The 2023 annual meeting of the American Venous Forum (AVF) heard the final results from the first U.S. trial of the emerging varicose vein treatment, Sonovein echotherapy, with data showing a 100% technical feasibility at three months—which was the principal study objective.

Antonios Gasparis, MD, director of the Center for Vein Care at Stony Brook University in Stony Brook, New York, told the AVF gathering in San Antonio, Texas (Feb. 22–25), that the Food and Drug Administration (FDA)-approved trial saw 20 great saphenous veins (GSVs) in 18 patients receive treatment using the high-intensity focused ultrasound (HIFU) procedure.

Gasparis said no anesthesia was used during the cases and that no post-procedure compression was performed. The study results further revealed that ablation of venous reflux was achieved in 95% of the cases, or 19 of the 20; ablation to flow was recorded at 65%; no complications were reported; and venous clinical severity score (VCSS) improved from 6.9 pre-procedure to 1.1 at three months.

Gasparis said the next step in assessment of the procedure is for the HIFU technology to be evaluated in a multicenter trial after FDA approval. “It’s here to stay,” he added.

Meanwhile, separately, Ferdinand Steinbacher, MD, from the Karl Landsteiner Institute for Functional Phlebosurgery in Melk, Austria, delivered the latest data from Europe on the Sonovein S+ and Sonovein HD iterations of the technology.

From the end of November 2021 through mid-December 2022, 40 GSVs and anterior accessory saphenous veins were treated, he revealed. Overall efficacy was 88%, Steinbacher said, with the first period of treatment (Nov. 30, 2021, to March 9, 2022) yielding a 71% occlusion rate (12 of 17) when only the Sonovein S+ was used. During the second period (April 26, 2022, to Dec. 14, 2022), during which both the Sonovein S+ and HD version were utilized, a 100% occlusion rate was achieved among the 23 veins ablated—10 with the S+ and 13 with the HD.

The top 10 most popular Vascular Specialist stories of February 2023

The top 10 most popular Vascular Specialist stories of February 2023

In February 2023, the hits with Vascular Specialist readers included positive safety and efficacy findings from the PRESERVE trial; the announcement of the scientific program for Sudan’s first vascular meeting; the release of a former Society for Vascular Surgery (SVS) President’s memoirs; and an interview with the three authors of the Vascular Surgery Oral Board Review textbook for trainees embarking on the Vascular Surgery Board Certifying Exam.

1. Likes, dislikes and reposts: The new age of the vascular surgery influencer

Whether on Twitter, LinkedIn, Instagram, or YouTube, vascular surgeons are posting their “successful” cases like never before. Why the constant need to do this… a cry for validation? Jean Bismuth, MD, and Jonathan Cardella, MD examine the motivations behind the rise in vascular surgery influencing.

2. New study demonstrates IVC filters ‘safe and effective’ in treating venous thromboembolism

Few adverse events are connected to the use of inferior vena cava (IVC) filters to help prevent deep vein blood clots from developing into pulmonary embolisms (PE), according to the findings of the PRESERVE trial.

3. Coding: New CPT codes for percutaneous arteriovenous fistula creation

For the 2023 Current Procedural Terminology (CPT) code set, two new codes (36836 and 36837) have been added that describe percutaneous arteriovenous (AV) fistula creation in the upper extremity—Sunita Srivastava, MD and David Han, MD explain the code change.

4. SVS Foundation board approves latest pilot programs to help underserved

The SVS Foundation has awarded grants to two SVS members to help them serve the underserved as part of the Vascular Care for the Underserved program—the initiative formerly known as VISTA (Vascular Volunteers In Service To All).

5. Patients with claudication receive more ‘aggressive’ surgical management in high-competition regions

M. Libby Weaver, MD, presented the case that intermittent claudication (IC) is a “novel and underdefined” driver of practice variation in management of patients at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico (Jan. 18-21).

6. Sudanese vascular association readies for first-ever conference

The Sudanese Association of Vascular Surgeons (SudAVaS) has announced the scientific program behind its first-ever international conference and is celebrating the “first steps in establishing vascular surgery as a standalone surgical specialty” in the northeast African country.

7. The case for aggressive intervention on symptomatic carotid web

The lead investigator behind new research from a center in Louisiana outlines how his new study—believed to be the largest single-institution analysis of symptomatic carotid web yet reported—shows that carotid duplex is “inadequate” for diagnosis, and medical management is “unacceptable.”

8. New book penned by vascular icon charts revolutionary spirit

A new memoir penned by former SVS President and vascular surgery leader Frank J. Veith, MD, which touches on a lifetime of service to the specialty and tackles some of its most monumental and controversial moments, was published this week.

9. Vascular surgery oral boards text seeks to fill certifying void

Vascular Surgery Oral Board Review: Behind The Knife Premium is a textbook aimed at vascular surgery trainees taking the Vascular Surgery Board Certifying Exam. It is the work of Andrew M. Wishy, DO, Ravi N. Ambani, MD, and Kevin R. Kniery, MD, the latter known for founding the surgical podcasts Behind the Knife and Audible Bleeding.

10. Spotlight: SVS members take up new positions, make endowment

Sean Lyden, MD, is now chief medical consultant for VESTECK and has joined the VESTECK Scientific Advisory Board, while Thomas Maldonado, MD, has been named chief medical officer for Koya Medical.

VESS 2023: pMAC score found to be ‘important predictor’ of CLTI revascularization outcomes

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VESS 2023: pMAC score found to be ‘important predictor’ of CLTI revascularization outcomes
Michael Conte

Having observed a strong relationship between calcification and subsequent limb loss, a research team led by investigators from the University of California San Francisco (UCSF) have conducted a single-center, retrospective follow-up extending an initial study evaluating pedal medial arterial calcification (pMAC) score and major amputation in patients with chronic limb-threatening ischemia (CLTI).

Presented at the 2023 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Whistler, British Columbia (Feb. 23–26), by Shant Vartanian, MD, senior corresponding author and associate professor of vascular surgery at UCSF. Michael S. Conte, MD, professor and chair in the division of vascular and endovascular surgery at UCSF, was also a senior author in this research. Speaking to Vascular Specialist, both Conte and Vartanian discussed the team’s findings.

The data suggest pMAC could become a “robust” marker for hemodynamic response to revascularization and risk of limb loss, and have the potential to better inform healthcare professionals on the most suitable treatment pathway, Conte said.

In their initial study, Vartanian and colleagues found that by measuring the extent of calcium buildup in the foot arteries, a higher incidence of limb loss risk was noted. However, as Conte admits, the calcification pattern is not something vascular specialists routinely consider when planning an intervention. This is unless the patient is diabetic or has kidney disease, which vascular surgeons are seeing “more and more,” he says—noting an increasing number of patients are presenting with “distal” and “challenging-to-treat” disease, extending beyond the calf and into the ankle and foot.

Adding to this, Vartanian recalls their initial intention was to study wound healing in correlation with disease severity, however difficulties investigating this retrospectively steered the investigators to focus on a “clean endpoint”—that being the relative contribution of below-ankle disease and outcomes in CLTI after revascularization.

When conducting a subsequent retrospective review, the team included 306 patients who had a technically successful index infrainguinal revascularization for CLTI between January 2011 and December 2020. They defined technical success as restoration of in-line flow through the target artery pathway into the foot. Furthermore, pMAC scores were blindly calculated by a single reviewer using two-view minimum plain foot radiographs and were subsequently classified using the Society for Vascular Surgery (SVS) WIfI staging system.

The revascularization approach was open bypass in 118 (38%) and endovascular in 188 (62%) patients, their results showed. The pMAC scores were trichotomized (0–1 [125; 41%], 2–4 [116; 38%], 5 [65; 21%]). In the bypass subgroup, the researchers state WIfI ischemia grade was improved in 35 of 46 (76%) patients—a total of 19 of 118 (16%) receiving major amputation—although data were not associated with pMAC scores. In the endovascular subgroup, WIfI ischemia grade was improved in 43 of 90 (48%), however 37 of 188 (20%) underwent major amputation.

Drawing conclusions from these results, Conte and researchers directed attention to the “selective differences” in the impact of pedal arterial calcification on revascularization outcomes in CLTI. Although pMAC score was “strongly and independently” associated with failure to improve WIfI ischemia grade after infrainguinal angioplasty or stent, the authors identified no factors associated with this outcome in those who underwent bypass.

“[Our results] at very least can help healthcare professionals discuss the odds of success with their patients, and rethink how aggressively to push for revascularization, or certainly have in mind that a standard revascularization may not work for a patient with a high pMAC score,” Conte explained. In concurrence, Vartanian noted that it is essential the implications of revascularization be studied prospectively and ultimately be “factored in upfront decision-making” for the management of CLTI and that measuring pMAC scores is a “simple and efficient” way to quantifying the burden of calcification.

Importantly, Conte noted that although the WIfI stage captures the clinical spectrum of CLTI, the pMAC score can describe the underlying pathology and provides useful information that may serve as an “important predictor of revascularization outcomes. Having been involved in the inception of the WIfI staging system, Conte believes the addition of pMAC scoring would be a “step forward” in stratifying patients with limb-threatening ischemia, delineating who is high-risk and should receive urgent care.

When reflecting on the audiences reception of their presentation at VESS 2023, Vartanian concedes that “cynicism is healthy”—particularly when confronted with a novel concept, noting: “There’s not a robust body of evidence to support [pMAC scoring] just yet. I think it’s natural to ask difficult questions and as cases of below-ankle disease increase, healthcare professionals should be having honest conversations with patients, assessing potential risks.” Distilling his thoughts, Vartanian continues—“I believe the take home message is to reassess adequacy of perfusion, and focus on vigilance short-term, then observation and reintervention sooner rather than later, if a case is not developing on a desirable clinical trajectory.”

Reflecting on the broader relevance of the team’s findings, Conte noted: “Measuring pMAC scores for all comers that are referred for possible limb salvage—rather than looking backwards after receiving a revascularization—could improve assessments and aid in defining treatment strategies for patients with CLTI.”

Looking ahead, Conte and Vartanian are clear that further validation is needed from other centers and larger datasets to define the role of pMAC scoring in producing differences in revascularization efficacy and limb salvage in patients with low vs. high burden of pedal calcification. Contemporary research on this topic is on an “exponential curve” upwards however, Vartanian adds, having spoken to fellow researchers at VESS they became aware of many studies at other institutions that will add to the body of knowledge—“I think we are going to see an explosion of papers on the subject in the next few years”, he stated.

AVF 2023: FLASH registry suggests ‘favorable safety and effectiveness profile’ in high-risk PE patients

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AVF 2023: FLASH registry suggests ‘favorable safety and effectiveness profile’ in high-risk PE patients
James Horowitz delivers FLASH data to AVF 2023 audience

Among 61 high-risk pulmonary embolism (PE) patients followed through to the 30-day visit in the U.S. cohort of the FLASH registry, no mortalities were recorded, while at 48 hours post-treatment with the FlowTriever mechanical embolectomy system, likewise, there were no major adverse events (MAEs), nor serious adverse events (SAEs) reported.

The outcomes emerged during a venous thromboembolism (VTE) session at the 2023 annual meeting of the American Venous Forum held in San Antonio, Texas (Feb. 22–25) in a paper delivered by James Horowitz, MD, from NYU Grossman School of Medicine in New York City.

The sub-analysis was drawn from the 800-patient prospective, multicenter, real-world registry in light of a paucity of data regarding the use of the percutaneous system among high-risk patients, Horowitz noted.

Horowitz reported that, post-embolectomy using the FlowTriever system, hemodynamic improvements were observed, with mean pulmonary artery pressure decreasing from 31.5mmHg to 24.3mmHg, and cardiac index (CI) increasing from 1.5L/min/m2 to 1.9L/min/m2. “Patients demonstrated immediate hemodynamic and vital-sign improvements following the procedure,” he added. “Echocardiographic, dyspnea and quality-of-life outcomes improved through 30 days.”

Horowitz and colleagues highlighted that the large-bore mechanical embolectomy system “has a favorable safety and effectiveness profile” in the high-risk group. They concluded: “In high-risk PE patients, there were no mortalities through 30 days or MAEs after mechanical embolectomy with the FlowTriever system. High-risk patients demonstrated significant improvement of acute hemodynamics and functional outcomes. Results from the FLASH registry suggest mechanical embolectomy is safe and effective for high-risk PE, leading to markedly lower acute mortality compared to previously reported mortality rates for this population.”

AVF 2023: Investigators report update on three-year first-in-human results for bioprosthetic venous valve

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AVF 2023: Investigators report update on three-year first-in-human results for bioprosthetic venous valve
Jorge Ulloa
Jorge Ulloa

Researchers in Colombia behind the first-in-human study of a novel bioprosthetic venous valve designed to treat chronic venous insufficiency (CVI) reported three-year results among eight patients during the 2023 annual meeting of the American Venous Forum (Feb. 22–25) in San Antonio, Texas, providing attendees with updated data on improvements in venous reflux of 63%, revised venous clinical severity score (rVCSS) of 64%, and visual analog scale (VAS) of 83% compared to pre-surgery levels.

The VenoValve device has been developed to be surgically implanted in the femoral vein of patients with C5–C6 disease on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification.

Presenter Jorge Ulloa, MD, from Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia, principal investigator of the first-in-human trial, said the findings demonstrated the VenoValve “appears to be safe with continued significant benefit.”

The two-year findings, presented at the 2021 Vascular Annual Meeting (VAM) in San Diego, showed 63% improvement in venous reflux time, 60% improvement in VCSS score, and a 93% improvement in recorded pain, or VAS, when compared with preoperative levels.

At AVF 2023 in San Antonio, Ulloa said the eight patients showed “continued and stable improvement” for three years, with no ipsilateral ulcer recurrence. “It appears that long-term anticoagulation may be necessary,” he added.

The VenoValve is currently undergoing clinical trial in the U.S. in the SAVVE study, or Surgical anti-reflux venous valve endoprosthesis.

AVF 2023: One-year analysis of CLOUT registry reveals ‘significant and sustained’ long-term clinical improvements

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AVF 2023: One-year analysis of CLOUT registry reveals ‘significant and sustained’ long-term clinical improvements
David Dexter presents at AVF 2023

Interim one-year outcomes from the multicenter, prospective, single-arm CLOUT registry investigating use of the ClotTriever thrombectomy system in all-comer patients with deep vein thrombosis (DVT) demonstrated that 93.5% of limbs had flow present, 97.1% were compressible and 10.5% of patients presented with moderate or severe post-thrombotic syndrome (PTS).

The results were presented by David Dexter, MD, an assistant professor of surgery at Eastern Virginia Medical School in Norfolk, Virginia, at the 2023 annual meeting of the American Venous Forum (AVF) in San Antonio, Texas (Feb. 22–25).

Dexter reported that 12-month follow-up among 176 patients was completed, with 20% presenting with a PTS Villalta score of greater than 4—and 17 limbs, or 10.5%, with a score greater than 9 (moderate or severe).

The primary effectiveness endpoint—complete or near-complete (≥75%) clot removal, assessed by an independent core laboratory—was achieved in 91.2% of patients. Nearly two-thirds of patients saw complete thrombus removal. “Patients reported immediate symptom relief and demonstrated sustained improvements in one-year clinical and quality-of-life outcomes,” Dexter told AVF 2023. Rates of PTS “remained low” at the one-year mark, he added.

Dexter concluded: “This one-year interim analysis from the real-world CLOUT registry indicates that the ClotTriever system can effectively remove thrombi with significant and sustained long-term clinical improvements, including PTS, pain, and quality of life. Follow-up with the complete dataset to two years is ongoing.”

New study demonstrates IVC filters ‘safe and effective’ in treating venous thromboembolism

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New study demonstrates IVC filters ‘safe and effective’ in treating venous thromboembolism
David L. Gillespie, MD

Few adverse events are connected to the use of inferior vena cava (IVC) filters to help prevent deep vein blood clots from developing into pulmonary embolisms (PE), according to the findings of the Predicting the safety and effectiveness of inferior vena cava filters (PRESERVE) trial, published jointly in the Journal of Vascular and Interventional Radiology (JVIR) and the Journal of Vascular Surgery Venous and Lymphatics (JVS-VL).

PRESERVE is an FDA-directed multicenter, prospective, open-label, non-randomized trial that studied the safety and efficacy of IVC filters from six manufacturers. It was a joint effort of the Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS). The study was conducted at 54 sites in the U.S. between Oct. 10, 2015, and March 31, 2019. During that time, filters were implanted in 1,421 patients, of whom 1,019 patients had an existing deep vein thrombosis (DVT) or pulmonary embolism (PE).

Researchers found that IVC filters were effective in helping to prevent PEs in patients experiencing a DVT where anticoagulation medicines failed or were not an option for the patient. Approximately half of the patients in the study had their filters removed within three months of placement without complication or recurrence of DVT or PE, according to study authors.

“The question should not be only ‘should we place a filter?’ but ‘how should we offer comprehensive filter-inclusive care of patients with venous blood clots, comprised of a detailed patient evaluation, a plan for retrieval after placement, and frequent follow-up with evaluation for filter removal or replacement,’” said Matthew S. Johnson, MD, an interventional radiologist and professor of radiology and surgery at Indiana University School of Medicine in Indianapolis, and co-principal investigator on PRESERVE. “PRESERVE showed what questions we should ask as clinicians: ‘does this person continue to require protection against PE, and, in light of changing clinical status and available therapies, is the current filter needed?’ and then make an informed decision on how to continue care.”

David L. Gillespie spoke exclusively on the PRESERVE trial at VEITHsymposium 2022.

“DVTs and PEs are a significant cause of death worldwide and understanding fully how tools like IVC filters can be used to prevent the progression of a DVT into a PE allow physicians to safely treat patients at risk of death from venous thromboembolism [VTE]” said David L. Gillespie, MD, a vascular surgeon at Beth Israel Deaconess Medical Center, Brockton, Massachusetts, and co-principal investigator on PRESERVE. “Now that the study is complete, we have a roadmap for better filter utilization. We need to solidify a clearer set of practice guidelines for venous thromboembolic disease, based on its symptoms, location and complications. Further studies will focus on how the different manifestations of venous thromboembolic disease may benefit from filter-inclusive care.”

Speaking at VEITHsymposium 2022 (Nov. 15–19, New York City), Gillespie outlined that “approximately ten years ago or so, the clinical management of patients with VTE and the prophylaxis of potential VTE in trauma patients was not well studied with regard to the use of IVC filters.” The result of the PRESERVE trial has been that “essentially, these filters are safe and effective for therapeutic [and prophylactic] use in the patient population [in question],” Gillespie continued, and this, despite the “challenges” of the COVID-19 pandemic, the “high dropout rate,” and the fact that “a large number of patients” had their filters removed.

To date, PRESERVE is the largest prospective study investigating the real-world patient outcomes of IVC filter use. “This trial represents an important step in collaborating across specialties to benefit the health and safety of our patients,” said SIR President Parag J. Patel, MD, from Medical College of Wisconsin, Milwaukee. “Thanks to the work of Drs. Johnson and Gillespie and all the investigators and patients involved in the trial, we now have higher quality evidence to support appropriate utilization and management of IVC filters in patients with venous thromboembolic disease.”

“Congratulations to Dr. Gillespie, Dr. Johnson, and their many colleagues for shepherding this large collaborative multispecialty, multicenter clinical trial to completion,” said Michael C. Dalsing, MD, from Indiana University Health, Indianapolis, president of the SVS. “This highly impactful study provides the real-world evidence needed when recommending IVC filter placement to protect our patients from a potentially lethal disease and when to remove that filter after it has accomplished the desired effect. It is a stellar example of collaboration across specialties for the betterment of patient care.”

PRESERVE study shows IVC filters are ‘safe and effective’ for prevention of pulmonary embolism

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PRESERVE study shows IVC filters are ‘safe and effective’ for prevention of pulmonary embolism

David Gillespie (Boston, USA) talks to Vascular Specialist about the PRESERVE study—established by the Society for Vascular Surgery and Society of Interventional Radiology—which is the largest prospective study to investigate real-world outcomes with contemporary use of inferior vena cava (IVC) filters in patients who are at risk for venous thromboembolism.

A total of 1,421 patients were enrolled at 54 sites across the U.S. and had IVC filters from seven different manufacturers placed. “It was a monumental task to enroll patients and get them to complete” states Gillespie, who goes on to outline some of the key challenges the study faced, including the changing regulatory landscape, COVID-19 and a large patient drop-out rate.

Despite these hurdles, PRESERVE has essentially shown in a non-randomized study that IVC filters “are safe and effective for therapeutic use” as well as in prophylactic use “with continued monitoring and early removal”.

‘Urgent action needed’ to improve implementation of guideline-directed medical therapy for PVI

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‘Urgent action needed’ to improve implementation of guideline-directed medical therapy for PVI
Kim G Smolderen and Carlos Mena-Hurtado

Almost one-half of the patients receiving a peripheral vascular intervention (PVI) in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry between 2017 and 2018 were not on guideline-directed medical therapy (GDMT). Kim G. Smolderen, PhD, and Carlos Mena-Hurtado, MD, both from Yale University School of Medicine in New Haven, Connecticut, with their Vascular Medicine Outcomes (VAMOS) team report this and other key findings from a recent study in JACC: Cardiovascular Interventions.

The researchers note there has been a “rapid rise” in the volume of PVIs over the last decade, which stands in contrast to what they describe as “clinical inertia” for implementing GDMT in peripheral arterial disease (PAD). The team hypothesized that a lack of GDMT in patients undergoing PVIs may increase mortality and amputation risk and therefore sought to study the association between GDMT and mortality/amputation and to examine GDMT variability among providers and health systems.

Smolderen et al performed an observational study using patients in the VQI registry who underwent PVI during the one-year study period, deriving two-year all-cause mortality and major amputation data from the Medicare claims database. The investigators defined compliance with GDMT as receiving a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker if hypertensive. They applied propensity 1:1 matching for GDMT versus no GDMT and performed survival analyses to compare outcomes between groups.

The team identified 15,891 patients (mean age, 72) who underwent a PVI in the 2017–18 period, specifying that 48.8% received GDMT and that 6,120 patients in each group were matched. They note that median follow-up was 9.6 months for mortality and 8.4 months for amputation.

Writing in JACC: Cardiovascular Interventions, Smolderen and colleagues report that mortality risk was higher among patients who did not receive GDMT versus those on GDMT (31.2% vs. 24.5%), as was risk of amputation (16% vs. 31.2%). GDMT rates across sites and provider ranged from 0% to 100%, the authors add, noting that lower performance translated into higher risk.

In their conclusion, Smolderen and colleagues summarize that one-half of the patients receiving PVI do not receive optimal GDMT and face an almost 40% increased risk of mortality, and an almost 20% increased risk of major amputation in the two years following their procedure. Speaking to the fact that GDMT rates were “highly variable” across sites and providers, they suggest this highlights “modifiable” rates and comment that “performance can be improved.”

“Offering PVIs without optimal GDMT is a low-value proposition for the patient, their families, health systems, and society at large,” the authors write. In light of this, they stress that “urgent action is needed to ensure the delivery of high-value PAD care as part of the interventional pathway.”

Considering what form this action might take, Smolderen et al state that, as part of the “PVI pathway,” national quality and reporting systems should be developed and tested to improve GDMT rates in patients with PAD.

The authors acknowledge some limitations to their study, including the fact that they limited quality metrics to three medications only, and that there is the “potential for unmeasured residual confounding” in the study due to its observational nature.

‘Time to step on the gas’

In an editorial comment, also published in JACC: Cardiovascular Interventions, Connie N. Hess, MD, and Marc P. Bonaca, MD, of the University of Colorado School of Medicine in Aurora, Colorado, write that Smolderen and colleagues’ study “adds additional confirmatory evidence of the persistent gap between guidelines and real-world treatment”.

However, they also stress that the observations of the analysis with respect to outcomes should be interpreted with caution. They elaborate that while randomized clinical trials have demonstrated that the individual components of GDMT can reduce major adverse cardiovascular events (MACE) in patients with vascular disease, including PAD, none of these therapies has been proven in randomized trials to reduce all-cause mortality or major adverse limb events (MALE). This, they write, makes it “difficult to infer a causal relationship between GDMT and improved survival and freedom from amputation.”

They deem Smolderen et al’s study an “impressive effort,” although stress that the analysis “illustrates the complementary nature of randomized trials and observational investigations,” labelling the former the “gold standard” for assessing the actual efficacy and safety, and the latter “necessary to understand use in practice and to generate additional hypotheses for further testing in trials”.

The study, Hess and Bonaca conclude, provides a “sobering reminder of the continued gap in PAD care that will continue to persist without better data and the new focus on implementation.” Clinical care “remains paramount,” they say, noting however that there is a need for “accelerated action” to speed up the “glacial pace” of translation of evidence to practice. Newer medical therapies for PAD are already available, they stress, but in terms of implementation, it is “time to step on the gas.”

BioGenCell begins recruitment for clinical trial of stem cell-based treatment for preventing limb amputation

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BioGenCell begins recruitment for clinical trial of stem cell-based treatment for preventing limb amputation
Using a unique patented biological process, the BioGenCell labs grow educated cells from the patient’s blood within a single day. After the process has been completed, the activated cells are packaged in a syringe, ready for use, and are transferred under strict conditions and controlled temperature to the treatment room, where they are injected into the damaged leg muscle.
The BioGenCell lab grows educated cells from the patient’s blood within a day

BioGenCell has announced that it is recruiting for an international clinical trial to assess the company’s stem cell-based therapy for chronic limb-threatening ischemia patients who are at risk for limb amputation.

The clinical trial is currently taking place in medical centres in Israel, Europe, and the US, a press release details.

The company notes that the news follows a recent investment round that brought in $16 million, led by the entrepreneur Marius Nacht, as well as FDA and Health Authorities approvals in Israel and Europe to carry out the study.

BioGenCell states that the company previously demonstrated the efficacy of their treatment in the prevention of limb amputation based on cells from patients’ blood in lab settings and in animal model, and reported promising results in a phase I clinical trial.

The company claims that their technology “transforms the patient’s self-blood cells to cells with rehabilitative functions”. These personal cells are then injected back into the patient, directly into the affected limb, where they encourage the generation of new, healthy blood vessels. By regenerating the blood flow to the limb, the therapy “potentially prevents limb amputation, or even death, and allows the patients to resume normal activity,” they write in the press release.

Yael Porat, founder and CEO of BioGenCell, commented on the company update: ”This is great news for patients with ischemic vascular diseases who are at risk of limb amputation.”

Shlomo Baytner of Laniado Hospital in Netanya, Israel, remarked: “BioGenCell’s innovative treatment is intended for patients who we can longer offer the option of catheterization or bypass. These patients suffer constant pain over a long period of time, and I am optimistic and hope that we will finally have a treatment available that can help these patients.”

SVS DEI Committee launches ‘Voices of Vascular’ series

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SVS DEI Committee launches ‘Voices of Vascular’ series

SVSTo help celebrate the diversity in the vascular surgery specialty, the Society for Vascular Surgery Diversity, Equity and Inclusion Committee has launched “Voices of Vascular,” a series highlighting the contributions of surgeons from a wide variety of backgrounds.

“Voices” debuts this month, during the celebration of Black History Month. The initiative will highlight the stories of SVS members while also emphasizing patient education and awareness and sharing health-related facts and information pertinent to the community. The series will continue throughout the year.

SVS members from all backgrounds are invited to share their stories (or nominate someone else) by filling out the form available at vascular.org/VoicesForm. The SVS Foundation added a new fourth pillar for DEI in 2022. The “Voices of Vascular” series is aimed at helping to raise awareness as the Foundation works to raise funds to support DEI initiatives. The first profiles will be available at vascular.org/VoicesOfVascular.

More than a research project: The vascular trainee’s role in tackling disparities in peripheral arterial disease

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More than a research project: The vascular trainee’s role in tackling disparities in peripheral arterial disease
peripheral arterial disease
Chloé Powell

One of my earliest clinical experiences with vascular disease was as a high school student shad­owing at a busy urban hospital in Detroit. A Black man with a longstanding history of diabetes developed a foot ulcer that ultimately required an amputation. Though I did not know the exact circumstances that led to his am­putation, I would later learn about the cumulative insults that not only impacted his health, but also other members of the community.

The problem at a glance

Disparities in peripheral arterial disease (PAD) care and vascular surgery outcomes persist despite improvements in technology and interventional therapies. Blacks, His­panics and Native Americans have higher rates of PAD, and undergo amputation at two-to-four times the rate of White patients. They are less likely to undergo revascu­larization prior to amputation, and have higher rates of morbidity and mortality after amputation and revascular­ization. Female patients with symptomatic PAD report greater functional impairment and worse outcomes after revascularization compared with male patients. Those patients belonging to lower socioeconomic backgrounds experience a higher burden of disease, higher risk for PAD-related hospitalizations, and higher odds of am­putation in the setting of severe PAD. Patients living in rural areas face unique challenges due to physical barriers to access to care, or lack of geographic availability of specialty care. Fortunately, through decades of work we have transitioned from viewing these adverse outcomes as intrinsic failures of the patient, to considering the barriers across the PAD care continuum.

PAD pipeline

I have conceptualized PAD care—albeit simplified—as starting with patient evaluation, PAD detection and medical management initiation. For those whose disease has progressed, interface with an interventionalist may become necessary. This pathway is the PAD pipeline. However, whether a person reaches this pipeline, and ultimately moves through, it is not equal. It is influenced by structural inequities. As an example, through historical policies, geographic segregation may limit the hospitals to which a person has access, where quality may be lower. Provider biases may serve as gatekeepers limiting access to care. Patient risk factors and comorbidity burden may be influenced by disparities in education and their built environment. As Joshua Beckman, MD, has proclaimed, “PAD is the disparity,” thus mitigating the development of PAD would be most ideal. However, for those that siphon through the pipeline, it should at least be optimized.

Altering the tide

Addressing disparities in PAD care and surgical outcomes will not occur overnight, and will require a movement toward focusing on health equity utilizing a multi-pronged approach. There is no one-size-fits-all intervention. The needs of local and regional communities differ, and thus innovative and successful solutions will take that into consideration. There are several ways we can try to alter the tide:

  1. Recognizing the disparities in PAD burden and outcomes are the result of structural inequities. By advocating for and supporting policies that promote equity broadly—but especially those targeted toward improving access to quality healthcare—we are likely to have the greatest impact and break the generational cycle of poor health.
  1. At the health system level, we need to develop both in­tra- and inter-specialty collaboration. Patients with PAD have complex social and medical needs, and, as such, numerous specialists are involved in managing their care. Improved interdisciplinary collaboration paves the way for enhanced risk factor modification, continuity of care and ensures patients receive high-quality care most aligned with their goals. The “toe and flow” model of care demonstrates the benefits of a collaborative team approach in dealing with patients with chronic limb threatening ischemia (CLTI). Collaboration should also include other health systems. The state of Michigan is rich with collaborative quality initiatives that really seeks to share strategies to improve the quality of care we deliver across the board.
  1. Because health is largely shaped by the social determi­nants of health, developing and fostering intentional and mutually beneficial community partnerships serves to build trust among communities that have faced discrimination and abuse by the medical community. By having a finger on the pulse of the community’s needs, partnerships can help to connect individuals with healthcare providers. For example, Michigan Medicine is developing an initiative called MSHIELD geared toward addressing the social determinants of health.
  1. When conducting research, we should generate ev­idence and examine data through the lens of inter­sectionality, cultural humility, and acknowledge the research process itself can be biased. We should also actively support efforts to engage, recruit and retain participants from historically excluded and exploited populations. This may require diversifying the research team or partnering with trusted organizations.
  1. On the clinical front, we need to continue to educate ourselves about the structural inequities and its implica­tion on patient health. We must ensure we are utilizing evidence-based medicine in a culturally sensitive man­ner to better provide patient centered care.

As a vascular surgery trainee, it is easy to think that vascular surgery is at the end of the PAD pipeline and all the “damage” is done. However, I would argue we have a unique perspective because of the longitudinal care we provide, and we too often bear witness to the devastating effects of progressive PAD. We have insight into problems that arise in routine practice that create gaps between evidence-based care and actual care. By capitalizing on these spheres of influence, vascular surgeons can bridge and accelerate the link between research, community, ad­vocacy, and clinical care in a way that is most relevant and beneficial to patients and vascular surgical practice.

Chloé Powell, MD, is a 5th-year resident in the integrated vascular surgery residency program at the University of Michigan in Ann Arbor. 

March’s free-access articles in JVS, JVS-VL

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March’s free-access articles in JVS, JVS-VL
JVS JVS-VL
JVS, JVS-VL

The March issues of the Journal of Vascular Surgery (JVS) and JVS: Venous and Lymphatic Disorders (JVS-VL) include eight articles that will be available via free-access by Feb. 21 (JVS-VL) and Feb. 23 (JVS). The fully accessible peer-review papers are as follows:

JVS

1. “Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to CLTI,” Editor’s Choice, with a visual abstract. Visit vascular. org/JVS-ClaudicationCLTIMarch23

2. “Females are less likely to receive best medical therapy for stroke prevention before and after carotid revascularization than males,” with a visual abstract and continuing medical education (CME) credit possible. This paper is set to be featured on an episode of the popular Audible Bleeding podcast. Visit vascular.org/JVS-Gende redMedicalManagementMarch23

3. “Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair,” with a visual abstract. Visit vascular.org/JVS-F-BEVARMarch23

4. “Mortality analysis of endovascular aneurysm sealing versus endovascular aneurysm repair,” with a visual abstract. Visit vascular.org/JVS-MoralityAnalysisMarch23

JVS-VL

1. “Clinical tolerance of untreated reflux after iliac vein stent placement.” Visit vascular.org/JVSVL-LilacVeinStentMarch23

2. “Percutaneous superior vena cava puncture for hemodialysis catheter placement.” Visit vascular.org/JVSVL-SuperiorVenaCavaPunctureMarch23

3. “Venous stent patency is independent of total stented length in non-thrombotic iliac vein and post-thrombotic venous stenoses,” Editor’s Choice and CME credit possible. Visit vascular.org/JVSVL-StentMarch23

4. “A practice audit of short-term outcomes of Wallstent versus Venovo stents for the treatment of non-thrombotic iliac vein outflow stenoses.” Visit vascular.org/JVSVL-IliacVeinOutflowMarch23

VAM 2023 meeting set to take place as exclusively in-person event

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VAM 2023 meeting set to take place as exclusively in-person event
VAM
Michael Dalsing, Andres Schanzer

A block party on opening day, session recordings available daily and—of course—the educational and scientific ses­sions for which the Society for Vascular Sur­gery’s Vascular Annual Meeting (VAM) is known: all this and much more will be part of VAM 2023.

The premiere educational event of the vas­cular world will be June 14 to 17 at the Gay­lord National Resort & Convention Center in National Harbor, Maryland, just outside Washington, D.C.

Educational sessions and abstract-based plenaries will take place across all four days, ending at 12:30 p.m. Saturday. The Annual Business Meeting will follow, from 12:30 to 1:45 p.m. and will mark the official close of the meeting.

The VAM Exhibit Hall, featuring the best products and services industry has to offer, will be open June 15 and 16. And people who love a party should be sure to purchase tickets soon for the SVS Foundation’s premier event, the “Great Gatsby Gala,” set for the evening of Friday, June 16.

VAM will feature not only the latest scientif­ic research but also educational sessions with topics for all career stages, from tips for young surgeons to financial planning for surgeons preparing to retire. With receptions and din­ners—not to mention chance meetings in the hallways and hotel—there will be plenty of opportunities to converse with friends and colleagues old and new.

People will need to be on site to experi­ence it all. With substantial winding down of COVID-19 and the availability of vaccines, no live-streaming (with the exception of the Vascular Quality Initiative’s VQI@VAM) will be offered this year. However, all sessions will be recorded and available to registrants during the week of VAM. These recordings will be available for three years post-meeting, so attendees have plenty of time to catch any sessions they may have missed on-site or give a presentation additional review.

Members previously have sought this quick access to session recordings and planners ex­pect this change to be a big hit.

In conjunction with SVS welcoming attend­ees and their families to VAM and National Harbor, the Society will hold its first annu­al Block Party Wednesday evening. This is a ticketed event; more information will be available at the VAM registration site. Other family-friendly activities and features, such as resources for nursing mothers, also are in the works.

As in years past, both the SVS Patient Safety Organization Vascular Quality Initiative (VQI) and the Society for Vascular Nursing (SVN) annual meetings will convene in collaboration with VAM.

VQI@VAM will be held the afternoon of Tuesday, June 13, followed by an early-eve­ning reception and poster presentation, and all day Wednesday, June 14. This meeting will be live-streamed for those who cannot attend in person and recorded for registrants.

The SVN’s 41st Annual Conference will be held on Wednesday and Thursday, with its Presidential Luncheon, including awards presentations on Wednesday and a Welcome Reception Wednesday evening. This meet­ing will not be live-streamed, but all sessions will be recorded and available starting the week of the meeting for up to three years post-meeting.

To take advantage of National Harbor’s proximity to the country’s seat of govern­ment, a trip to Capitol Hill is planned, as are two sessions on the importance of advocacy and how advocacy impacts vascular surgeons’ lives and livelihoods.

In the wake of the completion of the BEST-CLI (Best endovascular versus best surgical therapy for patients with CLTI) clinical trial, the Planning Committee has slated a session on outcomes and what comes next.

The United Kingdom’s BASIL-2 clinical trial—which is investigating outcomes of by­pass versus angioplasty in severe ischemia of the leg—will be discussed at the same 90-min­ute session. Trial investigators will summarize key findings of each. The presentation also will include a debate on appropriate therapies plus discussion of implementing recommen­dations from both trials.

The SVS introduces the new Frank J. Veith Distinguished Lecture, announced at VAM 2022, this year. It, too, will cover BEST-CLI.

Learn more about VAM at the VAM web­site, vascular.org/VAM. And be sure to circle March 15 on the calendar—and prepare for early-bird tickets.

Strategic planning session outlines SVS priorities for coming year

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Strategic planning session outlines SVS priorities for coming year

svsKey leaders from the society for Vascular Surgery (SVS) gathered in mid-January for a two-day Strategic Board of Directors (SBOD) meeting to work through the Society’s six strategic domains.

SVS Executive Director Kenneth M. Slaw, PhD, noted, “The SBOD provides a global and diverse perspective on SVS priorities; members selected from the major vascular societies represent the full spectrum of demographics and practice settings and keep the overarching needs of the entire specialty in mind as they work to set SVS priorities.”

The strategic domains focus on advo­cacy, education, clinical practice, quality, research and the overall health of the SVS.

“Through discussions of each domain, our Strategic Board of Directors provides the overarching strategy and directional objectives for the Society’s work over the next year but, more importantly, with an eye to a three-to-five-year horizon,” said SVS President Michael Dalsing, MD.

Slaw emphasized the importance of po­sitioning vascular surgeons to provide opti­mal care for their patients while working to ensure they have a fulfilling, rewarding and valued career.

Advocacy

Members across SVS worry about the sur­vival of vascular surgery within the current health policy and delivery system. Megan Tracci, MD, vice chair of the SVS Advocacy Council, and Megan Marcinko, SVS direc­tor of advocacy, led the conversation on the pressing issues regarding the vascular surgery payment policy.

“It is obvious that we need to continue to work within the system to represent our members on the Hill but more is needed, and lively discussions regarding proactive options were entertained,” said Dalsing. “It was good to see the enthusiasm and brainstorming that took place and suggests that a second payment summit needs to be convened. Vascular surgeons need to sculpt and map out a new future for vascular health delivery.”

Education

Plans for the coming year include building an enhanced online education platform to provide members with both formal education and “micro-learning” opportu­nities. “SVS Presents,” a monthly webinar series, is scheduled to begin in April, and will provide an evening of programming members can access at any time. The next version of the Vascular Education and Self-Assessment Program (VESAP), the online learning assessment and self-study tool, is in the works for later this year. In addition, education leaders plan a Vascular Annual Meeting Education Retreat for the fall to prepare for VAM for the next three to five years. Education Council Chair Linda Harris, MD, and Lisa Cohen, SVS director of education, presented the information.

 Clinical practice

Clinical Practice Council Chair Dan McDe­vitt, MD, and Reva Bhushan, SVS director of clinical guidelines and quality practice, presented the domain findings concerning clinical practice issues. The top priorities are the need to develop a Society position report on optimizing vascular surgery ser­vice, the role of vascular surgeons and the need for an optimized vascular team. This year will see the launch of the first phase of a national compensation study. The data will provide a vascular-specific, in-depth understanding of the different components of a vascular surgeon’s compensation and puts this in SVS members’ hands.

 Quality

Quality Council Chair Thomas Forbes, MD, presented priorities in this domain. This included the necessity of appropriate­ness of care and the next steps to launch SVS’ second appropriate use criteria (AUC) project, focused on carotid disease. Also discussed was the “Vascular Verification Program: A quality program with the So­ciety of Vascular Surgery,” in collaboration with the American College of Surgeons (ACS).

This program is designed to ensure quality, as well as quality improvement in vascular care, in both the inpatient and out­patient settings. The inpatient component is launching this winter, with the outpatient program expected to begin in the spring.

 Research

Of particular note in the research area is the finalization and publication of the updated research priorities, which will shape the focus and funding for vascular surgery research in the coming decade. The research council plans to focus on developing new scholarships and awards for translational research development. Re­search Council Chair Raul Guzman, MD, presented the priorities for this domain.

 SVS health and vitality

Slaw, presenting alongside SVS Secretary William Shutze, MD, highlighted the importance of building member value and improving membership retention, specif­ically among early-career members. The necessity of branding the specialty to its different audiences also is deemed critical, as is investing in the SVS communica­tions platform and infrastructure to reach audiences across different media channels and in different formats. The SVS will also press forward on its diversity, equity and inclusion (DEI) initiatives.

The meeting adjourned Jan. 14 with the near-finalization of the 2023 strategic objectives and budget discussion for fiscal year 2024. The SBOD will meet next on March 21.

 

Likes, dislikes and reposts: The new age of the vascular surgery influencer

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Likes, dislikes and reposts: The new age of the vascular surgery influencer
Jean Bismuth and Jonathan Cardella
vascular surgery
Jean Bismuth and Jonathan Cardella

The brave new world of social media, with its TikToks and Kar­dashians, has now invaded our once-sane specialty. No, this is not a veiled reference to controversial swim attire events in our past, but rather a totally new phenomenon.

Whether on Twitter, LinkedIn, Instagram, or YouTube, vascular surgeons are posting their “successful” cases like never before. Why the constant need to do this… a cry for validation? Sometimes it appears to be a not-so-subtle show of support for a friendly vendor, as is evidenced by the “clot warriors,” posting dramatic lengths of coagulum in an effort to prove mine is bigger than yours. Could it be that vascular surgeons just don’t feel championed by their own specialty, and they’re in dire need of basic validation, a simple pat on the back? Is there such a void of mentorship in our chosen specialty? Do we need to practice in a stadium full of adoring fans, hanging on to every stitch and stent like the Rolling Stones at Wembley? If I sold tickets to my next tibial bypass, would fans crash the Ticketmaster website like the Swifties?

The psychology of this phenomenon is curious. More than any specialty, vascular surgery is marred by complications. It’s the nature of the patients we treat. We treat very sick patients with difficult problems, and yet only successes are posted. Why not the failures? From our first days in surgery, we discovered that morbidity and mortality (M&M) rounds are where we learn the most valu­able lessons. A sensible surgeon will assess and reassess any complication incurred and apply rigor to all outcomes, even those that are viewed as successful. However, despite these lessons learned through our training and practice, there is still a need to “virtue signal” curated images and scenarios on social media and disregard any possible criticism that may be levied.

Virtue signaling is loosely defined as attempting to show you are a good person, or in this case doctor, through the expression of viewpoints (using angiograms, CT scans, etc.), usually on social media. It’s concerning that as phy­sicians, we carefully curate our best cases on social media, like others post luxurious Italian villas or diligently choreo­graphed Cardi B dance moves. The psychology behind the need to have this external validation from the public, many of whom are unknown, is puzzling. One would suspect that good outcomes and happy patients would suffice for many, but it appears this is not the case. There are concerns about this from many angles. What message does this send to the public? Many will view these posts and assume validity based on the detail of the information provided. It is also concerning that this becomes an example for our trainees, many of whom also follow on social media, that this external validation is required as a means of attaining relevance and satisfaction in their careers. Finally, it is not a huge stretch to foresee the HIPAA violations created by the specificity and detail presented in these cases.

Recently on LinkedIn, a vascular surgeon presented an absolute banality of a case—a cephalic arch recanalization and stenting. The waterfall of accolades was simply bewil­dering! Should it even matter that we all know that this will fail? When I made a comment to that effect and suggested a surgical alternative, I was sent an old article with a small series of cases where patients were treated successfully with stent-grafts. The surgeon also made a somewhat snide com­ment that he only believed in randomized controlled trials, and that this was an endovascular forum. This individual evidently failed to see the irony of his comment, but the absurdity naturally did not escape me. Of course, further interaction was futile. So the question begs, why post a case if it is not to engage in an open discussion about pros and cons? Is it really so basic that the person posting is merely petitioning for some emoticons that reinforce their greatness or dispel their insecurities? A stent-graft deployed in front of an army of fans where none dare to question the decision-making, regardless of the outcome?

It may be somewhat naïve to ex­pect those within vascular surgery to be transparent about their motivations for presenting cases. It would be helpful, though, to know the surgeon’s incentives behind their posts—no different than a disclosure slide in a presentation at a conference. Perhaps, before an intervention video on Twitter, a post should warn that DR. SIMPSON IS POST­ING THIS AWESOME CASE IN THE HOPES THAT YOU WILL CALL HIM AWESOME. Or maybe: DR. CLARK WOULD LIKE TO DECLARE THAT HE HAS ONLY RE­CEIVED RUDIMENTARY ENDOVASCULAR TRAINING BUT PLEASE SMASH THAT LIKE BUTTON!!!!

Should we suggest that fact-checkers evaluate cases post­ed for value and accuracy? In reality, we should be able to police ourselves without resorting to any sort of censuring. Still, one should be concerned about what is posted on social media, a public platform.

It is also crystal clear that the Federal Trade Commission (FTC) has very explicit guidelines on how to manage dis­closures when networking on social media If you have any financial interest with a brand… disclose it! As a surgeon on social media, you are an influencer because posts influence consumers (other physicians, patients). Don’t pretend to hide under the guise of a clinician, particularly when mo­tives are not transparent.

In the time preceding social media, these cases would continue in anonymity unless submitted, peer-reviewed, and published in a journal where they can be consumed by people familiar with the procedures at hand. In the social media era, the very key point of peer review is missing, allowing any charlatan to publish results and claims that may or may not have any academic or physiologic basis. This, again, gets back to motivation and disclosure. Is the incentive to garner social media “likes” in order to further promotion? Job security? Reputation? Financial gains from corporations? By circumventing the peer-review process, this arena has become the Wild Wild West. There are snake oil salespeople everywhere.

The misuse of social media has certainly not gone un­noticed by the state medical boards in the U.S. Recently, a plastic surgeon in Ohio had her license suspended for exploitation of Snapchat and TikTok by airing live videos of her surgeries. This doctor has a popular TikTok account, which, prior to being suspended and then set to private, had 841,600 followers and 14.6 million likes. Her Instagram account, now also set to private, has 123,000 followers. One of her pa­tients was quoted as saying: “I went to her because, I thought, from all of her social media, that she uplifted women. That she helped women em­power themselves. But she didn’t.” Plastic surgery has been plagued by a social media presence that often flirts with unethical standards. This space suffers from a lack of regulation, surveillance, consistent rating scales, user authentication and ethical accountability. People are building entire reputations based on Altmetric Attention Score (#altmetrics), which has, to a great degree, replaced the more traditional academic bibliometrics like h-index. The Altmetric Attention Score is a weighted count of all the online attention for an individual research output. This includes mentions in essentially every public forum, and social network platforms play a particularly important role. With the advent of endovascular techniques, vascular surgery is very analogous to plastics in that the graphics of the procedures make them very “post-” and “like-” worthy.

In 2015, Prestin et al estimated that 70% of adults got their medical information from the internet. Social media, therefore, is an extremely powerful tool. How we engage in that space plays a significant role in defining vascular surgery as a profession and speaks volumes about our character as individuals. Our posting habits and decisions have the power to sway consumers as well as dictate the reputation of our specialty.

Jean Bismuth, MD, is a vascular surgeon at Katy Heart and Vascular Institute in Houston and an associate professor of surgery at Louisiana State University. Jonathan Cardella, MD, is an associate professor of surgery at Yale School of Medicine in New Haven, Connecticut, and program director of Yale’s integrated vascular surgery residency.

The case for aggressive intervention on symptomatic carotid web

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The case for aggressive intervention on symptomatic carotid web
Clayton Brinster
symptomatic carotid web
Clayton Brinster

The lead investigator behind new research from a center in Louisiana outlines how his new study—believed to be the largest single-institution analysis of symptomatic carotid web yet reported—shows that carotid duplex is “inadequate” for diagnosis, and medical management is “unacceptable.” The results, he reveals, leave potential clues to possible genetic risk factors.

The appropriate modality used for diagnosis, treatment method and characterization of symptomatic carotid web could be key to tackling a condition that has been shown to result in high rates of recurrent stroke when managed with medical therapy alone, according to a new study carried out by Clayton Brinster, MD, and colleagues at Ochsner Health in New Orleans.

Because there is no bulky athereosclerotic lesion in the carotid bulb in the case of the shelf-like projection redolent of carotid web, the staff surgeon tells Vascular Specialist, this pathology “is often overlooked as an etiology of acute anterior circulation stroke.”

Brinster recently presented data from a rare 52-patient series from his institution at the 2023 annual meeting (Jan. 18–21) of the Southern Association for Vascular Surgery (SAVS) in Rio Grande, Puerto Rico, that led him to conclude that medical management is “no longer an option” to treat carotid web.

Over the six-year study period (2016–2022), the Ochsner re­searchers identified an average age of 49 years among their cohort of patients—71% of them women, two-thirds African American, and more than a third African-American women under the age of 50. Some 90% presented with stroke, Brinster told SAVS 2023. None were initially diagnosed using carotid duplex, he said. “Definitive treatment consisted of carotid end­arterectomy and carotid artery stenting.”

Brinster’s subsequent conclusions were bold. “To our knowl­edge, this is the largest single-institution analysis of symptomatic carotid web yet reported,” he said. “Our series demonstrates that carotid duplex is inadequate for diagnosis, and that medical

management is unacceptable for symptomatic carotid web. Recurrent stroke occurred in all patients managed early in our experience with medical therapy alone. We have since adopted an aggressive interventional ap­proach in cases of symptomatic carotid web, with no postoperative stroke reported over an average follow-up of 26 months.”

The findings offer key insights, Brinster reflects in an interview with Vascular Specialist after the SAVS meeting. For one, when confront­ed with a patient who has minimal carotid steno­sis, especially a younger patient, “and especially a younger African-American woman under 50 years old, which comprised one third of our series—astronomical when you think about it—this pathology must be ruled out,” Brinster explains. “And the most efficient way to rule that out in a stroke patient is with a high-powered CTA, particularly examining the sagittal projections, That is really where carotid web is most readily identified. It is very easy to miss in the axial and the coronal projections in the scan.”

Second, carotid web demands its own characterization, Brinster says. In the literature, the condition has traditionally been referred to as a form of carotid fibromuscular dysplasia (FMD), he notes.

“In addition to medical management being totally unac­ceptable for symptomatic carotid web, carotid web needs to be thought of as an independent pathology from tradi­tional carotid FMD,” Brinster relates. “Traditional carotid FMD occurs distally in the internal carotid ar­tery—anatomically in a different region. It appears radiographically totally differently than web. Web appears as a shelf-like pro­jection in the carotid bulb, whereas FMD has a very classical string-of-beads appear­ance in the more distal carotid. Third, the pathologic specimens of carotid web are completely different than pathologic and histologic examination of traditional FMD.”

The concerning point, Brinster says, “is that re­ferring to carotid web as simply a form of carotid FMD—which has a well-established treatment paradigm that includes medical management and balloon dilation—I think confuses practitioners.”

This may lead to either undertreatment, or mistreat­ment, and recurrent stroke in these patients, he argues. “It would be totally inappropriate to balloon angioplasty these lesions,” Brinster adds, with the risk of recurrent stroke “astronomical.”

Meanwhile, that younger African-American female por­tion of the cohort is set to form the basis of at least one dimen­sion of further digging. Thus far, Brinster says the group have only performed a pathologic evaluation on the cases they have analyzed. But, he continues, “what we really need to do is a fresh tissue analysis, and a genetic analysis of the tissue,” he reveals. “If this is based on sex and race, then it most certainly must have a genetic component. The larger French registry [of carotid web cases], called Caroweb, has alluded to a genetic basis, from Central and West African descent, through the Caribbean.” The historical migration patterns of the American South, particularly through the port of New Orleans, “is no coincidence” in the context of the findings contained in the series presented by the Ochsner group, Brinster points out. He now hopes to join forces with the physicians behind the Caroweb registry, first by creating and leading a national consortium in the U.S.

“The more people who know about it and the more peo­ple involved, the more strokes we can prevent,” Brinster says. “I can’t tell you how many people came up to me at the Southern meeting, and said, ‘I have seen this once or twice before and I didn’t know what to do. Now, I will.’ There is a lot more work to be done for these patients.”

There are hurdles to be crossed, but a potential roadmap appears to be forming. And that could involve a screening dimension.“If we try to prove some sort of genetic disposi­tion, that could lead to more effective screening,” Brinster says. “It may be worth screening family members of those with carotid web to rule out the pathology.” Still, carotid web is a “very tricky thing to screen for without a family member who has been diagnosed, and because ultrasound is not as reliable as CAT scans, and CAT scanning, of course, is expensive and you need contrast,” he adds.

Ultimately, an opportunity beckons, Brinster says. “We have an opportunity with the size of the series, and the fact it was presented at the Southern [annual meeting], to change the way people manage carotid web—and hopefully avoid recurrent strokes in a vulnerable population.”

New Government Grand Rounds series highlights how perspective matters in advocacy

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New Government Grand Rounds series highlights how perspective matters in advocacy
Government Grand Rounds
Matthew Sideman

Matthew Sideman, MD, and Megan Marcinko, MPS, unveil new advocacy column aimed at drilling into the actions of Congress, and how they impact vascular surgery. The first in the series looks at advocacy as a tool to “protect.”

Welcome to “Government Grand Rounds,” where we will examine and discuss how the actions of Congress and regulatory agencies affect vascular surgeons and the pa­tients they serve, and importantly, how sustained advocacy engagement is important for all SVS members.

“Advocacy” continues to rank high among SVS member priorities, and yet many remain unsure how to support SVS advocacy-related programs, what activities are available and how to measure success along the way.

Foundational in this series is the notion that perspective matters. Like all aspects of life, the importance of any given activity, goal or initiative is measured via the eye of the be­holder. Advocacy is no different, with everyone engaging, or not engaging, based on their interests, level of understanding and sense of urgency related to the issue at hand.

To enhance our perspectives on advocacy, this series will highlight some of the most important tools that advocacy provides us. This month we will examine advocacy as a tool to protect. How does “protect” relate to advocacy? As you may have guessed, it depends on your perspective and what you believe your role in the healthcare delivery system to be. Consider the following: as a vascular surgeon, is it “part of the job” to do the following and, if so, how?

  • Protect patient access to care
  • Protect the physician-patient relationship
  • Protect the future of private/community practice
  • Protect the autonomy of physician decision-making
  • Protect the value of quality vascular care

Lawmakers and regulators are constantly con­sidering health policy-related changes that will impact the practice of medicine. Stakeholder en­gagement is among the few tangible mechanisms for policy-makers to learn and, hopefully better understand, the real-time impact of their decisions. Absent sustained engagement from those within the healthcare delivery system, lawmakers lack the perspective relating to what a suggested policy (which may look good on paper) would mean in a practical or operational sense. In other words, becoming involved in advocacy is a tangible action to protect against bad policy becoming law and help to reinforce and/or shape the system in which you are pro­viding care for your patients.

While this might seem like a simplistic perspective, it is ac­tually a realistic assessment relating to the value of advocacy. If the SVS, as a whole and via its individual members, fails to engage in the policy-making process, we are ceding the collective expertise of our members and the importance of this experience regarding how policy translates to practice.

You may have heard the saying, “If you’re not at the table, you’re on the menu.” Let’s work together to engage poli­cy-makers to the greatest extent possible. By doing so, we can not only secure our seat at the table, but also play a role in determining what is served.

For more information about how the SVS’ Advocacy pro­grams help protect vascular surgeons and the patients you serve, visit vascular.org/advocacy.

Biotronik launches Oscar multifunctional peripheral catheter

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Biotronik launches Oscar multifunctional peripheral catheter
Oscar multifunctional peripheral catheter
Oscar multifunctional peripheral catheter

Biotronik has announced the Food and Drug Administration (FDA) 510(k) clearance and CE mark of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter.

The company notes in a press release that Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries.

The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components:

The Oscar system will be available in 11 total size configurations with either 0.014″/4Fr or 0.018″/6Fr guidewire/introducer sheath compatibility, Biotronik states. Additional standalone Oscar PTA balloons are also available separately to be used with the Oscar support catheter.

The company details that the Oscar support catheter and dilator are used in tandem to enable lesion access and crossing with a compatible guidewire, offering a wide range of support strength, adjusted with the extension of the dilator. At its strongest support level, Biotronik claims, the combination provides up to 55% more pushability than the leading 0.035″ support catheter.

The first procedure with the Oscar system in the USA was performed by Jihad A Mustapha, MD, president and chief executive officer and director of endovascular interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, Michigan. “Oscar is a game-changing product. In cases where we had previously failed with multiple treatment approaches, the Oscar catheter made it possible to succeed, while also saving time and reducing how long the patient needs to spend on the table. This is one of the best support systems I have ever used, and the length-adjustable balloon functionality is exceptional,” stated Mustapha.

More than 70 cases have been performed in U.S. hospitals with the Oscar device as part of Biotronik’s pre-launch evaluations. Despite highly complex disease, the Oscar catheter demonstrated a 90% crossing success rate and a PTA technical success rate of 95%, the company reveals. In some cases, physicians had previously tried and failed with traditional crossing devices and strategies.

Biotronik advises that the product will be commercially available in the U.S. starting in the Spring of 2023 and in CE mark accepting regions in the second half of 2023.

SVS annual meeting introduces early-bird registration

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SVS annual meeting introduces early-bird registration

The SVS is introducing a three-tiered pricing plan for the 2023 Vascular Annual Meeting (VAM). Early-bird rates start when registration opens March 15.

The cost of putting on major conferences and events is skyrocketing in the post-COVID era, requiring medical so­cieties, including the SVS, to plan as early and as accurate­ly as possible for anticipated costs. “There is a premium on getting as much advanced planning data on attendance as we can, to keep costs under control and allocated where they are needed most,” noted SVS Executive Director Kenneth M. Slaw, PhD.

Attendees can take advantage of the early-bird prices until April 5. The advance rate is then in effect from April 6 to June 12. The on-site rate begins June 13, when registration opens at the Gaylord venue in National Har­bor, Maryland.

“We have worked through the COVID-19 crisis and now are adapting to a post-COVID world of rising costs and inflation,” said Michael Dalsing, MD, SVS president. “This change to three tiers of registration enables us to better contain rising costs, which in turn al­lows SVS to keep registration fee increases to a minimum, while continuing to invest in increasing value for VAM attendees. I encourage our members to register as early as possible.” Full pricing across all membership categories and time frames, plus pricing for add-ons, is available at vascular.org/VAM23Registration.

Five-year outcomes of ESAR in patients with short neck

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Five-year outcomes of ESAR in patients with short neck
Frank R. Arko
ESAR
Frank R. Arko

Cohort analysis shows no migrations, a low rate of ruptures, and positive sac regression, researchers say.

Five-year outcomes in patients with short neck abdominal aortic aneu­rysms (AAAs) undergoing endosuture aneurysm repair (ESAR) using Heli-FX En­doAnchors with an Endurant stent-graft in the ANCHOR registry showed a freedom from all-cause mortality of nearly 70%, from aneurysm-related mortality of 90%, from aneurysm rupture of 95.6%, and from any secondary procedures of 77%, lead study author Frank R. Arko, MD— who disclosed a consultancy relationship with and receiving research funds from device maker Medtronic—told SAVS 2023.

The cohort, with a mean age of 72, included 70 patients with an infrarenal neck length greater than 4mm and less than 10mm enrolled from 2012–2015 and fitted with the Heli-FX EndoAnchor system, which was designed to improve the fixation and seal of aortic stent-grafts. At five years, the patient group had clinical and imaging follow up compliance rates of 85% and 70%.

Some 11 patients had a total of 16 sec­ondary procedures. None of the conver­sions had open repair that were for type Ia endoleaks, although there were patients who had this type of endoleak, Arko said. “The type of secondary procedures were endovascular in the majority, and there were three conversions to open repair.”

Through five years, eight had type Ia en­doleaks, three of which were resolved by the next follow-up, reported the vascular chief from Sanger Heart & Vascular Insti­tute in Charlotte, North Carolina. There were two type Ib endoleaks, 13 patients who had a type II, and there were no type III endoleaks.

After five years, 68.2% of the registry subjects had sac regres­sion, 13.6% had stable sacs, and 18.2% had increased sac diam­eter as compared to their one-month measurements, the study authors showed.

“Patients with infrarenal necks of between 4 and 10mm implanted with the Endurant II/IIs in combination with the Heli-FX EndoAnchor system showed durability of treatment through five years,” Arko concluded before the SAVS 2023 gathering in Rio Grande, Puerto Rico. “There is a need for close and lifelong surveillance in these patients with hostile necks due to occurrence of late events that appears to be appearing at around the three-year time period.

“The study is certainly limited by the small sample size and further prospective randomized con­trolled trials are needed, and these will be performed in the near future.”

Educate, educate, and educate again: The continuing quest for appropriate venous care

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Educate, educate, and educate again: The continuing quest for appropriate venous care

Prominent venous disease experts discuss venous stenting, appropriate care, and the pursuit of refined data and better education in a space where part of the problem involves practitioners moving “freely from being able to do arterial intervention and suddenly assume they can do a venous intervention.”

Education across the venous care delivery spectrum lies at the heart of efforts to ensure operator judgement is optimal and procedures—like the placement of venous stents—are carried out in the appropriate circumstances.

Or, as Steve Elias, MD, director of the Center for Vein Disease at Englewood Health in Network, New Jersey, says, “the trend is going to be perhaps that too many stents are going to be placed for a while until we educate people about when this is appropriate and when it’s not appropriate.”

Elias was speaking ahead of the 2023 American Venous Forum (AVF; 22–25 February, San Antonio, USA) where some of the latest data on venous stent usage trends between 2014 and 2021 are to be presented by Karem Harth, MD, director of the Center for Comprehensive Venous Care at UH Harrington Heart & Vascular Institute in Cleveland.

Stent migration and overstenting remain recurring themes as new research is presented and surgeons discuss outcomes.

New data from the clinical trial of the Abre dedicated venous stent saw investigator Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England—who led the trial with Erin Murphy, MD, from Sanger Heart and Vascular Institute, Atrium Health, in Charlotte, North Carolina—declare that, given the study showed no stent fractures through three years, and similarly, no delayed stent migrations, “… stent migration really does seem to be an operator issue rather than a stent issue”.

Elias underscores the point: 99.9% of the time the issue is not one of the stent but of the judgment of the operator, or poor training—“or an issue of considering venous stents as similar to arterial stents,” he says.

Elias emphasizes the role of device makers in education. “Those of us on the leading edge of this are working with all of industry to set up programs to better educate their salesforces and then also their physician customers regarding not just stents but also venous disease in general,” he says. “We all realize this is a problem and the only way to solve it is by all of us working together.”

Data: From IDEs to RCTs

Over the past decade, venous stenting has evolved from a “byword” into a “mainstream and accepted” practice, Black tells Vascular Specialist. Recently, several on-label, venous-specific devices have become available—four in the U.S.—along with the first prospective data in the form of investigational device exemption (IDE) trials, and, according to Black, there is now “more enthusiasm for treating patients” among providers in the venous space.

Murphy casts a positive light on how the field has changed over the past five to 10 years, pointing out there has been some “great progress” in technology.

At this juncture, Kush Desai, MD, from Northwestern University in Chicago, believes the time to embark on “real-world” studies is now, with the aim of “demonstrating the value of treatment of patients across a variety of disease states from non-thrombotic through post-thrombotic”. He explains that these data will help physicians to “clearly identify which patients benefit and what we can expect for outcomes”.

Black concurs, adding that randomized controlled trials (RCTs) will need to follow, despite the difficulties associated with carrying out such research. The “big problem” here is recruitment—a problem that is affecting various ongoing trials. This recruitment issue is multifactorial, Black notes, specifying that clinicians “feel they do not have equipoise anymore” and among some there is a “financial conflict bias,” while patients “do not want not to be treated.” The solution? According to Black, clinicians need to work as a group to “overcome our own biases,” in order to ensure randomized evidence ensues.

Murphy underlines some specific areas in which data would be beneficial, mentioning the need to determine thresholds for intervention in non-thrombotic disease. She further describes the need for more data supporting good stenting practices, citing intravascular ultrasound as one example. “I think this is something we all agree is essential for good outcomes in this space,” she says, however rigorous data are lacking. She adds that there is also room for “significant improvement” in data encompassing the areas of pre- and postoperative imaging as well as postoperative anticoagulation regimens.

Desai points to the importance of data consolidation, referencing in particular the work of the Deep Venous Academic Research Consortium, which he chairs alongside Black. “The goal of this is to improve the rigour and reproducibility of deep venous research,” Desai explains, by way of ensuring that studies are all collecting the same trial data, so that they can be compared. He hopes that this will create “more sound data” for the devices that practitioners are placing and will thus have a “downstream effect” on clinical practice.

Rabih Chaer, MD, chief of the division of vascular surgery at the University of Pittsburgh in Pennsylvania, notes that “longer-term” data might still be lacking for the individual stents and comparative data between the different stents available for venous placement.

“That becomes important because, at least the newer-generation venous dedicated stents have shown us that some have performed better in certain locations based on the design of the stent,” he says. “There may be some variability in the performance of each stent depending on which part of the vein and for which indication they are used.”

Appropriateness of care central to best practice

In parallel to the need for more data, Desai posits there is “quite a long way to go” in terms of refining venous stenting practice. “The devices are very good,” he says, noting that, while there is “certainly room for improvement,” outcomes across studies are “very similar, sort of agnostic to the stent device”.

Both Black and Desai highlight the importance of understanding the specifics of venous disease when it comes to best practice. “Part of the problem with venous is people move very freely from being able to do arterial intervention and suddenly assume they can do a venous intervention,” Black remarks. “It is like playing squash and tennis,” he analogizes, “they are both racket sports with a ball but the rules are not the same”.

According to Desai, the “biggest issues” in terms of practice are with patient selection and disease state recognition. “Simply put, there are far too many stents placed for non-thrombotic disease in the USA, meaning there is attribution of symptoms that are not likely to significantly improve with placement of a stent.” He states that this can be attributed in part to economic benefits to the operators—which he says “may be a uniquely US thing”—however notes that there are “likely a variety of problems at play”.

Murphy believes the field is “findings its way” in terms of best practice. She highlights that, five years ago, there was a “considerable problem” with undertreatment of venous obstruction. Considering current practice, she agrees with Desai that overtreatment of non-thrombotic patients is an issue, while also noting that practitioners are “still undertreating” the post-thrombotic group. Many of the latter patients are not referred for treatment.

Black stresses that “inappropriateness of care” is the key issue, and that one of the main challenges facing venous stenting practice is ensuring “the right patient is getting the right treatment by people who know how to do it properly”.

Non-thrombotic iliac vein lesions (NIVLs) are at particular risk of overtreatment, he says, because “the impetus is to treat anybody with any leg problem on the left-hand side” when there are lots of patients who do not need treatment. In the case of chronic occlusions and post-thrombotic disease, and potentially acute iliofemoral deep vein thrombosis (DVT), he notes there are lots of patients who are not getting treatment who would “probably benefit”.

Murphy also highlights the importance of appropriate treatment and is confident that, over the next few years, practitioners will “perfect” their patient selection. “I do not think that people are going awry on purpose,” she stresses, instead noting that this is a “developing” field and that the process of “sorting through who is going to get the most benefit” is ongoing.

Education and training

Considering how venous stenting practice can be improved, Desai believes education is key. “I think most providers would be open to the discussion that ‘maybe your stent is not helping patients,’ and would correct their behaviour,” he says, while remarking that it is “much more difficult to correct” the practice of providers who are financially driven. “More broadly speaking,” however, he is confident that education remains central “for providers that are willing to listen”.

Black points out that a number of educational efforts are in place—from company-run symposia and training to workshops at vascular meetings. He stresses however that training is a “two-way thing”. He explains: “You have to engage in training.”

In Murphy’s view, training in the form of “interested” physicians, who are already practicing, shadowing expert practitioners is working well. What is “majorly lacking” in education, she believes, is investment at the fellowship and trainee level, underscoring the need for “dedicated, comprehensive venous training programmes”. She explains that, currently, there are no programmes in the USA that spend a significant amount of time teaching lymphoedema, superficial venous disease, and deep venous obstruction. Programmes that teach all of these aspects in one place, she believes, is “extremely important” for the trainee.

Looking at the wider picture, Black highlights that, while vascular care “continues to suffer from an unreasonable focus on aortic disease,” there is a “huge opportunity in the treatment of venous disease to make a really big difference to a patient’s quality of life”. With this in mind, he encourages “all vascular enthusiasts” to commit to collecting the data, partaking in the training, and delivering the appropriate care that should be the hallmark of venous stenting’s next chapter.

VRIC: ‘High value placed on supporting young researchers,’ 2022 trainee awardee says

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VRIC: ‘High value placed on supporting young researchers,’ 2022 trainee awardee says
vric
Carson Hoffmann and Luke Brewster

Warm and inviting. Plenty of engagement at each presen­tation. A straightforward format that allows everyone to participate at all presentations. Sense of unity. Great support for young researchers. And the ability to talk with prominent scientific leaders.

That’s how Carson Hoffmann, MD, describes his experi­ence as a presenter at the 2022 Vascular Research Initi­atives Conference (VRIC). Scientists judged his abstract as one of the four top-scoring submissions, and all four trainees received the SVS Foundation’s Vascular Research Initiatives Conference Vascular Trainee Award and the opportunity to present at the conference.

His presentation was “Modifiable mesenchymal stem cell defects in veterans with diabetes mellitus.” His mentor is Luke Brewster, MD, former chair of the SVS Basic and Translational Research Committee, which oversees VRIC.

This year’s conference, held in conjunction with the American Heart Association’s Vascular Discovery Scientific Sessions, will be May 10 in Boston. Reg­istration for VRIC—which emphasizes basic and translational vascular science—opened Feb. 1.

After being part of past academic meetings, Hoffmann thought he knew what to expect from conference. He was wrong and, in fact, pleasantly surprised.

“Being a newcomer and mostly a stranger, I was received with a warm welcome and invited to participate as if I had attended for many years,” he said.

“I found this to be a very accepting and close-knit group of scientists that sought each other’s opinions and feedback to advance their academic pursuits just as much as they enjoyed the opportu­nity to gather as friends.”

Besides being an honor, his selection for the Trainee Award provided “a fantastic intro­duction with this scientific community,” Hoff­mann said, further explaining: “To be recognized in such a big manner for work done in the lab re­vealed the commitment of this group to fostering scientific research from up-and-coming researchers and wanting to get their efforts acknowledged.

“It was readily apparent that a high value was placed on supporting young researchers by the opportunity to be present for both the VRIC and the Vascular Discovery conference and to interact with highly esteemed and prominent scientific leaders in their respective fields.”

The top 10 most popular Vascular Specialist stories of January 2023

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The top 10 most popular Vascular Specialist stories of January 2023

In January 2023, most popular among the Vascular Specialist readers were several stories from the recent Southern Association for Vascular Surgery meeting, including a report of data shared to demonstrate the benefits of vascular involvement in non-vascular-led cases; an update on the use of the Human Acellular Vessel in peripheral arterial disease patients; and two articles centering around interpretations of the BEST-CLI trial data.

1. ESVS AAA guidelines alert recommends ‘enhanced surveillance’ in patients treated with Nellix device

The European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice that all patients in whom a Nellix (Endologix) device has been implanted “should be identified, properly informed and enrolled in enhanced surveillance.”

2. Envision, private equity and patient care: Substituted values 2.0

Arthur E. Palamara, MD, calls for hospitals to employ anesthesiologists directly rather than via private equity firms, which he believes “consume much” and “yield little”, with a knock-on effect on patient care.

3. SAVS 2023: President reveals upcoming change to Society seal

Southern Association for Vascular Surgery (SAVS) President William D. Jordan Jr., MD, used a portion of his 2023 Presidential Address to outline ways in which SAVS is set to further evolve as a professional body going forward, including a change of seal.

4. SAVS 2023: Study points toward CKD patients who would most benefit from renal artery stenting

A new study probing which chronic kidney disease (CKD) patients would benefit most from renal artery stenting points toward those who experience a more rapid decline in renal function over six months prior to the procedure.

5. SAVS 2023: Planned and unplanned vascular assists found to improve outcomes

An award-winning paper presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico, established an association between vascular involvement in non-vascular-led cases, where vascular expertise was required, and improved patient outcomes.

6. Vascular community starts process of wrestling with findings from BEST-CLI

One of the earliest multispecialty public gatherings of the vascular community following the release of the first results from the BEST-CLI randomized controlled trial (RCT) raised some of the early fault lines developing between different interpretations of the study’s key data. 

7. Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study results show

Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection or infection, the authors reported.

8. Medtronic announces first enrollment in head-to-head global randomized trial evaluating durability of EVAR

Medtronic has announced the first patient enrollment in the ADVANCE trial, a head-to-head randomized controlled trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs stent graft system and Gore Excluder abdominal aortic aneurysm (AAA) device family systems.

9. BEST-CLI: Analysis finds correlation between WIfI stage four CLTI and reports of poorer mental health

The BEST-CLI dataset has revealed a correlation between wounds, ischemia and foot infection (WIfI) stage and poorer quality of life due to mental, rather than physical, health for patients with chronic limb threatening ischemia (CLTI).

10. SVS Foundation changes name of program aimed at providing care for underserved patients

The Society for Vascular Surgery (SVS) Foundation program formerly known as VISTA has a new name. VISTA—an acronym for Vascular Volunteers In Service To All—is now simply Vascular Care for the Underserved™. Its mission, however, remains the same: “to provide outreach, screening and other resources to those who are impacted by lack of access, inadequate resources and/or distance from modern healthcare facilities.” 

Patients with claudication receive more ‘aggressive’ surgical management in high-competition regions, study finds

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Patients with claudication receive more ‘aggressive’ surgical management in high-competition regions, study finds
M. Libby Weaver

Demonstrating the “susceptibility” of care delivery to regional market competition, M. Libby Weaver, MD, presented the case that intermittent claudication (IC) is a “novel and underdefined” driver of practice variation in management of patients at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico (Jan. 18-21). Among Weaver’s most pointed messages: physicians and stakeholders must be called upon to alter procedural patterns to address the association between high competition and aggressive surgical management of vascular disease.

The research team behind the paper—first authored by now University of Virginia, Charlottesville, vascular surgeon Weaver—also included senior author Salvatore Scali, MD, from the University of Florida in Gainesville, and Caitlin Hicks, MD, and colleagues from Johns Hopkins Medicine in Baltimore, Maryland, a prolific investigator on the subject matter. Weaver was formerly a vascular fellow at Johns Hopkins Medicine.

Weaver began by outlining clinical practice guidelines set out by the Society for Vascular Surgery (SVS), which published recent appropriate use criteria (AUC) for the management of IC, which recommends best medical therapy (BMT) such as statin use and lifestyle modifications—which include smoking cessation and walking programs, as first-line treatments prior to revascularization.

Atherectomy and tibial-level interventions are not among the recommendations, and are specifically “advised against” in the treatment of IC, the presenter noted. Despite guidelines, Weaver continued, high market competition is incentivizing physicians to treat patients by aggressive means. She noted how two thirds of interventional procedures for claudication include revascularization and atherectomy, with an indication of claudication as a “predictor” of independent atherectomy use.

Although characteristics such as physician specialty and practice setting have “known” associations with atherectomy and tibial interventions, Weaver made clear that the causal relationship between IC management and regional competition has “not been explored” in clinical research.

Examining IC patients undergoing initial endovascular peripheral vascular intervention (PVI) in the SVS VQI from 2010–2022, the researchers assigned the Herfindahl-Hirschman Index (HHI)—a measure of regional physician market competition—to each center based on Census Core-Based Statistical Area, assigning four pre-defined categories: very high competition (VHC), high competition (HC), moderate competition (MC), and low competition (LC).

Exclusion criteria were comprised of patients who underwent prior revascularization procedures or had a non-claudication indication, a non-elective admission, or any missing data on their admission or indication status. Finally, Weaver confirmed that patients who were undergoing bilateral interventions, simultaneous atherectomy, or intervention at a treatment level categorized as aorta were excluded.

Their inclusion criteria identified 24,669 PVIs, revealing patients undergoing PVI in LC regions were more likely to be younger (66 vs. 69 years; p<.0001), white race (89% vs. 64%; p<0.0001), self-paid/uninsured (21% vs. 11%; p<0.0001), and active smokers (49% vs. 33%; p<0.0001). Continuing, Weaver drew attention to the “distinct treatment patterns” that became apparent when analyzing index peripheral procedures, noting that the odds of patients being on BMT increased with greater market competition.

The probability of undergoing aortoiliac interventions also decreased with increasing competition (0.81–0.87; p<0.0001), but the research team’s results showed higher odds of receiving tibial (1.30–1.50; p<0.0001) and multi-level interventions in VHC vs. LC centers (femoral + tibial: 1.03–1.14; p=0.001). Primary stenting decreased as competition increased (0.87–0.92; p<.0001), while risk of undergoing atherectomy increased with HC (1.11–1.19; p<0.0001). In subgroup analysis limited to patients undergoing single-artery femoropopliteal intervention with TASC A or B lesions (n=5,685), compliance with BMT remained higher (VHC 36% vs. LC/MC/HC 32%; p=0.004) and current smoking status lower (VHC 30% vs. LC/MC/HC 38%; p<0.0001) in VHC centers. However, odds of undergoing balloon angioplasty (34% vs. 28%: odds ratio [OR] 0.7, 0.6–0.8; p<0.0001) and primary stenting only (41% vs. 34%: OR 0.7, 0.6–0.8; p<0.0001) were higher in LC/MC/HC centers, while likelihood of receiving atherectomy remained significantly higher among VHC centers (35% vs. 22%: OR 1.9, 1.7-2.1; p<0.0001), suggesting disease severity is not a primary driver of these treatment differences.

Highlighting a clear trend in their results, Weaver posited: “Notably, analogous procedural associations were identified even among a subset of patients with TASC C and D lesions; however, compliance to BMT was significantly better in lower- as compared to higher-competition centers.”

Moreover, matching the entire patient cohort based on cardiovascular risk factors and characteristics known to impact PVI outcomes, market competition adherence to BMT was “no longer evident,” Weaver said. However, patients managed in very high competition regions remain “significantly” more likely to receive atherectomy or tibial-level interventions and less likely to undergo stenting, with or without angioplasty alone, across all intergroup comparisons, Weaver concluded.

Importantly, Weaver and colleagues emphasized that the overall correlation between high regional competition and inadvisable IC procedures “persisted” even when correcting for disease severity and comorbidities. Furthermore, addressing the correlation seen between increased BMT in HC regions, Weaver conveyed that this was also linked to “increased likelihood” of tibial- and multi-level interventions as well as atherectomy use.

Weaver believes their analysis demonstrates the “susceptibility of care delivery to regional market competition,” signifying an unconsidered “driver” of practice variation in management of patients with IC. Going forward, Weaver observed that this “novel” factor appears to play an “important role” in treatment patterns and placed emphasis on the important role healthcare providers must assume to design incentives which remedy these disparities, while encouraging “adherence to evidence-based treatment recommendations” to improve overall quality of claudication care.

Weaver and her team contend that stakeholders must implement processes and policies of care to facilitate education for IC patients, ensuring information is being shared so that they may become “better informed regarding best practices” and make more informed decisions over their choice of treatment.

VQI study leader highlights virtue of multispecialty gathering of best longitudinal data on PAD procedures

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VQI study leader highlights virtue of multispecialty gathering of best longitudinal data on PAD procedures

Daniel Bertges, MD, talks to Vascular Specialist about recent findings from his work investigating the IN.PACT Admiral drug-coated balloon (DCB). He related how they showed promising results in treating femoropopliteal in-stent restenosis in a Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry-based, postmarket surveillance study. Speaking at Vascular Interventional Advances (VIVA) 2022 in Las Vegas (Oct. 31–Nov. 3), Bertges details the benefits of “so-called real-world data,” the “rich repository” of information contained within the VQI, and the virtues of the multispecialty nature of the registry.

Vascular Specialist–February 2023

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Vascular Specialist–February 2023

In this issue:

  • Educate, and educate, and educate again: The continuing quest for appropriate venous care (p. 1 and 6)
  • Likes, dislikes and reposts: “The brave new world of social media, with its TikToks and Kardashians, has now invaded our once-sane specialty,” write Jean Bismuth, MD, and Jonathan Cardella, MD (p. 2 and 4)
  • More than a research project: The vascular trainee’s role in tackling disparities in peripheral arterial disease, according to Chloé Powell, MD, is outlined in this month’s Corner Stitch column (p. 5)
  • Extensive coverage from SAVS 2023 in Puerto Rico, including: “The case for aggressive intervention on symptomatic carotid web” (p. 10–11)

New book penned by vascular icon charts career in surgery, revolutionary spirit

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New book penned by vascular icon charts career in surgery, revolutionary spirit
Frank J. Veith

A new memoir penned by former Society for Vascular Surgery (SVS) President and vascular surgery leader Frank J. Veith, MD, which touches on a lifetime of service to the specialty and tackles some of its most monumental and controversial moments, was published this week.

A new memoir from vascular surgery icon Frank J. Veith is now available

The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia covers the breadth of Veith’s career as a vascular surgeon, from his early steps in the military as a member of the U.S. Army Medical Corps, through innovative work in lung transplantation and, crucially, limb salvage, during his time at Montefiore Medical Center, in the Bronx of New York City.

Veith, in whose name the maiden Frank J. Veith Lecture will take place at the Vascular Annual Meeting (VAM) in June, also recounts his role at the heart of U.S. vascular surgery’s endovascular revolution. He writes about how this coalesced, in the early 1990s, around his participation in the first endovascular aortic aneurysm repair (EVAR) in the country alongside technique trailblazer, the Argentinian vascular surgeon, Juan C. Parodi, MD.

The Medical Jungle also sketches out vascular surgery’s evolution as a separate surgical specialism, from its early roots in cardiac surgery through its status today as a comprehensive provider of vascular care outside of the heart and brain.

Finally, Veith charts the development of the world-renowned VEITHsymposium, an annual global gathering in New York City of vascular specialists that Veith started half a century ago, and outlines his philosophy on mentorship and training future vascular surgeons.

The book also contains an appendix bearing reprints of his presidential addresses as leader of both the SVS (1996) and the Eastern Vascular Society (1994), as well his John Homans Lecture, delivered at VAM in 2016.

Equivalency to clinical practice ‘varies considerably’ across recent carotid intervention trials

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Equivalency to clinical practice ‘varies considerably’ across recent carotid intervention trials
Hans-Henning Eckstein (L), Michael Kallmayer
Hans-Henning Eckstein

The transferability to real-world clinical practice of contemporary randomized controlled trials (RCTs) investigating carotid artery stenosis interventions “varies considerably,” according to a recent analysis published in the European Journal of Vascular and Endovascular Surgery (EJVES) by senior author Hans-Henning Eckstein, first author Michael Kallmayer, both from Technical University of Munich in Munich, Germany, and colleagues.

For this study, researchers aimed to analyze the exclusion criteria of recent RCTs comparing the two leading carotid revascularization approaches—carotid endarterectomy (CEA) and carotid artery stenting (CAS)—with the intention of assessing the eligibility of consecutive clinical practice cohorts compared to those RCTs.

An analysis of the clinical and anatomical exclusion criteria of RCTs for asymptomatic carotid artery stenosis (SPACE-2, ACST-2, CREST-1 and CREST-2) and symptomatic carotid artery stenosis (SPACE-1, CREST-1, ICSS and EVA-3S) was performed, the authors report.

A total of 200 consecutive asymptomatic and 200 consecutive symptomatic patients, treated by CEA or transfemoral/transcarotid artery stenting at a tertiary referral university centre, were assessed for their potential eligibility for each corresponding RCT. Patient data from the selected trials were pooled and differences from the clinical practice cohort analyzed. The authors note that statistics were descriptive and comparative using Fisher’s exact and t tests.

“The number of clinical and anatomical exclusion criteria differed widely between RCTs,” Eckstein, Kallmayer and colleagues write, relaying their results in EJVES.

Potential eligibility rates of the clinical practice cohort for RCTs with regard to asymptomatic carotid stenosis were 80.5% (ACST-2), 79.5% (SPACE-2), 47% (CREST-1) and 20% (CREST-2). For RCTs on symptomatic carotid stenosis, the eligibility rates were found to be 89% (ICSS), 86.5% (EVA-3S), 64% (SPACE-1) and 39% (CREST-1).

Michael Kallmayer

Both clinical practice cohorts were older by about three years, and patients were more often male, when compared to the carotid RCT populations, the authors also report.

“Furthermore, a history of smoking (asymptomatic patients), hypertension (symptomatic patients), and atrial fibrillation was diagnosed more often [in the clinical practice cohorts], whereas hypercholesterolemia and coronary heart disease (asymptomatic patients) were less prevalent,” Eckstein, Kallmayer and colleagues continue. “More clinical practice patients were on antiplatelets, anticoagulants and lipid-lowering drugs. Symptomatic clinical practice patients presented more often with retinal ischemia and less often with minor hemispheric strokes than patients in the RCTs.”

The authors conclude that, as such, patients in routine clinical practice differ from the selected carotid intervention trial populations with respect to age, comorbidities and medication.

“These data are of interest for clinicians and guideline authors, and may be relevant for the design of future comparative trials,” they add.

SVS: Pay 2023 dues to avoid lapse in benefits

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SVS: Pay 2023 dues to avoid lapse in benefits
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021

Members, have any of you missed your most recent issue of Journal of Vascular Surgery (JVS)? If so, it could be because your 2023 Society for Vascular Surgery (SVS) dues have not yet been paid.

As of Dec. 31, 2022, members with unpaid dues are considered no longer in good standing and thus unable to receive benefits—such as a free or heavily discounted subscription to JVS and, with the Vascular Annual Meeting (VAM) registration beginning in mid-March, discounted registration fees.

Membership suspensions and loss of member benefits will begin in mid-February. Other membership benefits include:

  • The SVS Branding Toolkit to enhance practice development
  • Advocacy and an important voice in Washington, D.C.
  • Exclusive member pricing on VAM and other educational courses such as the SVS Coding and Reimbursement Workshop, the SVS Complex Peripheral Vascular Intervention Skills Course that debuted in 2022, some webinars and others
  • Member pricing for the Vascular Education and Self-Assessment Program (VESAP) study tool
  • The opportunity to join targeted membership sections for young surgeons, women, physician assistants and members in community practice and/or outpatient-based facilities
  • Voting rights (Active and Senior only) in SVS elections
  • SVSConnect, the members-only online community
  • The weekly Pulse electronic newsletter
  • Education and networking opportunities
  • Practice management resources
  • Grants and scholarships
  • Career advancement through mentorship, scholarships and leadership opportunities
  • The SVS job board

Enjoy all the benefits SVS membership has to offer and remit those 2023 dues today. Visit vascular.org/invoices.

Abbott announces agreement to acquire Cardiovascular Systems

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Abbott announces agreement to acquire Cardiovascular Systems
Abbott Logo (PRNewsFoto/Abbott)

abbottAbbott and Cardiovascular Systems (CSI) have announced a definitive agreement for Abbott to acquire CSI. Under terms of the agreement, CSI stockholders will receive $20 per common share at a total expected equity value of approximately $890 million, according to an Abbott press release.

CSI is a leader in devices for atherectomy and also has an early-stage pipeline of vascular intervention devices in development.

“The acquisition of CSI will add new, complementary technologies to Abbott’s leading vascular device offerings,” said Lisa Earnhardt, executive vice president of medical devices at Abbott.

“We are pleased to have reached an agreement with a leading global company that shares our passion for the development and commercialization of innovative solutions for treating complex peripheral vascular disease and coronary artery disease,” said Scott Ward, CSI’s chairman, president, and chief executive officer.

Spotlight: SVS members take up new positions, make endowment

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Spotlight: SVS members take up new positions, make endowment
Sean Lyden

Sean Lyden, MD, is now chief medical consultant for VESTECK and has joined the VESTECK Scientific Advisory Board. VESTECK is an early-stage medical device company focused on the aortic repair and structural heart markets. Lyden chairs the Society for Vascular Surgery (SVS) Government Relations Committee and sits on the SVS Advocacy Council, and the Political Action Committee (PAC) Steering and Postgraduate Education committees. 

Louis Kozloff, MD, a former varsity swimmer at the University of Pennsylvania, with his wife, endowed a swimming and diving head coaching position to the university. Kozloff is a vascular surgeon in North Bethesda, Maryland, and a professor of surgery at the George Washington University Medical Center. He and wife, Rene, both are Penn graduates. 

Thomas Maldonado, MD, has been named chief medical officer for Koya Medical, which is developing treatments for lymphedema and venous diseases. 

Early data show ‘dramatic improvement’ in amputation-free survival after initiation of novel ‘Limb Alert’ for acute limb ischemia

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Early data show ‘dramatic improvement’ in amputation-free survival after initiation of novel ‘Limb Alert’ for acute limb ischemia
Charles J. Bailey

This advertorial is sponsored by Tampa General Hospital. 

In cases of acute limb ischemia (ALI), time is of the essence, says Charles J. Bailey, MD—from the moment a patient first reports to the emergency room (ER) through to the time of a revascularization procedure, every minute matters. Now, promising limb salvage and amputation-free survival rates emerging out of an analysis of a new “Limb Alert” system pioneered at Tampa General Hospital (TGH) Heart & Vascular Institute (HVI) have Bailey and the team behind the initiative excited at the potential for a ground-breaking advance in ALI patient care.  

For Bailey, director of both the HVI-Vascular Center of Excellence and the Limb Preservation-PAD Program at the University of South Florida (USF) in Tampa, Florida, the in-hospital and 30-day data thus far mark a significant step towards advancing what has proven a historically morbid condition.

The historical background is stark. Large studies that have plumbed Veterans Affairs1 and Medicare2 databases for temporal trends in ALI management have shown a decreasing incidence of hospital admissions and an increasing endovascular-first approach over the last two decades, but despite such trends the needle has not moved on ALI mortality outcomes out to one year, observes Bailey.

“Even with all the advancements in medical and procedural management for ALI, the observed rates of mortality, major-adverse cardiac and limb events at the in-hospital and post-discharge phases out to one year, have flatlined over the last two decades,” he says. “Endovascular therapies for ALI are less morbid, have expanded who we can treat safely, and are used with ever-increasing frequency with each new device brought to market, but that has not yet translated into improved mortality or reduced major-adverse outcomes post-discharge.”

That’s where the Limb Alert system steps in. “We have standardized the approach from patient triage up to the time of revascularization,” explains Bailey, also an assistant professor of surgery at USF. The idea is analogous to stroke or STEMI alerts in neurology or cardiac care, respectively, expediting the diagnosis and management for time-sensitive conditions. It functions through a paging system triggered by ER staff who, after triaging a patient and identifying a case of ALI, submit a hospital-wide alert to the limb salvage and peripheral arterial disease (PAD) program clinicians, ICU personnel and other key stakeholders.

Bailey points to an encouraging early dataset that suggests “a dramatic improvement in our limb salvage and amputation-free survival as compared to our pre-alert experience.”  The six-month data, starting from June 1 through Nov. 30, 2022, show that the Limb Alert system was activated 37 times, with a correct diagnosis of ALI confirmed in 28, which equates to a 76% positive prediction rate.

“Kudos for this goes to the ER staff for their clinical acumen and to the limb preservation team for all their efforts in education and planning for the launch of the alert system,” remarks Bailey. “Prospectively, we have measured different temporal phases of the alert system including time stamps from the time of triage to the initiation of the alert, time from alert to the start of heparin, time to imaging, and time to definitive procedure.

“Creating a uniform alert protocol and focusing on these temporal phases to expedite care has resulted in a 30-day limb salvage rate of 93%—26 of 28 limbs. We have had two in-hospital amputations and one person passed postoperatively due to cardiac complications. All considered, this amounts to an observed 30-day amputation-free survival rate of 89%.

“What is quite interesting here is that these numbers are much improved from what our own institutional experience had been pre-alert, and more successful than historical reports of in-hospital and 30-day amputation-free survival,” Bailey adds. “So, in short, the Limb Alert process works.”

Bailey credits the early success of the novel system to the true multidisciplinary approach at its core. “Limb Alert was developed as a collaborative effort between vascular surgery, the emergency department and our limb preservation team, including podiatry and radiology,” he says.  “After talking with colleagues in other parts of the country, there are lots of academic centers with multidisciplinary clinics to address critical limb threatening ischemia (CLTI), but very few have tried to streamline the clinical workflow for non-traumatic acute limb-threatening emergencies.”

With the system now in place and a standardized approach to ALI established, Bailey and colleagues plan to use the Limb Alert paradigm as a cornerstone for the creation of a modern, randomized controlled trial to explore the outcomes of operative and endovascular management of ALI. “This is just one move on the chessboard to gain a better insight into how we can improve the care of these patients—how we can improve the care of a condition that has historically high rates of perioperative morbidity and limb loss,” Bailey concludes.

References

  1. Andrew F Prouse, Paula Langner, Mary E Plomondon, P Michael Ho, Javier A Valle, Anna E Barón, Ehrin J Armstrong, Stephen W Waldo. Temporal trends in the management and clinical outcomes of lower extremity arterial thromboembolism within a national Veteran population. Vascular Medicine. 2019, 24(1):41–49.
  2. Donald T. Baril MD, Kaushik Ghosh PhD, Allison B. Rosen, MD, MPH, ScD. Trends in the incidence, treatment, and outcomes of acute lower extremity ischemia in the United States Medicare population. J Vasc Surg. 2014, 60:669-77.

SVS Foundation board approves latest pilot programs to help underserved

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SVS Foundation board approves latest pilot programs to help underserved
Julia Glaser and Tammy Nguyen 

The SVS Foundation has awarded grants to two Society for Vascular Surgery (SVS) members to help them serve the underserved as part of the Vascular Care for the Underserved program—the initiative formerly known as VISTA (Vascular Volunteers In Service To All).

They are: Julia Glaser, MD, who is set to conduct two health fairs to screen attendees for vascular diseases (abdominal aortic aneurysms [AAAs], carotid disease and peripheral arterial disease [PAD]), as well as for PAD risk factors. She also will conduct a qualitative study to determine factors that cause patients with critical limb ischemia to delay seeking care. 

And Tammy Nguyen, MD, who will look to address the limited access to preventative diabetes care and treatment for diabetic foot ulcers (DFUs) via mobile outreach clinics. 

Julia Glaser 

Glaser—an assistant professor of clinical surgery at Penn Medicine—works in Philadelphia, the United States’ seventh most populated city and one with a large high-poverty area, a high rate of diabetes and a disproportionately high rate of amputations. 

“I see patients when amputation was all we could do for them,” she said. “And we wish we’d seen them six months earlier.” 

She believes the city’s PAD burden is likely due to multiple factors in two main categories: lack of education and barriers to receiving care. Thus, her project includes both the health fairs and the qualitative research study to identify the barriers that prevent patients from seeking care earlier in the disease process. 

“We want to raise awareness and see patients earlier, so we have something to talk about besides amputation,” she said. 

The two health fairs would be held in early spring and late summer. Glaser anticipates each will reach 150 to 200 people, and will be held at churches in the west and southwestern Philadelphia areas. Multiple stations will screen individuals for vascular disease and for vascular disease risk factors, and offer information on hypertension, diabetes, PAD, AAAs, carotid disease and smoking cessation. Specialists in cardiology, vascular surgery, podiatry and primary care will be available. 

The fair will include: 

  • AAA screening 
  • A quick carotid screening 
  • Ankle-brachial index 
  • Blood pressure reading 
  • A point-of-care hemoglobin A1c 

Patients will receive the results, as well as care guidance, and will be encouraged to share the results with a primary care physician (including volunteers mailing the results at the fair). Information on primary care providers also will be provided. 

The qualitative study will help Glaser get “a full picture of the reasons patients do not present to care in a timely manner,” she said. “I make a lot of assumptions about why people don’t seek care but what if I’m wrong? Maybe the truth is not that people don’t know they need care, but they can’t make appointments because they don’t have transportation. Maybe they’re afraid because a relative also had a similar slowly darkening toe or non-healing wound who ended up in the hospital for months, with sequential amputations before succumbing to heart disease.” 

Study findings will help her make changes for the second fair, she said. “If a big problem is transportation, we’ll figure out ways to get people to me. We can have pamphlets outlining the transportation system. If smoking is an issue, we can have information on smoking cessation. We want to find out what’s preventing people from getting help.” 

She said there is little existing literature on some of these delays in seeking care. She hopes her study will uncover the factors that may be missed in more traditional questionnaires written by healthcare professionals. 

Glaser’s ultimate goal with her project? “I hope to put myself out of business.” 

Tammy Nguyen 

A major complication of poorly controlled diabetes is a DFU, which can lead to lower-extremity amputation. According to Nguyen, “Diabetes disproportionately affects more than 500,000 people suffering from homelessness or housing insecurities in the United States.” 

The homeless and housing-insecure population has a critical need for comprehensive care to prevent, diagnose and treat diabetic foot wounds because of the limited access to healthcare facilities either due to financial or transportation issues, or perceived barriers to care, she said. 

“Diabetic foot ulcers and non-healing wounds that lead to amputation have a profound effect on the homeless, impacting their ability to walk, maintain independence, and work,” she said. 

“The goal of our project is to impact and empower the homeless and housing-insecure population through preventative education and providing a welcoming healthcare venue that encourages diabetic foot care access and treatment. 

“Patients understand the severe ramifications of an amputation and that they don’t want that happening to them. To prevent amputation, it’s our role as vascular surgeons to be better educators and help people advocate for themselves.” 

The project is a pioneering approach to community outreach that is tailor-fit to address the unique needs of a disadvantaged community by improving access to multidisciplinary diabetic foot care in collaboration with local community facilities that already provide existing care to that population. 

As Nguyen outlines, “By providing access to multidisciplinary diabetic foot care in a forum that is familiar and accepted by our focus population, this allows us to bridge any distrust these marginalized communities may have with the medical profession. We are essentially meeting them where they are.” 

For example, at one event in the parking lot at the YMCA, a homeless man stood by, watching the mobile diabetic foot screening community outreach clinic for several hours, Nguyen related. Many volunteers asked him to register, but he refused, preferring to observe. At the end of the clinic, as volunteers packed up, he finally approached them and asked to be evaluated. He eventually told the volunteers of his prior bad experiences with doctors who, he said, “gave him meds he didn’t need and wouldn’t listen to him.” He told the volunteers he had a different view of them, calling them “good people who were just there to help,” said Nguyen. 

“This interaction gave me insight into the psyche of the population we are trying to serve. Some people suffering from homelessness or housing insecurities may have had negative experiences with healthcare and are afraid or wary to seek help, even though they know where to go. Our presence in the community helps break down that barrier,” she said. 

The mobile diabetic foot screening community outreach clinics combine essential features of two different establishments, she said: “The multidisciplinary resources of large academic hospitals (UMass Medical Center) with the accessibility of established community centers. By combining these two establishments over the past two years, UMass Medical Center and local trusted community centers, we have been able to successfully create mobile diabetic foot screening community outreach clinics.” 

The Vascular Care for the Underserved project will build on the experience of the previous five clinics. Each clinic provides not only core diabetic foot services, including vascular surgery, vascular non-invasive studies, diabetes, and podiatry, but also dermatology, ophthalmology, addiction behavioral health, and even COVID-19 vaccinations to an average of 40–50 homeless and housing-insecure participants at each event. 

In addition to expanding the mobile diabetic foot screening community outreach clinics, the new project will also focus on identifying the specific barriers to care, how to systematically address these barriers, and provide follow-up care to the homeless and housing-insecure population identified. 

In addition to this award, Nguyen also received the 2022 Vascular Cures Wylie Scholar Award and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K08 grant, which also will focus on non-healing DFUs. For that project, she will research how diabetes affects the immune system and how that, in turn, affects wound-healing. 

Coding: New CPT codes for percutaneous arteriovenous fistula creation

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Coding: New CPT codes for percutaneous arteriovenous fistula creation

For the 2023 Current Procedural Terminology (CPT) code set, two new codes (36836 and 36837) have been added that describe percutaneous arteriovenous (AV) fistula creation in the upper extremity. The most significant material difference between these two procedures is that one approach requires two catheters from two different percutaneous access sites, one in the vein and one in the artery that are then approximated using magnets. The other technique requires a single percutaneous access that connects the artery and the vein under ultrasound guidance and then uses mechanical capture for approximation. 

Both codes include all vascular access, angiography, imaging guidance, radiologic supervision and interpretation, and blood flow redirection or maturation techniques—for example, transluminal balloon angioplasty or coil embolization—that are performed for fistula creation. Prior to 2023, there were only open surgical codes available for reporting an AV fistula, requiring a surgical cut-down to expose the artery and vein, vein dissection, ligation of venous branches, arteriotomy, and suturing of the vein to the arteriotomy. The coding descriptions for the open access procedures (36818, 36819, 36820, 36821) also include completion ultrasound and completion contrast angiography, if performed. 

New codes 36836 and 36837 will have a 0-day global assignment, which means that any services or procedures performed on a day other than the date of the procedure may be separately reported. Surgeons also should keep in mind that percutaneous AV fistula creation in any location other than the upper extremity should be reported with code 37799, Unlisted procedure, vascular surgery. 

Sunita Srivastava, MD, is chair and David Han, MD, vice-chair of the Society for Vascular Surgery (SVS) Coding Committee.

Sex found to be ‘important variable’ in study and treatment of carotid atherosclerosis

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Sex found to be ‘important variable’ in study and treatment of carotid atherosclerosis

A systematic review and meta-analysis have demonstrated “convincing evidence” that sex differences exist in carotid atherosclerosis, with all types of plaque features—including those relating to size, composition, and morphology—found to be either larger or more common in men than in women.

“Our results highlight that sex is an important variable to include in both study design and clinical decision-making,” the authors, led by Dianne van Dam-Nolen, MD from the Department of Radiology and Nuclear Medicine at Erasmus University Medical Center, in Rotterdam, The Netherlands, write in the journal Stroke. “Further investigation of sex-specific stroke risks with regard to plaque composition is warranted.”

Over the past few decades, several individual studies on sex differences in carotid atherosclerosis have been performed, covering a wide range of plaque characteristics and including different populations, van Dam-Nolen et al state.

In addition to summarizing previously reported results on sex differences in this space, the researchers also sought to “present a roadmap explaining next steps needed for implementing this knowledge in clinical practice.”

They began by systematically searching PubMed, Embase, Web of Science, Cochrane Central and Google Scholar for eligible studies, including both male and female participants, and reporting the prevalence of imaging characteristics of carotid atherosclerosis. The eligible studies were then meta-analyzed. Van Dam-Nolen et al prespecified which imaging modalities had to be used per plaque characteristic and excluded ultrasonography.

After initially identifying more than 1,000 unique citations, screening of the articles based on the inclusion criteria whittled this number down to a total of 60 articles, with 42 being included in the final meta-analyses.

Six of these studies were included in a meta-analysis on the relationship between sex and atherosclerotic plaque size. All three of the characteristics used to measure plaque size—maximum wall thickness (1D size), wall area (2D size), and wall volume (3D size)—were more likely to be larger in men than in women, van Dam-Nolen et al report. However, conversely, the normalized wall index, which accounts for the total vessel size, did not statistically significantly differ between male and female participants, which the researchers describe as “surprising,” and possibly indicative of sex differences in plaque size being driven by contrasting vessel sizes.

In addition, analyzing three of the studies further regarding the degree of stenosis, the authors found no statistically significant sex difference for stenosis of 50–69%, although high-grade stenosis of 70–99% was more often seen in men than in women.

Meta-analyses relating to plaque composition examined the presence of calcifications, lipid-rich necrotic core (LRNC), and intraplaque hemorrhage (IPH), and found a higher prevalence in men versus women across all three components. Expounding briefly on their calcification findings, van Dam-Nolen et al report statistically significant differences between men and women for the presence and amount of carotid calcifications, but not in terms of calcification percentage i.e. the amount of calcification relative to the total plaque volume.

“Furthermore, we found more pronounced sex differences for LRNC in symptomatic as opposed to asymptomatic participants,” they add.

Five studies were also included in the meta-analysis of the relationship between sex and plaque morphology, with the presence of ulceration and the presence of a thin-or-ruptured fibrous cap both being higher in men.

In their report, the authors highlight multiple limitations of their analysis that “deserve comment”, including moderate-to-high heterogeneity among the included studies—especially with regard to plaque size and carotid calcifications—as well as the fact it was not possible to adjust for potential confounders on the relationship between sex and carotid atherosclerosis.

“The found sex differences in carotid atherosclerosis are of clinically significant importance, since the composition of plaque affects the risk of (recurrent) stroke,” van Dam-Nolen et al conclude. “Previous studies have shown that especially IPH contributes to a higher stroke risk. Carotid LRNC, calcifications, total plaque size, and plaque ulceration, have also been reported as important risk factors. With regard to sex-specific risk prediction and treatment, it is essential to investigate the effect of these plaque characteristics per sex separately. We hypothesize that the stroke risk as a result of specific plaque compositions varies among men and women.”

The authors further stress the importance of including an adequate number of men and women in clinical trials, as studies on sex-specific risks for (recurrent) stroke risk related to carotid plaque composition are “still lacking.” Men tend to have more “vulnerable” plaques than women, which has implications during stroke workup, for instance, and the role of IPH in carotid atherosclerosis underlines the relevance of using magnetic resonance imaging (MRI)—a modality that can identify IPH more reliably than ultrasonography or computed tomography angiography (CTA).

“It is important to realize that, although the exact mechanisms of sex differences in carotid atherosclerosis are still unclear, we are already able to act on these differences,” the authors add. “We can use this knowledge in clinical practice, being aware of differences in likelihood of having a vulnerable carotid plaque which affects patients’ stroke risk. Hence, the next step is to investigate the effect of plaque characteristics on stroke per sex separately. This will also allow us to make sex-specific risk scores in order to improve clinical decision-making.”

Vascular surgery oral boards text seeks to fill certifying void

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Vascular surgery oral boards text seeks to fill certifying void
Left to right: Ravi N. Ambani, Andrew M. Wishy and Kevin R. Kniery

Think of it as the omega of the vascular surgical textbook literature, quips Andrew M. Wishy, DO. As a training resource, it fits neatly on the trainee bookshelf on one side—the end to a partner title, The Vascular Surgery Review Book, the alpha, or the beginning, on the other.

He is referring to Vascular Surgery Oral Board Review: Behind The Knife Premium, a textbook aimed at vascular surgery trainees taking the Vascular Surgery Board (VSB) Certifying Exam (CE), a work he helped craft and publish last year alongside colleagues Ravi N. Ambani, MD, and Kevin R. Kniery, MD, the latter known as a founder of popular surgical podcasts, Behind the Knife and Audible Bleeding.

Like the author of The Vascular Surgery Review Book, Wishy, Ambani and Kniery produced their title to provide a training resource and help fill a void they identified as they made their way through their own training. The idea germinated as they studied together to take the VSB CE, realizing there was a lack of available material with which to prepare.

“Both Ravi and Kevin were general surgeons first and had been through the oral board before in the general surgery realm,” explains Wishy, who, in contrast, completed his training under the integrated vascular surgery residency pathway. “We always practiced and tried to simulate these kinds of things for the integrated resident like me in our training institution: How is this really going to go? How is the back and forth going to be between the examiner and examinee? What kind of information are they going to want me to know? What’s too much? What’s not enough?”

Oral board exam resource

As the CE preparation process was new to Wishy, that made him the perfect foil as the trio fine-tuned exactly what the textbook required. The ensuing text is comprehensive, he says.

“From cover to cover, you’re probably going to hit every high-yield topic there is [in vascular surgery], with every most-common procedure performed, and I would say the most common complications that I’ve ever ran into in practice, in the textbooks or heard from other people,” Wishy continues. “It’s not an all-inclusive resource by any means, but I think it’s a very good starting point, and covers the whole breadth of all the major and minor topics.”

The book has already proven a success among trainees since it was published last year, explains Ambani. “The three of us were able to pass our boards on the first attempt, and once we had the proof of concept that we did well, and now that we’re all Board-certified vascular surgeons, we thought it was best to get the cases and material we used down on paper, and get it published,” he says. “After this last round of oral boards, a bunch of people messaged to say that this was the only thing they used, and that they were successful and passed.”

Ambani reckons the two reference titles—their Vascular Surgery Oral Board Review: Behind The Knife Premium and Creeden’s The Vascular Surgery Review Book—meet vascular surgery at a crucial juncture. “Vascular surgery as a group is growing,” he says. “It’s becoming one of the most competitive specialties to match into after general surgery and after medical school, so the volume of trainees keeps going up and the interest keeps peaking. We have our own boards, so it’s time for us to develop resources to help people study for those specialty boards. The resources that exist currently are aimed at general surgery as a whole.”

The textbook tandem is “like a one-two punch,” Ambani adds. The Vascular Surgery Review Book plugs a hole for those preparing for the Vascular Surgery In-Training Exam (VSITE) and the VSB Qualifying Exam, while Vascular Surgery Oral Board Review: Behind The Knife Premium slots into the oral boards, or CE, realm. “Together, they are synergistic. They both came out a couple of months apart. These both are super useful in different ways, and together relatively low-cost resources for trainees that get them through their entire training—and hopefully through their boards.”

PRELUDE-BTK subanalysis highlights superior lumen gain, greater volumetric blood flow using serration angioplasty

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PRELUDE-BTK subanalysis highlights superior lumen gain, greater volumetric blood flow using serration angioplasty
Serranator PTA serration balloon catheter
Cagent
Serranator PTA serration balloon catheter

Cagent Vascular has announced the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty.

The study was led by Marianne Brodmann, MD, from Medical University of Graz in Graz, Austria. This subanalysis compared their PRELUDE-BTK subset to a consecutive plain balloon angioplasty group.

The Serranator-treated lesions had an average final residual stenosis of 17.2±8.2% vs. 33.7±15.7% in the plain balloon angioplasty group. This represents a 49% average improvement in final residual stenosis. In chronic total occlusions (CTO), there was a 62% improvement in final residual stenosis compared to the plain balloon angioplasty group. The average balloon inflation pressure was 5atm in the Serranator group vs. 9atm in the conventional balloon angioplasty group. Additionally, Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement versus plain balloon angioplasty. These data, analyzed by the same independent core lab, were recently published in the Journal of Endovascular Therapy.

Brodmann stated: “As an early user of serration angioplasty, it was meaningful to quantify through this subanalysis what we have experienced using the Serranator device. William Tang [UC Irvine, Irvine, California] developed a novel model, anchored by Poiseuille’s law, from which we were able to derive the volumetric blood flow from lumen gain achieved with the Serranator compared to conventional balloon angioplasty. These results suggest an advantage for serration technology that should allow for superior wound healing and patient outcomes, while minimizing the need for stent placement.”

Raman Sharma, MD, from Mount Sinai Medical Center in New York, was an early adopter of serration technology, and added: “When it comes to BTK interventions, there simply have not been great options for physicians to treat patients, who are often in jeopardy of limb loss. In these cases, our goal is to restore sufficient blood flow to allow a patient’s wound to heal, without leaving anything behind. The results from this subanalysis study support what we have seen in our experience; the Serranator provides greater lumen gain and blood flow versus conventional technology.”

Sudanese vascular association readies for first-ever conference

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Sudanese vascular association readies for first-ever conference
The Sudanese Association of Vascular Surgery (SudAVaS)

The Sudanese Association of Vascular Surgeons (SudAVaS) has announced the scientific program behind its first-ever international conference, marking the occasion by celebrating the “first steps in establishing vascular surgery as a standalone surgical specialty” in the northeast African country.

The meeting takes place in the Sudanese capital of Khartoum from Feb. 7–8, with the program covering the full gamut of the vascular beds, as well as training issues, vascular trauma and the history of vascular surgery in Sudan.

SudAVaS President Isam Osman, MBBS, hailed the Sudanese vascular surgical community ahead of the event, writing in an open letter: “… I must pay tribute to the few lonely vascular surgeons in Sudan who have toiled for years on their own, often in very challenging circumstances.”

Osman also expressed thanks to those who had helped craft the program. “We hope it will inspire our young graduates to consider a career in vascular surgery,” he added. “I apologize also to the dozens of colleagues who we would have liked so much to invite to attend in person but we were unable to do so as we have arranged this conference on a shoestring budget. I hope that in the future our partners in vascular industry will see Sudan as an emerging market.”

First patient enrolled in DEFIANCE trial of the ClotTriever system in DVT

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First patient enrolled in DEFIANCE trial of the ClotTriever system in DVT
The ClotTriever device

Inari Medical announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.

The trial is led by principal investigators Xhorlina Marko, MD, from Beaumont Health in Dearborn, Michigan, Steven Abramowitz, MD, from MedStar Health in Washington, D.C., and Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England.

The first DEFIANCE patient was enrolled by Abdullah Shaikh, MD, from Allegheny Health Network in Pittsburgh. DEFIANCE will enroll 300 DVT patients at up to 60 centers worldwide. DEFIANCE is Inari Medical’s second RCT, enrolling in parallel to the PEERLESS pulmonary embolism trial.

“We are thrilled to enroll the first patient and officially kick off this important clinical trial,” said Shaikh. “ClotTriever is fundamentally different to other DVT treatments. This trial is designed to produce definitive evidence to change standard of care.”

“DEFIANCE is an important step forward and will answer critical questions about how we manage DVT patients,” said Abramowitz. “Prior RCTs have focused on thrombolytic-based interventions, which have known downsides and limited effectiveness. This ClotTriever RCT is the first to compare lytic-free thrombectomy to anticoagulation for DVT.”

SVS Foundation: Get ‘Gatsby’ Gala tickets today

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SVS Foundation: Get ‘Gatsby’ Gala tickets today

Tickets—both individual and for tables—are selling faster than a Gin Rickey during Prohibition for the Society for Vascular Surgery (SVS) Foundation’s “Great Gatsby Gala,” to be held at the 2023 Vascular Annual Meeting (VAM).

From Feb. 3 to 18, individual tickets are $550. Starting Feb. 19, ticket prices will increase to $600 each. Tables of 10 are $5,000, with VIP tables at $7,500 and Champion Sponsor tables priced at $12,000.

The evening will include the Surgeon Speakeasy Cocktail Reception, including cocktails (A Bee’s Knees or Hemingway Daiquiri, anyone?) and passed hors d’oeuvres, Gatsby-inspired performers and more; three-course dinner with wine service; live and silent auctions and dancing. All proceeds will benefit the SVS Foundation and its efforts to fund the future of vascular health through its four pillars of research and innovation; community vascular care and patient education; disease prevention; and diversity, equity and inclusion (DEI).

Besides general tickets and table sales, SVS has sponsorship opportunities and table ticket levels available, including Title Sponsor, $60,000; Premiere Sponsor, $25,000; Young Surgeons/ Fellows Table Sponsor, $18,000; and more.To learn more about these opportunities, contact Scott Behm [email protected].

For more information and to purchase tickets, scan the QR code or visit vascular.org/2023gala.

VESAP5: Now up to 25% off

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VESAP5: Now up to 25% off

With the expiration of the fifth edition of the Vascular Education and Self-Assessment Program (VESAP5) in July, the Society for Vascular Surgery (SVS) is offering a discount of up to 25% on the program for a limited time.

The discount applies to both the comprehensive program as well as the vascular lab program.

Those who purchase the comprehensive package also will be granted access to a non-credit version from July 17 of this year through July 17, 2024.

The online program is intended to help vascular surgeons and trainees prepare for qualifying, certification and recertification exams in vascular surgery and to remain current in vascular surgery and endovascular therapy. Physicians also can earn Continuing Medical Education (CME) credits.

The evidence-based, self-assessment study tool includes both learning and exam modes.

This fifth version also includes four vascular lab modules geared toward ultrasound technicians, interventional radiologists, cardiologists, vascular medicine specialists and allied health professionals studying for their exams.

Subject areas for the comprehensive package include cerebrovascular disease, upper extremity vascular disease, dialysis access management, aortoiliac disease, renal and mesenteric vascular disease, lower extremity vascular disease, venous and lymphatic disease, vascular medicine, radiation safety and vascular lab (with four modules for the lab component). Learn more at vascular.org/VESAP5Modules.

Access to, and the opportunity to earn CME Self-Assessment (SA-CME) credits for VESAP5 will end July 14. Learners may continue to earn credit and generate certificates until that date.

Learn more and purchase VESAP5 at vascular.org/VESAP5.

NIH funding for vascular surgeon-scientists: ‘We need more funded vascular surgeons and better coverage of SVS priorities’

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NIH funding for vascular surgeon-scientists: ‘We need more funded vascular surgeons and better coverage of SVS priorities’
Pre-med student Amin A. Mirzaie delivers findings at SAVS 2023

Presenting at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico, Amin A. Mirzaie—a pre-medical student at Emory University in Atlanta—offered observations on the National Institutes of Health’s (NIH) “modestly” aligned vascular surgical funding distribution in the context of the current Society for Vascular Surgery (SVS) priorities.

Mirzaie—backed by a senior authorship that includes Samir K. Shah, MD, an assistant professor of surgery at the University of Florida in Gainesville, Florida—began by remarking on contemporary delegation of NIH funding, referring to a “precipitous and slow decline” in public service funding in the period 2006–2016, showing a decrease of 300,000 per year. Yet, during the same time period, he continued, the NIH received a $2 million budget increase, spurring Mirzaie and his fellow authors to investigate the characteristics of “rare” NIH-funded projects granted to vascular surgeon-scientists. They sought to extract the amounts, types and content areas, and determine their alignment with current SVS research questions. Rhetorically setting their research intentions for the audience, Mirzaie asked: “Who is being funded? […] Do funded projects align with SVS priorities?”

Estimating a total of $12 million is awarded to “all active projects,” Mirzaie introduced their methods of investigation, querying the NIH Research Portfolio Online Reporting Tools Expenditures and Results (RePORTER) database for active awards in April 2022. Excluding training awards (T Grants) and for-profit projects, they extracted grant research characteristics in instances which included a vascular surgeon as principal investigator (PI). Additionally, they acquired PI demographic and academic background information through institution profiles.

Identifying 53 active NIH awards given to 40 US vascular surgeon-scientists, and underlining the previously contended rarity of funding, Mirzaie reiterates that “only 1%” are receiving these awards. Continuing, he noted funded vascular surgeon-scientists are an average of 15.9 years out of training, with 37.5% being women—which Mirzaie alludes to being “much higher” than other sub-specialties—contending this shows “strong signs” for more frequent female NIH funding allocation.

Bringing the focus to the intersection between NIH and SVS research priorities, Mirzaie posed that eight out of 53 active projects given to vascular surgeon-scientists “directly addressed” any SVS primacies. Continuing, he noted that four SVS priorities included in the most recent 2021 refresh, were not “fulfilled by any NIH projects.”

Among active NIH projects, Mirzaie points out that 77.4%—the largest group assigned funding—have been awarded, or “skewed” he noted, to basic/translational research studies, while 22.6% are clinical/health services research projects. Abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD) are the most commonly funded disease areas, accounting for 56% of projects. Mirzaie also added that 15% of the NIH-funded projects meet one of the ten clinical research priorities defined by the SVS.

“Moving forward this shows that we need more funded vascular surgeons and better coverage of SVS priorities,” said Mirzaie, solidifying his observations for the audience. Recognizing that NIH funding is “complex,” he proposed multi-specialty schemes collaborating with the SVS could “create better training programs, respective grant holders, and funding institutes” to accurately address their overall priorities.

Of Mirzaei’s concluding thoughts at SAVS, emphasis was placed most particularly on ensuring future NIH-funded projects answer important clinical questions posed by the SVS, as well as on how their data can be employed to “reassess and reconsider current strategies” to produce future vascular surgeon scientists.

High-risk venous stasis ulceration patients show similar healing rates after multi-modal surgical therapy

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High-risk venous stasis ulceration patients show similar healing rates after multi-modal surgical therapy
Rachel Reed takes to the podium at SAVS 2023

A single-center evaluation of contemporary, multi-modal surgical therapy for venous stasis ulceration (C6 disease) suggests high-risk patients showed similar healing rates at one year, indicating a variety of intervention types should be pursued to achieve “optimal results.”

Presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 18–21) in Rio Grande, Puerto Rico, Rachel Reed, MD, a general surgery resident at Emory University in Atlanta, outlined the “significant burden” chronic venous disease (CVD) has for both patients and the U.S. healthcare system, estimated to affect 3% of the population, with 1–1.5% of the population projected to have healed or active ulcers.

Reed and authors conducted a retrospective review of patients treated with C6 disease at a single, public academic hospital between 2011–2021, with at least 12-months of follow-up. Addressing the field of research, she noted that there are currently “limited data” regarding combined surgical therapy in venous disease, introducing theirs as the “only” study performed to look at multiple types of surgical intervention.

Their primary outcome measure was defined as ulcer-free survival at one year following initial surgical intervention, which included venous ablation, deep venous stenting, and open deep venous valvuloplasty. Patients were classified using the Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) system, which categorizes C6 disease as its most severe form of venous disease, assessed by a multidisciplinary team.

Reed addressed several comorbidities characterizing the “high-risk” cohort, such as diabetes, elevated body mass index (BMI) and active insurance—specifying that 60% of the included population were classified as obese with a BMI of greater than 30, and 35% had a prior history of deep vein thrombosis.

Producing the results, Reed identified the 80 interventional procedures included in their review, segmenting these into 70% ablation, the most frequent treatment used, 21.3% stenting and 10% deep venous reconstruction (DVR). Their findings showed 54% of patients were ulcer-free at 12-month follow-up; however, no significant demographic disparities were found between patients who healed and those who did not. “Of note, those with high-risk features including diabetes and elevated BMI, healed at a similar rate to those without”, Reed asserted.

Overall, 37.7% of patients required more than one type of procedure, 71.7% underwent isolated venous ablation, 13.2% underwent isolated iliac vein stenting, and 1.8% underwent isolated valvuloplasty. Elucidating the data further still, she emphasized a prevalent “trend” that showed patients who required multiple types of intervention to obtain durable venous healing were more likely to have ulcer resistance at 12 months, most likely “highlighting the severity of their disease,” she determined. Yet, despite the number or type of procedure performed, no “statistically significant difference” was observed in level of ulcer healing, Reed stated.

Of note however, when the researchers segmented healing rates of patient limbs by intervention type, concomitant iliac vein disease appeared to be “associated with reduced ulcer healing at one year,” suggesting iliac stenting is associated with poor ulcer healing compared to those individuals who did not require this procedure.

Their research suggests that high-risk features such as diabetes and increased BMI are “not predictive” of poor ulcer healing, with patients from both cohorts healing at “similar” rates, Reed concluded. However, when considered through multivariable regression, Reed saw that significant demographics appeared to be “increased age and lack of insurance” as indicators of reduced healing at 12 months.

Finally, Reed posited the patient population to be the “main” limitation of the study, conveying the difficulties the researchers encountered when attempting to standardize care with the “heterogenous socioeconomic group” of high-risk patients. “Chronic venous disease remains a challenging disease to treat, and in which to obtain durable venous healing,” Reed contended, determining “future studies will need to be performed on optimal treatment pathways for these patients.”

Has the risk in the value-based payment model been sold as another ‘shiny new object’?

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Has the risk in the value-based payment model been sold as another ‘shiny new object’?
Bhagwan Satiani

Value-based payments (VBP), or “volume to value,” was the new buzz word over a decade ago, promising yet another chimera in ways to reimburse physicians and hospitals based upon “value,” instead of fee-for-service (FFS). VBP models link payment or compensation to healthcare outcomes, infrastructure and quality of care rendered. The value equation states that value is the product of the quality of care plus the patient experience at a given cost.

The idea was to bend the healthcare cost curve and improve healthcare outcomes. If these models succeeded, we would expect better patient satisfaction, greater efficiency, improved outcomes, and lower cost. 

I am reminded of advice for healthcare executives to follow these four points: Do not sell “risk” as a shiny new object; connect value-based care to existing priorities; message should be related to physician day-to-day work, not yours; and be sure to use risk to advance clinician engagement.1 This advice was priceless in retrospect. 

The Affordable Care Act (ACA) of 2010 ushered in the “VBP payment modifier,” starting with Medicare’s flagship Shared Savings Program (MSSP), Accountable Care Organizations (ACOs), followed by advanced alternative payment models (APM), the Medicare Access and CHIP Reauthorization Act (MACRA), the Merit-based Incentive Payment System (MIPS), and the list goes on. Currently, four main types of VBP models exist: performance-based payments, bundles, shared savings, and risk and capitation.2 

Value equation

The Department of Health and Human Services (HHS) aspired to convert 30% of FFS Medicare payments to VBP models by the end of 2016, and 50% to make the switch by 2018. Data show that 38.2% of healthcare dollars flowed through some type of VBP model as of 2019. 

The success of VBP programs is mixed with many models failing to show a major impact thus far. For a while, ACOs and VBPs showed some early cost reductions, but neither seemed to significantly impact the quality of care. A Deloitte survey of 680 U.S. physician respondents in 2020 showed that nearly all still relied on FFS reimbursement and only one-third said some of their compensation was tied to VBP.2 An AMA analysis in 2018 showed that salary is the most common method (52.5%), followed by productivity (31.8%). Some 33% of surgical specialists were paid strictly on productivity. Why is FFS still the dominant reimbursement method? 

Hospitals and physicians strongly prefer FFS since they are used to being reimbursed by the system, and they believe they are being compensated fairly. Although physicians remain split on whether FFS care is best (about 70% favor it), most agree that the time for it has come and gone since they see the waste in the system. They know FFS is more expensive. A survey from Bain & Company of almost 1,000 physicians, along with health system finance and procurement officers, showed that physicians feel helpless to control costs, even though they understand that both cost of clinical care and pharmaceuticals need to come down.3 Physicians feel they are being overruled and “managed” rather than being asked to sit at the table where decisions are made. 

Lack of great promise 

The lack of strong empirical evidence has also slowed the implementation of value-based care. Physicians are aware of many previous iterations of healthcare reimbursement models and the fact that population-based VBP models have not thus far shown great promise. Furthermore, there are not enough incentives for managing the total cost of care, and not many physicians are willing to take the downside risk with APMs. 

Physicians are also uncertain about the guiding principles for any new VBP formula. How is value defined and what does it mean? Are clinical-decision support and analytic systems up to date? Is there flexibility in the compensation for surgeons who wish to be compensated for working harder or working less? For surgeons, the quality component means judging the decision to operate or not, the choice of the appropriate procedure for that condition, the technical success or failure, and the ultimate outcome, compared with benchmarks. Since some of these targets are hard to measure, we are left with items like antibiotic guidelines or thromboembolic prevention as examples that have only a modest amount to do with the essence of surgery. 

Finally, the timing of payments is complex and may vary, making revenue collection difficult to predict. Take the shared savings programs such as bundled payments. Other than large hospitals and medical groups with resources to hire expert help, most physicians do not have the tools, processes, and the analytic capability to assess risk- or value-based contracts. So, while interest in VBP contracting over the last decade has been a high priority, the reality is that actual implementation has not matched the interest. 

While more data is awaited, VBP has had no significant impact on slowing the growth in healthcare costs thus far. The main reason is a consensus on the definition of value and data standards. Second, from a system standpoint, hospitals have difficulty determining the actual internal cost (not charges) and even quality of care at the individual level to plan for an outcomes-based payment model. Patient outcomes are also difficult to match with the standards because of absence of shared platforms.4 Third, incentives are not aligned from the system down to hospitals and medical groups. Finally, the infrastructure—including population and management analytics—is expensive, particularly in the beginning, and negates any savings.

Quality performance measures 

There are some bright spots. In an MGMA Stat poll in 2022, 42% of medical groups said quality performance measures are included in physician compensation plans.5 In another survey, two-thirds of physicians have linked to VBP, and over half believe it improves quality and trims costs.6 

Ironically, 69% are not using proper technology to identify at-risk patients, and 72% are not linking to medical and social data. So, in 2022, while the vast majority believe the end of FFS is here, 60% of FFS is either not linked or somewhat linked to value and quality, another 27% are APM models based on FFS, and 15% on population-based payments. 

Some bundled payment and ACO programs have succeeded, but most do not have the resources, time, or administrative or financial experience to take a higher risk proposition. 

The Centers for Medicare & Medicaid Services (CMS) estimates that since 2015, savings increased tenfold to more than $4 billion in 2020. It is also true that VBP programs may have done better with per-member-per month premiums during the COVID-19 pandemic than the unreliable FFS programs. 

After the last decade of experimentation, physicians want empirical evidence that evolving models of patient care management, compensation, and policies work.3 As Bain & Company maintain, without sound evidence, high quality of care will remain elusive, and unengaged physicians will remain on the sidelines. If physicians readily admit that FFS is expensive, their involvement at the grassroots to help lead the change is imperative. They should be part of agreements on guiding principles, transparency, equity across specialties, and adjust for personal choices for individuals consistent with the hospital’s financial and quality goals.2 

Some analysts believe the current VBP models are simply FFS “lite.” Goldsmith comments that MedPAC has called the VBP movement a disappointment.7 He also states that hospitals have not recovered the billions of dollars into these models. Moody’s data for 2020 showed that the median percentage of risk-based payment of total hospital revenues is 1.1%, down 0.5% from 2018. 

Furthermore, clinicians have spent countless non-reimbursable hours debating and documenting these quality measures. The impact of horizontal and vertical mergers of hospitals, physicians and insurers on VBP is unknown. 

The physician dilemma has been well stated by Berenson and Kaye who comment that “practical reality is that CMS, despite heroic efforts, cannot accurately measure any physician’s overall value, now or in the foreseeable future,” concluding, “yet the medical profession has been remarkably quiet as this flawed approach proceeds.”8 

And proceed it has. Some experts claim that COVID-19 has hastened the move to VBP, that private equity firms are betting on innovation and newer models of care, and that healthcare plans and payers are leading the way.9 The future remains clouded. My questions are: how is it going to be different this time, and are many physicians involved? 

References 

  1. Dailey E. Win physician buy-in for value-based care. https://www.advisory.com/Topics/Population-Health-ROI/2021/03/Win-physician-buy-in-for-value-based-care. 
  2. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/value-based-care-payment-models.html. 
  3. https://www.bain.com/insights/front-line-of-healthcare-report-2017/.
  4. DeLone M. If value-based contracts succeed…we might not need them anymore. Deloitte. 
  5. https://www.mgma.com/practice-resources/revenue-cycle/shifting-to-value-amid-pandemic-and-staffing-chall.
  6. https://innovaccer.com/resources/industry-reports/the-state-and-science-of-value-based-care.
  7. Goldsmith J. Commentary in https://www.healthaffairs.org/do/10.1377/forefront.20220125.362333/.
  8. Berenson RA, Kaye RK. Grading a Physician’s Value—The Misapplication of Performance Measurement. N Engl J Med 2013 Nov 28;369(22):2079-81. doi: 10.1056/NEJMp1312287. 
  9. Jacob A, Guthrie F. Accelerating value-based care: Why health plans now hold the keys | Viewpoint. https://www.chiefhealthcareexecutive.com/view/accelerating-value-based-care-why-health-plans-now-hold-the-keys-viewpoint.

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor . 

Back to basics: All the things I love about vascular surgery

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Back to basics: All the things I love about vascular surgery
Christopher Audu

Recently, after completing a difficult open aortic operation with my attending, a bright M3 asked me, “Why vascular surgery?” The question didn’t catch me off guard, as I always have a ready answer, and we had just finished a pretty awesome operation. Also, it was enlightening to hear how my attending stumbled upon vascular surgery. We finished that operation, and, thankfully, the patient did well.

Nevertheless, in the weeks since, my mind has wandered back to this simple question. It’s one I’ve had to answer many times over, starting from my interview days years ago. I wanted to share some of my answers in the hopes that it’ll inspire others to consider vascular surgery. 

Vascular pathophysiology 

The thought of intervening on arterial and venous pathology (all over the body, no less!) was strongly appealing to me. There is no other field of medicine that is able to do what we do operatively and clinically. We share the treatment of some vascular beds with other specialties, but none of them are able to provide the true comprehensive vascular care that a vascular surgeon can provide. 

That niche and the unique pathophysiology mean that we interact with almost every other specialty in medicine. Since most disease processes require vascular perfusion, it also means that vascular surgeons are often called upon to assist colleagues in unique ways. 

Vascular pathophysiology is, at the same time, intriguing, complex, personalized and nuanced enough to keep us intellectually stimulated and engaged. No two operations as a vascular surgeon are the same. 

The patient population 

The vascular surgical population spans the extremes. On the one hand, vascular surgery patients are some of the sickest in the hospital. This means that, by default, we care for the marginalized, disenfranchised and most ill of patients with multi-system failure. Our patients frequently require ICU-level care, requiring us to have a strong working knowledge of critical care. 

On the other hand, vascular surgery patients can be young, healthy athletes with thoracic outlet syndrome or popliteal entrapment, or they can be venous patients with varicose veins requiring outpatient intervention. I don’t like amputations, but as my training journey has progressed, I’ve come to see this intervention as less of a failure, but something that may help the patient achieve the goals of their lives after efforts at revascularization have not been successful. 

The vascular surgical community 

My first visit to the Vascular Annual Meeting (VAM) was in 2015, when it was in Boston. I remember walking away from that meeting feeling like I had finally found the group of physicians that I could fit into. 

At that time, I had visited national meetings for other specialties, but vascular was the only one that checked all my boxes for what I was looking for in a career. Since then, I’ve attended many other vascular-specific meetings like the Vascular and Endovascular Surgical Society (VESS) meeting, the Pacific Northwest Endovascular Conference (PNEC), the Vascular Research Initiatives Conference (VRIC) and I’m looking forward to some more this year. At each meeting, I’m impressed by how tight and small a community vascular is. But, more importantly, my initial impression of the field as a welcoming, innovative, research-embracing, and collegial field has not diminished. 

Research and mentorship 

On that note, in 2015, I walked among the posters specifically looking to see what the breadth of research was in the field, and if I could fit in. I was pleasantly surprised at the number of high-quality scientific projects that were being pursued. 

This discovery was very exciting because I knew that no matter what I decided to pursue in training or beyond, I knew I could find a mentor who had walked the road I sought to travel. Perhaps this was the biggest factor that drew me in to the field. And as a resident, the mentorship and sponsorship I’ve received have honestly kept me going. 

The X factor 

Okay, no, not the television show. Rather, the concept that there is just something indescribable about vascular surgery that just makes it cool. Maybe it’s the numerous endovascular devices we get to use, or it’s that we use fine needles and Castroviejo drivers to operate, or we respond to emergencies day or night, or it’s because we have the best operating room playlists; there’s just something about vascular surgery that makes it suave. 

These were some of the answers I gave my M3 student. She was very good, and I hope she considers vascular. To that end, in 2023 at Corner Stitch we hope to cover a broad range of topics and, ultimately, help others see why vascular surgery is the best specialty! 

Christopher Audu, MD, is the Vascular Specialist resident/fellows editor. 

‘Unique’ vascular meeting set to update surgeons, prioritize audience debate

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‘Unique’ vascular meeting set to update surgeons, prioritize audience debate
Keith Calligaro

Prioritizing “entertaining and informative” sessions, the 29th Annual Pennsylvania Hospital Vascular Symposium and the 3rd Annual Pennsylvania Hospital/University of Pennsylvania Non-invasive Vascular Laboratory Symposium (April 21–22) in Philadelphia returns, providing the latest open surgical and endovascular management of vascular disease. Discussing this year’s meeting, Keith Calligaro, MD, chair and director, says the program will center around “brief” seven-minute presentations and subsequent case appraisal, aimed at sparking debate and audience discussion to aid information sharing and learning. 

“It is a pretty unique conference,” Calligaro explains, “during each session we have around four or five speakers, but very brief talks and after that we present cases and say: ‘What would you do?’” 

The program seeks to encompass all areas of vascular surgery, including evolving fields such as increasing endovascular management of thoracoabdominal aortic aneurysms (TAAAs). Among other aspects of the program highlighted by Calligaro is the predominant theme of emerging techniques and technologies, including the role of artificial intelligence (AI). Leveling the playing-field, the meeting gives all participants the opportunity to share their methodology. Calligaro recalled a particular case he put to Bruce Perler, MD, who was chief of vascular surgery at Johns Hopkins: “I went up to him and asked ‘What would you do? […] He kept hedging, and I said you’ve got to make up your mind and say what you’re going to do. I thought he kept dodging my questions, and he finally said in an exasperated tone of voice, ‘whoa, whoa, whoa, I feel like I’m taking my vascular boards again!’” 

Calligaro commented on how the structure of the meeting has “evolved,” recalling the first 10 years, when the meetings were primarily devoted to one topic, such as aortic aneurysms or carotid disease. Following a more varied format over the next 20 years, he gathered feedback revealing the value audience members gained from active dialogue on a wider breadth of case presentations. Utilizing this back-and-forth as “reinforcement” for the core presentations, Calligaro now walks among the audience spotting dozing audience members and asking about their approach—“just to keep everyone on their toes.” 

“Every year we have three of the most famous vascular surgeons in the country present ‘My worst case with a bad outcome—they happen to me too’ during the second morning of the meeting,” he said. “I ask them not to present a tough case and the ending is how great you are. The ending should be that they are human and something didn’t go right, even for these experts. I think that’s the teaching point for the trainees.” 

Calligaro’s approach aims to bring humor to education, providing a unique twist to keep attendees engaged. Setting sights on April, Calligaro added that by “addressing controversial topics of interest” to vascular surgeons, reinforced by “lively, educational and fun” debate, he expects the meeting to be a success. 

Get FIT: Applications for VQI Fellowship in Training program open

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Get FIT: Applications for VQI Fellowship in Training program open
SVS Vascular Quality Initiative (VQI) logo

The Fellowship in Training (FIT) from the Society for Vascular Surgery’s Vascular Quality Initiative (SVS VQI) introduces residents and fellows in vascular-focused programs to the SVS Patient Safety Organization (PSO). FIT debuted just a year ago, in January 2022, with 16 inaugural trainees and 16 VQI mentors. 

The program lasts 12 to 18 months and is designed to foster an understanding of quality processes and metrics among the trainees through mentorship in the VQI. FIT is offered in collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology and Society for Vascular Medicine. 

VQI aims to raise the bar for vascular care, quality improvement and patient outcomes. Currently, 968 centers participate in the VQI’s 14 registries, and more than 1 million procedures have been captured. Vascular surgeons, cardiologists, radiologists and other specialists who perform vascular procedures participate in registry data collection. 

FIT is open to people completing medical residencies or fellowships in any vascular disease-focused specialty (vascular surgery, cardiology, radiology or vascular medicine). The trainees work closely with their mentors on participation in regional biannual meetings and review of comparative VQI data, including center-level quality improvement processes. 

They are part of the quality improvement process, plus work in quality charter development and research initiatives using VQI data. 

“This is an incredible opportunity for those who are invested in quality improvement and safety in vascular surgery,” said Gary Lemmon, MD. “Data—collecting it and sharing it—is at the heart of everything we do, and FIT participants learn how this all impacts patient care and outcomes.” 

Participants can: 

  • Gain knowledge/understanding of a PSO and its strengths and limitations on data sharing 
  • Gain familiarity with mechanics of data entry into the VQI website, including abstraction requirements, variable definitions and inclusion/exclusion criteria for registry data 
  • Learn the value of data review via regional group meetings, big-data analysis of VQI@VAM and how this cannot be done locally at a center or single institution 
  • Develop enthusiasm for participation in regional and national meetings as 1) potential for career networking, and 2) improving process of care back to center level 
  • Learn the value and mechanics in implementing a Research Allocations Committee (RAC) proposal and use of metadata via claims linkage such as Medicare 
  • Experience career advancement—again through networking capability, volunteer participation in steering committees/research/presentations and the value of mentoring from experienced vascular surgeons 

The first group of trainees will have the opportunity to present their work in June during VQI@VAM, the VQI annual meeting held in conjunction with the SVS Vascular Annual Meeting (VAM). These participants also will be competing for one of five coveted Jack L. Cronenwett Scholarships, worth up to $10,000 each, to continue their research and/or work more closely with committees and staff on VQI initiatives.

The scholarship is named for Jack L. Cronenwett, MD, vascular surgeon, educator and the VQI registry’s co-founder. More information is available at vascular.org/VQIFIT. 

The year in review: 2022 was an amazing 12 months for SVS

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The year in review: 2022 was an amazing 12 months for SVS
Michael C. Dalsing, left, and Kenneth M. Slaw

Despite any number of challenges, the Society for Vascular Surgery (SVS) had a hugely successful 2022 and looks forward to a bright 2023. 

Executive Director Kenneth M. Slaw, PhD, outlined a number of firsts for the Society, including: 

  • Publishing the first appropriate use criteria (AUC) to cover treatment of claudication 
  • Creating popular roundtable webinars on putting SVS guidelines into practice 
  • Holding the first hands-on training course, the Complex Peripheral Vascular Intervention Skills (CPVI) course 
  • Creating a new structure for the Journal of Vascular Surgery publications 
  • Conceiving and running the successful, first-ever Vascular Health Step Challenge, in which participants pledged to walk at least 60 miles during September—Peripheral Arterial Disease (PAD) Awareness Month—to highlight PAD and raise money for public awareness and other initiatives 

The year also included the conclusion of the year-long celebration of the Society’s 75th anniversary, which kicked off in San Diego in August 2021, during the 2021 Vascular Annual Meeting (VAM). 

Festivities ended in June 2022, with the “Cheers to 75 Years” Gala, which kept the crowd dancing and—not at all incidentally—netted the SVS Foundation more than $200,000 for programs and initiatives. 

Growing the specialty and adding new voices, through: 

  • Adding membership sections for women and young surgeons 
  • Including sessions at VAM 2022 for all five special membership sections. 
  • Holding a summit on diversity, equity and inclusion (DEI) 
  • Adding a fourth pillar, for DEI initiatives, to the SVS Foundation 
  • Creating a portal for recruitment into vascular surgery, choosevascular.com, through COVERS (Coalition for Optimization of Vascular Surgery Trainees and Students), a coalition comprised of the Association of Program Directors of Vascular Surgery (APDVS), Society for Clinical Vascular Surgery (SCVS), SVS and the Vascular and Endovascular Surgery Society (VESS) 

“Applying DEI awareness and principles is a culture-change journey, and we are well on the way to finding new balance,” said Slaw. “Through changes in governance committees like the Executive Board, Strategic Board, appointments, and the Nominating Committee, greater DEI awareness is influencing the way we work and what we do.” 

Advocacy in Washington to support patients and surgeons through: 

  • Holding the first Payment Reform Summit, bringing together people for two days of discussions on setting a new direction and alternative for government policies that affect vascular surgery 
  • Bringing aboard our new advocacy director and legislative assistant 
  • Organizing two separate “Weeks of Action,” urging member engagement with lawmakers in efforts to change policy on physician payment and reimbursement 

“Great challenges remain with addressing payment policy, and it is looking more and more like the current system offers no acceptable path forward, so alternative, creative solutions need to be brought front and center,” Slaw said. 

Expanding the SVS quality footprint in the United States and globally via: 

  • Establishing the Patient Safety Organization’s Vascular Quality Initiative as a premier provider of real-world evidence across medicine, government, and industry 
  • Expanding the Society’s work with the International Consortium of Vascular Registries 
  • Establishing SVS as the administrative home of the World Federation of Vascular Societies (WFVS) 

“Quality patient care is central to the SVS mission, and the SVS must establish itself as the epicenter and driver of quality,” Slaw noted. He went on to add his personal thanks to the SVS leaders and volunteers, and staff, who together “achieved great progress in the face of many significant challenges.” 

President Michael C. Dalsing, MD, said it has been his privilege to lead the organization as president for the past six months. “I am really looking forward to the next six as we prepare for the Vascular Annual Meeting in National Harbor,” he said. 

After looking back, he added, he is also looking ahead. “The year 2023 will be even better! My hope is we will continue to work together to advance the specialty, improve patient care, and have even ‘more voices’ drive our efforts and be a unified force for our members. The Strategic Board of Directors meets in January with a fresh Member Survey to guide our planning … game on!” 

SAVS reveals 2023–24 officeholders, including new president-elect

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SAVS reveals 2023–24 officeholders, including new president-elect
Alan Lumsden is the new SAVS president-elect (2023–24)

The Southern Association for Vascular Surgery (SAVS) officially announced its 2023–24 slate of officeholders following the conclusion of the recent SAVS annual business meeting.

The member-only proceedings marked the conclusion of the 2022–23 presidency of William D. Jordan Jr., MD, chief of the division of vascular surgery and endovascular therapy at Emory University in Atlanta.

David L. Cull, MD, professor of surgery at the University of South Carolina in Greenville, became SAVS president for the 2023–24 term after the meeting, which took place at the end of the 2023 SAVS annual meeting (Jan. 18–21) in Rio Grande, Puerto Rico.

Alan Lumsden, MD, the Walter W. Fondren III Presidential Distinguished Chair of the DeBakey Heart & Vascular Center at Houston Methodist, was revealed as the new president-elect.

New SVS series zeroes in on government’s impact on vascular surgery

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New SVS series zeroes in on government’s impact on vascular surgery

Starting next month, the Society for Vascular Surgery (SVS) will begin a series of articles focusing on how the actions of Congress and regulatory agencies affect vascular surgeons and the patients they serve, and importantly, how sustained advocacy engagement is important for all SVS members. 

“Government Grand Rounds” will strive to frame the importance of engaging in advocacy initiatives from a variety of perspectives. 

Advocacy” continues to rank high among SVS member priorities, and yet many members remain unsure how to support SVS advocacy-related programs, what activities are available and how to measure success along the way. 

The Government Grand Rounds series seeks to answer some of these questions and move the SVS closer to its goal of establishing a strong culture of engagement across our entire membership 

BEST-CLI: Analysis finds correlation between WIfI stage four CLTI and reports of poorer mental health

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BEST-CLI: Analysis finds correlation between WIfI stage four CLTI and reports of poorer mental health
Jeffrey Siracuse

The BEST-CLI dataset has revealed a correlation between wounds, ischemia and foot infection (WIfI) stage and poorer quality of life due to mental, rather than physical, health for patients with chronic limb threatening ischemia (CLTI).

Analyzing complete WIfI data from a total of 1,568 enrollees, the prospective randomized BEST-CLI trial compared open and endovascular revascularization strategies for patients with CLTI due to infrainguinal peripheral arterial disease (PAD). The study assessed health-related quality of life (HRQoL), which was the prespecified secondary endpoint of the trial and was used at enrollment and designated follow-up points. This measurement included data from multiple surveys, including the Vascular Quality of Life questionnaire (VascuQoL); 12-item short-form survey (SF-12), including the utility index score (SF6D-R2), mental composite scale (MCS), and physical composite scale (PCS); and EQ-5D.

The results were recently published online in the Journal of Vascular Surgery (JVS).

Jeffrey Siracuse, MD, a professor of surgery and radiology at Boston University School of Medicine in Boston, and colleagues sought to establish a correlation between limb severity and health-related quality of life, including details specifically connected to the affected limb and post-intervention changes in preoperative HRQoL scores.

Distribution between WIfI stages was: 35.5% reporting stage four, 29.6% with stage three, 28.6% with stage two, and 6.3% with stage one. Analyzing these groups further, the authors found that patients presenting with WIfI stage four were more often men (74.9% vs 69.6%), current smokers (25.4% vs. 17.6%), had end-stage renal disease (13.3% vs 8.5%), diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had higher median morbidity scores (4 vs 3; p<0.05).

Examining the correlation between WIfI stage and the other assessment modes, the authors found stage four to be associated with worse/lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; p<0.001) and SF6D-R2 scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; p=0.04).

Siracuse et al stated that patients presenting with an advanced WIfI stage had lower HRQoL assessments related to their mental health, however, the remaining assessments (VascuQoL, SF-12 PCS, and EQ-5D) which focused mainly on physical health, did not show a correlation with advanced WIfI stage. The authors noted that WIfI stage four had VascuQoL scores that were comparable to groups one to three (-0.12; 95% CI, -0.25 to 0.02; p=0.09), though female sex, current smoking and preoperative opioid use were associated with a lower score. These factors were also associated with lower SF6D (-0.02; 95% CI, -0.03 to 0.001; p=0.04) and SF-12 MCS (-2.43; 95% CI, -3.73 to -1.13; p<0.001) and PCS (0.04; 95% CI, -0.89 to 0.97; p=0.93) scores. However they were not found to affect a lower EQ-5D score (-1.85; 95% CI, -4.22 to 0.52; p=0.13).

“The presence of concurrent mental stress is important in patients with CLTI and has most likely been undertreated,” Siracuse concluded. Analysis has been previously carried out on the relationship between mental health and CLTI—The Nottingham Health Profile’s study demonstrated a significant correlation between HRQoL in patients with PAD and difficulties in work, family life and hobbies.

The researchers pointed out that, unlike mental health assessments, the physical assessments did not correlate with advanced WIfI stage, however emphasized that this disparity may be due to scores being low across all stages. Siracuse continues: “The PCS is focused on physical aspects and the VascuQoL and EQ-5D have a high focus on physical health components. One possibility is that the physical impairment associated with all stages of CLTI is advanced, and thus, any differences between stages will be much less pronounced.”

Development of a “CLTI-specific” instrument to evaluate HRQoL is needed, Siracuse determined, noting their study had limitations, including the influence of the site of survey administration (clinic or preoperative area) on patient responses. Patients were also asked to complete the survey after they had been made aware of their limb threatening condition. Furthermore, the measurement instruments have not been individually validated for CLTI which required the use of multiple questionnaires.

Reflecting on the continued research required in this area, Siracuse observed: “An improved understanding of HRQoL considerations could better guide care for this complex and vulnerable patient population and enhance patient engagement for joint decision-making.”

Surmodics provides regulatory update related to FDA premarket approval application for SurVeil

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Surmodics provides regulatory update related to FDA premarket approval application for SurVeil

SurmodicsSurmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).

In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. The letter stated that certain information within two general categories—biocompatibility and labelling—must be added by an amendment to the company’s PMA application to place it in approvable form. Although the information identified by the FDA to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data.

“We are disappointed by the FDA’s response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the TRANSCEND clinical study,” said Gary Maharaj, chief executive officer of Surmodics. “We are evaluating the issues raised in the FDA’s letter and plan to meet with Agency representatives regarding its contents. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development. We expect to address these topics further in connection with our upcoming first quarter fiscal 2023 earnings call.”

Surmodics notes in a press release that the SurVeil DCB is a next-generation device for the treatment of peripheral arterial disease and includes a proprietary drug-excipient formulation using an innovative process to improve coating uniformity. The company advises that, in the U.S., the SurVeil DCB is an investigational device, limited by Federal law to investigational use.

Bentley launches rebranded crossing catheter

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Bentley launches rebranded crossing catheter

Germany-based endovascular device company Bentley announced the launch of the BeBack crossing catheter—formerly known as the GoBack—designed for the treatment of heavily calcified lesions above and below the knee.

Bentley acquired the catheter in September 2022 from Upstream Peripheral Technologies, of Caesarea, Israel. The now re-branded BeBack crossing catheter is available in an 80cm and 120cm catheter in both 2.9F and 4F sizes.

The device makes use of a steerable and in-length adjustable nitinol needle, which can be used for crossing and targeted re-entry purposes, according to Bentley.

“A radiopaque marker indicates the direction in which the curved needle protrudes from the tip of the catheter,” the company says. “Multiple treatment options like antegrade, retrograde and crossover are possible with the BeBack catheter for intraluminal and subintimal approaches of stenotic or occluded lesions.”

The BeBack is CE marked and Food and Drug Administration (FDA) cleared.

Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study results show

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Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study results show
Human Acellular Vessel
Human acellular vessel

Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection or infection, the authors reported.

Humacyte, the biotechnology platform company behind the product, said the publication describes the long-term analysis of the clinical trial as it evaluates the bioengineered HAV as a conduit in patients with symptomatic peripheral artery disease (PAD). The research team, led by first-named author Piotr Gutowski, MD, from the Department of Vascular Surgery at Pomeranian Medical University of Szczecin in Szczecin, Poland, concluded that “the infection-resistant, off-the-shelf human acellular vessel could provide a durable alternative conduit in the arterial circuit setting, to restore lower extremity blood supply in patients with peripheral artery disease.” The results were recently published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).

No patients underwent amputation of the affected limb out to six years, they found, and none reported pain at rest or ischemic ulcers on the affected legs. Gutowski et al reported that “these data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodeling by the host.”

Gutowski commented: “Synthetic grafts can be limited due to poorly matched mechanical compliance, risk of infection, and variable patency rates. Furthermore, cryopreserved allogenic grafts are limited due to poor durability, thrombosis, and mechanical degradation. The HAV is designed to be consistent in size, durable in high-pressure circulation, show no clinical immunological response, and remodel with the patient’s own cells.”

The HAV has been evaluated in eight clinical studies in the U.S., Europe and Israel, including an ongoing phase II/III clinical trial in vascular trauma and an ongoing phase III trial as a hemodialysis access in end-stage kidney disease. The HAV is an investigational product and has not been approved for sale by the Food and Drug Administration or any international regulatory agency.

JVS group: Further changes in store for 2023

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JVS group: Further changes in store for 2023
Ronald Dalman

The planned changes for 2023 for the Journal of Vascular Surgery publications continue the momentum that began in mid- 2022. As former Editor-in-Chief Peter Gloviczki, MD, and Senior Editor Peter Lawrence, MD, ended their six-year run as editors of all publications, a restructuring took place. Ronald Dalman, MD, was named executive editor to oversee all things JVS and to enhance brand identity for the publications. 

Separate editors also were appointed to lead each journal: Thomas Forbes, MD, editor-in-chief of JVS; Ruth Bush, MD, and Matthew Smeds, MD, editors-in-chief of JVS: Venous and Lymphatic Disorders (JVS:VL) and JVS-Cases, Innovations and Techniques (JVS-CIT), respectively; and Alan Dardik, MD, from editor to editor-in-chief of JVS-Vascular Science (JVS-VS). 

Other changes and additions planned for this year include: 

  • Focus on author experience as a priority for all JVS journals, including expectation of a less-than-30-day interval from submission to first decision 
  • Updated editorial board lineups for each JVS specialty journal 
  • Adoption of new guidelines for aspiring editorial board (EB) members, with defined and transparent metrics for EB selection and further leadership opportunities going forward 
  • A social medial editor for each journal, with assistance from SVS JVS-assigned staff 
  • Expansion of Audible Bleeding podcasts highlighting Editors’ Choice of the month articles, featuring editorial team interviews of selected authors to get the “story behind the story.” Selected articles will rotate between portfolio journals each month 
  • The official transition in January of JVS:VL from print to digital. The switch to digital-only reduces not only costs but also its environmental footprint 
  • A virtual special issue on peripheral arterial disease (PAD) in JVS-VS guest edited by Alan Daugherty, PhD, and David Vorp, PhD 
  • JVS-CIT’s inaugural “Virtual Special Issue” on new developments in treating PAD. Frank Arko, MD, of the Sanger Heart and Vascular Institute, will guest-edit the issue, which editors hope to have online in the spring. An additional special issue is planned for later in the year. 
  • The introduction of “How I Do It” articles in JVS-CIT, highlighting the work of surgeons known to excel at particular procedures 
  • JVS-CIT articles taking a different focus, including “Cases in Leadership,” written by graduates of the SVS Leadership Development Program 

“We’re excited about what we’re introducing this year,” said Dalman. “Our editors have lots of ideas on how to increase engagement and make our journals even more relevant to our members and others in the vascular surgery specialty.”

SVS unveils latest addition to JVS family of publications

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SVS unveils latest addition to JVS family of publications
New SVS journal, JVS-Vascular Insights

The year 2023 promises to be one of change for the Journal of Vascular Surgery (JVS) family of publications, including the introduction of a fifth journal. JVS-Vascular Insights (JVS-VI) launched this month as an online-only, open-access (non-subscription) title. This model is similar to that of JVS-Cases Innovations and Techniques (JVS-CIT) and JVS-Vascular Science (JVS-VS). The second journal, JVS: Venous and Lymphatic Disorders, (JVS:VL) remains a subscription-based publication. 

Launching the new publication, said Executive Editor Ronald Dalman, MD, “reflects the shared vision of the Society for Vascular Surgery (SVS) and Elsevier to further enhance the relevance of the JVS portfolio for today’s vascular specialist.” 

Insights will not focus on particular topics, such as vascular disease, veins, hard sciences, or technology and innovation and cases. Instead, editors would like qualitative, hypothesis-generating, and background research (trial planning) manuscripts; review articles; single-center quality improvement projects; practice management, business and ethics topics; as well as commentaries and historical vignettes. 

Manuscripts now featured in the JVS “Education Corner” will be transitioned to JVS-VI later this year, and case-by-case, targeted manuscripts are being redirected from the other journals to JVS-VI. 

Dalman said a finer focus will evolve over time, but he said it is already clear that the new title’s dedicated education forum will provide for a “far more robust consideration” of the topic than was possible previously because of space limitations. 

“Perhaps most importantly, however, our hope is that JVS-VI will engage new constituencies within vascular surgery, including the SVS Community Practice Section, to contribute those members’ insights and best practices into the lexicon of contemporary vascular care,” said Dalman. 

“As the SVS/American College of Surgeons Vascular Center Verification and Quality Improvement Program (VCVQIP) begins its rollout later this year, JVS-VI will be an ideal forum to consider the effectiveness and impact of this partnership.” 

Dalman will lead JVS-VI through the initial launch period, with active support from the editorial leadership of the other four journals. 

Late last year, it was announced that JVS:VL was going green. From this month, the publication is published exclusively online. 

“Society for Vascular Surgery [SVS] members, and millions of people throughout the United States and the world, are concerned about the environmental impact of the choices we make,” said JVS:VL editor-in-chief Ruth L. Bush, MD, explained of the decision to cease print publications of the journal. 

SVS ends 2022 with latest ‘Week of Action’ to prevent Medicare payment reductions

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SVS ends 2022 with latest ‘Week of Action’ to prevent Medicare payment reductions
SVS members were asked to join in a push to prevent Medicare cuts by urging Congress to take action

The Society for Vascular Surgery (SVS) issued its thanks to December “Week of Action” participants.

Once again, SVS members showed incredible support for the Society’s advocacy efforts by engaging in the week’s various activities and continuing to amplify the specialty’s collective voice on Capitol Hill, according to the SVS. 

During the Week of Action, members were asked to join in a year-end push to prevent significant Medicare payment cuts by urging Congress to take action to address the critical issue before the end of its session. 

More than 700 messages were sent asking for the inclusion of new funds in year-end legislation for the explicit purpose of increasing the non-facility/office-based practice expense relative value units (RVUs) negatively impacted by the clinical labor update policy from the Centers for Medicare & Medicaid Services (CMS). 

These messages also included a parallel push to offer relief from the underlying fee schedule conversion factor adjustment, as provided in legislation introduced by Reps. Ami Bera, MD, and Larry Bucshon, MD (H.R. 8800). In tandem, advancement of these policies would help provide critical stability for vascular surgeons and ensure a positive foundation for ongoing deliberations regarding systemic reforms to Medicare physician reimbursement. 

Sending these messages wasn’t the only way members helped advocate during the Week of Action. Members also helped raise the profile of vascular surgery by promoting the specialty’s key issues on social media. Across all networks, more than 10,000 social media impressions, or “views,” were garnered. 

The SVS Advocacy Council thanked all those who took part for remaining engaged and determined to advocate for the vascular surgical specialty. “With the start of the 118th Congress, there is much work to be done, and the Council looks forward to continuing to facilitate opportunities for SVS members to engage in advocacy,” Council staff said.

Vascular Specialist–January 2023

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Vascular Specialist–January 2023

In this issue:

  • From SAVS 2023: Study probing which CKD patients would benefit most from renal artery stenting points toward those who experience a more rapid decline in renal function over six months prior to the procedure (p. 1 and 4)
  • SVS Foundation changes name of program aimed at providing care for underserved patients (p. 1 and 8)
  • SVS mourns passing of former President James S.T. Yao, MD (p. 1 and 17)
  • Christopher Audu, MD, ponders his vascular surgical loves in Corner Stitch (p. 6)

 

SVS Foundation: ‘Gatsby’ Gala tickets on sale

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SVS Foundation: ‘Gatsby’ Gala tickets on sale
The SVS Foundation’s 2023 Gala tickets are now on sale

Book your trip to the Roaring Twenties early, and save some money, perhaps for auction items. Early-bird ticket sales for the Society for Vascular Surgery (SVS) Foundation’s “Great Gatsby Gala,” to be held at the 2023 Vascular Annual Meeting (VAM), have begun. Tables of 10 will be available for $5,000, $7,500 and $12,000. 

This year’s Gala will transport attendees to the 1920s and the Jazz Age, the setting for the classic F. Scott Fitzgerald tale of mysterious millionaire Jay Gatsby. The “Gatsby Gala” will be held the evening of June 16 and will include the Surgeon Speakeasy Cocktail Reception, dinner, entertainment, live and silent auctions, and dancing. All proceeds will benefit the SVS Foundation and its efforts to fund the future of vascular health. 

Individual ticket sales will start at $500, beginning Jan. 20. This year, the Foundation is pleased to make a limited number of tickets available for young surgeons. “All of us involved in planning the Gala know that our young surgeons would probably find it hard to swing a $500 ticket,” said Gala Co-Chair Leigh Ann O’Banion, MD. “But as the future of the specialty and our Society, we want them to participate in this celebration of all things vascular.” 

Besides general sales, the SVS is offering a number of sponsorship opportunities and table ticket levels. 

SAVS 2023: President reveals upcoming change to Society seal

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SAVS 2023: President reveals upcoming change to Society seal
William D. Jordan Jr.

Southern Association for Vascular Surgery (SAVS) President William D. Jordan Jr., MD, used a portion of his 2023 Presidential Address to outline ways in which SAVS is set to further evolve as a professional body going forward.

Titled “Anatomy and physiology: 2.0,” Jordan’s lecture tackled the structure and function of vascular surgery as a specialty, and SAVS as a surgical society, as he addressed a need for change.

One aspect of SAVS set to evolve, he revealed, is the Society’s signature seal, a depiction of 19th-century pioneering surgeon Rudolph Matas, MD (1860–1957), who was selected by SAVS founding members to adorn the logo as an embodiment of the qualities they believed a southern vascular surgeon should possess.

Jordan told SAVS 2023 that SAVS had become aware of concern “that our image among many young surgeons is negatively impacted by having his likeness on our seal. Many of us have great respect for the work he has done, but some have expressed concern about parts of his academic work that was offensive and not respectful to disadvantaged groups of the day. He wrote about medical conditions of many Black patients without obtaining their consent for medical research. While accepted then, it would be considered inappropriate today.

“In our efforts to improve our Society, we turn our eyes to the future” Jordan continued. He said the Society leadership is focused on exploring ways in which SAVS can meet the needs of the current and future generations of vascular surgeons. “As a sign of this commitment,” he said, “your Executive Council voted to redesign our Society’s seal, create a new seal that will exhibit the standards of our professional society, and remains true to our mission of promoting the art and science of vascular surgery and providing comprehensive vascular care.”

SAVS members are being asked to participate in the redesign: “Submit your ideas and be creative; show us that we can remain the best regional vascular society,” Jordan added.

SVS Foundation changes name of program aimed at providing care for underserved patients

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SVS Foundation changes name of program aimed at providing care for underserved patients
The VISTA program is now Vascular Care for the Underserved™

The Society for Vascular Surgery (SVS) Foundation program formerly known as VISTA has a new name. VISTA—an acronym for Vascular Volunteers In Service To All—is now simply Vascular Care for the Underserved™. Its mission, however, remains the same: “to provide outreach, screening and other resources to those who are impacted by lack of access, inadequate resources and/or distance from modern healthcare facilities.” 

With many SVS members expressing interest in addressing disparities in care, and building on the Foundation’s successful grant programs for community awareness and prevention, the program provides opportunities for vascular surgeons to make a direct impact on patients. 

Vascular Care for the Underserved™ focuses particularly on bringing vascular care to underserved populations, such as Black, Native American, and Hispanic patients, and all those who lack access due to low socioeconomic status. 

“The new name better reflects what our goal is: to provide programs and resources to those who, for whatever reason, are underserved in terms of healthcare,” said SVS Foundation Chair Peter Lawrence, MD. “That’s the aim of our pilot programs, which will bring healthcare to people in need, particularly those with diabetes, and the homeless.” 

The program is being implemented through a phased approach, with two new programs recently approved. 

Three existing projects are “Disparities in Access to Care for Limb Salvage: The Oklahoma Project,” headed by Kelly Kempe, MD; “A Patient-Centered Approach to Reduce Diabetes-Related Lower Extremity Amputations among Underrepresented Minorities,” from Jospeh Mills, MD; and a project from Misty Humphries, MD, named “Targeted Outreach in Vascular Deserts to Improve Outcomes for Chronic Limb-Threatening Ischemia.” 

“Lack of appropriate care leads to limb loss, stroke, death and other serious issues,” said Lawrence. “And many of these situations are avoidable—if we can just get patients appropriate care. That is what this program strives to address.” 

The top 10 most popular Vascular Specialist stories of December 2022

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The top 10 most popular Vascular Specialist stories of December 2022

Among the most-read Vascular Specialist stories in December 2022 were the promising results  from a postmarket surveillance study of a paclitaxel DCB; the Society for Vascular Surgery (SVS) paid tribute to the passing of former president James (Jimmy) S.T. Yao, MD; Monica Majumdar, MD, presenting data at the 2022 Eastern Vascular Society (EVS) annual meeting showing an increase in female-driven research and SVS reveal its top priorities for the coming decade.

1. MVSS 2022: Study finds no link between frailty score and surgical site infection

A vascular surgery-specific composite frailty score was not associated with risk of surgical site infection in patients undergoing lower-extremity revascularization in a review carried out by Andrew Edsall, MD.

2. Bright future predicted for JVS internship program

Christopher Audu, MD, profiles Ulka Sachdev-Ost, MD, and Anand Brahmandam, MD, for the new and innovative Journal of Vascular Surgery (JVS) internship program.

3. SVS mourns the passing of former president

SVS members are mourning the death of James (Jimmy) S.T. Yao, MD, 88, former SVS president and Lifetime Achievement Award recipient. Yao died Tuesday, Dec. 20, in Chicago. He had been a very active member of SVS since 1974, holding many roles, including that of president in 1993.

4. Women’s Vascular Summit: Diving into issues around women’s vascular health and the female workforce

Ahead of The Women’s Vascular Summit 2023, meeting founder and course director Linda Harris, MD, tells Vascular Specialist about why the meeting came to be, and how it is being used to advance the cause of greater diversity and equity among the vascular workforce, and solve enduring disparities in vascular disease outcomes.

5. Paclitaxel DCB performs well in ‘challenging anatomy’ of femoropopliteal in-stent restenosis, VQI registry data show

The IN.PACT Admiral DCB (Medtronic) shows promising results in treating femoropopliteal in-stent restenosis (ISR) in a SVS Vascular Quality Initiative (VQI) registry-based, postmarket surveillance study presented by Daniel Bertges, MD.

6. BEST-CLI: Optimal medical therapy adherence ‘well below’ recommended level at baseline

A significant proportion of patients enrolled in the BEST-CLI trial did not meet OMT guideline-based recommendations at the time of their entry into the study, co-principal investigator Matthew Menard, MD, told the 2022 New England Society for Vascular Surgery (NESVS).

7. Endologix receives FDA approval of PMA supplement for AFX2 system

Endologix announced in December that it has received Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system.

8. EVS 2022: New study shows ‘encouraging increase in academic footprint of female-driven research’

Monica Majumdar, MD, a general surgery resident at Tufts Medical Center in Boston, presented data on how vascular surgery compares to other specialities in the growth of gender diversity in published research. “Are we leaders in the field, or are we trailing?”

9. Vascular trainee-developed VSITE review book sees sales soar

A new review textbook developed by a vascular surgery resident with the aim of helping fellow trainees prepare for milestones like the VSITE has accumulated sales of around 500 copies across some 14 different countries.

10. SVS reveals research priorities for next decade

The Society for Vascular Surgery (SVS) Research Council updated its top 10 research priorities in December, originally published in 2011, with patient-centered outcomes and personalized vascular care at their core, and a new emphasis on healthcare disparities.

SAVS 2023: Study points toward CKD patients who would most benefit from renal artery stenting

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SAVS 2023: Study points toward CKD patients who would most benefit from renal artery stenting
J. Gregory Modrall

A new study probing which chronic kidney disease (CKD) patients would benefit most from renal artery stenting points toward those who experience a more rapid decline in renal function over six months prior to the procedure. 

It is an area that has been a source of great frustration for vascular surgeon J. Gregory Modrall, MD, ever since, in 2014, the CORAL (Cardiovascular outcomes in renal atherosclerotic lesions) trial established no benefit from renal artery stenting over medical therapy in patients with CKD. It created, the professor of surgery at the University of Texas (UT) Southwestern Medical School in Dallas told Vascular Specialist, “a state of therapeutic nihilism, if you will, in our specialty on how to manage people with renal artery stenosis, and either hypertension or CKD.” Why? The patients kept coming, he said. And vascular surgeons were left with less certainty regarding how they should treat them, he said. 

So Modrall and colleagues set about identifying putative predictors to be able to select patients for renal artery stenting who are most likely to benefit. They dug into the Veterans Affairs Corporate Data Warehouse to find 695 patients who underwent renal stenting between 2000 and 2021, categorizing them as “responders” if eGFR (estimated glomerular filtration rate) at 30 days or greater post-stenting increased 20% compared to pre-stenting. All others were “non-responders.” 

The results were stark. Presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 18–21) in Rio Grande, Puerto Rico, they revealed that patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73m2) are the only sub-groups with a significant probability of improved renal function after renal stenting, with the rate of decline of preoperative eGFR over the months prior to stenting a powerful discriminator of patients who are most likely to benefit. 

“Both of those are helpful to clinicians because we can then look at the patient’s history of where their renal function is currently when we see them in the office, and where it’s been for the last six–nine months,” Modrall explained, “and we can make a much more educated estimation of the probability of improved renal function when we stent them. 

“By the same token, on the flip side of that is, if a patient has, for instance, very flat renal function over six or nine months prior to stenting, we can tell the patient that the probability of improved renal function is so low that it doesn’t even merit the treatment. That’s a huge help to clinicians.” 

The third—and negative—predictor, the research team uncovered in the study, is diabetes, Modrall continued. “This turned out to be an interesting finding that we have now seen in two successive studies with different datasets,” he said. “What that tells us is that, probably, with many patients with diabetes, their kidney is probably already too injured to benefit from stenting. While we’re not saying you shouldn’t stent those patients, we certainly would say you should be very circumspect and careful about choosing patients for stenting if they have diabetes.” 

Importantly, Modrall pointed out, the predictors highlighted in the study are “putative,” or “candidate predictors,” that have not been validated in a prospective series. “The next step is to take the data from this study, combine it with two of our prior studies, and in doing so we will have close to 1,800 patients with renal artery stents,” he said. “That represents the single largest dataset of renal artery stenting patients in existence to my knowledge.” 

Modrall and his team hope to then leverage the enlarged dataset to create an outcome prediction tool that clinicians could use in practice. He envisages a desktop- or phone-based application into which a patient’s parameters could be inputted in order to establish a probability of improved renal function. “We’re not there yet; we don’t with 100% certainty know that that would be feasible,” Modrall conceded. “But that is the goal, and that is where we are beginning to work currently.” 

Modrall believes the study also showcased the “unique partnership” between an academic institution, UT Southwestern, and a Veterans Affairs facility, the Dallas VA Medical Center, where he also holds an appointment. “This really benefits both facilities, both institutions and all of their patient populations,” he added. 

SAVS 2023: Planned and unplanned vascular assists found to improve outcomes

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SAVS 2023: Planned and unplanned vascular assists found to improve outcomes
Emma Rooney, center, collects the 2023 Founders Award at SAVS in Rio Grande, Puerto Rico, from moderators Adam Beck, MD, left, and Salvatore Scali, MD

An award-winning paper presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico, established an association between vascular involvement in non-vascular-led cases, where vascular expertise was required, and improved patient outcomes.

Emma Rooney, MD, a vascular surgery fellow at Emory University in Atlanta, collected SAVS’ prestigious Founders Award for the work on the first day of the meeting (Jan. 18–21). The study showed vascular involvement improved outcomes in cases where that participation was both planned and unplanned 

The retrospective analysis carried out by Rooney and colleagues looked at 245 patients treated at three non-trauma hospitals who had vascular surgery involvement in their cases led by a non-vascular surgeon. 

“Our initial interpretation was that we had improved outcomes in the planned cases because they did have favorable outcomes intraoperatively and postoperatively,” Rooney told SAVS attendees. However, upon further interpretation, Rooney said the analysis uncovered equivalent mortality in cases classed as unplanned, suggesting the specialty’s “high ability” to deal with complications. 

Membership clears bylaws changes

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Membership clears bylaws changes

The Society for Vascular Surgery (SVS) voting membership voted to approve proposed changes to the bylaws that will change the composition of the Society’s Nominating Committee. 

A minimum of 150 votes is required to establish quorum and this was exceeded with 284 votes registered. A two-thirds majority of those voting is required for bylaws passage, and this was exceeded with 77.5% support. Members voted in favor of three revisions to Article X of the SVS bylaws. 

The committee’s size will remain the same, at seven members, but expand the diversity of perspective. 

The changes affect the process for nominating SVS officers for 2023–24, which begins this month. The chair of the 2023 Nominating Committee is Kim Hodgson, MD. 

Intraoperative Positioning System (IOPS): Navigation technology to reduce radiation exposure and improve accuracy during complex aortic procedures

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Intraoperative Positioning System (IOPS): Navigation technology to reduce radiation exposure and improve accuracy during complex aortic procedures

This video is sponsored by Centerline Biomedical.

Matthew Eagleton, MD, chief in the division of vascular and endovascular surgery at Massachusetts General Hospital in Boston, is joined by fellow vascular surgeons Francis Caputo, MD, vascular surgery director of the Cleveland Clinic Aortic Center in Cleveland, and Satish Muluk, MD, assistant director for vascular surgery at Allegheny General Hospital in Pittsburgh, to discuss the FDA-cleared, Intraoperative Positioning System (IOPS) from Centerline Biomedical.

Caputo and Muluk describe their experience with IOPS’s 3D, non-radiation-based navigation in a range of complex procedures. “By using IOPS, you have the virtual gantry that allows you to really navigate—it’s actually very intuitive,” remarks Caputo.

Deadlines coming for scholarships, grants, awards

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Deadlines coming for scholarships, grants, awards
SVS and SVS Foundation awards deadlines are coming thick and fast

Deadlines arrive by March 1, with some as early as this month, for a number of Society for Vascular Surgery (SVS) and SVS Foundation awards, grants and scholarships.

SVS awards 

Feb. 1, 2023: Excellence in Community Practice Award, bestowed on members who have exhibited outstanding leadership within their communities as practicing vascular surgeons. 

March 1, 2023: The Lifetime Achievement Award and the Medal for Innovation in Vascular Surgery. The first is SVS’ highest honor, recognizing an individual’s outstanding and sustained contributions to the profession and the SVS, alongside his or her exemplary professional practice and leadership. Jonathan Towne, MD, received the award in 2022. The Medal for Innovation—awarded intermittently—honors individuals whose contributions have had a transformative impact on the science or practice of vascular surgery. The most recent honoree is Robert Kistner, MD, who received the accolade in 2019. Visit vascular.org/Awards for information on SVS awards. 

SVS Foundation Awards 

Feb. 1, 2023: Student Research Fellowship, intended to stimulate laboratory and clinical vascular research by undergraduate and medical school students attending universities in the United States and Canada. 

March 1, 2023: Clinical Research Seed Grant, to encourage interest in the development of clinical investigators among SVS members, particularly junior ones; the grant provides direct support for pilot clinical projects that can develop into larger studies funded by industry or government sources. The investigators are expected to conduct patient-oriented research, interacting directly with human subjects. 

Visit vascular.org/FoundationGrantsAwards. 

Viz.ai launches AI-powered Viz Vascular Suite

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Viz.ai launches AI-powered Viz Vascular Suite
Viz Vascular Suite

Viz.ai has announced the launch of Viz Vascular Suite—artificial intelligence (AI)-powered software enabling vascular care teams to automatically detect and triage care for suspected pulmonary embolism, right heart strain, aortic dissection, and abdominal aortic aneurysm (AAA). The company submitted a new 510(k) application to the Food and Drug Administration (FDA) for the AAA algorithm, a press release notes.

“Recognizing the symptoms of serious vascular conditions, such as aortic dissections, is hugely important because any delay in treatment can have a direct impact on patient outcomes,” said Philip Batista, MD, Cooper University Health Care, Camden, New Jersey. “When Viz identifies an abnormal scan, it quickly notifies the appropriate specialists regardless of their location, facilitating seamless communication via mobile application. We have been using the Viz software for the last several months and have seen improvements in patient care across our institution.”

Viz.ai says that the Viz Vascular Suite uses AI to automatically analyze an array of imaging modalities, including computerized tomography (CT), electrocardiogram (ECG), and more for suspected vascular diseases. If a suspected pathology is found, the app automatically alerts and displays high-fidelity patient scans on providers’ mobile devices. Clinicians can use Viz Vascular Suite to remotely coordinate vascular pathology care within a hospital system’s hub and spoke network and enable synchronous, HIPAA-compliant communication among specialists. The platform is enhanced by AI for immediate team activation and facilitates informed, efficient treatment decisions.

Medtronic announces first enrollment in head-to-head global randomized trial evaluating durability of EVAR

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Medtronic announces first enrollment in head-to-head global randomized trial evaluating durability of EVAR
Marc Schermerhorn, ADVANCE trial co-principal investigator

Medtronic has announced the first patient enrollment in the ADVANCE trial, a head-to-head randomized controlled trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs stent graft system and Gore Excluder abdominal aortic aneurysm (AAA) device family systems.

The ADVANCE trial is a global, post-market, prospective, interventional, multicenter, randomized study that will enroll a minimum of 550 patients at up to 50 centers globally. Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant family or Excluder family grafts and will be followed at one month, one year, and annually through five years.

The first patient in the ADVANCE trial was enrolled by the team led by Ray Workman, MD, at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina.

“Through the ADVANCE trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” said Hence Verhagen, MD, professor of Vascular Surgery at Erasmus Medical Center in Rotterdam, the Netherlands, and co-principal investigator of the trial. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”

The ADVANCE trial aims to further the understanding of sac regression by robust evaluation of CT imaging utilizing an independent core lab through five years. The trial will provide a comparison of aneurysm sac regression outcomes between the Medtronic Endurant II/IIs stent grafts and the GORE Excluder AAA device family stent grafts with additional evidence to analyze risk factors related to aneurysms that fail to regress. The trial will also compare other key clinical outcomes between the two stent grafts, including endoleaks, migration, secondary interventions, mortality, and renal complications.

“We are pleased to announce the first patient enrolled in the ADVANCE trial,” said Marc Schermerhorn, MD, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center in Boston, and co-principal investigator of the trial. “This milestone underscores the commitment to rigorous study of the long-term data around the durability of the Endurant system for patients in need of EVAR. The results of the trial aim to demonstrate contemporary outcomes and our overarching goal to deliver superior aortic patient care through robust and rigorous clinical data.”

The ADVANCE trial draws on clinical data showing that one-year sac regression is an early indicator of improved long-term survival. The outcomes were consistent with the eight-year results from the ENGAGE OUS Registry, published in January 2022, which demonstrated the long-term clinical safety and effectiveness of the Endurant Stent Graft System. The ENGAGE OUS Registry followed subjects through 10 years.

The Endurant II/IIs bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. Endovascular stent grafting may be an option for patients who have a AAA as determined by a vascular specialist.

ESVS AAA guidelines alert recommends ‘enhanced surveillance’ in patients treated with Nellix device

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ESVS AAA guidelines alert recommends ‘enhanced surveillance’ in patients treated with Nellix device
Nellix endovascular aneurysm sealing (EVAS) system
Nellix EVAS system

In a newly released “focused update” to their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice on the surveillance and management of patients treated with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix).

The committee advises that all patients in whom a Nellix device has been implanted “should be identified, properly informed and enrolled in enhanced surveillance.” If device failure is detected, it states that “early elective device explant should be considered in surgically fit patients”.

The alert, authored by Jon Boyle (Cambridge University Hospitals NHS Trust and University of Cambridge, Cambridge, UK) et al, was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

Boyle and colleagues note that they performed a scoping review of risk for late serious aortic-related adverse events in patients treated with EVAS for AAA based on a literature search in PubMed up to 7 December 2022. Following synthesis of the available evidence, the writing committee agreed on recommendations graded according to the European Society of Cardiology (ESC) grading system.

“EVAS has a very high incidence of late endograft migration resulting in proximal type 1 endoleak with risk of rupture, requiring open conversion with device implant,” the authors write, detailing their key finding from the review. They add that the reported mortality for elective explantation varies between 0% and 14%, while acute conversion for rupture has a “very dismal prognosis” with 67–75% mortality.

The authors detail that ESVS guidelines are renewed every five years or so, and that ESVS focused updates are issued “to convey important new data that have emerged in between the publication of the full guidelines, that affect patient safety or impact decision-making or management of the patients”.

In their 2019 guidelines on the management of abdominal aortoiliac artery aneurysms, the writing committee recommended that “conceptual new technologies, such as [EVAS], should only be used within studies approved by research ethics committees and with informed consent, until properly evaluated”.

In May of last year, Endologix ended production of the Nellix EVAS system, based on reportedly higher rates of leaks around the device’s implantation, endograft migration and aneurysm sac enlargement. The guideline committee recognised, however, that there was no clear guidance on surveillance and management of patients who have already undergone AAA repair with an EVAS device. It was for this reason that the ESVS AAA guidelines writing committee initiated a literature review on the topic. “The current accumulated knowledge suggests that patients treated with EVAS for AAA may be at high risk for serious aortic-related adverse events, which justified an updated guidance on the surveillance and management of patients already treated with EVAS,” they write in the new paper.

Commenting on the timing of the alert, the committee note that they decided it was important to publish before the fully updated guidelines will be available in 2024, “to highlight the issues with EVAS failure, to promote patient safety and to encourage clinicians to identify all patients in whom a Nellix device has been implanted”.

Deadline extension: VRIC 2023 abstracts now due Jan. 18

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Deadline extension: VRIC 2023 abstracts now due Jan. 18
Boston Harbor

The Jan. 11 deadline to submit research abstracts on vascular disease and treatment for the 2023 Vascular Research Initiatives Conference (VRIC) has been extended to Jan. 18 due to a high volume of requests. 

With early-bird registration anticipated to open Feb. 1 for VRIC—which focuses on emerging vascular science and is considered the SVS’ annual meeting for basic and translational research—submissions will now be taken through 6 p.m. CST on the new cut-off day.

VRIC will be May 10 in Boston and is held in conjunction and in the same location as the American Heart Association’s “Vascular Discovery: From Genes to Medicine” meeting on May 10–13. Learn more at vascular.org/VRIC23.

Submissions for the 2023 Vascular Annual Meeting (VAM) closed at 3 p.m. CST on Jan. 11. VAM 2023 will be June 14–17 at the Gaylord National Resort and Convention Center in National Harbor, Maryland, just outside Washington, D.C. Education runs across all four days; exhibits will be open June 15 and 16. The SVS “Great Gatsby Gala,” to benefit the SVS Foundation, will be the evening of June 16. Learn more at vascular.org/VAM.

SVS webinar on 3D printing showcases how technology could affect current and future practice

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SVS webinar on 3D printing showcases how technology could affect current and future practice
Scenes from the SVS 3D-printing webinar

The recording of the Society for Surgery (SVS) webinar on three-dimensional (3D) printing in vascular surgery is now available on the SVS website. 

The SVS Health Information Technology Committee (HIT) held the webinar, “3D Printing for Vascular Imaging,” in December 2022. Committee Chair Judith Lin, MD, and member Dan Kassavin, MD, co-moderated the webinar. Nick Carruthers, MD, Stacy Fisher, MD, Jeffrey Hirsch, MD, and Nicholas Osborne, MD, presented various aspects of 3D printing and its uses. 

“Three-dimensional imaging is becoming an essential tool in the workplace, including in medicine,” said Lin. 

Carruthers began the webinar with an overview on the use of 3D as well as a demonstration of how to “create a model from a CT scan and then print it mainly using consumer-grade printers and materials available to almost anybody.” 

Osborne demonstrated, in-depth, how to use the technology for complex aneurysm planning and practice for actual surgery. His conclusions are that such printing in these cases has value in planning, in education for residents, explaining details to patients, and operating room back-table customization. 

Fischer and Hirsch related how using 3D printing to make surgery safer for Fischer’s congenital heart disease patients led to requests from vascular surgeons to similarly help with aneurysm repair. The two also discussed which kind of imaging has led to the most success in 3D modeling; software; future directions, including personalized medicine with 3D models as part of a patient’s records; education; consultation with other providers; and more. 

“3D printing has become the largest instructive technology shift since the internet,” Lin said at the webinar’s conclusion. “It’s fascinating to see where technology will take us in the future and definitely something we look forward to.” 

The panelists’ information could “affect your current and future practices,” she told webinar participants, and the information presented during discussion could help surgeons take better care of their patients via various innovations. “Our next step is to strive for improvements in vascular care using these modern technologies,” she said. “Let’s innovate.” 

To view the recording visit vascular.org/3DprintingRecording. 

Penumbra launches Lightning Flash mechanical thrombectomy system

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Penumbra launches Lightning Flash mechanical thrombectomy system
Penumbra's Lightning Flash is the most advanced and powerful mechanical thrombectomy system on the market. It features Penumbra’s novel Lightning Intelligent Aspiration technology, now with dual clot detection algorithms.
Penumbra’s Lightning Flash

Penumbra have announced the Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.

“Lightning Flash features Penumbra’s novel Lightning intelligent aspiration technology, now with dual clot detection algorithms,” the company notes in a press release, adding that the system is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE).

“Penumbra’s Lightning Flash gives physicians a highly torqueable, larger catheter that is designed to remove a large clot burden in the pulmonary arteries or deep venous system more efficiently while maintaining an excellent safety profile because of Lightning’s computer-aided algorithms,” said James F. Benenati, MD, chief medical officer at Penumbra. “We believe that patients can have improved outcomes with this new technology because of the exceptional trackability and unique ability to distinguish flowing blood from clot.”

The company details that Lightning Flash, powered by the Penumbra Enging, uses both pressure and flow-based algorithms to detect blood clot and blood flow. The catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip designed to help navigate the complex and delicate anatomy of the body. When used together, the device is intended to help remove blood clots quickly while minimizing potential blood loss.

Lightning Flash is part of Penumbra’s Indigo system with Lightning portfolio.

Medicare payments: Congress fails to #StopTheFullCut

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Medicare payments: Congress fails to #StopTheFullCut

Despite intense pressure from the entire healthcare provider community, Congress failed to include provisions in its year-end legislative package to fully prevent Medicare payment cuts that took effect Jan. 1. 

The package—negotiated by congressional leadership—includes adjustments for the Medicare Conversion Factor (CF) for both 2023 (+2.5%) and 2024 (+1.25%) and postpones statutory “Pay Go” requirements to provide relief from an additional 4% reduction.

After accounting for these adjustments, both physician and non-physician clinicians should anticipate an across-the-board reduction of approximately 2% in Medicare payments for calendar year 2023, depending on services provided and any 2023 Relative Value Units (RVU) changes to those procedures. Additional reductions relating to year two of the clinical labor update policy transition will also apply, with a variable impact depending on practice type. 

The Society for Vascular Surgery (SVS) expressed disappointment that lawmakers are allowing any payment reductions to remain in place, a sentiment shared across the provider community 

Envision, private equity and patient care: Substituted values 2.0

Envision, private equity and patient care: Substituted values 2.0
Arthur E. Palamara

He was only 41, already burdened with multiple health problems. Diabetes, hypertension and renal failure had put him on dialysis, caused the amputation of his left leg, and now left him with poor circulation in his right leg. Signs of gangrene were already present in his toes. Only bringing more blood to his leg would prevent him from being a bilateral amputee, a condition that would place him entirely dependent on his family, who were already stressed by his debilitating illness. His two teenage sons visited him daily to give him courage. Only his mind remained mostly intact. And even then, his mental functions waxed and waned. 

Scheduled for an angioplasty in the early afternoon, his procedure was delayed by staffing issues: there were insufficient “anesthesia providers” to cover the case. The days of having a fully-trained anesthesiologist to provide anesthetic care were long gone. Previously, high-risk individuals like him were seen the night before, recommendations made, then delivered anesthesia the following day. Now, care was provided by anesthesiologists employed by a private equity firm, Envision Healthcare/KKR, an entity with different goals. Here, profitability was valued over patient care. Staffing was a problem, and high turnover resulted in a condition where the patient became a “case.” Whoever was available carried out the case, be it a doctor, a certified nurse practitioner or an anesthesia assistant. The shortage was made worse by the pandemic. Since large Wall Street firms cared little for their employees, the employees felt no loyalty to their employer, and moved from one hospital to another. The days of institutional loyalty were long over. 

The afternoon dragged on and the patient had not eaten since the day before. He received insulin that morning, but the insulin had little food to work on. The patient was sleepy but arousable. He smiled weakly, opening his eyes, and muttered a few incomprehensible words. His vital signs remained stable. One o’clock became two o’clock, then three then four. Finally, an anesthesia provider was found. He was placed on the radiology table and the case was set to begin. 

The nurse anesthetist, just assigned to the case, was very competent, but knew little about the “case” except an outline of his major problems. The procedure, minimally invasive, and done with local anesthesia and sedation, carried little risk of blood loss or serious complications. She gave the usual medications, the patient was prepped, and the procedure was about to begin. As the surgeon began, he felt no pulse in the femoral artery into which he was to place his needle. Wires and balloons would subsequently be inserted to open the blocked arteries. That was not to be. 

“Are we okay?” 

“Let me check,” the nurse anesthetist responded. 

He could hear the whirring of the blood pressure machine attempting, but failing, to find a blood pressure. The heart monitor recorded a stable heart rhythm, but the oxygen monitor bleeped a lower pitch with each heartbeat, consistent with falling oxygenation. 

“Start chest compressions! Call a code!” she yelled. 

A series of misadventures followed, and, while the heart was restarted, his brain—bereft of oxygen for an extended period of time—did not. He was left brain dead, and life support was discontinued two days later. 

Corporate overseers 

Reassessing this and similar events suggest that patients would be better protected by anesthesia departments that are staffed with a stable, dedicated and available workforce. Such aspirations are difficult to achieve in a Wall Street, entrepreneurial environment. The pandemic has taught us that physician and mid-level practitioners feel no obligation to corporate overseers who have asked them to provide service with little regard to their own well-being. This includes pay reduction, increased and dangerous staffing, liability exposure, and life-threatening illness. In fact, anesthesiologists look into the throats of mortally ill COVID-19 patients who potentially spew virus-laden droplets as endotracheal tubes are inserted into their windpipes. While these caregivers wear protective equipment, it is not a guarantee of their safety. Many of them have died. 

On April 20, Bloomberg News published a story describing KKR, or Kohlberg Kravis Roberts, one of the largest physician staffing companies in the United States, initiating a Chapter 11 bankruptcy. KKR was in the process of completing a leveraged buy-out of Envision, a company that employs a large number of anesthesiologists and radiologists. Envision’s debt of $1.23 billion has been trading at deeply reduced levels, about 30 cents on the dollar. Because of the pandemic and reduced outpatient/elective surgeries, Envision’s business was down about 70%. KKR agreed to buy Envision for $9.9 billion. Envision’s assets represent little more than an assemblage of physician contracts protected by restrictive covenants. Of course, like all good businesses experiencing declining revenue, it appealed to the federal government for a bail out under the CARES Act. 

Doctors and patients alike suffered the deleterious effects of this bankruptcy. Highly-skilled physicians were obligated by Envision to accept a “hold back” of a third of their 2019 salary. It was to be paid as a bonus on March 30, 2020. That “bonus” was canceled. Further, they were required to accept an indefinite 30% reduction of their current salary. 

More recently, an article was printed in the American Prospect by Eileen Appelbaum and Rosemary Batt—March 4, 2022— entitled “Envision Healthcare Hits the Skids,” which asserted: “Envision Healthcare—the private equity–owned emergency medicine group with some 70,000 health care professionals staffing 540 health care facilities in 45 states—is in serious financial trouble. Creditors have lost confidence in its ability to repay its huge debt. Envision’s $5.3 billion first-lien term loan, due in 2025, was trading in distressed-debt territory at the beginning of March 2022, at 73 cents on the dollar; and its senior unsecured note due in 2026 was trading at 53 cents on the dollar. How did this happen to the largest U.S. physician staffing firm, owned by KKR, one of the most financially successful private equity firms in the world? How can KKR extricate itself and protect its investment? And what happens to its doctors and patients?” 

Private equity firms like to boast about their closely guarded “secret sauce” recipe for how they buy a company, load it with debt, introduce new high-tech practices that increase efficiency and revenue, and then exit at a profit. But KKR and Envision demonstrate these assertions are empty. KKR acquired Envision in 2018 in a leveraged buyout that burdened the company with billions in debt. But KKR’s plan for paying off the debt, and garnering a high return for its investors, was low-tech. 

An article in Bloomberg by Eliza Ronalds-Hannon and Davide Scigliuzzo, from Oct. 5, 2022, details its immense challenge: Envision is in dire straits since it lacks the ability to support the roughly $7 billion debt that KKR structured into its 2018 buyout. Angelo Gordon & Co. and Centerbridge Partners, fund managers, were offering more than $1 billion of new capital. Even more unpalatable is the requirement that Envision must divest itself of its most profitable asset: AmSurg. Envision is in deep trouble because of high labor costs, patient-protection (surprise billing) legislation, as well as a drop in hospital visits. Further compounding Envision’s prospects are rising interest rates. Its position is additionally threatened owing to complex loans and bonds that make it difficult to determine Envision’s actual worth. Potential creditors have little protection and face steep challenges if faced with a default. A looming recession further dampens Envision’s chances of a successful outcome. 

What does this mean for anesthesiologists, surgeons and patients? Anesthesiologists are dedicated doctors who deal with complex patients in critical situations. Since they have little faith in their employers’ ability to pay them, and anticipate little future security, many have left for greener pastures. Locally here, three anesthesiologists resigned in the past month, while others are retiring. As such, hospitals have trouble recruiting new anesthesia providers. This lack of an essential service causes delays and postponement of cases. Complex cases are performed later in the day when adequately trained operating room personnel are not available. (Complications and mortality increase by 10% when cases are done “off-hours” or on weekends.) The “great resignation,” traveling nurses, and professional ennui have reduced the number of trained, experienced personnel. New hires are often unacquainted with complex procedures, which increases the chances of unfavorable outcomes. 

While most operations are straightforward, vascular cases are especially complex since many are hybrid. “Team” experience is the best safeguard to reduce errors. 

The anesthesia turnover is so great that it leads to loss of confidence in the person at the head of the table. With enthusiastic but inexperienced personnel providing anesthesia care, many anesthesia providers are unfamiliar with the surgeon and the procedure, and cannot anticipate what could potentially go wrong. Since most cases are being covered by nurse anesthetists or anesthesia assistants, albeit supervised by an anesthesiologist, newly minted providers lack the expertise to avoid trouble. 

The margin between success and failure is thin. Medicine is very personal. The surgeon looks the patient in the eye and assures them that they can expect a favorable outcome. It is incumbent that all of us as providers see patients as a person with a husband or wife, children and a life story. To the patient, the fact that the surgeon is unfamiliar with the anesthesia provider elevates their level of tension. Concern rises when this crucial element in the surgery is found to be untried and untested. 

The concerns cited above are real but correctable. Entities such as Envision/ KKR—interested as they are in their own profitability—provide no demonstrable benefit to patients, surgeons or hospitals. They provide even less benefit to the likes of anesthesiologists and anesthesia assistants themselves who are placed in an undesirable position through no fault of their own. These dedicated caregivers are additionally exposed to litigation, financial damages and professional sanctions. 

Envision/KKR’s position will become more precarious in 2023 and can only lead to under-performance of services. This will, by necessity, negatively impact on the quality of care. It is apparent that the solution lies in anesthesiologists (and mid-level providers) being hired by hospitals and treated as the dedicated professionals that they are. 

Hospitals may consider this an unnecessary administrative headache and financial burden, but their obligation to patients as well as protection of their reputation, make this an inevitable strategy. Private equity in healthcare consumes much, but yields little. 

Arthur E. Palamara, MD, is a vascular surgeon in Hollywood, Florida. 

Summit dedicated to tackling key issues related to women’s vascular health and female workforce seeks to ‘enable and empower’

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Summit dedicated to tackling key issues related to women’s vascular health and female workforce seeks to ‘enable and empower’
Linda Harris

Linda Harris, MD, is a prolific attendee on the national and regional vascular meeting circuit, a noteworthy academic vascular surgeon with trainees and papers on the scientific session plate, and a curious questioner of new research offered up from the podium. A few years back, she started to take serious note of a recurring theme. Harris, the vascular surgery program director at University at Buffalo in Buffalo, New York, had spotted a problem with papers delving into issues and outcomes related to disparities. 

“I was going to all the major national and regional meetings, and every meeting I would hear multiple papers saying women do worse, African Americans do worse, next paper, repeat, so we would hear the same mantra repeated over again that we acknowledge, ‘We have a problem with our patients,’ and yet we weren’t going anywhere,” she tells Vascular Specialist. 

The time had come, Harris figured, for a dedicated forum, “a venue [where] we can dive deeper into what the problem is, and, better yet, what can we do to change the outcome so that the answer is not women do worse, Blacks do worse, etc.,” she says. 

So was born the Women’s Vascular Summit, set to enter its 5th edition into the books. Harris, a course director and meeting founder, describes the meeting as having scored huge successes over the course, tackling both sides of its dual purpose: drilling down deeper on issues around women’s vascular health, and helping elevate and empower women vascular surgeons. 

This year’s iteration sees the summit take another leap forward: the creation of three research grants for mid-level women vascular surgeons who are interested in aortic disease. Scheduled to take place at Harris’ own Jacobs School of Medicine in Buffalo from April 28–29, the 2023 edition of the meeting also coincides with special issues of both Seminars in Vascular Surgery and Annals of Vascular Surgery that are dedicated to women’s vascular health and set to be released during the year. 

To be sure, Harris points out she is no critic of those regional or national vascular meetings. Rather, she feels they are not equipped to scale the enormity of the task of establishing the why of the disparate outcomes. “One of the problems is that when the books were written, the patients were considered to be White males, because we assumed women didn’t have cardiovascular disease,” Harris explains. “Women didn’t get chest pain; women didn’t get peripheral arterial disease [PAD] or aneurysms. We know that’s not true. But the symptomatology, the way it’s written, is for White males. So, when women present, they often have atypical symptoms. They’re really not atypical symptoms. As one of my friends said, they’re really women’s symptoms. 

“I believe in all of the meetings and organizations,” Harris continues. “The problem is they’re all very overburdened with multiple things they’re trying to accomplish. There is not the time during those meetings to really delve deeper into what the issues are. We used to have time periods for women’s get-togethers. Even when we have them, we maybe have two hours if we’re lucky. That’s not enough time. If we continue doing that, we won’t make progress.” 

Likewise, the summit aims to facilitate progress for the generations of women vascular surgeons following the trail of people like Harris and fellow course directors such as Amy Reed, MD, chief of vascular surgery at the University of Minnesota; Mariel Rivero, MD, an assistant professor of surgery also from the University at Buffalo; and Elizabeth Genovese, MD, director of the limb salvage program at the Medical University of South Carolina. 

“When I started,” Harris recalls of the early years of her career, “I’d walk into a room at major meetings, and there would be two or three other women and 100s of men. The opportunity for advancement was more difficult.” 

Rather than foster a scenario where women leapfrog men, Harris says, the spirit of the summit is about creating “ equal opportunity.” 

“Part of the problem is women haven’t always been given opportunities—99% of the time it is unconscious bias,” she says. “It’s not that our male colleagues are trying to put us down. But they just don’t always think of giving the opportunity of, ‘You might be good for this position,’ or, ‘Would you like to be a PI [principal investigator]?’” 

The meeting also seeks to provide a platform to tackle what Harris describes as an intrinsic conditioning often present among women in the workplace—scenarios where “women don’t feel as if they are prepared for a position even when they are more qualified than their male colleagues who will say they are prepared for a position.” 

Fundamentally, this strand of the summit—which consists of a day-and-a-half of programming—is about fostering diversity and equity, she says, and providing options for those women vascular surgeons who aspire to make natural career progression. “We’re trying to have a venue where women are comfortable communicating with each other, helping to promote [each other] and work together.” 

Vascular community starts process of wrestling with findings from BEST-CLI

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Vascular community starts process of wrestling with findings from BEST-CLI
Michael Conte addresses a packed BEST-CLI session that took place at the 2022 VEITHsymposium in New York City

One of the earliest multispecialty public gatherings of the vascular community following the release of the first results from the BEST-CLI randomized controlled trial (RCT) raised some of the early fault lines developing between different interpretations of the study’s key data. 

The co-principal investigators (PIs)—Alik Farber, MD, Matthew Menard, MD, and Kenneth Rosenfield, MD—have hailed the study as the largest RCT comparing revascularization treatment strategies in patients with chronic limb-threatening ischemia (CLTI), and have outlined how it will provide important information regarding their management. 

The trio stand at the vanguard of a study that set out to be a multidisciplinary endeavor. Yet, early disagreements exist even among the PIs themselves, a facet touched on before a packed standalone BEST-CLI session at the 2022 VEITHsymposium in New York City (Nov. 15–19) by Rosenfield himself. Results from BEST-CLI showed that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularization strategy for patients with CLTI who are deemed to be suitable for either an open or endovascular approach, the investigators reported. In patients without a suitable single-segment saphenous vein, both surgical and endovascular strategies were found to be effective in treating patients with CLTI, leading the investigators to conclude that there is “a complementary role for both revascularization strategies in these patients.” 

The session saw commentary being led by both Eric Secemsky, MD, representing a perspective from the endovascular community, and Michael Conte, MD, providing a view from the vascular surgery sphere. 

Secemsky, section head of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, said BEST-CLI provided robust critical evidence but bore limitations in terms of the inclusion of major reintervention in the primary endpoint, the representativeness of non-surgical specialties in the trial, as well as the “generalizability” of the patients enrolled. “Patient preference, surgical candidacy, prognosis, suitable anatomy, technical proficiency, costs and timely access to care remain important considerations when deciding whether to pursue a surgical versus endovascular strategy, “ he pointed out. 

Conte, chief of vascular and endovascular surgery at the University of California, San Francisco, said the trial showed that open surgery and endovascular intervention “are both safe and have complementary roles in the treatment of CLTI patients.” He said that open bypass with GSV provides more effective revascularization in suitable candidates, and “is likely under-utilized in current practice,” adding that “an endo-first or endo-only approach to all patients with CLTI is not evidence-based care.” Centers carrying out less than 20% bypass in CLTI “should probably take stock.” 

During the session, Farber, for his part, delved into potential trial weaknesses. “The study is not perfect; it had many limitations,” he said. “I think we need to be honest about it and lay those out.” It was a pragmatically designed trial, with the possibility for selection and operator bias in enrollment and intervention, he noted. “And equipoise and eligibility: Although everybody understands it exists, they were different across sites. There was also procedural heterogeneity.” 

Farber acknowledged the trial’s cohort 2 was likely underpowered. “The anatomical complexity is yet to be evaluated,” he added. “The percentage of female patients was lower than targeted. There is no question that the Katsanos meta-analysis and its effects probably has an effect on the use of drug-coated technologies in the trial.” 

Rosenfield noted the “controversy” the trial will generate: “[Amongst the BEST-CLI investigators] we have differences in the way we think it should be interpreted. My perspective is a little bit more muted than sort of the ‘Okay, this just tells the whole story about how you have to treat CLTI patients.’” His “top line,” he said, is that bypass fundamentally bears an important role in the treatment of CLTI, underscoring how the trial also showed that both procedures are safe. The lesser-discussed cohort 2, Rosenfield said, gets to one of his points of focus—that the study “raises a lot of questions that still need to be answered.” 

The trial answers questions “about those patients who were randomized in the trial,” he said, continuing, “We need to unpack better what were the characteristics of those patients who were entered into the trial.” That will help specialists determine the degree to which “we can generalize the findings: to which patients does this apply?”

Learning culture, errors and Melinda French Gates

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Learning culture, errors and Melinda French Gates
Bhagwan Satiani

Workplace culture is fascinating to observe because it is nebulous and hard to measure. There is also often a perceived gap between the existing and the intended culture in terms of how the organization deals with human errors or unintended mistakes. In Mayo Clinical Proceedings, Shanafelt and colleagues point to the incongruence between artifactual and espoused values in medicine. In other words, how we embrace the fact that to err is human in the professional culture domain.1 But our contradictory behavior reflects the profession’s aspiration to perfectionism and low self-compassion. This behavior is then transmitted to our students and trainees. 

I started thinking about this in the context of the existing culture in many if not most academic healthcare educational programs. One salient feature in these training programs is that besides being learners ourselves, there is a requirement that we commit to teaching learners (students and trainees). Most of us commit to it in academic surgery to varying degrees. I knew very early on in residency and private practice that I loved to teach and learn as well. I learned from many academic and private practice surgeons in my own training. The commonality was that there was a “learning” culture. 

Is academic culture synonymous with learning culture? It depends on how one defines “academic,” and what the existing culture is like. Academic is defined as “relating to education and scholarship,” so clearly either full-time academic faculty or voluntary faculty enthusiastic about teaching and learning are both included. What, then, is learning culture? Adam Grant, who carried out work for relates his work for Melinda French Gates, says psychologic safety is its foundation, allowing people the freedom to admit their lack of knowledge, have the humility to re-learn, take risks, and make mistakes. It then comes down to whether there is an existing culture of learning, which, broadly speaking, includes teaching, education, and scholarship. Therefore, it is the learning part that is the essential ingredient, which is critical in any academic environment whether at a university or a private teaching hospital. 

Grant relates his work for Gates, co-director of the Gates Foundation, as a perfect example of a learning culture when she agreed to provide psychologic safety to employees at the foundation by allowing everyone to see her reactions to her own negative reviews, which were shared by live video conferencing.2 He points out that allowing vulnerability by leaders is important and shows that they are also seeking to learn and improve themselves. In a non-clinical sense, learning culture is quite different from the performance culture that my generation experienced, where any decision was purely about results, with little room to fail. Arthur Kaplan, PhD, founder of the division of medical ethics at NYU Grossman School of Medicine, goes even further and has argued that even in the clinical area, other than “culpable” mistakes such as drugs or alcohol, etc., we need to learn from them. “We tend to pay attention to errors and want to know how to punish them,” he said. “The correct moral position, I think, is [to] prevent error.”3 

In a recent Search and Physician Wellness Services Organizational Culture Survey, a supportive management— non-clinical in this case—approach to mistakes was seen as one of three ranked as most important to physician satisfaction. Others have also advocated to minimize the culture of fear and blame in the clinical context. 

In 2013, the National Academy of Medicine proposed a framework for healthcare systems called the Learning Health System (LHS) to transform care delivery.4 The LHS was intended to facilitate “continuous knowledge development, improvement, and application,” while also recognizing the importance of vision, leadership, investment, and culture change.”5 

This requires a top-down push by senior leadership, but, more importantly, all stakeholders must be brought into the learning framework and supported by their immediate leader. While I am not aware of conclusive results associated with this approach, the impact on morale, work satisfaction and employee retention make sense. My point is that there is an authenticity gap related to learning in academic surgery. Consistency of people at the top and those under them has been described as “cultural coherence.” Leaders stand to benefit from cultural cohesion with high levels of connectivity with colleagues, employees and indeed the entire organization.6 Our leaders may think they are in alignment with the values and culture of learning in their faculty, trainees and employees—but many are not. Leaders should strive for this coherence and function as teachers and mentors, provide resources including continuing education time, and be seen as learners themselves. In return, they should require and expect up-to-date knowledge. 

To be clear, my observations relate to taking risks and making mistakes in the management and patient care context— they are not about jeopardizing patient safety. If non-culpable errors are made, a leader should counsel and protect trainees and employees, and use incidents as an opportunity to gain experience rather than to punish. This applies particularly to medical students and residents. They need to be taught self-compassion and be protected, but not coddled by us to lessen the learning anxiety at most training programs. This involves a conscious culture change in order to lower physician burnout and attrition rates. Leaders want to hold people accountable for their decisions and actions. 

The message may translate into “no mistakes are tolerated,” which makes people pull back and make few decisions at all. To become healthy, the academic culture must be a learning one. A single leader with vision can have an enormous impact on establishing a healthy culture—or changing an ill one.7 And what allows us to feel safe so we can all thrive? Self-aware leaders. 

References 

  1. Shanafelt TD et al. Healing the Professional Culture of Medicine. Mayo Clin Proc. August 2019;94(8):1556-1566 https://doi.org/10.1016/j.mayocp.2019.03.026. 
  2. https://www.strategy-business.com/article/Building-a-culture-of-learning-at-work. 
  3. Bean M, Carbajal E. ‘We can’t punish our way to safer medical practices’: 2 experts on criminalization of medical errors. https://www.beckershospitalreview.com/patient-safety-outcomes/we-can-t-punish-our-way-to-safer-medical-practices-2-experts-on-criminalization-of-medical-errors. 
  4. Smith M, Saunders R, Stuckhardt L, McGinnis JM, eds. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. National Academies Press (US); 2013. http://www.ncbi.nlm.nih.gov/books/NBK207225/. 
  5. Realizing a learning health system through process, rigor, and culture change. Healthcare Volume 8, Supplement 1, June 2021. https://doi.org/10.1016/j.hjdsi.2020.100478. 
  6. Global Culture 2021. PWC Report. 
  7. Runge MS. Medicine needs a culture change to retain talented physicians https://www.statnews.com/2019/01/28/medicine-culture-change-retain-talented-physicians/. 

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor. 

How a multidisciplinary team meets the complex challenges of fixing failed EVARs

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How a multidisciplinary team meets the complex challenges of fixing failed EVARs
H 103 - Tampa General Hospital brand campaign 3.0 commercial shoot with Dr. Murray Shames, Dr. Dean Arnaoutakis, Dr. Bruce Zwiebel, Nadine Mahmoudi and Marcelo Giarelli simulating an endovascular procedure on February 20, 2022.
Members of the Tampa General Hospital Aortic Disease Program team simulate an endovascular procedure

This advertorial is sponsored by Tampa General Hospital. 

The Aortic Disease Program at Tampa General Hospital’s Heart & Vascular Institute is no stranger to the challenges of complex care. Situated in the population center of Tampa, Florida, in the nation’s third most populous state, the tertiary referral center stands poised to meet the flow of incoming cases that show increasing degrees of complexity.

The times could not be more apt for the team’s collaborative approach. Tampa General Hospital performs a large volume of fenestrated endovascular aneurysm repairs (FEVARs) for abdominal aortic aneurysms (AAAs) compared to many other centers, and confronts a familiar problem, says Dean Arnaoutakis, MD, the medical director of the Tampa General Hospital Aortic Disease Program. The combination of a large elderly population with increased implementation of EVAR over the past decade has given rise to the increasingly common patient, popping up across the country, who presents with aneurysm sac growth, despite prior EVAR.

“We’ve done over 100 FEVARs in the last year,” observes Arnaoutakis, also an associate professor of surgery at the University of South Florida. “And about a third of that volume is for patients who have had failed prior EVARs, typically from a type I endoleak. So, we are amounting a rather robust experience and program of salvaging old EVARs by putting in custom fenestrated endograft to obtain more appropriate proximal aortic seal.”

This facility for endovascular salvage for prior failed EVARs is the result of a well of experience navigating the specific anatomic nuances and pathology of these complex cases. Though these EVAR revisions are showing up all across the U.S, Arnaoutakis sees a higher overall number owing to being at one of the region’s largest tertiary referral centers in addition to the large elderly population in the area, many of whom are former or active smokers, and thus more likely to have had an EVAR implanted in the first place.

Besides revisions linked to EVARs originally performed outside of instructions for use parameters, Arnaoutakis also points to the volume of cases he carries out related to older iterations of aortic stent grafts. “Previously published studies indicate that compliance with EVAR implantation guidelines is poor with up to 40-60% implanted off-label,” he says, which “will naturally lead to that device failing over time. I think we are now seeing more of these cases now.

“In addition, we’re seeing a lot of  first-generation devices, which are more than 10 to 15 years old, fail. We have learned over time that these earlier generation devices have either design or material imperfections. These issues are driving the high rate of failed EVARs in our practice.”

Arnaoutakis himself has been working to help find ways of dealing with these types of cases. One is a physician-sponsored investigational device exemption (PS-IDE) he gained earlier this year from the Food and Drug Administration (FDA) to evaluate the efficacy of fenestrated and branched EVARs using physician-modified endografts (PMEGs) in a clinical trial setting. “There were many reasons to apply for a PS-IDE to do F/BEVAR with PMEGs. The number of patients I encountered with failed prior EVAR who would not tolerate an open explant was certainly a driving factor as the current FDA-approved fenestrated device is typically not usable in this setting due to constraints with the device design. These patients often require a four-vessel fenestrated device with complete relining of the prior endograft, a device which is currently not commercially available,” he explains.

Increasing complexity, of course, comes with the inherent dangers posed by exposure to higher doses of radiation. In order to mitigate the effects, team members carrying out these procedures have access to zero-gravity, lead-based suits designed to decrease the amount of radiation to which they are exposed—which is “considerable” in the context of 100-plus FEVARs per year, Arnaoutakis points out. Similarly, the team uses cloud-based fusion imaging technology, which also helps reduce radiation exposure and speeds up procedural times, to make them more efficient and safe, he adds.

Arnaoutakis and the multidisciplinary Tampa General Hospital aortic team are well poised to deal with the incoming volume of these complex cases. “As our fenestrated endovascular aortic program has become more sophisticated, our overall practice has evolved such that we can salvage these failed endografts, which is decreasing our number of open explant operations. Our preliminary data suggests that this evolution in our practice has improved our patient outcomes,” he says.

That multidisciplinary team—previously led by Murray Shames, MD, now Tampa General Hospital’s chief of staff and the Richard G. Connar Endowed Professor and chair of surgery at the University of South Florida—includes key members from vascular surgery and interventional radiology. “We have a wonderful relationship with our interventional radiologists here who we often do these operations in conjunction with,” notes Arnaoutakis. “We each have a slightly different skillset, and, when combined, it really promotes our procedure technical success and improves patient outcomes.”

Varicose vein registry analysis finds women benefit from endovenous ablation with fewer complications

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Varicose vein registry analysis finds women benefit from endovenous ablation with fewer complications

clottriever-VIVA-19An evaluation of the Vascular Quality Initiative’s (VQI) Varicose Vein Registry (VVR) carried out by the Midwestern Vascular Surgical Society (MVSS) has found women to benefit similarly from endovenous ablation as men, but that they experience fewer complications post-procedure.

The MVSS study prospectively collected data from the VVR—a registry included within the VQI which tracks venous procedures. Uniquely, the VVR includes both patient-and physician-reported outcomes. Using these data, Benjamin A. Y. Cher, MD, from the University of Michigan, Michigan, and colleagues conducted a retrospective cohort evaluation of patients undergoing endovenous ablation procedures on truncal veins with or without treatment of perforated veins between 2015 and 2019. Inclusion criteria consisted of patients who underwent procedures to ablate truncal veins using radiofrequency or laser in the lower extremity within the specified period. The investigators assigned two follow-up points­—early at zero-to-three months post-procedure and greater than three months—to record symptom severity scores.

The findings were published in the November issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

The investigators conducted a univariate analysis to compare preprocedural, post-procedural and periprocedural changes in Clinical, Etiologic, Anatomic, and Physiologic (CEAP) classification and Venous Clinical Severity Score (VCSS) by gender and measured rates of complications including: deep venous thrombosis, endovenous head-induced thrombosis, leg pigmentation, blistering, paraesthesia, incisional infection and any others reported post-procedure. For each of the included cases initial demographic reporting consisted of age, gender, race and clinical history, such as prior varicose vein treatment, compliance with compression therapy, presence of deep reflux and other prescribed therapies such as anticoagulation, concomitant with phlebectomy and concomitant with sclerotherapy treatments.

Key results

Cher et al write that the cases included within the study amounted to 9,743 patients, 3,090 (31.7%) of which were men and 6,653 (68.2%) were women. By gender, averages for age, percent non-white race and body mass index (BMI) were largely similar.

When analyzing preoperative characteristics, compared with men, women had a higher preoperative symptom score (average 15.0 for women vs. 14.1 for men, p<0.001), despite presenting for treatment with lower overall CEAP classification (p<0.001) and VCSS classes (average 7.54 women vs. 8.84 men, p<0.001). Women also more frequently underwent prior varicose vein treatment (25.2% vs. 19.6%, p<0.001), whereas men were more likely to have a prior history of anticoagulation (13.0% vs. 6.5%, p<0.001).

In regression analyses, the authors found gendered disparities across perioperative changes in VCSS scores were as driven by additional characteristics such as BMI, presence of deep reflux and preoperative CEAP classification. In patients with a BMI greater than 40, women had a higher periprocedural improvement in VCSS score of 0.69 points (95% confidence interval [CI], 0.32–1.05). In patients with deep reflux, periprocedural VCSS scores were higher among women by 0.25 points (95% CI, 0.07–0.44). Additionally, among patients with a preoperative CEAP classification of 2 (739 men, 25.1%, 2,248 women, 35.1%), women reported a greater periprocedural decrease in VCSS score by 0.32 points (95% CI, 0.07–0.57).

Between both groups, incidence of post-procedural complications was low, with women showing a lower frequency overall. Cher and colleagues’ results show that in each of the measured areas of post-procedural complications, women benefitted more than men in terms of pain-incidence, including any leg complication (6.1% vs. 8.6%, p=0.001), endovenous heat-induced thrombosis (1.1% vs. 2.2%, p=0.002), and infection (0.4% vs. 0.7%, p=0.001).

Data collected from post-procedure outcomes revealed that women had a lower postoperative total VCSS score (3.50) compared with men (4.47), which marks a greater improvement in score for women than men (average -4.46 for men vs -4.13 for women, p<0.0001).

Drawing conclusions

The study authors conclude that women present for endovenous ablation with a lower VCSS score and lower CEAP classification than men, yet report a higher total symptom score, suggesting quantifiable differences in experience of venous disease between groups. The investigators remark that their results may complicate the accuracy of prevalent comparisons of venous disease by gender, positing variations in reasons for presenting for treatment and physiological differences between gender groups.

The authors note that men and women seek treatment for endovenous ablation for differing reasons, however considering the positive results found among women, endovenous ablation may be best suited to treating the common presentation characteristics women report (pain, achiness, and heaviness) rather than those reported among men (edema, inflammation, and itching). This hypothesis is supported by the finding that women presented for treatment with lower overall CEAP classification.

Physiologically, Cher et al point to the role of estrogen, noting the preprocedural change in VCSS score being greater among women with a higher BMI than men with a higher BMI—obesity and increased estrogen production being concurrent. The investigators note that gendered differences between estrogen physiology by BMI may also explain observed interactions between gender and deep reflux being more common among obese patients. However, the authors make clear some important limitations of the VVR registry, which does not contain data relating to the presence of tributaries, the location of deep reflux or data on postoperative ultrasounds, and additionally note the observational nature of the study itself as there remains the possibility of residual confounding by variables not captured in the VVR.

Cher and colleagues summarize that their findings demonstrate a similar benefit from endovenous ablation between women and men, with little incidence of post-procedural complications for both. However, considering the study’s procedural registry included almost twice as many women as men, findings which suggest a greater benefit from treatment for women are particularly significant. Commenting on the broader application of their results, the authors note, “our results suggest gender may be useful for patient selection and counseling for endovenous ablation, with particular usefulness among patients with high BMI, presence of deep reflux, and preoperative CEAP classification of 2.”

Meta-analysis of PTS finds one in five at risk of long-term symptoms following isolated distal DVT

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Meta-analysis of PTS finds one in five at risk of long-term symptoms following isolated distal DVT

A meta-analysis is first to report the pooled risk of post-thrombotic syndrome (PTS) after isolated distal deep vein thrombosis (DVT). Researchers revealed a one-in-five risk of long-term PTS after isolated distal DVT, with one in 50 patients progressing to severe PTS, potentially developing to ulceration.

Principal author Benedict R.H. Turner, MBChB, from Imperial College London in London, England, and colleagues evaluated The Cochrane Library, Embase, Google Scholar and MEDLINE databases following PRISMA guidelines to identify eligible prospective cohort studies analyzing the rate of PTS after first episode of isolated distal DVT. Published in the European Journal of Vascular and Endovascular Surgery the study comprised trials held between 2005 and 2021 that included between 52 and 403 participants, with a total of 1,105 included across all seven studies reporting the development of PTS.

Turner et al note that the baseline characteristics of included articles were varied—follow-up periods ranged between one month to four years after first DVT, and several studies additionally reported which of the distal deep veins were thrombosed and corresponding risk factors. Interventions used to treat PTS included stockings, though duration, adherence and degree of compression were heterogenous. Other patients also received anticoagulation, although duration of treatment was unspecified. Among patients who were anticoagulated, direct oral anticoagulants, low molecular weight heparin and vitamin K antagonists were used.

The authors report that one in five patients are at risk of long-term PTS after isolated distal DVT, with one in 50 experiencing severe symptoms that may potentially include ulceration. Going into detail, the authors observed a post-thrombotic rate of 17% (95% confidence interval [CI] 11–26%, p<0.01) across the seven studies, 217 cases and 1,105 participants. Three of these studies (302 patients) reported on the severity of PTS symptoms, 78% posited as mild (Villalta score 5–9), 11% as moderate (10–14) and 11% were severe (15 or more).

Even when modulating the follow-up period, the authors did not see a significant change in the risk of developing PTS (p=0.71). This, they write, suggests shorter follow-up periods may be adequate to collect data on symptom development in clinical trials. The authors note that methods of data collection may have been “confounding” due to recall bias, as most included studies only reported rates of PTS at the average follow-up duration, rather than pinpointing the exact time at which PTS was diagnosed.

Overall, Turner and colleagues state that the risk of PTS after isolated distal DVT appears to be half that in comparison to proximal DVT, although occurring in a similar timeframe. According to the authors, this information is key when considering anticoagulation duration and compression therapy, as  “PTS is noted to be the principal moderator of quality-of-life after VTE [for patients]”.

When considering preventative measures that can be taken by patients, the authors note that the most recent European Society for Vascular Surgery (ESVS) guidance recommends graduated compression stockings in the proximal context of DVT to prevent the onset of PTS, despite the UK National Institute for Health and Care excellence and American College of Chest Physicians withdrawing this treatment option since it demonstrated no additional benefit in the SOX trial. The authors highlight that analysis of stocking use is limited. They detail that trials including CHAPS, SOX and ATTRACT have set about evaluating the treatment for preventing PTS, however they each excluded distal DVT from their eligibility criteria due to assumed lower event rates, although it may constitute up to two thirds of all DVT cases.

Going further, Turner et al comment that the management of isolated distal DVT has been a complex area of consideration in the literature, though there have been no randomized trials to establish the role of therapies preventing PTS in distal DVT. They write that the CACTUS double-blind, randomized trial revealed that outcomes for patients with isolated distal DVT who received six weeks of anticoagulation with Nadroparin were not superior to the placebo group for the composite outcome of venous thromboembolism (VTE) extension, contralateral DVT or pulmonary embolism (PE). Despite a clear risk factor for PTS being poor initial anticoagulation, the author’s meta-analysis shows limited evidence to support its use and benefit when compared with participants who received no anticoagulation.

The investigators note some limitations of their study, including risk of selective reporting due to the inclusion of retrospective studies. Additionally, studies were deemed eligible irrespective of the use of anticoagulation and/or compression stockings, due to little evidence suggesting its effectiveness on reducing rates of PTS unlike proximal DVT.

Although heterogeneity may have been introduced by pooling data in this way, the authors comment on the strengths of the study, noting the “comprehensive inclusion criteria and a thorough statistical analysis that has yielded a credible rate of PTS after distal DVT.” Continuing, they note that future trials of interventional measures to prevent PTS after DVT “should include an isolated distal DVT subgroup considering the established occurrence of PTS in this underserved and clinically significant group […] [and utilize] a survival analysis to delineate the evolution of PTS over time after isolated distal DVT.”

The investigators conclude that randomized trials to analyze and support interventions that can effectively prevent PTS are “urgently needed” to improve patient care and subsequent outcomes after isolated distal DVT.

Women’s Vascular Summit: Diving into issues around women’s vascular health and the female workforce

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Women’s Vascular Summit: Diving into issues around women’s vascular health and the female workforce

The Women’s Vascular Summit was established five years ago with the twin purposes of delving deeper into the issues that surround women’s vascular health and disparate outcomes, and establishing a venue where women vascular surgeons could help elevate and empower each other to further their careers in what remains a male-dominated environment.

Ahead of the 2023 iteration (April 28–29), which is again set to take place in Buffalo, New York, meeting founder and course director Linda Harris, MD, tells Vascular Specialist about why the meeting came to be, and how it is being used to advance the cause of greater diversity and equity among the vascular workforce, and solve enduring disparities in vascular disease outcomes.

SVS mourns passing of former president

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SVS mourns passing of former president
James S.T. Yao

Society for Vascular Surgery (SVS) members are mourning the death of James (Jimmy) S.T. Yao, MD, 88, former SVS president and Lifetime Achievement Award recipient. Yao, professor emeritus at Northwestern University, died Tuesday, Dec. 20, in Chicago. He had been a very active member of SVS since 1974, holding many roles, including that of president in 1993.

He was born in Guangzhou, China, and did most of his growing up in Macau. He returned to China before medical school and, seeing the political turmoil there, went instead to Hong Kong, where his family had moved. He attended medical school at National Taiwan University Medical School and then decided to obtain more education in the United States. He trained at what was then Cook County Hospital in Chicago, earned a PhD in London, and then returned to America, spending nearly his entire career—from 1972 on—at Northwestern University.

He is considered one of the fathers of the modern vascular laboratory. He created formal protocols for noninvasive studies and helped establish the Society for Noninvasive Vascular Technology. In 1998, he received the Society for Vascular Technologies’ Pioneer Award in recognition of his contributions in this area.

His thesis in London was related to his experiments using Doppler to study patients with peripheral vascular disease. “From this work came the commonly applied ankle-brachial index that is widely used,” said SVS member William H. Pearce, MD, in an article in the Annals of Vascular Surgery upon Yao’s retirement in 2005.

“He essentially, for all intents and purposes, invented the ankle-brachial index, a simple but fundamental invention for vascular surgery,” said longtime friend—and former trainee—Walter McCarthy, MD. “There aren’t that many people who really invent something that important for our specialty. That was his PhD thesis—and he did this at such a young age.”

Yao established the first blood flow laboratory in Chicago, created a vascular fellowship training program, served as president not only of SVS but also of American Venous Forum (AVF), American Venous Forum Foundation, Chicago Surgical Society, the Lifeline Foundation (now known as the SVS Foundation), and the Midwestern Vascular Surgical Society (MVSS).

John Bergan, MD, recruited Yao to Northwestern, said Pearce, where the two began the Northwestern December symposium, still held today, and the vascular fellowship, launched in 1975. “Many of their trainees have gone on to lead divisions of vascular surgery, medical schools and even universities. The cumulative contributions of the Bergan-Yao combination and their many vascular trainees have had enormous influence in American vascular surgery,” said Pearce.

Pearce said Yao also was known for “his passion for research,” and his work with what is now the SVS Foundation to help fund research projects and awards.

McCarthy called Yao “not only a brilliant person but also an extremely excellent technical surgeon.” Other talents also made him stand out, including his interest in history, in teaching and mentoring, his expertise in vascular laboratories, and his writing skills, said McCarthy. Yao published more than 300 articles in scholarly journals, 200 textbook chapters and 50 academic books.

Within SVS itself, Yao also will be known as the guiding light behind the SVS History Project, leading a work group to preserve the Society’s history by interviewing those notable in the vascular surgery field. Members conducted more than 90 interviews—including one with Yao himself as the subject.

The project had part of its roots in the Society’s 50th anniversary in 1996, when then present-day members interviewed Michael DeBakey, MD, and Harris B. Shumacker, MD, the sole surviving of the 31 founders. And he and Calvin B. Ernst, MD, edited a special issue of the Journal of Vascular Surgery commemorating the anniversary. More than a decade later, concentrated efforts to interview leading figures began in earnest.

Yao also worked with videographer Jan Muller to compile three additional videos, “A Modern History of the Society for Vascular Surgery (1946–2017),” with the first focusing on “Era I: Antiquity and Reparative Surgery,” “Era II: Direct and Reconstructive Surgery” and “Era III: Endovascular Surgery.”

The Society honored Yao for his many contributions in 2007 with one of its highest honors, the Lifetime Achievement Award. He and wife Louise have three children, Kathy, a surgeon; John, a professional musician (whose music is heard on the history videos); and Pauline, curator of a new museum in Hong Kong. “Jimmy’s loyal friendship, dedication to excellence, untiring loyalty and devotion to family will be remembered by all who have worked and trained with him,” said Pearce.

Tributes began coming in quickly. “He was one of my vascular heroes as a trainee and early-career surgeon,” said William Shutze, MD, now SVS secretary.

“It was my extreme good fortune to have trained under Dr. James S.T. Yao (Jimmy) in the early 1980s,” said SVS President Michael Dalsing, MD. “Jimmy was an exceptionally skilled vascular surgeon who also had the ability and willingness to train others. He was not afraid to innovate on the spot if it meant that his patient would do better—his care was always patient-centered. It was truly a joy to watch him operate and to mimic his skills in some small way. Jimmy expected remarkable things from himself and from you—measure to improve; ‘do it once, do it right and you don’t have to do it again’; improve others by adding to the literature; and ‘no tomatoes,’ meaning no hematomas.

“But with all his success he never forgot who he was—truthful, dedicated, humble and intellectually fearless. Dr. James S.T. Yao has been my longest and unfailing teacher, mentor and sponsor during my career, and I will greatly miss him. We have all lost a friend and colleague who is irreplaceable—‘one of a kind.’”

“Jim was a giant in our vascular surgery specialty and as one of our past presidents,” said Immediate Past President Ali AbuRahma, MD. “God bless him; our hearts are with his family.”

“What a great man—he will long be remembered,” said President-Elect Joseph Mills, MD, adding that on a personal level, Yao was always kind and supportive to Mills early in his career. Quoting Maya Angelou’s poem, “When Great Trees Fall,” Mills said of Yao, “In the forest of vascular surgery, he was a great tree.”

Students and residents: Attend VAM 2023 on a scholarship

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Students and residents: Attend VAM 2023 on a scholarship

Medical students and general surgery residents have the chance to change their lives. Perhaps they are still seeking some direction for their medical careers. Perhaps they’re considering vascular surgery but aren’t sure that’s right for them. 

A trip to the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) could be just what they need to point them to their future. Applications opened Dec. 5 for the SVS Diversity Medical Student Vascular Annual Meeting Travel Scholarship and the SVS General Surgery Resident/Medical Student Vascular Annual Meeting Travel Scholarship. 

Nathalie Baroum attended VAM 2021 on a travel scholarship after finishing her first year of medical school. She was already interested in vascular surgery but wasn’t entirely sure about heading that direction because of her lack of exposure to the specialty. “Overall, receiving the scholarship and experiencing both the conference and the specialized meetings for the recipients really solidified for me that I wanted to go into the field,” she said. 

Applications will close at 3 p.m. CST on Jan. 9. Visit vascular.org/VAMDiversityTravel23 and vascular.org/VAMtravel23. 

‘Impressive’ 12-month Flex vessel prep data presented at VEITHsymposium

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‘Impressive’ 12-month Flex vessel prep data presented at VEITHsymposium

VentureMed Group, a medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for peripheral arterial disease (PAD), announced data presented at the 2022 VEITHsymposium (Nov. 15–19) in New York City that demonstrated that Flex vessel prep used prior to balloon angioplasty improves 12-month outcomes both in PAD and AV fistulas and grafts.

“AV Access management is a critical component of successfully treating AV patients over time,” said John Aruny, MD, from the Dialysis Access Institute in Orangeburg, South Carolina, primary investigator of the Flex Vessel Prep AV registry clinical study, the 12-month outcomes of which he presented at VEITH. “The FLEX AV Registry 12-month outcomes shows that utilizing Flex vessel prep provides more time between interventions and continues to excel in the very difficult cephalic arch lesions.”

The study was a single arm, prospective study conducted in eight centers in the U.S. with 114 real world patients. The Flex AV Registry 12-month outcomes demonstrate sustained patency across most patients and particularly good results specifically in the cephalic arch.

  • 49% patency for all AV fistula patients (comparable historical data 26%)
  • 59.7% patency for cephalic arch lesions (comparable historical data 0–33.9%)
  • AV grafts had average time to target lesion revascularization of 228 days (41.2% patency at nine months)
  • No observed serious adverse events.

“Vessel preparation has become a necessary step for better patient outcomes,” said Eric Secemsky, MD, director of vascular intervention, Beth Israel Deaconess Medical Center in Boston, who presented the 12-month results of the Belong study with Flex vessel prep system prior to drug-coated balloon (DCB). “Vessel preparation in PAD with Flex creating longitudinal microincisions prior to DCB therapy had impressive freedom from clinically driven target lesion revascularization and looks to improve outcomes by lowering balloon inflation pressures and potentially enhancing drug delivery.”

The Belong study was a single-center, single-arm, prospective study conducted with 41 patients in Fribourg, Switzerland.

12-month efficacy results:

  • 97.5% (39/40) freedom from clinically driven target lesion revascularization
  • 84.2% (32/38) freedom from target lesion restenosis via duplex
  • 14/32 patients had stents
  • 100% freedom from major amputation.

VSGBI spotlights data-driven financial incentives for PAD revascularization

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VSGBI spotlights data-driven financial incentives for PAD revascularization
Rob Sayers

The President’s Symposium at the Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting (Nov. 23–25) in Brighton, England, saw Rob Sayers, MD, from the University of Leicester, presenting, “CLTI CQUIN [Commissioning for Quality and Innovation] has raised the profile of PAD and will lead to fewer amputations.” Sayers’ take-home message for delegates was that the National Health Service (NHS) Commissioning for Quality and Innovation (CQUIN) for chronic limb-threatening ischemia (CLTI) will prove a valuable package of measures when it comes to raising awareness of peripheral arterial disease (PAD) and improving outcomes for patients, but that the question now lies in “how best we measure [these improvements].” 

The CQUIN, Sayers began by outlining, was started in April 2022, and the premise of it is for the NHS to give “financial rewards for excellence [in the hope] that that translates into better patient outcomes.” The presenter noted, with relevance to the VSGBI audience, that their society had made sure to inform all its members of the CQUIN at its launch, and that the Society’s own PAD quality improvement framework (QIF) is complementary in its patient outcome focus. 

Then providing background to the CQUIN process, Sayers shared that “you are more likely to be successful if your bid is patient-focused [and it is easy to implement],” adding that it is “competitive.” The resulting financial incentive that a successful bid bestows “depends on the size of your unit,” Sayers proceeded, and in the case of the CLTI CQUIN, “most [units] will receive between £500,000 and £1.5 million.” 

Speaking to the merits of the CLTI CQUIN, Sayers described it as a “well written and clear proposal,” adding that there are benefits for patients.” 

Moreover, the successful application could perhaps be set against the backdrop of “a lot of support from the NHS for various vascular services […which were] particularly hard-hit by the pandemic.” Sayers went on to stipulate that “[this] was noticed, and we became a protected specialty.” 

Regarding the conditions of the CLTI CQUIN funding, “it requires you to revascularize patients within five days of referral,” Sayers detailed for the symposium audience. 

“If you revascularize 60% of your patients within five days, you get the full payment, and if you revascularize less than 40%, you do not get any money at all.” The amount awarded for achieving results in between these benchmark figures is graduated, Sayers expanded. 

Data monitoring is key to the CQUIN’s operation, delegates then heard. This is carried out “by local commissioners who compare data such as HES [Hospital Episode Statistics], and NVR [National Vascular Registry…] so if you were tempted to underreport, that would be spotted,” Sayers cautioned. 

Moving on to address how the CQUIN can help patients, Sayers underlined that the goal is to “raise awareness of PAD and the PAD QIF, and CLTI, among clinicians and managers.” This then increases the chance of reinvestment to improve services, such as limb salvage clinics. 

As of April 2023, the CQUIN will be up for renewal, Sayers conveyed, and the decision will be based on a number of factors, including whether participating units themselves “found [it] worthwhile.” However, there are limitations when it comes to how successful the CQUIN may be at achieving improved outcomes: “It requires very reliable data capture,” Sayers admitted. It “may [also be argued that] the targets are challenging” and “not particularly evidence-based,” he furthered. 

Sayers rounded off by taking a long and wide view of VSGBI’s role in putting patients at the heart of members’ work and calling successive presidents to prioritize data gathering to facilitate this. 

Maintaining relationships with exam boards so that the specialty adheres to “very good” professional standards was also among Sayers’ pieces of advice. 

“There is no doubt that the Society needs to continue to foster its good relationship with NHS England,” he asserted, before opining that “work with commissioners” can “no doubt” serve as a solution to the problem of the post-COVID vascular services backlog. 

Questions following the symposium centered on data monitoring and the quality of datasets, which reflected Sayers’ message that this is pivotal in the success of measures like those comprising the CLTI CQUIN. 

In addition, Sayers was posed the question of whether “in order to ensure the development and appropriate investment in CLTI management, do you think some units will need to take one for the team and fail?” The presenter responded by referring to the “current data” from the CQUIN—“there are 55 units in England that are eligible for the CQUIN scheme [of whom] about 10–12 are currently below the threshold of 40% and [there are] probably another 5% [whose data] we do not [have].” 

He reiterated that the CQUIN is “about improving your service to improve outcomes for patients,” and concluded, therefore, that those units that are currently falling short have the choice “whether they want to try to improve things for patients,” rather than it being about “taking one for the team.” 

SVS issues membership dues reminder

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SVS issues membership dues reminder

To avoid a lapse in their benefits, Society for Vascular Surgery (SVS) members are encouraged to pay their 2023 member dues by Dec. 31. 

These benefits of SVS membership include access to the Journal of Vascular Surgery publications at reduced or no cost; the customizable SVS Branding Toolkit, discounts on education programs—including the Vascular Annual Meeting (VAM) and Coding and Reimbursement Workshop—as well as networking, practice management resources and more. 

For 2023, the SVS has created the Early Active member category specifically for those vascular surgeons completing their training. Dues are lower, just $275 for the year, instead of the $695 fee for Active members, to help these new members transition to working life. 

SVS also has simplified the application process for Early Active membership, dropping a formal application and any required letters of recommendation. 

The 575 members who have finished training within the past three years have been notified that they have automatically become Early Active members. 

Members will automatically transition to full Active status after achieving their Vascular Surgery Board (VSB) certification and a minimum of two years of Early Active membership. 

Paclitaxel DCB performs well in ‘challenging anatomy’ of femoropopliteal in-stent restenosis, VQI registry data show

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Paclitaxel DCB performs well in ‘challenging anatomy’ of femoropopliteal in-stent restenosis, VQI registry data show
Daniel Bertges

The IN.PACT Admiral drug-coated balloon (DCB) shows promising results in treating femoropopliteal in-stent restenosis (ISR) in a Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry-based, postmarket surveillance study. This is according to Daniel Bertges, MD, a vascular surgeon from the University of Vermont Medical Center in Burlington, Vermont, who presented interim, 24-month data from the prospective, non-randomized study in a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2022 in Las Vegas (Oct. 31–Nov. 3). 

Bertges revealed a freedom from target lesion revascularization (TLR) rate of 89.8% at one year and 72% at two years in the “challenging anatomy” of in-stent restenosis within the femoropopliteal artery segment as the headline findings. 

The presenter informed VIVA 2022 that he and colleagues conducted a multicenter study involving 300 patients at 43 US sites within the SVS VQI. The primary endpoint was TLR within 12 months post-index procedure, and secondary endpoints—assessed at 12, 24, and 36 months—included all-cause mortality, TLR, target vessel revascularization, major target limb amputation, and technical success, which was defined as successful deployment of the balloon without resulting in occlusion and having residual stenosis ≤30% and resting systolic pressure gradient of <10mmHg, if measured. 

Bertges noted that patients were included in the study if they were ≥18 years of age, had undergone single-limb and single-treatment during index procedure and received primary treatment of the ISR lesion with an IN.PACT Admiral DCB, and had de novo or recurrent ISR in the superficial femoral and/or popliteal artery and documented ischemia with Rutherford classification 2, 3, or 4. Those patients who had undergone bilateral femoropopliteal artery repair or had a history of tissue loss in the target limb were excluded. Failure to successfully cross the target lesion was another exclusion criterion. 

Giving details of the patients included in the IN.PACT SVS ISR registry, Bertges explained that 20% of patients (60/300) had chronic limb-threatening ischemia (CLTI), 56% (168/300) had diabetes, and 53.7% (161/300) had TASC C–D lesions, among other characteristics. 

In his conclusion, the presenter remarked that these results “demonstrate the ability of the VQI to conduct postmarket evaluation of peripheral devices in partnership with industry and federal regulators.” 

Speaking to Vascular Specialist following his VIVA 2022 presentation, Bertges commented that one of the main benefits of registry data is that it is “obtained from everyday practice,” and therefore “includes data from a variety of practitioners working to care for a variety of patient populations, as opposed to the sometimes restrictive inclusion and exclusion criteria of clinical trials.” 

With reference to a particular benefit of the VQI registry, he stressed that there is “power in numbers,” noting that the VQI includes “several hundred thousand procedures recorded over the past decade or more” and that it continues to accrue tens of thousands of patients annually. “That’s a rich repository of information.” 

Furthermore, Bertges referenced the multispecialty nature of the VQI registry— which includes vascular surgeons, cardiologists, radiologists—as another of its strong points, as well as its “continued efforts towards gathering the best longitudinal data on our procedures for our patients.” 

Looking ahead to what is next for the study, Bertges informed Vascular Specialist that the researchers are looking to track their results out to three years. “We expect those findings to be reported back to the investigators, to the sponsor, and to our FDA [Food and Drug Administration] regulators in the early part of the summer of 2023, and so we look forward to bringing those results to the vascular community following that.” 

Voting on SVS bylaws revisions ends Dec. 18

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Voting on SVS bylaws revisions ends Dec. 18
Voting began Dec. 1

Active and Senior Society for Vascular Surgery (SVS) members in good standing have until Dec. 18 to cast their ballots to change the composition of the Society’s Nominating Committee. 

Online voting began Dec. 1 on consideration of three revisions to Article X of the SVS bylaws regarding the committee’s composition. The committee’s size would remain at seven members but would expand the diversity of perspective. 

The questions address: 1) Reducing the number of past presidents on the Nominating Committee from three to two; the most current past president, who serves on the Executive Board, will join the Nominating Committee one year removed from this service.

2) Adding the SVS Diversity, Equity and Inclusion (DEI) Committee chair, or vice chair if the chair is unavailable, as a voting member of the Nominating Committee, replacing the chair of the Leadership Committee. The Leadership Committee chair was added when the committee’s name was the Leadership and Diversity Committee, but diversity has since moved to the DEI Committee.

3) Adding the chair of the Young Surgeons Section, or the vice chair if the chair is unavailable, as a voting member of the Nominating Committee. The Young Surgeons Section chair has been serving as a non-voting ex-officio member. 

The process for nominating SVS officers for 2022–23 begins in January 2023. The special referendum ensures that any changes enacted will be in time to affect the 2023 nominating process and elections. 

Read the proposed changes at vascular.org/2023NomCommBylawsChange.

Efemoral Medical closes financing round to fund ongoing study of its vascular scaffold system

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Efemoral Medical closes financing round to fund ongoing study of its vascular scaffold system

EfemoralEfemoral Medical has today announced the closing of its $4.9 million preferred Series A1 round. Supported by existing investors as well as an experienced cohort of new investors, the proceeds will further Efemoral’s device development and expand enrollment in its ongoing first-in-human clinical trial, EFEMORAL I, investigating the Efemoral vascular scaffold system (EVSS) with FlexStep technology.

The new funds will also complement Efemoral’s recently announced phase II Small Business Innovation Research (SBIR) grant award, which will support pre-clinical studies.

The EVSS with FlexStep technology offers a new approach to treating peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg, Efemoral states in a press release. Through the use of inter-scaffold spaces, the patented FlexStep technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system is designed to open vessels and sustain healthy blood flow. The novel bioresorbable scaffold with long-term Sirolimus elution aims to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind, the company’s statement adds.

“The implantation of strong, balloon-expandable, drug-eluting stents has conclusively been shown to be the best therapy for diseased human arteries. Their results in the coronary arteries of the heart have been no less than spectacular,” said Lewis B Schwartz, MD, co-founder and chief medical officer (CMO) of Efemoral Medical. “However, these rigid devices cannot be safely implanted into the arteries of the legs because they would be crushed as the patient walks or sits. The EVSS uses a unique design of alternating dissolvable scaffolds and spaces that, for the first time, allows the long arteries of the legs to be treated with the same, effective, balloon-expandable technology proven to be successful in other human vascular beds.”

“The initial clinical experience in EFEMORAL I has demonstrated that the EVSS has the potential to be a highly effective treatment for femoro-popliteal disease,” said Christopher Haig, co-founder and chief executive officer (CEO) of Efemoral Medical. “This new funding will allow us to build additional confidence in our device by taking it to multiple hospitals and enrolling more patients. We remain committed to advancing the science behind our device and are excited about the potential of our technology to offer a durable clinical solution to patients and physicians.”

EU Commission to propose delay to MDR implementation

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EU Commission to propose delay to MDR implementation
Stella Kyriakides

Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023. 

Kyriakides informed health ministers from the EU’s 27 member states of the plan at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Brussels on Friday (Dec. 9), where the council members discussed the current status of the implementation of the MDR.  

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic.  

Concerns have been raised over the impact of the transition to the new regulatory regime, with the European Society of Cardiology (ESC) last week calling upon ministers to act to prevent a “shortfall of essential medical devices for cardiovascular patients,” which the Society warned could include diagnostic and ablation catheters and some stents. 

At Friday’s meeting, Kyriakides informed ministers that she will propose an extension to the transition period for the implementation of the MDR in early 2023—with the measure then to be voted upon by the European Council and Parliament. 

“Patients rightly expect to have safe and high-quality medical devices,” Kyriakides told journalists at a press conference that followed the council meeting, where she acknowledged it is now a “crucial time” for the transition to the new rules. 

“We have been following the progress achieved towards this goal very closely in the past months and, while the number of notified bodies have increased and actions have been taken to prepare manufacturers, this is not enough,” Kyriakides added. “In addition, we are now experiencing supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.  

“This is why I announced today to ministers that we will propose to extend the transition period to mitigate any short-term risks. This targeted amendment will take into account the risk class of different devices and address the sell-off date. At the same time, we will work on medium- and long-term solutions to address the more structural issues that have arisen with the new rules. 

“Our citizens do not only expect medical devices to be safe, they also expect them to be available. We will do everything in our power to ensure that this transition does not create any disruptions.” 

Endologix receives FDA approval of PMA supplement for AFX2 system

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Endologix receives FDA approval of PMA supplement for AFX2 system
AFX2 endovascular AAA system

Endologix recently announced that it has received Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system.

According to a company press release, Endologix received approval to include an updated warning and the most contemporary clinical information in the labelling for the AFX2 system.

Clinical data added to the instructions for use (IFU) includes: final results from the five-year LEOPARD randomized controlled trial, and results from the recently published, independently performed, VQI-VISION analysis on abdominal aortic aneurysm (AAA) endografts.

Endologix notes that in both reported studies, out to three years, the rates shown for rupture and reintervention are comparable between the AFX/AFX2 device cohort and endovascular aneurysm repair (EVAR) comparator devices.

Additionally, results from the LEOPARD study demonstrated no significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the AFX/AFX2 device cohort and the EVAR comparator devices.

Corner Stitch: A reflection on 2022…

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Corner Stitch: A reflection on 2022…
Christopher Audu

This month’s column chronicles the exciting year we’ve had here at Corner Stitch. As the section editor, I’ve been most proud of the various authors who have contributed, and the range of topics discussed in the different monthly write-ups this year. 

To take a brief trip down the archive lane, we welcomed a new set of interns (who are now six months in!), learned how to write winning abstracts for meeting presentations (May 2022—Dr. DeCarlo), welcomed new fellows (April 2022—Dr. Aru), discussed the role of mentorship (VAM edition—Shane Dong, M3), and even profiled the founders of the Audible Bleeding podcast (September 2022) and the new Journal of Vascular Surgery internship program (November 2022). 

It’s been a banner year, and the diversity of voices has helped shape the topics so that they are relevant to the trainee navigating the training environment. Thank you to all the contributors this year. 

The year 2023 will bring a new set of challenges and topics. For instance, we now have the results of the BEST-CLI trial to help guide treatment options in our peripheral arterial disease patients. How will this affect trainees as we counsel patients? Moreover, what are key clinical trials that we all should know as trainees? Also, in 2023, we will welcome a new set of trainees at the resident and fellowship level. And there will be numerous conferences to attend—in particular the Vascular Annual Meeting (VAM). 

Looking forward to the new year, we at Corner Stitch intend to continue the trend of having trainee voices share their experiences on a variety of topics. I hope you look forward to these exciting monthly installments. We have an exciting lineup, and are always open to suggestions. 

As the 2022 calendar year draws to an close, have a safe holiday season… and if you’re on call, may the vascular surgery force be with you! 

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the Vascular Specialist resident/fellow editor. 

The 10 most popular Vascular Specialist stories of November 2022

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The 10 most popular Vascular Specialist stories of November 2022

Among November’s most read Vascular Specialist stories were updates from the BEST-CLI trial in the form of new data and funding; a guest editorial calling for (better) training vis-à-vis counseling patients about their treatment options; news of positive results from the TRANSCEND study of a drug-coated balloon; and a write-up of a VEITHsymposium session centering on the merits of incorporating artificial intelligence into vascular practice.

1. First data from BEST-CLI bring surgical bypass into the forefront of discussion for patients with high-quality great saphenous vein

The first results from the BEST-CLI randomized controlled trial of 1,830 patients show that surgical bypass with adequate single-segment great saphenous vein is a more effective revascularization strategy for patients with chronic limb-threatening ischemia who are deemed to be suitable for either an open or endovascular approach.

2. ‘Significant’ increase in atherectomy use in U.S. largely driven by office-based procedures, VQI data show

In the United States, atherectomy use in peripheral vascular interventions “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published U.S. data from the Vascular Quality Initiative (VQI).

3. End-stage CLTI: Deep-vein arterialization procedure demonstrates amputation-free survival of 66% at six months

Six-month results from the PROMISE II trial of the LimFlow deep-vein arterialization system showed an overall amputation-free survival of 66%—“well above” the primary endpoint target of 54%.

4. New analysis: Four multicenter trials support primary use of drug-coated balloons over bare metal stents in femoropopliteal lesions

A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicenter trials support the primary use of drug-coated balloons versus bare metal stents in moderately complex femoropopliteal lesions, new data show.

5. BEST-CLI attracts $3.3m funding injection to continue data analysis

The Novo Nordisk Foundation has made a $3.3 million contribution toward the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) clinical trial.

6. Vascular surgeons: The ‘oncologists’ of the surgical arena

Adam Tanious, MD, on why he is “always a bit apprehensive when it comes to any major vascular case, from a carotid endarterectomy to a complex bypass—and particularly open aortic surgery“.

7. SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND

In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (Surmodics) demonstrated “excellent efficacy and safety” out to 24-month follow-up, according to new data presented at Vascular Interventional Advances (VIVA) 2022 (Oct. 31–Nov. 3) in Las Vegas.

8. Virtual visits versus in-person: Telemedicine study detects ‘substantial’ cost savings for patients

Virtual consultations appear comparable to care received in-person when it comes to clinical outcomes as well as patient and practitioner satisfaction, a systematic review and meta-analysis of all primary studies evaluating virtual patient visits in vascular surgery has demonstrated.

9. VEITHsymposium panel probes ‘value’ of artificial intelligence in vascular surgery

One of the meetings focused on machine learning and artificial intelligence in vascular surgery with a panel discussion honing in on the cost-effectiveness and wider “value” of emerging technologies in this space. 

10. CEA, TCAR ‘continue to show superior outcomes’ to TF-CAS

Researchers found that carotid endarterectomy (CEA) remains the most-used strategy in carotid revascularization, with CEA and transcarotid artery revascularization (TCAR) showing decreased odds of stroke or death compared to transfemoral carotid artery stenting (TF-CAS). 

WVS 2022: New evidence of radiation reduction benefit emerges

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WVS 2022: New evidence of radiation reduction benefit emerges
Cydar Maps

Surgical augmented intelligence in the form of 3D mapping during complex aortic procedures can decrease radiation exposure, fluoroscopy time and contrast use when combined with real-time fluoroscopic images, a new analysis has established 

The results were presented during the 2022 Western Vascular Society (WVS) annual meeting in Victoria, Canada (Sept. 17–20), by Rohini Patel, MD, from the University of California San Diego. The researchers aimed to flesh out whether surgical augmented intelligence can be used to decrease radiation exposure in the operating room. 

The retrospective chart review, from 2015–2021, looked at 116 patients who underwent a complex aortic repair—with 76 receiving a procedure using augmented intelligence. The majority underwent physician-modified endograft (PMEG) repair. 

“Our group that was treated with augmented intelligence had almost half the amount of radiation exposure, with 1,955mGy compared to 3,755mGy in the non-augmented intelligence group,” Patel told WVS. 

The former also saw a decrease in fluoroscopy time of around 56 minutes compared to 87 minutes in the latter group of patients, with contrast use significantly decreased to 122cc from 199cc, she added. 

Adjusted analysis showed these significant reductions remained, Patel explained. “Overall, we believe that surgical augmented intelligence is a way to decrease radiation exposure for the entire team and should be further investigated,” she said.

EVS 2022: Weaving magic in academic vascular surgery at JVS

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EVS 2022: Weaving magic in academic vascular surgery at JVS
Peter Gloviczki speaks before EVS 2022 gathering

Past Journal of Vascular Surgery (JVS) group editor-in-chief Peter Gloviczki, MD, invoked his hobby of magic to help illustrate what it requires to take the reins of an illustrious peer-reviewed publication like JVS during the Eastern Vascular Society (EVS) annual meeting in Philadelphia (Sept. 29–Oct. 1). 

Role models and mentors, commitment, the pursuit of competence, compassion and family support are some of the keys to success, he told EVS 2022 attendees in a keynote lecture. 

“A journal editor is competent if she or he has an established record of academic excellence and scientific integrity, is a prolific author … and has leadership qualities since editing a journal is teamwork,” Gloviczki said. 

“My life from being a young Hungarian magician to become editor of JVS has been exciting, sometimes difficult, but ultimately joyful and most satisfying.”

Veterans Affairs: A call to surveillance

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Veterans Affairs: A call to surveillance
In this closeup, both a therapist and military patient are unrecognizable as the therapist uses a digital tablet during a session with the wheelchair bound warrior.

For many of those injured in combat, the transition in care from the Military Health System (MHS) to the Veterans Health Administration (VHA) can be a daunting one, fraught with logistical and clerical challenges. The deluge of administrative tasks as one shifts from active military service to civilian life can drown even capable and medically sophisticated individuals. Certainly, great strides have been made over the past two decades. The Department of Defense and Department of Veterans Affairs have made it a priority to ensure that veterans have access to healthcare. But there currently exists a cohort of patients with vein bypass grafts who are not receiving adequate surveillance. 

These patients are well-known to the federal healthcare system, the MHS and the VHA, but for some, injury-specific healthcare has not been provided. When we reviewed nearly 100 veterans who had undergone vein bypasses for combat-related arterial injuries during Operation Iraqi Freedom and Operation Enduring Freedom, we found only 13% had had an imaging study appropriate for bypass surveillance in the last two years. Even fewer had been seen by a vascular specialist. Among these veterans, 88% had a documented visit with a healthcare provider within the previous two years, including 81% who had seen a primary care provider. Similarly, Haney et al, reporting on data from the VA Vascular Injury Study (VAVIS), could only find imaging studies to confirm patency in 30% of a similar cohort of injured patients. 

Few would argue that the best care for patients with a vein bypass includes regular surveillance by a vascular specialist, including imaging of their vein grafts. The specialized care necessary to treat an individual’s unique injuries, which may be complex, may be overlooked when one gets referred to the VHA, as may be the case for those veterans who have suffered vascular injuries over the last two decades. The scope of the current problem is neither small and inconsequential, nor grand and insurmountable. And it’s something we’ve faced before. During and after the Vietnam War, long-term patient follow-up was conducted almost single-handedly by Norman Rich, MD, with the Vietnam Vascular Registry. 

Still, the present need for a solution is urgent, as the consequences of missed care could be catastrophic. Approximately 52,000 United States services members were wounded in action in Iraq and Afghanistan. In those casualties, the rate of vascular injury was 12–17%. Approximately 80% of these injuries occurred in the extremities and 50% underwent repair, of which interposition or bypass graft with vein were the most common methods. A conservative estimate would suggest that between 700 and 1,500 veterans underwent a vein graft repair for vascular injury. To have nearly 90% of these veterans miss adequate surveillance and vascular care is a true misfortune, even taking into account that a percentage might have received care outside of the VHA or MHS. 

The call to action is before us. We suggest a three-pronged approach to recapturing those veterans who have undergone service-related vein bypasses in the past 20 years. First, the MHS and VHA should attempt to identify as many veterans with vein graft repairs as possible. Second, efforts should be made to contact these veterans either directly or through Veterans Service Organizations (VSOs). Lastly, we must educate primary care and other first line non-vascular providers on the need for ongoing surveillance for vascular injuries. 

Certainly, these initiatives will face many fiscal, logistical, administrative and psychological challenges. By aligning veterans who have undergone arterial repair in the past with current vascular surveillance, we can optimize the vascular care of one of our most deserving patient populations. 

References 

  1. Unpublished Data. Walter Reed National Military Medical Center IRB #927445. Lauria AL, Kersey AJ, White JM, Rsamussen TE, White PW. 
  2. Haney LJ, Bae E, Pugh MJV, Copeland LA, Wang CP, MacCarthy DJ, Amuan ME, Shireman PK. Patency of arterial repairs from wartime extremity vascular injuries. Trauma Surg Acute Care Open. 2020 Dec 24;5(1):e000616. doi: 10.1136/tsaco-2020-000616. PMID: 33409373; 
  3. Shireman PK, Rasmussen TE, Jaramillo CA, Pugh MJ. VA Vascular Injury Study (VAVIS): VA-DoD extremity injury outcomes collaboration. BMC Surg. 2015 Feb 3;15(1):13. PMID: 25644593; 
  4. Zierler RE, Jordan WD, Lal BK, Mussa F, Leers S, Fulton J, Pevec W, Hill A, Murad MH. The Society for Vascular Surgery practice guidelines on follow-up after vascular surgery arterial procedures. J Vasc Surg. 2018 Jul;68(1):256–284 PMID: 29937033. 
  5. Rich NM, Elster EA, Rasmussen TE. The Vietnam Vascular Registry at 50 years: An historical perspective and continuing legacy. J Trauma Acute Care Surg. 2017 Jul;83(1 Suppl 1):S4-S8. doi: 10.1097/ TA.0000000000001545. PMID: 28452900. 
  6. White JM, Stannard A, Burkhardt GE, Eastridge BJ, Blackbourne LH, Rasmussen TE. The epidemiology of vascular injury in the wars in Iraq and Afghanistan. Ann Surg. 2011 Jun;253(6):1184-9 PMID: 21217514. 
  7. Patel JA, White JM, White PW, Rich NM, Rasmussen TE. A contemporary, 7-year analysis of vascular injury from the war in Afghanistan. J Vasc Surg. 2018 Dec;68(6):1872–1879. PMID: 29945835 
  8. Clouse WD, Rasmussen TE, Peck MA, Eliason JL, Cox MW, Bowser AN, Jenkins DH, Smith DL, Rich NM. In-theater management of vascular injury: 2 years of the Balad Vascular Registry. J Am Coll Surg. 2007 Apr;204(4):625-32. PMID: 17382222. 

Paul W.White, MD, and Erin K. Greenleaf, MD, are members of the SVS VA Vascular Surgeons Committee; Alexis Lauria, MD, is an SVS surgical resident member, stationed at Walter Reed National Military Medical Center. 

MVSS 2022: Study finds no link between frailty score and surgical site infection

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MVSS 2022: Study finds no link between frailty score and surgical site infection

A vascular surgery-specific composite frailty score was not associated with with risk of surgical site infection in patients undergoing lower-extremity revascularization in a review carried out by Andrew Edsall, MD, a general surgery resident in the Gundersen Health System in La Crosse, Wisconsin, and colleagues. 

The research team sought to assess an adapted version of the Risk Analysis Index using the Vascular Quality Initiative (VQI), or the VQI-RAI. 

Some 1,130 patients treated between 2007 and 2019 were retrospectively analyzed, with an overall rate of observed surgical site infection of 8.05% noted, most of them superficial, Edsall revealed as he delivered the results at the 2022 Midwestern Vascular Surgical Society (MVSS) annual meeting in Grand Rapids, Michigan (Sept. 15–17).

EVS 2022: New study shows ‘encouraging increase in academic footprint of female-driven research’

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EVS 2022: New study shows ‘encouraging increase in academic footprint of female-driven research’
Monica Majumdar presents during EVS 2022 in Philadelphia

How does vascular surgery compare to other specialties in the growth of gender diversity in published research? “Are we leaders in the field, or are we trailing?”

Those were questions posed by Monica Majumdar, MD, a general surgery resident at Tufts Medical Center in Boston, during the Eastern Vascular Society (EVS) annual meeting in Philadelphia (Sept. 29–Oct. 1) as she presented new data on the topic.

“In the Journal of Vascular Surgery [JVS] there was a statistically evident linear increase in female-first authorship over time at only 5.3% in 2010 compared to 20% in 2020. And while there appeared to be some gains in the percentage of last authorship and overall proportion of female authors, these trends were not linear or significant over the 10-year study period,” she said.

When compared to ophthalmology and neurosurgery, the trend showing “an encouraging increase in the academic footprint of female-driven research” in vascular surgery “is significantly greater.”

For SVS Foundation Gala, prepare to return to the Roaring 1920s

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For SVS Foundation Gala, prepare to return to the Roaring 1920s

Attendees at the 2023 SVS Foundation Gala will be taking a trip 100 years back in time—to the Roaring Twenties and Prohibition. 

The “Great Gatsby Gala” is set for Friday, June 16, during the Society for Vascular Surgery’s Vascular Annual Meeting (VAM). The “Surgeons’ Speakeasy” will be open for special Prohibition-style cocktails, with flappers and their elegantly clad escorts recreating F. Scott Fitzgerald’s tale of mysteriously wealthy Jay Gatsby and Daisy Buchanan on Long Island in the madcap, music-filled era of the 1920s. 

This year, the SVS Foundation will offer special early-bird tickets for the “Gatsby Gala,” which will go on sale soon. 

Meanwhile, SVS members can turn festive season shopping at www.smile.amazon.com into a donation for the SVS Foundation. For those who have designated the Foundation as their “smile” organization, the retail giant donates 0.5% of every eligible purchase to it. 

These donations aren’t restricted to the end of the year. Every purchase that starts on “smile,” garners contributions to the SVS Foundation. 

Conference watch: Submit research to VRIC, VAM

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Conference watch: Submit research to VRIC, VAM

Submissions already are open for 2023 Vascular Research Initiatives Conference (VRIC), which will be May 10, 2023, in Boston. The conference includes abstract sessions, a translational panel, posters and the Alexander W. Clowes Distinguished Lecture. 

VRIC is held in the same location and in conjunction with as the American Heart Association’s “Vascular Discovery: From Genes to Medicine” meeting on May 10–13, 2023. The AHA’s cost for submission is $49. VRIC submissions will close Jan. 11, 2023. Visit vascular.org/VRICabstracts23. 

Abstract submissions for the 2023 Vascular Annual Meeting (VAM) opened Nov. 16. New this year is a requirement for abstract authors to include with their submission one self-assessment question for post-presentation evaluation 

“This is an opportunity for SVS members to present their research on all aspects of vascular diseases—causes, pathology, prevention, diagnosis and care,” said Andres Schanzer, MD, who chairs the SVS Program Committee. 

“We’re interested in any and all research that moves the ball forward in terms of taking care of our patients, from peripheral arterial disease, thoracic outlet syndrome, dealing with complications, preventing amputations, even artificial intelligence,” he said. “All have a place in helping improve the care for our patients. We are also especially interested in championing and spotlighting research that deals with disparities, diversity, equity and inclusion.” 

Abstract submissions will close at 3 p.m. CST Jan. 11, 2023. Read more at vascular.org/VAM23AbstractProcess. 

Vascular trainee-developed VSITE review book sees sales soar

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Vascular trainee-developed VSITE review book sees sales soar
Thomas Creeden
Sales of The Vascular Surgery Review Book have been brisk

A new review textbook developed by a vascular surgery resident with the aim of helping fellow trainees prepare for milestones like the Vascular Surgery In-Training Exam (VSITE) has accumulated sales of around 500 copies across some 14 different countries.

Such has been the success of The Vascular Surgery Review Book, author Thomas Creeden, DO, from the University of Massachusetts in Worcester, Massachusetts, who birthed the title just before the 2022 Vascular Annual Meeting (VAM) in June, already has outline plans for a second edition to be released next fall.

The book has registered as one of top-selling books on Amazon within the vascular and thoracic surgery category, Creeden tells Vascular Specialist. “Copies have sold in 14 countries, and have made their way into many of the current vascular surgery training programs,” he says.

With the next annual VSITE just around the corner, Creeden hopes other trainees and programs might make use of a nearly 300-page book designed to be high-yield—both easier and quicker to work through than weighty modern-day textbooks.

“I believe [the book] has also reached many medical students and vascular surgery interest groups [VSIGs]. Industry has also gained interest in the book, and it is now on many of the industry-sponsored ‘book lists’ for vascular surgery trainees,” Creeden says. “The feedback has been very encouraging, and overall very well received. I’ve enjoyed having met various medical students and residents who are finding the resource useful, and using it for both clinical application and exam prep.”

The planned second edition is set to contain clinical updates, new study results, procedural steps for common vascular surgeries, and additional figures and illustrations, Creeden added.

SVS 10-year research goals: Why create research priorities?

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SVS 10-year research goals: Why create research priorities?
Four of the SVS’ nine priorities in 2011 have been explored in national multicenter trials

As was the case with the 2011 set, researchers hope the updated priorities will serve as a starting point to align research efforts within the Society for Vascular Surgery (SVS) and among vascular surgeons and scientists. This, in turn, will help drive larger investigations that lead to improved patient care.

For SVS and SVS Foundation awards, the stated priorities help the organizations determine what kind of studies should be considered. External organizations—such as the National Institutes of Health, the Veterans Administration and other organizations—also will know what SVS is looking to as important goals,” said the SVS Research Council’s Matthew Corriere, MD, who proposed updating the 2011 priorities.

Four of 2011’s nine priorities have been explored in national multicenter trials “that addressed the questions we posed,” said Edith Tzeng, MD, former chair of the SVS Research Council who orchestrated the current process to update the priorities. “Those original priorities provided some momentum in setting up trials. That helps drive the important message that, by listing priorities and putting them down on paper, it helps us as a Society and helps other researchers develop related trials. That’s our hope again—that’s the purpose of doing this,” she said of the update.

The four trials based on the initial research priorities are:

  • Carotid Revascularization Endarterectomy versus Stenting-2 (CREST 2), seeking to define optimal management of asymptomatic carotid disease
  • Best Endovascular versus Best Surgical Therapy in patients with critical limb ischemia (BEST-CLI) evaluating the effective of open versus endovascular treatment of CLI. This was ranked third in 2011 and results of the trial were just announced
  • Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT), to identify medical therapies for the prevention of the growth of abdominal aortic aneurysms (AAAs), specifically testing the ability of doxycycline to prevent AAA growth. Identifying and evaluating medical therapy to prevent AAA growth was ranked eighth in 2011. No clear benefit was demonstrated but “this trial represented the culmination of bench-to-bedside efforts of a number of SVS members working together to identify a medical therapy for AAA disease,” said the article

Finally, studies showed that ultrasound examination works for surveillance following endovascular AAA repair. That has been incorporated into recent SVS practice guidelines, and ultrasound surveillance has supplanted computed tomography angiography. Follow-up was the ninth priority in 2011.

“Our signature topics include aortic, carotid, and lower extremity vascular diseases,” Raul Guzman, MD, current chair of the Research Council, said. “Clinical trials would be very valuable in answering the big questions. We can invigorate and support research along the lines of our priorities now that we’ve stated what they are.”

The aim is stated in the Journal of Vascular Surgery. “It is our hope that, with the support of our partners in the National Institutes of Health, the American Heart Association, the Patient-Centered Outcomes Research Institute, the Veterans Administration, and other non-profit organizations such as Vascular Cures, we will continue to develop large-scale clinical trials and translational research efforts aimed at addressing many of these priorities. It is also our hope that these efforts will exceed the success of the inaugural set of research priorities, all for the betterment of our specialty and for the health of our patients.”

How the new priorities were created

The process of updating the nine Society for Vascular Surgery 2011 research priorities began in 2020, jump-started by SVS Clinical Research Committee Chair Matthew Corriere, MD, who noted that, after nine years, an update might be in order.

A total of 106 people involved in research were invited to answer an open-ended question: what are the “two most important questions that need to be answered in vascular research for the care of our patients?”

Those selected included the 2011 participants, SVS leadership, members of SVS Research Committees from 2019 to 2021 and members involved in vascular research. Sixty-six people responded with 134 questions, which were collected into topic areas. Lower extremity arterial disease was the focus of nearly 40 questions, followed by research methodologies, approximately 23; aortic disease, nearly 20; and carotid disease, approximately 17.

The council then identified 28 unique research priorities “of significant contemporary interest to the SVS membership,” including:

  • Five for carotid disease
  • Five, aortic disease
  • Six, lower extremity arterial disease
  • Four, venous disease
  • Three, dialysis access
  • Two, health care disparities
  • Three, medical management of vascular disease

Participants convened for a virtual meeting in May 2021, where subject matter experts presented summaries of their topic areas, and focused on key knowledge gaps.

Attendees reviewed and discussed the topics and identified additional holes, creating a final list of 36 research questions to score. The list was distributed to the 28 stakeholders for voting, with 26 people—93%—responding and SVS administration tallying the results.

In the larger topic areas of carotid, aortic and lower extremity arterial disease, the top two priorities were selected. The top-scoring question in venous disease, dialysis access, health care disparities and medical management of venous disease made the list.

Gaining approval

The Research Council reviewed and approved the final 10 research priorities. The majority of those who responded to the request for research priorities were in the 40–49 and 50–59 age ranges, but the larger group did include both younger and older members. Most of the respondents were male, with 20% female representation.

This breakdown is similar to the demographics of the overall SVS membership, said Tzeng, former chair of the Research Council, and lead author of the article on the priorities in the Journal of Vascular Surgery.

The full breakdown by age and sex of respondents and SVS membership can be found in the article at vascular.org/ResearchPriorities. The council hopes to further diversify respondents for the next update on priorities, Tzeng added.

The Research Council recognized the SVS Executive Committee and SVS staff, particularly Sarah Murphy, senior director for research and education, who participated in the 2011 process and coordinated the updating effort, said Tzeng, Corriere and Guzman.

SVS reveals research priorities for next decade

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SVS reveals research priorities for next decade
Female nurse assisting patient undergoing renal dialysis in hospital room
Female nurse assisting patient undergoing dialysis in hospital room

The Society for Vascular Surgery (SVS) Research Council has updated its top 10 research priorities, originally published in 2011, with patient-centered outcomes and personalized vascular care at their core and a new emphasis on healthcare disparities.

The priorities help the Society target research proposals for its own grants and awards, and provide external organizations with what SVS members regard as important goals, said Edith Tzeng, MD, and Matthew Corriere, MD, of the Research Council.

The updated areas of research focus on aortic, carotid, lower extremity arterial (two priorities each) and venous disease, along with dialysis access, healthcare disparities and medical management of vascular disease (one priority each).

The new priorities add disparities as well as vascular medicine/vascular health as areas of focus, highlighting a shift in emphasis over the past decade. “We can’t focus on everything,” said Corriere. “Part of our discussion was ‘what do we want to call attention to in the updates?’”

 The updated priorities “reflect our increasing awareness of the need to understand vascular disease pathogenesis and prevention in the context of a diverse patient population. Importantly, patient-centered outcomes and personalized vascular care are at the core of these updated priorities,” said members of the SVS Research Council writing about the priorities in the November issue of Journal of Vascular Surgery (JVS). Tzeng, the former council chair, is first author. 

“With our greater social awareness, it is paramount that we address these disparities and understand their impact on patient health and outcomes of treatment,” said Tzeng. 

Currently, there is a big emphasis on medical optimization, said Corriere, “That aligns with paying attention to healthy living and disease prevention.” 

“We think disparities and patient-centered care are extremely important aspects of what we can do to improve health in the broader community,” said Raul Guzman, MD, current chair of the Research Council. “We’re very aware of the issues related to providing care for a diverse patient population and, by doing research in this area, we hope to improve care for all of our patients.” 

Healthcare assessment is also moving from technical outcomes to more patient-centered outcomes, said Guzman. And research in coming years will focus on what patients consider to be the most important aspects of their care. 

The 10 priorities were selected through a lengthy process (see adjacent article), which began with 106 selected surgeon-scientists asked to submit “the two most important questions in vascular research that need to be answered for the care of our patients.” 

The new priorities create a ”framework for vascular surgeons to engage in research in ways that the wider community thinks are significant and will improve patient care,” said Guzman. 

“We hope to help our young investigators focus on problems that our Society’s membership feels are important in terms of our daily practices. If we can encourage our members to become enthusiastic about these particular topics, that would be a big accomplishment,” he said. 

Researchers hope the updated priorities will serve as a starting point for aligning research efforts within the SVS and among vascular surgeons and scientists, and that they will help drive larger investigations that lead to improved patient care. 

This occurred with the 2011 priorities; four of the nine priorities have been explored in national multicenter studies “that directed the questions we posed,” said Tzeng. “By listing priorities and putting them down on paper, it helps us as a Society and helps other researchers develop trials to look into these topics.” 

Priorities from 2011 remain important to the vascular research community said all three doctors, emphasizing that the new priorities listed are not the only areas of research that are important. “At this moment, these are areas that membership believe should be a higher priority,” said Corriere. 

Corriere, Guzman and Tzeng also pointed out that for this update, the group overall intentionally refers to the updated priorities as simply “research priorities,” removing the word “clinical.” 

“Although these priorities are clinically oriented, the answers to these important questions may lie in investigations that focus on basic, translational or clinical research,” said the article. “These priorities are intended to be as inclusive as possible, encouraging research approaches that may use genomic data to identify disease-specific mutations, cell-based therapies, computational modeling, novel imaging technology, implementation science, clinical trials and so on.” 

What’s the future for the priorities? Guzman foresees a shorter time interval between updates, “because treatments and care are evolving so rapidly,” he said, with treatments common today that simply were not available in 2011. “There are things just now being discovered that in five years will make the cut,” said Guzman. 

After all, it was partly such advances that spurred the review. “There are so many new technologies and medications that appear and make us review an old question,” said “Corriere. “We wanted to get fresh eyes on the priorities (from 2011) in light of new evidence and treatments.” 

All three surgeons hope people read the JVS article and review the priorities. “It shows what our members think are important topics and demonstrates the success of the prior priorities,” said Tzeng. “It says, ‘here are our updated research priorities. Look at how much we have achieved since the original set of priorities.’“ 

Read the article in JVS at vascular.org/ResearchPriorities. 

SVS vascular leaders: Cohort four of Leadership Development Program selected

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SVS vascular leaders: Cohort four of Leadership Development Program selected

Twenty-nine people have been selected for development as future leaders of the profession and the Society for Vascular Surgery (SVS). 

They represent cohort four of the Leadership Development Program (LDP), a nine-month-long interactive course designed to help them reach their full potential as leaders and positively impact their workplaces, communities, the vascular surgery specialty and other important areas of their lives. 

Content includes the functional day-to-day behaviors and skills that drive success in leadership, how and where physicians can lead most effectively in complex health delivery systems, the science and physics of leadership, personality styles and emotional intelligence, strategies to strengthen resilience and avoid leader burnout, as well as conflict resolution and negotiation strategies. 

“I think more about switching gears between how I interact with colleagues in the operating room compared to clinic, the office, etc.,” said Max Wohlauer, MD, a cohort three member. “It was a very positive experience.” Fellow participant Mark Wheatcroft, MD, said the experience “taught me the importance of spending time gathering as much information as possible from the right people before acting, and to think deeply about strategy development. “I also find the LDP toolkit very helpful with analysis.” 

The program also provides four $3,000 Mastery Grants to LDP graduates, permitting them to continue leadership education. 

Selected for 2022–23 are: Clayton Brinster, MD, of Ochsner Health, New Orleans; Joseph Hart, MD, of Medical College of Wisconsin, Milwaukee, Wisconsin; Sharon Kiang, MD, from VA Loma Linda Healthcare System, Loma Linda, California; and Elisa Greco, of the University of Toronto, Toronto, Ontario, Canada. It is co-sponsored by the Society for Clinical Vascular Surgery (SCVS) and the Vascular and Endovascular Surgery Society (VESS). 

See Cohort 4 at vascular.org/LDP. 

Vascular Specialist–December 2022

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Vascular Specialist–December 2022

In this issue:

  • Women in vascular: Annual summit dedicated to tackling key issues related to women’s vascular health and female workforce seeks to ‘enable and empower’ (p. 1 and 4)
  • Vascular community starts process of wrestling with findings from BEST-CLI trial (p. 1 and 6)
  • Guest editorial: Arthur E. Palamara, MD, on Envision, private equity and patient care (p. 2 and 4)
  • JVS-VL: Journal dedicated to venous disease set to go online-only (p .18)

 

NESVS 2022 Presidential Address: ‘We can create a bold new future for vascular surgery: It’s go time’

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NESVS 2022 Presidential Address: ‘We can create a bold new future for vascular surgery: It’s go time’
Andres Schanzer delivers the 2022 NESVS Presidential Address

“Collaborate, innovate, mentor, champion DEI [diversity, equity, and inclusion] and relish the opportunity to form deep connections with our amazing patients.” This was the key take-home message delivered by Andres Schanzer, MD, chief of vascular surgery at the UMass Memorial Medical Center in Worcester, Massachusetts, during his Presidential Address at the New England Society for Vascular Surgery (NESVS) 49th Annual Meeting in Newport, Rhode Island (Oct. 14–16). 

The topic of Schanzer’s address was “creating a bold new future for vascular surgery,” and one of the keys to this—according to the president—is to focus on the patients. “They are the ones who inspire us to get up each morning, and deal with the challenges that we all encounter every single day.” He expressed his belief that the “rich, long-term relationships” with patients that are “unique to vascular surgery” is what will keep the field “thriving.” 

He added that, while the cure for burnout is “different for everyone,” for him it is rounding on his patients once in the morning and once before he heads home in the evening. “That is what keeps me going.” 

Schanzer also placed a spotlight on DEI as another crucial point of focus. “As providers, we need to build a workforce that looks more like our patients,” he stressed. “This is not about committees and statements and tweets, it is about hiring, promoting, paying, and acknowledging the indisputable fact that diversity makes us better. If you are not bringing underrepresented groups to the table in whatever leadership capacity you have, then you are the problem.” The president also remarked on the wider importance of championing DEI: “We need to do this not for ourselves, but for our patients, for our trainees, and for our society.” 

Schanzer had a specific message for the trainees and young faculty who are the future of the vascular surgical specialty and will “undoubtedly face challenges” in the years to come. “Remember this,” he said: “Try to take yourself a little less seriously. I know that I need to do this often.” 

In closing, Schanzer summarized: “It is not about any one person or any one career, it is certainly not about mine. It is about our field and advancing it by sticking to and leveraging these key anchor values that makes vascular surgery so special. We can create a bold new future for vascular surgery: it’s go time.”

BEST-CLI: Optimal medical therapy adherence ‘well below’ recommended level at baseline

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BEST-CLI: Optimal medical therapy adherence ‘well below’ recommended level at baseline
Matthew Menard

A significant proportion of patients enrolled in the BEST-CLI trial did not meet optimal medical therapy (OMT) guideline-based recommendations at the time of their entry into the study, co-principal investigator Matthew Menard, MD, told the 2022 New England Society for Vascular Surgery (NESVS) annual meeting in Newport, Rhode Island (Oct. 14–16). 

The investigators were looking to understand the utilization of OMT at the inception point, with baseline data—post-consent, prior to revascularization—showing that 87% of patients enrolled had hypertension, 74% had hyperlipidemia, 69% diabetes, and 36% were active smokers, Menard told attendees.

“How did we do?” he pondered. “Not so well. The data show those who had controlled blood pressure was 64%, “so just shy of two thirds,” said Menard. The number of those still smoking was greater than one third, he continued, with those on at least one lipid-lowering medication “a little better at 72%,” while those on at least one antiplatelet medication was 73%. 

He further revealed how just a quarter met all four OMT criteria, with 2% not meeting any of the stated components. Some 38% met three, another quarter two, and 11% just one of the criteria. 

Multivariate analysis showed Hispanic ethnicity, prior or existing coronary artery disease, stroke and diabetes were among positive predictors of a higher optimal medical therapy score, while Black race and participation in Cohort 1 were negative predictors. 

“Patients in this BEST-CLI dataset had utilization rates of defined optimal medical therapy well below recommended at the time of presentation,” Menard said. 

“Where do we go from here? The most important work is to turn participation in the trial into improved utilization of optimal medical therapy.” 

Changes from baseline utilization of optimal medical therapy over the course of BEST-CLI and associated impacts on clinical outcomes and quality of life are to be further assessed, Menard added.

Dec. 12 webinar to examine 3D printing for vascular imaging

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Dec. 12 webinar to examine 3D printing for vascular imaging

Society for Vascular Surgery (SVS) members can learn some of the ins and outs of three-dimensional (3D) printing for vascular imaging at a webinar on Dec. 12.

The SVS’ Health Information Technology (HIT) Committee is sponsoring the webinar, which begins at 6 p.m. CST.

With 3D printing, vascular surgeons get a replica of a patient’s unique vascular anatomy—from heart valves to blood vessels—before performing open surgery on endovascular procedures. “This offers the vascular surgeon increased detail to optimize the procedure and patient outcomes,” said Judith Lin, MD, chair of the HIT Committee.

She and Adam Johnson, MD, will moderate the webinar. Topics will include, among other topics, a 3D printing overview and presurgical planning using 3D modeling. There will be time for questions and discussion.

To register, visit vascular.org/3DWebinar.

Roundtable on varicose veins guidelines set for Dec. 6

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Roundtable on varicose veins guidelines set for Dec. 6

A virtual, multidisciplinary and interactive roundtable discussion on varicose veins will be held Dec. 6.

The free roundtable, set for 6 to 7:30 p.m. CST, will be based on the recently published joint clinical practice guidelines developed by the Society for Vascular Surgery (SVS), American Venous Forum (AVF) and the American Vein and Lymphatic Society.

“Translating Guidelines into Practice: Management of Patients with Varicose Veins of the Lower Extremities,” will feature internationally recognized experts in venous disease. Peter Glovizcki, MD, Peter Lawrence, MD, and Suman Wasan, MD, will moderate.

The roundtable will cover:

  • Diagnostic evaluation of vein incompetence, including using duplex scanning to confirm pathologic superficial truncal reflex, with Mark H. Meissner, MD, presenting
  • High ligation and surgical stripping versus endovenous ablation, Andrea T. Obi, MD
  • Thermal ablation versus non-thermal ablation of saphenous veins, Anil P. Hingorani, MD
  • Perforating vein ablation in patients with varicose veins (CEAP Class C2), Arjun Jayaraj, MD
  • Saphenous vein ablation with concomitant versus staged treatment of varicose tributaries, Harold J. Welch, MD
  • Panel discussion

This session aims to help expand physicians’ knowledge base and improve their clinical confidence and effectiveness in treating patients with varicose veins.

The faculty will use case vignettes to design treatment strategies and demonstrate how to put the recommendations from the evidence-based, clinical practice guidelines into practice. A short survey will be conducted before and after the session and a follow-up survey will follow 60 days later to gauge and evaluate if guidelines were easy to translate into daily clinical practice.

Vascular surgeons: The ‘oncologists’ of the surgical arena

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Vascular surgeons: The ‘oncologists’ of the surgical arena
Adam Tanious

Like any good presentation I feel obligated to start with my disclosures: 1) I am married to a woman who decided to pursue a separate fellowship in bioethics, even after a fellowship in pediatric anesthesia. This means that every time I come home and start to discuss a patient’s tough clinical situation, I am invariably met with the question, “Did you discuss all their options with them?” And, 2) I just celebrated my one-year anniversary of being an attending, and, while my confidence slowly grows with each day, I am still always a bit apprehensive when it comes to any major vascular case, from a carotid endarterectomy to a complex bypass—and particularly open aortic surgery. 

Allow me to present Patient X, a 70-year-old male who was transferred to our hospital while I was on call. He presented to an outside hospital with obstipation of several days’ duration with associated abdominal pain. His history was notable for an aortic endograft placed for aneurysm four years prior which was explanted and replaced with a rifampin-soaked interposition graft for infection in the last two years. The outside physicians were concerned mostly about his bowel obstruction but thought something was “off ” about how the bowel was associated with the graft. Like most centers, we accepted the patient to get them to our hospital and figured we would get the necessary teams involved upon arrival. Upon his arrival to our hospital, we got our gastrointestinal surgery colleagues involved and began working through his history and current status. His initial labs showed a severe leukocytosis and within 24 hours his blood cultures were growing pseudomonas. Additionally, within 24 hours of presenting to our hospital, he began to show signs and symptoms of a colovesicular fistula. A nuclear medicine study was done showing definitive uptake at the site of his aortobifemoral bypass. 

To summarize, we have a 70-year-old man with a prior infected endovascular aneurysm repair (EVAR) that was explanted and repaired with a rifampin-soaked Dacron graft which was now also infected and causing a bowel obstruction, leading to sepsis, in addition to a colovesicular fistula. 

At this point I’d like to introduce the term “end-stage vascular disease” and, with the readers’ permission, apply it to Patient X. I do not make this statement lightly, nor mean anything offensive by it. My wife and I were discussing patients one evening and she made a comment that really stuck with me. She equated vascular surgery to medical oncology in the sense that in the world of medicine, medical oncology patients often have very tough pathology to treat, “wins” are hard to come by, and any intervention, more often than not, alters the future quality of life for the patient in addition to duration. Furthermore, there are patients that present with terminal disease who despite all the best efforts and current medicine/technology available, intervention is unlikely to alter the inevitable outcome. 

I consider myself more than fortunate to have trained at some of the best institutions in the country where the above story is only all too common. These patients present to our hospitals as we are usually the only facility in the state/region with the appropriate recourses and supporting personnel capable of handling such complex pathologies. Their understanding of their pathology is understandably limited, and they appreciate the gravity of the situation only as it applies to need for their transfer. As a trainee, I’d get fairly excited about this pathology and the opportunity to undertake a major vascular surgery to cure the patient of their infection that could (and most likely would) result in death in the not-too-distant future. When consenting them and their families for their procedure, we were trained to be as accurate as accountants when it came to risks associated with the specific procedure each patient would need while still being human—talking them through the potential outcomes and try to paint a picture of what life would look like should the patient make it through their procedure. 

The next few weeks would proceed in a fairly standard fashion including a complex and lengthy surgery with major blood loss; some form of a post-operative complication; prolonged hospital stay; and a transition to inpatient rehabilitation. While the life of a trainee meant that I was usually on a different service/rotation by the time these patients came back for follow-up, my particular interest in these patients infected aortic pathology made me track their outcomes and, not surprisingly, only about 50% of these patients ever made it back for their follow-up once discharged, with about 25% never making it out of the hospital. 

So, 13 months into practice, I am presented with Patient X and it is my job to discuss with him our options on how to proceed, knowing that regardless of his decision, I am about to affect the course of not just his life, but the life of all his friends and family. If I’m being honest, I was torn. Here I am talking to a man who just retired and had grand plans to finally enjoy his well-earned retirement with his wife by traveling and experiencing the world. If I steered him towards surgery, we all know what his life would look like for the next year as well as the associated numbers as stated above. But what was my alternative suggestion? What would my peers and partners think? Would they think I was simply scared to tackle this type of procedure? This would be the biggest case I could have done as junior faculty and I know it is the only “life-sustaining” option? We are taught to offer surgery when the benefits outweigh the risks. The risk of not operating in patients with end-stage vascular disease is most often death. This could be an imminent death, a death within a certain amount of time, or eventual death—but death is the conclusion. 

I kept thinking about what Patient X’s life would look like and how he would remember his final days should we proceed with surgery. Then I discussed the case with my wife. Physicians, specifically surgeons, often fall victim to the following sentiment “[doctors] will do everything they can to prolong someone’s life… many medical practitioners are not trained to handle conversations that focus on quality of life or relief of pain and suffering, and instead lean toward recommending their own treatments.” This is a quote from Jeffrey Schnipper, MD, research director for the Division of General Internal Medicine and Primary Care at Brigham and Women’s Hospital, taken from an article about physicians’ lack of understanding regarding end-of-life care. In a study titled “Surgeons’ perceived barriers to palliative and end-of-life care” in the Journal of Palliative Care Medicine from 2018, 76% of surgeon responders cited no formal training or education in palliative care, while more than one-third cited lack of training in how to forgo life-sustaining measures and communication regarding these matters. 

What if Patient X’s final days involved a few extra medications to treat symptoms but also family dinners and a trip to an exotic destination he had always wanted? He would ultimately succumb to his infective process, but did that mean not enjoying the time between then and now? Could we offer a picture that focused on enjoying the time he had instead of “fighting” through the proposed surgical course? 

I sat down and had a family meeting with Patient X, his wife, his brother and sister-in-law. I drew pictures, explained the proposed procedure(s), potential complications, and expected hospital and post-operative course. I laid out a timeline. I was blunt. I was not callous, but I was direct. I then offered some alternatives (after discussing with our infectious disease, gastrointestinal surgery, and urology colleagues). I offered Patient X the option of antibiotic therapy and pain medication to treat his symptoms. I painted a picture of what his life would look like through this option’s lenses. I then told everyone in the room that Patient X had my support no matter his decision and that we would do everything in our power to ensure the best outcome regardless of his choice. Then I sat there silently. 

What felt like an eternity passed. Patient X broke the silence. He started by thanking me. All parties asked several questions to understand the details that were pertinent to them. They asked me what I would do. The question I feared but prepared for. I told them that the answer to that question depends on what each individual values. I couldn’t decide for Patient X what values were most important to him. All I could do is paint as realistic picture as possible and hope that one option would resonate with them. I told them that I know individuals who would happily select either path based on their values and that there is no wrong answer. They thanked me again and asked for some time to decide. 

I felt drained. What had I just done? Was I being a coward? My goal is not to talk all of my complex patients out of their complex surgeries. I do feel strongly that we as a society, and surgical community, need to focus more on these types of conversations and goals when interacting with our patients and our trainees. Quality of life is a metric more recently making into the literature, but why is it not a course that all medical students are taught or a rotation that interventional trainees must spend one month to counsel patients appropriately about all their options? 

I was paged not too long after the conversation… Patient X wanted to go home on antibiotics and take a trip to a city he and his wife had been looking forward to visiting for many years. 

Adam Tanious, MD, is an associate program director for the vascular surgery residency program at the Medical University of South Carolina (MUSC) in Charleston, South Carolina.

Swiss parliament votes to accept FDA-approved medical devices

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Swiss parliament votes to accept FDA-approved medical devices

The Swiss Federal Assembly has voted in favor of accepting medical devices with the Food and Drug Administration (FDA) marketing authorization in Switzerland.

A motion for ‘more freedom of action in the procurement of medical products for supply of the Swiss population’ was discussed and put to a vote in the country’s parliament on Nov. 28, with many industry groups, including Swiss Medtech, supporting the acceptance of FDA-approved devices.

In a press release, Swiss Medtech described this as a “necessary and urgently needed decision,” and stated that it is “essential” for this order to now be implemented swiftly and pragmatically. It further draws on Australia and Israel as examples of countries in which “efficient procedures” to recognize FDA approvals in parallel with the CE mark have “proven successful,” and “can be achieved in an uncomplicated manner.”

“Swiss Medtech very much welcomes the policymakers’ important and forward-thinking decision,” added Peter Biedermann, managing director of Swiss Medtech. “It is a response to circumstances that could no longer be ignored. Specifically, problems with the implementation of the new European Medical Device Regulation [MDR], and the negative consequences concerning availability, product range and quality of medical devices throughout Europe. As innovations are increasingly being introduced first to the market in the US, new products reach Europe with a delay, at best.”

The Swiss Federal Council—the executive body of the country’s federal government—opposed this proposition, citing the administrative burden that would be brought about by this regulatory shift, and patient safety concerns caused by risk classification discrepancies between the U.S. and Europe.

On May 30, 2022, the potential acceptance of FDA products was voted on by the 46 members of the Swiss Council of States (the upper house of the country’s Federal Assembly), with 23 voting to accept and 12 voting to reject.

Shortly following this decision, the Federal Council asserted in a press release that there was no need to accept non-CE-marked medical devices, such as FDA-approved devices, at that time—describing the extension of simplified market access to other countries outside of the EU as “disproportionate”—before noting that it would re-evaluate this situation at the end of 2024. It added that the supply of safe medical devices in Switzerland was “currently guaranteed,” referencing various backup measures it took back in 2021 to ensure this “even without an updated MRA [Mutual Recognition Agreement].”

The parliamentary vote that took place earlier this week was borne out of the introduction of the European MDR on May 26, 2021, with the MRA and all related trade-facilitating effects for medical devices between the EU and Switzerland also ceasing to apply from the same date.

And, while devices “in conformity” with the MDR can be certified and placed on the market until May 25, 2024, marketed devices must be certified directly under the MDR from the following day (May 26) onwards. With this deadline drawing ever closer, concerns have been raised regarding regulatory challenges, supply chain gaps and device shortages, and the impact this could have on patient care and industry alike.

As a statement from Swiss Medtech notes, “more than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products—they are not prepared to meet the additional requirements for the limited Swiss market, and patients in Switzerland are the ones to suffer.”

The motion to accept FDA approval of devices in Switzerland was brought up to the 200-seat Swiss National Council (the lower house of the country’s Federal Assembly) on Monday, with 100 votes in favor and 79 against being cast. As such, both chambers of Switzerland’s national parliament have now voted to adopt the initiative, and will instruct the Swiss Federal Council to adapt legislation to allow devices with FDA clearance onto the market.

Details of this new system and the logistics of implementing it, as well as when it will come into effect, are yet to be confirmed.

Diversifying clinical trials: ‘There needs to be some kind of cultural competency’

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Diversifying clinical trials: ‘There needs to be some kind of cultural competency’
Vincent Rowe

The COVID-19 pandemic exposed lingering mistrust in the U.S. healthcare system among patients from minority communities as physicians continue to confront the conundrum of healthcare disparities in terms of outcomes alongside a lack of diversity in clinical trials, a roundtable discussion at Vascular Interventional Advances (VIVA) 2022 in Las Vegas (Oct. 31–Nov. 3) heard. 

Vincent Rowe, MD, chair of the SVS Diversity, Equity and Inclusion (DEI) Committee, told the gathering, entitled, “How to be a trialist,” that despite a National Institutes of Health (NIH) intervention nearly 30 years ago aimed at recruiting more minorities into clinical research, “we haven’t seen much change.” 

“We’ve talked a lot about clinical trials, their importance and how they have to be applicable to the full population of patients that we deal with,” he said. “Unfortunately, there are still a lot of disparities in our outcomes, so we’re going to need a diverse cohort to be able to understand the differences.” 

Rowe pointed to a study that looked at patients eligible for cardiometabolic trials. The problems that emerged, mostly from the patient side, included lack of awareness, lack of information, mistrust, and a lack of comfort with the process. He highlighted how historical experiences with the healthcare system have led to low levels of trust, especially among the Black community. “And if you think that it is all over and things have gotten better, I think the COVID pandemic was a perfect microcosm of this mistrust that happened,” he said. 

Rowe said combating these problems is multifactorial but suggested greater diversity among site investigators and cultural competency as among potential remedies. “You need people in your trials to be applicable to all the patients that you’re seeing,” Rowe said, demonstrating how enrollment for the BEST-CLI trial at his institution among the Hispanic community was bolstered by the involvement of a colleague fluent in both the culture and language. “There needs to be some kind of cultural competency,” but that does not require race concordance, he added. “There just needs to be someone talking to them that’s technically competent and understands the culture.” 

The role of referring physicians, too, is key, in order that they receive the support required “to send us patients from a culturally diverse environment,” Rowe told the VIVA gathering. “We’re going to need to increase these patients in clinical trials,” he said. “It may be difficult based on the times we are in. People say they are so entrenched in their views, but I think it is possible—and it can only help to improve the care for all of our patients.” 

Eastern Vascular gathering challenged to forge next generation of evolution

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Eastern Vascular gathering challenged to forge next generation of evolution
Robert Rhee addresses EVS 2022 in Philadelphia

Evolution was the core theme of the Presidential Address Robert Rhee, MD, delivered from the Eastern Vascular Society (EVS) annual meeting stage in Philadelphia (Sept. 29–Oct. 1). “Let’s Evolve,” it was entitled. But, Rhee told those gathered, the society lays claim geographically to the Eastern seaboard of the United States and Canada, which is home to “the most incredibly diverse and quantitatively the largest number of training programs” anywhere else in North America. So he had a specific audience in mind for his presidential message contained. 

“I thought it would be befitting to direct my address to the younger and possibly the greatest generation of vascular surgeons ever, because you are going to take us into that next level of evolution,” said Rhee. 

The endovascular aneurysm repair (EVAR) revolution encapsulates the essence of out-of-the-box thinking required to achieve that revolution, he told the audience. 

“We, as a pioneering specialty, turned a very maximally invasive operation into a minimally invasive one,” Rhee said—with “excellent long-term results 25 years later.” 

“It’s not a failed experiment, as some recent editorial in the JVS [Journal of Vascular Surgery] has suggested. It transformed our specialty overnight to the highest levels, with excellent outcomes, which could not be really compared to any open AAA [abdominal aortic aneurysm] repair at most institutions.” 

Rhee turned to the example of Timothy Chuter, MD, a pioneer in the development of endovascular repair, with whom he worked for a time: “Initially, when he came to us, he was thought to be crazy because the vascular chief at that time ridiculed him constantly at conference. I remember sitting down with him, and him preaching to me how stupid it was to treat a disease of expanding radial force with a device that has constant radial force. 

“What would have happened if Timothy Chuter did not forge on and ignore his critics. He was not allowed to do the research involved with EVAR at the main university hospital because they thought he was crazy. So he went to a local, large community hospital, and they said, ‘Do it.’ They actually had the insight to allow him to do his EVAR studies.” 

Rhee challenged members of the EVS gathering: “To all of you surgeons out there: be a Tim Chuter; don’t be a follower. If somebody discourages you, and you have an idea, pursue it.” 

When it comes to evolution and revolution in vascular surgery, Rhee honed in on four high-level areas: Understanding the disease process and the limitations on what can be done. Embracing new technology “but not being blinded by false prophets.” Escaping from the ethical black hole. And embracing diversity to achieve success. 

“Vascular surgery is still a relatively new field,” Rhee said, explaining how the specialty developed out of a sense of necessity among cardiac surgeon leaders in those early days. “Let us evolve and not overestimate our abilities by offering solutions that overtreat our patients.” 

He was taught, by the vascular elder statesmen like Kenneth Cherry, MD, and Kenneth Ouriel, MD, that “less is better and faster is better for the patient.” 

Rhee emphasized the need to ensure patients are not being overtreated by raising the figure of the late Roy Greenberg, MD, another vascular pioneer. 

“He introduced one key concept that we should all take a second look at in 2022, “ he said. “That is, he advocated, after coming back from Malmo, Sweden, that we should always treat to the healthy aorta. It’s a modus operandi that is religiously followed by all these aortic surgeons throughout the world now. But it’s a very dangerous concept in essence, because, by definition, it overtreats patients. Because you’re putting in stents and devices into healthy portions of the aorta.” 

Rhee asked the audience whether this level of treatment was truly required in an arena of care where there is no cure, but where vascular specialists are pursuing “endovascular protection.” 

“It’s almost heresy to say that, but when you look back, and at the history of vascular surgery and surgical management, you realize if you have a patient with abdominal aortic aneurysm, the entire aorta is diseased; there is no healthy aorta. So, what are you treating to? I challenge you. I do four-vessel thoracoabdominal [aneurysms] all the time, but I’m saying that we all should take a look at it, and not follow religiously at this point.” 

Question everything as new technology emerges, continued Rhee. “From the very beginning, vascular surgery had access to a dizzying array of tools, and we embraced that. There are countless examples of tools we have developed for the management of vascular disease; however, there is a dark side to the technology.” 

The Food and Drug Administration (FDA) approval process brings countless numbers to the table every year, specifically through the 510k route, he noted—“about 80% of the devices you all use now.” 

This means, Rhee said, “a device company is allowed to sell their devices to you to be used in your patients because the device looks and performs like a similar, already approved device. Many of these devices don’t have any data, and they are still approved and marketed for use in your patients.” 

Therefore, “not all of the shiny new toys have the data,” he commented, and it is incumbent upon vascular surgeons to conduct research to establish device safety, raising the concept of what he called “false prophets.” 

Rhee urged caution over the ethical conundrums that face the profession. “We have this financial pressure to produce not just volume, but also in clinical research and basic research. We have to make sure there is an ethical component and accuracy of the research is ever-present throughout our careers.” 

Rhee also addressed diversity, tackling the topic through the prism of his challenge for the specialty to “question everything.” He referred to the experience of a female senior resident who during his own training questioned a leading surgeon who held viewpoints that held that she should not enter vascular surgery because of the fact she was a woman. “Should we cancel him because he said that?” Rhee stated. “He was thinking 1989 beliefs. Yes he was an incredible pioneer but he had the beliefs of back then. The essence is of evolution is to question everything.” That female resident fought through the pushback and entered vascular practice, Rhee added. 

He placed vascular surgery in the guise of “a microcosm of the world’s controversies.” And as vascular surgery evolves to the next level, inclusivity will be key, Rhee said. In that vein, the EVS is poised to extend full membership to all allied health members and beyond. “Vascular surgeons do not own vascular disease,” Rhee added. “There are blood vessels everywhere … It doesn’t matter where the controversy is. But my vision is that vascular surgery—because our field encompasses the entire body—we should be the gatekeepers and the quality keepers of vascular disease.”

Bright future predicted for JVS internship program

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Bright future predicted for JVS internship program
Ulka Sachdev-Ost and Anand Brahmandam
This month on Corner Stitch, Christopher Audu, MD, profiles a new and innovative program offered by the Journal of Vascular Surgery (JVS). It’s called the JVS internship program, and with us this month are Ulka Sachdev-Ost, MD, and Anand Brahmandam, MD. Sachdev is a professor of vascular surgery at the University of Pittsburgh, and the founder of the program, now in its second year, and Brahmandam is the chief integrated vascular surgery resident at Yale and was one of the inaugural JVS interns last year. 

VS: What is the JVS internship program? How does it work? How do you apply? 

AB: The Journal of Vascular Surgery reviewer internship program is a reviewer training program initiated by the editors of the JVS family of journals and Society for Vascular Surgery (SVS). The goal of this program is to train the next generation of vascular surgeons how to review research papers and be fair, balanced and respectful reviewers in their career. During this year-long internship, trainees are paired with a mentor (senior editor for JVS) and are expected to review around 10–12 manuscripts under the guidance of their mentor. In addition to reviewing papers, there are monthly group sessions and lectures focusing on a variety of topics pertinent to the peer-review and editorial process. 

The call for applications is typically through social media, SVS connect and/ or Audible Bleeding, and requires a current CV, a brief statement of interest, and two letters of support (one from a program director, and one from a faculty mentor). 

VS: What are you looking for in potential JVS interns? 

US: We are looking for an individual who brings a unique perspective based on past experiences and background. We are also looking to create a diverse intern “class” from across the country who have experiences in both urban and rural settings. And of course, we are looking for someone who is interested in contributing to the journal for years to come! 

VS: What was the impetus for creating a JVS internship program? It seems pretty neat and unique. Are there similar programs at other journals you’re aware of? 

US: There are other journals that have internships but it is definitely not common, particularly in a surgical journal. The impetus to start the program was really to help expand the reviewer pool in a way that has a lasting impact. The program allows the next generation of vascular specialists to get exposure to the role of reviewer in a formalized way so that they can offer unbiased contributions to peer review for our society. It also gives them an exposure to journal leadership which is hugely important. I’d love to see our interns become editors of journals themselves one day! 

VS: That’s really neat and a great way to generate a pipeline of qualified reviewers. As an alumnus of the program, Andy, how did the JVS internship help you? Do you review for other journals now because of it? 

AB: Excellent question! Prior to this program, I had done some ad hoc reviewing for non-vascular surgical journals. The JVS reviewer internship program gave me formal training in reviewing and the entire editorial process. And who better to learn from than the editors of JVS! Not only did this process help me with reviewing papers, but I think it has helped me formulate stronger clinical research and write better. Moreover, I do review for other vascular surgical journals as well now—thanks to the JVS reviewer internship program! 

VS: That’s amazing! Now to your mentor, Dr. Sachdev. How did having an intern shape your style of reviewing? Did you find that it helped you become a better reviewer? 

US: Most definitely. Teaching and mentoring makes one accountable and deliberate in a very specific way. I think the experience was really good for all of the mentors involved. 

VS: So, this seems like a win-win situation for everyone! Dr. Sachdev, what advice would you give to a new editor taking on an intern? 

US: Excellent question. The mentors have already had experiences helping residents and fellows through the clinical spheres of our profession. Thus, they already have the background to be good mentors. I would encourage them to pick articles that will challenge their mentees. Send them articles that are outstanding as well as those that might need some help or are not appropriate for publication. As I told Anand, one of my key criteria for accepting a paper is whether an author did what they said they were going to do. Sometimes the results and conclusions are not congruent with the stated goals of the project. I think each mentor has a similar pearl that they can pass on to their mentees. 

VS: That’s sage advice. I’m gonna pocket that one. Dr. Brahmandam, what advice would you give to a new intern? 

AB: This process is very much like first year of surgical residency; therefore, it is important to find a workflow system early on. One of the most important tips on reviewing Dr. Sachdev gave me was—are the authors doing what they say they are? And is the methodology appropriate to answer that question? This led me to a very simplified approach of looking at manuscripts. Similarly, I am certain every senior editor/mentor will have their own simplified approach to reviewing. My suggestion to the new interns is to find a simplified system of reviewing—whether it’s from one mentor or multiple mentors—stick to that system, and to make it a habit through repetition. Additionally, while the program is certainly very high-yield, there is a time commitment and especially for those trainees in active clinical years, there is some deliberate planning and time-management is needed. 

VS: You both have been amazing at answering these questions. Last question is for both of you. What do you hope for the future of the program—especially since there’s now a new cohort of JVS interns? 

US: I’d love to see the program expand if possible, and I am hoping to put together a publication with the results of its efficacy. 

AB: The future of this program is clearly bright! I was so fortunate to be part of a star-studded class from across the country and it was great to finally meet them in person at this past VAM! In the short-term, I would love to see this program collaborate with other surgical journals and expand the scope of “reviewer-training” to all surgical specialties. For the long-term, I hope to see graduates of this program on the editorial board or as editors of various journals and mentors for future reviewer interns! 

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the Vascular Specialist resident/fellow editor. 

Miss the SVS webinars? Take advantage of the recordings

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Miss the SVS webinars? Take advantage of the recordings

The Society for Vascular Surgery (SVS) hosts a number of Town Halls, roundtables and webinars for the benefit of its members. 

In the past few months, members were able to participate in a webinar on how best to use electronic medical records as well as a three-part series of virtual webinars on putting the Global Vascular Guidelines on chronic limb-threatening ischemia (CLTI) into daily clinical practice. 

For those who missed the sessions or who want a refresher, recordings of all four are now available for members to access. 

“Hacking the EMR: How to Make the EMR Work for You” covered how to manage records to benefit daily practice needs; using EMRs in small independent practices, including outpatient-based (OBL) facilities; and how to manage the burnout so many physicians and surgeons feel as a result of dealing with electronic records. It was sponsored jointly by the Society for Vascular Surgery’s Community Practice Section and the Health Information Technology and Wellness committees. 

Visit vascular.org/EMRrecording to go directly to the recording or visit vascular.org/VascularTools to see other available practice tools. Once there, click on the recording link within the “Hacking the EMR” description. 

The roundtables, held in August, September and October, covered “Translating Guidelines into Practice: Global Vascular Guideline on the Management of Patients with CLTI.” 

Session One focused on overall medical care of CLTI patients, including the current state of optimal medical management; recent developments in anti-thrombotic, anti-hypertensive and lipid-lowering management; and best ways to help patients quit smoking. 

Session Two covered Wound, Ischemia and Foot Infection (WIfI) staging and the use of the WIfI stage calculator; a review of contemporary data on the relationship between WIfI staging and important clinical outcomes in CLTI patients; current approaches and limitations to hemodynamic assessment and perfusion measurement in the foot and how they are employed in both pre- and post-revascularization; and how WIfI staging drives triaging of care. 

Session Three discussed every-day clinical decision-making around revascularization options and the Global Limb Anatomic Staging System (GLASS). It covered the system, its current limitations, the growing impact of pedal artery disease in clinical practice and the latest data on the risks and benefits of drug elution in the CLTI population. 

Visit vascular.org/CLTIrecordings to access all three sessions. 

Deadline extension: SAVS extends travel scholarship application cut-off for 2023 meeting

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Deadline extension: SAVS extends travel scholarship application cut-off for 2023 meeting
Some 20 travel scholarships are available for the 2023 SAVS annual meeting

The Southern Association for Vascular Surgery (SAVS) has announced a deadline extension to Dec. 5 for 20 travel scholarships that are available to medical students and general surgery residents to attend the 2023 SAVS annual meeting (Jan. 18–21).

Half of the 20 $1,000 grants for the gathering in Rio Grande, Puerto Rico—partially funded by W.L. Gore through the Association of Program Directors in Vascular Surgery (APDVS)—are reserved for women and underrepresented minorities.

To qualify, applicants must be either a medical student (years 1–3) or a general surgery resident (PGY 1–3) interested in vascular surgery and able to attend the meeting from Wednesday, Jan. 18, through Saturday, Jan. 21, according to SAVS.

“As the purpose of these scholarships is to increase interest in vascular surgery, students and residents already applying for training positions are not eligible,” the association notes.

The travel scholarships include complimentary registration for the meeting alongside the $1,000 award for travel reimbursement.

To apply, visit: savs.org/forms/2022/Travel-Scholarship.cgi.

VAM 2023: Apply for international scholars program by Dec. 31

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VAM 2023: Apply for international scholars program by Dec. 31
VAM 2023

Young vascular surgeons from outside the United States and Canada have until Dec. 31 to apply for scholarships to attend the 2023 Vascular Annual Meeting (VAM).

VAM will be held June 14–17, 2023, in National Harbor, Maryland, just outside Washington, D.C. 

Working with a mentor, recipients—who cannot be older than 40 in the year they submit their application—will not only attend VAM but also will visit clinical, teaching and research programs before or after the meeting. 

Recipients will receive free VAM registration plus a $5,000 stipend to defray travel.

Required materials include a personal statement, three letters of recommendation, three publication reprints, curriculum vitae of no more than 10 pages and a headshot or photograph.

Learn more and download the application form at vascular.org/InternationalScholars. 

Spotlight: SVS members in the news

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Spotlight: SVS members in the news

Several SVS members have been making moves recently, attracting recognition in the form of awards and promotions.

Katherine Gallagher, MD, of the University of Michigan, has been elected to the National Academy of Medicine for her “innovative translational research on epigenetic regulation of immune cells during normal and pathologic tissue repair and other cardiovascular disease processes.” Gallagher chairs the Society for Vascular Surgery (SVS) Basic and Translational Research Committee and is a member of the Research Council. 

Donald Baril, MD, has been named director of the Vascular Surgery Fellowship Program in the Smidt Heart Institute at Cedars-Sinai in Los Angeles. Baril joined Cedars-Sinai in 2020. 

Two SVS members, Daniel Clair, MD, and Michael Dake, MD, have been honored with awards from the VIVA Foundation. Clair, from Vanderbilt University Medical Center, received the Leader In EndoVascular Education (LIVE). Dake, senior vice president of Health Sciences at the University of Arizona Health Sciences, received the ATLAS (A Teacher, Leader And Scholar) Award. 

Viz.ai announces positive new data from large aortic dissection AI real-world study

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Viz.ai announces positive new data from large aortic dissection AI real-world study

Viz.ai recently announced new data from a large aortic dissection artificial intelligence (AI) real-world study that supports the use of its AI technology for the detection of suspected aortic dissection. Data from the new study, which were presented this week at VEITHsymposium 2022 (Nov. 15–19) in New York City, validate the Viz.ai’s dissection detection algorithm, according to the company.

An abstract by Viz.ai, in collaboration with Avicenna.ai, entitled “Real-world validation of a deep learning AI-based detection algorithm for suspected aortic dissection,” reported the performance of the Viz Aortic Dissection Algorithm on 1,303 CT angiography scans collected from over 200 U.S. cities. The algorithm demonstrated a sensitivity of 94.2%, specificity of 97.3%, as well as a positive predictive value of 80.1% and negative predictive value of 99.3%.

The authors concluded: “These findings provide significant real-world validation of a deep-learning AI-based detection algorithm for suspected aortic dissection. Automated detection may have a positive downstream effect on patient triage leading to accelerated care coordination, earlier diagnosis, timely initiation of life-saving interventions, and better patient outcomes.”

According to a company press release, Viz Aortic accelerates time-to-notification to specialists giving them access to clinically-relevant imaging and patient information for appropriate patient treatment plans. The solution includes AI-powered alerts, high-fidelity mobile image viewing, relevant clinical information, and HIPAA-compliant communication to facilitate workflow and improve patient care for all aortic conditions.

“Acute aortic dissection is a deadly disease, and mortality for an untreated dissection is about 50% by 24 hours. In 2011, the IRAD [International Registry of Acute Aortic Dissections] investigators showed us that there is often a delayed recognition and treatment of acute aortic dissection, leaving many patients at risk for another cardiovascular event,” said Jayme Strauss, chief clinical officer at Viz.ai. “These new data shows that Viz Aortic has the power to help care teams coordinate and improve care for these patients in a real-world setting with a diverse patient population.”

First-in-human patients continue to benefit from VenoValve at average of three years post-surgery, new data show

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First-in-human patients continue to benefit from VenoValve at average of three years post-surgery, new data show
VenoValve
first-in-human
VenoValve

Positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve (Envveno Medical) first-in-human clinical trial were recently presented at the VEITHsymposium 2022 (Nov. 15–19) in New York City.

Principal investigator Jorge Hernando Ulloa, MD, from University of the Andes in Bogota, Colombia, reported that the VenoValve patients, who are now an average of 36 months post VenoValve implantation, continue to benefit from the VenoValve and have experienced no relapses of severe chronic venous insufficiency (CVI) and no recurrences of venous ulcers. Safety events were limited to one thrombosis after discontinuation of anticoagulation medication.

The presenter added that average improvements in reflux, CVI disease manifestations (revised Venous Clinical Severity Score [rVCSS]), and pain (Visual Analogue Scale [VAS]) remained stable at 63%, 52%, and 84% respectively, when compared to pre-surgery levels, for the cohort of eight patients that agreed to be followed at conclusion of the one year first-in-human trial. One patient experienced an increase in rVCSS due to dermatitis, which Ulloa noted was unrelated to the VenoValve or vascular disease.

A company press release details that the VenoValve is a first-in-class, surgically implanted replacement venous valve that is currently being evaluated in the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) US pivotal trial—a prospective, non-blinded, single-arm, multicenter study of 75 CVI patients.

VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. Envveno Medical estimates that approximately 2.5 million people in the USA that suffer from the debilitating impacts of severe deep venous CVI would be candidates for the VenoValve.

Cyclical topical wound oxygen therapy: A new generation of wound healing device showing sustained results

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Cyclical topical wound oxygen therapy: A new generation of wound healing device showing sustained results
AOTI’s cyclical Topical Wound Oxygen Therapy (TWO2) device in action

This advertorial is sponsored by AOTI.

In the beginning, it took a little convincing for Anil Hingorani, MD, to come around to the idea that cyclical Topical Wound Oxygen Therapy (TWO2) could be the sort of device he would add to his armamentarium with some degree of confidence. But then he saw the results in some of his most intractable patients, and he started to see value in the multi-modal approach to wound healing.

Anil Hingorani

“Remarkable,” was how the clinical professor of vascular surgery in the Department of Surgery at NYU Grossman School of Medicine in New York described the progress in some of the wounds he treated with TWO2. 

“We tried hyperbaric oxygen for a while and found that to be helpful in certain patients, but hyperbaric oxygen was expensive,” explains Hingorani, also describing issues around insurance company authorization difficulties, transportation convenience and potential systemic complications. Home oxygen therapy, on the other hand, “circumvented a lot of those problems,” he said. “We started using TWO2 on our patients who were some of the most difficult—the nonhealing on whom we’d tried everything,” Hingorani continues, describing how the technology was put to use among a demographic of his patients in south Brooklyn who are challenging both economically and in terms of their level of basic medical education. 

“Finally, we said, ‘Let’s try this new product.’ We didn’t know if it was going to work, but we had some patients who had had ulcers for years, and other practitioners had tried to take care of these patients. Then we had some positive results. And we started to notice a consistent pattern. That’s why we started using this TWO2 device. Based upon the fact we had some experience with arterial patients, now we’re using this new product with both arterial and venous patients—on diabetic foot ulcers [DFUs]—and we’ve had some very good responses.” 

TWO2 combines supplemental oxygen with non-contact cyclical compression and humidification through a single-use extremity chamber system, which is accompanied by a controller and oxygen source. 

“For me, what really drives TWO2 is that the machine itself is a little bit different from prior generations in that it not only applies some relatively low oxygen, but also the pressure it puts on is fairly low,” observed Hingorani. The extremity chamber, or boot, extends up to and above the knee, he says, and can be placed over all but occlusive dressings.” 

A multinational randomized, double-blinded, placebo-controlled trial to evaluate the efficacy of TWO2 in the treatment of chronic DFUs (known as the TWO2 Study), led by podiatric surgeon Robert G. Frykberg, DPM, and colleagues, showed that the system was six times as likely to heal a DFU wound at 12 weeks compared to optimal standard of care alone after adjusting for ulcer severity (p=0.004). The data, published in the peer-reviewed journal Diabetes Care, demonstrated that TWO2 therapy was “safe, without complications, and provided more durable healing for those who had wound closure compared to optimal standard care alone,” the trial investigators concluded. Additionally, they reported, TWO2 can be “administered by the patient at home without the expense and difficulties of daily travel to a specialized center” and can be combined with other advanced wound care modalities. 

Hingorani believes such data—allied to upcoming randomized prospective data being collected for publication in the vascular surgery literature—might help to trigger more widespread uptake of the device. 

“TWO2 has shown not only positive wound healing at 12 weeks for DFUs, but also sustained wound healing, especially in patients with DFUs,” he says. “The retrospective data from Ireland for venous stasis ulcers has also shown benefit at 12 weeks for those patients using the product.” 

Richard Neville

The system “is not meant to replace what you are already doing,” emphasizes Hingorani. Rather, the cyclical pressure—applied twice per minute with oxygen—”makes a big difference in some of our patients” owing to how that component helps combat edema in the wound, which is, “I think, an underappreciated cause for some of our wounds not to heal,” he adds. 

Richard Neville, MD, chairman in the Department of Surgery and associate director of Inova Heart and Vascular Institute in Falls Church, Virginia, recently sat in on a presentation on TWO2, leaving with a resolve to dig deeper on the positive impression the technology made on him. “I was impressed by this particular technology more than some of the other ones I’ve heard, and I’m hoping that we can investigate it and that it has a role in our system,” he says. 

A wound care expert colleague, Vickie R. Driver, DPM, is keen to pursue research on its efficacy, Neville explains. “The right people think highly of it, so we’re going to look to either investigate—or start to use—the technology, and then hopefully we’ll be able to make some presentations in the vascular space.” 

While his hospital system has four hyperbaric oxygen chambers, Neville adds, “this seems different. This is more of a focused raising of oxygen tension in the tissue, which theoretically leads to some advantages that the hyperbaric chamber may not. 

Frank J. Veith

Meanwhile, vascular surgery luminary Frank J. Veith, MD, a limb salvage pioneer for more than half a century, says preliminary data behind TWO2 suggest it may hold some promise. He highlighted the device’s advantage of oxygen application in combination with compression and moisture versus hyperbaric oxygen therapy, describing the early findings on the tri-modality approach as a potential indicator that it could prove to be an important adjunct to revascularization. “The data that I’ve seen, although not conclusive indicates that TWO2 could prove to be an adjunct to help save limbs that might not otherwise be saved,” says the New York University and Cleveland Clinic professor of surgery, and former Society for Vascular Surgery (SVS) president. “The technology is not going to replace revascularization, but every little bit helps.” 

For Hingorani, one other component stands out: the people behind the equipment at Advanced Oxygen Therapy Incorporated (AOTI). “In south Brooklyn, our patients can be quite challenging,” he says. “A lot of them have problems with not only education in general but medical education is very, very poor, and getting the patients to actually comply with a lot of their wound care, diabetes care, venous stasis care, coming into the office even—basic stuff you would think would be fairly standard—can be very challenging. 

“Having the people behind it, the company behind it, the personnel behind it, who are willing to work with some patients who may not have all of the resources that other patients may have in our neighborhood, makes the biggest difference. We have been very fortunate to have some people behind the product who are willing to go the extra mile with some of our challenging patients to really work with them to get them the products they need, some of the wound care and some of the basic education about how to take care of their wound. 

“So, it’s not just the machine, not just the product, not just the oxygen; it’s also the people behind it who matter a lot.”

Complete SVS member priorities survey by Nov. 22

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Complete SVS member priorities survey by Nov. 22

To help the Society for Vascular Surgery (SVS) chart a path into the future, members—and non-members alike—are asked to complete an ongoing survey by Nov. 22. 

The survey is to help SVS better understand members’ and non-members’ perception of top priorities and professional needs and challenges, as well as their experiences with SVS. This feedback is critical to ensure SVS can best support members over the next three-to-five years. 

This survey is intended for both current members and non-members eligible for SVS membership. It should take about 20 minutes to complete. Respondents can enter a drawing to win one of three $100 Amazon gift cards. 

Avenue M. Group LLC, an independent market research firm and SVS’ partner for the survey, emailed participation invitations in early November. For information, contact Joanna Bronson at [email protected]. 

SWING trial 12-month data: Novel sirolimus DCB shows ‘great promise’ in ‘challenging’ CLTI population

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SWING trial 12-month data: Novel sirolimus DCB shows ‘great promise’ in ‘challenging’ CLTI population
SWING
Ramon Varcoe at VEITH 2022

The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI [chronic limb-threatening ischemia] population,” and has a primary patency rate of 80% at 12 months in a per-protocol analysis population. Ramon Varcoe, MD, from Prince of Wales Hospital in Sydney, Australia, presented these findings from the SWING first-in-human study at the VEITHsymposium 2022 (Nov. 15–19) in New York City.

Varcoe, who is co-lead investigator of the trial, added that the research team observed no major amputations, “very low” rates of major adverse events, and “impressive” luminal gain, which was sustained out to six-month angiogram. In addition, Varcoe reported that Rutherford category and the functional outcome measures were improved.

“The Sundance sirolimus-coated balloon is a novel device,” Varcoe informed VEITH attendees. He elaborated: “It has a microcrystalline surface, but also a very sophisticated proprietary excipient, which, rather than using nanoparticles or microreservoirs uses chemistry to deliver the drug into the blood vessel wall and have it retain that much more so than the other devices on the market.”

The presenter noted that SWING is a prospective, multicenter, single-arm feasibility study that looked at patients with stenotic or occluded lesions. The researchers enrolled 35 patients over eight sites in Australia, New Zealand, and also in Europe.

Noting some key inclusion criteria, Varcoe detailed that patients had to be either Rutherford 4 or 5. He added the caveat that Rutherford 3 patients were included, but numbers were capped at 20% of the total cohort. Furthermore, patients had to have de novo or restenotic lesions and at least 50% stenosis by visual estimate of the investigator. They could have up to two distinct lesions in the same or different below-the-knee (BTK) artery, and had to have successfully treated inflow, as well as an unimpaired outflow artery in continuity to the ankle or foot.

The investigators performed both an intention-to-treat and a per-protocol analysis, Varcoe informed the audience. “The reason for that was because [the trial] was conducted over the COVID-19 pandemic period, so we lost seven patients to the primary endpoint of angiography,” he noted, adding that there were also three post-protocol deviations. For these reasons, the research team focused on the 25 patients who had the per-protocol analysis.

The presenter stressed that the patients included represent a “real-world” population, including a high proportion of patients who are smokers and have diabetes, as well as a majority of patients with Rutherford 4 or 5 disease. “They also had high proportions of moderate-to-severe calcification in excess of 18%, and around a third of these patients had total occlusions,” he added.

The study had two primary endpoints. The first was a safety primary safety endpoint—freedom from major adverse limb event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint was the rate of late lumen loss at six months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING trial were achieved, Varcoe revealed.

Varcoe reported that, in the per-protocol population, there were no major amputations, no major reinterventions, and complete freedom from perioperative death, “so it was a safe device”.

The team also saw a rate of all-cause death that was 0%, target lesion amputations were 0%, and a “very low” rate of clinically driven target lesion revascularization at 8%.

Varcoe added that the minimal luminal diameter at the end of the procedure was “very high”, which he thinks “represents modern-day angioplasty techniques”, and reported a late lumen loss of 1mm at six months—results that compare “very favorably” to other equivalent DCB trials below the knee, he remarked.

As six months, the researchers observed a primary patency of 88.5%. Varcoe noted that primary patency was retained and consistently retained out to 12 months at 80%—a figure that he said is “very good for this part of the vasculature”.

Varcoe added that, “pleasingly,” the team also saw improvement in Rutherford Becker classification, which was sustained and improved out to 12 months. Regarding quality of life, he noted that patient-reported outcome measures were again consistently improved out to that 12-month endpoint.

In closing, Varcoe shared his belief that the Sundance device has “great promise” and “warrants evaluation in a large-scale pivotal trial” based on these latest findings.

Vascular Specialist–November 2022

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Vascular Specialist–November 2022

In this issue:

    • First data from BEST-CLI are revealed at the American Heart Association (AHA) Scientific Sessions (p. 1 and 12–13)
    • The Society for Vascular Surgery (SVS) unveils its new 10-year research priorities (p. 2 and 18–19)
    • Robert Rhee, MD, talks evolution during Eastern Vascular Society (EVS) Presidential Address (p. 16)
    • SVS debuts new member classification as 2023 dues deadline approaches (p. 21)

VEITHsymposium panel probes ‘value’ of artificial intelligence in vascular surgery

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VEITHsymposium panel probes ‘value’ of artificial intelligence in vascular surgery
Barry Katzen (left) was part of a panel that discussed artificial intelligence in vascular surgery

A session at the 2022 VEITHsymposium in New York City (Nov. 15–19) focused on new concepts, machine learning, and artificial intelligence (AI) in vascular surgery, with a panel discussion honing in on the cost-effectiveness and wider “value” of emerging technologies in this space. 

“What’s the benchmark for success going to be?” moderator Barry Katzen, MD, of the Miami Cardiac & Vascular Institute in Miami questioned. 

Katzen made particular reference to the current economic environment in healthcare environments around the world, and was keen to get the experts’ take on how healthcare economics might influence which technologies survive. 

Panelist Rachel Clough, PhD, FRCS, of Imperial College Healthcare NHS Trust in London, England, noted that, in her opinion, “the key to this is getting the technology out there for patient benefit in as many healthcare systems as possible.” 

Clough added: “I think in many systems around the world, it is all about […] cost-effectiveness, about value of the product, and so I think it is about trying to first of all gain regulatory approval and get a decent evidence base, and then get providers to begin to purchase [these technologies].”

The top 10 most popular Vascular Specialist stories of October 2022

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The top 10 most popular Vascular Specialist stories of October 2022

The most-read Vascular Specialist stories in October covered an investigation of thoracic endovascular aortic repair (TEVAR) timing presented at the Eastern Vascular Society (EVS) meeting in Philadelphia (Sept. 29–Oct. 1); the editor-in-chief’s open letter to the National Rifle Association; tips on how to take feedback on board as a vascular trainee; and the presidential addresses from two recent regional society meetings that set out ideas for helping vascular surgery thrive as a specialty.

1. SVS officer elections 2022: A glimpse into the electorate

The SVS Executive Board highlights details of the most recent Society for Vascular Surgery (SVS) elections to inform members and further strengthen the process. 

2. EVS 2022: Study suggests lower rates of aortic rupture, mortality after TEVAR for uncomplicated TBAD in subacute phase compared to medical management

TEVAR carried out for uncomplicated type B aortic dissections (TBAD) saw worse mortality and aortic-related outcomes when performed in the acute phase compared to those treated in the subacute phase and those managed medically.

3. An open letter to the National Rifle Association

Vascular Specialist Editor-in-Chief Malachi Sheahan III, MD shares his thoughts around the statistic that firearms are now responsible for more child fatalities in the US than road traffic accidents. He calls for “a national, safety-driven organization with complete access to all gun-related data.”

4. NESVS 2022: Study illustrates relationship between increased distance from medical center and higher treatment costs among complex aortic patients

Research detailing that patients traveling farther for complex aortic surgery have higher procedural costs, postoperative imaging costs, and comprehensive one-year costs was among the new science being presented at the 2022 annual meeting of the New England Society for Vascular Surgery (NESVS).

5. Signal-to-noise ratio: Thoughts on fine-tuning feedback during vascular surgery training

Christopher Audu, MD, recently took the Registered Physician in Vascular Interpretation (RPVI) exam. He tells how there are multiple voices in the ears and heads of vascular trainees, and how to decipher this overwhelming and/or contradictory feedback.

6. Prepare to submit research for VAM, VRIC 2023

The Society for Vascular Surgery (SVS) wants members’ research on vascular disease for the 2023 Vascular Research Initiatives Conference (VRIC) and the 2023 Vascular Annual Meeting (VAM).

7. Regional vascular presidents measure state of specialty

Vincent Rowe, MD, and Raghu Motaganahalli, MD, delivered Presidential Addresses at the Western Vascular Society (WVS) and the Midwestern Vascular Surgical Society (MVSS) that spelled out ways in which vascular surgery can advance—and thrive.

8. Interacting with EMR best practice advisory ‘significantly’ improves AAA screening rates

Positively interacting with best practice advisory notifications is correlated with an increased rate of abdominal aortic aneurysm (AAA) screening, according to an analysis of all patients who triggered these communications alerts in an electronic medical record (EMR) system at a single tertiary medical center.

9. Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in US

The Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device—used to treat aortic arch disease—under the inpatient prospective payment system (IPPS).

10. Abre stent data show ‘struggle to maintain patency’ among post-thrombotic syndrome patients

The Abre venous stent demonstrated three-year primary patency rates of 97.1%, 76.5% and 70.4% respectively for non-thrombotic iliac vein lesion (NIVL), acute deep vein thrombosis (DVT), and post-thrombotic syndrome (PTS) patient populations within the ABRE clinical study.

Veterans Day: Remembering Korea, ‘accidental pioneers’ and M*A*S*H

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Veterans Day: Remembering Korea, ‘accidental pioneers’ and M*A*S*H
A Korean War battle scene in 1950

During November—Nov. 11, specifically—the United States salutes and honors all those who have served this country in its armed forces. This November, the Society for Vascular Surgery (SVS) highlights the Korean War, where vascular surgeons typically served in Mobile Army Surgery Hospitals. The idea of moving care closer to the battlefield was born during World War II, with the first MASH unit organized in 1948.

This past September marks the 50th anniversary of the launch of the television show M*A*S*H, which ran for 11 seasons on CBS. Two episodes during those 11 years included advances in vascular surgery. Marking the occasion, in August the SVS’ Audible Bleeding podcast aired “MASH-Part 1,” on how the young surgeons working near the battlefield in MASH units during the Korean War pioneered vascular wartime repair.

The “MASH” episode is part of Audible Bleeding’s “Vascular Origin Stories,” which explore “the fun and engaging stories that shaped vascular surgery.” Visit vascular.org/AudibleBleedingMASH1 for more.

In addition, “Korea, MASH and the accidental pioneers of vascular surgery” appeared in the Journal of Vascular Surgery (JVS) in 2017, outlining the use of the army hospitals, the youthfulness of the surgeons, arterial repair and the writing of the book that led, eventually, to the television show.

“Despite their limited training and preparation, the horrific working conditions, the ongoing threats of court martial for attempting to save rather than sacrifice limbs, and the endless cataracts of broken and maimed young soldiers requiring desperate treatment, the MASH surgeons in Korea cared for their patients with extraordinary dedication and perseverance. As a result, a new surgical specialty was born—“and soldiers walked … who might not have,” concludes Steven G. Friedman, MD, author of the JVS article.

“From World War II, to Korea, to Vietnam, to Iraq—twice—and Afghanistan, our members have stepped up when needed, and done their best to treat those wounded in battle,” said SVS President Michael C. Dalsing, MD. “We salute not only their service but their quick thinking and innovations that led to many advances in the specialty. War truly was the catalyst for many advances in vascular surgery we take somewhat for granted today.”

New diversity, equity and inclusion pillar signals additional priority for SVS Foundation

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New diversity, equity and inclusion pillar signals additional priority for SVS Foundation
Vincent Rowe

The Society for Vascular Surgery (SVS) Foundation has been guided by the three long-term pillars of research and innovation, community vascular care and patient education, and disease prevention. Recently, the Foundation added a fourth pillar—for diversity, equity and inclusion (DEI) initiatives. It will emphasize, among other projects, research into healthcare disparities and care delivery solutions, scholarships and career advancement for underrepresented minority vascular surgeons, and workforce development.

“DEI is an important cornerstone of the Society for Vascular Surgery itself and we applaud adding diversity, equity and inclusion as a bedrock pillar for the Foundation as well,” said Vincent Rowe, MD, chair of the SVS DEI Committee.

“This helps us support our community of vascular surgeons,” said Palma Shaw, MD, co-founder of the SVS Women’s Membership Section. “We are investing into the future of vascular health with programs for our diverse communities and helping the Society more closely resemble the patient population. People want a surgeon who looks like them.

“The new pillar reaffirms the Society’s commitment to DEI and enables the SVS Foundation to serve as the portal for initiatives of SVS’ many regional societies, such as diversity scholarships or attendance at training courses. I look forward to witnessing how the SVS and SVS Foundation move forward in the space of DEI.”

Early plans for DEI initiatives include targeted scholarships, awards and research grants for diversity candidates, research projects focused on healthcare disparities or bringing programs to underserved areas.

The new pillar highlights, among other tenets, research into healthcare disparities—one of the updated SVS research priorities.

The new pillar reaffirms the Society’s objectives, supported by the DEI Task Force, which now has become an ongoing committee, as well as a summer DEI summit, with outcomes to be announced soon ahead of a second summit planned for January 2023. In addition, the Society’s new research priorities added healthcare disparities as one of seven important topic areas. The focus in that area is evaluating “interventions aimed at improving vascular health in all socioeconomic, racial and ethnic populations.”

Both Rowe and Shaw pointed to how commemorative months—Black History Month, Women’s History Month, Pride Month and Hispanic Heritage Month, among them—celebrate the diversity of modern life. “We mark these months and others to celebrate the diverse voices of the vascular community,” said Shaw.

“We will be funding the future of vascular health through a lot of these initiatives,” said Rowe. “We want to grow and nurture these initiatives, while we grow and cultivate our increasingly diverse vascular workforce.”

To learn more about the SVS Foundation, visit vascular.org/SVS-Foundation.

Chocolate Touch DCB for treatment of peripheral arterial disease receives FDA approval

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Chocolate Touch DCB for treatment of peripheral arterial disease receives FDA approval
Chocolate Touch DCB

Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed by TriReme Medical for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and the popliteal artery. 

The Chocolate Touch DCB was shown to have statistically superior patency and non-inferior safety at 12 months as compared with Lutonix DCB based in a head-to-head, randomized trial of patients with symptomatic femoropopliteal disease. 

The Chocolate Touch showed statistical superiority in its primary efficacy endpoint of 12-month true DCB success—a measure of the target vessel remaining patent without the need for bail-out stenting. Primary patency by Kaplan-Meier (KM) estimate was 83.3% for the Chocolate Touch and 73.0% for Lutonix DCB at 12 months.

The primary safety endpoint of 12-month freedom from major adverse events (MAEs) was 88.9% for those treated with the Chocolate Touch versus 84.6% for Lutonix DCB.

Additionally, Chocolate Touch results reported the lowest all-cause KM mortality value as compared to reported mortality for FDA-approved DCBs in pivotal studies. Mortality rates for Chocolate Touch using KM estimates at three years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.  

“This next-generation paclitaxel DCB is based on the chocolate mechanism of pillow-and-groove formation resulting in an increased balloon surface facilitating effective drug release to the vessel wall and potentially reducing the need for permanent implants,” commented co-principal investigator Thomas Zeller, MD, from Universitaets-Herzzentrum in Bad Krozingen, Germany. “The recently completed randomized, controlled study demonstrated excellent primary results, with statistical superior effectiveness as compared to the control DCB. The Chocolate Touch is a DCB category of its own.”

NESVS Robert R. Linton Lecture features complex aortic masterclass from Europe

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NESVS Robert R. Linton Lecture features complex aortic masterclass from Europe
Stéphan Haulon at NESVS 2022

World-leading aortic surgeon Stéphan Haulon, MD, from the Aortic Centre at Hôpital Marie Lannelongue in Paris, France, took attendees of the 2022 New England Society for Vascular Surgery (NESVS) annual meeting on a whirlwind, 15-year journey through the evolution of aortic arch endografting from his personal vantage point—the most advanced view in the world, 2021–22 NESVS President Andres Schanzer, MD, said as he introduced the 2019–20 president of the European Society for Vascular Surgery (ESVS). 

Haulon started the 2022 Robert R. Linton Lecture by introducing his first case in this arena, from 2007, which involved undertaking “a very simple endovascular approach.” From there, he explained, with more confidence, he proceeded to perform various combinations of fenestrations and debranching, choosing patients selectively.

“But we started moving to more and more challenging cases, such as chronic dissections,” Haulon explained, showing slides of his first such case in which the dissected innominate artery necessitated a crossover bypass, and involved two fenestrations covering the left common carotid and left subclavian arteries.

Eventually, Haulon continued, he and colleagues began “to move away from this early experience with the fenestrated endograft,” showing the current device they are using—a graft with inner branches. Then came a “game-changer,” he said, with the advent of hybrid treatment, which he said “we had to fight for” in order to get access to the requisite devices.

“Then we started doing those procedures under fusion guidance, and that was a huge difference.” Now, he continued, “we can locate the origin of the coronary arteries, you can see the endograft tracking, we could have a large field where we could see both the left ventricle and the top of the arch … the origin of the target vessel, the innominate bifurcation—all those markers that we need during the procedures.” 

From this initial experience, he and colleagues learned much, seeing much better outcomes in a later cohort of patients. “In [our] second paper, [we showed] no mortality, [and] the stroke rate went down to less than 10%, and mostly minor stroke,” Haulon noted. 

He further referenced the latest emerging option, a total percutaneous approach to aortic arch repair recently described in a type-A dissected patient. 

Looking even further ahead into the future of aortic technology, he told NESVS: “I don’t think open surgery is still the golden standard for arch repair; [but] it’s not the old standard either. We need expertise in both fields, and to discuss cases.”

What’s next? “The acute type A dissections,” Haulon said. One device in particular bears scrutiny, “a very simple device with only three fenestrations.” Work is ongoing with the graft but it could be another “game-changer,” Haulon concluded

SOOVC sub-section introduces two awards

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SOOVC sub-section introduces two awards

The Society for Vascular Surgery’s sub-section for those who provide service in outpatient settings has created two professional development opportunities for its members, a research grant and a presentation award to present already completed research. 

Applications for the Sub-Section on Outpatient and Office Vascular Care (SOOVC) Presentation Award and the SOOVC Research Seed Grant are due Dec. 31. Up to three recipients for each award may be selected. 

The SOOVC Research Seed Grant will provide vascular surgeons $5,000 for a data analyst to analyze research data for insights, quality improvement and patient care. Research must have been completed in an office-based lab (OBL) or ambulatory surgery center (ASC). Criteria for evaluation will include: 

  • How the research will positively impact care and/or procedures provided in the outpatient setting 
  • Why this research is necessary 
  • Whether the research will benefit patients, physicians, payors and the healthcare system at large 

Three recipients will be selected, and the grant is renewable for a second year, based on first-year outcomes. Applicants must be an SVS Active or Candidate member—including trainees, fellows and residents—practicing in an OBL or ASC setting. 

Research presentations will take place at the SOOVC session during the Vascular Annual Meeting (VAM). Learn more and apply at vascular.org/OBLResearchGrant. 

The SOOVC Presentation Award will recognize vascular surgeons who have completed clinical research projects in an OBL or ASC practice. Three recipients will be selected to present their research at the SOOVC session during VAM 2023 in National Harbor, Maryland. Priority will be given to projects that will serve communities with the greatest health disparities and those projects that include community partnerships. 

The significance and innovative nature of the proposed project, as determined by the potential to impact vascular health, awareness and prevention, also will factor into the selection process. 

Applicants must be an SVS Active or Candidate Member practicing in an OBL or ASC setting. Vascular interventionalists, trainees, fellows and residents are eligible. Visit vascular.org/OBLPresentationAward for information and to apply. 

“There is an identified need for research that specifically targets the OBL or ASC settings,” said Anil Hingorani, MD, chair of the SOOVC sub-section. “We want to encourage this research, which we expect to lead to improved care within the settings or improvements in the way we perform procedures in the OBL.” 

The presentation awards, particularly for 2023, will highlight existing research, he said. “We’re excited about these new awards, which came from suggestions from our members. As a whole, vascular surgeons love research and the chance to use science to improve our procedures and our care. We expect these grants and awards to be pretty popular.” 

The SOOVC sub-section is part of the SVS Community Practice Section, for those members who practice in the community setting. Learn more at vascular.org/SOOVC. Applicants can apply for both the research grant and, subsequently, the Presentation Award after the research is complete. 

CMS: An update on quality measures for vascular surgery

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CMS: An update on quality measures for vascular surgery

An upcoming national reporting change/addition from the Centers for Medicare and Medicaid Services (CMS) includes three important elements of which Society for Vascular Surgery (SVS) members should be aware.The SVS Performance Measures Committee (PMC) represents SVS member interests regarding national quality reporting required by CMS for participation in the Quality Payment Program (QPP). 

Physicians can report through the Merit-based Incentive Payment System (MIPS) or Alternative Payment Models (APMs). Beginning in 2023, CMS is adding MIPS Value Pathways (MVPs), designed to “align and connect measures and activities across the quality, cost and improvement activities performance categories of MIPS.” 

There are three important, related developments to highlight for SVS members. 

The first concerns changes to the quality measure roster in the 2023 CMS Proposed Rule. Currently, there are fewer than 20 quality measures available for vascular surgeons’ use in MIPS reporting. The SVS is responsible for maintaining and updating only four of these measures at present. CMS is planning a net reduction to 194 quality measures, including the elimination of two SVS-sponsored measures: 

  • #258 (percent of patients undergoing open, non-ruptured, infrarenal AAA repair without major complications and discharge to home no later than postoperative day #7), and 
  • #260 (percent of asymptomatic patients undergoing carotid endarterectomy discharged to home no later than postoperative day #2) 

The rationale cited for removal is “insufficient volume of data submitted for performance year 2020 to establish a historic benchmark.” 

In other words, the measure cannot be benchmarked and validated. Two related measures, for endovascular aneurysm repair (EVAR) and carotid stenting, may be similarly removed. As the reporting year cited was almost entirely encompassed by the COVID-19 public health emergency, the lack of reportable data is unsurprising. If finalized, elimination of these measures will reduce the reporting options for vascular surgeons, thus impacting the development and utilization of relevant MVPs. 

The second development is that the SVS has rejoined the National Quality Forum (NQF), a decision carefully considered by the SVS Quality Council and Executive Board. Membership will allow the SVS to leverage the NQF’s considerable resources and experience in measure development and maintenance. 

This occurs at a time when the vascular community needs to develop new measures to address the changing QPP landscape. In addition, historically CMS is more likely to accept NQF-endorsed measures, given the extensive testing and vetting process required to receive this endorsement. 

Finally, members of the PMC can serve as individual NQF members, who are in turn eligible to serve on expert panels and work groups. This is another avenue for SVS and its members to influence national healthcare policy. 

The third development is the plan to develop MVP(s) designed specifically for vascular surgeons. While several new MVPs are forthcoming, none specifically address the vascular space. The PMC has discussed options, including the development of separate disease-focused (e.g., aneurysm, venous disease, lower-extremity occlusive disease) pathways versus a global MVP that all vascular surgeons could participate in, regardless of practice focus. 

We expect the MVP development process to take at least a year or more, and in either iteration, several new vascular quality measures must be developed. Given the work required to develop and maintain MVPs, the PMC felt that developing a single, more global option would serve vascular surgeons and the SVS most effectively. The quality measure area is dynamic: new measure development must respond to CMS’ evolution in priorities. These priorities include increased use of claims-based measures (designed to reduce reporting burden by relying on existing administrative data), patient-reported outcomes and consideration of health equity, while balancing the need to remain clinically relevant, measure what matters, and, where possible, incorporate existing quality programs such as the Vascular Quality Initiative (VQI) to reduce additional administrative burden and maximize participation, efficiency and validity. 

References 

  1. Quality Payment Program: MIPS Value Pathways. Available at: https://qpp.cms.gov/mips/mips-value-pathways. Accessed 9/17/22 
  2. Federal Register: CMS CY 2023 Proposed Rule, Available at: https://www.federalregister.gov/documents/2022/07/29/2022-14562/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other. Accessed 9/17/22 
  3. Quality Payment Program: Quality Performance Category: Traditional MIPS Requirements. Available at: https://qpp.cms.gov/mips/quality-requirements. Accessed 9/17/22 

Lily E. Johnston, MD, and Jeniann A. Yi, MD, are SVS PMC members. Evan Lipsitz, MD, is the committee chair. 

SVS adds ‘service’ criterion to Distinguished Fellows process

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SVS adds ‘service’ criterion to Distinguished Fellows process

The Society for Vascular Surgery (SVS) has added service to the Society as an important component of its Distinguished Fellows process, an honor annually bestowed upon a handful of members. 

This accolade goes to Active, International or Senior vascular-surgeon members who have distinguished themselves in a sustained matter by making substantial contributions in two of three categories: research, service or education. 

Examples of service to the SVS include but are not limited to being a member or chair of an SVS committee, council, task force, writing group or section; the SVS Executive Board or Strategic Board of Directors; the Vascular Surgery Board (VSB); the Association of Program Directors of Vascular Surgery (APDVS); and/or of a Journal of Vascular Surgery (JVS) editorial board. 

In addition, members of the SVS Awards and Distinctions Committee will consider presentations at the SVS Vascular Annual Meeting (VAM) or other SVS educational program, authorship of an SVS publication, or a member of the SVS Foundation or the Patient Safety Organization (PSO). 

“The SVS Awards and Distinctions Committee felt strongly that for people to be distinguished members of our Society, they should have exhibited service to our Society and that service should be part of the selection process,” said SVS Treasurer Keith Calligaro, MD. 

As treasurer, he chairs the SVS Awards and Distinctions Committee, which selects those members who will be put forward as candidates for the designation for voting by all SVS Distinguished Fellows. 

“The Society for Vascular Surgery offers innumerable opportunities to become involved, including writing groups for guidelines, innumerable committees and task forces, JVS, VSB and more,” Calligaro said. 

“Nor does service include only committee work. Members can offer to review articles for the Journal of Vascular Surgery publications, regardless of whether or not they are academic vascular surgeons or community practice vascular surgeons. 

“Other members may want to mentor younger surgeons or offer to create and lead webinars on an important topic.” 

The SVS Executive Board enthusiastically endorsed the addition, Calligaro added. The nomination/application deadline for 2023 is March 1, 2023. Distinguished Fellows are recognized during the Opening Ceremony at VAM and receive their certificates at the Presidents Dinner at the annual meeting. 

For the full and current list of SVS Distinguished Fellows, visit vascular.org/DistinguishedFellows. 

First data from BEST-CLI bring surgical bypass into the forefront of discussion for patients with high-quality great saphenous vein

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First data from BEST-CLI bring surgical bypass into the forefront of discussion for patients with high-quality great saphenous vein
L-R: Alik Farber, Matthew Menard, and Kenneth Rosenfield
L-R: Alik Farber, Matthew Menard, and Kenneth Rosenfield

The first results from the BEST-CLI randomized controlled trial (RCT) of 1,830 patients show that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularization strategy for patients with chronic limb-threatening ischemia (CLTI) who are deemed to be suitable for either an open or endovascular approach. Researchers also found that both strategies can be accomplished safely and are effective for treatment for CLTI.  

Further, the investigators urge that patients with CLTI who are candidates for limb salvage should undergo an evaluation of surgical risk and conduit availability. “Bypass surgery with adequate single-segment saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of a fully informed shared decision-making. Level one evidence from BEST-CLI does not support an endovascular-first approach to all patients with CLTI. In patients without a suitable single-segment saphenous vein, both surgical and endovascular strategies are effective in treating patients with CLTI, so we believe that there is a complementary role for both revascularization strategies in these patients,” they say, bringing the “quality of vein” back into the center of discussion on revascularization strategy.

The co-principal investigators—Matthew Menard, MD, director of the vascular and endovascular fellowship program at Brigham and Women’s Hospital in Boston; Alik Farber, MD, chief of vascular and endovascular surgery at Boston Medical Center; and Kenneth Rosenfield, MD, section head of vascular medicine and intervention at Massachusetts General Hospital, also in Boston—note that this is the largest RCT comparing revascularization treatment strategies in patients with CLTI and will provide important information regarding the management of these patients.  

Today, Farber presented the much-anticipated clinical results, and Menard the quality-of-life analysis, from BEST-CLI at the American Heart Association (AHA) Scientific Sessions (Nov. 5–7) in Chicago. The results were simultaneously published in the New England Journal of Medicine.

BEST-CLI (Best endovascular versus best surgical therapy for patients with CLTI) randomized patients with CLTI and infrainguinal peripheral arterial disease (PAD) to receive either infrainguinal bypass or endovascular intervention. The trial consisted of two parallel trials: Cohort 1 included patients with single-segment great saphenous vein; Cohort 2 included patients who lacked single-segment GSV and therefore alternative autogenous vein or prosthetic was used in those randomized to the open arm.  

According to Farber, the best way to evaluate whether a patient has single-segment GSV—one he says needs to be at least 2.5mm in diameter, but ideally above 3mm, and must be free of thrombus—is by using duplex ultrasound. Speaking to Vascular Specialist on this topic, Menard notes that while assessment of the vein is common practice for vascular surgeons, it is not for other specialties. In the wake of BEST-CLI, he suggests that evaluation of the GSV—a “very important” part of the assessment for treatment—should be included in the guidelines. 

Farber tells Vascular Specialist: “We are not claiming to bring down the 10 commandments here; all we are saying is that we are introducing some level one data into a space that has almost no level one data.[…]. Here is another study that says the endovascular-first [approach] is a great thing for some people, but [it is not] for everybody. So, if a patient is a candidate for surgery and [..] has a good single-segment saphenous vein, there should be a conversation about surgery, for that individual.” 

Key results  

The investigators found that surgery was more effective than endovascular therapy in the Cohort 1 patients. At AHA, Farber revealed that there was a reduced rate of major adverse limb event (MALE) or all-cause death—the primary endpoint—in patients with good single-segment GSV who underwent open surgery, as well as fewer major reinterventions, at median follow-up of two point seven years. The maximum follow-up time in these patients was seven years.  

Going into the details, Farber noted that Cohort 1 included 1,434 patients with single-segment GSV who were randomized 1:1 to either surgical or endovascular treatment. At median follow-up, the rate of MALE or all-cause death was 42.6% in the surgery arm compared to 57.4% in the endovascular arm (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; p<0.001). In terms of secondary endpoints, he revealed that 10.4% of patients in the surgery arm underwent above-ankle amputation of the index limb versus 14.9% in the endovascular arm, in addition to rates of 9.2% vs. 23.5% for major reintervention on the index limb and 33% vs. 37.6% for all-cause death for patients in the open and endovascular arms, respectively.

In patients who did not have adequate saphenous vein, i.e. those in Cohort 2, there were no significant differences in the primary endpoint. Farber detailed that that this group included 396 patients who were randomized 1:1 to either surgical or endovascular treatment. The median follow-up was 1.6 years and maximum follow-up, 5.1 years. Farber reported that the rate of MALE or all-cause death in this cohort was 42.8% vs. 47.7% in the open and endovascular arms, respectively (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; p=0.12). The corresponding figures for the secondary endpoints were as follows: 14.9% vs. 14.1% for above-ankle amputation of the index limb; 14.4% vs. 25.6% for major reintervention on the index limb; and 26.3% vs. 24.1% for all-cause death. 

Farber added that there were no differences in perioperative mortality or major adverse cardiovascular events (MACE), and that mortality and MACE were similar between treatment strategies over the course of follow-up. 

The presenter concluded that surgery with adequate saphenous vein “should be offered as a first-line treatment option for suitable candidates with CLTI, as part of fully informed, shared decision-making.” He added that level one evidence from BEST-CLI “does not support an ‘endovascular-first’ approach to all patients with CLTI,” and instead supports a “complementary role” for both revascularization strategies. He noted that further studies are needed to better elucidate the comparative outcomes in subsets of patients. 

While the primary focus of the trial was clinical outcomes in the comparison of open surgery versus endovascular therapy, Menard tells Vascular Specialist that the investigators planned two “very important” ancillary assessments: cost-effectiveness—which the team is yet to conduct—and quality of life. With regards to the latter, he noted that the team used a number of different metrics for this, including the vascular disease-specific VascuQoL, as well as the EQ-5D and the SF-12. 

According to Menard, the baseline scores for quality of life speak to the impact of CLTI on patients’ everyday lives: “The quality of life for all patients at baseline on entry into the trial was extremely poor and low, and that is consistent with what is known about the devastating impact of CLTI on patients’ overall function, the mental status, their physician limitations, and their high degrees of pain.” 

Menard reports that both revascularization strategies resulted in “significant gains” across every metric studied, noting also that there was not any significant difference between the two treatment arms.  

Making the case for the benefits of the endovascular approach, Rosenfield emphasizes: “This is the first trial that really shows that when you compare ‘endo’ to surgery, certainly in the disadvantaged vein group, they both actually had durable outcomes. A lot of us had questions about how durable outcomes for the ‘endo’ approach would be. And it should be clear that it is an approach, because sometimes touch-ups are needed on both sides and those are not considered MALE events. You really had to have a major reintervention to reach an endpoint of MALE, or an amputation. But I think that this for the first time shows that, in a head-to-head trial, that both are durable and that, on the ‘endo’ side, once you achieve successful technical outcome, it is comparable even in the group that had reasonable vein in cohort one.” 

BEST-CLI meets ‘astronomic’ need for high-quality, practice-changing data 

At AHA, Farber noted that data from the Vascular Quality Initiative (VQI) from centers of excellence in North America revealed “tremendous” center-specific variability in treatment strategy in the use of bypass versus endovascular for CLTI patients, which BEST-CLI national trial manager Michael Strong tells Vascular Specialist attributes to the lack of evidence-backed guidelines in the space.  

Speaking to this newspaper, the investigators express their confidence that the results of BEST-CLI will change practice and impact the Global Vascular Guidelines published in 2019. Menard believes there is “no question” that guidelines will change, partly because the current guidelines are “riddled with gaps.” He notes that anywhere from 10–15% of current guidelines are based on level one data—a “miserably low” figure in his opinion. “The need for quality data that the BEST-CLI represents is astronomic,” he says. 

Rosenfield remarks that the trial will “definitely change practice” as it provides the clear message that “surgery is not dead, in fact it is very much alive and well for the appropriately selected patients.” He stated that the data “should be described to patients—simple as that,” and that patients “should have the option of deciding, but they should be knowledgeable that they will do better with surgery [in selected cases], and that is an appropriate response to [these results].”  

Farber concurs, noting that there is now level-one evidence to support the role of bypass in certain patients. “It supports a body of literature that is not as strong, and so I think [guidelines] will change,” he comments. 

“I think it is nice for us to have all these arrows in our quiver to treat CLTI patients, and that is what this is; it is about saying this arrow does work and it should be used in some situations,” Farber summarizes. “That is a great thing to add because, before BEST-CLI, the data were not as strong.” 

‘The first step’  

While the investigators agree that BEST-CLI will be practice changing, they acknowledge that it represents “the first step” in a long trajectory of future investigations and discussions in CLTI research.  

At AHA, Farber noted some limitations of the trial, including selection and operator bias in enrollment and intervention, the fact that equipoise and eligibility were determined locally and were variable, and that anatomic complexity is yet to be evaluated. In addition, cohort 2 was likely underpowered, anatomic complexity yet to be evaluated, percentage of female patients lower than targeted, and use of paclitaxel balloons or stents affected by the Katsanos meta-analysis during enrollment, they elaborate. 

“We need to dig deeper,” Rosenfield says. He describes the trial as a “game-changer in many respects,” but stresses that “this field is still a moving target” and so BEST-CLI must be seen as “the first foray into developing very solid level one evidence.” Specifically, he notes that techniques will “continue to improve and get better.” Looking ahead, Rosenfield believes that those who treat CLTI will “learn a lot more over the course of the next couple of years as we peel back the layers of the onion.” 

According to Menard, the trial stimulates two topics that will take center stage in the “great discussions that are going to be had” in the coming months. “We are all trying to figure out exactly how we are going to interpret the results for our own practices, and in order to do that, you really need to understand the patients enrolled into the trial, and that is a big focus of the future work—defining what their anatomy was […] and a bit more about overall demographics. You can have selection bias, but you cannot imply or in any way get around the fact that at that institution they were deemed appropriate for both [open and endovascular strategies],” he tells Vascular Specialist. 

Farber stresses that further investigation might also elucidate how an operator decides between adopting an open or endovascular approach in certain patients. “We all know that if it is an easy ‘endo,’ then of course the patient should have an ‘endo,’ there is no equipoise, and then on the other extreme there are cases where everything is blocked from the groin to the foot and somebody might say of course surgery is the way to go, and then there is everything in between,” he says. What remains, according to Farber, is for the investigators and others in the field to “dig deep” into these data to answer the question of how to define appropriateness for a certain treatment. 

For now, Rosenfield notes that the investigators are “really excited” about analyzing the “treasure trove” of data that BEST-CLI provides and seeing what they can learn. Looking beyond this, Menard expresses the team’s hope that “many more trials will come along and build on what the trial has laid as a foundation.”

SVS asking members to expand diversity in Nominating Committee

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SVS asking members to expand diversity in Nominating Committee
Michael C. Dalsing

The Society for Vascular Surgery (SVS) will ask voting-eligible members to consider three revisions to article X of the SVS bylaws that would take a step toward change on the SVS Nominating Committee.

In the past several years, the membership of the committee, which selects candidates for officer consideration, has expanded from the three most recent past presidents to include four more members: a member of the Strategic Board of Directors, an at-large member elected from among the membership, the vice chair of the Community Practice Committee and the chair of what formerly was called the Leadership and Diversity Committee. There also has been an ex-officio, non-voting representative of the Young Surgeons Committee (now Section).

The referendum changes would keep the Nominating Committee membership at seven, while expanding diversity of perspective. The SVS Executive Board has proposed—and the Strategic Board of Directors has approved—putting the following three changes to the membership for a vote:

  1. Reducing the number of past presidents on the Nominating Committee from three to two; the most current past president, who serves on the Executive Board, will join the Nominating Committee one-year removed from this service
  2. Adding the SVS Diversity, Equity and Inclusion (DEI) Committee chair, or vice chair if the chair is unavailable, as a voting member of the Nominating Committee, replacing the chair of the Leadership Committee. The Leadership Committee chair was added when the committee’s name was the Leadership and Diversity Committee, but diversity has since been migrated to the DEI Committee
  3. Adding the chair of the Young Surgeons Section, or the vice chair if the chair is unavailable, as a voting member of the Nominating Committee. The Young Surgeons Section chair has been serving as a non-voting ex-officio member

These changes have been proposed and approved to further increase the diversity of perspective and voice in the Nominating Committee process. Because the process for nominating SVS officers for 2022–23 begins in January 2023, this special referendum is being called to ensure changes are implemented in time for the 2023 nominating process and elections.

“We feel it is imperative to broaden the perspective of the group that selects our candidates, to hear from the wide range of voices among our members,” said SVS President Michael C. Dalsing, MD. “The Strategic Board of Directors feels making this change before our next election cycle is so important, in fact, that we’re taking the unusual step of holding an off-cycle referendum election.”

Online voting on the questions will begin in early December. Only Active and Senior members in good standing are eligible to vote.

Read the proposed changes at vascular.org/2023NomCommBylawsChange.

Amplifi vein dilation system continues to show promise following latest first-in-human study update

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Amplifi vein dilation system continues to show promise following latest first-in-human study update
Surendra Shenoy

An update from the first-in-human study assessing the Amplifi vein dilation system (Artio Medical) was delivered by Surendra Shenoy, MD, from Washington University School of Medicine in St Louis, during the first-ever late-breaking clinical trials session at this year’s Venous Endovascular Interventional Strategies (The VEINS) conference (Oct. 30–31) in Las Vegas.

“It is probably the most exciting thing to have happened in vascular access since the description of the arteriovenous fistula [AVF] for the first time in 1966,” Shenoy noted during his presentation. “It is poised to make a huge impact for our patients.”

The Amplifi vein dilation system has been designed to overcome the age-old problem of AVF non-maturation in the forearm. While native fistulas are still widely considered the optimal, initial vascular access strategy in the majority of patients—particularly ones created at the forearm, due to reduced complication rates and the fact they preserve proximal sites for future accesses—these anastomoses are often associated with a high likelihood of maturation failure, whereby the access is not successful in providing a usable conduit for dialysis treatments.

In addition, small vein diameters are strongly correlated with maturation failure. An Artio press release details that 6mm veins have a 75% probability of maturation versus just 10% for 3mm veins. As such, the company’s Amplifi device, comprised of a wearable pump and catheters, is intended to improve AVF maturation rates by instigating vein dilation prior to creation of a fistula. This is achieved by delivering non-pulsatile, supraphysiologic wall shear stresses within the patient’s target vein to stimulate flow-mediated dilation.

In the prospective, non-randomized, single-arm, open-label, first-in-human study determining the safety and effectiveness of the Amplifi system, an initial cohort of five end-stage kidney disease (ESKD) patients were treated at Sanatorio Italiano (Asunción, Paraguay) between the first and third quarters of 2021. Positive results from these early investigations, including forearm and upper-arm mean cephalic vein diameters more than doubling across a mean treatment duration of 8.6 days, were also disclosed by Shenoy himself at last year’s Vascular Interventional Advances (VIVA) conference (Oct. 4–7, 2021) in Las Vegas.

At VEINS 2022, Shenoy delivered data on a second groups of patients treated through the third quarter of this year in the first-in-human trial, reporting a mean treatment duration of 6.3 days, and noting that all AVFs in this most recent cohort were created in the forearm. The speaker further stated that no serious device-related or procedural adverse events were seen here. Treatment with the Amplifi system resulted in a 151% increase in cephalic vein diameter, with a 134% concomitant increase in flow rate, he added, and AVFs made with Amplifi-treated veins were fully mature within two weeks and all patients were cleared for hemodialysis using their AVFs by week six.

The Amplifi vein dilation system is currently in development and therefore not available for commercial use, according to Shenoy, and further data bolstering these promising early signals are required—with a Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trial of the device now planned and set to begin enrollment in 2023.

Virtual visits versus in-person: Telemedicine study detects ‘substantial’ cost savings for patients

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Virtual visits versus in-person: Telemedicine study detects ‘substantial’ cost savings for patients
Arshia Javidan (left) and Faysal Naji

Virtual consultations appear comparable to care received in-person when it comes to clinical outcomes as well as patient and practitioner satisfaction, a systematic review and meta-analysis of all primary studies evaluating virtual patient visits in vascular surgery has demonstrated. 

“The data tell us telemedicine can help save patients time and money. However, in considering the effectiveness of telemedicine moving forward, one thing we have to ask ourselves is: Are there other unintended downstream healthcare costs with the use of virtual consultations and visits?” first-named investigator, Arshia Javidan, MD, a second-year vascular surgery resident at the University of Toronto, observed in an interview with Vascular Specialist, after delivering data from the study at the 2022 annual meeting of the Canadian Society for Vascular Surgery (CSVS) in Vancouver (Sept. 9–10). “For example, are additional investigations, or even unnecessary investigations, being ordered when we’re seeing a patient virtually and not necessarily being able to perform a comprehensive physical exam?”

Javidan was part of a research team led by Faysal Naji, MD, vascular surgeon and assistant professor at McMaster University in Hamilton, Ontario, who delved into the data produced by the analysis. Some 22 studies were included in the review and involved around 29,000 patients. The study group’s limited meta-analysis of three randomized-controlled trials (RCTs) assessing diabetic foot ulcers did not detect any statistically significant differences in terms of ulcer healing, mortality or amputation rates, they noted. “In terms of other clinical outcomes, we grouped together what we were able to find based off the data available,” Javidan said. “Other clinical outcomes included post-operative readmission rates and data collected from patient questionnaires related to patient-related outcome measures. Largely, there was no statistically significant difference between virtual and in-patient care.” 

From a cost savings point of view, continued Javidan, the study found that patients were saving time, money and fuel through the use of virtual consultations. In terms of travel distance savings, the number “was relatively substantial at between 31 and 150 miles, 39 to 115 minutes of travel time, and 2.2 to 12 gallons of fuel saved. When you consider that a lot of vascular surgery patients will require longitudinal follow-up with several visits per year, this can really add up.”

Among seven studies evaluating patient satisfaction, patients generally felt telemedicine was either comparable or better than in-person visits, Javidan and colleagues found.

The researchers had felt there was a need to assess the merits of telemedicine—particularly through the lens of vascular surgery practice—from a higher level after analyzing a plethora of level three and four evidence, mostly in the form of cohort studies and case series. “Despite its increasing use in vascular surgery, there was not yet a comprehensive review looking at how virtual visits are used in our specialty, and so we sought to put things together and aggregate results,” Javidan said. 

Naji added, “As COVID calmed down a little bit, we noticed that telemedicine was still being used, kind of begging the question that maybe there were some hidden benefits to these shifts in practice patterns that we weren’t identifying.” 

Summing up their findings at CSVS 2022, the research team noted: “Telemedicine has the potential to augment vascular surgery practice while reducing resource use for patients and providers alike. Additional high-quality evidence comparing telemedicine to in-person clinical encounters is required to further elucidate the effect that telemedicine and virtual consultations have on clinical outcomes.” 

‘Significant’ increase in atherectomy use in US largely driven by office-based procedures, VQI data show

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‘Significant’ increase in atherectomy use in US largely driven by office-based procedures, VQI data show

In the United States, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published U.S. data from the Vascular Quality Initiative (VQI), which also revealed wide regional variability in the use of atherectomy. 

According to authors Tonga Nfor, MD, a cardiologist at Aurora St Luke’s Medical Center, in Milwaukee, Wisconsin, and colleagues, small, older studies have indicated that the use of atherectomy devices has become common in PVIs despite what they describe as the “paucity of strong clinical guidelines.”

The study, published in the Journal of Vascular Surgery (JVS), was a retrospective analysis of prospectively-collected data from the VQI registry, which the investigators say provides a “unique opportunity” to fill knowledge gaps in this field of research using real-world data originating across the U.S. The team identified all patients who had undergone endovascular PVIs for occlusive lower-extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group, Nfor et al write. 

In the study period, the authors note that a total of 205,377 PVIs were performed for 152,693 unique patients. The key finding, they report in JVS, is that, during the 10-year study period, 16.6% of the PVIs had used atherectomy, with the data showing that use “significantly increased” from 8.5% in 2010 to 19.7% in 2019. 

Geographic variation was evident in the study results, with Nfor and colleagues stating that they found a significant difference in the prevalence of atherectomy use across 17 geographic regions, ranging from 8.2% to 29%. 

These regions were further split into North, East, South, and West, the authors write, revealing that the observed frequency of atherectomy use in PVIs during the 10-year period was highest in the South at 22.5%, followed by the West (19.9%), North (17.3%), and East (12.6%; p<0.0001). 

According to the study authors, the strongest predictor of use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17–11.09) or ambulatory center (OR, 4; 95% CI, 3.65–4.39) versus a hospital setting. Furthermore, the geographic trend in atherectomy use followed the distribution of the proportion of office-based PVI procedures—South (6.1%), followed by the West (4%), North (3.9%), and East (0.5%). 

They note that the presence of severe (OR, 2.6; 95% CI, 2.4–2.85) or moderate (OR, 1.5; 95% CI, 1.4–1.69) lesion calcification was also predictive of atherectomy use. 

The researchers also examined the reimbursement aspect of the atherectomy discussion. For angioplasty performed in a hospital, the physician total relative value units (RVUs) was 12.94, averaging about $466, they report. For the same procedure performed in an office-based laboratory [OBL], the total RVU was 100.68 (procedure total), translating to $3,628. 

Nfor et al further reveal that, when angioplasty was performed with atherectomy in a hospital, the physician RVU was 17.61, averaging $635. However, when atherectomy with angioplasty was performed in an OBL, the reimbursement increased to 345 RVU—approximately $12,444. 

The authors, however, point out that these total RVU reimbursement figures for office and ambulatory center procedures includes the technical and facility fees. 

“To provide patients with the highest quality of care, physicians must allow their decision-making to be guided only by the clinical factors and the best interest of the patient, and should be mindful of any biases that might influence their practice, including the reimbursement structure and financial incentives,” the researchers stress. 

Despite the financial incentives that exist, the authors acknowledge that clinical considerations “play an important role in interventional decisions that guide patient care.” 

For example, the investigators note that patients in the hospital setting will tend to have more acute disease with greater urgency and a greater risk of complications. 

Routine use of atherectomy for infrainguinal PVI called into question 

Caitlin Hicks

In a commentary on Nfor and colleagues’ report, Caitlin Hicks, MD, a vascular surgeon from Johns Hopkins University School of Medicine, Baltimore, Maryland, underscores the “overwhelming message” of the analysis: that atherectomy is being overused in the U.S. 

“This is not an attack on physicians who work in OBLs,” Hicks stresses at the outset of her commentary, but rather a “statement of the facts,” of which she assembles four from this latest addition to the available research: 

  • Atherectomy use for infrainguinal PVI has been “increasing rapidly” in the U.S. 
  • No high-quality evidence is available that atherectomy improves outcomes compared with alternative endovascular therapies 
  • Atherectomy is much more frequently used in OBL settings than in hospital-based settings 
  • And reimbursement for atherectomy procedures is substantially higher than that for stenting and balloon angioplasty in the outpatient setting 

“Based on these facts, the routine use of atherectomy for infrainguinal PVI is suspicious at best,” Hicks remarks. She acknowledges that cases exist for which atherectomy has proven beneficial—calcific disease, popliteal lesions that cannot or should not be stented, and recalcitrant lesions, for example. However, Hicks also notes that the data have shown the use of atherectomy in up to 100% of cases by some physicians—a fact that is “not right” in her view.

Hicks concludes: “As a field, vascular surgeons need to come together and unite on this issue. If we do not police ourselves regarding the appropriate use of high-cost technologies, the Centers for Medicare and Medicaid [CMS] will most certainly do it for us.”

Disrupt PAD III observational study results confirm safety and effectiveness of IVL in complex calcified lesions

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Disrupt PAD III observational study results confirm safety and effectiveness of IVL in complex calcified lesions
Ehrin Armstrong at VIVA 2022
Disrupt
Ehrin Armstrong at VIVA 2022

The final 1,373-patient cohort analysis from the Disrupt PAD III observational study (OS) demonstrates consistent intravascular lithotripsy (IVL; Shockwave Medical) outcomes in complex and challenging lesions across multiple peripheral vessel beds.

Ehrin Armstrong, MD, from an interventional cardiologist from Adventist Heart and Vascular Institute in St Helena, California, presented this conclusion during a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2022 (Oct. 31–Nov. 3), noting that the study represents the largest prospective “real-world” evidence supporting the treatment of complex, heavily calcified peripheral arterial disease (PAD) with IVL.

Key findings from Disrupt PAD III OS include:

  • IVL resulted in consistent reduction in the diameter of stenosis with no associated distal embolisation, abrupt closure or thrombotic events at any time
  • IVL was the only calcium-modifying therapy used in most cases, required a limited need for adjunctive therapy tools (i.e. embolic protection), and had better results with appropriate IVL sizing
  • IVL results were comparable to the previously reported outcomes from the Disrupt PAD III randomized clinical trial (RCT) showing that IVL safely and effectively modifies calcium across multiple peripheral vessel beds

“These consistent results in a ‘real-world’ population, combined with the recent long-term outcomes from the Disrupt PAD III RCT, reinforce the positioning of IVL as a reliable, potential first-line therapy for the treatment of large and diverse patient populations with calcified PAD,” said Armstrong. “The significant amount of data on IVL continue to show both consistent efficacy and safety across the most challenging lesions, various peripheral vessel beds, and even in the most complex, high-risk patients.”

Disrupt PAD III OS is a prospective, multicenter, single-blind study of “real-world” patients. The analysis looked at the total 1,373-patient cohort enrolled in the study from November 2017 to June 2021 at 30 global sites.

Of the 1,531 lesions treated in the iliac, common femoral, superficial femoral, popliteal and infrapopliteal arteries, 90% presented with moderate/severe calcification, with an average calcified length of 115mm. At VIVA 2022, Armstrong reported that the use of IVL in these lesions resulted in a final residual diameter stenosis of 24%, similar to Disrupt PAD III RCT (22%).

The presenter also revealed that patients experienced minimal procedural complications, with only 0.7% and 0.2% experiencing final dissections (Type D–F) and perforations, respectively. Notably, there were no instances of embolisation, thrombus formation, no reflow or abrupt closure.

End-stage CLTI: Deep-vein arterialization procedure demonstrates amputation-free survival rate of 66% at six months

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End-stage CLTI: Deep-vein arterialization procedure demonstrates amputation-free survival rate of 66% at six months
Daniel Clair presents six-month LimFlow data

Six-month results from the PROMISE II trial of the LimFlow deep-vein arterialization system showed an overall amputation-free survival of 66%—“well above” the primary endpoint target of 54%, chief investigator Daniel Clair, MD, told the 2022 Vascular Interventional Advances (VIVA) meeting (Oct. 31–Nov. 3) in Las Vegas.

The PROMISE II research team further demonstrated a limb salvage rate of 76% and overall survival rate of 87% in a group of patients that Clair, professor and chair in the Department of Vascular Surgery at Vanderbilt University in Nashville, Tennessee, described as “the sickest group of patients ever enrolled in a lower-extremity pivotal trial.”

PROMISE II was conducted at 20 sites in the U.S. with more than 100 enrollees, all of whom were classed as having Rutherford 5 and 6 levels of peripheral arterial disease (PAD)—commonly referred to as a “no-option” group of end-stage chronic limb-threatening ischemia (CLTI) patients.

Clair reported a technical success rate of 99% across “a wide range of investigators from all different specialties” using the LimFlow transcatheter arterialization system among a patient population he described as predominately older, male, diabetic and who bore the “typical group of comorbidities,” with around 20% on dialysis.

There was a large difference in outcomes for dialysis vs. non-dialysis patients—driven primarily by an increased mortality in the dialysis group, Clair noted. “The primary reason this group did not meet [the target] is really overall survival,” he told VIVA 2022. “This is obviously a very sick group of patients. If you have end-stage renal disease, and in addition, reach the point where your limb is not salvageable, there is probably major changes that we need to do in order to improve their overall survival.”

Six-month results also showed a wound healing rate of 75% (either healed or healing), Clair said, rising to almost 80% at the 12-month mark, according to independent core lab evaluation. Pain scores for this patient population, too, continue to decline over time alongside “a significant improvement in their quality of life,” he added.

Additionally, Clair reported an improvement in the patient group’s Rutherford classification at the six-month point, telling VIVA that almost 20% were categorized as either Rutherford 0 or 1. Out to a year, he continued, “at least preliminarily,” nearly 60% were recorded as Rutherford 0.

Concluding, Clair said: “The PROMISE II study met its endpoint with a very reliable amputation-free survival. Transcatheter arterialization is safe and effective. These results are very much in line with what we saw in the PROMISE I outcomes, and from my viewpoint, now we have to find a new name for this group of patients.”

BEST-CLI attracts $3.3m funding injection to continue data analysis 

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BEST-CLI attracts $3.3m funding injection to continue data analysis 
The much-anticipated clinical results from BEST-CLI are due to be revealed on Monday morning (Nov. 7)

The Novo Nordisk Foundation has made a $3.3 million contribution toward the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) clinical trial, the Denmark-based entity has announced. The grant is set to be used by investigators to continue analyzing the wealth of data produced by the nearly eight-year-long study. 

Originally funded by the U.S. National Institutes of Health (NIH), BEST-CLI trial compares the treatment efficacy, functional outcomes, quality of life and cost–effectiveness of surgical bypass and endovascular revascularization for 1,840 patients with CLI across North America, Europe and Asia.

The trial is being led by co-principal investigators Matthew Menard, MD, director of the vascular and endovascular fellowship program at Brigham and Women’s Hospital in Boston; Alik Farber, MD, chief of vascular and endovascular surgery at Boston Medical Center; and Kenneth Rosenfield, MD, section head of vascular medicine and intervention at Massachusetts General Hospital, also in Boston.

The much-anticipated clinical results—as well as quality-of-life analyses—from BEST-CLI are due to be presented at the American Heart Association (AHA) Scientific Sessions (Nov. 5–7) in a late-breaking session on Monday morning (Nov. 7).

The trial started in August 2014 and was completed in March of this year. Patients were followed for at least two years and up to seven years.

The fresh funding injection from the Novo Nordisk Foundation will be used by the investigators to continue plumbing the trial data, perform a comprehensive cost–effectiveness analysis, and establish an imaging core laboratory to collate and analyze the radiographic imaging collected.

“BEST-CLI is a landmark trial that has the ambitious goal of establishing the evidence foundation that will help clinicians and caregivers provide the best possible care to patients with critical limb ischemia,” said Menard.

“Unprecedented in its effort to bring together all of the specialties that treat CLI, as well as in its global reach, BEST-CLI aims to define a sorely needed standard of care for this particularly vulnerable population of patients. Given the truly alarming rates of diabetes around the world, and the projected rise in the number of patients afflicted with critical limb ischemia, it is of paramount importance that we understand the full impact of our surgical and endovascular interventions.”

In addition to the initial NIH funding, the Society for Vascular Surgery (SVS), the Society for Clinical Vascular Surgery (SCVS) and a slew of other national and regional vascular societies are among those to have contributed funds toward BEST-CLI. Industry sources of financial support included Janssen, Gore, BD, Medtronic, Cook Medical, Boston Scientific, Abbott, Cordis and Cardiovascular Systems, Inc.

CEA, TCAR ‘continue to show superior outcomes’ to transfemoral stenting

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CEA, TCAR ‘continue to show superior outcomes’ to transfemoral stenting
Hanaa Dakour Aridi takes to the MVSS 2022 podium

Researchers led by a vascular team in Indianapolis found that carotid endarterectomy (CEA) remains the most-used strategy in carotid revascularization, with CEA and transcarotid artery revascularization (TCAR) showing decreased odds of stroke or death compared to transfemoral carotid artery stenting (TF-CAS). 

Those were among the main findings delivered by Hanaa Dakour Aridi, MD, an integrated vascular surgery resident at Indiana University in Indianapolis, during the 2022 annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Grand Rapids, Michigan (Sept. 15–17), after a analysis of regional variation in patient selection, practice patterns and outcomes based on techniques used in carotid revascularization logged in the Vascular Quality Initiative (VQI) from 2016–2021. 

The research team divided 19 geographic regions into three quantiles based on the average annual volume of carotid procedures performed: low (956 cases), medium (1,533) and high (1,845) centers. They looked at a total of 126,768 carotid revascularization cases, with most patients asymptomatic. CEA was the most common procedure (>60%) across all regional groups, with 13% performed using TF-CAS and 17% with TCAR. 

“Overall, there was a trend towards increased utilization of TCAR since its introduction in 2016 up to 2021,” Aridi told MVSS 2022. “This seems to have been mirrored by an increase in the percentage of CEA cases.” 

Aridi reported the research team found no significant differences in stroke and death between CEA and TCAR across the three regional volume groups. “However, TF-CAS was associated with a higher odds of stroke and death compared to CEA, and TCAR was associated with a decreased odds of stroke or death compared to TF-CAS,” she said. “These variations were also seen when we analyzed the regions individually.” 

Despite significant variation in clinical practice, Aridi concluded, “no significant regional variation was observed in the outcomes of carotid revascularization. TCAR and CEA continue to show superior outcomes to TF-CAS across all regional groups. Our study identifies some gaps in adherence to societal guidelines, mainly in terms of intraoperative procedural variability that can potentially lead to worse outcomes. It also highlights the need for uniformity in management of patients with carotid artery disease.” 

Raghu Motaganahalli, MD, the study’s senior author, told Vascular Specialist: “What we are seeing is TCAR has grown at the cost of CEA, not at the cost of TF-CAS,” further noting, “We would love to see growth happening at the cost of TF-CAS because it is probably at a higher risk of stroke and complications.” 

SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND

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SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND
SurVeil
Kenneth Rosenfield presents the new data at VIVA 2022

In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated “excellent efficacy and safety” out to 24-month follow-up. This is according to Kenneth Rosenfield, MD, from Massachusetts General Hospital in Boston, who presented the new data at Vascular Interventional Advances (VIVA) 2022 (Oct. 31–Nov. 3) in Las Vegas. 

The TRANSCEND trial randomized 446 patients at 65 global sites to assess the safety and efficacy of the SurVeil DCB versus the IN.PACT Admiral DCB (Medtronic) for treatment of superficial femoral and proximal popliteal artery lesions. TRANSCEND 12-month data, presented in January 2021, showed the SurVeil met its primary safety and efficacy endpoints and was non-inferior to the IN.PACT Admiral DCB while utilizing a lower dose of the anti-proliferative drug paclitaxel. Patients in the TRANSCEND trial will be followed for 60 months.

Rosenfield, who is the principal investigator of TRANSCEND, outlined 24-month data at VIVA 2022 that demonstrated comparable, sustained clinical outcomes between the SurVeil DCB and IN.PACT Admiral DCB cohorts. Functional outcomes for treated patients also demonstrated continuous improvement at the two-year point.

“These 24-month trial results validate the benefits that patients are experiencing after receiving treatment with the SurVeil DCB, and I am pleased to see that the SurVeil DCB continues to demonstrate excellent efficacy and safety in this pivotal RCT, [randomized controlled trial],” said Rosenfield. “I am excited about the potential of this next-generation DCB, which offers an attractive low dose therapeutic alternative to improve outcomes in our PAD patients.”

At 24 months, 81.8% of patients treated with SurVeil met the secondary safety endpoint, a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically driven target vessel revascularization (CD-TVR) vs. 83.2% of patients treated with the IN.PACT Admiral DCB. Fewer than 15% of patients in both arms of the trial required repeat revascularization procedures. One patient in the IN.PACT group required major leg amputation.

The TRANSCEND trial’s two-year data showed a primary patency rate of 70.8% for SurVeil DCB patients vs. 70.4% for IN.PACT Admiral. Both the SurVeil and IN.PACT Admiral DCBs utilize paclitaxel drug coatings. However, Surmodics notes in a press release announcing the results that the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5µg/mm²) than the SurVeil device, which has a 2.0 µg/mm² drug load.

New analysis: Four multicenter trials support primary use of drug-coated balloons over bare metal stents in femoropopliteal lesions 

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New analysis: Four multicenter trials support primary use of drug-coated balloons over bare metal stents in femoropopliteal lesions 
Mehdi Shishehbor presents the new data at VIVA 2022

A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicenter trials support the primary use of drug-coated balloons (DCBs) versus bare metal stents (BMS) in moderately complex femoropopliteal lesions, new data show. 

Lead researcher Mehdi Shishehbor, DO, revealed adjusted Kaplan-Meier estimates showing a 12-month primary patency of 90.4% for DCB vs. 80.9% for BMS (p=0.007); freedom from 36-month clinically driven target lesion revascularization of 85.6% for DCB vs. 73.7% for BMS (p=0.001); and cumulative 36-month major adverse events of 25.3% for DCB vs. 38.8% for BMS (p<0.001). 

The results show “superior effectiveness” in favor of DCB use and no differences in mortality, amputation, or thrombosis, Shishehbor, from University Hospitals Health System, Harrington Heart & Vascular Institute, Cleveland, Ohio, and colleagues report. 

Shishehbor delivered the data during the 2022 Vascular Interventional Advances (VIVA) meeting (Oct. 31–Nov. 3) in Las Vegas, with the results published in the Journal of the American College of Cardiology (JACC). 

Patient-level data were pooled from the DCB arms of the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled trials, and the prospective, multicenter, single-arm Complete SE and DURABILITY II BMS studies. DCBs and BMSs were compared using the inverse probability of treatment weight method with weighted log-rank p values.  

“The question for us was comparing the safety and efficacy of DCB versus bare metal stents in patients with femoropopliteal disease who have Rutherford class 2–4,” Shishehbor told VIVA 2022. 

A total of 771 patients (288 DCB; 483 BMS) were included in the primary analysis. Demographic, baseline lesion and procedural characteristics were matched between treatment groups after adjustment.  

“In this prospective, patient-level pooled analysis with advanced statistical methods comparing the safety and efficacy of DCB vs. bare metal stent in prospectively conducted studies with core lab adjudication, we showed that DCBs had a superior primary patency at 12 months on duplex ultrasound and superior freedom from clinically driven [target lesion revascularization] at 36 months compared to BMS,” Shishehbor concluded at VIVA. “There were no significant differences at 36 months for all-cause mortality amongst the three arms. This analysis supports the use of DCB vs. bare metal stenting in moderately complex femoropopliteal lesions, which are amenable to both treatments.” 

‘Excellent’ three-year results presented for the BioMimics 3D stent in longer lesions

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‘Excellent’ three-year results presented for the BioMimics 3D stent in longer lesions
Michael Lichtenberg at VIVA 2022
BioMimics
Michael Lichtenberg at VIVA 2022

At the 2022 Vascular Interventional Advances (VIVA) meeting (Oct. 31–3 Nov. 3), Michael Lichtenberg, MD, from Arnsberg Clinic, Arnsberg, Germany, reported a subgroup analysis of the MIMICS-3D EU registry, revealing a headline finding of “excellent” three-year outcomes for the BioMimics 3D stent (Veryan Medical) in longer lesions.

The presenter noted that the MIMICS-3D EU registry forms part of the wider MIMICS clinical research program, which he said will enroll more than 1,750 patients worldwide. In the most recent findings, Lichtenberg noted that the BioMimics 3D stent showed impressive durability through three years of follow-up in the prospective, single-arm, multicenter MIMICS-3D EU registry in a challenging, ‘real-world’ patient population. At VIVA, Lichtenberg presented a post-hoc subgroup analysis which investigated the three-year performance of BioMimics 3D in patients with long and very long lesions.

According to Lichtenberg, the patients in the MIMICS-3D EU registry represent a more challenging population than typically enrolled in registry studies. Specifically, he detailed that 9% of patients had long lesions (140mm to ≤190mm), 24% had very long lesions (>190mm), 24% had chronic limb-threatening ischemia (CLTI), 53% had moderate-to-severe calcification, and 57% had chronic total occlusions (CTOs).

The MIMICS-3D EU registry enrolled 507 patients at 23 European sites, Lichtenberg noted. The long lesions and very long lesion cohort consisted of 165 patients (33%), 46 in the long lesion subgroup (mean lesion length of 160.2±22.6mm, 33% diabetes, 25% severe bilateral wall calcification, 58% occlusion) and 119 in the very long lesion subgroup (mean lesion length of 269±61mm, 40% diabetes, 38% severe bilateral wall calcification, 92% occlusion).

Lichtenberg informed VIVA attendees that the primary safety outcome of major adverse events (MAE) at 30 days was 100% for the long lesion subgroup and 97% for the very long lesion subgroup. He added that the primary efficacy endpoint demonstrated as Kaplan-Meier estimate for freedom from clinically driven target lesion revascularization (CD-TLR) was 85% at 12 and 78% at 36 months for the long lesion subgroup and 82% and 70% at 12 and 36 months respectively, for the very long lesion subgroup.

Furthermore, the presenter noted that the Kaplan-Meier estimate of primary patency was 85% and 75% at 12 and 36 months for long lesions and 78% and 61% at 12 and 36 months for very long lesions. Finally, he revealed that investigator-reported fractures through 36 months were low for both groups; 0% and 0.8% for the long lesion and very long lesion groups, respectively.

Mechanical thrombectomy for DVT: Randomized data needed to boost growing evidence base

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Mechanical thrombectomy for DVT: Randomized data needed to boost growing evidence base
mechanical thrombectomy
David Dexter at The VEINS 2022

Two datasets presented during the late-breaking clinical trials session at The VEINS (Venous Endovascular Interventional Strategies) 2022  (Oct. 30–31) in Las Vegas—the latest results from CLOUT and a propensity score-matched analysis of CLOUT versus ATTRACT—bolster the evidence base for mechanical thrombectomy in the field of deep vein thrombosis (DVT) management. However, discussion at the meeting pointed to the need for further, high-quality data to solidify the role of this treatment modality.

The latest analysis from the now fully-enrolled CLOUT registry demonstrates the “excellent safety profile and effective thrombus removal” of mechanical thrombectomy with the ClotTriever system (Inari Medical) in a “real-world” DVT population of 500 patients. This is according to David Dexter, MD, from Sentara Vascular Specialists, Norfolk, Virginia, who presented in-hospital and 30-day outcomes from this multicenter, prospective registry at The VEINS 2022. Steven Abramowitz, MD, from MedStar Washington Hospital Center, Washington D.C., also presented data on the ClotTriever system, sharing results of a propensity score-matched analysis of early clinical outcomes from the CLOUT and ATTRACT studies.

The CLOUT (ClotTriever outcomes) registry is an all-comer, multicenter study evaluating patient outcomes following treatment of proximal, lower extremity DVT with the ClotTriever system, and, according to Dexter, represents the largest mechanical thrombectomy study in the field of DVT. All-comer patients were enrolled, irrespective of symptom duration, thrombus age, prior failed treatment of the current DVT, or bilateral disease. The primary endpoint was complete or near-complete (≥75%) thrombus removal, assessed by an independent core laboratory.

Dexter reported that the primary endpoint was achieved in 91.2% of limbs, and the 30-day device-related severe adverse event rate was 0.2%. Nearly all procedures were single session (99.4%), median estimated blood loss was low (40mL), and only 2.2% of patients received overnight post-thrombectomy intensive care unit monitoring, he added. Furthermore, patient symptoms (e.g. pain and edema) were significantly reduced at discharge and showed sustained improvement through 30 days.

The presenter also revealed recovery of vessel flow and compressibility as measured by duplex ultrasound, improvements in revised Venous Clinical Severity Score and EuroQoL five dimensions quality-of-life score, median 5.5-point reduction in Villalta score, and <10% of patients with a moderate or severe Villalta score (≥10).

A question from the panel probed what is next for the field of mechanical thrombectomy in light of these results. Dexter pointed to the need for more studies, and also stressed what the focus of future research should be: “We need to show a real, long-term result on post-thrombotic syndrome”.

CLOUT versus ATTRACT

mechanical thrombectomy
Steven Abramowitz at The VEINS 2022

In Abramowitz’s presentation of the propensity score-matched analysis, the presenter summarized that CLOUT patients showed better thrombus extraction and improvement in 30-day Villalta scores than ATTRACT patients. Specifically, the presenter revealed that nearly two times more CLOUT patients had complete thrombus removal, and that 13% fewer CLOUT patients had Villalta scores ≥5 at 30 days.

Abramowitz explained that ATTRACT is a reference trial evaluating interventional treatment for DVT that showed no added benefit compared to anticoagulation. “New interventions have emerged since the completion of ATTRACT, and their comparative effectiveness is unknown,” he said. Using propensity score-matched data, the investigators compared outcomes from the CLOUT registry with those from the treatment arm of the ATTRACT trial.

To adjust for differences in study design, patients with bilateral DVT, symptom duration >4 weeks, or incomplete case data were excluded. Propensity score matching (1:1) on 11 baseline covariates (age, sex, body mass index, sidedness, prior venous thromboembolism, race, symptom duration, DVT location, presence of provoked DVT, Villalta score, and Marder score) was performed between the remaining CLOUT and ATTRACT patients, resulting in 166 matched pairs.

No significant differences in baseline characteristics remained after matching, the presenter noted. Rates of stenting and venoplasty were similar between the groups and, as expected based on differences in mechanism of action, rates of thrombolytic use (0% vs. 100%, p<0.0001), single-session treatment (98.2% vs. 25.3%, p<0.0001), and postprocedural hospital overnights (mean, 1.7 vs. 3.4, p<0.0001) were significantly different.

Abramowitz reported that thrombus extraction as measured by core laboratory-assessed Marder scores was 22.3% better in CLOUT patients (p<0.0001), and 22.2% more CLOUT patients achieved ≥75% thrombus clearance (p<0.0001). Similarly, 12.7% fewer CLOUT patients had Villalta scores ≥5 at 30 days (p<0.05). Logistic regression on ATTRACT showed that 30-day Villalta scores significantly predicted post-thrombotic syndrome at six months, one year, and two years (odds ratios, 1.37, 1.32, and 1.43; p<0.0001), which the presenter said highlights the potential long-term effect of these differences.

Closing his presentation, Abramowitz echoed Dexter’s call for more data, noting that randomized controlled trials such as the recently announced DEFIANCE trial “will further clarify the role of the ClotTriever system in treating DVT.”

Abre stent data show ‘struggle to maintain patency’ among post-thrombotic syndrome patients

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Abre stent data show ‘struggle to maintain patency’ among post-thrombotic syndrome patients
Stephen Black presents at The VEINS 2022

The Abre venous stent demonstrated three-year primary patency rates of 97.1%, 76.5% and 70.4% respectively for non-thrombotic iliac vein lesion (NIVL), acute deep vein thrombosis (DVT), and post-thrombotic syndrome (PTS) patient populations within the ABRE clinical study, a late-breaking session at The VEINS (Venous Endovascular Interventional Strategies) 2022 conference (Oct. 30–31) in Las Vegas heard.

Presenter Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England, delivered the breakdown of clinical outcomes from the trial based on initial clinical presentation two weeks after revealing an overall effectiveness rate through 36 months of 81.6% and a freedom from clinically driven target lesion revascularization (CD-TLR) rate of 89.3% at the American Vein and Lymphatic Society (AVLS) 2022 annual meeting (Oct. 13–16) in New Orleans. The data show that the “struggle to maintain patency” largely rests in the PTS patient population, Black noted.

The multicenter study enrolled 200 patients at 24 sites—16 in the U.S. and eight in the European Union. Some 47.5% of the pool was made up of PTS patients, with 36% presenting with NIVLs and 16.5% with acute DVTs. Furthermore, Black reported that 88 of the subjects, 44% of the study population, were fitted with a stent extending below the inguinal ligament—70.5% of them in PTS patients.

In terms of secondary endpoints, Black revealed that the study showed no stent fractures through three years, and similarly, no delayed stent migrations. “This speaks to the topic we’ve been continuing to discuss: that stent migration really does seem to be an operator issue rather than a stent issue,” Black told The VEINS 2022 attendees.

Quality-of-life assessments showed a “steep increase” in the first six months, which “was maintained through all the follow-up time points [12, 24 and 36 months] for all the population subgroups, acute DVT, PTS and NIVL,” he said. The same was true for functional assessments of the venous system, Black added.

“This was a challenging and complex patient population, with a significant number of patients with PTS with stent extension into the common femoral vein below the inguinal ligament,” he concluded of the subgroup analysis. “[We saw] a sustained primary patency out to 36 months, with the NIVL group in particular performing well. There have been no issues with stent integrity in terms of fracture or delayed stent migration through 36 months.

“And, most importantly, [we saw] improved quality of life in all presenting subgroups maintained throughout the follow-up period, with similar in venous function.”

Session panelist Raghu Kolluri, MD, from OhioHealth in Columbus, Ohio, asked Black where this data places the Abre device in the larger landscape of venous stents. “All the IDE [investigational device exemption] studies show similar results,” Black responded. “The performance in the NIVL group has been excellent, with drop offs in the acute DVT and PTS groups that we’ve seen before. So, where does it fit? It just adds to the data we now have to say that treating patients with chronic disease is sustainable and improves quality of life. We need to continue with randomized trials to really give us that weight of evidence.”

The study also reiterated the challenges of the PTS population, Black added. “A 30% patency loss at 36 months is something we probably need to improve,” something true “of all the other studies as well.”

An open letter to the National Rifle Association

An open letter to the National Rifle Association
Malachi Sheahan III
Hello,

I think it is time we talked about guns. I know you don’t like to discuss these things after a school shooting, so I waited. It has been four months since Uvalde. It seems there have been three more since, but I had to look that up. Some school shootings don’t even make the news these days. 

I have spent a lot of time trying to figure out what happened to you, and if there is a way forward. Look, you were never really easy to talk to, but at least there was debate. A chance for compromise. When you were formed in 1872 by Civil War General Ambrose Burnside, the goal was to promote rifle practice and improve marksmanship on a scientific basis. Burnside was pretty annoyed by the horrendous aim of his Union soldiers. It was estimated they fired 1,000 shots for every Confederate soldier struck. And this was in the days you couldn’t pick up a gross of armor-piercing shells at Walmart with the groceries. The charter goals of the NRA were to promote shooting, hunting and conservation. 

Fifty years after your formation, gun-wielding gangsters such as Al Capone and John Dillinger committed a rash of brazen crimes. Addressing the situation, your president Karl T. Frederick stated: “I do not believe in the general promiscuous toting of guns. I think it should be sharply restricted and only under licenses.” The NRA then lent its support to the National Firearms Act of 1934 and the Gun Control Act of 1938. 

The 1960s saw a series of public assassinations, including John F. Kennedy, Robert Kennedy, and Martin Luther King, Jr. In response, Congress passed the Gun Control Act of 1968. California Governor Ronald Reagan, who would go on to become the first U.S. president endorsed by the NRA, supported the law. You opposed the bill, but mildly. Your statement read, “…the measure as a whole appears to be one that the sportsmen of America can live with.” 

This tempered approach continued for the first 100 years of the NRA’s existence. A fundamental change occurred in the 1970s when Neal Knox led an insurgence culminating on May 21, 1977, with the “Revolt at Cincinnati.” Knox used bylaw provisions to vote out the NRA old guard and replace them with men such as Harlon Carter. Carter was a colorful character and holder of many national shooting awards. At 17, he had been convicted of murder for shooting another youth, but this was overturned on a technicality. Carter was a former U.S. Border Patrol director who led an operation along the southern border with a title too racist to print in my family-friendly publication. Let’s just say Carter was not a fan of Mexicans. He was, however, a skilled lobbyist and authored the “No compromise. No gun legislation” ethos that the NRA carries to this day. 

Behind its new activist leadership, NRA membership soared. Your goal became the rollback of the 1968 restrictions and the abolition of the Bureau of Alcohol Tobacco and Firearms (ATF). By increasing your lobbying pressure, the NRA compelled Congress to pass the Firearm Owners Protection Act of 1986. This law eased restrictions on interstate firearms sales and prohibited the creation of a national database of gun ownership. Complaining about the NRA’s new tactics, Republican Senator Bob Dole stated, “You have to have a litmus test every five minutes, or you’re considered wavering.” 

The spirit of the NRA became increasingly anti-government. A mailing to members declared a proposed assault rifle ban “gives jackbooted government thugs more power to take away our constitutional rights, break in our doors, seize our guns, destroy our property and even injure and kill us.” 

After anti-government sentiments drove the April 1995 federal building bombing in Oklahoma City, many NRA members became uncomfortable with this rhetoric. Former U.S. President George H.W. Bush was one. He resigned in protest. 

The April 1999 Columbine High School massacre proved to be your litmus test. I am sure it would have been great to lay low and offer empty platitudes to the dead. Unfortunately for you, the NRA annual meeting was scheduled to occur 10 days later in Denver, a few miles away. Just one day after the shooting, the NRA held a conference call to discuss the options. Respectfully cancel or delay the convention? Or defiantly press on? 

Luckily we don’t have to guess about the substance of this conversation as it was secretly taped and obtained by National Public Radio. On the recording, NRA top official Jim Land made the argument for continuing with the meeting: “I got to tell you, we got to think this thing through because if we tuck tail and run, we’re going to be accepting responsibility for what happened out there.” PR consultant Tony Makris delivered the counterargument, “…it’s far worse to go out there and be painted as a bunch of insensitive, disrespectful turds than it is to say we’re sorry it happened and we’ll bow out.” 

Remorse or defiance? I guess you decided the show must go on, and what a show it was. The final lines were delivered by your president Charlton Heston: “The dirty secret of this day and age is that political gain and media ratings all too often bloom on fresh graves.” This statement summed up a brilliant strategy that would condemn anyone who would bring up our gun problem after an event that obviously illustrated our gun problem. Unfortunately, it was a tactic you would have to rely on frequently in the ensuing years. So instead of meaningful discussion after a school shooting, we got thoughts and prayers. 

If Columbine was your turning point as an organization, Sandy Hook was ours as a nation. A moral reckoning, and one that we failed. Could we accept the vision of 20 first graders crumpled dead in their classrooms? Tiny bodies shredded by an AR-15 that had been modified by the manufacturer for close combat in confined spaces, such as a grammar school. A gun that had been advertised by the slogan “Consider your Man Card reissued”. The horror of Sandy Hook was so great that most gun advocates knew there was no logical way to debate. Out of desperation, some even resorted to calling it a hoax. Could our nation stomach all of this and do nothing? Apparently so. 

People often think the NRA does the bidding of the firearms industry, but I am certain the opposite is true. After Sandy Hook, the only significant legislation that came close to passing was the Manchin-Toomey Proposal, which would have strengthened and expanded background checks for firearms sales. The NRA was even involved in the negotiations to prepare the bill. The National Shooting Sports Foundation (NSSF), the firearms industry’s trade association, signaled their endorsement of the proposal. But, unbelievably, the NRA withdrew support and declared that the vote would be “scored.” Meaning if a senator did not vote the way the you wanted, their precious NRA grade would be affected. Senator Joe Manchin saw his A grade plummet to a D, just for voting for the legislation that the NRA helped to draft. The NSSF, predictably, fell in line and financed commercials opposing the bill. Manchin-Toomey failed to get the required 60% vote and was defeated on April 17, 2013. The threat of an NRA score even scared five democrats into voting no. 

Why do you have such a hold over politicians? Most of your members support common-sense measures. That must be inconvenient for you. To be truly valuable you need a unified voting base. Politicians love single-issue voters. No need to worry about fixing things or making anyone’s life better. Just vote a certain way on a certain issue. I bet if asked, “Should a guy who beats the crap out of his wife and kids be able to buy a gun?”, most of your members would vote no. Inconvenient. Ask any member of a high school debate team the key to a good faith debate, and they will tell you—defining the terms. So, to obscure a good faith debate, you appeal to emotion. Everything is a slippery slope. You label these “red flag laws” and convince your members that if some lunatic can’t buy a gun, they will be next. 

Politicians are also afraid of the fruitcakes and wackos in your organization. These are the folks most likely to show up at a town hall and scream at their representatives. Those pejorative terms aren’t mine, though. They’re yours. In the recorded call leading up to the Denver convention after Columbine, your leadership expressed fear that “The fruitcakes are gonna show up,” as PR consultant Tony Makris put it. Marion Hammer, your first female president, seemed to agree, “…you’re gonna have the wackos… dressing like a bunch of hillbillies and idiots…” Maybe it is ironic that your leadership has disdain for some of its most politically valuable constituents. Although I think irony may be lost on an association that opposes all efforts to curb gun violence while garnering tax-exempt status as a social welfare organization. 

The NRA’s tactics have caused a sea change in conservative opinion over the past 40 years. Before becoming an NRA darling, Ronald Reagan actually passed strict gun control measures as governor of California. Conservative Chief Justice Warren Burger said, “The Gun Lobby’s interpretation of the Second Amendment is one of the greatest pieces of fraud, I repeat the word fraud, on the American People by special interest groups that I have ever seen in my lifetime.” Even Justice Antonin Scalia said, “The Second Amendment is not a right to keep and carry any weapon whatsoever in any manner whatsoever and for whatever purpose.” 

Today the U.S. is awash in guns. More than one for every person. Despite your best efforts to curb research on gun violence through stripping the Centers for Disease Control and Prevention (CDC) of research funding and the Tiahrt Amendment, the facts are pretty damning. Guns are involved in 51% of suicides and 73% of homicides. Since 2015, toddlers have killed more Americans than terrorists. Worldwide, 97% of children four and under killed by guns happen in the U.S. More children die in a year by gunfire than on-duty police officers and active military members. The explosion of AR-15 purchases happened after the Assault Rifle Ban expired in 2004. A weapon formerly used mainly by law enforcement and the military was now marketed to the public by over 500 manufacturers. To compete, they would make improvements, which, in this context, means making the rifle more lethal. 

Many people from urban areas underestimate the emotional connection individuals from more rural regions can have to guns. Some of their fondest memories can be hunting and going to shooting ranges with their family. Heck, I live in Louisiana and work with a surgeon who unironically owns a cannon! Interestingly though, while the number of guns is increasing, the number of homes with a gun has actually decreased. So who is buying all of these AR-15s? Somehow I don’t think these purchases are driven by a love of the Great Outdoors. 

A 2020 study by the National Shooting Sports Foundation (NSSF) labeled the fastest-growing segment of customers Urban Defenders, or those likely to buy guns because they “don’t trust others around them.” So while gun advocates often bristle at the suggestion that the AR- 15 is a weapon of war, the industry clearly promotes it as such. Consider this advertisement from gun manufacturer Daniel Defense: “whether you’re on the battlefield … or protecting your family in the middle of the night.” 

It’s time to put to rest all of the myths about protecting kids from guns. Uvalde ended the notion that “good guys with guns” can save us. And please Google “Triangle Shirtwaist Factory” before suggesting schools should have a single entry and exit. But I don’t really expect a good faith argument here. The Protection of Lawful Commerce in Arms Act of 2005 protects gun manufacturers from civil lawsuits resulting from the “misuse” of their products by others. NRA president Wayne LaPierre called it the most significant piece of pro-gun legislation in 20 years. I agree. Let’s roll it back. Holding gun manufacturers once again responsible under the 1972 Consumer Product Safety Act may be the best recourse the public has. 

Finally, gun advocates often make the bad faith argument that “cars are dangerous too, maybe we should ban them.” Well, if Honda decides to start equipping Civics with Mad Max style flamethrowers, then, yes, we must take action. But maybe we can start addressing gun violence in the same manner as we did car fatalities. The formation of the 1970 National Highway Traffic Safety Administration led to a number of improvements and hazard-mitigating regulations in the automotive industry. Motor vehicle casualties have steadily fallen among children and teens. In fact, firearms now surpass vehicular accidents as the number one cause of death in children. It is time to establish a national, safety-driven organization with complete access to all gun-related data. We need to know where to put our resources. Smarter policing? Gun regulations? Improved mental and social services? It is far past time to launch a data-driven campaign to end gun violence. Oh, I almost forgot to mention that I saw that you are having a myriad of financial problems. Sending my thoughts and prayers. 

References 

  1. Nicholas Kristof. Preventing Mass Shootings Like the Vegas Strip Attack. New York Times. Oct 2, 2017. 
  2. Melinda Wenner Moyer. More Guns Do Not Stop More Crimes, Evidence Shows. Scientific American. Oct 1, 2017. home.NRA.org 
  3. David Frum. Mass Shootings Don’t Lead to Inaction—They Lead to Loosening Gun Restrictions. The Atlantic. Oct 3, 2017. 
  4. Antonio Cediel, Amber Goodwin, Michael McBride and Ciera Walker. Why Do We Ignore Initiatives That Reduce Gun Violence? New York Times. Oct 6, 2017. 
  5. Ron Elving. The NRA Wasn’t Always Against Gun Restrictions. NPR. Oct 10, 2017. https://www.npr.org/2021/11/09/1049054141/a-secret-tape-made-after-columbine-shows-the-nras-evolution-on-school-shootings

Malachi Sheahan III, MD, is the chief medical editor of Vascular Specialist. His opinions do not reflect SVS policy or positions.

A recent snapshot of pediatric vascular trauma injuries

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A recent snapshot of pediatric vascular trauma injuries
Amanda Tullos

A study of major pediatric vascular injuries delivered in the Vascular and Endovascular Surgery Society (VESS) Paper Session during the 2022 Vascular Annual Meeting (VAM) in June found that 70.2% of the cohort analyzed presented with penetrating trauma.

More specifically, noted authors Amanda Tullos, MD, a research fellow at Lousiana State University in New Orleans, Malachi Sheahan III, the institution’s vascular chief, and colleagues 60.8%, or 45 of 74, were secondary to gunshots.

Arterial injuries were the most common (67 of 74, 90%). In 55.2% (32 of 58) of the patients who underwent surgery, the vascular repair was performed by a vascular surgeon; the remaining (44.8%, 26 of 58) were conducted by trauma surgeons. 

Tullos and Sheahan charted the demographics, injuries, and outcomes of the pediatric vascular trauma population, identifying any risk factors associated with complications or death.

“Although pediatric vascular trauma is rare, it can result in severe functional deficits or death,” they noted, concluding: “Pediatric trauma is a leading cause of death in patients under 18 years of age. Although vascular trauma is uncommon in pediatric patients, it is associated with high morbidity and mortality.”

Study: Combined antiplatelet, NOAC use linked to worse limb outcomes after suprainguinal bypass

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Study: Combined antiplatelet, NOAC use linked to worse limb outcomes after suprainguinal bypass
William Robinson

A new analysis that found combined antiplatelet and novel oral anticoagulant (NOAC) therapy after suprainguinal bypass was associated with worse limb outcomes and equivalent survival compared to antiplatelet use alone has “weaknesses” but is “hypothesis-generating,” the senior author insisted during a scientific session at the 2022 annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Grand Rapids, Michigan (Sept. 15–17). 

William Robinson, MD, the chief of vascular surgery at Southern Illinois University School of Medicine in Springfield, Illinois, was responding to a question from the floor of the gathering that called into question aspects of the study’s patient population. 

The research comes as recent trials report that NOACs, or direct oral anticoagulants (DOACs), alongside antiplatelet use, reduce limb and cardiovascular events when compared to antiplatelet therapy alone after infrainguinal surgical revascularization. Robinson, Syed Zaidi, MD— who delivered the findings at MVSS 2022—et al retrospectively analyzed patients in the Vascular Quality Initiative (VQI) who had undergone the bypass from 2014 until last year. 

Zaidi noted that rates of antiplatelet usage were “pretty steady” over the eight-year study period, whereas warfarin use “steadily decreased,” with NOAC administration “steadily increasing.” 

Univariate analysis showed that at one year, “the NOAC-plus-antiplatelet group had a statistically significantly reduced primary patency rate compared to antiplatelet alone.”Multivariate analysis demonstrated that NOAC use, prior bypass, diabetes and acute ischemic limb presentation “all were independently significant predictors of a reduced primary [and] primary assisted patency at one year.” Likewise, secondary patency rates showed a similar finding, Zaidi stated. 

Further, at 12 months, univariate analysis showed NOAC use associated with a lower major adverse limb event-free survival rate compared to the antiplatelet group. “We found several independent predictors on multivariate analysis— NOAC use, prior bypass, patient being non-ambulatory, rest pain or tissue loss and acute ischemic limb presentation—of increased major adverse limb events,” said Zaidi. 

NOAC use was also associated with reduced major amputation-free survival at one year, he continued, with multivariate analysis showing that non-ambulatory status, having an axillary bypass graft origin, tissue loss or acute ischemic limb presentation were associated with increased rates of major amputation. 

Univariate analysis demonstrated that overall survival in the NOAC group was 89% at one year compared to 91.3% in the antiplatelet group, Zaidi added. “We did find that warfarin ultimately had similar outcomes as NOAC therapy but, ultimately, did not include it in the final analysis due to its decreased usage over time,” he noted. 

“Combined antiplatelet and NOAC therapy after suprainguinal bypass was associated with worse limb outcomes and patency but equivalent statistically significant survival compared to antiplatelet therapy alone,” Zaidi concluded. “NOAC use in suprainguinal bypass has typically been extrapolated from infrainguinal data and can’t be recommended for routine use based on our experience. Additional prospective investigations are required to determine the role of NOACs and optimal antithrombotic therapy after suprainguinal bypass.” 

The questioner from the floor who noted some concern over the findings asked whether the study was dealing with equivalent patients. “I’m a little concerned that, if you publish this, you’re probably not comparing apples to apples; you’re going to give the recommendation that patients shouldn’t go on [rivaroxaban], or whatever,” he said. 

In response, Zaidi explained that the message was more “to be discriminating” about “who should get NOACs, [and] who shouldn’t.” 

Rising from the audience to explain further, senior author Robinson said he wanted to add some caveats. “We do know NOACs are being used a lot, and we don’t have a lot of data for their use. You bring up a lot of good points: Certainly, we can’t identify hypercoagulant states. Do we know every anatomic aspect of these patients in the VQI? No … 

“There is a fair bit of data you can control for, and I think using both propensity score matching and pretty aggressive multivariate analysis within that—you can’t do much better shy of a randomized trial is the bottom line. If you look at the randomized trials, we actually don’t have any of that information either.” 

Expanding on where the study might lead, Robinson added, “I do think [this study] adds a little bit, mostly being that it’s hypothesis-generating.” 

Gore completes first-in-human implants of Viafort vascular stent

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Gore completes first-in-human implants of Viafort vascular stent

W. L. Gore today announced the first implants of its investigational Gore Viafort vascular stent as part of a recently initiated pivotal clinical study for the treatment of inferior vena cava (IVC) occlusive disease with or without iliofemoral vein involvement.

The first patient procedures were completed at the Auckland City Hospital in Auckland, New Zealand, by interventional radiologist Andrew Holden, MD.

“Right now, there are limited device options indicated for both IVC and iliofemoral venous disease,” said Holden. “Implanting the Gore Viafort vascular stent in patients represents a significant step forward in research.”

The stent, which has received Breakthrough Device designation from the Food and Drug Administration (FDA), utilizes expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wound nitinol frame. The Investigational Device Exemption (IDE) study is evaluating the device in a treatment range of 10–28mm diameter for iliofemoral veins and the IVC.

The top 10 most popular Vascular Specialist stories of September 2022

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The top 10 most popular Vascular Specialist stories of September 2022

September’s top stories featured news of a trial to evaluate women’s experience of early endovascular aneurysm repair, and of a special women-focused edition of the Annals of Vascular Surgery. A guest commentary on the importance of advocacy in vascular surgery and findings of a Black-White disparity in ruptured abdominal aortic aneurysm repair wait times were also among the most-read articles last month.

1. Aortobifemoral grafting in the endovascular era: An exploration of the open procedure and its merits among ‘good-risk’ patients today

Aortobifemoral grafting for aortoiliac occlusive disease (AIOD) probably remains “very safe” in the era of endovascular repair, according to the senior author behind a new paper exploring optimal approaches to the often burdensome condition.

2. WARRIORS randomized trial aims to examine early EVAR in women

A multinational collaboration of researchers received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for the WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial.

3. No time like the present: The moral imperative for advocacy in vascular surgery

“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the typical reasons. Our patients’ blood pressure wasn’t sky high in pre-op, and our case wasn’t being bumped for the trauma du jour.

4. Annals of Vascular Surgery announces special issue dedicated to original work by women

The Annals of Vascular Surgery peer-review journal has announced an upcoming special issue dedicated to original work by women that is set to be guest edited by Caitlin W. Hicks, MD.

5. Black patients wait more than twice as long as White patients for rAAA repair, VQI analysis finds

Black patients saw significantly delayed care for ruptured abdominal aortic aneurysms (rAAAs), with a Vascular Quality Initiative (VQI) analysis showing a median time from hospital admission to intervention of 168 vs. 78 minutes compared to White patients. 

6. WVS 2022: Study probes who benefits from EVAR among patients with chronic kidney disease

Patients with advanced chronic kidney disease (CKD) represent a high-risk group who may not benefit from elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) under traditional sizing criteria. 

7. PAD: Endovascular revascularization ‘superior or not significantly different’ in terms of outcomes versus open repair

A real-world analysis of peripheral arterial disease (PAD) patients in Canada indicated open revascularization may not offer a long-term benefit over endovascular intervention.

8. Corner Stitch: Audible Bleeding cuts down to vascular core

Many Corner Stitch readers subscribe to Audible Bleeding, the vascular surgery podcast for updates on all things vascular. We were lucky to pick the brains of founders Adam Johnson, MD, and Kevin Kniery, MD. 

9. Society for Vascular Surgery Vascular Quality Initiative celebrates one million procedures

The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry announced it has now collected more than one million procedures in its database.

10. Treating PAD: ‘Run, don’t walk, to sign up for this incredible course’

“This is going to be a great course with experts in the field teaching novel endovascular technologies,” said Leigh Ann O’Banion, MD, one of 18 faculty members for the Society for Vascular Surgery’s Complex Peripheral Vascular Intervention (CPVI) Skills course.

TCAR has ‘tremendous appeal’ as alternative to transfemoral carotid artery stenting

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TCAR has ‘tremendous appeal’ as alternative to transfemoral carotid artery stenting

This video is sponsored by Silk Road Medical.

Richard Powell, MD, from Lebanon, New Hampshire, talks to Vascular Specialist at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM; June 15–18) in Boston about his initial interest in the transcarotid artery revascularization (TCAR) procedure, noting that the benefit of TCAR is that “we are able to access the carotid artery without manipulating the arch” and the “tremendous appeal” of having embolic protection before crossing the lesion.

“Early on we were somewhat conservative with the patients we would offer it [TCAR] to. As time went by we saw the outcomes were good and we started to broaden the patients that we would treat,” says Powell.

The recent decision by the US Food and Drug Administration (FDA) to allow TCAR to be used in standard-risk surgical patients is “very interesting and appealing,” says Powell. For surgeons considering TCAR, Powell notes that the learning curve is “relatively short” and, in his experience, the procedure takes around half the time as that of a standard endarterectomy.

“The future of TCAR is promising,” says Powell, who concludes that the patient populations that should be addressed in the future “are those with low carotid lesions which are close to the clavicle, as well as patients with heavily calcified carotid lesions.”

MVSS 2022: Research on hemodialysis access surgery attracts inaugural Midwestern Vascular disparities award

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MVSS 2022: Research on hemodialysis access surgery attracts inaugural Midwestern Vascular disparities award
Shannon McDonnell wins the MVSS’ inaugural Disparities Research Award at the 2022 annual meeting

The authors behind a new study that found “significant differences” in hemodialysis vascular access outcomes after first-time arteriovenous (AV) fistula or graft creation “directly related” to a patient’s race said the findings speak “to an injustice within the field of vascular surgery.” The research won the Midwestern Vascular Surgical Society’s inaugural MVSS Disparities Research Award at the organization’s 2022 annual meeting in Grand Rapids, Michigan (Sept. 15–17).

The data were presented by Shannon McDonnell, a medical student from Loyola University’s Stritch School of Medicine in Maywood, Illinois, who was mentored by Pegge Halandras, MD, from Loyola University Medical Center. 

The research team carried out a single-institution, retrospective cohort study of 926 patients undergoing AV procedures from 2007 to 2021, capturing subsequent AV creations and maintenance procedures. Of the total pool, 45% identified as White and 37% as Black, McDonnell reported. A total of 494 (53%) patients had no additional procedures, 258 (28%) had one additional procedure, 95 (10%) had two additional procedures, and 78 (9%) had three or more procedures. 

“Black patients have higher frequency of hypertension, COPD [chronic obstructive pulmonary disease], diabetes and anemia,” McDonnell told MVSS 2022. “Just over half of our patients required only the initial fistula or graft placement. Black patients were at a significantly higher risk of having additional AV access surgical procedures, including both maintenance and new creations as compared to their counterparts of other races. Further exploration of these disparities is necessary in order to discover the root of these inequities in care.” 

In acknowledging limitations in the study, McDonnell pointed to race’s frequent association with lower socioeconomic status. “Lower socioeconomic status influences a patient’s utilization of healthcare and can lead to poorer outcomes, and worse-managed chronic conditions,” she said.

McDonnell also pointed to some reasons why patients may only have one procedure at the study team’s institution, such as a patient receiving a kidney transplant or choosing to continue to dialyze through a catheter instead of undergoing another procedure. 

‘Week of Action’ raises awareness of SVS advocacy activities

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‘Week of Action’ raises awareness of SVS  advocacy activities

From sending emails to lawmakers, posting on social media to amplify legislative issues, and donating to the Society for Vascular Surgery Political Action Committee (SVS PAC), SVS members embraced a variety of activities to support the Society’s first-ever Advocacy “Week of Action,” Sept. 26–30. 

“These seemingly simple advocacy activities, when done collaboratively across the SVS membership, help to significantly raise the profile of our issues on Capitol Hill and help to secure legislative victories that will benefit our practices and the patients we serve,” said SVS President Michael C. Dalsing, MD.  

Activities included sending pre-written messages to lawmakers urging action to prevent pending Medicare payment reductions and signing up to become an SVS REACH 535 key contact to strengthen the SVS’ grassroots foundation.

In writing about her own experiences, Megan Tracci, MD, vice-chair of the SVS Advocacy Council said: “Remember that vascular surgeons are not as isolated or powerless as it can sometimes feel—the SVS advocacy effort is stronger than it has ever been. Together we can, and will, make a difference.”

Mark Mattos, MD, co-chair of SVS PAC added the additional sentiment that he participated in all aspects of the “Week of Action.” “I signed up because I want to make a difference for our patients, for my practice, for my partners, and for you my SVS colleagues. I want to make a difference for all of us!”

Learn more about the Society’s advocacy efforts at vascular.org/advocacy.

Regional vascular presidents measure state of specialty

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Regional vascular presidents measure state of specialty
Raghu Motaganahalli and Vincent Rowe speak before MVSS 2022 and WVS 2022, respectively

Vincent Rowe, MD, and Raghu Motaganahalli, MD, delivered Presidential Addresses at the Western Vascular Society (WVS) and the Midwestern Vascular Surgical Society (MVSS) that spelled out ways in which vascular surgery can advance—and thrive.

Rowe has been on the regional vascular meeting circuit this fall delivering invited guest lectures that drill down on the need to focus on the social determinants of health in order to tackle enduring disparities of vascular outcomes, not least of which in the area of peripheral arterial disease (PAD) and amputation, a personal area of professional focus. He spoke before both the MVSS and the New England Society for Vascular Surgery (NESVS) on the topic during September and October, and it also formed a portion of his WVS Presidential Address in Victoria, Canada, as he brought his 2021–22 term as president to a close at the 2022 WVS annual meeting (Sept. 17–20). In all three lectures, Rowe drew on an up-close example of how the artificial lines that bound the sorts of communities impacted by disparities can play out.

“This is the zip we live in, and this is the zip code just below us,” he said of his home in Los Angeles, gesturing toward a slide in which he showed maps of the two zones and how the pair of areas neatly fit together. The street on which he lives, Rowe pointed out, marks the boundary between the two zip codes. “All of sudden,” he said, referring to a recent inquiry he made into home values in the area, he realized a disheveled-appearing property across the street was worth about $100–150 per square foot more than his own. 

“I’m like, ‘Come on, this guy’s house is a dump compared to ours.’ But it doesn’t matter. He’s in the zip code that matters. The school district is different, income level is different, because that zip code goes in a different direction. So I think we have to be careful, because we can’t just categorize it just on zip code. Hopefully we can start to get more data from our patients, and we’ll have those self-reported determinants to be able to understand. They’ll tell us their educational level, they’ll tell us their mean income, and then we can start to understand better how that all impacts our health.”

Pushing the envelope, Rowe raised targeted screening for PAD as a way to get out ahead of eventual treatment like amputation in order to catch communities vulnerable to disparate outcomes at the prevention stage.

Over in Grand Rapids, Michigan, at the MVSS annual meeting (Sept. 15–17), meanwhile, the day after Rowe gave a visiting lecture on disparities in vascular disease management at the Midwestern meeting, MVSS President Raghu Motaganahalli focused his own Presidential Address on the rich fabric of vascular surgery and the contributions made by international medical graduates (IMGs)—a population from which he hails—to vascular surgery practice.

The vascular chief from Indiana University School of Medicine compared the vascular profession to an intricate silk rug from Persia, saying that, like these carpets, “we are knitted” by the many individuals who make up the specialty, each coming in different shapes and forms, and with different beliefs, “but, at the end of the day, our profession is far more rich by having those individuals.”

Motaganahalli cast the position of IMGs and the hurdles they must negotiate in the U.S. healthcare system against the specter of the coming physician—and vascular surgeon—shortages facing the country. “We are only about 4,000 individuals in a population of about 400 million, and our profession doesn’t have much of a leeway, much of a flexibility, to lose individuals,” he told MVSS 2022. “Our profession is clearly at a crossroads when we either accept that portions of our care are relegated to the other professions or specialists, or improve upon our workforce.”

According to American College of Surgeons (ACS) data, observed Motaganahalli, there are about 2,800 IMG surgeons operating in the U.S. Vascular surgery’s share of that number equates to 7%, he said. Of the 4,000 vascular surgeons in the U.S., just 15% are women—”are we happy about this?” Motaganahalli continued. “Each vascular surgeon caters to about 80,000 patients, which underscores the value of each one of you. Compared to several other specialties, this is a profession that caters to a very large volume of patients.” 

While placing a lens over the contributions made by IMGs, Motaganahalli also zeroed in on the position of women vascular surgeons. “I’d like to use this forum to recognize the need to recruit more women into our specialty. As I showed you, 15% of our current workforce are women, but the current trends are increasing, telling us one third of our future workforce will be women. While that is a promising sign, our work is not done yet.”

In the same vein, he raised the importance of recognizing IMGs and “their value to enhance the diversity of our profession,” explaining, “Currently, 17% of our vascular surgery workforce is comprised of international medical graduates.”

The IMG application pipeline is stagnant, with about 14% of current trainees hailing from that demographic, he said. “Clearly, in a timeline where we have a shortage of manpower, I think we need to come up with a better system, or better existing mechanism for us to create some novel pathways to help address the physician shortage.”

From an entirely different angle, Rowe suggested a novel approach to tackle the vascular workforce pipeline problem—and potentially diversify the field. Invoking the example of a kid who parlayed a passion for Gran Turismo on the PlayStation into a career as a racing car driver, he raised the potential of a mobile surgical simulation suite to raise the stakes in sparking interest in vascular surgery. “Why don’t we do something? Why don’t we get this big truck? Say it’s our pipeline to surgery,” Rowe said, showing a slide of a refrigerated semi-trailer. “Why don’t we outfit it—put in a laparoscopic station, put a suturing station, put a robotics station back there? Industry can afford it. They’ll put an endovascular station back there. Then we’ll take this big truck, and we park it wherever we want to.”

The tackling of both the social determinants of vascular health—the focus of Rowe’s address—and the workforce pipeline issues, to which both Rowe and Motaganahalli referred, find common ground in what the outgoing MVSS president called “the diversity bonus,” from a eponymous book by Scott E. Page. “If we truly want to be viable as a professional organization, as a profession itself, we have the duty to protect and strengthen the fabric of our profession,” Motaganahlli implored. “Different kinds of thinkers outperform homogeneous groups on complex tasks,” he said. “You need to have a diverse group of people addressing these tasks so as to have what we call diversity bonuses.”

At the close of his WVS 2022 address, Rowe asked, “Can we improve our vascular team?,” before answering, “I think we can, we have to do it; the time is now, and I think together we can celebrate as a group.”

Slew of regional vascular societies welcome new leaders for 2022–23 

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Slew of regional vascular societies welcome new leaders for 2022–23 
Robert Rhee delivers the EVS 2022 Presidential Address before departing the role

A number of regional vascular societies across the U.S. and Canada introduced their 2022–23 slew of officers during their annual meetings across the fall months.

Among the leaders taking office in the U.S. were Jeffrey Jim, MD, who took over as the Midwestern Vascular Surgical Society (MVSS) president; Peter Faries, MD, who assumed the same role at the head of the Eastern Vascular Society (EVS); Wei Zhou, MD, the new president of the Western Vascular Society (WVS); and Sean Roddy, MD, now the New England Society for Vascular Surgery (NESVS) top office holder. 

In Canada, John Harlock, MD, assumed the reins of the Canadian Society for Vascular Surgery (CSVS) for the next 12 months. 

Taking their leave from the presidential stage for the 2021–22 year were Raghu Motaganahalli, MD, from the MVSS; Robert Rhee, MD, of the EVS; Vincent Rowe, MD, at the WVS; Andres Schanzer, MD, atop NESVS; and Luc Dubois, MD from the CSVS.

CX Aortic Vienna: Onus on industry to meet clinician desire for devices that function, adapt in long term

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CX Aortic Vienna: Onus on industry to meet clinician desire for devices that function, adapt in long term
Left to right: Roger Greenhalgh, Tilo Kölbel and Roberto Chiesa

The need for vascular companies to home in on developing longer-lasting devices—perhaps even ones that adapt over time to match patients’ changing anatomies—was underscored as part of the Juxtarenal session on day two of the CX Aortic Vienna 2022 Digital Edition (Oct. 24–26).

Following a presentation from Michael Stoner, MD, professor of surgery at the University of Rochester in Rochester, New York, who detailed studies showing that device problems over time may instigate endovascular aneurysm repair (EVAR) failures more directly than anatomical factors, Roger Greenhalgh, MD, from London, England, posed the question of whether industry can rise to the challenge of preventing this in the future. “The desire of clinicians is for a device that can change with time as the aorta dilates,” Greenhalgh said.

In addition to devices that can conform to the ways a patient’s body changes throughout their life, devices that can cope with the more long-term expectations being places on them nowadays were also in focus, with Stoner noting that “patients are outliving the original graft designs.” Greenhalgh corroborated this view, praising Stoner for focusing on this topic, as engineers thought the implantable devices they made in the past may only be used for 10 years, but “we now expect [them] to last forever.”

Tilo Kölbel, MD, from Hamburg, Germany, stated that the reality is these devices often end up being repaired via other endovascular approaches, with explants frequently being required due to endoleaks too. This built on another part of Stoner’s presentation in which he identified type 1a, 1b and 3 endoleaks as the most common causes of EVAR failure.

Stoner also detailed the results of in vitro tests involving multiple different companies’ technologies that indicated failures over time were seen across many different devices—further demonstrating that this is consistent “across the board.”

Innovative techniques in focus

Also in day two’s Juxtarenal session, panel discussions following several edited cases highlighted the importance of innovative techniques to achieve success in challenging cases—as seen in a pair of edited cases from Kölbel in which he had to adapt his access approach in two thoracoabdominal aortic aneurysm (TAAA) patients.

In the first, he presented the delivery of a covered bridging stent via transcaval access in a ruptured Type V TAAA—ultimately detailing a “good result”—and, in the second, a thoracic endovascular aneurysm repair (TEVAR) procedure involving a “significantly sick” patient with a symptomatic pseudoaneurysm (TAAA Type II), who underwent transvenous access via the common femoral vein.

The presenter’s approaches to overcoming the challenges seen in emergent “no-access” anatomies drew praise from session anchor Greenhalgh and moderator Roberto Chiesa, MD, from Milan, Italy, for “thinking fast on his feet” to treat very sick patients with a “great, new idea.” Greenhalgh further noted that, while other practitioners may have approached these cases differently, you “cannot make a mistake with these patients” and they would most likely have died if he had not acted “very quickly.”

These talks were preceded by another edited case from Stefano Fazzini, MD, from Rome, Italy, who delivered the practical application of an on-label, chimney endovascular aneurysm repair (ChEVAR)-indicated stent graft in a ruptured abdominal aortic aneurysm (AAA). Among his concluding messages was the fact that ChEVAR is “not an easy procedure.” Responding to a question from Chiesa on managing proximal progression, he said ChEVAR is not “the ultimate” here, and branched endovascular aneurysm repair (BEVAR) may be a useful tool in the surgeon’s armamentarium.

Vascular practice: Financial wellness is focus of Nov. 2 SVS webinar

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Vascular practice: Financial wellness is focus of Nov. 2 SVS webinar

Responding to members’ requests for more information on financial education, a nationally known estate and tax attorney will provide information and guidance on financial wellness at a Society for Vascular Surgery (SVS) webinar on Nov. 2.

The free webinar, “MONIES for the Vascular Surgeon: Managing, Organizing and Navigating Investment choices for Economic Success,” will be held from 7–8:30 p.m., CDT. Registrants will receive materials helpful for financial planning.

Alan Gassman, a board-certified trust and estates lawyer, regularly lectures to medical, legal and accounting groups about financial, tax and estate planning, and creditor protection. His presentation will include financial information for vascular surgeons at all career stages—including residents and fellows—and will cover: 

  • Investment options
  • Unnecessary costs that reduce retirement resources
  • Creditor protection
  • Estate planning
  • Tax consequences
  • Insurance needs 
  • Asset protection

“It is clear that physicians receive very little education in business/finances, despite spending many years in training. Yet vascular surgeons are involved in some of the most sophisticated business models, especially those running their own practices with or without OBL [office-based lab] or ASC [ambulatory surgery center] participation,” said Robert Molnar, MD, chair of the SVS Community Practice Section. “No matter what practice type a surgeon finds himself or herself practicing, this webinar will provide information and tools to help ensure financial wellness.” 

A recent survey of all SVS members showed great interest in learning more about financial wellness, he said. The webinar addresses this need and will cover issues not only for every career stage but also in all practice settings: private practice, single-specialty group, employed, and academic surgeons. 

Gassman has a master’s degree in taxation and an undergraduate degree in business with a concentration in accounting, plus a law degree. He speaks annually at the Mote Vascular Foundation Conference and national symposiums.  

In-person attendees will receive Gassman’s presentation slides plus the books 8 Steps to a Successful Estate Plan, by Gassman, and Grow Your Medical Practice, and Get Your Life Back, which he co-authored with David Finkel and Parikisth Singh, MD.

Learn more and register at: vascular.org/MONIES. Join the SVS Community Practice Section (vascular.org/CommunityPracticeSection) to receive information on future educational opportunities being planned by the section. Email [email protected] for more information.

SVS weighs in on 2023 Medicare payment rules for physicians and hospital outpatient services

SVS weighs in on 2023 Medicare payment rules for physicians and hospital outpatient services

The Society for Vascular Surgery (SVS) has submitted comment letters in response to the proposed rules issued by the Centers for Medicare and Medicaid Services (CMS) on Medicare Physician Fee Schedule (MPFS) and the Medicare Hospital Outpatient Perspective Payment System and Ambulatory Surgical Center Payment System (OPPS). Both proposed rules are for calendar year (CY) 2023. 

Each year CMS announces proposed rules for the MPFS and the OPPS, usually in July, and provides a 60-day comment period when the public can submit input on the proposed rules. After reviewing the comments, CMS issues final rules on the MPFS and OPPS, typically on or around Nov. 1; rules take effect on Jan. 1 of the following calendar year. 

Members of the SVS Coding and Performance and Measures committees review these rules each year and assist in developing the SVS comment letters submitted to CMS. This year’s MPFS and OPPS proposed rules contained several important issues that impact vascular surgeons.

MPFS rule comment letter

In the comments on CY 2023 MPFS proposed rule, SVS members stressed the need for stability in Medicare physician payment. The CMS proposes to reduce the MPFS conversion factor by nearly 4.5%, rebase and revise the Medicare Economic Index (MEI) and move forward with year two of the four-year implementation of the clinical labor pricing update finalized in the CY 2022 MPFS rule. This will result in payment cuts that are unsustainable for vascular surgeons. 

This recurring scenario with the annual MPFS payment rule that necessitates congressional action to mitigate Medicare payment cuts demonstrates that the Medicare physician payment system is broken. Factors that adversely impact the physician payment system are the lack of an annual inflationary update and the statutory budget-neutrality requirements that trigger across-the-board decreases in payment for all physicians when increases are provided for any physician fee schedule service. Updates to the conversion factor have consistently failed to keep up with inflation, in large part due to the fee schedule budget-neutrality requirements as depicted in the chart below. We strongly stated to CMS that “our policy-makers, both within the Administration and in Congress, have a duty to ensure a Medicare system that provides financial stability through a baseline positive annual update reflecting inflation in practice costs, and eliminate, replace or revise budget-neutrality requirements to allow for appropriate changes in spending growth.” 

Percutaneous arteriovenous fistula creation 

We requested that CMS reconsider its rejection of the RUC recommended work Relative Value Units of 7.50 for CPT code 368X1 and 9.60 for 368X2. The CMS proposed work RVUs of 7.20 for CPT code 368X1 and 9.30 for CPT code 368X2 do not accurately reflect the intensity of the physician work associated with these services. We believe the RVS Update Committee (RUC)-recommended values for these codes account for the complexity and intensity of the procedures and are supported through the survey data collected. We urged CMS to accept the RUC-recommended work RVUs of 7.50 for CPT code 368X1 and 9.60 for CPT code 368X2. 

SVS commended CMS for accepting the RUC-recommended increased work values for the hospital inpatient and observation codes. However, we reiterated our strong objection to CMS’ continued refusal to incorporate the 2021 office Evaluation and Management (E/M) visit increases to the visits bundled into global surgery payment. 

CMS requested public comment on strategies to improve the accuracy of payment for the global surgical packages. We expressed strong opposition to the CMS position that physicians are not performing the follow-up care with their patients that is included in the global surgical package. Noting the many flaws of the RAND study, which CMS uses to defend its position that physicians are not seeing patients for follow-up care, we urged CMS to follow the established process of identifying individual codes as potentially misvalued if there is concern with the post-operative visits assigned to a particular service. A blanket approach to address all 010-day and 090-day global surgical packages inappropriately impacts physicians performing surgeries.

Quality Payment Program

In response to several CMS proposed changes to the Quality Payment Program (QPP) Merit-Based Incentive Payment System (MIPS) benchmark and reporting requirements, we raised our continued concerns about increased reporting requirements and how they conflict with CMS’ goals of reducing administrative burden within the MIPS program. Annual program changes increase the administrative burden and complexity of the MIPS program and divert physician time and resources from providing patient care. Physicians who comply with MIPS reporting requirements should be offered a bonus potential for having increased reporting requirements as an incentive to do that work instead of being penalized. We urged CMS to hold harmless all eligible clinicians and groups from a MIPS penalty during the 2023 performance year due to the ongoing circumstances of the COVID-19 pandemic. These flexibilities should be continued until COVID cases are markedly reduced. 

SVS responded to CMS’ request for information (RFI) on the potential development of a quality measure which would assess the percent of patients with diabetes who receive neurologic and vascular assessment of their lower extremities to determine ulcer risk and if they receive a follow-up plan of care. We expressed general support for a new measure related to diabetes control that includes a neurologic and vascular assessment and suggested that including a referral to a specialist would enhance the measure’s effectiveness in reducing diabetes-related lower-extremity amputation. However, we noted such a measure would not be appropriate for specialists who are seeing patients after an ulcer has been identified. This measure would be appropriate for primary care providers at the group level within the same specialty and those treating the patients’ underlying conditions who have frequent contact with the patients.

OPPS rule comment letter

We appreciate that CMS has acknowledged the impact of the recent Supreme Court decision on American Hospital Association v. Becerra, which requires CMS to apply a rate of ASP (average sales price) +6% to drugs and biologicals. We urged CMS to provide as much detail as possible in the final rule related to the conversion factor modifications that will impact HOPPS payments as a result of the revised 340B drug payment policy and provide opportunities for public input regarding how it will conduct retrospective policy changes if such changes are necessary.

In CMS’ comprehensive Ambulatory Payment Classification (APC) methodology, if two J1 services are reported together and meet specific frequency and cost criteria, a complexity adjustment can be applied, thus moving the payment rate to the next highest APC. We requested that CMS allow a complexity adjustment for CPT Code pair 37187 (venous thrombectomy) and 37248 (venous balloon angioplasty) based on frequency and cost data. CMS currently recognizes CPT Code pair 37187 (venous thrombectomy) with 37238 (venous stent) for complexity adjustment consideration. 

In the 2020 OPPS/ASC (ambulatory surgical center) final rule, CMS established a prior authorization process for certain hospital outpatient department (HOPD) services, which is now being applied to vein ablation. We are concerned that CMS continues to misinterpret an increase in the volume of utilization for certain procedures in the HOPD setting as “unnecessary,” when such increases may reflect an appropriate site-of-service shift, a change in practice guidelines, decreases in corresponding/related services or changes in coverage determinations. 

We urged CMS to holistically review data (i.e., site of service, guidelines, coverage determinations, etc.) prior to expanding prior authorization requirements. 

Temporarily office-based

CMS reviewed CY 2021 volume and utilization data for several procedures, including two vascular duplex scan procedures (CPT Codes 93985 and 93986). 

Based on low volume, CMS is proposing to continue to designate these two vascular duplex scan procedures as temporarily office-based for CY 2023. We expressed appreciation for CMS’ proposal to extend the temporary designation for CY2023 to allow for further analysis before determining if it is appropriate to permanently designate them as office-based.

Additionally, SVS opposes CMS’ proposal to change the terminology currently applied to “skin substitutes” to “wound care management products” and encouraged CMS to work with specialty societies and the American Medical Association Current Procedural Terminology (CPT) Editorial Panel to address terminology confusion. 

CMS will review the SVS comment letters along with those submitted by other stakeholders and members of the public and will issue final CY 2023 rules for both the MPFS and the OPPS later this fall. 

Information on the finalized rules will be provided in SVS publications and resources will be available to assist SVS members in understanding and preparing for the implementation of the new Medicare MPFS and OPPS payment policies in the new year.

Read the full letters at vascular.org/FeeSchedule23Comment and vascular.org/HOPPS23Comment.

Trisha Crishock, Megan Marcinko and Jill Rathbun are members of the SVS Washington, D.C., office.

NESVS 2022: Study illustrates relationship between increased distance from medical center and higher treatment costs among complex aortic patients

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NESVS 2022: Study illustrates relationship between increased distance from medical center and higher treatment costs among complex aortic patients
Zach. M. Feldman at NESVS 2022

Research detailing that patients traveling farther for complex aortic surgery have higher procedural costs, postoperative imaging costs, and comprehensive one-year costs was among the new science being presented at the 2022 annual meeting of the New England Society for Vascular Surgery (NESVS) in Newport, Rhode Island (Oct. 14–16). 

Investigators, including first-named author Zach M. Feldman, MD, a vascular surgery resident at Massachusetts General Hospital in Boston, and senior author Mark F. Conrad, MD, drew this conclusion after conducting a retrospective review of all patients in the Vascular Quality Initiative (VQI) and Vascular Implant Surveillance and Interventional Outcomes Network (VISION) databases undergoing complex endovascular aortic repair (EVAR). The paper won the NESVS’ 2022 R. Clement Darling Award.

Between 2011 and 2018, they looked at 8,782 patients, including 4,822 with complex EVARs, 2,672 complex thoracic EVARs (TEVARs), and 1,288 complex open abdominal aortic aneurysm (AAA) repairs. Median travel distance was 22.8 miles, with the research team establishing that patients traveling farther were more likely female and having had prior aortic surgery. 

“These patients should be targeted for increased care coordination for improved outcomes and healthcare system burden,” the researchers concluded.

Elsewhere, a team from the University of Massachusetts Medical School in Worcester led by Andres Schanzer, MD, delivered data on their initial experience with the emerging Fiber Optic RealShape (FORS) imaging technology. The findings were delivered by Eric J. Finnesgard, MD, with the paper achieving the NESVS’ 2022 Deterling Award.

They presented findings from 21 procedures carried out with FORS guidance that were matched to 63 non-FORS procedures. Ninety-five FORS cannulation tasks were attempted (87 visceral target artery, 8 contralateral bifurcated gate), they reported, with technical success achieved in 81 cannulations (85%). Furthermore, 15 (16%) were completed without any fluoroscopy, they add. “Use of FORS guidance was associated with lower median procedural and fluoroscopy times, dose area product, and air kerma.” 

Meanwhile, a team from Beth Israel Deaconess Medical Center in Boston, led by Marc Schermerhorn, MD, demonstrated use of FORS in internal iliac artery navigation in a video presentation.

“Much of the attention garnered by FORS is for use in complex aortic surgery … however, we have found that the FORS system is also particularly useful for navigation of the internal iliac artery,” they noted.

The video showed two examples of internal iliac artery navigation with the FORS wire and catheter. “Specifically, [the cases] demonstrate the ability to employ extreme angles that would either not be possible with conventional fluoroscopy or subject personnel to high radiation doses,” the team added. “These cases also demonstrate the ability to use two different fluoroscopy angles simultaneously.”

Signal-to-noise ratio: Thoughts on fine-tuning feedback during vascular surgery training

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Signal-to-noise ratio: Thoughts on fine-tuning feedback during vascular surgery training
Christopher Audu

I recently took the Registered Physician in Vascular Interpretation (RPVI) exam. While studying for it, one of the concepts that stood out was the signal-to-noise ratio (SNR) in vascular ultrasound, and how it accounted for the quality of images. Don’t worry. I have no intention of putting up the Doppler equation in this month’s write-up. It’s just that for those of us in the trenches of surgical training, this concept of SNR is very relatable. 

No one doubts that the long road to becoming competent, confident and compassionate surgeons requires constant evaluation and re-evaluation during training. At any given time as trainees, however, there are multiple voices in our ear and in our heads. We’ve all gotten that feedback or evaluations that leaves us overwhelmed and/or is contradictory. 

So, how do we begin to decipher what’s important? 

The patient comes first 

Perhaps we should start where any great surgeon starts—with the patient in front of us. There is no greater litmus test about how we’re doing in training than to know that our clinical decisions are providing the right care for the right patient at the right time. Do I have a knowledge or skillset deficit that puts patients at risk of harm? Then, that needs to be remedied. Does an evaluation point out a blindspot that is potentially harmful to patient care? Then that evaluation needs to be taken seriously, and that blindspot fixed. Providing appropriate care for our patients is the most important signal—even if it means that doing so, sometimes, can generate a lot of noise. 

The transducer

The RPVI exam impressed upon me the importance of the transducer properties in improving SNR. In training, this is akin to having the right mentors whose opinion you genuinely respect. We all have surgeons that we’d like to emulate our practice after training. Seek out these people after working with them on various rotations and ask for honest feedback. For me, these surgeons help me determine what’s working and what’s not. 

But if I’m being really honest, sometimes the best feedback comes from the non-surgeons in our professional lives—from the operating room nurses who see our efforts and have direct comparison to how everyone else they have trained has done, to the administrative staff who have access to my CV. I have personally found these people to be some of our strongest allies in helping cross the finish line in training. For the most part, they all want us to genuinely succeed.

And of course, one cannot forget a most important set of people—the loved ones in your personal life. From parents, friends, spouses to kids, these people provide grounding to reality. While they may not always have medical advice to proffer, their evaluation and advice can help us become a more compassionate person—and they are often adept at recognizing burnout before you do. 

Internal reflection

Last, but most importantly, is you and your goals. Introspection is key to goal alignment in training. This gets at the concept of meaningful work. What are your personal and professional goals for training? Sure we all want to become excellent surgeons, but are there nuances unique to you and your situation? Perhaps seeking opportunities that get you to that goal while letting go of ones that are a waste of time, will allow for a more meaningful and fulfilling experience that will translate into more competence and confidence in training. There is no surefire answer here but learning to define appropriate boundaries that align with your ambitions and goals, can be a good place to start.

In training, there are a lot of voices—including your own. This month, as we barrel towards the end of the calendar year, I hope that your SNR remains high so that the image of who you’re becoming as a surgeon remains crisp and aligned with the image of whom you want to become.

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the Vascular Specialist resident/fellow editor.

Prepare to submit research for VAM, VRIC 2023

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Prepare to submit research for VAM, VRIC 2023

The Society for Vascular Surgery (SVS) wants members’ research on vascular disease for the 2023 Vascular Research Initiatives Conference (VRIC) and the 2023 Vascular Annual Meeting (VAM).

VRIC will be held Tuesday, May 10, 2023, at the Boston Marriott Copley Place in Boston. VAM is set for June 14–17, 2023, at the Gaylord National Resort and Convention Center in National Harbor, Maryland, outside Washington, D.C. 

VRIC submissions open Oct. 26. These submissions are coordinated with the American Heart Association’s submission site for the “Vascular Discovery 2023: From Genes to Medicine” conference. That conference will be May 10–12, 2023, in the same location as VRIC. 

The VAM submission site will be open from Wednesday, Nov. 16 through 3 p.m. Central Standard Time Wednesday, Jan. 11, 2023. 

Learn more about VRIC at vascular.org/VRIC23. VAM submission categories and guidelines are expected to be available by mid-October at vascular.org/VAMGuidelines23. Learn more about VAM at vascular.org/VAM.

SVS prepares for important member survey to be held in November

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SVS prepares for important member survey to be held in November

The Society for Vascular Surgery (SVS) will survey members in November to continue to track demographic changes, how members would like the SVS to strengthen its value of membership, and what they consider the most important strategic trends to address in the next three to five years.   

This biennial census survey is focused on key demographic and strategic information, asking respondents about their needs, interests and member satisfaction. Participation is vital to the Society’s commitment to ensure diversity, equity and inclusion, and to provide an opportunity for all to participate. The survey will be held Nov. 2–22. Participation is essential as the SVS Strategic Board prepares for its January 2023 retreat.  

The data collected will help leaders understand how members perceive current member benefits and what potential gaps remain; how they access educational information and information about the Society; what professional issues and trends are most impacting their work; and political advocacy engagement and their perceptions of the Society’s effectiveness in tackling these advocacy issues.

Other questions will provide information on critical strategic priorities members want the SVS to focus on; what drives members to join and stay with the SVS; how members prefer to get information on critical issues; establish their involvement in other vascular societies and where SVS fits within the overall picture from their perspective; education, travel and quality improvement initiatives; as well as programming and how to fund it. Participants also can enter a draw for a chance to win prizes. 

“We want to better understand your professional needs and challenges and your experiences with SVS,” said SVS President Michael Dalsing, MD. “Your feedback is critical to ensure that SVS can best support you and other allied professionals in the vascular field. SVS members helped us to chart our current course and it is time to look to the next three- to five-year horizon.“ 

Participation invitations will be emailed Nov. 2 from Avenue M. Group LLC, an independent market research firm and SVS partner for this survey.

SVS officer elections 2022: A glimpse into the electorate

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SVS officer elections 2022: A glimpse into the electorate
Michael Dalsing

The SVS Executive Board highlights details of the most recent Society for Vascular Surgery (SVS) elections to inform members and further strengthen the process. 

In 2020, Society for Vascular Surgery (SVS) leadership proposed, and SVS members resoundingly approved with a 97.7% majority (170-4), a bylaws change affecting officer elections. The change mandated that the SVS Nominating Committee propose two candidates for each open officer position and that voting be open to all qualified SVS members, regardless of their ability to be present at the Annual Business Meeting (ABM) at the Vascular Annual Meeting (VAM).

While the existing bylaws had permitted the committee to advance a slate of multiple candidates, historically this had been uncommon, with the Nominating Committee more typically advancing just one candidate for each open position and the membership present at the ABM endorsing that selection. SVS leadership proposed the bylaws change to ensure that members would always have a choice in the election of their officers and, therefore, empower them to truly influence the direction of the SVS.   

Demographics at a glance

The second facet of the bylaws change—opening up the election to all qualified SVS members—required a transition to electronic voting. This change permitted 10 times more SVS members to vote than usually attend the ABM, further empowering the membership to shape and direct the SVS. The results of this change were immediately evident as the inaugural internet election in 2020 engaged 482 voters, substantially more than the 250–300 typically present at the ABM. In 2021 and 2022 the number of members that voted grew to 611 and 602 respectively. 

Since internet voting was established in 2020 for that year’s election, the goal has been first to double the number of votes that used to be cast at the in-person ABM at VAM, which averaged 300. This goal has been met with the last two elections engaging 611 and 602 votes, respectively. But aspirations of the SVS Nominating Committee and Executive Board are much higher, with sights set on achieving 1,000 votes amongst eligible voters in the election. Currently, only Active and Senior Members in good standing at the time of the election are eligible to vote. 

The Nominating Committee continues to carry out its crucial charge in identifying, vetting, and advancing highly qualified nominees based on commitment and service to the SVS, time availability, track record of leadership success, strategic vision, and a growing awareness and mindfulness of SVS diversity, equity, and inclusion principles.   

The 2022 election for SVS officers was held May 23–June 3, during which time 602 members cast their votes for vice president, secretary, and several bylaw referendum changes. The election was well publicized, with SVS members receiving 44 reminders and prompts to vote via various media and social media channels, in addition to 39 reminders and posts regarding the candidate Town Hall, during which candidates and issues were announced and introduced. In all, members were sent more than 70 notices and reminders during the week prior and during the 10-day election period.   

The transition to internet voting was initiated to engage every voting eligible member across the country to participate. There are approximately 2,900 eligible voting members in the SVS. Compared to other medical societies that hold internet elections, a 20% voter turnout is considered healthy and above average. The goal of the Nominating Committee and the Executive Board is to achieve at least 1,000 votes, or 33% of eligible voters 

In looking at the pool of 602 voters in the 2022 election, the demographics of the voter pool largely parallel the demographics of the overall voter-eligible SVS membership, although there are some differences. 

With regard to gender, 80% of those who voted identified as male, 18 % female, and 2% undisclosed. This compares to 84%, 11%, and 5% in the overall voter-eligible membership. The percentage of female voters was slightly larger than the voter-eligible SVS membership, 18% vs. 11%; and the percentage of males slightly lower, 80% vs. 84%. 

With regard to age, 28% of voters were 60+ years of age, followed by 27% each for those 51–60 and 41–50, 9% were under 40 years of age. This compares to 42% over 60 in the overall voter-eligible membership, 17% 51–60; 19% 41–50; and 4% 31–40. In general, those who voted were slightly younger than represented in the voter-eligible membership with 36% of the vote from members under age 40, compared to 22% in the voter-eligible membership.  

With regard to geographic location, the population of voters was very close in parallel to the voter-eligible SVS membership, with the South Atlantic at 21% for both voters and voter-eligible membership; Mid-Atlantic nearly identical with 17% and 16%, respectively; East North Central slightly over-sampled with 16% and 13%; New England slightly over-sampled with 10% vs. 7%; the Pacific slightly under-sampled with 13% vs. 14%; and West South Central identical with 8%. 

Lastly, with regard to ethnicity, it is difficult to make comparisons as the percentages of members who identify as minorities underrepresented in medicine (URiM) are small. Overall, the percentage of voters who represent as non-Caucasian ethnicities appears slightly higher than in the voter-eligible membership, 29% vs. 25%, but this may be due to more non-Caucasian members identifying as a different ethnicity compared to the voter-eligible membership profile.  

The transition to open internet elections in the SVS is going into its third full-year. The work of the  Nominating Committee is challenging because the SVS is blessed with an abundance of qualified nominees, and it is likely that due to the high quality of candidates, elections will be predictably close, so every vote matters. “It takes your vote to shape the Society you want to see into the future,” noted SVS President Michael Dalsing, MD. The SVS Executive Board and Nominating Committee are currently deliberating further improvements to broaden diversity and choice in candidates, and increase member engagement in the election. If you have comments, email [email protected].

Only a few seats remain for CPVI hands-on skills course

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Only a few seats remain for CPVI hands-on skills course

Only a few spots remain available for the Society for Vascular Surgery’s new Complex Peripheral Vascular Intervention (CPVI) Skills Course. Today—Thursday, Oct. 20—is the final day to register.

The interactive course will be held Oct. 23 and 24 at the OLC Education and Conference Center in Rosemont, Illinois. It will include both case-based and hands-on learning; participants will be able to practice the latest procedures on cadavers and benchtop models during small-group simulations.

Case directors are Patrick Geraghty, MD, Vikram Kashyap, MD, and Daniel McDevitt, MD. The three have assembled what they call an all-star faculty of 19 renowned surgeons well-versed in interventions for peripheral arterial disease (PAD).

Treating patients with PAD is the largest clinical area for vascular surgeons in the United States, said Kashyap. “Surgeons need to become familiar with the latest treatments and technology so they can provide the best patient care possible,” he said.

The course, he said, was designed by vascular surgeons for vascular surgeons. It will include a demonstration of a percutaneous deep vein arterialization system, currently under evaluation.

Learn more and register at vascular.org/CPVI.

Why 25 years of patient-centered innovation really matters

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Why 25 years of patient-centered innovation really matters
Pre-implant and four-year follow-up showing aortoiliac aneurysms treated with bilateral iliac branch devices

This advertorial is sponsored by Gore.

One mainstay endovascular aneurysm repair (EVAR) device is celebrating not just a quarter century of being commercially available, but the innovation it has inspired along the way. Michel Makaroun, MD, and Willy Davison, PhD, discuss the evolution and innovation of the GORE® EXCLUDER® device family over time. 

Twenty-five years of patient impact and durability is worth celebrating in the life of any medical device. And when a device reaches this milestone, it is celebrating more than just 25 years in the treatment landscape. It is a legacy of making a difference for physicians and their patients. 

The GORE® EXCLUDER® AAA Endoprosthesis for abdominal aortic aneurysm (AAA) is commemorating 25 years of commercial availability since earning its CE mark in September 1997. It has been used to treat more than 440,000 patients worldwide* and has become the most-studied EVAR device according to company-sponsored trials and registries shown on ClinicalTrials.gov for currently available stent grafts. 

EXCLUDER® device design features a nitinol stent, sutureless stent-to-graft attachment and proprietary ePTFE film layers

“The EXCLUDER® AAA Endoprosthesis has been on the market helping patients for well over two decades: A truly remarkable accomplishment and the longest stretch in the industry,” said Makaroun, chief of the Division of Vascular Surgery at the University of Pittsburgh Medical Center and an investigator in each EXCLUDER® device clinical study. 

“The close collaboration between medical community and manufacturer has allowed for numerous innovations and improvements along the way, providing for more accurate deployment and better outcomes.” 

“As EVAR became more prevalent and additional patient needs were uncovered, it was important that W. L. Gore & Associates—the global materials science company behind the device—continue exploring and improving EVAR solutions,” said Davison, Abdominal Aortic Global Business leader at Gore. 

“We recognized the broader potential of the device but knew that there was still a need to keep improving, keep innovating, to help address even more patients’ unique needs and anatomies.” 

Over the next two decades, Gore developed and studied additional solutions within its EVAR portfolio, receiving approvals for larger trunk and contralateral limb diameters, an iliac branch device, and a next generation of the EXCLUDER® device that is conformable and offers optional angulation control—allowing physicians more treatment options to consider for their patient’s anatomy. 

For more information on the GORE® EXCLUDER® AAA Endoprosthesis and the GORE® EXCLUDER® device family, scan the above QR code

Davison said that at Gore, collaboration with the medical community is key to developing solutions that continue to advance patient care. “We are immensely grateful to the physicians who have put their trust in our devices to help their patients maintain their quality of life and those who have partnered with us as we continue exploring future solutions for AAA patients,” he said. 

*Based on the number of trunk-ipsilateral legs distributed. 

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. Please see accompanying prescribing information in this journal. Products listed may not be available in all markets. GORE, Together, improving life, EXCLUDER and designs are trademarks of W. L. Gore & Associates. ©2022 W. L. Gore & Associates, Inc. 

EVS 2022: Study suggests lower rates of aortic rupture, mortality after TEVAR for uncomplicated TBAD in subacute phase compared to medical management

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EVS 2022: Study suggests lower rates of aortic rupture, mortality after TEVAR for uncomplicated TBAD in subacute phase compared to medical management
Matthew Muller presents at EVS 2022

Thoracic endovascular aortic repair (TEVAR) carried out for uncomplicated type B aortic dissections (TBAD) saw worse mortality and aortic-related outcomes when performed in the acute phase compared to those treated in the subacute phase and those managed medically.

That was the chief conclusion of an investigation of TEVAR timing presented at the 2022 Eastern Vascular Society (EVS) annual meeting in Philadelphia (Sept. 29–Oct. 1) by Matthew Muller and colleagues from Albert Einstein College of Medicine in New York City.

Patients with acute uncomplicated TBAD between 2007 and 2019 were identified using the TriNetX Analytics Network, a federated network of nationwide healthcare organizations that provides de-identified patient data.

The study looked at 17,018 patients with TBAD, with 918 (5.4%) undergoing acute TEVAR, 328 (1.9%) subacute, and 15,772 (92.7%) being treated nonoperatively.

After 1:1 propensity matching, the research team found that the acute TEVAR group had higher rates of endovascular reintervention (7.76% vs. 1.09%; p<0.001) and aortic rupture at 30 days (3.93% vs. 1.09%; p<0.001) and three years (9.51% vs. 3.93%; p<0.001), when compared to medical management. The subacute group had significantly higher rates of endovascular intervention at three years when compared to medical management (9.17% vs. 3.06%; p=0.001). The rate of aortic rupture at three years was significantly higher in the acute TEVAR group compared to the subacute TEVAR group (10.2% vs. 3.51%; p=0.001). There were no significant differences in 30-day and three-year mortality rates, or three-year rates of open reintervention, between the three groups.

Muller told the EVS gathering that the acute TEVAR group was found to have higher rates of mortality compared to both the medical management and subacute TEVAR groups but this finding was not found to be statistically significant. Additionally, the subacute TEVAR group had lower three-year mortality rates compared to the medical management group, but this, too, was not found to be statistically significant.

“Our data shows that when TEVAR is performed in the subacute phase, there are lower rates of aortic rupture and mortality compared to medical management,” Muller concluded in his EVS 2022 presentation. “These are similar findings to previously discussed studies looking at the timing of TEVAR with regards to both complicated and uncomplicated type B aortic dissections.”

Mortality drops for acute type A aortic dissection, still high for patients not receiving surgery

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Mortality drops for acute type A aortic dissection, still high for patients not receiving surgery

The chance of a patient surviving after an acute type A aortic dissection has improved significantly, but mortality remains high if not recognized early and repaired surgically. This is according to new research from a team at Michigan Medicine at the University of Michigan in Ann Arbor, Michigan.

A team of researchers examined early mortality rates for over 5,600 patients admitted to the hospital and examined hourly with acute type A aortic dissection between 1996 and 2018 from the International Registry for Acute Aortic Dissection (IRAD).

Findings published in JAMA Cardiology reveal that 5.8% of patients with acute type A aortic dissection died within the first two days after hospital arrival, a mortality rate of 0.12% per hour. The rate is significantly lower than that reported in the 1950s, which estimated that 37% of patients died within the first 48 hours, with an increasing mortality rate of 1–2% per hour.

“We believe that advances in diagnosis and management, especially a focus on early surgical repair, may have contributed in part to these improvements in mortality for acute aortic dissection,” said Kim Eagle, MD, senior author of the paper and director of the University of Michigan Health Frankel Cardiovascular Center.

Of all the patients, 91% either received surgery or were intended for surgery, with the others managed medically due to advanced age and complications, such as stroke and kidney failure. Nearly 24% of those receiving medical treatment alone died within two days, compared to 4.4% of patients treated with surgical repair—a death rate more than 5 times higher.

“Patients who were managed medically were likely not surgical candidates due to their comorbidities,” said Bo Yang, a professor of cardiothoracic surgery at University of Michigan Medical School, in a press release announcing the results of the study. Yang was not involved in the study, the release notes. “The medically managed patients could die from aortic dissection-associated complications—such as malperfusion, cardiac tamponade, aortic rupture and acute aortic insufficiency, which can be treated with surgery—or from their existing medical conditions which could be worsened by the aortic dissection.”

Only 1% of patients deemed suitable for surgery died before the procedure. These patients died after an average of nearly nine hours from being admitted to the hospital, exceeding the six-hour median time to surgery for all patients.

Interhospital transfer is needed in more than 70% of aortic dissection cases, causing inherent delays. Before this study, Eagle says, it was thought that early death from this condition was so prohibitive that operating urgently, even in hospitals with limited volume of aortic dissection surgery and resources, was the preferred strategy.

However, there is evidence that surgery at a low-volume hospital can double the risk of dying while undergoing repair compared to the highest volume providers. Additionally, mortality rates for open repair of acute type A aortic dissection are nearly three times higher when the operation is not performed by a dedicated aortic surgeon.

“Hospital mortality at a high-volume center like U-M [University of Michigan], where aortic dissection patients are taken care only by highly experienced aortic surgeons, can be as low as 5%, while the same patient operated on at a low-volume center may be 20% or higher,” Eagle said. “With this new information, it is clear that the ‘cost’, or risk, of a four-to-six-hour delay caused by transfers is more than offset by the lower risk of surgery at experienced hospitals.”

Cases are rare. Approximately three in 100,000 people suffer aortic dissection each year. The condition most commonly affects older men, and a person experiencing the tear may feel a “knifelike, tearing pain through the back,” according to IRAD.

It is estimated that up to 50% of patients will die before ever reaching the hospital, making the overall mortality for aortic dissection substantially higher, the press release from Michigan Medicine notes.

“There is a need to identify the high-risk population of aortic dissection, such as those with a family history of aortic aneurysm and dissection, especially at a younger age, or known pathogenic genetic variants, so that we can replace the proximal aorta electively to prevent acute type A aortic dissection,” Yang said. “For young people under 55 years old with severe chest pain, we have to prove if patients have aortic dissection or otherwise.”

ABRE clinical study 36-month data show ‘long-term durability’ of venous stent system

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ABRE clinical study 36-month data show ‘long-term durability’ of venous stent system
Abre venous stent

Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the company’s Abre venous self-expanding stent system, intended for the treatment of symptomatic iliofemoral venous outflow obstruction.

The study results were presented in a late-breaking clinical trial session at the American Vein and Lymphatic Society (AVLS) 2022 annual meeting (Oct. 13–16) in New Orleans. Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England, co-principal investigator for the ABRE study, presented the data.

“The 36-month ABRE data have continued to demonstrate the long-term durability of interventions in patients suffering from deep venous disease,” Black said. “The results show a sustained result in both technical aspects, but more importantly, in patient outcomes.”

The ABRE study included a complex set of patients. Within this patient group:

  • 47.5% of patients were categorized as having post-thrombotic syndrome (PTS)
  • 35.8% of PTS patients presented with a complete venous occlusion confirmed by the core lab
  • Mean lesion length of patients was 112.4mm
  • 44% of patients had stents that extended below the inguinal ligament

Of note, the study results showed:

  • Overall, effectiveness following treatment with the Abre venous stent was sustained through 36 months as evidenced by a Kaplan-Meier estimated primary patency rate of 81.6% and a Kaplan-Meier estimated freedom from clinically driven target lesion revascularization (CD-TLR) rate of 89.3%
  • No stent fractures or delayed stent migrations were reported through 36 months
  • Sustained and clinically meaningful improvements were observed through 36 months compared to baseline as measured by EQ-5D and VEINES-QoL quality of life
  • Sustained and clinically meaningful improvements through 36 months as measured by Villalta and VCSS venous functional assessments indicates less severity of PTS disease and venous disease overall

Vascular Specialist–October 2022

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Vascular Specialist–October 2022

In this issue:

  • Regional vascular society presidents measure state of specialty (p. 1 and 4)
  • Study: Combined antiplatelet, NOAC use linked to worse limb outcomes after suprainguinal bypass (p.1 and 20)
  • From the editor: Malachi Sheahan III, MD, takes aim at the NRA (p. 2 and 6)
  • SVS Executive Board: A demographic breakdown of voting in the SVS officer elections (p. 8–9)
  • Inaugural award: Midwestern Vascular Vascular Surgical Society (MVSS) initiates new prize for disparities research (p. 10)
  • New England Society for Vascular Surgery (NESVS): Stéphan Haulon, MD, discusses future of aortic arch technology in New England lecture (p. 26)

 

Six-month data from SWING below-the-knee, first-in-human trial presented at AMP Europe

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Six-month data from SWING below-the-knee, first-in-human trial presented at AMP Europe

Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention Symposium (AMP) held Oct. 9–11 in Lugano, Switzerland.

The SWING study is a prospective, multicenter, single-arm feasibility study to evaluate the safety and performance of the Sundance sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

The study’s primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major reintervention was reported among the 35 trial subjects, a Surmodics press release reports. Data for the primary efficacy endpoint show a late lumen loss (LLL) of 1mm (±0.79mm) across 35 lesions at six months, indicating that the large luminal gain achieved immediately after the procedure was sustained six months post-treatment.

“At six months we observed a consistent improvement in Rutherford category and functional measures, as well as an excellent primary patency of 88.5%, which compares favorably to other DCBs used in the infrapopliteal circulation,” said SWING trial co-lead investigator Ramon Varcoe, MD, a vascular surgeon at the Prince of Wales Hospital and associate professor of vascular surgery at the University of New South Wales in Sydney, Australia.

The SWING trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter (RVD) of 2mm to 4mm, and a total lesion length of ≤230mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and multiple locations in Europe. They will be followed for 36 months following the index procedure.

“The novel coating on the Sundance sirolimus DCB was evaluated in a challenging, predominantly CLTI [chronic limb-threatening ischemia] population with a high proportion of diabetes and moderate-severe calcification,” said trial co-lead investigator Andrew Holden, MD, director of interventional radiology at the University of Auckland in Auckland, New Zealand. “This first-in-human study demonstrates that the Sundance sirolimus DCB could be a safe and promising treatment for occlusive disease of the infrapopliteal arteries.”

The Sundance sirolimus DCB utilizes a “next-generation” coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, which, according to Surmodics, enhances sirolimus delivery and sustains therapeutic levels in the artery.

In a press release, Surmodics notes that sirolimus is a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. “The delivery of sirolimus to the vessel wall during mechanical dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis,” the company adds. Surmodics advises that the Sundance sirolimus DCB is not available for sale anywhere in the world, and currently is for investigational use only.

Interacting with EMR best practice advisory ‘significantly’ improves AAA screening rates

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Interacting with EMR best practice advisory ‘significantly’ improves AAA screening rates

Positively interacting with best practice advisory notifications is correlated with an increased rate of abdominal aortic aneurysm (AAA) screening, according to an analysis of all patients who triggered these communications alerts in an electronic medical record (EMR) system at a single tertiary medical center.

Nearly 1,300 patients triggered a notification over the three-year study period of the investigation carried out by a team of researchers from St. Louis University in St. Louis, Missouri, led by first-named author Amin Mohamed Ahmed, MD, a vascular surgery fellow at the institution, and senior author Matthew Smeds, MD, professor of surgery.

Presenting the data at the Midwestern Vascular Surgical Society (MVSS) annual meeting in Grand Rapids, Michigan (Sept 15–17), the investigators found that providers interacted with—rather than dismissed—the alerts in 20.4% of patients. The overall screening rate in the cohort was 28.2%. “Interacting with the best practice advisory significantly increased the odds of being appropriately screened for a AAA [odds ratio (OR) 2.48)],” they reported.

Registry data highlight long-term trends in hemodialysis access profile of failed kidney transplant patients

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New findings, recently published in the Journal of Vascular Access (JVA), provide insight into the hemodialysis access profile of failed kidney transplant patients treated in the Catalonia region of Spain over an 18-year period. 

Researchers Ramon Roca-Tey, MD, a senior consultant in nephrology from Hospital Universitari Mollet in Barcelona, Spain, and colleagues note that data on vascular access use in failed kidney transplant patients returning to hemodialysis are limited. In the present study, therefore, the investigators sought to analyze the vascular access profile of this patient group, the factors associated with the likelihood of hemodialysis reinitiation through an arteriovenous fistula (AVF), and the effect of vascular access in use at the time of kidney transplant on kidney graft outcomes. 

In their report, Roca-Tey et al write that they examined data from the Catalan Renal Registry on failed kidney transplant patients restarting hemodialysis and incidence hemodialysis patients with native kidney failure over the period from 1998–2016. 

The authors report in JVA that the vascular access profile of 675 failed kidney transplant patients at hemodialysis reinitiation compared with that before kidney transplant, and with 16,731 incident patients starting hemodialysis was 79.3% vs. 88.6% and 46.2% (p=0.001 and p<0.001) for AVF; 4.4% vs. 2.6% and 1.1% (p=0.08 and p<0.001) for arteriovenous graft (AVG); 12.4% vs. 5.5% and 18% (p=0.001 and p<0.001) for tunneled central catheter; and 3.9% vs. 3.3% and 34.7% (p=0.56 and p<0.001) for non-tunneled catheter. In addition, they reveal that the likelihood of hemodialysis reinitiation by AVF was significantly lower in patients with cardiovascular disease, a kidney transplant duration of more than five years, those dialyzed through AVG or tunneled central catheter before kidney transplant, and those of the female sex. 

The authors add that analysis of Kaplan-Meier curves showed a greater kidney graft survival in patients dialyzed through arteriovenous access than in patients using catheters just before kidney transplantation. Finally, Cox regression analysis showed that patients on hemodialysis through arteriovenous access at the time of kidney transplantation had lower probability of kidney graft loss compared to those with catheters, Roca-Tey and colleagues write. 

The authors conclude that the vascular access profile of failed kidney transplant patients returning to hemodialysis and incident patients starting hemodialysis was different. They also note that, compared to before a kidney transplant, the proportion of failed kidney transplant patients restarting hemodialysis with an AVF decreased significantly at the expense of a tunneled central catheter, and that patients on hemodialysis through arteriovenous access at the time of a kidney transplant showed greater kidney graft survival compared with those using a catheter. 

According to the researchers, there are two clinical implications that can be derived from their findings. “To reduce the proportion of failed kidney transplant patients returning to hemodialysis with a central line, better vascular access management is needed,” they state, outlining the first implication. The second implication, Roca-Tey et al believe, arises from the impact of arteriovenous access on kidney graft outcomes. They elaborate: “If our results are confirmed in further studies, including a larger number of kidney transplant patients and not simply patients returning to hemodialysis, routine arteriovenous access closure after a successful kidney transplantation should not be performed.” 

In the discussion of their data, the authors state that a number of factors limit the strength of their findings. They highlight the use of a population registry database for this study as a key weakness, for example. “The variables used are restricted in number and can have low clinical specificity,” they note, giving the example that the number of litigated accesses, as well as those with spontaneous thrombosis and not salvaged, were not recorded. Furthermore, the researchers acknowledge a weakness pertaining to the effect of vascular access on kidney graft survival—a secondary aim of the study. They write: “Kidney transplant patients who returned to hemodialysis were considered instead of all kidney transplant patients, and this may be a bias in our study.”

Vascular surgeons step up for PAD awareness campaign in September

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Vascular surgeons step up for PAD awareness campaign in September

Walking is instrumental to keeping the 60,000 miles of blood vessels in the human body healthy—especially for patients with peripheral arterial disease (PAD). That is why throughout the month of September, also known as PAD Awareness Month, the Society for Vascular Surgery (SVS) Public and Professional Outreach (PPO) Subcommittee and the SVS Foundation brought life to a new campaign—the Vascular Health Step Challenge.

Throughout the campaign, SVS members, patients and members of the general public were challenged to walk 60 miles while working toward a collective fundraising goal of $60,000. The funds raised throughout the campaign will support the SVS Foundation in amplifying the importance of vascular health while promoting healthy vascular health habits in communities across the country.

Over 400 walkers rose to the occasion, logging over 35,000 miles throughout September. A total of 880 individuals donated to the campaign, and together they raised more than $80,000.

Individuals were welcome to create or join teams, or to participate individually. Many participants joined teams with their professional colleagues, families and peers; and some institutions hosted a walking event.

“Walking is such an integral part of a healthy life for each of us, patient and healthcare professional alike,” says Benjamin Pearce, MD, who chairs the SVS PPO Subcommittee. “I think it is incredible the range of disease processes impacted positively by walking—heart disease, stroke, abdominal aortic aneurysm and venous reflux to name several. But even more amazing is that walking can be a therapeutic agent for our patients with PAD and may be the only intervention they need to improve their life.

“Each of the participants—donors and walkers—in the first annual Vascular Health Challenge has rallied behind our patients to get the word out about walking and PAD and provide much needed assistance to our patients. We can’t wait to walk and raise even more next year!”

The SVS Foundation plans to host the Vascular Health Step Challenge again next September and encourages all SVS members to get involved. For more information, contact [email protected].

The SVS and the SVS Foundation extended “the sincerest message of thanks” to the campaign’s presenting sponsor, Advanced Oxygen Therapy Inc., Globetrotter level sponsor Abbott and Explorer level sponsor Peripheral Vascular Associates.

Roundtable for treating CLTI: GLASS will make it clear

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Roundtable for treating CLTI: GLASS will make it clear

The final of three roundtables on treating Chronic Limb-threatening Ischemia (CLTI) will cover the Global Limb Anatomic Staging System—GLASS.

The virtual roundtable, on GLASS staging and treatment outcomes, will be held from 6 to 7:30 p.m. CDT Monday, Oct. 10. Register at vascular.org/CLTIRoundtable3. “Revascularization” is part of “Translating Guidelines into Practice: Global Vascular Guideline (GVG) on the Management of Patients with CLTI.”

Michael Conte, MD, a lead GVG editor, will moderate this session. Speakers will include Leigh Ann O’Banion, MD, Patrick Geraghty, MD, Marc Schermerhorn, MD, and Peter A. Schneider, MD.

Participants should download the SVS Interactive Practice Guidelines (iPG) app from either the (Apple) App or Google Play stores.

GLASS involves defining a preferred target artery path, and then estimating limb-based patency, with three resultant stages of complexity for intervention. GLASS was proposed as part of the development of the Global Vascular Guidelines for patients with CLTI.

“We will be focusing on every-day clinical decision-making around revascularization options,” said Conte, including delving into assessing the anatomic complexity of disease and use of GLASS scheme and calculator in addition to surgical candidacy overall. The session will help expand physicians’ knowledge base and improve clinical confidence and effectiveness in treating CLTI patients.

It will cover GLASS plus its current limitations and the growing impact of pedal artery disease in clinical practice. Finally, panelists will address the latest data on the risks and benefits of drug elution in the CLTI population.

Throughout the roundtables, speakers have used a single sample patient to design treatment strategies and demonstrate how to apply the recommendations from the GVG into practice.

Conte will first provide an introduction and overview for the focus of this session. Other topics and speakers include:

A short survey will be conducted before and after the session, and follow-up survey will follow 60 days later to gauge and evaluate if guidelines were easy to translate into daily clinical practice. Participants will receive the clinical practice guidelines, implementation tools consisting of guideline pocket guides, and link to the app to ensure practicality in aiding participants in improving their clinical practice.

Conte pointed out these three webinars are important to present now, with trial results on treating CLTI patients due to be published in the coming months. The BEST-CLI trial is investigating open and endovascular options while BASIL 2 and 3 (Balloon versus stenting in severe ischemia of the leg) looks into the use of different kinds of stenting, including plain balloon angioplasty and the use of drug-coated balloons and drug-eluting stents.

Learn more about the roundtable and register at vascular.org/CLTIRoundtable3.

Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in US

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Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in US

The Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device—used to treat aortic arch disease—under the inpatient prospective payment system (IPPS).

The add-on payment is effective in CMS’ FY23 fiscal year, starting on Oct. 1, has been assigned the maximum new technology add-on payment—65% of the average cost of the technology, for a case involving the use of the Thoraflex Hybrid device. The Thoraflex Hybrid received CE mark approval in 2012, with more than 13,000 devices sold commercially around the world over the past 10 years.

Thoraflex Hybrid is the first of its kind device used in frozen elephant trunk (FET) repair in the U.S., according to Terumo Aortic. It was granted Breakthrough Device designation by the Food and Drug Administration (FDA) in 2020 followed by FDA approval for commercial sale in the USA earlier this year. This hybrid device allows patients with suitably limited disease to be treated in a single stage procedure rather than two procedures which has previously been the conventional pathway in the U.S. for this group of patients.

The add-on payment will allow hospitals to be reimbursed for the incremental costs relating to the implantation of the Thoraflex Hybrid FET device to support the treatment of patients with complex aortic arch disease—this is in addition to the diagnosis related group (DRG) reimbursement.

FLASH results demonstrate ‘excellent safety profile’ of the FlowTriever system in full US cohort

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FLASH results demonstrate ‘excellent safety profile’ of the FlowTriever system in full US cohort
Catalin Toma

Results of the FLASH registry demonstrate the “excellent safety profile” of the FlowTriever system (Inari Medical) in 800 real-world patients.

This is according to Catalin Toma, MD, from the University of Pittsburgh Medical Center, Pittsburgh, who presented outcomes for the full U.S. cohort of FLASH at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT; Sept. 16–19) in Boston. 

The results were simultaneously published in EuroIntervention. Toma reported a 1.4% major bleeding rate and 0.4% rate of other major adverse events (MAEs) in what the presenter described as the largest prospective interventional study in pulmonary embolism (PE).

All-cause mortality was <1% at the 30-day visit in this real-world population with prevalent baseline predictors of mortality, the presenter added, noting also that hemodynamics improved on-table, acute vitals and right ventricular (RV) strain normalized, and clinical recovery continued through six months.

The presenter noted that acute all-cause mortality following PE has remained high (>10%) over two decades. 

New study indicates cost-effectiveness of Denali IVC filter over Option device

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New study indicates cost-effectiveness of Denali IVC filter over Option device
Jasmine Bhinder

Tilting or hooking occurred significantly less often in the process of retrieving the Denali inferior vena cava (IVC) filter than with the Option IVC device, a retrospective review at a tertiary care center has established. 

The research team behind the analysis—which was designed to compare outcomes and costs of IVC filter retrieval when using the two most commonly deployed devices for the procedure—showed that use of the Denali filter resulted in lower retrieval costs owing to shorter procedure and fluoroscopic times, “offsetting the initial [higher] expense of the filter.” 

Jasmine Bhinder, MD, and colleagues University at Buffalo in Buffalo, New York, were delivering the findings at the Eastern Vascular Society (EVS) annual meeting in Philadelphia (Sept. 29–Oct. 1). 

Bhinder et al looked at all patients who underwent IVC filter retrieval or attempted retrieval at the university-affiliated medical center over a five-year period across demographics, comorbidities, filter brand, procedural data, retrieval cost and complications. 

Retrieval was attempted in 57 Denali and 44 Option IVC filters, with secondary procedures attempted in none of the Denali cases vs. 4.5% of the Option deployments (p=0.44), the research team reports. 

They further find that Denali filters “were less likely to have significant tilt of greater than 5° [14.0% vs. 38.6%] or have the hook embedded in the IVC wall [0% vs. 11.4%; p< 0.001].” Device fracture (1.8% vs. 0%) was similar (p=0.38), Bhinder and colleagues demonstrate. Months to retrieval was 12.4 for Denali vs. 11.2 for Option (p=0.75). The Bard retrieval device was used in 89.5% of Denali and 71.7% of Option cases (p =0.09). 

Additionally, the Denali was more likely to be successfully retrieved on first attempt (94.7% vs. 79.5%; p =0.019), with similar overall success following secondary attempts (94.7% vs. 81.8%; p=0.056), they show. Need for adjunctive procedures was similar (0% vs. 8.7%; p=0.08), as were procedure-related complications (0% vs 4.3%; p=0.08), the team adds. The Denali device also had shorter fluoroscopy time (7.4 minutes vs. 22.2 minutes; p=0.001), procedural time (32.0 minutes vs. 60.7 minutes; p<0.001), total hospital costs ($3,154 vs. $5,245; p<0.001), and procedure costs ($1,333 vs. $1,985; p<0.001). 

When secondary retrieval attempts were included, hospital costs—distributed across all Option retrievals—increased to $5,981 and procedural costs to $2,098, Bhinder et al reveal. The average price of the Denali filter is $1,675 vs. $850 for the Option, they note. 

“Although the price of the Denali IVC filter is nearly double that of Option, tilting or hooking occurred significantly less often with Denali,” the researchers concluded. “These factors, which make retrieval more difficult, resulted in shorter procedure and fluoroscopic times with [the] Denali and, ultimately, in lower retrieval costs, offsetting the initial expense of the filter.”

VEITHsymposium to include world federation session

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VEITHsymposium to include world federation session

The World Federation of Vascular Societies (WFVS) is set to hold a session in November during the VEITHsymposium in New York City. The 90-minute session will be held from 5 to 6:30 p.m. Eastern Standard Time, on Friday, Nov. 18, at the VEITH host site, the New York Hilton Midtown, 1335 Avenue of the Americas, NYC. 

The WFVS includes member societies of federated national and affiliate member vascular societies. Its aim is to improve the quality of care of vascular patients worldwide by providing a forum for the international exchange of scientific and educational knowledge related to the diagnosis, treatment and prevention of vascular diseases. 

The session will include presentations from across the globe reflecting each society’s contribution to the WFVS educational mission. A 20-minute discussion period will follow the 11 talks. 

Topics will include a presentation on a global program to advance vascular surgery in low-and middle-income countries, the huge international variation in carotid surgery, infected abdominal aortic and common iliac artery aneurysms, frozen elephant trunk, abdominal aortic and iliac artery aneurysms, repair in vascular Ehlers-Danlos Syndrome, and a national Japanese study of surgical treatment for popliteal artery entrapment syndrome in the Far East country. 

Also being covered will be whether primary open bypass treatment is better for diabetic patients with chronic limb-threatening ischemia (CLTI) and substantial foot necrosis; the failure of single-stage brachiobasilic arteriovenous fistula; barriers to vascular care for CLTI patients; whether the 2019 Global Vascular Guidelines on CLTI already needs a significant update; and guideline and aortic changes after thoracic endovascular aortic repair (TEVAR) for acute aortic dissection. 

The WFVS, Society for Vascular Surgery (SVS) and the European Society for Vascular Surgery (ESVS) all collaborated on the Global Vascular Guidelines. Philippe Kolh, MD, who will give the presentation on a possible update, was the ESVS editor for the guidelines. 

WFVS member societies include the SVS, ESVS, the Japanese Society for Vascular Surgery, the Vascular Society of Southern Africa, the Vascular Society of India, the Australian and New Zealand Society for Vascular Surgery, the Asian Society for Vascular Surgery and the Latin American Association for Vascular Surgery. 

Registration is included with the VEITHSymposium fee (visit www.veithsymposium.org). Learn more about WFVS at www.worldfvs.org. Contact the society at [email protected].

Trainees step up to learn coding, reimbursement

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Trainees step up to learn coding, reimbursement

The Society for Vascular Surgery’s (SVS) efforts in coding and reimbursement work have taken another step forward, with four new doctors now in training to learn the ins and outs of the entire process. 

The SVS has a long tradition of advocacy training under leaders such as David Han, MD, Sunita Srivastava, MD, and Matthew Sideman, MD, plus Robert Zwolak, MD, in creating procedural codes, descriptions of work and relative value (RVU) recommendations. These leaders help guide appropriate reimbursement of vascular surgeons’ work and practice expenses.

The SVS actively trains future leaders in the physician payment system or Resource-Based Relative Value Scale (RBRVS) to advocate for present and future coding and reimbursement. Two panels within the American Medical Association (AMA), the Relative Value Scale Update Committee (RUC) and the Current Procedural Terminology (CPT) panels, are critical to ensure the SVS has a voice in shaping CPT, RVUs and Medicare reimbursement. 

The advisory work and AMA process representation workload is divided among CPT and RUC teams, each with an advisor, alternate advisors and trainees. The SVS is pleased to announce four new trainees. Joining the CPT team in representation are Jonathan Thompson and Xiaoyi Teng, and for the RUC team are Mark Iafrati and Justin Hurie. The SVS coding and reimbursement team look forward to training the new leaders. 

Ukrainian surgeons present clinical update on Human Acellular Vessel in vascular trauma at ESVS 2022

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Ukrainian surgeons present clinical update on Human Acellular Vessel in vascular trauma at ESVS 2022
Human Acellular Vessel
Human Acellular Vessel

Humacyte recently announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov (Dnipro State Medical University, Dnipro, Ukraine) and Vasyl Shaprynskyi (State Institution of Science “Research and Practical Center for Preventive and Clinical Medicine” State Administrative Department, Kyiv, Ukraine) at this year’s ESVS Annual Meeting (ESVS 2022; 20–23 September, Rome, Italy).

Humacyte notes in a press release that the company’s investigational HAV is designed to offer off-the-shelf availability and resistance to infection and to address long-standing limitations in vascular tissue repair and replacement.

Shaprynskyi attended the conference in person and presented a live talk entitled, “The first experience of using the Human Acellular Vessels in Ukraine for the treatment of patients with vascular trauma,” while Sokolov spoke virtually from Ukraine and presented, “Vascular trauma due to blast injury. Experience of Dnipro in Russian-Ukrainian war 2022.”

“Shaprynskyi and Sokolov have been instrumental in establishing their hospitals as medical strongholds during the Russian-Ukrainian war and reported that blast trauma, causing massive tissue damage and infected wounds, accounts for approximately 82% of incoming vascular trauma cases to their medical centres,” the press release reads. Trauma to the extremities makes up the majority of injuries, the statement adds, noting that these are primarily vascular injuries to the lower extremities and shoulders.

“Access to the HAV, a biologic conduit, has improved our ability to perform vascular reconstructions by eliminating the need to harvest a venous conduit and saving time required to look for useable vein, assisting greatly in limb salvation. While we continue to face this crisis in our country, partnerships with groups like Humacyte allow us to overcome many limitations in wartime medical care that we previously experienced such as lack of readily available conduits that are resistant to infection, particularly important in the contaminated battlefield setting,” said Dr. Shaprynskyi.

Drs. Shaprynskyi and Sokolov reported that surgeons in Ukraine have utilized the HAV to treat patients with a multitude of wartime injuries. Dr. Sokolov provided a clinical update on a patient with a blast injury to the shoulder who received a repair using the HAV. The patient is now beyond three-month follow up without complication. Another patient who suffered a blast injury to the lower leg underwent successful HAV implantation and is now one-month past surgery without complication. Dr. Shaprynskyi reported on a patient with a gunshot wound to the right thigh that was initially treated with a synthetic graft, but ultimately the graft failed due to infection, putting the patient at risk of limb loss. The HAV was used to replace the infected graft, and three months later the HAV is supplying blood flow to the limb and is infection free.

Humacyte worked closely with the Office of International Programs of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to provide the HAV as an additional treatment option to those affected with vascular injury in Ukraine. Humacyte is currently evaluating the HAV in a Phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency.

Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte, added, “As we progress in our humanitarian efforts with the HAV, being able to witness these firsthand patient cases from surgeons in Ukraine is a powerful experience. We set out to develop engineered replacement vessels that are durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel repair, both for civilians and for military personnel. Given our existing designation as a Priority Product from the U.S. Department of Defense, it is gratifying to see that the HAV is helping patients suffering from wartime injuries in Ukraine right now.”

SVS launches program to ‘REACH 535’ lawmakers

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SVS launches program to ‘REACH 535’ lawmakers

To leverage the power of direct engagement with lawmakers on the part of constituents, the SVS advocacy team is launching a grassroots advocacy plan to help foster this direct communication between SVS members and their federal lawmakers. 

The program will serve two purposes, said SVS Advocacy Council Chair Matthew Sideman, MD: connecting SVS members with their lawmakers to establish tangible channels for vascular surgeons to personally advocate on issues that significantly impact their practices and their patients; and establishing a concrete mechanism for the SVS to amplify its advocacy efforts by ensuring advocacy team members can quickly reach the 535 decision-makers on Capitol Hill. 

To become a key contact in REACH 535, members should complete the sign-up form to identify their federal representatives and senators. 

The form is available at vascular.org/REACH535form. Information also is available by emailing [email protected]. 

ESVS publishes ‘pioneering’ clinical practice guidelines on radiation safety

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ESVS publishes ‘pioneering’ clinical practice guidelines on radiation safety
Bijan Modarai
Bijan Modarai, co-chair of the writing committee, presented the new guidelines at ESVS 2022

The European Society for Vascular Surgery (ESVS) has released clinical practice guidelines on radiation safety, which the writing committee notes are the first guidelines on the topic to be published under the auspices of a vascular surgical society. The guidelines were published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES) and presented for the first time at this year’s ESVS Annual Meeting (ESVS 2022; Sept. 20–23) in Rome, Italy.

Bijan Modarai, MBBS, from Guy’s and St Thomas’ NHS Foundation Trust and King’s College in London, England, and Stéphan Haulon, MD, from Hôpital Marie Lannelongue, GHPSJ in Paris, France, co-chaired the guideline writing committee that included 13 members in total who, as well as vascular surgeons and interventional radiologists, included a radiation protection scientist and a medical physicist.

In EJVES, the authors outline the aim of the guidelines as being “to inform the reader about radiation physics and radiation dosimetry, raising awareness of the risks of ionizing radiation, and describing the methods available to protect against radiation exposure.”

The need for guidelines on radiation safety has grown in line with the rise of endovascular procedures over the last two decades, Modarai, Haulon et al state in the introductory chapter. They note that the risks of radiation exposure, however, are “not universally recognized” due to a “poor understanding of key concepts and paucity of educational material directly relevant to vascular surgery.”

In the newly published guidelines document, the authors cover the following seven topics:

  • Measuring radiation exposure and the associated risks of exposure
  • Legislation regarding exposure limits for radiation-exposed workers
  • Measuring, monitoring and reporting occupational radiation exposure
  • Radiation safety practice in the endovascular operating room
  • Radiation protection equipment in the endovascular operating room
  • Education and training in radiation protection
  • Future technologies and gaps in evidence

In their chapter on future technologies and gaps in evidence, Modarai et al underline the fact that many of their recommendations are supported by level C evidence and are reliant on expert opinion of the committee, which they say “highlights the need for the vascular community and allied disciplines to instigate studies that will strengthen the evidence base for radiation protection matters.” New technologies—including three-dimensional (3D) navigation, robotic tracking, and artificial intelligence—that require a reduced need for X-ray “should be embraced and evaluated carefully,” for example.

The authors also stress the need for international standardization of regulatory practices “in order to promote global harmonization.” They underscore an important consideration as being low- and middle-income countries, where resources are limited. “In these environments the most cost-effective means of reducing radiation exposure should be identified and prioritized to allow the best protection that is feasible,” Modarai, Haulon and colleagues elaborate.

At ESVS 2022, Modarai stated that the “pioneering” new document, as described by writing committee member Anders Wanhainen, MD, from Uppsala University in Uppsala, Sweden, is long-awaited—the culmination of two years of work. He expressed that while the guidelines will help to raise awareness amongst stakeholders and set the standard for individuals and institutions, they also underline the fact that this is an evolving area of practice and highlight areas where more research is needed.

No time like the present: The moral imperative for advocacy in vascular surgery

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No time like the present: The moral imperative for advocacy in vascular surgery
Chelsea Dorsey, MD
Chelsea Dorsey, Luka Pocivavsek and Ross Milner

“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the typical reasons. Our patients’ blood pressure wasn’t sky high in pre-op, and our case wasn’t being bumped for the trauma du jour. Regrettably, Medicaid unexpectedly denied approval of an investigational thoracic endovascular repair (TEVAR) for this 65-year-old Black male with a known history of a complicated type B aortic dissection (TBAD) two weeks prior to his planned intervention. Though insurance denials are not uncommon for “out-of-network patients” at our institution (an issue ripe for a follow-up editorial at a later date), our team was both surprised and devastated to find that this patient’s “in-network” procedure was denied because cardiovascular trial devices were not covered under his Illinois Medicaid insurance policy—with no exceptions. Our surgical plan was not only toast, but this man’s hopes of obtaining a cutting-edge thoracic repair were gone simply because of his reliance on state medical aid. 

Like so many of our vulnerable patients on the underserved South Side of Chicago, this man’s path towards a repair was anything but linear. The patient was originally diagnosed in 2015 but was lost to follow-up for several years. He re-presented to our institution in March 2022 as a victim of gun violence in an altercation where he suffered an injury to his left arm—his wife and son were killed in the incident. A trauma pan-scan at the time showed that his TBAD had grown significantly and therefore met criteria for repair. The dissection remained distal to the left subclavian, and the aneurysmal portion was predominantly in the descending thoracic aorta. The patient had, in the intervening seven years, also suffered a stroke and myocardial infarction. Given that his multiple comorbidities also included morbid obesity and diabetes, the patient was not an optimal candidate for an open thoracoabdominal repair. Furthermore, the patient was anatomically not a candidate for a TEVAR with or without traditional debranching to allow for landing in zone 1 or 2. Given these findings, the patient was enrolled in the Nexus-ENDOSPAN trial for an arch device with zone 0 landing. 

The patient was seen multiple times preoperatively, and the trial was explained to him in detail. He was eager to participate, something not always encountered given the understandable mistrust of the research process often seen in Black patients. His anatomy was evaluated by the review board, and he was found to be an excellent candidate for the investigative device. The patient was scheduled for the two-part surgery in early August. After being notified of the denial, we participated in a lengthy peer-to-peer conversation with a physician representative from the patient’s Medicaid provider, but our efforts failed. The procedure was canceled. And there we were—highly trained surgeons technically able to offer all options to the patient but handcuffed to an open approach, which carried with it a much higher morbidity and mortality for this particular patient. 

The investigational process is well regulated by both federal (Food and Drug Administration, or FDA) and institutional (IRB) oversight committees. The oversight and approval process has been in place for many years, and, at its core, has the safety of patients in mind. Clinical trials provide safe access to novel devices for select patients with complex problems. 

As for “select”— this is an interesting word choice in this context. Typically, patients must meet specific eligibility criteria to be enrolled in a clinical trial. The criteria commonly include such factors as a minimum and maximum age. In addition, specific anatomic characteristics are assessed as part of the trial design and vary based on the investigational device. As a frequent site for clinical trials, our institution commonly uses such standards in our decision-making on who is safe to be treated and who is not. Noticeably absent from this algorithm is the categorization of patients based on their insurance status. This is an appropriate omission given that uniformly that data point is irrelevant in deciding whether a patient should or should not be entered into a trial. In other words, patients should never be “selected” or excluded due to their insurance status. This unfair decision specifically targets an already marginalized group of patients. Clinical trials should be available to all patients. This fact is highlighted by the paradoxical elimination of a high-risk patient as seen in this scenario. The reality is that this is a patient who unequivocally needs our care the most. 

As practicing vascular surgeons on the South Side of Chicago, we treat individuals from our local community and from all over the Midwest. It is reasonable to surmise that most physicians who find themselves in this particular corner of the city chose to work here to plant roots at an innovative medical institution with the ability to provide outstanding care to all patients regardless of race, ethnicity, gender, sexual orientation, and insurance status. To deny us the ability to do so feels like a dereliction of duty and a contradiction to the Hippocratic oath we all swore to uphold. The challenges we faced with this particular patient also bring to light a much larger question of how advocacy plays a role in our daily lives as vascular surgeons. Collectively, our reasons for entering the field are varied, but fundamentally we all have an interest in serving patients and providing the best surgical care possible. Advocates are defined as individuals who fight for a cause or a particular group, so it is no stretch of the imagination to think advocacy is actually intimately involved in our work as surgeons.1 Moreover, for many of us who work in under-resourced regions, our efforts in this area are not only important, but in many cases life- and limb-salvaging. 

For some, the idea of becoming an “advocate” may seem daunting, especially given the paucity of information that is passed along to surgeons during their training surrounding this topic.2 In thinking about how to approach this issue, it is important to keep in mind that advocacy comes in all shapes and sizes. For us and this situation, we began by contacting the clinical leadership team at our hospital to better understand the policies preventing this patient from obtaining care through this clinical trial. This ultimately led to further discussions with the institution’s leadership as well as those involved in government relations for the university as a whole. We have recently connected with our state’s legislators, and we are now working to ensure this patient’s story is heard loud and clear in our state’s capitol in the coming months. 

Alternatively, for some, there may be an urge to get more involved with grassroots organizations, depending upon the issue at hand. In other circumstances, you may feel inclined to contact your local legislator directly, or you may find avenues to get more deeply involved with specific local, state, or national healthcare policy.1 In recent years, the Society for Vascular Surgery (SVS) and larger organizations like the American College of Surgeons (ACS) have made it easier for us to get involved by providing educational resources and offering ample opportunities to have our surgical voice heard on Capitol Hill.3,4 Whether we like it or not, times have changed. No longer can we ignore or choose not to acknowledge that the clinical care we provide is intimately intertwined in the complex social circumstances of our patients. Advocacy is in our DNA as vascular surgeons. The sooner we acknowledge it, the sooner we can get to work. 

References 

  1. Political advocacy in surgery: The case for individual engagement. The Bulletin https://bulletin.facs.org/2015/08/ political-advocacy-in-surgery-the-case-for-individual-engagement/ (2015). 
  2. Surgeon advocacy in action: Challenges, accomplishments, and futuredirection. The Bulletin https://bulletin.facs.org/2021/08/surgeon-advocacy-in-action-challenges-accomplishments-and-future-direction/ (2021). 
  3. News & Advocacy | Society for Vascular Surgery. https://vascular.org/news-advocacy. 
  4. Participate. ACS https://www.facs.org/advocacy/get-involved/. 

Chelsea Dorsey, MD, is an associate professor of surgery at The University of Chicago. Luka Pocivavsek, MD, is an assistant professor at the same institution. Ross Milner, MD, is the The University of Chicago’s vascular section chief. 

Corner Stitch: Audible Bleeding cuts down to vascular core

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Corner Stitch: Audible Bleeding cuts down to vascular core
Adam Johnson and Kevin Kniery

Many Corner Stitch readers subscribe to Audible Bleeding, the vascular surgery podcast for updates on all things vascular—from vascular knowledge, to reviewing key Journal of Vascular Surgery (JVS) papers, to speaking on diversity, equity and inclusion (DEI) efforts, and even looking at the history of vascular surgery, Audible Bleeding has been engaging the audience and providing much needed content. This month, we were lucky to pick the brains of founders Adam Johnson, MD, and Kevin Kniery, MD. 

Johnson is a vascular surgery fellow at Cornell/ Columbia New York Presbyterian Hospital, and is current director of Audible Bleeding. Kniery is a vascular surgeon at Brooke Army Medical Center in San Antonio, Texas. Here’s what they had to say. 

VS: Starting a podcast is very hard thing to do, especially during training. Can you give a brief history of how it all started? 

KK: I remember all the way back to my fellowship interviews, Dr. Sharif Ellozy was very interested in my work with Behind The Knife [BTK]. Having a podcast on your CV wasn’t always viewed in high esteem so that really stuck out to me. I think given his experience and work in surgical education, he was drawn to it. 

By chance, a friend of mine from medical school, Adam, was coming to the same fellowship, and we had talked about working on BTK for some vascular related episodes in the past. So, late in my first year of fellowship, it all came together with Adam about to move to New York, and my co-fellow, Matt Smith, was super excited about the idea. Dr. Ellozy was a perfect senior mentor having the knowledge, experience and connections, and, Nicole Rich, the other incoming fellow, also thought it would be a fun project to work on. 

AJ: Yeah, that’s how I remembered it, too. As he mentioned, Kevin and I were medical school classmates at Tulane, and I had been a huge fan of his work with Behind the Knife. I approached him about whether I could get involved, and he suggested that there might be a role for a whole new podcast just for vascular surgery. During these conversations in early 2018, I applied for a vascular fellowship and matched at the New York-Presbyterian Columbia/Cornell program, so it turned out he would be my senior fellow! 

Dr. Ellozy started approaching his network of surgeons, and we decided to publish our first interview with Dr. Frank Veith in the fall of 2018, right before the VEITHsymposium meeting. We got some initial excitement, and guests kept saying yes to coming to the podcast. 

VS: That sounds fortuitous, really, and not too dissimilar from how some other famous brands got their start. But, as you know, brand names are important. How did you come up with the name Audible Bleeding? 

KK: I remember texting back and forth names, I think one that may have come up was “Behind The Wire.” Dr. Matt Smith came up with Audible Bleeding, and it was an immediate hit given the double entendre. 

VS: Bravo to Dr. Smith. That name makes perfect sense to the vascular surgeon and is intriguing enough to get non-vascular surgeons to want to figure out what the podcast is about. So now, what were some of the goals for the Audible Bleeding podcast when it first started, and have you met some of them? 

AJ: Our initial goal was to highlight the stories of surgeons within vascular surgery to give trainees broader insight into the field. We then started creating free study resources to help trainees learn basic concepts within vascular surgery. Within our first year, we had name recognition with almost every trainee I met, and they all found it a valuable resource—so we had already met our initial goal by the end of our first year! 

KK: We wanted to bring vascular surgery education to a podcast platform. We started with interviewing leaders in the field and learning from them, and then it slowly branched out to what it is today. 

VS: Ok, so you guys definitely hit a nerve and tapped into a whole new generation of trainees who love podcasts. Today, Audible Bleeding is supported by the Society for Vascular Surgery. How did that partnership develop? 

AJ & KK: This process was a bit more organic than we would have expected. Initially, we started out as an LLC with a small investment from each of our team members. We all agreed from the beginning that the intent of the investment was just to get the podcast off the ground, and we had no interest or expectation for a financial return on the investment. We then received some unexpected donations from listeners, and the podcast became listener-supported pretty much by our second year. 

During COVID-19, however, we started to really increase our content and hold some webinars and help with a multi-institutional lecture series based on Wake Forest. We helped to host a few events for the SVS, and they were impressed with the work we were doing. Dr. Kim Hodgson, the president at the time, reached out to us to see if we wanted to be the official podcast for the SVS. They had thought about having a Society-affiliated podcast for a while and recognized we had a quality product in that space. 

So instead of competing with us, they figured they would offer to support us. We were sufficiently listener-supported, so we didn’t need the funding, but we figured our team wouldn’t be running the podcast forever, and affiliating with the SVS would help us to recruit and maintain team members moving forward. 

So, essentially we were already doing many collaborations with them, and they were trying to find new ways to connect with the younger generation, so it was a perfect fit. In addition, Dr. Ken Slaw, executive director of the SVS, was also very involved with our transition. 

VS: I’m sure you’re not the only team that has thought of a vascular surgery-centric podcast. Are there others out there? And do you partner with them? 

AJ: There are tons of great podcasts out there for vascular surgeons. Behind the Knife, of course, has great content for vascular surgeons and general surgeons. Backtable is a very high-quality podcast put out by a group of interventional radiologists that has a lot of content that vascular surgeons would find useful. Let’s Talk Surgery is put out by the Royal College of Surgeons of Edinburgh and is one I have started listening to while I have been in the United Kingdom. The Retrograde Approach is a podcast out of Australia that has some great review episodes. And finally, Yale Vascular Review is put out by a couple of trainees from Yale that give short summaries of recently published articles grouped by clinical topic. 

KK: To my knowledge there are a couple others. We have not done significant collaborations. Audible Bleeding has done multiple crossover episodes with Behind The Knife in attempts at educating and drawing general surgery trainees in to vascular. 

VS: What advice would you give to current vascular surgery trainees for conceiving and maintaining a start-up during training or as faculty? 

AJ: Hmm…good question: I think it all comes to value. What is the value that you are hoping to provide to your community, and what value is this endeavor providing to you? If you see start-ups and innovation and a get-rich-quick scheme, you might be successful, but you’ll likely get frustrated. If you find something that provides value to yourself and your community beyond financial reimbursement, then you’ll find yourself wanting to work on it, no matter the time of day, and you will find people around you supporting your work. 

KK: I couldn’t agree more with AJ. But I also think it is all about finding the right team, which is impossible to know at first. A good place to start is finding a small core group that is passionate about the same vision or goal. You may have one idea and then you collaborate with others with differing view points and experiences and then the idea matures and becomes much bigger and better than you initially anticipated. 

VS: Last question, I promise. Looking into the future, what do you hope Audible Bleeding will grow into? 

AJ: One of our big pushes this year is to provide a more comprehensive online resource for exam preparation. We will be publishing a free e-book this fall to accompany our exam prep episodes. 

We plan to re-publish our review episodes starting in November for a simple, free, and easily accessible study schedule to prepare for the U.S. in-training exams. Keep a look out for more details this fall! 

SVS advocacy in action: Protecting and advancing the interests of vascular surgery

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SVS advocacy in action: Protecting and advancing the interests of vascular surgery
Kenneth Madsen

Deep in to the second half of the year, there is no rest for the weary regarding Society for Vascular Surgery (SVS) advocacy initiatives. In July the Centers for Medicare & Medicaid Services (CMS) released its calendar year 2023 proposed rule to revise payment policies under the Medicare Physician Fee Schedule. Thus, we are now poised to fight yet another round of payment cuts that could significantly impact vascular surgery. Having submitted a detailed comment letter to CMS at the start of this month, we are now redoubling our efforts to engage lawmakers on Capitol Hill and ensure policies to mitigate the pending cuts are included in must-pass legislation before the end of the year. With this scenario on the horizon, and an acute need for increased engagement from SVS members, it feels like a good time to provide a refresher regarding our advocacy offerings. 

As I hope you are aware, the SVS utilizes a multi-faceted approach for advocacy with an overarching goal of protecting and advancing the interests of vascular surgery. This includes traditional legislative advocacy and lobbying with federal lawmakers on Capitol Hill, activating our SVS colleagues to engage in grassroots campaigns via our “Voter Voice” system and supporting the campaigns of candidate and incumbent lawmakers through the SVS’ political action committee, SVS Political Action Committee (PAC). 

By simultaneously engaging in these core tenets of effective advocacy, the SVS has achieved many successes over the last several years, including (but not limited to): mitigating scheduled Medicare physician payment reductions, securing passage of legislation to address physician wellness and garnering significant bipartisan and bicameral support for legislation designed to ease the burdens of prior authorizations. But let’s take a closer look at each of these advocacy tools in action. 

Working the legislative process 

A significant achievement during the current 117th Congress was passage of the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 1667). This critical legislation authorized grants for programs that offer behavioral health services for front-line healthcare workers. It also requires the Department of Health and Human Services to recommend strategies to facilitate healthcare provider well-being and launch a campaign encouraging health care workers to seek assistance when needed. The bill was signed into law by President Joseph Biden in March 2022. 

In addition, the SVS, in collaboration with a broad coalition of physician organizations, has successfully sought legislation over the last two years to significantly reduce scheduled payment cuts within the Medicare physician fee schedule. Led by physician lawmakers Reps. Drs. Larry Bucshon, MD (R-IN), and Ami Bera, MD (D-CA), the physician community continues to make the strong argument that the payment system is broken, and Congress must act to provide greater stability while relevant stakeholders and lawmakers can identify long-term policy reforms. 

In addition to sponsoring legislation and delivering letters to both CMS and congressional leadership, Bucshon and Bera have worked to raise awareness among their colleagues regarding this healthcare crisis and are in the process of facilitating a roundtable meeting to discuss this ongoing issue and build upon our work over the last two years to advance the goal of systemic payment reform. 

With few healthcare professionals in Congress, the support of Bucshon and Bera is critical, as they are important assets in terms of the cumbersome process of educating lawmakers who are not familiar with the healthcare delivery system and/or the intricacies associated with physician payment. The SVS is engaging in similar efforts this year and we anticipate continued work on these issues through the remainder of the year. 

Building momentum with grassroots 

Although lawmakers are accustomed to meeting with lobbyists and other organizational representatives, what really matters most to them is you— their constituents. As a result, all SVS members should be looking for, and participating in, every “Voter Voice” grassroots call to action they receive. 

This easy-to-use grassroots platform allows SVS members to send pre-written messages to their lawmakers to articulate the SVS’ position on a variety of active legislative or regulatory issues. This sort of “at-home” engagement is often an essential component for securing a lawmaker’s support for a piece of legislation or sign-on letter. 

Since mid-2020, SVS members have sent more than 5,000 messages to their federal lawmakers. This is a great measure of engagement, but we still have room to grow and continue to leverage this important advocacy strategy. To help provide a more comprehensive foundation for our grassroots outreach, the SVS has launched a new key contacts program—REACH 535—to identify contacts for each legislative district and ultimately amplify our messages to lawmakers. 

To learn more about this critical program, I encourage you to contact our advocacy team at [email protected] or visit vascular.org/REACH535. 

Tying it together with SVS PAC 

SVS PAC is the collective voice of vascular surgery on Capitol Hill and serves as the political arm of our ongoing advocacy efforts. Via contributions from our members, the SVS PAC supports incumbent lawmakers and candidates who will champion the issues important to vascular surgery and the patients we serve. SVS PAC is non-partisan and issue-driven. 

With more than 4,000 federally registered political action committees, SVS PAC is the only one focused on identifying and supporting pro-vascular surgery lawmakers. To help facilitate the development of strong relationships with lawmakers, representatives from the SVS PAC Committee and/or our Advocacy staff, attend fundraising events where SVS’ top legislative priorities are discussed directly with the member of Congress and his or her top staff. 

During one such event with Rep. Angie Craig (MN-2nd District), Dr. Patrick Ryan was able to eloquently outline the plight of office-based practices as well as the immense value these practices offer in terms of providing care in an efficient and cost-effective manner. 

Following the exchange, Rep. Craig vowed to further investigate the issue and articulated an interest in becoming more involved. This is the type of dialogue SVS PAC helps to facilitate. Members of Congress are busy on many fronts and are often not familiar with these healthcare issues. 

It is our opportunity to organize (let them see that we are thoughtful and united), to educate (help them plainly see the consequences of inaction) and to advocate (present them with viable proposals and ask for their support). 

Our challenge: Building a unified coalition 

Various threads on SVSConnect have pointed out that financial decisions by CMS affect all of us and our ability to plan for our practices and deliver high-quality care to our patients. Recent SVSConnect posts have stressed that we are all in this together. Having these discussions is healthy and resolving differences of opinion in a healthy fashion will help us solidify our message and our ability to support the specialty. However, we must also transform these discussions into action and work collaboratively to ensure that the strength of each of the aforementioned advocacy tools continues to grow. 

We must continue to build a coalition of congressional representatives who are willing to bring our issues to light to the Congress. We need to guide these representatives so that appropriate legislation can be drafted and passed such as recent legislative successes. Our engagement as individuals, group practices and academic centers is crucial to this cause! 

PAC donations raise money needed to gain audience with members of Congress and build our platform. More importantly the percentage of us donating is a direct and tangible metric demonstrating our level of commitment. 

Writing to our local representatives has been stressed by the lawmakers with whom we have met, especially in “vulnerable” districts. Everyone’s congressional representative needs to know that there is a healthcare crisis that is threatening their constituents’ access to vascular care! 

Our representatives need to know that it is not fiscally responsible for us to invest in staff, supplies or in any other meaningful ways when we know that there will be budget cuts looming every single year. The representatives are sympathetic to these issues but only when the issues are put before them in a direct and concise manner. 

This is not the time for complacency. Just as surely as night follows day, we find ourselves on the brink of additional reimbursement cut proposals that will surface in the coming weeks. Thanks to all who are doing their part but now is the time for all members of the SVS to step up! 

Donate to the PAC at vascular.org/PAC. 

Kenneth Madsen, MD, is a member of the SVS Political Action Committee Steering Committee 

Experts establish international standard set of outcome measures for patients with VTE

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Experts establish international standard set of outcome measures for patients with VTE

The International Consortium for Health Outcomes Measurement (ICHOM) venous thromboembolism (VTE) working group has developed a standard set of outcome measures for patients with VTE. The consensus recommendation—published in the September edition of The Lancet Haematology—is designed to “facilitate the implementation of the use of patient-centered outcomes in daily practice.” 

Authors Adam Gwozdz, MBBS, from King’s College London, England, Cindy de Jong, MD, from the Leiden University, Leiden, The Netherlands, and colleagues explain in their report that the ICHOM assembled an international working group of VTE experts and patient representatives “to develop a standardized minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision-making and benchmarking of quality of care.” 

The group selected a total of 15 core outcomes important to patients and healthcare professionals, and then categorized these outcomes into four domains: patient-reported outcomes, long-term consequences of the disease, disease-specific complications, and treatment-related complications. They write that the outcomes and outcome measures were designed to apply to all patients with VTE aged 16 years or older. Gwozdz, de Jong et al selected a measurement tool package for inclusion in the core standard set. “Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required,” the authors note. 

In a section on implementation, the researchers advise that the final set of outcome measures is now available online for use within clinical practice and potentially research. They elaborate: “After signing up for free through ICHOM Connect, all materials related to the set (i.e. a flyer, reference guide, and data dictionary) can be downloaded.” 

The investigators state that the overarching aim of their work is to achieve a globally adopted standard set. However, they acknowledge that there are “different resources, digital infrastructures, and healthcare contexts in low-income, middle-income, and high-income countries that can affect the speed and success of implementation.” They write that “training and education, commitment, and enabling attitudes of healthcare professionals are believed to facilitate implementation” and “offset more structural challenges within the healthcare system.” 

“We anticipate that the introduction of this set will contribute substantially towards increasing value in VTE care,” Gwozdz, de Jong and colleagues state in their concluding remarks. They also recognize the benefit of the document for patients, asserting that implementation of this set will “empower patients with VTE to actively participate in their care and, together with involved professionals, make better informed decisions about healthcare options.

WVS 2022: Study probes who benefits from EVAR among patients with chronic kidney disease

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WVS 2022: Study probes who benefits from EVAR among patients with chronic kidney disease
Mitri Khoury

Patients with advanced chronic kidney disease (CKD) represent a high-risk group who may not benefit from elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) under traditional sizing criteria. 

That was among the chief findings in a paper presented by Mitri Khoury, MD, who recently completed his residency at the University of Texas Southwestern in Dallas and a current fellow at the Massachusetts General Hospital, and colleagues, presented at the 2022 Western Vascular Society annual meeting in Victoria, British Columbia, Canada (Sept. 17–20).

Those with CKD ranked 3b, 4, and 5—found to be high-risk—had worse one-year mortality rates compared to the remainder of the cohort, Khoury et al report, with CKD 1–3b patients showing a one-year mortality benefit following EVAR regardless of AAA size. “CKD 4 patients had no demonstrable benefit following EVAR at any AAA size. CKD 5 patients had worse actual one-year mortality rates with EVAR than predicted one-year mortality without EVAR for AAAs <5.5cm, although there was a mortality benefit with EVAR for AAAs >7.0cm in the CKD 5 group,” they elaborate. 

The patient pool was derived from the Vascular Quality Initiative (VQI), with nearly 35,000 patients meeting the study criteria. Some 8,183 (23.4%) were classed as CKD 1 patients, 16,888 (48.4%) CKD 2, 6,038 (17.3%) 3a, 2,708 (7.8%) 3b, 624 (1.8%) 4, and 485 (1.4%) CKD 5.

The research team noted notable differences in the baseline and operative characteristics: CKD 5 patients were less likely to be fully functional and were more likely to have a prior aortic aneurysm repair than the remainder of the cohort, while patients with CKD 1 and 2 had the lowest Gagne Indices, the measure used “to understand which subset of patients with CKD are most likely to experience a survival benefit following elective EVAR for AAAs,” while patients with CKD 3b and 4 had the highest.

Patients with CKD 3b, 4, and 5 had the longest operative times, they find. Khoury and colleagues comment that their study is noteworthy owing to the fact that it suggested CKD 5 patients being intervened on for AAAs less than 5.5cm “may be harmed if offered EVAR.” 

They explain: “The indication for repair for AAAs <5.5cm is unclear in this study. Nonetheless, we did find that CKD 5, in addition to CKD 1, had the highest proportion of patients with concomitant iliac artery aneurysms. Therefore, there is a possibility that the indication for repair was the iliac artery aneurysm rather than the AAA. This would lead to an underestimation of the predicted one-year mortality rate in these patients since the rupture risk of the iliac artery aneurysm was not accounted for with our methodology. The VQI defines an iliac artery aneurysm as anything greater than 2cm, which is below the recommended threshold for repair of 3.5cm, so we are unable to ascertain in the current study whether the iliac artery aneurysm was the indication for repair among patients with AAAs <5.5cm.” 

In an interview with Vascular Specialist, Khoury explained that combining the Gagne index and the predictive aneurysm-related mortality based off aneurysm size yields the prediction without repair. “We compared the prediction of one-year mortality without EVAR vs. what their actual one-year mortality is with EVAR, and then figure out which patients may benefit for repair,” he said. “This is obviously not a randomized-controlled trial, but what we found suggests that with advanced CKD patients, the underlying comorbidities are so high, the size threshold should be a little bit higher in these patients.” 

Vascular Specialist–September 2022

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Vascular Specialist–September 2022

In this issue:

  • No time like the present: The moral imperative for advocacy in vascular surgery (p. 2 and 4)
  • Corner Stitch: Audible Bleeding cuts down to vascular core (p. 10)
  • Trial supports full-dose anticoagulation to prevent blood clots in COVID-19 patients (p. 18)
  • New study indicates cost-effectiveness of Denali IVC filter over Option device (p. 20)
  • Canadian Vascular: Endovascular revascularization ‘superior or not significantly different’ in terms of outcomes versus open repair in PAD (p. 25)

Annals of Vascular Surgery announces special issue dedicated to original work by women

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Annals of Vascular Surgery announces special issue dedicated to original work by women
Caitlin W. Hicks

The Annals of Vascular Surgery peer-review journal has announced an upcoming special issue dedicated to original work by women that is set to be guest edited by Caitlin W. Hicks, MD, the associate fellowship program director for vascular surgery and endovascular therapy and associate professor of surgery at Johns Hopkins Medicine in Baltimore, Maryland.

The issue, which will be published next September to coincide with Women in Medicine Month, will feature original scientific work whose first and last authors identify as women, with men welcomed as co-authors. Hicks will be supported by an all-female editorial team.

“We encourage all women to submit your best original scientific work related to vascular surgery for peer review and possible publication in our special issue,” Hicks said. “Please note that we will not accept review articles, case reports, or commentaries given the high volume of competitive original scientific works that we anticipate.”

Abstract submissions are due by Monday, Dec. 5

Interested researchers are being encouraged to submit an abstract for review by the editorial team, with those selected then offered the opportunity to submit a full manuscript. Issue editors note that abstracts may have been presented at or submitted to a meeting, but should be free from embargo by September 2023.

They should be uploaded by Monday, Dec. 5, with all authors notified of their abstract’s selection or rejection by Monday, Dec. 19. Selected manuscript submissions will be due by Feb. 1, 2023. “Annals of Vascular Surgery is excited about the opportunity to highlight the amazing research being performed by women in our specialty,” added Hicks.

Questions about the process, should be directed to Hicks directly at [email protected] or Annals of Vascular Surgery managing editor Camilla Davies at [email protected]. The full abstract link is: www.surveymonkey.com/r/AVSWomen.

Society for Vascular Surgery Vascular Quality Initiative celebrates one million procedures

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Society for Vascular Surgery Vascular Quality Initiative celebrates one million procedures

The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry announced this week it has now collected more than one million procedures in its database.

The SVS VQI is a not for profit clinical registry dedicated to improving the care of vascular patients through a data-driven approach to healthcare. According to an SVS press release, the “big data” the initiative provides has led to scientific discovery that has dramatically impacted patient care, with changes in practice that have saved thousands of lives. This data collection milestone reflects the interest and engagement of SVS VQI centres and their commitment to elevate the delivery of vascular care.

“Capturing one million procedures is an incredible accomplishment, and each one adds value to the registry and to our body of knowledge that allows us to improve patient care,” said Jens Eldrup-Jorgensen (Maine Medical Center, Portland, USA), medical director for the SVS Patient Safety Organization, which governs SVS VQI. “We are grateful for the continued commitment of vascular specialists to our mission of improving the safety, effectiveness and cost of vascular healthcare by providing clinicians the data and tools necessary to facilitate quality improvement.”

The SVS VQI started as the Vascular Study Group of Northern New England in 2003. At inception, there were four registries and eight participating centres, with only a few thousand procedures entered by the end of that year. Today, the SVS VQI has more than 6,000 contributing physicians—vascular surgeons, interventional cardiologists, radiologists and more—from over 940 centres and 14 clinical registries with one-year follow-up.

The organisation is staffed by experts in vascular disease, quality improvement and clinical analysis, with 250 volunteer physicians lending additional support. Registries contain demographic, clinical, procedural and outcomes data from vascular procedures performed in the USA, Canada, Puerto Rico and Singapore. Given its wealth of data, SVS VQI has been the basis for more than 600 scientific presentations and publications in peer-reviewed journals.

To learn more, visit https://www.vqi.org.

Aortobifemoral grafting in the endovascular era: An exploration of the open procedure and its merits among ‘good-risk’ patients today

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Aortobifemoral grafting in the endovascular era: An exploration of the open procedure and its merits among ‘good-risk’ patients today
At left, an aortobifemoral graft repair for aortoiliac occlusive disease. At right, imaging of an endovascular repair

Aortobifemoral grafting for aortoiliac occlusive disease (AIOD) probably remains “very safe” in the era of endovascular repair, according to the senior author behind a new paper exploring optimal approaches to the often burdensome condition. The research team, led by Jonathan Bath, MD, an associate professor of surgery and the vascular surgery fellowship program director at the University of Missouri in Columbia, Missouri, carried out a comparative analysis of outcomes of endovascular repair and aortobifemoral bypass for AIOD over a five-year period (2016–2021) at their institution, exploring adult patients with Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) II A-D lesions at their institution. 

They presented the results—delivered by Benjamin Liu, BS—at the 2022 annual meeting of the Midwestern Vascular Surgical Society (MVSS), which was held in Grand Rapids, Michigan (Sept. 15–17). 

The researchers established equivalent outcomes between those treated with both aortobifemoral bypass grafting and unibody endografts (UBEs) in terms of such occurrences as stroke, major adverse cardiac events (MACE) and myocardial infarction (MI). They also reported mid-term outcomes for patency and survival that were similar across the two treatment modalities. The team further found that the best option for TASC C and D lesions—those deemed most complex—remains unclear. 

“The thrust of this is that surgeons have been doing aortobifemoral bypass since the 1950s and 60s, and it is well enshrined in vascular surgery as a great option for many patients,” Bath explained in an interview with Vascular Specialist ahead of the MVSS meeting. 

“However, we’ve obviously had this endovascular evolution. It is not an entirely new topic but the series have been small, so we don’t have a—collectively—large amount of data to guide us as to which therapy is more appropriate.” 

He continued: “We’ve looked at our institutional experience, which, again, is relatively small and modest compared to many, but it has decent, moderate follow-up—36-months in our study. We tried to cohort patients who were similar. If you look at demographics between patients, they really aren’t dissimilar, so we are trying to do an apples-to-apples comparison. We are also going to perform a subgroup analysis on the TASC C and D lesions, the more complex lesions. That was a significant difference between studies: Most of the unibody endografts, or UBEs—the Endologix device—were more TASC A and B patients, with fewer TASC C and D lesions, when compared to the aortobifemoral bypass graft. Obviously, this is a retrospective study; we certainly didn’t randomize these patients. This is operator preference.” 

The study included 133 patients who had complete data, 82 of whom had AIOD only. Twenty one of these patients were treated with a UBE (26%), while 61 underwent aortobifemoral bypass grafting (74%). Significant differences in perioperative variables included surgery length (UBE: 213 minutes; bypass: 360), pre- and postoperative ankle-brachial indices (the UBE was lower than the bypass), and sizes of the iliofemoral arteries (larger in the case of the UBE). 

The study data also highlighted significant differences in sizes of the iliac, common femoral and superficial femoral arteries between genders—all were smaller in females, Bath notes. 

The senior author also described points of interest in terms of study outcomes. “The [patient cohorts] are very similar in terms of the overall outcomes; honestly speaking, there were very few differences in areas such as patency, stroke, MACE and MI in a population that is similar. What that really says, probably, is that aortobifemoral bypass grafting is still very safe, even in the endovascular era.”

There were also specific differences in the size of the arteries in terms of gender, he explained. “That always has implications regarding whether or not an endovascular therapy is going to be superior, or inferior, or the same, versus an open therapy,” Bath said.

“Again, artery size was associated with an overall reintervention risk, so we know the size of the artery does portend a risk of having a reintervention. That might be—in the case of an aortobifemoral bypass graft—that the limb thromboses, and you have to perform a thrombectomy, or, in the case of a unibody endograft, that you may have to extend things, or you may have to perform thrombolysis or some similar procedure in order to maintain patency.” 

With all of that being said, Bath finished, “it is true that the aortobifemoral bypass group was more complex and had a greater number of TASC C and D lesions.” 

He added: “We really don’t have a great comparison group from the unibody endograft group, so, in this day and age, when there really is a thrust and desire to perform a lot of endovascular therapies, should we be discounting the aortobifemoral bypass graft in patients who are good risk, younger, who may be female with smaller arteries, and who can tolerate an aortobifemoral bypass graft? You would think these TASC C and D lesions would have a greater number of interventions than the TASC A and B [lesions]—i.e. there would a difference between the aortobifemoral bypass group and the UBE—but that did not really play out. So, it really does say that, a) we need a bit more research on the TASC C and D lesions, but b) aortobifemoral grafting is still an excellent option for patients.” 

Training implications 

The study also recalls the issue of open aortic training volumes amid declining numbers of open abdominal aortic aneurysm (AAA) repairs. During the 2022 Annual Symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas earlier this year, Malachi Sheahan III, MD, chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans, pointed out that aortobifemoral bypass surgery should be part of conversations about trainee involvement in open aortic surgery in discussion over how to tackle shortfalls in the number of such cases tackled by trainees. Bath weighed in on training deficits and the position of aortobifemoral bypasses in the discussion, describing the ongoing hot topic of the last decade as “the deskilling of our specialty with burgeoning endovascular use.” 

“We no longer perform as many open aneurysm repairs,” he said, “we no longer perform as many aortobifemoral bypass grafts, and many trainees won’t graduate with the same numbers that we did five and 10 years ago. There has been talk of having open aortic fellowships.” But, like Sheahan, Bath looks toward the bypass further down the vascular tree—not as a panacea but a part of a larger solution. “I would argue that the aortobifemoral bypass graft, although it doesn’t have the same aspects as the aneurysm repair—one cannot say they are comparable— it does teach you many of the principles of open aortic surgery, which is safe exposure and rapid exposure, finding adequate clamp sites; these are all important tenets sewing on an aorta, which oftentimes, people don’t get to do,” he said. “So, I like this operation for that reason. I think we have a bit of a bias, probably, toward performing an aortobifemoral bypass graft in most patients who can tolerate it. And I think it’s good for our trainees.” 

Returning to the core of his new study, Bath acknowledged that “there are limitations, there are biases,” saying: “This is a single institution study; surgeons definitely have their biases towards aortobifemoral bypass graft vs. UBE; but I really think this paper demonstrates that aortobifemoral bypass grafting can be performed safely, and has the added benefit of being able to teach residents and trainees how to perform aortic surgery. I think it’s an operation that should remain.” 

WARRIORS randomized trial aims to examine early EVAR in women

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WARRIORS randomized trial aims to examine early EVAR in women

This month a multinational collaboration of researchers received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for the WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial.

The trial aims to answer the question, should women have their aneurysms repaired electively using endovascular aneurysm repair (EVAR) at smaller diameters than men to improve their survival and quality of life? Imperial College London in London, England, is co-ordinating the study that will include collaboration with vascular surgeons from Canada, Denmark, The Netherlands, Sweden and and the U.S. The researchers mention that new partners such as Australia may also be joining.

The investigators note in a press release that the rationale and need for this trial, which seeks to recruit nearly 1,200 women, stems from the poor outcomes suffered by women with abdominal aortic aneurysm (AAA). Although women contribute 15–20% of total AAA burden, and one-third of ruptures, they have been significantly under-represented in trials which guide current AAA repair, the investigators detail, adding that women have smaller arteries, a four-fold higher rupture risk and lose eligibility for EVAR at smaller AAA diameters. Treated at the current threshold, the researchers note that a greater proportion receive either higher-risk open surgery or no repair at all. Those that do receive elective repair, do worse, with nearly double the rate of operative mortality (open surgery 6%, endovascular aneurysm repair [EVAR] 2.3%), higher postoperative complication rates and longer hospital stays.

“We have learnt that women worry a lot about their AAA and modeling has suggested that repair of AAA at 4cm for women might result in improved quality of life and reduced overall cost,” the investigators write. “These potential benefits as well as reduction in aneurysm-related mortality, would need to be balanced against the operative risk of early repair.” They state that these areas of uncertainty, regarding the optimal strategy for AAA repair in women, are what the trial seeks to answer.

The endorsement provided by the GCRFF allows the investigators to move forward and seek priority funding from their partner organizations. The team is also hoping for some support from industry for specific aspects of the trial and/or associated registry.

According to the investigators, WARRIORS would be the first randomized trial of AAA management with multinational, wide-ranging, expertise and to have received endorsement from the GCRFF. However, they stress that this is the just the first step.

They elaborate: “To gain funding within each participating country and to implement the trial successfully we will need considerable support from the vascular and multidisciplinary community. The disadvantage of women with AAA can no longer be ignored, and we hope that you will support us, in what will hopefully be a major step towards readdressing the imbalance in AAA outcomes for women and men. We also hope that this initiative will pave the way to obtain evidence about the management of other underserved patient groups, minorities and rarer diseases managed by vascular surgeons.”

To find out more, or be put in touch with your country team, contact the WARRIORS investigators at Imperial College London—Colin Bicknell, Anna Pouncey and Janet Powell—at [email protected].

Treating PAD: ‘Run, don’t walk, to sign up for this incredible course’

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Treating PAD: ‘Run, don’t walk, to sign up for this incredible course’

No matter if you’re a surgeon with a few years—or a few decades—of experience, faculty members of a new, upcoming Society for Vascular Surgery course say you’re sure to learn valuable skills and strategies to help in treating patients with peripheral arterial disease (PAD). 

“This is going to be a great course with experts in the field teaching novel endovascular technologies,” said Leigh Ann O’Banion, MD, one of 18 faculty members for the Society for Vascular Surgery’s Complex Peripheral Vascular Intervention (CPVI) Skills course. 

The two-day course, with a dedicated hands-on component, will be Oct. 23 and 24 at the OLC Education and Learning Center at 9400 W. Higgins Road, Rosemont, Illinois. The center is minutes from O’Hare International Airport. Discounted early-bird pricing ends Sept. 23. 

Limited spots are available for the course, designed by vascular surgeons for vascular surgeons. 

“We’re crossing a horizon with a lot of new interventions, especially in the below-the-knee space,” said O’Banion. “Intravascular ultrasounds, retrograde pedal access, Shockwave lithotripsy … these are all new tools we can use to treat patients with advanced chronic limb-threatening ischemia.” 

And surgeons at all career stages can add these skills as useful tools in their toolboxes, she added. 

Innovations and new devices and technologies in patient treatment are introduced frequently, spurring surgeons to keep themselves updated, O’Banion said. “Maybe I’m biased as a faculty member, but I see value in this course for all vascular surgeons.” 

With limited openings, “Run, don’t walk, to sign up for this incredible course,” said faculty member Venita Chandra, MD. 

“I don’t think there’s a better course out there to give surgeons a comprehensive hands-on experience and advanced training for these really challenging patients that all of us are seeing more and more frequently in our clinical environment.” 

Beyond learning new skills, think of “fun” as a bonus reason to attend. 

“Any time you can network with your colleagues, where there are that many people in a room passionate about PAD, where instructors are pushing the limits of limb salvage, constitutes a good experience,” said O’Banion. 

“I’m excited to go peek at some of the tables and watch Dr. Dan Clair teaching LimFlow and watch Dr. Venita Chandra do a retrograde peroneal access. There are always new things you can be learning at every stage of your career. We can all learn from each other.”

Learn more, get the course lineup and register at vascular.org/CPVI. 

PAD: Endovascular revascularization ‘superior or not significantly different’ in terms of outcomes versus open repair

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PAD: Endovascular revascularization ‘superior or not significantly different’ in terms of outcomes versus open repair

A real-world analysis of peripheral arterial disease (PAD) patients in Canada indicated open revascularization may not offer a long-term benefit over endovascular intervention. In a population-based retrospective cohort study, researchers from the University of Toronto in Toronto, Ontario, found that in PAD patients eligible for both strategies, endovascular revascularization is associated with “superior or not significantly different outcomes” relative to open repair. 

The findings are part of research presented at the Canadian Society for Vascular Surgery (CSVS) annual meeting in Vancouver, British Columbia (Sept. 9–10) by Jean Jacob-Brassard, MD, and colleagues from the Department of Surgery at the University of Toronto.

The investigators looked at all Ontarians 40 years or older revascularized between April 1, 2005, and March 31, 2020, through either an endovascular or open approach, with a primary outcome of amputation-free survival and secondary outcomes of major amputation, death, major adverse limb events (MALE), and major adverse cardiovascular events (MACE).

They used Cox proportional hazards models to compare patients undergoing endovascular vs. open revascularization, with weighting by propensity score-based overlap weights to account for baseline characteristics. Analyses were repeated for pre-specified subgroups: diabetes, isolated infrainguinal disease, and tissue loss. 

Among the 28,864 patients identified as having been revascularized for PAD, 39% (n=11,203) underwent endovascular revascularization. Median follow-up time was 4.42 years. 

In the full cohort weighted analyses, endovascular revascularization was associated with better amputation-free survival, no difference in major amputation, lower mortality, and lower hazard of MALE after four years, the researchers found. There were no differences in MACE.

“Among subgroups, there were no differences in [amputation-free survival], major amputation or death,” Jacob-Brassard et al report. “Endovascular revascularization resulted in lower long-term MALE for those with infrainguinal disease only and those with tissue loss. There was no difference in MACE.”

Black patients wait more than twice as long as White patients for rAAA repair, VQI analysis finds

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Black patients wait more than twice as long as White patients for rAAA repair, VQI analysis finds
Ben Li

Black patients saw significantly delayed care for ruptured abdominal aortic aneurysms (rAAAs), with a Vascular Quality Initiative (VQI) analysis showing a median time from hospital admission to intervention of 168 vs. 78 minutes compared to White patients. 

The finding is part of data on the impact of race on outcomes following rAAA repair presented by Ben Li, MD, a vascular surgery resident at the University of Toronto in Toronto, Ontario, and colleagues at the annual meeting of the Canadian Society for Vascular Surgery (CSVS) in Vancouver, British Columbia (Sept. 9–10). 

Li and colleagues plumbed the VQI database for all Black and White patients who underwent endovascular or open rAAA repair between 2003 and 2019. 

The study’s primary outcomes were in-hospital and eight-year mortality. Some 310 Black and 4,679 White patients were included. 

Li et al found that a greater proportion of Black patients received endovascular repair (73.2% vs. 56.1%), were younger and more likely to be female, and that a greater proportion were uninsured (4.8% vs. 3.3%). 

“Although Black patients were more likely to have cardiovascular comorbidities, they were not more likely to receive risk reduction medications,” Li reported. 

After adjusting for differences in demographic, clinical, and procedural characteristics, in-hospital mortality was similar for Black and White patients, they revealed. There was no difference in eight-year survival between Black and White patients, “which persisted when stratified by endovascular and open repair,” the investigators added. 

“There are important racial differences in demographic, clinical, and procedural characteristics for patients undergoing rAAA repair,” Li and colleagues concluded. 

“In particular, the door-to-intervention time for Black patients of 168 minutes does not meet the Society for Vascular Surgery [SVS] recommendation of 90 minutes. 

“Despite these differences, eight-year mortality is similar for Black and White patients. Future studies should assess reasons for these disparities and [what] opportunities exist to improve rAAA care for Black patients.”

TCAR: First patient enrolled in ROADSTER 3 post-approval study

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TCAR: First patient enrolled in ROADSTER 3 post-approval study

Silk Road Medical has announced enrollment of the first patient in ROADSTER 3, which the company claims is the the first prospective, multicenter, single-arm study to assess real-world treatment of standard surgical risk patients with carotid artery disease using transcarotid artery revascularization (TCAR). The procedure was performed by Animesh Rathore, MD, from Sentara Norfolk General Hospital in Norfolk, Virginia.

ROADSTER 3 is a post-approval study designed to prospectively evaluate real-world use of TCAR among standard surgical risk patients and will enroll a maximum of 400 per protocol patients across up to 60 sites.

The primary endpoints include a hierarchical composite of major adverse events (death, stroke, or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure. The incidence of cranial nerve injury within 30 days post-procedure is a key secondary endpoint.

With the enrollment of the first patient, the launch of the ROADSTER 3 study achieves the first of a series of milestones set forth by the Food and Drug Administration (FDA)’s post-approval requirements.

“Positive outcomes in high surgical risk patients treated with TCAR have been well documented over the years,” said Rasesh M. Shah, MD, site principal investigator at Sentara Norfolk General Hospital for the ROADSTER 3 study.

“A study to confirm the efficacy of TCAR in the treatment of standard surgical risk patients is incredibly valuable as the physician community looks to improve its overall approach to treating carotid patients, independent of their surgical risk. I am honored to be participating in this first ever study to collect prospective data on the treatment of a recently approved patient population using TCAR.”

The top 10 most popular Vascular Specialist stories of August 2022

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The top 10 most popular Vascular Specialist stories of August 2022

top 10 vascular specialistThe top 10 most-read stories on the Vascular Specialist website in August included a look at the state of diversity, equity and inclusion (DEI) in vascular surgery, the confessions of dual-trained vascular- and trauma-trained surgeon, and the digital edition of the July/August issue of our newspaper. 

1. DEI initiatives in vascular surgery: How are we doing?

The 2022 Vascular Annual Meeting (VAM) had been touted as the most diverse to date. A dedicated session, named “Building diversity and equitable systems in vascular surgery,” should have been the perfect setting for the Society for Vascular Surgery (SVS) membership and leadership to showcase its stated commitment to DEI initiatives, but, the shockingly low attendance by members and leaders “left us feeling like we had witnessed a fumble at the one-yard line,” wrote Imani E. McElroy, MD, and Carla C. Moreira, MD.

2. Confessions of a dual-trained, dual-practicing vascular-trauma surgeon

Joseph DuBose, MD—source of the term “lesion vision” that Vascular Specialist editor-in-chief Malachi Sheahan III, MD, rounded on in a recent editorial tackling chatter around the necessity of vascular surgeons in vascular trauma—analyzes the world of the dual-trained amid an apparent void in vascular injury skillsets among practicing trauma surgeons. “Can my own unique breed of dual-trained surgeons, and the numerous vascular surgeons who are also interested in trauma, be of service in this regard?” he writes.

3. Vascular Specialist@VAM–July/August Review Edition

The VAM 2022 review edition of our paper—a special double issue—was dominated by coverage of the SVS’ annual meeting.

4. Corner Stitch: A letter to new vascular interns

“Every intern starting vascular surgery this year is incredibly talented, and soon to be a member of a tight-knit, supportive, and fiercely passionate group of surgeons,” wrote Kirthi Bellamkonda, MD, is a PGY-2 vascular surgery resident at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire. “I remember being on the cusp of my first day a year ago, having spent the interview season talking the talk, yet wondering whether I could walk the walk … so I’m hoping to pass on some of the lessons I learned this year.”

5. A brilliant plan to increase vascular surgeons’ income—and decrease the incidence of stroke!

Former Vascular Specialist medical editor Russell H. Samson, MD, garnered an audience with a satirical commentary on carotid revascularization and imaging: “I have come up with a brilliant plan that will decrease the incidence of stroke nationwide, provide an excellent source of income for vascular surgeons, and reduce vascular surgeons’ stress and burnout,” he wrote. “My concept is based on two recent trends in the management of patients at risk for carotid territory stroke.”

6. Diversity gains momentum at JVS

The addition of a DEI editor at the Journal of Vascular Surgery (JVS) was found to be associated with more diversified publications and perspectives—including a significant increase in the number of women involved in the peer-review process—in a new analysis led by researchers from the University of Florida. 

7. APDVS president reflects on training challenges of COVID-19, ‘supply and demand’ conundrum of the future

“There are not enough vascular surgeons to do the work our specialty provides.” Those were the stark words of Jason T. Lee, MD, president of the Association of Program Directors in Vascular Surgery (APDVS), as he reflected on some of the training challenges that were posed to the vascular profession during the pandemic in a video interview with Vascular Specialist during the 2022 Charing Cross (CX) International Symposium in London (April 26–28).

8. SVS Vascular Health Step Challenge asks surgeons to walk the walk

In September, the SVS challenged vascular surgeons to step up, so to speak, for the SVS Vascular Health Step Challenge as part of National Peripheral Arterial Disease (PAD) Awareness Month. 

9. Intraoperative vascular mapping during hemodialysis access ‘should be incorporated into routine practice’

Intraoperative ultrasonographic venous mapping is a useful tool to evaluate vessel suitability for arteriovenous fistula (AVF) creation, Yana Etkin, MD, associate professor of surgery at the Zucker School of Medicine at Hofstra/Northwell in Lake Success, New York, VAM 2022.

10. Researchers study role of frailty in post-discharge mortality

SVS members developed new methods and tools to assess patient frailty and possible surgical outcomes more simply before patients undergo vascular surgical procedures.

Trial supports full-dose anticoagulation to prevent blood clots in COVID-19 patients

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Trial supports full-dose anticoagulation to prevent blood clots in COVID-19 patients

Treatment of critically ill COVID-19 patients with full-dose anticoagulation lowers the risk of venous and arterial clotting complications by 44% compared with the standard dose, according to late breaking research presented in a Hot Line session at ESC Congress 2022 (Aug. 26–29) in Barcelona, Spain. The addition of clopidogrel did not provide further protection.

The COVID-PACT trial evaluated whether a higher intensity of anticoagulation and/or the use of antiplatelet therapy prevents blood clots with an acceptable safety profile in patients with severe COVID-19 infection. COVID-PACT was a 2×2 factorial, randomized controlled trial in critically ill patients with COVID-19 conducted at 34 sites in the U.S. Patients requiring ICU-level care (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow nasal cannula, or vasopressors) were randomized to either full-dose or standard-dose prophylactic anticoagulation.

Use of unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) for either regimen was at the discretion of the managing clinicians. In patients without another indication for antiplatelet therapy, there was an additional randomization to either the antiplatelet clopidogrel or no antiplatelet therapy. Patients were assessed clinically and with lower extremity venous ultrasounds 10 to 14 days after randomization and followed until hospital discharge or for 28 days, whichever occurred first.

The primary efficacy outcome was the hierarchical composite of death due to venous or arterial thrombosis, pulmonary embolism, clinically evident deep vein thrombosis (DVT), type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent DVT, through hospital discharge or 28 days. Primary efficacy analyses included an unmatched win ratio and a time-to-first event analysis during treatment.

A total of 390 patients were randomized (390 to an anticoagulation strategy and 292 to an antiplatelet strategy). In the primary efficacy analysis of anticoagulation, a greater proportion of wins occurred with the full dose (12.3%) versus standard dose (6.4%; win ratio 1.95, 95% confidence interval [CI] 1.08–3.55, p=0.028). Results were consistent in the time-to-event analysis (19 [9.9%] events on the full dose vs. 29 [15.2%] on the standard dose; HR 0.56, 95% CI 0.32–0.99, p=0.046).

The primary safety outcome of fatal or life-threatening bleeding occurred in four patients (2.1%) on full-dose anticoagulation and one patient (0.5%) on standard-dose anticoagulation (p=0.19); all of these were life-threatening bleeds and there were no fatal bleeding events. There was no difference in all-cause mortality between groups (HR 0.91, 95% CI 0.56–1.48, p=0.70).

In the antiplatelet analysis, there were no differences in the risks of clotting complications or of fatal or life-threatening bleeding in patients treated with clopidogrel compared with no antiplatelet therapy.

David Berg, MD, a cardiologist from Brigham and Women’s Hospital and Harvard Medical School in Boston, said: “COVID-19 treatment guidelines recommend full-dose anticoagulation for hospitalized patients outside the ICU and the standard dose for those in the ICU. This discordant advice has left many clinicians confused about what to do, particularly in COVID-19 patients at the border-zone of needing ICU-level care. The recommendation for ICU patients is largely based on a trial which found that full-dose anticoagulation, compared with the standard dose, did not decrease the number of days alive without organ support in critically ill patients with COVID-19. COVID-PACT shows that full-dose anticoagulation more effectively prevents the clotting complications of COVID-19, which may be a more appropriate focus for antithrombotic therapy as a preventive intervention, and is the basis for anticoagulation recommendations in ICU patients without COVID-19.”

SVS meets AMA membership requirement, retains House of Delegates seat 

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SVS meets AMA membership requirement, retains House of Delegates seat 

The Society for Vascular Surgery (SVS) has exceeded the necessary compliance threshold required to retain its seat in the American Medical Association (AMA) House of Delegates, the Society has announced.  

Members were informed that the SVS had received an official notification from the AMA confirming it had met the requirement at the beginning of the Labor Day weekend.

Had the SVS not met the requisite membership threshold, said Megan Marcinko, the Society’s advocacy director, “the SVS would have been stripped of its seat within the House of Delegates, and perhaps more significantly, our position as a member of the RVS [Relative Value Scale] Update Committee [RUC].”

The AMA stipulates that in order to maintain a seat in its House of Delegates, a 20% share of SVS members would also be required to hold AMA membership.

“Representation at the RUC is critical as it serves as the main advisory body to the Centers for Medicare and Medicaid Services [CMS] on relative values for new and revised Current Procedural Technology [CPT] codes,” Marcinko said.

“Actively engaging with the AMA also provides various benefits beyond the House of Delegates and CPT/RUC activities, including participation in coalition activities, promoting the interests of vascular surgery, and ensuring collaboration across the House of Medicine.”

Clinical outcomes of the ClotTriever system in DVT set to be evaluated in RCT

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Clinical outcomes of the ClotTriever system in DVT set to be evaluated in RCT
ClotTriever device

Inari Medical has announced planned enrollment of the DEFIANCE randomized controlled trial (RCT), which is designed to compare the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.

The trial will enroll 300 patients at up to 60 centers worldwide. DEFIANCE is Inari’s second RCT and it will run in parallel to the PEERLESS trial. PEERLESS commenced earlier this year and compares the FlowTriever to catheter-directed thrombolytics in pulmonary embolism.

“Anticoagulation is still the predominant therapy used in the management of DVT and in some studies has been associated with post-thrombotic syndrome (PTS) in up to 50% of patients,” said Steven Abramowitz, MD, chair of vascular surgery at MedStar Health, Washington, D.C., co-principal investigator.

“PTS is a debilitating condition with symptoms including swelling, difficulty walking, skin changes and poorly healing open wounds. Research has shown PTS quality of life scores can be as low as those of patients suffering from heart failure or cancer. Mechanical thrombectomy procedures, using technology like ClotTriever, rapidly remove large volumes of DVT and may thereby reduce the risk of PTS.”

“DEFIANCE is the first RCT to compare mechanical thrombectomy to anticoagulation for the treatment of DVT,” said Xhorlina Marko, MD, a radiologist at Beaumont Health in Dearborn, Michigan, co-principal investigator. “The primary endpoint for the trial is a hierarchical composite of treatment failure and PTS severity at six months. The trial has the potential to influence guidelines and change the standard of care.”

Give gift of SVS membership to vascular nurses

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Give gift of SVS membership to vascular nurses
Active SVN members automatically receive affiliate SVS membership as part of their dues

Sept. 4 to 10 is Vascular Nurses Week. It’s the perfect opportunity for Society for Vascular Surgery (SVS) members to “give the gift of dual membership” to both SVS and the Society for Vascular Nursing (SVN) to their vascular nurses.

The SVN has made its management home with the Society for Vascular Surgery (SVS) since 2017. All Active SVN members automatically receive affiliate SVS membership as part of their dues. This permits these vascular nurses to receive SVS communications and e-newsletters, discounts on the Journal of Vascular Surgery and SVS meetings, the SVS job board and the SVN and SVS online communities on SVSConnect.

It’s two memberships for the price of one. And it’s as simple as filling out a form, at vascular.org/GiveSVNmembership.

“We celebrate vascular nurses throughout the year, but especially during Vascular Nurses Week,” said SVS President Michael Dalsing, MD. “This week celebrates the commitment and dedication that vascular nurses display every day on behalf of their patients, who are our patients. They are invaluable to the vascular surgery world.”

All members who give this gift will be recognized. A group discount of 10% is available for those who give four dual memberships.

Dalsing urged his fellow members to provide memberships—annual dues are just $150—to the nurses who work in their practices. “SVS members know the value of their memberships: the discounts on education, the chance to talk with others in the profession, the camaraderie that comes with shared purpose. Give that to your vascular nurses, to help enhance their skills and careers.”

Incoming SVN President Kristen Alix, RN, said, “I joined as a novice bedside nurse, only expecting to glean knowledge of the vascular patient. There was that and so much more. SVN gives the ability to network with national nursing leaders, provides expert content and encourages individual professional growth. I never thought I would lecture on a national stage, be a part of a Board of Directors, or add to vascular education and research. It is so much more than a society; it is a network of friends with a shared passion.”

Beyond SVS communications and other discounts, the benefits of SVN Active membership include:

  • A subscription to the Journal of Vascular Nursing, the leading resource for vascular health research and news
  • Educational conferences tailored to individual needs, including member-exclusive discounts on registration
  • Discounts on the ANCC (American Nurses Credentialing Center) cardiac/vascular certification
  • Annual award program recognizing excellence in education, research, practice, and service to the Society
  • Clinical and patient education resources
  • Quarterly virtual roundtable discussions
  • Opportunities for leadership through task forces and committees, and mentorship through the SVN Mentor Match program
  • The SVSConnect online communities

Visit vascular.org/GiveSVNmembership to learn more and take advantage of the special offer.

Researchers study role of frailty in post-discharge mortality

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Researchers study role of frailty in post-discharge mortality
Julie Hales

Society for Vascular Surgery (SVS) members have developed new methods and tools to assess patient frailty and possible surgical outcomes more simply before patients undergo vascular surgical procedures.

Larry Kraiss, MD, Shipra Arya, MD, SM, and Julie Hales, MS, RN, discussed these methods and tools and their use during “Tracking Frailty in the VQI” as part of the Vascular Quality Initiative (VQI) annual meeting.

Kraiss, who is a professor of Surgery at the University of Utah in Salt Lake City, Utah, noted that he and his team have created a frailty assessment tool that maps variables already used in the comprehensive geriatric assessment (CGA) to established VQI variables. The assessment is an exhaustive survey, taking 90 or so minutes to complete, and is used to estimate longevity.

For the new tool, the team added two variables known to be associated with frailty but not included in the CGA. Using a VQI dataset containing 265,000 arterial reconstructions, researchers tested how well a frailty tool encompassing these data elements correlated with perioperative and long-term survival.

Focusing on VQI long-term mortality measured at nine months, they discovered the model has “excellent predictive power.” Kraiss said that the team found only seven of the tested variables were necessary to accurately model long-term postoperative mortality. The variables were congestive heart failure, renal impairment, chronic obstructive pulmonary disease (COPD), compromised ambulatory status, not living at home, anemia and being severely underweight.

This tool allows comparison of the expected natural history of a vascular condition to be compared with expected 9-month mortality after surgical repair.

In response to concerns that even the shortened VQI frailty assessment tool was too cumbersome to use in a busy surgical clinic, the University of Utah team has been exploring use of the Clinical Frailty Scale (CFS).

“You can consider it to be a simple eyeball test,” said Kraiss during the VQI gathering, which took place during the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). Using a continuum from one to eight (with nine being a special category for the terminally ill), researchers found the division is between four and five, between “non-frail but vulnerable,” to “mildly frail,” typically including an inability to shop independently and may require help with cooking and housework.

“CFS when applied by a geriatrician correlated very well with frailty scoring using CGA,” said Kraiss. “It’s appealing for use in surgery clinic; no additional testing is required and it’s quick and simple.”

Thus far, researchers have had an “encouraging single-site experience,” though the presenter brought up the question of whether CFS can be used “in multiple institutions by multiple providers and still retain its accuracy.”

Hales, who has been a research nurse and the VQI data manager at the University of Utah’s Division of Vascular Surgery for the past seven years, presented on a multi-institution experience with CFS.

Hales and colleagues charted CFS scores over three years at four participating centers in order to evaluate whether CFS is being accurately and consistently used across the centers.

Their data included 336 paired scores, which show how frailty status changed after VQI procedure. The presenter reported that 14% of those deemed non-frail before a procedure declined to frail status and that preoperative frailty improved in 40% of patients. Lower-extremity revascularization was found to be the procedure that most frequently caused frailty status changes.

Hales relayed a preliminary conclusion that these centers are using CFS differently. “There is a need for future analysis to calibrate the CFS score to a common gold standard, such as the VQI frailty scale or the risk analysis index or both,” the presenter commented.

In another presentation, Arya, who is an associate professor of surgery at Stanford University in Stanford, California, outlined a 30-second frailty screening tool called the Risk Analysis Index (RAI) she and her research team developed and then demonstrated how surgeons can use the RAI to measure frailty.

Arya has been studying frailty and surgery since 2014. “I knew the old methods wouldn’t work,” she said. “We need the tool to be rapid, able to be used by anyone, not be variable in terms of who’s using it, and easily administered.”

The team developed a 12-question, 14-point assessment around the five domains of function, physical, cognitive, nutritional and social. “The score robustly predicts who is going to die in the next six months,” she said. “As the score increases, we see an exponential rise in six-month mortality.”

She and her team have used the RAI with Veterans Affairs data and in a modified format in the VQI (VQI-RAI), finding it “highly predictive.” In addition, research into frailty and surgery has shown that vascular surgery “definitely is a specialty with a much higher burden of frailty,” she said, with almost 20% of patients in a high-risk category.

She also has researched the stress of surgery itself, with data indicating that in the frailest patients, the six-month mortality figure is 30 to 40%, “no matter the procedure.”

Arya concluded that RAI offers a “robust tool” for frailty assessment, and suggested that frailty assessment in the VQI could be improved by adding two to three more variables such as cognition, cancer comorbidity and granular function measures.

The study into clinical use of RAI continues, with a four-year VA funded trial on improving outcomes, using a “bundled care” approach. The presenter remarked on the overarching significance of the work: “We’re learning a lot about how to put specialists together to discuss how to optimize outcomes for the high-risk patient, do less-invasive or non-invasive procedures and provide goal-concordant care.”

Shape Memory Medical completes enrollment in the AAA-SHAPE early feasibility study

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Shape Memory Medical completes enrollment in the AAA-SHAPE early feasibility study

Shape Memory Medical has announced the completion of patient enrollment in AAA-SHAPE, the company’s prospective, multicenter early feasibility safety study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

The AAA-SHAPE study, which enrolled a combined 35 patients across two centers in New Zealand and three in The Netherlands, will follow patients for two years.

Shape Memory Medical notes that Impede-FX RapidFill, the study device, incorporates a proprietary shape memory polymer, which is a high volume, porous embolic material that self-expands upon contact with blood.

According to the company, AAA-SHAPE is the first prospective clinical trial to evaluate the application of this novel material in AAA patients and its potential to improve aneurysm sac regression rates following EVAR.

“We have been talking for years about the need to directly manage the AAA sac due to the link between aneurysm failure to regress post EVAR and increased mortality risk,” said Andrew Holden, MBChB, from Auckland City Hospital in Auckland, New Zealand, principal investigator for AAA-SHAPE New Zealand. “Impede-FX RapidFill could be a significant tool for addressing this need, so we could not be more pleased to participate in AAA-SHAPE.”

Michel Reijnen, MD, from Rijnstate Hospital, Arnhem in The Netherlands, principal investigator for AAA-SHAPE Netherlands added, “Although we are still early in the course of patient follow-up, we are seeing signals of impressive sac shrinkage at six months and one year. We look forward to the ongoing evaluation of these patients and how their aneurysms respond longer-term.”

Retrospective study is ‘first to systematically explore predictors of venous stent occlusion’

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Retrospective study is ‘first to systematically explore predictors of venous stent occlusion’
Hügel and colleagues say their study is the first to systematically explore predictors of venous stent occlusion that can be incorporated into the decision-making process prior to an intervention

New data indicate that venous stent failure “may be predicted by low peak flow velocity and post-thrombotic changes in inflow veins” and that endovascular venous stenting for chronic outflow obstructions is an “efficacious and safe” treatment in selected patients. These findings were recently published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

The authors of the study—Ulrike Hügel, MD, from Bern University Hospital, Bern, Switzerland) and colleagues—write that endovenous stent placement has become a first-line approach to prevent post-thrombotic syndrome in patients with chronic post-thrombotic obstruction (PTO) or non-thrombotic iliac vein lesions (NIVLs) if conservative management fails. “This study aims to identify factors associated with loss of patency to facilitate patient selection for endovenous stenting,” Hügel et al state.

The investigators retrospectively analyzed 108 consecutive patients following successful endovenous stenting for chronic vein obstruction performed at a single institution from January 2008 to July 2020. They explain their methods in the JVS-VL paper: “Using multivariable logistic regression, we explored potential predictive factors for loss of stent patency, including baseline demographics, post-thrombotic changes as well as peak flow velocities measured in the common femoral vein (CFV), deep femoral vein (DFV) and femoral vein (FV) using duplex ultrasound.”

Hügel and colleagues detail that the mean follow-up duration was 41±26 months and that participants, 46.3% of whom were women, had a mean age of 47.4±15.4 years. They add that 90 (83.3%) patients had PTO and 18 (16.7%) had NIVLs. Loss of patency occurred in 20 (18.5%) patients who were all treated for PTO, the authors communicate, noting also that comorbidities, side of intervention and sex did not differ between patients with occluded and patent stents.

“Stent occlusion was more common with increasing number of stents implanted (p<0.001) and with distal stent extension into and beyond the CFV (p<0.001),” Hügel et al report in JVS-VL.

The authors also reveal that lower duplex ultrasound peak velocity in the CFV (odds ratio [OR] 7.52; 95% confidence interval [CI] 2.54–22.28; p<0.001) and FV (OR 10.75; 95% CI 2.07–55.82; p<0.005) was a preinterventional predictive factor for stent occlusion. Post-thrombotic changes in the DFV (OR 4.51; 95% CI 1.53–13.25; p=0.006) and FV (OR 3.62; 95% CI 1.11–11.84; p=0.033), they add, was another predictive factor. Finally, the authors state that peak velocities of ≤7cm/s (interquartile range 0–20) in the CVF and ≤8cm/s (IQR 5–10) in the FV were “significantly associated with loss of patency”.

In the discussion of their findings, Hügel and colleagues claim that their study is the first to systematically explore predictors of venous stent occlusion that can be incorporated into the decision-making process prior to an intervention. They also acknowledge “several” limitations to their study, noting, for example, that the sample size was “moderate” and that the retrospective, single-center design and midterm follow-up duration limit the generalizability of the results.

“Insufficient venous inflow as assessed by low peak velocities in the CFV and FV as well as post-thrombotic findings represent reliable risk predictors for stent occlusion, warranting their inclusion into the decision-making process for invasive treatment of PTO,” the authors conclude.

A brilliant plan to increase vascular surgeons’ income—and decrease the incidence of stroke!

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A brilliant plan to increase vascular surgeons’ income—and decrease the incidence of stroke!
Russell Samson

I have come up with a brilliant plan that will decrease the incidence of stroke nationwide, provide an excellent source of income for vascular surgeons, and reduce vascular surgeons’ stress and burnout. My concept is based on two recent trends in the management of patients at risk for carotid territory stroke. 

First, medical management is now so advanced that it can prevent almost all strokes in asymptomatic patients. Therefore, prophylactic carotid endarterectomy or carotid stenting is now inappropriate and unnecessary, except, possibly, in patients with truly critical stenosis in the >90% range. 

Second, according to a paper presented at the 2022 Vascular Annual Meeting (VAM), if surgery is performed, follow-up duplex scanning is unnecessary, since most patients will not develop a subsequent stroke, nor will they develop significant restenosis that requires revision. Thus, vascular surgeons face diminished income since they will not be performing large numbers of prophylactic carotid procedures, nor subsequent follow-up duplex scans. 

My profoundly elegant concept is simple. Vascular surgeons must immediately stop performing highly-stressful carotid endarterectomy or stent procedures in asymptomatic patients. However, if high-grade stenosis is detected, they must continue to do six-monthly carotid duplex scans ad infinitum, just in case a truly critical stenosis is ultimately encountered. Since the reimbursement for a carotid endarterectomy is usually around $900, whereas the reimbursement for a duplex scan is approximately $150, equipoise in reimbursement will be achieved after just three years. 

Thereafter, since the patient is unlikely to have a stroke, and therefore will likely live a long time, the vascular surgeon will make a stress-free $300 a year with ongoing testing. Rather than having to waste time going to the hospital, sit around waiting for anesthesia to see the patient and put them to sleep, worry that the patient will wake up stroke-free, and speak to the family and write the op note etc., they can now relax at the beach drinking a piña colada while they read the duplex scans on their laptop. 

Further, they will no longer need to pay the exorbitant malpractice fees that are associated with the risk of carotid endarterectomy-related stroke, nerve injury and death. Concomitantly, the national incidence of stroke will fall precipitously, and everyone will be happy! 

Russell H. Samson, MD, is a vascular surgeon at Sarasota Vascular Specialists in Sarasota, Florida. He is a 2020 recipient of the SVS Excellence in Community Practice Award and a former medical editor of Vascular Specialist.

VQI analysis links high levels of neighborhood deprivation to more severe PAD

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VQI analysis links high levels of neighborhood deprivation to more severe PAD
Lucas Mota

Patients categorized as living in neighborhoods with high levels of disadvantage under the Area Deprivation Index (ADI) measure of community adversity have more advanced peripheral arterial disease (PAD) and lower rates of revascularization versus amputation, a new retrospective analysis of Vascular Quality Initiative (VQI) data demonstrates. 

The study, led by senior author Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, showed patients residing in the most disadvantaged zip codes were less likely to present with claudication, more likely to report rest pain, and less likely to undergo a revascularization for their PAD than those who live in areas classed as having the lowest levels of deprivation. 

The ADI is composed of five quintiles, with the 5th the most deprived. 

Adjusted analysis showed patients in the 5th ADI quintile being twice as likely to undergo intervention for rest pain rather than claudication, and 40% less likely to undergo revascularization compared to those in the first quintile, according to the analysis. 

The data were presented at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18) by Lucas Mota, MD, a Beth Israel Deaconess general surgery resident. 

The research included nearly 80,000 patients who received open and endovascular infrainguinal revascularization or amputation from 2003–2020. The investigators established that 5th quintile patients were younger, with a mean age of 65, and more likely to be Black, have comorbidities, be former smokers or current smokers, and be uninsured. 

Mota said the ADI was selected as a better measure of the underlying social determinants of health related to neighborhood conditions rather than simply a focus on individual factors such as race, income and insurance status. “Attention needs to be given to understanding neighborhood factors that are contributing to these disparities in order to identify community-level targets for improvement,” Mota told VAM 2022. 

Engaging with primary care providers ‘critically important’ to improving AAA screening

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Engaging with primary care providers ‘critically important’ to improving AAA screening
Matthew Mell

Matthew Mell, MD, has spent a lot of time looking into issues around screening for abdominal aortic aneurysms (AAAs). The problem, says the chief of vascular surgery at University of California Davis in Sacramento, California, is a difficult one to shake: “In the U.S., we under-screen.” 

Mell looks at some of the studies that have come out of the Kaiser Permanente healthcare system in Southern California—a fully integrated health maintenance organization (HMO), or closed system—as instructive. There, physicians were able to use an electronic health record (EMR) to help increase AAA screening rates to “a very high” 50–80%. 

But in non-HMO, or open, systems like his own institution, no one had attempted to find out if such an approach might help boost screening rates, he tells Vascular Specialist. 

Mell and colleagues recently sought to fill that void in the literature against a backdrop of more than 70% of Medicare beneficiaries not being enrolled in a fully integrated HMO and AAA screening poorly utilized by Medicare at-risk populations. 

Mell et al established that primary care providers (PCPs) are “key to optimizing AAA screening rates” and that “out-of-network patients are particularly vulnerable due to a lack of a PCP.” To improve screening rates, at-risk patients need a PCP, and PCPs need both knowledge of U.S. Preventive Services Taskforce (USPSTF) recommendations and active partnership with vascular surgeons to increase patient buy-in, the research team suggested. 

“We looked at both in-network and out-of-network patients—in other words, patients who had their primary care provider within our system and without, or who got their care within our system or their care outside, and what we found was that patients who got the care in our system were much more likely to have a PCP,” Mell explains. “We found that patients who had a PCP were far more likely to accept screening when we offered it to them. I will say, though, that the screening rate was still low. Our patients who have PCPs, I think, had around a 35 or 36% acceptance rate, which was low compared with closed healthcare systems.” 

The UC Davis findings—presented earlier this year during the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Snowmass, Colorado, by medical student Angela Aguirre, BS—showed that of 1,073 eligible patients, review of medical records and calls confirmed previous imaging in 46%. Among the remaining 578, in-network patients (n=117, or 20%) were more likely to have a PCP (95% vs. 53%, p<.001). Successful contact was more likely for patients with a PCP (odds ratio, 2.36; 95% confidence interval 1.62– 3.45; p<.001). Of those offered screening, 31.9% accepted. The most common reason for declining was deference to a PCP (58%). On multivariate analysis, having a PCP remained the strongest predictor of screening. 

“We concluded with this study that engaging the PCP, both at the individual level and, perhaps, at a system level, is going to be really, critically important to improving screening rates for patients who are at risk and eligible,” Mell says. 

Locally, Mell and colleagues have set up educational meetings between their group and primary care to elucidate who is eligible for screening, how to receive it and clear up misconceptions among patients over who pays for screening. “In Europe and in other systems, healthcare systems that are nationalized, patients are used to getting a piece of mail from the healthcare system saying, ‘You’re eligible for this screening test,’ and they go and do it. We have don’t have that, and I think it is clear that a much more personalized approach is really the only way to be effective.” 

Study is first to elucidate lower-limb amputation epidemiology in a Latin American low- and middle-income country

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Study is first to elucidate lower-limb amputation epidemiology in a Latin American low- and middle-income country
x-ray image below knee amputation or BKA amputation
x-ray image below knee amputation or BKA amputation
Below-knee amputation

A study recently published in the World Journal of Surgery claims to be the first to provide comprehensive population-level data on the epidemiology of lower-extremity amputation (LEA) in a Latin American low- and middle-income country (LMIC). The investigators write that their data, which focus on the Brazilian state of Sao Paulo, are “crucial to plan strategies to reduce the burden of LEA.”

“Lower-limb amputations represent a high social, economic and health burden,” Rodrigo Bruno Biagioni, MD, a vascular surgeon at Hospital do Servidro Público Estadual de São Paulo, São Paulo, Brazil, et al write. According to the authors, most lower-limb amputations are preventable, and reflect areas for improvement in healthcare. For these reasons, they stress that it is “essential” to know the epidemiology of these amputations, underscoring the rationale behind their study.

The investigators detail that LEA rates are “highly variable” across the world and that LEA trends are “conflicting.” These factors, they say, necessitate population-based studies in particular, “not only to truly know the local epidemiology of LEA, which reflects the quality of the health system, but also to build a global panorama in order to establish standards and goals.”

According to the authors, several countries in Europe, North America and Australasia have reported their amputation epidemiology, with most data coming from high-income countries (HICs). “Data from [LMICs] are scarce,” they write, noting that in Latin America no such study existed before the present analysis, to the best of their knowledge. “The paucity of data on LEA in LMICs is of particular concern,” the researchers note, “as the burden of PAD and [diabetes mellitus] is increasing in rates higher in LMICs than those observed in HICs.”

Biagioni et al’s study was a retrospective, population-based, cross-sectional analysis on all lower-limb amputations performed in public hospitals in Sao Paulo—the most populous Brazilian state—between 2009 and 2020. The authors relay that they used a public database to evaluate types, rates and trends of the amputations performed, main etiologies leading to the indication for amputation, hospital length of stay and in-hospital mortality rates, demographics of the amputees and procedure costs.

The study included data on 180,595 lower-limb amputations and surgical revisions of amputations, with toe amputations (45%) and major amputations (33%) being the most frequent types of surgeries. Biagioni and colleagues report a significant increase in the rates of both of these procedures. They add that peripheral arterial disease (PAD) was found to be the most frequent underlying diagnosis for LEA, followed by diabetes mellitus, with an increasing trend for both over the last 12 years. Furthermore, they also observed seasonality in procedure rates, with peaks in August in all years.

The authors also reveal that most patients were male (69.3%), Caucasians (55.6%) and elderly. Other findings included a 6.6% rate of in-hospital mortality and lower-limb amputations and total of US$67,675,875.55 reimbursed by the government.

Based on these findings, the authors propose some preventive strategies—namely foot ulcer screening, multidisciplinary diabetic foot care, and encouraging revascularization procedures, which, they claim, have not significantly increased in the city of São Paulo, the capital of the state of Sao Paulo, since 2008.

In the discussion of their results, the research team considers some possible explanations for PAD being the main underlying diagnosis for all LEA in Sao Paulo, one of which is that Brazil is “late in the epidemiological transition concerning LEA.” They predict that it is likely Brazil will reach similar statistics to those found in most recent nationwide studies—which point to diabetes mellitus as the most common underlying cause of LEA—in the coming years, as the prevalence of smoking is reducing and that of diabetes mellitus is rising.

Furthermore, Biagioni et al address the finding that August showed the highest number of amputations in all years of their study. They write that, although this contrasts a previously reported finding from Hong Kong of higher LEA frequency due to diabetes mellitus during the summer, in this study the main underlying diagnosis was PAD, and it is possible there may be a worsening in PAD during winter. They elaborate: “Even though impaired circulation of lower limbs is documented for venous insufficiency, it is reasonable to think it may also play a role in arterial insufficiency.”

The authors recognize there are some limiting factors to their study, including the accuracy of their findings being “susceptible to inherent miscoding or data entry errors,” as with any database-driven study. In addition, they acknowledge that their data represent only the state of Sao Paulo, which depends solely on the public health system. “An integrated database covering data from public and private health systems would be more comprehensive,” they note.

Speaking to Vascular News, a Vascular Specialist partner publication, corresponding authors Andressa Cristina Sposato Louzada, MD, and Nelson Wolosker, MD, both from Hospital Israelita Albert Einstein, São Paulo, Brazil, comment on the study findings: “Knowledge of the data is essential for decision-making by public policy managers. Knowing the real amputation rates, increased investment in risk factor controls, and increased access to revascularization become the most obvious attitudes. Soon, adopting such attitudes, amputation rates will probably decrease. This way, Brazilian society can evolve, an example for other countries.”

Maximize reimbursement: Learn latest in coding at SVS workshop

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Maximize reimbursement: Learn latest in coding at SVS workshop

When it comes to coding, information gaps can lead to revenue gaps. Proper coding and documentation are integral to receiving appropriate reimbursement for vascular procedures. 

And coding for these procedures can be tricky, with many nuances. The Society for Vascular Surgery’s 2022 Coding and Reimbursement Workshop will help surgeons decode the terminology of global surgical packages, how Medicare values services, surgical modifiers, Current Procedural Terminology (CPT) codes, documentation, audit risks and more. Learning correct coding can help a surgeon’s bottom line. 

The workshop teaches surgeons (and/or their staff ) what they need to know to make certain they receive all the reimbursement to which they are entitled, said course director Sean Roddy, MD. 

The workshop and half-day optional workshop for Evaluation and Management (E&M) coding will be Oct. 1–2. The optional half-day workshop will be from 8 a.m.–12 p.m. Oct. 1, with the full-day workshop from 1–5 p.m. Oct. 1 and from 7:30 a.m.–4:30 p.m. Oct 2. Both will be at the OLC Education and Conference Center in the SVS Headquarters office, 9400 W. Higgins Road in Rosemont, Illinois, just minutes from Chicago’s O’Hare International Airport. 

“Coding and reimbursement are two totally different concepts,” said Roddy. “Coding is how you report what you do. Reimbursement is how you get paid.” 

The course teaches surgeons and their coding staff how to code and, just as importantly, how to document accurately to maximize their appropriate reimbursement. “I always say we don’t want our members leaving money on the table. The government will be only too happy to keep it,” said Roddy. 

He stressed two practicalities of correct coding and documentation: It’s generally accepted that correct coding lessens a surgeon’s audit risk. “We try to teach the proper way for appropriate coding to avoid an audit,” he explained. If a surgeon is denied the first time around, “the chances of a claim getting paid eventually go down precipitously and a surgeon has to pay the staff to re-work it.” It’s just best to do it right the first time around, he said. 

Important changes for 2023 include Medicare payment modifications, new guidelines for E&M coding and change in the Medicare Physician Fee Schedule. The content level is intermediate to advanced and is appropriate for all career levels, from vascular trainees to surgeons. 

SVS members receive discounted pricing. Early-bird pricing is available through Sept. 1, and the adjacent Hampton Inn and Suites has discounted room rates when rooms are booked before Sept. 2.

Tying healthcare waste and spending to productivity incentives

Tying healthcare waste and spending to productivity incentives
Bhagwan Satiani

A 74-year-old woman was recently hospitalized for a pulmonary embolus from acute deep vein thrombosis (DVT) of the mildly edematous left lower leg. She had previous DVT in the same leg 10 years ago, wore stockings and was active. She had no family history or evidence of underlying hematologic, or other risk factors. Her son sent me the video, pre- and post-thrombectomy, performed by her cardiologist. It showed non-occlusive bilateral lower-lobe embolization. While I was not privy to many details, her hemodynamic parameters did not appear to me to warrant catheter thrombectomy. She was also advised (I was present as a friend) that she next needed venous thrombectomy of the left leg to “prevent post-thrombotic consequences.” Her next appointment, four weeks hence, was for inferior vena cava (IVC) filter removal. She did well and was discharged on daily apixaban. Was all of this necessary? 

Another recent example is that of a vascular surgeon who mandates a full duplex lower-extremity (LE) arterial study, along with a full physiologic LE arterial study, on all patients with possible arterial complaints. 

As far as I know, only a few folks who follow the literature on guidelines would question similar decisions—they do not because they wish to keep their heads down, possibly because there is no “quality” issue. 

Just like retrospective calculation of deaths from medical “errors,” there is a lot of variation, with even experts disagreeing on what test or procedure is warranted. Unwarranted variation in care is that which “cannot be explained on the basis of illness, medical evidence, or patient preference, but is accounted for by the willingness and ability of doctors to offer treatment.”1 

It is estimated that waste or low value (in my opinion, no-value care) in the clinical sense represents about 5.4–24.6% of all healthcare spending in the U.S.2 The largest percentage of this has been attributed to administrative complexity (7%) and pricing failure (6.1–6.3%). Although half of the waste has not been related to physicians, we do not get off easy. Overtreatment (2–2.7%), care delivery (2.7–4.4%), fraud and abuse (1.6–2.2%) and care coordination (0.7-2.1%) are to varying degrees part of our responsibility.2 Retrospectively labeling a clinical decision to treat is many times a judgment call. But, assigning a profit motive to that decision taints all of us.

In a survey of 2,106 physicians from the American Medical Association (AMA) Physician Masterfile, a median of 20.6% of healthcare in the U.S. was seen as unnecessary.3 This included prescription medications (22%), tests (24.9%) and procedures (11.1%). Physicians surveyed estimated that 36% of tests and procedures were unnecessary. Over 70% of them believed that profit was a motivator to perform unnecessary procedures (and I assume tests). Medical specialists were 42.4% of the sample. Granted, the study had limitations, including the fact that most respondents were not in surgical practice and may not have had enough surgical expertise. 

Profit implies revenue left over after all expenses are paid to allow paying physician salaries. But if 70% of a group of physicians perceive a profit “motive,” suggesting a conflict of interest in their fiduciary role, is there any practice model that does not create such a conflict? Even the Veterans Affairs (VA) or the foundation physician employment models have conflicts. These can be financial (profit, bonus), productivity targets, promotions, hospital budgets or other incentives that are beneficial to the physician in some way. Every test, patient visit or procedure has represented a financial conflict to varying degrees for decades. However, the work relative value unit (wRVU) compensation model in recent employment agreements creates an ethical challenge for the most principled surgeon. I have written previously about the misalignment of incentives in physician employment by hospitals.4 Employment contracts tie base and bonus compensation to wRVUs and may therefore drive up the volume of services and national healthcare spending, some of which could be wasteful. This occurs at the same time as hospitals are publicly participating in accountable care organizations (ACOs), a shift to “value-based” payments assumed to be cooperating in controlling healthcare spending. 

Employer hospitals incentivize maximal physician productivity and stay profitable to service the community, plan future expansion, pay for new technologies, and cover the regulatory and liability onslaught. However, compensating physicians based on pure productivity incentives goes against their responsibility of controlling wasteful spending at the front end. Instead, hospitals are mostly concentrating at the backend by monitoring quality of care, encouraging compliance with national guidelines and specialty self-monitoring. They are correct that physicians do not wish hospitals to interfere with their clinical autonomy. The problem remains that unnecessary care may be done safely, and, since there is considerable grey in guidelines, the amount of wasteful spending goes undetected or ignored. So, is this a stalemate? 

The “choosing wisely” initiative has had very limited impact on unnecessary spending. Meanwhile, eliminating all unnecessary care is unlikely, partly because in many cases honest people will differ on the indications of procedures/tests. Several strategies would help, such as better education of trainees and referring physicians with clear guidelines, easier access to outside electronic health records to avoid duplication, and better monitoring of vascular care for appropriateness rather than just quality of care. Rather than pure (100%) productivity, some institutions use formulas to encourage teamwork and reduce competition within the hospital to combat low-value care. As an example, compensation may then be based on the financial performance of the individual (60%), unit (20%), department (10%) and hospital (10%). Self-employed practitioners can come up with a similar model. Quality of care and outcome targets can also be worked into the formula. 

For our specialty, barring emergencies or urgent cases, elective procedures can be presented to the practice or division group prior to interventions. For non-elective cases, the indications can be listed and presented to the group after the fact. 

For non-interventional procedures such as the vascular lab, we should take responsibility for educating folks about appropriateness and sharing national guidelines, even if other physicians are requesting tests. As medical director of such a lab, ours was probably one of the few departments to decline repeated and inappropriate carotid or venous scans. The sonographers were aware of my criteria for initial or repeat testing. If residents, physician assistants or nurse practitioners who ordered them disagreed with sonographers, they were told to have the attending text or call me if they still wanted the tests. A common example was venous scans of all four limbs for a suspected pulmonary embolus, or a repeat venous scan for major axial lower extremity DVT within a week or two after diagnosis. In many cases, it was obvious that the attending was unaware that the test was requested, and I rarely got contacted. This was not popular, but I did my best to educate.5,6

Again, the lack of “growth” may sometimes cause a problem with hospital administration, so a clear explanation is needed ahead of time. Waste results from “failures of care delivery, failures of care coordination, overtreatment, pricing failures, administrative complexity, and fraud and abuse.”1 We can debate the amount of low-value or unnecessary care and waste, but, in many cases, most of us know it when we see it. 

My point is that, even if there is no physical harm, profligate spending justifies a concerted effort to tighten our approach and come up with innovative ways to monitor unnecessary care before our clinical autonomy becomes a dream. I am not suggesting that any—or many—of us are providing low-value care, but the perception is out there. Regardless of the exact percentage of waste we have control over, and whether employed by hospitals or not, it is our obligation to be true to our patients, model our behavior for our students and residents, and sleep well at night. 

References 

  1. Wennberg JE. Time to tackle unwarranted variations in practice. BMJ. 2011; 342:d1513 
  2. The Role of clinical waste in excess US health spending. https://www.healthaffairs.org/do/10.1377/hpb20220506.432025/full/ 
  3. Lyu H, Xu T, Brotman D et al. Overtreatment in the United States. PLoS ONE 12(9): e0181970. https://doi.org/10.1371/journal. pone.0181970 
  4. Satiani B. Physician incentives may not be aligned with their health system employer. What is a physician to do? Surgery. 2012; 152(5):923–6 
  5. Mouawad NJ, Go MR, Haurani MJ, Moseley M, Satiani B. Elimination of medically unnecessary duplex venous scanning based upon an established algorithm can result in significant cost savings under Medicare for the institution and the taxpayer. Accepted for publication. Journal of Vascular Surgery. Venous and Lym Dis 2015; 3:107–12 
  6. Yoo T, Agrawal R, Braithwaite S, Satiani B, Haurani JH. Four extremity venous duplex ultrasonography for suspected deep venous thrombosis is an anachronism.” Journal of Vascular Surgery: Venous and Lym Dis 2019; 7:325–32 

Bhagwan Satiani, MD, is professor emeritus in the division of vascular diseases and surgery in the College of Medicine at The Ohio State University, Columbus, Ohio. 

SVS charts its course ahead for diversity, equity and inclusion

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SVS charts its course ahead for diversity, equity and inclusion
Michael Dalsing

Society for Vascular Surgery (SVS) President Michael Dalsing, MD, has added two more liaisons—Vincent Rowe, MD, and Palma Shaw, MD—to the SVS Executive Board to “increase the diversity of perspective.”

They will serve for the remainder of the fiscal year and join Linda Harris, MD, the recently re-elected representative of the SVS Strategic Board of Directors, to the Executive Board.

In addition, SVS has hired a consultant in diversity, equity and inclusion (DEI) to develop a translational webinar and guide in DEI principles and values that will be mandatory for all elected and appointed members of boards, councils, committees, sections and task forces.

The move, approved by the board, came as a result of listening to multiple groups and member constituencies within SVS following a sparsely attended session on diversity, equity and inclusion (DEI) at the Vascular Annual Meeting and relatively low participation of members participating in the online office election held prior to VAM.

Though SVS “has made significant progress in many ways, it was clear that SVS must not rest on its laurels and needs to stay vigilant and committed to the current trajectory of change.”

DEI issues were front and center during the Executive Board Retreat in late July, where members debated many potential ideas on promoting DEI values. Immediate actions were hiring the consultant, plus planning for a follow-up “DEI summit” across vascular surgery in January. Collaboration also will be increased between the DEI and Communications committees to shape SVS focus and messaging consistently.

Other ideas proposed at the retreat need more thought, Dalsing said, and may lead to substantive changes in SVS governance and bylaws. He is forming a Special Bylaws Subcommittee to review and discuss potential changes that could be implemented for this current fiscal year. Any proposals that impact bylaws to take effect before the year ends on March 31, 2023, would require a special member referendum before Jan. 31, 2023.

Dalsing asked members to “stay positive, hopeful and deeply engaged with SVS. It is the only way to ensure that the Society will advance and meet its optimal potential for all members.”

Navigating EMRs: SVS webinar to demonstrate how to make them work for vascular surgery

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Navigating EMRs: SVS webinar to demonstrate how to make them work for vascular surgery

Vascular surgeons can learn how to make electronic medical records (EMRs) work for them at a webinar Sept. 7. The webinar, sponsored jointly by the Society for Vascular Surgery’s Community Practice Section and the Health Information Technology and Wellness committees, will begin at 6 p.m. Central time.

Panelists will discuss how to manage records to benefit daily practice needs; using EMRs in small independent practices, including outpatient-based (OBL) facilities; and how to manage the burnout so many physicians and surgeons feel as a result of dealing with electronic records.

Malachi Sheahan III, MD, who has written extensively on EMR issues, will discuss “Stating the problem of whether the EMR works for us or the other way around,” as well as burnout, mitigation strategies and SVS’ role to resolving the issue.

Other topics and speakers include:

  • Daniel Bertges, MD, strategies and updates on SVS discussions with Epic and PowerChart on ways to integrate vascular-specific documentation requirements and streamlining data entry.
  • London Guidry, MD, how the smaller independent group can effectively use EMRs in daily practice and/or the OBL setting, including barriers, challenges and advantages.
  • James Craven, MD, on the employed vascular surgeon experience.
  • Jeniann Yi, MD, on the challenges and opportunities of integrating different EMRs.

To learn more and to register, visit vascular.org/EMRwebinar22.

DEI initiatives in vascular surgery: How are we doing?

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DEI initiatives in vascular surgery: How are we doing?
Doctors and medical staff wearing surgical masks, they are standing together, coronavirus prevention concept

The 2022 Vascular Annual Meeting (VAM) has been touted as the most diverse to date. As attendees ourselves, we can attest to the increased representation among attendees, presenters and moderators. 

A dedicated session, named “Building diversity and equitable systems in vascular surgery,” should have been the perfect setting for the membership and leadership to showcase its stated commitment to diversity, equity and inclusion (DEI) initiatives. However, the shockingly low attendance by members and leaders at this session left us feeling like we had witnessed a fumble at the one-yard line. This less-than-optimal outcome was met by notable expressions of frustration and disappointment by the few attendees who were present. Quickly, these sentiments were being echoed and amplified on social media platforms. The Society for Vascular Surgery (SVS) Executive Board responded to the smoldering controversy with a written statement posted on the official SVS website with a brief statement vowing continued efforts to prioritize DEI principles and accelerate change while acknowledging organizational shortcomings.1 Certainly, scheduling so many competing events had a significant impact. 

Empty seats and sparsely attended sessions notwithstanding, what lessons should the SVS and those of us working on DEI-focused initiatives take away from these events? Does lack of attendance equate with lack of interest in DEI? More importantly, what is the current state of DEI efforts in vascular surgery? Are vascular surgeons appropriately interested, engaged, and equipped with the knowledge and skills to combat health inequities? Do current and future vascular surgeons understand how paramount DEI interventions are to building a diverse workforce more mindful of the barriers our most vulnerable patients face? 

We don’t ask these questions to be hyperbolic. Rather, we ask in the hope of eliciting thoughtful and frank, at times painful, discussions about the root cause of many of these complex issues and our roles in addressing them. Broadly speaking, DEI has been seen as the panacea to increase diversity and inclusion in our workforce, address bias in the clinical learning environment, and eliminate health inequities and disparities.2-3 Each of the objectives are pillars of DEI that exist in their separate but interconnected domains. The SVS has adopted these same principles in its bylaws and efforts to change the organizational culture of vascular surgery. As SVS members, we are all tasked with the work to advance “excellence and innovation in vascular health through education, advocacy, research and public awareness.” As such, advancing DEI initiatives is in keeping with our mission as vascular surgeons. 

However, in its current iteration, we’ve treated DEI as a secondary outcome, whereas it should be treated as a primary outcome. So how, then, do we make this transition to appropriately position DEI efforts within our day-to-day practice? We propose that adopting instruments and metrics to capture and analyze patients’ social determinants of health (SDoH) in clinical care, research, and quality improvement initiatives is a concrete first step that individual and organizations can take today. 

It has been well documented that patients with low-income levels, and racial and ethnic minorities, have worse outcomes with amputations and are more likely to undergo fewer revascularization attempts prior to intervention.4-5 SDoH provides a good mechanism to interrogate the reasons behind these disparate outcomes and help provide evidence-based, patient-centered comprehensive vascular care. Also, integrating these datapoints into our root-cause analysis during peer-review conferences can serve as teaching moments for our trainees and quality improvement opportunities. 

Vascular surgery finds itself at the intersection of SDoH, patient outcomes and a perilous healthcare system. This presents challenges but also opportunities. We are privileged to take care of simultaneously the most diverse, disenfranchised and comorbid populations in our society. As this population ages and the health gap widens, it is more important than ever that we put the correct emphasis on DEI interventions. 

References 

  1. https://vascular.org/news-advocacy/articles-press-releases/prioritizing-dei-principles. Accessed June 22, 2022 
  2. Aulivola B, Mitchell EL, Rowe VL, et al. Ensuring equity, diversity, and inclusion in the Society for Vascular Surgery: A report of the Society for Vascular Surgery Task Force on Equity, Diversity, and Inclusion. J Vasc Surg. 2021 Mar;73(3):745–756.e6. doi: 10.1016/j.jvs.2020.11.049 
  3. Dalman RL, Murphy SA, AbuRahma AF, et al. The Society for Vascular Surgery Executive Board response to the Diversity, Equity and Inclusion Taskforce Report. J Vasc Surg. 2021;73(3):757–761. doi:10.1016/J. JVS.2020.11.048 
  4. Fanaroff AC, Yang L, Nathan AS, et al. Geographic and socioeconomic disparities in major lower extremity amputation rates in metropolitan areas. J Am Heart Assoc. 2021;10(17):21456. doi:10.1161/ JAHA.121.021456 
  5. Gober L, Bui A, Ruddy JM. Racial and gender disparity in achieving optimal medical therapy for inpatients with peripheral artery disease. Ann Vasc Med Res. 2020;7(4). Accessed July 19, 2022. /pmc/articles/ PMC7877491/ 

Imani E. McElroy, MD, is a resident at Massachusetts General Hospital in Boston. Carla C. Moreira, MD, is an associate program director at Alpert Medical School of Brown University in Providence, Rhode Island. 

Diversity gains momentum at JVS

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Diversity gains momentum at JVS
M. Libby Weaver

The addition of a diversity, equity and inclusion (DEI) editor at the Journal of Vascular Surgery (JVS) was found to be associated with more diversified publications and perspectives—including a significant increase in the number of women involved in the peer-review process—in a new analysis led by researchers from the University of Florida. 

Results from the study were hailed by outgoing JVS group editor-in-chief Peter Gloviczki, MD, as a sign of the progress made at the Society for Vascular Surgery (SVS) journals since the DEI editor, Ulka Sachdev-Ost, MD, was appointed nearly two years ago—but also of the opportunity for further improvement in diversity, equity and inclusion that still remains. The DEI editorial role was created in the wake of the “Medbikini” controversy in which JVS published a since-retracted paper entitled “Prevalence of unprofessional social media content among young vascular surgeons.” 

Findings from this new study, “The measurable impact of a diversity, equity and inclusion editor on diversifying content and perspectives represented in the Journal of Vascular Surgery (JVS),” were presented by M. Libby Weaver, MD, during the 2022 Vascular Annual Meeting (VAM) in Boston ( June 15–18). Weaver is a vascular fellow at the University of Florida School of Medicine in Gainesville, Florida, who is about to become a vascular surgeon at the University of Virginia. 

Weaver and colleagues set out to measure the impact of Sachdev-Ost’s role on the presence of DEI topics and women authorship over a period stretching from a year prior to Sachdev-Ost’s appointment through May of this year. “Women and minorities remain underrepresented in academic vascular surgery, and this persists in the editorial peer-review process, and may contribute to publication bias,” she told VAM 2022. 

Authorship and content examination were stratified into three periods: November 2019–October 2020, or the period prior to the creation of the DEI editor’s role; November 2020–October 2021, the period afterward; and September 2021–May 2022, a period incorporating the average 47-week lag time from submission to publication in JVS. 

The researchers found that editorial, guideline, and non-primary research articles dedicated to DEI topics increased from zero before to four by May 2022. “The proportion of these articles on any topic with women as first or senior authors more than doubled from 24% to 53%,” said Weaver. Invited commentaries and discussions were “significantly increasingly” written by women as the study period progressed—from 19% to 40% (p=0.02). 

“There were 56 research studies and systematic reviews on DEI-related topics published during the entire study period—the majority of which were patient-centered,” Weaver explained. “The proportion of research studies dedicated to DEI topics initially decreased but then significantly increased to 7% [5.4% pre; 3.1% post; p=0.04] when taking into consideration the lag in publication time for a total of 23 thus far in the nine-month lag period.” 

Clinical research and systematic review manuscripts on DEI topics were nearly twice as likely to have women as first or senior authors (71.4%) compared to non-DEI specific manuscripts (37.5%; p<0.001), the investigators discovered. They also recorded an increase in the number of women reviewers from 31 of 191 (16.2%) to 51 of 245 (20.8%; p=0.22), and of women distinguished reviewers from three of 107 (2.8%) to 16 of 73 (21.9%; p<0.001). 

“The addition of a DEI editor to the JVS is associated with diversification of publications and perspectives represented in the journal,” Weaver told VAM 2022 attendees. “Women in particular contribute significantly to the scientific literature focused on underrepresented patient populations and diversifying the vascular surgery workforce. There was also a significant increase in women invited to perform peer reviews during the study period. Ongoing efforts are necessary to continue to improve diversification of subject matter and perspective in the vascular surgery literature, and reduce publication bias.” 

Commenting at the close of Weaver’s presentation, Gloviczki explained how the JVS leadership came to the decision two years ago to tackle the diversity issue by creating a dedicated editorial role. “This is a deficiency of the peer-review process and the editorial process at the journal, and we made, as you beautifully demonstrated, significant changes,” he said. 

Yet women, he continued, remain just 15% of the JVS reviewer pool. “We have 706 reviewers of the JVS, and only 104 are women.” The number is twice as high as before 2020, but the journals “desperately” need more, Gloviczki said. 

“We try to send every paper to a woman or underrepresented minority reviewer, but they are overwhelmed, and they cannot really be reviewers of all the papers.” 

Elsewhere, Gilbert Upchurch Jr., MD, chair of the University of Florida Department of Surgery, asked whether Weaver and colleagues had detected impactful journals in the wider scientific literature “that actually blind to race and gender when sending reviews out” as a potential alternative to the paucity of female reviewers. 

“I do know of a paper in the scientific literature—that is not specific to the surgical literature—that demonstrated that, when the assigning editors are women, they are more likely to assign peer reviews to women,” Weaver answered. “And the alternative is true, so I worry that it would actually potentially cause the opposite problem.” 

Weaver suggested that a solution may lie in diversifying the editorial board as well as the contingent of assigning editors. 

Session moderator Ellen Dillavou, MD, the medical director and division chief of vascular surgery at the WakeMed Hospital System in Raleigh, North Carolina, said the discussion offered an opportunity to encourage younger members of the vascular surgery community, or those who might not think they qualify, to sign up to review and help swell the ranks. “Proportionally, by age, we are a much more diverse group the younger we are,” Dillavou added. 

Weaver pointed out that one of the qualifications needed to become a JVS reviewer is Board-eligibility, challenging the journals to take another look at this requirement. “I think that carefully selected trainees can provide very thoughtful reviews, and that might be a way to quickly diversify your pool and add to it a little bit.”

Key differences in presentation, outcomes for distal versus proximal DVT uncovered

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Key differences in presentation, outcomes for distal versus proximal DVT uncovered
Doctor holding touching hands Asian senior or elderly old lady woman patient with love, care, helping, encourage and empathy at nursing hospital ward : healthy strong medical concept

A new study highlights key differences in clinical features and comorbidities, as well as short-term and also long-term outcomes for patients with distal deep vein thrombosis (DVT) versus proximal DVT. The findings were recently published in JAMA Cardiology.

The differences between the clinical presentation, short-term and long-term outcomes for patients with isolated distal DVT (smaller thrombi in veins below the knee) versus proximal DVT have been unclear, Behnood Bikdeli, MD, from Brigham and Women’s Hospital in Boston, and colleagues write.

In order to investigate this gap in the literature, the researchers conducted a multicenter, international cohort study in participating sites of the Registro Informatizado Enfermedad Tromboembólica (RIETE) registry from March 1, 2001, though Feb. 28, 2021.

The team found that patients with isolated distal DVT had lower comorbidity burden and a lower risk of 90-day mortality. They were also at lower risk of developing a pulmonary embolism or a new venous thromboembolism (VTE) in one year.

The authors note that some of the differences in the outcomes are attributable to the risk profile of these patients. Patients with distal DVT were younger, more likely to have had DVT in the setting of transient provoking factors such as surgery or hormonal use but less likely to have serious comorbidities such as cancer or anaemia.

“Our findings may have implications for risk stratification and for practice,” said Bikdeli. “While we find less ominous outcomes for isolated, distal DVTs, they are not entirely benign. Even among patients who received initial anti-coagulation treatment, almost half had signs or symptoms of post-thrombotic syndrome, a chronic manifestation of these clots. Randomized clinical trials are needed to assess the best long-term management for patients who have had isolated, distal DVT.”

SVS addresses pair of critical payment-related proposed rules

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SVS addresses pair of critical payment-related proposed rules
CMS is proposing to cut the Medicare conversion factor by approximately 4.5% for CY2023

In July, the Centers for Medicare and Medicaid Services (CMS) released two critical payment-related proposed rules for CY2023—the highly anticipated Medicare Physician Fee Schedule (MPFS) Proposed Rule followed by the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. 

Of note, in the MPFS, CMS is proposing to cut the Medicare conversion factor—the basic starting point for calculating Medicare payments—by approximately 4.5% for CY2023. In addition, payment reductions for many vascular surgeons are compounded by the second year of CMS’ phased-in implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule. 

“This year’s proposed rule is yet another example of how the current payment system fails to support physicians and the patients they serve,” said Matthew J. Sideman, MD, chair of the Society for Vascular Surgery (SVS) Advocacy Council. “These significant year-over-year payment cuts will most certainly jeopardize patient access to critical vascular healthcare. Congress must begin work in earnest to avert these cuts and establish a new payment system that will provide stability for both physicians and patients.” 

In the OPPS rule, CMS is proposing to update payment rates by 2.7% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.1%, reduced by a 0.4 percentage point for the productivity adjustment. 

The SVS is analyzing both rules and will submit extensive comments to CMS. SVS members should be prepared to engage in these ongoing advocacy efforts through the remainder of the year, said Sideman.

Limb salvage in focus: New VAM lectureship, born of a pioneering spirit, thrills honoree

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Limb salvage in focus: New VAM lectureship, born of a pioneering spirit, thrills honoree
Frank J. Veith

It all started around the late 1970s, early 1980s. Back then, recalls Frank J. Veith, MD, the notion of aggressively pursuing limb salvage in a gangrenous foot or toe went against the grain of current thinking. What Veith and his colleagues were undertaking represented “very distal bypasses,” and, at the time, what he was doing seemed to amount to virtual heresy, he muses. No one else seemed to accept the legitimacy of the surgeries. Yet they worked, says the vascular surgery luminary, former Society for Vascular Surgery (SVS) president, and current chairman of the internationally renowned VEITHsymposium. 

“Everybody thought, if you had a gangrenous foot, toe or any kind of ischemic lesion of the foot that was due to atherosclerosis below the groin, that the right treatment was an amputation,” Veith tells Vascular Specialist. “We were amongst the first to start advocating aggressive limb salvage. We were able to save, I guess, more than 90% of the patients that presented with limb-threatening ischemia, to save their leg.” 

Veith was speaking shortly after the occasion of a new Vascular Annual Meeting (VAM) named lectureship being announced by the SVS—in his honor—that will focus on peripheral arterial disease (PAD) and, in particular, limb salvage. Coined the Frank J. Veith Lecture, the maiden talk is set to take place next year at VAM 2023 in National Harbor, Maryland (June 14–17). 

The focus of the lecture, Veith says, bears particular importance for the SVS amid the currently crowded field of physicians from other specialties involved in the treatment of PAD. It was vascular surgeons who originated the treatment for limb salvage, he continues, and so it is vascular surgeons who should lead the limb salvage charge going forward. “Now, of course [limb salvage] surgery has been accepted around the world, and, even more importantly, we were among the first to do percutaneous angioplasties in association sometimes with a bypass,” Veith elaborates. “But now the treatment has largely become interventional—I’d say 75–80% of limb salvage procedures are done endovascularly—and the field has exploded. Now the other interventional specialists, like interventional cardiology and interventional radiology, are becoming strong advocates of limb salvage.” 

Despite being progenitors of the procedure, Veith says, in many communities vascular surgery is gradually losing out to these other specialties. “I think the SVS putting emphasis on these procedures, some of which are going to require open vascular surgery, many of which will be done interventionally by vascular surgeons, I think is going to go a long way to maintaining vascular surgery’s leadership in this area.” 

Placing a focus on limb salvage might also help attract up-and-coming vascular trainees and surgeons to a largely unglamorous area of the specialty, Veith adds. “We think that this lectureship will promote progress by vascular surgeons in the sometimes-unpopular field of lower-extremity revascularization. Right now, everybody is interested in fenestrated and branched endografts and treating big, complex aneurysms. That is an important field, and the advances are really quite dramatic. But the less glamorous field of treating patients with limb-threatening ischemia, I think, is extremely important for vascular surgery to maintain a leadership position in.” 

For medical students, trainees and emerging surgeons who might be viewing the broad swathe of vascular surgery with a curious eye, Veith has a succinct message. “Sometimes it’s best, if you want to achieve leadership in a specialty, to go into a field that is not primarily popular,” he says. “In other words, don’t try and replace all of the extremely skillful vascular surgeons doing these complex aneurysm repairs endovascularly—go into a field that is maybe a little less glamorous and sub-specialize in it, and you may achieve prominence more quickly than you might if you went with the crowd.” 

CX Aortic Vienna: Cardiac, vascular surgeons collaborate at the vanguard of aortic care

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CX Aortic Vienna: Cardiac, vascular surgeons collaborate at the vanguard of aortic care

CX Aortic Vienna returns in October for its third edition (Oct. 24–26, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The meeting will showcase the latest approaches—open and endovascular—for the treatment of complex aortic problems spanning the aortic valve to the iliac arteries.

Having attracted a global, online audience during its first two editions, CX Aortic Vienna will continue to reach out to the worldwide aortic surgery community. The 2022 edition features three days of high-quality digital programming, to be broadcast live for the wider global audience, delivering a total of 15 hours of aortic education, which will also be available on-demand to registered attendees after the event.

Click here for latest program and registration details.

The format for the digital edition will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast. The program includes open and endovascular aortic techniques and technologies, including edited aortic cases.

For the first time, the meeting will also offer an in-person component from its home city, Vienna, Austria, where CX Aortic Vienna has been invited to provide two 90-minute primetime cutting-edge English-language sessions for attendees of the Dreiländertagung—the joint meeting of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG) and the German Society of Vascular Surgery (DGG)—on Thursday, Oct. 20.

World-leading faculty

The full program has been curated by a Vascular, Endovascular and Cardiothoracic Executive board comprised of leaders in the field of aortic care, including CX Aortic Vienna founding chair Roger Greenhalgh (London, UK), alongside Tilo Kölbel (Hamburg, Germany) who will moderate the in-person session at Dreiländertagung, Afshin Assadian (Vienna, Austria), Roberto Chiesa (Milan, Italy), Martin Grabenwöger (Vienna, Austria), Stéphan Haulon (Paris, France), Gustavo Oderich (Houston), Markus Steinbauer (Regensburg, Germany) and Alexander Zimmermann (Zürich, Switzerland).

“This is, as always, a focus upon the aorta as managed by cardiac aortic surgeons, open vascular surgeons and endovascular surgeons; from the aortic valve at one end, to the iliacs at the other end,” says Greenhalgh of the event’s 2022 edition. “CX Aortic Vienna, for those of you who have been to it before, is for all of those who manage the aorta,” he adds. “This is not just the surgeons, but the physicians—we have radiologists, imaging experts, vascular scientists and vascular nurses. All who manage aortic patients are welcome to come and join us for the digital edition on 24, 25 and 26 October this year.”

“October is the time for aortic disease and to discuss newest trends, technologies and features in aortic therapy,” comments Kölbel. “We are focusing on both open and endovascular techniques and we are inviting the cardiovascular and vascular communities to come to CX Aortic Vienna, with a presence during the Dreiländertagung, and very much to the virtual event that happens a few days later.”

Multidisciplinary approach

The importance of multidisciplinary aortic approaches will be a key strand running through CX Aortic Vienna’s content and discussion, and the 2022 event will continue its mission to bring together specialists of all skills—be they cardiac, vascular or endovascular—to provide a comprehensive overview of cutting-edge aortic treatment.

“CX Aortic Vienna is the unique chance to get together with cardiac surgeons and all kinds of vascular specialists that are treating the aorta,” says Zimmermann, discussing the importance of the multidisciplinary focus at the heart of CX Aortic Vienna. “The problem is that we have a transition zone in the arch and we—as vascular surgeons—move further and further into the ascending aorta with our endovascular techniques. This can only be done with the support of the cardiac surgeons, and this is the reason why we really look forward to CX Aortic Vienna because everyone comes together addressing this complex field.“

Talking points

The program encompasses discussion and debate spanning key talking points in the aortic space including aortic arch interventions, thoracic dissection, thoracic imaging, thoracoabdominal techniques, juxtarenal, abdominal aortic and iliac artery therapies.

“I have had the honor and the privilege during my career to treat the aorta from the aortic valve all the way to the femoral arteries,” notes Joseph Coselli (Houston), who has been among the expert speakers to have participated in previous editions of CX Aortic Vienna and is returning in 2022. “The entire history of aortic surgery, and vascular surgery to the same extent, has been one of technical and clinical evolution.”

Coselli adds: “The Charing Cross meetings are among the best with regard to the broad spectrum of technology and clinical information and sharing among experts. I would invite everyone to take the opportunity to learn a lot about vascular and aortic surgery at CX Aortic Vienna.”

From 2023 onwards, CX Aortic Vienna will be held annually in October as a hybrid meeting in-person in Vienna whilst simultaneously livestreaming globally.

Innovation within the Veterans Health Administration

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Innovation within the Veterans Health Administration
Frederick Beavers and George Akingba

If one were to ask the average citizen where cutting-edge technology is developed, the most probable answer would be “private industry”; think Apple, Tesla, Uber. This lies in the belief that the U.S. government is slow, risk-averse and cumbersome when it comes to innovation efforts. But taking a deep dive into the recent history of innovation in the U.S. would yield a different perception.

For example, consider the Defense Advanced Research Projects Agency, known as DARPA. Born out of the realization that the U.S. had fallen behind the Union of Soviet Socialist Republics (USSR) in the Space Race, DARPA was created in 1958 to catch up to Russia and ensure that the U.S. would never lag behind technologically in matters of national security. 

A few years later, DARPA expanded its mission. A partnership was formed between the military (Air Force) and academia (Douglas Engelbart and the Stanford Research Institute) to create the framework for modern computers (the oN-Line System). This model of an academia and private-sector partnership would be used repeatedly to innovate, eventually leading to the invention of the internet. 

In the 1960s, the Lockheed Corporation developed Eclipsys, allowing physicians to place orders electronically. In 1977, the federal government laid the groundwork for an electronic health record (EHR) system with the Computer Assisted System Staff (CASS). CASS was developed at the Veterans Affairs (VA) Medical Center at Massachusetts General Hospital and became the precursor of today’s Veterans Administration’s EHR platform, Veterans Health Information System and Technology Architecture (VistA). In short order, the VA allowed unrestricted access to this EHR technology, providing the private sector the opportunity to expand its use. Two decades later, the VA developed and implemented the Computerized Patient Records System (CPRS), the first clinically usable EHR in the world. 

Patient care has also benefited from government innovation. In 1978, a joint venture between the U.S. Navy and DARPA led to the technology of Excimer lasers, used for laser eye surgery and arterial atherectomies. In 2006, a joint venture—LUKE—between the VA, DARPA and the private sector (DEKA Research and Development Corporation) led to the development of an electromechanical prosthetic upper arm with near-natural control. These examples are just the tip of the iceberg. 

In 2020, the Veterans Health Administration (VHA) launched two new programs: VA Ventures and the Office of Healthcare Innovation and Learning (OHIL). VA Ventures’ mission is to promote collaboration between the VHA, academia, start-up companies and industry to drive healthcare innovations towards sustainable, high-impact solutions and to ensure that innovations are delivered initially to military veterans. 

Direct patient care technologies include: 3D bioprinting, artificial intelligence (AI) and machine learning imaging, robotics, and augmented and virtual reality. One project directly applicable to the surgical community that highlights the VA’s push for innovation is Project Convergence. The VA is leveraging a public-private partnership between the VA, Verizon, Medivis, Azure and Microsoft to develop a 5G medical campus. The goal is to convert 2D imaging to 3D-holographic imaging, leading to better preparation and planning for surgery. 

Thus, it is shown that the U.S. government, and, by extension, the VHA, has recognized that to stand still is to be left behind. The VA has been at the forefront of developing new ways to deliver healthcare to veterans and the general population. Through public-private partnerships, the VA will continue to innovate and look for new, better and more effective ways to provide progressive patient care. 

Frederick Beavers, MD, is a member of the SVS VA Vascular Surgeons Committee. George Akingba, MD, is a vascular surgeon at the VA Medical Center in Washington, D.C. 

AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system

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AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system

AngioDynamics recently announced receiving Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.

The FDA recently cleared the expanded indication for the Auryon system’s 2mm and 2.35mm catheters to include adjacent thrombus aspiration when treating stenoses in native and stented infrainguinal arteries. Both catheters have aspiration capabilities as atherectomy devices, including in-stent restenosis (ISR).

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK), and ISR, and to date, has been used to treat more than 21,000 patients in the U.S., a company press release reported.

“Combining the 2mm and 2.35mm Auryon laser atherectomy with the aspiration capability has changed our practice. We now treat acute limb ischemia in a single session where we remove the acute component as well as treat the underlying lesion. Patients are now discharged in less than 24 hours without the need for an ICU bed or overnight lysis,” said Carlos J. Guevara, MD, an interventional radiologist from Washington University School of Medicine in St Louis, Missouri.

Vascular experts establish appropriate use of IVUS in peripheral interventions

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Vascular experts establish appropriate use of IVUS in peripheral interventions

Royal Philips today announced an important milestone in the evolving standard of care for treating patients with peripheral vascular disease: the establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower-extremity arterial and venous interventions.

Published in the August 2022 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions, the new consensus document from 30 global vascular experts recommends routine use of IVUS as a preferred imaging modality in all phases in many peripheral vascular disease procedures.

“The voting panelists considered a variety of clinical scenarios and based on their extensive experience, arrived at a strong consensus,” said lead author Eric A. Secemsky, MD, from Beth Israel Deaconess Medical Center in Boston. “They recommend routine use of IVUS as a preferred imaging modality in all phases for many peripheral interventions, both diagnostic and therapeutic, as it enables such exquisite visualization of the target vessel and lesion. Their recommendations, which withstood the rigor of peer review, can now be considered in the formulation of clinical guidelines for the diagnosis and treatment of peripheral vascular disease.”

Peripheral vascular disease affects an estimated 200 million people worldwide, including approximately 40 to 45 million Americans, according to the American Heart Association. The authors noted that minimally invasive approaches for peripheral vascular disease interventions are increasingly common, but traditional imaging techniques like angiography have limitations, including two-dimensional projections of three-dimensional vasculature, which can complicate diagnosis and intraprocedural optimization.

Supported in part by research grants from Philips and Boston Scientific, the study was conducted and analyzed independently by Smith Center for Outcomes Research, gathering a wide spectrum of vascular expert opinion to ascertain the role of intravascular imaging in contemporary clinical practice.

Patient-reported outcomes in vascular surgery are here to stay

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Patient-reported outcomes in vascular surgery are here to stay
Patient at hospital

In 2022, the Centers for Medicare and Medicaid Services (CMS) is again emphasizing the importance of patient-reported outcomes (PROs) through legislation regarding the Quality Payment Program. In the Merit-based Incentive Payment System (MIPS), the use of PRO tools was designated as a highly weighted Improvement activity.1 The objective of this activity is to incorporate PRO data into routine clinical care, thus increasing patient engagement and health outcomes for all populations. PRO improvement activities require both documentation of promotion of PRO tools and PRO data collection for 2022. 

In addition, this year eight of the MIPS Quality Measures involve the use of PROs.2 The measures focus on functional status changes for patients with a range of orthopedic pathologies; one asthma- and one psoriasis-focused quality measure assessing patient-reported disease control; and one primary care measure that captures 11 patient-reported items to assess the broad scope of primary care. Overall, CMS is increasing its focus on PRO measures in both the quality and improvement spaces, and vascular surgeons need to be aware of and prepared for this shift. 

There are a number of PRO measures (PROMs) relevant to vascular disease. Last year, the Society for Vascular Surgery (SVS) Performance Measures Committee (PMC) identified all available PROMs relevant to vascular surgeons. The PMC also evaluated PROMs perceptions, barriers to implementation and concerns.3 

The PMC identified 31 PROMs related to vascular surgery diseases, and three sub-themes in knowledge gaps among vascular surgery physicians: lack of awareness of existing PROMs; knowledge of how they are developed and validated; and clarity around how they should be used. 

Participating physicians were concerned about the usefulness of PROMs in vascular surgery, barriers to the use and implementation of PROMs, and possible unintended consequences of reporting PROMs. Based on these findings, the PMC recommended four actions to facilitate the widespread implementation of vascular surgery-related PROMs: develop more vascular surgery-specific PROMs that expand our ability to assess response to treatments for vascular disease; develop recommended best practices for their collection and use; provide education about them; and partner with stakeholders to improve PROM development and implementation. 

One of MIPS’ major limitations to date has been the relevance of quality measures to vascular surgery. There are less than a handful of vascular-specific measures recognized by CMS, and two are currently up for potential removal due to a lack of reporting in performance year 2020. Given the CMS focus on PROs, it may be valuable for the SVS to advocate for PROM development for use in MIPS and, ultimately, MIPS Value Pathways (MVPs). The SVS PMC is currently tackling this issue, along with the action items around PROMs noted above.3 In order for PROMs to be effectively applied, SVS members need to better understand and implement these measures moving forward. 

References 

  1. Quality Payment Program. 2022 Improvement Activities: Traditional MIPS. Available at https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2022 Accessed 7/15/2022. 
  2. Quality Payment Program. 2022 Quality Measures: Traditional MIPS. Available at https://qpp.cms.gov/mips/explore-measures?tab=qualityMeasures&py=2022. Accessed 7/15/2022. 
  3. Hicks CW, Vavra AK, Goldsborough E 3rd, et al. Current status of patient-reported outcome measures in vascular surgery. J Vasc Surg. 2021 Nov;74(5):1693-1706.e1. 

Evan Lipsitz, MD, is PMC chair, Caitlin Hicks, MD, the vice chair, and Ashley K. Vavra, MD, a member of the committee. Karen Woo, MD, is past chair. 

Selution SLR receives second FDA IDE approval

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Selution SLR receives second FDA IDE approval
Selution SLR

Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).

This comes only a few months after the company received IDE approval for Selution SLR in the treatment of below-the-knee (BTK) indications (May 2022).

Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centers in the U.S. and an additional 20 centers around the world. This study will enroll 300 patients to demonstrate superiority over balloon angioplasty (POBA). The principal investigator of this study is George Adams, MD, the director of cardiovascular and peripheral vascular research at Rex Hospital in Raleigh, North Carolina.

“We are very excited that U.S. patients suffering from PAD [peripheral arterial disease] will have the opportunity to receive this novel sirolimus drug-coated balloon technology. This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly,” Adams commented.

Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary artery disease in May 2020. The FDA has awarded Selution SLR four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee; and AV-fistula indications.

In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing Selution SLR with any limus drug-eluting stent [DES]. This is the largest drug-eluting balloon (DEB) study ever initiated.

MedAlliance’s DEB technology involves MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.

CLTI: Translating guidelines into practice

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CLTI: Translating guidelines into practice
Michael Conte, U.S. editor of the Global Vascular Guidelines for CLTI

Clinical practice guidelines (CPG) are integral to helping achieve optimal patient care. The Society for Vascular Surgery (SVS) clinical guidelines are evidence-based and the recommendations assist physicians in clinical decision-making in their daily practices. 

The challenge for practicing physicians “is to determine how these recommendations apply to our own patients,” said John White, MD, who will moderate the first roundtable. Thus, the SVS has developed three instructional webinars on the guidelines for patients with chronic limb-threatening ischemia (CLTI). The webinars are “devoted to informing you how to apply the guidelines to the care of your patients, the limb and anatomy,” he said. 

The free webinars will be held monthly in August, September and October, and cover “Translating guidelines into practice: Global Vascular Guidelines on the management of patients with CLTI.” These webinars are based on the published guidelines, developed by the SVS, the European Society for Vascular Surgery (ESVS) and the World Federation of Vascular Societies (WFVS). See the guidelines at vsweb.org/GlobalCLTI. 

The first session will be moderated by White and will be held from 6–7:30 p.m. Central Daylight Time on Monday, Aug. 15. It will focus on overall medical care of CLTI patients, including the current state of optimal medical management; recent developments in anti-thrombotic, anti-hypertensive and lipid-lowering management; and best ways to help patients quit smoking. 

The session will feature internationally recognized speakers in peripheral arterial disease (PAD), a chief cause of CLTI and limb loss. The speakers include: Sonia Anand, MD, professor of medicine and epidemiology at McMaster University in Hamilton, Canada; Joshua A. Beckman, MD, professor of medicine at Vanderbilt University in Nashville, Tennessee; Marc Bonaca, MD, executive director of vascular research at the University of Colorado School of Medicine; and Jonathan Golledge, MChir, professor of medicine at James Cook University in Townsville, Australia. 

They will use one sample patient to design treatment strategies and demonstrate how to put the global vascular care guidelines into practice. 

Attendees will fill out short surveys before and after the session, and a follow-up survey 60 days later, to determine if the guidelines have been easy to put into daily clinical practice. All participants will receive the guidelines, implementation tools, printed guideline pocket guide and relevant references, and a link to the SVS Interactive Practice Guidelines app. 

The remaining two webinars will be Monday, Sept. 12, with “Diagnosis and staging of the limb,” moderated by Joseph Mills, MD; and Monday, Oct. 10, on “Revascularization,” moderated by Michael Conte, MD, who was the U.S. editor for the Global Vascular Guidelines. 

CLTI is an important clinical issue and treatments are being studied in the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial. “These three webinars will be coming at an important time as we all anticipate the upcoming results of the BEST-CLI 2 and 3 trials in the next several months,” said Conte. 

The SVS urges all members to participate in this important learning opportunity. Learn more, find recommended readings and register at vascular.org/CLTIroundtables. 

Gore acquires InnAVasc Medical

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Gore acquires InnAVasc Medical

Gore has announced the acquisition of InnAVasc Medical, a privately held medical technology company focused on advancing care for patients with end-stage renal disease who utilise graft circuits for dialysis treatment.

Jeffrey Lawson, MD, PhD, and Shawn Gage, PA-C, of Duke University School of Medicine’s Department of Surgery in Durham, North Carolina, developed the InnAVasc device, which is specifically designed to allow for safe, easy, reproduceable and durable access for dialysis treatment of patients with graft circuits.

The investigational InnAVasc device is designed to protect the graft from backwall punctures and reduce the damage associated with frequent needle sticks which occur over the lifespan of a dialysis graft. This can lead to circuit failure and shortened circuit life. “To be stuck with two needles three times a week for hemodialysis for 52 weeks, that’s 312 times a needle goes into a patient’s graft each year,” said Stephen Hohmann, MD, vascular surgeon at Texas Vascular Associates in Dallas, Texas. “So having a graft that has the ability to decrease risk potential and long-term injury is definitely something that would be a game-changer.”

“Backwall punctures and damage due to excessive needling are painful and can cause unwanted bleeding, delay or stoppage of treatment, and reduced graft durability,” said Prabir Roy-Chaudhury, professor of medicine at the Division of Nephrology and Hypertension at the University of North Carolina in Chapel Hill, North Carolina. “I greatly appreciate how this technology is intended to be so patient-centric, addressing this important interface need, for both clinicians and home caregivers.”

JACC study makes case for expanding coverage for carotid artery stenting

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JACC study makes case for expanding coverage for carotid artery stenting
Christopher White Credit: Ochsner Health

Research from Ochsner Health published in the Journal of the American College of Cardiology (JACC) is likely to influence expanded insurance coverage for carotid artery stenting.

The paper, “Carotid artery stenting: JACC state-of-the art review”, details significant advances in the field of carotid stenting. It concludes that the technique “has achieved parity with carotid surgery for stroke prevention,” and that the data “support updating the national coverage decision for carotid stenting from the Centers for Medicare and Medicaid Services [CMS] to equal coverage for carotid surgery”.

“Carotid artery stenting is a minimally invasive procedure compared to open surgery,” explains first author Christopher White, MD, system chairman for cardiovascular disease director and director of John Ochsner Heart & Vascular Institute in New Orleans, Louisiana. “Overall, stenting and surgery are equivalent in patients who are good candidates for both, and the patient and their doctor should discuss which one is better for the individual patient.”

The paper analyzes several large, multicenter randomized controlled trials encompassing data from over 25 years and more than 10,000 patients to demonstrate that carotid artery stenting can be just as effective as surgery when it comes to long-term stroke prevention and durability.

The paper suggests that the current CMS coverage decision regarding carotid stenting is outdated and places Medicare patients at a disadvantage by restricting their options for less invasive treatment, and recommends expanding coverage to be equivalent to open surgery.

“The current literature supports equivalent results for carotid stenting and carotid surgery in patients who are suitable candidates for both procedures,” says White. “Some patients will not be good candidates for stenting and should receive surgery, while some patients will be poor candidates for surgery and should receive stents.”

Current coverage is likely to be expanded in the near future to include coverage for carotid stenting that is equal to carotid surgery for those who are symptomatic with a carotid stenosis ≥50% and ≤99%, and those who are asymptomatic patients with carotid stenosis ≥70% and ≤99%.

“We believe our multidisciplinary paper, written by neurologists, neurosurgeons, vascular surgeons, and cardiologists, will be an important summary of the most recent evidence that will support CMS in reimbursing both procedures on an equal basis,” says White.

Compression duration affects pain during superficial venous intervention, study finds

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Compression duration affects pain during superficial venous intervention, study finds

Roshan Bootun application of compression stockingsPostprocedural compression of one to two weeks after superficial venous incompetence (SVI) treatment is associated with reduced pain compared with a shorter duration. This is according to a study published in the August edition of the British Journal of Surgery (BJS).

Authors Abduraheem H Mohamed, of Hull York Medical School in Hull, England, and colleagues note that international guidelines recommend postprocedural compression when treating symptomatic SVI. However, they stress that there is no agreed timescale for this. In order to investigate the optimal application of postprocedural compression, the research team carried out a systematic review of randomized controlled trials (RCTs).

Mohamed et al write that they used the UK National Institute for Health and Care Excellence’s Healthcare Databases Advanced Search Engine to identify all English-language RCTs of compression following treatment for SVI. Postprocedural pain, venous thromboembolism (VTE), health-related quality of life (HRQoL) and anatomical occlusion were the main outcomes of interest, they note.

The investigators included a total of 18 studies comprising 2,584 treated limbs in their systematic review. Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression, Mohamed and colleagues relay.

Writing in BJS, the authors report that a one to two week period of compression was associated with a mean reduction of 11 (95% confidence interval [CI] 8–13) points in pain score on a 100mm visual analogue scale compared with shorter duration (p<0.001). Mohamed et al also reveal that this was associated with improved HRQoL and patient satisfaction, however note that greater than two weeks’ compression did not add further benefit.

“There was low-quality evidence suggesting that 35mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures,” the authors add, noting also, “there were no significant differences in [VTE] rates or technical success in any group, including no compression”.

In their conclusion, Mohamed et al acknowledge the evidence gaps that persist: “The optimal interface pressure and type of compression, and the impact on [VTE] risk, remain to be determined”.

Digging deep into DOACs for PAD post-revascularization in fight to stave off amputation

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Digging deep into DOACs for PAD post-revascularization in fight to stave off amputation
Anahita Dua

This advertorial is sponsored by ACHL.

“It’s really sad—but it’s true: In the PAD [peripheral arterial disease] space, we’re really behind. We’re behind in our understanding of the physiology, the anatomy to some extent, the way the disease permeates through the leg.” 

Those are the words of Anahita Dua, MBChB, an assistant professor of surgery at Massachusetts General Hospital in Boston, as she discusses the fight against amputation in PAD patients who have been revascularized. She is speaking alongside Kush Desai, MD, associate professor of radiology at Northwestern University Feinberg School of Medicine in Chicago, and Christian T. Ruff, MD, director of general cardiology at Brigham and Women’s Hospital in Boston, as the trio of vascular specialists consider the use of direct oral anticoagulants (DOACs) for the treatment of PAD post-revascularization, and novel data that can be used to mitigate the risk of thrombosis, in a new multi-part CME activity entitled, “Beyond the Procedure: Evolving the Current Standard of Care for Patients with PAD.” 

Calling upon emerging data on DOAC use among PAD patients, the panel of experts survey the current PAD guidelines and the pivotal COMPASS trial, the latter of which looked at the benefit of low-dose rivaroxaban plus aspirin as compared with aspirin alone in those patients with chronic vascular disease. 

Christian T. Ruff

In part one, “Digging Deeper Into DOACs for PAD,” Ruff delves into guidelines from both the vascular and cardiology worlds as he introduces the subject matter. For patients with symptomatic PAD, he says, if a patient has recently also had a coronary stent placed or acute coronary syndrome, they will likely benefit from dual antiplatelet therapy (DAPT). More broadly, Ruff adds, this is where a strategy of aspirin and clopidogrel, or aspirin plus rivaroxaban, can be considered. 

“There is some equipoise here with either DAPT or low-dose rivaroxaban plus aspirin to reduce adverse cardiovascular events,” he explains. “It is important to remind the audience there are no clinical trial data comparing DAPT as a strategy to the low-dose rivaroxaban and aspirin strategy.” 

Ruff points out more intensive strategies are favored in patients with high ischemic risk and those with “overt” atherosclerotic disease or diabetes, for example. “Anytime you’re using combination antithrombotic therapy, patient selection is critical because obviously we want to reduce ischemic and thrombotic events—but it will always come at the cost of an excess in bleeding,” he says. 

Who gets rivaroxaban? 

Dua asks her fellow panelists more specifically how specialists determine which patients receive a strategy that includes rivaroxaban. Ruff summarizes his thought process by asking, “Is this a patient who is at high risk in the acute period, do they have disease in multiple beds? 

“And, if they do,” he says, “I’m going to be more intensive—particularly, the dual pathway strategy is good for preventing MACE [major adverse cardiac events] in general, but also limb events— and use it in my patient. But I’m definitely much more thoughtful in the chronic setting, or in patients who maybe just have single-bed disease, maybe just PAD.” 

In part two of the CME activity, Dua points out the only level 1A evidence specialists have to call upon in the guidelines to support the way in which they treat PAD patients post-revascularization is to give them “monotherapy with aspirin, whether that be in an endovascular situation” or in a surgical setting. Yet, treatment strategies carried out are “all over the board,” she says, which “is problematic because it is not data-driven.” Dua highlights the importance of recognizing that in the endovascular space specialists have used DAPT, typically with aspirin and clopidogrel, which amounts to “weak” level 2C evidence, she says. 

DOACs after revascularization 

Dua then introduces the VOYAGER PAD trial, which looked at more than 6,500 PAD patients who had undergone successful revascularization and who, within the 10 days afterwards, were randomized to a regimen of either rivaroxaban plus aspirin, or a placebo plus aspirin. Pointing to the trial’s primary efficacy outcome, Dua says the most important takeaway “is that, if you’re giving patients rivaroxaban plus aspirin versus aspirin alone, patients have less of a need to treat, less of a need to reintervene, and there is an absolute risk reduction in the primary outcomes.” 

Kush Desai

The trial was successful in demonstrating this among the patient cohort. VOYAGER’s main point was to make sure that giving rivaroxaban plus aspirin would result in a reduction in thrombotic and ischemic events “and simultaneously not increase the bleeding profile,” she adds, leading the Food and Drug Administration (FDA) to expand the approval for rivaroxaban plus aspirin to include patients who received lower-extremity revascularization for symptomatic PAD. 

The panel goes on to ponder the implications of the VOYAGER trial data for practice. “One thing that this underscores is how difficult this is, and the investigators are to be applauded,” says Desai. The data are particularly important for those patients who have had to undergo a revascularization. Among other patients, such as those being managed for lifestyle modification, “we probably err on the side of being more conservative than with an intense therapy, unless they have significant polyvascular disease.” 

Ruff says the question is a good one: “What’s an optimal strategy, DAPT or aspirin plus low-dose rivaroxaban? I don’t think we know the answer to that question,” he says. “So, if I have a patient that requires DAPT, say for their coronary disease, that might be what I choose for that patient. If the patient doesn’t require DAPT, and they need a more intensive regimen, and they’ve just had peripheral revascularization, then this might be an appealing strategy, particularly if their bleeding risk is reasonable.” 

Case studies 

Part three of the CME activity hones in on three sample PAD patients who are potential candidates for a rivaroxaban plus aspirin treatment strategy. Ruff, Desai and Dua introduce the cases and discuss application of data previously outlined during the activity. They include one patient who presents with polyvascular disease and symptomatic PAD; another who has undergone endovascular revascularization for lower-extremity PAD, has a 50-year smoking history and is a diabetic; and a third with non-healing wounds, chronic limb-threatening ischemia and coronary artery disease who was already on warfarin for a history of atrial fibrillation. 

In discussion, Dua points toward the “new frontier” posed by increasing issues specialists are seeing in the microvasculature. Patients are living longer, are more complex, and they have more chronic kidney disease, she says. 

By 2045, Dua adds, “we’re talking about thousands of patients who are going to be affected.” 

In all three case studies, concludes Desai, “you can make a case that a dual-pathway approach makes sense in all those patients, whereas before we were a little bit in the hinterlands trying to figure out what’s the right thing to do.”

Visit https://www.achlcme.org/pad-patient-care-svs and learn about mitigating thrombosis risks to stop amputation post-PAD revascularization. Supported by an educational grant from Janssen Scientific Affairs, LLC. 

Confessions of a dual-trained, dual-practicing vascular-trauma surgeon

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Confessions of a dual-trained, dual-practicing vascular-trauma surgeon
Joseph DuBose

Like most of the other readers of Vascular Specialist, I look forward to perusing each release for not just useful information but also insightful editorials that frame ongoing issues in thoughtful and entertaining ways. I personally find that I am rarely disappointed in what I find in this newspaper in this regard, and the recent article by our medical editor, Dr. Malachi Sheahan III, titled “A modest proposal: Let’s eat the trauma surgeons” was no exception. It left me with many things to think about… including how I would season the half of my body that Dr. Sheahan satirically suggested I should cannabilize. 

Let me explain. I am a dual-trained trauma and vascular surgeon who continues to fight to maintain a balanced practice in both fields. For six years after completing a surgical critical care/trauma two-year fellowship, I worked as an academic military trauma surgeon. I confess I am one of those slightly deranged individuals who actually enjoys the struggle of creating order from chaos at times when most sane individuals would probably rather be in bed. For me clinically, there is simply nothing like the adrenaline and reward that can be found trying to save a trauma victim from bleeding to death at midnight on a Saturday. 

Ask any busy trauma surgeon what their most interesting recent case was and I would be willing to bet some vascular injury is a common response. I relished these challenges perhaps more than most of my trauma colleagues. It was not hard to appreciate, however, that I had some gaps in my training that limited my ability to care for many of these challenges. Endovascular technologies were already emerging as effective solutions to vascular injuries at some anatomical locations and improving outcomes as they did so. In the open surgical realm, I found it challenging to find avenues by which I could consistently maintain my skillsets in exposure, control and repair of blood vessels. More military deployments or trauma call were not going to fix these deficiencies very efficiently. 

And so, with the support of my military leadership and some respected trauma mentors, I self-demoted from mid-level trauma attending to vascular fellow. It was at times a humbling experience. But now, seven years into a dual practice, I can honestly say that I have found the clinical niche that I find most personally rewarding. I take as much trauma call as any of my trauma partners, and also have a busy vascular practice treating the full spectrum of elective and emergent vascular disease. It makes for a very busy workload for sure, but an advanced vascular skillset has empowered me to be clinically happy in my interest area—and even to expand into areas that one would not typically associate with traditional vascular or trauma surgery practice. For example, my current vascular group performs the majority of the solid organ and hemorrhage control embolization interventions for our trauma program. 

Joseph DuBose responds to criticism over his comments regarding vascular surgery’s place in the management of vascular injury—and his coining of the term “lesion vision”

Despite my contentment with my dual practice, I must confess it often presents me with interesting dilemmas. I do sometimes find myself asking existential questions related to my professional identity. Am I a trauma surgeon with a passion for vascular injury? Or, rather, am I a vascular surgeon with an interest in vascular trauma? The answer is sometimes complex and dependent upon the context. When my two training background split personalities converge in the deciding of how to manage a complex vascular injury, the real quandaries can begin. In these moments, all the debates regarding the future of vascular trauma and optimal vascular injury treatment in the endovascular era, that rage across the “Twittersphere,” become my internal dialogue. 

In attempting to make sense of these often dueling perspectives, I worked with a group of vascular and trauma surgeons as lead author on an editorial called “Beyond the crossroads: Who will be the caretakers of vascular injury management?” for Annals of Surgery. The intent was to outline the challenges all stakeholders face as changes in technology, training and trauma center organization influence the ongoing evolution in vascular injury care. It was my attempt to highlight for consideration the potential potholes on this road that both vascular and trauma surgeons must travel together. As one who will readily “nerd out” about vascular trauma, this publication was a way of giving voice to the debating portions of my overly trained mind. 

The response? Well, let’s just say it was not necessarily warmly received in all sectors. Many trauma surgeons criticized me for suggesting they are no longer capable of caring for vascular injury in the era of endovascular technologies. Some vascular colleagues perceived that I was implying they fail to understand the nuances of vascular injury management in the context of the severely injured trauma patient. My well-intentioned highlight of potential present and future challenges had backfired to some degree. The article left me best known in some circles as the evil spirit who coined the term “lesion vision,” thereby arming some of my fellow trauma surgeons with a war cry against further encroachment of vascular surgeons into their cherished vascular injury excitement. 

By way of apology, I offer as backstory that the first time I ever used “lesion vision” was in presenting one of my own morbidities where I had clearly let focus sharpen too narrowly on the hybrid operating room (OR) screen, and missed important changing physiology of a bleeding trauma patient under my own care. As such, if I coined the term in later self-deprecation at our M&M meeting, then I am also the first documented victim of this malady. As I genuflect remorsefully in your collective directions, I hope that you will forgive me and let me return from the outcast lunch table at the annual vascular community picnic. 

It is also my fervent hope that you will help me make room at that table for others like me. When I started down this pathway of dual training, I could count on one hand the individuals that I knew of working as true dual-practicing vascular and trauma surgeons in the U.S. Now, however, this pathway seems to be making some small gains, and our numbers are growing. At present, these individuals seem to cluster at major high-volume trauma centers around the U.S. Baltimore, Denver and Austin all harbor collections of dual-practicing vascular/trauma surgeons. A more substantial number of dual-trained surgeons primarily practice more exclusively in vascular surgery but serve as exceptional ambassadors to vascular injury care, and outstanding resources to their trauma partners at their trauma centers. At least monthly, I get a call from a surgical resident or trauma fellow to talk about the benefits of pursuing dual training in the context of changes in vascular injury care. It may not be a massive movement, but it does seem to be a potential “thing.” 

The question remains, however: Is there a real role for this sort of a training pathway? There is clearly a need for more vascular surgeons to support trauma, as has been discussed on the pages of this periodical very effectively. No rational individual would argue that vascular surgeons are not an absolutely necessary part of the endovascular advancement of vascular injury care. The days of open blunt aortic repair have given way to thoracic endovascular aneurysm repair (TEVAR). Other anatomic locations are following suit. Only the vascular community is uniquely positioned to effectively guide this evolution. Open vascular repair skills will almost certainly continue to be required for vascular trauma management, but no one has the ability to develop and maintain this skillset like the modern vascular surgeon. The role of the vascular surgeon in trauma is secured for those that are interested in incorporating it into their practice. 

But there is also a clear and present interest among trauma surgeons in remaining engaged in vascular injury care. In a recent survey of both vascular and trauma surgeons, it was noted that, despite significant interest in vascular injury by practicing trauma surgeons, most feel unprepared to do so. The most commonly cited reasons for this discomfort were inability to maintain the skillset and unfamiliarity with techniques. Can my own unique breed of dual-trained surgeons, and the numerous vascular surgeons who are also interested in trauma, be of service in this regard? Can we, in the least, do a better job of educating the next generation of trauma trainees in the capabilities we have to offer that might augment the care of the most challenging of the patients they are called upon to care for? I hope the answer is “Yes”… or I will have to figure out yet another new career plan. 

In my own vision of a future utopia, I can see a time when there may be at least one dual-practicing trauma and vascular surgeon at most of the leading trauma centers in the U.S. In this ideal world, these individuals could serve as ambassadors between their vascular and trauma divisions. They will be valuable in improving the knowledge base and skillset of their trauma colleagues and their trainees, and finding ways to empower trauma surgeons to engage actively and productively in the vascular injury care evolution. They will also free their vascular partners to focus their energies more actively on the unique vascular practice models they are passionate about—be they aortic, peripheral, cerebrovascular or venous in nature. They might be “odd ducks” like myself, but they have the potential to be valuable resources to both disciplines they have pursued. And in this utopian future, no one will remember what “lesion vision” means. 

Joseph DuBose, MD, is a professor of surgery in the University of Texas at Austin’s Dell Medical School in Austin, Texas. 

SVS Vascular Health Step Challenge asks surgeons to walk the walk

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SVS Vascular Health Step Challenge asks surgeons to walk the walk
The SVS Vascular Health Challenge takes place during September, National Peripheral Arterial Disease (PAD) Awareness Month

Most American adults take an average of 5,000 steps per day. In fact, this simple act—getting out and moving—can be the key to prevention and treatment of many chronic diseases of the cardiovascular system. 

The Society for Vascular Surgery (SVS) hopes to step up, so to speak, that 5,000-step number with a major initiative aimed squarely at promoting the health benefits of walking. The SVS Vascular Health Step Challenge takes place during September, National Peripheral Arterial Disease (PAD) Awareness Month. 

During challenge, vascular surgeons will not only talk the talk but walk the walk, competing in teams whose members each pledge to walk at least 60 miles during the month. The 60 miles represent the 60,000 miles of blood vessels in the human body. 

The Vascular Health Step Challenge is not just a fundraiser but an opportunity for vascular surgeons across the country and the world to engage with their communities and spread the word about the importance of vascular health. 

The initiative also will raise awareness about vascular disease, and what a vascular surgeon is and what they do. The SVS Public and Professional Outreach Sub-Committee is spearheading the project. “As vascular surgeons, we put patient health and outcomes above everything else, and the SVS Vascular Health Step Challenge is a tangible way to demonstrate that commitment,” said Benjamin Pearce, MD, committee chair. 

The SVS Vascular Health Step Challenge also will raise awareness about vascular disease, and what a vascular surgeon is and what they do

After all, vascular surgeons focus a great deal of time to mitigate the effects and causes of vascular disease without surgery, said committee member Alan Dietzek, MD. “There’s no more beautiful message than surgeons doing their best to keep their patients out of surgery,” agreed Pearce. “It all links back to our motto, ‘Surgery is only part of our story.’” Pearce himself is a big advocate of walking, eschewing golf carts while partaking in a favorite activity. “I’ve been an adamant walker for years on the golf course,” he said. He estimates a golfer can log nearly 2,000 more steps in nine holes when walking versus riding in a cart. Dietzek said the No. 1 complaint his older patients give, when asked how aging affects their lives, is “I can’t walk the golf course anymore.” 

Pearce, Dietzek and the other committee members want to link the SVS and walking. “When you think of smoking cessation, you think of the American Lung Association,” said Pearce. “I want people to automatically think of SVS when they think about walking for health.” 

Walking affects many aspects of cardiovascular health, from PAD to hypertension to slowing the growth of abdominal aortic aneurysms (AAAs). The SVS has created lists of factoids on the benefits of walking that SVS members can download and give to patients. One such infographic is the “Steps for Vascular Health” poster, tying the health benefits of various numbers of steps. 

PPO Committee members will be among the first to form their walking teams. The idea is straightforward. Individuals sign up on the Charity Footprints website, at vascular.org/VascularHealthChallenge, and pair their personal fitness devices, such as a Fitbit or Apple Watch, to the site, download the Charity Footprints application on smartphones, or log in manually on the website. SVS members will join their respective regional team, and community participants can start their own team or join an existing one. Then, between Sept. 1 and 30, participants get walking, logging the steps, and transferring them to the website. Walkers can seek donors for an overall amount or a per-step contribution. All proceeds will go to the SVS Foundation, which will use the monies generated to assist vascular patients with exercise therapy. In addition, proceeds will help create additional public education materials about vascular health and support further development of the SVS Supervised Exercise Therapy (SET) app. 

Committee members also are thinking creatively about how to undertake the challenge. Pearce is hoping to walk with his team on a Grand Prix racetrack in his home state of Alabama. Dietzek wants to involve the world of professional golf. “Think of an area in your community that would provide an inspiring way to finish the challenge,” urged Pearce. “It could be the track around the high school football stadium, or a riverwalk, or a well-known park.” 

Vascular Specialist@VAM–July/August Review Edition

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Vascular Specialist@VAM–July/August Review Edition

In this VAM 2022 conference review issue:

  • Diversity gains momentum at the Journal of Vascular Surgery (p. 1 and 4)
  • SVS walking challenge—Vascular Health Step Challenge—asks surgeons to walk the walk (p. 1 and 8)
  • Comment & Analysis: A brilliant plan to increase vascular surgeons’ income—and decrease the incidence of stroke! (p. 11)
  • Happy 75th birthday, SVS! Foundation Gala declared a smash hit (p. 25)
  • Interview: Engaging with primary care providers ‘critically important’ to improving AAA screening (p. 33)
  • Quality: Patient-reported outcomes in vascular surgery are here to stay (p. 37)

 

New data suggest patients at AAA repair thresholds can be safely deferred

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New data suggest patients at AAA repair thresholds can be safely deferred
Mark A. Eid

Data from the PROVE-AAA cluster-randomized trial (Preferences for open versus endovascular repair of abdominal aortic aneurysm) of a novel decision aid to assist veterans decide between their options demonstrated that surgeons can safely defer AAA repair in patients with a 5cm-plus aneurysm diameter “for a moderate time.”

Mark A. Eid, MD, a general surgery resident at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues from the PROVE-AAA research team looked at 235 patients enrolled across 23 VA medical centers—109 at 11 control sites and 126 at 12 intervention sites who were either provided with their usual preoperative care or a decision aid before meeting with their surgeon. The full cohort were then given a series of surveys to assess their preferences, ultimately making the decision to either undergo surgery or active surveillance.

“Among the study participants who deferred surgery, 23 were in the decision aid arm, while 17 were in the control arm who received their usual care,” Eid said as he presented results from the study at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18).

Within the decision aid group, some 13% of veterans chose to defer their care—compared to 15% among those who received their usual care. “The vast majority of those who deferred were still awaiting surgery, primarily due to OR shutdowns at the beginning of the COVID-19 pandemic,” Eid revealed, also showing that more veterans in the decision aid group chose to refuse surgery compared to their counterparts receiving usual care.

“At the end of our surveillance period in the summer of 2020, no veterans had suffered aneurysm death or rupture.”

Furthermore, the PROVE-AAA study showed approximately 20% of veterans with a AAA meeting Society for Vascular Surgery (SVS) criteria for repair had their repair deferred, and that this contingent were similarly satisfied to those who underwent surgery, Eid concluded. “At least in the short term, our data suggests that even patients at or slightly above the repair thresholds can safely consider their choice about proceeding with their aneurysm.”

APDVS president reflects on training challenges of COVID-19, ‘supply and demand’ conundrum of the future

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APDVS president reflects on training challenges of COVID-19, ‘supply and demand’ conundrum of the future

“There are not enough vascular surgeons to do the work our specialty provides.” Those are the stark words of Jason T. Lee, MD, president of the Association of Program Directors in Vascular Surgery (APDVS), as he reflects on some of the training challenges that were posed to the vascular profession during the pandemic, and as he ponders key workforce shortage issues of the future, shortly after helping lead a COVID-19 session during the recent 2022 Charing Cross (CX) International Symposium in London (April 26–28).

“It’s up to program directors in each country to match the supply and demand,” Lee, who provided a North American perspective on behalf of the Society for Vascular Surgery (SVS) at CX 2022, tells Vascular Specialist. “The program directors’ association has to respond to provide more quality by creating more quality training programs so that the supply meets the demand of what is out there in this growing population.”

Corner Stitch: A letter to new vascular interns

Corner Stitch: A letter to new vascular interns
Kirthi Bellamkonda

Every intern starting vascular surgery this year is incredibly talented, and soon to be a member of a tight-knit, supportive, and fiercely passionate group of surgeons. I remember being on the cusp of my first day a year ago, having spent the interview season talking the talk, yet wondering whether I could walk the walk. In surgery there is really no “trial run” to internship—most sub-internships are focused on operating room (OR) time and interviews on non-clinical achievements, so I’m hoping to pass on some of the lessons I learned this year.

There will be many false alarm pages. Don’t let complacency creep in. We like to find patterns in everything. After seeing five pages about postoperative pain in five different patients, all benign, it’s natural to assume the same on the sixth. That is when you will miss a graft thrombosis, a compartment syndrome, a hematoma, or an infection. The pager will “cry wolf” most of the time, but the safest intern always assumes the wolf is really there and acts accordingly.

Know how (and where) everyone on your team does their job

There are many things in your day-to-day that happen in the background of your awareness—but if you are responsible for making sure it gets done, then you should also know how to do it. I have had to program an intravenous (IV) pump, dig through central supply for an obscure dressing, and sign for unlabeled specimens in the lab building. Pay attention, not just to what other physicians do, but what the support staff do. Ask your techs to show you how to work the ultrasounds. Ask the critical care nurses to show you how to pass meds in a code. Ask physical therapy how to safely mobilize a patient. Know how to spike an IV. Drive a bed with someone from transport. And when you have a few spare minutes, find dialysis, magnetic resonance imaging (MRI), computed tomography (CT), hyperbaric, pathology, pharmacy, central stores, instrument reprocessing—you should be able to find your patients and your tools at any point in the day.

Experience and knowledge are not interchangeable

Being present and caring for patients is a critical part of training, but that alone will not get you to the level of knowledge needed. As hard as it is, carve out time to read Rutherford and do Vascular Education and Self-Assessment Program (VESAP) questions, even intern year.

Efficiency comes from observing efficient colleagues often

Everyone in medicine develops a system for looking through a chart and managing workflow, and it’s easy to become attached to the first thing your first senior shows you in your first block. I would encourage you to keep watching co-interns and seniors do “basic” things, even after you know how to do all the usual intern tasks. There will always be someone who has found a new shortcut or an automation. My personal efficiency tips: Medical issues should always be addressed face-to-face with patients, but the operator can always help you call an inpatient for quick questions about rides home or pharmacies to save time. If you have access to a mobile app/orders for your electronic medical record (EMR), use it. I always knock out—at least—one task while walking somewhere. It also sends me push notifications for all important lab results. Organize your EMR tabs to chart round in the fewest clicks. Most modern EMRs have huge amounts of personalization options.

You are never truly alone

In the clinical world, being on call without an in-house senior can seem lonely. But most life-threatening overnight inpatient issues are medical in nature, and you will have in-house critical care and senior medicine trainees. Although not part of their job, our in-house trauma, cardiology and anesthesia trainees have reinforced that they would always help an intern finding themselves all alone in an emergent situation, no questions asked. It is always better to call for help than to demonstrate your independence at the expense of safety.

And finally, a few practical points: Always hold pressure for longer than you think you need to after a groin puncture; take the United States Medical Licensing Examination (USMLE) Step 3 before you forget how to read a fetal heart tracing. Intensive care unit (ICU) is a good time, and buy the best own-specialty private disability insurance you can afford.

The learning curve is steep, but your knowledge this year will grow exponentially without you even realizing it. Don’t forget to step back and take time for yourself on days off and acknowledge all the hard work you have done. Good luck!

Kirthi Bellamkonda, MD, is a PGY-2 vascular surgery resident at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

Proposals sought for VAM 2023

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Proposals sought for VAM 2023

Members are still raving about the 2022 Vascular Annual Meeting (VAM) even while organizers seek topics for educational sessions for the 2023 edition. Proposals are due at 3 p.m. Central Time on Wednesday, Aug. 24.  

Submissions for the invited sessions opened today.

“As vascular surgeons, we know what issues we come up against frequently—such as dialysis access, particular vascular conditions, practice management problems. I’m asking members to think about what they need to know more about, or what solutions they may have devised to help with patient treatments or other topics,” said William Robinson, MD. He chairs the Postgraduate Education Committee, which organizes VAM educational content for breakfast, concurrent, Ask the Expert and special membership section sessions, plus postgraduate education courses.

Sessions could also address complications and how to deal with them successfully, tips for younger surgeons in their first few years of practice and other targeted topics, he said. “If you’ve ever been at VAM and wondered, ‘why don’t they address this,’ now is the time to write out those thoughts and send them in,” he said.

VAM 2023 will be June 14 to 17 at the Gaylord National Resort and Convention Center in National Harbor, Maryland, outside Washington, D.C. Educational programming will be held all four days of the conference. The Exhibit Hall will be open June 15 and 16, and the SVS Gala, benefiting the SVS Foundation, will be held the evening of Friday, June 16.

Leadership program applications due by Aug. 15

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Leadership program applications due by Aug. 15
Twenty-five to 30 surgeons will be selected for the third iteration of the SVS Leadership Development Program

Learn to be a leader or enhance your leadership skills—applications to be part of the fourth cohort of the Society for Vascular Surgery (SVS) Leadership Development Program (LDP) are due Aug. 15.

The year-long, highly interactive learning experience is recommended for those five to 10 years out of training. The aim is to help participants enhance their leadership skills, reach their full potential as leaders and apply what they learn in the vascular surgery specialty and in their workplaces, communities and lives.

Twenty-five to 30 surgeons will be selected for the program, which runs from Sept. 28 through the 2023 Vascular Annual Meeting (VAM), June 14–17, 2023.

The selected surgeons will participate in webinars, mentoring and a 1.5-day in-person workshop, plus identify and tackle real-life challenges leaders in vascular surgery face. Cohort members will practice applying what they learn during the course to such real-life challenges.

LDP is sponsored jointly by SVS, the Society for Clinical Vascular Surgery (SCVS) and the Vascular and Endovascular Surgery Society (VESS). Learn more and apply at vascular.org/LDP22.

Pioneering center reports ‘moderate’ success rate with Fiber Optic RealShape technology in first 50 patients

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Pioneering center reports ‘moderate’ success rate with Fiber Optic RealShape technology in first 50 patients
Giuseppe Panuccio

Vascular surgeons from the medical center that pioneered use of the radiation-lowering Fiber Optic RealShape (FORS) imaging modality reported a 62% technical success rate using the first-generation version of the technology across the first 50 procedures performed. 

The data were reported at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18) by Giuseppe Panuccio, MD, from University Heart and Vascular Center Hamburg in Germany, who told those gathered his team’s work with the system represented “moderate success cannulating aortic branch vessels and a high potential in reducing radiation exposure.”  

The cases involved—mostly branched and fenestrated endovascular aneurysm repairs (B/FEVARs) all performed by three operators—were carried out between February 2020 and February 2021 in Hamburg using the FORS guidewire and a pair of FORS catheters (with conventional catheter compatibility). A total of 186 tasks were included in the study. 

Challenges related to vessel catheterization, including stenosis >50% and angulation >45º, were assessed, as were the time required for each catheterization as well as radiation exposure. 

Panuccio reported no FORS-related complications as he delivered the data showing a 62% rate of technical success, with 38% of the cases abandoned. “What was really impressive was that when FORS was successful, the amount of radiation required for catheterization was really minimal,” he said. “You have to consider that inside of the radiation needed for catheterization, we consider also the angiography that was performed before the catheterization.” 

Reduced technical success was associated with cannulation of renal arteries, vessel angulation, and vessel stenosis, he told VAM 2022. Catheterization tasks through a branch of a complex aortic endograft frequently required a non-FORS catheter—technical success with the FORS catheter was 18% (p<0.001), Panuccio revealed. Successful FORS task catheterization was associated with a significant three-fold radiation exposure reduction (dose area product 12.5 vs. 4.4 cGycm2, p<0.001). Further, success ranged from 81% at the superior mesenteric artery to 42% at the celiac trunk. Panuccio said the operators also encountered problems with branches (success rate of 52%), angulation (33%), and stenosis greater than 50% (17%). 

“The reduced success rate observed in challenging anatomy appears related to the limited availability of FORS catheter shapes and its device properties,” the authors concluded. “Iterative FORS improvements are underway to address these limitations with the hopes of increasing success.” 

Panuccio said the researchers expect visualization improvements when using conventional catheters to be forthcoming. Further evaluation is ongoing through a FORS multicenter registry, which includes nine transatlantic centers and more than 350 enrolled patients. 

Gustavo Oderich, MD, a moderator of the session in which Panuccio was presenting, commented on the “changing paradigm” the technology and associated data represented, and also queried Panuccio on how many of the tasks he and his colleagues couldn’t complete were down to not having the proper wire or catheter versus an inability to see other landmarks. 

“One of the main limitations was the material properties—but also how we learn how to use it,” Panuccio said. “You have to completely reset how you use the wire and with which catheter is the best combination. Material properties have to be developed, improved.” 

Enrollment begins in PERSEVERE clinical trial of hybrid prothesis for aortic dissection

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Enrollment begins in PERSEVERE clinical trial of hybrid prothesis for aortic dissection
Artivion logo

Artivion announced today that it has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis. The trial is designed to support the company’s forthcoming application to the Food and Drug Administration (FDA) for premarket approval of the AMDS.

The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial consisting of approximately 100 participants in the U.S., who have experienced an acute DeBakey Type I aortic dissection. Each participant will be followed for up to five years. The combined primary efficacy and safety endpoints will determine the impact of the AMDS hybrid prosthesis on reducing mortality, new disabling stroke, myocardial infarction, and new onset renal failure requiring dialysis, and also re-expansion of the true lumen of the aorta.

Wilson Szeto, MD, chief of cardiovascular surgery at Penn Presbyterian Medical Center, Philadelphia, the PERSEVERE national principal investigator, said: “Acute aortic dissection is a devastating disease with high morbidity and mortality. The surgical treatment is technically demanding. With the PERSEVERE trial, we intend to show the benefits that AMDS brings to patient outcomes and expand the therapy to more surgeons.”

Principal investigator Mohiuddin Cheema, MD, a cardiac surgeon from Hartford Health, Hartford, Connecticut, who implanted the first AMDS in the trial, said: “I am thrilled to be participating in the PERSEVERE study and to have treated the first patient with the AMDS in the USA. Implantation of the device was simple and added minimal time to the surgery. On the post-op CT scan we saw expansion of the true lumen and resolved malperfusion. Additionally, there was no presence of distal anastomotic new entry (DANE), which gives confidence that the aorta will continue to remodel positively over time and decrease the risk of future reoperation.”

Pat Mackin, chairman, president, and chief executive officer of Artivion, said: “If the trial proceeds as planned and meets its endpoints, we believe we can achieve FDA approval for patient access to the AMDS in late 2024 or early 2025.”

Intraoperative vascular mapping during hemodialysis access ‘should be incorporated into routine practice’

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Intraoperative vascular mapping during hemodialysis access ‘should be incorporated into routine practice’
Yana Etkin

Intraoperative ultrasonographic venous mapping is a useful tool to evaluate vessel suitability for arteriovenous fistula (AVF) creation, Yana Etkin, MD, associate professor of surgery at the Zucker School of Medicine at Hofstra/Northwell in Lake Success, New York, concluded at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). According to the presenter, the technique may increase the rate of distal fistula creation and lower the rate of graft replacement, and therefore “should be incorporated into routine clinical practice.”

Etkin and colleagues note in the abstract of their study that there is currently no consensus on how best to evaluate the suitability of vessels for AVF creation. They write that use of preoperative sonographic vascular mapping performed by a vascular imaging facility is common despite a lack of evidence on AVF outcomes. The goal of the present study was to evaluate the utility of intraoperative vascular mapping performed by the operating surgeon during access creation.

The research team performed a single-institution, retrospective study of 239 AVFs that were created at their institution between 2019 and 2021, Etkin informed the VAM audience. The team only included patients who had intraoperative and preoperative vein measurements recorded. The presenter detailed that the operating surgeon performed intraoperative measurements and that the certified vascular lab carried out preoperative measurements.

Etkin noted that site selection for fistula creation was based on distal to proximal and superficial vein first approach. This meant that the team considered radiocephalic fistulas first followed by brachiocephalic and then brachiobasilic fistulas, the presenter explained. Veins with a diameter of at least 2mm on intraoperative mapping were used for fistula creation.

The investigators compared intraoperative measurements of the veins used for fistula creation to preoperative measurements of the veins in the same anatomic location, the presenter explained. She added that the researchers reviewed the preoperative mapping and analyzed which hemodialysis access would have been created if intraoperative mapping was not performed.

The presenter reported at VAM that, on average, intraoperative vein measurements were about 1mm larger than preoperative vein diameters (3.6mm vs. 2.5mm) and that this was consistent in all anatomic sites including forearm cephalic vein, upper arm cephalic vein and basilic vein. The team also found that anesthesia type did not significantly affect intraoperative measurements. In patients who had regional anesthesia, the mean intraoperative vein diameter was about 3.6mm, compared to 3.4mm in patients who had local anesthesia.

When looking at preoperative mapping alone, Etkin revealed that 71% of patients would have the same access created. Ten percent of patients would require a more proximal fistula created utilizing superficial veins, 13% would have fistulas created using deep veins, and 6% would require a graft, the presenter added. In this subset of 70 patients who had a different access created based on intraoperative mapping, maturation rates were similar, at 84% as compared to 88% in the rest of the cohort.

Etkin noted that there were several limitations to the study. She reiterated that this was a single-institution, retrospective study, and that only a small number of patients were included.

In the discussion following Etkin’s presentation, one audience member expressed their “surprise” that type of anesthesia did not appear to affect AVF creation in the study. “Is it perhaps sedation that causes vasodilation as opposed to the type of anesthesia?” they asked the presenter. “This is something we are looking at,” replied Etkin. “It might be sedation.” However, due to the small sample size of the study, she stressed that the team needs to collect data from more patients in order to carry out such an analysis.

Another VAM delegate asked whether preoperative vein mapping might correlate better if it is performed well after the time of dialysis, stressing that the patients could be dehydrated when they come in for mapping. “That is the question that is almost impossible to answer,” the presenter replied. “We always operate the day after dialysis, but preoperative mapping might have been done on the day of dialysis, when the patient is dehydrated. It is very hard to tell what their fluid status is during mapping.”

There was widespread agreement with Etkin’s conclusions among the VAM audience, with one delegate likening the research to a consensus statement. This prompted the presenter to question why the guidelines do not yet endorse the intraoperative mapping as a standard of care. “That is why we wanted to put these data out there, to see if there is interest in adding the recommendation of intraoperative mapping into national guidelines.”

Black adults treated for common arterial disease are at greater risk of amputation, death than white adults, researchers show

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Black adults treated for common arterial disease are at greater risk of amputation, death than white adults, researchers show
Eric Secemsky

About 6.5 million Americans over the age of 40 suffer from peripheral arterial disease (PAD). In the U.S., Black adults in their 50s are at least twice as likely to suffer from PAD as their white counterparts, a disparity that continues to increase with age.  

In a new paper published in Circulation, researchers at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center (BIDMC) in Boston conducted a large, nationwide analysis of Medicare beneficiaries to document racial differences in revascularization treatment for PAD, and outcomes for patients with PAD. The team found that Black adults underwent significantly more endovascular peripheral vascular interventions (PVI), were treated for more advanced disease and were also more likely to experience adverse outcomes following PVI procedures, including amputation and death.   

“Black race was significantly associated with worse one-year outcomes after revascularizations, after adjusting for age and sex,” said senior corresponding author Eric Secemsky, MD, director of Vascular Intervention at BIDMC, as well as section head of Interventional Cardiology and Vascular Research at the Smith Center for Outcomes Research at BIDMC. “This link persisted after we adjusted for individual and regional socioeconomic factors. However, the association between Black race and worse outcomes was no longer apparent after we adjusted for comorbidities, suggesting that the well documented Black-white disparities in the prevalence of PAD risk factors, including hypertension, diabetes and end-stage renal disease, explain the disproportionate development of PAD among Black adults.”

The analysis included 215,320 patients who underwent the gold-standard revascularization procedure—PVI—between 2016 and 2018. Black adults had a higher incidence of treatment, with 0.86 percent of Black Medicare beneficiaries undergoing the procedure, compared to 0.51 percent of white Medicare beneficiaries. What is more, a greater proportion of Black adults were treated for more severe arterial disease, while more white patients were treated for a milder form of PAD. Despite their relatively greater severity of disease, a lower percentage of Black adults were prescribed key cardiovascular medications.

“Structural racism perpetuates these health disparities,” said Secemsky, who is also an associate professor of Medicine at Harvard Medical School. “One important way in which these systemic and structural factors lead to worse outcomes in Black patients is through comorbidities. This suggests a critical need for targeted, upstream intervention to reduce the disproportionate burden of PAD in the Black population.” 

Female sex is associated with reintervention and mortality following elective EVAR

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Female sex is associated with reintervention and mortality following elective EVAR
Taylor Corsi

Women are more likely to die within five years of having elective surgery to repair an abdominal aortic aneurysm (AAA) or need repeat surgery, according to a recent study.

Writing in the Journal of Vascular SurgeryTaylor Corsi, BS, a medical student at Rutgers University, Piscataway, New Jersey, and colleagues said the disparity between men and women who undergo the surgery needs to be addressed by including women in early aortic aneurysm screening as well as incorporating more women in clinical trials of aortic medical devices.

The data were originally presented at the 2021 annual meeting of the Eastern Vascular Society (EVS) in Charleston, South Carolina. An update was delivered at the 2022 Society for Clinical Vascular Surgery (SCVS) Annual Symposium held in Las Vegas in March.

“Despite the fact that men are more likely to be diagnosed with and to die from AAA, women are still under-represented in many clinical trials for the aortic devices used in minimally invasive aortic aneurysm repair,” said William Beckerman, MD, a vascular surgeon at Robert Wood Johnson University Hospital, New Brunswick, New Jersey, who led the study. “As men and women are known to have different aortic anatomy, this study highlights the need for an increased focus on, and inclusion of women in aortic device creation and subsequent trial enrollment.”

William Beckerman

Researchers conducted a retrospective chart review of 273 patients—75% of them male and 25% female—who underwent endovascular aneurysm repair (EVAR) from 2011 to 2020 at a tertiary medical centre. The idea was to learn how many patients survived five years beyond the surgery and how many needed reintervention. The females were older on average than the males and were more likely to have chronic obstructive pulmonary disease, require home oxygen therapy or dialysis.

Despite some variations in morbidities, the differences in survival and reintervention were statistically significant, the researchers found. Females had significantly lower survival rates at five years as well as a higher rate of reintervention within those years.

“Our question was, knowing all these things that we do, do men and women have different outcomes—even though they are being operated on by the same surgeon, at the same hospital with the same devices?” Beckerman said. “The answer to that was ‘yes.’ Men and women do differently after surgery.”

“Our data suggests factors beyond patient age and baseline health risk likely contribute to greater surgical morbidity and mortality for females following elective EVAR,” Beckerman added.

Prepare for Board exams at UCLA/SVS review course

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Prepare for Board exams at UCLA/SVS review course

Planning to take the upcoming Vascular Surgery Board (VSB) exams? Prepare for them at the “Seventh Annual UCLA/SVS Symposium: A Comprehensive Review and Update of What’s New in Vascular and Endovascular Surgery.”

The course is coming up quickly. It will be held Aug. 25 to 28 at the Beverly Hilton in Beverly Hills, California.

This 3.5-day symposium, a joint effort of the Division of Vascular and Endovascular Surgery at the University of California Los Angeles (UCLA) and the Society for Vascular Surgery (SVS), offers an in-depth review of the vascular surgery specialty for those preparing to take their vascular board examinations. It also provides the basic didactic education for vascular residents and fellows in training.

The course recognizes four major pillars of vascular surgery practice, conventional open operations, catheter-based intervention (endovascular surgery), the medical aspect of patient management, and diagnostic imaging and noninvasive testing.

Learn more at vascular.org/ReviewSymposium22 and register today.

SVS PA Section seeks Steering Committee members

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SVS PA Section seeks Steering Committee members
Doctor holding touching hands Asian senior or elderly old lady woman patient with love, care, helping, encourage and empathy at nursing hospital ward : healthy strong medical concept

The Society for Vascular Surgery (SVS) Physician Assistant (PA) Section seeks applicants for its Steering Committee. The committee will be developing content for section members to help them improve patient care and quality.

Applications are due Aug. 3. Learn more and apply here. CVs can be submitted to [email protected].

The PA Section is charged with uniting PAs engaged in vascular surgery, to support one another in the unique challenges PAs face and to promote and leverage the vascular PA skill set in delivering care to patients with vascular conditions.

Recent survey initiatives have identified that PAs’ work in diverse settings and their education requirements may differ based on practice type and practice setting.

SVS looks to maintain AMA House of Delegates representation

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SVS looks to maintain AMA House of Delegates representation
Nicolas Mouawad

To maintain its seat in the American Medical Association (AMA) House of Delegates—and, importantly, be able to provide information that impacts physician reimbursement—a 20% share of Society for Vascular Surgery (SVS) members must also maintain active membership at the AMA. The SVS, currently 60 members short of meeting this required threshold, has until Sept. 1 to meet this membership metric.

If the SVS loses its seat within the AMA House of Delegates, the impact will be significant, as SVS also would lose its representation on the RVS (Relative Value Scale) Update Committee (RUC). The RUC is the main advisory body to the Centers for Medicare and Medicaid Services (CMS) on relative values for new and revised Current Procedural Technology (CPT) codes, said SVS member Nicolas Mouawad, MD.

The RUC includes 32 physicians and more than 300 other representatives in each sector of medicine, including primary care physicians and specialists.

Mouawad, the SVS delegate to the AMA, said he understands that many members may have negative feelings about the AMA. However, the organization manages the RUC, which provides critical input to CMS on procedural codes and relative values on both physician work and direct practice expenses, which then drive both positive and negative trends in reimbursement, he said. Thus, “it is crucial that SVS is represented at the RUC.”

Actively engaging with the AMA also provides various benefits beyond the House of Delegates and CPT/RUC activities, including participation in coalition activities, promoting the interests of vascular surgery, and ensuring collaboration across the House of Medicine.

Though the AMA deadline is September, SVS leaders hope to reach the membership threshold before then. “Please join the AMA and notify SVS by emailing [email protected] when your membership is confirmed. That will let us know when we reach the number needed to keep our seat,” Mouawad said.

Taking this simple step, he added, can collectively “make a vital difference for our specialty.”

Become a member or renew membership at vascular.org/AMA.

Female sex is associated with additional treatments following surgery for intermittent claudication, study shows

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Female sex is associated with additional treatments following surgery for intermittent claudication, study shows
Scott R. Levin

A new U.S. study has found that female sex is associated with more reinterventions after surgical treatment for intermittent claudication. Additionally, guideline-directed medical therapy, including aspirin and statin use, was used less frequently among female compared with male patients in both the preoperative and postoperative settings.

“Based on these findings, we recommend that vascular interventionists treating female patients with intermittent claudication increase their efforts to maximize medical therapy and discuss with their patients the differences in intervention durability based on patient sex,” explained first author Scott R. Levin, MD, from Boston University School of Medicine and Boston Medical Center, Boston.

The researchers conducted a retrospective analysis of patients undergoing vascular interventions for intermittent claudication in more than 800 academic and non-academic centers in North America from 2010–20. Among the 64,752 peripheral vascular interventions, 38% were performed in female patients. Out of the 9,314 infrainguinal bypasses and 3,227 suprainguinal bypasses, 30% and 37% were performed in female patients, respectively. Female compared with male sex was associated with increased reinterventions after peripheral vascular interventions, infrainguinal bypasses and suprainguinal bypasses at one year.

Additionally, they found that regardless of patient sex, one-year amputation rates were higher than expected compared to medical management (smoking cessation, aspirin and statin therapy, a walking program) alone prompting Levin to recommend that surgeons attempt an adequate period of medical therapy prior to offering invasive interventions for intermittent claudication.

According to the researchers, increasing medical options, particularly for an elective vascular procedure, is essential and an area for immediate improvement. “However, this is only one factor that may mitigate the disparity in reintervention rates by patient sex. Future prospective analysis is warranted to assess the reasons for the type of intervention offered, as well as for suboptimal medical therapy, treatment failures, and need for reintervention among female patients,” said Levin.

These findings appear online in the journal Annals of Vascular Surgery.

Cordis announces start of enrollment in RADIANCY clinical study in Europe

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Cordis announces start of enrollment in RADIANCY clinical study in Europe

Cordis has announced the start of the European RADIANCY premarket clinical study of a stent system designed for radial access in the treatment of peripheral artery disease (PAD).

RADIANCY is a prospective, multicenter, single-arm study to assess the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system intended for treatment of lesions in the iliac, superficial femoral, or proximal popliteal arteries via radial artery access through 30-day follow-up, a company press release details.

The first procedure was performed by Mercedes Guerra, MD, head of vascular and endovascular surgery at the University Hospital of Guadalajara, Guadalajara, Spain, using the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal angioplasty (PTA) balloon catheter to facilitate delivery of the S.M.A.R.T Radianz self-expanding stent in an iliac lesion.

Upon completion of the procedure, Guerra said: “My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study. We applaud Cordis for pursuing the technological innovation to meet the need for radial access solutions in lower extremity interventions. We look forward to contributing our findings to the global endovascular community as part of the RADIANCY clinical study.”

The RADIANCY study, led by principal investigator Raphaël Coscas, MD, a professor of vascular surgery at Ambroise Paré Hospital, Boulogne-Billancourt, France, is planned to enroll 159 patients at approximately 15 sites across seven European countries. “The RADIANCY study initiation marks a new course for the future management of patients with [PAD] by expanding their treatment options from current conventional femoral to radial access,” Coscas said.

Coscas also highlighted the era of practice evolution in this space: “As the gold-standard approach in coronary interventions, radial is in its exciting inception phase for PAD and offers unequivocal patient-centric advantages in terms of early mobility and comfort, critical in both in-patient and out-patient practice settings.”

The S.M.A.R.T. Radianz vascular stent system, specifically engineered for radial access, was approved by the Food and Drug Administration (FDA) earlier this year, and successful first-in-human procedures were performed in June 2022 by Jihad Mustapha, MD, an interventional cardiologist from Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids, Michigan.

AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic stenosis treatment

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AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic stenosis treatment

A prospective, multicenter study involving the Covera vascular covered stent (BD) has confirmed the benefits of immediate, post-percutaneous transluminal angioplasty (PTA) placement of the device in treating arteriovenous graft (AVG) venous anastomotic stenosis when anatomically and clinically suitable.

Writing in the Journal of Vascular and Interventional Radiology (JVIR) on behalf of the AVeVA (Arteriovenous stent graft in the treatment of stenosis at the graft-vein anastomosis of AV graft circuits) study investigators, Bart Dolmatch, MD, an interventional radiologist at Palo Alto Medical Foundation, Mountain View, California, and colleagues report a 30-day freedom from safety-related events of 96.4% and a six-month target lesion primary patency (TLPP) of 70.3% with the Covera stent.

The authors begin by noting that, as per three prospective, multicenter, randomized trials, placement of a covered stent has previously led to statistically superior TLPP rates compared to PTA alone in restoring flow and maintaining hemodialysis access.

They add that the current study, AVeVA examined a self-expanding nitinol covered stent (Covera) that is more flexible than the device used in two of those prior studies (Flair, BD).

AVeVA study

Between August 2016 and February 2017, 110 patients were treated by investigators across 14 U.S. centers in AVeVA—a single-arm, investigational device exemption (IDE) study without a concurrent control. Dolmatch and colleagues—the team of investigators includes vascular surgeons Clifford Sales, MD, and Erin Moore, MD—note that, because prospective trials of previous-generation covered stents had been completed and published, and the devices had been approved by the Food and Drug Administration (FDA) for the indication being studied, pooled mean values from these trials as well as additional published data on the use of PTA alone for hemodialysis graft stenosis were used to develop safety- and patency-related performance goals for AVeVA.

The primary safety endpoint was 30-day freedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalization or death. The primary efficacy endpoint was six-month TLPP, or the interval following treatment until the next clinically driven reintervention at the site of the target lesion or until the AVG was abandoned. Prespecified secondary endpoints included acute technical and procedural success, access circuit primary patency (ACPP), cumulative patency, number of reinterventions, index of patency function (IPF), and adverse events through two years.

Of the 181 patients who gave informed consent to participate, 71 did not meet the study eligibility criteria—with 75% deemed not to have angiographic evidence of ≥50% stenosis and clinical evidence of graft dysfunction—meaning 110 patients (mean age=64.3 years, 54.5% female, mean body mass index [BMI]=28.7kg/m2) were ultimately enrolled and treated with the Covera device. The vast majority (98.2%) had an upper-arm AVG.

New Covera data

The authors detail that the mean anastomotic lesion stenosis at the time of treatment was 71.5%, decreasing to a mean residual stenosis of 21% following PTA predilation. One covered stent was used to treat each study lesion, meaning 110 stents were deployed, and all but two of these were postdilated. The mean residual stenosis at procedure completion was 0.9%, Dolmatch and colleagues report. In all cases, the covered stent was deployed to the intended location and eliminated preprocedural symptoms of access dysfunction—constituting a technical and procedural success rate of 100%. All but two patients (98%) resumed dialysis after the procedure using their AVG.

At 30 days, freedom from adverse events was 96.4%. Four patients (3.6%) required additional reintervention and one patient (0.9%) underwent required/prolonged hospitalization. The primary safety endpoint was therefore adjudged to be superior to the performance goal of 88% derived from prior studies and existing literature.

A total of 102 patients (92.7%) were available for the six-month primary efficacy analysis. TLPP at six months was 70.3% among these patients, the authors detail, and this was deemed superior to the prespecified performance goal of 40%. The only observed difference in patient subgroup analyses related to thrombosed AVGs, as those who presented with thrombosis within 30 days of the index procedure and/or at the time of the procedure demonstrated inferior TLPP rates at six months to those in non-thrombosis groups. Dolmatch and colleagues note that reasons behind this are unknown, but the fact this was observed in their study supports the “long-suspected belief” that a thrombosed AVG is more likely to fail due to TLPP loss, even when treated with a covered stent.

Noting secondary endpoint data, which they say should be considered observational and were calculated at predetermined intervals through the end of the study, the authors state that the Kaplan-Meier survival estimates for TLPP were 54.2% at 365 days and 36.9% at 730 days after the procedure, while Kaplan-Meier survival estimates for ACPP were 40.4%, 16.7%, and 7.8%, at 180, 365 and 730 days, respectively. A total of 91 adverse events across 53 patients (48.2%) were reported through 24 months, and 18 patients experienced device- or procedure-related events, meaning 86.3% were free from such events at 24 months.

Concluding messages

The Covera stent did an “adequate job” of maintaining target lesion patency over time, they add, but the “marked” and “ongoing” loss of ACPP (7.8% at 24 months) indicates that—regardless of TLPP improvement with a covered stent—some AVGs may be prone to recurrent stenosis or the development of new stenoses elsewhere in the circuit. The authors state that the 24-month cumulative circuit patency rate of 73.6% further supports this notion, and the finding that TLPP was “acceptable” with covered stent placement. The mean number of reinterventions to maintain patency was 1.6 at the treatment site and 3.6 in the access circuit at 24 months.

Dolmatch and colleagues conclude their JVIR report by noting that AVeVA was designed as “a first-in-human look at the Covera covered stent” in treating AVG venous anastomotic stenosis—and it demonstrated rates of freedom from major adverse events at 30 days (96.4%) and TLPP at six months (70.3%) that were both superior to literature-devised performance goals.

They also note, however, that AVeVA is not directly comparable with other, similar trials like FLAIR Pivotal, RENOVA and REVISE, and outline limitations of the current study, such as the inclusion of thrombosed AVGs and non-target stenoses (rather than a more homogenous AVG group), and the potential for an “inherent bias” being created by its single-arm design and the selection of historical studies. “A comparative, powered, randomized study would be needed to determine patency differences between different covered stents within the same demographic population,” the authors add.

The top 10 most popular Vascular Specialist items of June 2022

The top 10 most popular Vascular Specialist items of June 2022

June’s top stories spanned a range of presentations from the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18), covering topics including burnout among vascular surgeons, amputation rates in Black and Hispanic CLTI patients, and VAM’s inaugural Women’s Section education session. Vascular Specialist also talked presidential priorities with new SVS president Michael Dalsing, MD.

1. Open repair of infrarenal aortic aneurysm proves preferable to endovascular repair

As part of the VAM International Fast Talk session on the morning of Wednesday, June 15, Emiliano Chisci, MD, from San Giovanni di Dio Hospital in Florence, Italy, presented the results of a 15-year follow-up of open repair (OSR) of an infrarenal abdominal aortic aneurysm (AAA).

2. Vascular surgeons ‘have a role to play’ in transcatheter aortic valve replacement procedures

Vascular surgery assistance in transcatheter aortic valve replacement (TAVR) can facilitate safe and effective device introduction through cases involving challenging femoral or iliac access. This was the conclusion delivered by Enrico Gallitto, MD, from the University of Bologna, Bologna, Italy, during VAM 2022.

3. An antidote for burnout: Vascular surgeons as hospital administrators

The much-maligned electronic health record (EHR)—sometimes referred to as electronic medical record, or EMR—is not among the causes of burnout, per se, but rather a symptom, VAM 2022 heard during the John Homans Lecture on the Saturday morning of the Boston gathering.

4. New SVS president outlines priorities for his tenure as Society aims to reach out

Michael Dalsing, MD, who took over as Society for Vascular Surgery (SVS) president at VAM 2022, talks about the priorities he has set out for his time at the helm, which include advocating for vascular surgery amid the recurring threat of Medicare payment cuts, furthering the Society’s efforts to build brand awareness of the specialty, and contributing to the quest to broaden access to quality vascular care.

5. Researchers report higher three-year amputation and reintervention rates in Black and Hispanic CLTI patients

In a study of over 7,000 chronic limb-threatening ischemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention rates; survival, however, was higher among Black patients and similar between Hispanic and White patients. Aderike Anjorin, BA, Duke University Medical Center, Durham, North Carolina, delivered these findings during the William J. von Liebig Forum at VAM.

6. Study of post-carotid endarterectomy surveillance prompts protocol discussion

The results of an analysis of nearly 2,000 carotid endarterectomies (CEAs) “challenge the notion” that patients benefit significantly from the current post-operative surveillance guidelines, and suggest that these may be contributing to “oversurveillance”—an issue that should be addressed in future protocols for patient management post-CEA.

7. F/BEVAR has high technical success and low mortality in chronic post-dissection TAAA

Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is associated with high technical success and low mortality in patients with chronic post-dissection thoracoabdominal aortic aneurysm (PD-TAAA). This conclusion was presented by Mohamed A. Abdelhalim, MBChB, a PhD research fellow at St Thomas’ Hospital, London, England, who detailed a multicenter, transatlantic experience with F/ BEVAR for chronic PD-TAAAs during VAM 2022.

8. Talking about women surgeons’ lives and careers

Women—and more than a few men—flocked to the inaugural VAM education session of the Society for Vascular Surgery’s new Women’s Section. The topics of “Supporting Women Vascular Surgeons—From Recruitment through Senior Leadership” reflected the name with sessions on the needs of the youngest generation of women vascular surgeons, radiation and women, and how senior women surgeons can leave a legacy.

9. First results from BEST-CLI poised to reveal ‘very low’ quality of life for patients entering the trial, especially women

An analysis from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial presented at VAM 2022 demonstrated patient-specific variables such as self-reported female gender, current smoking, impaired mobility and opioid use are associated with lower health-related quality of life (HR-QOL) as captured by multiple measurement tools.

10. Vascular surgery review book seeks to plug hole in VSITE preparation process

When University of Massachusetts Medical School integrated vascular surgery resident Thomas Creeden, DO, was preparing for his first Vascular Surgery In-Training Exam (VSITE), it struck him there was a gap in the market. While those training in most other surgical specialties had access to a high-yield textbook with which to prepare for exams, boards and even rotations, he mused, vascular surgery did not.

PAD: Ra Medical Systems receives FDA 510(k) clearance for the Dabra 2.0 catheter

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PAD: Ra Medical Systems receives FDA 510(k) clearance for the Dabra 2.0 catheter

Ra Medical Systems has announced receipt of Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system for the treatment of peripheral arterial disease (PAD).

A company press release details that the catheter features enhancements including a braided overjacket design that is intended to improve deliverability and kink resistance when navigating tortuous anatomy, as well as a six-month shelf life.

“While we are pleased to receive this regulatory clearance, it comes as our board continues its evaluation of strategic alternatives to optimize our company’s path forward in the current challenging economic environment,” said Will McGuire, Ra Medical Systems CEO. “As we have previously announced, the Dabra 2.0 catheter represents an interim step in our work to develop a guidewire-compatible version of the Dabra catheter, and at this time we have no plans to commercialize the Dabra 2.0.”

On May 16 this year, Ra Medical Systems disclosed that its board of directors is reviewing strategic alternatives with the goal of maximizing shareholder value. In conjunction with this review, on June 6 the company filed a report on Form 8-K with the Securities and Exchange Commission (SEC) announcing initiation of a reduction in force under which approximately 65% of the company’s full-time employees were terminated.

Non-terminated employees were offered conditional retention arrangements for a period of approximately 60 days from the date of the filing to allow for evaluation and monitoring of the company’s near-term personnel needs based in part on the company’s financial status and the board’s review of strategic alternatives.

The purpose of the reduction in force is to preserve capital with the goal of maximizing the opportunities available to the company during the board’s review of strategic alternatives, Ra Medical Systems said.

First patient enrolled in Wrapsody endoprosthesis registry study

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First patient enrolled in Wrapsody endoprosthesis registry study
Wrapsody grafts

Merit Medical has announced the successful enrollment of the first patient in its WRAP registry study in a press release. The study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving hemodialysis that experience stenosis or occlusion of blood vessels required for dialysis.

Globally, over 2 million patients with advanced kidney disease receive dialysis. Hemodialysis, the primary approach used for dialysis, requires long-term vascular access that is typically achieved through the surgical creation of an arteriovenous fistula (AVF) or placement of an arteriovenous graft (AVG). However, complications, such as stenosis and/or occlusion within the dialysis outflow circuit of an AVF or AVG, can impair vascular access which compromises the ability to provide adequate dialysis treatment. The Wrapsody cell-impermeable endoprosthesis was created to help overcome this challenge by maintaining the integrity of the dialysis outflow circuit.

Dean Huang, MD, consultant diagnostic and interventional radiologist at King’s College Hospital in London, England, enrolled the first patient in the WRAP Registry. “The patients being treated with the Wrapsody cell-impermeable endoprosthesis have historically had few clinical options,” Huang said. “These patients have typically faced frequent reinterventions to maintain vessel patency resulting in multiple procedures and hospitalizations. The WRAP study will add to the growing body of evidence on Wrapsody’s ability to achieve durable outcomes for this vulnerable patient population.”

The WRAP registry study will enroll up to 500 patients with outflow circuit stenosis or occlusion who are receiving hemodialysis at medical facilities throughout Europe, South America, Australia, and New Zealand. Clinical outcomes of patients after the initial placement of the Wrapsody cell-impermeable endoprosthesis will be evaluated over a two-year period in accordance with the instructions for use associated with its CE Mark.

The Wrapsody cell-impermeable endoprosthesis is an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (PTFE) and an internal layer of spun PTFE with an interposed cell-impermeable layer. The Wrapsody cell-impermeable endoprosthesis system is being studied under an investigational device exemption (IDE) in the U.S.

Cognitive dissonance, unhappy physicians and burnout

Cognitive dissonance, unhappy physicians and burnout
Bhagwan Satiani

Emotional intelligence has been widely accepted as an important element of leadership. The seminal work of Daniel Goldman informs us that the education of leaders involves the four essentials of emotional and social intelligence (self-awareness, self-regulation, social awareness and social regulation). Grunberg and colleagues maintain that healthcare professionals must also gain these skills to lead others to counsel and treat patients, and assist with their physical and behavioral health.1 

While the other three facets of emotional intelligence are often discussed, social regulation is often not mentioned in the literature. I have previously discussed self-imposed silence as one cause of burnout. Yet, of the four parts of social regulation, cognitive dissonance is of great importance for employed physicians dealing with burnout. 

Cognitive dissonance was coined by psychologist Leon Festinger, who saw it as an attempt to be internally consistent. When we are not, we are psychologically distressed and experience cognitive dissonance.2 As a non-mental health professional, cognitive dissonance seems to me like a struggle between our cognition and our behavior. When I have been conflicted, I have experienced anxiety, mental tension and, occasionally, regret for having chosen a certain behavior. I have discovered that there were others like me who were self-aware but lacked understanding of the science behind the concept. “Cognitive dissonance is ever-present in both the smallest, simplest examples to the deepest layers of humanity that impact the way we interact with each other and view ourselves and the world,” according to Lawlor.3 Stress results when the dissonance occurs frequently, for long periods of time and “involve[s] difficult decisions and a commitment to action.”4 

Now, to a couple of examples. One of my own personal life rules has been to avoid participating in fundraisers, and asking friends and colleagues for money. When I volunteered for an anti-domestic violence organization, and then became an officer, I was expected to raise money. The prospect of going “begging,” as I perceived it, was distasteful. Though many friends, relatives and colleagues obliged, the discomfort dogged me throughout. I have been a strong and sometimes partisan advocate for physicians throughout my career. When I was appointed to the board of a large healthcare system, I was advised that I had a “fiduciary” duty to represent the board rather than physicians. I sensed that physicians were expected to mostly watch, listen and stay silent.

In contrast, the medical staff expected me to represent their views. I did speak out at several critical junctures representing physicians’ views, but sadly not enough. In four years on the board, I felt bottled up inside. I tried to deal with this by “buttonholing” individual lay board members to better explain our perspective. 

Clinical practice also involves some degree of cognitive dissonance, even if we are following our internal ethical voice. An example often cited is that in evidence after research showed no benefit with arthroscopy for osteoarthritis of the knee. The surgeon is wrestling with the cognitive part related to the new research versus the firm belief hundreds of patients were helped (confirmatory bias). This is different from misrepresentation. We may overestimate the positive side of our decisions, justify sub-optimal outcomes, or be reluctant to admit that the benchmark outcomes reported are better. 

Physician-leaders can often have two different views of an issue—one for the outside world and one for themselves. As an example, some leaders may not act when they have publicly-stated support for a position, such as advocating for more resources. This duality may be appropriate at times, or seen as hypocritical. Can a leader in this position preserve their integrity and resolve the dissonance? 

By recognizing the dissonance, we are provided with an opportunity to clarify our principles and beliefs, and then to decide on a course of action. Some may resolve the dissonance by distorting their cognition through self-justification.5 The leader can either change his or her belief system, or change the action to resolve the dissonance. When neither is possible, they may justify their action. The bottom line is that self-awareness is important in this regard. 

Batista advises that, first, we should expect cognitive dissonance with important executive or managerial roles.5 Festinger opines that we either avoid situations that create the dissonance, or recognize it, try to reduce dissonance, and attain consonance to feel more comfortable. Third, we should recognize the stress that the dissonance will create, and have mechanisms ready to deal with it. Finally, good leaders always have trusted advisers, a coach, or a small kitchen cabinet to help settle internal conflict. Self-awareness and understanding of cognitive dissonance also need to be taught in training programs. 

References

  1. Grunberg NE, McManigle JE, Barry ES. Using Social Psychology Principles to Develop Emotionally Intelligent Healthcare Leaders. Front. Psychol., 29 July 2020 | https://doi.org/10.3389/fpsyg.2020.01917)
  2. Festinger, L. (1957). “An Introduction to the theory of dissonance,” in A Theory of Cognitive Dissonance, ed. L. Festinger (Stanford, CA: Stanford University Press), 209–219.
  3. Lawler M. Cognitive Dissonance: The Theory, Real-Life Examples, and How It Affects Your Day-to-Day Life. https://www.everydayhealth.com/cognitive-dissonance/
  4. Jones EH et al (2015) Action-Based Model of Cognitive Dissonance Processes, page 185, Current Directions in Psychological Science.
  5. Battista E. The Cognitive Dissonance of the CEO. https://www.edbatista.com/2018/07/the-cognitive-dissonance-of-the-ceo.html.

Mentorship: Why more vascular surgeons should consider mentoring young minds

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Mentorship: Why more vascular surgeons should consider mentoring young minds
7/31/18 Research Program Students
Sheng Dong

Addressing challenges of diversity and inclusion within medical schools and the larger physician workforce should begin with a conversation about the intrinsic barriers to higher education. In an economic analysis report of medical school matriculants published by the AAMC, it was found that nearly 75% of each medical school class from 2007–2018 came from the top two quintiles of family income (Youngclaus & Roskovensky, 2018). In fact, only 5% of students in medical school come from the lowest quintile of familial income.

Had someone told me that I only had a 5% chance of getting into medical school, I may have chosen a different career path. Getting a four-year undergraduate degree, study materials for the MCAT, applying to dozens of schools, and possible gap years to strengthen your application only to tackle four more years of tuition is a colossal commitment to make—exponentially more-so for children of lower working-class families.

In addition, students from lower socioeconomic status families may also struggle to adapt to the steep learning curve of the hidden curriculum, which requires one to understand the social norms and practices associated with becoming a more competitive applicant (Giroux & Penna, 1979). What these students are looking for is not a golden ticket that grants free admission into medical school—what they are really searching for is guidance on how to navigate the systems necessary to succeed. 

Growing up, my mother always told me to get a proper education so that I would never be forced to work as gruelingly as she does. Guidance was hard to come by when your parents don’t know the language, culture, or systems of the country you live in. Back in 2013 as a junior in high school, my life was forever changed when I attended a 10-week medicine immersion program for under-represented and disadvantaged youths at Mount Sinai Icahn School of Medicine. It was this experience that connected me with my mentor, Dr. Vicki Teodorescu (AKA Dr. Teo), who inspired me to embrace the challenge of becoming the first in my family to attend college. 

It’s never too early or too late to become a mentor 

Never underestimate the impact you can have on a potential mentee. From a fresh intern to someone bordering on retirement, there is knowledge to be imparted that can enrich a student’s personal and academic journey. Throughout my time shadowing Dr. Teo, I learned about the importance of developing meaningful relationships with people to achieve a common goal, the impact of fluid teamwork in overcoming challenging tasks and the value of being inquisitive. Mentorship is more than just helping improve clinical decision-making or operative skillset, it can help mentees develop self-efficacy towards achieving their goals. Even simple gestures like giving positive affirmation and motivation can be significant to mentees. 

We should view mentorship as an investment in the life of another. Finding meaningful extracurricular activities to strengthen college applications can be a struggle for many students from working-class families. Experiences with a physician mentor can act as a stepping-stone for many students of disadvantaged backgrounds to be considered for other competitive programs, which may help spark a passion for a field of medicine they never considered before. 

It was during the clinic visits with Dr. Teo that I first learned about the concept of social determinants to health. Although I did not understand the concept at the time, I began noticing certain trends and patterns in the patients that we saw, and I could not help but ask questions. Why there were so many patients who were homeless requiring dialysis access? Why were visits with non-native English speakers longer than usual? Why did patients on Medicaid seem to have longer patient charts than patients with private insurance? This curiosity in the social determinants behind vascular surgery then led to my decision to major in the social sciences in college, conduct research on the interaction of education and health, become an AmeriCorps English teacher, and pursue a graduate degree in public health, and become a medical student. Mentorship helped expose me to a world that I had never known about before, which planted the seed for my educational journey. 

Mentees must be proactive: It’s a two-way street 

There are several qualities that make a great mentee. Becoming one requires a dedication to learning and an unrelenting desire for continuous self-improvement. It is not enough for mentors to provide the opportunity – mentees must also be proactive. 

However, tackling new challenges can often be intimidating, since there is a risk of failure. Failure can become crippling to new learners but mentees that clearly communicate their needs and demonstrate a commitment to problem-solving, soon learn to embrace their failures and learn from them. In fact, failure is often a necessary ingredient in the recipe for success in any venture. 

Maximizing the impact of mentorship 

There are several different styles of mentorship. Mentorship can be an evolving process, one that requires trying different approaches and seeing what works and what doesn’t. Systems of constructive feedback are crucial. 

Mentorship is such a valuable tool at the disposal of physicians. It has the capacity to not only change the lives of students, but to shape what the future of medicine can look like. As I reflect on the impact of mentors in my life, I’m inspired to want to become a future mentor myself—particularly to students who come from lower working-class families that face challenges of social inequity and barriers of access to higher education. Dr. Teo’s mentorship catalyzed my academic journey into medicine. For most of my upbringing the idea of college felt unobtainable and unaffordable to an inner-city public-school kid like myself. Had it not been for this experience, I would not be here today—just like Dr. Teo. 

It is my hope that more vascular surgeons consider the possibility of mentoring students of working-class backgrounds as they can bring such unique diversity in life experience to the profession of medicine. Tackling the challenge of representation is an extraordinary task but creating more opportunities for mentorship can be the first step in investing towards the future of vascular surgery. 

Sheng Dong, MPH, is a medical student at George Washington University School of Medicine and Health Sciences in Washington, D.C. 

Artificial intelligence can predict risk of complications after endovascular aneurysm repair

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Artificial intelligence can predict risk of complications after endovascular aneurysm repair
Becky Long

Artificial intelligence (AI) models can be developed to predict the risk of postoperative complications after endovascular aneurysm repair (EVAR) with “high accuracy,” research presented at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18) demonstrated. 

“Complications after EVAR can be fatal,” Becky Long, MD, Central Michigan University, Saginaw, Michigan, informed attendees, noting in her presentation that patient follow-up for surveillance imaging is becoming more challenging as fewer patients are seen, particularly after the first year. 

The aim of Long’s study was to develop an AI model to predict the complication probability of individual patients to better identify those needing more intensive surveillance. The research involved collecting preoperative computed tomography angiography (CTA) 3D reconstruction images of abdominal aortic aneurysm (AAA) from 273 patients who underwent EVAR from 2011‒2020. 

Of these patients, 48 had postoperative complications including endoleak, AAA rupture, graft limb occlusion, renal artery occlusion, neck dilation, pelvic ischemia, and graft migration. 

Using a deep convolutional neural network model, the researchers utilized the 3D CT images to predict the risk of complications after EVAR. The model was built with Tensorflow software and run on the Google Colab Platform. 

A training subset of 40 randomly selected patients with complications and 189 without were used to train the AI model. Eight positive and 36 negative cases tested its performance and prediction accuracy. Data downsampling was used to alleviate data imbalance and data augmentation methodology to further boost the model’s performance. 

Long’s presentation reported that successful training was completed on the 229 cases in the training set and then applied to predict the complication probability of each individual in the held-out performance testing cases. 

The model provides a complication sensitivity of 100% and identified all the patients who later developed complications after EVAR. Of 36 patients without complications, 16 (44%) were falsely predicted to develop complications. 

The results, therefore, demonstrated excellent sensitivity for identifying patients who would benefit from more stringent surveillance and also alleviate the need for surveillance in 56% of patients unlikely to develop complications, the presentation will show. 

This, Long concluded, demonstrates that AI models can be developed to predict the risk of postoperative complications with high accuracy. 

“Compared to existing methods, the model developed in this study did not require any expert-annotated data but only the AAA CTA images as inputs,” Long’s presentation showed. “This model can play an assistive role in identifying all patients at high risk for post- EVAR complications and the need for greater compliance in surveillance.” 

Outgoing SVS president’s message of unity: ‘We must work together to improve, advance vascular care’

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Outgoing SVS president’s message of unity: ‘We must work together to improve, advance vascular care’

The Society for Vascular Surgery (SVS) is no longer the organization it was half a century ago. That was one of the core messages from the Society’s now Immediate Past President Ali AbuRahma, MD, during his Presidential Address at the 2022 Vascular Annual Meeting (VAM) in Boston. A number of members—many in community practice—had been in contact with him to say that “they didn’t think the SVS was inclusive enough,” he tells Vascular Specialist@VAM shortly after giving the address. “So, I reviewed the structural changes, the governance changes, that we have [undergone] to show them how we have radically changed over the last 50 years.”

In our interview, AbuRahma also highlights the potentially “disastrous” Medicare payment cuts the vascular specialty is once again confronting, improvements in diversity at SVS committee level, and efforts at striking a balance between the different vascular practice settings—be it surgeons in outpatient venues such as the office-based lab (OBL), specialists who are hospital employed, or those operating in academia.

Jonathan Towne honored with SVS Lifetime Achievement Award

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Jonathan Towne honored with SVS Lifetime Achievement Award
Jonathan B. Towne

An “amazing clinician and leader.” Devoted to the specialty of vascular surgery. Investigator and researcher. Champion of the in-situ technique for lower-extremity bypass. Former SVS secretary and president. And a leader in creating the Vascular Surgery Board (VSB).

For all these accomplishments, and more, the Society for Vascular Surgery (SVS) bestowed upon Jonathan B. Towne, MD—to a standing ovation—one of its highest honors: the SVS Lifetime Achievement Award. 

“The older you get the sweeter it is,” he told the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18), the venue in which he received the award. He had no speech prepared, but simply said, “I thank you. I had the very good fortune of being involved with vascular surgery relatively early on and in its early adolescence,” he said. 

“Vascular surgery had a stormy, stormy young adulthood; it’s now matured and as I look around and follow what’s happening, I like where you are,” he said. “Thanks to all of you who helped me do the things I was involved with that led to this. It is indeed an honor.” 

His path to Thursday’s award was influenced by chance. In medical school at the University of Rochester, Towne met vascular pioneer Charles Rob, MD, who was developing the concept of vein bypass grafting. That sparked an interest in surgery and what was evolving to become the specialty of vascular surgery. 

Following medical school, general surgery residency and a two-year stint in the Air Force, Towne continued his training with a fellowship at Baylor University Medical Center in Dallas. Victor Bernhard, MD, then recruited Towne to join the faculty at the Medical College of Wisconsin (MCW), where he would spend his entire professional career until his retirement in 2007. 

There, Towne and Bernhard started one of the earliest vascular fellowships. Towne eventually trained 29 fellows plus countless general surgery residents and medical students. One of his mentees said, “Under his leadership, the Division of Vascular Surgery at the Medical College of Wisconsin became a major regional referral center, which it remains today.” 

He established at MCW and at a Veterans Affairs center intensive follow-up protocols, maintained to this day. 

Towne served as a principal investigator for a “seminal study” that established carotid endarterectomy as an effective treatment in preventing stroke in patients with asymptomatic carotid artery disease, a colleague said. Towne embraced endovascular therapy both early on and, as the technology evolved, participated in early studies evaluating endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms. He was an early adopter of the team strategy in vascular surgery and supported and promoted expertise in the vascular lab and vascular nursing. 

A former colleague said, “We would not be where we are today as a specialty or a society if it had not been for Jon Towne leading the way during uncharted times.” 

Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US

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Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US
Thoraflex Hybrid

Following the recent approval by the Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial implant of the device in the United States.

Thoraflex Hybrid is a single use medical device combining a Gelweave polyester graft with a Nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and repair of the descending thoracic aorta with or without involvement of the ascending aorta, in cases of aneurysm and/or dissection.

The implant was performed by the principal investigator of the Thoraflex Hybrid study, Joseph Coselli, MD, professor and executive vice chair in the division of cardiothoracic surgery at Baylor College of Medicine in Houston, Texas.

“The procedure was very successful, the device performed well, and the patient is making a good recovery”, said Coselli. “Thoraflex Hybrid is the first of its kind device used in FET repair in the United States and it will allow U.S. physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single stage procedure for those with suitably limited disease, instead of two procedures which has been the conventional pathway in the United States for this group of patients.”

Thoraflex Hybrid received CE mark approval in 2012 and FDA approval in 2022.

Cydar Medical and King’s College London partner on randomized controlled trial of Cydar EV Maps

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Cydar Medical and King’s College London partner on randomized controlled trial of Cydar EV Maps
Cydar Maps

Cydar Medical has partnered with King’s College London to initiate the ARIA study—a randomized controlled trial to assess the clinical-, technical- and cost-effectiveness of a cloud-based, artificially intelligent image fusion system in comparison to standard treatment to guide endovascular aortic aneurysm repair.

Endovascular aneurysm repair (EVAR), an alternative to open aortic surgery due to perceived advantages in patient survival, reduced post-operative complications and shorter hospital lengths of stay, still sees significant variability in pre-operative planning and sizing, problems associated with imprecise visualization and device positioning intraoperatively, and inconsistent patient outcomes, Cydar said in a press release.

“Our central hypothesis is that digital technology—specifically cloud-computing and artificial intelligence (AI)—can be used to assess and learn from large volumes of data to inform clinical decision-making and has the potential to improve the predictability of individual patient outcomes and the consistency of outcomes in the NHS,” said Rachel Clough, MD, principal investigator of the ARIA Study and clinical senior lecturer from King’s College London in London.

The randomized trial will enroll 340 patients at 10 sites across the United Kingdom with a clinical diagnosis of abdominal aortic or thoracoabdominal aortic aneurysm (AAA and TAAA, respectively) suitable for endovascular treatment. The trial will follow patients for one year and assess the effect of Cydar EV Maps—certified software-as-a-medical device—on clinical-, technical- and cost-effectiveness in comparison to standard treatment in endovascular aortic aneurysm repair, used for both standard and complex devices.

The study was initiated with the first patient enrolled at the Liverpool University Hospitals NHS Foundation Trust in Liverpool, England. “Cydar EV Maps is a game-changing technology for vascular navigation,” said Simon Neequaye, MBBS, principal investigator at the institution. “The ARIA study provides a unique opportunity to demonstrate the benefits like reduced procedure time and reduction to radiation exposure, although some of the more subtle benefits related to procedural quality and reduced operator fatigue may never be directly measured but are obvious as an operator.”

Cydar EV Maps is currently available in the EU, UK and U.S. with both European Union CE mark and Food and Drug Administration (FDA) 510(k) clearance.

SVS creates limb salvage-focused Frank J. Veith Lectureship

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SVS creates limb salvage-focused Frank J. Veith Lectureship
Frank Veith is presented before the 2022 SVS Annual Business Meeting in Boston

Next year’s Vascular Annual Meeting (VAM) will include a new named lecture: the Frank J. Veith Lecture, named in honor of former Society for Vascular Surgery (SVS) President Frank Veith, MD.

Immediate Past President Ali AbuRahma, MD, announced the new lecture—which now joins the John Homans Lecture and the Roy Greenberg Distinguished Lecture—during the 2022 Annual Business Meeting on Saturday June 18, VAM 2022 closing day, in Boston. Initially, it will be presented every other year, starting in 2023.

The lecture will focus on limb salvage and ground-breaking research into the diagnosis and treatment of peripheral arterial disease (PAD). The Society president will select the speaker in consultation with the Executive Board.

“I am truly overwhelmed and most grateful to the SVS for affording me this recognition,” Veith told those present at the meeting. “I’m really blown away by it.

“Of all the organizations in the world, I’ve always held the SVS in the highest esteem,” he said, calling establishment of the Lectureship “a singular honor.”

He added that he believes PAD and limb salvage are topics of importance for vascular surgery to recognize and highlight. He encouraged his colleagues to maintain and sustain the leadership of vascular surgery and SVS in the care of PAD patents.

In addition to being a past SVS president, Veith is chair of the VEITHsymposium, which brings together not only vascular surgeons but also interventional radiologists, interventional cardiologists and other vascular specialists learn the most current information about what is new and important in the treatment of vascular disease.

This is the first new named lectureship in many years, noted AbuRahma. The Roy Greenberg Distinguished Lecture debuted at the 2013 VAM. SVS established the Homans Lectureship in 1950 at the fourth annual Vascular Annual Meeting. For many years, it was not necessarily presented annually, as it is now.

Vascular surgery review book seeks to plug hole in VSITE preparation process

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Vascular surgery review book seeks to plug hole in VSITE preparation process

When University of Massachusetts Medical School integrated vascular surgery resident Thomas Creeden, DO, was preparing for his first Vascular Surgery In-Training Exam (VSITE), it struck him there was a gap in the market. While those training in most other surgical specialties had access to a high-yield textbook with which to prepare for exams, boards and even rotations, he mused, vascular surgery did not. “The modern-day textbook is something like 4,000-pages long, and seems kind of daunting,” Creeden told Vascular Specialist@VAM. 

So he decided to do something about the anomaly: After some encouragement from mentors, he went ahead and produced one himself. The result is The Vascular Surgery Review Book. 

What started out as a culling-together of his notes in intern year morphed into a more organized undertaking during the second and third. Eventually, he got serious with the encouragement of UMass vascular chief Andres Schanzer, MD, and program director Jessica Simons, MD. 

The driving force was to create a reference text that would be fundamentally easier and quicker to work through. 

The book was published in the middle of June, and is available both in print and as a Kindle edition. It was also available at the University of Massachusetts table at the General Surgery Resident/Medical Student Program: Residency Fair during the Vascular Annual Meeting (VAM) in Boston (June 15–18). 

Creeden, who was in attendance at the table, was himself drawn to vascular surgery after a process of elimination, realizing he enjoyed the blend of minimally invasive procedures, open surgery, medicine and critical care. 

“Once I spent a month on it, I wanted to spend another month on it, and then another month, and it just started snowballing for me,” he said. 

The book publishing process ramped things up a notch. Creeden spent much of his spare time putting the title together, but then realized over the last three or four months the easy part was writing it. 

Once he had navigated potential copyright pitfalls, he hired professional help to complete the publishing process, including a medical illustrator and a cover designer. “I’ve been very encouraged hearing other vascular surgery training programs are already utilizing the book and providing copies for their residents,” he added 

Bolstering the workforce: Session details how to start a vascular training program

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Bolstering the workforce: Session details how to start a vascular training program
Malachi Sheahan (pictured, center) and Jeffery Jim staged the latest edition of a recurring VAM session designed to provide guidance for the creation of new vascular training programs at VAM 2022 in Boston

The workforce shortage issues set to plague vascular surgery over the next few decades, alongside an aging population and increase in vascular disease, formed the backdrop to a 2022 Vascular Annual Meeting (VAM) breakout session in Boston (June 15–18) designed to help surgeons navigate the tricky waters of starting a vascular training program. 

Organizers and moderators Malachi Sheahan III, MD and Jeffrey Jim, MD, who together chaired the new program development section of the SVS Future of Vascular Surgery Task Force, sought to answer two top-line questions for those mulling over the possibility: “Do you have the resources? And where can you find help?” in an intimate, accessible setting at the Hynes Convention Center, the VAM 2022 host site.

The session ushered attendees through the process of establishing programs, including leadership and faculty requirements, the constitution of curricula, and other needs like a vascular lab. 

Sheahan introduced a guidebook, entitled How to Develop A Vascular Surgery Training Program, a collaborative work from the Association of Program Directors in Vascular Surgery (APDVS) and the Society for Vascular Surgery (SVS). 

The session was cast against the ever more pressing backdrop of predicted shortfalls in the number of practicing vascular surgeons.

“The U.S. population is increasing and aging,” he told those looking to help plug the workforce shortages expected to ensue through 2050. With cardiovascular disease continuing to be the country’s leading cause of death and morbidity, and the prevalence increasing 1–2% annually, the burden will remain, he outlined.

The workforce phenomenon is international, Sheahan added, sharing statistics laying out the scale of shortages in the United Kingdom, France and Canada. The session sought to explore the concept of increasing the supply of vascular surgeons, meaning more trainees, and explore the question of “can we preserve vascular surgery?”—which comes amid a burgeoning field of “vascular specialists” who are not vascular surgeons, Sheahan told Vascular Specialist@VAM. 

Through the APDVS-SVS guidebook, a session aid, attendees heard about the complexities and intricacies of both the five-year integrated vascular residency and the vascular fellowship. 

Earlier this year, Sheahan and Jim outlined the scale of the task at hand in a presentation at the annual meeting of the Society for Clinical Vascular Surgery (SCVS) annual meeting in Las Vegas. Helped by the task force’s efforts, Sheahan explained, 28 new vascular training programs had been established nationwide. 

The collaboration formed between the SVS and APDVS helped clear up the prerequisites of the Residency Review Committee (RRC) of the Accreditation Council for Graduate Medical Education (ACGME) for the faculty and program director requirements needed to start both an integrated program and a fellowship. 

The APDVS also provided stewardship to help guide those getting started through an often “byzantine and confusing” process, Sheahan said at SCVS 2022. They had also increased outreach efforts through such mediums as the VAM 2022 session in question, which is currently a recurring feature on the VAM schedule, he had added before the Las Vegas gathering. “With a bit of a push, there are a lot of people out there who want to train vascular surgeons,” Sheahan said. 

Off-the-shelf branched endograft for TAAAs demonstrates safety and effectiveness through two years in both stable, symptomatic patients

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Off-the-shelf branched endograft for TAAAs demonstrates safety and effectiveness through two years in both stable, symptomatic patients
L to r: Manuel Garcia-Toca, Fedor Lurie, Ahmed Abou- Zamam, Jr., Palma Shaw, and Nikolaos Tsilimparis

Two-year target vessel-related freedom from all-cause and aneurysm-related mortality for an off-the-shelf multibranched endovascular device for the treatment of thoracoabdominal aortic aneurysms (TAAAs) came in at 78.5% and 98.6%, 2022 Vascular Annual Meeting (VAM) attendees heard. 

The data relate to clinical outcomes and target vessel patency in patients who underwent endovascular TAAA repair with the Zenith t-Branch in the first company-initiated, real-life registry of a patient pool covering elective, symptomatic and ruptured TAAAs. 

Nikolaos Tsilimparis, MD, from Ludwig Maximilian University in Munich, Germany, reported the results during the International Fast Talk session that took place at the VAM 2022 in Boston (June 15–18). 

The analysis was carried out at three European sites between 2012–2020 on repairs in patients receiving t-Branch and bridging stents for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal arteries (RRA). 

Nikolaos Tsilimparis

Eighty patients (mean age 71.0) were enrolled—six patients had symptomatic TAAAs, with 15 patients having contained ruptures. Technical success was achieved in 98.75% of patients. Median follow-up was 22.2 months. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related), Tsilimparis told VAM. 

Tsilimparis said the research team went through each target vessel in order to determine how each of them performed. Throughout the study duration, two patients had bridging stent compression, including covered and uncovered CA stents in one patient, and a covered LRA stent in the other, he revealed. Freedom from secondary intervention was 76.3% at 24 months. Seven patients had nine endoleaks (seven Type III and two Type Ic) involving bridging stents. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. One reintervention involved bridging stent placement as part of a staged procedure. Freedom from loss of primary patency were 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. Freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% 

“The celiac artery with the bridging stents seemed to do very well: the first year there were only a few occlusions, and primary and secondary patency were high. The two-year results were pretty similar to one year,” Tsilimparis explained. “After the few occlusions, there was a stable finding. The superior mesenteric artery was the vessel that performed the best and had the least concerns, with 100% patency at two years. More challenging were the renal arteries.” 

He concluded, “At two years, specifically looking at target vessels, the results are supportive of the safety and effectiveness of the device and the technique and, of course, we need long-term data.” 

New SVS president outlines priorities for his tenure as Society aims to reach out

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New SVS president outlines priorities for his tenure as Society aims to reach out

Michael Dalsing, MD, who took over as Society for Vascular Surgery (SVS) president at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18), talks about the priorities he has set out for his time at the helm, which include advocating for vascular surgery amid the recurring threat of Medicare payment cuts, furthering the Society’s efforts to build brand awareness of the specialty, and contributing to the quest to broaden access to quality vascular care.

At VAM 2022, Dalsing put together this year’s E. Stanley Crawford Critical Issues Forum, which took a deep dive into some of the issues that hinder better availability of vascular surgical care in different geographical and cultural settings across the country. The Crawford Forum is customarily organized by the incoming SVS president.

New project will develop nanoparticles with imaging and medicine-delivery capabilities to better treat PAD

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New project will develop nanoparticles with imaging and medicine-delivery capabilities to better treat PAD
Kytai Ngugen Credit: University of Texas at Arlington
kytai nguyen
Kytai Nguyen
Credit: University of Texas at Arlington

A University of Texas at Arlington bioengineer is leading a project to develop biodegradable nanomaterials that will take pictures and deliver medicine to combat peripheral arterial disease (PAD), the university announced in a press release.

Kytai Nguyen, a UTA bioengineering professor, is the principal investigator in the four-year, $2.1 million National Institutes of Health (NIH) grant-funded project. She is collaborating with Jian Yang, a Penn State University in University Park, Pennsylvania, bioengineering professor and former UTA faculty member, and Ralph Mason, a professor of radiology at UT Southwestern in Dallas, Texas.

“What is important in this project is that the technology carries fluorescent and ultrasound imaging capabilities, which will provide patients and doctors with more detailed information,” Nguyen said. “It also gives patients more targeted medicine, making it more efficient.”

PAD, more commonly known as either atherosclerosis, is a condition commonly found in the elderly. It affects more than 200 million people worldwide and is associated with high rates of morbidity and mortality.

The research aims to develop novel biodegradable nanoparticles to deliver therapeutic agents that specifically protect cells under stress conditions, facilitate the formation of blood vessels under hypoxia and allow noninvasive multimodal imaging methods.

One impact of the research is to use these new nanoparticle platforms to deliver any therapeutics locally, treat the disease effectively and monitor the treatment noninvasively by imaging. “The overall goal is to reduce complications and improve the quality of life for PAD patients,” Nguyen said.

Michael Cho, chair of the UT Arlington Bioengineering Department, said Nguyen’s innovative research could greatly help those who live with PAD.

“This cutting-edge technology has a chance to change our protocols on how to deal with atherosclerosis,” Cho said. “When you are able to target localized lesions for treatment, that is so much better for the patients and much less invasive than current treatment.”

Nguyen, who has been at UTA since 2005, received Cancer Prevention & Research Institute of Texas grants in 2010, 2016, and 2021. She also has received funding through the NIH, National Science Foundation, American Heart Association, and U.S. Departments of Education and Defense, among others.

ALI can occur with or without atherosclerotic disease, portends worse prognosis in COVID-19 patients, VESS session told

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ALI can occur with or without atherosclerotic disease, portends worse prognosis in COVID-19 patients, VESS session told

Acute limb ischemia (ALI) can occur with or without atherosclerotic disease and portends a worse prognosis in patients with COVID-19. This risk persists after COVID-19 infection due to a lingering co-inflammatory state, and D-dimer may be a useful screening test in at-risk patients.

This is according to Max Wohlauer, MD, assistant professor of surgery at the University of Colorado Denver in Aurora, Colorado, who yesterday outlined a study assessing revascularization outcomes of ALI in COVID-19 patients. Wohlauer delivered the presentation during a Vascular and Endovascular Society (VESS) paper session at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18) on behalf of first author Mahmood Kabeil, MD, senior author Robert F. Cuff, MD, assistant professor at Spectrum Health in Grand Rapids, Michigan, and on behalf of the Vascular Surgery COVID-19 Collaborative (VASCC). 

“Coagulation and inflammation are linked, and a coagulopathy has been described with SARS and other respiratory viruses,” said Wohlauer, noting an increased D-dimer and other coagulation derangements in patients with COVID-19 infection. Giving additional context to his talk, the presenter noted that ALI is a risk factor for amputation and mortality in patients with COVID-19 infection, and that high D-dimer levels are associated with an increased risk of thrombosis in COVID-19 patients. 

Outlining their methods for the study in an abstract, the researchers note that VASCC formed the basis of their analysis. A registry was developed in March 2020, they write, in order to assess the impact of COVID-19 infection on vascular surgery patients and practices. At VAM, Wohlauer reported an interim data analysis of 94 patients from 18 sites across five countries with the aim of providing an insight into revascularization strategies and outcomes for COVID-19-associated ALI. 

The speaker noted that the 94 patients included in the interim analysis had a mean age of 64 years and that 37% were female. In this cohort, only 15% had a history of peripheral arterial disease (PAD), he added, and none had a prior hypercoagulable state. Only 2% had active cancer, and the rate of tobacco use was 21%. 

Wohlauer was keen to emphasize the fact that 90% of the patients in the cohort had no prior history of vascular intervention. In addition, he detailed that ALI was the initial COVID-19 presentation in 21% of the cases, with the remaining 79% experiencing ALI a median of eight days after a positive COVID-19 test. 

Giving further details on the patient cohort, the presenter noted that 53% were categorized as Rutherford 2b. He added that 89% of the thrombus was located in the lower extremity, 8% in the upper extremity, and 3% in the infrarenal aorta. Of the patients with lower extremity thrombus, he detailed that the majority was in the femoropopliteal region. 

Reporting revascularization strategies in this cohort, Wohlauer detailed that 63% of patients underwent open revascularization, 16% endovascular, and 22% had no revascularization. In the patients who had no revascularization, he specified that 52% of the time it was because the limb was not salvageable. For others, it was related to the severity of COVID-19 pneumonia. 

In terms of other outcomes, the presenter revealed that the mean hospital stay was 14.7 days, and mean intensive care unit (ICU) stay was 5.6 days. Thirteen percent required an amputation, 5.2% had a pulmonary embolism, 5.2% had a stroke, and 6.2% had sepsis. There was a 15.5% major adverse limb event rate in this cohort. 

One of the key findings Wohlauer highlighted was a 31% in-hospital mortality rate. He also reported that, on the other end of the scale, 40% of patients had no major complications in hospital. Age was an independent risk factor for in-hospital mortality, he said, but was not a risk factor for major adverse limb events. 

Wohlauer summarized that ALI is the initial COVID-19 symptom in up to one-third of patients, and that the overwhelming majority of patients with COVID-19 ALI have no prior vascular history, and that age is an independent risk factor for mortality, but not a risk factor for major adverse limb events. D-dimer, he informed the audience, may be a useful screening test in patients at risk for COVID-19-associated ALI. 

He thanked all of the VASCC members who contributed data to this project, and acknowledged the VASCC Project 2 ALI Working Group. He mentioned that the study is actively recruiting patients and that the organization welcomes contributions. 

Greenberg Lecture raises prospect that ‘less is more and more is less’ with aortic disease treatment

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Greenberg Lecture raises prospect that ‘less is more and more is less’ with aortic disease treatment
Jan S. Brunkwall

Jan S. Brunkwall, MD, from the University of Cologne in Cologne, Germany, delivered the Roy Greenberg Distinguished Lecture at the 2022 Vascular Annual Meeting (VAM), telling attendees “more is less, and less is more!” when it comes to treatment for aortic disease. 

“After many years with open surgery, the endovascular technique came into our armamentarium,” he began his talk before the VAM 2022 gathering (June 15–18), before presenting attendees with a visual conundrum.

The late Roy Greenberg, of the Cleveland Clinic, died in December 2013 at the age of just 49, of cancer. He was known for his innovations and research, particularly in complex aortic disease, and for embracing endovascular surgery. He also was known worldwide as a teacher, mentor and researcher. According to published reports, he was issued nearly 100 patents on endovascular therapy on the basis of his research.

Brunkwall, who spent time with Greenberg during a previous role in Malmo, Sweden, in 1998, showed a video of a young boy skillfully conquering the use of chopsticks as an eating utensil. “For the older ones of you, I put this question: Can you all manage to eat with chopsticks? Can you treat all aneurysms endovascularly?” said Brunkwall. “For the younger ones, maybe this is quite natural, like for this little boy here.” As the video continues, the boy, now emboldened, is depicted confidently pushing on with the chopsticks—before floundering: “A hybrid solution is sometimes better,” Brunkwall concluded to audience laughter.

His Greenberg Lecture focused on abdominal aortic aneurysms (AAAs), juxtarenal AAAs and type B aortic dissections (TBAD).

Part of his message delved into the hot topic of AAA case volumes and training, emphasizing the importance of high-volume centers to adequate trainee caseload. “I ask you to have less aortic centers than you maybe have [currently],” said Brunkwall. “Because learning is crucial, and so is training. It goes for everybody—for tennis players, for artists, for Formula 1 drivers, air pilots. Why doesn’t [this] go for surgeons?”

Shortly before giving the lecture, Brunkwall explained in an interview with Vascular Specialist@VAM: “My presentation will highlight that endovascular treatment is less invasive than open surgery, and therefore the preferred option for many patients. However, a key factor is the impact of case volume load; high volume centers are associated with results whereas less experience tracks to more complications and more deaths. Another important consideration that is quite obvious but not adhered to by everybody is that strict compliance with instructions for use (IFU) yields better results, and I will illustrate this using examples.” 

During the lecture, open surgery was forefronted as a “very” durable option and good solution for juxtarenal AAAs and AAAs,  avoiding more extensive endovascular procedures. 

Touching on acute TBAD treatment, Brunkwall maintained that endovascular treatment is less invasive and has better results with respect to mortality and devastating complications, such as paraplegia, than open surgery. 

Again, sticking within the IFU will deliver long lasting results, he said, pointing out some examples of endovascular treatments that should never have been on the market. “Less humble means more trouble,” he said, referencing these procedures. 

Vascular Surgery Interest Groups propel students’ awareness and engagement in the specialty, VAM 2022 hears

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Vascular Surgery Interest Groups propel students’ awareness and engagement in the specialty, VAM 2022 hears
Richard Li

A study of the impact of Vascular Surgery Interest Groups (VSIGs) can have on piquing awareness and engagement of medical students in the specialty found a spike among first years taking electives in vascular surgery after a series of interest group meetings were initiated. 

The finding was delivered under the title “Gaining access: Events with the greatest impact on student interest in vascular surgery” during the International Fast Talk session at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). 

Presenting author Richard Li, BS, a third-year medical student at Carle Illinois College of Medicine in Urbana, Illinois, and colleagues investigated the relationship between the type of event staged and the impact it had on retaining event attendees, increasing interest in vascular surgery, and enhancing knowledge and awareness of the field. 

Li pointed out an important backdrop to the research: These days, more than 70% of matched medical students in surgical specialties identified surgery as their top choice by the second year of medical school, he said. 

The Carle VSIG held four interest group meetings throughout the school’s fall semester—one each with the group’s physician mentor, a vascular surgery resident, the program director of the Carle vascular surgery residency program, and demo deployments from industry representatives. 

“Before each event, students were asked to fill out a form inquiring about their interest and knowledge of the field of vascular surgery on a scale of 1–10, with 1 being the lowest interest and knowledge,” Li detailed. “After each event, students were again asked to fill out a form which included the same questions regarding their interest and knowledge of the vascular surgery field.”

Li said the research team found that post-event surveys showed students as having a high interest in vascular surgery: “The average level of interest stayed consistent with minor fluctuations before and after the events. Of note, the event with the program director had the largest increase, from 5.91 to 7.53. Regarding interest in vascular surgery, each event had a high standard deviation. This could be due to students who are both changing their opinions and solidifying their thoughts about vascular surgery as a career choice.” 

The students who attend the VSIG’s events tend to have an interest in vascular surgery, Li added, “and we do find that a large standard deviation for change of interest is a desirable outcome—having a student go from a two to an eight is just as important as an eight to a two.” Attendance was “very high,” he said, averaging between 20–30 students from an average class size of 50. 

“Why does this matter?” he pondered. Just 13% of students were interested in vascular surgery when they arrived. “Since we’ve started, over seven students have elected to do electives in vascular surgery, with five of them starting their first year of medical school—up from zero.” 

VSIGs “definitely” have an impact, Li said, “and I highly recommend for this to be a call to action to reach out to your VSIGs.” Li and colleagues plan to put the data from the study to use in order to develop a series of events with “maximum impact” for increasing exposure and awareness of vascular surgery. 

“Event responses demonstrate that VSIGs are critical to educating medical students about vascular surgery and promoting interest in the field.” 

Moderator Ahmed M. Abou-Zamzam, MD, noted an element of surprise at the statistic showing they had established 13% interest in vascular surgery from “the get-go.” He further asked whether the research group had tracked elements such as food offerings. “Two of the events, we actually had no food,” Li said in response. “We still managed to get high representation.” 

An antidote for burnout: Vascular surgeons as hospital administrators

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An antidote for burnout: Vascular surgeons as hospital administrators
Bruce Perler

The much-maligned electronic health record (EHR)—sometimes referred to as electronic medical record, or EMR—is not among the causes of burnout, per se, but rather a symptom, the 2022 Vascular Annual Meeting (VAM) heard during the John Homans Lecture on the Saturday morning of the Boston gathering (June 15–18). 

“Burnout is accepted by us as an epidemic problem in healthcare, and there are numerous proposed causes, most notably the electronic health record,” this year’s lecturer, the former SVS President Bruce Perler, MD, told Vascular Specialist@VAM ahead of the talk. “My belief is that the EHR, and other professional irritants,” are not the cause of burnout, but rather the symptom of the problem, and the problem is physicians’ loss of control of our healthcare system. 

One prescription that might help alleviate this burden is vascular surgeons—and other like physicians—taking on leadership positions at the hospital administration level, Perler proposed in a talk titled, “Surgeons as hospital administrators: An antidote to burnout and benefit for the healthcare system.” 

Perler, who is currently vice president of the American Board of Surgery (ABS), is in a position to know how this might have impact. He was, until recently, the vice chair of clinical operations and finance at Johns Hopkins University School of Medicine and Johns Hopkins Hospital in Baltimore, Maryland—a position he had held since 2013. 

“The message I hope to communicate is not one that has received much attention at the SVS to date, but one that I believe is incredibly important for our practitioners moving forward,” Perler said. “Today, an increasing number of physicians and surgeons have given up independent practice to become full-time hospital employees. Secondly, increasingly these hospitals are now being run by non-clinicians. For example, in 1935 one-third of hospital president/CEO positions in the United States were held by physicians and one-third by nurses. Today, no more than 2–5% of these leadership positions in the U.S. are held by physicians and about 2% by surgeons.” 

More and more, this means vascular surgeons are working for administrative leaders with no connection to patient care, he continued. “This structure in the U.S. is in contrast with much of the industrialized world where these CEO positions are filled by physicians—from 25% (England) to 75% (Germany) of institutions—in countries with far less expensive healthcare systems than in the U.S.” 

The move toward healthcare delivery being assessed in terms of quality rather than volume presents an opening, Perler advised. 

“I’ve always believed that times of difficulty represent moments of enormous opportunity for those with wisdom and leadership skills, and I believe that the time is now for us to become engaged in healthcare administration and hospital leadership,” he said. “Healthcare outcomes are increasingly being assessed by quality and not volumes—i.e., patient-centric care—and who better to lead in the delivery of patient-centric care than physicians.”

Perler produced multiple published studies “that affirm that hospitals that are currently led by physicians in the U.S. and internationally, have the best outcomes in terms of clinical and financial metrics,” he explained. “Healthcare administrative leadership organizations have recognized this and increasingly are urging their administrators to engage clinicians to join the C-suite.” 

Options to get involved in hospital leadership abound, Perler suggested. Senior surgeons can join a hospital committee, for instance; or a mid-career surgeon can seek training in healthcare administration, which is now being provided by organizations such as the ACS. “But most importantly, we can provide opportunities for medical students and residents to become trained in the business of medicine and select this as a part of their professional careers moving forward.” 

He also has a more transcendent message amid the specter of burnout. While the vascular-surgeons-as-hospital-leaders prognosis might live in a space best described as “a generational process of transformation,” he says, burnout can be tackled, at least in part, on an ongoing basis through daily mindfulness. 

“I firmly believe if each of us as vascular surgeons take just a couple of minutes each day to reflect on how blessed we are to do what we do, burnout won’t be such a problem,” Perler added. “Think about it: complete strangers come to us with their clinical problems and entrust their lives and limbs to our judgment and care. There is no other profession in which its members shoulder such responsibility, or engage in such meaningful work, or enjoy so much satisfaction for what we do for others. We are truly blessed to do what we do. I think if we reflect just a couple minutes a day on what we really do, the EHR and other minor annoyances won’t seem so significant.” 

Female sex ‘should be considered an independent risk factor’ for new stroke occurrence after carotid revascularization in symptomatic patients

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Female sex ‘should be considered an independent risk factor’ for new stroke occurrence after carotid revascularization in symptomatic patients

A preliminary report lends evidence to support female sex being considered as an independent risk factor for new stroke occurrence after carotid revascularization in symptomatic patients, according to a research team from Italy who presented at the International Chapter Forum during the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). 

Presenting author Pasqualino Sirignano, MD, a vascular surgeon at the University of Rome in Rome, Italy, detailed how the team’s analysis was carried out amid uncertainty in the Italian guidelines over specific recommendations for female patients undergoing revascularization treatment for both symptomatic and asymptomatic carotid disease. 

“We reviewed our experience to better review any possible gender-related difference [in outcomes] in patients treated in Italy for a symptomatic carotid lesion—either by carotid endarterectomy [CEA] or carotid artery stenting [CAS],” he told the forum. 

The retrospective study matched CAS patients treated within one month of symptom onset—pulled from the IRONGUARD 2 study—with CEA patients collected by the University of Rome during the same period. 

The researchers were aiming to evaluate any new stroke occurrence within the first 30 days of follow-up. They included 265 patients, 72 of whom were women. Half of the patient pool was treated in the urgent or emergent setting, Sirignano said. Five out of nine new strokes were recorded among female patients, he continued. 

“The most important thing we found was that, even though there were only 72 women in the cohort, the nine strokes were recorded within this female population, and no differences were found at baseline between the two sexes,” Sirignano explained. 

“Emergent patients treated within 24 hours of symptom onset have worse outcomes compared to patients treated in the urgent or elective setting. Looking at multivariate analysis, once again we found that female sex, and timing of surgery, were the only two independent risk factors for worse outcomes after both carotid endarterectomy and carotid artery stenting.” 

Sirignano concluded: “Although this is another preliminary report on this rising topic, we have to admit that female sex should be considered as an independent risk factor for new stroke occurrence after carotid revascularization in symptomatic patients.” 

Session moderator Palma Shaw, MD, noted how Sirignano and colleagues had mentioned timing of procedures impacted worse outcomes. “We have seen in prior presentations that intervening within 48 hours of an event has a worse outcome,” she said. “Are you changing your approach to intervention in [the] acute [setting]?” 

He said that his practice had already been altered, explaining: “We try to treat patients between three and seven days from symptom onset whenever it’s possible. But for unstable patients, we really don’t know what to do—unstable meaning crescendo, transient ischemic attack, or recurrent stroke. These were treated during the first 48 hours, and that was the reason for worse outcomes.” 

Shaw suggested the data produced was being obscured by the inclusion of such patients and that removing them might elucidate a difference. 

Study of post-carotid endarterectomy surveillance prompts protocol discussion

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Study of post-carotid endarterectomy surveillance prompts protocol discussion
Colleen P. Flanagan

The results of an analysis of nearly 2,000 carotid endarterectomies (CEAs) “challenge the notion” that patients benefit significantly from the current post-operative surveillance guidelines, and suggest that these may be contributing to “oversurveillance”—an issue that should be addressed in future protocols for patient management post-CEA.

These were among the talking points to emerge from a presentation delivered by Colleen P. Flanagan, MD, an integrated vascular surgery resident from the University of California San Francisco, who presented the results of a retrospective study looking at the long-term results of post-CEA surveillance within an integrated regional healthcare system, delivered during a plenary session at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18).

Flanagan and colleagues, along with senior author Robert Chang, MD, assistant chair of vascular surgery at San Francisco’s Kaiser Permanente Foundation Hospital, the healthcare system in question—sought to evaluate the long-term utility of surveillance after CEA in preventing stroke and identifying restenosis.

Current Society for Vascular Surgery (SVS) guidelines recommend a surveillance regimen consisting of up to five duplex ultrasound assessments in the first two years after a CEA, with annual scans thereafter, Flanagan noted in her presentation.

Conversely, current recommendations from the European Society for Vascular Surgery (ESVS) favor a less rigorous approach, advocating carotid artery surveillance if there are signs of cerebral malperfusion during carotid clamping.

The study included patients who underwent CEA for severe (70–99%) carotid artery stenosis between 2008 and 2012, who were then followed up until 2019. Flanagan described Kaiser Permanente as a “large, integrated regional healthcare system,” and detailed that patients who had undergone ipsilateral intervention previously, or who died within 30 days of their operation were excluded.

The primary outcomes, Flanagan told delegates, were ipsilateral severe restenosis or occlusion, and ipsilateral stroke. She also noted that a competing risks analysis was used to quantify freedom from the primary outcomes. In terms of results, 1,923 carotid arteries in 1,816 patients were treated with CEA during the study period, Flanagan noted, of which 831 (43.2%) were for symptomatic indication.

Mean follow-up time was 6.6 years (SD=3.3 years). A median of three surveillance studies were completed across the patient population during the study period, lower than the five recommended under current SVS protocols, and 13.5% of patients received no postoperative surveillance at all, Flanagan reported.

The presenter noted that 1.4% of arteries underwent reintervention during the study period, and of the 71 ipsilateral postoperative strokes that occurred, only three occurred in the setting of a known severe restenosis. The five-year risk of severe restenosis, occlusion and ipsilateral stroke seen in the study were 6%, 0.9% and 2.7% respectively, Flanagan noted.

“The risk of severe restenosis and occlusion were especially low, if [a] patient’s first postoperative imaging study was normal, whereas ipsilateral stroke decreased only slightly,” she stated.

“Despite less frequent surveillance compared to SVS guidelines, our observed ipsilateral stroke rate was actually lower than those previously reported in clinical trials,” Flanagan went on to remark. “Risk of restenosis was also particularly low, especially if the patients received a normal postoperative imaging study.

“Our data suggest a reconsideration of carotid surveil-lance protocols are warranted after CEA. Following a normal first postoperative imaging study, additional scans are likely not necessary.”

The study team is conducting further analysis in order to identify any sub-populations that may require more frequent surveillance and attempting to understand the concurrent contralateral disease rate within this population, the presenter reported. The study’s findings elicited a strong response from Ali AbuRahma, MD, speaking from the floor, who commented that he has been “preaching on the same issue” for over a decade.

AbuRahma said that he had been involved in collecting randomized trial data over 10 years ago which he said suggest that: “If you do surgery right from the first time… the value of having postoperative ultrasound frequently, to me, was absolutely unacceptable.”

A need for additional and unnecessary surveillance may place an increased financial burden on overstretched healthcare systems, he said. “I am trying to keep that in mind when we put the guidelines together this time for carotid management,” AbuRahma commented further. “I want the audience to be careful and perhaps we need to revisit the same issue.”

Expanding, Flanagan told Vascular Specialist@VAM that “oversurveillance is a problem primarily because it con-strains important resources that other patients need.” The day-to-day implications of this overuse of finite hospital resources can be delays in access imaging, which many patients require as part of screening, surveillance or diagnosis of their conditions, the research team elaborated. 

VAM 2022 Opening Ceremony: ‘Our Society is what it is because of you,’ SVS members hear

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VAM 2022 Opening Ceremony: ‘Our Society is what it is because of you,’ SVS members hear
Andres Schanzer addresses attendees during the VAM 2022 Opening Ceremony

From the first Vascular Annual Meeting (VAM) that featured just eight papers, to VAM 2022 with many more times that number of presentations, each gathering through this year’s 75th edition has featured research, friendships and the desire to improve patient care.

“For 75 years, vascular surgeons have been demonstrating their ingenuity, tenacity, and collaboration at this meeting, and, unless this is your very first VAM, you understand firsthand the power that comes from this meeting,” said Society for Vascular Surgery (SVS) President Ali AbuRahma, MD, at the Wednesday morning VAM 2022 (June 15–18) Opening Ceremony.

“If this is your first year attending VAM, we are so glad you are here. You are in for a wonderful time, full of innovation, friendship, scholarship, and plenty of fun. Never before have we had a meeting with such a wide range of opportunities,” AbuRahma continued, adding he hopes all attendees are engaged and inspired.

“VAM 2022 takes it to the next level for all skill levels, all practice environments,” and a wide range of business and clinical topics sure to engage.

SVS Program Chair Andres Schanzer, MD, welcomed everyone to the meeting, saying it was taking place in “what I consider my hometown.”

“This is the premiere vascular meeting for the presentation of new research,” he said and thanked the more than 100 SVS members who spent hundreds of hours planning VAM 2022.

One of the upsides of COVID, he said, is that “it forced us to innovate. The streaming we embraced out of necessity now allows us to reach those who can’t be here with us.” Thus, the livestreaming introduced last year has been expanded to an afternoon track as well, with a total of 24 sessions livestreamed.

Other considerations or improvements for 2022 include access to all VAM recordings to be available as early as the week of June 20. All those with in-person and livestreaming registrations will have access to all VAM recordings for up to three years.

The event also featured expanded and improved sessions from the Postgraduate Education Committee—including breakfast, concurrent, “Ask the Expert” and special section sessions and the postgraduate courses themselves. Educational sessions have been planned for each of the five special SVS membership sections, including the Physician Assistants, Community Practice, the Sub-Section on Outpatient & Office Vascular Care (SOOVC), and the new Young Surgeons and Women’s sections. “This helps us bring in new and diverse voices in 2022 and in the future,” Schanzer said.

There were also visual abstracts, created with the support and enthusiasm of the Young Surgeons Section and published in advance of the meeting and now available on the VAM website, vascular.org/VAM, under the program button. Additionally, Schanzer pointed to expanded networking opportunities. “Take advantage of these,” he urged attendees. “Our Society is what it is because of you.”

Feedback is critical to planning for following years, said Schanzer, as he urged attendees to provide information that will lead not only to improvements and innovations but also for content members will find useful. “Push us to try new things,” he said. “Tell us what you want.”

AbuRahma said, “I have immense pride for our organization, for our specialty, and for you – our members and attendees who are resilient and dedicated to always striving towards the moving goal post of improvement. Thank you.”

First results from BEST-CLI poised to reveal ‘very low’ quality of life for patients entering the trial, especially women

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First results from BEST-CLI poised to reveal ‘very low’ quality of life for patients entering the trial, especially women
Richard J. Powell

An analysis from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial presented at the 2022 Vascular Annual Meeting (VAM) demonstrated patient-specific variables such as self-reported female gender, current smoking, impaired mobility and opioid use are associated with lower health-related quality of life (HR-QOL) as captured by multiple measurement tools.

Richard J. Powell, section chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, told Vascular Specialist@VAM this is a unique dataset that acquired information from three different patient-reported quality of life measures (VascQOL [Vascular Quality of Life Questionnaire], EQ-5D [EuroQoL 5D], and SF-12) and shed light on the baseline demographics of the 1,830 patients enrolled into the BEST-CLI randomized controlled trial that is set to be presented in fall 2022. Data were obtained from the majority of patients (94.9%, 95.8%, and 95.8% of subjects completed the VascQOL, EQ5D, and SF-12 instruments at baseline). “I think that is the power of it. It is not just one quality of life measure, so if you see these factors reproducing themselves across instruments, it is probably real,” he said. 

BEST-CLI is an ongoing, National Institutes of Health-sponsored, multicenter trial comparing revascularization strategies in patients with chronic limb-threatening ischemia (CLTI). The latest data was presented in a VAM 2022 (June 15–18) plenary session in Boston.

Powell outlined that there is limited evidence regarding the role of health-related quality of life (HRQOL) measures in patients with CLTI. Speaking particularly on female gender being associated with lower quality of life in multiple QOL measurement tools, he said: “This bears looking into as it is present with other disease processes as well. Are women less able to receive social support to weather the storm? Are they not being looked after in the same way as men? Do they present with later-or end-stage disease? These remain questions to be researched.” 

Powell is also categorical that while QOL scores assess perceptions of independence, mobility and mental sharpness and how “functional” patients are, they are not a direct indicator of happiness and that this is where is all gets “tricky.”

“If the patient is a golfer who can no longer play golf, because they’ve got a sore on the bottom of their foot, they may be very functional but they’re likely to be miserable. But if it’s a person who gets up in the morning and watches TV all day, they could have lost their leg and still be perfectly happy because they’re doing everything they want to do. And it’s the doctor’s role to keep people happy for as long as possible.” 

Vitally, this dataset allows physicians to look at the modifiable risk factors that cause patients to have low quality of life. “Smokers across the board have worse quality of life than non-smokers. So that’s a modifiable risk factor. Another is independence. So, trying to do everything possible to keep the patient working, and that might go along with things like making sure they have an orthotic or something to walk on and that they remain weight bearing [is really important]. But I think those sorts of patient modifiable factors have a direct impact on quality of life. And yet there are some non-modifiable risk factors like female gender and it is important for vascular specialists to be aware of this.” 

The mean (standard deviation) SF-12 physical and mental health reads for all patients in the study will be revealed to be significantly lower than the national SF-12 scores for the U.S. population over 60 years of age. Indeed, Powell emphasized that these BEST-CLI SF12 baseline population scores are similar to a population of patients with cancer and three to four additional chronic conditions—typically characterized by impaired mobility and chronic pain. “Interestingly, these scores are a little bit better than those reported by the BASIL trial, and significantly better than three previous trials, so it might be that we are doing a better job of medically managing patients’ associated comorbidities,” he said. 

Speaking to the wider interest that the dataset could garner, Powell stated that it could serve as a benchmark. “Other groups of people will find this useful if they are interested in planning a CLI trial, because they’ll be able to use this as a point of reference. The FDA could actually use it as a performance goal. So, if you know the average quality of life measure for CLI patients in these different scores, you could run a single-arm trial and use these data as a benchmark to simplify evidence generation,” he said. 

Systemic heparin during TEVAR deemed safe for selected traumatic brain injury patients

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Systemic heparin during TEVAR deemed safe for selected traumatic brain injury patients
Senior author Matthew Mell

The use of systemic heparin during thoracic endovascular aneurysm repair (TEVAR) for blunt thoracic aortic injuries (BTAI) appears to be safe in selected patients with traumatic brain injury (TBI), a new study presented at the 2022 Vascular Annual Meeting (VAM) indicated. The finding was a central conclusion from data delivered by Rafael Lozano, MD, a general surgery resident at the University of California Davis Medical Center, Sacramento, California, at the Boston gathering (June 15–18). 

In an effort to compare the impact of intraoperative systemic heparinization on post-TEVAR outcomes for patients with TBI, researchers reviewed all patients admitted with BTAI from 2011 through 2021. Collected data included injury grading, demographics and concomitant traumatic injuries. The study’s primary outcome was progression of TBI after TEVAR. 

The cohort comprised 174 patients (mean age=46 years; 68% men; median injury severity score [ISS]=34)—after excluding three who died upon arrival. Median door-to-repair time was 19 hours and 79% of the study population received systemic heparin. In addition, BTAI treatment was aligned with guidelines for 87–89% of patients. Repair (all TEVAR) was required for 63% of patients and time to repair was delayed for TBI patients. 

Heparin was used in the majority of TBI patients—but was used less frequently than for those without TBI. Overall mortality was 8% (12.5% with BTAI observed vs. 5.5% with BTAI treated) with no BTAI-related deaths. Repair being delayed by more than 48 hours did not decrease mortality (5% vs. 5.6%). Vascular complications occurred in 8.2% of those receiving TEVAR, with an overall re-operation rate of 4.5%. 

Progression of TBI was not associated with severity of BTAI by either grading system, the study found. Progression of TBI after TEVAR was also not impacted by intraoperative systemic heparin use (4.6% with vs. 6.7% without). Mean follow-up after TEVAR was 7.9 months and 97% of repaired patients experienced resolution of their injury. 

Based on these findings, the researchers conclude that the use of systemic heparin during TEVAR for BTAI appears to be safe in selected patients with concomitant TBI, without causing TBI progression. Finally, they note that clinical expertise remains key in determining optimal management of these patients. 

Senior author Matthew Mell, MD, professor and chief of vascular surgery at UC Davis, outlined what he believes are the clinical implications of the findings in an interview with Vascular Specialist@VAM in Boston. 

“The main significance is we think it’s safe to heparinize trauma patients for TEVAR, even if they have a head injury,” he said “Our practice has been to wait 12–24 hours to make sure the head injury is stable, and it appears that when that practice is followed, giving heparin is safe. 

“These injuries are complex and nuanced. It’s really important to make these decisions as a multidisciplinary team. This, we hope, will contribute the literature, that will allow people to be a little more comfortable to treat these with heparin.”

Diversity in care: ‘From being exclusive to more inclusive’

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Diversity in care: ‘From being exclusive to more inclusive’
Outgoing SVS President Ali AbuRahma

The role diversity played in the past, how it functions in the present, and where it might take vascular surgery in the future formed one of the central themes running through the Presidential Address delivered by outgoing Society for Vascular Surgery (SVS) President Ali AbuRahma, MD, during the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). 

AbuRahma is the 16th SVS president to be born outside of the United States—which were an important backdrop to his opening remarks in “SVS past, present and future: From being exclusive to more inclusive.” 

He dipped into the Society’s storied three-quarter-century history—pulling out and highlighting the 15 past presidents before him who were born outside of the United States—to settle on an important question posed to him by members: “Are we inclusive enough, or are we still as exclusive as we were 50 years ago?” 

Those international names represent important figures in vascular surgery, important advances in the specialty as a whole, and many contributions to the development of the SVS, he told the VAM 2022 audience. The contingent includes two SVS charter members: Hungary-born Geza de Takats, MD, president in 1953; and Robert Linton, MD, a Scot who followed de Takats as president two years later. AbuRahma spotlighted the major contributions of all 15, including more recent predecessors such as Anton Sidawy, MD, who hails from Syria and was SVS president in 2010; Peter Gloviczki, MD, also born in Hungary, and the 2013 SVS president; and Michel Makaroun, MD, who was born in Lebanon and led the SVS in 2019. 

“At a time of unfortunate xenophobia in our culture, the SVS has always been an open international society, and this is no better reflected than in the backgrounds of so many of our past leaders,” he told attendees. The “unparalleled leadership of the SVS” in the field of vascular disease “reflects not only the wisdom of our past leaders,” but the organization’s commitment to evolution going forward, AbuRahma said. 

The chief of vascular and endovascular surgery at West Virginia University School of Medicine/Charleston Area Medical Center in Charleston, West Virginia, highlighted how this evolution at the SVS has played out at the structural and committee levels. 

“In the early SVS years, and during the first 50 years, there were very limited numbers of standing committees, including the membership, program, nominating [committees], and a committee on arrangements for VAM,” he said. 

AbuRahma outlined how the membership has expanded and become more inclusive, and how new dedicated membership sections for women, young surgeons and physician assistants, and for areas such as community practice and office-based labs, have broadened discussion and educational offerings. 

He also pointed out how changes at the SVS Nominating Committee level capture the essence of the Society’s evolution. “In the past, the SVS Nominating Committee consisted of three members appointed by the president one month before VAM, usually the three immediate past presidents, and its function was to compile a slate of officers to be presented to the Executive Council and members at the VAM,” AbuRahma informed attendees. “Currently, it consists of seven members—the three most recent and surviving and available past presidents with the most senior as chair, one member that is elected annually from and by the 11 representatives of the regional and vascular societies serving on the Strategic Board, one member-at-large elected from the SVS membership who is not currently serving on the Executive Board, the vice-chair of the Community Practice Section, and the chair of Leadership and Diversity Committee.” 

Looking ahead, AbuRahma continued, the SVS must maintain focus on key areas, such as branding the specialty, continuing the fight for “fair and appropriate payment,” and continuing to provide support for those in community practice: “We must be united and have a common message across members and keep investing in embracing diversity and cultural change,” he said. 

“We should keep investing in our health and wellness and our early-career members which is critical for our future. We must continue to embrace quality in vascular patient care and finally we must work towards finding a common pathway in working with other non-vascular surgeon providers who practice endovascular therapy based on acceptable dedicated training in endovascular intervention.” 

That harkens back to AbuRahma’s chosen topic for last year’s E. Stanley Crawford Critical Issues Forum at VAM 2021 in San Diego. The then incoming SVS president focused on the role of multispecialty care in vascular and endovascular surgery, hoping to get at least some answers to the question: Can the competing specialties of the vasculature work together? 

AbuRahma assembled a panel of physicians covering every specialty involved in the treatment of vascular disease for the event. During the forum, AbuRahma himself declared: “Vascular providers must have defined, dedicated vascular and endovascular training during their formal residency or fellowship. Multispecialty practice, if feasible, will enhance and improve vascular care.” 

At VAM 2022, AbuRahma returned to the topic, and posed such questions as what strategy vascular surgery should deploy in order to ensure vascular procedures are carried out by appropriately trained specialists. “Many specialties are attracted to performing vascular procedures in light of workforce shortage, and mal-distribution creates access issues to vascular surgeons,” he said. “Advances in treatment and device technology make therapy for an increasing number of vascular conditions within the perceived scope of other specialists, some of whom are without adequate training. The current policies and incentives are rewarding the wrong behavior with consequences of quality challenges, increased complications landing in vascular surgery practices, payment inefficiencies with overutilization and unnecessary procedures.” 

He once again raised the virtues of multispecialty practice, which traces its roots to his state—West Virginia—and the concept of a Vascular Center of Excellence model, such as the one developed at his institution, which includes eight board-certified vascular surgeons, two board-certified cardiologists/vascular interventionists, one board-certified vascular medicine interventionist, and one board-certified interventional radiologist. 

In that vein, AbuRahma conducted a survey of SVS members to assess the level of interest in multispecialty models of practice. Among the results, he found more than 50% of respondents saw cardiologists/interventional cardiologists and interventional radiologists as a threat among non-vascular surgeon providers performing procedures for vascular disease, while 58% said they did not form part of a multispecialty group that includes non-vascular surgeons. 

What, then, should the strategy be? AbuRahma asked: “How can the SVS best position itself to take the lead in shaping the future of vascular surgery care delivery, and optimizing patient outcomes? Can demonstrated competence and quality metrics be established and agreed upon across specialties? Who are the critical partners to engage in the dialogue?” And, he added, “Are there highly successful multispecialty models to be demonstrated? All of us know politics are local. Can we or should we influence and or impact training guidelines?”

New findings support benefits of structured discharge approach for post-discharge transition of care

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New findings support benefits of structured discharge approach for post-discharge transition of care
New findings support the benefits of a structured discharge approach for post-discharge transition of care, researchers find

Researchers have found that restructuring the discharge process of a vascular surgery service decreased escalation to clinical staff from an automated post-discharge phone call and improved early post-discharge visits. Thirty-day readmission rates remained unchanged despite these efforts, however, and was increased for patients requesting escalation.

Cara G. Pozolo, MD, a resident at University of California Davis Medical Center in Sacramento, California, presented these findings at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). 

The investigators—led by senior author Matthew Mell, MD—looked at all patients discharged from their vascular surgery service who underwent procedures from April 2021 through October 2021 with pre-discharge process improvement (PI) and compared these with a historical cohort discharged from May 2018 through July 2019. 

For both cohorts, Polozo detailed, all patients received an automated phone call from a third-party vendor (CipherHealth, New York), with an option to escalate to a clinical nurse. 

The investigators analyzed a total of 469 patients who received an automated call (1.4±1 days) after discharge, with 271 in the control group and 198 in the PI group. Polozo revealed that no significant change in overall 30-day readmission rates was observed (11.8% control vs. 10.6% PI; p=0.7). In addition, she communicated that request for escalation to the clinical nurse was significantly less frequent after intervention (28% control vs. 16.7% PI; p=0.004), and that escalation was associated with increased 30-day readmission (8.6% vs. 20.1%; p=0.001) for all patients. Direct calls were made for patients considered high risk for readmission (2% control vs. 43% PI; p<0.001) regardless of escalation status, the presenter added. 

On multivariate analysis, Polozo reported that escalation and direct calls were each independently associated with readmission. 

Finally, the presenter detailed that the median interval from discharge to post-discharge visit was markedly improved with PI (24 days [IQR 14–33] compared to 16 days [IQR 11–32]; p=0.007). Compared with control, she added, median days from discharge to visit with escalation was not significantly improved. 

“These findings support the benefits of a structured discharge approach for post-discharge transition of care,” she concluded.

Study demonstrates feasibility, effectiveness of at-home exercise therapy plus cognitive behavior therapy for IC

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Study demonstrates feasibility, effectiveness of at-home exercise therapy plus cognitive behavior therapy for IC
Oliver Aalami

A mobile phone-administered, home-based exercise therapy program for patients with intermittent claudication (IC) incorporating cognitive behavior therapy (CBT) was found to be feasible, with 78% of participants completing the whole course, the 2022 Vascular Annual Meeting (VAM) heard.

The findings were part of a study delivered by Oliver Aalami, MD, from the Stanford University School of Medicine, Stanford, during VAM 2022’s William J. von Liebig Forum on the opening day of the meeting in Boston (June 15–18). 

Previous studies have shown “a trend towards improved outcomes with greater patient engagement and higher intensity and duration walking session recommendations,” Aalami explained. 

Aalami reported having chosen patients whose peripheral arterial disease (PAD) had been confirmed by abnormal ankle-brachial or toe-brachial index, or who had IC. The program they participated in was 12 weeks of home-based, mobile phone-delivered, exercise therapy, Aalami elaborated. Participants were tasked with performing phone-based, six-minute walk tests and completing mini-WIQ QOL [Walking Impairment Questionnaire and Quality of Life] surveys. They were also asked to complete three health education courses (What is peripheral arterial disease?; Exercise; and Nutrition) and were asked to record at least three 30-minute exercise therapy walks a week using their personal mobile phones. Participants also received daily “doses” of health education via text message. 

Alongside this, participants had regular weekly check-ins with health coaches trained in CBT techniques such as motivational interviewing. They also spoke with a health coach at the beginning, middle and end of the program to discuss their progress. Aalami stated that his reasoning for wanting to include CBT techniques in the program was that it is linked to immediate and lasting behavior change. 

Of the 145 patients (40% women; mean age=65) onboarded across 18 institutions (of which 44% did not offer in-person exercise therapy), 78% of patients completed the program, Aalami told VAM delegates. In total, patients recorded having spent 149,135 minutes walking 5,205,943 steps as part of the exercise therapy program. Aalami added that 19 of those initially enrolled paused, withdrew or were non-responsive due to medical issues, technical difficulties or privacy concerns. Ninety-two percent of patients achieved the CBT S.M.A.R.T goals (specific; measurable; achievable; realistic; timely) they had set prior to beginning the program, Aalami then acknowledged. 

Regarding freedom from intervention, at six months, the figure was 92%, and at 12 months, 69%. This, Aalami told Vascular Specialist@VAM, is promising, as it goes some way to mirroring the five-year results observed in an in-person supervised exercise therapy study in the Netherlands. 

He also spoke to the challenges of implementing exercise therapy for IC and PAD patients in the U.S. Among the obstacles, he cited poor program availability, the requirement for patients to travel to a facility for in-person therapy, and the low rate of reimbursement. While the Centers for Medicare and Medicaid Services granted National Coverage Determination for Medicare beneficiaries with IC in 2017, the reimbursement only includes facility costs, leaving physician fees uncovered. Aalami asserted that “the biggest challenge is not the tech or the patients or the providers, it is reimbursement.” 

Aalami underscored to the VAM audience that he and his team found a mobile phone-administered, home-based exercise therapy program incorporating CBT to be feasible, adding how it could be deemed effective since 92% of patients achieved their CBT S.M.A.R.T goals. He explained that engagement rose as a result of the home-based exercise therapy being offered where it had not been previously in the traditional format. 

Aalami concluded that “accessible and lower-cost digital health approaches to exercise therapy for patients with PAD and intermittent claudication could play a role in addressing the wide supervised exercise therapy utilization gap faced today.” 

Humacyte provides update on patients treated at front-line hospitals in Ukraine with the Human Acellular Vessel for repair of vascular trauma injuries

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Humacyte provides update on patients treated at front-line hospitals in Ukraine with the Human Acellular Vessel for repair of vascular trauma injuries

Humacyte today announced that the first Ukrainian patients have received implants of the Human Acellular Vessel (HAV) for the treatment of vascular trauma injuries. The implants are part of Humacyte’s humanitarian relief initiative to provide investigational HAVs to multiple front-line Ukrainian hospitals for the treatment of patients with traumatic injuries.

Humacyte’s HAVs are engineered replacement vessels designed to be durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel tissue repair and replacement. The first two Ukrainian patients—one injured by shrapnel and the other by a gunshot wound—received HAVs earlier this month and are being followed through their recovery. The Ukrainian patient who suffered a severe gunshot wound to the leg had already suffered a failed repair of his artery with a synthetic graft which became infected, and was at risk of limb loss. The HAV implantation restored blood flow to the injured leg, a company press release reports.

“We are inspired by the dedicated and skilled physicians, nurses and medical staff who were trained on use of the HAV and are endeavoring to bring the innovative technology to Ukrainian patients in need,” said Laura Niklason, chief executive officer of Humacyte. “The HAV has demonstrated durability and infection resistance in multiple clinical trials across various vascular applications, and its off-the-shelf availability means it can be quickly employed in emergency vascular repair. We are honored to be able to contribute to the ongoing Ukraine medical relief work to help save the limbs and lives of patients during this conflict.”

The HAV is being evaluated in a Phase 2/3 clinical trial in vascular trauma, when saphenous veins are not a good option or not available, and has received priority designation for the treatment of vascular trauma by the US Secretary of Defense. As the humanitarian effort in Ukraine progresses and patients are treated with the HAV, a press release details that Humacyte continues to work alongside the Office of International Programs within the US Food and Drug Administration (FDA) and the Ukrainian Ministry of Health.

The HAV is an investigational product and has not been approved for sale by the US FDA, the Ukrainian Ministry of Health, or any international regulatory agency, the company advises.

Carotid stenting demonstrates comparable short- and long-term results to endarterectomy

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Carotid stenting demonstrates comparable short- and long-term results to endarterectomy
Jon Matsumura
Jon Matsumura

Pooled patient-level data from more than 2,500 asymptomatic, non-octogenarian subjects have shown that carotid artery stenting (CAS) achieved comparable short- and long-term results to carotid endarterectomy (CEA). The findings of this analysis have been published by Jon Matsumura (University of Wisconsin, Madison, USA) and colleagues in the Journal of Vascular Surgery.

The study authors begin by detailing that asymptomatic carotid stenosis is the most frequent indication for CEA in the USA. Published trials and guidelines support CEA indications in selected patients with longer projected survival and in instances where periprocedural complications are low, they note, while transfemoral CAS with embolic protection is a newer treatment option.

With this in mind, the set out to compare outcomes in asymptomatic, non-octogenarian patients treated with CAS, versus those treated with CEA, via a widescale analysis of patient-level data.

Matsumura and colleagues report that a total of 2,544 patients with ≥70% asymptomatic carotid stenosis, who were randomised to receive CAS or CEA in addition to standard medical therapy, were included in their study. This was based on data from two large, randomised trials. One of these enrolled 1,091 patients (548 CAS; 543 CEA) and the other enrolled 1,453 asymptomatic patients who were less than 80 years of age (1,089 CAS; 364 CEA).

Independent neurologic assessment and routine cardiac enzyme screening was performed, the authors detail. The prespecified, primary composite endpoint of their study was any stroke, myocardial infarction or death during the periprocedural period, or ipsilateral stroke within four years after randomisation.

The authors report their results, stating that there was “no significant difference” in the primary endpoint between CAS and CEA (5.3% vs 5.1%; hazard ratio=1.02; 95% confidence interval, 0.7–1.5; p=0.91). In terms of the periprocedural rates for each component part of this composite endpoint, they also detail the following:

  • Any stroke: 2.7% with CAS and 1.5% with CEA (p=0.07)
  • Myocardial infarction: 0.6% with CAS and 1.7% with CEA (p=0.01)
  • Death: 0.1% with CAS and 0.2% with CEA (p=0.62)
  • Any stroke or death: 2.7% with CAS and 1.6% with CEA (p=0.07)

They go on to note that, after this period, the rates of ipsilateral stroke were “similar” between the two groups (2.3% with CAS versus 2.2% with CEA; p=0.97).

This led Matsumura and colleagues to conclude that, in a pooled analysis of two large, randomised trials of CAS and CEA in asymptomatic, non-octogenarian patients, CAS ultimately achieved comparable short- and long-term results to CEA.

Speaking to NeuroNews, Matsumura said: “The impact of this large study is that it uses the best available evidence—prospective, randomised controls, intention-to-treat analysis, federal regulatory oversight, independent neurologic exams and biochemical screening—and studies the largest population (asymptomatic, non-octogenarian patients) with severe carotid stenosis receiving interventional treatment in the USA. It has direct relevance for patient care, treatment guidelines and payor policy. It is also highly congruent with the recently published international trial, ACST-2.”

Eagleton and Shutze: SVS members elect new vice president, secretary

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Eagleton and Shutze: SVS members elect new vice president, secretary

The Society for Vascular Surgery (SVS) announced that Matthew Eagleton, MD, has been elected as the organization’s next vice president. The news was revealed during the SVS Annual Business Meeting, which took place on Saturday, June 18, in Boston during the 2022 Vascular Annual Meeting (VAM).

William Shutze, MD, was also unveiled as the next SVS secretary during the same business meeting.

Voting in the online elections for the two roles started in late May, and saw 600 SVS members taking part over the 10-day voting period.

Eagleton, of Massachusetts General Hospital and Harvard Medical School, is now 2022–2023 vice president, while Shutze, of The Heart Hospital-Plano and Texas Vascular Associates in Plano, Texas, is 2022–2025 secretary.

Getting the most out of meetings like VAM

Getting the most out of meetings like VAM
Christopher Audu

It’s Friday at Vascular Annual Meeting (VAM) 2022 in Boston! Hopefully, many of us trainees are getting to mingle and meet leaders in the field in addition to other trainees outside of our usual orb. In his 2020 Vascular and Endovascular Surgical Society (VESS) Presidential Address, Matthew Corriere, MD, from the University of Michigan, spoke on the topic of “Meetingology” and shared his tips for conducting meetings within the context of COVID-19 social distancing practices. 

Some of those lessons still apply today. While we are enjoying the privilege of an in-person VAM thanks to efficient COVID-19 vaccines, I imagine that the notion of making the most of this meeting weighs heavy on many a trainee’s mind. 

And if you’re an introvert like me, you may feel intimidated to speak to surgeons you don’t know and whose names and faces you’ve only ever seen in print. 

There’s no right way to engage a meeting but here’s a few things I’ve found to be helpful for me in navigating meetings like VAM. 

Define your goals 

If you’re here to present your work, do so with gusto…and then take a break and relax. If you’re here as part of the resident and trainee programming, engage with the program. Ask questions. Get business cards. Go to the poster session when no one is there and peruse the posters. It may give you a feel for the meeting and your potential role in vascular surgery. Come to the Residency & Fellowship fair! Talk to all the programs you’re interested in. 

Use your mentors and friends as resources 

If you have an assigned mentor, find them and connect early. Often, your mentor can also help introduce you to people you may have never met before. If you don’t have a mentor, say hello to a stranger. Introduce yourself. Make eye contact. The cold introduction can be intimidating, and oftentimes, the well-known folks are surrounded or they have to run to other obligations, but if you have the chance to say hello, don’t let the opportunity go. 

Step outside the box 

The presentations are incredible at VAM but exploring the city is fun too. Or going to dinners/gatherings. Or sports events. Or just hanging out with friends you haven’t seen in a long time. You’re building social capital and that is important too. Sometimes, the best thing about these meetings are the honest conversations you get to have outside the formal meeting and I hope you get to enjoy this experience. 

Have fun and enjoy VAM 2022! 

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the Vascular Specialist resident/fellow editor. 

Iliac vein stenting should remain a viable treatment option for higher BMI patients

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Iliac vein stenting should remain a viable treatment option for higher BMI patients
Jinseo Kim

Despite greater comorbid conditions, patients with obesity benefited as much as patients with normal body mass index (BMI) from iliac vein stent placement for proximal venous outflow obstruction (PVOO) in a study from a research group in New York. Jinseo Kim, BS, undergraduate research assistant to Wind­sor Ting at Icahn School of Medicine at Mount Sinai, New York, presented the study findings yesterday during the Vascular Annual Meeting (VAM).

Kim and colleagues outline in an abstract that it was their aim to determine the role of BMI in iliofemoral vein stent placement among patients who are normal weight, over­weight, and those with obesity.

In order to achieve this, the research team retrospectively analyzed a clinical registry of 624 patients who underwent iliofemoral vein stenting for chronic PVOO from 2011 to 2021. The team divided patients into three groups based on their BMI: normal (n=250, 18.5≤BMI≤25), overweight (n=249, 25≤BMI≤30), and obese (n=125, BMI≥30).

Among patients with PVOO undergoing vein stent place­ment, Kim informed VAM attendees that the prevalence of obesity was 20% (n=125) and overweight was 39.9% (n=249) with mean BMIs of 35.3kg/m2 and 27kg/m2, respectively.

The presenter noted that diabetes (normal: 16% vs. over­weight: 22.5% vs. obese: 40.8%; p<0.001), hypertension (40.8% vs. 75.2% vs. 52.6%; p<0.001), coronary artery dis­ease (CAD; 7.6% vs. 26.2% vs. 9.3%; p<0.001), cancer histo­ry (10.4% vs. 19.2% vs. 9.6%; p=0.017), and mean Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) class (3.4 vs. 3.7 vs. 3.5; p=0.017) differed significantly across the three groups.

Univariate logistic regression, Kim revealed, showed that obesity was associated with increased risk of major reinter­vention (odds rato [OR], 1.88; 95% CI, 1.13–3.06; p=0.013). The speaker added that, after controlling for age, gender, CAD, race/ethnicity, and diabetes status, the association between obesity and major reinter­vention became no longer signifi­cant (OR, 1.06; 95% CI, 0.5–2.17; p=0.882).

Furthermore, he communi­cated that log-rank test similarly showed no difference in reinter­vention-free survival for major or minor reoperations among those who were of normal, overweight, or obese BMI (p=0.4).

Finally, the presenter noted that improvement in mean Venous Clinical Severity Score (VCSS) composites preop­eratively to postoperatively (p=0.802), one-year follow-up (p=0.111), and five-year follow-up (p=0.44) showed no dif­ferences across the three groups.

He summarised that patients classified as being either overweight or obese were prevalent among vein stent pa­tients. Kim added that, after controlling for the risk factors associated with greater comorbid conditions, patients with obesity benefited as much as patients with normal BMI from iliac vein stent placement for PVOO, as reflected in similar improvement in VCSS com­posite scores.

“Obesity does not impact il­iofemoral stent outcomes,” Kim concluded, adding that the pro­cedure “should remain as a viable treatment option for those who have higher BMI and those with obe­sity”.

In the discussion following Kim’s presentation, moderator Misty Hum­phries, MD, MS, of University of California Davis Health in Sacramento, California, questioned how these findings might change practice. Kim responded: “I think obesity is very prevalent among the U.S. population, and providing a solid option of treatment for those patients who have a higher BMI is very important.”

One delegate commented from the floor that it is “very comforting” to know that patients with obesity can get the same benefit as that demonstrated in prior randomized controlled trials for this type of procedure.

Another delegate expressed some caution, however, stressing that “we need to be careful with reintervention” in this patient group, because obesity “cuts out the open option,” and multiple endovascular interventions “may compromise long-term outcomes.”

Speaking to Vascular Specialist@VAM, senior author Windsor Ting responded to this concern: “Reintervention we found to be an excellent option to extend the benefits and outcomes of vein stenting among these patients. Very few vascular surgeons resort to an open option in this disease.”

Six years, much growth and multiple changes to JVS publications

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Six years, much growth and multiple changes to JVS publications
Peter Gloviczki and Peter Lawrence

Their terms about to end, Peter Gloviczki, MD, and Peter Lawrence, MD, editor-in-chief and senior editor, respectively, of the Journal of Vascular Surgery family of publications reflect on their time at the helm and the changes they’ve seen—and implemented—along the way.

JVS publications include the flagship journal, Journal of Vascular Surgery, in its 39th year of publication; Journal of Vascular Surgery: Vascular and Lymphatic Disorders (JVS-VL), now in its 10th year of publication; JVS-Cases, Innovations & Techniques (JVS-CIT) and the newest member of the family, focusing on basic and translational science, JVS-Vascular Science (JVS-VS). The journals are sometimes known—in a type of shorthand—by their cover colors, a change instituted by Gloviczki and Lawrence, with red for JVS, blue for JVS-VL, gray for JVS-CIT and green for JVS-VS.

They have overseen a number of changes and accomplishments. “We have considerably transformed our editorial policies, increased the diversity of our editorial boards and included more than 25 percent more women and underrepresented minorities,” they said in a farewell message of sorts in the journals’ June issues that reflects upon their six years as editors. Their terms end at the end of June.

In addition, the journals now are part of a JVS portfolio that encompasses a wide range of communications vehicles, with the additions reflecting changing landscape media and information platforms. Among the portfolio are monthly “Editors’ Choice” videos, press releases, visual abstracts, the increasingly popular JVS Journal Clubs and the Audible Bleeding podcasts.

Today, JVS has an all-time high impact factor of 4.268, and the PlumX metrics, reflecting social media impact, has seen a major increase.

“I think we had a vision of what we wanted to achieve,” said Gloviczki. At the time, the two had known each other well for more than a decade, with a common history. Both had connections with Leslie and Susan Gonda, vascular benefactors who contributed generously to Mayo Clinic, institutional home of Gloviczki, as well as to the University of California Los Angeles, where Lawrence is director of the UCLA Gonda Vascular Surgery.

“I thought we would do very well together as a pair of editors of the Journal,” said Gloviczki.” Said Lawrence of their time in leadership: “He was the driving force, but he and I walked together.”

Chief among their aims was to maintain the journals’ excellence, and also grow them and broaden their scope to cover additional key areas of vascular disease management.

“We knew our specialty was (and is) becoming more diverse. More women are going into it, there is more ethnic, racial and cultural diversity,” said Lawrence.

“And we knew vascular surgeons were not all doing the same operations. To keep the involvement of members as the field changed, we needed to change as a journal. We needed to separate the types of papers being published.”

For example, increasingly more papers were being submitted to JVS that belonged, instead, to JVS-VL, published in collaboration with the American Venous Forum. The journal first known as “Case Reports” and then “Cases and Innovative Techniques” was renamed “JVS: Cases, Innovations and Techniques.”

This permitted expanding the range of papers. “We could take topics originally published in JVS that concentrated on innovations in practice management or education and put them in CIT,” said Lawrence.

Both also felt that there needed to be a place in JVS and the SVS for papers concentrated on basic and translational research, not simply emphasizing clinical research.

“If we wanted to stay a Society on the cutting edge, we could not marginalize basic research, which is critical to vascular surgery. So we initiated JVS-Vascular Science—and got a renowned basic research scientist to be editor [Alan Dardik],” said Lawrence.

They also oversaw creation of four separate websites, for submission to each journal, plus separate editorial boards.

The two emphasized an international presence, attending meetings around the world and spreading the word about the journals. They invited surgeons in other countries to be part of the editorial boards and sought international guidance on certain clinical practice guidelines. Today, more than 50 percent of submissions come from outside the United States, compared to approximately 10% earlier.

They added an internship program, to train young people how to become good reviewers while also emphasizing diversity, equity and inclusion issues. “We took the cream of the crop,” said Gloviczki. The seven Year 1 interns, who will be honored at the Vascular Annual Meeting, wrote peer reviews and commentaries attended monthly lectures and national vascular meetings and studied how to incorporate DEI into research and medical/science journals.

“It was a very successful first year of the program and without a double it is going to grow,” he said.

Lawrence also takes pride in the publication’s online Journal Club, led by Paul DiMuzio, MD, and Misty Humphries, MD. The club educates vascular surgical trainees in interpreting high-level clinical and basic science articles and how to appropriately apply the information to clinical practice and future research.

Both men know they are leaving the “family” in good hands, particularly with the restructuring to add strength and guidance. Past President Ronald Dalman, MD, has been named executive editor, to oversee the big picture and to enhance brand identity for all things in JVS. Thomas Forbes, MD, takes over editorship of JVS, while Ruth Bush, MD, and Matthew Smeds, MD, are the new editors-in-chief of JVS-VL and JVS-CIT, respectively. Alan Dardik, MD, will become editor-in-chief of JVS-VS.

This spreads the workload around, will help to continue differentiation of the journals and will increase involvement of SVS members, especially younger ones, as reviewers and eventually associate editors.

“It’s a good idea to have someone at the top overseeing all four journals,” said Gloviczki. “They certainly have a very bright future.”

Both also praised the staff and reviewers for the successes of the publications. “None of this progress would have been possible without the expert and dedicated team of the JVS family,” they said. “Great things, as [Apple Computer co-founder] Steve Jobs once said, are always done by a team of people.”

Vascular Specialist@VAM–Conference Edition 2

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Vascular Specialist@VAM–Conference Edition 2

Featured in this VAM daily edition:

  • F/BEVAR has high technical success and low mortality in chronic post-dissection TAAA (p. 1 and 3)
  • Systemic heparin during TEVAR deemed safe for selected traumatic brain injury patients (p. 6)
  • Female sex ‘should be considered an independent risk factor’ for new stroke occurrence after carotid revascularization in symptomatic patients (p. 12)
  • Talking about women surgeons’ lives and career (p. 15)

 

Talking about women surgeons’ lives and careers

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Talking about women surgeons’ lives and careers
Julie A. Freischlag

Women—and more than a few men—flocked to the inaugural Vascular Annual Meeting (VAM) education session of the Society for Vascular Surgery’s new Women’s Section yesterday.

The topics of “Supporting Women Vascular Surgeons—From Recruitment through Senior Leadership” reflected the name with sessions on the needs of the youngest generation of women vascular surgeons, radiation and women, pregnancy logistics and wellness, optimal partnerships for women, the role of mentorship in advancing in leadership, and how senior women surgeons can leave a legacy.

The membership section was established roughly six months ago and followed creation of four similar membership sections, including the also new Young Surgeon’s Section. All are welcome, said moderator Audra Duncan, MD, co-leader with Palma Shaw, MD, of the section steering committee.

She told women that to become involved in ongoing setting and communicating of goals, women should simply send her their names. Many irons are in the fire. And a real priority is that everyone is seen, and everyone gets to do things they love and to talk about them, she said. “But our main goal is membership and making sure you are all engaged.”

Avianne Bunnell, MD, kicked off the session talking about the needs of the youngest women vascular surgeons and Ageliki G. Vouyouka, MD, discussed radiation and women. Other topics were optimal practice partnership for women (Patricia C. Furey, MD, MBA); the role of mentors and sponsors in advancing in leadership (Incoming President Michael C. Dalsing, MD); and how senior women surgeons can create a legacy (Julie A. Freischlag, MD).

With pregnancy and raising children an important consideration during women surgeon’s child-bearing years, Meryl Logan, MD, an Air Force surgeon, discussed pregnancy, both before, during and after, a time she called “the fourth trimester.”

“There is no perfect time for anything,” she said of pregnancy. “There is only now. You have to do what’s best for you and your family.” The same is true for when to tell the news to whom is another personal decision. “There are no rules. Do what makes you comfortable.” She added wryly, “If you’re sick all day as I was it’s hard to hide.”

Though women surgeons aren’t known for taking care of themselves, she urged pregnant surgeons to prioritize self-care. “Don’t skip OB appointments. And go to the bathroom!”

To great laughter, she told the audience that she gave herself an ultrasound during her pregnancy. Every. Single. Day. In the second trimester, tools of the trade include water and snacks. Bigger scrubs. Bigger lead aprons.

And, “If you don’t wear compression socks, now is the time to start. Wear the socks!” In the last three months, begin thinking about when you should adjust caseloads. Sit when you can. Know the baby will get in the way. Determine who will take care of patients and tell them the plan.

Consider stopping patient appointments two weeks before the due date in case Jasper or Jane comes early. In that “fourth trimester,” take as much leave as you can, she advised.

“You’ll never get it back.” Simplify life through automatic home deliveries and a cleaning person. Oursource. Prepare for any breastfeeding needs.

“If that what you want to do, you can find a way to do it,” she said. Stock extra clothes and a second nursing bra for work. “You will leak,” she said.

Finally, showing a montage of pregnant women physicians, she said, “You are not alone! “Pregnancy can suck. It did for me,” she said. “But it’s all worth it. You have these beautiful little babies at the end!”

Vascular surgeons ‘have a role to play’ in transcatheter aortic valve replacement procedures

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Vascular surgeons ‘have a role to play’ in transcatheter aortic valve replacement procedures
Enrico Gallitto

Vascular surgery assistance in transcatheter aortic valve replacement (TAVR) can facilitate safe and effective device introduction through cases involving challenging femoral or iliac access.

This was the conclusion delivered by Enrico Gallitto, MD, from the University of Bologna, Bologna, Italy, during the 2022 Vascular Annual Meeting in Boston in a presentation looking at the role of the vascular surgeon in transcatheter aortic valve implantation.

During Thursday’s Plenary Session 3, Gallitto delivered the findings of an analysis of TAVR procedures assisted by vascular surgeons between 2016 and 2020—in what Gallitto describes as a “high-volume tertiary hospital.”

Gallitto noted that TAVR has become the standard treatment for severe aortic valve stenosis among patients at both high and intermediate operative risk for surgical valve replacement. Percutaneous transfemoral access is the preferred route for the procedure, he added, due to its low invasiveness and lower perioperative morbidity and mortality compared to transapical, transaxillary or transaortic approaches.

However, Gallitto added that vascular access complications occurring from the transfemoral access are associated with prolonged hospitalization and 30-day mortality, and the presence of severe peripheral arterial diseases as well as aortic aneurysm or cerebrovascular insufficiency may necessitate concomitant endovascular management.

“A multidisciplinary team with interventional cardiologists and vascular surgeons may minimize the rate of vascular access complications in patients with challenging femoral/ iliac access and significant disease of other vascular districts,” he added, noting that this may be important to optimize the outcome of transfemoral TAVR.

The study sought to evaluate the role of vascular surgeons in transfemoral TAVR.

Gallitto and colleagues looked at pre-, intra- and postoperative data for the given time period, which were clustered and retrospectively analyzed by a dedicated group of both interventional cardiologists and vascular surgeons.

Vascular access complications were defined according with the Valve Academic Research Consortium (VARC) 2 guidelines, and the outcomes of TAVR procedures with vascular surgeon involvement were assessed as the study’s endpoints. Overall, Gallitto and colleagues assessed a total of 937 TAVR procedures performed with a transfemoral approach ranging between 78% (2016) and 98% (2020).

Vascular surgeons were involved in 67 (7%) procedures. Of these, three (4%) had indications for concomitant abdominal aortic aneurysm (endovascular aneurysm repair [EVAR]+TAVR), two (3%) with severe carotid stenosis (TAVR+CAS), and 62 (93%) had hostile femoral or iliac access or vascular access complications.

Balloon angioplasty of iliac artery pre-TAVR was performed in 51 cases (conventional percutaneous transluminal angioplasty [PTA]: 38/51‒75%; conventional PTA+intravascular lithotripsy [IVL]: 13/51–25%).

The TAVR procedure was successfully completed via the percutaneous transfemoral approach in all 62 cases with challenging femoral/iliac access, Gallitto reported.

Vascular access complications necessitating interventions occurred in 18 out of the 937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively.

They were managed by surgical or endovascular maneuvers in 3/18 (83%) and 15/18 (25%) cases, respectively. Fifteen/18 (83%) vascular access complications were treated during the index procedure, Gallitto reported, adding that there were no instances of procedure-related mortality or 30-day readmissions.

In his concluding remarks, Gallitto commented that the necessity of vascular surgeon assistance in TAVR procedures is “not infrequent,” and participation by vascular specialists allows safe and effective device introduction through challenging femoral/iliac access, for example.

“Similarly, the concomitant significant disease of other vascular districts can be safely addressed potentially reducing postoperative related mortality/morbidity,” he noted. “The organization of composite cardiological and vascular surgery teams should be encouraged wherever possible.”

F/BEVAR has high technical success and low mortality in chronic post-dissection TAAA

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F/BEVAR has high technical success and low mortality in chronic post-dissection TAAA
Mohamed A. Abdelhalim

Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is associated with high technical success and low mortality in patients with chronic post-dissection thoracoabdominal aortic aneurysm (PD-TAAA). This conclusion was presented by Mohamed A. Abdelhalim, MBChB, a PhD research fellow at St Thomas’ Hospital, London, England, who detailed a multicenter, transatlantic experience with F/ BEVAR for chronic PD-TAAAs during the Vascular Annual Meeting (VAM) yesterday.

Findings from the study, which was co-authored by Emanuel R Tenorio, MD, and Gustavo Oderich, MD, both of The University of Texas Health Science Center at Houston, Houston, alongside senior author Bijan Modarai, PhD FRCS, Guy’s and St Thomas’ NHS Foundation Trust, London, England, were presented during Thursday’s Plenary Session taking place in Ballroom A/B.

“F/BEVAR has been used widely in the treatment of thoracoabdominal aneurysms,” Abdelhalim told attendees of the morning session, adding that PD-TAAAs present a unique set of endovascular technical challenges.

The study aimed to analyze outcomes of F/BEVAR for treatment ofchronic PD-TAAAs by reviewing clinical data of consecutive patients treated by F/BEVAR for Extent I-III PD-TAAAs in 16 centers from the United States and Europe from 2008‒2021. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts.

Endpoints for the study included any-cause mortality and major adverse events (MAEs) at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12Fr sheath) and major (open or >12Fr sheath) secondary interventions, and patient survival and freedom from aortic-related mortality (ARM).

Abdelhalim presented data from 246 patients (76% male; median age 67 years [interquartile range (IQR) 61‒73]), who were treated for Extent I (7%), Extent II (57%) and Extent III (36%) PD-TAAAs (Median aneurysm diameter, 65mm [IQR 59‒73]) by F/BEVAR. Of these, 18 patients (7%) were octogenarians, 212 (86%) were American Society of Anaesthesiologists (ASA) class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms.

Abdelhalim reported that there were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. He noted that technical success of the procedure was 96%.

The author reported that the study investigators found “favorable” 30-day mortality among the patient cohort, with a rate of around 3%, whilst adding that MAEs occurred in 28%, including acute kidney injury in 8%, new-onset dialysis in 1%, major stroke in 1%, spinal cord injury in 7% and permanent paraplegia in 2%, he noted. Mean follow-up was 24±23 months, wherein patient survival and freedom from ARM were 65±10% and 93±5% at five years, respectively.

Secondary interventions were needed in 93 patients (38%), Abdelhalim noted, including minor procedures in 63 (26%) and major in 30 (12%). There was one conversion to open repair (<1%), while freedom from any secondary intervention was 44±9% at five years. The five-year freedom from target artery instability was 82±3% and instability was significantly more likely to affect branches than fenestrations.

Major causes included endoleaks and stenosis, the presenter commented. In his concluding remarks, Abdelhalim noted that F/BEVAR was associated with high technical success and low mortality (3%), new-onset dialysis (1%) and permanent paraplegia rates (2%) in patients with chronic PD-TAAAs.

Although the procedure is effective against ARM, he commented, overall patient survival at five years (65%) reflects the fact that patients treated have advanced age and significant comorbidities. Freedom from secondary interventions at five years was 44%, although most were minor procedures and conversion to open repair was needed in only one patient.

“Fenestrated and branched EVAR can be used in the treatment of chronic post-dissection aneurysms with low mortality and low morbidity,” Abdelhalim said. “However,” he cautioned, “this does carry a significant intervention rate, and because of this, a bespoke approach is required for each patient, and this includes close follow-up and monitoring of the long-term outcomes.”

The importance of long-term follow-up was a theme picked up in the discussion following the presentation, during which a number of audience members remarked on the significance of the data presented by Abdelhalim.

Speaking from the floor, Ian Loftus of St George’s University Hospital NHS Foundation Trust, London, England, described these as “really important data” and echoed the point that long-term outcomes are key.

“You have highlighted that these are very sick patients and it is very complex technology, and therefore is very expensive and time consuming,” remarked Loftus. “How do you think that we can prove that we are altering long-term outcomes for these patients, and how are we going to prove cost-effectiveness of these technologies?” he asked.

“The follow-up in this cohort is two years, so the only way to do that is for us to continue monitoring these patients and see where we are in a number of years from now,” Abdelhalim responded.

Study co-author Oderich, who joined Abdelhalim at the podium for the discussion, further remarked: “I think what this shows is that we selected a very high-risk population, and that reflects the fact that it is the beginning of the experience with fenestrated-branched grafting. “As time goes by and we enrol patients that are intermediate or lower risk, I think we will be able to achieve a longer follow-up.”

Vascular Specialist@VAM–Conference Edition 1

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Vascular Specialist@VAM–Conference Edition 1

Featured in this VAM daily edition:

  • Researchers report higher three-year amputation, reintervention rates in Black and Hispanic CLTI patients (p. 1 and 2)
  • Six years, much growth and multiple changes to Journal of Vascular Surgery publications (p. 1 and 2)
  • Crawford Forum: Trust, transportation, insurance hamper ‘quality vascular surgery care for all’ (p. 4)
  • Bolstering the vascular workforce: Session details how to start a training program (p. 14)
  • Corner Stitch: Mentorship: Why more vascular surgeons should consider mentoring young minds (p. 19)

 

Low rate of new white lesions detected after TCAR using diffusion-weighted MRI 

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Low rate of new white lesions detected after TCAR using diffusion-weighted MRI 
Raghu Motaganahalli

New white lesions are not a common occurrence in patients who have undergone transcarotid artery revascularization (TCAR), a study in which patients were assessed post-procedurally using diffusion-weighted magnetic resonance imaging (DW-MRI), has found. 

This was the finding delivered by Raghu Motaganahalli, MD, who presented data from a multicenter, single-arm, open-label study evaluating the incidence and volume of new white lesions occurring within 30 days after TCAR. Motaganahalli told attendees of Plenary 2 at the 2022 Vascular Annual Meeting (VAM) Wednesday morning that the outcomes of the analysis should serve as the benchmark for future comparisons evaluating carotid revascularization strategies on cerebral new white lesions. 

Diffusion-weighted imaging has high sensitivity and specificity for the early detection of ischemic lesions, Motaganahalli detailed in his presentation, noting that on DW-MRI, early ischemic lesions appear as new white lesions. Data from previous studies suggest that there is around a 17% chance of patients developing new white lesions following a TCAR procedure, Motaganahalli said, adding that the study presented at VAM 2022 is the first in the U.S. to evaluate the occurrence of new white lesions using DW-MRI. 

For the study, a total of 55 patients were enrolled across five centers from the U.S., as well as centers in Madrid, Spain, and Munich, Germany. Each patient underwent three MRI scans, one within the 72 hours preceding the TCAR procedure, another before their discharge from hospital, and a third at 30-day follow-up. 

Relating to the study’s primary endpoint, detection of new white lesions from the DW-MRI scan, Motaganahalli detailed that new white lesions were seen in 14.5% of patients prior to the TCAR procedure, with a mean volume of 0.11cc. New white lesions were then seen in 21.8% of the study population in scans taking place between 12–60 hours post-procedure, with a mean volume of 0.03cc. Predominantly these were distributed in the territory of the middle cerebral artery, Motaganahalli said. 

“When you look at the 30-day follow-up, the majority of these lesions disappear,” Motaganahalli then detailed, adding that lesions persisted in only 5.8% of the patients assessed at this timepoint. The mean volume of the lesions at this point was 0.21cc, which were again predominantly located in the territory of the middle cerebral artery. No incidences of stroke or neurological death, the study’s secondary endpoints, were seen. 

“Patients who underwent transcarotid artery revascularization and DW-MRI post-procedurally had a low incidence of new white lesions,” the presenter told attendees of the Plenary 2 session. Of these, he added, the majority were in the ipsilateral hemisphere, and located in the middle cerebral artery territory and distribution. 

“These lesions are very small, and those procedures [when] followed-up the majority of them are resolved,” Motaganahalli added. The results of the study should serve as a benchmark, and point to the detection of new white lesions as a surrogate marker for future carotid revascularization clinical trials, he concluded. 

Medicare cuts: ‘It is crucially important we stay engaged in the process’

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Medicare cuts: ‘It is crucially important we stay engaged in the process’

Society for Vascular Surgery (SVS) members deemed payment and reimbursement among the top advocacy priorities for 2022. A session Wednesday at VAM informed attendees about Medicare payment issues and relayed information on the past, what’s going on in the present and how members can impact the future. 

Matthew Sideman, MD, chair of the SVS Advocacy Council, kicked off the session, hosted by the Government Relations Committee, by briefly reviewing the process of the legislative and regulatory processes. 

While laws are in discussion, vascular surgeons have many chances to impact what those laws look like. “It’s crucially important we stay engaged in the process.” 

Surgeons fought the Medicare Sustainable Growth Rate (SGR) for 15 years. Its replacement, the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, hasn’t provided its planned financial stability. “Many in Washington, D.C. view it as a failed policy” 

Current advocacy efforts are focused not only on replacing MACRA but also on shorter-term issues on important legislation, including prior authorization. 

Megan Tracci, MD, Advocacy Council vice chair, explained why Medicare payments are still going down. 

Seventeen SGR patches over 12 years cost more than $169 billion, to no good effect. SGR was then replaced by MACRA; results have been mixed and MACRA has meant vascular surgeons losing ground in every single year” since its passage. 

“Our conversion factor is essentially the same as it was in 1998,” said Tracci. “Physicians have “been tightening our belt for 25 years and aren’t really the problem, she said. Medicare spending has continued to grow, but its distributions have shifted. “It’s now $787 billion, and we’re down to 9 % of that. We’re not going to save our way out of the U.S. government on healthcare.” 

With the funding trend unsustainable, she said, “We need to drive change.” Fixing the payment model and fixing funding must go hand-in-hand, she said. “Advocacy must be data-driven, and we have to bring our data to the table.” 

“We are one vascular surgery team,” emphasized Sean Lyden, MD, committee chair, who discussed recent committee efforts to impact change. “We represent all portions of vascular surgery (in all settings) and represent everybody equally.” 

He stressed the necessity to donate to the SVS Political Action Committee, which currently receives donations from only 7% of SVS members. “If government doesn’t feel like we’re a big voice, they don’t care,” he said. 

“Government relations is about building relationships and getting in front of lawmakers. This requires money, he said. It also means continued reaching out to lawmakers and vital grassroots advocacy. 

Despite some legislative success, such as mitigating proposed payment cuts, battles remain on the horizon, said Lyden. These include the 2023 Medicare Physician Fee Schedule proposed rule and identifying system payment reform options.

Trust, transportation, insurance hamper ‘quality vascular surgery care for all,’ Crawford Forum hears

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Trust, transportation, insurance hamper ‘quality vascular surgery care for all,’ Crawford Forum hears
The Crawford Forum at VAM 2022

An absence of patient trust in their doctors and hospital systems yesterday morning emerged as a key talking point amid a comprehensive deep dive into some of the problems vascular surgeons tackle in their efforts to broaden access to quality vascular care.

A panel of experts assembled by Society for Vascular Surgery (SVS) President-elect Michael Dalsing, MD, for the 2022 E. Stanley Crawford Critical Issues Forum at the Vascular Annual Meeting in Boston—“Quality Vascular Surgery Care for All—An Aspirational Goal of Merit”—were probing some of the key impediments to universal access across the United States, covering such challenges as workforce numbers and distribution, rural isolation, urban care deserts, access to insurance, and diversity and inclusion.

A question from the audience that came after the panel had each delivered a presentation on an aspect of the access hurdles—posed by Mahmoud B. Malas, MD, chief of vascular and endovascular surgery at the University of California Davis—raised the specter of the level of trust patients place in their providers based on the care they had received in the past.

Part of the problem is transportation, Malas said, but trust, he insisted, figures greatly in the conundrum.

“When we were trying to understand why a majority of African Americans were getting PTFE grafts instead of vein, even though they have good veins, or that they were getting a catheter a lot more to start their dialysis than fistulas, we didn’t really understand what was going on until we started interviewing patients,” he said. He was referring to a study of all U.S. dialysis patients that he was involved in while based at Johns Hopkins Hospital that looked at racial disparities.

“Every single patient said I don’t trust Hopkins, doctors, or hospitals. There is a lot of concern that they have no trust in us as doctors, hospitals and providers, because they had had a historically bad outcome, and had no trust in the hospital system.”

Samantha Minc, MD, who had delivered a talk looking at the issues surrounding access to care in rural America, said Malas’ example was “an exact reason why mixed methods research is going to be the way for us to understand these issues related to disparities.”

“We’ve done a really great job quantifying it. We know that these things exist. We have the numbers. But we don’t know why,” continued the assistant professor of vascular surgery at West Virginia University in Morgantown, West Virginia. “Doing that qualitative aspect really provides this amazing synergy where we figure out the question and we can also start finding answers.”

Community engagement and reversing lack of trust, said Andrew Gonzalez, MD, assistant professor of vascular surgery at Indiana University School of Medicine in Indianapolis, are dimensions that build through the development of long-term partnerships.

He described how his mother was a pediatric hematology oncologist in the 1960s and would brave her urban setting, blighted by drug problems of the time, to give out childhood vaccinations. That was realistic back then as it was a practice incentivized by the county hospital. “But I think most of us, if we announced to our division chief, that we had a plan to get the doppler and roll through the ’hood checking ABIs [ankle-brachial indices], we would probably be laughed out of the room. It’s just not incentivized anymore, and there is no way to really do that.”

Gonzalez, who in his talk laid out the access problem in “urban vascular care deserts,” emphasized “the need to think of multilevel, multilateral interventions—and we probably need to do this by partnering.”

One of the ways in which this can be achieved, he said, is through financial incentives being aligned for both hospitals and government entities.

“It is also important we have a role in being seen in the community. It is not just some place you jump into when it’s time to sign people up for your study. It is a place where you have to have been previously embedded. That is important to have overall success.”

Minc, meanwhile, suggested that should a way be found to make transportation grant feasible “a lot of communities are going to benefit.”

Her work right now, she said, is focused on community engagement. “As vascular surgeons, what a community is to us may differ a little bit.” Primary care providers (PCPs), Minc pointed out, represent a community with which to partner. “In rural areas, especially where we are, very isolated areas, these PCPs do everything. They are very independent. They multitask. They come to me and say, ‘Just show us how to do the wound care and we’ll do it.’”

Vincent Rowe, MD, whose topic covered the intersection between diversity and inclusion, and access, said the problems Minc reported concerning rural communities were also prevalent in the urban setting of Los Angeles.

For his part, in his opening remarks, incoming SVS President Dalsing posed the overarching question behind the forum topic: “Where are we now? Do we have enough vascular surgeons? Are they in the right place?”

Data shows there won’t be enough overall, “at least in 2025,” he said

“We know that there is a major distribution issue in terms of where vascular surgeons are and where the disease is and where the patient is.” In terms of both rural and urban America, neither is homogenous, he added.

“We know something about the problem; I’m not sure we know about the solutions; and I think we may not know what we don’t know.

Researchers report higher three-year amputation and reintervention rates in Black and Hispanic CLTI patients

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Researchers report higher three-year amputation and reintervention rates in Black and Hispanic CLTI patients
Aderike Anjorin

In a study of over 7,000 chronic limb-threatening ischemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention rates; survival, however, was higher among Black patients and similar between Hispanic and White patients. Aderike Anjorin, BA, Duke University Medical Center, Durham, North Carolina, delivered these findings yesterday during the William J. von Liebig Forum at the Vascular Annual Meeting (VAM) in Boston (June 15–18).

Framing the research, Anjorin stated that Black and Hispanic patients have higher rates of CLTI and suffer worse outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities are unclear, she said, specifying that data on long-term outcomes are limited. In order to address this gap in the literature, Anjorin and colleagues examined differences in three-year outcomes after open infrainguinal revascularization for CLTI by race/ethnicity and explored potential factors contributing to these differences.

The research team identified all CLTI patients undergoing primary open infrainguinal revascularization in the Vascular Quality Initiative (VQI) registry from 2003–2017 with linkage to Medicare through 2018 for long-term outcomes, the presenter detailed. She communicated that primary outcomes were three-year amputation, reintervention, and survival, and that secondary outcomes were factors associated with disparate outcomes.

Anjorin informed the VAM audience that a total of 7,108 CLTI patients were included in the study. Of these patients, she specified, 5,599 (79%) were non-Hispanic White, 1,053 (15%) were Black, 48 (1%) were Asian, and 408 (6%) were Hispanic.

Presenting the study findings, Anjorin reported that Black patients had higher rates of three-year amputation (32% vs. 19%; hazard ratio [HR]: 1.9 [95% confidence interval: 1.7–2.2]), reintervention (61% vs. 57%; HR: 1.2 [1.1–1.3]), and survival (62% vs. 58%; HR: 1.1 [1.01–1.2]) compared with White patients. Hispanic patients, the speaker added, experienced higher rates of amputation (27% vs. 19%; HR: 1.6 [1.3–2]) and reintervention (70% vs. 57%; HR 1.4 [1.2–1.6]) compared with White patients; however, survival was similar between the groups (62% vs. 58%; HR: 1.1 [0.98–1.3]).

In addition, Anjorin relayed that the low number of Asian patients prevented meaningful assessment of amputation (20% vs. 19%; HR: 0.9 [0.4–2]), reintervention (55% vs. 57%; HR: 0.8 [0.5–1.2]), or survival (64% vs. 58%; HR: 1.2 [0.8–1.9]) in this group.

In adjusted analyses, the speaker communicated, the association of Black and Hispanic race with amputation and reintervention was explained primarily by differences in demographic characteristics (age, sex) and baseline comorbidities (tobacco use, diabetes, renal disease).

Anjorin concluded that disparities in amputation and reintervention rates are partly attributable to demographic characteristics and the higher prevalence of comorbidities in Black and Hispanic patients with CLTI. “Interventions to improve early diagnosis, risk factor modification, and postoperative surveillance in these populations may confer long-term limb salvage benefits,” the speaker told VAM attendees.

“Is ethnicity simply a marker for socioeconomic status, and is that driving these outcomes?” was the first question in the discussion following Anjorin’s presentation. “It is very likely that socioeconomic status plays a role,” the speaker responded. However, she stressed that the data used in the team’s study make it hard to establish exactly how big a role it plays, in part because all patients that have been included are insured, and therefore likely do not represent the entire CLTI population.

Expanding on this point in response to another question, Anjorin remarked that there are other factors at play in the differing outcomes. She emphasized the importance of considering social determinants of health, such as health literacy and geographic location affecting access to centers for exercise therapy, for example. “Unfortunately, we do not have these variables in the current dataset,” she said.

SVS president and session moderator Ali AbuRahma, MD, West Virginia University, Charleston, West Virginia, was keen to get Adjorin’s take on whether CLTI patients were visiting a physician too late and therefore presenting with too advanced disease for treatment. The speaker replied: “We did look at urgency status, and in our adjusted analysis this did not really play a huge role for amputation or reintervention, so it really was the higher burden of comorbidities that drove these differences.”

In another question from the audience, a delegate asked whether the presenter could comment on racial disparities as they pertain to the decision to undergo primary amputation, i.e. those who have an upfront decision to undergo primary amputation as opposed to revascularization and then amputation. Given that the research team used VQI data, Anjorin responded that they do not have the data on individual patient decision-making.

Honing in on the specifics of the study, one delegate asked whether the study group looked at target artery for their analysis. The team looked at distal bypass, Anjorin communicated, noting that they focused on bypass into an infrapopliteal target specifically. “For Black patients, the association with amputation was slightly attenuated, I think by 0.1, and for Hispanic patients, when we looked at distal bypass reinterventions specifically, the association for Hispanic patients and reintervention was attenuated.”

Anjorin performed the analysis and delivered the presentation “Racial and ethnic disparities in long-term outcomes following open revascularization for chronic limb-threatening ischemia” under the guidance of senior author Marc L. Schermerhorn, chief of the Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center, Harvard Medical School.

A number of the researchers involved in this study have authored other, published work on the topic of healthcare disparities in vascular disease management, including, most recently, a paper titled “Disparities in five-year outcomes and imaging surveillance following elective endovascular repair of abdominal aortic aneurysm by sex, race, and ethnicity” by Marcaccio et al. This study was also led by Schermerhorn.

The research team behind this study report in the May 2022 edition of the Journal of Vascular Surgery (JVS) that Black females had higher five-year aneurysm rupture, reintervention, and mortality after elective endovascular aneurysm repair (EVAR) compared with White male patients, while White females had higher rupture, mortality, and loss-to-imaging follow-up. They relay that Asian females also had higher rupture, and Black males had higher reintervention and loss-to-imaging follow-up. “These populations may benefit from improved preoperative counseling and clinical outreach after EVAR,” Marcaccio and colleagues suggest, adding that a larger-scale investigation of current practice patterns and their impact on sex, racial, and ethnic disparities in late outcomes after EVAR is required to identify “tangible targets for improvement.”

Silk Road to evaluate TCAR in standard surgical risk patients with ROADSTER 3 study

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Silk Road to evaluate TCAR in standard surgical risk patients with ROADSTER 3 study

Silk Road Medical today announced a post-market study to evaluate the transcarotid artery revascularization (TCAR) system in the treatment of standard surgical risk patients with carotid artery disease.

The ROADSTER 3 study will fulfill the US Food and Drug Administration’s (FDA) condition of approval for the recent expansion of labelling for Silk Road’s Enroute transcarotid stent system, which now includes patients at high and standard risk of complications from carotid endarterectomy (CEA) as of May 2022.

This prospective, multicenter, single-arm study is designed to assess the real-world treatment of standard surgical risk patients with carotid artery disease using TCAR, targeting a maximum enrollment of 400 patients across approximately 50 sites. Primary endpoints include a composite of major adverse events (death, stroke or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure. The incidence of cranial nerve injury within 30 days post-procedure is a key secondary endpoint.

“This study is providing physicians with the unique opportunity to participate in a first-ever prospective study to demonstrate the safety and efficacy of TCAR among the standard surgical risk patient population,” said co-national principal investigator Jeffrey Jim, MD, from Allina Health Minneapolis Heart Institute, Minneapolis. “I am honored to be included as principal investigator and eagerly await clinical results that will help expand a less invasive treatment option for carotid patients regardless of their surgical risk.”

Regional society leaders look forward to VAM and beyond

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Regional society leaders look forward to VAM and beyond

We asked the presidents of all five major regional vascular societies in the United States for an update on the latest goings-on in their organizations, how their presidencies are progressing, and what papers and talks they are looking out for at this year’s Vascular Annual Meeting (VAM).

Andres Schanzer, MD, president of the New England Society for Vascular Surgery (NESVS), Robert Rhee, MD, the current Eastern Vascular Society (EVS) president, President William Jordan, MD, from the Southern Association for Vascular Surgery (SAVS), Raghu Motaganahalli, MD, president of the Midwestern Vascular Surgical Society (MVSS), and Western Vascular Society President Vincent Rowe, MD, fill us in.

1. Can you tell us a little about the latest developments across your society? 

Andres Schanzer: We introduced a new research fellowship that leverages the Vascular Study Group of New England (VSGNE)/NESVS relationship and the many strong investigators in our region who will be providing the teaching content. This course, designed and led by Kimberly Malka, MD, will help to jumpstart high-impact research careers for junior members in our region. We have tried to increase our region’s social media presence in order to better serve our members. This effort, initiated by Alan Dardik, MD, during his presidency last year, has been an enormous success. The NESVS now has more than 1,000 followers on Twitter, and regularly posts on this platform and others like Instagram. We continue to work on our society’s diversity, equity, and inclusion (DEI), and want our society membership to look like our patients. Beth Blazick, MD, and Patricia Furey, MD, chair our DEI committee. Finally, we have put significant effort into making the NESVS a home for all who take care of vascular surgery patients. Our Allied Health program continues to grow. 

Robert Rhee: We have in the past had quite selective, exclusive committees at the EVS—we have in excess of 20 committees. In the past, the president would appoint people he knows, people who are in the academic circle. What I did this year was to open it up to any member who wants to serve. Even if you are one year out of a fellowship, and if you’re a laboratory tech, or a physician’s assistant, and you want to serve to help advance the treatment of vascular disease, you can. Our committees are much larger, we have a lot more manpower, and we’re going to use that manpower to develop more robust, web-based content, in terms of patient testimonials, and interviews of experienced vascular specialists doing certain procedures. We aim to be a society not just focused on an annual meeting, but a year-round service to all the members. 

William Jordan: In January of 2022, many of our members were able to gather in Florida for our annual meeting as we emerged from the pandemic. The science shared in the plenaries was inspiring, and the techniques shown in the postgraduate course were truly innovative. SAVS has the distinction of having the highest proportion of meeting manuscripts published in the Journal of Vascular Surgery (JVS). We are also proud of progress we’ve made in attracting underrepresented groups to our society. Over the last five application cycles, nearly 40% of our new Active members have been from underrepresented groups—including females and ethnic minorities. We are excited for our continued growth in this area. 

Raghu Motaganahalli: The MVSS established a new DEI Committee, led by Bernadette Aulivola, MD, and Lee Kirksey, MD, as chairs. Several recommendations were made from the committee, including scholarships for health disparities research. We will implement them at this year’s meeting in Grand Rapids, Michigan. We continue to host the popular New Horizons webinar series. At each of these events, we’ve presented topics on new technologies and debated on controversial topics. These programs were well attended by our members and trainees. Our society has invested in medical students who want to pursue a career in vascular surgery by giving them access to our educational webinars, travel scholarships and our residency fair. Our Medical Student and Resident Committee has done a great job of connecting with vascular special interest groups in order to attract the best and brightest for our specialty. 

Vincent Rowe: This year, the WVS has re-instituted the Mock Oral examinations, led by Warren Chow, MD, from University of Washington. We have also had webinars for our DEI Committee and Vascular Surgery Interest Group. 

2. What priorities did you set for your presidential year, and how are they progressing? 

AS: My priorities for this year included introducing a new research fellowship for NESVS members that leverages our relationship with the VSGNE and the many talented investigators in our region; expanding our social media presence; integrating DEI consideration into every single decision/appointment we make; growing our APP program/offerings; and using the shared SVS/NESVS membership lists to perform a focused membership drive, with the goal of all SVS members in our region also being members of NESVS. 

RR: For my presidential year, I’ve really focused on making this medical society a little bit more inclusive. One of the things I initiated—and will be legislated and enacted by our annual meeting in September—is no longer requiring an MD or DO as a membership requirement, meaning that we have been, for the last several years, pushing to get Allied Health (physicians assistants, techs, nurses, anybody who is involved in vascular care) to join the EVS as an equal voting member. The days of stuffy old physicians’ societies are gone. Those are significant changes for a 750-member regional society. 

WJ: Our primary focus heading into this term is building upon the success of our last meeting, and continuing to foster a great sense of togetherness. We are excited to welcome more in-person attendees to our next annual meeting in Puerto Rico in January of 2023. We are confident that eased COVID-19 restrictions, coupled with a beautiful setting, will lead to even more engagement amongst our members. My priority as president is to bring our society and specialty closer together in order to advance the science and understanding of vascular disease to better serve our patients. 

RM: During my presidential year, my main priority is to increase the membership of the MVSS. Membership engagement at all levels is a top priority for the society. Be it Active, Candidate or Medical Student members, we want to strengthen the organization at the grassroots level by continuing to host successful membership drives throughout the year. We want to make sure we welcome as many vascular surgery practitioners and trainees in the Midwest as possible, and encourage them to become members of the MVSS. I am also passionate about our new DEI Committee and its mission to promote diversity, equity and inclusion amongst our general membership, committee volunteers and society leadership. We are committed to mentoring a diverse group of medical students and trainees, and to set the example for others for follow. It is our intent to not only sustain these efforts, but to continuously improve and expand our goals. 

3. What paper on the VAM 2022 schedule are you most looking forward to and why? 

AS: There are many excellent studies on a broad array of topics, covering every aspect of vascular surgery. One presentation I am particularly excited about hearing is by a group of authors from Hamburg, Germany, who are at the very front edge of procedural imaging technology using Fiber Optic RealShape (FORS; Philips). This technology allows catheter and wires to be visualized in 3D without the use of radiation. They are presenting their first 50 complex aortic patients that they have treated with this technology. It will be exciting to hear about how well this technology performs, where the gaps are, and what future developments might be necessary for FORS to become more widespread. 

RR: The papers that I’ll be looking for at VAM are those that are relevant to the everyday vascular surgeon. Those papers that are going to help the in-the-trenches vascular specialist to do their job well, and not really the esoteric procedures that are limited to certain institutions. 

WM: I am looking forward to the paper presented by Olamide Alabi, MD, Luke Brewster, MD, and Yazan Duwayri, MD—three members of our outstanding Emory faculty—comparing 90-day peripheral arterial disease (PAD) outcomes in office-based labs versus outpatient procedures. 

RM: Every year, I look forward to the E. Stanley Crawford Critical Issues Forum. This year, the program focuses on “Quality Vascular Surgery Care for All—An Aspirational Goal of Merit.” This will be an opportunity to learn more about the chasms in vascular care as it applies to urban and rural America, workforce issues, as well as DEI challenges with access to vascular care. These are hot-button topics, and I am sure this will be a great learning experience for all of us. 

VR: Right now, I am curious about the paper from Beth Israel Deaconess Medical Center to better understand how social determinants effect outcomes in vascular disease—”The impact of neighborhood social disadvantage on peripheral artery disease presentation and management.” 

Missing something? View VAM 2022 on-demand sessions

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Missing something? View VAM 2022 on-demand sessions
On-demand recordings will be available through the Online Planner

Pre-recorded videos from Vascular Annual Meeting (VAM) 2022 sessions are now available on-demand. If videos were submitted by faculty in advance, they will be available right after the session concludes. Access them now in the mobile app or in the Online Planner. 

All registrants—regardless of in-person or livestreamed registration—will have access to the meeting recordings, letting them watch something they couldn’t because of schedule conflicts or reviewing a session for additional details.

Be sure to revisit meeting content to help implement new practices and improvements to your practice. The on-demand recordings will be available through the Online Planner (after logging in) for up to three years.

Please note: To claim Continuing Medical Education (CME) credits, participants must attend the session live (as it is happening).

A handy guide for VAM attendees: 2022’s Online Planner

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A handy guide for VAM attendees: 2022’s Online Planner
The Online Planner allows handy access to, among other useful resources, the full schedule

The Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) 2022 Online Planner is an invaluable companion at the event in Boston’s Hynes Convention Center.

Users can easily search for meeting information via laptop, tablet or phone. Visit the VAM 2022 Online Planner, and get the full schedule and accreditation information.

Read the abstracts, learn about faculty and presenters, view the posters, see what exhibitors are attending and even acquire Continuing Medical Education (CME) credits (once a session is finished).

Once signed in with SVS user name and password, users can mark as “favorite” those sessions they don’t want to miss. (To find favorites easily, hover over the blue “favorite” star and click it; all favorites will be identified.

Log into the Online Planner by clicking the “Login” button in the top right corner.

Vascular Live: Variety of vascular concerns on the slate

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Vascular Live: Variety of vascular concerns on the slate
Vascular Live events will take place at the back of Aisle 700 in the Exhibit Hall, on Level 2

Be sure to save time for the Vascular Live theater-in-the-round presentations in the Exhibit Hall at the 2022 Vascular Annual Meeting (VAM) in Boston. These sessions, on a variety of topics of importance to vascular surgeons, frequently play to big crowds.

All Vascular Live events will take place at the Vascular Live stage, at the back of Aisle 700 in the Exhibit Hall, on Level 2 of the Hynes Convention Center. 

THURSDAY, JUNE 16 

10–10:25 a.m. 

Tips and Tricks for Suture-Mediated Closure and Repair for Arterial Access Sites 

Sponsored by Abbott 

Speaker: Elena Rinehardt, MD 

12:15–12:40 p.m. 

Real-World Clinical Strategies with the Venovo Venous Stent System 

Sponsored by BD 

Speaker: Patrick Muck, MD 

1–1:25 p.m. 

Overcoming Challenges in TEVAR, Today and Tomorrow 

Sponsored by Gore 

Speaker: To be Announced 

3–3:25 p.m. 

Reimagine Aspiration With Hydrodynamic Thrombectomy Systems 

Sponsored by Abbott 

Speaker: Loay Kabbani, MD 

5:15–5:40 pm 

Treating Complex VTE in My Practice 

Sponsored by Penumbra 

Speaker: Carlos Bechara, MD 

Overview: This presentation will focus on the use of Lightning 7 Intelligent Aspiration in cases and to assist in treating complex venous thromboembolism cases. 

FRIDAY, JUNE 17 

9:30 –9:55 a.m. 

Advancing Health Equity by Addressing Disparities with TWO2 Homecare Therapy 

Sponsored by Advanced Oxygen Therapy 

Speakers: Mike Griffiths, MD, and Anil Hingorani, MD 

Synopsis: Non-healing venous leg ulcers and diabetic foot ulcers pose a disproportionate impact on minority and low-socioeconomic populations. Advanced Oxygen Therapy’s unique cyclical-pressure Topical Wound Oxygen (TWO2) therapy offers hope for addressing such health inequities. The growing body of randomized controlled trial and real-world evidence demonstrating significantly-reduced ulcer recurrence, hospitalizations and amputations will be reviewed. The impact that more durable wound healing has on both patient-and payer-centric outcomes will also be explored. 

12:15–12:40 p.m. 

Remove with Rotarex 

Sponsored by BD 

Speakers: Frank Arko, MD, and Bryan Fisher, MD 

1–1:25 p.m. 

The Role of Covered Stent Grafts in the Treatment of Complex Aortoiliac Occlusive Disease 

Sponsored by Gore 

Speaker: To be announced 

3 to 3:25 p.m. 

TCAR: The Road to Standard of Sare 

Sponsored by Silk Road Medical 

Speakers: Marc Schermerhorn, MD, Megan Dermody, MD, and Jeffrey Jim, MD 

Presentations: 

  • TCAR in 2022 and beyond: The current and future state of TCAR” 
  • How can TCAR improve efficiencies within your practice” 
  • TCAR: Perspectives from a practicing physician: How TCAR can benefit patients” 

Vascular Live presentations are not eligible for CME credit. Listing is correct as of May 31, 2022. 

SVS special membership sections stage education sessions

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SVS special membership sections stage education sessions
SVS membership sections are staging special sessions at VAM 2022

For the first time, all those who are part of the five Society for Vascular Surgery (SVS) membership sections have educational presentations geared specifically to them at the Vascular Annual Meeting (VAM).

VAM has offered education targeted to vascular physician assistants (PAs) for several years, with a section for those in the outpatient-based setting added after that. The SVS recently established three additional membership sections, for women, young surgeons and those in community practice. This year, at VAM 2022 in Boston, all have educational meetings tailored to their needs and career settings and stages. 

“These sessions let those who lead those membership sections present what they believe are the most pressing topics and issues for these membership groups,” said William Robinson III, MD, chair of the SVS Postgraduate Education Committee, which oversees this and a host of other educational programming. 

“They all work in the vascular surgery field, yes. But the needs of young surgeons differ from older surgeons in specific ways. Women and PAs, likewise, have issues specific to them. We’re very excited to add these personalized educational sessions this year.” 

Thursday sessions are for PAs, women and young surgeons. Friday will feature programming for community practitioners and those in the outpatient setting, now known as the Sub-Section on Outpatient and Office Vascular Care (SOOVC); those sessions will be highlighted in the on-site editions of Vascular Specialist@ VAM, the new name of the VAM daily newspaper. 

Physician Assistants: PAs will enjoy lunch and networking from 11:30 a.m.–1 p.m., with their education session following from 1 to 5 p.m (Hynes Convention Center, Room 304/306). 

“We selected the topics based on a combination of a PA education survey, topics of interest and what we have enjoyed at past conferences,” said Holly Grunebach, PA-C, chair of the PA Section Steering Committee. The goal, she said, is to present a meaningful program plus get as many physician assistants involved as possible. 

Topics include several presentations on imaging, including one from the Society of Vascular Ultrasound; complex abdominal aortic repair cases; managing penetrating vascular trauma; chronic limb-threatening ischemia; and a case presentation on acute aortic occlusion in a COVID-19 patient. 

The group will also hear presentations on leadership; multidisciplinary management; venous insufficiency and varicose veins; managing venous ulcerations wounds. The session will end with “Optimal imaging modalities and interpretation review for aortic disease” and “Detecting and treating the silent killer: Review of abdominal aortic aneurysms from presentation to intervention.” 

The hope is that PAs “gain clinical knowledge, explore new ways to practice and make connections with providers working in the same specialty,” said Grunebach. It is what makes the membership section “so unique and valuable to physician assistants practicing in vascular surgery,” she added. 

Women’s Section: Audra Duncan, MD, and Maureen Sheehan, MD, will co-moderate the women’s section session, “Supporting Women Vascular Surgeons, from Recruitment Through Senior Leadership,” from 1:30–3 p.m. Thursday (Room 210). 

Duncan co-chairs the section Steering Committee with Palma Shaw, MD, who will introduce the program. The 90-minute presentation will cover items of particular importance to women surgeons, including radiation, logistics and wellness for pregnant surgeons, and optimal practice partnership scenarios for women. 

The various stages of a woman’s career also will be discussed, including those of the youngest generation of women vascular surgeons, the impact of mentors and sponsors on leadership advancement. Julie Freischlag, MD, SVS’ only female president to date and the current president of the American College of Surgeons, will discuss leaving a legacy. 

“We worked together with our steering committee, which includes representatives from four stages of careers (trainee, early-career, mid-career and senior surgeon) and tried to address a critical issue at each stage,” said Duncan. 

“In addition, we wanted topics that would address support of women’s careers that would speak to both men and women who want to mentor, hire, retain and guide women surgeons.” 

Young Surgeons Section: The needs of young surgeons are front and center in the session devoted to the new section: “Navigating the Launch of Your Career as a Young Surgeon,” from 3:30–5 p.m. Thursday (Room 210). Topics include how to become indispensable in that first year of practice, navigating workplace politics and mentors, sponsors and coaches. 

Michael McNally will tell attendees all about the “Worst mistakes I made in my first years of practice.” The final two talks will focus on research collaboration and the Vascular Quality Initiative, and leadership. Moderators are Edward Gifford, MD, Chelsea Dorsey, MD, member and chair, respectively of the section Steering Committee, and Jeanwan Kang, MD. 

Community Practice Section: Community practitioners will meet from 1:30–3 p.m. Friday (Room 210) to discuss “Starting Your Own Independent Practice— What you Need to Know.” The session is being co-moderated by Daniel McDevitt, MD, and Sean Lyden, MD. 

Sub-Section on Outpatient and Office Vascular Care: Members will be discussing “Providing Outpatient Vascular Care in the Office-based Lab (OBL)— Evaluating Trends, Quality and Value-based Care” from 3:30 to 5 p.m. in Room 210, also on Friday. Robert Molnar, MD and Jayer Chung, MD, will be at the helm.

Open repair of infrarenal aortic aneurysm proves preferable to endovascular repair

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Open repair of infrarenal aortic aneurysm proves preferable to endovascular repair
Emiliano Chisci

As part of the Vascular Annual Meeting (VAM) International Fast Talk session on the morning of Wednesday, June 15, Emiliano Chisci, MD, from San Giovanni di Dio Hospital in Florence, Italy, will be presenting the results of a 15-year follow-up of open repair (OSR) of an infrarenal abdominal aortic aneurysm (AAA). The results demonstrate, Chisci will tell the VAM 2022 gathering in Boston, that open repair of an infrarenal AAA is superior to endovascular aneurysm repair (EVAR), even in case of sac shrinkage.

Chisci et al, in their report, will detail long-term results from 1,777 consecutive AAA repairs in a single tertiary hospital between 2003 and 2018. In their written abstract, they note primary outcomes of all-cause mortality, AAA-related mortality, and reintervention rate. Open repair was offered to patients whose functional capacity was greater than, or equal to, four metabolic equivalents (METs), who were also predicted to live longer than 10 years. In contrast, the authors explain, EVAR was performed where patients had a hostile abdomen, they could be deemed anatomically feasible for a standard endovascular graft, and where their functional capacity was lower than four METs. 

Of the 1,777 repairs included in the study, 47% (n=828) were open repairs and 53% (n=949) were EVARs. The mean age of patients was 78.3 years, 93.5% (n=1,661) were male, and mean follow-up was 79 months. Also of note, the authors define sac shrinkage as “a reduction of both anterior-posterior and latero-lateral diameter of the sac of at least 5mm at the last follow-up versus the first postoperative follow-up imaging.” 

According to Chisci et al’s findings, the study yielded results showing that 30-day mortality was 0.7% (n=6) and 0.6% (n=6) for open repair and EVAR, respectively. Survival rate was 97.6% and 94% at one year, 83.6% and 75% at five years, 59.6% and 45.8% at 10 years, and 33.1% and 20.7% at 15 (p<0.001). The researchers specify, that where patients had sac shrinkage, a statistical difference was found (p=0.1). With regard to AAA-related mortality, at final follow-up, deaths were 1.8% (n=15) vs. 2.4% (n=23) in the open repair and EVAR patient groups (p=0.37). Lastly, freedom from intervention in the open repair vs. EVAR groups was 97% and 96% at one year, 96.5% and 88.4% at five years, 95.8% compared with 81.7% at 10 years, and 94.6% vs. 72.3% at 15 years (p<0.001). 

Furthermore, the authors detail that reinterventions were greater in number in the EVAR group, although the sac shrinkage subgroup (p<0.001) underwent fewer reinterventions. However, this number remains greater than those in the open repair group. 

By way of conclusion, Chisci et al opine that open repair of an infrarenal AAA is superior to EVAR, even in the case of sac shrinkage at very long-term follow-up. This, they state, is in line with current guidelines, and consequently, they offer the recommendation that the “[open repair] proportion of AAA repair should not be less than 40–45% in a vascular center.” 

Chisci’s presentation takes place from 6:35–6:40 a.m in Room 210 of the Hynes Convention Center.

Discussing ERAS—Enhanced Recovery After Surgery

Discussing ERAS—Enhanced Recovery After Surgery
Katharine L. McGinigle

Enhanced Recovery After Surgery (ERAS) pathways have been beneficial for many surgical specialties and are now available to guide the perioperative care of patients undergoing open aortic operations. The Vascular Quality Initiative (VQI) will discuss this important topic starting at 8:35 a.m. Wednesday, June 15, during the VQI@VAM annual meeting at the Hynes Convention Center (Room 312) Boston (June 14–15). 

The Society for Vascular Surgery (SVS) and the ERAS Society jointly endorsed the recent consensus statement, “Perioperative care in open aortic vascular surgery,” which was published in the Journal of Vascular Surgery in June. With the goal of delivering high-quality perioperative care and reducing the physiologic stress of surgery, this consensus statement is intended to help address the many perioperative challenges faced by vascular surgery patients, who are often older, frailer and with more comorbidities than the average surgical patient. 

The 36 graded recommendations emphasize the coordination and timing of care across disciplines to reduce unnecessary care variation and to give patients the best chances of quickly getting back to normal. Recommendations based on the universal ERAS elements include preadmission (screening, preoperative exercise therapy/prehabilitation, perioperative anti-platelet, anticoagulation plan); preoperative (fasting, carbohydrate loading, venous thromboembolism prophylaxis, pre-anesthetic sedative and analgesia medication, antimicrobials, nausea/vomiting prevention); intraoperative (anesthetic protocols, epidural analgesia, body temperature management, drainage of surgical site); and postoperative (multimodal analgesia and opioid reduction strategies, nasogastric drainage, oral feeding, fluid therapy, urinary drainage, glycemic control, early mobilization strategy, discharge education, audit of outcomes). 

Some of the recommendations are a clear departure from current routine care but should be carefully evaluated as there is high-level evidence that change is needed. For example, pre-operative fasting times should be dramatically reduced and the use of post-operative nasogastric tubes should be minimized. There are other recommendations based on more heterogenous and less rigorous data, particularly around pre-operative optimization and fitness for surgery. Numerous research gaps have been identified, and as ERAS programs are developed across the country there will be opportunities for multicenter research and VQI-supported quality improvement charters.

Open surgical bypass to distal targets at the ankle is ‘viable’ infrapopliteal CLTI treatment

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Open surgical bypass to distal targets at the ankle is ‘viable’ infrapopliteal CLTI treatment
Othman M. Abdul-Malak

The Vascular and Endovascular Surgical Society (VESS) Paper Session at the Vascular Annual Meeting (VAM) in Boston on Wednesday, June 15, will see Othman M. Abdul-Malak, MD, from the University of Pittsburgh Medical Center in Pittsburgh, deliver results from “Midterm outcomes and predictors of failure of lower-extremity bypass to paramalleolar and pedal targets.” Open surgical bypass to distal targets at the ankle remains a viable option for treating infrapopliteal chronic limb-threatening ischemia (CLTI), Abdul-Malak and colleagues conclude, with patency and amputation-free survival rates shown to be of an acceptable level. 

Abdul-Malak states his reasons for conducting the study: to determine whether or not the recent decrease in frequency of distal lower extremity bypass for infrapopliteal CLTI is warranted, based on poor paramalleolar and pedal target outcomes. 

The data on infrapopliteal CLTI patient lower-extremity bypass outcomes came from the Vascular Quality Initiative (VQI) infrainguinal database from 2003–2021. Primary outcomes were graft patency, major adverse limb events (MALE) and amputation-free survival at two years. 

Some 2,331 procedures (1,265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, and 283 tarsal/plantar) were included in the analysis. Abdul-Malak details how he was able to conclude that bypasses to distal targets have decreased from 13.37% of all procedures in 2003 to 3.51% in 2021 (p<0.001). 

Across the 18 years of data, the majority of cases presented with Rutherford Class 5/6 ischemia (81.25%), with Class 4 representing 14.5% and Classes 1–3, 4.25%. Regarding postoperative complications, the study references the 8.9% incidence of major cardiac events, and that of surgical site infections, which occurred in 3.6% of cases. 

Abdul-Malak reports that major amputations occurred in 16.8% of patients at one-year follow-up, and postoperative mortality within the same timeframe was 10%. On unadjusted Kaplan-Meier survival analysis, primary patency was 50.56±3.6%, primary assisted patency was 58.79±4.03%, secondary patency was 60.48±4.12%, MALE was 63.49±3.27%, and amputation-free survival was 71.71±0.98%, with all data collected at two-year follow-up. 

With comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume all adjusted for, the paper presents that conduits other than the great saphenous vein (GSV) and prior ipsilateral vascular interventions (open/endovascular) were predictors of loss of primary patency and increased MALE. 

Conversely, high center volume at a rate of over 60 procedures per center over the total time period, was positively correlated with increased primary patency, as well as lower MALE at two-year follow-up, Abdul-Malak and colleagues find. 

The data showed that increasing age, dialysis dependence, and recourse to conduits other than GSV during the procedure were all associated with a lower amputation-free survival rate at two years, he reveals. 

“Although it is now a lesser-used procedure, open surgical bypass to distal targets at the ankle is nonetheless a viable option for treatment of infrapopliteal CLTI, as demonstrated by data on patency amputation-free survival rates at two years,” Abdul-Malak said. “Furthermore, the conduit used, and whether or not the patient has undergone prior vascular interventions, are the key predictors of [lower-extremity bypass] failure.” 

To increase chances of procedural success, Abdul-Malak suggests that bypasses to distal targets be performed at high-volume centers. He will take to the podium in the Hynes Convention Center, Ballroom A/B, from 12:50 p.m.–1:03 p.m.

Wound healing research earns SVS Foundation prize, place on VAM stage

Wound healing research earns SVS Foundation prize, place on VAM stage
Christopher Audu

University of Michigan resident and Vascular Specialist resident/fellow editor Christopher Audu, MD, has been granted the SVS Foundation Resident Research Award for 2022. And, already, he is looking ahead to where the research might go next, and the wider importance of addressing his chosen research topic—wound healing—which he describes as a common and persistent problem in vascular surgery and beyond. 

The award is given out to a resident in training who has engaged in basic science research, with the aim being to encourage scientific endeavors in the field of vascular surgery. Applicants must submit letters of recommendation and a summary of their research, as well as a manuscript that is in its preliminary stages. The award is given out annually, and the prize is an opportunity for the winner to present their work at the Vascular Annual Meeting (VAM). Audu’s paper will kick off the William J. von Liebig Session, the first plenary, Wednesday, June 15, from 8–8:10 a.m. (Hynes Convention Center, Ballroom A/B). “This is the biggest stage that we have for vascular,” says Audu, describing the significance of the annual conference in the vascular surgery field. This year, Audu’s research into the proteins involved in diabetic wound healing stood out among the competition and, in doing so, earned a place on the agenda of this year’s meeting. 

Specifically, under the guidance of Katherine Gallagher, MD, Audu has been looking at one of several reasons why wounds do not heal—inflammation— and his work suggests there may be a “light switch” that controls various inflammatory pathways. Audu has been working on the prize-winning research for the past year and a half, he tells Vascular Specialist. At the University of Michigan, residents are allowed two years in between their training for professional development. “I used those two years as my post-doctoral years in the laboratory to pursue this research,” Audu explains. 

Wound healing, he notes, is a common problem in vascular surgery that has “defied a lot of treatment options,” particularly when it comes to medications. “Usually, these patients have very poor circulation to the extremities—their fingertips and their toes are often the worst hit—and when they get wounds there, they just do not heal,” he explains. With his current research, Audu is “picking away” at one of the many reasons why wounds do not heal, which is ongoing inflammation. 

Audu details that the aim of his research was to understand what it is about macrophages in wounds that prevent them from healing. He considered a particular protein called JMJD3, which he discovered is involved in turning on cytokines that play a role in inflammation. “Initially, you need some sort of inflammation when you get a bruise, and then that should transition to a point where you are healing,” says Audu. “In the diabetic state, what we found was that that signal is on way longer than it needs to be, and that this particular enzyme, JMJD3, is partly responsible.” In addition, the team found that this enzyme turns on a number of other genes that are involved in inflammation. 

Audu and his colleagues in the Gallagher lab then tried to understand these processes mechanistically, he continues, reporting that they were able to find a small molecule that could specifically inhibit macrophages in the wound and thereby improve wound healing in a diabetic mouse model. Audu notes that this research originated with Gallagher—the principal investigator of the study and an “expert” in epigenetics and in wound healing, according to Audu, as well as a vascular surgeon. When Gallagher pitched the research project to Audu, he recounts that he simultaneously pitched the idea of looking at a particular pathway called STING—an acronym for stimulator interferon genes. “So, we put our heads together and came up with a joint project that combined both of our interests,” Audu recalls. 

“The work that we have done mechanistically shows that there is a way to target inflammation, and maybe even target a ‘light switch’ that controls several different inflammatory pathways—that’s the big picture idea,” he summarizes. 

A medicinal chemist by training, Audu is eager to “take a project from the beginning right through to finding something that could be a therapeutic angle.” Looking at what is next for the research, he states that the first step will be to get the paper published, but what he hopes for subsequently is that the team develop this “therapeutic angle” into something that can be applied directly to wounds. 

Wound healing in diabetic patients is “important to most vascular surgeons,” says Audu, pointing to a desire within the specialty to find solutions for this patient population. But the problem is not confined to vascular surgery, and it is not only vascular surgeons who want to see changes in this area. Indeed, Audu points to the fact that specialists in various other areas, such as plastic surgery and podiatry to name just two, also encounter these patients on a regular basis. 

Elsewhere in the Gallagher lab, Audu details that he is involved in some other research into the multitude of different types of cells within wounds that could be contributing to poor wound healing and diabetes. Outlining this other research, he says that it revolves around the fact that certain cells are known to interact with a person’s T-cells, and that those T-cells are known to facilitate chronic inflammation in wounds, particularly if they overproduce inflammatory cytokines. “We have found that diabetic pDCs [plasmacytoid dendritic cells] are altered, and they are actually involved in turning these T-cells into inflammatory phenotype.” Details will be presented in a poster at VAM, he says. Further down the line, Audu is keen to bring his expertise in chemistry to vascular surgery and usher in drug development and design as a focus. “In the future, I hopes this is something I can advance in my own lab someday.” 

Aside from presenting his prize-winning science and some poster work, Audu is also looking forward to the in-person aspect of this year’s meeting. “I’m excited about meeting people in person who I have only even seen in Zoom meetings. That will be a highlight.” 

Early TCAR results in higher ipsilateral postoperative stroke rates when compared to carotid endarterectomy

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Early TCAR results in higher ipsilateral postoperative stroke rates when compared to carotid endarterectomy
Adham Elmously

Adham Elmously, MD, a fellow at New York Presbyterian Hospital, New York, is set to present outcomes of early transcarotid artery revascularization (TCAR) vs. carotid endarterectomy (CEA) after acute neurologic events during the opening day of the Vascular Annual Meeting (VAM) in Boston (June 15–18).

Speaking on behalf of senior author Danielle Bajakian, MD, of Columbia University Medical Center, New York, and colleagues, Elmously will on Wednesday conclude that TCAR within 14 days of a neurologic event results in higher ipsilateral postoperative stroke rates when compared to CEA, especially when performed within 48 hours. 

Elmously and colleagues state that carotid revascularization within 14 days of a neurologic event is recommended by society guidelines. They note that TCAR carries the lowest overall stroke rate for any carotid artery stenting technique, but stress that “outcomes of TCAR within 14 days of a neurologic event have not been studied or directly compared to CEA.” 

The research team compared in-hospital outcomes of symptomatic patients undergoing TCAR and CEA within 14 days of stroke or transient ischemic attack (TIA) from January 2016 to February 2020 using the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) carotid artery stenting and CEA databases. They note that propensity score matching was used to adjust for patient risk factors, and that the primary outcome was a composite of postoperative ipsilateral stroke, death, and myocardial infarction (MI). The researchers detail that 1,281 symptomatic patients underwent TCAR and that 13,429 patients underwent CEA within 14 days of a neurologic event. After 1:1 propensity matching, they add, 728 matched pairs were included for analysis. 

At VAM, Elmously will communicate that the primary composite outcome of stroke, death, or MI was more frequent in the TCAR group (4.7% vs. 2.6%, p=0.04). The presenter will inform delegates that this was driven by a higher rate of postoperative ipsilateral stroke in the TCAR group (3.8% vs. 1.8%, p=0.005). In addition, they will report that there was no difference between TCAR and CEA in terms of death (0.7% vs. 0.8%, p=0.8) or MI (0.8% vs. 1%; p=0.7). 

Although TCAR procedures were shorter (69 minutes, interquartile range 53–85 vs. 120 minutes, IQR 93–150, p<0.001) and postoperative length of stay was similar (two days, p=0.3) compared to CEA, TCAR patients were more likely to be discharged to a facility other than home (26% vs. 18.9%, p<0.01), Elmously will detail. He will also report that performing TCAR within 48 hours of a stroke was an independent predictor of postoperative stroke or TIA (odds ratio [OR] 5.4, 95% confidence interval [CI] 1.8–16). 

A numbers of the paper’s authors have previously been involved in published research on the topic of TCAR. Recently, co-author of the VAM paper Ambar Mehta, MD, a resident at New York Presbyterian-Columbia University Irving Medical Center, was lead author of the 2021 Journal of Vascular Surgery (JVS) paper “Transcarotid artery revascularization versus carotid endarterectomy and transfemoral stenting in octogenarians.” 

Bajakian, as well as co-authors of the VAM paper Priya B. Patel, MD, of NYP-Columbia University Medical Center in Fords, New Jersey, and Virendra I. Patel, chief of vascular surgery at NYP-Columbia University Medical Center, were also a part of the JVS paper study team. In this study, Mehta et al conclude that TCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and one-year rates of stroke/death. They suggest that TCAR “may serve as a promising, less invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.” 

They begin the paper by noting that transfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with CEA. 

However, they stress that TCAR may have similar outcomes to CEA. In the JVS study, therefore, the authors set out to compare outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. The researchers included all patients with carotid artery stenosis and no prior endarterectomy or stenting who underwent either a CEA, TFCAS, or TCAR in the VQI from September 2016 (when TCAR became commercially available) to December 2019. The team categorized patients into age decades: 60–69 years; 70–79 years; and 80–89 years. 

Writing in JVS, Mehta and colleagues report that they identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis, where one-half were symptomatic. They reveal that the overall rate of 30-day stroke/death was 1.5% and of one-year stroke/death was 4.4%. Octogenarians had the highest 30-day and one-year stroke/death rates relative to their peers, the authors communicated, at 2.3% and 6.3%, respectively. 

Mehta et al add that, among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death and slightly higher for one-year stroke/ death. Among octogenarians, however, they report that the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death and one-year stroke/death. Finally, they communicate that TFCAS related to CEAs had higher hazards of both 30-day stroke/death and one-year stroke/ death in octogenarians. 

Elmously will deliver the early TCAR outcomes presentation during the William J. von Liebig Forum (Hynes Convention Center, Ballroom A/B), from 8:23–8:34 a.m. 

‘Endovation’: Guidelines from the front lines

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‘Endovation’: Guidelines from the front lines
Sukgu M. Han

Among the highlights from the “‘Endovation’—Endovascular Innovation for Urgent and Emergency Complex Aortic Disorders” session coming up at the 2022 Vascular Annual Meeting (VAM) Wednesday, June 15, is a presentation by Sukgu M. Han, MD, from the Keck Medical Center at University of Southern California, Los Angeles—“Guidelines from the front lines: Can we develop best practices or standardization for endovascular alternative techniques, and when should we use alternative techniques?” 

“I will be reviewing our own aortic center experience at the Keck Medical Center of University of Southern California, serving as a regional aortic center accepting more than 250 urgent aortic transfers annually,” Han tells Vascular Specialist, offering VAM 2022 attendees a glimpse of what they can expect. 

“Among the acute aortic pathologies, I will focus on urgent and emergent thoracoabdominal, suprarenal aortic aneurysms (TAAA/SRAAA),” he notes, adding that the presentation will include a brief overview of results from the Keck Medical Center, as well as those reported in literature on various off-label complex endovascular aneurysm repair (EVAR) techniques, which he details will include parallel grafting, in-situ fenestration, and physician-modified endografting. 

Han continues: “Our own institutional algorithm for treatment of TAAA/SRAAA will be shared, while highlighting the fact that each individual algorithm may differ depending on access to technology, technical expertise, regulatory, and reimbursement challenges.” Finally, says Han, standardization in technique and clinical indication for these techniques is possible only when “we have robust data, which is currently lacking.” His presentation will end by summarizing some of the work currently ongoing for a multicenter, international PMEG registry. 

Elsewhere, the Endovation will feature a range of non-traditional surgical solutions in emergency situations during the non-traditional Endovation session at VAM (3–4:30 p.m. Wednesday, Room 210). Beyond lecture presentations, vascular trainees will discuss cases they submitted that used innovative surgical solutions, solving an aortic problem with endovascular means. 

The case discussion portion is called “Cases Under the Stars” and will occur in a reception-like setting and atmosphere with drinks included. Trainees have submitted case studies for possible use in the session. 

“This educational session aims to highlight options for treatment of complex aortic disorders using existing approved devices in innovative and creative ways,” said Jonathan Bath, MD, who is helping plan the Endovation line-up. 

“We hope that this session will provide an overview of current solutions in contemporary practice to bridge the gap for patients with a need for complex aortic treatment.” 

The focus will be on solutions that can be applied in urgent or emergency situations, he said, encompassing: 

  • Device modification (e.g., chimney, laser, back-table fenestration) 
  • A device used in a non-traditional manner, such as OCTO fen, an innovative solution utilizing standard infrarenal devices associated with fenestrated graft to repair a thoracoabdominal aneurysm 
  • Hybrid operations, such as a combination of an endovascular device with surgery, e.g., a bypass sewn to modified aortic device 

“Clearly for some patients in this era, an open operation may be neither tolerated nor warranted due to surgical risk,” said Bath. “Although there are an array of complex devices in clinical trials or within the auspices of an investigational device exemption, there are a limited number of physicians who have been granted access to these devices.” 

Most physicians who may encounter complex endovascular problems cannot rely upon these avenues, he said. In addition, patients in emergency or urgent situations may not be able to wait, or for whom access to a facility with such devices is simply not feasible. 

Grayson Pitcher, MD, and Sherene Shalhub, MD, will co-moderate this concurrent session. In addition to the case studies, presentations cover a broad array of complex aortic interventions. 

  • “Chimney, snorkel and other parallel graft techniques—patient selection, configuration and access are key to durability,” Ross Milner, MD 
  • In-situ laser fenestrated techniques for the visceral segment: Strategies for visceral perfusion, target cannulation and lessons learned,” Jonathan Bath, MD 
  • In-situ fenestrated techniques for the aortic arch: How to minimize cerebrovascular complications and ensure adequate seal,” Mathew D. Wooster, MD 
  • “Navigating regulatory and reimbursement pathways: Experiences from the PMEG and IDE landscape,” Sara L. Zettervall, MD 
  • “Failure modes of endovascular therapy for complex aortic disorders: When is enough enough,” Eanas S. Yassa, MD 

The Endovation session takes place from 3–4:30 p.m. in Hynes Convention Center Room 210.

New data support covered stent use in complex aortoiliac occlusive disease treatment

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New data support covered stent use in complex aortoiliac occlusive disease treatment
Koen Deloose

One-year outcomes from the BELSTREAM trial add to a growing pool of data that covered stents are safe and effective in the treatment of complex aortoiliac occlusive disease (AIOD).

At the Leipzig Interventional Course (LINC) 2022 in Leipzig, Germany (June 6–9), Koen Deloose, MD, a vascular surgeon at Sint Blasius Hospital in Dendermonde, Belgium, reported a primary patency rate of 94% and freedom from target lesion revascularization (TLR) rate of 95% using the Lifestream balloon-expandable vascular covered stent (BD) in complex lesions.

Deloose highlighted that it was in 2008 when a study by Robert W. Chang, MD, then of Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, et al first showed some advantage of covered stents over bare metal stents in the aortoiliac field. The study was published in the Journal of Vascular Surgery. He also referenced the randomized COBEST trial, in which covered stents performed better than bare metal stents in a subgroup of patients with complex TASC C and D lesions.

In order to further investigate the use of covered stents in AIOD, Deloose and colleagues initiated the BELSTREAM trial with the Lifestream stent. The presenter noted that this stent has been studied in the treatment of AIOD once before, in the BOLSTER trial, but only in relatively uncomplicated lesions. This BOLSTER was a prospective, multicenter, single-arm study that included 155 patients from 17 sites across the world. The researchers of this study reported a freedom from TLR rate of 87.6% at two years, according to Kaplan Meier analysis. “It is important to say that these were mainly TASC A and B lesions,” said Deloose, noting that the mean lesion length was 3cm and that there were occlusions in 21% of the cases.

Deloose informed the LINC audience that BELSTREAM is a prospective study being carried out in six Belgian centers. Seventy patients, with 133 lesions in total, have been enrolled. The primary efficacy endpoint is primary patency of the target lesions and one year without reintervention. The primary safety endpoint is freedom from procedure- or device-related events—such as major amputation and clinically-driven TLR—at 30 days.

The presenter was keen to stress the complexity of the patients included in the BELSTREAM trial, noting that 41.4% had total occlusions, all of which were TASC C (20%) and D (20%). He added that the aortic bifurcation kissing configuration was performed in 77% of cases—in “very calcified” lesions—and that pre-dilation was carried out in almost 40% of the cases.

Presenting 12-month data from the trial for the first time, Deloose reported at LINC that the primary patency rate at one year in this “difficult” TASC C and D patient and lesion cohort was 94.5%. He noted that this figure rose to 97.4% in a subanalysis of the kissing stent cohort, which included 77% of the total patient population.

In addition, the speaker revealed that freedom from TLR in the complete cohort was 95.3%, and that the corresponding figure in the kissing configuration group was almost 98%. “I would like to remind you that the freedom from TLR in the BOLSTER trial of TASC A and B lesions was 94.5%,” he said.

Deloose also conveyed the latest clinical outcomes from the trial, noting a sustained ankle-brachial index (ABI) progression and “very good evolution” in Rutherford categorization. Speaking finally on safety outcomes, he said that there were three clinically-driven TLRs and four deaths at 12 months, however none were device or procedure related.

“There is now more evidence that covered stents are performing better in complex AIOD treatment,” Deloose concluded. He summarized that the Lifestream covered stent has already been shown to be safe and effective in treating “easier” TASC A and B lesions in the BOLSTER trial, and that the latest results from BELSTREAM “confirm these findings in complex lesions.”

A show of hands after Deloose’s talk suggested the audience were convinced by the data, with a majority of delegates in attendance at the session voting that they would use a covered stent as a primary option in AIOD pathology.

The top 10 most popular Vascular Specialist stories in May 2022

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The top 10 most popular Vascular Specialist stories in May 2022

News on the Society for Vascular Surgery (SVS) ballots set to determine the next vice president and secretary, a hard-hitting column about vascular surgery’s role in treating vascular injury, and a look inside the most recent issue of Seminars in Vascular Surgery were among the most-read stories on the Vascular Specialist website during the month of May.

1. Voting for SVS vice president, secretary begins May 23

SVS Active and Senior members started voting May 23 for a new SVS vice president and secretary for 2022–23. Election results will be announced at the SVS Annual Business Meeting on June 18 during VAM in Boston.

2. A modest proposal: Let’s eat the trauma surgeons

Medical editor Malachi Sheahan III, MD, tackles the trauma surgeons’ reboot of a tired, ridiculous feud. “Vascular surgeons may not be the heroes the trauma surgeons want, but we are the ones they need,” he writes. “The only sane pathway forward is collaboration.”

3. War in Ukraine: A tale of unspeakable horror, unprecedented unity and unquenchable thirst for freedom

Andriy Nykonenko, MD, Maksym Karpusenko and Jean-Baptiste Ricco, MD, wrote this guest editorial in the days leading up to April 2. It was co-published with the European Journal of Vascular and Endovascular Surgery.

4. Cancer patients face greater risks from AAA repair

Elective abdominal aortic aneurysm (AAA) repair in patients with a cancer diagnosis is associated with several poor postoperative outcomes, according to a newly published study from researchers at the University of Missouri School of Medicine.

5. Collaborators not cases: Engaging patients with aortic dissections as partners in patient-centered outcomes research

The latest issue of Seminars in Vascular Surgery focuses on the work being carried out by the Aortic Dissection Collaborative. Guest editor Sherene Shalhub, MD, who founded the patient-centered organization, and the journal’s editor-in-chief, Caitlin Hicks, MD, tell Vascular Specialist about the importance of the publication—and why it represents a landmark in the field of aortic dissection treatment.

6. Supply & demand: [Private] practice matters

Vascular surgeons in private practice could play a crucial role in alleviating one of the existential problems currently vexing the specialty: The training of future generations of specialists and its intersection with declining numbers of open AAA repairs.

7. Less frequent post-EVAR surveillance might be safe in some patient groups, study suggests

Results from the multicenter, retrospective ODYSSEUS study carried out in The Netherlands suggest that less frequent surveillance after endovascular aneurysm repair (EVAR) may be warranted. However, authors Anna C. M. Geraedts, MD, of Amsterdam University Medical Centres, Amsterdam, The Netherlands, and colleagues stress that future studies are needed to determine the patient groups in which this would be safe.

8. From proposal to podium: Tips for getting your abstract accepted at academic conferences

“Striving for excellence in research is one of the defining characteristics of an academic surgeon,” writes Charles DeCarlo, MD, in our Corner Stitch column. “But simply doing great research is not enough. The dissemination of that research through academic forums, presentations and publications is just as critical because others need to share in that research, peer-review it, and, ultimately, implement your findings for the world to become a better place.”

9. SVS Foundation seeks applicants for VISTA projects

The SVS Foundation started to seek proposals in mid-April for pilot outreach projects to help identify needed vascular services in underserved portions of the U.S. 

10. FDA approves expanded indications for TCAR’s Enroute stent

The Food and Drug Administration (FDA) approved expanded indications for the Enroute stent system—part of the transcarotid artery revascularization (TCAR) procedure—to include patients at standard risk for adverse events from carotid endarterectomy (CEA), Silk Road Medical announced today. Previously, the stent was approved for use only in patients with anatomic or physiological criteria that put them at high risk of complications from more invasive surgical procedures.

Revascularization strategy for BTK intervention should hinge on diagnostic modality, LINC hears

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Revascularization strategy for BTK intervention should hinge on diagnostic modality, LINC hears
Michael Lichtenberg

New data provide “another argument” for the use of intravascular ultrasound (IVUS) in below-the-knee (BTK) interventions. This is according to Michael Lichtenberg, MD, from Arnsberg Vascular Center in Arnsberg, Germany, who presented one-year outcomes from the PRESTIGE pilot study at the 2022 Leipzig Interventional Course (LINC) June 6–9 in Leipzig, Germany.

This study was designed to investigate whether an IVUS-guided lesion preparation strategy with the Phoenix atherectomy system (Philips) before drug-coated balloon (DCB) angioplasty can improve outcomes in chronic limb-threatening ischemia (CLTI) patients. The results led Lichtenberg to conclude that the revascularization strategy for below-the-knee (BTK) intervention should be based on diagnostic modality to achieve optimal lumen gain.

How can enough and stable lumen be achieved? This is a central question in daily interventional practice, according to the presenter. In order to address this issue, Lichtenberg and colleagues initiated the core-lab adjudicated prospective, single-arm trial PRESTIGE pilot study, which is being carried out across five centers in Germany. The primary efficacy endpoint is patency at six months, and the primary safety endpoint is freedom from major adverse limb events and/or 30-day perioperative death.

A total of 50 patients have been enrolled in the study, Lichtenberg detailed. Due to the fact that this is a CLTI study, the presenter stressed that the patients presented with high risk profiles and significant comorbidities. “A lot of these patients had renal insufficiency, and a lot had diabetes,” he noted.

Lichtenberg pointed out that the challenging nature of the patients included in this study was also apparent in their clinical symptoms, highlighting that the majority (35/50) were Rutherford 5 and that the mean pre-procedure Wound, Ischemia, foot Infection (WIfI) score was 3.25. Additionally, of the 96 lesions treated in the registry, most were longer than 20cm.

Reporting 12-month results of the PRESTIGE pilot study in a first time data release presentation at LINC, Lichtenberg first revealed outcomes of the technical success analysis. The combination therapy of IVUS-guided lesion preparation followed by DCB angioplasty brought the diameter stenosis down from 93% to 26.02% based on angiography analysis, he relayed.

In addition, the presenter revealed that the overall survival rate was 85.9% after one year and that the major amputation-free survival rate was 100%. The figure for target-lesion-revascularization-free survival, he added, was 88.8% after one year.

In terms of the efficacy analysis, Lichtenberg conveyed that there was a “very good clinical outcome” in terms of the WIfI score, which came down from baseline to six months and stayed at a low level out to 12 months. In addition, the Rutherford scale showed a “clinically favorable outcome” for this combination therapy, he informed viewers.

A notable finding of the study, according to Lichtenberg, was that the baseline reference vessel diameter based on angiography was lower than that based on IVUS. “We significantly underestimate [vessel] diameter on angiography in patients with CLTI,” he informed LINC viewers, stressing that “there is a need to find an appropriate diagnostic modality for correct vessel sizing.”

SVS has patient resources and guidelines on strokes

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SVS has patient resources and guidelines on strokes

May was Stroke Awareness Month, and the Society for Vascular Surgery (SVS) and SVS Foundation offer educational resources for Society members to provide as a resource to their patients at risk of the potentially devastating disease no matter the time of year. 

The Society also has created clinical practice guidelines that evaluate the evidence in the scientific literature, assess the likely benefits and harms of a particular treatment, and enable healthcare providers to select the best care for a unique patient based on his or her preferences. SVS guidelines aid members and their patients in the decision-making process. Visit vascular.org/CPG to see the guidelines. 

Patient resources include detailed information about strokes, including symptoms, causes, diagnosis, treatments and prevention. In addition, SVS offers patient fliers on carotid artery disease, cholesterol, smoking and physical activity, all of which impact vascular health and disease. 

As members know all too well, smoking is a major cause of strokes and cardiovascular disease leading to strokes. Physical activity, likewise, helps prevent strokes and other vascular conditions and illness. 

Members can download patient education fliers from the patient-education portion of the SVS website at vascular.org, or via the members-only Branding Toolkit; those materials can be customized with a member’s name, practice and contact information. Any of the materials can then be available in members’ offices or mailed or emailed to at-risk patients. 

“We all know the numbers,” said SVS President Ali AbuRahma, MD. “We know that up to 5% of people older than 65 have carotid artery disease, which increases the risk of stroke, that cholesterol is a top factor when it comes to vascular disease, and that lifestyle changes such as quitting smoking and increasing physical activity are major preventive measures. 

“Help your patients by helping educate them,” he said. “You never know what piece of information might make the difference and turn things around.” 

The Branding Toolkit also includes condition fliers, including one on claudication, that can be customized and sent to referring physicians. 

Visit vascular.org/PatientFliers for the patient fliers, and vascular.org/BrandingToolkit for all other materials. 

A new pathway for preventing dementia?

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A new pathway for preventing dementia?
Craig Weinkauf
Craig Weinkauf, MD, is leading a trial looking into a connection between Alzheimer’s and carotid stenosis. ‘We want to try to quantify the brain: volumes, structural connectivity, functional connectivity and other relevant findings associated with neurodegeneration,’ he says.

Society for Vascular Surgery (SVS) member Weinkauf enrolled patient No. 1 just a few months ago in a National Institutes of Health (NIH) study to determine the impact of carotid disease on cognitive impairment and Alzheimer’s disease. 

Alzheimer’s affects an estimated 5.8 million Americans and is the fifth-leading cause of death among those 65 and older. It is the most common type of dementia. 

Carotid disease can be slowed or reduced though lifestyle management, medication and surgical intervention. Because it’s modifiable, finding a connection between carotid disease and Alzheimer’s could provide a new pathway for decreasing dementia risk, Weinkauf said.. 

He is leading the study, funded by a $4.9 million NIH grant, working with a host of other experts in neuroimaging, magnetic resonance imaging, vascular disease, Alzheimer’s disease and neurocognitive function. Weinkauf is an assistant professor in the Department of Surgery’s division of vascular and endovascular surgery at the University of Arizona College of Medicine. 

Carotid disease, in which vessels carrying blood to the brain become occluded, causes 10 to 20% of strokes. Weinkauf said that many physicians might not consider it a major problem if one or two of these blood-carrying vessels are occluded because the brain still has so much collateral blood flow. The point of the study, he said, is what if this thinking is wrong? 

“We’re looking into this question: does carotid disease infer specific risk for Alzheimer’s disease beyond that of baseline cardiovascular-risk factors?” Weinkauf said. “We’re looking beyond stroke, beyond general cardiovascular risk factors, at how blockages in the arteries that lead to your brain affect your brain health?” 

Researchers started in March and will continue over the next five years to recruit roughly 240 patients, primarily in Arizona. Then, with advanced imaging, neurocognitive testing, and other specialized tests the researchers will investigate which specific pathological changes specific to Alzheimer’s are associated with carotid disease; how (and if) carotid disease leads to those changes; and which treatments for carotid disease are effective at preventing or improving Alzheimer’s-associated neurodegeneration. 

The team will start by determining patients’ baseline cognitive function, and what constitutes a normal decline that comes with aging. 

This trial continues research from an earlier project in which Weinkauf and close collaborators tried to see if they could quantify cognitive function and changes in the brain. They quantified various aspects of cognition and brain structure, including brain volumes of the Hippocampus, the portion of the brain that supports memory—especially new memories, learning, navigation and space perception. It is also thought to perhaps play a role in Alzheimer’s disease. 

The brains in Alzheimer’s patients have a “quantifiably smaller” Hippocampus, said Weinkauf. “We found the same thing in patients with severe carotid stenosis (defined as >70% stenosis) compared to well matched controls with <50% carotid stenosis bilaterally. 

“It’s something you can quantify to see if something’s changing. The project started by asking these kinds of questions. 

“We want to try to quantify the brain: volumes, structural connectivity, functional connectivity and other relevant findings associated with neurodegeneration,” he continued. “We didn’t have these tools 20 years ago, or even five years ago in some cases, so even if someone had thought of this then they wouldn’t have necessarily had the tools to investigate. 

“We’re lucky to have surgical treatments for this problem,” he said. “We will also be able to follow that population to see if they have key structural and functional brain changes that improve with intervention.” 

Related questions are being asked in various ways by other groups as well, including the CREST-H (hemodynamics) part of the CREST-2 trial. “It is clear that these types of questions are in the air and hopefully as a field we will be able to improve care for our vascular patients by better understanding the connection between carotid artery stenosis and brain health.” 

Some carotid patients have told him that, following a procedure for carotid disease, their vision, hearing and thinking all improved, he said. “I think there’s more overlap between these two large patient populations, those with carotid and those at risk for Alzheimer’s than is currently appreciated. 

The research team hopes to be able to determine if baseline factors can identify those people at increased risk for Alzheimer’s and/or other forms of cognitive impairment and dementia. In a similar fashion they will be looking to determine which baseline factors may help define who benefits from intervention. “This strategy gets at a key deficit in how we currently approach carotid disease management: there is minimal patient selection for defining subpopulations of patients with carotid disease who may benefit most from treatment,” Weinkauf added.

“Risk-stratification of this population will be integral for honing/improving our vascular care and obtaining important objectives like personalization of carotid vascular care. We hope that our study can help us better understand brain health in our patients and define key, quantifiable markers that help guide our surgical care.” 

For more information or to learn about enrolling patients contact Weinkauf at [email protected]. 

Register today for two SVS courses

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Register today for two SVS courses

Registration has opened—along with early-bird pricing—for two Society for Vascular Surgery (SVS) in-person courses in coding and reimbursement, and peripheral artery disease (PAD) skills. Both will be held in October after being postponed in 2021 because of a surge in COVID-19 cases.

Both courses will be held in the OLC Education and Conference Center, in the SVS Headquarters Office, 9400 W. Higgins Road, Rosemont, Ill. The building is minutes from Chicago’s O’Hare International Airport. 

The SVS Coding and Reimbursement Workshop, with an optional workshop for evaluation and management (E&M) codes, will be held Oct. 1 and 2. 

This intensive course provides a comprehensive review of current coding and reimbursement information, including critical updates. It is one of the only vascular surgery-specific review courses in the country and is designed for vascular surgeons and office staff such as practice managers, physician assistants, nurses and nurse practitioners, surgery schedulers and coders. 

The optional E&M Coding Workshop will be from 8 a.m. to 12 p.m. Oct. 1. Registration for the main course opens at noon that same day, with the course set for 1 to 3:30 p.m. Oct. 1 and from 7:30 a.m. to 4:30 p.m. Oct. 2. Registration on the second day opens at 7 a.m. Learn more and see the preliminary agenda at vascular.org/Coding22. 

The two-day SVS Complex Peripheral Vascular Intervention (CPVI) Skills Course will be Oct. 23 and 24. Participants will learn from expert faculty through a combination of didactic and case-based presentations and practicing the latest procedures on cadavers and benchtop models during small-group simulations. 

“Treatment of patients with peripheral arterial disease (PAD), especially chronic limb-threatening ischemia (CLTI), remains the one of the largest clinical areas for vascular surgeons in the U.S.,” said course co-director Vikram Kashyap, MD. “Thus, surgeons should be familiar with the latest treatments and technology so they can provide the best patient care possible,” he said. “We have tremendous innovations in treating occlusive disease,” he said. “SVS members have asked for this type of course to keep up to date with their endovascular skills.” 

The course also will include a demonstration of a percutaneous deep vein arterialization system. The procedure is designed to restore blood flow to the ischemic foot, when all other options have been exhausted, in so-called no-option patients. Course hours are 9 a.m.–4:45 p.m. Oct. 23 and 7:30 a.m.–4 p.m. Oct. 24. Learn more, including viewing the agenda, at vascular.org/PeripheralIntervention22.

Urban or rural: Ensuring access to quality vascular care ‘no matter what’

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Urban or rural: Ensuring access to quality vascular care ‘no matter what’
Michael Dalsing, MD, talks to Vascular Specialist about how his formative years growing up in rural Wisconsin, as well as experience of operating in inner-city Indianapolis, helped inform the topic he chose for this year’s Crawford Critical Issues Forum set to take place at Vascular Annual Meeting (VAM) in Boston: “Quality Vascular Care for All—An Aspirational Goal of Merit.” 

Even among many medical colleagues, the common misconception seems to go a little like this, says Michael Dalsing, MD, the Society for Vascular Surgery (SVS) president-elect: vascular surgeons may not have a lot of interest in preventing vascular disease before serious issues arise or, they’re “just focused on procedures.” Rather, says Dalsing, access to complete quality vascular care is a topic “all of us are interested in. I think it’s a universal mission, or goal, of every vascular surgeon. We want to make sure that everybody with vascular disorders is taken care of well, in the right time, in the right place, and by the right people.” 

“We’re concerned about the full spectrum of the disease. Certainly, if we could stop the disease early and have people not have issues, that would be great. If patients get to the point where something has to be done, then we have options for them.” 

That ability to reach people early forms a large part of the impetus behind why Dalsing selected matters concerning access to vascular care across the great hulking mass of the U.S.—urban and rural, insured and uninsured—for this year’s E. Stanley Crawford Critical Issues Forum, which takes place Wednesday, June 15, from 10:45 a.m.–12:15 p.m. at VAM 2022 (Hynes Convention Center, Ballroom A/B).

But the selection also drew inspiration from the incoming SVS president’s personal story. Dalsing grew up in rural Wisconsin and saw how remote communities could struggle for access to the expertise of a vascular surgeon, watching, for instance, how uncles who developed abdominal aortic aneurysms (AAAs) had to travel some distance to large cities in order to access appropriate treatment. His professional career, too, was instructive. The Indiana University School of Medicine professor emeritus has helped lead outreach efforts in inner-city Indianapolis and out into rural Indiana. 

Speakers will tackle such topics as the vascular surgery workforce shortages, as predicted over the next 20 years (Michael Go, MD, associate professor of surgery in the division of vascular diseases and surgery at The Ohio State University in Columbus, Ohio); how insurance affects access to quality vascular care (Mohammad Eslami, MD, chief of vascular surgery at the University of Pittsburgh Medical Center [UPMC] Mercy in Pittsburgh); the problems associated with access in rural communities (Samantha Minc, MD, assistant professor of vascular surgery at West Virginia University in Morgantown, West Virginia); so-called “urban vascular care deserts” (Andrew Gonzalez, MD, assistant professor of vascular surgery at Indiana University School of Medicine); the potential role of vascular population health initiatives on quality care for all (Leila Mureebe, MD, professor of vascular surgery at Duke University in Durham, North Carolina); and how diversity and inclusion impact the kind of care patients receive (Vincent Rowe, MD, chief of the vascular surgery service at the University of Southern California in Los Angeles).

Talks will be limited to seven minutes each to allow a maximum amount of time for discussion. 

“The way I chose the speakers was based on either leadership roles in the SVS that dovetailed with the topic, or they may have published on something that I thought would bring a different perspective to the discussion,” explains Dalsing. 

The final presentation is being given by Jens Eldrup-Jorgensen, MD, leader of the SVS Foundation Vascular Volunteers In Service To All (VISTA) program, an early-stage select series of pilot projects aimed at enhancing vascular healthcare in underserved communities—rural and urban—or areas of need, such as among African Americans, Hispanics, Native Americans and others who lack access due to low socioeconomic status. “VISTA looks at ways to address some of these shortages, it looks beyond what we are observing in the community and into potential solutions,” says Dalsing. In some cases, areas identified for improvement might simply rest on education, he continues. “How do people know they have a vascular issue? Some have no idea. They don’t know that the infection on their toe is due to the fact they don’t have enough blood supply.” 

Or it might involve providing local providers with a go-to vascular surgeon to ask how best to take care of patients they think may have vascular problems, Dalsing says. “I think these early pilot projects might give us a real good idea about how we might extrapolate programs into bigger populations, or other areas, or also what is most important to provide up front, and then how you work from there.” 

The SVS has undertaken considerable work in trying to get in front of U.S. legislators in an effort to create a level playing field for access to vascular care, adds Dalsing. Which gets back to the heart of his forum topic. “You shouldn’t have to come to Indianapolis to make sure you’re going to be OK if you have a vascular problem,” he says. “You should be able to get care that is appropriate no matter what.” 

SVS PA Section has new leaders

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SVS PA Section has new leaders
Holly Grunebach

With previous terms ending, new members have been named to the steering committee for the SVS Physician Assistant Membership Section (PA Section). 

Holly Grunebach, PA-C, MSPH, chairs the committee. Other members are Jessica Fernandes, Katherine Ann Kinser, Stephen Robischon, Robert Skasko Jr. and Connor Westfall, all PA-C; and Danielle Scribani, O, PA.

The PA Section is the Society for Vascular Surgery’s oldest membership section, having been added in 2017. It provides a “professional home” to PAs working in vascular care and now has approximately 200 members.

For information on the PA section visit vascular.org/JoinSVS/PASection. 

SVS online community adds quality improvement group

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SVS online community adds quality improvement group
Jessica Simons

The SVS Quality Improvement Committee has created a community on the subject matter on SVSConnect. This will be a forum for QI education and discussion. 

The committee invites SVS members to join, then post their questions, challenges and successes. These will be reviewed and responded to by committee members. 

Those interested should search for “Quality Improvement Community” on the main SVSConnect page and request to join the community. 

“We hope to have a lively forum for sharing challenges and successes in quality improvement,” said Jessica Simons, MD, committee chair. “We welcome your input regarding the issues you’re facing.”

Visit the SVSConnect homepage at svsconnect.vascular.org. 

Research indicates low stroke risk and benefit of medication alone in asymptomatic carotid stenosis

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Research indicates low stroke risk and benefit of medication alone in asymptomatic carotid stenosis
Robert Chang

The risk of having a future stroke caused by asymptomatic carotid stenosis is “so low” that most patients with this condition could potentially be treated with the newest medications and may not require surgery. That is according to new research from Kaiser Permanente.

“The question of how to best treat patients with narrowing of the carotid artery without symptoms has been a longstanding research priority,” said Robert Chang, MD, the assistant chair of vascular surgery for the Permanente Medical Group in Oakland, California. “We decided to take a step back and begin our study by asking how likely it is that these patients will actually have a stroke related to their severe stenosis. Our analyses showed that this risk is so low that it appears that, for most patients, surgery may not be necessary.”

The study, published in May in The Journal of the American Medical Association (JAMA), is believed to be the largest and most current assessment of long-term stroke risk in this population, according to Kaiser Permanente.

Carotid stenosis occurs when plaque builds up in one or both of the large arteries on either side of the neck that carry blood to the brain, face, and head. This narrowing in the artery is typically diagnosed after a patient has experienced symptoms of a stroke, but it can also be found during a routine physical examination.

Randomized clinical trials conducted prior to 2010 concluded that surgery to remove the blockage was the best option for reducing stroke risk in patients with severe stenosis. But, as medical treatments for reducing stroke risk have improved, physicians have begun to wonder whether surgery should remain the preferred treatment for asymptomatic patients, a Kaiser Permanente press release states.

To answer that question, Chang and his colleagues identified 3,737 Kaiser Permanente members in Northern California who had been diagnosed with severe asymptomatic carotid stenosis (70–99% blockage) between 2008 and 2012. None of these patients had previously had surgery.

The research team first looked to see how the stenosis had been treated. Reviewing the patients’ medical records showed that 1,423 patients had had surgery to treat the stenosis, and 2,314 had not. The team also tracked which patients were taking a statin to help lower cholesterol in the blood or medication to reduce high blood pressure. Next, the team looked to see how many patients had a carotid-related stroke on the same side as the severe carotid stenosis. They followed the patients through 2019.

Overall, 133 strokes were diagnosed in 129 patients during the follow-up period. Statistical analyses showed that the patients who did not have surgery had a 4.7% cumulative risk of having a stroke within five years of their carotid stenosis diagnosis.

The study’s senior author, Mai Nguyen-Huynh, MD, from the Permanente Medical Group in Oakland, California, said the findings did not surprise her. “We suspected that we may find a low risk of stroke in these patients because there are now better stroke-prevention treatments, including medications to control blood pressure, prevent blood clots, and reduce cholesterol, than when the original randomized trials were done,” she said. “I think our study will make many patients and their doctors think twice about surgery if they can instead be on an effective aggressive medical management program to lower their stroke risk from asymptomatic carotid disease.”

Chang and Nguyen-Huynh also currently lead a team at the Kaiser Permanente division of research affiliated with the national, randomized clinical trial, CREST-2, that is enrolling patients in a study comparing surgery or stenting to medical management in patients with asymptomatic severe carotid stenosis. “This head-to-head comparison of carotid surgery versus medical management in a clinical trial is what we need to help us determine the appropriate approach,” Nguyen-Huynh added.

75 facts in 75 days to celebrate 75 years

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75 facts in 75 days to celebrate 75 years
Alton Ochsner

Alton Ochsner, MD, was the first president of the Society for Vascular Surgery (SVS), which was formed in 1946. The first annual meeting—a half-day affair—was held in Atlantic City, New Jersey, June 8, 1947. Julie Ann Freischlag, MD, was the first woman president (and to date the only one). And the first 10 people to serve as SVS president were all among the 31 charter/founding members. 

During the 2022 Vascular Annual Meeting (VAM) in June, the SVS will officially end a year-long celebration of its 75th anniversary. To help mark the occasion, the SVS is publishing 75 Facts in 75 Days. 

The short facts have been running daily since April 5, 75 days out from VAM’s close on June 18 (weekend posts appear the following Monday). 

“This is the brainchild of the Communication Committee’s Social Media Chair Dr. Meryl Logan,” said Communications Committee chair Amy Reed, MD.  “As chair, I encouraged the rest of the committee to brainstorm thoughts and ideas. It was fun to hear all the interesting tidbits the committee members gave!” 

That’s when Logan developed the idea for 75 facts. 

“We were all thinking about creative ways to celebrate the upcoming 75th VAM, and the idea of a ‘75-day countdown’ came to me as a fun way to not only celebrate this anniversary, but also promote the meeting,” said Logan. “We’ve been posting these little tidbits to social media and they include not only VAM history, but also SVS and vascular surgery historical facts and firsts. I think it’s been an engaging and entertaining social media endeavor.” 

Expanded Medicare coverage for TCAR in standard surgical risk patients announced

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Expanded Medicare coverage for TCAR  in standard surgical risk patients announced

Silk Road Medical today announced that the Centers for Medicare and Medicaid Services (CMS), through collaboration with the Society of Vascular Surgery’s Patient Safety Organization (SVS PSO) and their Vascular Quality Initiative (VQI), has expanded coverage for TCAR to include standard surgical risk patients within the SVS VQI TransCarotid Revascularization Surveillance Project.

This decision is effective immediately and comes on the heels of the recent Food and Drug Administration (FDA) approval for expanded indications for the Enroute stent system to include patients at high risk and standard risk for adverse events from carotid endarterectomy (CEA), the company explained in a press release.

The TCAR surveillance project is a prospective, national, open-ended observational registry designed to monitor the safety and effectiveness of transcarotid stents placed directly into the carotid artery while reversing blood flow to reduce stroke risk. Reimbursement for TCAR within the project will now apply to Medicare beneficiaries who are deemed to be at high and standard surgical risk for adverse events from CEA, Silk Road added.

Silent coronary ischemia: FFRCT reduces cardiac death, myocardial infarction in carotid endarterectomy patients out to three years, study finds

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Silent coronary ischemia: FFRCT reduces cardiac death, myocardial infarction in carotid endarterectomy patients out to three years, study finds
Christopher Zarins

Diagnosis of silent, or unsuspected, coronary ischemia in patients undergoing carotid endarterectomy (CEA) using fractional flow reserve-computed tomography (FFRCT), with selective postoperative coronary revascularization, significantly reduced cardiovascular death, cardiac death and myocardial infarction through three years of follow-up when compared to CEA patients receiving standard cardiac evaluation, researchers will report at the 2022 Vascular Annual Meeting (VAM) on Wednesday, June 15. 

First-named author Dainis Krievins, MD, a vascular surgeon at Stradins University Hospital in Riga, Latvia, will present results revealing that among a group of 100 patients who received FFRCT, researchers recorded extensive coronary calcification, with more than 50% stenosis in 46% of them. 

“FFRCT analysis revealed silent coronary ischemia in 57% of patients, with left main in 7% and multivessel ischemia in 28%. Severe coronary ischemia was present in 44% of patients,” he will tell VAM 2022 during Plenary Session 2 (9:45–9:56 a.m.; Ballroom A/B). 

The research compared the 100 elective CEA patients receiving FFRCT—enrolled in a prospective institutional review board (IRB) study—to 100 concurrent matched controls who underwent standard pre-operative cardiac evaluation and no post-op coronary revascularization. In the first group, lesion-specific coronary ischemia was defined as FFRCT ≤0.80, with FFRCT ≤0.75 indicating severe ischemia, the research team will explain. The status of coronary ischemia was unknown in group two. 

After CEA, group one patients with silent ischemia were selected for coronary angiography one to three months post-surgery, with elective coronary revascularization carried out in 33, Krievins and colleagues will show. Group two patients had no coronary revascularization. 

At three years, the rates of myocardial infarction, cardiac death and cardiovascular death were significantly lower in group one compared to group two (p<0.05), with no significant differences in stroke or all-cause death, they will reveal. The researchers cite the need for prospective, controlled studies “to further evaluate the role of FFRCT-guided coronary revascularization in CEA patients.” 

Christopher Zarins, MD, senior author of the study and founder of HeartFlow, the company behind the FFRCT analysis used, told Vascular Specialist that the CEA patient study builds on the research group’s study of FFRCT use in critical limb ischemia patients.

“The guideline-directed current standard of care for CEA patients is that if you do not have any cardiac symptoms or history, then you just go ahead and have your CEA, and afterwards you get treated with best medical therapy,” he said. “Everybody thinks and assumes that the way you treat cardiac risk is with medical therapy. In fact, medical therapy doesn’t really work if you’ve got left main disease, you have proximal LAD [left anterior descending] disease or severe coronary ischemia—you need to get your coronaries revascularized,” he added.

The ABS-VSB: Extolling the virtues of vascular surgery’s independent board

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The ABS-VSB: Extolling the virtues of vascular surgery’s independent board
Thomas Huber

The evolutionary process by which vascular surgery became a bona fide independent discipline has much to thank the American Board of Vascular Surgery (ABVS), but the specialty’s certification interests are now fully met by the American Board of Surgery Vascular Surgery Board (ABS-VSB), the annual meeting of the Florida Vascular Society (April 28–May 1) heard.

The message came during the gathering’s Presidential Address, entitled “The Vascular Surgery Board of the American Board of Surgery: Our independent board,” delivered by Thomas Huber, MD, also the current chairman of the ABS-VSB.

Huber took attendees on a history tour of the vascular surgical specialty’s development through the prism of evolving qualification and certification requirements; the evolution of the VSB inside the ABS into the status it occupies today; and the emergence of the ABVS in 1996 as it sought a fully separate board for vascular surgery. 

The purpose of the talk, Huber told Vascular Specialist in an interview shortly after his address, was to place the ABS-VSB in historical context and to elucidate its independent role in the certification of vascular surgeons. 

“Vascular surgery as a discipline really has evolved since the mid-1950s, and perhaps more so since the mid-70s,” he explains. “By the early-80s, it had come to the point where it was perceived, at least by the providers, as a separate discipline. The American Board of Surgery recognized that with additional qualifications in vascular surgery that morphed into added qualifications. The discipline continued to evolve into the 80s and the 90s.” 

By the mid-90s, a feeling had developed among the vascular surgery leadership of the time that their profession had evolved into “a truly separate discipline,” and that the ABS “was no longer meeting our needs,” Huber continues.

It was a divisive time for many, he says. But by 2006, a primary certificate for vascular surgery had emerged under the then sub-board VSB: “Despite the controversy and concerns, we were morphing in the right direction,” Huber says.

Meanwhile, the discipline itself was undergoing its “most dramatic change on top of all that” with the development of endovascular therapies, through the 90s and into the 2000s. “It was disruptive technology for vascular care so that the only people doing vascular surgery now in 2022 are truly vascular surgeons,” he adds.

At this juncture, Huber says the ABS-VSB has met vascular surgery’s needs for board certification, its primary responsibility. There are, of course, ongoing matters concerning the likes of predicted workforce shortages, appropriateness of care, and the training volume of open repairs, but the core purpose of the VSB is to certify candidates or maintain certification for practicing candidates, he points out.

In that vein, a “Blueprint” redesign is currently underway in order to eventually update what the VSB defines as “vascular surgery” in the wake of the discipline’s evolution.

The overarching message, Huber underscores, is that vascular surgery has evolved into a separate, independent discipline, “partly as a result of the leadership and effort of the ABVS,” he says. 

“For most vascular surgeons,” Huber reiterates, the issue of a separate board  has “come and gone,” adding: “My message is to be conciliatory: For the people who have brought this forward, all their goals, desires and wants have been met. We have moved on in a very positive light.” 

Vascular Specialist–May/June 2022

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Vascular Specialist–May/June 2022

In this re-launch issue:

A modest proposal: Let’s eat the trauma surgeons

A modest proposal: Let’s eat the trauma surgeons
Malachi Sheahan III

Well folks, after more than two years of the pandemic, racial injustice, and medical misinformation, I have decided it is time to return to writing about what I truly love: fake feuds with other specialties. Remember the heady days of 2019 when surgeons took on the Association of periOperative Registered Nurses (AORN) in the Bouffant War? All it took was a global plague and international shortages of personal protective equipment (PPE) to prove that AORN’s 47 evidence-free recommendations for surgical attire might not be addressing the most pressing needs in modern medicine. Today, we are free to put on our skullcaps and bask in our victory, earlobes and napes of our necks exposed like the day our mamas made us.  

Now we are being pulled into a new, ridiculous feud. I think the millennials would describe it like this:

No one:

Absolutely no one:

Trauma surgeons: Hey, I don’t think we need vascular surgeons anymore!

The first salvo came in 2020 with the Annals of Surgery perspective article “Beyond the crossroads­: Who will be the caretakers of vascular injury management?” The authors of this piece made several salient points detailing the lack of adequate training in vascular injuries for trauma and acute care surgeons. Our esteemed profession, however, endured several cheap shots in the process. “As vascular practitioners become more focused on elective endovascular procedures, they often develop ‘lesion vision,’ similar to ‘tunnel vision,’ focusing on obtaining gratifying before/after images, whereas failing to use the patient’s other injuries or physiology in the decision making of how the vascular injury should be managed.”

Lesion vision? That’s not even catchy. I mean come on, “stenosis psychosis” is right there. Besides, who has lesion vision? Vascular surgeons, or the people calling us at 4 a.m. because they think they see a 5mm blush near the superficial femoral artery on an 18-year-old with palpable pulses?

Elsewhere in the article, the authors declare without evidence that “Patients with injuries that may be best treated by open surgery receive endovascular care because that is what the local vascular surgeon knows.” Other random grievances are aired. Vascular surgeons are apparently so afflicted with Lesion VisionTM that we fail “to fully prepare and drape the trunk and extremities to allow for rapid default for open proximal control or a later fasciotomy…” A remarkably specious accusation to cast at a specialty who routinely prep their endovascular aneurysm repairs (EVARs) from nipples to groins despite last performing an open conversion before the iPad was invented. 

I was fortunate to contribute to the response to this article organized by Drs. Brigitte Smith and Erica Mitchell. The resulting perspective was thoughtful and measured (despite my best efforts). The answer, we maintained, was collaboration between vascular surgeons and trauma surgeons. 

It certainly says something about our commitment to patients that we are so willing to battle over the management of vascular trauma. These cases live in that godless patch of night starting around 3 a.m., where you leave the comfort of your bed with the terrible knowledge that your day has now begun, and an Odyssean journey separates your return. Masochistically, I run the dispiriting math on the way to the hospital. Let’s see, I can finish this trauma by 7, get to my clinic at 8, grab a fast lunch, make war with the Trojans, three quick cath lab cases, then sail home to Penelope. Hopefully, there won’t be traffic on the Aegean. 

The back and forth in Annals of Surgery should have been the end of it, but, ladies and gentlemen, I regret to inform you that the trauma surgeons are back on their bullstuff. In the recently published study “Trauma surgeon-performed peripheral arterial repairs are associated with equivalent outcomes when compared with vascular surgeons,” the trauma surgeons from the Medical College of Wisconsin purport that their brachial and femoral artery repairs had the same short-term outcomes as those performed by their institution’s vascular surgeons. In an unfortunate blow to the scientific validity of this conclusion, the femoral injuries treated by the vascular surgeons were significantly more complex and more likely to be associated with other operative injuries. The brachial injuries treated by the vascular surgeons had a higher rate of gunshot mechanism, complete transection, and associated non-vascular injuries requiring surgery, although these factors did not achieve significance, likely due to the small sample size. The authors also cited a faster transition time to the operating room (OR) for the trauma surgeons, which they postulated may be due to the vascular surgeons ordering more imaging studies. 

While it is certainly possible that the generally more complicated cases being managed by vascular surgeons required a longer workup, a simpler explanation lies in the laws of physics. It is probably quicker to get to the OR from the emergency room than it is from your bed at home. 

Based on their data, the authors concluded they had “no difference in short-term clinical outcomes” compared to the work performed by their vascular surgeons. While that is one way to interpret the numbers, isn’t it also true that the vascular surgeons repaired more complex injuries with more associated orthopedic injuries without an increase in reinterventions, complications or mortality? 

I spoke with Dr. Peter Rossi, chief of vascular surgery at the Medical College of Wisconsin, regarding this paper from his trauma colleagues. He expressed disappointment and noted that “what should have been an opportunity for learning and collaboration” was instead conducted without their input. 

Accompanying this paper in the Journal of Trauma and Acute Care Surgery is a commentary written by Dr. Thomas Scalea, one of the co-authors of the original “Beyond the crossroads” piece. Titled “Caring for vascular injuries: Training more vascular surgeons may not be the answer,” the article provides no evidence to support its provocative title but does give Dr. Scalea a chance to roll out his Lesion VisionTM zinger once again. Dr. Scalea also provides anecdotal evidence of young trauma patients being treated in the community with stents, which he has had to subsequently remove. He also bemoans the lack of data supporting the increase in endovascular interventions. This is decidedly misleading. An analysis of matched patients in the National Trauma Data Bank found that those undergoing endovascular repair had nearly half the in-hospital mortality compared with the open surgery cohort. 

Some of the greatest advances in trauma care this century have been led by endovascular innovations. The benefits of stent grafting in aortic repair are obvious, but it also improves outcomes in other locations, such as axillosubclavian injuries where “…the morbidity of the operation is much less given that large complex incisions do not need to be made, there is much lower blood loss, and less operative time is needed.” Of course, there is no need to remind Dr. Scalea of these facts as I pulled the quote directly from his recent article, “Endovascular management of axillosubclavian artery injuries.”

Finally, Dr. Scalea notes, “The decisions, when to do definitive repair versus damage control and how to order the repair of vascular injuries in patients with multisystem trauma must remain the purview of the injury specialists, that is, the trauma surgeon.” Here we agree. Too often I have arrived at the hospital to find a patient with concomitant vascular and orthopedic injuries left in the ER for the respective specialists to battle it out. Early in my career, I was quick to repair these vessels only to find my bypass perplexingly thrombosed after the ensuing ortho procedure. After taking the time to actually witness an open reduction and internal fixation, let’s just say I am no longer perplexed!

While trauma surgeons may bemoan the ceding of vascular injury expertise to us, they have made little effort to correct the current status quo. Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowships in surgical critical care require no case minimums and can be essentially non-operative. The Acute Care Fellowship sponsored by the American Association for the Surgery of Trauma (AAST) mandates the management of only 10 vascular injuries: certainly not a pathway to competence. In 2021, general surgery graduates reported an average of 2.8 vascular trauma procedures over their five years of training—including 1.3 fasciotomies. Even experience does not automatically translate to aptitude and proficiency. Competence must be acquired from the competent. 

Vascular surgeons may not be the heroes the trauma surgeons want, but we are the ones they need. The only sane pathway forward is collaboration. Recognition of the importance of the vascular surgeons to a trauma center is key, and the trauma surgeons need to support our efforts here.

In the United States, trauma centers are designated by regional governments and most rely on the standards set by the American College of Surgeons (ACS). The trauma center verification program was approved by the ACS Board of Regents in 1986, and the first Level I trauma center was verified in 1987. The most recent standards were published in March of this year in the Resources for Optimal Care of the Injured Patient manual. 

There is often confusion regarding the prerequisites for vascular surgery coverage in trauma centers. The ACS manual is partly to blame. On page 45, “Specialty Liaisons to the Trauma Service” are listed. Here orthopedics and neurosurgery are required but vascular is not mentioned. Flip to page 61, however, and expertise in vascular surgery is mandatory with continuous 24-7, 365-day availability for all Level I and Level II adult and pediatric trauma centers. This is a Type I standard, meaning verification is automatically withheld if it is not met. 

I know for a fact there are many trauma centers in the U.S. without continuous vascular coverage. Perhaps there is a perceived loophole in the “expertise” designation? The ACS guidelines require physicians with board certification or eligibility in general surgery, neurosurgery, orthopedic surgery, anesthesia, emergency medicine, and radiology, but it is not specified for vascular surgery. We need the ACS to hold those claiming vascular surgery “expertise” to the same standards. Stricter enforcement by the ACS will incentivize institutions to offer equitable call pay to vascular surgeons, as they do for our orthopedic and neurosurgery colleagues. 

The modern care of vascular injuries requires training and proficiency in both open surgical and endovascular techniques. In the U.S., completion of an ACGME-certified vascular training program, and subsequent Vascular Surgery Board (VSB) certification, is the sole pathway designed and proven to ensure these competencies. 

The “expertise” loophole is arbitrary, disingenuous, and a danger to the public. To safeguard the care of vascular trauma patients, we need to continue to grow the vascular surgeon workforce and take the steps needed to ensure their proper valuation by trauma centers. 

Disclaimer: All politics are local. At our Level I Trauma Center, University Medical Center New Orleans, I work with some of the finest trauma surgeons in the world. Vascular injuries can be extremely difficult to treat but we achieve excellent results through collaboration.

Malachi Sheahan III, MD, is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans. He is medical editor of Vascular Specialist.

SVS Foundation continues call for VISTA project applicants

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SVS Foundation continues call for VISTA project applicants
Jens Eldrup-Jorgensen chairs the VISTA steering committee

The SVS Foundation VISTA (Vascular Volunteers In Service To All) pilot project continues to seek applications for innovative, community-based projects.

The initiative grants support for those projects designed to explore solutions to the significant disparities in vascular surgical care across the U.S.

Up to $150,000 will be awarded to SVS members, with priority given to projects that provide outreach, screening, and other resources to patients impacted by lack of access, inadequate resources, or distance from modern health care facilities. Visit vascular.org/VISTA.

Projects should help identify improved pathways to treatment, optimizing or expanding use of existing local providers. The Foundation wants proposals that emphasize providing evidence-based management of vascular disease, not the promotion of specific products, devices or medications. The expected timeline would be two to three years. Ideal proposals would include: 

  • A concise impact statement delineating a realistic potential benefit to the target community 
  • Metrics for success and specific deliverables 
  • Plans for ongoing communication and either virtual or physical support for the target community 
  • Follow-up plans and information on potential scalability of the project consistent with planned future phases of the VISTA Program

FDA grants IDE approval for Selution SLR drug-eluting balloon

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FDA grants IDE approval for Selution SLR drug-eluting balloon
Selution SLR
MedAlliance SELUTION SLR
Selution SLR

MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the Food and Drug Administration, making it the first limus DEB to be available to U.S. patients, the company announced in a press release.

The Selution SLR (sustained limus release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). The device was granted breakthrough device designation by the FDA in March 2019 and further in September 2019 for below-the-knee (BTK) indications in peripheral artery disease.

“This is a major milestone for MedAlliance,” the company states in its press release. MedAlliance has announced it will begin enrollment in the below-the-knee (BTK) IDE randomized clinical trial (RCT), SELUTION4BTK, immediately outside of the U.S. and early this summer in U.S. centers. Principal investigators of the study are Ehrin Armstrong, MD, from Adventist Heart and Vascular Institute, St Helena, California; Marianne Brodmann, MD, from Medical University of Graz, Austria; and Tjun Tang, MD, from Singapore General Hospital, Singapore.

Selution SLR was awarded CE mark approval for the treatment of peripheral artery disease in February 2020. The device has shown early promising clinical results in treatment of patients with chronic limb threating ischemia (CLTI) and below-the-knee artery disease.

In the PRESTIGE study, which was presented as a late breaking trial at VIVA 2021 (Oct. 5–7) in Las Vegas by Tang, use of Selution SLR in complex BTK lesions resulted in sustained safety and efficacy outcomes out to 18 months. An additional 75 patients with BTK disease and Selution SLR treatment have been studied in the PRISTINE registry and the results are scheduled to be presented at LINC 2022 (June 6–9, Leipzig, Germany).

Based on the early data following the use of Selution SLR in treatment of BTK disease, MedAlliance has moved forward with the design of the SELUTION4BTK RCT to further investigate the safety and efficacy of this device and prepare for FDA approval.

Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained limus release (SLR) of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures.

MedAlliance’s proprietary CAT (cell adherent technology) enables the MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon. Selution SLR is available in Europe and all other countries where the CE mark is recognised.

Medtronic gains FDA nod for IN.PACT 018 DCB

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Medtronic gains FDA nod for IN.PACT 018 DCB
IN.PACT 018 paclitaxel-coated PTA balloon catheter
IN.PACT 018 paclitaxel-coated PTA balloon catheter

Medtronic has announced approval from the Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.

“The IN.PACT 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” said Prakash Krishnan, MD, from the Icahn School of Medicine at Mount Sinai, New York, who also serves on a scientific advisory board for Medtronic. “The available long-term data [from the IN.PACT Admiral studies] on its benefits gives physicians another effective treatment for PAD in complex anatomies.”

The IN.PACT 018 DCB uses the same drug coating formulation and is built upon equivalent technology to the IN.PACT Admiral DCB, which is compatible with 0.035” guidewires. The IN.PACT 018 DCB is indicated for PTA of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4‒7 mm. It is engineered to cross tight lesions, provide better deliverability and is compatible with 0.018″ guidewires, Medtronic states in a press release.

The IN.PACT 018 DCB will be the only commercially available DCB with a 200cm over-the-wire (OTW) catheter length, providing physicians the option to treat via femoral or radial access. This is in addition to the to the 130 cm OTW catheter length.

Register for August Vascular Surgery Board review course

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Register for August Vascular Surgery Board review course

Get ready for the American Board of Surgery Vascular Surgery Board (ABS-VSB) Qualifying Exam in September by attending a comprehensive review course in August. 

The University of California, Los Angeles, and the Society for Vascular Surgery (SVS) collaborate on the “UCLA/SVS Symposium: A Comprehensive Review and Update of What’s New in Vascular and Endovascular Surgery.” The seventh annual course will be Aug. 25 to 28 at the Beverly Hilton, in Beverly Hills, California. 

The course emphasizes four major pillars of vascular surgery practice: open, endovascular, medical and imaging. Learn more at vascular.org/ReviewSymposium22.

ESVS publishes 2023 guidelines on management of atherosclerotic carotid and vertebral artery disease

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ESVS publishes 2023 guidelines on management of atherosclerotic carotid and vertebral artery disease

The European Society for Vascular Surgery (ESVS) has just released 2023 clinical practice guidelines on the management of atherosclerotic carotid and vertebral artery disease. The guideline document, authored by chairperson Ross Naylor, MBChB, from Leicester Vascular Institute, Leicester, England, co-chairperson Barbara Rantner, MD, from Ludwig Maximilian University of Munich, Munich, Germany, et al, was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

The document contains 133 recommendations, including 38 that are new and 11 that have been “regraded” since 2017, which is when the last ESVS guidelines on this topic were published. The manuscript contains 629 references, 289 of which are new (i.e. published between 2017 and 2022). Thirty-nine of the references are from randomized controlled trials, 71 are systematic reviews and/or meta-analyses, and the references also include data from 50 vascular registries or quality initiative programs.

In the document, the authors first address what is new in the 2023 guidelines. They write that each section has been revised or rewritten and that five new sections have been added:

  • Management of free floating thrombus
  • Management of carotid webs
  • Management of symptomatic patients with an ipsilateral 50–99% carotid stenosis and atrial fibrillation
  • Planning carotid interventions in anticoagulated patients
  • Timing of carotid interventions in patients with acute ischemic stroke undergoing thrombolysis.

Naylor, Rantner and colleagues add that the new guidelines highlight similarities and discrepancies with the 2021 American Heart Association (AHA) guidelines on the management of stroke/transient ischemic attack (TIA), the 2021 European Stroke Organisation (ESO) guidelines on carotid endarterectomy (CEA) and carotid artery stenting (CAS), the 2021 German-Austrian guidelines on the management of carotid disease, and the 2021 Society for Vascular Surgery (SVS) guidelines on the management of patients with carotid and vertebral artery disease.

In addition, the authors note that a series of unanswered questions in the 2017 guidelines were highlighted as being priorities for future research. “These involved scenarios where there were either no data, or conflicting evidence that did not allow recommendations to be made,” they elaborate. The current guidelines have addressed some of these questions, which include: Is there a validated algorithm for identifying ‘higher risk for stroke’ ACS [asymptomatic carotid stenosis] patients? Does ACS cause cognitive decline and can this be reversed or prevented by CEA or CAS? And which recently symptomatic patients with <50% stenosis might benefit from urgent CEA or CAS?

The guideline document, which is currently in press, can be found here.

VentureMed completes enrollment of Flex Vessel Prep system randomized controlled trial in arteriovenous fistulas

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VentureMed completes enrollment of Flex Vessel Prep system randomized controlled trial in arteriovenous fistulas

VentureMed Group recently announced that it has completed enrollment of a randomized controlled trial (RCT) entitled “Flex Vessel Prep prior to PTA for the treatment of obstructive lesions in the native AVF.” This RCT was conducted to assess primary patency at six months when using Flex Vessel Prep system prior to percutaneous transluminal angioplasty (PTA) versus PTA alone for the treatment of obstructive lesions of native arteriovenous fistulas (AVFs) in the upper extremity. 

The FLEX RCT was a prospective, multicenter, randomized study conducted at seven sites across the U.S. Seventy-five patients were enrolled and it includes 30-day, three-month, and six-month follow-up.

“Although fistula are the preferred access for hemodialysis, fistula dysfunction and failure remains a significant issue in AV dialysis access care. Balloon angioplasty considered the gold standard by most, still has its limitations due to the resistant and recurrent nature of these hyperplasic lesions, often requiring the use of high-pressure balloons,” said Sanford Altman, MD, from Open Access Vascular Access in Miami.

“These high-pressure balloon treatments can cause vessel wall damage accelerating restenosis and shortening the time between interventions. By utilizing the Flex Vessel Prep prior to angioplasty, we are hoping to see improved vessel compliance, reducing the need for high-pressure balloons while reducing the barotrauma to the vessel wall thereby extending the primary patency and time between interventions.”

“The rapid enrollment of these 75 patients at seven U.S. centers during a COVID-19 surge is encouraging”, said Denis Harrington, president and chief executive officer of the VentureMed Group. “We are excited to report our previous study, the FLEX AV Registry, will be presented at the VASA 2022 Symposium [June 9–11; Charleston, South Carolina]. 2022 is becoming a very impressive year for Flex Vessel Prep.”

Collaborators not cases: Engaging patients with aortic dissections as partners in patient-centered outcomes research

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Collaborators not cases: Engaging patients with aortic dissections as partners in patient-centered outcomes research

To date, research in aortic dissection has focused on management and outcomes focused on technical results, and survival. Little is known about what is important to patients living with or at risk for aortic dissection. The Aortic Dissection Collaborative was founded to bring patients’ voices into the conversation, to develop research priorities informed by all members of the aortic dissection community and advance patient-centered research in this area.

With initial funding from the Patient-Centered Outcomes Research Institute (PCORI), the Aortic Dissection Collaborative was founded in 2019 by Sherene Shalhub, MD, associate professor of vascular surgery at the University of Washington in Seattle. Led by an advisory group of patients and family members who have experienced aortic dissection, along with a stakeholder group of nearly 100 patients, advocacy organizations, family members, clinicians, and researchers, the Aortic Dissection Collaborative has been conducting foundational work to bring together a cohesive aortic dissection community and better understand patient experiences and needs in aortic dissection.

This work is presented in the March 2022 edition of Seminars in Vascular Surgery. This fully open access edition contains 11 articles reporting on the detailed methods used to engage the aortic dissection community; the results of landscape reviews of the seven key topics identified as important to the community (education, genetics, medication, mental health, pregnancy, surgery and telemedicine); important findings from in-depth interviews conducted with individuals with or at risk for aortic dissection; and results of a survey assessing the impacts of COVID-19 on this community.

“This is a landmark in aortic dissection research, and it would not be possible without our nearly 100 stakeholder partners,” says Shalhub. “Not only did our partners contribute to the work itself, but several organizations who are part of the Collaborative provided funds to help us make this an entirely open access issue.”

Sherene Shalhub and Caitlin Hicks

Most of the major national and international advocacy and research organizations focusing on aortic dissection are partners in the Aortic Dissection Collaborative, including Aortic Dissection Awareness UK & Ireland, the Ehlers-Danlos Society, the Genetic Aortic Disorders Association (GADA) Canada, the International Registry of Acute Aortic Dissections (IRAD), the John Ritter Foundation for Aortic Health, the Loeys-Dietz Syndrome Foundation, the Montalcino Aortic Consortium, the National Registry of Genetically Triggered Thoracic Aortic Aneurysms and the Cardiovascular Conditions (GenTAC), The Marfan Foundation, The VEDS Movement, Think Aorta, Vascular Cures, the Vascular Low Frequency Disease Consortium, the Vascular Surgery COVID-19 Collaborative (VASCC), and the VEDS Collaborative.

“This special issue of Seminars in Vascular Surgery not only shares findings relevant and important to the aortic dissection community that we can use as a roadmap in the years ahead to guide research in aortic dissection, but it also provides a model that others can use as a template for involving patients and other stakeholders in research in other disease processes,” says Shalhub.

Seminars in Vascular Surgery is an invitation-only journal that examines the latest thinking on a particular clinical problem in vascular surgery. “The work that Dr. Shalhub and the Aortic Dissection Collaborative is doing to better understand aortic dissection from multiple stakeholder perspectives is absolutely cutting-edge, and well-aligned with the mission of Seminars in Vascular Surgery,” says Caitlin W. Hicks, MD, editor-in-chief of the journal. “I was thrilled to work with Dr. Shalhub to publish this important work in an international forum that is accessible to readers from all backgrounds.”

Following the work reported in Seminars in Vascular Surgery, the Aortic Dissection Collaborative translated identified research topics into patient-centered outcomes and comparative effectiveness research questions and surveyed the aortic dissection community for their priorities in research as well as their willingness to participate in future research. Results of this survey will be available later this year. The Aortic Dissection Collaborative Seminars in Vascular Surgery edition can be found online here.

Cloud-based fusion imaging found to improve operative metrics during FEVAR

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Cloud-based fusion imaging found to improve operative metrics during FEVAR
Charles J. Bailey

A single-center retrospective review demonstrated a trend towards shorter operative times, and significant reductions in both iodinated contrast use and radiation exposure during fenestrated endovascular aneurysm repair (FEVAR) using Cydar’s EV Intelligent Maps—representing the first report of an improvement in metrics with the Zenith Fenestrated (ZFEN) graft while utilizing the fusion imaging system, according to the study authors.

“Intelligent map guidance improves the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner,” concluded Charles J. Bailey, MD, and colleagues from the University of South Florida and Tampa General Hospital in Tampa, Florida.

Results from the study were presented during the 2022 annual meeting of the Southern Association for Vascular Surgery (SAVS) held in Manalapan (Jan. 19–22). A retrospective review of a prospectively maintained aortic database was carried out to identify all patients who underwent commercially available FEVAR between 2013 and 2020, as well as all endovascular aneurysm repairs performed using the Cydar cloud-based fusion imaging platform at the institution starting from 2018.

Being solely focused on de novo FEVAR procedures, a comparative analysis was conducted on 53 FEVARs performed without EV Maps and 63 with the system. Cohorts were found to be similar in terms of patient demographics, medical comorbidities and aortic aneurysm characteristics. Bailey highlighted that body mass index was the same across both cohorts—”something to consider, as the larger the patient, the more radiation they will require.”

No significant difference in major adverse postoperative events, length of stay, or length of intensive care unit stay was noted between the groups, the research team found. Use of EV Maps resulted in non-significant decreases in mean fluoroscopy time (69.3 vs. 66.2 minutes, p=0.598), and a positive trend towards shorter operative times (204.4 vs. 186 minutes, p=0.278). Notably, a statistically significant decrease in both iodinated contrast volume (104.7 vs. 83.8ml, p=0.005), and patient radiation exposure via dose-area product (1049841 vs. 630990mGy/cm2, p<0.001) was observed in patients undergoing FEVAR with EV Intelligent Maps, the researchers reported.

Furthermore, Bailey pointed out the learning-curve element involved in use of the imaging platform, describing how the team took the relevant 63 patients and divided them into groups of 10. “After the 10th case, there was a significant and sustained reduction in radiation exposure,” he said.

Bailey told SAVS 2022: “This is a single center retrospective review. There is a learning curve to any novel technology. Maybe there is a bias to how much attention we pay to distance from operator … practitioner to radiation source, but it’s what we have embraced to do these complex procedures safely, both to us, and the patient and practitioners in the room. This is where we should be thinking with complex endovascular devices.”

New long-term data of paclitaxel devices continue to show no increased mortality compared to non-drug coated devices

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New long-term data of paclitaxel devices continue to show no increased mortality compared to non-drug coated devices

New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (May 19–22) in Atlanta. The analysis found no meaningful difference in survival between patients treated with a paclitaxel drug-coated device and those treated with a non-drug-coated device for up to six years after the index procedure, regardless of the patient’s mortality risk and device type.

The SAFE-PAD study was created in collaboration with the Food & Drug Administration (FDA) to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral arterial disease (PAD).

The study included Medicare beneficiaries ≥66 years treated with a drug-coated device or non-drug-coated device from April 1, 2015, to Dec. 31, 2018. Non-inferiority between devices was evaluated for mortality through 21 July 2021. A number of prespecified subgroups, including a cohort at the lowest risk of mortality defined as those aged 66–70 with no chronic limb-threatening ischemia (CLTI) and ≤2 comorbidities, were evaluated.

“Our goal is to give patients the most durable treatment possible that will keep them out of the hospital and living their lives. Patients with PAD tend to be of lower socioeconomic status, more likely to be underserved minority populations and often need to travel long distances or take time off work to seek treatment,” said Eric Secemsky, MD, from Beth Israel Deaconess Medical Center, Boston. “Not having access to important treatment options known to reduce the risk of repeat intervention can have a substantial influence on our PAD patients, ultimately impacting their outcomes and quality of life. The findings presented today add to the growing body of evidence showing these devices are safe for use.”

Of 168,553 patients, 70,584 (41.9%) were treated with a drug-coated device. Median follow-up was 3.52 years. The weighted cumulative incidence of mortality at 6.3 years was 63.6% with non-drug-coated devices and 62.5% with drug-coated devices (p<0.0001). Findings were consistent among all subgroups. In particular, there was no difference in risk among those at lowest risk of mortality (n=4,212; weighted hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.87–1.10).

Researchers note there will in future be several reports from the SAFE-PAD study, with a final report published in the next two years.

Shockwave IVL maintains ‘superiority’ to angioplasty in calcified peripheral disease at two years

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Shockwave IVL maintains ‘superiority’ to angioplasty in calcified peripheral disease at two years
Shockwave IVL

Shockwave Medical announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with intravascular lithotripsy (IVL) led to excellent long-term outcomes out to two years with preservation of future treatment options compared to percutaneous transluminal angioplasty (PTA) in the treatment of calcified peripheral arterial disease (PAD).

The final outcomes of what Shockwave claims to be the largest randomized trial of severely calcified peripheral lesions were presented by investigators today in a featured clinical research session at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (May 19–22, Atlanta) and published simultaneously in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).

As previously published, IVL at 30 days demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30% without flow-limiting dissection, prior to drug-coated balloon (DCB) or stent, with a rate of 65.8% vs. 50.4% (p=0.0065) as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections (1.4% vs. 6.8%, p=0.03), a reduction in stent implantation rate (4.6% vs. 18.3%, p<0.001) and no distal embolisation or perforation events.

These new long-term results found that the powered secondary endpoint of primary patency (defined as freedom from clinically-driven target lesion revascularization [CD-TLR], restenosis determined by duplex ultrasound and provisional stenting) favored IVL over PTA at one year (80.5% vs. 68.0%, p=0.017) and remained favorable through two years (Kaplan-Meier estimate: 74.4% vs. 57.7%, p=0.005), respectively.

“Prior to the PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials,” said William Gray, MD, system chief, division of cardiovascular disease, at Main Line Health, Wynnewood, Pennsylvania, co-principal investigator of PAD III who presented the long-term results. “The primary endpoint at 30 days showed IVL to be a superior vessel preparation strategy by demonstrating stenosis resolution with significantly fewer complications including severe dissections and the subsequent need for bailout stent implantation. Avoiding unplanned stent implantations allows interventionalists to preserve all their future treatment options should reintervention be necessary. These new long-term data show that vessel preparation with IVL followed by DCB result in excellent efficacy and durable patency out to two years, and taken together the acute and long-term results reinforce IVL as a preferred vessel preparation strategy for calcified femoropopliteal disease.”

Disrupt PAD III was a prospective, multicenter, randomized study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a DCB or stent. The study enrolled 306 patients randomized between IVL and PTA at 45 sites in the USA, Germany, Austria, and New Zealand. In the IVL arm, 82.9% of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129.4mm.

Tissue samples show paclitaxel effect in minority of CLTI patients receiving DCB angioplasty, study finds 

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Tissue samples show paclitaxel effect in minority of CLTI patients receiving DCB angioplasty, study finds 
Rabih Chaer

Paclitaxel effect was witnessed in tissue specimens of a minority of chronic limb-threatening ischemia (CLTI) patients treated with drug-coated balloons (DCBs)—but was not dependent on DCB type, nor the dose level of the drug administered, and was not associated with major adverse limb or clinical events, a new single-center analysis of debrided and amputated tissue found. Researchers behind the study said the evidence supports the safety of using DCBs in patients with CLTI. 

Rabih Chaer, MD, from the University of Pittsburgh Medical Center Presbyterian, Pittsburgh, and colleagues worked on the hypothesis that “the paclitaxel dose administered might play a role in the pathogenesis of any possible side effects associated with its use,” looking at the impact on wound healing.

They prospectively enrolled 50 patients with Rutherford class 5 and 6 ischemia who received angioplasty with either an IN.PACT Admiral (27) or Lutonix (23) DCB in the superficial femoral or popliteal arteries and who also had planned minor amputation or debridement within 90 days.

Collected tissue samples were analyzed for medial necrosis, medial arterial wall inflammation, foreign-body reaction, emboli and paclitaxel crystals, Chaer said.

Results showed that 66.7% of patients healed or improved their wounds; 29 underwent planned minor amputations, with 20 improving, four worsening, and six eventually requiring major amputation due to non-reconstructable tibial disease or infection, Chaer revealed during the 2022 Annual Symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas (March 19–23). Some 18 patients underwent wound debridement—11 improving, one worsening, and six eventually undergoing major amputation, Chaer continued.

“Major amputation-free survival at six months was 71.4%,” he told SCVS 2022. “Evidence of medial necrosis was observed in 10 specimens, with no difference among DCB type. There was no correlation between paclitaxel and major amputation or wound healing, and between DCB type and wound healing.”

Primary patency was 97.1% at six months, Chaer noted, with overall survival nearly 88% at six months and 63.7% at one year.

“What was interesting to note was that the total paclitaxel dose was actually higher in the patients who did not have any downstream paclitaxel effect on histology,” he added

Non-optimal therapy for CLTI ‘more prominent in females’

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Non-optimal therapy for CLTI ‘more prominent in females’
Lena Makowski

A real-world claims data analysis of nearly 200,000 patients with chronic limb-threatening ischemia (CLTI) showed that female patients were older, underwent vascular procedures less often, and received guideline-recommended drugs less frequently. However, it also highlighted that female sex was associated with better outcomes. The study was recently published in the European Heart Journal.

Authors Lena Makowski, MD, of the Department of Cardiology at University Hospital Münster, Münster, Germany, et al state that the prevalence of CLTI is increasing, adding that available data often derive from cohorts with various selection criteria. “In the present study,” they communicate, “we included CLTI patients and studied sex-related differences in their risk profile, vascular procedures, and long-term outcomes.”

The researchers analyzed 199,953 unselected patients of the AOK Health Insurance Fund—which they describe as the largest public health insurance in Germany—hospitalized between 2010 and 2017. They detail that female CLTI patients were older and more often diagnosed with hypertension, atrial fibrillation, chronic heart failure, and chronic kidney disease, while male patients suffered more frequently from diabetes mellitus, dyslipidemia, cerebrovascular disease, and chronic coronary syndrome, and were more likely to smoke. Within hospitalized patients, Makowski et al note that females represent the minority (43% vs. 57%; p<0.001).

Writing in the European Heart Journal, Makowski and colleagues report that, during index hospitalization, women underwent less frequent diagnostic angiographies (67% vs. 70%) and revascularization procedures (61% vs. 65%; both p<0.001).

Furthermore, they reveal that women received guideline-recommended drugs like statins and antithrombotic therapy less frequently at baseline—35% vs. 43% and 48% vs. 53%, respectively (both p<0.001).

“Interestingly,” the authors underline, “after including age and comorbidities in a Cox regression analysis, female sex was associated with increased overall survival (hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.94–0.96) and amputation-free survival (HR, 0.84; 95% CI, 0.83–0.85; both p<0.001).”

In the discussion of their findings, Makowski et al weigh up various strengths and limitations of their research, noting in particular that their choice of claims database was a key strength of the investigation. They explain that the almost 200,000 lower extremity arterial disease patients included in the study were insured by the AOK Health Insurance Fund, which they note covers almost 32% patients in Germany. Makowski and colleagues add that the AOK consists of 11 independent regional Health Insurance Funds, which covers healthcare nationwide in Germany. However, they highlight that AOK-insured patients have a lower socioeconomic status and higher migration background and presence of cardiovascular risk factors, found in all regions compared with other health insurances. “These differences, probably leading to different healthcare supply depending on the regional Health Insurance Fund, can influence the data but demonstrate a nationwide healthcare supply in a heterogeneous patient population,” they write.

The researchers also point to the study design as another strength. “In contrast to randomized trials, observational studies, and registries, the studied health claims data are not subject to selection bias by the sponsor or implementer.”

In addition, the authors communicate that follow-up was good, both in terms of length and data availability. “Patients were included until 2017 and the follow-up phase was until 2018, displaying the current care situation under current guidelines with a longer follow-up to nine years. A very low loss to follow-up was determined, since the change in the health insurance is rather rare, especially in older age groups.”

Moving on to limitations, Makowski et al acknowledge that their analysis is somewhat hindered by the use of health claims data, in that there may be missing information on factors such as clinical status and parameters, the success or failure of interventions, or patient compliance. Moreover, they note that the basis for the analysis was diagnostic codes, which they used for validation reasons. “This means non-billable diagnoses were often not present and thus not included in our analysis,” Makowski and colleagues detail. Another limitation was that differences depending on biological sex (e.g. hormone status), socioeconomic, financial, or health educational aspects could not be included in the analysis.

“[CLTI] should be considered as a multi-organ disease with an ever increasing prevalence and a poor prognosis,” the investigators posit in their conclusion. They stress that CLTI patients “do not receive optimal therapy,” and that this is “more prominent in females.”

Venovo venous stent returns to US market after 2021 recall

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Venovo venous stent returns to US market after 2021 recall
The Venovo stent

BD recently announced that its Venovo venous stent is back on the U.S. market following a recall last year.

In 2019, the company reported that the Food and Drug Administration (FDA) had granted premarket approval for the Venovo venous stent. In a recall notification dated May 12, 2021, however, BD communicated that the company had expanded a safety notice issued earlier in the year for the Venovo venous stent system to include all sizes and lots within expiry date.

The company details that the Venovo venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” says Michael Dake, MD, of the University of Arizona, Tucson, Arizona, the principal investigator for the Venovo investigational device exemption (IDE) trial. “Most importantly,” says Dake, “it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”

Dake presented positive one- and two-year results of the VERNACULAR trial of the Venovo stent at meetings in 2018 and 2019, respectively.

Cancer patients face greater risks from AAA repair

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Cancer patients face greater risks from AAA repair
Jonathan Bath

Elective abdominal aortic aneurysm (AAA) repair in patients with a cancer diagnosis is associated with several poor postoperative outcomes, according to a newly published study from researchers at the University of Missouri School of Medicine.

“Due to the strong association between AAA and cancer, we wanted to determine if cancer patients who underwent elective AAA repair had a greater risk of in-hospital death, cardiac complications, infection and respiratory problems compared to patients without a cancer diagnosis,” said senior author Jonathan Bath, MD, assistant professor of surgery at the University of Missouri and Harry S. Truman VA.

Bath’s team analyzed data from the Cerner Health Facts database. Out of 8,663 patients who underwent AAA procedures, 270 were identified with a cancer diagnosis. The researchers found patients with cancer who underwent AAA were associated with a hospital stay longer than 10 days, renal failure, respiratory problems and infection.

“We did not find that a cancer diagnosis increased the risk of in-hospital mortality, cardiac complications or stroke,” Bath said. “But cancer patients did experience more vascular complications such as bleeding, thrombosis or the need to undergo a repeat procedure.”

Researchers found male patients with a cancer diagnosis had higher odds of a prolonged length of stay, infection and respiratory failure than women with a cancer diagnosis, but there were far fewer women in the sample, making this finding less robust.

“Cancer diagnosis had no effect on mortality at 30 and 90 days unless the patient had lung cancer,” Bath said. “The mortality rate at the end of the study period was significantly higher in patients with a diagnosis of cancer than not, but many cancers will ultimately lead to patient death despite treatment. These findings illustrate the importance of careful patient selection when determining the need and type of aneurysm repair.”

The study, “Outcomes of elective abdominal aortic aneurysm repair in the setting of malignancy,” was recently published by the Journal of Vascular Surgery.

Georgia Tech researchers develop wireless implantable vascular monitoring system

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georgia techResearcher Woon-Hong Yeo and his collaborators at the Georgia Institute of Technology (Atlanta, USA) are trying to improve the odds for vascular patients with development of an implantable soft electronic monitoring system. Their new device, according to a Georgia Tech press release, consists of a smart stent and printed soft sensors, is capable of wireless real-time monitoring of hemodynamics without batteries or circuits.

“This electronic system is designed to wirelessly deliver hemodynamic data, including arterial pressure, pulse, and flow, to an external data acquisition system, and it is super small and thin, which is why we can use a catheter to deliver it, anywhere inside the body,” said Yeo, whose team released its study recently in the journal Science Advances.

Yeo added, smiling, “It’s like a stent with multiple tricks up its sleeve.”

For example, when this device is installed in a patient with atherosclerosis, in addition to expanding and preventing the artery from narrowing, like a traditional stent, restoring normal blood flow, it will also provide a constant flow of data.

“Now, once you have deployed a stent, you’re not sure if the problem was resolved and patients may come back with the same issue,” Yeo said. “It can be a defect of the stent, or an issue with stent deployment, or perhaps a problem with the patient’s blood flow.”

And the current standard way to monitor all of that is with an angiogram. That can be expensive and in rare instances, particularly with patients also struggling with diabetes, the dyes and radiation used in angiogram imaging can cause cancer. Yeo’s system seeks to circumvent the need for an angiogram or other imaging requirements.

His wireless smart stent platform, integrated with soft sensors, is operated by inductive coupling to offer wireless real-time monitoring that can detect a wide range of vascular conditions.

75th anniversary: Celebrate SVS history through photos

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75th anniversary: Celebrate SVS history through photos
This photo entry, from SVS Immediate Past President Ronald L. Dalman, features the Stanford University vascular during their morning huddle

A week remains in the SVS Photo Contest, which celebrates the Society for Vascular Surgery’s 75th Anniversary. Members are sharing images that tell the Society’s collective story.  

The contest began in March and ends May 19. One winner and three runners-up will be selected in each category, and all honorees will be recognized on the SVS website, vascular.org, and during the 2022 Vascular Annual Meeting (VAM).

For information on consent forms and to submit photos, visit here. The remaining category is “75th Anniversary,” involving historic photos of vascular surgery, with the submission timeframe from May 12 to 19.

The top 10 most popular Vascular Specialist stories in April 2022

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The top 10 most popular Vascular Specialist stories in April 2022

top 10 vascular specialistThe digital version of the April 2022 issue of Vascular Specialist, the most recent editorial by our medical editor focusing on diversity within the vascular surgery workforce, and an interview chronicling the new age about to begin at the Journal of Vascular Surgery (JVS), all feature among the best-read stories appearing on the newspaper website last month.

1. Vascular Specialist—April 2022

In March, we were on the ground at the 2022 Society for Clinical Vascular Surgery (SCVS) Annual Symposium, and the cover of our subsequent April issue was dominated by reporting on a training and education session from the meeting in which new evidence laid out out how vascular surgeons in private practice could play a crucial role in alleviating one of the existential problems currently vexing the specialty: the training of future generations of specialists.

2. Our past is prologue: We are losing the battle to train more Black doctors

Our April editorial from Vascular Specialist medical editor Malachi Sheahan III, MD, saw the Louisiana State University vascular chief discuss how the medical profession is losing the battle to train more Black doctors.

3. Interview: JVS group enters new era with brand chief and team-based approach

With changes occurring regularly in the publication business of scientific journals, the Society for Vascular Surgery (SVS) is preparing for changes with its own JVS publications.

4. Terumo Aortic announces FDA approval for Thoraflex Hybrid frozen elephant trunk device

Terumo Aortic announced that the Food and Drug Administration (FDA) had granted approval of the Thoraflex Hybrid frozen elephant trunk device for commercial sale in the U.S. for the treatment of patients with complex aortic arch disease.

5. Sex discordance and postoperative outcomes: We should be vigilant of a real disparity in health outcomes

In a recent commentary, Karen Woo, MD, discussed a study in which sex discordance between surgeons and patients was shown to “negatively” affect outcomes following common procedures.

6. AVF 2022: Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus

Six-month outcomes from the ongoing CLOUT registry demonstrated the “safety and efficacy” of the ClotTriever thrombectomy system in a real-world deep vein thrombosis (DVT) population regardless of clot chronicity level, the 2022 annual meeting of the American Venous Forum (AVF) in Orlando, Florida (Feb. 23–26) heard.

7. PROMISE II U.S. pivotal trial of device designed for ‘no-option’ CLTI patients completes enrollment

Enrollment was completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialization system designed to prevent amputations in so-called “no-option” chronic limb-threatening ischemia (CLTI) patients, the eponymous device maker announced.

8. Increased market competition linked to higher odds of revascularization among asymptomatic patients with moderate carotid stenosis

A vascular surgery research team with a growing reputation for its work investigating appropriateness in care in the peripheral vascular bed uncovered an association between increased regional market competition among proceduralists and higher odds of revascularization being carried out for moderate- versus high-grade asymptomatic carotid stenosis.

9. VAM 2022 will offer innovative formats

The SVS Postgraduate Education Committee is breaking up the format in favor of change and innovation for two sessions at this year’s Vascular Annual Meeting (VAM).

10. CX 2022: Overtreatment in venous disease: Financial incentives are ‘the elephant in the room’

To combat the “overtreatment problem” in the appropriate care of venous disease, “a concerted, complex, multimodal effort” is required from specialists across disparate parts of the world, the 2022 Charing Cross (CX) International Symposium (April 26–28) heard last month

Less frequent post-EVAR surveillance might be safe in some patient groups, study suggests

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Less frequent post-EVAR surveillance might be safe in some patient groups, study suggests
Anna C M Geraedts

Results from the multicenter, retrospective ODYSSEUS study carried out in The Netherlands suggest that less frequent surveillance after endovascular aneurysm repair (EVAR) may be warranted. However, authors Anna C. M. Geraedts, MD, of Amsterdam University Medical Centres, Amsterdam, The Netherlands, and colleagues stress that future studies are needed to determine the patient groups in which this would be safe.

The study, recently published in the European Journal of Vascular and Endovascular Surgery (EJVES), highlighted the fact that discontinued imaging surveillance post-EVAR is common in The Netherlands. It also shows that discontinued yearly follow-up in patients with initial postoperative computed tomography angiogram (CTA) without abnormalities is not associated with poor outcomes.

“EVAR has become the predominant modality for the treatment of infrarenal abdominal aortic aneurysms (AAA) in The Netherlands,” the authors write, adding that lifelong surveillance is recommended following the procedure. However, they also note that there are concerns regarding the long-term durability of EVAR, lifelong follow-up routines, and adherence to surveillance programs. This study, therefore, aimed to examine the association between adherence to postoperative surveillance and survival and secondary interventions in patients with an initial postoperative CTA without abnormalities.

Between 2007 and 2012, all consecutive patients undergoing EVAR for intact AAA in 16 hospitals were identified retrospectively, the authors write, noting that patients were followed up until December 2018.

Geraedts et al specify that patients were included if the initial postoperative CTA showed no type I–III endoleak, kinking, infection, or limb occlusion. Primary outcomes were aneurysm-related mortality and secondary interventions, and secondary outcome was all-cause mortality.

Of the 1,596 patients included in the study, the authors report that cumulative aneurysm-related, overall, and intervention-free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at one, five, and 10 years, respectively. They note that American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR], 3.810; 95% confidence interval [CI], 1.296–11.198), increase in AAA diameter (HR, 3.299; 95% CI, 1.408–7.729), and continued follow-up (HR, 3.611; 95% CI, 1.780–7.323) were independently associated with aneurysm-related mortality. The same variables and age (HR, 1.063 per year; 95% CI, 1.052–1.074) were significantly associated with all-cause mortality, the authors add.

In terms of secondary interventions, Geraedts and colleagues relay that no differences were observed between patients with continued versus discontinued follow-up (89/552; 15% vs. 136/1,044; 13%; p=0.091).

Writing in EJVES, the authors acknowledge various limitations of their study, including its retrospective, observational study design. This carries a risk of information bias, they state, noting for example that “it was unclear if patients were lost to follow-up, if imaging studies had been discontinued after uncomplicated surveillance, or if patients had undergone imaging surveillance elsewhere.”

Furthermore, they recognize that the inclusion of patients until only 2012 limits the ability to draw conclusions from more recent devices, there were no clear protocols as to when a patient might be discharged from further follow-up, there was missing information on cause of death, and also the fact that reasons why patients were no longer under surveillance were not noted.

Despite these limitations, Geraedts et al also highlight some notable strengths of the research such as the use of population-based data with long-term follow-up and the accuracy of verifying deaths through the National Death Register. In addition, they note that the investigation comprises all imaging studies made following EVAR, and “thus provides a complete overview of national practice and adherence to the ESVS [European Society for Vascular Surgery] guidelines.”

Geraedts and colleagues conclude that “discontinued follow-up is not associated with poor outcomes,” noting however that “future prospective studies are indicated to determine in which patient groups follow-up can be safely reduced.”

War in Ukraine: A tale of unspeakable horror, unprecedented unity and unquenchable thirst for freedom

War in Ukraine: A tale of unspeakable horror, unprecedented unity and unquenchable thirst for freedom
A Kharkiv university building after being shelled by Russian forces

This editorial was written in the days leading up to April 2.

At about 4 a.m. (Kyiv time) on Feb. 24, Russian President Vladimir Putin announced the start of a military operation aiming to “demilitarize and denazify Ukraine.” A few minutes later, Russian troops crossed the Ukrainian border and started shelling. Russian ships approached the Ukrainian coasts from the Black and Azov seas and bombed Mariupol.

Countless Ukrainians were awakened that day by heavy explosions. While nobody knows for certain where Putin was when his army attacked Ukraine, President Volodymyr Zelensky was at home with his wife and two children. It was they who woke him early on Feb. 24: “They told me there were loud explosions.”

After a minute, he received the signal that a rocket attack was underway. The United States offered him a passage to safety. He chose to stay.

Kharkiv

As it turned out, Kharkiv, the hometown of one of us, Maksym Karpusenko (MK), became one of the fiercest battlefields. Since day one, and for more than a month, it has been besieged from the northwest, the north and the east, and its outskirts have been shelled indiscriminately. According to Mayor Ihor Terekhov, 1,292 residential buildings have been destroyed, as well as 70 schools, 54 nurseries, 15 hospitals, and 239 administrative buildings, including the university. All but deafened by artillery shelling, anti-aircraft defense systems, machine guns and airplanes, people are forced to hide several times a day. From the very outset, Russians exalting “liberation from fascists and denazification” were shooting and killing. Kharkiv endured huge civilian casualties, including numerous dead and wounded children. As evidenced by video recordings and telephone conversations between Russian military personnel and their relatives in Russia, they were expressly targeting ambulances, private vehicles, residential facilities, orphanages, and hospitals.

Located close to Russia, Kharkiv has been bombarded every day. MK hears the squealing of Russian planes overhead and the sound of explosions. He wakes up trying to determine whether his bedroom was a military target. Since that day, the people of Kharkiv and other Ukrainian cities have spent most of their time in queues for food and drugs. Medicine is very scarce. Many old people have been stuck on high floors in buildings where the lifts are disabled. All the time they hear shells in the distance falling in waves; while MK never imagined that something like this could happen, he feels proud and inspired by the many Ukrainian friends and neighbors who have helped unstintingly.

An unexploded shell by a children’s play area

Despite superb work by local utility services, the city’s infrastructure has been severely damaged, leaving hundreds of blocks without gas or electricity. In some outlying areas, all food shops have been destroyed, which means that elderly and disabled people now rely on volunteers to bring food. One of the few landmarks of the residential district of Saltivka, “Rost” supermarket, was obliterated by a missile, with some Russian media claiming that it was a military warehouse. From the very first day, thousands of Kharkovites have sheltered in underground stations or cellars. Outside, everywhere, even in kindergartens, unexploded shells litter the ground. Evacuation has been organized by the Ukrainian railway and volunteers, carrying primarily women and children to towns in western Ukraine. Fantastic work is being done by charity foundations such as “Dobra Samarytyanka,” which delivers food and medicines, and evacuates residents. With most of its inhabitants more fluent in Russian than Ukrainian, Kharkiv appeared to the Russians to be a pro-Russian city, where they expected to be cheered. Instead, Kharkiv has become an unassailable citadel.

When Putin ordered Russian troops into Ukraine, he was not alone in thinking victory would be swift. By the time the war was entering its sixth week, the side contemplating victory was not conquering Russia, but tearful Ukraine.

Mariupol

Kharkiv was far from the only town hit. In Mariupol, Russian bombardments have cut off the city’s water and power supply. Families have been huddling together for days, freezing in the dark. Dead bodies are reportedly strewn over the streets, with bombs falling. For weeks, hardly anyone was allowed to leave. In recent days, however, survivors have managed to flee, bringing first hand testimony according to which, every building has been hit. Missile casings litter the streets. People spend most of their time underground sitting in the dark, running up at times to rescue babies and the elderly from the ruins. Many have relatives in Russia, some of whom refuse to believe what has been happening. According to the Kremlin line, only neo-Nazis have been hit.

Today, the city is practically ruined, the infrastructure is destroyed, as are hospitals, administrative buildings and factories. Civilian evacuation is blocked on the route to Zaporizhia by Russian checkpoints in Melitopol and Vasilievka.

Zaporizhzhia

In Zaporizhzhia, and elsewhere, the Russian leadership has expressly targeted factories, agricultural equipment, and medical and pharmaceutical plants. That is why Andriy Nykonenko (AN), another of us and a vascular surgeon, had difficulty finding drugs and sterile linen to care for the wounded. Plants in or around Kyiv have been destroyed or were under constant rocket fire and inaccessible. In times of dire emergency, a decisive role has been assumed by volunteer organizations, which in the nick of time appeared in every city. Most consisted of young people with their own vehicles organizing collection of drugs and food. Their heroism was of critical importance in the first month of the war, when healthcare systems were in a state of shock. With the active help of European colleagues, Ukrainian volunteers developed a network to ensure supply of medicines and medical devices. The third of us, Jean-Baptiste Ricco (JBR), was present at the border. The goods collected by volunteers throughout Europe were being transported by train or truck. The entire continent was mobilized in support of the Ukrainians’ fierce and unyielding resistance.

Under catastrophic circumstances, organization was the key. In Zaporizhzhia, one of us, AN, organized vascular surgery procedures in active warfare zones. The first week of the war had caught everyone unaware. As many patients as possible were discharged from his vascular unit, but some could not go home as there was no transport available or because their towns were occupied by the Russian military. Since wounded persons were expected and the hospital was in danger of being bombed, scheduled operations were postponed. Moreover, supply chains from Kiev and other centers had been disrupted, and no one had previously experienced such an emergency.

That said, what the Russians did not expect was the unprecedented unity of the Ukrainian people, which prevented them from capturing large Ukrainian cities and destroying the country’s economy.

A nationwide healthcare network

Against his will, AN left Zaporizhzhia with his family for the relative safety of Uzhgorod. The journey to Uzhgorod was a four day ordeal, with air raid sirens and rockets in cities along the way. When arriving in Uzhgorod, near the Slovakian border, AN discovered a city sheltering more than 600,000 refugees. With the support of a few of us, AN and his colleagues created a nationwide network designed to provide hospitals with much-needed medical supplies. During the first weeks, many had received humanitarian aid, but in most cases, it was not logistically coordinated and failed to meet their needs. Via the Viber and Telegram messaging services, AN and colleagues organized a first-aid package conveying selected medical supplies to war-zone hospitals for the treatment of all types of injuries, including vascular trauma. A few days later, a report was presented to the Executive Committee of the European Society for Vascular Surgery (ESVS), describing the organization, indicating its needs, and requesting accelerated aid that would circumvent bureaucratic European holdups.

A few weeks later, organizationally-equipped to deal with immediate emergencies, AN and colleagues were performing more complex surgical procedures in safe medical centers. In parallel, they were dealing with chronic pathologies whose evolution required rapid treatment.

Why Ukraine must win

While Ukraine has won the first phase of this war by surviving, more Western help is needed in a context where President Zelensky has stayed with his people, constantly evoking the sanctity of human life, the need for compassion, and the fight for freedom.

The Kremlin initially planned to destroy the Ukrainian army, force the government to surrender, recognize the “people’s republics” and Crimea as Russian territory, change the Constitution and declare Ukraine’s neutrality. From the outset, Russian tactics involved high- and low-precision missile attacks, which caused massive infrastructure and residential destruction, killing servicemen and civilians alike.

This war is a continuation of the conflict started by Russia in 2014 in Crimea and Donbas. The March 2, 2022, U.N. General Assembly resolution condemned the Russian invasion of Ukraine. Nobody knows how this conflict will evolve, and history is littered with wars meant to be short but which dragged on for years. To conclude, we have written this editorial to inform the readers of this journal of the war in Ukraine, the resources deployed to help the population, and the urgent need for European assistance.

Andriy Nykonenko, MD, of the vascular surgery and transplantation unit, is chief of the Department of Surgery, Zaporizhzhia State Medical University, Zaporizhzhia, Ukraine. Maksym Karpusenko is a senior lecturer at the Karazin Kharkiv National University, Kharkiv, Ukraine. Jean-Baptiste Ricco, MD, is professor emeritus at the University of Poitiers, France. This editorial was co-published with the European Journal of Vascular and Endovascular Surgery. The authors wish to thank all the Ukrainian volunteers who accompanied them in this struggle for freedom as well as Jeffrey Arsham, who helped in an emergency to translate and to edit the manuscript.

Artificial intelligence could make endovascular aortic repair outcomes more predictable, CX 2022 hears

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Artificial intelligence could make endovascular aortic repair outcomes more predictable, CX 2022 hears
Tom Carrell speaks at CX 2022

At the 2022 Charing Cross (CX) International Symposium (April 26–28) in London, England, Tom Carrell, MD, a vascular surgeon in Cambridge, England, and founder of Cydar Medical, delivered a Podium 1st presentation titled “Making endovascular aortic repair outcomes more predictable: Artificial intelligence [AI] takes on a 20-year-old challenge.”

“Given any individual patient with some anatomic complexity, do we really know—particularly with the ever-expanding range of treatment options— what is going to be the outcome for them?” According to Carrell, this is the key question at the center of the 20-year-old challenge the speaker referred to in the title of his talk. Twenty years ago, he detailed, the pioneers of endovascular surgery recognized that anatomic severity was a major determinant of outcomes and therefore probably required reporting standards. “A scoring system would need to strike a balance between having enough granular detail to be useful and also being simple enough to be usable in everyday practice,” he said. A scoring system was built, with the expectation being that subsequent clinical investigations to test the system would be used to modify it.

In the 20 years since then, Carrell highlighted that a number of papers on the anatomic severity grade scoring system have been published, showing that it does indeed predict outcomes and complications. However, “there has not been quite so much progress in terms of using that data to modify the schemes,” Carrell pointed out. The speaker noted that there are probably a number of reasons for this, one being that “some of the things that go into the scoring schemes turn out to be rather complicated.” For example, he said, measuring infrarenal neck angulation is “really contentious,” with “very high intra-observer variability.”

“Can AI offer both that detail and simplicity?” Carrell asked, highlighting a key question in 2022. He explained that Cydar Medical is developing an extended capability to operate with what the company calls Intelligent Maps. “The concept is that when you plan a case, you are being informed by the outcomes of previous patients with similar anatomy and disease,” he explained.

The company’s current product, which is used for planning, guiding, and reviewing endovascular surgery, uses “virtual guidewires.” Carrell elaborated: “We use [virtual guidewires] for planning, but the main function is to identify where you are going to be operating, so that your planning is rendered in the form of a map and overlaid on a live fluoroscopy. As your real guidewires deform the anatomy, the virtual guidewires deform the map so that you have an overlay that reflects the real-time anatomy.”

Carrell provided some details on where the software is headed: “What we are doing with Intelligent Maps is taking that capability with the virtual guidewires and the AI that we have in the system and the data from all the thousands of patients who have been treated with Cydar EV Maps and building tools to analyze anatomy.” He added that these tools are a combination of deterministic algorithms using the virtual wires and also using simulated neural networks, or deep learning, to not just segment the vessels, but also to label the aorta and the iliacs according to what branches are coming off at each level. “For each patient, you bring these things together so that you have your geometry, but you have it in the context of where you are right the way along the aorta and the iliac system. This is highly deterministic, so you put the CT scan in and these measures come out, put the same CT scan in or a similar CT scan in and you get the same things coming out.”

One of Carrell’s key takeaway messages was that this software has relevance for helping inform decision-making. “You take one patient that produces the analytics and then we use it to match to other patients in the database already, patients who have similar anatomy. It is literally as simple as entering in the CT scan and finding those matching patients. We can then find out what treatment those patients had, what type of approach they had.”

Next, Cydar will be working on bringing in the “final steps” of the technology—the outcome metrics for the surgical strategy that was used. “We want to close that 20-year ambition to have the feedback loop in there to modify the scoring system,” Carrell concluded.

SCAI releases multi-society position statement focused on core competencies for endovascular specialists providing care for CLTI

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SCAI releases multi-society position statement focused on core competencies for endovascular specialists providing care for CLTI

The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement outlining competencies for endovascular specialists who provide care for chronic limb-threatening ischemia (CLTI).

The first-of-its-kind document, “SCAI/ACR/APMA/SCVS/SIR/SVM/SVS/VESS position statement on competencies for endovascular specialists providing CLTI care,” published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of the American Podiatric Medical Association (JAPMA), Journal of Vascular Surgery (JVS), and Vascular Medicine (VMJ), is a collaborative effort from eight societies representing many specialties engaged in the care of CLTI patients. The expert writing group aims to standardize expected competencies for endovascular specialists to help ensure patient-centric and evidence-based therapy is delivered to this unique patient population.

“Care for patients with CLTI is typically complex, multifaceted, and multidisciplinary. Standardizing expected competencies for endovascular specialists is an important step to ensure that patient-centric and evidence-based therapy is delivered,” said Beau M. Hawkins, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, chair of the writing group for the document. “This new framework is a starting point to enable training programs, professional medical societies, and other entities to develop curricula that address the needs of this unique patient population.”

The position statement details the key skills that all endovascular specialists should possess to deliver successful outcomes for CLTI patients. The skillsets are categorized into six core competencies based on the Accreditation Council for Graduate Medical Education (ACGME) core competencies framework: medical knowledge, patient care and procedural skills, systems-based practice, practice-based learning and improvement, professionalism, and interpersonal and communication skills. To account for a range in complexity across the competencies, the writing group also provides examples stratified into “fundamental” and “advanced” categories.

“This unprecedented collaborative effort among these eight multidisciplinary medical societies is another step forward towards advancing care for patients with CLTI, said Mehdi Shishehbor, DO, of the University Hospitals Harrington Heart & Vascular Institute, Cleveland, Ohio, co-chair of the writing group. “I hope that these efforts will evolve and translate into better care for these high-risk patients at risk of limb loss,” he continued.

The statement also discusses institutional requirements and resources necessary for learners to obtain the necessary skillsets. Recommendations for formal training or independent courses in a post-training practice are also included.

The position statement was endorsed by the American College of Radiology (ACR), American Podiatric Medical Association (APMA), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Interventional Radiology (SIR), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), Society for Clinical Vascular Surgery (SCVS), and Vascular and Endovascular Surgical Society (VESS).

Voting for SVS vice president, secretary begins May 23

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Voting for SVS vice president, secretary begins May 23
SVS vice presidential candidates Matthew Eagleton and Amy Reed

Society for Vascular Surgery (SVS) Active and Senior members will begin voting May 23 for a new SVS vice president and secretary for 2022–23. Election results will be announced at the SVS Annual Business Meeting on June 18 during the Vascular Annual Meeting (VAM) in Boston.

Vice presidential candidates are Matthew Eagleton, MD, and Amy Reed, MD. Candidates for secretary are Kellie Brown, MD, and William Shutze, MD. All four have been active, involved SVS members. (Get to know the candidates, and register for the Town Hall, here.)

The SVS Nominating Committee will first hold a virtual Town Hall at 7 p.m. Monday, May 23, to explain the process by which nominations were gathered and candidates selected. All four candidates also will briefly address Town Hall participants. Members can submit questions for the candidates here. Questions are due by May 19.

Internet voting will begin immediately after the Town Hall ends, closing at 5 p.m. Central Daylight Time Friday, June 3. Only Active and Senior members in good standing may vote. Those whose dues are in arrears will not be able to participate; they will be prompted to pay any invoices and then will immediately be able to vote. The SVS Nominating Committee sought nominations for the two open positions in February and March, and then selected two candidates each.

In 2020, members approved bylaws changes that permitted multiple candidates be selected for member voting, and also instituted online voting, said Michel S. Makaroun, MD, Nominating Committee chair. “We also moved to online voting, which permits all of our members in good standing to be part of the officer selection process, not just those who are in attendance at VAM and the Annual Business Meeting. Our members have fully embraced this change.”

In addition to the vice president and secretary nominees, the following slate of officers will be presented at the Annual Business Meeting: incoming President Michael Dalsing, MD, President-Elect Joseph Mills, MD, Treasurer Keith Calligaro, MD (year three of three), and Immediate Past President Ali AbuRahma, MD.

Voting on proposed bylaws amendments also begins May 23. See the proposed amendments here.

New sirolimus data provide encouragement despite ‘potentially disappointing’ efficacy results

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New sirolimus data provide encouragement despite ‘potentially disappointing’ efficacy results

The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access for dialysis. These findings were delivered by Tjun Tang, MD—who also highlighted “excellent” technical and clinical success rates and positive safety outcomes—via a Podium 1st presentation during the Charing Cross (CX) Symposium 2022 Vascular Access Masterclass. 

Tang presented 12-month results from the ISABELLA (Intervention with Selution SLR agent balloon for endovascular latent limus therapy for failing AV fistulas) trial, which assessed the utility of the Selution SLR sirolimus-eluting balloon (MedAlliance) for minimizing the effect of neointimal hyperplasia and treating arteriovenous fistula (AVF) stenosis. 

The speaker noted that ISABELLA had a recruitment target of 40 patients, with 34 of these patients (85%) ultimately being evaluated at the 12-month follow-up timepoint in November 2021. He also detailed that the majority of these patients had either radiocephalic or brachiocephalic fistulas with recurrent lesions requiring treatment—and the most common indication for intervening was a drop in access flow, observed in 61.5% of cases. 

Moving on to 12-month data from the trial, Tang reported a target-lesion primary patency (TLPP) rate of 44% (16/36 lesions) and a circuit access patency rate of 31% (10/32 lesions), which represented decreases from 72% and 63%, respectively, at six months. In addition, he stated that the overall rate of secondary patency—defined as freedom from access circuit abandonment—was 94.1% (32/34 patients) at 12 months compared to the 97.2% (35/36 patients) observed at six months. 

“In conclusion, the ISABELLA study showed excellent technical and clinical success rates [100%],” Tang said. 

He also relayed that the use of Selution SLR in patients with AVF stenosis appears safe, with no serious adverse events, such as pulmonary embolism or bronchopneumonia, being associated with its use in the study. And, in terms of efficacy, Tang added that—while the results are “potentially disappointing”—this is a small, exploratory study and alluded to possible confounding factors within these findings. 

“We do need longer-term data and randomized controlled studies […] if we are going to move forward seriously within this field, and with this technology,” Tang concluded. He noted the importance of being careful when interpreting the results of an exploratory pilot study—especially one that was designed to power a randomized controlled trial, as this one has been. 

“I do not think it is actually a setback at all,” he continued. “In fact, I think it is very encouraging. I think the fact we are not getting any serious adverse events with the balloon […] is reassuring.” 

Tang said that, with the exception of the IN.PACT AV Access study (Medtronic), a similar drop-off in patency rates between six and 12 months had been observed in several previous studies using paclitaxel to treat dysfunctional dialysis access. 

FDA approves expanded indications for TCAR’s Enroute stent

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FDA approves expanded indications for TCAR’s Enroute stent

The Food and Drug Administration (FDA) approved expanded indications for the Enroute stent system—part of the transcarotid artery revascularization (TCAR) procedure—to include patients at standard risk for adverse events from carotid endarterectomy (CEA), Silk Road Medical announced today. Previously, the stent was approved for use only in patients with anatomic or physiological criteria that put them at high risk of complications from more invasive surgical procedures.

Silk Road submitted a premarket approval supplement, which included data extracted from the Vascular Quality Initiative (VQI) representing real-world outcomes in 20,264 patients considered at standard surgical risk, the company said. Those data demonstrated that use of the TCAR system is statistically non-inferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (CNI) (2.7% vs 0.3%, p<0.001), the press release added.

“Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes. I speak for the vascular community in welcoming this label expansion for TCAR, and recognizing this as a vital advancement in the treatment paradigm for patients at risk of stroke,” said Marc L. Schermerhorn, MD, chief in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston.

“The decision regarding which patients to treat with TCAR is no longer restricted to patients at high surgical risk, providing a greater opportunity for the care team to pursue the less invasive approach for a broader set of their patients.”

The Enroute stent is intended to be used in conjunction with TCAR’s Enroute neuroprotection system. The system combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.

SVS Foundation seeks applicants for VISTA projects

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SVS Foundation seeks applicants for VISTA projects
The deadline to submit VISTA proposals is August 1, 2022

The SVS Foundation started to seek proposals in mid-April for pilot outreach projects to help identify needed vascular services in underserved portions of the U.S. 

The projects will be part of the Foundation’s VISTA (Vascular Volunteers In Service To All) program. The initial focus is expected to be on defining barriers to care and on the education of both local community healthcare providers and their patients. 

“We want our surgeons to survey the medical landscape around them, asking themselves, ‘What is the need here and how can I help?’“ said Foundation Chair Peter Lawrence, MD. “It could be basic information about vascular disease, the importance of knowing risk factors, public education on when to seek care. A person with diabetes might not have the specific knowledge needed to know when to see a physician about foot ulcers that could lead to the need for amputation.” 

Projects should help identify improved pathways to treatment, optimizing or expanding use of existing local providers. The Foundation wants proposals that emphasize providing evidence-based management of vascular disease, not the promotion of specific products, devices or medications. The expected timeline would be two to three years. Ideal proposals would include: 

  • A concise impact statement delineating a realistic potential benefit to the target community 
  • Metrics for success and specific deliverables 
  • Plans for ongoing communication and either virtual or physical support for the target community 
  • Follow-up plans and information on potential scalability of the project consistent with planned future phases of the VISTA Program 

The deadline to submit proposals is August 1, 2022. Learn more about VISTA at vascular.org/VISTA. 

Foundation announces VRIC trainee award-winners

The SVS Foundation has selected four trainees to present their high-scoring research at the 2022 Vascular Research Initiatives Conference (VRIC) in Seattle, on May 11. 

VRIC is dedicated to stimulating and encouraging interest in research among trainees who are aspiring academic vascular surgeons, according to the Foundation. “The meeting’s exclusive and intimate atmosphere allows for the free exchange of ideas and development of collaborative projects equally among senior and junior investigators.” 

Recipients are:

  • Mario Figueroa, MD; general surgery resident at Rutgers-UMDNJ; post-doctoral research fellow at Medical University of South Carolina; “Vascular smooth muscle cell mechanotransduction through serum and glucocorticoid inducible kinase-1 promotes interleukin-6 production and macrophage accumulation in murine hypertension.” Mentor: Jean Marie Ruddy, MD 
  • Carson Hoffmann, MD; research fellow, Emory University; “Modifiable mesenchymal stem cell defects in veterans with diabetes mellitus.” Mentor: Luke Brewster, MD 
  • Kevin Mangum, MD, PhD; vascular resident, University of Michigan; “MOF expression regulates interferon ß in diabetic wound macrophages and impairs tissue repair.” Mentor: Katherine Gallagher, MD 
  • Molly Schieber, MS; MD-PhD student, G3, University of Nebraska Medical Center; “Microvessel oxidative stress predicts changes in leg function of patients with peripheral arterial disease after supervised exercise therapy.” Mentor: Iraklis Pipinos, MD 

CX 2022: IN.PACT AV DCB shows sustained and superior performance compared to PTA through three years

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CX 2022: IN.PACT AV DCB shows sustained and superior performance compared to PTA through three years
Andrew Holden

New randomized controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 36 months, with no difference in mortality, was revealed during a Podium 1st presentation at the 2022 Charing Cross (CX) Symposium in London, England, Medtronic announced.

“The 36-month data from the IN.PACT AV Access study validates that treatment with the IN.PACT AV DCB can lead to less life disruption and fewer reinterventions for patients for an extended period of time, further reinforcing the results of earlier data milestones,” said Andrew Holden, MBChB, director of interventional radiology and associate professor of radiology, Auckland University School of Medicine, Auckland, New Zealand. “As the only pivotal DCB study in arteriovenous (AV) access to meet its primary effectiveness endpoint, the IN.PACT AV DCB has shown unrivaled long-term clinical benefits that support its use as the standard of care for AV fistula maintenance in patients with end-stage kidney disease.”

As vessel restenosis limits the ability to use AV fistulas effectively over time, patients often undergo up to three AV fistula maintenance procedures per year to restore function. The need for frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system.

The IN.PACT AV Access study’s three-year data further demonstrates the ability for the IN.PACT AV DCB to extend time to reinterventions from the index procedure by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care. Over three years, the IN.PACT AV DCB group demonstrated a continued clinical benefit compared to the PTA control group. Key highlights for this dataset include:

The Kaplan-Meier estimated target lesion primary patency through 36 months was 43.1% in the IN.PACT AV DCB group compared to 28.6% in the PTA control group (log-rank p<0.001). The Kaplan-Meier estimated access circuit primary patency through 36 months was 26.4% in the IN.PACT AV DCB group compared to 16.6% in the PTA control group (log-rank p<0.001).

The Kaplan-Meier estimated cumulative incidence of all-cause mortality post-vital status update through 36 months was 26.6% in the IN.PACT AV DCB group and 30.8% in the PTA control group (log-rank p=0.709).

SVS turns its sights to FY2023, long-range future

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SVS turns its sights to FY2023, long-range future

In January, the Society for Vascular Surgery (SVS) Strategic Board met and forged its objectives for the coming fiscal year. Two months later the course is being set for action as goals translate into objectives, and objectives transform into programs embedded in the budget for the 2023 financial year, or FY2023. Here are a few highlights of the year to come. 

Advocacy 

It is going to be another year of intense battle over Medicare payment cuts as the enormous efforts to delay the full impact of 2022 cuts hit their deadlines and the full brunt are back on the table for potential implementation. The SVS Policy and Advocacy Council, led by Matthew Sideman, MD, and Megan Tracci, MD, and the PAC Steering Committee, led by Mark Mattos, MD, and Peter Connolly, MD, are standing firm to meet these challenges. But they need help… your help. They need your engagement, your voice, your letters to Congress and your PAC donations, which open doors to discussion and action. 

But the first subtle winds of change are blowing as members of Congress and various Congressional staff tire of the seemingly endless annual battle, and begin to question whether there is a more permanent solution to current challenges with the Medicare Physician Fee Schedule. To accelerate these winds of change, the SVS Medicare Payment Reform Task Force is convening in a “Payment Reform” Summit in June to begin sculpting and shaping alternative solutions for Medicare payment. 

To shape and strengthen the advocacy leaders of the future, the council is also implementing its first Advocacy Leadership Program Cohort, seeking 10–12 SVS members with a passion for public policy and advocacy to get into the pipeline for future SVS advocacy leadership. The Coding Committee is following a similar track in seeking interns and early-career vascular surgeons with a passion for coding policy to begin training as the next members who oversee work values and codes. 

The Government Relations Committee, chaired by Sean Lyden, MD, will be pressing hard on payment, but also accelerating efforts to advance legislation to ease burdens on prior authorization and augment solutions for ever-growing workforce shortages and challenges. 

Education 

The Education Council under the leadership of Linda Harris, MD, will introduce and implement a new three-year education strategic plan for the SVS, built upon results from the comprehensive Needs Assessment completed in 2021. 

The future portends a holistic, integrated approach for the entire organization, with the goals of expanding SVS education offerings to meet the needs of a rapidly diversifying membership. To be relevant and competitive, the SVS will embrace an education strategy that allows for a centralized content planning and a decentralized implementation process. 

Additional programs, new formats, personalized programs for different audiences and demographics, and more opportunities for vascular surgeons to earn continuing medical education (CME) credit, are around the corner. 

And then there is the Vascular Annual Meeting (VAM) in Boston in June. VAM 2022 will continue the celebration of the 75th Anniversary of the SVS, which kicked off the festivities as an organization at VAM 2021 in San Diego, and will mark the 75th VAM in the Cradle of Liberty. The VAM Program Committee, led by Andres Schanzer, MD, and the Postgraduate Education Committee (PGEC), headed up by William P. Robinson, MD, have worked overtime to continue making improvements and enhancements to heighten the value and increase the reach of the meeting experience for SVS members and guests. 

These improvements include expanding the number of streaming sessions, implementing several new innovative PGEC sessions, and adding sessions on policy and advocacy and our new Women’s and Young Surgeons Sections. In addition, we will be providing all available OnDemand content from the meeting within the week following the meeting. We will also create a plan to engage younger surgeons both in the development of content and accessing content through visual abstracts. 

Research 

The Research Council, led by Raul Guzman, MD, is literally sculpting the future of vascular research. The council recently hammered out its top 10 research priorities for the decade to come, soon to be published in the Journal of Vascular Surgery (JVS). The top 10 will be leveraged to help shape focus and funding for vascular surgery research. The priorities tell a story about how the specialty and the SVS are evolving, with the introduction of vascular population health and vascular health disparities to the list. 

The Vascular Research Initiatives Conference (VRIC), popular with the vascular research community, will link back up in May 2022 proximal to the American Heart Association’s Vascular Discovery Conference. 

As a champion for research, the Research Council also has completed an extensive evaluation of key SVS and SVS Foundation research awards and found every dollar invested in early-career researchers leads to an almost 10-fold return in future research grant funding. SVS and Foundation programs are major career and discovery accelerators. 

Clinical practice 

William Shutze, MD, chairs the Clinical Practice Council, which has launched some of the most important and innovative new efforts overseen by the SVS in the past several years. It has supported the initiation and growth of the Wellness Task Force, led by Dawn Coleman, MD, and Malachi Sheahan III, MD, into a full SVS standing committee, and is poised to implement an array of innovative programs and approaches to meet a growing need within the SVS membership. 

This council also championed the workforce initiative to develop an economic valuation study of vascular surgery, published in 2021, which is driving the launch of a first-of-its-kind healthcare consulting initiative within SVS, partnering with SG2, to deliver solutions to systems seeking to optimize vascular care. 

The council also supported and facilitated the evolution of the SVS Community Practice Committee, which under the leadership of Daniel McDevitt, MD, transitioned to the Community Practice Section, giving hundreds of SVS members the opportunity to engage more deeply with colleagues who share a common interest in community practice. The interest, investment in, and support of community and office-based programs will be enormous in the coming years—including establishment of new research networks, educational programs and representation within SVS. 

The Clinical Practice Council and Quality Council are working together to develop an educational series of webinars to facilitate learning and transfer of knowledge to assist in translating clinical practice guidelines into vascular surgery practice. 

The long-range future of the Clinical Practice Council has also started to come into focus with initiatives to explore the potential of regional emergency vascular care networks, and the potential development of a vascular emergency care course, working closely with the SVS Physician Assistant Section and the Society for Vascular Nursing (SVN). 

New future initiatives under exploration also include development of a third-party peer-review program for smaller community and outpatient practices that have sporadic access to feedback, and the development of an expert witness program. 

Quality 

The SVS Quality Council was established four years ago and is currently led by Thomas Forbes, MD. It is focused on advancing and optimizing the SVS as the go-to center delivering guidance and education derived from evidence-based models of quality and appropriateness in vascular care. Many of the council’s initiatives that began with its inception are nearing launch-ready in the coming year. 

The SVS has been working with the American College of Surgeons (ACS) for the past two years on the design, testing and launch of a national verification program for vascular centers of excellence that will add vascular to the portfolio of such programs within the ACS. Eights pilot sites—four in-patient and four office-based center—have helped shape and refine the program standards and process in 2021 and the Vascular Center Verification and Quality Improvement (VCVQI) program appears ready for launch by mid- 2022. This effort began within the SVS under the leadership of Kim Hodgson, MD, and Tony Sidawy, MD, and is now led by R. Clement Darling III, MD, and William Shutze, with continued support and engagement of Sidawy who is the chair of the Board of Regents of the ACS. 

No topic has sparked more interest and discussion this past year than appropriateness of care, and the role and responsibility of the SVS as a society to provide clinical guidance. This is especially challenging in areas of practice where strong evidence is sparse. Establishing appropriate use criteria (AUC) is the mechanism, process and tool utilized by medical societies to provide some guidance. 

The SVS Appropriateness Committee, led by Jeffrey Siracuse, MD, has been working on producing its first AUC on intermittent claudication, with the AUC process led and expertly facilitated by Karen Woo, MD. The first SVS AUC is expected to be approved and published soon. Next up for an AUC? Carotid disease treatments. 

Another major challenge has been to advance quality improvement initiatives throughout the SVS and its membership. To that end, the Quality Council helped establish a new Quality Improvement Committee, led by Jessica Simons, MD, to develop and deliver education and initiatives. Work has begun to compile survey and needs assessment data from SVS members about their approaches to quality improvement in practice, and a compendium of articles forming a primer is under development for publication in JVS. 

The centerpiece, or core, of SVS quality initiatives is our registry, the Vascular Quality Intiative (VQI). Under the leadership of Fred Weaver, MD, and Jens Eldrup-Jorgensen, MD, the VQI continues to set the bar, not only for quality in registry data integrity, structure and process, but also in leveraging the power of real-world evidence to advance quality and safety in vascular care. In the year ahead, the VQI will continue to drive quality initiatives in its regional network, foster and expand original real-world evidence research, and continue discussions regarding optimal position and utilization of the VQI to advance and accelerate national and international quality initiatives. 

SVS vitality 

With regard to the health and vitality of the SVS as a medical society, there is virtually no aspect of the SVS that has not been explored for potential change and innovation the past several years. The willingness to do this by past SVS Presidents Ronald Fairman, MD, R. Clement Darling , Michel Makaroun, MD, Kim Hodgson, and Ronald L. Dalman, MD, as well as current President Ali AbuRahma, MD, and President-elect Michael Dalsing, MD, has literally reshaped the SVS and positioned it well for whatever the future brings. 

Over the past six years, the SVS has restructured its governance with a new Executive and Strategic Board model; moved to an internet election for open officer positions, providing a choice of two candidates for each vacancy; established new governance-level Diversity, Equity and Inclusion (DEI) and Communications committees to organize and advance SVS in such areas as its branding campaign and toolkit; and established four new pilot member sections for Community Practice, Young Surgeons, Women and Physician Assistants to drive and enhance member value. 

The SVS appointments process has been overhauled to maximize the number of members who can engage and serve on SVS committees, with an eye toward early-career and DEI representation. The SVS also developed a management relationship with the SVN in alignment with the goal of supporting the “vascular team.” 

On the horizon for the SVS is exploration of ways to further enhance communications and value for members through a potential SVS Enterprise App; continued investment in furthering and integrating DEI principles across SVS activities and initiatives, including a planned multi-vascular society DEI Summit; a substantial increase in focus, investment, and engagement of early-career members; and further focus on dialogue and collaboration with vascular societies to strengthen unity across the specialty and diminish divisions. 

The FY2023 budget, approved March 29, and effective April 1–March 31, 2023, is embedded with the resources and support to move all of these key initiatives forward. 

CX 2022: Overtreatment in venous disease: Financial incentives are ‘the elephant in the room’

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CX 2022: Overtreatment in venous disease: Financial incentives are ‘the elephant in the room’
Armando Mansilha and Manj Gohel

To combat the “overtreatment problem” in the appropriate care of venous disease, “a concerted, complex, multimodal effort” is required from specialists across disparate parts of the world.

That was the conclusion delivered by Manj Gohel, MD, of Cambridge University Hospitals, Cambridge, England, during the opening day Venous & Lymphatic Challenges session—Appropriate Care Challenges—at CX 2022 on Tuesday. He further told attendees: “But the elephant in the room is reimbursement. Until that is sorted,” he said, “we will not be able to get on top of this.”

During his presentation, “How to curtail inappropriate care in venous disease interventions,” Gohel had stressed how the aim was to curb overtreatment but also not reduce innovation.

“Probably the most inappropriate care in venous disease is actually undertreatment. We have masses of undiagnosed, and definitely undertreated, venous problems. Overtreatment is however an enormous problem.”

Why? Education plays a part, he said, along with such elements as patients’ desire for intervention and an evidence gap in some areas of care that “allows variations in practice.” Yet, the biggest is financial gain, Gohel outlined. “Reimbursement systems around the world are poorly incentivized,” he said.

Earlier in the session, Steve Elias, MD, director of the Center for Vein Disease, Englewood, New Jersey, spoke on the extent of overtreatment in superficial venous disease care, stating how evidence demonstrated such overtreatment clearly represented inappropriate care—“people treating  the wrong patients, or doing too many things on who we consider the right patients.”

Responding to a question posed by Armando Mansilha, MD, of the University of Porto, Porto, Portugal, a session moderator, about how aspects of the overtreatment problem might be addressed, Elias offered one potential solution: “Stop paying people for doing the wrong thing by partnering with payors,” he said. Elias had referenced outliers in practice who may perform many more ablations per patient than the 1.8 shown in a Medicare data analysis from 2019. “Because the payors know what claims are being sent in. Let us start with those who were two standard deviations away from the norm,” Elias added. These interventionists may be doing the right thing, or perhaps they are seeing patients with more advanced disease, but such a move to partner with payors would represent a move in the right direction, he explained.

Kathleen Gibson, MD, of Lake Washington Vascular, Bellevue, Washington, turned the spotlight on deep venous disease, speaking on “managing the safe introduction of medical devices,” focused particularly on the developing area of dedicated venous stents.

“When these were approved, it was kind of like taking people who were used to driving a stick shift [car],” Gibson said, making an analogy to heretofore use of the nondedicated Wallstent. “Now we have got a fleet of automatics.” Everyone could now drive easier, she said, except the dawn of dedicated venous stents “led to some disasters.”

“Maybe we should curb our enthusiasm,” Gibson suggested.

She pondered what venous disease specialists can do differently. “We need to make sure we have the right doctors doing the procedure with appropriate skills, judgement and ethics,” Gibson said. That means “correct patient selection in terms of diagnosis and application of technology, and short- and long-term follow-up,” along with increased rigor of venous training, discouraging inappropriate use, and publishing complications.

The value of recently published European Society for Vascular Surgery (ESVS) guidelines on chronic venous disease in the promotion of evidence-based care was highlighted by Marianne De Maeseneer, MD, of Erasmus Medical Centre, Rotterdam, The Netherlands, who is chair of the ESVS guideline-writing committee.

“The new ESVS guidelines certainly help to promote evidence-base care for our patients with chronic venous disease,” she said. “A vast majority are class 1 and 2a recommendations, so they are clear guidance for the clinician. The level of evidence should still be improved in future research,” and gaps in the evidence should be filled by randomized controlled trials and real-world registries, De Maeseneer added.

Gibson, meanwhile, offered perspective from the United States during the questions and answers following Gohel’s presentation on ways to curtail overtreatment.

Venous disease is not well taught in fellowship or training Stateside, she said. Trainees receive lots of arterial training during the training years, yet a large portion of what they confront in practice is venous disease—and they are “not trained”, she said.

Regulation, too, figures as an issue, Gibson added. While “hospitals can regulate who can put things in,” she said, “a lot of devices like iliac stents are put in in the office setting”, where there is no regulation, and where a dermatologist armed only with their state medical license can be performing venous procedures.

Gohel was succinct as he added one further concluding statement. “If you have the right healthcare culture, humility, focus on patients, desire to audit and be transparent with your results, and amend your practice based on your results, that is the right approach,” he said.

SVS members receive deep discount on key textbooks

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SVS members receive deep discount on key textbooks
Rutherford’s Vascular Surgery and Endovascular Therapy and Rich’s Vascular Trauma

Society for Vascular Surgery (SVS) members receive many important discounts as a privilege of belonging. These perks include discounts to important references in diagnosing and treating vascular injury, including Rich’s Vascular Trauma and Rutherford’s Vascular Surgery and Endovascular Therapy. 

Both works are published in association with the Society. Members receive 30% off when using the SVS discount code, SVS30. The fourth edition of Rich’s Vascular Trauma was released in November 2021. The fully updated edition reflects recent changes in vascular injury patterns, wounds and trauma care. It draws from current research and a wide variety of peer-reviewed publications to keep surgeons up to date with the latest evidence-based management strategies and techniques, according to publisher Elsevier. 

It was written and edited by vascular surgeons who are also trauma specialists with proficiency in both open-surgical and endovascular techniques. Editors are Todd E. Rasmussen, MD, and Nigel R. M. Tai, MS FRCS. With the SVS discount, the cost of Rich’s is $160.99. 

Visit vascular.org/Rich’s for information and to buy the book. Pre-orders are being accepted now for the 10th edition of Rutherford’s Vascular Surgery and Endovascular Therapy, to be released in November. Multidisciplinary and international authors contributed to the two-volume set, which is considered an “outstanding reference for vascular surgeons, vascular medicine specialists, interventional radiologists and cardiologists, and their trainees who depend upon Rutherford’s in their practice,” said Elsevier. 

Former SVS Presidents Anton Sidawy, MD, and Bruce Perler, MD, are again the editors. See vascular.org/RutherfordQandA for a question-and-answer session with Perler on the new edition. With the SVS code, the price of Rutherford’s drops to $297.49. Visit vascular.org/Rutherford10 to purchase the set and get more information.

From proposal to podium: Tips for getting your abstract accepted at academic conferences

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From proposal to podium: Tips for getting your abstract accepted at academic conferences
Charles DeCarlo

Striving for excellence in research is one of the defining characteristics of an academic surgeon. But simply doing great research is not enough. The dissemination of that research through academic forums, presentations and publications is just as critical because others need to share in that research, peer-review it, and, ultimately, implement your findings for the world to become a better place. 

On the personal front, presenting your research at meetings is an excellent way to maximize the exposure of your research, while simultaneously providing a platform for career advancement, networking and collaboration. After a great research project is conceived and completed, the next step is to get your work to an academic conference. But this can be a daunting and confusing task. I am excited to share my tips for success with you for every step in the process.

Choose a project that is both relevant and feasible 

Making your project stand out and be worthwhile starts at the design phase. Your research question should aim to fill a gap in knowledge and not reproduce something that has already been done. However, strictly filling a gap in knowledge may not be enough to earn a plenary presentation. An attractive abstract addresses current events/developments in the field, studies rare disease processes, or introduces or expands on new techniques or methods. 

Producing a methodologically-sound abstract that addresses one of the aforementioned is the best way to secure the podium. 

Before embarking on a project, familiarize yourself with the literature in the field and ascertain exactly where your project fits in. It does not have to be something earth-shattering; simply detailing how new guidelines on a topic impact your local hospitals practices may be enough as long as someone, somewhere will be able to use your research to take better care of patients. To that end, make sure that your project is feasible—it should be something you can complete in the time, and with the money, or resources, allotted to you.

Writing and submitting your abstract

The title, the background/introduction, and conclusion of your abstract are key to piquing interest in your work, while summarizing your key findings and conveying the overarching message. Each of these sections should be concise yet emphasize the significance of your work. While we all strive to have robust and valid methods, the gritty details of your statistical methods do not need to be included in your abstract.

Conferences want their program to include content on a broad array of vascular disease. Try to ensure your research is categorized appropriately, but recognize some categories are harder to be selected for than others simply because the space does not exist on the program. To that end, familiarize yourself with all the conferences in your specialty so you can ensure the maximal chance of acceptance, ideally for a podium presentation.

Prepping for your talk

Congratulations on getting accepted! People have different processes for preparing, so this might not work for everyone. Personally, I write down everything that I am going to say and memorize it rather than relying on presenter mode or written notes. I find that this helps my confidence, improves the flow of the presentation, and allows for better eye contact with the crowd. For your slides: keep it simple. Figures and pictures are good; copious text is not. 

Your big moment

It is hard not be nervous when presenting, especially if it is your first time; however, there are a few things in your favor. First, you know your project and data better than anyone in the crowd. Second, most people who stand up to ask questions have found your project interesting—people very rarely will stand up to attack you. 

Writing the manuscript before your presentation (or at least doing the literature review), and anticipating questions with the help of your mentors, are the best ways to be prepared for discussion of your presentation at the podium. While this is certainly a step outside most people’s comfort zone, it gets easier the more you do it.

The rest of the meeting

Networking is a great way to create new professional relationships, and advance your exposure and career. While there are sometimes organized events to promote, this such as job fairs, most networking opportunities occur outside of the meeting sessions. Welcome receptions, dinners and breaks between sessions are great opportunities to meet people. Conferences should also be an enjoyable experience, so don’t hesitate to set aside time to check out the host cities, meet up with friends, etc. Attendings want to talk and hear from you. 

As a final word, rejection of your abstract from a meeting is not an indication of a poor abstract. Many great abstracts do not make the cut, and everyone has had an abstract rejected that they thought was great. Do not let rejection deter your efforts. Find another meeting and resubmit.

Charles DeCarlo, MD, is a PGY6 integrated vascular surgery resident in the division of vascular and endovascular surgery at Massachusetts General Hospital in Boston.

Veteran community care: Ensuring community care plays a vital role within the VA health system

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Veteran community care: Ensuring community care plays a vital role within the VA health system
Michael Costanza and Vivienne Halpern

Concerns about veterans getting access to quality healthcare in a timely fashion led to the Veterans Choice Act in 2014 followed by the VA MISSION Act in 2019. These programs provide veterans with the opportunity to receive healthcare in the community that is paid for by the Veterans Health Administration (VHA). 

The initial Veterans Choice Act was available to veterans if they lived more than 40 miles from a VA facility or could not be scheduled for an appointment within the VHA wait time goals (usually less than 30 days). The MISSION Act expanded eligibility criteria to include: 

  • Service not available at a VA, or veteran lives in a state without a full-service VA 
  • Drive time: >30 minutes for primary care; >60 minutes for specialty care; >40 miles to a VA providing specified care 
  • Appointment wait time: >20 days for primary care; >28 days for specialty care 
  • Community care in the veteran’s best medical interest as determined by patient and clinician 
  • Quality of care provided by the VA for the veteran’s specific condition fails to meet its own quality standards 

Even before the expansion of services triggered by the MISSION Act, the VA provided non-VA, community-based healthcare for more than 25% of veterans. The 2022 VHA budget requested $23 billion in discretionary funding for community care that represents an increase of 26.5% from the 2021 budget and makes up nearly one-fourth of the total medical care appropriations. In 2021, the more than 4.75 million veterans received community care referrals, of which approximately 34,000 (less than 1%) were referred for vascular surgery care. The most common reason for vascular surgery referrals was distance (50%) followed by unavailable service (33%). 

The MISSION Act aims to provide veterans with timely access to high-quality healthcare that is geographically accessible. However, meeting these ambitious goals may require a more nuanced solution than simply increasing referrals to community care providers. Challenges include how to evaluate the outcomes of community services, helping veterans make informed decisions about community care, maintaining open communication between the community and the VA, evaluating the cost effectiveness of community services, and determining when geographic proximity increases quality. Recognizing and addressing each of these areas will be important in the future success of VA-sponsored community care. 

For many veterans, travel to a large VA medical center represents a hardship, and the MISSION Act attempts to address this by allowing for community care that is geographically closer. However, community care, regardless of its convenience, does not always translate into faster or better-quality service. Remote areas rarely offer surgical specialty care, and veterans requiring these services may be best served by staying within the VA. 

Quality studies comparing the VA and community services have shown that the VA has the same or lower rates of surgical morbidity and mortality compared to the general community. Wait times for specialty care also may not be uniformly shorter in the community compared to the VA. Ensuring that veterans benefit from the MISSION Act will require close evaluation and monitoring of the availability and timeliness of community services. 

To achieve the goals set by the MISSION Act, veterans and their VA caregivers will have to make informed decisions regarding community care. Ideally, quality metrics from the community and the VA will be available for comparison so the veteran can make an informed choice. The access and sharing of these quality measures requires active participation by the VA. Raising awareness of the VA’s quality measures and performance among veterans and VA providers represents half of this equation. The other half should focus on setting up incentives for community health systems to track and share quality measures with VA providers and patients. 

The VA’s healthcare system centralizes patient data and facilitates communication between VA providers. This system promotes quality care and reduces cost by decreasing the risk of duplicated therapy and coordinating care programs for veterans with medical and mental health concerns. 

As community care expands, the VA will need to develop an effective communication system in order to promote sharing information between the VA, community providers, and veterans. Opening and maintaining these communication channels will foster efficient care, and possibly lead to a comparative evaluation of community and VA outcomes and patient experience. 

Telehealth may allow the VA to provide more timely and efficient care by meeting veterans where they are. In addition to routine follow-up appointments, which can occur in the veterans’ home, telehealth can also support more detailed, specialty-specific evaluations. Telehealth visits conducted in community-based outpatient centers (CBOCs), or local wound clinics, can employ licensed nursing staff to perform a basic vascular exam. These telehealth encounters shorten wait times and eliminate the barrier of long travel distances. Maximizing the use of telehealth could help decrease the number of community care referrals placed for “distance.” An expanded role for telehealth will also bring new challenges unique to a technology-reliant healthcare system. Rural areas often lack broadband availability to support telehealth encounters. Ensuring that veterans have access and technologic support will play a role in determining how much telehealth can provide for more timely and convenient care. 

Non-VA providers play an extremely important but potentially overlooked role in the VA’s community care program. The rapid increase in community care requests triggered by the MISSION Act has undoubtedly taxed the entire referral system. Non-VA providers who have the expertise and capacity to care for referred veterans often experience difficulty in gathering information from the VA and in getting authorizations for follow-up visits. 

Bureaucratic inefficiencies and delays in receiving compensation can discourage non-VA providers from accepting future referrals. Long-term success for the MISSION Act hinges on the VA’s effort to engage non- VA providers. Creating a user-friendly referral system that maintains continuity of care and provides prompt and appropriate compensation for non-VA providers will help foster a network of high-quality care. The VA stands alone as an effective and committed provider for the nation’s largest integrated healthcare system. With the MISSION Act, the VA steps into a more prominent role as a healthcare payor. Ensuring that veterans continue to receive timely and high-quality care will require sustained cooperation and coordination between the VA and community providers. 

Efforts that promote sharing and comparing quality measures, open communication, cost containment, and the innovative use of telehealth, will be be central to ensuring that community care plays a vital role within the VA health system. 

References 

  1. Kullgren JT, Fagerlin A, Kerr EA. Completing the MISSION: A blueprint for helping veterans make the most of new choices. J Gen Intern Med 2019;35:1567-70. 
  2. Massarweh NN, Itani KM, Morris MS. The VA MISSION Act and the future of veterans’ access to quality healthcare. JAMA 2020;324:343-4. 
  3. Schlosser J, Kollisch D, Johnson D, Perkins T, Olson A. VA-Community dual care: Veteran and clinician perspectives. J Community Health 2020;45:795-802. 
  4. Stroupe KT, Martinez R, Hogan TP, Gordon EJ, Gonzalez B, Kale I, Osteen C, Tarlov E, Weaver FM, Hynes, DM, Smith BM. Experiences with the Veterans’ Choice Program. J Gen Intern Med 2019;34:2141-9. 

Michael Costanza, MD, and Vivienne Halpern, MD, are members of the SVS VA Vascular Surgeons Committee. 

VAM packed from beginning to end

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VAM packed from beginning to end
Robert B. Smith was the 2020 winner of the SVS Lifetime Achievement Award. He collected the accolade during the VAM 2021 in San Diego

From the opening session on the Wednesday morning of the Vascular Annual Meeting (VAM), to announcing the winners of the Poster Competition Championship Round on Saturday afternoon, attendees at the 2022 meeting will find plenty to keep them interested. 

That’s by design, said Andres Schanzer, MD, chair of the SVS Program Committee, which oversees the VAM schedule. He added attendees should be sure to keep that in mind when making travel arrangements. “We’ve been adjusting the schedule, starting last year, to make sure the plenary sessions are free from competing sessions. Then, working with the Postgraduate Education Committee [PGEC], which oversees more than 25 other educational sessions, we crafted a schedule with as few overlapping topics as possible.” 

On Wednesday morning, for example, attendees can move from the abstracts at the International Fast Talk session, to the Opening Ceremony, to the William J. von Liebig Forum (the first plenary session), to the second plenary session, and then to the E. Stanley Crawford Critical Issues Forum, without missing any other sessions. 

In the afternoon, attendees can choose the Vascular and Endovascular Surgical Society (VESS) abstract presentations from 12:45 to 6 p.m. or two “Ask the Expert” sessions, a special session on policy and advocacy, as well as the International Poster Competition and a welcome reception for the World Federation of Vascular Societies (WFVS). 

Similar choices are in store Thursday through Saturday between postgraduate courses and other educational sessions. “All in all, we’ve reduced overlap as much as possible,” said William P. Robinson, MD, PGEC chair. The readjustments allow attendees to maximize their experience, taking in sessions on a wide variety of topics. And beyond the educational offerings, there continue to be several special events as well, among them: 

The Roy Greenberg Lecture, 9:30 to 10 a.m. Thursday, presented by Jan Brunkwall, MD, of the University of Cologne, Germany 

The Awards Ceremony, presenting the recipient of the SVS Lifetime Achievement Award and/or of the SVS Medal for Innovation

Rockman: A family story of self-identity

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Rockman: A family story of self-identity

Outgoing Society for Vascular Surgery (SCVS) President Caron Rockman, MD, delved into her family history from late-19th century and early- 20th century Russia to deliver a poignant message to Annual Symposium attendees during the 2022 SCVS Presidential Address: “the importance of embracing all aspects of our self identity,” she said— as individuals, as people and as vascular surgeons.

“Mirror, mirror, on the wall…” told the story of Rockman’s maternal great grandfather and his youthful dream of becoming a pharmacist, a feat ultimately achieved by his daughter, Rockman’s grandmother. Her grandmother briefly became a female pharmacist in the U.S. of the 1930s, an unusual role among her peers for the time, before becoming a housewife and mother.

Rockman told SCVS delegates gathered in Las Vegas (March 19–23) she knew none of this story while her grandmother was alive. She also later discovered among her late grandmother’s effects that, although she had not worked as a pharmacist for more than 60 years, she had paid to have her license maintained well into the later years of her life. All of this factored into the thinking behind the address, Rockman informed Vascular Specialist in an interview.

“I often wondered over the years about what she saw when she looked in the mirror,” she had told her SCVS audience. “Did she see herself as a housewife, mother and homemaker typical of her generation? Or did she see, instead, an educated professional woman unusual among her peers. My sense is that she was trying to see both sides of herself.” 

That resonated, Rockman told VS, because she too had faced that dilemma—and many of her own peers may perhaps face such conflicts. 

VAM: Gala auctions taking shape

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VAM: Gala auctions taking shape
Live and silent auctions will form part of the SVS “Cheers to 75 Years” Gala at VAM in Boston

It’s spring now, but those whose winters seem never-ending might consider bidding on a week-long stay in Florida for next winter. Cold and snow are much more bearable when a week of sun and sand beckons part-way through. 

Access to a three-bedroom condominium in Ormond Beach, Florida, is just one of the attractions being offered via the live and silent auctions, part of the SVS “Cheers to 75 Years” Gala to benefit the SVS Foundation. The event will be held the evening of Friday, June 17, during the 2022 Vascular Annual Meeting (VAM) in Boston. 

Also available is a custom loupes box hand-crafted of imported exotic wood, complete with an inscription of the high bidder’s choice. A long weekend in the Hamptons in New York—that string of seaside communities on Long Island immortalized in books and movies—will be on the auction block, as will a fishing weekend for two in Florida and a week-long stay in Hermosa Beach, California. 

Though the Gala’s live auction will be available only to Gala ticket-holders, anyone, anywhere, can bid on the silent auction prizes, via computer. Those items will be available in early June, ahead of the Gala itself. 

Organizers still seek additional items for the two auctions. Of particular interest are sporting events, especially in upgraded seating such as skyboxes; experiences such as a weekend fly-fishing; or, as at the 2019 Gala, climbing Mount Rainier in Washington state; and artwork, fine liquors and wine. 

A dwindling number of tickets remain available for the Gala, which will feature a reception, plated dinner, entertainment and dancing—plus the live auction—at the Sheraton Boston Hotel, the VAM “Headquarters” hotel. 

Tickets are $500 each, or $5,000 a table. As of late March, two Platinum and one Gold Premium tables ($20,000 and $10,000 each, respectively) remained available. Learn more at vascular.org/Gala22Tickets. 

Meanwhile, elsewhere at VAM, while the vast majority of programming is included in the registration fee, some courses and events require a ticket— even if there is no fee associated with it. Be sure to include ticketed sessions in your registration, or return to registration to add them. Visit vascular. org/VAM-2022/registration.

Terumo Aortic announces FDA approval for Thoraflex Hybrid frozen elephant trunk device

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Terumo Aortic announces FDA approval for Thoraflex Hybrid frozen elephant trunk device
Thoraflex Hybrid frozen elephant trunk device

Terumo Aortic today announced that the Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk device for commercial sale in the U.S. for the treatment of patients with complex aortic arch disease.

Thoraflex Hybrid is the first-of-its-kind device used in frozen elephant trunk repair in the U.S. and was granted Breakthrough Device designation by the FDA in 2021.

Thoraflex Hybrid is a single-use medical device combining a Gelweave polyester graft with a nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta, with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.

“This approval represents a significant milestone in the treatment of patients who need total aortic arch replacement and have significant disease of the descending thoracic aorta,” said Joseph Coselli, MD, professor and executive vice chair in the division of cardiothoracic surgery at Baylor College of Medicine in Houston, who was the principal investigator of the Thoraflex Hybrid investigational device exemption (IDE) study.

“They can now be treated anytime in a single stage procedure with this hybrid device rather than two procedures, which has been the conventional pathway in the United States for this group of patients. This, in turn, has led to lowering the risk of major adverse events by 22.6% in the first year over traditional treatments.

“Thoraflex Hybrid facilitates secondary interventions for distal extension and, in the United States, is designated for usage with Terumo Aortic’s RelayPro NBS device. This unique labeling aspect provides surgeons with additional confidence should patients have continued aortic disease progression.”

Thoraflex Hybrid received CE mark approval in 2012.

SCAI issues position paper on transaxillary arterial access

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SCAI issues position paper on transaxillary arterial access
Darren B. Schneider

The Society for Cardiovascular Angiography & Interventions (SCAI) has released an official position statement providing evidence-based recommendations for percutaneous transaxillary arterial access and training for clinicians. The document was published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), with Society for Vascular Surgery (SVS) representative Darren B. Schneider, MD, and Vascular and Endovascular Surgery Society (VESS) representative Yazan Duwayri, MD, co-authors.

The femoral artery is the most frequent access site for percutaneous placement of large-bore arterial sheaths and devices. However, transfemoral access may be limited in a specific group of patients due to prior surgical interventions, disease, or other health issues. In these situations, axillary artery access can be a more feasible and beneficial alternative. Due to its benefits, usage of the transaxillary approach is progressively increasing. A formal SCAI statement regarding this access route was warranted to inform clinicians on best practices and guide future training options, the organization said.

“With the increasing use of percutaneous temporary mechanical circulatory support options for patients with cardiogenic shock, a wide range of specialists will need to be familiar with these concepts including advanced heart failure, interventional cardiology, and cardiothoracic and vascular surgery,” said David A. Baran, MD, of the Cleveland Clinic Heart, Vascular and Thoracic Institute, Weston, Florida, co-chair of the writing group.

The expert consensus statement aims to review the anatomic considerations and risks for percutaneous axillary artery access, suggest best practices for access techniques, hemostasis/closure strategies, and complication management.

“Axillary access is the predominant ‘alternative site’ for large-bore structural and endovascular procedures, and fortunately is less frequently affected by atherosclerosis. However, it is less muscular and more prone to injury than the femoral artery and potentially poses some unique risks to the unfamiliar operator. We brought together interventional cardiologists, vascular surgeons, interventional radiologists, and heart failure specialists to share their best practices for this important technique, including anatomy, positioning, ultrasound guidance, dry closure, and complication management,” said Arnold H. Seto, MD, Long Beach VA Medical Center, Long Beach, California, writing group chair.

The statement concludes with recommendations for areas to explore in the future such as imaging for axillary access, approaches to axillary device removal, and securing devices for longer term use. There is also a strong emphasis on the importance of developing training criteria and requirements, and privileging considerations.

The document was endorsed by the American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Society for Interventional Radiology (SIR), and VESS.

The top 10 most popular Vascular Specialist stories in March

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The top 10 most popular Vascular Specialist stories in March

Among the posts catching Vascular Specialist readers’ eyes last month were the digital flipbook version of our March print edition, a new study looking at the Society for Vascular Surgery (SVS) open abdominal aortic aneurysm (AAA) recommendations, and an interview with one of the founders of a novel vascular scaffolding device to treat peripheral arterial disease (PAD). March’s top 10 also included a story covering new VenoValve data, and a video interview with Ulka Sachdev-Ost, MD, focused on diversity.

1. Vascular Specialist—March 2022

Our April print issue featured several stories reported from the 2022 annual meeting of the American Venous Forum (AVF) in Orlando, including “Dedicated vs. non-dedicated,” a piece looking at talks in which researchers placed venous stenting under the spotlight.

2. Study ‘supports’ SVS open AAA volume recommendations

A multicenter, retrospective database analysis suggested improved open AAA outcomes when surgeon volume is greater than seven cases yearly and performed in hospitals with a 30-day mortality rate less than 5%.

3. AVF 2022: VenoValve improvement ‘maintained’ for 2.5 years without adverse events

Envveno Medical announced positive 30-month data from the first-in-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF) annual meeting (VENOUS2022) held in Orlando, Florida (Feb. 23–26).

4. Potential ‘new paradigm’ in treatment of long occlusive lesions emerges

Lewis Schwartz, MD, spoke to us as one of the co-founders behind a novel, balloon-expandable, resorbable, drug-eluting device, which featured among the scientific presentations at last year’s annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Chicago.

5. Writing and reviewing in the DEI space: Progress evident but ‘there’s a lot of work to do’

In a video interview, Ulka Sachdev-Ost, MD, sat down with us to speak about her role as diversity, equity and inclusion (DEI) editor on the Journal of Vascular Surgery (JVS). She outlined milestones reached and how her journey as the first-ever JVS diversity editor had evolved in her time at the helm.

6. Silence is golden—but does self-imposed silence lead to burnout?

Last month, readers flocked to our February edition guest editorial by Bhagwan Satiani, MD, who asked: “Silence is golden—but does self-imposed silence lead to burnout?”

7. SCVS 2022: ‘We should not allow our industry relationships influence how we choose to treat patients’

Industry players and device makers have helped spark new science and innovation in vascular surgery amid flatlining National Institutes of Health (NIH) funding, but physicians must pay heed to the conflicting agendas in the partnerships formed with these companies, a focus session on ethical issues in practice at the 2022 annual symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas (March 19–23) heard.

8. Houston, we have a dialysis access problem

The concept of dedicated vascular access centers fueled a turbocharged Texan tussle with Karl Illig, MD, of Flow Vascular Institute in Houston, who took on Eric Peden, MD, an associate professor of cardiovascular surgery at Houston Methodist Hospital, in a no-holds-barred debate on how best to deliver longitudinal patient care. The burning question was: who will patients call with “Houston, we have a (dialysis access) problem”?

9. F/BEVAR review reveals less than 20% of patients suffered intraoperative adverse event

A retrospective evaluation of 600 fenestrated or branched endovascular aneurysm repairs (F/BEVARs) for the treatment of complex aneurysms revealed that fewer than one in five patients experienced an intraoperative adverse event, according to a new study published in the March 2022 edition of the JVS.

10. The pandemic has been a challenge, but perhaps it imposed some equity

In our March print issue, guest editorialist Lauren Cralle, BS, pondered the pandemic-imposed birth of the virtual interview for vascular residency applications, writing that the remote mode of assessment “may be the great equalizer to some degree.”

Supply & demand: [Private] practice matters

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Supply & demand: [Private] practice matters
Since 2019, there has been a sharp increase in the number of vascular training programs compared to the three years prior

Vascular surgeons in private practice could play a crucial role in alleviating one of the existential problems currently vexing the specialty: The training of future generations of specialists and its intersection with declining numbers of open abdominal aortic aneurysm (AAA) repairs.

The ability of those in private practice to contribute to the total number of training positions available across the United States, as well as to broaden the church of open aortic cases available for trainee involvement amid the fall in AAA repairs performed surgically, was brought into sharp focus during a training and education scientific session held during the 2022 Annual Symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas (March 19–23). Discussion was stirred by data delivered by Malachi Sheahan III, MD, on the success of a national initiative carried out to explore how to overcome barriers and better help those interested in starting new vascular training programs, as well as new statistics presented by Thomas F. X. O’Donnell, MD, that showed the “significant proportion” of open AAAs completed without any trainee participation. 

Sheahan, chief of vascular surgery at Louisiana State University (LSU) in New Orleans, told SCVS attendees how since he was charged with helping spark an increase in vascular training programs in 2019, his research had demonstrated a sharp increase to 28 new programs in the last three years—compared to just seven in the three years prior. 

Working under the auspices of the Society for Vascular Surgery (SVS) and the Association of Program Directors in Vascular Surgery (APDVS), he and colleagues on a taskforce formed for the initiative reached out to 172 general surgery programs then without an associated vascular surgery program, and 12 large private practice groups thought large enough to support a fellowship. 

They tackled the issue at a critical juncture: since the inception of the integrated vascular surgery residency training paradigm in 2007 through 2015, the sum of new programs increased every year, Sheahan pointed out. Then the level essentially flat-lined for four years. “You can see that the number of new training programs stagnated around 0–2 a year. Since the initiative was started, we have 28 new programs. In the three years before the taskforce, we had seven programs total approved, then in the three years after we have 28 new programs,” he said. 

Malachi Sheahan III et al looked into data on the progress being made to increase the number of vascular training programs in the U.S.

Four key planks of the initiative aided the taskforce efforts, Sheahan explained. First, they sought—and gained—clarification from the Residency Review Committee (RRC) of the Accreditation Council for Graduate Medical Education (ACGME) over faculty and program director requirements needed to start both an integrated program and a fellowship. They then set about providing stewardship to help guide those getting started through an often “byzantine and confusing” process, Sheahan said. They also increased outreach efforts through such mediums as a recurring Vascular Annual Meeting (VAM) session on how to start a vascular training program, the creation of an ad hoc APDVS committee to act as a home for continuing efforts, and one-on-one mentorship for new program leaders. Ultimately, the initiative worked, said Sheahan. Stressing more work remained to be done on the matter, “with a bit of a push, there are a lot of people out there who want to train vascular surgeons,” he added. 

Private practice interest 

Meanwhile, Sheahan’s data also showed that just two of the 12 private practices identified and contacted as potential sites for vascular fellowships expressed an interest in starting a program within the following three years, with the most common barriers cited being financial (50%), administrative (42%), and lack of interest (42%). 

During post-presentation questions, this detail prompted Brigitte Smith, MD, program director of the vascular surgery fellowship at the University of Utah in Salt Lake City, to ponder whether private practices could partner with programs such as her own to increase opportunities. 

“I have one spot a year for fellowship; could I offer two spots a year if I partnered with these private groups?” she asked “They don’t need to start their own program necessarily, but would they be willing to take trainees? That seems like a way to increase spots, if not programs.” 

Sheahan explained that the absence of any kind of fellowship in the hospitals where the private practice surgeons operated appeared to be the main hold-up, alongside a gap in knowledge. “Part of it is still the RRC’s fault, in that how big some of these requirements are. So them clarifying in the last couple of years allowed a bloom in programs,” he said. 

Responding to acknowledgment from the floor over recently successful Match seasons, Sheahan noted that the first two virtually administered interview processes during the pandemic for both integrated and fellowship programs saw 100% of positions filled—essentially a first. Earlier, Sheahan had conceded how when the question of vascular surgery training programs was looked at through the prism of “supply and demand,” he belonged to the demand side of the equation, arguing for a need to increase the number of students and residents in order to generate more programs. “We built all these programs but it seems like we are increasing demand as well,” he added during the question period. 

Those operating outside of traditional training institutions potentially making a contribution to raising the level of trainee involvement in open aortic cases was the backdrop to O’Donnell’s data, which was garnered from the National Inpatient Sample between 2004–2015. 

Thomas F. X. O’Donnell at the SCVS 2022 podium

By looking at 140,000-plus cases, O’Donnell and colleagues at Beth Israel Deaconess Medical Center in Boston showed that some 38% of open AAA cases were performed at institutions classed as urban non-teaching hospitals, with 58% carried out in urban teaching locations and 4% at rural hospitals. 

“Over time, open AAA volume in rural hospitals fell 89%, urban non-teaching volume dropped 87%, and urban teaching hospitals fell 58%,” he said. “At the end of the study period, rural hospitals accounted for 2.9% of open AAA volume, urban teaching centers 78%, and urban non-teaching hospitals 19%. However, in the last two years of our sample, non-teaching hospitals still accounted for almost 1,400 open repairs on average annually.” 

O’Donnell continued: “Overall, mortality was 5%. There was no difference between teaching status in either group or in adjusted analyses. Despite concerning training experience with open AAA repair in recent years, a significant proportion of the open AAA repairs in the United States occur without any training participation. These data suggest that partnerships between vascular training programs and unaffiliated hospitals offer one potential solution to current deficiencies in open aortic training.” 

Yet, bringing private practice vascular surgeons into the fold is not without challenges, members of the audience observed. Most of those practicing in non-teaching hospitals do so because they don’t want to perform cases with residents and fellows, said Linda Harris, MD, program director of the vascular fellowship and vascular residency programs at the University at Buffalo in Buffalo, New York. She also queried O’Donnell over how many open cases were realistically available at the 92 hospitals highlighted in the study, with the post-2015 period showing a sharp decline according to his research. “Based on the way of the trend, it’s probably about a thousand per year or so, maybe a little less than that,” O’Donnell said. “It’s a large opportunity; it’s certainly not every private hospital that will want to have residents come or fellows come. But any improvement is good, so we’ll take what we can get.” 

In his capacity as an audience member, Sheahan chimed in to point out that aortobifemoral bypass surgery should be part of conversations about trainee involvement in open aortic surgery. “We have to get away from reporting open AAA as open aortic numbers, because they are not synonymous,” he said. “If you combine aortobifemoral and AAA, it’s not as dire as it looks. Yeah, open AAAs are going away, but we’re still doing a fair number of aortobifemorals, so consider that, too, when you publish.” 

Robert Hacker, MD, a vascular surgeon at SSM Health in St. Louis, remarked that he would gladly cooperate with the teaching hospitals in the area to boost trainee exposure to open aortic surgery at his non-teaching urban medical center. “I’m really concerned that the people going to take care of me and you guys are not going to have the experience to do open,” he said. “Because as these aneurysms with endografts start failing, there’s no more metal to put in, and they’re going to have to be done open. I think you’re going to see a big mortality jump in a few years,” as surgeons at institutions like the Mayo Clinic start to retire, Hacker added. “I would strongly encourage the academic centers to reach out to the private and academic people like myself and develop relationships, because there’s a lot to be learned and lot of people who can teach.”

Gilbert R. Upchurch Jr., MD, a session moderator, brought the conversation to a close with a note on inroads being made. “We need to partner with people in practice. We’re doing that at the University of Florida,” he said. “We have a third fellow who’s going to be going down to work in Daytona. I know they’re doing this at SIU with conversations I had today. There is hope.” 

Cydar Medical announces strategic collaboration with Medtronic

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Cydar Medical announces strategic collaboration with Medtronic
Cydar Maps

Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and case support, with the goal of improving patient care.

The Cydar EV Maps software harnesses the latest in cloud graphics processing unit (GPU) computing, computer vision and machine learning technology to advance surgical visualization and decision-making in theatre and across the care pathway. This enables clinicians to create detailed patient-specific 3D maps for procedure planning, image-guided navigation, and post-operative review, resulting in less radiation exposure to the patient and the clinical team, reduced procedure time, and increased delivery confidence. This pilot program will also inform the future development of predictive analytics to support procedure planning, by assessing factors such as the risk of endoleaks, sac regression probability and more.

Medtronic is the first medical technology company to enter a public strategic collaboration in digital endovascular technology to advance aortic patient treatment decisions. The collaboration is part of Medtronic’s ongoing commitment to innovation in aortic care for physicians and their patients.

Our past is prologue: We are losing the battle to train more Black doctors

Our past is prologue: We are losing the battle to train more Black doctors
Malachi Sheahan III

My mother was a child of the 1960s. Despite not having a college degree, she was determined to teach my sister and me that women could do anything. I guess my sister was really the intended target, but I was certainly along for the ride. Every doctor she ever took us to was a woman—to the point where I didn’t even realize men could be doctors. It was never a conscious thought, just an ingrained assumption that all doctors were women. My realization to the contrary came embarrassingly late. 

My family spent a good part of my early life living in a remote part of New York, near Montreal. We were culturally isolated. The TV shows were in French, so I could barely figure out what the Flintstones were up to, never mind the guys living in green tents on M*A*S*H. Somewhere near my 11th birthday, I decided it was time to announce my career choice. “I’m going to be a paleontologist,” I confidently declared. Without looking up from her newspaper, my mother shut it down quickly and viciously. “You’re never going to meet a wife digging around in the desert. You should be a doctor.” Slightly stunned by my mother’s uncharacteristically sexist take, I retorted, “I’m not even looking for girls, I’m looking for DINOSAU… Wait, I can be a doctor?” 

It is easy to overlook or minimize the importance of representation. Until you experience a lack of it. As we have seen with the increasing numbers of women in our specialty, representation truly matters. We know that enrolling more Black students in medical school will help recruitment for decades to come. The barriers, though, to increasing the number of Black doctors in the U.S. are deep-rooted. 

In the early 1900s, the Carnegie Foundation commissioned Abraham Flexner to evaluate the state of medical education in North America. Flexner visited all 155 medical schools in Canada and the U.S., issuing a detailed report of his findings in 1910. Flexner concluded that the rise of for-profit schools resulted in an overproduction of poorly trained physicians. The ensuing Flexner Report led to radical changes in medical education and became the basis for our now antiquated model, which includes two years of basic science. Critics pointed out that Flexner had received no medical instruction and valued science over clinical training. Pioneering physician William Osler worried that this emphasis on basic science would produce a generation of “clinical prigs.” 

While I am unsure of the precise definition of “prig,” I do enthusiastically add my support to Osler’s concerns regarding medical curricula. However, more germane to this discussion is that within 15 years of the Flexner Report, more than half of all U.S. schools had closed. The seven existing Black medical schools, with fewer resources, were disproportionately affected. By 1920, only two, Meharry Medical College and Howard University, remained. These closures had an enduring and tragic effect on our ability to produce Black doctors. By 2018, Black and African American individuals represented 13.4% of the U.S. population but only 5% of physicians.

A 2020 JAMA study estimated that if all seven Black medical schools had remained open, an additional 35,315 Black physicians would have entered the workforce. Flexner’s recommendations that led to the demise of these five medical schools do not appear to be based on any deep-felt bigotry. There is ample evidence that Flexner argued fervently for the survival of Meharry and Howard. Still, he is quoted stating that Black students should be trained as “sanitarians,” and in that role would also be protecting white people from disease. Flexner, though, knew Howard and Meharry could not survive without significant financial endowments from white people, so some have painted these statements as an appeal to these potential donors. 

At best, Flexner was an ignorant idealist, too rigid in his beliefs to appreciate that the need to continue educating Black doctors should supersede his desire to impose daunting standards on the schools willing to train them. 

AMA requirements 

Flexner was not solely responsible for the onerous requirements placed on Black medical schools. In 1906, the American Medical Association (AMA) Council on Medical Education sent a letter to every medical school urging them to require at least a year of college science classes prior to admission. This prerequisite would immediately and dramatically reduce the number of qualified Black applicants since few Black colleges offered these courses, and even fewer white colleges would admit them. Another AMA requirement banned classes after 4 p.m., which disproportionately affected Black students who had to work to pay tuition. Under these new restrictions, three Black medical schools closed before Flexner began his tour. 

A DEI panel convened at the 2022 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Last Vegas, March 19–23. From left to right: Eanas Yassa, Vincent Rowe, Malachi Sheahan, Misty Humphries, Bernadette Aulivola, John Charitable, Claudie Sheahan, Erica Leith Mitchell, M. Ashraf Mansour

After the Flexner Report, the surviving two Black medical schools were caught in a tug of war. On one side, Flexner stated the AMA’s regulations were “choking” the few remaining Black schools, particularly Meharry. The AMA countered that Flexner and the Carnegie Institute should help secure large financial endowments for the schools to help them meet the requirements. 

The AMA’s suppression of Black doctors began in the 1800s. Six of the first 13 AMA presidents resided in active slaveholding and trading states. The AMA claimed not to discriminate based on race, leaving admission decisions to its local chapters. Black doctors, however, found few chapters that would accept them, particularly in the South. AMA membership was critical for a physician and often tied to licensure and hospital admitting privileges. 

In 1869, the AMA chapter in the District of Columbia refused admission to three qualified Black doctors. A subsequent U.S. Senate investigation found the group guilty of excluding doctors “solely on account of color.” A bill to repeal their charter was presented to Congress but never passed. In 1870, the three excluded doctors joined other D.C. physicians to form the racially integrated National Medical Society (NMS). 

When the NMS attempted to be recognized by the AMA the following year, they were accused of admitting irregulars, specifically those who had not received a formal medical license or education. This was an extremely unfair hurdle because their licenses would have been issued by the D.C. chapter that had already excluded them. That year, the AMA Committee on Ethics reviewed charges against three groups accused of admitting irregulars. The accusations against the two all-white delegations were tabled, and these groups were recognized. The racially integrated NMS was denied entry by a 114–82 vote, in which 36 members of the D.C. chapter were allowed to participate. At the same convention, the AMA voted to issue the statement, “That inasmuch as it has been distinctly stated and proved that the consideration of race and color has had nothing whatsoever to do with the decision of the reception of the (NMS) delegates.” In other words, they voted to declare themselves not racist. 

Great Society 

By 1950, Meharry and Howard combined to produce about 100 Black doctors annually, while the remaining white schools added only 10 to 20 more. President Lyndon Johnson began the Great Society programs in the 1960s with the lofty goals of ending poverty and injustice. Johnson believed that education would be the great equalizer. His projects, combined with the advances of the Civil Rights era, led to minority enrollment in U.S. medical schools climbing from 2% to nearly 9%. Unfortunately, this progress then stagnated for 20 years. 

In 1991, Robert Petersdorf, president of the Association of American Medical Colleges (AAMC), announced a plan to enroll 3,000 Black and Hispanic medical students annually. He spoke to the 124 U.S. medical school deans, who met him with some skepticism. They did not even receive 3,000 minority applications a year. How were they supposed to double enrollment? Undaunted, Petersdorf launched Project 3000 by 2000. 

Under Petersdorf, the AAMC began new efforts at nearly every level of the education system. Pipelines programs were built, and articulation agreements were formed in which medical schools automatically admitted students meeting set academic goals. Race and ethnicity were factored into admission decisions, and for the first time in decades, progress was achieved. Black and Hispanic enrollment in U.S. medical schools increased from 1,500 in 1990 to more than 2,000 in 1995. But then, a seemingly unrelated legal ruling in Louisiana threatened everything. 

Project 3000 by 2000 employed a method commonly referred to as affirmative action. Even though affirmative action is the only technique that has ever proven successful in increasing minority enrollment in higher education, it has a long and tangled legal history in the U.S. 

The first mention of affirmative action came on May 6, 1961, in Executive Order 10925. President John F. Kennedy called on government contractors to “…take affirmative action to ensure that applicants are employed and that employees are treated during employment without regard to their race, creed, color, or national origin.” In 1966, President Johnson established the Office of Federal Contract Compliance Programs in the U.S. Department of Labor to enforce these requirements. Subsequently, President Richard Nixon issued Executive Order 11478, which called for unilateral affirmative action in all government employment. 

In 1978, affirmative action faced its first major legal challenge. Allan Bakke, a white male who had been denied admission to the University of California Davis School of Medicine two times, filed a lawsuit against the university. The medical school reserved 16 out of 100 spots for minorities at that time. The case found its way to the Supreme Court, where Bakke won and was granted admittance to the school. The court, however, did rule that race could be used as a factor in admissions, but quotas violated the 14th Amendment’s Equal Protection Clause. 

In 1992, Cheryl Hopwood and three other white applicants to the University of Texas Law School filed suit alleging that the school discriminated against them by using an affirmative action admissions process that placed Black and Mexican American applicants in a separate admissions pool and consequently accepted members of those groups over non-minority students who had comparable grades and test scores. The U.S. District Court for the Western District of Texas found in favor of the university. U.S. District Judge Sam Sparks stated in the decision, “until society sufficiently overcomes the effects of its lengthy history of pervasive racism, affirmative action is a necessity.” The case was then brought to the U.S. Court of Appeals for the Fifth Circuit. Here, Hopwood v. Texas was overturned, and affirmative action rejected. The ruling read, “the University of Texas School of Law may not use race as a factor in deciding which applicants to admit in order to achieve a diverse student body, to combat the perceived effects of a hostile environment at the law school, to alleviate the law school’s poor reputation in the minority community, or to eliminate any present effects of past discrimination by actors other than the law school.” 

The Supreme Court declined to review Hopwood v. Texas. Therefore the ruling became law in Texas, Mississippi and Louisiana. Even though the decision only applied to three states, the precedent was far-reaching. Schools across the U.S. adjusted their admissions policies, fearful of lawsuits. A 2003 Supreme Court decision in Grutter v. Bollinger later invalidated Hopwood v. Texas. Here, the court held that the Equal Protection Clause of the 14th Amendment does not prohibit the narrowly tailored use of race in university admission plans as part of a compelling interest in promoting student diversity. 

Still, the reversal came too late. Project 3000 by 2000, which had made the first progress in minority medical school enrollment in over 20 years, was abandoned. 

AMA apology 

In 2008, the AMA issued an apology for its “past history of racial inequality toward African American physicians.” In 2020, the AAMC removed Abraham Flexner’s name from its award for distinguished service to medical education. Today, though, more than atonement is needed. 

Every year, 21,000 students are admitted into the 154 U.S. medical schools. Black men often make up less than 500 of them. The AAMC reports that essentially every minority group saw an increase in medical school enrollment between 1978 and 2014, except for Black men. Black males face specific challenges: a higher likelihood of attending underfunded high schools and a lower chance of participation in AP courses, gifted programs and STEM classes. A 2021 UCLA study published in the Journal of General Internal Medicine found that the percentage of doctors who are Black males has remained unchanged since 1940. 

Financial considerations are also important. More than 70% of medical students come from homes with an average income of over $74,000 (2016 terms). Underrepresented minorities disproportionately come from lower socioeconomic backgrounds. As such, they carry an average debt of over $200,000 upon graduating from medical school. The Brookings Institute found that the net worth of the average Black family is about 10% of the average white family. 

The Medical College Admission Test (MCAT) poses another potential fiscal barrier. The registration is $320, but more affluent applicants can afford to spend thousands on tutoring, creating another disparity. The AAMC walks a tightrope in defense of the role of the MCAT in the admissions process. They have asked medical schools to de-emphasize the scores, but the AAMC also administers the exam. 

This fall, the use of race as a consideration in admissions may face its death in the Supreme Court. Edward Blum, an anti-affirmative action crusader, has filed separate lawsuits against Harvard and the University of North Carolina. Both cases were unsuccessful in federal district court, and the litigation against Harvard failed in the First Circuit Court of Appeals. The Supreme Court has paired the lawsuits and is bringing them to Washington to hear. Previous Supreme Court rulings allowing affirmative action have been close decisions, usually with a moderate conservative justice holding the swing vote. No moderate conservatives remain on the court. Many legal experts anticipate a 6–3 decision mandating complete “color blindness” in the admissions process. Based on Blum’s own documents, he expects that if his petition is successful, and affirmative action declared illegal, the share of Harvard students who are Black would fall from approximately 14% to about 3%. While its legal basis hangs in peril, we should consider the ethical implications.

To dispute the validity of affirmative action as a tool in higher education admissions, one must successfully defend one of two positions. Either diversity does not matter, or a means other than affirmative action can achieve it. Neither position, however, is scientifically viable. At a certain point, ignorance becomes a choice. 

Malachi Sheahan III, MD, is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans. He is medical editor of Vascular Specialist.

Alucent Biomedical announces first patient enrolled in first-in-human natural vascular scaffolding clinical trial

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Alucent Biomedical announces first patient enrolled in first-in-human natural vascular scaffolding clinical trial

alucent biomedicalAlucent Biomedical announced in a press release that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate the safety and efficacy of its natural vascular scaffolding (AlucentNVS) technology. The therapy is designed to open vessels and maintain patency without the use of permanent implants for the treatment of peripheral arterial disease (PAD) of the lower extremities.

The AlucentNVS vessel restoration system with photoactivated linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel. The intervention is designed to deliver restoration of the vessel’s lumen and sustained improvement of blood flow, without the introduction of a foreign implant, such as a metallic stent. AlucentNVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil. Sustained, improved blood flow is expected to result in pain relief, limb preservation, and an improved quality of life for patients.

The first patient in the ACTIVATE II study was enrolled by Chris Delaney, MD, at Flinders Medical Centre in Adelaide, Australia. In total, the trial will enroll up to 50 subjects at up to 12 research sites, which will include Prince of Wales Hospital in Sydney, The Alfred Hospital in Melbourne, Royal Perth Hospital, and Sir Charles Gairdner Hospital in Perth. The primary endpoints of the study are freedom from composite investigational-device, procedure-related major adverse events, primary patency as assessed by Doppler ultrasound, and freedom from clinically-driven target lesion revascularization (CD-TLR) at one year.

ACTIVATE II follows the completion of enrollment for ACTIVATE I safety study of AlucentNVS in the U.S. Pre-clinical testing of AlucentNVS in animal studies has shown acute and long-term safety and patency without the pro-inflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel.

Help tell the SVS story through images

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Help tell the SVS story through images
The SVS is staging a nine-week photo contest through May 25

Thanks to smartphones, almost everyone usually has a good camera at hand and thousands of digital photos in storage. 

So get that phone charged and be ready to click the button and capture your lives and specialty, from photos of your practice and your travels, to vascular training and vascular surgery’s history. You could win recognition along the way. 

In celebration of its 75th anniversary, the SVS is hosting a photo contest highlighting the past, present and future of vascular surgery. By sharing photos of life as a vascular surgeon, trainee, student, nurse or other vascular professional, members will help tell the Society’s collective story. 

The nine-week contest began in March and will end on May 25, with a new photo category—and honorees—each week. One winner and three runners-up will be selected in each category. All 36 winners will be recognized on the SVS website and during VAM.

For information on consent forms and to submit photos, visit vascular.org/2022PhotoContest. 

CLTI, VTE and post-thrombotic syndrome: Leading experts discuss crucial decision-making in interventional approaches

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CLTI, VTE and post-thrombotic syndrome: Leading experts discuss crucial decision-making in interventional approaches
Anahita Dua

This advertorial is sponsored by ACHL.

For Anahita Dua, MBChB, the stark realities and complexities of peripheral arterial disease (PAD) patients undergoing endovascular treatment for chronic limb-threatening ischemia (CLTI) coalesce into one important truth: the necessity of entering the operating room armed with “a plan A, a plan B and a plan C.”

Readiness is key, according to the assistant professor of surgery at Massachusetts General Hospital and Harvard Medical School in Boston, if the ultimate goal of restoring appropriate flow to the foot is going to be obtained.

Dua was speaking as part of an expert group of faculty drawn from across vascular surgery, interventional cardiology and interventional radiology to discuss the latest advances and key decision-making strategies used when considering intervention for four key vascular conditions: CLTI, venous thromboembolism (VTE) encompassing acute iliofemoral deep vein thrombosis (DVT) and acute pulmonary embolism (PE), and post-thrombotic syndrome (PTS).

In a series of Interactive CME Touchpoints, Dua and other leading expert clinicians cover the identification of candidates for interventional procedures, the latest clinical trial data on available and emerging devices, as well as case-based applications for practice, for each disease process.

When it comes to CLTI, she is clear on what constitutes the key to interventional success: “Procedural planning is probably the most important thing when you’re approaching a patient from an endovascular standpoint,” Dua tells viewers of the 45-minute activity during which she and Mitchell Weinberg, MD, chair of the Department of Cardiology at Staten Island University Hospital in New York, discuss the latest updates in approaches to interventions for CLTI.

In a series of Interactive CME Touchpoints, Dua and other leading expert clinicians cover the identification of candidates for interventional procedures

“You can only know your enemy if you’ve looked at the procedural planning prior, and you know what you have available to you on the shelf in order to approach these patients. Obviously in the case of endovascular treatment, no matter how good you may be, if you don’t have the tools that you need, and you don’t have them readily available for you, [then] you can’t achieve the goals that you want. So, in procedural planning the key is two-step: One, you need to look at the previous imaging of the patient, and two, look at the most recent imaging, and compare it to the previous imaging to determine where exactly your target is and how you intend to get there.”

Alternative plans gather importance given interventionists can confront numerous challenging scenarios, Dua adds. That might be failure to navigate a lesion, or achieving breakthrough, but the balloon won’t track. Over the course of the CLTI Touchpoint activity, Dua and Weinberg cover risk assessment of CLTI, examples of above-the-knee interventions, the challenges faced when treating PAD below-the-knee, along with the latest clinical trial and safety data, and case-based applications for practice.

Management of acute iliofemoral DVT

Kush Desai, MD, associate professor of radiology, surgery and medicine at Northwestern University Feinberg School of Medicine in Chicago, notes the fertile grounds interventionists currently occupy in the treatment of DVT. In the acute iliofemoral DVT activity in the Touchpoint series, he outlines how despite advancements in the medical treatment of DVT, nearly half of all patients go on to develop post-thrombotic syndrome (PTS).

Endovascular interventions have shown promise, Desai tells viewers. “This is a really exciting time in DVT management and DVT intervention because we now have prospective, high-quality evidence that is giving us a clearer idea of when we should intervene on patients,” he says. “DVT is a really common problem, and there are patients that have more severe forms of DVT—those that expand up into the iliac vein. In those patients, we have the possibility through endovascular interventional methods of actually improving their quality of life, in the short-term improving some discomfort, and, most importantly, reducing the severity of post-thrombotic syndrome that can result if they were treated with just anticoagulation alone.”

The 30-minute Touchpoint includes video commentary on key clinical trial data and patient selection for endovascular interventions to reduce the risk of PTS. Meanwhile, Desai also addresses the impact and severity of PTS, and the role of interventions in improving patient quality of life. He covers topics such as the PTS burden, specific clinical trials that examine the use of catheter-directed interventional methods for improving outcomes after DVT, and a “How I Do It” case.

Closing in on PTS

Erin Murphy

Meanwhile, Desai introduces Erin Murphy, MD, director of the Venous and Lymphatic Institute at Sanger Heart and Vascular, part of Atrium Health, in Charlotte, North Carolina, at the juncture of PTS.

While discussing the latest updates in the condition, the expert pair in venous disease review the newer dedicated venous stents now available, as well as limitations with conservative therapies in another 30-minute Touchpoint activity.

Making use of images, charts and graphs, Desai and Murphy offer their expert perspectives on the treatment of PTS, the benefits of venous stenting, and the best follow-up approach in patients post-stenting. They delve into risk assessment of PTS, non-procedural versus procedural care, the latest clinical trial data on the four dedicated venous stents that have been developed, and case-based applications for practice.

“The incidence of DVT in the U.S. is about 1 million cases per year, or just under,” Murphy points out, “so the occurrence of PTS is also correspondingly high. Further, the prevalence is very high because often the patients are not treated. They are managed with compression, so there’s more and more patients over time that have this [condition]. Unfortunately for them, quality of life mirrors that for other severe, underlying medical conditions, including COPD [chronic obstructive pulmonary disease], heart failure, diabetes with complications, and these are often younger patients in those groups.”

Addressing a question from Desai on whether she saw any gaps in the treatment of PTS, viewers hear from Murphy on knowledge deficits she sees among many physicians who encounter these patients—and the patients themselves. “There is a gap in education for referring providers,” she explains. “I think we’ve seen a greater increase in referring in the past five years or so, but I think a lot of physicians still don’t know that we can treat these patients.”

A lot of technical training needs to be done, she tells Desai. “I think we both still treat a lot of stent complications as more providers start doing these procedures without formal education, so I think there’s a need for training. From a technical standpoint, I think we still need treatment options for the inflow. Some patients are not candidates for stenting because of poor inflow or have stent failures because of poor inflow, and we don’t really have good options once these stents occlude, which is why it’s important to treat them correctly and to select patients correctly.”

Crucial decision-making in acute PE

In addition, Adrian Messerli, MD, an interventional cardiologist and a professor of medicine at the University of Kentucky in Lexington, navigates viewers through updates on guidelines and trials dotting the current interventional therapeutic PE landscape. In this Touchpoint, Messerli draws particular attention to “the underuse” of catheter-directed thrombolysis. “A common question is whether or not catheter-directed therapies are underused for treatment in acute PE,” he explains. 

“I think level-1 evidence is still lacking, so this is a somewhat contentious question. However, when you look at surrogate endpoints, namely right ventricle to left ventricle ratio reduction, and recognizing the benefits for patients in terms of in-hospital mortality and recurrent PE, I think there’s a strong argument that these therapies should be used more liberally. 

“In addition, for those who have been using these therapies for a while, anecdotally these patients typically feel better quicker, and I think that’s an important issue as well.”

Ensure you are prepared to optimally manage your patients with CLTI, VTE, or post-thrombotic syndrome by accessing these engaging CME activities today. Visit www.achlcme.org/interventional-approaches-svs and learn about tackling complications from this group of expert faculty. Supported by an educational grant from Boston Scientific.

Interview: SCVS leaders discuss training challenges, position of private practice, diversifying generation of surgeons

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Interview: SCVS leaders discuss training challenges, position of private practice, diversifying generation of surgeons
A DEI panel deep in discussion during SCVS 2022 in Las Vegas

Barriers thrown up between the worlds of private or community vascular surgery and academic practice need to be dismantled for the betterment of the specialty at large. At stake are some of the very fundamentals of what makes vascular surgeons unique among specialists who tackle disease of the vasculature. 

Those were some of the themes emerging out of reflections on a robust pair of sessions at the recent Society for Clinical Vascular Surgery (SCVS) Annual Symposium that focused on key questions of the future direction and demographics of the specialty. 

The generational changes taking place across society at large, and in medicine and vascular surgery, found purchase in a scientific session on training and education issues such as the state of open aortic repair, but also, crucially, on matters related to diversity, equity and inclusion (DEI), and how these impact the specialty’s body politic. Outgoing SCVS President Caron Rockman, MD, director of NYU Langone’s vascular surgery residency and fellowship programs in New York, captured parallels running through some of the key existential changes taking place that the SCVS sessions brought into focus—suggesting how breaking down barriers might further the vascular surgical cause. 

“In our field, as in almost all fields these days, there’s talk about increasing diversity of our workforce, and trying to recruit diverse individuals,” Rockman told Vascular Specialist. “Women in particular in the past have been traditionally, perhaps, discouraged from entering very specialized surgical fields, and this certainly has changed very significantly over the past couple of years, but I think we still have more work to do. 

“The issue of the training itself, and the decrease in open aortic surgery, is a real challenging one. I don’t think it’s going to get better, because as our endovascular, or less invasive interventions, get better and better and better, there is going to be, by nature, a decrease in open aortic surgery, and the nature of that surgery is going to be more complicated. 

“I thought the idea of talking about ‘private practice’ surgeons, or community surgeons, to aid in this is a wonderful resource. I also think that for those people who are doing a lot of open aortic surgery by the nature of their patient population, it would be nice if they could be assisted to start formal training programs. The lines between the ‘academic surgeon’ and the pure private practice surgeon in our field—the walls need to come down in some way. I think it’s an artificial distinction that is not necessarily helping us.” 

The training and education session had touched on such topics as the Vascular Surgery Board (VSB) Certifying Examination and the virtual interviews that have been the new reality for both program directors and vascular surgery trainees over the last couple of years. And while the session delved into the number of open aortic procedures taking place in different types of vascular practices, and touched on the prospect of increased private practice involvement in training future vascular surgeons, it also heard about sobering data laying out programmatic engagement with DEI in U.S. training programs, as well as the obstetric experience of trainees. 

This coalesced with some of the personal experiences laid out in the later DEI focus session. The visceral nature of some of the perspectives offered were not lost on incoming SCVS President-elect M. Ashraf Mansour, MD, professor and chair of the department of surgery at Michigan State University in Grand Rapids, who moderated the focus session, and new Vice President Jean Bismuth, MD, a vascular surgeon at the Katy Heart & Vascular Institute, in Houston, Texas, and associate professor of surgery at Louisiana State University. “My bias is that vascular surgeons are educated people,” Mansour told Vascular Specialist in a joint interview with Bismuth. “But, obviously, being educated and being sensitive are two different things. Certainly, there are some people out there who are in powerful positions who are completely insensitive and completely ignorant of the issues, and of the impact of their behavior on their trainees or their colleagues. 

“When Jean and I were training, the understanding was you were going to come to work, you were going to work hard and you were not going to complain. There was no 80-hour week; if you were tired, it didn’t mean you could go home. I remember many times being tired at work and having to do more work, and falling asleep on my way home driving. I think that stuff doesn’t happen as much these days, because we have rules in place, and people are more sensitive to all of these things.” 

The generational divide some of these issues exposes highlights a need for greater understanding and interaction among those of an older vintage in what is “a much more sensible and sensitive space,” continued Bismuth. 

The DEI focus session heard from University of Southern California chief of vascular surgery Vincent Rowe, MD, an African American, “who bared his soul,” said Mansour, and Erica Leith Mitchell, MD, the vascular chief at the University of Tennessee Health Science Center in Memphis, over her struggles in academic medicine. Bismuth recalled the experience of a colleague, who, after speaking at a regional society meeting a few years ago about some of the struggles he was facing in his personal life, attracted some negative post-address commentary from attendees. The recent SCVS perspectives “are in direct contrast to that,” he said. “We are actually saying that we would like to hear these things. These are the human aspects of what we do every day. We share more today, and there should be a common understanding.” 

Then there are those more acute training issues, such as adequate numbers of procedures in certain types of cases, particularly aortic. “The whole notion of recruiting the community surgeons to have trainees rotate through their cases is brilliant,” Bismuth reflected. Even if only 30–40% of those in private practice were keen on the idea, that would represent big progress, he added. “And it brings the private practice guys into the circle in a very meaningful way. We keep on talking about how to involve the private practice guys more—I can’t think of a better way.”

Vascular Specialist–April 2022

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Vascular Specialist–April 2022
In this issue:
  • In our April cover story, we report from the Society for Clinical Vascular Surgery (SCVS) Annual Symposium on new evidence that lays out out how vascular surgeons in private practice could play a crucial role in alleviating one of the existential problems currently vexing the specialty: the training of future generations of specialists, and its intersection with declining numbers of open abdominal aortic aneurysm (AAA) repairs (p. 1 and 10–11)
  • Medical editor Malachi Sheahan III, MD, discusses how the medical profession is losing the battle to train more Black doctors (p. 4 and 6)
  • All of the latest news around this year’s Vascular Annual Meeting (VAM) in Boston, June 15–18 (p. 8)
  • The latest Corner Stitch column sees Charles DeCarlo, MD, provides tips for getting your abstract accepted at academic conferences (p. 18)

At VRIC 2022, Clowes lecturer to walk in research footsteps of field progenitor

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At VRIC 2022, Clowes lecturer to walk in research footsteps of field progenitor
Kathleen Martin

When Kathleen Martin, PhD, gives the Alexander W. Clowes Distinguished Lecture at the 2022 Vascular Research Initiatives Conference (VRIC) in May, she’ll be discussing research that the late Clowes himself studied. “He’s really the father of this field,” she said. “I’m pleased to be able to build on what he founded. My research is very much in the same field that he started.” 

Martin said Clowes, a renowned surgeon-scientist who contributed greatly to VRIC, established the first models of vascular injury after surgical interventions. He died in 2015 and the VRIC lecture named for him was created a few years later. 

This year’s conference theme is “Translational Immunology and Cardiovascular Disease.” Martin will discuss the plasticity of smooth muscle cells (SMC), which are “incredibly versatile and almost stem cell-like in nature” in that they can change their phenotype dramatically and are highly proliferative, forming new lesions after vascular injury. “Dr. Clowes outlined how this happens,” said Martin. 

Her research lab at Yale University in New Haven, Connecticut, wants to define the cellular signaling and epigenetic mechanisms that regulate vascular SMC function in intimal hyperplasia, atherosclerosis and transplant vasculopathy. Understanding how these cells dramatically alter their phenotype may provide new insights for treatment and prevention of vascular disease. SMCs make up the muscular layer of blood vessels, allowing them to contract and relax, and help control blood pressure, vascular tone and blood supply. Her lab’s major focus is studying how SMCs can so dramatically change their state, from a healthy contractional phenotype to cells that lose their ability to contract and can potentially become fibrotic. Her lab has identified novel master regulators of SMC phenotypic switching. 

This smooth muscle plasticity impacts many vascular diseases, she said, including atherosclerosis—“the reason we need so many vascular interventions.” Other diseases include aneurysms, intimal hyperplasia, transplant vasculopathy, vascular calcification and more. It also affects the interventions—stenting, ballooning, bypass procedures, grafts and others—performed to treat vascular diseases. 

“This smooth muscle plasticity is relevant to a wide range of cardiovascular diseases, as well as transplant pathology,” said Martin. Science has come a long way toward eliminating outright organ rejection, but chronic transplant rejection is a major concern and cause of death with limited treatment options, she said. Her recent work has suggested new possibilities. “If we can contribute something that could help transplant patients […] we’d be thrilled,” Martin added. 

Martin, who trained as a cell biologist, got her first research position in vascular surgery at Dartmouth Medical School in Hanover, New Hampshire, where she learned of the challenges vascular surgeons face in treating vascular disease. In fact, there, she and SVS members Richard Powell, MD, and Eva Rzucidlo, MD, worked together on stent therapeutic drugs in SMC. “It really opened up this new research direction to me,” she said. “Most cells don’t have this ability to completely change their fate. I found it fascinating.” 

She misses that day-to-day contact with vascular surgeons, though she still collaborates with SVS member Alan Dardik, MD, and many other physician-scientists. “I’m excited to get feedback from the SVS community at VRIC, and eager to hear their suggestions,” she said. 

VRIC takes place Wednesday, May 11, at the Sheraton Grand Seattle Hotel, Seattle—the day before and in the same venue as the American Heart Association’s Vascular Discovery Conference. To learn more and to register, visit vascular.org/VRIC22. 

Rare case series shows 100% limb salvage in pediatric bone tumor resections with vascular involvement

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Rare case series shows 100% limb salvage in pediatric bone tumor resections with vascular involvement
Osteosarcoma of the proximal humerus

A retrospective review of a rare set of pediatric bone tumor resection cases with significant blood vessel involvement has demonstrated 100% limb salvage and 0% local recurrence.

The 14-year experience involved 117 cases treated at Louisiana State University (LSU) and Tulane University in New Orleans by a vascular and pediatric orthopedic surgical team. First-named researcher Malachi Sheahan III, MD, chief of vascular surgery at LSU, said the series likely represents the largest known set of its kind in the literature, demonstrating how a multidisciplinary team can tackle pediatric bone tumors “with minimal blood loss, excellent limb salvage and low rates of local recurrence.”

Data on the findings were revealed during the 2022 annual meeting of the Southern Association for Vascular Surgery (SAVS) in Manalapan, Florida (Jan. 19–22).

Sheahan and colleagues started to take part in pediatric bone tumor cases—comprising osteosarcomas, osteochondromas and aneurysmal bone cysts—in 2006, later discovering no apparent reports of the value provided by vascular surgery in their execution.

Sheahan told SAVS attendees how the series counted 57 osteosarcomas, 51 osteochondromas and nine aneurysmal bone tumors through 2019, and provided an insight on the techniques utilized in order to arrive at the outcomes he reported from the podium. The average age of the population of patients in the study was 11.6, with 56% of them being female. The patients were derived from across the U.S., with their varied chemotherapy and radiation therapy treatment regimens accounting for a central weakness of the dataset, he pointed out.

When dealing with osteosarcomes, Sheahan explained, “it’s our job to find out what’s tumor and what’s inflammation. With every single one of these, it looked like the blood vessels were involved based on the preoperative MR [magnetic resonance], but in most cases you can develop a plane between the tumor and the vessels. If you can’t, then you ligate the vessels and reconstruct. It’s cancer, so you don’t leave anything behind.”

Sheahan said his team’s approach involves securing the neurovascular bundle as a unit to then achieve exposure to the bone. The technique used when dealing with osteochondromas is similar to that used with osteosarcomas, he added. “With aneurysmal bone cysts, in the literature these have a very high rate of recurrence,” Sheahan continued. “They’re not malignant but they are very, very vascular and devastating to the bone involved. You can’t resect the entire bone, so either you do curettage or embolization. Our technique is to do both. The literature reports a 30% recurrence rate, and I’m going to report a 0% recurrence rate with this technique.”

Speaking from the conference floor, Martyn Knowles, MD, a vascular surgeon at UNC Health Care in Raleigh, North Carolina, the designated discussant for the paper,  queried Sheahan on how the patient population was followed and how decisions were made over when and when not to resect. “We follow them for life—we don’t have literature on kids and reconstructions to let us know when it’s OK to let them go, ” Sheahan said.

“The technique is as much art as science. At the start of this approach, we started sending a lot of frozen sections of tissue off to see if there was tumor present. That led me to be more aggressive with the vessel salvage and identifying what’s inflammation and what’s tumor. That’s easier to do in situ than radiographically, I think,” he added.

Interview: JVS group enters new era with brand chief and team-based approach

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Interview: JVS group enters new era with brand chief and team-based approach
Peter Henke

With changes occurring regularly in the publication business of scientific journals, the Society for Vascular Surgery (SVS) is planning changes with its own Journal of Vascular Surgery (JVS) publications. Effective July 1, Immediate Past President Ronald Dalman, MD, will be executive editor of JVS, and will oversee its three sibling journals, JVS-Venous and Lymphatic Disease, JVS-Cases, Innovations and Techniques and JVS-Vascular Science. “He’s chief of the overall JVS ‘brand,’” said Peter Henke, MD, chair of the SVS Publications Committee. 

Thomas Forbes, MD, will take over as editor-in-chief of JVS, while Matthew Smeds, MD, Ruth Bush, MD, and Alan Dardik, MD, become editors-in-chief of JVS-VL, JVS-CIT and JVS-VS, respectively. Each editor will recruit and form his or her own teams of associate and assistant editors to carry the journals forward, said Henke. “It’s a team, not just one editor-in-chief,” he said. “This will be the editorial team discussing and coming to consensus on policies and direction.” 

With the second of three-year-long terms for the existing editors—Peter Gloviczki, MD, and Peter Lawrence, MD—ending this summer, plus the need for a new publishing contract, the SVS Executive Board thought this the perfect time to investigate possible changes overall, added Henke. The SVS hired a publishing consulting firm to review the entire editorial structure, comparing it to that of other similar publications. This led to SVS leadership’s decision “to make a fairly significant change,” Henke said. 

Currently, Gloviczki and Lawrence oversee all four journals. “It’s become a full-time job, and they already have careers,” said Henke. He noted that it became clear the workload needed to be spread across more people.

The team approach also helps the Society fulfill its commitments to diversity, equity and inclusion (DEI) promises to engage younger and more diverse members of SVS as reviewers and editors. With each editor developing his or her own team, many more early-career vascular surgeons will have the chance to get involved and become engaged as reviewers, and move up over time to become editors, he said. 

The changeover officially begins July 1, but the new team is already part of the existing one, attending editor calls and learning the ropes. “We’ll take the next three-to-four months to get everyone up to speed and ensure a smooth transition,” Henke said. 

Dalman and Forbes are working on their own vision of the future, and they count themselves fortunate and grateful for the “robust team in place with outstanding leadership from the current editorial team,” said Dalman. 

“We’re honored to be handed the reigns of the JVS journals and to build on the legacy of Drs. Gloviczki and Lawrence, and their predecessors,” agreed Forbes. 

Dalman said both are looking ahead to workflows and other structures to ensure everyone remains “aligned and ‘on brand’ for the high editorial standards of the JVS.” He and Forbes want to boost the efficiency of the review process and institute other changes to ensure all the JVS journals “remain the optimal choice for authors and high-impact manuscripts.”  

Dalman added: “We want to explore more synergies between the journals and other media portals of the JVS. Despite its limitations in defining quality and influence in our specialty, we will continue to make structural changes to drive the impact factor to reflect the true value of the journals and their intellectual content. And, we will continue to explore new publishing structures, including further open access ventures, to maximize the impact of our journals’ content.”

Forbes called this an exciting time for academic publishing, “with new opportunities to meet the needs of our audience and our authors and to continue to be the premier vascular surgery journal and platform,” he said. “Just as vascular surgeons are known for their innovations, we will develop innovative delivery models for new knowledge to the benefit of all vascular surgeons and their patients.”

VAM: How abstracts are selected

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VAM: How abstracts are selected
VAM 2021 in San Diego

The abstracts presented at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) are the result not just of thorough research, but also a meticulous—and blind—selection process. 

The procedure starts months ahead of the yearly annual meeting, with the posting of guidelines and policies just prior to abstract submissions opening in mid-November. The submission period runs for eight weeks. The 25-member SVS Program Committee reviews all abstracts. Each member first expresses preferences for three of the 13 or so abstract topic categories and the chair, currently Andres Schanzer, MD, assigns four to five people to one of five groups. One of the five reviews all submissions in the “aortic” category, which is typically the largest. The other four groups tackle several categories—such as vascular medicine, trauma or carotid—each.

Each group also includes one to two members each from the Vascular and Endovascular Surgical Society (VESS), the SVS’ longtime VAM collaborator. VESS holds its spring meeting in conjunction with VAM and sponsors several hours of abstract presentations on the Wednesday of the meeting. 

Members of these small groups perform blinded reviews, assigning each abstract a score from 1–5. The final score report for all abstracts includes the average score, standard deviation, any conflicts of interest and comments. 

“It is an important—even vital—part of the selection process that reviewers don’t have any idea who is part of the research team,” said Schanzer. “We select abstracts based on the science presented, not the researchers’ names.”

On separate conference calls, each group uses the score report and notes to select the top 10 to 15 abstracts from each category to put forward for the VAM program. After the small groups make their selection, volunteers search on PubMed and other search engines to determine if the work has been published or presented before, which is against the clearly stated policies. 

Finally, all abstracts are presented to the entire Program Committee for selection for VAM presentation. At the selection meeting, members involved with a paper as an author, or even part of the institution where the researchers are affiliated, leave the room, explained Schanzer. 

Submitting authors may choose which sessions where they do, or do not, want their work presented. Selecting to speak only at a plenary session is perhaps the biggest obstacle to an author’s chances of making the program, he added. “It behooves an author to select
all categories.”

SVS’ AMA membership push aimed at safeguarding vascular surgery voice on coding issues

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SVS’ AMA membership push aimed at safeguarding vascular surgery voice on coding issues
Matthew Sideman

The Society for Vascular Surgery (SVS) is urging members to join the American Medical Association (AMA) in a bid to maintain a critical voice in the decision-making process for the specialty.

The reason is simple: Unless the percentage of dual members increases, the Society is in danger of losing its place at the table when critical decisions are made regarding coding for vascular procedures and the Relative Value Scale (RVS) Update Committee (RUC), which advises Medicare on how to value a physician’s work, says SVS Policy and Advocacy Council chair Matthew Sideman, MD.

The RUC is a multispecialty committee dedicated to describing the resources required to provide physician services which the Centers for Medicare & Medicaid Services (CMS) considers in developing Relative Value Units (RVUs). Ultimately, these recommendations are critical to physician reimbursement.

To participate in the AMA’s RUC meetings, a specialty must have a seat in the AMA House of Delegates. To have that important seat—which provides that specialty with a voice in decision-making—the organization must have a certain percentage of members who also are AMA members, said Sideman.

Sideman acknowledged that some SVS members hold ill will against the AMA because of the payment cuts that went through at the beginning of the year. “Some of our members see the AMA as part of the problem, and not the solution,” he said. He urged all members, despite that sentiment, to join the AMA.

“Whether you agree with the AMA, or if you don’t feel like they speak for you, they are the way to be heard in the current system,” said Sideman. “The AMA is how we have a voice. If we lose our spot there, we lose our voice.”

The AMA wields great importance in its role in sending recommendations for reimbursement to CMS. Should SVS lose its all-important spot in the House of Delegates, the SVS will no longer be able to influence coding and RVU decisions. Members stand to lose far more than the $420 membership dues, he said. Costs are lower for those in their first four years in practice, and for military physicians and those working in the Department of Veterans Affairs ($280.)

Although the RUC provides recommendations, CMS makes all final decisions about what Medicare payments will be. Many physicians believe, erroneously, that the RUC determines payment. Instead, the group of physicians provide comments to the government about policy. The committee summarizes all the deliberations and forwards them to CMS and CMS determines RVUs and values. Congress then sets the conversion factor for the Medicare Physician Fee Schedule, which determines reimbursement.

Sideman said if SVS loses its representation, SVS could submit its own comments on codes relevant to vascular procedures. “But those recommendations would be seen as biased and self-serving, whereas those from the RUC process are deliberated by multiple specialties; they have the ‘stamp of approval’ of an independent multispecialty body.”

Shockwave Medical announces global launch of new peripheral IVL catheter

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Shockwave Medical announces global launch of new peripheral IVL catheter

Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both Food and Drug Administration (FDA) and CE mark clearance.

A company press release details that the Shockwave M5+ catheter is specifically designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes.

“Shockwave’s new peripheral catheter offers remarkable improvements that enable efficient and effective treatment for some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas, MD, of Miriam and Rhode Island Hospitals, Providence, Rhode Island, one of the first physicians to use the new catheter.

“While treating patients with long, severely calcified lesions will always be challenging, the new Shockwave catheter is appropriately sized for larger vessels and has been optimized to expand options for facilitating vessel access, all while decreasing the amount of time needed to perform IVL in the procedure.”

Shockwave M5+ incorporates valued customer feedback to improve IVL efficiency in tackling complex calcified lesions, including quicker cycle time that delivers two pulses per second, an increased catheter length of 135cm, and a new, larger 8mm size, the company communicates. The catheter is specifically designed to treat otherwise difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities, including the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries.

Shockwave Medical advises that the M5+ catheter is now commercially available in Europe and the U.S.

Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system

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Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system
The Zenith Thoraco+ graft, part of the Zenith Thoraco+ endovascular system

Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the Food and Drug Administration (FDA), a press release reports. 

The company details that, while the product is not commercially available yet, the benefits of the designation include priority review, and interactive and timely communication with the FDA during the clinical trial and pre-market review phases in order to help get lifesaving devices to patients more quickly.

The Thoraco+ is the second product from Cook Medical to receive a Breakthrough Device designation in 2022. Cook communicates that the device is built on the strength of the Zenith platform and represents a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms. The system is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms (Crawford classification I–IV).

The Thoraco+ is an off-the-shelf device incorporating four side branches for the celiac artery, superior mesenteric artery, left renal artery, and right renal artery. Cook advises that, to accommodate varied patient anatomy, the Thoraco+ will be available in a range of diameters and lengths.

Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV DCBs

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Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV DCBs
IN.PACT Admiral DCB

Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. This is according to a news alert from the company dated March 31.

Medtronic communicates that approximately 6,000 IN.PACT Admiral catheters and three IN.PACT AV catheters distributed to customers globally are impacted by this recall. “Medtronic is communicating to customers with affected product on hand to immediately quarantine and return the product to Medtronic, as well as send back a signed confirmation form,” the company details.

The news alert continues: “The pouch damage was discovered during a routine inspection. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, to ensure that no further issues, production on all lines was paused until a follow up packaging inspection was completed. No further errors were discovered.”

According to Medtronic, the company has received zero complaints involving this issue. In addition, they report that there have been zero reports of injury or death related to this issue. “There are no actions required for patients where the affected IN.PACT Admiral and IN.PACT AV catheters were used during a procedure. Patients should continue to be monitored in accordance with the medical facility’s standard care protocols,” the release reads.

The company stresses that, for most regions, there is little or no impact for customers to order replacement product. It advises that customers may reach out to Medtronic Customer service (800-551-5544, selection option “Vascular”) for any questions regarding their return or ordering replacement product.

The company notes that no other Medtronic products are affected by this issue, and that all appropriate regulatory bodies have been notified.

Select gene SNPs found to be associated with venous ulcer formation and persistence

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Select gene SNPs found to be associated with venous ulcer formation and persistence
Rabih Chaer

Looking to the future, genetic testing may play a role in guiding the intensity of therapeutic interventions and preventive strategies in patients with venous disease. This finding comes from a case-control study on the clinical implications of genetic variation of venous stasis ulceration, presented by lead researcher, Rabih Chaer, MD, at the 2022 annual meeting of the American Venous Forum (AVF) held Feb. 23–26.

Venous stasis ulcers are the most common cause of non-healing lower-extremity wounds and can persist despite adequate pressure and ablation therapy, Chaer, chief of vascular surgery at UPMC Presbyterian in Pittsburgh, explained. “Although great progress has been made in wound care and treatment regimes, the response remains variable, and, regardless of the clinical strategy used, it is evident that there is a lot of variability in the outcomes of patients who present with similar disease patterns.”

Few institutional theories have examined the role of single gene polymorphism independent genesis of venous stasis alteration, he said, and the most recently published series have typically focused on a few target genes and were limited by small sample size.

Chaer dials in remotely to AVF 2022

Chaer’s case-control study, funded by the AVF and AVF-JOBST Clinical Research Grant, held the hypothesis that genetic profiling of venous status ulcers can potentially stratify patients according to their potential for disease progression, healing, and also guide them through preventive strategies and levels of therapeutic intervention. Chaer relayed that the study’s purpose was to determine whether single nucleotide polymorphisms (SNPs) in select genes can affect ulcer formation or healing.

He noted that genotyping was carried out for 19 targeted SNPs associated with wound healing or thrombophilia, using Taqman SNP genotyping technology. Of those, five of the markers were validated using real-time PCR to ensure genotype clustering. Repeat samples were performed at the initial run and multiple replications were performed to ensure genotype accuracy.

Data related to the patients’ venous disease were prospectively collected for two years and included demographics, ulcer information and clinical management. Additionally, logistic regression models were used to identify factors associated with ulcer formation and healing using a cut-off p-value of 0.2 to capture trends. He explained that the primary endpoints were ulcer healing or ulcer recurrence, and the secondary endpoints included the genetic association with ulcer healing, and time for healing and recurrence. The researchers also looked at genotype and phenotype correlation for the variables, and analyzed the clinical variables in conjunction with ulcer healing and recurrence.

Chaer said that MMP12 was found to be significant in the study as associated with inflammation. Another is associated with fibroblast activity, such as GP6. F13A1 (factor 13A1) was associated with thrombophilia.

The study enrolled a total of 377 patients: 23% (n=85) CEAP 5, 33% (n=126) CEAP 6, and 44% (n=166) controls (50 or older). All patients underwent a systematic evaluation of their superficial venous system. The average patient age was 63±12 years, 13.3% (n=50) were African Americans, and 56% (n=211) were females. Chaer noted there were more females in the patient control group. The average follow-up time for CEAP 5/6 patients was 19±10 months (range: 0–50 months; median: 23 months). CEAP 5/6 patients had a lower incidence of the GP6 SNP (rs1654416).

Recalling the results, Chaer said that in the CEAP 5 group, 17.1% (19/111) of limbs had ulcer recurrence (average time period to ulcer recurrence was 13.62 months). In the CEAP 6 group, 46.9% of limbs (n=67/143) healed, 32.2% (n=46) improved, and 21% (n=30) worsened (mean time to ulcer healing was 7.38 months). On multivariate logistic regression, GP6 (rs1654416) and MMP12 (rs651159) SNPs were protective against ulcer formation, whereas F13A1 (rs5985), SLC40A1 (rs11568351), and HFE (rs1800730) were associated with ulcer persistence. GP6 was the only gene which was found to be significantly less expressed across the cases.

“Select gene SNPs seem associated with venous ulcer formation or persistence and genetic testing may play a role in guiding the intensity of therapeutic interventions and preventive strategies, as well as patient and provider expectations,” Chaer concluded.

SCVS 2022: WIfI score does not predict successful healing after transmetatarsal amputation, study finds

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SCVS 2022: WIfI score does not predict successful healing after transmetatarsal amputation, study finds
Jake Hemingway delivers WIfI research at SCVS 2022

A higher initial Wound, ischemia, and foot infection (WIfI) classification score at initial presentation in chronic limb-threatening ischemia (CLTI) patients who underwent a transmetatarsal amputation (TMA) was not associated with a major amputation down the road, according to a retrospective review of 55 TMAs performed at the University of Washington (UW) in Seattle.

A research team at the institution sought to establish whether the Society for Vascular Surgery (SVS) lower-extremity threatened limb risk stratification system could predict successful healing following TMAs, ultimately determining it does not—with the data showing this included both the wound and ischemia score on presentation as well as after revascularization.

The study findings were revealed during the Society for Clinical Vascular Surgery (SCVS) annual symposium in Las Vegas (March 19–23). Despite the core conclusion, presenting author Jake Hemingway, MD, a vascular surgery resident at UW, told delegates: “We found that excellent wound healing can still be achieved despite very advanced CLTI and, thus, we shouldn’t use the WIfI stage alone to try and preclude patients from attempts at limb salvage. There still is a need for further investigation into how we can monitor our patients after undergoing a TMA to know when further work needs to be done to maintain that wound.”

The 51 patients included in the study saw a 12-month major amputation rate of 33%—12 carried out below the knee, and six above. Hemingway said the data demonstrated that an unsuccessful TMA was down to primary failure in 10 patients, “in which they simply never were able to heal their wound, as opposed to secondary failure, which was wound breakdown remote from their initial TMA.” Four patients saw TMA failure due to infection, developing either necrotizing infection or wet gangrene during their initial healing process, he added.

“When we looked at the factors that were actually associated with major amputation, we found that none of the following were: Either a higher initial WIfI stage wound or ischemia score at the initial presentation; or whether patients had improvement following revascularization—this was also not associated; neither was the ischemia score post-revascularization,” Hemingway said.

Hemingway revealed during questions after his presentation that the UW research team is set to enter a new phase of the study to look at other non-invasive, nonpressure-based measures such as pedal acceleration times in order to establish the most predictive system for successful healing after a TMA.

Randomized trial suggests carotid endarterectomy does not affect dementia risk

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Randomized trial suggests carotid endarterectomy does not affect dementia risk
Alison Halliday

Carotid endarterectomy (CEA) does not appear to either reduce or increase the risk of dementia, despite it having been shown to reduce stroke risk. This is according to 20-year results from the ACST-1 trial, published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

ACST-1 (Asymptomatic carotid surgery trial) showed that surgery for asymptomatic carotid stenosis significantly reduces long-term stroke risk, Alison Halliday, MS FRCS, a professor of vascular surgery at the University of Oxford, Oxford, England, and colleagues write. They note, however, that the effect of CEA on later dementia is “uncertain.”

The investigators underline the fact that prolonged follow-up of trial participants is now possible with the linkage of national electronic records. In addition, they note that dementia records have a good positive predictive value for clinical diagnosis, though they are likely to underestimate the true risk. The combination of these factors, the authors write, “provides the opportunity to investigate the longer-term effects of CEA on incident dementia.”

In the present study, the researchers randomly allocated all U.K. and Swedish patients in ACST-1 (n=1,601/3,120) to either immediate CEA (n=796) or deferral of CEA (i.e. no intervention was performed unless or until triggered by ipsilateral transient ischemic attack or stroke; n=805) and followed them for 16–26 years, to study effects on dementia. The median follow-up was 19.4 years (interquartile range, 16.9–21.7).

Halliday et al report that dementia was recorded in 107 immediate CEA patients and 115 allocated delayed surgery. A total of 1,290 patients died, 1,091 before any dementia diagnosis, they add.

The investigators found that dementia incidence rose with age and with female sex (men, 8.3% aged <70 years at trial entry vs. 15.1% aged ≥70; women, 15.1% aged <70 years at trial entry vs. 22.4% aged ≥70 years) and was higher in those with pre-existing cerebral infarction (silent or with prior symptoms, 20.2% vs. 13.6%, respectively).

In addition, the authors relay that dementia risk was similar in both randomized groups: 6.7% vs. 6.6% at 10 years and 14.3% vs. 15.5% at 20 years, respectively.

The dementia hazard ratio (HR) was 0.98 (95% confidence interval [CI], 0.75–1.28; p=0.89), with no heterogeneity in the neutral effect of immediate CEA on dementia related to age, carotid stenosis, blood pressure, diabetes, country of residence, or medical treatments at trial entry (heterogeneity values: p>0.05), Halliday and colleagues detail.

Considering the main strengths of their research, Halliday et al highlight the fact that early CEA was randomly allocated, and so intervention and control groups were matched for known confounders at recruitment. In addition, they write that the use of electronic health records reduces potential bias, because the electronic health record includes participants who may not respond to active follow-up.

The authors also recognize some limitations. They acknowledge that face-to-face interviews of participants throughout follow-up would have been the “ideal method” to detect cognitive impairment and dementia, but this was not possible. They also state that dementia may be under ascertained using electrical records and that there was no consistent dementia ascertainment over time. In addition, they remark that the study confidence interval did not exclude a proportional benefit or hazard of about 25%.

Increased market competition linked to higher odds of revascularization among asymptomatic patients with moderate carotid stenosis

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Increased market competition linked to higher odds of revascularization among asymptomatic patients with moderate carotid stenosis
Caitlin W. Hicks and Rebecca Sorber

A vascular surgery research team with a growing reputation for its work investigating appropriateness in care in the peripheral vascular bed recently uncovered an association between increased regional market competition among proceduralists and higher odds of revascularization being carried out for moderate- versus high-grade asymptomatic carotid stenosis. The investigators detected no similar impact among symptomatic patients, leading Rebecca Sorber, MD, a general surgery resident at The Johns Hopkins University School of Medicine in Baltimore, and colleagues to conclude that a more competitive marketplace, or more physicians in a given region offering such carotid procedures, “may influence more aggressive behavior” when treating asymptomatic carotid disease patients who may otherwise be good candidates for surveillance. 

Senior author Caitlin W. Hicks, MD, associate professor of surgery at Johns Hopkins, told Vascular Specialist in an interview: “We do a lot of really important procedures and a lot of great care for patients but I also think we do too many procedures, or things that are not necessarily in patients’ best interests.” 

This latest project probing the contentious space of asymptomatic carotid intervention through the lens of market competition follows a body of work on atherectomy practice patterns and the appropriateness of its use, and was recently presented at the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS), held in Snowmass, Colorado ( Jan. 27–30). 

“This one is a unique take on [that type of work], and it looks at the regional market competition characteristic, which is an interesting way to understand market influences, perhaps, in practice patterns,” Hicks explained. 

To arrive at their findings, Sorber, Hicks and colleagues plumbed the Vascular Quality Initiative (VQI) database for all patients undergoing first-time carotid revascularization for carotid artery stenosis of 50–99% between 2016–2020, stratifying them by symptomatology and degree of stenosis (moderate: 50–<80%; high grade: ≥80%). They then used 10 U.S. Health and Human Services (HHS) designated regions to measure competition amongst physicians, ultimately looking at nearly 150,000 patients. 

Competition by region was overall “quite high,” Sorber told VESS, which she said reflected the large number of proceduralists offering carotid revascularization in the U.S. The most competitive was the Great Lakes/Chicago region, with the least competitive identified as Denver/Rocky Mountains. Sorber revealed how a 10-point decrease in the Herfindahl-Hirschman Index (the measure the research team used to calculate physician market competition)— which corresponded to increased competition—was associated with an odds ratio of 1.02 increased likelihood of revascularization in moderate grade asymptomatic carotid stenosis versus those with high grade (95% confidence interval [CI] 1.01–1.03).

“As expected, an identical analysis in symptomatic patients showed no significant association between competition and revascularization threshold,” she told VESS. Furthermore, in-hospital outcomes showed that the moderate grade asymptomatic patients had a significantly higher likelihood of stroke and stroke-death following revascularization compared to their high-grade asymptomatic patients counterparts, Sorber said.

“Again, an identical analysis among symptomatic patients did not demonstrate this relationship, instead showing a slightly increased risk of mortality for high-grade patients.” Multivariable analysis demonstrated that moderate grade revascularization was independently associated with the composite adverse outcome of stroke-death among asymptomatic patients, Sorber added. 

Sitting alongside Hicks later, Sorber detailed how much of her mentor’s work has focused on disease processes that have clearer guidelines of what physicians should be carrying out. In those cases, she said, “we can really make judgments on whether what people are doing is appropriate,” she said. “With asymptomatic carotid disease, we don’t necessarily have that—a lot of the new trials are still in progress. So, this is the right time to do this project and look at this data, but it’s a difficult time to contextualize the results.”

The bottom line though, Sorber told Vascular Specialist, is that the project uncovered data showing physicians surrounded by a lot more competitors who are also treating carotid disease were “more likely to offer an operation to somebody with a lower percentage of stenosis.” That was consistent with results derived from other analyses of surgical behavior in more competitive markets, she said. 

Summing up the group’s findings during VESS, Sorber pointed to “the small but significant increases in adverse perioperative outcomes demonstrated for moderate-grade asymptomatic patients” as highlighting a need for “critical reflection” about factors motivating decisions to offer revascularization to asymptomatic patients with less than 80% stenosis. “At a minimum,” she said “there is room for improvement in ensuring patients with asymptomatic carotid stenosis and symptomatic stenosis are on best medical therapy prior to revascularization” as the carotid space awaits results from trials such as CREST-2. 

Medical students reach out to hemodialysis community in times of COVID-19

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Medical students reach out to hemodialysis community in times of COVID-19
Hallie Byrd tends to a hemodialysis patient during an LSU VSIG outreach event

As president of the Louisiana State University (LSU) Vascular Surgery Interest Group (VSIG), I’ve been eagerly exploring opportunities to engage with community members and uplift them on their journeys to improved health. 

As all are acutely aware, COVID-related restrictions on medical facilities and medical students alike have made it quite difficult for community involvement in a time when some (e.g., Zoom-based medical students and certain patient populations) could deeply benefit from greater socialization. One group of vascular patients that comes to mind are those receiving hemodialysis; between the dietary restrictions and burden of the treatment regime that such patients must regularly endure, I considered inspirational ways to hearten their recent Valentine’s Day (hello, off limits phosphate-laden chocolate). 

So, this Valentine’s Day, with the help of LSU’s Nephrology and Hypertension Interest Group (NHIG), LSU’s VSIG spearheaded a campus-wide drive for hemodialysis and diabetes-friendly candy and cards. These items were hand-packaged into individual goodie bags by several interest group members. On Feb. 14, we personally delivered these treats and handwritten cards to many of the 80 patients at our local DaVita Memorial dialysis unit. 

While only a small gesture, we could readily see the positive impact it had on the patients in the center. From the response, it seemed to make their day a little brighter and perhaps their treatment a bit more bearable. Hopefully, this will serve as a reminder that even small acts of kindness and consideration can impact our patients’ lives and health in a substantial way. 

Hallie Byrd, MS, is a medical student at LSU Health School of Medicine in New Orleans. 

Nominations due March 31 for community practice award

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Nominations due March 31 for community practice award
Past winners

Nominations for the Society for Vascular Surgery‘s prestigious Excellence in Community Practice Award are due March 31. 

The honor, formerly known as the Excellence in Community Service Award, is exclusively for those who practice in the community setting, including members in an office-based lab (OBL) setting. Selection recognizes an individual’s sustained contributions to patients and their community, as well as exemplary professional practice and leadership. 

To be considered, applicants must be community practitioners and have been in practice as a vascular surgeon for at least 20 years, been an SVS member for at least five years, and show evidence of impact on vascular care or community health. Learn more at vascular.org/CommunityPracticeAward. 

Peer-reviewed COVID-19 archive grows

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Peer-reviewed COVID-19 archive grows

Two years in, an indicator of COVID-19’s continuing presence in the world is the growth of the “COVID-19 Collection” in the pages of the Journal of Vascular Surgery publications.

Launched in April 2020, the research has appeared in not just the signature JVS publication (98 papers), but also two of the three companion publications, JVS: Venous and Lymphatic Disorders (43 articles) and JVS: Cases and Innovative Techniques (22 papers). 

Some of the most recent papers include an update of the European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on managing acute limb ischemia in light of the pandemic; resolution of acute pulmonary embolism using anticoagulation alone; the resident and fellow experience; and one covering the “drastic increase” in hospital labor costs during the pandemic and how that has led to sustained financial loss for an academic vascular surgery division. See vsweb.org/CovidCollection. 

Diabetes: Impact of local medicolegal landscapes on costs

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Diabetes: Impact of local medicolegal landscapes on costs

More litigious U.S. states did not see decreased amputation rates over those where the medicolegal environment was less adverse, according to an analysis of Medicare data exploring the association between the realities of local medical-legal landscapes and diabetes-related care costs. 

A team of researchers from the Mayo Clinic Arizona in Phoenix and UMass Memorial Health in Worcester, Massachusetts, found that across U.S. states, a 1% increase in lawsuits per 100 physicians was associated with a greater than 10% increase in risk-adjusted standardized per-capita costs. An adverse medicolegal environment is “independently associated” with high healthcare costs, but doesn’t necessarily result in improved outcomes, they concluded.

Per-capita spending on diabetes ranged from $15,799 in states with infrequent and lower malpractice payouts compared to $18,838 on average in states with higher and more frequent settlements (p<0.05). Diabetic patients in states with adverse medicolegal environments had more procedures, imaging tests, and readmissions (p<0.05), Austin Pierce, MD, a general surgery resident from the Mayo Clinic, told the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting (Jan. 27–30) in Snowmass, Colorado, as the findings were presented for the first time. On multivariate analysis, amputation rates were associated with increased spending, co-morbidity prevalence, and race, but not medicolegal factors. 

“An adverse medicolegal environment is pretty clearly associated with higher healthcare spending, driven through greater intensity of service utilization,” senior study author Andrew J. Meltzer, MD, Mayo Clinic Arizona vascular chair, told Vascular Specialist. 

“The one thing that we can certainly measure in terms of outcomes based on available data, that’s relevant with our population in particular, would be amputation rates … this higher intensity of testing and higher spending does not correlate with any improvement in outcomes; it really simply reflects the external pressures that are placed upon those taking care of patients in an environment that is overly litigious.”

SCVS 2022: ‘We should not allow our industry relationships influence how we choose to treat patients’

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SCVS 2022: ‘We should not allow our industry relationships influence how we choose to treat patients’
Alik Farber
Alik Farber

Industry players and device makers have helped spark new science and innovation in vascular surgery amid flatlining National Institutes of Health (NIH) funding, but physicians must pay heed to the conflicting agendas in the partnerships formed with these companies, a focus session on ethical issues in practice at the 2022 annual symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas (March 19–23) heard.

“Industry sponsors a huge amount of significant research and NIH funding has been stable for a long time,” Alik Farber, MD, chief of vascular and endovascular surgery at Boston Medical Center, Boston, told the SCVS 2022 gathering. “Given NIH funding that is limited, and given the pay lines that have been decreased recently, industry-sponsored research adds new science and innovation. I’m sure industry leadership when they plan their trials, try to do everything they can to make useful clinical trials to try to help physicians and patients. But [industry’s] clear primary fiduciary duty is to get their devices through the regulatory process to market, sell them and optimize profits.”

It is therefore incumbent upon surgeons participating in industry-sponsored trials and partnerships to “understand the conflicting agendas” and be transparent about them, he said. The comments came as Farber delivered a presentation entitled, “Are we too cozy with industry?”

Farber used signposts from his own career to demonstrate how industry had aided certain aspects of his own trajectory, such as the beginning of his endovascular practice in which an industry representative provided him with the devices he needed, as well as the BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischemia), of which he is a principal investigator. “BEST-CLI ran out of money,” he explained. “We approached societies and everybody gave—including the SCVS—but we also approached industry. Initially, we did not want industry involved at all but we had no choice, facing a disaster, and they helped us.”

Yet, the two-way relationship is much more problematic than benefits to care, Farber continued. There are incentives on both sides, he said, but those are not necessarily aligned.

Farber referenced a study carried out at his institution that sought to capture a snapshot of the financial relationships between academic vascular surgeons and industry. They found that in 2017, $8.5 million went to 997 academic vascular surgeons—86% of those captured under the academic vascular surgeon designation. Some 115 of that number accounted for $7 million of the total figure, he noted. “We concluded that most academic vascular surgeons have received payments from industry,” Farber told SCVS 2022. “The top decile of surgeons received more than 80% of the transactions.”

To balance these relationships and ensure they are lawful, “we should accept the fact we have our own agendas” he added, and that “we are not exempt from the influences of human nature,” meaning that “gifts have an effect.” Be aware of laws and rules in the jurisdictions in which practice, Farber emphasized.

Importantly, he said: “We should not allow our relationships to influence how we choose to treat patients. I could repeat that 10 times. This is critical.” Returning to his initial question, Farber asked once more: “Are we too cozy with industry? I think as a specialty we’re not, but I think individually we need to look at ourselves in the mirror and figure it out.”

Apply for health policy program by March 25

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Apply for health policy program by March 25

Applications are due by 11:59 p.m. Central Standard Time on March 25 for the joint American College of Surgeons/Society for Vascular Surgery scholarship to attend a health policy leadership course taking place in June. 

The $8,000 ACS/SVS Health Policy Scholarship defrays tuition, travel, housing and food costs to attend the Executive Leadership Program in Health Policy and Management at Brandeis University near Boston from June 5–12. 

The course is set to take place in person; a virtual option will be made available should circumstances change. 

Since 2004, the Heller School has offered an annual Leadership Program in Health Policy and Management for 30 to 35 physician and surgeon leaders partially sponsored by the American College of Surgeons and the Thoracic Surgery Foundation. 

This intensive one-week program equips health leaders with the knowledge and skills essential for creating innovative and sustainable solutions to improve the quality, cost-effectiveness and efficiency of healthcare service delivery, as well as for participating in healthcare policy and reform. 

Program sessions and case studies offer the latest in national health policy and management frameworks. 

Sample program topics include health policy in the United States; economics and financing; individual and group decision-making; managing clinics and the care process; effective leadership styles; managing change in complex systems; conflict negotiation; and financial literacy for physician leaders.

Learn more about the scholarship at vascular.org/HealthPolicyScholarship. 

Vascular Surgery Board seeks director nominees

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Vascular Surgery Board seeks director nominees

The Vascular Surgery Board (VSB) of the American Board of Surgery (ABS) is seeking director nominees to serve a six-year term beginning July 1, 2022. The VSB is comprised of approximately 12 members who represent the spectrum of vascular surgery and are responsible for both initial and continued board certification. Accordingly, the VSB is responsible for the Vascular Surgery In-training Examination (VSITE), the Qualifying Examination (QE), the Certifying Examination (CE) and the Continuous Certification Assessment (CCA).

Directors will participate in developing the various examinations and administering the annual oral examination (CE). It is the expectation that they will assume leadership roles in one of the VSB committees responsible for the examinations or those dedicated to communications or research/education. Directors must be currently certified by the ABS in vascular surgery and must remain under the age of 65 years of age during completion of their term. The time commitment is approximately 10 days per year including the oral examination, examination reviews, and biannual retreats, in addition to the various committee responsibilities.

The VSB has recently transitioned to a competency-based selection process and away from an organizational- or regional-based process to optimize its performance. Accordingly, individuals with one or more of the following competencies are sought:

  • Experience in non-academic settings including rural, community and/or military settings
  • Experience with the development/implementation of Entrustable Professional Activities (EPAs)
  • Prior service to the ABS or VSB as a question writer or examiner

Emphasis will be placed on elements of diversity across all dimensions, including race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability or age or other elements that bring a different voice to the organization, the VSB emphasized.

Nominees will be accepted from societies, peers, or self-nomination. All nominations will require a letter of support (i.e., completion of the Nominate/Support Form) from either an organization or from an ABMS-certified physician. Both the nominator and nominee forms must be completed for each candidate by April 15, 2022. Access the nominator and nominee forms at these links:

Potential ‘new paradigm’ in treatment of long occlusive lesions emerges

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Potential ‘new paradigm’ in treatment of long occlusive lesions emerges
Rym El Khoury and Lewis Schwartz

Vascular surgeon Lewis Schwartz, MD, has had an interest in biomedical engineering since very early in his career. So his involvement in the early-stage Efemoral vascular scaffold system marks a significant milestone in a mission to save legs and provide better care for patients with peripheral arterial disease (PAD). 

Schwartz, a clinical professor of surgery at University of Illinois College of Medicine in Park Ridge, Illinois, is one of the co-founders behind the novel, balloon-expandable, resorbable, drug-eluting device, which late last year saw results from a study in domestic farm swine delivered at the annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Chicago. 

The pre-clinical trial showed that “long, mobile, peripheral arteries can be successfully treated with multiple, short, balloon-expandable, bioresorbable scaffolds,” presenting author Rym El Khoury, MD, told MVSS attendees. 

El Khoury—formerly a general surgery resident at University of Illinois Metropolitan Group Hospitals in Chicago and now a vascular surgery fellow at the University of California San Francisco (UCSF)—explained how the results were drawn from a total of 38 resorbable scaffolds implanted in eight iliofemoral arteries of four female swine. Configurations, she said, consisted of two scaffolds in two arteries, four scaffolds in another two arteries, six scaffolds in three arteries, and eight scaffolds in one. The total arterial scaffolded length ranged from 32–97mm. 

The Efemoral system, or EVSS, being developed under the auspices of Efemoral Medical, has been heralded as a “new paradigm” in the treatment of long-segment lesions with a device made up of multiple, short scaffolds. “The EVSS is directed to the long, occlusive, atherosclerotic lesions typical of the human peripheral arterial tree and was designed to become the first absorbable stent with widespread clinical viability,” reflects Schwartz in an interview with Vascular Specialist. 

It seeks to succeed where previous bioresorbable scaffolds have suffered pitfalls in five ways, he continues. “By targeting the unmet clinical needs of peripheral vascular intervention, as opposed to coronary intervention; by exhibiting the radial force typical of balloon-expandable metal stents, as opposed to self-expanding nitinol stents; by employing a co-polymer to enhance strength and ductility; by formulating the scaffold to degrade within the first two years, as opposed to the four years typical of historical absorbable stents; and by serially mounting multiple, independent scaffolds over the device length in order to mitigate fracture and facilitate the treatment of long lesions.” 

Schwartz details how the design of radial strength is exhibited “like a freight train negotiating a tight bend in the tracks, the individual scaffolds maintain the arterial lumen with high radial force while the inter-scaffold spaces are free to bend and compress during limb movement. 

“As such, the EVSS can readily treat the short lesions of the femoropopliteal arteries that have been traditionally enrolled in clinical trials of peripheral vascular intervention; in addition, simply by loading more scaffolds onto longer angioplasty balloons, the EVSS can be easily adapted for the treatment of long femoropopliteal lesions heretofore inaccessible using currently available technology,” Schwartz says. 

‘Preserved structural integrity’ 

El Khoury elaborates further on the results presented at the MVSS in Chicago. “Angiographic and optical coherence tomography (OCT) images were obtained of the hindlimb in natural extension and exaggerated flexion showed that native porcine iliofemoral arteries significantly deformed with passive hindlimb flexion as expected (bending 110±20° and compression 20±14%) while preserving their mean luminal diameter even with extreme deformation (4.7±0.4mm vs. 5.0±0.2mm in extension vs. flexion; p=0.16),” she tells Vascular Specialist. 

“Following EVSS implantation, supra-physiologic flexion created similar patterns of deformation in the treated artery (bending 113±19° and compression 15±15%) while mean luminal diameter remained stable without kinks or occlusion (4.7±0.7mm vs. 4.7±0.5mm in extension vs. flexion; p=0.80). Arterial deformation was borne by shortening of the inter-scaffold spaces (2.2±08mm vs. 1.9±0.7mm in extension vs. flexion; p<0.01) as well as the scaffolds themselves (10.7±1.4 vs. 9.9±1.1mm in extension vs. flexion; p<0.01). OCT and 3D micro-computed tomography (micro-CT) imaging confirmed consistent wall apposition and preserved structural integrity in all scaffolds,” El Khoury further explained. 

The first-in-human EFEMORAL I trial, meanwhile, is a prospective, single-arm, open-labeled, multicenter, clinical investigation enrolling patients with an arterial diameter of ≥5.5mm and ≤6.5mm, and lesion length ≤90mm receiving a single EVSS, Schwartz details. Its purpose is to evaluate safety and performance of the sirolimus-eluting EVSS in patients with symptomatic peripheral arterial occlusive disease from stenosis or occlusion of the femoropopliteal or external iliac artery. The principal investigator is Andrew Holden, MDChB, director of interventional radiology at Auckland City Hospital, Auckland, New Zealand. The trial has a primary safety endpoint of freedom from major adverse events at 30 days and a primary efficacy endpoint of freedom from binary restenosis at 12 months. 

Also of note, Schwartz explains, is that the EVSS was originally formulated with paclitaxel as the anti-proliferative agent of choice. However, after the 2018 meta-analysis by Konstantinos Katsanos, MD, et al suggested the drug “carries an increased risk of late mortality […] Efemoral felt it prudent to abandon the cytotoxic drug paclitaxel in favor of the cytostatic drug sirolimus.” 

Schwartz reiterates his drive to tackle “the unmet clinical need for effective lower-extremity revascularization.” With the historical strategy of open surgical bypass, he says, some “14–44% of long bypass leg incisions become infected and up to 69% of patients are re-hospitalized in the first year, with excessive mortality and morbidity.” Yet, while “the current paradigms” of endovascular therapy—such as employing balloon dilatation and dilatation with specialty balloons coated with antiproliferative drugs—are generally effective in treating short lesions, Schwartz continues, “the results of endovascular intervention in the long, chronic occlusions observed in critically ischemic patients remain dismal.” 

Combating leg amputation 

Schwartz says the EVSS design and development have been informed by a long career that has included early training in biomedical engineering, general and vascular surgery, a decade of academic basic and clinical investigation, and a decade of designing and developing biomedical device intravascular strategies, in addition to “a tragic but lifelong experience of leg amputation.” 

Improvements in the treatment of PAD over the last near half century “have been quantum” but failure, including extremity amputation, “remains commonplace,” he says. “We can do better.” For now, Schwartz adds, the device holds promise. “Assuming consistent demonstration of the safety and efficacy of the EVSS in pre-clinical and clinical investigations, the device could potentially become commercially available in the U.S. as early as 2027.” 

Moments suspended in time: Joining the vascular fold

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Moments suspended in time: Joining the vascular fold
Lindsey Olivere

Noon on March 19, 2021, marked the end of an unprecedented year in the world of resident recruiting. Months of virtual interviews, “away” rotations done through a computer screen, and a few short trips to prospective cities amidst rolling waves of lockdowns all culminated in this moment on a friend’s patio in a makeshift Match Day celebration. Moments after seeing the words “Vascular Surgery—University of Pittsburgh Medical Center” on a letter printed by a friend in an ode to in-person Match Days of the past, I received an email from my new program coordinator and a flurry of congratulatory messages from colleagues, both within and outside my future home in Pittsburgh. 

What many don’t realize, particularly in a world as small as that of vascular surgery, is that opening your Match letter immediately welcomes you into the fold of not only your new training program, but a remarkably innovative and multidisciplinary field. 

The weeks from Match Day to June 2021 were a blur of spending precious last moments in Durham, North Carolina, my home of nearly a decade. Seeing family and friends. Filling out countless onboarding documents. And ultimately moving to Pittsburgh with my partner, who thankfully joined me as a UPMC anesthesia intern. I also had the opportunity to travel to Texas and finally meet friends from the virtual interview trail at a pre-intern bootcamp. 

Soon enough, I was at a Pirates game, staring at those incredible yellow bridges spanning the Allegheny River and bracing myself for the moment when I would don my long white coat as an MD. As we enter March 2022 and I reflect on personal and professional growth over the last year, I can’t believe it has only been 12 months since opening that letter. I am still adjusting to life as a surgical resident, but there are a few things I know played a pivotal role in easing this transition. 

First, the friends made on the interview trail—many of whom I met for the first time in Texas—have remained sources of support throughout the last few months. It is worthwhile to invest in relationships with individuals who will become lifelong colleagues. Second, I spent time with family and friends before July—it is much harder to find time to get away during residency, particularly if you are training far from home, as well as to have protected time with a partner or spouse before your schedule becomes more hectic. Third, I invested time getting to know my co-residents. The beginning of the year can be overwhelming, but I tried to take advantage of every opportunity I could to spend time with my awesome co-intern, other vascular residents, as well as my new general surgery colleagues, who have all become my primary social network and support here in Pittsburgh. 

After a year of virtual interviews, I also took the time to explore my new city after Match Day and find a home in a neighborhood that would meet my needs as a resident. When time at home is limited, it has made a difference to come home to a place I love living in. 

Finally, and perhaps most importantly, I have tried my best to be patient with myself in this transition. When it gets hard to maintain this perspective, I have called upon old mentors, and sought out new ones, to remind me both of how far I’ve come, and how much time still lies ahead to hone skills and explore interests. 

Overall, the time from Match Day to the start of intern year can feel overwhelming, and it is normal to fear your first moments alone with a pager. To all the new future vascular surgeons joining our community in March 2022: enjoy the time that lies ahead, and respect the time it will take to transition to life in residency. In the meantime, I can’t wait to welcome you all into the fold! 

Lindsey Olivere, MD, is a first-year vascular surgery resident at the University of Pittsburgh Medical Center.

SVS creates membership section for women

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SVS creates membership section for women
Audra Duncan

Women make up a growing percentage of vascular surgeons. And they now have a new professional membership home within the Society for Vascular Surgery (SVS)—the SVS Women’s Section. 

SVS leadership approved the new membership section in 2021. It is intended as a partnership with the growing women’s vascular surgery membership of SVS and the larger Society to develop a centralized home to discuss specific gender-based issues, support women in practice, research and networking, and organize a grassroots social media campaign to be available to the larger SVS membership. 

Goals are to strengthen the communication and collaboration of women in vascular surgery and enhance development and leadership skills that will permit a more robust presence for women who will be able to engage in the SVS, including in leadership roles. 

Beyond the benefits available to all SVS members, those joining the new section will enjoy dedicated educational programming at the Vascular Annual Meeting (VAM). A special women’s community section on the online SVSConnect community is coming soon. 

Audra Duncan, MD, and Palma Shaw, MD, co-chair this new section. 

Its roots go back decades, said Duncan, with women vascular surgeons meeting informally for coffee, lunch or dinner at VAM and other meetings, “back when Palma and I were junior staff.” While acknowledging strong efforts by the SVS to support recruiting women vascular trainees, “there was a gap in the support of practicing women vascular surgeons, and especially those moving into senior and leadership roles. Therefore, although the percentage of women in SVS is constantly increasing, the face of SVS leadership has remained stagnant in terms of diversity.” 

A WhatsApp chat for vascular surgeons that began shortly before the pandemic hit also played a part. Amid the isolation, more women surgeons joined and found it an important way to connect informally with other women undergoing the same shared experiences, said Shaw. The chat, plus the VAM gatherings over the years and the Women’s Leadership Dinner held at VAM 2021, served as the basis for formation of the Women’s Section, she said. 

One of the first orders of business has been planning the section’s education session at VAM 2022 in Boston. “Supporting Women Vascular Surgeons: From Recruitment Through Senior Leadership” will cover the needs of the youngest generation of women vascular surgeons; radiation, logistics and wellness for pregnant surgeons; optimal practice partnerships; mentors and sponsors; and how senior women surgeons can create a legacy. 

The two-year plan includes promoting involvement; increasing retention of women in vascular surgery; networking and leadership opportunities; programs on female surgeons’ needs; communication via an online network; work-life balance and more. 

Both Shaw and Duncan are pleased with how the section is progressing so far, with female surgeons from other countries also expressing interest. 

“Women have a lot to give back to SVS and we feel like this may be best accomplished when we have a common voice,” said Duncan. “Overall, it’s a win-win for both the women members and the SVS.” 

“We are very grateful to the SVS leadership for supporting this initiative,” said Shaw. “This will help women at many levels achieve their potential and improve work-life satisfaction and wellness for these hard-working, bright and talented women of the SVS.” 

Section membership is open to any SVS member who identifies as she/her. To apply for section membership, email staff liaison Emily Milkes at [email protected]. 

Boston calling: Registration for VAM 2022 is open

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Boston calling: Registration for VAM 2022 is open

Registration and housing for the Society for Vascular Surgery (SVS) 2022 Vascular Annual Meeting (VAM) are now open. This year’s premiere educational event for all vascular professionals is set for June 15–18 at the Hynes Convention Center in Boston. The headquarters hotel is the Sheraton Boston Hotel, which is directly accessible to the Hynes Convention Center. 

For 2021, VAM organizers noted that “Wednesday is the new Thursday,” as a number of events that formerly took place on Thursday moved to Wednesday. Wednesday is still the new Thursday, because those events—the Opening Ceremony, the William J. von Liebig Forum, the E. Stanley Crawford Critical Issues Forum and the first plenaries—remain firmly in place on the Wednesday schedule. 

“This was very well-received last year and continues to allow us to reduce scheduling conflicts,” said SVS Program Committee Chair Andres Schanzer, MD. The committee determines much of the scheduling and programming for the meeting, along with the SVS Postgraduate Education Committee, which handles sessions such as concurrent, breakfast, “Ask the Expert” and special sessions, and postgraduate education courses. 

Also returning is the livestreaming registration option, with even more content going out via the virtual medium. This will allow those who cannot attend in person to view nearly 20 sessions as they unfold. For 2022, most international livestreamed sessions have been moved to early morning, to permit those overseas to watch at a more reasonable time of day. In addition, an entire afternoon of livestreamed content will now accompany the morning content, allowing viewers to login all day long. 

VAM 2022 encompasses four full days of education, networking and learning, and two days of exhibits from industry throughout the vascular world. Topics range from hard science to discussion of diversity issues, the vascular surgery workforce, quality care and improvement, an update on the SVS Foundation VISTA (Vascular Volunteers in Service to All) program and much more. Reviews of recently published SVS guidelines will close each plenary session.

“We aim to cover a broad variety of topics that will be of interest to our diverse members, from emerging trends to highlighting particular vascular conditions and treatments, to situations our members face frequently, such as dialysis access, thoracic outlet syndrome and chronic limb-threatening ischemia,” said Schanzer. “This meeting will have important content for all SVS members.” 

Database analysis findings ‘matched precisely’ with reported reasons for venous stent recalls

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Database analysis findings ‘matched precisely’ with reported reasons for venous stent recalls

A recent analysis recalled Venovo and Vici venous stents—initiated last year—characterized “significant differences” between reported device and patient issues, and subsequent interventions for the two systems, with findings ultimately matching the reasons given for the recall at the time.

A team of researchers from the Virginia Commonwealth University School of Medicine in Richmond, Virginia, tapped the Food and Drug Administration (FDA) MAUDE database for all adverse event reports related to the recalls.

Delivering the results at the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Snowmass, Colorado (Jan. 27–30), Yuchi Ma, BS, a Virginia Commonwealth University second-year medical student, informed attendees the team had found 341 reports for the Venovo stent (BD) and 50 for the Vici (Boston Scientific).

The former was recorded as having activation failure (289 events, or 85%) as its predominant device-related issue, while the Vici saw 24 events, or 48%, registered as related to stent migration. Fracture, meanwhile, made up a significant proportion of reported issues for both (7% of the Venovo and 16% for the Vici). 

“For both venous stent systems, the majority of the cases experienced no clinical symptoms or consequences,” Ma told VESS, but the Venovo “did seem to show a significantly higher percentage.” 

Subsequent interventions performed included ballooning, stent extraction, utilization of a new device, and stenting over the previous stent, all of which were reported in higher percentages in the Vici. 

The research team—completed by Michael F. Amendola, MD, divisional vascular chief at Virginia Commonwealth, Kedar S. Lavingia, MD, assistant professor of surgery, and James M. Dittman, BS, a senior medical student—conceded their findings were limited by either under- or overreporting given the MAUDE database does not capture all procedures performed using the two stent systems.

In a later interview with Vascular Specialist, Dittman elaborated: “The MAUDE database hasn’t been extensively used by the vascular community to characterize devices prior to these adverse events … [This] was an ideal exercise for us to see the power of MAUDE in determining whether or not those were the signals we actually saw in the adverse events that were reported.” 

Ma added, “The findings that we saw in the database matched precisely with reasons why these stents were recalled.” 

The pandemic has been a challenge, but perhaps it imposed some equity

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The pandemic has been a challenge, but perhaps it imposed some equity
Lauren Cralle

Years from now when we look back, will we measure time in terms of B.C. and A.C.—Before Covid and After Covid? It’s hard to imagine a time when we will we once again feel comfortable walking hospital halls without a mask. Between businesses converting to work-from-home models and all levels of education adapting to the virtual world, there’s a new normal. As someone with a healthy appreciation for technology, one that at times borders on obsession, I was excited by the prospect of another virtual residency interview season. This would be the second rendition. Kinks would be smoothed, and surely, I could show off my charm and wit via Zoom/Webex/Thalamus. Plus, I was grateful for the chance to save a couple thousand dollars. 

But, when I sat and thought about what being virtual meant, ambivalence washed over me. We, as bright-eyed, bushy-tailed medical students, would be choosing our futures via computer screen, not that I had any misconceptions about the power of the in-person interview. Anyone can put on a show for a day and a half, albeit it is easier to do so on Zoom. My cohort of future physicians would be entering three-, five-, seven-year contracts with hospitals they may have never seen, in states they may have never visited.

The five to seven years we spend as vascular surgery residents, the hours we spend with the same people within the same four walls, are longer than some marriages. We were being asked to choose that partnership virtually, limited to computer screens, Google searches, video conferences, and Grubhub deliveries. There wouldn’t be a true resident dinner where we could ask the questions we were too scared to ask on the big day. We could try to ask on the Zoom socials, but there wasn’t that human connection. Usually, one or two applicants might be the ones steering the conversation, popping up on screen more often than others. Occasionally, residents would have questions for each of us, icebreakers. Other times, we would sit there in awkward silence as the residents joked amongst themselves. Hard to read the room when the room is pixelated. 

In a time when masks and nasopharyngeal swabs weren’t barriers to in-person smiles and handshakes, I imagine I would pick a program by looking at how people interact. It worked for medical school. I chose based on tangibles such as research, community outreach, rank and rigor, but in a tie between two programs, I thought back on culture. During the tours, who smiled at friends, greeted faculty without pause, and who made room for the janitor and treated them with respect? I chose right. I have been encouraged to grow and been supported in strife. 

Now, we’re being asked to do so behind a screen, without that extra touch. So, I looked at the way people communicated in the main session, how engaged they were in the conversations, who they acknowledged when I asked what they’re most proud of about their institution. For me, it was about the people. 

I tried my best to see where I could challenge myself to grow as a person and as a leader, be surrounded by those that support my learning and my inevitable failures, and learn to be an outstanding vascular surgeon. It’s hard without being in the room. 

There has been a lot of talk about how to bridge health disparities in the U.S. Overwhelmingly, we need more doctors that look, sound and think like our patients. Underrepresented students already have enough on their plates with student loans, implicit bias, racial inequality, gender discrimination. We hope to make medical education more accessible, yet we have been asking disadvantaged students to pay out-of-pocket to interview. 

To even get the interview, there are biases and barriers. Passing standardized tests is anything but fair, between the cost to merely sit for the exam, the disadvantage for non-native English speakers, and the limitations on persons with disabilities. Having famous mentors and letter writers is a luxury of your institution. Performing well on rotation is at the mercy of your circumstances. Life happens. 

Away rotations 

Moreover, beyond the cost of interviews, there’s the “aways.” In a typical year, students do up to five away rotations. Financially, this means covering rent at home, and subletting on the road, paying for food, transportation, and utilities along the way. 

This practice favors the fiscally fortunate, and pushes others less so into more debt. That certainly is not helping to bridge disparities in the field. At times, it seems medicine, for all its advances, is stuck in its ways and needs a push in the right direction. Forcing programs to interview virtually and limiting students to one away could be the push we needed. 

The virtual interview may be the great equalizer to some degree. My peers have interviewed in Los Angeles, Miami, Chicago, Seattle, when they would have never taken the chance because flights and hotels are expensive. 

These peers are brilliant scientists and compassionate leaders who will one day be life-changing physicians. The schools beyond their typical reach would be lucky to train them. 

But what about the mental burden of overthinking Zoom lighting and audio quality, of the ever-present risk of technical difficulties and lost internet connections, of choosing a future home without stepping foot on site, without a single handshake? Equalizer yes, easy no. 

Force for good? 

At the end of the day, is virtual our new normal? Did we choose correctly? Did we use our technological aptitude for good? Like any other marriage, we pick residency programs for better or worse. Sitting at the end of the interview season, tired of staring at screens and adjusting lighting, I’m reminded that this is nearly the end of a long journey. Years of schooling and hours spent on resume-building, volunteering, research—all for this. As students, we shadowed, scribed, and nervously followed residents on rounds hoping that we had the right dressings in our white coat pockets. Now, we would be adding MD to our names and, with it, the very real responsibility for patients. While the remainder of our medical education has been relegated to online lectures and our board exams may have been delayed more times than we care to count, we’re ready. 

When we walk through the hospital come July, the beginning of the end, I’ll be happy to see where this journey takes us—possibly to a place we would have never seen if not for a microscopic virus forcing our hand. The pandemic has been a challenge, but perhaps it imposed some equity on a process long due for a change. 

Lauren Cralle, BS, is a medical student who will graduate in the Class of 2022 from University of Massachusetts Medical School. 

Life of Achilles: Turning weakness into bursts of innovation, creativity

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Life of Achilles: Turning weakness into bursts of innovation, creativity
Jason Lee giving the VESS 2022 Presidential Address

Themes rooted in the life of Achilles, the heroic figure from Greek mythology, and the concept of “emotional stamina” underpinned the message delivered from the presidential podium during the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS). 

The specter of Achilles has loomed large over the life and times of the man behind the message. In recent years, Jason Lee, MD, the now immediate past president of VESS and an active sportsman, has suffered two ruptures of his Achilles tendon. Taking inspiration from the legend of Achilles’ exertions during the Trojan War, Lee drew on both the warrior and leadership characteristics Greek mythology bestows on Homer’s central hero of the Iliad to illustrate character traits redolent of progress and recovery during the 2022 VESS Presidential Address. 

“His swiftness was what made him a great warrior,” Lee told the VESS gathering in Snowmass, Colorado (Jan. 27–30). “The ability to get in and out of trouble quickly, to make quick decisions and move swiftly.” But demigod Achilles also had human traits, he continued, including deep loyalty to family and friends. Perhaps like a lot of young vascular trainees, Lee suggested, he began as slightly angry and impulsive. “But perhaps like most of our trainees who have gone on to be wonderful junior faculty and senior faculty, he adapted.” 

Achilles progressed through a well-described leadership improvement as he rose through the ranks, Lee explained. Battle after battle, or “surgery after surgery,” he said, Achilles was undefeated—“even though the larger war that we all stage every day at the hospital was perhaps at a stalemate.” 

His eventual retreat from war, subsequent return to the fray and ultimate death were tied up in conflict with higher leadership, a failing plan B, as well as vengeance and loyalty. Crucially, the arrow that would claim his life— Achilles’ heel— Lee informed his audience, is shrouded in much mystery and debate. But for Lee, the key to the answer, and the inherent lesson, may lie in scholarly literature that focuses on the warrior’s “imperfect” vulnerability. “Despite whatever armor we put on,” he said, “all of us have that vulnerability, and embracing it perhaps is the best way to adapt to the day-to-day issues we come up with,” he related.

Those Achilles ruptures Lee himself suffered in the last half decade offered up personal trajectories of progress and recovery: “Armed with a continued desire to compete, and even after a second rupture a year later,” the Stanford vascular chief and competitive tennis player told VESS, “[it was] back to the OR [operating room], back to the tennis courts—it turns out these bilateral Achilles ruptures happen with some frequency: and we’re back to everything. This was [about] overcoming the inability to recover physically, and then realizing the emotional recovery necessary for it.” 

Lee asked VESS attendees to consider their own Achilles ruptures, and to consider lessons to be derived from the warrior’s legend. Fierce devotion to protect as well as sponsor the next generation. A warrior’s mentality of battle strategy and teamwork, as in the OR and clinics. Loyalty and dedication to causes and movements. Recognizing strengths can be weak points, and vice versa. That it’s okay to be vulnerable. That leftfield ideas can change history. To remember to respect those who came before. Just as he had when faced with those ruptures, “climb the mountain, and then do it again.” And weather the storm in the spirit of “emotional stamina.” 

Back during VESS 2016, Lee could be seen wheeling around the conference venue on a scooter having incurred the first of those Achilles ruptures. Back then, it soon dawned on him the significance of the moment, he told Vascular Specialist a few days after giving the 2022 VESS Presidential Address. “It was compelling the idea of how indestructible we all like to think we are in trying to put on a strong vascular surgery face for our patients, for our colleagues, for our trainees,” he said. “But we actually all need to have a lot of self-introspection about our own vulnerabilities. Rather than think of those things as weaknesses, we should actually embrace when we’re in those times and turn them into moments of change, innovation and creativity—and make good of them.” 

F/BEVAR review reveals less than 20% of patients suffered intraoperative adverse event

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F/BEVAR review reveals less than 20% of patients suffered intraoperative adverse event
gustavo oberich
Gustavo Oderich

A retrospective evaluation of 600 fenestrated or branched endovascular aneurysm repairs (F/BEVARs) for the treatment of complex aneurysms revealed that fewer than one in five patients experienced an intraoperative adverse event, according to a press release announcing study results published in the March 2022 edition of the Journal of Vascular Surgery.

Thoracoabdominal aortic aneurysm (TAAA) repair is among the most complex and serious operations in the realm of surgery, the press release notes. Endovascular repair of these aneurysms is now established as a viable alternative to open surgical repair, and, according to the principal author, Gustavo Oderich, MD, of the University of Texas Health Science Center in Houston, “studies have demonstrated superior results to open repair.”

“However, despite many technical improvements in complex endovascular repairs, the procedure remains technically demanding with significant risks. Technical failures indeed may result in disastrous complications such as loss of a kidney, bowel or spinal ischemia.”

As reported in the March 2022 edition of the Journal of Vascular Surgery, the aim of this study was to review the incidence of intraoperative adverse events and the impact on outcomes of F/BEVAR for the treatment of complex aortic aneurysms.

The authors reported on 600 consecutive repairs performed at the Mayo Clinic between 2007 and 2019. The overall 30-day mortality was 2% and there were 122 intraoperative adverse events, defined as any intraoperative complication or technical problem requiring an additional or unplanned procedure among 105 patients (18%). The most frequent events included 55 target arteries, 46 access, and seven graft complications.

Although intraoperative adverse events did not affect patient survival (odds ratio of 1), suggesting the intraoperative rescue maneuvers were successful, there were more major adverse events in the intraoperative adverse event group, mostly due to acute kidney injury (27% vs. 11%, p<0.001). Risk factors for the intraoperative adverse events included female sex (odds ratio 2.5), presence of target artery stenosis (odds ratio 2), and Crawford Extent II aneurysm (odds ratio 1.9).

“Data on the incidence of intraoperative adverse events during F/BEVAR and the clinical sequelae has not been previously described in detail,” said Oderich. “This large single-centre study showed that intraoperative adverse events were present in 18% of patients who underwent this procedure, two-thirds of which required additional procedures to treat the complications.

“Endovascular technology continues to evolve. Novel devices have added preloaded systems, lower profile fabric, and steerable catheters and sheaths to minimize procedural difficulty.” The study also underscores the need for not only careful treatment planning but also for operators should have an armamentarium of skillsets and devices to address these intraoperative adverse events.

Biomarkers of heart failure show early reversal with catheter thrombolysis compared to anticoagulation alone in a secondary analysis of the SUNSET sPE trial

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Biomarkers of heart failure show early reversal with catheter thrombolysis compared to anticoagulation alone in a secondary analysis of the SUNSET sPE trial
Investigators, Elizabeth Andraska and Efthymios Avgerinos

In a secondary analysis of the SUNSET sPE randomized control trial, lead investigator Efthymios Avgerinos, MD, of the division of vascular surgery, University of Pittsburgh Medical Centre, Pittsburgh, Pennsylvania, and colleagues found differences in biomarker levels in response to treatment with catheter-directed therapies compared to anticoagulation alone. These data were presented at the 2022 annual meeting of the American Venous Forum (AVF) held Feb. 23–26 in Orlando, Florida.

Investigators, Elizabeth Andraska and Efthymios Avgerinos

Endovascular interventions for submassive pulmonary embolism (sPE) are becoming increasingly popular, and device options are diversifying rapidly. The ULTIMA trial, a few years ago, compared ultrasound-assisted thrombolysis (USAT) to anticoagulation alone and found an earlier reversal in RV:LV ratio in the USAT group, suggesting an earlier recovery with catheter-based therapy. However, the consequences of these findings on early changes in biomarker profile and functional outcomes have not been investigated.

The multicenter SUNSET sPE randomized control trial compared USAT to standard catheter-directed thrombolysis and found no differences in rates of thrombus resolution between the groups. As a secondary analysis of this study, biomarker data and functional outcomes of patients with sPE treated with catheter-directed therapies were compared to patients receiving anticoagulation alone.

Elizabeth Andraska, MD, a fifth-year vascular surgery resident at the University of Pittsburgh presented the results of this secondary analysis at AVF. They reported that baseline characteristics, biomarker, and RV:LV ratios were similar between the two groups. While three-month functional outcomes, as well as the quality of life metrics, were no different between groups, biomarkers CXCL10 and Pentraxin 3, which are associated with heart failure and adverse cardiac remodeling, returned to baseline more rapidly after catheter thrombolysis compared to anticoagulation only (p=0.04). These results may suggest a role for biomarker analysis when evaluating response to therapy and long-term outcomes. The group is excited to evaluate the implications of these findings on long-term outcomes.

Avgerinos reported to Venous News: “Biomarker profiling will ultimately help us better identify those acute PE patients who will progress to a long-term PE syndrome and implement early therapeutic strategies. Catheter thrombolytics seem to normalize faster heart failure biomarkers but it remains unknown if this correlates to a clinically meaningful long-term protection”

This work was awarded as the top abstract of AVF 2022 and will be presented in the forthcoming European Venous Forum meeting.

Dedicated vs. non-dedicated: Researchers place venous stenting under the spotlight at AVF 2022

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Dedicated vs. non-dedicated: Researchers place venous stenting under the spotlight at AVF 2022
Anthony Comerota at the AVF 2022 podium

Venous stenting was a hot topic on the agenda of the recent American Venous Forum (AVF) annual meeting, held this year Feb. 23–26 in Orlando, Florida. Catching the audience’s attention, researchers highlighted a head-to-head study of dedicated versus non-dedicated stents, as well as new subgroup data on the Zilver Vena (Cook Medical) venous self-expanding stent. 

“Iliofemoral venous obstruction when not adequately treated results in chronic debilitating disease and poor quality of life,” said Lillian Tran, MD, of the department of surgery at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, who noted that deep venous stenting is “increasingly preferred” as the mainstay treatment over medical therapy alone. 

According to Tran, this move towards stenting necessitates studies comparing the performance of novel, dedicated venous stents with the more traditional, non-dedicated stents. At AVF, Tran reported the findings of such a head-to-head study at a single center, detailing that the use of dedicated venous stents was associated with a significant reduction in extension into the inferior vena cava (IVC) without reduced early patency rates compared to non-dedicated stents. 

The presenter stressed that outcomes after iliac vein stenting rely on multiple technical considerations and stent attributes. “In addition to adequate sizing and consistency in deployment, […] venous stents must establish a balance between radial force, flexibility and crush resistance,” she informed the audience. Tran detailed that dedicated, nitinol-based stents have been developed to meet these requirements and are now on the market in the U.S. and Europe. Four of these stents have been approved by the Food and Drug Administration (FDA) for venous indications, the presenter relayed, noting, however, the fact that the Vici (Boston Scientific) and Venovo (BD) stents were recalled last year. 

Outcomes data from investigational device exemption (IDE) trials of the four dedicated venous stents have demonstrated excellent patency rates, Tran communicated. However, she highlighted that head-to-head, comparative performance data against the more traditional Wallstent (Boston Scientific) and other non-dedicated stents are limited. 

Tran et al therefore performed a retrospective review of all patients who underwent iliofemoral venous stenting for acute thrombotic, post-thrombotic and non-thrombotic indications at their institution between 2014 and 2021, grouping patients based on the use of novel, dedicated venous stents versus non-dedicated stents during their treatment. 

The team measured 30-day stent failure and one-year patency rates as primary outcomes, Tran detailed, adding that secondary outcomes included stent sizing and extension. 

A total of 135 patients (186 limbs) were treated in the study, Tran told AVF attendees, specifying that 63 limbs were treated using novel dedicated stents, while 123 were treated using the traditional Wallstent or another non-dedicated stent. 

The team noted no preference in stent type in treating acute thrombotic or post-thrombotic lesions at their institution, but they did observe that dedicated venous stents were more likely to be used in non-thrombotic lesions. 

Addressing the AVF audience, Tran reported that fewer stents were deployed per limb with the use of novel dedicated venous stents. In addition, she revealed that one patient had a stent fracture without thrombosis, and that there were no cases of deployment failure or stent migration in either group. 

Additionally, larger size was observed in limbs using the Wallstent alone compared to dedicated venous stents and proximal stent extension into the IVC greater than 50% was significantly reduced with the use of novel venous stents compared to the non-dedicated devices, Tran detailed. 

The presenter relayed some further key outcomes from the study: “Overall, dedicated venous stent use was not significantly associated with differences in early stent patency rates, nor was it a predictor of 30-day stent failure using a logistic regression analysis.” 

In addition, she reported that primary patency rates remain comparable between novel venous stents and non-dedicated stents at one year. On subgroup analysis, the researchers did not see any differences between the non-dedicated and dedicated stents in either 30-day or one-year stent patency rates. 

Tran acknowledged some limitations of the group’s study, including its retrospective nature, small sample size, short follow-up and no concurrent measurement of clinical improvement. 

“In our experience, we found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel, dedicated venous stents compared to Wallstents alone,” Tran concluded. In addition, she recapped that there were no significant differences in early outcomes between the two stent types. 

Also highlighted at AVF were new data on one of the dedicated venous stents. In a presentation on three-year subgroup outcomes from the VIVO clinical study, Anthony Comerota, MD, of the Inova Heart and Vascular Institute in Falls Church, Virginia, summarized that the latest results “continue to support the safety and effectiveness” of the Zilver Vena venous self-expanding stent, designed to treat patients with symptomatic iliofemoral venous outflow obstruction. The aim of the subgroup analysis was to report on three-year patency, clinical improvement and stent integrity in a “real-world” population, including patients with post-thrombotic syndrome (PTS; 43%); those with acute deep vein thrombosis (aDVT; 24%); and patients with non-thrombotic iliac vein lesions (NIVLs; 33%). Looking at patient demographics, Comerota highlighted that the PTS patients had particularly long lesions with a mean length of 12.5cm, double the mean of the lesions in the NIVL group. 

Comerota also noted that 54% of the PTS patients had the stent traversed below the inguinal ligament. The figures were 24% in the aDVT group and 10% among the NIVL patients. In addition, he informed the AVF audience that almost 40% of the PTS patients had a complete occlusion of their iliac venous system, “really putting them at a much higher risk for failure.” This compared to 21% of the aDVT patients. 

Comerota revealed an overall three-year patency rate of 90%, averaging out rates of 100%, 84% and 86% in the NIVL, aDVT and PTS groups, respectively. Looking at three-year freedom from clinically-driven reintervention data, the presenter reported an overall rate of 93–94%, with a 100% rate for NIVL patients, 92% in the aDVT group and 87% among the PTS patients. 

The venous clinical severity score (VCSS) was shown to be “significantly improved” at one month and that observation remained at three years’ follow-up, the presenter relayed, noting that the rates were exactly the same for each of the three groups. 

In addition, a “marked improvement” in the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification was evident in each of the three groups. “Of course, we recognize that the aDVT patients may have a bit more clinical improvement for obvious reasons—their presentation was acute and it was acutely relieved,” said Comerota. In addition, the speaker noted improvement in the venous disability score (VDS) in each of the three groups. 

A “very important issue” in venous stenting is quality of life, Comerota remarked, noting a sustained improvement from one month to three months overall, and when the data are broken down into the three subgroups, a significant improvement at one month and out to three-year follow-up. 

Finally, core lab analysis of the 79 stents that were extended below the inguinal ligament demonstrated that there was no evidence of stent fracture in any of the three groups at one-, two- and three-year follow-up, Comerota communicated. 

The presenter concluded: “The results through three years continue to support the safety and efficacy of the Zilver Vena venous stent. High rates of patency by ultrasound and freedom from clinically-driven reintervention were seen, clinical improvement after stent placement was demonstrated by markedly improved VCSS, VDS, improvement of the CEAP and, most importantly, improved quality of life.” In addition, he reiterated that there was no evidence of stent fracture in those patients with stents extending below the inguinal ligament. 

PROMISE II U.S. pivotal trial of device designed for ‘no-option’ CLTI patients completes enrollment

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PROMISE II U.S. pivotal trial of device designed for ‘no-option’ CLTI patients completes enrollment
The LimFlow system

Enrollment has been completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialization system designed to prevent amputations in so-called “no-option” chronic limb-threatening ischemia (CLTI) patients, the eponymous device maker announced today.

“The PROMISE II investigators are very encouraged by our experience using the LimFlow system to treat CLTI patients with no other options. These are likely the sickest patients ever to have been enrolled in a limb salvage trial,” said Daniel Clair, MD, PROMISE II principal investigator, and professor and chair of the department of vascular surgery at Vanderbilt University Medical Center Section of Surgical Sciences in Nashville, Tennessee. “Major amputations have a devastating effect on the lives of patients and their families. We are excited about the prospect of helping improve the lives of more of these patients once this novel technology becomes broadly available.”

PROMISE II is a multicenter, prospective, single-arm study being conducted at sites in the U.S. of 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, with subjects followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat CLTI, according to LimFlow.

The company also announced completion of enrollment in the CLariTI study of approximately 200 high-risk and no-option CLTI patients. The prospective, observational, multicenter CLariTI study will track the clinical progression of CLTI and incidence of death, amputation, and revascularization attempts in patients undergoing standard medical management for the disease over a one-year period.

“Despite suffering from the most advanced form of CLTI, these no-option and high risk patients have been excluded from other trials,” said Anahita Dua, MD, CLariTI principal investigator and assistant professor of surgery at Harvard Medical School in Boston. “Our hope is that the CLariTI study gives us better insights into the reintervention, amputation and death rates in no-option and high-risk patients treated with the current standard of care.”

Viabahn use in claudicants with long, complex SFA lesions ‘safe and effective’ through five years

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Viabahn use in claudicants with long, complex SFA lesions ‘safe and effective’ through five years
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
The Viabahn endoprosthesis

Recently published research indicates that stent grafting with the Viabahn endoprosthesis (W L Gore & Associates) of long and complex superficial femoral artery (SFA) lesions in patients with claudication is a safe and effective long-term treatment option.

Writing in the Journal of Vascular Surgery (JVS), study authors Takao Ohki, MD, of the department of surgery at The Jikei University School of Medicine, Tokyo, Japan) and colleagues detail that freedom from target lesion revascularization (fTLR) was 79.1% and that no leg amputations, acute limb ischemia or stent fractures were observed out to five years in a population of 103 patients.

Once consigned “almost exclusively” to bypass surgery, long and complex SFA lesions can now often be treated successfully with stent grafting, Ohki et al write, noting that primary patency rates are “approaching parity” with surgical bypass outcomes.

In order to assess the long-term safety and efficacy of endovascular stent grafting to treat long, complex SFA lesions with the Viabahn endoprosthesis—a heparin-bonded stent graft—the researchers conducted a prospective, non-randomized, multicenter, single-arm study at 15 Japanese hospitals.

Ohki and colleagues note that patients with Rutherford category 2–5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9 and SFA lesions ≥10cm long with ≥50% stenosis were included in the study.

The key efficacy and safety outcomes were primary-assistant patency and adverse events through 24 months, respectively, and the secondary outcomes included primary patency, secondary patency, fTLR and Vascular Quality of Life questionnaire score, the authors communicate.

Ohki et al detail that, of the 103 patients included in the study, the mean age was 74.2±7 years, 82.5% were male and 100 (97.1%) had intermittent claudication. They add that the average lesion length was 21.8±5.8cm and that 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively.

Ohki and colleagues report in JVS that the Kaplan-Meier-estimated primary-assisted patency, primary patency and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3–91.5%), 78.8% (95% CI, 68.8–85.9%) and 92% (95% CI, 82.4–96.5%) at 24 months, respectively. The mean ankle brachial index was 0.64±0.12 at baseline and 0.94±0.19 at 24 months (p<0.0001).

They also reveal that fTLR was 87.2% (95% CI, 78.9–92.3%) and 79.1% (95% CI, 67.9–86.8%) at 24 and 60 months, respectively. In addition, no device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through five years, and no stent fractures were detected on the annually-scheduled follow-up radiographs.

Furthermore, the authors advise that the vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at one through 24 months compared with the baseline scores (p<0.0001 for both), and that one patient had required conversion to open bypass during the five-year follow-up period.

The top 10 most popular Vascular Specialist stories in February

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The top 10 most popular Vascular Specialist stories in February

top 10 vascular specialistFebruary’s top 10 includes a highlight from the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting and an interview with Melissa Kirkwood, MD, and colleagues at UT Southwestern in Dallas, Texas, regarding the lightweight shield designed to reduce radiation dose during complex endovascular procedures. Additionally, this month’s highlights include the important discussion of the silent epidemic—burnout—and interesting findings of index atherectomy interventions for claudication. 

1. VESS 2022: Novel use of TCAR to treat complex brachiocephalic disease shown to be effective, researchers report

A “unique” case series of patients undergoing transcarotid artery revascularization (TCAR) in which the system was put to novel use for proximal intervention or incorporated in a hybrid approach to complex brachiocephalic disease demonstrated it to be effective in “providing safe, comprehensive treatment solutions,” the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Snowmass, Colorado (Jan. 27–29) heard.

2. Radiation protection: Lightweight shield designed to reduce dose during complex endovascular procedures gains ground

It all started with a “we should do research together; this is fascinating.” The result—the production of a prototype eyewear that decreases radiation to the eye and brain—is the more-than-decade-long toil of Melissa Kirkwood, MD, and colleagues at UT Southwestern in Dallas, Texas. From conference podium to conference podium, through endless research studies and paper-writing, Kirkwood has put in the miles to get the disposable, lightweight shield patented. Here, the UT Southwestern vascular chief tells Vascular Specialist about her journey and production of the “much-needed” device aimed at helping surgeons and interventionalists combat radiation exposure.

3. Index atherectomy interventions for claudication ‘is associated with higher’ reintervention rates vs. other technologies

Atherectomy use during index peripheral vascular interventions in claudicants is associated with higher reintervention rates when compared to other technologies, a newly unveiled study by Caitlin Hicks, MD, and colleagues at Johns Hopkins Hospital in Baltimore, Maryland, shows.

4. Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system

On Feb. 7, Medtronic issued a notice emphasizing that the same warnings and precautions issued for the HawkOne directional atherectomy system also apply for the company’s TurboHawk Plus 6Fr system due to design similarities. The company stresses that this is not a new issue.

5. Interview: Combating the problem of spin, or overinterpretation, in randomized controlled trials

The presence of spin, or overinterpretation, in scientific papers that ultimately demonstrate statistically insignificant findings had been gnawing away at Thomas Forbes, MD, for quite some time, here he speaks to Vascular Specialist.

6. Complex TAAA: US ARC IDE registry reports better survival vs. real-world data after endovascular repair

Patients treated in Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials for complex thoracoabdominal aortic aneurysms (TAAAs) in the U.S. Aortic Research Consortium (ARC) had better 30-day and one-year survival compared with those recorded in the real-world Vascular Quality Initiative registry, new data presented at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting revealed.

7. New data add to body of evidence highlighting ‘importance’ of vascular surgery in trauma center setting

Another study has emerged showing vascular surgery’s heavy intraoperative consult activity in a level 1 trauma center setting, lending further fuel to the “vascular firefighter” analogy.

8. Worldwide TCAR analysis provides ‘roadmap’ to evaluate future training approaches

An analysis of the worldwide experience of transcarotid artery revascularization (TCAR) has produced key objective proficiency metrics and an analytic framework to assess adequate training for the procedure. “Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases,” Brajesh K. Lal, MBBS, professor of vascular surgery at the University of Maryland, Baltimore, and colleagues conclude in the Journal of Vascular Surgery.

9. Patients in Florida with complex aortic pathology gain unique access to F/BEVAR

Patients with complex pararenal and thoracoabdominal aortic aneurysm (TAAA) disease are faced with limited treatment options outside of one of the most technically and physiologically demanding operations on a vascular surgeon’s schedule: open repair, with fenestrated/branched endovascular aneurysm repair (F/BEVAR) offering a safer option.

10. Silence is golden—but does self-imposed silence lead to burnout?

Bhagwan Satiani, MD, outlines the “silent epidemic” associated with burnout among surgical residents and other physician employees.

Lesson learned: Entering vascular residency during first wave of pandemic 

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Lesson learned: Entering vascular residency during first wave of pandemic 
A recent SVS Town Hall focused on effects of the COVID-19 pandemic on vascular surgery

An insight into the benefits of virtual learning from the perspective of a medical student on the cusp of residency as the early stages of the pandemic played out was delivered during the most recent Society for Vascular Surgery (SVS) virtual Town Hall (Feb. 3). 

Tony Nguyen, DO, now a vascular surgery resident at the University of South Florida in Tampa, told those tuned in how he recognized his status as a student was beneficial almost immediately. 

“I was a fourth-year medical student during the first round of COVID-19 and part of the first cohort to go through the audition rotation virtually,” he said. 

“You have multiple face-to-face sessions with faculty where they teach you vascular surgery, and you have their (mostly) undivided attention as you present on a topic. You can do multiple of these virtual audition interviews with really no cost to the applicant.” 

Nguyen pointed to the absence of travel and housing expenses that meant effectively “free face-to-face time with faculty, program directors and chiefs of division” as he navigated the uncharted waters of launching a career in the thick of a pandemic.

He said downsides included less time with residents and the inability to fully project personalities, as well as an absence of clinical, hands-on experience. But, he countered, “it seems like a good trade-off as a medical student to get all of this opportunity while not having to wake up at 4:30 a.m,” before adding that the cost burden had landed on the side of institutions and that might be why many had since “fallen off.”

Vascular Specialist–March 2022

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Vascular Specialist–March 2022

In this issue:

New JVS editorial leadership structure announced

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New JVS editorial leadership structure announced
New JVS group executive editor Ronald L. Dalman

The Executive Board of the Society for Vascular Surgery (SVS) recently revealed the new composition of the Journal of Vascular Surgery (JVS) publications‘ senior leadership. The changes are set to take effect on July 1.

The editorial structure atop the SVS’ peer-reviewed journals now features editors-in-chief for each of the group’s four titles, overseen by an executive JVS editor.

The latter role will be assumed by Ronald L. Dalman, MD. Thomas Forbes, MD, takes over as editor-in-chief of JVS; Ruth L. Bush, MD, heads up JVS-Venous and Lymphatic Disorders; Matthew Smeds, MD, takes the reins of JVS-Cases, Innovations & Techniques; and Alan Dardik, MD, leads JVS-Vascular Science.

Writing and reviewing in the DEI space: Progress evident but ‘there’s a lot of work to do’

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Writing and reviewing in the DEI space: Progress evident but ‘there’s a lot of work to do’

It’s been more than 18 months since the Journal of Vascular Surgery (JVS) implemented changes aimed in part at diversifying involvement with the publication and addressing how papers on social determinants of health are written and reviewed. Part of that process was the recruitment of a diversity editor.

With more than a year under her belt in the role, Ulka Sachdev-Ost, MD, sat down with Vascular Specialist for a video interview during which she outlined milestones reached and how the journey has evolved so far. Sachdev-Ost talked through opportunities with the journal, highlighting in particular a new internship program that allows vascular trainees to get reviewing experience. In addition, she noted the importance of accountability on the part of both authors and editorial staff to consider whether papers speak to any social determinants of health as they pertain to vascular surgery.

The diversity editor also had some tips for authors looking to write and report better academic papers in the arena of diversity, equity and inclusion (DEI), and healthcare disparities for publication in JVS and beyond. Despite Sachdev-Ost’s belief that the Society for Vascular Surgery (SVS) has been responsive to a call to “be more curious” about diversity issues in vascular surgery as a whole over the last 18 months, she stressed that there is still room for improvement. “There’s a lot of work to do,” she said.

Venous stents remain durable following pregnancy, researchers find

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Venous stents remain durable following pregnancy, researchers find

Iliac vein stents tolerate a gravid uterus well and a possible future pregnancy should not contraindicate their usage in the treatment of pelvic venous insufficiency (PVI), according to new research published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

According to lead author Peter Pappas, MD, r at the  “The standard of care for the treatment of chronic pelvic/leg pain secondary to PVI is iliac vein stenting with or without ovarian vein embolisation. As many women receiving this therapy are of childbearing age, we assessed stent patency and re-intervention rates in women who became pregnant after undergoing iliac vein stenting.”

As reported in the March 2022 issue of JVS-VL, the researchers reviewed collected data from the Center for Vascular Medicine from January 2014 to December 2020. This involved 23 centers in four states. Surgeons placed 2,046 stents in 1,698 women during this time. From this cohort, information on 15 women with 16 iliac vein stents for PVI who had 17 pregnancies were studied.

Characteristics of the 15 patients included a average age of 35 +/- 4 years, all were CEAP classification 0–3, 14 were non-thrombotic in nature, and average time between stenting and pregnancy was 31 months. In 11 of the 17 pregnancies, patients were treated with enoxaparin. None of the women carried the diagnosis of hypercoagulability.

All patients underwent a post-partum ultrasound revealing no stent-related issues complicating any of the pregnancies. Only one patient was lost to follow up, and in the remaining 16 pregnancies, no stent occlusions were observed at an average time of 43 +/- 24 months following the pregnancy.

Pappas said, “A major unresolved question related to iliac vein stenting and pregnancy is in regard to the necessity of anticoagulation during and after pregnancy. The main indication for considering anticoagulation during and after pregnancy is the known increase in clotting factors during pregnancy, the increased incidence of venous thromboembolic events in pregnant women compared with non-pregnant women, and the fear of medical liability.”

Considering the general low risk for anticoagulation, it appears reasonable to anticoagulate pregnant patients with iliac stents who have a known hypercoagulable state, underwent stenting for thrombotic disease, and underwent stenting for non-thrombotic disease if low-risk for bleeding.

Houston, we have a dialysis access problem

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Houston, we have a dialysis access problem
Karl Illig (left) and Eric Peden

The concept of dedicated vascular access centers fuels a turbocharged Texan tussle with Karl Illig, MD, of Flow Vascular Institute in Houston, taking on Eric Peden, MD, an associate professor of cardiovascular surgery at Houston Methodist Hospital, in a no-holds-barred debate on how best to deliver longitudinal patient care. The question is: who will patients call with “Houston, we have a (dialysis access) problem”?

Illig tips his hat at renowned vascular access educator John Ross, MD, and “his greatest contribution”—the creation of the concept of the total dialysis access provider and total dialysis access center. Ross’ clinical career culminated in the creation of the Dialysis Access Institute in Orangeburg in 2013, and Illig is an unapologetic advocate for similar comprehensive dialysis access centers as the model to deliver the best patient care. In a presentation titled “Dialysis access in the 21st century: A call to arms” Illig is categorical about his message to renal care physicians providing dialysis services: “You do it wrong—patients die early. You do it right—quality and quantity of life significantly improve.”

His core message is that with no dedicated plan, training and staff, patients face the prospect of every event occurring in isolation, resulting in excessive catheter contact time, which leads to higher morbidity and mortality. “This is the perfect area of medicine to change care from ‘technique-driven’ to ‘problem-driven’ care,” he says.

The total dialysis access center concept to reinvent the delivery model consists of “several, overlapping and interlocking ideas: one-stop shopping for creation, maintenance, complex salvage, hemodialysis and peritoneal dialysis.” Such centers aim to draw on surgery, endovascular interventions, hybrid procedures and nephrology. This is a designed counterpoint to the accepted format of the system being geared towards “big cases.” In the main, “our patients are sick—but procedures are very low-risk,” avers Illig.

“All operating rooms are set up for surgery and endo[vascular] seamlessly,” he adds. “To the nephrologist, we say: ‘just send [the patient].’ There is a near-same day service. There is no set schedule, walk-ins are welcome; we have imaging, anesthesia, labs, clinical trials and operating rooms under the centre’s control. There is no waiting.”

Longitudinal care sits at the heart of such centers that only provide dialysis care. Illig notes that there is a sense of a plan for all patients that includes recognizing when plan A is not working and identifying when maturation is taking too long. “Of course, the devil is in the detail. How can you do this in a cost-effective manner? At the end of the day, your income must meet your expenses,” he says.

In favor of comprehensive centers

Peden’s riposte is that the most beneficial aspect to practicing in a hospital system is that you can provide truly comprehensive care. “No matter how sick the person, no matter what their other medical troubles are, there are additional resources available at the hospital setting that are simply not available at some outpatient settings,” he states.

Peden acknowledges that freestanding centers offer a variety of advantages for what he terms “garden variety” vascular access care. “In the hospital setting, we are certainly not as limber as the freestanding access centers, which are set up to provide same-day service. For some emergent procedures, such as clotted fistulas or grafts, I think it is better for patients to go to a freestanding centre because the convenience factor is impossible to overcome. For standard creations, I think that is probably reasonable as well, but if there is a bleeding complication, or a person needs transfusion, then you probably need to be in a bigger facility,” he continues.

“In other scenarios, when things are more complicated—when patients have potassium issues, or heart issues such as rhythm problems, or any other serious conditions that dialysis patients have—then care really cannot be provided safely at the access center. Heaven forbid there are complications, those really need to be managed in a hospital,” he says.

“No matter how sick the person, no matter what their other medical troubles are, there are additional resources available at the hospital setting that are simply not available at some outpatient settings.”

His argument relies heavily on the point that a tertiary care hospital is capable of providing heart-lung support or “whatever is needed.” Other complications, such as bleeding, clotting or embolus, are also very difficult to manage if providers do not have access to full surgical facilities, or additional equipment or tools like snares, embolectomy catheters and surgical techniques that can be provided in a hospital operating room or interventional suite that may not be available at a freestanding center.

“Many freestanding centers do not have covered stents, which is probably an error because if they have rupture and bleeding, those things have to be dealt with—occasionally with a stent graft,” Peden adds. “If all you can do is put a balloon up, that is a problem, because it means patients are eventually sent to a hospital or clinic, such as where I work, and then we take care of it through the emergency room and operating room. The question is: what degree of complexity does the person need to have that they might need more support?

“My focus is complex access. So, I take care of a lot of complicated patients that need big, extensive revisions that I think would be really challenging to do in standalone dialysis access centers. At the hospital, we are able to offer more definitive care. A great example is someone I am treating who has had angioplasty upon angioplasty every few months for stenosis of the central venous lesion. To alleviate the thoracic outlet compression, we might surgically remove a rib or clavicle, reconstruct the subclavian vein and fix the aneurysm, but that could turn into a much bigger deal that simply cannot be offered in access centers. There are some bigger and more complicated procedures that definitely need to be done in surgical programs like mine.”

Illig responds to underscore that, at Flow Vascular, operations are performed in an (arteriovenous access-only) hospital, and that their office-based labs are used for office visits and “very straightforward” elective fistulagrams.

Both agree that for a fairly clear-cut, urgent procedure, a freestanding dialysis access center is probably the most convenient first port of call for patients, all the way from simple things, such as parking, to path to care and speedy treatment being easier to navigate than in a hospital setting where the logistics and requirements can be substantial, especially in the COVID-19 era. Further, access centers plan for same-day evaluation and procedure, whereas there are generally days or weeks between the two in a hospital setting.

Multidisciplinary care

Illig is insistent that at freestanding dialysis centers “we all take care of all patients, and communication is key.” He further asserts: “There are well-trained physicians who want to be there and do this. The care delivered is based on a high degree of standardization and skill arising from repetition. Academic and educational focus takes centre stage, and the same team is in the operating room every day.”

This enables surgeons, interventionalists and nephrologists “all working truly together in one place—not just paying lip service from each separate office.” The key issues other than interdisciplinary decision-making are same day service (or close to it), getting everything needed in one step on one day, and zone defense, where all patients are cared for by the team at hand rather than waiting for “their” person.

Such centers, Illig offers, also “allow for control of your own procedure space, which is, incidentally, set up for both surgery and endovascular intervention in all cases. We just do what is best for the problem at hand rather than what we happen to have a certificate on the wall for.”

Peden aims to land a direct hit when he notes that, barring a few well-run freestanding access centers, many do not have multidisciplinary teams on hand. “There are centers with just vascular surgeons performing both open and endo procedures. So, although they carry out both types of procedure, I am not sure that is a multidisciplinary conversation unless you are talking to your ‘endo’ self and your ‘open’ self, back and forth. Of course, there are some centers where transplant, surgery and radiology work really well together and provide comprehensive care. But many vascular surgeons of my generation and younger provide the full gamut of treatments and usually do most of the work themselves,” he notes.

Outcomes

Another pertinent question is: does setup have a bearing on outcomes? According to Illig, it does. “A recent audit of 671 cases reviewed over a six-month period showed that overall infection rate was 2.7% and serious infection rate was 0.6%,” he reports. In addition, the mortality rate was found to be 0.5% (including one self-withdrawal), results for arteriovenous fistula 30-day patency rate (not maturation) were as follows: radiocephalic=100% (n=4); brachiocephalic=95%; brachiobasilic first stage=89%; brachial vein transposition second stage=89% (77% overall); brachial vein transposition single stage=82%. Illig notes: “They also placed 24 HeRO grafts (Merit Medical) with a 30-day patency of 94% and a 30-day infection rate of 4%. The Flow Vascular team also placed 37 peritoneal dialysis catheters with a 30-day function rate of 96%. The center also recorded catheter prevalence rates of between 4% and 9%.”

Peden weighs in to say that the results from his hospital “are similar”—but warns against easy comparisons. “Complication rates might actually be higher in a center like mine only because the low-hanging fruit in terms of the easier procedures in healthier patients are being done in freestanding centers, and more complicated procedures, such as in a stroke victim on oxygen and anticoagulation-dependence—those things come downtown,” he says.

He also counsels against assuming the catheter prevalence rates from Flow Vascular are indicative of all freestanding centers. “I think [these rates] are really dialysis center-to-dialysis center-dependent and are heavily influenced by how that centre is run, and the referral patterns they have. The numbers you say are good and should be what people are trying to achieve i.e., less than 10% catheter rates.”

Leftover surgery at midnight

Illig maintains that dialysis access deserves more respect; “other than venous disease, it is the most common problem our patients have. AV [arteriovenous] access in most places is a low-priority operation, including at universities that I have been affiliated with. It brings to mind surgery at midnight—you get bumped by everybody else. Typically, it is the junior resident helping out as nobody else wants to do it and care received can be speciality-driven, with usually only surgical options available.”

Peden counters sharply by stating: “Of course, Friday at five, where is the person going to go? If they are knocking on the access centre door, they are going to be knocking for a while because nobody is coming until Monday morning. Whereas we are available 24/7, right? This weekend, my partner was doing thrombectomies all weekend, followed by temporary catheter placement for urgent dialysis, because those problems happen.”

“AV [arteriovenous] access in most places is a low-priority operation, including at universities that I have been affiliated with. It brings to mind surgery at midnight—you get bumped by everybody else.”

To the specific charge of surgery at midnight, Peden replies: “I might say better midnight than Monday morning! Because, in many access centers, patients are going to be given a bottle of kayexalate and told ‘good luck over the weekend, see you on Monday morning,’ which is a real problem. In my center, we have two operating rooms dedicated to dialysis access, every day, Monday through Friday, and for emergencies as they arise at the weekend.”

But, he agrees there is legitimacy to the allegation of being bumped. “Of course, there are other hospitals where access is not really a primary focus. For sure, patients are going to have to wait until all the gallbladders, hearts and traumas are done, which sometimes means a patient is waiting for days and days to have the procedure…that is clearly not a service to the patient. And that is why, if it is straightforward, going to an access centre—where that is their focus—is helpful.”

Established systems best serve dialysis patients

Peden’s memo to colleagues reads: “Honestly, dialysis patients are best cared for where there is a system in place, so the two scenarios of access centre and hospital-provided care do not have to be exclusive. I work with lots of people at access centers. I will absolutely send patients to access centers if they need a catheter exchange or such like, which can be quickly treated. They really like coming to these centers and the swag they provide.

“And then, if there are more complications, they will come back and see me, or if they have a preference for more anesthesia or more sedation. So, the two do not have to live in exclusivity or competitive spirit. I think there are many sick people out there who need as much help as they can get and both places can provide good care. But I think there will always be a role for big facilities like mine to help take care of people with more complicated troubles.”

Peden and Illig both sign up to the view that patients are best served by a team taking care of people with dialysis needs as efficiently as possible, and concede they simply emphasize different strategies of war to achieve the same goal. The essential principle, they agree, is that everyone involved in dialysis access should take it seriously and “be access whisperers. Remember, doing it right saves lives”.

VAM 2022 will offer innovative formats

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VAM 2022 will offer innovative formats
VAM 2022 will take place in Boston from June 15–18

The Society for Vascular Surgery (SVS) Postgraduate Education Committee is breaking up the format in favor of change and innovation for two sessions at this year’s Vascular Annual Meeting (VAM).

These in-person-only events will involve both networking and social media. 

Endovation: Endovascular Innovation for Urgent and Emergency Complex Aortic Disorders, 3–4:30 p.m., Wednesday, June 15 

With “Endovation,” this concurrent session gets into the spirit of innovation, as its title suggests. It will bring together experts in “creative but understudied techniques” for complex aortic repair to discuss drawbacks, regulatory issues and best practices for those who are either considering or currently performing, off-label techniques in urgent and emergency settings. 

“Endovation” starts with didactic podium presentations on various facets of the repairs, pre-recorded video presentations of challenging aortic cases involving non-traditional surgical solutions, and a panel discussion. 

The audience will be part of the conversation for discussion of the challenging cases. “Cases Under the Stars” encourages mingling and vascular conversation in a reception-type setting with light refreshments and beverages. Organizers may turn to social media to solicit the case-based content. 

JVS Special Session, 1:30–2:30 p.m., Thursday, June 16 

This special session highlighting the Journal of Vascular Surgery (JVS) publications will be an Audible Bleeding podcast using ESPN’s “Pardon the Interruption” program format. 

As envisioned, panelists will cover a handful of provocative, entertaining topics. JVS editors will work with the SVS Social Media Subcommittee to solicit, via social media, interesting questions and topic ideas in advance of VAM. Audience involvement is key, said Paul DiMuzio, MD, assistant editor for social media for all JVS publications. He likened the informal give-and-take to “discussion around a workplace water cooler.” 

The audience has the chance to pose any question they wish to those involved with the Journal of Vascular Surgery, at all levels of involvement in the publication process, DiMuzio said. Topics will be sought fairly close to the meeting itself, to ensure “the questions will be fresh and topical,” said session organizer Gale Tang, MD. For example, in terms of diversity, equity and inclusion (DEI) issues, a member could seek to ask how the “be careful what you post in social media” article of 2020—which prompted a firestorm of criticism and plenty of social media posts of female doctors in swim attire—could possibly have made it through the review process. 

Another member may want an answer as to whether published papers are even relevant in the era of social media/YouTube videos and sound bites. 

The session will include a podcast with Imani McElroy, MD, one of Audible Bleeding’s regular personnel as a co-moderator. It also will feature a short interview with Peter Gloviczki, MD, JVS editor-in-chief, while Peter Lawrence, MD, senior editor, will be on the panel answering questions. Gloviczki and Lawrence are completing their five-year terms at the head of the JVS publications. 

Tang hopes participants will come away with “a better idea of what is involved with putting together the premier vascular surgery journal and how they can get involved with JVS at any career level.” 

VAM takes place June 15–18, at the Hynes Convention Center in Boston. Registration and housing opens early to mid-March; educational offerings and plenary sessions take place across all four days; and exhibits are open June 16–17. Meanwhile, the SVS Foundation “Cheers to 75 Years” Gala is June 17. 

Visit vascular.org/VAM for more information. 

AVF 2022: Emerging autogenous venous valve formation system sees ‘continual improvement’

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AVF 2022: Emerging autogenous venous valve formation system sees ‘continual improvement’
William Marston delivers data on the early U.S. experience with the BlueLeaf venous valve formation system

An emerging endovenous valve formation system designed to treat patients with chronic venous insufficiency (CVI) with evidence of deep venous reflux has demonstrated continual improvement since U.S. investigators started performing clinical cases with the device 18 months ago, according to recently presented early data.

The BlueLeaf procedure, currently undergoing clinical research worldwide, has shown a rate of 90% technical success among the first 10 patients treated in the U.S., William Marston, MD, one of the INFINITE-US early feasibility study investigators, told the 2022 annual meeting of the American Venous Forum (AVF) in Orlando, Florida (Feb. 23–26).

These data are part of a total of 30 patients treated at sites worldwide, demonstrating a 93% technical success rate of forming at least one valve, said Marston, who disclosed a consultancy relationship with InterVene, the company behind the BlueLeaf device.

Enrolled patients, classed as C5–6 on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification of disease severity, all had significant deep vein reflux in two main segments between the knee and the common femoral vein, adequate inflow and no acute deep vein thrombosis (DVT), Marston, the vascular surgery division chief at the University of North Carolina at Chapel Hill, explained.

Thus far, all subjects in the study have had a maximum of two valves formed using the device—most performed on the right leg and all monocuspid valves (Food and Drug Administration [FDA] approval has now been granted to form bicuspid valves). The patient pool has a mean age of 59, presented with a venous clinical severity score (VCSS) of 15, and 70% had a previous history of DVT (six on the ipsilateral limb).

Marston told AVF attendees how the U.S. investigators had achieved success in nine out of the 10 patients, with the mean number of leaflets formed standing at 1.7. He further noted how procedure time was currently decreasing, explaining how the system requires a period of adjustment as physicians adapt to patient and equipment positioning. Marston pointed out two minor device deficiencies that did not lead to any complications.

In terms of VCSS among the first six subjects with follow-up out to 12 weeks, investigators saw a mean decrease of 2.3, he said, though he cautioned the early-stage nature of the data. Marston reported no major adverse events, one partial valve pocket thrombosis at one day and one partial distal intraluminal thrombosis. Both were asymptomatic and no longer seen after 30 day duplex follow-up, he added.

The process behind the development of the BlueLeaf system—which gained FDA Breakthrough Device designation late last year—”has been under evolution such that we’re just starting to do bicuspid valves and, in fact, we are scheduled to do the first one in the U.S. next week,” Marston said. “The device we are using today is quite different from the one we used 18 months ago.”

The system involves retrograde access; a high pressure balloon expanded to force the deck of the device up against the vein wall; an advanced needle that enters the vein wall and hydrodissects a flap; and then a nitinol dissector advanced into the flap, expanding and deepening the formation to create a valve cusp.

Improvements made to the latest generation of the device means the valve cusp formed has more depth and a deeper capture of blood after creation, Marston elaborated. Additionally, “the device balloon has been strengthened to help puncture post-thrombotic veins, as most of the patients enrolled are post-thrombotic.”

Marston drew attention to one of the study cases with one year of follow-up to demonstrate the BlueLeaf system’s evolution. The 53-year-old male patient, who had two monocuspid valves created, showed no DVT through 365 days follow up and a VCSS improvement from a baseline of 9 to 6. Marston noted how the valve cusp still showed some motion at one year compared to initial formation. “We’d like to see more but this was with a very early version of the device,” he said. “The cusps are now deeper and wider and hopefully will move better at 365 days than we see here. But this patient did have a well-preserved improvement in VCSS.”

Concluding, Marston told the AVF meeting the BlueLeaf procedure “is technically feasible,” capable of forming valve cusps and under “continual improvement.” “The cusps we are forming today are much better than they were a year ago,” he said, pointing to an “exciting” future as study investigators progress into bicuspid valve formation and the hope of greater luminal coverage.

FDA advisory panel issues recommendations on lifelong surveillance for EVAR

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FDA advisory panel issues recommendations on lifelong surveillance for EVAR

The Food and Drug Administration (FDA) recently announced it has issued a letter to healthcare providers emphasizing the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR).

“Regular imaging surveillance, within 30-days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss of patency, and failure of aneurysm sac regression before the occurrence of potentially serious and life-threatening adverse events,” the FDA communicates.

During an FDA meeting on Nov. 3, 2021, the Circulatory System Devices Panel of the Medical Devices Advisory Committee discussed the long-term safety and effectiveness of endovascular stent grafts for AAA treatment, how to strengthen data collection on real-world device performance for currently marketed and future devices, and input on the outcomes that are most important to capture during long-term follow-up.

According to the current announcement, the panel provided input on these topics and the FDA agrees with the panel’s conclusions, including:

  • EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients
  • Patients should complete follow-up visits 30 days post implantation and lifelong annual follow-up thereafter. As is outlined in current professional society guidelines, a six-month follow-up visit should occur if concerns are identified from imaging at 30-day follow-up
  • A real-world surveillance system should be created to collect data through 10 years post-EVAR
    • The surveillance system should assess the following clinical endpoints: all-cause mortality, aneurysm-related mortality, aortic rupture and aortic reintervention
    • The surveillance system should be designed to capture imaging endpoints including endoleaks, aneurysm size, and device patency because these endpoints are associated with adverse clinical events. Collection of high-quality imaging data using standardized imaging protocols and core lab review may be most feasibly accomplished at selected clinical centers
  • Renewed efforts from physicians, health systems and medical professional societies are needed to increase patient and physician compliance with follow-up imaging recommendations post-EVAR

In their letter to healthcare providers, the FDA recommends the following:

  • For patients that providers have treated or follow who are implanted with EVAR devices, regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures to maintain favorable long-term results
    • The FDA urges physicians to ensure compliance with the follow-up recommendations outlined in device instructions for use (IFU) and the Society for Vascular Surgery (SVS) guidelines. SVS guidelines recommend follow-up visits with imaging 30-days post implantation and annual follow-up thereafter, with concerning findings from the 30-day imaging prompting a six-month follow-up visit
  • For patients under care who are being considered for EVAR, physicians should discuss the risks and benefits of all available AAA treatment options with patients (including open surgical repair), while emphasizing the need for lifelong follow-up imaging and the possibility of reinterventions following EVAR. A patient’s willingness and ability to comply with annual imaging follow-up should be considered and discussed in determining the most appropriate treatment option
  • If problems with devices are observed, healthcare providers should report them to the device manufacturer and the FDA’s Voluntary MedWatch Reporting system

These recommendations do not change or affect the Endologix AFX AAA endovascular graft recommendations from January 2022, the FDA advises.

The agency states that it will work collaboratively with key stakeholders to help drive the effort to improve EVAR patient follow-up and postmarket data collection forward and will continue to keep healthcare providers and the public informed if new or additional information becomes available.

Time’s nearly up: Apply for VAM travel scholarships by March 9

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Time’s nearly up: Apply for VAM travel scholarships by March 9
Medical student Kevin Yei presents at last year’s VAM in San Diego

Time is quickly running out for medical students and general surgery residents to apply for Society for Vascular Surgery (SVS) travel scholarships to attend the 2022 Vascular Annual Meeting (VAM) in Boston this June.

“I wasn’t sure what I wanted to be when I grew up,” one vascular surgeon tweeted, encouraging students and residents to apply. “My mentor … helped me find the magical world of vascular surgery through grants such as the SVS VAM Travel scholarship, where I met surgeons who continue to inspire me. Take the leap!” she advised.

Applications are due March 9 for the SVS General Surgery Resident/Medical Student VAM Travel Scholarship and the SVS Diversity Medical Student VAM Travel Scholarship. Each provides not only a travel award to underwrite expenses to attend VAM, but also complimentary meeting registration, a mentorship program, mock interview practice session and a dedicated educational and networking program.

Diversity scholarship winners also will participate in the Meet the Leaders Luncheon with members of the SVS Leadership Development and Resident and Student Outreach committees and mentors.

Those who live in the Boston area will not receive the travel award portion of the scholarship. VAM 2022 will be held June 15 to 18 in Boston. Scholarship notifications will occur in mid-April.  Learn more at vascular.org/VAMTravel1 and vascular.org/VAMTravelDiversity.

Tickets selling briskly for Gala: ‘Cheers to 75 Years’

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Tickets selling briskly for Gala: ‘Cheers to 75 Years’
Gala proceeds benefit the SVS Foundation

More than 330 people have registered their intentions to raise a glass to toast the Society for Vascular Surgery’s quarter-century of helping vascular patients during the Vascular Annual Meeting (VAM) in Boston this summer.  

They have already purchased tables and tickets for the SVS Foundation’s “Cheers for 75 Years” Gala on Friday evening, June 17.

Festivities begin at 6:30 p.m. at the Sheraton Boston Hotel, the VAM headquarters hotel. The evening will kick off with a reception, followed by dinner, entertainment, the live auction, raise the paddle event and dancing. Dress is semi-formal/black-tie optional.

All proceeds benefit the SVS Foundation for its research, public education and awareness and other programs to improve patient care and vascular care.

Tickets are $500 a person or $5,000 a table. The Foundation is offering Platinum and Gold table packages as well, with just two and six, respectively, still available. The Silver table package is sold out.

In response to a social media post about purchasing tickets a group from the University of Texas tweeted, “We’ve got our table! Get yours and support (the) SVS Foundation! Looking forward to seeing our #VascTwitter friends in Boston at VAM2022.”

The vascular division at University of Massachusetts Medical School was quick to respond. “We’ll be there next to you, U of T Vascular, with our table. It is critically important to support (the) SVS Foundation. The ROI (return on investment) can be seen all around us, locally, regionally, nationally. Lead the science, lead the field.”

The most recent Gala, held in 2019, was a huge success, selling out in just a few weeks. The gala-goers themselves enjoyed themselves, with many dancing on stage with the DJ and not leaving until after the final notes of the final song. Organizers believe the 2022 event, in the wake of COVID-19 and so many cancellations, will bring colleagues together to celebrate in a big way. In fact, Matthew Eagleton, MD, Gala Committee co-chair, was first out the gate to purchase a table.

With Immediate Past President Ronald L. Dalman, MD, the committee chair, and Venita Chandra, MD, who also co-chairs, in California and Eagleton in Massachusetts, the three have the country covered, and they want everyone in between the two coasts to join in the fun. Purchase tickets at vascular.org/Gala22tickets.

AVF 2022: Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus

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AVF 2022: Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus
David Dexter delivers CLOUT registry data at AVF 2022

Six-month outcomes from the ongoing CLOUT registry demonstrate the “safety and efficacy” of the ClotTriever thrombectomy system in a real-world deep vein thrombosis (DVT) population regardless of clot chronicity level, the 2022 annual meeting of the American Venous Forum (AVF) in Orlando, Florida (Feb. 23–26) heard.

Norfolk, Virginia-based vascular surgeon David Dexter, MD, was delivering the latest subgroup analysis update from the prospective, multicenter study on behalf of the CLOUT registry investigators based on the first 250 patients enrolled at 24 sites, telling attendees, “We were able to meet the performance goal of greater than 75% in all three [chronicity] groups.” Dexter, of Eastern Virginia Medical School and Sentara Vascular Specialists, explained, “We had remarkably low device-related serious adverse events at one month. And our rates of post-thrombotic syndrome [PTS]—including moderate to severe—at six months were similarly low.”

The data from the registry show 33% of the 250 patients with acute thrombus, 35% with subacute and 32% with chronic clot. Almost all procedures were single session, with an average of four passes using the ClotTriever device (Inari Medical) for all chronicity subgroups, Dexter said. No patients required adjunctive thrombolytics. Adjuvant angioplasty was used in 73% (acute: 70%; subacute: 68%; chronic: 84%) and stents in 47% (acute: 46%; subacute: 42%; chronic: 50%) of cases.

Complete or near-complete thrombus removal was achieved in 85% (acute: 90%; subacute 81%; chronic: 84%) of limbs, including 51% (acute: 54%; subacute: 49%; chronic: 49%) with 100% thrombus removal. The post-thrombectomy median hospital stay was one day for all subgroups.

At six months, 90% (acute: 86%; subacute: 89%; chronic: 96%) of the treated limbs had flow present, and 90% (acute: 84%; subacute: 90%; chronic: 91%) were compressible. Any PTS at six months was about 20% in the acute, 25% in the subacute and 30% in the chronic arms. “Statistically, this has a p value of 0.5—we’ll see how that holds out in another two years when we have finished enrollment of 500 patients,” Dexter said. On the other hand, moderate-to-severe PTS, “was remarkably low at 5% in the acute arm, and about 10% in the subacute and chronic arms.”

Major adverse and serious adverse events “were similar and also rare,” Dexter added. “All-cause mortality was three patients throughout the first 250.”

Furthermore, in terms of venous clinical severity score (VCSS) numbers, at 30 days and six months they were “nicely low” at 3 and 2 for the acute group, 4 and 3 among subacute patients, and 4 and 4 in the chronic subset, Dexter pointed out. Pain score numbers were “essentially zero across the board.” The same was true when measuring quality of life, he said. “The average quality of life went back to the patient’s baseline regardless of the chronicity believed to be in the clot for acute, subacute and chronic.”

The CLOUT registry’s follow-up out to two years is ongoing. Total enrollment of 500 patients at up to 50 sites has the intention of probing all-comers—across acute, subacute and chronic clot subgroups.

AVF 2022: VenoValve improvement ‘maintained’ for 2.5 years without adverse events

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AVF 2022: VenoValve improvement ‘maintained’ for 2.5 years without adverse events
Sebastian Cifuentes presents during AVF 2022

Envveno Medical announced positive 30-month data from the first-in-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF) annual meeting (VENOUS2022) held in Orlando, Florida (Feb. 23–26).

The results showed that VenoValve recipients—now an average of 30 months post-VenoValve implantation—continue to benefit from the device and have experienced no relapses of severe chronic venous insufficiency (CVI), no recurrences of venous ulcers, and no material adverse safety events, the company reported. Average improvement in reflux was 55%, average improvement in venous clinical severity score (VCSS) was 61%, and average improvement in visual analog scale (VAS) was 81%, all compared to pre-VenoValve levels for the eight first-in-human patients who agreed to be followed, including one patient now three years post implantation.

The data were presented by Sebastian Cifuentes, MD, until recently a vascular surgery research fellow at Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia, and part of a research team led by principal investigator Jorge Ulloa, MD, of the same institution.

Cifuentes told AVF 2022 delegates that patients implanted with the VenoValve showed improvement was “maintained” out to 2.5 years without the occurrence of adverse events, with no recurrence in C5 patients and no new ulcers on the ipsilateral side in C6 patients based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification of disease severity.

The VenoValve is currently being evaluated in the SAVVE (surgical anti-reflux venous valve endoprosthesis) U.S. pivotal trial, with a primary safety endpoint of absence of material adverse safety events in 26% or less of the patients at one month post-implantation, and a primary effectiveness endpoint of improvement in reflux of at least 30% measured at six months.

VAM 2022: More science, discussion, streaming

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VAM 2022: More science, discussion, streaming
SVS President Ali AbuRahma speaks during VAM 2021 in San Diego

With abstract selection finished this month and the lineup of many other sessions in place, organizers are excited about the offerings of the 2022 Vascular Annual Meeting (VAM). 

VAM 2022 will be held June 15–18 at the Hynes Convention Center in Boston. Educational programming will be held all four days and exhibits will be open June 16–17. The Society for Vascular Surgery (SVS) Foundation “Cheers to 75 Years” Gala, celebrating the Society’s 75 years of treating patients with vascular disease, will be June 17. Registration and housing are expected to open in early-to mid-March. 

Andres Schanzer, MD, chairs the SVS Program Committee, which oversees overall VAM programming. He offered several innovations for the 2022 meeting, most made in response to participant feedback of previous iterations of VAM. 

VAM 2022 will include two additional podium-based plenary sessions, and eight overall. “This allows us to offer more science in the program and the opportunity to highlight more of our talented investigators,” said Schanzer. 

There will be more discussion. This is a change based on overwhelming feedback from members who find the discussion period following abstract presentations very valuable, said Schanzer. Thus, the discussion period for the three-minute rapid-paced presentations has been extended from three to four minutes. “We hope this will allow for even richer discussion and exchange of ideas,” he added. 

Two sessions will offer innovative formats, including visual abstracts and content shaped by social media as opposed to more standard didactic presentations followed by questions and answers. 

“Members told us that livestreaming in 2021 was really valuable for those who couldn’t attend VAM in person so we have added more,” said Schanzer. “For 2022, we will again offer livestreaming of the morning sessions, which generally are plenaries, and we have added one full afternoon track on each day. We will also be livestreaming all of the international sessions in order to reach those who are unable to travel from abroad.” 

Recording practices are being altered this year; Schanzer said the goal is to have all content available to VAM registrants rapidly. “We are shooting for an aspirational goal of having all video content of all presentations available on Monday, June 20, 48 hours after close of the meeting,” he said. 

SVS members have been celebrating the Society’s creation in 1946 since the 2021 VAM in San Diego. Festivities will culminate in the SVS Foundation Gala on the evening of Friday, June 17. 

“We hoping it’s going to be the biggest and best VAM we’ve ever had,” Schanzer added. 

For more information about VAM, including the meetings and conferences of the Vascular Quality Initiative (VQI) and the Society for Vascular Nursing, visit vascular.org/VAM. 

Sex discordance and postoperative outcomes: We should be vigilant of a real disparity in health outcomes

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Sex discordance and postoperative outcomes: We should be vigilant of a real disparity in health outcomes
Karen Woo

The recent JAMA Surgery publication “Association of surgeon-patient sex concordance with postoperative outcomes” is a population-based, retrospective cohort study of more than 1 million patients that concluded “sex discordance between surgeons and patients negatively affected outcomes following common procedures.”1 Furthermore, the finding is driven by “worse outcomes among female patients treated by male surgeons.” 

My initial reaction upon reading these conclusions was: “How can this be possible?” The scientist in me was certain I could find something(s) in the methodology that could easily explain how they got these seemingly outrageous findings. Thus, I set off to meticulously review the article.

The authors used the Ontario Health Insurance Plan database, derived from the single government payer for Ontario, Canada. The strength of this dataset is that it is representative of the population of Ontario, more so than most administrative databases available in the U.S., such as Medicare claims, which all have some limitation in the population captured. The authors linked the database to four other databases that provided follow-up data for hospitalizations, emergency department visits, patient demographic information and surgeon level data. This looked like about as strong a dataset as you could get in the world of “big data.”

The investigators then imposed a number of inclusion criteria that I won’t bore you with. Suffice it to say, I was satisfied that they carefully considered situations that could represent data entry errors (e.g. date of death preceded date of surgery) or could skew the data (e.g. multiple surgical procedures in the same day and sex-specific procedures). These cases were excluded, leaving the authors with 1,320,108 unique patients—an impressive sample size. 

Well, what about the statistical methods? I thought surely I could find something to pick apart there. The methods described in detail the sophisticated statistics used (multivariable generalized estimating equation with an independent correlation structure and clustering on the procedure performed). The investigators appeared to have accounted for all the covariates and potential confounders they could in their statistical modeling with the available data. I found myself commending the authors for their appropriate, rigorous and robust statistical approach. 

“Big data” analyses such as this are often criticized for being “fishing expeditions,” where the investigators do not start out with a hypothesis and then perform hundreds of comparisons looking for anything that might be statistically significant and then assign it meaning. Wallis and colleagues were careful to indicate throughout the manuscript that this was not a “fishing expedition.” They presented the preliminary data to support their explicitly stated hypothesis which was that “sex discordance between surgeons and patients may contribute to differences in postoperative outcomes, with worse outcomes in female patients treated by male surgeons.” They carefully outlined the “pre-planned” stratified and subgroup analyses in the methods. 

The primary outcome was a composite of death, readmission or major complication (e.g. acute renal failure, stroke, myocardial infarction) within 30 days after surgery. The composite outcome rate was 14.9%. Sex discordance between patient and surgeon was independently associated with a 7% increase in the likelihood of the primary outcome. Analyses stratified by physician, patient and hospital factors demonstrated that this effect largely persisted in the stratified analyses. Further, among female patients, those treated by a male surgeon were 15% more likely to experience the primary outcome compared to those treated by a female surgeon. In contrast, among male patients, those treated by a female surgeon were no more likely to experience the primary outcome compared to those treated by a male surgeon. 

Poking holes in the way the study was executed was proving to be difficult. Certainly, the study suffered from the limitations that are inherent to all administrative data studies, namely lack of granularity, which in this case, as the authors acknowledge, included the inability to distinguish between sex and gender. The authors also acknowledged that case complexity could contribute to the findings if male surgeons perform more high-risk cases. The authors did perform an analysis of low- vs high-risk cases, and found that the association of discordance with the primary outcome was robust to this analysis. However, low-risk was defined as appendectomy, cholecystectomy and carpal tunnel release. All other operations were defined as high-risk. Relevant to vascular surgery, femoropopliteal bypass and abdominal aortic aneurysm (AAA) repair were categorized as high risk. Clearly, within each of those operations, there are complexities such as redo bypass, or short angulated AAA neck, that cannot be captured by administrative data.

Nevertheless, my mind shifted to thinking, “Maybe they have something here.” The only thing these kinds of “big data” analyses can do is demonstrate an association. It is simply not possible to prove causality using a retrospective cohort study design. In a retrospective study, it is entirely possible for two variables to be associated with each other without one causing the other. That said, the investigators did a good enough job with this study for me to believe the observed association in this dataset was real. The obvious next question was “What is the underlying cause?” The authors speculated in the discussion that these findings may be a result of the way sex discordance between surgeon and patient may “adversely affect the physician-patient relationship.” There are abundant data, although largely in medical specialties, to demonstrate that the physician-patient relationship and communication can influence long-term health outcomes.2,3 

This study generated a wide range of reactions on social media, with everything from “Of course women surgeons do a better job than men” to “This study is a lie.” Once we’ve processed our visceral reactions, as clinicians that prioritize our patients’ well-being above all else, we should be concerned that these results may represent a real disparity in health outcomes. The data scientists among us can and should do more work to investigate whether this association holds true in other populations. However, as surgeons, and even data scientists, we are poorly trained and poorly equipped to properly investigate whether the patient-surgeon relationship is the driver of these findings. We need to partner with those who have appropriate expertise, such as sociologists, to rigorously study this issue. In the meantime, this study reminds us that what all of us can do now, regardless of whether the findings are valid, is strive to treat each of our patients equally with the utmost compassion, respect, and diligence.

References

  1. Wallis CJD, Jerath A, Coburn N, et al. Association of surgeon-patient sex concordance with postoperative outcomes. JAMA Surgery. 2021; doi:10.1001/jamasurg.2021.6339.
  2. Coelho KR, Galan C. Physician cross-cultural nonverbal communication skills, patient satisfaction and health outcomes in the physician-patient relationship. International Journal of Family Medicine. 2012;2012.
  3. Street RL, Makoul G, Arora NK, Epstein RM. How does communication heal? Pathways linking clinician–patient communication to health outcomes. Patient Education and Counseling. 2009/03/01/ 2009;74(3):295–301. https://doi.org/10.1016/j.pec.2008.11.015.

Karen Woo, MD, is associate professor of surgery at the University of California, Los Angeles (UCLA). She is also associate director of the Vascular Low Frequency Disease Consortium.

Study ‘supports’ SVS open AAA volume recommendations

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Study ‘supports’ SVS open AAA volume recommendations
decline in open surgery aaa
The Society for Vascular Surgery (SVS) published updated practice guidelines in 2018 that recommended open AAA repair be limited to centers that meet a case volume threshold and outcome target

A multicenter, retrospective database analysis suggests improved open abdominal aortic aneurysm (AAA) outcomes when surgeon volume is greater than seven cases yearly and performed in hospitals with a 30-day mortality rate less than 5%.

“Open AAA repair has decreased in frequency owing to the increasing adoption of endovascular techniques, prompting concern that the decreased yearly clinical experience will affect operative results,” said senior author Adam Doyle, an associate professor of vascular surgery at University of Rochester Medical Center, Rochester, New York.

The Society for Vascular Surgery (SVS) published updated practice guidelines in 2018 that recommended open AAA repair be limited to centers that meet a case volume threshold and outcome target. Specifically, open AAA repair should be conducted in centers that have a mortality rate of less than 5% and that perform at least 10 open repairs per year. Doyle said: “In the present study, we used a pragmatic approach to gauge the effect of the SVS guidelines by analyzing two groups—one that met the recommendations versus one that did not. We then tried to determine if surgeon versus hospital volume was more important for good outcomes.”

As reported in the February 2022 edition of the Journal of Vascular Surgery, Doyle and colleagues utilized the Statewide Planning and Research Cooperative System (SPARCS) managed by the New York Department of Health to determine mortality and morbidity following open AAA repair between the two groups.

The study, which queried records from 2000–2014, involved 7,594 patients treated by 542 surgeons at 137 hospitals. The annual open AAA repair case volume averaged 12.9 (median seven) for the hospitals, and five (median three) for the surgeons.

Overall, 4,000 cases were performed in centers meeting the SVS criteria versus 3,594 cases performed in centers that did not. Comparing outcomes between the groups, the researchers noted significant differences in centers meeting criteria (one-year mortality 9.2%; 30-day mortality 3.5%) and not meeting criteria (one-year mortality 13.6%; 30-day mortality 6.9%).

Of note, complication rates between the groups were similar except the rate of pulmonary complications, which was significantly lower in centers meeting the SVS criteria.

“In the present study, we attempted to bring previous theoretical volume-outcome work into the practical sphere by directly evaluating current guidelines,” said Doyle. “These data showed a positive correlation between the 2018 SVS AAA guidelines and outcomes for elective open AAA repair within the SPARCS dataset.

“Further, whether the surgeon volume or hospital volume better predicts outcomes has been disputed. Our analysis suggests the superior outcomes are achieved by surgeons who perform greater than seven open AAA cases yearly and by centers with an established open AAA 30-day mortality rate of less than 5%.”

Doyle suggested: “This supports centralizing elective open AAA operations to higher-volume surgeons at high-quality centers. This may have educational value for trainees as high-volume surgeons tend to practice at teaching hospitals.”

Each year, nearly 200,000 people in the U.S. are diagnosed with an AAA, the authors note, adding that approximately 15,000 people die each year from a ruptured AAA. This study supports the SVS guidelines for open AAA repair and provides guidance for patients who have the opportunity to choose where and by whom their aneurysm is to be fixed, JVS editors said.

Perioperative care in open aortic surgery: SVS and ERAS Society issue consensus statement

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Perioperative care in open aortic surgery: SVS and ERAS Society issue consensus statement
Doctor holding touching hands Asian senior or elderly old lady woman patient with love, care, helping, encourage and empathy at nursing hospital ward : healthy strong medical concept
The SVS and ERAS Society have released a consensus statement

The Society for Vascular Surgery (SVS) and the Stockholm, Sweden-based Enhanced Recovery after Surgery (ERAS) Society have released a consensus statement intended to help address perioperative challenges faced by vascular surgery patients.

The ERAS pathways have proven beneficial for a number of surgical specialties, and the application of these pathways will be important to address the needs of patients undergoing open aortic operations, according to a press release.

With the goal of delivering high-quality perioperative care and accelerating recovery, this consensus statement is intended to help address the many perioperative challenges faced by vascular surgery patients, who are often older, frailer and have more comorbidities than the average surgical patient.

This document focuses on both transabdominal and retroperitoneal approaches—including supraceliac, suprarenal and infrarenal clamp sites—for aortic aneurysm and aortoiliac occlusive disease operations.

Recommendations for the defined, universal ERAS elements are described, and include the following:

  • Preadmission: Screening, preoperative exercise therapy/prehabilitation, perioperative anti-platelet, anticoagulation plan
  • Preoperative: Fasting, carbohydrate loading, venous thromboembolism prophylaxis, pre-anesthetic sedative and analgesia medication, antimicrobials, nausea/vomiting prevention
  • Intraoperative: Anesthetic protocols, epidural analgesia, body temperature management, drainage of surgical site
  • Postoperative: Multimodal analgesia and opioid reduction strategies, nasogastric drainage, oral feeding, fluid therapy, urinary drainage, glycemic control, early mobilization strategy, discharge education, audit of outcomes

This document additionally reviews some traditional clinical practices where the literature does not allow firm recommendations, such as, Preoperative medical risk assessment, Skin preparation and Intraoperative fluid therapy. The writing group has summarized the current state of knowledge because of the common use of these practices in many institutions, although they were not included in the formal recommendations in the consensus statement.

The recommendations for elective open aortic surgery are important as they are the first published and have summarized a large volume of heterogeneous studies across all ERAS elements for operations performed for either aortic aneurysm disease or aortoiliac occlusive disease. As a result of this, the existence of numerous research gaps has been demonstrated.

These recommendations support the use of care teams to enhance patient optimization and shared decision-making in this population. There is a focus on physiologic stress minimization and reduced variation in postoperative convalescence, which promises to improve the safety and outcomes for patients undergoing open aortic operations.

Katharine McGinigle, MD, chair of the SVS writing group, stated, “The ERAS Writing Group and I are thrilled to share this consensus statement for perioperative best practices for open aortic surgery, and really believe that our patients have much to gain. Each of these recommendations are really nothing new on their own, but it is the collection of them that makes the group of recommendations novel. They emphasize the coordination and timing of care across disciplines to reduce unnecessary care variation and to give our patients the best chances of an improved convalescence.”

This consensus statement provides a carefully reviewed and graded summary of the existing literature, which can guide vascular surgeons and other specialists from other disciplines who treat patients with aortic disease. It defines current standards enabling multidisciplinary teams to implement these procedures in their practice with the intent of improving patient outcomes.

To read this consensus statement, visit vascular.org/SVSERASdocument.

‘Cheers to 75 Years’: Anniversary Gala tickets go on sale on Feb. 22

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‘Cheers to 75 Years’: Anniversary Gala tickets go on sale on Feb. 22
Gala tickets can be obtained by scanning this QR code

How will you help the Society for Vascular Surgery (SVS) celebrate “Cheers to 75 Years?” 

Maybe it’s offering an adventure in the wilderness, on a mountain or secluded location. Perhaps it’s providing the chance to stay in a house by the ocean or obtain a case of high-end wines put together by a connoisseur. 

The committee overseeing this year’s SVS Foundation Gala, “Cheers to 75 Years,” is seeking contributions for both the live and silent auctions that are a big part of the fun during the Gala. 

This year’s Gala, to be held Friday, June 17, during the 2022 Vascular Annual Meeting (VAM) celebrates the 75th anniversary of the founding of SVS in 1946. The celebration began in San Diego during the 2021 VAM and will end with the last tune spun by the DJ in June. 

Festivities begin at 6:30 p.m. at the Sheraton Boston Hotel, the VAM headquarters hotel. The evening starts with a reception, followed by dinner, entertainment, the live auction, raise the paddle event and dancing. Tickets—sales open Feb. 22—are $500 each or $5,000 for a table of 10. VIP tables and sponsorship packages are available now for purchase at vascular.org/Gala22Tickets. 

All proceeds will benefit the SVS Foundation, to fund ongoing research into the causes and treatments of vascular disease, public awareness programs and patient education efforts, among other initiatives. Dress is semi-formal, with black-tie attire optional. 

Everyone, no matter where in the world they are on June 17 can participate in the Silent Auction. All they need is an internet connection to be able to view the items and to place a bid. Notifications will even let participants know when someone has upped the ante on a particular offering. Bidding for Silent Auction items will open several days before the Gala itself. 

The 2019 “Vascular Spectacular Gala” in National Harbor, Maryland, was a huge hit. Tickets sold out within weeks and guests enjoyed dinner, entertainment and spirited bidding, and then danced the night away. 

“You know how we surgeons are,” said Ronald Dalman, MD, Gala Committee chair. “If they’re not competing with each other to put together the most elaborative and imaginative adventure possible, they’re preparing for the competition to outbid each other. We expect some great items to be offered.” 

Venita Chandra, MD, and Matthew Eagleton, MD, are the Gala Committee co-chairs. 

While all contributions are welcome, the sub-committee handling ticket sales and auction items is particularly interested in sporting events and skyboxes, sports memorabilia, travel and timeshares, food, entertainment, wine and high-end liquors, artwork, activities such as golf, chef classes, jewelry and educational experiences. 

To donate, email Catherine Lampi at [email protected]. For information on the gala visit vascular.org/Gala22Tickets. 

Ra Medical Systems receives FDA approval for increased enrollment in atherectomy clinical trial

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Ra Medical Systems receives FDA approval for increased enrollment in atherectomy clinical trial

Ra Medical Systems, a medical device company focused on developing the excimer laser system to treat vascular diseases, has announced that enrollment has reached 95 subjects in the pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD).

The company also announces approval from the Food and Drug Administration (FDA) to increase subject enrollment from 100 subjects to 125 subjects.

DABRA has been cleared by the FDA for crossing chronic total occlusions (CTOs) in patients with symptomatic infrainguinal lower-extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease.

The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2–5) at up to 10 sites. Outcome measures include safety, acute technical success and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA and before any adjunctive treatment.

The trial’s safety and clinical success endpoints are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at six months.

SVS PAC: A voice for vascular surgeons on Capitol Hill

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SVS PAC: A voice for vascular surgeons on Capitol Hill

As everyone turned the page on 2021 and entered 2022 with a new hope for a return to normalcy, vascular surgeons continue to be at the forefront of the fight to combat the COVID-19 pandemic. 

Our days and nights are taxing as we handle the challenging vascular manifestations of COVID-19, the life- and limb-threatening consequences of delayed medical care for chronic vascular conditions, the limited hospital bed capacity and the healthcare workforce shortages. 

The resulting burnout, diminishing financial reimbursements and sluggish growth in the vascular surgery workforce necessitate a further push for vascular surgery’s seat at the legislative table as healthcare policies are developed that impact our patients and us. 

In 2021, the Society for Vascular Surgery Political Action Committee (SVS PAC) focused on the following goals: 

  • Advocacy for fair and appropriate payment for vascular surgeons 
  • Advocacy for relief from regulatory burdens such as prior authorization 
  • Awareness about physician wellness issues 
  • Resolution of workforce attrition issues 

Overall, the SVS PAC continues to grow in a positive direction, with 254 unique members (6% of the SVS membership). Despite this growth, the SVS PAC lags other specialty societies in the amount and percentage of contributing members—a crucial metric to open the doors for our advocacy efforts in Congress. The SVS PAC aims to increase the percentage to 10% of the SVS membership as unique members of the PAC by the end of this election cycle, Dec 31, 2022. 

In December 2021, because of multiple advocacy efforts by SVS PAC, Congress passed legislation to halt several Medicare physician payment cuts including a delay in resuming the 2% Medicare sequester for three months (Jan. 1–March 31), followed by a reduction to 1% for three months (April 1–June 30); the erasure of the 4% Medicare PAY-GO cut and prevention of any additional PAY-GO cuts through 2022; and a one-year increase over the Conversion Factor of 3% (0.75% less than the expired conversion factor “patch” provided for 2021). However, the clinical labor update went into effect on Jan. 1, as year one of four. 

These Medicare reimbursement results represent partial success of tremendous advocacy efforts, by the SVS PAC and other healthcare organizations. But, we still need your help as we continue to work on the clinical labor updates and its impact on office-based vascular surgery procedures. 

Congress must hear your voice and the SVS PAC needs your continued support to do so. Please continue to contact your elected representatives and to contribute to the SVS PAC for 2022. Vascular surgeons deserve representation equal to our role in the fight for a healthier society. 

Shahram Aarabi, MD, and Yazan Duwayri, MD, are members of the SVS PAC Steering Committee. 

VRIC input in 2021 helped strengthen research, says award-winner

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VRIC input in 2021 helped strengthen research, says award-winner

The Society for Vascular Surgery (SVS) Vascular Research Initiatives Conference (VRIC) in 2021 helped Sriganesh (Sri) Sharma, MD, better understand his own work. 

During the free-wheeling discussion following his presentation, “I got a lot of meaningful input into my research,” he said. “I was introduced to perspectives of my own research that I hadn’t thought of before.” 

Under the mentorship of Andrea Obi, MD, at the University of Michigan, Sharma studied the intersection of inflammation and coagulation as it pertains to COVID-19 patients, with a goal of creating a therapy that would protect COVID-positive patients from blood clots. The timing was fortuitous; Sharma joined Obi’s lab with an interest in immunology, including the immunology of blood-clotting. “The pandemic had just started,” he said. “It seemed like a very compelling question without many answers.” 

The abstract on his research was not only selected for presentation at VRIC 2021 (held during the 2021 Vascular Annual Meeting) it also was judged as one of the top four among trainees, earning him and three researchers the SVS Foundation VRIC Trainee Travel Award. (His conclusions: “The coronavirus infection inflammatory state induces MLL1 and urokinase expression in bone marrow derived Mφs and circulating Mφs. MLL1- urokinase regulation contributes to the hyperfibrinolytic phenotype seen in critically ill patients with COVID-19 and represents a potential immunotarget to curb fibrinolysis.”) 

VRIC draws from throughout the field of vascular biology and the conference is well-known for the robust and instructive discussion following presentations. “It’s a fantastic venue,” said Sharma. “I love that the presentations are from different fields in vascular biology and from people at different levels of training.” 

“It’s a diverse crowd with diverse perspectives,” Obi agreed. And because of that, plus the almost ubiquitous problem of blood clots from across almost all specialties and fields, Sharma said. 

He has continued his work with Obi, with a manuscript set for publication, and he hopes his findings since a year ago, with much more now known, are selected for presentation this year. “This is a fascinating subject to study. I thought it would be a flash in the pan when I started,” Sharma said. “But what we found is incredibly interesting and we want to learn more about it.” 

Where the goal was once to create a therapy protecting COVID patients, the two now see broader applications. “We’ve known for 30 years that these innate immune cells are involved in thrombosis” said Obi. “But to date, no one has come up with an immune therapy to target it.” 

Those experiencing clots typically are put on blood thinners, but the side effect of bleeding can be problematic and sometimes life-threatening. 

“Maybe we can get rid of the clotting propensity without putting a patient on thinners,” said Obi. “That’s what Sri is studying.” Coincidentally, given Sharma’s work in immunology, this year’s conference theme is “Translational Immunology and Cardiovascular Disease.” Sharma will feel at home. 

VRIC 2022 will be held Wednesday, May 11, in Seattle. Registration has opened. Visit vascular.org/VRIC22 to register and for more information. 

Diversity efforts while in training: Is it just another box to check?

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Diversity efforts while in training: Is it just another box to check?
Christopher Audu

2020 was a herald year. It ushered in a global pandemic and a reckoning with issues of diversity, equity and inclusion (DEI) in our workspaces. Vascular surgery, by nature of the diseases we encounter and our longitudinal relationship with our patients, have been front and center in both the clinical and social effects of the pandemic. Resultingly, we have been at the cutting edge of surgical treatment for COVID sequelae, and have the opportunity to be at the center of effective diversity efforts. However, the plethora of DEI efforts sometimes seems overwhelming, superficial or forced; and to the vascular trainee—you!—it can be another item to check off our ever-growing competency list. 

So how do we begin to engage DEI efforts as a trainee in a meaningful way? If you’re like me, your plate is already full. There is no easy answer here, but from talking with colleagues who are also navigating this, and from taking notes from our colleagues in other specialties, here are a few simple ideas on how to approach this as a trainee. 

Listening to our patients to really hear them 

Clinical medicine trains us to listen for buzz words, symptoms and pattern recognition. We learn much about pathophysiology. However, what we are not taught is how our patients experience the disease that we are tasked with helping them through.

To get at this important and critical communication point, we must listen to what our patients are telling us and what is not being said. Ask open-ended questions without judgement. Acknowledge their reality. If appropriate, verbalize the obvious emotion. Listen. Don’t rush to fill the silence void. Patients know you’re busy, and most want to respect your time, but what active listening does is communicate that their perspective is valued and heard.

To our minoritized patients, many of whom have been explicitly or implicitly told that their opinions, experiences and expressions don’t matter, this simple act is much appreciated—even if you eventually have to relay bad news regarding their disease diagnosis and prognosis. Everybody desires to be truly heard, and not summarily dismissed or ignored. When you acknowledge the patient experience of their disease, both trainee and patient grow towards a common health goal. 

Checking our implicit biases during patient care 

We all have biases based on our individual experiences, expectations, upbringing and cultural norms. As surgical trainees, who are often tired and running on caffeine, it can be easy to revert to how we see the world and assume that everyone sees it that way as well.

It can be easy to revert to common stereotypes and tropes when that consult page comes in at the end of your call shift, or when you have to explain instructions to a difficult patient after you’ve just endured a negative evaluation, or when you finally get to see a patient who has “been lost to follow-up” or has “no-showed” clinic appointments.

This is not fair to the patient—nor to you, as a surgeon. We must seek to know our biases (there are several online tools for this), and then inwardly reflect on them. This is easier said than done but the effort to do it will pay off, especially when communicating with our minoritized patients and/or anyone who doesn’t share the same heritage and upbringing as you. And this brings me to my next point. 

Sitting with discomfort and learning 

Sometimes, our biases show up when we least expect it. A situation may make us uncomfortable, unpleasant or upset—and we can’t put a precise finger on why. I love these moments, personally, because they reveal deeply held convictions, thoughts or experiences that beckon us to examine them thoughtfully.

Other times, our biases are pointed out to us by our seniors, peers or friends. These are all opportunities for self-reflection, a resetting of our priorities, and if needed, personal education. Just as we strive to improve technically and in clinical judgement as our training goes on, and we constantly evaluate our own performances when we hit negative feedback, I advocate that we sit with our discomfort and use it to propel us to grow. 

Recruiting talent 

There is a linear relationship between being a trainee and increasing responsibility. One year you’re the medical student, and in a few short years, you become the chief. No matter where you are on this journey, you have the power to positively influence someone else, especially those who are historically underrepresented in our profession.

These don’t have to be grandiose efforts. It can be as simple as giving positive feedback when someone does something right; or letting your junior know that you value them and their work; or helping someone navigate the hidden curriculum at your institution; or encouraging that student who is on the fence to seriously consider vascular surgery, letting them know that they belong.

There is no doubt that having a surgeon who shares your experience and culture (and maybe even language) goes a long way in building a positive therapeutic alliance, and we should recruit as much talent to our team as possible.

This list is by no means exhaustive. Rather, I write this to show that engaging in meaningful DEI efforts as a trainee doesn’t need big budgets or lofty programs to be impactful, but can begin with a kind word, a listening ear and a reflective attitude. To our minoritized patients, colleagues and juniors, these are what make a difference in the day-to-day grind that is vascular surgery. May we be up to the task of becoming competent, confident and compassionate surgeons. 

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the Vascular Specialist resident/fellow editor.

Community practice award deadline extended

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Community practice award deadline extended

There’s still time! The Society for Vascular Surgery (SVS) has extended the deadline to nominate an SVS member for the prestigious Excellence in Community Practice Award. 

Applications now are being accepted through March 31 for this award, formerly known as the Excellence in Community Service Award. The honor is exclusively for those who practice in the community setting, including members in office-based labs (OBLs). Selection recognizes an individual’s sustained contributions to patients and their community, as well as exemplary professional practice and leadership. 

To be considered, applicants must be community practitioners and have been in practice as a vascular surgeon for at least 20 years, been an SVS member for at least five years, and show evidence of impact on vascular care or community health. Learn more at vascular.org/CommunityServiceAward.

From the SVS journals

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From the SVS journals

The Journal of Vascular Surgery Cases, Innovations and Techniques has been growing rapidly, publishing an estimated 33% more articles this year than two years ago, according to JVS editors Peter Lawrence, MD, and Peter Gloviczki, MD.

“In 2021, we modified the name of the journal to reflect its increased scope, which will now accept articles on all areas of innovation, including practice, education, outcome assessment and procedural technique as well.” See vsweb. org/JVSCITtransformation. 

What’s the role of diet in managing PAD? JVS-Vascular Science discusses this topic in “Nutrition in the management of peripheral arterial disease: Should we pay more attention to what our patients eat?” See vsweb.org/JVSnutritionandPAD.

Silence is golden—but does self-imposed silence lead to burnout?

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Silence is golden—but does self-imposed silence lead to burnout?
Bhagwan Satiani

Burnout is associated with silence in various contexts. It is called the silent crisis, the silent epidemic, or the silent killer. What is not talked about is the pressure or fear at work, whether professional or personal, that can lead to avoidance behavior and self-imposed silence. Surgical residents have been reported to have burnout rates >60%, and it is likely that causative factors include the pressure or fear at work. My concern has to do with silence associated with physician employees in non-clinical roles at the individual level. 

To this end, the effects of silence on burnout were studied in 600 adults.1 Four differentially motivated types of silence (acquiescent, quiescent, prosocial, and opportunistic) were studied with three components of burnout (depersonalization, emotional exhaustion, and perceptions of reduced personal accomplishment). Pro-social and opportunistic types of silence were self-imposed, whereas acquiescent and quiescent silence were forced. The authors concluded that silence likely leads to burnout, not the other way around. 

It is also likely that one of the critical factors leading to burnout in employed physicians is self-imposed silence. As an employee, their ability to speak out or “voice” is defined as the “discretionary communication of ideas, suggestions, concerns, or opinions about work-related issues with the intent to improve organizational or unit functioning.”2 In contrast, employee “silence” is the “conscious withholding of information, suggestions, ideas, questions, or concerns about potentially important work- or organization-related issues from persons who might be able to take action to address those issues.”2 

There is obviously some nuance to this, rather than a binary choice. Benign examples of silence include new hires choosing to be silent in order to scan the workplace and, with time, evolve into a voice. Experienced hires may start as a voice but, either from bad experiences associated with career derailment or fatigue based on learned helplessness (lack of response for change) may choose to stay silent. Also, physicians may be a voice on some and adopt silence on other issues.

Furthermore, because one is a voice in meetings does not mean that person does not have hidden feelings and, similarly, the quiet physician does not necessarily imply that that physician has hidden issues they are holding inside. In addition to individual or intrinsic factors, silence may be self-imposed due to extrinsic factors. Some of us may resent being under pressure to stay silent in order to avoid personal harm, and take on passive-aggressive behavior by being a voice on easy, non-controversial issues, but withhold important and critical information from leaders. 

Reasons for this self-imposed silence may be several, but primarily because it represents a danger in some way, or is seen as pointless. Job security, academic promotion, or moving up in a professional society may lead to internal pressure to inhibit expression and modify behavior, which then takes a psychological toll on the physician—especially in a personality that wants to progress but does not like making “waves.” 

Is there a link between silence, psychological safety and burnout? Apparently, yes. Knol indicates that it is frequent silence, particularly “high silence” (suppression of serious flaws), that engenders burnout rather than voice reducing it.1 Sherf and colleagues contend that we rely on our biologically based intrinsic “behavioral activation system” and “behavioral inhibition regulatory system” to assist us on when we use our voice or silence.3 The former is more of a positive state of mind and hopeful, whereas the latter is concerned with the worry, even threats, from speaking out. They also point out that individual personality traits— such as extroversion for instance—may affect outcomes. 

Having had experience in both the private sector as well as the academic workplace, I have observed that the latter physician is more prone to suffer burnout from pressure to remain silent, probably because one expects to express one’s thoughts and ideas freely in the learning environment. I have seen senior faculty fear for their job and career advancement if they were to speak out and displease a chair or a dean. This forced silence then becomes incorporated into the culture as younger folks watch and learn that they do not have the freedom to dissent. Among other stressors, inability to express ideas at work is a recipe for burnout. One could blame the general erosion of free speech, but this facet existed long before current trends. 

Why is this important for hospital leaders? Leaders may not be aware that they are suppressing employee voices and fostering silence, because high silence in a health system is not only related to exhaustion and burnout, but hurts productivity. It also harms patient care in the safety and quality-of-care sphere. 

Leaders are also trying to combat burnout using all the tools they have but may remain non-cognizant of the link between silence and burnout. Instead, their way of addressing burnout is of a transactional nature. 

How does the leader provide psychological safety to physicians and other employees and assure their well-being? Psychological safety is described as ‘‘the degree to which people view (their) environment as conducive to interpersonally risky behaviors like speaking up or asking for help.”4 

Establishing psychological safety has to be part of a cascading organizational culture. In the non-clinical areas, leaders should allow, support and commend physicians to take risks by sharing information and ideas, asking questions, offering feedback and airing concerns. Anonymous surveys that do not ask for demographic data, may allow frank input. 

While supportive voices are given more weight by leaders and managers, giving physicians space to freely share their thoughts and ideas in a safe manner needs to be emphasized. Besides the resilience, as well as mindfulness training, tips on communication skills that include techniques to express thoughts in a non-threatening manner may also be useful. 

Ultimately, our leaders need to be encouraged to allow respectful dissent and discussion under the umbrella of psychological safety for physician employees. Self-imposed silence is an important stressor for burnout. 

References 

  1. Knoll M, Hall RJ, Weigelt O. A longitudinal study of the relationships between four differentially motivated forms of employee silence and burnout. Journal of Occupational Health Psychology. 2018; 24(5), 572–589. 
  2. Morrison, E. W. Employee voice behavior: Integration and directions for future research. The Academy of Management Annals. 2011; 5(1), 373–412. 
  3. Sherf EN, Parke MR, Isaakyan, S. Distinguishing voice and silence at work: Unique relationships with perceived impact, psychological safety, and burnout. Academy of Management Journal. 2021; Vol. 64, No. 1, 114–148. 
  4. Edmondson AC, Higgins M, Singer S, et al. Understanding psychological safety in health care and education organizations: A comparative perspective. Res Hum Dev. 2016; 13:65–83. 

Bhagwan Satiani, MD, is professor emeritus in the division of vascular diseases and surgery in the College of Medicine at The Ohio State University, Columbus, Ohio. He is an associate medical editor of Vascular Specialist. 

Patients in Florida with complex aortic pathology gain unique access to F/BEVAR

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Patients in Florida with complex aortic pathology gain unique access to F/BEVAR

This advertorial is sponsored by Tampa General Hospital. 

Dean Arnaoutakis

Patients with complex pararenal and thoracoabdominal aortic aneurysm (TAAA) disease are faced with limited treatment options outside of one of the most technically and physiologically demanding operations on a vascular surgeon’s schedule: open repair. 

With high morbidity (30–50%) and mortality (4–20%) rates associated with open repair, minimally invasive options via fenestrated/branched endovascular aneurysm repair (F/BEVAR) represent a safer alternative. But given the investigational nature of the endovascular devices used to treat patients with complex pararenal and TAAA pathology, access to these devices remains extremely limited to clinical device trials at certain medical centers and subject to Food and Drug Administration (FDA) restrictions.

The access problem is particularly magnified in the state of Florida, which is where Tampa General Hospital vascular surgeon, Dean Arnaoutakis, MD, steps in. Arnaoutakis recently acquired a physician-sponsored investigational device exemption (PS-IDE) from the FDA to study and perform F/BEVARs using physician-modified endografts (PMEGs) in a clinical trial setting—one of the limited pathways vascular surgeons can offer for this type of F/BEVAR repair.

Using PMEGs under the auspices of a PS-IDE trial is the only one of its kind in Florida. This opens up more members of the state’s sizable population who have complex pararenal and TAAA pathology to the prospect of an alternative to open repair, explains Arnaoutakis.

The left image shows four fenestrations created on a PMEG for the celiac (black arrow) and superior mesenteric (black arrow) arteries, as well as one for each renal artery (white arrows). The image on the right demonstrates a further four on another PMEG for the celiac (red arrow), superior mesenteric (black arrow) and, again, one for each renal (white arrows)

“I embarked on this mission because most of our patients with aortic disease, not surprisingly, are elderly, frail, and have underlying cardiopulmonary conditions,” he says. “The traditional open pararenal or thoracoabdominal repair is an incredibly morbid procedure and very poorly tolerated in this particular patient population.”

Florida is the third most populous state in the U.S. with a population of more than 21 million people, over 20% of whom are older than 65, Arnaoutakis points out. The percentage of elderly people in the state is projected to increase over the next decade. Given that aortic disease typically affects the elderly, the incidence of patients with aortic pathology in the state is relatively higher than other states. As a large tertiary referral center, Tampa General Hospital cares for a high volume of patients with aortic disease, many of whom have complex pathology. “For example, in the fiscal year 2020, our center saw 750 patients with aortic pathology in the outpatient setting and performed over 250 aortic operations,” Arnaoutakis, an associate professor in the division of vascular surgery at the University of South Florida College of Medicine, elaborates.

The process of being granted a PS-IDE clinical trial from the FDA in order to offer potentially safer repair options for these patients was lengthy, he notes. The application involved several rounds of both pre- and official submissions, taking nearly two years to complete.

Being able to offer a PMEG significantly broadens treatment options for patients in Florida, Arnaoutakis says, as access to off-the-shelf and/or custom-made devices through clinical trials is so limited. “There are no commercially approved F/BEVAR devices. Enrollment in the TAMBE [thoracoabdominal branch endoprosthesis] clinical trial, an off-the-shelf branched device, has been challenging at times due to the numerous yet necessary inclusion/exclusion criteria. Referring patients to one of the select centers with restricted access to custom-made devices is another option, but can be somewhat impractical. Most of my patients don’t have the financial means, family support, or wherewithal to travel long distances to see one of those surgeons.”

Until now.

“There’s certainly a need in our region to treat patients with complex aortic disease in an endovascular fashion. Once I realized that garnering access to custom-made devices through industry was going to be unrealistic in the short-term, I developed expertise in PMEGs. As my clinical volume of PMEGs increased, I recognized that it was most prudent for patient care to obtain an IDE from the FDA to examine the efficacy of these procedures.”

First patient enrolled in PEERLESS study of FlowTriever system

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First patient enrolled in PEERLESS study of FlowTriever system
FlowTriever thrombectomy device
FlowTriever thrombectomy device

Inari Medical has announced that the first patient has been enrolled in PEERLESS prospective, randomized controlled trial (RCT) comparing the outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever system versus catheter-directed thrombolysis (CDT).

The first PEERLESS patient was enrolled by Amir Kaki, MD, interventional cardiologist, Ascension St John Hospital, Dearborn, MI. PEERLESS will randomize 550 patients and will also enroll up to 150 patients in a registry cohort for patients who cannot be randomized due to an absolute contraindication to thrombolytics. The trial will include up to 60 centers in the U.S. and Europe.

“We are excited and honored to enroll the first patient in this landmark clinical trial,” said Kaki. “From our own experience, the FlowTriever system has the potential to change the way we treat PE patients, safely removing significant clot burden while avoiding thrombolytics and procedure-related ICU stay. Ascension St John’s research team continues to be on the cutting-edge of medical device research and we look forward to contributing and developing the evidence base for the treatment of pulmonary embolism.”

“The start of PEERLESS represents an exciting milestone in the advancement of PE treatment, where randomized clinical data evaluating relevant patient outcomes has been limited,” said global co-principal investigator, Carin Gonsalves, MD, professor of radiology and co-director of the Division of Interventional Radiology at Thomas Jefferson University in Philadelphia.

“PEERLESS marks an opportunity to directly compare FlowTriever outcomes to CDT outcomes, addressing current gaps in our understanding of PE and providing critical information to clinicians on the optimal treatment for these patients.”

“The treatment of PE is undergoing a transformation. We have been thrilled by the desire of physicians to move this field forward and generate high-quality data through PEERLESS,” said Thomas Tu, Inari’s chief medical officer. “We are grateful for the collaboration and dedication of our clinical trial investigators on this first of many PE studies to come.”

New data add to body of evidence highlighting ‘importance’ of vascular surgery in trauma center setting

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New data add to body of evidence highlighting ‘importance’ of vascular surgery in trauma center setting
Abigail Hatcher

Another study has emerged showing vascular surgery’s heavy intraoperative consult activity in a level 1 trauma center setting, lending further fuel to the “vascular firefighter” analogy.

A research team that included fourth-year medical student Abigail Hatcher, MS, of Emory University School of Medicine, Atlanta, and study lead Jaime Benarroch-Gampel, MD, assistant professor of vascular surgery, found that vascular surgery was consulted at a higher rate in both emergent and immediate operative trauma cases than any other surgical subspecialty at Atlanta’s Grady Hospital over a five-year period from 2015–2019.

Hatcher and colleagues noted that the retrospective analysis showed vascular consults ahead of orthopedic surgery and neurosurgery, both of which—unlike vascular surgery—are required in order for an institution to attain American College of Surgeons (ACS) level 1 trauma center certification.

Overall, vascular surgery was the only surgical group to see a statistically significant upward trend in intraoperative consultation over the period, whereas the other top surgical subspecialties did not experience any statistically significant change, Hatcher revealed. On multivariate analysis, she continued, “immediate trauma operations, younger patients, and those who presented with a severe injury severity score were independently associated with intraoperative vascular surgery consultation.”

Jaime Benarroch-Gampel

The results were presented at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting in Manalapan, Florida (Jan. 19–22) by Hatcher, who told delegates the team hopes to expand the study by recruiting other level 1 trauma centers regionally and nationally in order to more broadly analyze consultation rates of surgical subspecialties. “We propose an assessment of the financial impact of vascular surgery’s contribution in trauma centers, and the adequacy of on-call coverage by vascular surgeons,” said Hatcher, who plans to enter general surgery residency on completion of her medical degree. “We recommend a re-evaluation of not only ACS but regional and local guidelines and polices to reflect our findings and the importance of vascular surgery in the trauma setting.”

Study development

Speaking to Vascular Specialist after presenting the data, Hatcher and Benarroch-Gampel described how their coming together, mentee with mentor, got the research project rolling.

Hatcher’s background interest in healthcare policy and Benarroch-Gampel’s robust experience of vascular surgery’s need at the coalface of a level 1 trauma center seeded the endeavor.

“We work incredibly well with our trauma peers here, and we get along incredibly well, and I have seen how much we assist them when they need us,” explained Benarroch-Gampel. “That brought us to the question: vascular surgeons in one of the busiest trauma hospitals in the nation, though we are pretty involved with them, how come we’re not what we call part of the table? The ACS guidelines for level 1 trauma certification does not require vascular surgery—why not?”

That’s when the team decided they needed to compare vascular surgery’s trauma consult rate with the other surgical subspecialties. As they sifted through the data, they discovered that of 2,265 patients identified, 221 required vascular consultation, which compared with 507 across the other surgical subspecialties combined. Hatcher, Benarroch-Gampel and colleagues further found that in addition to vascular surgery recording the highest rate of intraoperative consultation overall, it also saw the highest rate among consultations on cases classed as “immediate,” or patients taken to the operating room in under 60 mins.

“Abigail did a really good job finding the data because after I saw what it told us, I said, ‘Wow, we actually come out with more than the required subspecialties in emergent cases,’” said Benarroch-Gampel. “And I call them emergent because if you have six hours to fix a problem, you can just send the patient somewhere. But if you have to fix the problem in hours, you better have the way to fix the problem in hours.”

Armed with such evidence of vascular surgery’s import in the level 1 trauma setting, the researchers continue to mull over how best the certification anomaly might be rectified. “It takes buy-in from not only other vascular surgeons and programs across the country—because this is a nationwide guideline that we’re addressing—but also the individual hospitals and the trauma teams that you’re assisting,” said Hatcher. “It’s not something that is going to happen overnight, but it is an appropriate change to start talking about and working towards.”

In the meantime, it is imperative that vascular surgery continue to provide a high level of assistance in trauma cases when called upon, Benarroch-Gampel said. There are signs of promise, added Hatcher, who noted major changes to the ACS guidelines in the past, suggesting further updates of this nature “are not out of the realm of possibilities.”

Important cog in healthcare wheel

The Society for Vascular Surgery (SVS) last year published a document chronicling the value of the modern vascular surgeon to the healthcare system. The report from the SVS Valuation Work Group highlighted the unique mix of medical, open surgical and endovascular skills vascular surgeons provide, along with the critical role they play in a safe operating room environment. Benarroch-Gampel said the Atlanta studies represents yet another example that can be used to show how important vascular surgeons are to healthcare systems. “In many cases, we are called the firefighters,” he elaborated. “The value we provide should be highlighted. And the value we provide should be appreciated. Here, it is. We just need to be sure that nationwide this is something where people understand what vascular surgeons provide.”

Benarroch-Gampel said his group previously published data showing that they had seen a rise in their vascular trauma workload—from about 12% to nearly 80%—with good results. “As a society, we need to support that; we need to show that in the vascular trauma field, we are providing a good job compared to other specialties.”

The research team’s attention now turns to getting their latest data published, but Hatcher disclosed that the SAVS meeting room has already yielded interest from senior vascular surgeons about chipping in with data from their own institutions. “They said, ‘We would love to offer our data over the same time period, or a similar time period,’ to see if this is something that they think they’re already experiencing, but they also want to prove, and contribute to a wider dataset.” For Benarroch-Gampel, the question beckons: Are these results isolated to the Atlanta data, or are they occurring across the country? “I personally believe this is nationwide, and not just in one place,” he said. “This is one of the busiest places, with one of the most well-trained trauma surgeon teams, and we still come in and assist when needed.”

Complex TAAA: US ARC IDE registry reports better survival vs. real-world data after endovascular repair

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Complex TAAA: US ARC IDE registry reports better survival vs. real-world data after endovascular repair
Ryan Heslin delivers ARC TAAA data at SAVS 2022

Patients treated in Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials for complex thoracoabdominal aortic aneurysms (TAAAs) in the U.S. Aortic Research Consortium (ARC) had better 30-day and one-year survival compared with those recorded in the real-world Vascular Quality Initiative (VQI) registry, new data presented at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting revealed. 

Results from the consortium’s retrospective analysis of U.S. ARC and VQI procedures carried out between 2011–2019 were delivered by Ryan Heslin, BS, a medical student at the University of South Alabama College of Medicine in Birmingham, Alabama, with senior author Adam Beck, MD, vascular division director at the University of Alabama at Birmingham and one of the IDE investigators, present as a moderator of the scientific session in which the paper featured. 

The research team aimed to compare the real-world setting of the Society for Vascular Surgery (SVS) VQI database to that of the now 10-strong physician-sponsored U.S. ARC trials in order to evaluate the effect of custom-built or off-the-shelf fenestrated/branched endovascular devices. Despite the fact there are no commercially available devices for the repair of TAAAs in the U.S., an increasing number of patients are felt to be at high risk for open repair and are therefore undergoing endovascular repair, Heslin noted. 

“These data are collected in the SVS VQI registry,” he said. “The U.S. Aortic Research Consortium has access to these custom-built branched/fenestrated endovascular devices that are designed to match patients and are not present in the VQI.” 

The analysis of 3,212 patients—all of whom underwent elective procedures for asymptomatic, non-ruptured aneurysms, and had defined zones of endograft deployment—showed a 30-day mortality rate of 6.1% in the VQI vs. 2% in the U.S. ARC for Crawford classification system extent 4 TAAAs. At one year, the equivalent rates were 12.3% (VQI) vs. 8.4% (ARC). Similarly, 30-day and one-year mortality in the cases of extent 1–3 and 5 aneurysms were 7.3% (VQI) vs. 2.6% (ARC), and 16.3% vs. 13.1%, respectively. 

“The appearance of our Kaplan Meier survival curves mostly mirror our findings at 30 days and one year, with a significant drop off in the perioperative period for the VQI group, but a significant difference in survival was noted in both groups,” Heslin added. 

Commenting on the idiosyncrasies two registries, Heslin explained that though the patient populations studied are similar in terms of pathology, “the conditions under which they are studied are quite different.” He continued: “The VQI represents real-world practice using off-label techniques, including physician-modified grafts [PMEGs] and parallel-stenting techniques. This dataset allows us to evaluate endovascular techniques outside of clinical trial settings, and thus is much more representative of the general population. 

“The U.S. ARC is a group of investigators with physician-sponsored IDEs that has access to endovascular repair using custom-built or off-the-shelf medical devices. This allows us to evaluate the outcomes of endovascular repair in a clinical trial setting. It is important to know these patients are highly selected for and studies are under heavy scrutiny from multiple avenues.” Heslin pointed out that the researchers had elected to study Crawford extent 4 aneurysms separately from extents 1–3 and 5 mostly because of overall volume, their lack of a thoracic component, and differences in overall management. 

Notable differences among extent 4 patients in the U.S. ARC population included the fact they were more often Caucasian, male and in possession of a history of coronary artery disease (CAD), he said. The VQI equivalent patients more commonly had a history of chronic obstructive pulmonary disease (COPD) and diabetes. Those with extent 1–3 and 5 aneurysms in the ARC dataset were more likely to be older by about a year, Caucasian, and have a history of CAD. Their VQI counterparts were more likely to have a history of congestive heart failure and COPD. “It is important to note that maximal aneurysm diameter did not vary across the VQI or ARC datasets in any Crawford extent,” said Heslin. 

He conceded certain limitations to the study. “We did not evaluate risk-adjusted mortality,” he began. “While patients overall had similar comorbidities, disease-specific death was not used to compare overall survival. We believe that risk adjusting this type of analysis removes the clinical decision-making that is critical in these elective procedures in complex aneurysms. Additionally, we did not evaluate long-term mortality after one year. We believe that 30-day mortality likely represents procedural success in patient selection, and one-year mortality is indicative more specifically of patient selection. 

“Although reintervention and device or aortic failures may impact longer-term survival, this is likely more impacted by patient factors such as age and comorbidities, as well as unmeasured outcomes such as cancer-related deaths. In summary, in both the ARC and VQI cohorts, more extensive aneurysms, extents 1, 2, 3 and 5, have poorer survival at 30 days and one year. Survival at 30 days and one year was statistically better for ARC patients in both groups.” 

The challenges faced in repairing TAAAs with endovascular devices has bred brisk surgeon activity in the arena, Heslin commented. “Limitations of endovascular repair have largely been challenges related to the inclusion of aortic branches, thus patients needed to be anatomically suitable for optimal repair,” he said. “This problem has inspired numerous and creative ways that vascular surgeons have continued to approach thoracoabdominal aneurysm repair, including PMEGs, parallel-stenting grafts and other techniques, and most-recently custom or purpose-built endografts designed to specifically match patient anatomy.” 

That’s where the IDE trials come in. 

Concluding, Heslin highlighted that the IDE trial patients studied had better perioperative and one-year survival compared to patients treated off label or entered in a real-world registry, regardless of extent. 

“The reasons for these differences require further analysis and remain unclear,” he said. “A couple of things they could be related to would be differences in devices or device durability, differences in device comorbidity profiles, the intangible surgeon and patient psychosocial factors related to when, whether and how to repair these aneurysms, as well as volume-related outcomes. All of these IDE centers have dedicated teams of research coordinators and nurses. These include dedicated resources and additional infrastructure that help manage those patients. This allows for a more programmatic approach to each patient, which likely contributes to better outcomes.” 

Designated discussant Michol A. Cooper, MD, an assistant professor in the division of vascular surgery and endovascular therapy at the University of Florida College of Medicine in Gainesville, Florida, asked for further comment on the survival curves, saying: “Although the overall mortality for the VQI is greater for patients in both groups, based on the Kaplan Meier curves, the majority of the difference appears to be in the initial postoperative period, after which the mortality curves parallel each other.” 

Heslin pondered several possibilities associated with a “really high” relative risk of perioperative mortality. “We discussed patient selection and procedural success previously, which we believe certainly could play a role. Additionally, it could be related to a high-volume center. You could have staff and nurses and dedicated teams, like there is in the IDEs, that are much more comfortable managing the complications that may arise. So, successfully managing these perioperative complications may additionally lead to decreased perioperative mortality as well.” 

The data also prompted Murray Shames, MD, chief of vascular surgery at the University of South Florida (USF) Health Morsani College of Medicine in Tampa, Florida, to ask Heslin whether “industry has a responsibility to expand access if it is shown that [these] devices are better than what is being done in the real world.” The rest of the world has access to such devices, he said. “Europe has devices, Asia has devices, Australia has devices, and we are still limited to [the IDE] sites.” 

U.S. ARC investigator and session moderator Beck stepped in, arguing that responsibility also falls upon the FDA to expand access. “These things are going to be expanded,” he said. “It is just going to take time. Unfortunately, we may be talking about five or 10 years down the road before these things are available.” 

Shames said his institution has two IDE trials of its own—one involving purpose-built and the other PMEG devices. Beck reasoned that PMEG IDEs “would be really interesting to study in addition to the VQI data, which are non-IDE PMEG devices, essentially.” David Minion, MD, a professor of surgery at the University of Kentucky in Lexington, Kentucky, added that specialists faced a reproducibility crisis. “Seventy percent of all studies are not reproducible.” He wondered whether the right question was being asked: “Is it getting more access to more centers? How do we deal with that crisis of being able to compare these things?”

Apply for VAM travel scholarships by March 9

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Apply for VAM travel scholarships by March 9
In this high angle view, a group of medical students stand in their classroom. They look up and smile for the camera.
Medical students and general surgery residents can apply for VAM scholarships until March 9

Medical students and general surgery residents have until March 9 to apply for Society for Vascular Surgery (SVS) travel scholarships that enable attendance at the 2022 Vascular Annual Meeting (VAM) in Boston this June. 

The scholarships are the SVS General Surgery Resident/Medical Student VAM Travel Scholarship and the SVS Diversity Medical Student VAM Travel Scholarship. Each provides not only a travel award to underwrite expenses to attend VAM, but also complimentary meeting registration, a mentorship program, mock interview practice session and a dedicated educational and networking program. Diversity scholarship winners also will participate in the Meet the Leaders Luncheon and Leadership Development Program graduation with members of the SVS Leadership Development and Resident and Student Outreach committees and mentors. 

Students who live in the Boston area will not receive the travel award portion of the scholarship. Students and residents may apply to each scholarship program but are eligible to receive only one award per year. Priority will be given to those who have not previously received any type of SVS travel scholarship, are not presenting an abstract/poster at the meeting, and have not already matched into a training program. VAM 2022 will be held June 15–18 in Boston. Scholarship notifications will occur in mid-April. More information is available at vascular.org/VAMTravel1 and vascular.org/VAMTravelDiversity. 

March 1 awards deadline nears 

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March 1 awards deadline nears 
Robert Smith collects his SVS Lifetime Achievement Award at VAM 2021 in San Diego

The deadline is March 1 for several awards and honors from the Society for Vascular Surgery (SVS) and the SVS Foundation. They include the SVS Lifetime Achievement Award, the Medal for Innovation in Vascular Surgery, the Distinguished Fellow Designation, as well as SVS Foundation Clinical Research Seed Grants. 

  • Lifetime Achievement Award: This is the highest honor the SVS bestows on an individual member. This recognizes an individual’s outstanding and sustained contributions to the profession and the SVS, as well as their exemplary professional practice and leadership. The most recent recipient was Robert B. Smith III, MD, of Georgia (in 2020), who received his honor at the 2021 Vascular Annual Meeting (VAM) in San Diego 
  • Medal for Innovation in Vascular Surgery: This honors an individual whose contribution has had a transformative impact on the practice or science of the vascular surgical specialty. The most recent recipient was venous surgery pioneer Robert Kistner, MD, in 2019 
  • Distinguished Fellow designation: This designation goes to Active, International or Senior members who are vascular surgeons and who have made substantial contributions in two of the three categories of research, service and education. Visit vsweb.org/DistinguishedFellow for more information 
  • Clinical Research Seed Grants: These awards provide $25,000 in direct support for clinical pilot projects that have the potential to become larger studies funded by industry or government sources 

For more information on the awards, visit vascular.org/SVSAwards or vascular.org/FoundationAwards. 

Vascular Specialist–February 2022

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Vascular Specialist–February 2022

In this issue:

Worldwide TCAR analysis provides ‘roadmap’ to evaluate future training approaches

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Worldwide TCAR analysis provides ‘roadmap’ to evaluate future training approaches
Brajesh K. Lal

An analysis of the worldwide experience of transcarotid artery revascularization (TCAR) has produced key objective proficiency metrics and an analytic framework to assess adequate training for the procedure. “Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases,” Brajesh K. Lal, MBBS, professor of vascular surgery at the University of Maryland, Baltimore, and colleagues conclude in the Journal of Vascular Surgery (JVS).

“TCAR is a new hybrid approach to carotid artery revascularization,” the authors begin. They note, however, that proctored training on live cases is an “effort-, time-, and resource-intensive approach to learning new procedures.” Against this backdrop, Lal et al analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to traditional in-person training on live cases.

The researchers describe how physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures; (2) supervised training on human cadavers; and (3) supervised training on synthetic models. Lal and colleagues then compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were non-inferior to proctored training.

Lal et al communicate that, in the period March 3, 2009, to May 7, 2020, 1,160 physicians underwent proctored (19.1%), cadaver-based (27.4%) and synthetic model-based (53.5%) TCAR training and subsequently performed 17,283 TCAR procedures. “The present study is one of the largest to analyze the clinical and technical outcomes stratified by training mode,” the authors note in the discussion of their findings. The proctored physicians treated younger patients and more patients with asymptomatic carotid stenosis and had more prior experience with transfemoral carotid stenting, the researchers specify.

Writing in JVS, the authors report that the over 24-hour composite clinical adverse event rate (1%; 95% confidence interval [CI], 0.8–1.3%) and composite technical adverse event rate (6%; 95% CI, 5.4–6.6%) did not differ significantly by training mode. In addition, they relay that the proficiency measures of cadaver-trained and synthetic model-trained physicians “were not inferior to those for the proctored physicians.” The team identified four key proficiency measures for TCAR, namely the mean contrast volume used during the procedure, the fluoroscopy time required for imaging, the duration of carotid artery flow reversal, and the total skin-to-skin time.

The authors recognize certain limitations of the present study. The retrospective nature of the analysis was subject to selection bias, they acknowledge. However, they stress that the clinical and technical composite outcomes were similar to those reported from prospective studies. Another limitation they highlight was the fact that trainees were not randomized to the three study groups nor to a no training control group.

Lal and colleagues conclude that the analytic approach outlined in their paper provides a “roadmap” to evaluate the effectiveness of training approaches for new technologies and surgical techniques in the future.

Study highlights need to extend scope of cerebrovascular health disparities research

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Study highlights need to extend scope of cerebrovascular health disparities research
Daniela Renedo

A new research letter in Stroke outlines use of the novel National Institutes of Health (NIH) All of Us research program dataset of diverse participant data to identify factors that increase the risk of carotid artery stenosis and those who undergo revascularization. The study, authored by Daniela Renedo, MD, a postdoctoral research fellow Yale School of Medicine, New Haven, Connecticut, and colleagues, includes electronic health record data from over 200,000 U.S. patients.

“It is increasingly recognized that underrepresented groups defined by factors other than race and ethnicity also carry a disproportionate burden of cardiovascular disease,” the authors begin. In order to test the hypothesis that the burden of carotid artery stenosis and the proportion of persons who undergo carotid revascularization differ in broadly defined underrepresented groups, the researchers utilized data collected via the All of Us research program.

According to the NIH website, the All of Us research program is inviting 1 million from across the U.S. “to help build one of the most diverse health databases in history,” welcoming participants from all backgrounds. “Researchers will use the data to learn how our biology, lifestyle, and environment affect health,” with the ultimate aim of finding ways to treat and prevent disease, the website adds.

The team performed a cross-sectional study including All of Us participants with available electronic health records data, considering underrepresented groups defined by factors other than race and ethnicity, including education (less than high school degree); income (less than $35,000); and gender identity/sexual orientation.

Of the 203,813 patients included in the study, the average age was 51.5 years and the majority (61%) were female. The authors relay that the prevalence of carotid artery stenting was 2.7% (n=5,420) and the proportion of patients who underwent carotid revascularization was 7.3% (n=395).

Writing in Stroke, Renedo et al report a key finding that persons with income of less than $35,000 were more likely to have both carotid artery stenosis and undergo revascularization, detailing that income of less than $35,000 was associated with higher odds of carotid artery stenosis (odds ratio [OR], 1.15 [95% confidence interval (CI), 1.07–1.24; p=0.001] and carotid revascularization (OR, 1.38 [95% CI, 1.04 – 1.83]; p=0.024).

The investigators also found that, when evaluating underrepresented groups defined by race and ethnicity, Black (OR, 0.87 [95% CI, 0.78–0.96], p=0.006) and Hispanic participants (OR, 0.83 [95% CI, 0.73–0.94] had a lower prevalence of carotid artery stenosis, which they note is consistent with prior reports.

Moreover, the authors communicate that Black participants with carotid artery stenosis (OR, 0.41 [95% CI, 0.24–0.68]; p=0.001) had lower estimates of carotid revascularization. They remark that this could be explained by lower rates of high-grade stenosis, but stress that other factors should be explored further, including the potential presence of care access bias.

Renedo and colleagues acknowledge that their study may be subject to volunteer bias, leading to an increased number of healthy people enrolled. In addition, they note that not all participants chose to share their electronic health records.

“These results highlight the need to extend cerebrovascular health disparities research beyond groups defined by race/ethnicity,” the researchers conclude, adding that this goal will be “significantly facilitated” by the newly established All of Us research program.

Speaking to Vascular Specialist partner publication, Vascular News, Renedo conveys the key takeaway message from the study, that more attention should be given to the present healthcare disparities in this condition. “Clinicians should be aware of these disparities, and offer patient-centered recommendations to prevent, mitigate and manage carotid artery stenosis across diverse populations,” she elaborates.

The first author advises that, in the near future, the All of Us research program will provide access to genetic data from the participants. Renedo is part of a lab team at Yale headed by Guido J. Falcone, MD, that is focused on genetic epidemiology, and therefore the team will use the data from this study “to better understand the interaction between social determinants of health and biological factors that ultimately lead to carotid stenosis and its consequences.”

The top 10 most popular Vascular Specialist stories in January

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The top 10 most popular Vascular Specialist stories in January

top 10 vascular specialistJanuary’s top 10 includes “Our forever plague,” a combined editorial by Malachi Sheahan III, MD, our medical editor, on fake news and science, and coverage of the U.S. investigational device exemption (IDE) Aortic Research Consortium and how the chief investigators believe it has produced strong data on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR). Numerous announcements for the 2022 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) also caught the attention of many readers, highlighting the opportunity for travel scholarships and the return of livestreaming at VAM 2022.  

1. Our forever plague 

The following is a combined and revised version of the November and December 2021 editorials on fake news and science denial published in Vascular Specialist. Supplemental information and resources have been added to assist physicians in combating science denial and vaccine hesitancy during the COVID-19 pandemic.  

2.  VAM travel scholarship applications are available this month 

Medical students and general surgery residents can now apply for travel scholarships to attend the 2022 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM). The meeting will be June 15–18 in Boston. 

3. Nominate ‘giver, doer’ for Excellence in Community Service Award 

The Society for Vascular Surgery (SVS) is asking members to consider who among the many excellent vascular surgeons they may know in community practice might be worthy of nomination for the 2022 SVS Excellence in Community Service Award. 

4. Livestreaming to return at VAM 2022 

After a successful debut in 2021, livestreaming of a variety of sessions will return to the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) this year. 

 5. ‘Leveraging multiple teams and cardiovascular specialists’ 

The latest Leadership Corner features Young Erben, MD, interviewing Charles B. Ross, MD, chief of vascular and endovascular services at Piedmont Heart Institute, Piedmont Hospital, Atlanta, since 2012. 

 6. US IDE Aortic Research Consortium ‘pushes the envelope’ on F/BEVAR 

The U.S. investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer, MD, professor and chief of vascular surgery at the University of Massachusetts Medical School in Worcester, Massachusetts, claimed at Critical Issues in Aortic Endografting 2021 (Dec. 17–18) in Paris, France. As a result of the group’s work, “more patients are getting better care, by more providers, using F/BEVAR devices,” he remarked, summarizing key datasets presented since 2018. 

7. SVS PAD course postponed 

The new Society for Vascular Surgery (SVS) Peripheral Arterial Disease (PAD) Skills Course has been postponed amid the COVID-19 pandemic recent surge in cases, the Society announced. 

8. VA: Cutting through the ‘red tape’ of research 

Creating an academic career with a perfect blend of clinical work and protected time for productive research is a struggle for many surgeon-scientists. Many have viewed a surgical career in the Veterans Health Administration as a perfect opportunity to achieve that amalgamation. The 2018 revision to the Common Rule has simplified and increased the efficiency of the regulatory components for human subject research. 

9. VESS: A society primed for young vascular surgeons, trainees, and medical students 

Welcome to December where the calendar is filled with abstract and registration deadlines to various meetings through the summer of 2022. In this month‘s column, we are highlighting the Vascular and Endovascular Surgery Society (VESS). Formerly known as the Peripheral Vascular Surgery Society (PVSS), VESS traditionally holds its winter annual meeting at a ski resort and is renowned for its casual attire dress code at its meetings. VESS is chic and boasts a loyal membership. But what is its secret sauce?

10. Medtronic recalls HawkOne directional atherectomy system 

Medtronic has recalled 95,110 HawkOne directional atherectomy system devices distributed in the United States between Jan. 22, 2018, and Oct. 4, 2021, the Food and Drug Administration (FDA) announced. 

Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system

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Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system

On Feb. 7, Medtronic issued a notice emphasizing that the same warnings and precautions issued for the HawkOne directional atherectomy system also apply for the company’s TurboHawk Plus 6Fr system due to design similarities. The company stresses that this is not a new issue.

“There is no product retrieval or disposal requested at this time,” Medtronic communicates in a news alert, which details that approximately 800 devices are impacted by this recall. “Additionally, there are no actions required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices,” the alert continues.

Medtronic advises that there have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device.

Index atherectomy interventions for claudication ‘is associated with higher’ reintervention rates vs. other technologies

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Index atherectomy interventions for claudication ‘is associated with higher’ reintervention rates vs. other technologies
Qinqwen Kawaji

Atherectomy use during index peripheral vascular interventions in claudicants is associated with higher reintervention rates when compared to other technologies, a newly unveiled study by Caitlin Hicks, MD, and colleagues at Johns Hopkins Hospital in Baltimore, Maryland, shows.

The researchers found that 48.9% of those who received an index atherectomy procedure later underwent reintervention, but just 29.8% of patients who did not undergo an initial intervention via an atherectomy did so. Some 59.7% of the study group—drawn from 2019 Medicare data on more than 15,000 patients intervened upon for claudication—received index atherectomy, with the patient pool followed through June 2021.

Comparing reintervention between groups stratified by index procedure, Hicks et al revealed that 85.7% of patients undergoing a first-known intervention with atherectomy also received a reintervention using the same procedure. This compared with just 30.9% among those whose initial intervention was carried out using a different technology.

The data were delivered by Qinqwen Kawaji, MD, a general surgery resident, at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting held in Manalapan, Florida (Jan. 19–22).

Probing physician side characteristics, the research team also found the estimated 2.5-year cumulative incidence for first-time reintervention was 60% among practitioners deemed high atherectomy users vs. 42.4% in those found to be standard atherectomy users.

After adjusting for all patient characteristics, atherectomy continued to be associated with a 33% higher risk for reintervention, Kawaji told SAVS attendees. “Other characteristics associated with reintervention include Black race, diabetes and urban residence,” she said.

Meanwhile, patients treated initially by high atherectomy user physicians were associated with a 49% increased risk for intervention compared to “first quartile” atherectomy users—with those in quartiles 1–3 being termed “inlier” physicians and those in quartile 4 “outliers.”

Vascular surgeons were associated with associated with a lower risk of reintervention than cardiologists, radiologists, CT surgeons and physicians from other specialties, according to the research team. Other significant physician characteristics associated with reintervention included male sex and high volume peripheral vascular intervention practice, Kawaji said. “Previously, physicians working at ASCs (ambulatory surgery centers) OBLs [office-based labs] have come under scrutiny for atherectomy use,” she added. “In our adjusted model, we did not find an association between site of service and reintervention.”

Kawaji concluded: “Index femoropopliteal atherectomy for claudication is associated with high reintervention rates, and high atherectomy physician users and nonvascular surgeons perform more peripheral vascular reinterventions than their peers. Because of the limitations of our study, we were unable to elucidate whether or not the high reintervention rates were related to atherectomy device failure or physician practice patterns. Our study suggests that appropriateness for atherectomy use in initial peripheral vascular reinterventions for claudication needs critical re-evaluation.”

The analysis builds on previous findings by Hicks and colleagues in recent years. Last year, her group reported on a study of physician practice patterns using the same Medicare dataset in which they found that some 420 physicians, or 25.8%, performed atherectomy in 87.5%-plus of their index femoropopliteal disease intervention cases. Another 133 physicians (8.2%) performed atherectomy in 100% of their index femoropopliteal peripheral vascular intervention cases. They also demonstrated that high users of atherectomy were more frequently cardiologists (38.3% vs. 34.2%) or radiologists (14.1% vs. 6.9%), and less frequently vascular surgeons (34.1% vs. 48.2%).

How an aortic ally can help physicians optimize patient outcomes

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How an aortic ally can help physicians optimize patient outcomes

This advertorial is sponsored by Gore.

Kimberley Wunder

The aorta is special. As one of the most complex and critically important vessels of the vascular system, the aorta presents unique challenges. As such, it deserves an investment in constant and specialized care to ensure optimal patient outcomes. 

I’ve often heard the question “What is the device manufacturer’s role beyond providing products?” Clinicians benefit greatly from a device manufacturer relationship that provides much-needed clarity on recommended solutions for their patient. From highly responsive device delivery, to deeply specialized technical expertise, to complete consultative discussions, physicians need to know they can count on their medical device provider as a source of integral support. Physicians need an aortic ally who is equally invested in achieving the best possible outcomes for patients. 

Whether a vascular or cardiothoracic surgeon is performing an endovascular aneurysm repair (EVAR) or thoracic EVAR (TEVAR) procedure, they need to feel they can trust and rely on the device, as well as the manufacturer’s clinical and technical knowledge that support the use of that device. 

For example, a trusted aortic ally supports the physician well beyond the acquisition of a product, providing technical expertise for their device of interest and supporting clinical decision-making by sharing their knowledge of clinical trials and outcomes. What type of experience and knowledge does the clinical or sales representative offer? How many cases do they support on average? They should be able to rely on their aortic ally for timely responses, trusted information, and essential technical device proficiency for EVAR and TEVAR procedures, literature case studies, and device specificity for unique anatomies and cases. 

How does a medical device manufacturer evolve to demonstrate commitment to innovation and valuable experiences to provide the best outcomes for patients? A good aortic ally is committed to the development, support and refinement of physician-supportive resources. Such resources include case studies and educational webinars to share surgical expertise, thought leadership on cutting-edge research, clinical trial developments, and the latest product innovations, demonstrations and videos of device use, product information and literature, and peer recommended techniques. This array of supporting resources should be simple to navigate, have practical application, and be succinct and easy to share with physician peers. 

In today’s fast-moving surgical landscape, this means device manufacturer support that goes beyond products and considers holistic solutions that can be tailored to different types of patients. Equally important is an understanding of aortic device limitations in critical cases. A device manufacturer committed to the best patient outcomes includes a sales force with a focus on supporting physicians in choosing the right product for each patient, even when that product is not their own. 

Ultimately, an aortic ally combines innovation with reliability for solutions that deliver real-world improvements to the lives of patients with aortic disease. 

Visit goremedical.com/aorticsupport to find out how an aortic ally can help you. 

Kimberley Wunder, PhD, is a Clinical Application Specialist at W. L. Gore & Associates, delivering clinical and operational expertise, and providing education and training support within the aortic product portfolio to clinical end-users. She is passionate about engaging with customers, and accelerating research and development efforts into improved clinical outcomes.

Marston: Diversity required to deliver comprehensive care to vascular disease population

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Marston: Diversity required to deliver comprehensive care to vascular disease population
William A. Marston delivers his address at SAVS 2022

William A. Marston, MD, was recalling a recent experience acting as a bone marrow donor for a family member, and the moment it dawned on him, after the harvesting procedure with a specialist in the field, the true value of the knowledge, skill and training it takes to make the routine routine in his own domain of vascular disease treatment.

“In our world, this is devalued,” said the vascular surgery division chief at the University of North Carolina at Chapel Hill. He was addressing the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 19–22) in Manalapan, Florida, his swansong as SAVS president. “These procedures are life and limb saving,” he told attendees. “The things that we do, we do them every day—but we don’t internalize or appreciate it. We need to, both personally and collectively.”

Marston provided a prescription for his peers struggling to fully appreciate what it is they do day after day.

“Take satisfaction in providing good patient care, even if it’s not procedural. If you advise someone not to have a procedure, that may sometimes be the best thing that you could do,” he said. “And we do this well at this association: that is, talk about complications and bad outcomes. Let’s learn from them, not hide from them, and acknowledge that they occur.

“Support your peers, talk to each other; we all have complications, be realistic about them. And sometimes, amputation is the best option for our patients. Sometimes it’s best to leave the aneurysm alone.”

Beware comparing yourself to podium experts, Marston continued. “Most of us are experts in little narrow things. When we talk about some great case we did, for me it might be a vena cava reconstruction. But I don’t do complex aneurysms with Mark Farber around. I don’t do retrograde pedal access. So, if you’re treating a broad selection of vascular patients, do a good job, do the best techniques you can and sleep well with it.”

He titled his address around the concept of the vascular surgeon and what might be “the right stuff” for practitioners—a play on the eponymous 1980s movie about the pioneering days of the U.S. space development program and the space race’s symmetry with the swashbuckling gestation period of the vascular surgical specialty.

“In the movie,” Marston said, “astronauts competed to be the first; they all wanted to be the first in space, and that had to be the best one. But I believe that today, in 2022, the right stuff should be defined by the collective success of a program to provide focused care for the largest population of patients with vascular disease possible. To achieve this, we need vascular surgeons of all backgrounds, all races, all ethnicities with the diversity to deliver care to all patients with vascular disease.”

Interview: Combating the problem of spin, or overinterpretation, in RCTs

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Interview: Combating the problem of spin, or overinterpretation, in RCTs
Thomas Forbes

The presence of spin, or overinterpretation, in scientific papers that ultimately demonstrate statistically insignificant findings had been gnawing away at Thomas Forbes, MD, for quite some time.

The practice, the University of Toronto vascular chair reflects, is by no means unique to vascular surgery but would often spring to the forefront of his mind as he pored over randomized controlled trials (RCTs) comparing endovascular aneurysm repair (EVAR) to open repair, and carotid stenting to carotid endarterectomy (CEA).

In the case of EVAR vs. open repair, he recalls, he would see trial researchers with nonsignificant studies declare the former “no better” than the latter. “So, the new kid on the block is no better than the gold standard,” he says. “By saying no better, that has a negative connotation.” On the other hand, he would see authors involved with carotid stenting trials write that the new kid on the block—in this case stenting—was “just as good as” the gold-standard CEA. “Whereas,” Forbes points out, “statistically there was no difference. There was a positive connotation in one aspect, and a negative in the other.”

The problem percolated in his mind, and together with a team made up of two medical students and one cardiothoracic resident, he set about establishing the extent of the problem in an analysis of abdominal aortic aneurysm (AAA) and carotid stenosis studies.

What they found was that a large proportion of statistically nonsignificant RCTs yielded interpretations that were inconsistent with their results, and the research team disseminated their findings last year in a poster presentation at the 2022 Vascular Annual Meeting (VAM) in San Diego and again at the virtual annual meeting of the Canadian Society for Vascular Surgery (CSVS). They identified spin in nine abstracts and 13 main texts among 18 AAA articles, and seven abstracts and 10 main texts across 13 carotid stenosis studies.

In reality, Forbes says, whether findings have a positive or negative connotation should be left to the interpretation of the reader. “As a reader, I should say, ‘With the new treatment, should I be disappointed that it is no better, or should I be happy that it’s just as good?’”

The researchers further looked at whether overinterpretation might be related to the publishing journal’s impact factor, the source of trial funding, and where exactly in the papers the spin occurred. No significant association was detected in terms of funding source, and increasing journal impact factor was associated with a statistically significant lower likelihood of spin in the study title or abstract conclusion, the team reported. As for location, overinterpretation was “very common” in discussion sections, says Forbes.

“But I think more importantly, it was also quite prevalent in the titles as well as the abstract conclusions. Why I say that’s very important is I think readers of the scientific literature are deluged with massive amounts of information. And I’m sure most of us, if we’re honest, in our everyday practice, there’s very few papers that we read from front to back. There’s maybe a bit more where we actually read the entire abstract, and there’s maybe a bit more that we actually just read the conclusion of the abstract. So, spin, or overinterpretation of findings, in abstract conclusions and in titles has much more impact than the spin that occurs buried in the paper.”

It is incumbent on peer reviewers and journal editors to hold authors accountable for their wording so that overreach does not occur, Forbes muses. “As an associate editor of the Journal of Vascular Surgery myself, that’s one of the big things that we go back and say to the authors,” he explains. “We say, ‘Look, you had a negative finding. Don’t give that negative or positive connotation. Just say you were unable to find a change.’

“I think it is up to the peer review process to be the gatekeepers of the language and hold it true to the science. Remember that these are supposed to be scientific investigations and not necessarily opinion pieces. I think sometimes we err too much in that respect.”

Words matter, Forbes concludes. “Try not to become a salesman for your science. Let it speak for itself.”

Risk of venous stent migration ‘rare’ but probably ‘underreported,’ systematic review finds

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Risk of venous stent migration ‘rare’ but probably ‘underreported,’ systematic review finds
Stephen Black

Stent migration following treatment of acute iliofemoral thrombus or venous obstruction is “rare but may be underreported,” with the majority of reported cases being shorter and smaller diameter stents. This is the main concluding finding of a systematic review published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

First-named author Mohamed Hosny Sayed, MRCS, of the vascular surgery department at Guys & St Thomas’ NHS Foundation Trust, St Thomas’ Hospital in London, England, and colleagues note that little research is available on percutaneous endovenous stenting—the primary treatment for acute iliofemoral thrombus or venous obstruction. In order to address this paucity in the literature, Sayed et al carried out a systematic review, with the specific aims of identifying the number of cases reported in published literature, as well as recognizing associated risk factors and outcomes of venous stenting.

Following data collection, the researchers included cases between 1994 and 2020 in their review. Sayed and colleagues reveal that a total of 31 articles, consisting of 29 case reports and two case series, provided data for 54 reported events of venous stent migration. Of these 54 cases, only 47 provided details on the size of stent used. The average age of the patients in whom stent migration was reported was 50 years (range 19–88), and 57.6% (n=30) of the cohort were male. The authors also relay that, in 85% of the migrated stent events, retrieval was attempted with 56% via an endovascular approach. In these cases, immediate outcome was reported to be 100%, regardless of retrieval approach, however, Sayed et al point out that stent migration could result in immediate death, which precluded attempts at retrieval.

The review found that no migrated stents were reported to be larger than 100mm in length, with 38 out of 46 (82.6%) reported to be less than 60mm, and only 3.6% of reported migrations involved stents greater than 14mm in diameter.

Sayed and colleagues conclude that venous stent migration appears to be a rare complication of venous stenting, however, when it does occur, has the potential to cause “significant morbidity and mortality.” The data also suggest that migration is more likely to occur with shorter length (≤60mm) and smaller diameter (≤14mm) stents, with the combination being the most common. “This adds weight to the significant role that appropriate sizing of stents in treatment may play in preventing this catastrophic complication,” senior author Stephen Black, MD, of the department of vascular surgery at St Thomas’ Hospital, King’s College London, London, remarks, speaking to Vascular Specialist partner publication, Venous News.

Looking ahead, Sayed and colleagues write that “more formal data collection would provide a truer reflection of incidence,” especially given that this complication is “undoubtedly underreported,” according to Black. They highlight that the data retrieved for this review were of too low quality for meaningful statistical analysis. However, the researchers also stress that “clear strategies to avoid migration need to be followed to prevent this complication occurring.” This is “strongly related” to training and education, says Black, which he believes “may help prevent patients coming to harm.”

Radiation protection: Lightweight shield designed to reduce dose during complex endovascular procedures gains ground

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Radiation protection: Lightweight shield designed to reduce dose during complex endovascular procedures gains ground
A model of the face shield

It all started with a “we should do research together; this is fascinating.” The result—the production of a prototype eyewear that decreases radiation to the eye and brain—is the more-than-decade-long toil of Melissa Kirkwood, MD, and colleagues at UT Southwestern in Dallas, Texas. From conference podium to conference podium, through endless research studies and paper-writing, Kirkwood has put in the miles to get the disposable, lightweight shield patented. Here, the UT Southwestern vascular chief tells Vascular Specialist about her journey and production of the “much-needed” device aimed at helping surgeons and interventionalists combat radiation exposure.

VS: Can you give an overview of your research journey in radiation so far?

MK: Yes, about 11 years ago our vascular division was flagged for having a high radiation dose case. The case involved a physician-modified aortic stent graft in a morbidly obese patient. Because of this, our radiation physicists had to come and speak with us as a group. I was fascinated by the topic and what they were discussing. There are so many simple things that we can do to decrease our radiation dose. After this talk with the physicists, I went up to Dr. Gary Arbique and Dr. Jeffrey Guild and said, “We should do research together; this is fascinating.”

Our first project was simply looking at the radiation dose from our complex cases before and after our talk with the physicists, where we learned some tricks to decrease dose. After controlling for multiple factors, we were able to show that by implementing simple things, you can significantly drop the radiation dose. We then looked at the risk of deterministic effects, namely skin injuries in patients following high radiation dose cases. We studied this initially retrospectively and then started a prospective study, following these patients with skin exams. What we found was skin injuries are extremely rare and are likely multifactorial, with some patient predisposing factors and not solely based on dose.

Then we progressed and looked deeper, specifically at surgeon dose. We found that factors like where the surgeon stands around the table, whether the table mounted lead skirt is utilized, and what type of case is performed matters significantly. This paper showed that fenestrated aortic endovascular repairs (FEVARs) are by far the highest dose case that we perform as vascular surgeons. So then we took a deeper dive, looking only at FEVARs. We showed that not all FEVARs are equal in dose, that custom-made devices require more dose then pre-manufactured devices, and that the number of vessel fenestrations is a driver of increased dose. After this study, we focused on additional adjuncts to lower the dose during FEVARs, like using dual fluoroscopy with live digital zoom instead of magnification modes, employing a two-dimensional vessel navigator roadmap instead of an on-table 3D CT, as well as ensuring all equipment is up to date on new dose-lowering software.

Most recently, we have been focusing on what does not work for radiation. We have shown that the no-brainer surgical caps and regular leaded caps do not decrease brain radiation at all, because the radiation that hits the head is from scatter radiation already attenuated through the patient and not hitting the head at 90-degree angles. After discovering this, we questioned the effectiveness of leaded eyewear. Sure enough, we proved that leaded eyewear does not decrease eye dose at all due to the significant air gap between the face and the leaded lens. The leaded lens can only attenuate direct X-rays to the eyes, and since all the scatter is from the patient hitting the interventionalist at angles not covered by the glasses, they are completely ineffective. However, this seemed like a solvable problem. Our first attempt at this was studying the efficacy of adding leaded shielding to the lateral and inferior aspect of the glasses. This was a success. Closing the air gap between the operator’s face and their eyes significantly decreased eye dose. Yet, this design was heavy, uncomfortable and caused fogging.  Therefore, we have been working on perfecting the design and have created a prototype, which is patented at UT Southwestern Medical Center. The eyewear attachment has been proven to decrease both eye and brain dose to the operator and works equally well added to leaded or non-leaded routine prescription eyewear. This was recently presented [at the 2021 Western Vascular Society meeting].

VS: What more can you tell us about the latest study?

MK:. In this study, we have shown that when this prototype is added to leaded or non-leaded glasses, the dose to the lens, temporal lobe and midbrain is reduced by 85%, 81% and 71%, respectively. This means that interventionalists do not have to buy and wear leaded lenses anymore. Our prototype is just as effective when added to plastic safety glasses or prescription eyewear. The device is lightweight, detachable and reversible, so it can be used for either the right or left eye/face. Only the eye that is closest to the X-ray source needs coverage. The prototype has a sleeve for the temples of the eyewear, and then the shield is molded around the operator’s face and the inferior aspect of the lenses by a conformable wire. The adhesive strip attaches to the surgical mask, eliminating any air gap between the lower face and the eyewear. It is made of lead-equivalent shielding—sewn into soft cloth material. Even though it is disposable, it is not necessarily single use. I have worn it in multiple procedures without any decrease in efficacy. And the best part is that it is comfortable and there is no fogging. We are really excited about this shield because it is an easy adjunct that can be incorporated into daily practice to improve operator safety. When the interventionalist goes to grab his/her hat, mask, shoe covers, etc., that is the time to grab the eye/face shield too!

VS: Do you think the findings will change future practice?

MK: I hope so. Many reports have shown an increased prevalence of radiation-induced lens damage (cataracts) and brain cancer in interventionalists. The International Commission on Radiological Protection (ICRP) has set the occupational dose limit to the lens of the eye at 20mSv/year on average over five years, with no annual dose in a single year exceeding 50mSv. Thus, the results from this study have shown that with the addition of our prototype, operators can safely perform exponentially more cases and still stay under the aforementioned ocular dose threshold. We strongly believe that our design can help mitigate some of the long-term health complications that interventionalists can experience and hope that using our eye/face shield becomes standard practice to improve safety.

VS: Have there been any other recent developments?

MK: Not on this study, but we did just present at the 2022 Southern Association for Vascular Surgery (SAVS) meeting the efficacy of lower-leg leaded garments in decreasing lower body radiation dose during FEVARs. We also presented some new data on the CLEAR-MAX imaging technology system and how it lowers radiation dose on Siemens systems.

VS: What comes next for the prototype?

MK: Next steps are working with UT Southwestern to find a commercialization partner to bring the product to market. Stay tuned!

VESS 2022: Novel use of TCAR to treat complex brachiocephalic disease shown to be effective, researchers report

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VESS 2022: Novel use of TCAR to treat complex brachiocephalic disease shown to be effective, researchers report
Viraj Pandit

A “unique” case series of patients undergoing transcarotid artery revascularization (TCAR) in which the system was put to novel use for proximal intervention or incorporated in a hybrid approach to complex brachiocephalic disease demonstrated it to be effective in “providing safe, comprehensive treatment solutions,” the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Snowmass, Colorado (Jan. 27–29) heard.

Viraj Pandit, MBBS, delivered the findings on behalf of a University of Oklahoma, Tulsa, team of researchers led by vascular chief Peter R. Nelson, MD, informing delegates that a total of 94 patients underwent TCAR, with 8.5% (n=10) undergoing combined procedures. They found that two patients had concomitant common carotid artery stenosis, four patients had subclavian artery stenosis and one had an occluded contralateral internal carotid artery. None in the combined group had postoperative complications—stroke, myocardial infarction or cranial nerve injury—and all were discharged home on postoperative day one, Pandit added.

TCAR experience is expanding for the treatment of internal carotid artery stenosis, but its applicability in patients with more complex brachiocephalic disease has not been described, the research team reasoned as they set out to analyze the series. In that vein, they explored their experience with TCAR used in combination with other cerebrovascular interventions, including retrograde common carotid artery stenting and carotid-subclavian bypass. “This unique case series of patients undergoing TCAR in association with other cerebrovascular interventions demonstrated successful outcomes,” Pandit—formerly a vascular surgery fellow at OU Health and now a surgeon with VA in Fresno, California, and colleagues concluded.

Speaking to Vascular Specialist, senior author Nelson elaborated: “This paper probably falls between a traditional patient series and a technical note. Compared to traditional literature, this approach seems applicable to the new technology. It doesn’t require endarterectomy to accomplish the same combination of treatment. We can do it through the less invasive approach of a TCAR. The technical aspects are more or less how to maneuver the delivery system and how to engage the flow protection system that we’ve come to adopt with TCAR.”

Some of that older literature “suggests that doing tandem lesions had increased complication rates—and we’ve not seen that,” Nelson explained. “This is obviously a small number of patients, but we’ve seen no increase in complications and arguably similar or less complications in this small group,” he added.

Office-based laboratory setting proves ‘safe’ for iliac vein stenting

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Office-based laboratory setting proves ‘safe’ for iliac vein stenting

A retrospective study of 1,223 iliac vein cases performed in three office-based laboratories (OBLs) demonstrated a major complication rate of 0.41%, suggesting these procedures are safe and well-tolerated in this setting, the authors say.

According to corresponding researcher Levan Sulakvelidze, BS, from the Center for Vascular Medicine in Greenbelt, Maryland, “Because OBLs are not regulated to the same degree as in-patient facilities or ambulatory centers, questions have been raised regarding patient safety and outcomes in this environment.

“The safety profile of iliac vein stenting in the OBL setting has not been thoroughly evaluated. The purpose of the present study was to evaluate the complication rate and safety profile of this procedure when performed in an OBL.”

As reported in the January 2022 issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders, Sulakvelidze, senior author Peter Pappas, MD, part of the leadership at the Center for Vascular Medicine, and colleagues reviewed prospectively collected data from 1,104 patients who underwent a total of 1,223 iliac vein stents in OBL centers.

Three patient groups were studied based on presentation: lower-extremity symptoms alone (305), pelvic symptoms alone (91) and a combination of the two (827).

Trained nursing personnel, under the supervision of the attending interventionalist, administered conscious sedation to all patients. Typical dosing involved midazolam (1mg) and fentanyl (50µg). Excluded from this setting were patients with significant cardiac/pulmonary risk, history of severe airway issues, morbid obesity and complex venous lesions (e.g., inferior vena cava [IVC] obstruction).

There were no mortalities and no complications related to the sedation rendered. The total complication rate was 7.8%, including five major complications (0.4%) and 90 minor complications.

Sulakvelidze comments: “In the study, because most of the complications were considered minor, including suspected over-reported hematomas, we have presented strong evidence that demonstrates iliac stenting performed in the OBL setting is safe. Given these promising results, we recommend all OBLs become Joint Commission [formerly the Joint Commission on Accreditation of Health Care Organizations, or JCAHO]-certified and include quality assurance efforts to maximize patient safety.”

Patient safety and quality care remain the most important goals of any procedure rendered by a vascular interventionalist, according to JVS editors. “This important study confirms that both can be achieved in the OBL setting for patients who require iliac vein stenting.”

FDA issues guidance documents for including patient perspectives in medical device studies

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FDA issues guidance documents for including patient perspectives in medical device studies

The Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.  

As per an FDA press release, the finalized version of the first of these two guidance documents, entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies,” features key points including:

  • Describing how device developers, sponsors and industry can voluntarily use patient engagement to improve clinical study design and conduct
  • Providing examples of approaches to consider when device developers, sponsors and industry wish to incorporate patient advisor input in clinical studies
  • Describing which patient engagement activities are generally not considered by the FDA to constitute an activity subject to the FDA’s regulations regarding Institutional Review Boards (IRBs)
  • Clarifying how sponsors can receive feedback from the FDA on plans to voluntarily include patient advisors’ input on their clinical study through the Q-submission process.

The second of these two newly issued guidances, entitled “Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation,” intends to:

  • Describe principles that may be considered for instruments that capture and measure patient-reported outcomes
  • Provide recommendations about the importance of ensuring these instruments are fit-for-purpose.
  • Outline best practices for selecting, developing, modifying, or adapting a patient-reported outcome instrument for use in medical device evaluation.

WFVS seeks to help shape future of global vascular training through technology and collaboration

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WFVS seeks to help shape future of global vascular training through technology and collaboration
Palma Shaw during a recent video interview covering the latest developments at the WFVS

The World Federation of Vascular Societies (WFVS) recently entered a new era of governance with the aim of better disseminating science and best practices for vascular surgeons operating in every corner of the globe. Palma Shaw, MD, WFVS secretary-general, spoke to Vascular Specialist in a recent video interview about some of the strides made so far and what plans are in store for future progress in vascular training— including collaborative efforts and the potential use of simulation. This is an abridged outtake from the video.

Shaw, a professor or surgery at Upstate Medical University in Syracuse, New York, details that the WFVS identified a need to focus on education and training following discussions with council representatives from various societies across the world. This will involve leveraging digital strategies, she explains: “We are working on developing access for a virtual education program, like the Society for Vascular Surgery [SVS] has already developed.”

Simulation, or virtual learning, will also be used for the purposes of education and training, Shaw adds. In fact, the WFVS has been exploring opportunities with different companies to try to see what is available and what might work for its purposes. “We will try to increase access, especially in those countries that are underserved, and we would like to really get ultimately all vascular surgeons to a minimum level of training,” Shaw outlines.

Collaboration will also be key to attaining the WFVS’ education and training goals. The secretary-general communicates that the new webpage and portal, currently in its design phase, “will serve as a hub for scientific exchange, collaboration and networking between members of the global vascular community” once completed. In this vein, the WFVS also intends to identify societies across the world that it might be able to connect with in order to help augment training in various locations.

Looking to the future

Considering what lies ahead for the WFVS, Shaw sketches a future plan to reach out to various quality initiatives—including the Clinical Practice Project or the Vascular Registry Project of the SVS, the Vascular Surgery COVID-19 Collaborative (VASCC) started by Max Wohlauer, MD, of the University of Colorado Anschutz Medical Campus, Aurora, Colorado, or the International Consortium of Vascular Registries—in order to help disseminate the work of the WFVS and “reach further out into the globe and expand our knowledge base.” Shaw also mentions the future involvement of the WFVS in global guidelines being developed for diabetic foot management. “That will be a several-year project.”

Finally, Shaw highlights that the federation would like to offer mentorship in the coming years. This may involve not only a web-based platform for education, but also hands-on learning. “We can be a connector for those countries that need more on-site training, and those that are able to offer that to them.”

Watch the full-length video interview with Shaw on the rebooted WFVS here.

Study suggests more proximal landing zone is preferred for TEVAR of acute type B aortic dissections

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Study suggests more proximal landing zone is preferred for TEVAR of acute type B aortic dissections
Jean Panneton

A review evaluating the results of thoracic endovascular aortic repair (TEVAR) following acute type B aortic dissection suggests most patients have less than 2cm of proximal healthy descending thoracic aorta. In patients treated for complicated acute type B aortic dissection, zone 2 TEVAR is associated with a lower need for aortic reintervention and aortic-related adverse events than Zone 3 TEVAR, researchers behind the study found.

Further, patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when zone 2 TEVAR is done with left subclavian artery revascularization, according to senior author Jean Panneton, MD, chief of vascular surgery at Eastern Virginia Medical School in Norfolk, Virginia. The study was published in the Journal of Vascular Surgery (JVS) this month.

“TEVAR for the treatment of complicated acute type B aortic dissection has been shown to have favorable outcomes compared to both open aortic repair and medical therapy,” he said. “However, the optimal approach for this therapy, including timing, coverage length and landing zone remains to be fully elucidated.

“The aim of this study was to evaluate and compare postoperative outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated complicated acute type B aortic dissection with proximal endograft deployment in landing zones 2 versus 3.”

Panneton and colleagues performed a retrospective chart review, from a single center, of adult patients who underwent TEVAR for complicated acute type B aortic dissection within six weeks of diagnosis. The chart review was for patients treated from January 2008 to December 2018. Reviewers excluded patients with prior type A repair and connective tissue disorders.

Some 83 patients were evaluated and separated into two groups based on landing zone: zone 3 (35), zone 2 (48), with the latter subdivided between left subclavian artery revascularization (38) vs. coverage without revascularization (10). Imaging evaluation revealed that only 11% of the study population had more than 2 cm of healthy descending aorta to land the TEVAR. Overall 30-day survival (88%) did not differ between the groups (p=0.6), with zone 3 at 89%, zone 2 covered at 80% and zone 2 revascularized at 90%. The postoperative spinal cord ischemia rate was 3.7%—2.7% for zone 2 revascularized, 0% for zone 3, and 20.0% for zone 2 covered (p=0.012).

Subsequent retrograde aortic dissection was observed in three patients (4%)—one zone 2 and two zone 3 patients. The overall aortic reintervention rate at 36 months after TEVAR differed significantly between the groups (p=0.25), with zone 3 at 31% and zone 2 at 10%

“The proximity of the primary tear to the origin of the left subclavian artery can make it difficult to achieve a secure 2cm landing zone of healthy aorta without coverage of one of the aortic arch branch vessels. Notably, 90% of our study patients had a less than 2cm proximal landing zone,” said Panneton. “Factors which may contribute to the better outcomes observed for the zone 2 patients may include a landing zone that is further away from the aortic pathology and is more optimal in terms of seal given it is less curved than in zone 3. Additionally, our low rate of retrograde dissection may be related to avoiding proximal endograft oversizing (>10%) and post-deployment balloon molding.”

Many technical details must be considered to achieve excellent outcomes in this difficult patient population, according to JVS editors. “Strong consideration for landing the TEVAR in zone 2, including subclavian artery revascularization, appears important to better long-term outcomes.”

Conveying vascular surgery’s essential ‘coolness’

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Conveying vascular surgery’s essential ‘coolness’

Let’s start with a question: how do we communicate coolness? No, I am not referring to a cool or cold foot in the emergency room in need of assessment for acute limb ischemia. We have validated clinical scales to communicate that information effectively. At the risk of dating myself by invoking the spirit of Arthur Herbert Fonzarelli from Happy Days, what I am talking about is, how do we communicate how cool (i.e., chill, sick, drip, Gucci, hip, trendy) our specialty is to bright young minds contemplating their career choices? Biased as I may be, I think if they really knew how cool vascular surgery is, many more would pursue it as a career. This is obviously important for us to recruit the best people to our field. It is specifically important for the learner in their pursuit to find their best fit, but it is also critically important to address the shortage and maldistribution of vascular providers we currently and will continue to face.

This topic came up during dinner with a recent visiting professor. We were discussing our newly formed group in Tulsa, and I was asked to reflect. I said something like what I appreciate most is that we have assembled a really “cool” group of vascular and podiatric surgeons. What I was referring to in part was the individuals themselves—their personalities, their passion for the field, and their passion for clinical care, education, and research. But I was also reflecting on the fact that we, as a team, complement each other very well in each of those areas, support each other both professionally and personally, address challenges with unified advocacy, and, importantly, have fun working together. No disrespect to Simon Sinek who promotes with “Start with why”… I might offer it is important to “Start with who,” and/or “The who is the why” for a team leader.

During the presentations that day, wellness data were presented to the faculty, trainees and students across the entire campus. As is often the case with this discussion, one slide depicted data from a study on distress and career satisfaction compared amongst surgical specialties, and vascular surgery faired poorly. We were dead last in wanting to pursue surgery as a career for either ourselves if we had to do it over again, or for our children. We were second worst in burnout rates, fifth in screening for depression and sixth in low mental quality of life.

A more recent introspective look by the SVS Wellness Task Force shows that vascular surgeons still have high rates of burnout in part due to advancing age, work-related physical pain, and work-home imbalance that led to higher risk for depression and suicidal ideation. This seems paradoxical to our impression of our specialty’s coolness. To be fair, our group has even contributed to this literature showing job dissatisfaction amongst vascular surgeons influenced by factors including unhealthy work-life balance, insufficient hospital support, hostile hospital culture, discontent with supervision, and unhappiness with career choice leading to early retirement. Although alarming and important, these typical metrics somehow miss the mark in being able to convey just how cool our specialty really is and how we have very cool people working hard to address these more visible statistics.

Do we have data on coolness? Well, if you do a simple internet search on how we define or quantify coolness, you get entries describing Fahrenheit, Celsius, Kelvin, etc., as ways to measure temperature. Then you see a few entries on coolness as defined as “a quality lacking friendliness or enthusiasm,” which, for the sake of this discussion, is the “anti-cool.” If you dig a little deeper, you see that the business world, and especially marketing, understandably grapples with this concept extensively in order to predict the next cool product, company or brand. Research in business suggests that descriptors that define cool include: “authentic,” “inspiring,” “creative,” “attractive,” “edgy,” “rebellious,” “surprising,” “mysterious,” “unique” and “takes risks.” One strategy in the business world is to “let cool find you,” meaning if they create a brand that satisfies these criteria, then millennials or members of Gen Z—who are very bright, savvy, and, importantly, information-focused—will find it and make it cool. We can’t do that in vascular surgery, or at least haven’t been able to until now, because the information available to them, as discussed above, is largely negative and works against our brand.

If you search for what makes a surgical specialty cool, you get little specific or quantifiable information. On one end of the spectrum, you will find opinion pieces which commonly portray surgeons as masochists who endure pain, or as cantankerous, dominant, arrogant, hostile, impersonal, egocentric people who don’t communicate well. If they are fair, you might find that we get some credit for being decisive, well organized, practical and hard-working.

Fortunately, on the other end, you will find some practical information aimed at informing and preparing students for a career in surgery. Some of the business attributes listed above seem relevant to defining cool when it comes to a medical specialty, but we should work to define the specific characteristics that apply to our field. We currently spend a significant amount of time with students during clerkships, sub-internships, vascular surgery interest group (VSIG) meetings, regional and national programs like the Next Generation program at the Vascular and Endovascular Surgery Society (VESS) and the SVS Medical Student and Resident Program, trying to convey the concept of the coolness of vascular surgery. We, or at least I, think we do a pretty good job getting the message across, but better defining what coolness means in our case would help us communicate with the target audience more effectively.

Unfortunately, our ability to convey coolness has been hampered by virtual meetings, virtual interviews, and the inability to interact in person. Several creative adaptations have been developed, including virtual open houses, virtual conferences allowing multi-institutional or even multinational attendance, virtual away rotations, etc., which have enabled us to be somewhat effective. I am not a psychologist, but it seems likely that the sense of coolness of any individual or group is best conveyed and, importantly, best perceived in person. It seems we are making our way back to in-person interaction—VAM 2021 was a success, other regional and national meetings are getting back to in-person or at least hybrid formats, and our visiting professor meeting mentioned above was our first in-person visiting professor in over 18 months—so hopefully these opportunities for direct interaction will re-emerge. More positive data are surfacing in several areas. These include how important vascular surgery is to a healthcare system; data regarding the prevalence of vascular disease in a still aging population; data on disparity of care and the need for outreach to underserved communities; data on projected need for vascular surgeons to provide this outreach; data on salaries of vascular surgeons; and data on how we favorably compare to competitive interventional specialties.

Let’s add to this objective (and subjective) data as to our coolness. Do we need a focused, well-designed qualitative study that specifically asks: “What makes vascular surgery cool?” In the meantime, there is currently a large amount of effort being put forth to promote our specialty, so let’s support the SVS DEI and Wellness committees, the SVS branding efforts, and similar efforts from other vascular societies. And during this interview season, let’s show everyone just how cool we really are.

Peter R. Nelson, MD, is the Mary Louise Todd chair in cardiovascular research and chief of the section of vascular surgery at OU Health in Tulsa, Oklahoma.

Priorities and objectives will guide 2022 SVS programs

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Priorities and objectives will guide 2022 SVS programs
The SVS is looking ahead to member-driven priorities for 2022

Whether it’s branding, advocacy or determining research initiatives, the process of setting Society for Vascular Surgery (SVS) priorities and objectives begins with SVS members.

The SVS conducts a census, which includes asking members to rank-order priorities, every other year. In the off-years, such as this one, SVS adds new and emerging priorities to the existing list and asks members of the Strategic Board of Directors (SBOD), and council and committee volunteers, to do new rank-ordering for the next fiscal year.

The SBOD will meet virtually Jan. 14–15 to set priorities, programming and activities for the 2022–23 fiscal year, which begins April 1. The meeting was to have been in-person, but the Omicron variant forced a change. “What we do begins with input from our members: Learning about their biggest concerns and determining how the SVS should address them,” said SVS Executive Director Kenneth M. Slaw, PhD. The five SVS councils each address priorities that fall within their purviews, establishing two or three objectives for potential programs that allow the Society to make progress on those priorities. The Executive Board addresses priorities of several other committees and programs.

“The method is not haphazard but, rather, data-driven and focused, with the SBOD shaping strategic policy to realize members’ key priorities,” said SVS President-Elect Michael Dalsing, MD. Then, “Council and committee volunteers plan, implement and monitor for success projects to help realize the strategic plan with the support of the administrative staff.”

Late last year members declared advocacy the No. 1 priority for this fiscal year, which ends March 31. Through digging further into the survey data, payment emerged as the important point within that priority. “So the Policy and Advocacy Council discussed challenges with payment and what we could proactively do going forward in the new year,” said Slaw.

Last July’s virtual fly-ins with lawmakers—resumed after a COVID-induced hiatus—directly addressed the payment issue, as will next summer’s advocacy skills-building course. The course will be geared to those interested in learning more about how advocacy affects healthcare decisions and policies in Washington, D.C.

Of course, members saw payment return to center stage during the summer, after the Centers for Medicare and Medicaid Services (CMS) released its preliminary Physician Fee Schedule, which included large cuts to vascular surgery reimbursement. Combined with a number of other planned reductions, vascular surgeons were facing cuts that for some members could total nearly 20%. The Policy and Advocacy Council has worked for months to meet with lawmakers to encourage legislation to reduce or delay the devastating reimbursement reductions and encourage grassroots efforts on the part of SVS members. Congress ultimately voted to delay some of the cuts, but more work remains.

All signs, said Slaw and Council Chair Matthew Sideman, MD, point to advocacy, payment and reimbursement remaining one of the top items on the FY22–23 priority list.

While the core of the initiatives process focuses on what members want and need, the SBOD also tries to broaden its focus to what’s on the horizon—what experts are saying that might impact medicine, surgery and vascular surgery in the coming three to five years. “We discuss those at the Strategic Board retreat as well, to make sure we’re not missing something critical on the larger landscape,” said Slaw.

“Reflecting on the next three to five years, change is a certainty,” said Dalsing. “Whether it is a friend or foe is up to us. We will have to embrace change over and over again as we reshape ourselves into the vascular surgeons and SVS of the future. Changing political winds, increasing regulation, new payment structures, population health, surgical innovations and other future forces will provide us the opportunity to be even more influential advocates for our patients. We have to be up to the task and, if past experience is foreshadowing, we will be successful.”

Following discussion of member priorities and accompanying programming ideas from respective councils, the Strategic Board reviews all ideas and further prioritizes them into the top three or four in each council that will move forward.

Then, said Slaw, “all those programs and ideas become part of the budgeting process, so we can make sure we have the resources available to move programs forward. We try to include as many as we can accommodate in the budget, which is approved in March, to go into implementation beginning April 1.”

Late in 2021, with surveying and ranking ongoing, council chairs nonetheless offered their early opinions as to priorities for 2022–23 and discussed the value of the overall process.

Clinical Practice Council

Chaired by William Shutze, MD, this council oversees the Community Practice Section, which includes the Sub-Section on Outpatient and Office Vascular Care (SOOVC); the Physician Health and Wellness Committee (formerly Task Force); the Health Information Technology Committee; and the Population Health Task Force, whose work is winding down.

The SBOD retreat provides the very real benefits of getting a wide range of people, viewpoints, backgrounds and areas of focus together, said Shutze. Members sometimes bring up suggestions others hadn’t considered, or a concern that’s not currently on the radar. “Everyone is able to weigh in with their ideas,” he said.

Shutze said that clinical practice is “kind of the translational end of quality and research; how do you translate those components into clinical practice?” Shutze added, “We also look at issues uniquely related to clinical practices, such as physician value and the physician workforce. That’s why the Wellness Committee—and wellness is an important issue—and the Community Practice Section are part of the Clinical Practice Council.”

The council works with the others in terms of this translational effect, providing feedback on how other issues affect—positively or negatively—clinical practice. For example, payment cuts could speed retirements and impact workforce issues, he said.

The entire process of setting priorities began earlier this year, with an impetus to think in visionary terms when investigating ideas at the retreat, he said, adding, “We’ve had three or four terrific suggestions for 2023 Clinical Practice Council goals” the council hopes to bring to the retreat for discussion.

On surveys, Shutze noted, “The information is vitally important, but response rates remain an issue.” They will be a valuable way for the SVS to understand itself and its direction, he added.

Education Council

Important changes are ahead for members in terms of the education SVS offers, said Linda Harris, MD, chair of the Education Council. The council oversees the Education, Leadership Development, Postgraduate Education, Program, Resident and Student Outreach, and VAM Video committees.

Atop the list is introducing the SVS’ new 2022–2025 education strategic plan. This includes adding a framework and cataloging for its educational offerings and stresses collaboration, coordination and shared planning among councils, committees and SVS staff.

All councils and committees have ideas for educational offerings, said Harris. Each is subject to three questions: “Is a new product helping our members, improving patient care or the healthcare systems, or our members’ own health? Is it fulfilling one of those three?”

Appropriate benchmarks also are important, she said. “New product development has to be based on what our membership needs, not what we assume is a good idea. We want what our membership wants, not what we think they want.”

The new strategic plan focuses on five pillars: A portfolio approach, shared content planning, a global plan for content use/reuse, using best practices in formal education methodologies, and enhancing the SVS governance structure to accelerate the development and implementation of education of importance to members and their patients.

Plan tactics include a universal content framework to catalog current educational offerings. “We will know what we currently have to offer within our educational portfolio and where the gaps are. All education will be categorized before and as it’s being created, rather than after the fact,” said Harris. “For example, if the Clinical Practice Council hosts a webinar, organizers would tag it appropriately as they’re preparing the webinar.”

The goal is simple. “We want SVS to be the premier source for education. And that means our offerings have to be searchable to allow for ease of use and reuse.”

Harris credited Education Committee Kellie Brown, MD, for spearheading the framework project. “It was an enormous undertaking, and I thank the Education Committee for this herculean effort. SVS is now in a great place to roll this out for use in 2022.”

Other parts of the plan include:

  • Plans to re-use and share content, avoiding duplication of efforts
  • Enhanced communication across the councils and with staff to determine what new content should be created in this portfolio approach
  • Developing a methodology in order to
  • consistently assess SVS programs and offerings
  • Considering how to move forward with educational offerings. With remote learning now part of the mix, that includes possibly collaborating with regional and other national societies
  • Analyzing the recently completed Educational Needs Assessment Survey, which has provided a wealth of information

One of the council’s biggest issues from an overall education perspective and with financial ramifications is, “What’s COVID done to us,” said Harris. “There are huge issues going forward. How do we integrate changes? Hybrid is much more expensive, and virtual education has its own set of issues. How do we continue to evolve the VAM? We’ve already transitioned to year-long education—one benefit of the pandemic. But we have to look at what people can afford both financially and in time away from work and family. We must find an appropriate, forward-thinking plan to deliver education when and where people need it.”

The SVS’ new new learning management system (LMS) is making education accessible, but more opportunities, both online and in-person, exist, she said. “And we know we can offer more opportunities both online and in-person.” At the same time, Harris stressed that while remote and hybrid opportunities have their pluses, human interaction is vitally important and cannot be duplicated. “We expect an in-person meeting to remain a key factor for SVS for many years to come.”

Advocacy and Policy Council

Matthew Sideman, MD, chairs the Advocacy and Policy Council, but it’s his additional position as co-chair of the SVS Medicare Cuts Task Force that helped with SVS members’ No. 1 priority during the current fiscal year: payment.

The latter entity was created in the summer of 2021 after CMS released the 2022 Medicare Physician Fee Schedule, which included a 3.75% cut for vascular surgeons. This cut, plus four others, meant vascular surgeons were facing cuts of more than 20%, depending on practice setting and other factors.

In mid-December, after months of work by the task force and council, Congress moved to delay some of the cuts.

However, warned Sideman and others, the job isn’t done. “There is still a lot of work to be done to reach a permanent solution. Vascular surgeons provide valuable, life-saving work to society’s most vulnerable patients. We are not going to rest until our healthcare system recognizes that value with real, long-term solutions to reimbursement.”

Task force members will work toward ending automatic cuts and provide suggestions for payment answers.

“This remaining work will undoubtedly be a major focus in setting priorities,” he said. He added, in tandem with other council chairs, that payment issues can trigger other changes—such as retirements and career changes—which could impact workforce shortages. Payment could also lead to possible difficulty in paying dues or program fees, which would impact overall SVS revenue and the Society’s ability to offer robust programming.

“We have our work cut out for us,” said Sideman in mid-December. “After an incredibly busy time fighting this latest round, we will get a brief respite over the holidays and begin again in January on more permanent answers.”

Dalsing offered his own personal reflection on the “big picture” of medicine. “All of us in the medical profession are in the same boat but do not seem to realize it,” he said. “We have been forced to bicker over slices of a small and shrinking financial pie resulting from a lack of cost-of-living increase perpetuated over decades, which other stakeholders in the medical space have not had to endure. Eventually, all physicians—with vascular surgery at the leadership table—will have to find a solution to this conundrum.”

Research Council

The Research Council, chaired by Raul Guzman, MD, will soon have a new set of research priorities. A list of some 10 priorities cover such areas as carotid, aortic, and lower-extremity arterial and venous disease; dialysis; healthcare disparities; and vascular medicine/vascular health.

The SVS strategic plan guided the Research Council in drafting the new priorities, which the SBOD will discuss, tweak and approve at the retreat, said Guzman. This is especially true of three specific proposed new priorities “aimed at improving quality and appropriateness, optimizing vascular intervention, and assessing population health measures,” he said.

These priorities are expected to guide research initiatives for the coming decade. While noting again that priorities are yet to be finalized, Guzman believes one of his council’s top concerns is related to identifying areas within vascular surgery that would benefit from increased investigational efforts. “Results from studies in these priority domains will be important for moving forward with guidelines and appropriate use criteria for many of our major areas of interest,” he said.

Quality Council

“Quality is job one,” said Thomas Forbes, MD, offering his apologies in advance to Ford Motor Co. for using the automaker’s slogan in relating what members emphasized in previous surveys.

“I think tracking quality outcomes has always been in the DNA of vascular surgeons. It’s in our blood,” noted Forbes, chair of the Quality Council. And over the past several years, he said, “The SVS has invested in quality in terms of people, time and expertise.”

“We heard loudly and clearly that patients should have quality of care, regardless of where they live and who they’re being treated by,” he said. Quality initiatives have and continue to include the creation of clinical practice guidelines, a “distillation of the current body of evidence … that indicates how we should be treating our patients.” Under the direction of Ruth Bush, MD, and the Document Oversight Committee, a number of guidelines are being prepared.

Appropriate use criteria (AUC), an exciting initiative chaired by Adam Beck, MD, is another. The first AUC, on peripheral arterial disease (PAD), is in the finalization phases. These criteria account for some “specific nuances of very specific clinical situations,” based on the “best of the current review of the evidence.”

Then there is the Vascular Center Verification and Quality Improvement Program (VCV&QIP), being spearheaded by Kim Hodgson, MD, and Anton Sidawy, MD. “You can’t talk about quality without talking about this program,” said Forbes. Now nearing the end of its pilot phase, the program is nearly ready for official kick off, with both inpatient and outpatient facilities able to enroll in the accreditation process. “And the whole purpose is improving patient care,” he emphasized.

The Vascular Quality Initiative (VQI), an SVS Patient Safety Organization (PSO) program, meanwhile, has seen an investment of time and money make “huge inroads into the general quality initiative of the SVS over the last number of years,” said Forbes. But because not all SVS members participate in VQI, “it’s important to have a culture of quality both within and outside VQI.”

The new Quality Improvement Committee, which is advancing the overall strategy of quality and engagement within and outside VQI, is “an opportunity for other national registries to be used,” he said. “It’s made huge inroads and will continue to do so.”

SVS Health and Vitality

The SVS Health and Vitality umbrella includes a large number of committees, overseen by the SVS Executive Board. The Communications Committee and its three subcommittees, in fact, owe their creation to a previous SVS initiative of a few years ago. The Diversity, Equity and Inclusion (DEI) Committee, likewise, graduated from task force status as a result of its important work in its previous form and the SBOD’s commitment to DEI issues.

The Executive Committee oversees these diverse committees, and manages the everyday challenges and opportunities that surface in an active society, said Dalsing. “It is a structure built for innovation and success in a constantly changing world.”

Strength in numbers: Global VASCC COVID-19 project helps identify framework to tackle delayed cases

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Strength in numbers: Global VASCC COVID-19 project helps identify framework to tackle delayed cases

When Robert Cuff, MD, and Max Wohlauer, MD, first launched the Vascular Surgery COVID-19 Collaborative (VASCC) back in the spring of 2020, the pandemic was still in its first wave, and the goal of a new vascular surgery registry to leverage key data with the the goal of preparing for the fallout from future outbreaks was in its nascent stages.

Fast forward to the waning weeks of 2021, as the Omicron variant ravaged the globe, and Cuff, Wohlauer and a burgeoning team of VASCC collaborators were already counting the positive impact of interim data gathered from one of two core VASCC projects.

One of the most interesting aspects of the data emerging out of VASCC Project 1—covering the impact of COVID-19 on scheduled vascular operations—so far surrounds its use outside of the pandemic context, explains Cuff, a co-founder of the registries with Wohlauer.

“At our institution, we’ve been delaying a lot of surgeries, not necessarily because of our COVID numbers, but because we’re facing a large nursing shortage and therefore our bed capacity has decreased, as we don’t have people to take care of them,” says Cuff, program director for integrated vascular surgery residency at Spectrum Health-Michigan State University in Grand Rapids, Michigan.

“This is a nationwide problem. Every surgeon I have talked to is facing the same issues. So although the data that we gather in VASCC is on delays due to the pandemic, that data is going to be helpful in determining what patients should be delayed for in other situations like the one we’re facing now.”

It comes down to weighing competing priorities, Cuff explains.

“We have several aneurysm and open surgery patients who have been delayed for almost a month from their originally scheduled surgery, and this data that we developed was actually helpful in trying to figure out: should we move them up regardless, versus patients who have carotid disease or other disease,” he says.

“Maybe we can delay them a little longer in order to use beds as wisely as we can. So this is not just applicable to the pandemic or the COVID situation, but it is actually providing a framework for looking at delays for any reason that may be outside of a short-term situation for a few days, to help give guidance as to which patients may have to be treated sooner or later when it comes down to a bed crunch.”

Interim data presented at fall 2021 meetings

Fellow co-founder Wohlauer, a vascular surgeon at the University of Colorado-Anschutz in Aurora, Colorado, summarized interim results delivered at high-profile vascular meetings in the second half of last year, giving some insight into the type of findings Project 1 yielded. “At VAM, we presented our interim data analysis for aortic disease, chronic limb-threatening ischemia [CLTI], venous disease and end-stage renal disease [ESRD], and at the European Society for Vascular Surgery [ESVS] annual meeting, our impact on carotid disease interim data analysis—and we found some interesting things,” says Wohlauer. “We found that the overall mortality in our aortic group was about 5%, ESRD was about a 6% perioperative mortality, and I think 2% or maybe 4% died while waiting for their surgery. We found that patients with CLTI had about a 4% risk of decompensating while waiting for their operation, and that those patients who required an emergency surgery did very poorly—about 60% of them ended up having an amputation. We found in this group of patients with CLTI that diabetes has a strong association with major adverse limb events. And we found that, overall, with venous and carotid procedures in our cohort, patients were postponed and rescheduled with minimal complications.”

The international breadth of the VASCC endeavor has opened doors and broken some fresh ground, while also posing unique challenges. Alongside Project 2, which is focused on thrombotic complications of COVID-19, Project 1 lives at three separate locations, which each governing specific geographical area for the VASCC registries: the European hub in Rome, Italy, led by Giovanni Tinelli, MD; the U.S. hub at the University of Colorado; and the international hub, managed by Susan Heard at CPC Clinical Research, which is affiliated with the University of Colorado. While Project 1 looks at outcomes following delays to vascular procedures related to the virus (across the five modules of carotid, aortic, peripheral, venous and hemodialysis), Project 2 probes COVID-related thrombotic issues in cases of acute limb ischemia (ALI), acute mesenteric ischemia, symptomatic venous thromboembolism (VTE) and stroke.

Data privacy concerns and regulatory differences across borders complicate the management of a VASCC database that spans the U.S. and Europe, Wohlauer says. The single database at three locations is aimed at facilitating widespread participation among vascular surgeons from different countries, practice types and levels of seniority in order “to get a sense of what’s happening around the world with patients whose surgeries were postponed during the pandemic,” he shares.

Chiming in from Italy, Tinelli lauded the international scope of the collaborative. “This is a great opportunity to create a real network in Europe and around the world,” he says. “VASCC is a great opportunity inside the COVID pandemic because the real great solution from the vascular registry is that it is taking place during the first, second, third and now fourth wave.”

Mahmood Kabeil, MD, a research scholar at the University of Colorado assisting the VASCC projects, highlights the far-reaching nature of the surgeons and institutions inputting data—from Ireland to Australia and multiple points in between. The latest involvement numbers show around 250 sites in almost 50 countries, and “the collaboration is growing,” Kabeil discloses.

As manager of the international hub, Heard—CPC’s clinical data manager—says VASCC is treading largely virgin territory in terms of information gathering. “To my knowledge, this is a fairly novel approach in terms of using REDCap as our data collection tool. Because we have three completely separate instances in three different locations but we’re using the same database structure, as any changes need to be made, it’s very easy for us to be able to do that so that our databases continue to sync as we are collecting data separately but together.”

Ethan Moore, a research assistant at the University of Colorado assigned to work on VASCC, detailed a list of physician meetings drawn from disparate locations across the globe—recently Ireland and Indonesia, later Japan and Australia—that proved an eye-opening experience in terms of the vantage point they provided into how different countries are dealing with the pandemic at different times depending on their local circumstances. “It offers a real-time opportunity to look at each country and see how they’re dealing with it,” Moore adds.

Perioperative risk stratification

Meanwhile, as VASCC looks ahead, Kathryn Colborn, MD, an associate professor at the University of Colorado and biostatistician working on the registries, details the use of a novel risk stratification system developed within thoracic surgery named the Surgical Risk Preoperative Assessment System (SURPAS).

SURPAS utilized American College of Surgeons National Surgical Quality Improvement (ACS NSQIP) data to develop a preoperative risk surveillance system, she explains. In short, it involves a logistic regression model with eight variables collected at the preoperative visit to estimate the risk of 12 postoperative complications, thus producing a risk score.

The system helps in a number of ways, Colborn explains, such as enabling discussion with patients preoperatively about their risk and also to risk adjust rates postoperatively.

“The goal for VASCC was to incorporate SURPAS so we could estimate observed-to-expected event ratios in these patients,” she says. “In some patients, we might expect certain complications. But if we can evaluate their preoperative risk, we can evaluate whether we had higher-than-expected event rates in this population.”

Meanwhile, Wohlauer describes a specialty equipped to deal with the vagaries of COVID-19. “In vascular surgery, we are like cobblers—each shoe is a little different. That’s how we see ourselves,” he says. Ultimately, VASCC is a team effort, Wohlauer reflects, and what the research aims to do is use high-quality data to understand best practices, and in which situations a certain operation works best.

“There are clinical trials like BEST-CLI that are helping answer these questions as well. I think they are really healthy for our community to be answering these questions in this way,” he continues.

“This organization shows we can custom-build a database to answer a specific question, and that harmonizes with the important work national registries do, which have less plasticity—and they collect orders of magnitude more data than we do.”

VASCC also demonstrates a proof of concept, Wohlauer says. “The projects that we’re completing right now show this proof of concept: taking a working group of experts in the field, making sure we have diverse representation of views— seniority, gender, ethnicity, country of origin—to make sure we’re asking the questions the way we want to answer them; spending a lot of time with our registry managers building the registry; and also thinking a lot about the data analysis before even looking at the data.” All of this was accomplished during a time of great limitation—not only on procedure scheduling, but on doing research, he adds. “We found a way to do it.”

Guidelines recognize potential role for earlier endovascular treatment of uncomplicated type B aortic dissection

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Guidelines recognize potential role for earlier endovascular treatment of uncomplicated type B aortic dissection

New clinical practice guidelines published today aim to act as “guard rails” to determine the treatment options and best practices for managing patients with type B aortic dissection. An important update in the document is the potential for earlier endovascular treatment in patients with uncomplicated type B aortic dissection at higher risk of progressive disease.

The guidelines, produced jointly by the Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS) are published online today in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery. The new document offers evidence-based recommendations that include employing a “stepwise approach” to the evaluation and treatment of patients with uncomplicated type B aortic dissection, followed by close clinical surveillance.

“There has been an explosion of information in the form of research reports of varying quality regarding the treatment of type B dissection over the past decade,” said author G. Chad Hughes, MD, from the division of cardiovascular and thoracic surgery at Duke University Medical Center in Durham, North Carolina. “This guideline is unique in providing surgeons with a comprehensive, up-to-date summary of the state of the evidence, while also serving as ‘guard rails’ that outline treatment options and best practices in certain scenarios. This is a first for any document in the field of type B dissection management.”

A dissection of the aorta occurs when a tear develops within its wall. Type B describes the location of the tear, originating in the descending part of the aorta in the chest and potentially extending into the abdomen.

According to the guideline, aggressive medical therapy is the first step and considered the gold standard for managing patients with uncomplicated type B dissection, while open surgery should be reserved for complicated  cases.

Importantly, the guidelines recognize advances in less invasive treatment options for the disease, including the new role of earlier endovascular treatment such as thoracic endovascular aortic repair (TEVAR) in patients with uncomplicated type B aortic dissection. In the early phase of treatment, surgery previously was reserved for patients who had complicated type B dissection; in later phases, for patients who had progression of their disease. Now, the guidelines suggest that surgeons may be able to identify subsets of patients with uncomplicated type B dissection who have a higher risk of progressive disease and treat them earlier with TEVAR—before progression develops. However, this recommendation remains secondary to medical management, and patient selection still needs to be better defined in the future.

For complicated type B dissection patients, TEVAR or open surgery, depending on the anatomy, should be the first-line treatment, according to the guideline. The collective data demonstrated improved outcomes with TEVAR for these patients compared to open surgery or medical therapy alone.

The guideline also states that for some type B dissection patients—such as those with connective tissue disorders or chronic dissections—whose disease has progressed despite medical therapy, a “more durable” open surgical repair may be recommended over TEVAR.

“We expect this guideline to improve the quality of care of patients with type B aortic dissection by providing surgeons the most up-to-date summary of when and how to effectively use which therapies, whether open surgery, endovascular therapy, or a combination of the two over the lifetime of the patient,” said Dawn S. Hui, MD, of the department of cardiothoracic surgery at the University of Texas Health Science Center at San Antonio in San Antonio, Texas.

“In contrast to individual studies, clinical practice guidelines are unique because they are a high-quality summary and synthesis of what is already known about this topic,” added Hui. “Guidelines are written according to a scientifically rigorous process. Thus, they can help resolve conflicting findings of different studies or define what treatment options are best for specific circumstances.”

UPDATED: Last call for community practice accolade

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UPDATED: Last call for community practice accolade
The award deadline now falls March 31

The clock is ticking to submit nominations for the 2022 Society for Vascular Surgery (SVS) Excellence in Community Practice Award—with an extended deadline now set for March 31.

The honor is exclusively for those who practice in the community setting, including members in the office-based lab (OBL) setting. Nominations had originally been due by Feb. 1 (the accolade was previously called the Excellence in Community Service Award).

So what denote “excellence”? Past recipients have mentored students, brought vascular service to underserved areas and/or to patients’ homes, developed training or other educational programs, developed practice guidelines covering high-risk vascular patients, and been active in SVS or local and state vascular organizations

To be considered, applicants must be community practitioners and have been in practice as a vascular surgeon for at least 20 years; been an SVS member for at least five years; and show evidence of impact on vascular care or community health.

Learn more at vascular.org/CommunityPracticeAward.

Cook Medical receives FDA breakthrough designation for new drug-eluting stent

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Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Graphic representation of BTK intervention. Image courtesy of Cook Medical

Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI).

The Breakthrough Device designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

While the product is not commercially available yet, the benefits of the designation include priority review and interactive and timely communication with FDA during the clinical trial and premarket review phases in order to help get lifesaving devices to patients more quickly, a Cook Medical press release details.

SAVS 2022: ‘Recruiting more women without knowing race/ethnicity of those women only tells part of story’

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SAVS 2022: ‘Recruiting more women without knowing race/ethnicity of those women only tells part of story’
SAVS 2022 poster presentation

Failure to stratify gender by race or ethnicity, or vice versa, leads to missed opportunities in the recruitment of underrepresented members from the potential vascular surgery trainee pool.

That was one of the examples delivered in a poster presentation at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting in Manalapan, Florida (Jan. 19–22) that delved into the intersection of race and sex, which the authors called out as an overlooked dimension of diversity recruitment.

Among integrated vascular surgery residents in the U.S. and Canada in 2020, 63.2% identified as male, 53.9% as white, 7% Hispanic, 5.8% Black, 1.5% American Indian or Alaska Native, and 0.3% Native Hawaiian or other Pacific Islander, according to a research team that included first author Lauren N. West Livingston, PhD, and senior investigator Gabriela A. Velazquez, MD, of Wake Forest School of Medicine in Winston-Salem, North Carolina.

Similarly, the analysis found that among vascular surgery fellows, 67.2% were male, 59.5% were white, 6.6% Hispanic, 3.5% Black, 0.4% American Indian or Alaska native, and 0.4% Native Hawaiian or other Pacific Islander. Livingston and colleagues used data drawn from the Association of American Medical Colleges, compared with data on the sex/gender and race/ethnicity of practicing vascular surgeons.

The researchers said the analysis demonstrated that minorities continued to be underrepresented in medicine, but that the data were limited by training paradigm. Furthermore, they did not examine results with an “intersectional lens,” the team conceded. Analyzing the data in this way, they concluded, would have allowed further stratification of the figures by combination of race and gender, or the subgroups within certain racial/ethnic identities.

“For example, recruiting more women without knowing the race/ethnicity of those women only tells part of the story,” the investigators added.

Medtronic recalls HawkOne directional atherectomy system

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Medtronic recalls HawkOne directional atherectomy system
HawkOne

Medtronic has recalled 95,110 HawkOne directional atherectomy system devices distributed in the United States between Jan. 22, 2018, and Oct. 4, 2021, the Food and Drug Administration (FDA) has announced.

The FDA has identified the recall as a Class I—the most serious type in that “use of these devices may cause serious injuries or death.” So far, there have been 163 complaints, 55 injuries and no deaths reported in relation to the device issue, the FDA reported.

HawkOne consists of a catheter and cutter driver, and is used during procedures intended to remove blockage from peripheral arteries. The recall was made “due to the risk of the guidewire within the [system’s] catheter moving downward or prolapsing when force is applied during use,” according to the FDA.

The company distributed an urgent medical device notice to customers on Dec. 6, 2021, requesting they share reports of the defect with all relevant parties, and review both HawkOne’s instructions for use (IFU), and the warnings and precautions listed in the urgent notice letter, before using the product.

“In accordance with our commitment to patient safety, Medtronic recently initiated a voluntary recall to customers related to the risk associated with tip damage caused by guidewire prolapse in its 6 French (6Fr) HawkOne directional atherectomy system,” Medtronic said in a statement. “In our letter to customers, Medtronic noted that a small number of customer reports of tip damage (at a rate of 0.168% when compared to quantity of devices distributed) during the use of the 6FR HawkOne devices. While most of these instances were resolved without patient issue, a small number required endovascular retrieval (0.033%) or open surgical retrieval (0.028%).”

The statement added that there are no product retrievals or disposals requested associated with the recall and no actions required for patients treated with HawkOne.

Should the catheter function as outlined, the FDA reported in a medical device recall advisory, “the catheter tip may break off or separate and this could lead to serious adverse events, including a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip.”

Medtronic asked customers to complete a confirmation form enclosed in the urgent notice letter and email them to [email protected].

SVS to hold Surgical Coaching Program webinar Jan. 24

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SVS to hold Surgical Coaching Program webinar Jan. 24
3/9/18 Environmental portraits of Surgical Doctors at the NCRC.

Professional athletes and musicians have coaches to help them “up their games.” It follows then that vascular surgeons can benefit from coaching within the specialty.

The Society for Vascular Surgery (SVS) will hold a webinar on surgical coaching from 6–7 p.m. Central Standard Time on Monday, Jan. 24. Panelists will discuss what surgical coaching is, how surgical coaching contributes to wellness, additional benefits of surgical coaching and the background of the SVS Surgical Coaching Program through a collaboration with the Academy for Surgical Coaching. Coaches will share their experience and the webinar will also include a question-and-answer period with coaches, SVS members and representatives of the Academy for Surgical Coaching.

“Even the best of the best can benefit from coaching,” said Dawn Coleman, MD, co-chair of the SVS Wellness Committee, which oversees the coaching program. “We’ve worked closely with the Academy for Surgical Coaching, which has trained a number of SVS members and vascular surgeon leaders to serve as peer surgical coaches.”

“The program offers expert advice from vascular surgeon colleagues in the field,” she said. “Our committee can’t recommend coaching highly enough to improve problem-solving and negotiating skills, feel better and take your career up a notch.”

SAVS 2022: Skyrocketing vascular nursing costs hammer division’s financial bottom line

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SAVS 2022: Skyrocketing vascular nursing costs hammer division’s financial bottom line
Clayton Brinster

The profit margin of a vascular surgery division at a prominent health system in New Orleans was severely eroded during the COVID-19 pandemic period—despite consistent revenue generation throughout—as nursing labor costs dramatically escalated, according to a deep financial analysis carried out by a local research team.

The investigators, led by members of the academic vascular surgery practice at Ochsner Health, looked at the division’s total (across both hospital and outpatient clinics) profit margin, as well as totals for vascular surgery nursing unit expenses, nursing unit expense-per-case, vascular surgery nursing labor expenses per-patient-day and total nursing expense per-relative-value-unit (RVU), uncovering what lead author and Ochsner senior staff surgeon Clayton Brinster, MD, described as “a disturbing story of increasing total nursing expenses.” He pointed to a top line increase over the last nine months of 67% per month in total nursing expenses in the institution’s vascular surgery units. Considering that most health systems operate at slim (0 to +3%) to negative net financial margins, “this is a staggering increase,” Brinster stated.

The results were derived from seven cohorts corresponding to three-month periods dating to the start of the pandemic in March 2020 through November 2021, and compared with the 14-month period preceding the COVID-19 outbreak. The findings build on data, delivered a year ago, showing that the Ochsner vascular division recorded three-month sustained decreases in operative and outpatient clinical volume, as well as a “severe” financial loss, during the initial stages of the pandemic.

Delivering the group’s findings at the 2022 Southern Association for Vascular Surgery (SAVS) annual meeting in Manalapan, Florida (Jan. 19–22), Brinster told attendees traditional determinants of surgical net revenue—such as total cases per month, RVU per month, and Centers for Medicare and Medicaid Services (CMS) case mix index—showed no significant difference when the post-COVID cohorts were compared with the pre-COVID era. Yet, he informed the gathering, they observed a “consistent erosion of vascular surgery margins,” despite consistencies in revenue generation.

As the team delved deeper into the data, standardizing against a per-case basis, “we saw a similarly disturbing trend, with an increase of about 75% per vascular surgery case—that’s the increase in nursing costs alone,” Brinster said. System-wide, nursing labor costs in 2021 increased about 200%, or $104 million more than the 2020 number, he noted. “Don’t forget: 2020 was a pandemic year with elevated nursing costs as well. So this is a really dramatic situation.”

Brinster and colleagues went further. The pandemic inevitably will lead to about 80 million Americans either becoming uninsured or seeing their health insurance status altered, resulting in shifts in the insurance payor mix and associated distribution, Brinster explained. This, in turn, directly impacts reimbursement, net revenue and profit margin, he said. “When we looked at our own vascular surgery payor mix, we saw some shifts during the course of the pandemic: the equivalent increase in the more profitable commercial payor is about +5% on average, and the more costly lower-reimbursing Medicaid payor is about +5%. This likely will offset, but just looking at +5 and +5 does not show the whole picture, so we wanted to take it a step further in terms of standardizing our clinical cost data.”

This led Brinster et al to scrutinize total nursing expense per RVU, which he described as “perhaps the most accurate standardized measure of variation of clinical expenses over time.” In this analysis, they demonstrated “a dramatic 55% conglomerate increase” during the COVID era compared with the post period. The RVU dimension also served the purpose of making the data generalizable beyond Ochsner and capable of application across the country, he said.

Overall, pandemic peaks in the COVID positivity rate in New Orleans was closely followed by spikes in nursing labor costs that were “almost proportional to the degree of positivity,” Brinster observed. “When you consider that nurses incur a disproportionately high COVID exposure risk, that means subsequent quarantines and recoveries, requiring the use of mandatory sick time,” he said. “That then leads to decreased available labor, increased agency usage and increased costs.”

Summing up, Brinster said the pandemic had intensified “an evolving nursing labor crisis that has been going on for decades,” with the results from the Ochsner study demonstrating a “severe erosion of vascular surgery profit margin in the presence of dramatically escalating nursing labor costs, despite consistent revenue generation present throughout the pandemic.” The accuracy of the data used was made possible through a unique collaboration between the section of vascular surgery and Ochsner’s finance and decision support team, Brinster added.

Meanwhile, tackling the gravity of the nursing problem represents a mammoth task, he said. The government has taken action, pledging to invest $1.5 billion in an attempt to combat the national crisis. “The educational debt of over 22,000 nurses and nurses assistants will be absolved in exchange for a commitment to work in critically underserved areas affected by the pandemic.” Elsewhere, Brinster said, the 2022 Medicare Physician Fee Schedule will support physician practices that rely very heavily on nursing support staff, medical assistants and other clinical staff covered by Medicare, with rates for registered nurses increasing by 67% and those for medical assistants by 50%.

Ultimately, the plans seem “stopgap”—and the resulting situation “untenable”—at both the national and individual health system levels, he argued. The long-term remedy requires institutional, state and national programs to alleviate the workforce and financial crises, Brinster said. “Realistically, additional CARES Act or other type of government funding is the avenue to financial security,” he concluded. “As we struggle to recover from the ongoing pandemic, investments should really be focused on nursing education, training and recruitment—and established permanently.”

A balance is required with non-compete agreements in surgical practice

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A balance is required with non-compete agreements in surgical practice
Bhagwan Satiani and O. William Brown

Unless prohibited by state law, most physicians employed by hospitals or physician groups are required to sign non-compete agreements (NCAs). A recent survey of 2,000 primary care providers (PCPs) in five states, 50% of office-based and 37% of hospital-based or free-standing centers, had signed an NCA.1,2 Our experience is that almost all surgical specialists are required to sign one.

NCAs are generally subject to state regulation, not federal. The Federal Trade Commission (FTC) convened a workshop in 2020 on whether it could justify NCA actions through rule making rather than legislation. Both the American Medical Association (AMA) and American Bar Association (ABA) were against the proposal. Some of the opposition is based upon federalism arguments, which favor these regulations to be left to the states. In most states, like Ohio, NCAs are enforceable provided “the restrictions are no greater than necessary to protect the employer’s legitimate business interests; they do not impose an undue hardship on the employee; and the restrictions would not injure the public.”3

Other factors include that the NCA must be part of an employment contract in writing, narrowly tailored and have reasonable limits of distance and duration. In Columbus, two major health systems restrict their physicians from practicing within 20–25 miles for one to two years. Most courts will enforce a “reasonable” NCA and rule on factual, case-by-case situation. (BDO Seidman vs. Hirschberg, 93 N.Y.2d 382 1999). Many states—such as Colorado (limited ban), Delaware, Massachusetts, Louisiana, North Dakota—ban NCAs. Others, such as Connecticut, limit the geographical distance to 13 miles from the primary site of practice and the duration to one year.

It is believed that NCAs limit worker movement, entrepreneurship, and information-sharing such as academic or scientific discoveries. However, a complete ban on NCAs will hurt the ability of companies to protect trade secrets, especially for small- and medium-sized businesses.

There is evidence that about 50% of private sector businesses require some employees to sign an NCA. Some wonder if healthcare executives also sign NCAs. That depends on many factors, but, in general, senior executives, especially in private corporations, may be required to sign one. Similarly, most private practices also require NCAs. It is common in technical and executive positions, and it is estimated that 36–60 million Americans have signed an NCA. Among these workers, about 45% of primary care physicians are estimated to have signed an NCA.2

Even if the NCA is heavy handed and unduly restrictive, health systems know that physicians may not have the resources and time to contest them in court. Another contractual option maybe to have themselves or their new employer negotiate the payout (if there is one) with the previous employer.

The Hamilton Project suggests several proposals to balance the interests of firms and workers: require that employees be informed in advance that a NCA will be required to be signed; compensate existing employees who are asked to sign a new or revised NCA without retaliation; stop the state from allowing judges to modify existing NCAs; give state attorneys general power to end unenforceable NCAs; and, finally, institute regulations to allow easier enforcements of NCAs.4

If located in a large metropolitan area with multiple hospitals, it may be necessary to undertake some planning before signing an NCA in case a move becomes necessary. However, could this common practice in many industries may be changing?

President Joseph Biden signed an executive order on July 9, 2021, called “Promoting Competition in the American Economy.”5 The order urges the Federal Trade Commission (FTC) to “curtail unfair use” of NCAs. It is likely that this order is directed at lower income or hourly workers, who probably do not hold any trade secrets.

For instance, the District of Columbia passed a law banning an NCA for low-wage workers. However, the ban excluded physicians with incomes greater than $250,000, provided the physician was shown the non-compete clause at least 14 days before signing an NCA.

In fact, 70% of people in some management positions are asked to sign an NCA after receiving a job offer, and almost half sign on their first day or after they join a company.2 It is too early to say whether this strike against NCAs will have any long-term impact on their widespread use in physician employment agreements. Finally, physicians should remember that termination of an employee, with or without cause, should result in the termination of an NCA.

References

  1. Lavetti K, Simon C, White WD. The impacts of restricting mobility of skilled service workers: Evidence from physicians. http://kurtlavetti.com/UIPNC_vf.pdf
  2. Has your career been affected by a non-compete clause? https://www.medscape.com/viewarticle/943622
  3. Are non-compete agreements enforceable in Ohio? https://ohio-employmentlawyer.com/ohio-noncompete-agreements/
  4. Marx M. Reforming non-competes to support workers. https://www.hamiltonproject.org/papers/reforming_non_competes_to_support_workers
  5. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/

Bhagwan Satiani, MD, is professor emeritus in the division of vascular diseases and surgery in the College of Medicine at The Ohio State University. O. William Brown, MD, is chief of the section of vascular surgery at William Beaumont Hospital, Bingham Farms, Michigan. He is also a professor of surgery at Oakland University/William Beaumont School of Medicine and an adjunct professor of law at Michigan State University College of Law.

Giving November initiative brings in $50,000-plus to SVS Foundation

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Giving November initiative brings in $50,000-plus to SVS Foundation

The SVS Foundation’s extension of Giving Today into Giving November was a big success, with more than $50,000 donated to Foundation research, grants, awards and projects.

A host of Society for Vascular Surgery (SVS) members provided matching funds of more than $20,000 in giving challenges for both Giving November and Giving Tuesday. The latter is the global day of giving held annually on the Tuesday after Thanksgiving—which was Nov. 30 in 2021.

The SVS Executive Board of Directors and the SVS Foundation Board of Directors, plus the chairs of the SVS Development Committee, banded together to match up to $20,000 in donations. That goal was reached well before the month’s end, said Peter Nelson, MD, chair of the Development Committee.

In all, the Foundation received $29,910 from 183 individuals and one society— including the Giving Tuesday campaign. A separate SVS staff challenge resulted in $1,315 in donations from 17 staff and contracted individuals, with that amount matched by donations from Executive Director Kenneth M. Slaw, PhD, and SVS Foundation Executive Director Rupa Brosseau.

“Our members have made November 2021 one of the most monumental and memorable months that the Foundation has ever seen,” said Nelson.

“SVS members have really stepped up in the past few years, with not only larger donation totals but also more members participating,” added Foundation Chair Peter Lawrence, MD. “Both factors are pivotal to the success of our mission. Without money, there is no mission. I am grateful to our members and also to our leadership’s example in leading the way to a strong SVS Foundation.”

Visit vascular.org/SVSFoundation to learn more about the Foundation and its programs and mission.

Thrombolex: Investigational RESCUE trial yields ‘exciting’ interim data

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Thrombolex: Investigational RESCUE trial yields ‘exciting’ interim data
Bashir endovascular catheter

The prespecified interim analysis of the first 62 evaluable pulmonary embolism (PE) patients enrolled in the investigational RESCUE trial produced positive results, Thrombolex has announced.

RESCUE is a prospective multicenter, single-arm pivotal trial evaluating patient outcomes after treatment of acute intermediate risk PE. This pivotal trial is scheduled to enroll at least 100 evaluable patients. The trial is evaluating the efficacy and safety of the Bashir and Bashir S-B endovascular catheters in the treatment of acute PE under an investigational device exemption (IDE) from the Food and Drug Administration (FDA). An analysis of the interim data was presented in the late-breaking clinical trials session at this year’s International Symposium on Endovascular Therapy (ISET 2022) held Jan. 16–19 in Hollywood, Florida by Ripal Gandhi, MD, a cardiologist at Miami Cardiac and Vascular Institute in Miami, on behalf of the RESCUE investigators.

During this session, Gandhi reported new detailed data on the reduction of clot burden in segmental pulmonary arteries. According to Thrombolex, these initial data have not been reported in any of the previous clinical trials of acute PE.

The data demonstrated a 90% reduction in the number of totally occluded segmental pulmonary arteries (p<0.0001) and a 72% reduction in subtotal and total occlusions of segmental arteries (p<0.0001) at 48 hours post procedure compared to baseline by computed tomography (CT) angiogram. Each of the 20 segmental arteries showed a reduction in the degree of obstruction. The trial met its primary endpoint for reduction in right heart strain, and at 72 hours post procedure there were no major bleeds, no major adverse events and a zero-mortality rate. Collectively these patients experienced substantial improvement in hemodynamics and symptoms, which translated to improvements in right heart strain, cardiac function and functional status.

“These interim results from the RESCUE trial are very exciting,“ said Gandhi, a RESCUE trial investigator. “The reduction in thrombus burden at 48 hours after treatment, as assessed by the independent core lab, is remarkable especially with no bleeding complications. Complete resolution of thrombus burden should be an important goal of treatment. This represents a promising novel technology for the treatment of acute PE and other forms of large vessel venous thromboembolic disease.”

Thrombolex’s Bashir and Bashir S-B endovascular catheters have received FDA 510(k) clearance for the localized infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The goal of the RESCUE IDE study is to achieve an additional indication for use of these devices in the treatment of acute PE.

Live-streaming to return at VAM 2022

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Live-streaming to return at VAM 2022
Ronald L. Dalman delivers his Presidential Address at VAM 2021

After a successful debut in 2021, live-streaming of a variety of sessions will return to the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) this year.

VAM 2022 will be June 15–18 at the Hynes Convention Center in Boston and will be the Society’s 75th meeting. The meeting will feature educational content—and live-streams—across all four days; exhibits will be open June 16–17.

“We will follow many of the guidelines we established in 2021: stream all scientific plenary sessions, special lectures and forums, with the Presidential Address also among them,” said SVS Program Committee Chair Andres Schanzer, MD. “We want to offer exciting, interesting sessions that will give the at-home viewers needed cutting-edge research, educational content, diverse food for thought, and useful tips for their practices.”

Organizers have already implemented one scheduling change from 2021: moving international sessions to early morning, because of time zone differences. This will enable international attendees to watch sessions particularly applicable to them during their daytimes, and not late at night, said Schanzer. Currently scheduled for live-streaming are:

  • VQI@VAM, the Vascular Quality Initiative annual meeting, on Tuesday and Wednesday
  • International Fast Talk, International Chapter Forum, the meeting of the World Federation of Vascular Surgery (WFVS), and the International Young Surgeons Competition
  • All eight plenary sessions
  • The Vascular and Endovascular Surgery Society (VESS) session
  • The E. Stanley Crawford Critical Issues Forum
  • The Roy Greenberg and John Homans lectures
  • The Awards Ceremony
  • Two concurrent sessions each on Thursday and Friday
  • The Presidential Address
  • A postgraduate course on Saturday

The Opening Ceremony also may be live-streamed. Details, Schanzer cautioned, are subject to change. Learn more about VAM 2022 at vascular.org/VAM.

Formally introducing Christopher Audu

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Formally introducing Christopher Audu
Christopher Audu in the OR

The team at Vascular Specialist—led by Malachi Sheahan III, MD—is pleased to announce the appointment of University of Michigan resident Christopher Audu, MD, as our new resident/fellow editor. He replaces Laura Marie Drudi, MD, who last year graduated from fellowship and now practices as a vascular surgeon at Centre Hospitalier de L’Universite de Montréal in Canada. Here, Audu talks us through his vascular journey so far.

Tell us a little about your background and journey into vascular surgery.

CA: I was born and raised in Nigeria, where I lived until after high school, when I was fortunate to pursue a chemistry degree from Purdue University. I then matriculated to Dartmouth for medical and graduate school where I got a Chemistry PhD. My interest in vascular surgery came about circuitously. I did not decide on surgery until the end of my MS3 year, and I began looking for a surgical field that would value what I had to offer as a basic scientist interested in medicinal chemistry. One of my PhD projects had examined the role of endothelin receptor activation as a therapeutic target against rapid vascular smooth muscle cell proliferation (aka intimal hyperplasia), so I was hooked on vascular pathophysiology and the role for medicinal chemistry. I attended the 2014 Vascular Annual Meeting (VAM) and walked among the poster boards, and was delighted to see that there was a robust presentation of immunology, biochemistry and pharmacologic projects on display. On return from VAM, I completed my surgery rotation and fell in love with the breadth of expertise that vascular had to offer.

How did your involvement with Vascular Specialist come about?

CA: Ever since starting residency, I would read through Vascular Specialist with keen interest in Resident’s Corner [now Corner Stitch]. I had the opportunity to virtually meet Dr. Laura Drudi last year, and, after chatting for a bit, she asked me to consider writing a post for interns last July. That was my first post, and I guess the lessons I learned from my experiences resonated with enough people that I was asked to become a recurring contributor to the column.

What plans do you have for the paper in your role as resident/fellow editor?

CA: It is an honor and privilege to follow Dr. Drudi’s footsteps in this role, and I am grateful to have her as a mentor. The goal for Corner Stitch has always been to highlight topics that are germane to the vascular trainee in the here and now—from the medical student level up to the graduating resident/fellow. I would like to continue in this tradition and invite contributions from as diverse a body of trainees as is possible.

What do you feel are the biggest issues with vascular training at the present moment?

CA: That’s a great question. The number one goal as a vascular trainee is to become proficient, confident, compassionate surgeons who offer our patients the full gamut of comprehensive vascular care— and who are humble enough to learn new techniques, or refer to an expert if a particular skill is not in our wheelhouse. Ultimately, the patient in front of us is who matters foremost. I do believe our current training paradigms allow us to meet this goal, even though there is variation in regional practice and training patterns. Notwithstanding, the biggest issues with vascular training, I think, are twofold: inflow to the specialty and a need for wellness initiatives that are meaningful for the trainee.

Do you have any key advice for students and trainees eyeing vascular surgery?

CA: To students and others looking into vascular surgery, I’d encourage you to attend local and/or national vascular conferences. While there, see if the specialty checks the boxes of what you are looking for in a surgical career. Introduce yourself to people, or, if you are there with a mentor, have them introduce you to people. Finally, apply for residency/fellowship and don’t give up. We need you.

Corner Stitch: From intentions to gratitude in 2022

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Corner Stitch: From intentions to gratitude in 2022
The year ahead brings forth a number of possibilities across the spectrum of issues trainees will tackle

A time of transition, like the dawn of a New Year, usually commences the mass drive for New Year’s resolutions and intentions. Many of us have had the pleasure of covering the New Year’s call shift, and it was also so striking to see the new fads healthcare professionals began to take on—from green smoothies to workout challenges. But let’s begin this year with some gratitude and predictions.

First, to our diverse readership, thank you for your continued support in opening up our monthly newspapers, and perusing and sharing our content. Thank you for the feedback you have given because, with your continued involvement, our newspaper becomes stronger with every passing issue. Thank you, and we will continue to serve you and have your voices heard.

To our community of leaders and authors of Vascular Specialist: we have shared stories from nurses and allied healthcare professionals trying to stay afloat during this pandemic; struggles and barriers surgeons face daily to deliver comprehensive vascular care; and stories from leaders on how they have navigated and led their teams in times of crisis. Despite the challenges, we are all to be commended on not only surviving a difficult year, but for being present for our patients, colleagues, families and ourselves. Thank you all, and we will continue to serve you and have your voices heard.

And finally to our Society for Vascular Surgery (from the leaders to the membership): the SVS has shown tremendous resilience in the face of the COVID-19 pandemic, and has been at the forefront in complete transparency with virtual webinars, Town Halls, and ongoing initiatives to aid the membership. Wellness has been at the forefront of our society before the pandemic, but has truly been—a priority during this time of crisis. The SVS Wellness Committee (formerly Task Force) under the leadership of Drs. Dawn Coleman Malachi Sheahan III, and others have brought peer support and coaching to SVS members. Thank you all for the work that you do. We will continue to serve the SVS and have all voices heard.

Now, here are a few predictions for what we may learn in 2022. We will have to circle back at the end of the year to see if any of these comes to pass.

Prediction #1

First off, a return to in-person interviews. We hope that, with widespread vaccine availability and growing scientific advances towards therapeutics (see here for latest wonder drug against COVID-19 that is currently in clinical trials), we will have a return to in-person interviews, both for residency and fellowship. While video conferencing has been a natural substitute, most programs take pride in showing off their facilities, their towns/ cities, and their trainees in person. It’s just not the same, and we hope 2022 brings things back to some sense of semi-normalcy.

Prediction #2

We will finally know if carotid endarterectomy is better than stenting for stroke prevention. The CREST-2 trial, currently ongoing, is predicted to have a primary completion date of December this year. While we may not have the official trial results in print for another year or so, we predict that 2022 will bring more clarity on this important subject. We will be watching conference abstracts closely for result teasers.

Prediction #3

More vascular surgery residency spots. OK, so this is pure speculation on our part, but we hope that more slots for the 0+5 residency training paradigm open up. This will continue to help increase the pipeline and number of vascular surgeons in the next decade. We predict five to 10 more spots for trainees to choose from. And yet, most of all this year, we look forward to working with you, our readers. Email us your topic pitch, or tell us what you may want to read about. What is most germane to you?

In 2022, we look forward to meaningful interviews, wisdom and write-ups that challenge us to expand our thinking—and help us perfect that sometimes elusive, but exquisitely important, Corner Stitch column.

Christopher Audu, MD, is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan, and the newly installed resident/fellow editor of Vascular Specialist. His predecessor, Laura Marie Drudi, MD, is a vascular surgeon at Centre Hospitalier de L’Universite de Montréal in Montreal Canada.

Members involved in suggesting topics for VAM 2022 sessions

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Members involved in suggesting topics for VAM 2022 sessions

Society for Vascular Surgery (SVS) program planners are finalizing the lineup and topics for several types of educational session for the 2022 Vascular Annual Meeting (VAM). VAM is set for June 15–18 in Boston, with educational programming across all four days.

SVS members are becoming more involved and engaged in proposing topics for many of the sessions they would like to see at VAM, said William Robinson, MD, chair of the SVS Postgraduate Education Committee (PGEC).

For 2022, members submitted 58 proposals for breakfast and concurrent sessions, postgraduate courses and the always popular “Ask the Expert” small-group sessions, explained Robinson.

The number of member submissions has increased steadily since the process began several years ago. For this year, the committee worked to increase awareness and engagement among members. And the PGEC altered the process to provide for blind review of proposals, to enhance fairness and assure “the most well-developed and thoughtful proposals were selected,” said Robinson. “This helps us get the best programming—with both clinical and non-clinical topics—and also lets us look ahead and create a well-balanced program.”

Frequently similar topics come in, so committee members ask those who proposed content to work together and with the PGEC to develop content in more depth. “It gets more people involved and provides for more viewpoints,” said Robinson.

This year, the PGEC also is incorporating programming specifically from and for four SVS membership “sections”: Community Practice (SVSCPS), Outpatient and Office Vascular Care (SOOVC), as well as Women’s and Young Surgeons. Three are new sections. “This allows these section leaders, working with the PGEC, to deliver content their members think is important and relevant to the SVS membership,” said Robinson.

With programs close to finalization and scheduling completed, “I am thrilled with the program that is shaping up” he said. The 21 invited sessions include 13 clinical and eight non-clinical topics. The section sessions, plus one for the Journal of Vascular Surgery publications and others, bring the total to 28.

VAM 2022 organizers also continue the practice of recent years—responding to member feedback— of scheduling days to minimize overlap; the general goal is to have three or fewer similar sessions happening simultaneously. “There’s a balance between hitting a breadth of topics and just having too much going on,” said Robinson.

“We try to be inclusive and incorporate as many ideas as we can if it’s reasonably possible,” he said. “Even really good proposals had to be deferred, because they were similar to sessions last year. It doesn’t mean they are not worthwhile. It just may be better for an upcoming year.”

The committee aims to broadly cover the topics inherent in vascular surgery practice. Not every topic can be covered in detail every year, so planners try to make sure important topics get detailed treatment every two to three years, said Robinson. Generally, topics all vascular beds, plus thoracic outlet syndrome and other less common pathologies. Meanwhile, invited sessions include five “Ask the Expert” small-group sessions.

Philips integrates cloud-based AI and 3D mapping into its mobile C-arm system series

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Philips integrates cloud-based AI and 3D mapping into its mobile C-arm system series
Philips’ Zeniton mobile C-arm platform

Royal Philips has announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system—Zenition. The system will deliver enhanced clinical accuracy and efficiency, according to Philips, and aims to improve outcomes for patients undergoing endovascular treatment. The company has signed a strategic partnership agreement with Cydar, a United Kingdom-based provider of cloud-based procedure maps software to plan and guide surgery in real time.

As patient numbers rise and procedures become more complex and time-consuming, patient-specific real-time procedure planning and guidance, optimization of equipment utilization, and usability have become ever more important. To help overcome these challenges, Philips details that its image-guided therapy mobile C-arm system—Zenition—brings together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ image-guided therapy platform Azurion. Like Azurion, the Zenition mobile C-arm system allows hospitals to maximize operating room performance, enhance their clinical capabilities, and provide staff with a seamless user experience, the company claims.

The integration of Cydar EV Maps software into the Zenition platform now adds extended procedure planning and real-time 3D guidance capabilities.

Cloud-based AI and computer vision

Philips states that Cydar EV Maps assists in the planning, real-time guidance, and postprocedure review of the endovascular surgery. It brings cloud-based artificial intelligence (AI) and computer vision to mobile surgery, enabling reductions in radiation exposure, fluoroscopy time, and procedure time together with improved ease of use. It enables surgeons to create a detailed, patient-specific 3D map of the target vasculature to help plan surgery, the company adds, and then uses these maps to augment intraoperative live image guidance, updating the maps in real time to account for deformations during surgery, such as guidewires and instruments deforming the patient’s blood vessels.

Cydar Maps

Philips notes that Cydar EV also facilitates post procedure outcome analysis. The combined result of this integration of procedure planning, guidance and review is that surgeons can work more accurately and efficiently—enabling an approximate 50% reduction in radiation exposure, a significant reduction in fluoroscopy time and a reduction of procedure times by more than 20%, according to Philips, all while helping achieve better outcomes for patients.

Cydar EV Maps is currently in use across the EU, U.K. and U.S. It is certified Software-as-a-Medical Device with EU CE mark and Food and Drug Administration (FDA) 510(k) clearances.

VA: Cutting through the ‘red tape’ of research

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VA: Cutting through the ‘red tape’ of research
Sharon C. Kiang

Creating an academic career with a perfect blend of clinical work and protected time for productive research is a struggle for many surgeon-scientists. Many have viewed a surgical career in the Veterans Health Administration as a perfect opportunity to achieve that amalgamation. The 2018 revision to the Common Rule has simplified and increased the efficiency of the regulatory components for human subject research.

The Common Rule, established in 1981, is a code of ethics that governs biomedical and behavioral research for human subjects in the United States at the level of the Institutional Review Board (IRB). It followed the 1975 Declaration of Helsinki and is included in the 1991 U.S. Department of Health and Human Services (Title 45 CFR 46 Subparts A, B, C and D). The Common Rule is considered the baseline code of ethics for government-funded research in the U.S.

The details for Common Rule compliance can be tedious and burdensome, deterring some from pursuing human subject research. The 2018 revision simplified some of this tediousness, with leaders hoping to maintain human subject safety while decreasing the administrative burden. Major changes in Common Rule regulations that impact surgeon-scientists include development of 1) new exemption categories, 2) allowance of a Limited IRB, 3) allowance of a Single IRB Mandate, and 4) implementation of a Designated Research and Development Review. The new categories are summarized below.

New exemption categories (after 1/29/2019)

Studies qualified for exemption are not subject to the requirements of the Common Rule. Oversight of exempt studies are reviewed by the IRB and the Veterans Affairs (VA) Research and Development Committee (R&D) for continuing reviews and amendments and must still remain compliant with the Privacy Rule or Act. In addition, the Research Compliance Office (RCO) retains the right to audit these studies for compliance. The new exempt categories are as follows:

  1. Exemption category 1: Education research (38 CFR 16.104d(1)) “Research conducted in established or commonly accepted education settings, that specifically involved normal education practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.” Broadly speaking, this pertains to research on education strategies or the effectiveness and/or comparison of strategies, curricula or classroom management.
  2. Category 2: Education tests/survey/ interviews/observations (§ 16.104(d) (2)) “Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording),” as long as one of the following is met: 1) Identity cannot be readily ascertained, 2) there is no risk of criminal/ civil liability/ financial standing/ employability/ educational advancement/ reputation or 3) the IRB conducts a limited review.
  3. Category 3: Benign behavioral interventions (brief, harmless, painless) (§ 16.104(d)(3)) “Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry), or audiovisual recording” as long as one of the following is met: 1) Identity cannot be readily ascertained, 2) there is no risk of criminal/ civil liability/ financial standing/ employability/ educational advancement/ reputation or 3) the IRB carries out a limited review.
  4. Category 4: Secondary research (§ 16.104(d)(4)) “Secondary research for which consent is not required, secondary research use of identifiable private information or identifiable biospecimens,” as long as one of the following is met: 1) Information is publicly available or 2) Subject specimen is not identifiable and the investigator does not contact or try to re-identify subjects.

Limited IRB Review

One of the changes to the Common Rule also allows for the use of the Limited IRB Review, permitting the initial approval to be expedited. After the initial approval, the study still falls under IRB oversight (amendment, reporting, etc.), but the study no longer requires a Continuing Review. Most local policies still request an “Annual Update” submission. However, there is no regulatory requirements of a continuing review in order for the study to continue. The Limited IRB review category is allowed for Exemption categories 2 and 3—as long as the IRB can assure the privacy of patients and confidentiality of their data (HIPAA waiver).

Single IRB Mandate

The Single IRB Mandate is simplifying the ability for Veterans Affairs (VA) studies to be part of multi-institutional studies outside of a VA Cooperative Study. The VA can now enter into agreements to rely on commercial IRBs as IRBs of record for multicenter trials to have only one IRB review. The Single IRB allows for increased ability to bring in funded, sponsored research in addition to collaborating as a trial site for other government institutions, such as the National Institutes of Health (NIH).

R&D designated review process

The inclusion of this new category is intended to increase efficiency for review of appropriate studies.

Rather than follow through with the tedious process of initially undergoing an IRB review only to be subsequently sent for a full R&D Committee review, the following activities may be approved by the chair of the R&D Committee, or a voting member designated by the chair:

  1. Minor changes to a protocol required by the R&D Committee, following full board review
  2. Final approval for protocols approved contingent on the full approval of a subcommittee, if the subcommittee had not required major changes (as defined in local standard operating procedures) to the protocol since the R&D Committee conducted its review
  3. Final approval for protocols approved contingent upon completion of the privacy officer (PO) and information system security officer (ISSO) review
  4. Exempt human subject research protocols and protocols approved by expedited review by the IRB
  5. Single patient expanded access protocols approved by the IRB chair or another appropriate IRB voting member
  6. Protocols that do not involve human subjects; biosafety level (BSL-3) or higher containment; use of select agents or non-exempt quantities of select toxins; U.S. Department of Agriculture (USDA)-regulated animal species or any animal research involving more than momentary pain or distress to the animals

A robust research program is critical to not only the faculty, but also to the new faculty just starting their academic careers. The new changes in the common rule ease the administrative burden and increase the efficiency of the regulatory process, thus encouraging a lifelong career of cutting-edge clinical practice alongside a productive research enterprise for young faculty joining the VA.

Sharon C. Kiang, MD, chief of the division of vascular surgery at the VA Loma Linda Healthcare System in Loma Linda, California, is a member of the Society for Vascular Surgery VA Vascular Surgeons Committee.

ISET 2022 audience hears latest data on endovascular therapies

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ISET 2022 audience hears latest data on endovascular therapies
Erin Murphy presents 24-month ABRE data at ISET 2022

At this year’s International Symposium on Endovascular Therapy (ISET), being held Jan. 16–19 in Hollywood, Florida, experts presented an array of late-breaking trial results on topics ranging from venous stenting to abdominal aortic aneurysm (AAA) sac sealing.

Waseem Wahood, MS, a medical student at Dr. Kiran C Patel College of Allopathic Medicine in Davie, Florida, gave a U.S. national perspective on disparities in the treatment of peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI). The presenter highlighted major disparities in PAD and CLTI treatments for non-white populations, detailing that non-white patients are more likely to receive amputations, and less likely to receive revascularization (for PAD) compared to white patients. However, Wahood stressed that “the gap is slowly closing,” which “may demonstrate that guidelines have been effective in mitigating disparities.”

George Adams, MD, UNC REX Healthcare, Chapel Hill, North Carolina, delivered the results of a pooled subanalysis from the Tack optimized balloon angioplasty (TOBA) studies of the Tack endovascular system (Intact Vascular/Philips). The TOBA studies are unique, he informed the ISET audience, in that they are the first and only studies to enroll 100% dissected arteries. The studies demonstrate very low rates of clinically-driven target lesion revascularization (CD-TLR) and bailout stenting, he summarized, concluding that dissection repair with Tack produces positive short- and long-term results while preserving future treatment options.

Relaying findings from a multicenter experience with the WavelinQ endovascular arteriovenous fistula (endoAVF) 4Fr system (BD), Bulent Arslan, MD, of Rush University Medical Center in Chicago detailed a 72% primary patency, 88% secondary patency, 78% successful two-needle cannulation and 80.7% freedom from reintervention in 120 patients—the largest series to date, he claimed. Arslan encouraged attendees to look out for the results of ongoing clinical trials in the space, including WAVE-Global and CONNECT-AV, both designed to assess WavelinQ, and also the Ellipsys vascular access system (Avenu Medical/Medtronic) postmarket surveillance study.

Also on the agenda were the latest data on venous stenting. Erin Murphy, MD, director of Venous and Lymphatic Institute at Sanger Heart and Vascular, Atrium Health, Charlotte, North Carolina, outlined 24-month data from the ABRE trial—a prospective, multicenter, single-arm study of 200 patients with symptomatic iliofemoral venous outflow treated with the Abre venous self-expanding stent system (Medtronic).

The presenter revealed that effectiveness was sustained though 24 months, with a primary patency of 85.7% and freedom from CD-TLR of 90.9%. In addition, Murphy communicated that no stent fractures and no stent migrations were reported through 24 months. Finally, the presenter detailed that all patients demonstrated sustained and clinically meaningful improvements in quality of life measures and venous functional assessment scored at 24 months.

In the abdominal aortic space, Andrew Holden, MBChB, of Auckland Hospital, Auckland, New Zealand) spoke on AAA sac sealing with the Impede-FX RapidFill embolisation plug (Shape Memory). He conveyed early data from the AAA-SHAPE early feasibility studies—prospective, multicenter investigations being conducted at two centers in New Zealand and three in The Netherlands. In the period September 2020–December 2021, 16 patients were treated for endovascular aneurysm repair (EVAR), Holden detailed, reporting a 100% technical success rate so far and concluding that AAA sac filling during EVAR with Impede-FX RapidFill may improve aneurysm sac regression and reduce endoleak. However, he stressed that these are preliminary data from an ongoing investigation and that continued studies with long-term follow-up are needed.

Finally, Ripal Gandhi, MD, of Miami Cardiac & Vascular Institute and Miami Cancer Institute, Miami, expanded on an interim analysis of the RESCUE trial presented by Akhilesh Sista, MD, of New York University School of Medicine, New York, at Vascular Interventional Advances (VIVA) 2021 (Oct. 5–7) in Las Vegas. The RESCUE trial is a multicenter, prospective single-arm clinical trial, which is evaluating the safety and efficacy of pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter, specifically in patients with intermediate-risk acute pulmonary embolism.

The interim analysis included 62 patients and showed a reduction in the right ventricular to left ventricular (RV/LV) ratio of 32.1%, at 48 hours. There was also a reduction in the thrombus burden, as measured by the Modified Miller index on the computed tomography (CT) scan of 36.3%, at 48 hours and no major bleeding or device-related adverse events.

“The new datapoints are that there was a 90% reduction in the number of totally occluded segmental pulmonary arteries, and a 72% reduction in the total, or subtotal occlusions by 48 hours, as measured on a CT angiogram. This is really remarkable, because when we look at this reduction, this treatment is quite striking, and has never been reported with any other treatment modality that we have seen yet for pulmonary embolism. In fact, the mean number of occluded segmental arteries per patient that decreased by 72.5%. The restoration of the pulmonary arterial blood flow, really should be an important goal for treatment, and has not really been evaluated well in other studies for acute pulmonary embolism to date,” Gandhi exclusively told Vascular News, a Vascular Specialist partner title.

Powell: Studies linking EVAR and cancer risk continue to mount

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Powell: Studies linking EVAR and cancer risk continue to mount
Janet Powell

Evidence continues to accumulate of a link between endovascular aneurysm repair (EVAR) and cancer, with even small amounts of radiation potentially converting epithelial cells “to a precancerous or a cancerous state in smokers or ex-smokers,” according to world-renowned vascular disease researcher Janet Powell, MD.

The Imperial College London, England-based professor of vascular biology and medicine was speaking on the increasing concern that emerged about 12 years ago over CT surveillance of endografts and the associated radiation burden this might contribute to patients.

Back in 2011, explained Powell before an audience of 2021 VEITHsymposium (Nov. 16–20) attendees in Orlando, Florida, she and colleagues were preparing “the very long-term follow-up” of the EVAR1 trial, which included testing a hypothesis that late cancer deaths would be higher in the group of patients treated with EVAR vs. those who received open repair.

Over an eight-year period, the team found no difference in the rate of cancer deaths between the two groups. Beyond eight years, however, “the rate in the EVAR group escalated to 4.2 per 100 person years. This was almost twice as much as in the open repair group,” said Powell.

A year later, she continued, another group in London showed that radiation also causes DNA damage in the lymphocytes of EVAR operators.

Another couple of years on, Powell explained, and an English population-based cohort study demonstrated that after seven years, the hazard ratio of all cancers was 1.09 in patients treated with EVAR vs. those undergoing open repair—“a significant difference, with a particularly significant difference for abdominal cancers.”

A year after that, she said, a study that emerged out of South Korea looked at a population who had undergone aneurysm repair after an initial diagnosis of cancer and showed that the patients treated with EVAR had “a much higher proportional death rate from cancer than those treated with open repair.”

“So now that’s three separate studies: increasing risk of cancer after EVAR,” Powell told VEITH 2021 delegates.

She then turned to the specter of patients who continue to smoke and EVAR treatment. “What’s the etiology? Actually, what have we forgotten?” Powell asked. “What we have forgotten is that the cancer risk of smoking and radiation are multiplicative and not additive. And the evidence of this comes from a variety of studies.” At the cellular level, Powell added, the damage to DNA from smoking increases over time. “When radiation hits, the damage to non-smokers’ cells is limited,” Powell said. “But it escalates to those who are still smoking to produce cancerous cells.”

Vascular Specialist–January 2022

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Vascular Specialist–January 2022

In this issue:

CSI announces development of IVL technology for the treatment of PAD

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CSI announces development of IVL technology for the treatment of PAD

Cardiovascular Systems (CSI) recently announced that it has made significant progress towards the commercialization of its intravascular lithotripsy (IVL) system for the treatment of calcific peripheral arterial disease (PAD).

A company press release notes that feasibility testing of a proprietary console and associated IVL balloon catheters is complete. The company’s IVL systems are designed to improve upon the limitations of incumbent technology, the release details, allowing physicians to cross and treat more challenging atherosclerotic lesions. CSI is also developing IVL technology to treat coronary artery disease (CAD).

Cardiovascular Systems’ peripheral orbital atherectomy devices are primarily used by physicians to treat long, diffuse calcified arteries below the knee. Introducing a peripheral IVL system to the company’s offering will expand its treatable patient population across an even broader spectrum of calcified arteries above and below the knee, the press release states. The company plans to begin first-in-human experience for the peripheral IVL system in calendar 2023.

Europe: ESVS publishes 2022 guidelines on management of chronic venous disease of the lower limb

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Europe: ESVS publishes 2022 guidelines on management of chronic venous disease of the lower limb

The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limb to update its 2015 recommendations. The document, authored by Marianne De Maeseneer, MD, a venous specialist at Erasmus Medical Centre, Rotterdam, The Netherlands, and colleagues, was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

The focus of the new guidelines, according to the ESVS, is on CVD of the lower limbs, related to pathology of the superficial, perforating and deep veins of the lower limb as well as to abdominal and pelvic venous pathology.

Compared with the 2015 version of the guidelines, the authors communicate that the global structure of the document has been modified considerably in an attempt to make it more practical and user friendly. In addition, they write that special subsections on management strategy with accompanying flowcharts have been added to the different chapters.

There are several new chapters in the 2022 document, addressing the management of patients with venous leg ulcers and of patients with varicose veins, related to underlying pelvic venous disorders, special patient characteristics and their potential influence on management strategy, and gaps in evidence and future perspectives.

De Maeseneer et al detail that five recommendations have been upgraded in the 2022 guidelines, covering the the treatment of varicose vein tributaries by phlebectomies, foam sclerotherapy or both; transcutaneous laser for treatment of telangiectasias; endovenous thermal ablation (EVTA) for treatment of small saphenous vein incompetence in preference to surgery and ultrasound-guided foam sclerotherapy (UGFS); surgical or hybrid deep venous reconstructions in patients with iliac vein outflow obstruction, suffering from a recalcitrant venous leg ulcer, severe post-thrombotic syndrome or disabling venous claudication; and multilayer or inelastic bandages or adjustable compression garments (≥40mmHg ankle pressure) for patients with active venous leg ulcers.

In addition, they note that three recommendations have been downgraded: post-procedural compression after UGFS or EVTA of an incompetent saphenous trunk; ultrasound-guided tumescent anesthesia for high ligation and stripping; and phlebectomies with preservation of the saphenous trunk (ambulatory selective varicose vein ablation under local anesthesia; ASVAL) for uncomplicated varicose veins.

New recommendations promote ‘appropriate and effective’ use of social media in medicine

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New recommendations promote ‘appropriate and effective’ use of social media in medicine
Nicolas J. Mouawad and Edward D. Gifford

In response to a rapid augmentation of social media use in medicine over the past five years, the Society for Vascular Surgery (SVS) has published a set of recommendations on appropriate practice. The document aims to provide guidance on “how to interact online in a transparent, collegial and ethical manner while all along protecting patient privacy,” Nicolas J. Mouawad, MD, chief and medical director of vascular and endovascular surgery at McLaren Health System, Bay City, Michigan, tells Vascular Specialist. In this interview, Mouawad, along with joint first author Edward D. Gifford, MD, of Hartford HealthCare in Hartford, Connecticut, outline the document’s key messages, detail how COVID-19 has “catapulted” the use of virtual communication, and consider how the use of social media in medicine might evolve moving forward.

VS: What are the key takeaway messages from the new recommendations document?

NW: The SVS is committed to supporting the appropriate and effective use of social media through honest, transparent and well-informed content. The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members in different practice patterns and employment models, geographic locations, cultural backgrounds and clinical experiences to help craft a document to help guide both novice and experienced users to the use of social media platforms in vascular surgery. Key takeaway messages in a nutshell are (1) absolutely protect patient privacy, (2) obtain consent when using and sharing images, (3) ensure you follow your institution’s requirements, (4) disclose conflicts of interest, and (5) maintain an amicable and professional online environment as there are multiple specialties involved in vascular care.

EG: Adding to that, social media is a great melting pot of different medical specialties. We have a lot we can learn from each other, and while we may not always agree on a case that is shared, we wanted to advocate for trying to find common ground where possible while avoiding ad hominem attacks or other cyber-bullying behavior.

VS: What do you think are the main benefits and drawbacks of social media in medicine?

NW: Social media is a powerful tool to disseminate information, educate patients and providers, and allow for exchange of ideas, resources and knowledge, literally at the recipient’s fingertips. However, with this great ability comes responsibility and accountability. I believe the main benefit is the ease of information transmission, and the ability to learn and network from other healthcare professionals that you may have never interacted with or been able to reach. The drawbacks in my mind are how to ensure the credibility of the information (to minimize the spread of disinformation) and the legitimate concern for breaching patient privacy. We must protect that at all costs!

EG: Social media can pull us out of our medical comfort zone. Often, new technology or procedures are limited to vascular surgery. For instance, at an endovascular-focused conference we might be exposed to novel therapeutic options. By comparison, how often do we find ourselves at a plastic surgery or orthopedic trauma conference? Social media brings data from those specialties that might be very relevant to our field right to our fingertips. Take for instance the use of pie-crusting to allow for delayed primary closure of fasciotomy incisions. This technique was popularized on social media by Yelena Bogdan, an orthopedic trauma surgeon. However, it has now been shared among many vascular surgeons on social media, and we in our group have even used it with success after learning about it online. The rapid dissemination of information, and the ability to interact with other specialists in real-time, can have a real positive impact on how we practice both the art and science of medicine. Of course, this is tempered with some legitimate drawbacks. First and foremost, in my opinion, is the risk to patient privacy. Just as the reach of social media goes well beyond that of a traditional lecture hall, so too does our use of an illustrative case run the risk of violating a patient’s privacy.

VS: Why do you think it was necessary to produce such a document and at this particular time?

NW: Vascular surgeons are at the cutting edge of new technology and devices, and are very tech savvy. It is no surprise to me that most are very active on social media already. The idea was borne of the Young Surgeons Committee of the SVS, and really was focused on providing guidelines on how to interact online in a transparent, collegial and ethical manner while all along protecting patient privacy.  In addition, I really do believe that COVID-19 catapulted our use of social media in an effort to maintain physical distancing and other public health parameters.    

EG: That is a great question, and I think it is important to keep in mind that the presence of vascular surgery and vascular surgeons on social media has changed a lot from when we first contemplated this document. The idea for this sprang from the Young Surgeons Committee. We noticed that more and more vascular surgeons were using social media, in particular Twitter. Personally, as a young member of that group, I was looking for some guidance about how to deal with some of the conflicts already mentioned. Could I share images of an interesting case? What is the best way to go about doing that? We also felt that social media was a great medium to interact with trainees and medical students who might be interested in vascular surgery, but maybe did not have access to a large vascular surgery interest group (VSIG) at their home institution. As COVID-19 encouraged online interaction for many of us, we felt that the SVS taking a positive stance on social media use was more important than ever.

VS: How do you think social media use in medicine has changed in the COVID-19 era?

NW: COVID-19 has forced us to practically move and live online. It has been very challenging in the beginning months but we have found that although we are socially distant, we have never been closer. The world has become even smaller, with all of us able to communicate with colleagues internationally and learn from them as they learn from us depending on what COVID-19 wave is occurring and where. Social media during the COVID-19 era allowed us to build new friendships and foster new relationships that continue strong. As a matter of fact, some of us on this social media writing group have actually never even met each other in person. We have communicated over social media and electronically to complete the guidelines and have e-met online.

EG: Almost two years into COVID-19, it is impossible to not have days where we feel isolated. A lot of this was heightened early in the pandemic when we could not rely on in-person meetings to connect with trainees, peers and mentors. Social media was a great forum to bring many of us together. Online, we have been able to interact with vascular surgeons and other healthcare workers from around the country and the world, and we have built some truly worthwhile connections along the way. I love seeing colleagues share everything from a new community initiative on limb salvage, to how to tackle large varicose veins after ablation, to Play-Doh vascular anatomy.

VS: How do you think the use of social media in medicine might evolve in the future?

NW: Social media will continue to evolve—there is no doubt in my mind about that. We have seen how meetings have moved into the virtual space, as well as full annual conferences. Applicants and interviews are being conducted this way nowadays for ease of access and cost savings, alongside online open houses for candidates. Even interest groups are becoming well developed in the online sphere. This, in my opinion, is an excellent opportunity to advertise to the younger generation and literally show them with images and videos our specialty.

EG: I think certain things adopted during the pandemic may be here to stay, at least in one form or another. Take for instance the virtual interview process of our residency and fellowship applicants. There will likely be some virtual component to application season in perpetuity. Whether this is a virtual open-house to
learn about a program, faculty vignettes, or online journal-clubs, I think we are going to see use of social media for these group endeavors increase. While I hesitate to say that we are going to be providing patient-specific medical care on social media, we are already seeing community education events via social media forums such as Facebook Live. The reality is that a lot of our patients use social media. If we want to provide factual education about vascular disease to them, social media might provide a lot of opportunity for that. Lastly, as we anticipate the intersection of social media and medicine growing, this may result in some form of oversight or regulation.

US IDE Aortic Research Consortium ‘pushes the envelope’ on F/BEVAR

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US IDE Aortic Research Consortium ‘pushes the envelope’ on F/BEVAR
Andres Schanzer in Paris

The U.S. investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer, MD, professor and chief of vascular surgery at the University of Massachusetts Medical School in Worcester, Massachusetts, claimed at Critical Issues in Aortic Endografting 2021 (Dec. 17–18) in Paris, France. As a result of the group’s work, “more patients are getting better care, by more providers, using F/BEVAR devices,” he remarked, summarizing key datasets presented since 2018.

The primary objective of the U.S. F/BEVAR Aortic Research Consortium (ARC), first conceived of in 2018, is to evaluate custom-made fenestrated and branched endovascular devices for the treatment of patients with complex abdominal, thoracoabdominal and arch aneurysms, Schanzer detailed. He noted that, currently, the literature includes primarily iterative, single-center reports, the findings of which “may be limited due to the potential for a type 1 error secondary to limited statistical power.” According to Schanzer, medical director of ARC, that is about to change, as the ARC includes prospective, physician-sponsored data from across 10 U.S. sites and is independently monitored and Food and Drug Administration (FDA) audited. Referencing an email he sent to investigators when initiating this effort in early 2018, Schanzer communicated: “If we are able to pull this off and figure out a way to aggregate our data in a relatively seamless way and work together as a team of investigators, I believe we have the potential to make a much more significant impact than multiple iterative, single-center reports.”

Key datasets highlight growing pool of evidence

Members of the U.S. F/BEVAR ARC have presented data on behalf of the consortium at several key conferences since 2018. The datasets started off small, Schanzer relayed. At the Society for Vascular Surgery (SVS) 2018 Vascular Annual Meeting (VAM) in Boston, for example, Emanuel R. Tenorio, MD, a postdoctoral researcher at the University of Texas Health Science Center at Houston, Houston, Texas, presented outcomes of endovascular repair of post-dissection and degenerative thoracoabdominal aortic aneurysms (TAAAs) using fenestrated and branched stent grafts. The study, which incorporated 240 patients, showed F/BEVAR to be safe and effective, with similar outcomes in patients with post-dissection and degenerative TAAAs, and also that patients with post-dissection had more type II endoleak during follow-up. Tenorio stressed that larger clinical experience and longer follow-up was needed to better evaluate differences in mortality, spinal cord injury, target vessel instability and secondary interventions.

At the same meeting, Schanzer recounted, Darren B. Schneider, MD, chief of vascular surgery and endovascular therapy at the University of Pennsylvania, Philadelphia, presented target artery outcomes after branched and fenestrated endovascular repair of pararenal aortic aneurysms and TAAAs in 661 patients. Schneider summarized that the selective use of fenestrations and directional branches for visceral artery incorporation is durable, that the risk of target artery instability is higher for renal versus mesenteric arteries, and that greater TAAA extent is associated with increased target instability. Future efforts, he informed the VAM audience, should focus on improving renal artery patency and reducing interventions.

Later that same year, Schanzer recalled that Carlos H. Timaran, MD, the Sam H. Phillips, Jr. MD Distinguished Chair in Surgery at University of Texas Southwestern, Dallas, Texas, gave evidence on the expanded use of preloaded branches and fenestrated endografts for endovascular repair of complex aortic aneurysms. Speaking at the 32nd European Society for Vascular Surgery (ESVS) Annual Meeting in Valencia, Spain, Timaran presented data on 564 patients, concluding that the expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with even higher technical success and lower early mortality.

Schanzer then looked back to the 2019 VAM in National Harbor, Maryland, where he presented results of F/BEVAR after failed infrarenal EVAR in 893 patients. He noted that F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes as compared to patients without prior EVAR, while differences in procedural metrics indicated higher level of technical challenge when performing F/BEVAR in patients with prior failed EVAR. The speaker concluded that F/BEVAR, at high-volume centers, is a viable option for the treatment of EVAR failure that compared favorably to historical reports of open conversion.

At the 33rd ESVS Annual Meeting in Hamburg, Germany, in 2019, Fernando Motta, MD, a vascular surgeon at the University of North Carolina, Chapel Hill, North Carolina, informed the audience that F/BEVAR is a safe and effective option for octogenarians in training complex aortic aneurysms compared to non-octogenarians, Schanzer detailed, outlining data from 893 patients.

Finally, Schanzer gave an overview of the largest U.S. IDE Consortium dataset so far—a study on sex-related outcomes after F/BEVAR for TAAAs involving 1,681 patients. Announcing the findings during ESVS Month in 2020, Matthew P. Sweet, MD, a vascular surgeon at the University of Washington, Seattle, revealed that women experienced higher rates of technical failure for extensive aneurysms, non-home discharge and postoperative sac expansion.

A turning point for fenestrated and branched procedures

Addressing the Critical Issues audience, Schanzer summarized that the U.S. F/BEVAR ARC is the largest dataset of fenestrated and branched procedures in the world, involving a core group of investigators “committed to improving patient care and pushing the envelope on endovascular therapies from the aortic valve to the common femoral artery.” The consortium is “an engine for exchange of ideas and promotion of F/BEVAR technologies,” the speaker continued, emphasizing his hope that the group’s work will have an impact not just in the U.S. but across the globe.

On a more practical level, Schanzer added, the consortium “offers infrastructure and a more agile regulatory pathway for testing emerging technologies to obtain preliminary data,” and also represents a departure from single-center reports. The project provides a framework in which to conduct randomized trials, Schanzer stressed, noting that the trajectory of F/BEVAR technologies has reached an “inflection point,” and that larger studies will henceforth reveal the direction of travel in this developing field.

Our forever plague

Our forever plague
Malachi Sheahan III

The following is a combined and revised version of the November and December 2021 editorials on fake news and science denial published in Vascular Specialist. Supplemental information and resources have been added to assist physicians in combating science denial and vaccine hesitancy during the COVID-19 pandemic. 

“The most effective way to destroy people is to deny and obliterate their own understanding of their history”

—George Orwell

In March 2019, the first wave of the COVID-19 pandemic hit an unprepared New Orleans hard. Hospitalizations and deaths soared unabated. But as the city had done so many times in the past, we came together. We took our medicine. Masks, social distancing, and shutdowns—bitter pills for a place where the economy is based on tourism and the culture is built on community. The city had survived worse. Fires and floods have destroyed the infrastructure here many times over. But like all great places, what makes New Orleans special isn’t the buildings—it’s the people. Resilience and rebirth are in their fabric. So the subsequent outbreaks of COVID-19 seemed self-limited. In Louisiana, we can teach our children the English alphabet from hurricane names and now the Greek alphabet from COVID-19 variants.

The Delta and Omicron waves, though, seem different, darker. The numbers are even greater. On Aug. 21, 2021, one in 1,500 Louisianans are hospitalized with COVID-19. The majority of these patients are unvaccinated. Children are getting sick at an alarming rate. Maybe this time we didn’t all come together. Some of us didn’t take our medicine. Everyone versus the virus started to seem like us versus them. During the first wave, we came together. We buckled down. Physicians retrained to help in the overwhelmed emergency rooms and intensive care units. Some became line teams, putting an endless number of patients on dialysis. We reused our personal protective equipment (PPE), storing our trusty N-95 masks in paper bags for unclear scientific reasons. We took near chemical showers to prevent bringing the virus home to our families. Some of us even learned to recognize that look in our spouse’s eye that said, “I am homeschooling three boys, do not ATTEMPT to complain about your day.” As doctors, though, we did our job. We really did our job.

Physicians need to delicately balance empathy and depersonalization to be effective. If the pendulum swings too far in one direction, our patients suffer, as will we along with them. What happens to our well of empathy when the disease we are facing is entirely preventable? Our actions—which felt heroic at the start of the pandemic—now seem futile. These new deaths were avoidable, so somehow even more tragic. Conspiracy theorists claim the original COVID-19 virus was man-made; well, these endless variants certainly are.

More people in the U.S. died of COVID-19 in the year after the vaccine was approved than in the year before. As of Nov. 30, 2021, 59% of Americans are fully vaccinated. We are 60th in the world. It is a public health catastrophe that was almost entirely preventable. Too often, science and medicine have become matters of opinion, of personal belief. There are solutions to this infodemic, but not all are intuitive.

The truth hurts, but the lies are killing us.

“Tyranny of Doctorcraft!!! Do not be alarmed by the small-pox. Vaccination does cause loathsome and often fatal diseases”

—Excerpts from anti-vaccination pamphlet authored by Alexander M. Ross, MD, in 1885

Science denial is nothing new. We have seen it from the tobacco industry, fossil fuel companies, and even electronic health record (EHR) vendors. Their stance is easy to understand. Create doubt and block consensus. When “the jury is still out,” profit follows. What about science denial that serves no apparent benefit? What about when it is harmful or even fatal? The rise of misinformation during the COVID-19 pandemic has been so widespread that the World Health Organization (WHO) labeled it an “infodemic.” To combat the disinformation, physicians need to lead. In the office, in the community, even on social media. Our medical societies need to unite in this process. The American Medical Association’s own House of Delegates directed their organization to collaborate with other specialty groups to combat public health disinformation. But first, we need to understand where the distortions are coming from and why so many people believe them. And then perhaps the most significant test: How do we convince the doubters?

“Standard gargle, mouthwash, has been proven to kill the coronavirus”

—Sen. Ron Johnson (R-Wis)

Our society is overrun with pseudoscience. Chiropractors, holistic healers, and herbalists promote dubious benefits. Homeopathy claims efficacy through quantum physics (?!). Colonics provide a strikingly unpleasant example of the trust some will place in fake remedies. Think of the “male enhancement” industry, with regular national TV ads featuring celebrities and retired athletes. These ginkgo biloba delivery agents can’t actually promise any specific results, so they are given pornographic names like Malestrom, Lengthergize and others that can’t be mentioned in a family publication like Vascular Specialist. At the start of the pandemic, much of this pseudoscience seemed quaint or silly, but now thousands are dead.

Table 1: How to spot misinformation

As information gains new pathways, so does misinformation. Fake news is as old as the news itself. Thomas Jefferson once lamented: “Nothing can be believed which is seen in a newspaper. Truth itself becomes suspicious being put into that polluted vehicle.” Jefferson didn’t have to look too far for evidence. Co-Founding Father Benjamin Franklin would frequently write fabricated accounts of murderous Indians working with the British troops. Fake news has always been profitable. In 1835, The New York Sun published a popular series about an alien civilization on the Moon. More recently, journalist Craig Silverman discovered that 140 popular fake news sites all emanated from a small city in Macedonia. Here, a bunch of teenagers were getting rich publishing stories with headlines like “Obama’s Ex-Boyfriend Reveals Shocking Truth That He Wants To Hide From America.”

As information gains new pathways, so does misinformation

Traditional media coverage can be skewed even while factual. Think of the focus on anti-maskers and anti-vaxers, even though both healthcare measures have broad support among the population. While the most shared story on Facebook from January to March 2021 concerned whether the vaccine had led to the death of a single physician, more than 3,600 healthcare workers died of COVID-19 during the first year of the pandemic.  The press seems especially interested where vaccines fail. Think about how often we learn precisely how ineffective the annual influenza vaccine is, versus how many lives it saves. Of course, fake news can’t spread without an audience. In 1620, Francis Bacon wrote that one of the main barriers to learning the truth was that humans are more likely to believe facts that fit our preconceived notions—a psychological phenomenon we now refer to as confirmation bias. As social groups form and need to feed their preconceived notions, an ecosystem develops to provide this material for profit.

Social beasts

It is often said that humans are social animals. So much so that those who eschew community are labeled with a psychiatric diagnosis (Avoidant Personality Disorder, ICD- 9 301.82). But the need for a group can be pathologic as well. Humans fear social death more than actual death. Shame and embarrassment are two of the most powerful emotions. Suicide bombers, the tragedy at Jonestown, and the Japanese tradition of seppuku are just some examples of individuals choosing physical death over social.

Our communal groups are defined more than ever by social media. Former Facebook manager Tim Kendall testified to Congress that his company “took a page from Big Tobacco’s playbook, working to make our offering addictive from the outset.” He stated that they used the term engagement as a euphemism for the addictive properties of the medium. “The social media services that I and others have built over the past 15 years have served to tear people apart with alarming speed and intensity.” While tearing some apart, social media can also build powerful social groups. So strong are these connections that their members would rather risk death than expulsion.

For some groups, vaccine hesitancy is ingrained. In Native and African Americans, we reap the consequences of our historical sins. Other groups argue that mask and vaccine mandates are threats to “American Freedom”—a claim also used by the tobacco companies against government regulation of their product. So while Patrick Henry exclaimed, “Give me liberty, or give me death!” in 1775, in 2021, they can come as a package deal.

“Let us tell the American people—smokers and non-smokers—that the real issue is freedom of choice. Once the government can control our smoking behavior it can turn the thumbscrews and control other behavior as well”

—Statement of H.R. Kornegay, President, The Tobacco Institute, at the 19th Annual Meeting  of the Tobacco Growers Information Committee, Oct. 14, 1977

Indeed, once the pandemic became political, it seemed that we were doomed. Research from the University of Strathclyde in Glasgow, Scotland, by Stephanie Preston et al demonstrated that individuals are more likely to believe a fake news story if they have personal experience with the subject matter or if the report confirms one of their preconceived opinions. Stories that uncover a “hidden problem” or use numeric graphs are particularly effective. The researchers also found that emotional intelligence was protective. This is a key finding because emotional intelligence can be learned.

One simple trick can tone your abs and identify fake news!

Clear communication and instructions are a cornerstone of public health, but as the battle over the pandemic became political, the waters were muddied. One official who kept a sound, consistent message was Jennifer Avegno, MD, director of the New Orleans Health Department. Folksy at times, “Wash your hands like you just ate crawfish and you need to take your contacts out,” but never failing to keep a coherent dialog. “People who continue to refuse to take the lifesaving COVID vaccine are now also putting the entire community in jeopardy.” Avegno’s efforts led to a higher than the national average vaccination rate in New Orleans. We also became the first city in the U.S. with a proof-of-vaccination or negative COVID-19 test requirement for indoor bars and restaurants.

U.S. vaccination rates lag behind dozens of countries

When I asked Avegno about techniques for reaching the vaccine-hesitant, she told me, “It really depends on why they’re hesitant. Some people just want to talk to a trusted medical professional who will answer their concerns calmly and without judgment. Others need myths they’ve read on the internet debunked, though that’s really hard to do. I think the majority of people who are left unvaccinated now are afraid but don’t even know why, or are so far down a political rabbit hole that there’s little you can say to change their minds.”

In its quixotic quest for objectivity, the mainstream media often confuses the public with “both sides” reporting. So while 97% of climate scientists believe in anthropogenic climate change, only 55% of the U.S. adult population are aware that consensus has been achieved. It is common practice for the media to deliver the opinions of dissenting scientists and physicians as if they were experts, even if their expertise is in another field. Mark McDonald, MD, a consultant to Florida Gov. Ron DeSantis, was quoted as saying ivermectin was an “effective, safe, inexpensive treatment” for COVID-19. McDonald is a child psychiatrist. Scott Atlas, MD, was an advisor to the president of the United States, faculty at Stanford, and a fellow at the Hoover Institution.

In April 2020, Atlas said: “We can allow a lot of people to get infected. Those who are not at risk to die or have a serious hospital-requiring illness, we should be fine with letting them get infected, generating immunity on their own, and the more immunity in the community, the better we can eradicate the threat of the virus.” Atlas has no training in infectious disease; his expertise is in magnetic resonance imaging. In fact, his lack of relevant knowledge and experience was so egregious, it was called out by dozens of his former Stanford colleagues as well as Richard Baron, MD, the president and CEO of the American Board of Internal Medicine.

Understanding science

In searching for dissenting opinions, the media often amplifies the voices of the uniformed. Some call it the death of expertise. Much like the one-out-of-five dentists who does not recommend sugarless gum for their patients who chew gum, contrarians can always be found. In my own household, there is an extremely vocal faction that believes Squid Game is appropriate viewing for 12- and 9-year-olds. Fortunately, since this faction is comprised solely of 12- and 9-year-olds, they receive very little publicity.

“You are not a horse. You are not a cow. Seriously, y’all. Stop it”

—8/21/21 Tweet from FDA regarding Ivermectin use

Too often, the media portray science in absolutes, as offering proof. But math is based on proof; scientists continually collect evidence and refine hypotheses. As time goes on, science improves. While we initially hypothesized that the airborne transmission of COVID-19 was unlikely, subsequent evidence contradicted this belief. Therefore the Centers for Disease Control and Prevention (CDC) issued new guidance, and our knowledge evolved. As reported in the media, however, this seemed scattershot and led to an erosion of confidence in science.

Fake news sources have flourished as traditional vehicles fail. Recognizing misleading or false stories is a skill that can be learned, but the tell-tale signs may be more subtle than a generous offer from a foreign monarch. Clickbait often proposes “One simple trick” or something “You won’t believe.” Here’s some fun, generate your own clickbait:

  1. Start with some digits
  2. Add a gerund (a continuous form of a verb)
  3. And then some superlative adjectives like cutest, best, and most unbelievable.

Here’s mine: 23 reasons why reading Vascular Specialist will give you the hottest body! OK, your mileage may vary, but by learning how to create fake news, you also learn to recognize it. False stories arise too quickly and spread too far to debunk in real-time. So psychologists at the University of Cambridge came up with a way to pre-bunk them. They developed an online game called Bad News. In it, the user creates a fake news site and learns the six different techniques commonly employed: impersonation, emotional exploitation, polarization, conspiracy, discredit, and trolling. In a controlled trial, the researchers found that individuals who played the game demonstrated a significant increase in their ability to detect fake news items.

Since over 40% of U.S. adults report getting their news from Facebook, instilling emotional intelligence in our population is imperative to mitigate the fallacies of fake news. One such program, already in schools, is called social-emotional learning (SEL). SEL curricula emphasize critical thinking, emotion management, conflict resolution, decision-making, and teamwork. A 2011 meta-analysis of 213 SEL programs comprising over 270,000 students demonstrated an increase in academic performance and a decrease in adverse neurologic symptoms such as anxiety and depression. The concept of SEL is not new. Benjamin Franklin created the first system in the 1700s. For decades, these programs have existed in all 50 states with widespread bipartisan support. Recently, however, organizations such as Parents Defending Education have tried to turn them into political footballs. Taking issue with standards such as “I can make ethical decisions about when and how to take a stand against bias and injustice in my everyday life or community,” the group has accused SEL programs of being vehicles for social justice activism. By politicizing SEL programs, these advocacy groups threaten our best defense against the rising wave of anti-science disinformation campaigns.

Psychologists have demonstrated that the actions of elite cues and advocacy groups affect the gap between scientific and public consensus on many issues. In 1956, Elvis Presley was publicly inoculated with Salk’s polio vaccine on the set of the Ed Sullivan Show. At that time, the vaccination rate among American teens was 0.6%. In the next six months, 80% of US teens would follow his elite cue and join Elvis among the vaccinated. Today, perhaps no one has the cultural reach of Elvis, but we need to find influencers who can push public health measures and create safe social norms in this pandemic. This is why it was a big deal for Louisiana Republican Rep. Steve Scalise to endorse the vaccine publicly; he serves as an elite cue to many conservatives. If nothing else, we need to counter the overhyped media coverage of vaccine skepticism among certain NFL players, and past and present celebrities (say it ain’t so Busta Rhymes!).

Luke, age 6—vaccine skeptic

When contemplating how to approach my vaccine-hesitant patients, I considered the almost automatic method in which they are delivered in our pediatrician’s office. Truth be told, I used to think my kids got vaccines essentially every visit. The reality was my wife maintained the vaccination schedules imprinted in her memory with Terminator-like accuracy. When the visit calls for a shot, she becomes “busy,” and I step in. This statistical improbability occurred suddenly to my youngest on a drive to the doctor’s office one afternoon. The kids were in the joyous merriment reserved for Christmas, Disney trips, and days they get to leave school early. Suddenly Luke looked up and said, “Wait a minute, why is DADDY driving us to the doctor?” Dread quickly replaced the festive atmosphere of the back seat of my car. Someone, or (oh God), someones were getting the jab. Think about how a pediatrician’s office conducts this process. The doctor doesn’t say, “It looks like Luke has some vaccine hesitancy. Perhaps he would like to hear me debunk Andrew Wakefield’s 1998 Lancet article, which falsely linked the MMR vaccine to autism?” Instead, vaccinations are treated as the social norm. Presumptive language is employed, “Today, Luke is getting his polio and varicella vaccines.”

As physicians, we can help our vaccine-hesitant patients, friends, and family members, but, too often, we use the wrong technique. Doctors frequently engage in a method of debate called topic rebuttal. This is how we discuss and deliberate papers with our peers at scientific meetings. Topic rebuttal is conducted through fact-based counterarguments. This process, though, is only effective in good faith arguments where both sides are open to learning. Lecturing, shaming and ostracizing are also wildly ineffective methods for changing firmly held opinions, usually only serving to entrench your subject further. The fake news complex is well developed and (ironically) very scientific in its approach. Most physicians have not learned useful modes of persuasion. Our attempts often backfire.

Establishing trust

In 350 B.C., Aristotle identified the three rhetorical appeals, Logos (logic), Ethos (credibility) and Pathos (emotion). Aristotle described Pathos as almost a cheat code, effective for overruling reason and logic. Most science deniers don’t necessarily lack information, but they almost always lack trust. To override the emotional connection to their beliefs, we must employ patience and empathy.

“It really had a lot to do with what we thought people would be able to tolerate”

—CDC Director Rochelle P. Walensky on why the isolation period was shortened to five days

Motivational interviewing is a collaborative, goal-oriented style of communication that has even shown efficacy in one of the most challenging clinical scenarios— physical addiction. When using this technique with the vaccine hesitant, it is essential not to ask why they don’t want the vaccine. That only reinforces their negative feelings. It is better to start with, “On a scale of one to 10, how motivated are you to vaccinate?” If they answer anything other than one, focus the discussion on why they didn’t pick a lower number. This highlights their positive feelings towards the vaccine. The conversation can then be guided by technique rebuttal in which you discuss the standard methods science deniers use to mislead. These commonly include cherry-picking evidence, creating impossible expectations, conspiracy theories, false logic, and fake experts. Reviewing these practices also serves to indoctrinate against further susceptibility to bogus claims. Another key component of technique rebuttal is non-judgmental empathetic listening. The goal is to find your subject’s reasons for hesitancy and bounce them out of a rationalization loop. People who answer one on the motivation scale are in a precontemplation state. Thankfully, this is relatively rare. In studies of parents who oppose childhood immunizations, only 3% were in a precontemplation state.

Table 2: The standard techniques of science denial

There are many reasons why someone might not be open to persuasion. Feeling threatened or hopeless are the most common. An interesting method for communicating with people in a precontemplation state is Street Epistemology. The goal of this process is not to change the other person’s mind entirely but to shift their confidence in their belief. Here is a simplified version of the method:

  1. Build rapport (Ethos)
  2. Identify the claim your subject is making
  3. Confirm to them that you understand the claim
  4. Clarify the terms your subject is using (e.g., mind control, politics, microchip)
  5. Identify their confidence level in their claim
  6. Identify your subject’s methods for arriving at their confidence level
  7. Ask questions to determine if their techniques and sources are sound

Whatever system of persuasion you employ, the goal is to open your subject to an ambivalent position—one where a good faith discussion can be had. Remember, people in certain groups not only don’t care about your approval, they actively don’t want it. Consequently, it is easier to convince some individuals to get the vaccine than wear a mask. A vaccine can be obtained in secret, while wearing a mask can lead to ostracization by their social group.

Consider your faith in the vaccines. Is it based on reading every page of the Food and Drug Administration (FDA) reports? More likely, you believe because the people you have confidence in—people like you—believe. It is improbable you can convince the vaccine hesitant to trust these same people. But with effort and the proper approach, you might be able to get them to trust you.

“There is a certain movement to insist that now everyone must be vaccinated against the coronavirus COVID-19, and even that a kind of microchip needs to be placed under the skin of every person, so that at any moment, he or she can be controlled regarding health and regarding other matters, which we can only imagine as a possible object of control by the state”

—Catholic Cardinal Raymond Burke

References

  1. Preston S, Anderson A, Robertson DJ, Shephard MP, Huhe N. Detecting fake news on Facebook: The role of emotional intelligence. PLoS One. 2021 Mar 11;16(3):e0246757
  2. Fleming N. Coronavirus misinformation, and how scientists can help to fight it. Nature. 2020 Jul;583(7814):155–156.
  3. Caulfield T. Pseudoscience and COVID-19—we’ve had enough already. Nature. 2020 Apr 27.
  4. https://www.niemanlab.org/2019/06/yes-its-worth-arguing-with-science-deniers-and-here-are-some-techniques-you-can-use/
  5. https://www.scientificamerican.com/article/to-understand-how-science-denial-works-look-to-history/
  6. https://www.nytimes.com/interactive/2021/05/20/opinion/covid-19-vaccine-chatbot.html
  7. https://www.theguardian.com/books/2019/nov/22/factitious-taradiddle-dictionary-real-history-fake-news
  8. https://www.bbc.com/news/blogs-trending-42724320
  9. https://www.politico.com/magazine/story/2016/12/fake-news-history-long-violent-214535/
  10. https://www.americanpurpose.com/articles/a-short-history-of-fake-news/
  11. Preston S, Anderson A, Robertson DJ, Shephard MP, Huhe N (2021) Detecting fake news on Facebook: The role of emotional intelligence. PLoS ONE 16(3): e0246757. https://doi.org/10.1371/journal.pone.0246757
  12. Lewandowsky S, Pilditch TD, Madsen JK, Oreskes N, Risbey JS. Influence and seepage: An evidence-resistant minority can affect public opinion and scientific belief formation. Cognition, Volume 188, 2019, Pages 124–139
  13. https://popular.info/p/the-new-bugaboo
  14. https://www.scientificamerican.com/article/how-elvis-got-americans-to-accept-the-polio-vaccine/
  15. Fackler A. When science denial meets epistemic understanding. Sci & Educ 30, 445–461 (2021)
  16. https://www.nature.com/articles/d41586-021-02152-y
  17. https://www.niemanlab.org/2019/06/yes-its-worth-arguing-with-science-deniers-and-here-are-some-techniques-you-can-use/
  18. https://www.scientificamerican.com/article/to-understand-how-science-denial-works-look-to-history/
  19. https://www.nytimes.com/interactive/2021/05/20/opinion/covid-19-vaccine-chatbot.html

Malachi Sheahan III, MD, is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans. He is medical editor of Vascular Specialist.

Deadlines near for slew of awards, honors

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Deadlines near for slew of awards, honors
A couple of key awards deadlines have been extended

It’s awards season at the Society for Vascular Surgery (SVS) and the SVS Foundation, with deadlines in January, February and March for many awards and honors—and two have been extended.

“These awards honor both the past and the future,” said SVS President Ali AbuRahma, MD. “Our SVS awards recognize those who have contributed not only to our Society but also to our specialty. Our research awards, meanwhile, recognize those working to affect the future, to forward new treatments to impact the course of vascular disease.”

January includes the SVS Foundation VRIC Trainee Award, now due Jan. 19. This award recognizes trainees in general surgery or vascular surgery who are conducting basic and translational research projects. Authors of four top-scoring abstracts will be invited to present their research at VRIC.

The second month of the year sees the SVS Foundation Resident Research Award deadline come due on Feb. 1, another extension. This prestigious award recognizes trainees—in general surgery or vascular surgery—who are performing basic and translational research under the guidance of a vascular surgeon-scientist mentor. The trainee presents his or her research from the podium during a plenary session at the Vascular Annual Meeting (VAM).

Also in February, the SVS Foundation Student Research Fellowship deadline falls on Feb. 1. The award supports undergraduate and medical students at universities in the United States and Canada who are conducting laboratory or clinical vascular research projects.

Meanwhile, the SVS Excellence in Community Service Award is also due Feb. 1, honoring members who have exhibited outstanding leadership within their communities as a practicing vascular surgeon. This includes those who practice in outpatient-based facilities. Email [email protected] with questions.

Elsewhere, applications are due March 1 for several awards, including some of the Society’s most prestigious honors.

SVS Awards

The SVS Lifetime Achievement Award, the highest honor the Society bestows on a member, is among the deadlines on the first day of March. This recognizes an individual’s outstanding and sustained contributions to the professions and SVS, and their exemplary professional practice and leadership. The most recent recipient was Robert Smith, MD, of Georgia (in 2020), who was honored at the 2021 Vascular Annual Meeting.

March 1 also includes the deadline for the Medal for Innovation in Vascular Surgery, which honors an individual whose contribution has had a transformative impact on the practice or science of vascular surgery. The most recent recipient was venous surgery pioneer Robert Kistner, MD, in 2019.

SVS Foundation Awards

Over at the SVS Foundation applications for Clinical Research Seed Grants, providing $25,000 in direct support for pilot clinical projects that could potentially become larger studies funded by industry or government sources, are due March 1. Examples include pilot clinical trials, studies on the natural history of vascular disease, pathophysiology or mechanisms underlying success or failure of vascular interventions; application of quality-of-life, functional status and resource utilization measures to assess the impact of vascular interventions; development and validation of clinical risk-prediction models or diagnostic tools and studies addressing the nature of disparities in care and outcomes.

In addition, applications and nominations for the SVS Distinguished Fellow designation also are due March 1. This designation goes to Active, International or Senior members who are vascular surgeons and who have made substantial contributions in two of the three categories of research, service and education. Visit vsweb.org/DistinguishedFellow for more information.

For award information visit vascular.org/Awards or vascular.org/SVSFoundationAwards.

FDA issues updated safety communication on use of Endologix AFX endovascular grafts

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FDA issues updated safety communication on use of Endologix AFX endovascular grafts

The Food and Drug Administration (FDA) has issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from a November 2021 meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee. In addition, the FDA announced that it is providing new recommendations to healthcare providers who treat patients with abdominal aortic aneurysms (AAAs) using the Endologix AFX2 device, the currently available AFX product.

“Based on the available data and advisory committee input, the FDA recommends that healthcare providers consider using available alternative treatment options for AAA patients rather than the AFX2 device,” an FDA statement reads. “The FDA emphasizes the importance of at least yearly, lifelong follow-up with a healthcare provider for all patients who have had their AAA treated with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) to monitor for type III endoleaks.”

The safety communication provides:

  • Recommendations for patients with AAAs treated with any AFX endovascular graft or considering treatment with AFX2
  • Recommendations for healthcare providers who treat and follow patients with AAAs
  • Background on the issue and the FDA’s actions to address the issue
  • Instructions for reporting problems with Endologix AFX endovascular AAA graft systems to the FDA

VAM travel scholarship applications available this month

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VAM travel scholarship applications available this month
Many attendees took part in the resident and medical student reception at VAM 2021 in San Diego

Medical students and general surgery residents will be able to apply this month for travel scholarships to attend the 2022 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM)—with the application period opening toward the end of the month. The meeting will be June 15–18 in Boston.

SVS offers the SVS General Surgery Resident/Medical Student VAM Travel Scholarship and the SVS Diversity Medical Student VAM Travel Scholarship. Each provides a travel award to underwrite expenses to attend VAM, as well as complimentary meeting registration, a mentorship program and a dedicated educational and networking program.

Diversity scholarship winners also will participate in the Meet the Leaders Luncheon with members of the SVS Leadership Development and Resident and Student Outreach committees and mentors. Priority will be given to those who have not previously received any type of SVS travel scholarship and have not already matched into a vascular surgery training program.

Students who live in the Boston area will not receive the travel award portion of the scholarship but are eligible to participate in the program. Students and residents may apply to each program but are eligible to receive only one award per year.

“These scholarships provide medical students and general surgery residents the opportunity to explore vascular surgery as a career choice,” said Bernadette Aulivola, MD, chair of the SVS Resident and Student Outreach Committee (SROC), which helps oversee the scholarship award process.

“Attending VAM as a student is sometimes the first step toward becoming a vascular surgeon,” said RSOC Co-chair Cassius Iyad Ochoa Chaar, MD. “For students already interested in the field of Vascular Surgery, the experience can provide important affirmation of the decision.”

Aspiring applicants are encouraged to keep an eye on their email inboxes and/or social media for the opening date. More information is available at vascular.org/VAMTravel1 and vascular.org/VAMTravelDiversity.

2012 scholarship recipients discuss the experience

Julia D. Glaser, MD, a fourth-year medical student when she attended the 2012 VAM, is now an academic surgeon within the University of Pennsylvania Health System. “The opportunity to go to VAM as a medical student exposed me to the welcoming community that is vascular surgery,” she said. “The meeting highlighted advances in the specialty with an interesting and engaging program, and I was able to meet medical students as well as trainees and attendings from other parts of the country.”

Matthew Wooster, MD, attended 10 years ago as a fourth-year medical student who had just matched into an integrated vascular program. He’d already decided on vascular surgery, with camaraderie amongst vascular surgeons something he experienced and appreciated even before that annual meeting. That, he said, “definitely attracted me to the field over, say, CT surgery or interventional cardiology.”

“VAM itself was particularly helpful for re-establishing connections with many of the students I saw along the applicant trail and have remained friends with to date, as well as with re-connecting with faculty I met at various programs” he said. I have stayed in touch with them and often reach out to even now whether to participate in national committees or most recently, for career help.”

“Attending VAM as a travel scholarship recipient was important in reinforcing my decision to pursue vascular surgery,” said Doug Jones, MD. “As a general surgery resident, I had enough exposure to the field that I felt a strong affinity to the patient and procedures; I also had very strong mentorship in medical school and residency.

“It was attending VAM, though, that crystallized a few important aspects of the field. As a smaller subspecialty, there is a lot of camaraderie among vascular surgeons and everyone is invested in each other’s success.  I felt very welcomed and was encouraged by all to continue on my path.”

SVS PAD course postponed

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SVS PAD course postponed

The new Society for Vascular Surgery (SVS) Peripheral Arterial Disease (PAD) Skills Course has been postponed amid the COVID-19 pandemic recent surge in cases, the Society has announced.

The course—which had been set to run Feb. 11–12—will now take place in August this year, with the specific date to be determined by the end of January.

“While this decision was not made lightly, the health and safety of our members and learners remains our top priority,” the SVS said in statement. “If you were registered for the course, there is a necessary action item for you—please check the email you used when registering for the course.”

The course contains education pertinent to the vascular surgeons, with the expert faculty committed to teaching the course once case numbers have reduced, the Society added.

The SVS asks that questions regarding the course be directed to the Society’s Education Team at [email protected].

Hospital wins battle against time for one patient’s aortic emergency

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Hospital wins battle against time for one patient’s aortic emergency
TAAA rupture, though uncommon, is recognized as one of the most complex aortic emergencies to treat

This advertorial is sponsored by Tampa General Hospital.

Aortic emergencies, if not diagnosed and managed in due time, are, of course, life threatening. Responding to them effectively requires the rapid activation of a complex health ecosystem. Even when these responses are done well, the healthcare team must still battle against unfavorable mortality odds.

Such was the case in Florida, when a patient was found down in his home, pale and diaphoretic. The EMS team, unable to obtain a blood pressure, initiated resuscitation efforts and transferred him to a community hospital in the area. There, a computed tomography (CT) angiogram of the chest, abdomen and pelvis with contrast confirmed that the patient was suffering a ruptured fusiform thoracoabdominal aortic aneurysm (TAAA), a diagnosis the hospital recognized needed specialty care they were not equipped to offer.

A TAAA occurs when the abdominal aorta bulges from the chest into the abdomen. Left undetected and untreated, TAAA can expand beyond its normal limits and will rupture, causing uncontrolled bleeding. TAAA rupture, though uncommon, is recognized as one of the most complex aortic emergencies to treat. Each hour of delayed care increases the already staggering 80% mortality rate by an additional 1–2%, and usually results in death. So emergent are these cases that some health care organizations, like Tampa General Hospital, have crafted comprehensive policies to coordinate care and guide care teams for rapid, effective responses.

Murray Shames

In short, the patient needed the support of a Level 1 trauma center and the aortic specialization they offer. So, the care team contacted the Tampa General Hospital (TGH) Transfer Center, their aortic team, and a vascular surgeon, who requested the patient’s CT scan be transferred immediately. The vascular surgery aortic team reviewed the study to determine that they could in fact treat this emergent case.

With imaging in-hand in real time, not only was the aortic team able to confirm that they could accept the patient, they began their operative planning right away. While the patient was en route to Tampa General Hospital, his new care team got busy in a hurry—evaluating the possible repair options and preparing the cardiovascular operating room. In addition, the aortic surgical team studied the patient’s medical images to determine if endovascular surgery was an option to repair his aneurysm. When the patient arrived at Tampa General Hospital via medevac, his surgical team was ready for him.

The Society for Vascular Surgery (SVS) ruptured abdominal aortic aneurysm (rAAA) algorithm recommends that a patient be emergently evaluated and have intervention started within 30 minutes of arrival at the specialty surgical center.

The patient’s door-to-cardiovascular operating room time was 10 minutes. The patient’s operation lasted approximately five and a half hours, and he spent 28 days in the ICU recovering from this surgical emergency. To survive an aortic emergency such as this one, every second counts. More, it requires a multidisciplinary, integrated team approach ranging from imaging, radiology and superior technologies to the physicians, surgeons and nurses who care for the patient. All of these disciplines came together around a well-executed plan at Tampa General Hospital, which saved this patient’s life, and saves the lives of other TGH patients every day.

“I am incredibly proud of our aorta team. Managing complex aortic pathologies is why we are here. We are committed to providing comprehensive, multidisciplinary care using the most advanced technology available,” said Murray Shames, MD, associate director of the TGH Heart and Vascular Institute and director of the Aorta Center, professor and chief of vascular surgery at the University of South Florida (USF) Health Morsani College of Medicine, and the 2020–21 Association of Program Directors in Vascular Surgery (APDVS) president.

Deadlines near to submit VRIC and VAM abstracts

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Deadlines near to submit VRIC and VAM abstracts
VRIC and VAM abstract deadlines are approaching

Abstract submissions for possible presentation at the 2022 Vascular Research Initiatives Conference (VRIC) and the 2022 Vascular Annual Meeting (VAM) in Boston are due Jan. 11 and Jan. 12, respectively.

Submissions for VRIC, which emphasizes basic and translational vascular science, are due by 6 p.m. Central Time Jan. 22. Submissions are being accepted through the American Heart Association (AHA) Vascular Discovery 2022 abstract portal (vascular.org/SubmitVRIC22). Those submitting will first need to create a free AHA account or sign in with existing credentials. The non-refundable $49 allows researchers to submit one abstract for each meeting.

VRIC will be held May 11 at the Sheraton Grand Seattle in Seattle, the day before and in the same location as the AHA Vascular Discovery sessions (May 12–14).

Abstracts for VAM 2022 are due by 3 p.m. Central Time Jan. 12. Abstracts will be presented in plenary sessions, the Vascular and Endovascular Surgery Society (VESS) spring meeting, International Fast Talk, International Young Surgeon Competition and three poster sessions, including the International Poster Competition, Poster Competition and Interactive Poster Session.

Videos will be accepted for plenaries and the “How I Do It” program. Learn more, including submission policies and guidelines, at vascular.org/VAM.

VIVID study on Duo venous stent system now fully enrolled, Vesper Medical announces

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VIVID study on Duo venous stent system now fully enrolled, Vesper Medical announces

Vesper Medical recently announced the completion of enrollment in its pivotal study—VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system).

VIVID enrolled its 160th patient earlier this month, marking completion of enrollment in the trial. VIVID is a prospective, multicenter, single-arm study to evaluate the safety and efficacy of the Vesper Duo stent system in the treatment of patients with iliofemoral occlusive disease.

The Vesper Duo stent system is designed to be the next generation venous stent technology, uniquely engineered to address the challenges of deep vein obstruction, a press release details. The modular portfolio is intended to provide physicians clinical versatility with both the Duo-Hybrid and Duo-Extend stent options in a full range of lengths and diameters to customize therapy for each patient depending on their specific disease location within the iliofemoral vein.

“I would like to thank all of the investigators and their teams for the commitment, skill and hard work they brought to the VIVID trial. This has been a tremendous team effort that will ultimately benefit the millions of patients who suffer today with chronic venous insufficiency [CVI],” said Mahmood Razavi, MD, director of clinical trials at St Joseph Heart and Vascular Center in Orange, California, and principal study investigator.

The VIVID trial is a global study designed to enroll 160 patients at centers in the U.S. and Europe. It will assess freedom from major adverse events at 30 days post-procedure and primary efficacy of the stented segment at 12 months. Patients enrolled in the study will be followed for three years.

‘Meet the Experts’ webinars now available OnDemand

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‘Meet the Experts’ webinars now available OnDemand
Three “Meet the Experts” webinars are now available on SVS OnDemand

Society for Vascular Surgery (SVS) members now have another chance to “Meet the Experts,” via computer screen and at no charge.

Three of the “Meet the Experts” webinars held in spring and summer are now available on SVS OnDemand, part of the Society’s online education platform.

These one-hour recordings include hemodialysis access aneurysms, type II endoleak prevention and management, and advanced techniques for inferior vena cava (IVC) filter removal.

Members have free access to these videos, each carrying 1 AMA PRA Continuing Medical Education (CME) credit. Non-members pay $35. Visit SVSOnDemand.vascular.org.

VESS: A society primed for young vascular surgeons, trainees and medical students

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VESS: A society primed for young vascular surgeons, trainees and medical students

Welcome to December where the calendar is filled with abstract and registration deadlines to various meetings through the summer of 2022. In this month‘s column, we are highlighting the Vascular and Endovascular Surgery Society (VESS). Formerly known as the Peripheral Vascular Surgery Society (PVSS), VESS traditionally holds its winter annual meeting at a ski resort and is renowned for its casual attire dress code at its meetings. VESS is chic and boasts a loyal membership. But what is its secret sauce?

To find out, we’ve invited two young surgeons and a past president to share their VESS origin stories and more. Matthew Smeds, MD, is the chief of vascular surgery at the St Louis University Hospital, St. Louis, and is involved with several VESS committees; Venita Chandra, MD, is the vascular surgery fellowship and residency program director at Stanford Health Care, Stanford, California, and co-chairs the resident education committee at VESS; and Matthew Corriere, MD, is a vascular surgeon at the University of Michigan, Ann Arbor, Michigan, and the immediate past president of VESS. Here’s what they had to say:

Matthew Smeds

Matthew Smeds

On his VESS origin story: I was encouraged to attend the VESS (then the PVSS) winter meeting during my vascular surgery fellowship by Brian Peterson, a younger faculty member at my institution. I presented a paper on the early use of the C3 excluder in high-risk aortic necks and was blown away by the camaraderie, openness to discussion, and support of trainees, medical students, and young faculty by the membership. Another defining moment was the then VESS president (and one of my mentors from medical school) Karl Illig walking into the morning session where I was supposed to present. He was in his bathrobe and making an announcement that if we were wearing ties, we were doing it wrong (in response to which I slowly removed my tie!).

After becoming faculty, I began to regularly attend the winter meeting; I’ve been to all but one since graduation, and an early mentor of mine, Peter Nelson, encouraged me to get involved with society committees. I became a member of the program committee for the spring meeting and have been involved in many other committees since then.

On VESS and developing a surgical career: VESS has been instrumental in my career development, as it’s given me the opportunity to have a voice in a national society both by my involvement with the societal committees, but also as a platform in which to present research and network with like-minded surgeons. I have gone on to collaborate with many individuals who I’ve met at the meeting, or in committees, and developed good friendships with many. I think the best thing about VESS is the society’s openness to involving young vascular surgeons. It’s very easy to get involved and contribute. You don’t have to be a “bigwig” or have gray hair. And, what’s more, I feel a lot of things are actually accomplished by the various committees, as it’s a much easier society to navigate than some of the larger surgical societies. One example was an idea we had to create a virtual residency fair during the first year of COVID for medical students who were not able to travel to visit institutions. I proposed the idea in June, and the society made it happen by September with very little red tape.

What VESS has to offer young surgeons and trainees: VESS has many wonderful opportunities for medical students, trainees, and younger faculty. The medical student education program during the winter meeting is a great opportunity for students to learn about vascular surgery, experience a national vascular meeting, and meet surgeons, other students/trainees, program directors and leaders of institutions across the country in a very non-threatening and enjoyable atmosphere. VESS has sponsored virtual residency fairs yearly for the past two years that will likely continue, and this provides applicants the opportunities to meet with programs from across the country prior to the interview season.

Similar to the student program, the resident/fellow educational session is a great chance for trainees approaching the end of their training to network and learn about the “real world” (and attend the VESS winter meeting if they haven’t already). During the spring meeting held at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM), the opportunity exists for young faculty to be “discussants” for abstracts being presented. This helps them get familiar with standing up in front of a crowd and discussing a paper/asking questions of presenters.

For young surgical faculty, opportunities such as the mentorship program, the traveling fellowship, and committee positions/involvement can help them get involved and active in the society. For everyone, the opportunity to submit abstracts for presentations is great, and the society really embraces hearing new voices and topics during its meetings. My rule is to always have something submitted to VESS, and you should too! Finally, there are significant opportunities in social media to take part in societal happenings. I’d encourage everyone to follow the society (@VESurgery) on Twitter or Instagram and to check out the VESS YouTube channel that has prior meeting presentations, as well as surgical technique videos uploaded. VESS is truly the premier society for young vascular surgeons. Any medical student, vascular trainee, or young surgical faculty should try to get actively involved. You won’t regret it.

Venita Chandra

Venita Chandra

On her VESS origin story: I first got involved in VESS as a vascular surgery fellow several years ago now. I found the programming for trainees at the time really helpful—targeted and thoughtful topics that were very relevant to me at that point. I also appreciated the opportunity to listen in on the conference. It was so refreshing to hear good science in a more casual environment. I was rubbing shoulders with people I looked up to, finding them all very approachable. Meeting people at this conference was a key part of my feeling like I “belonged” in the vascular surgery community.

VESS and developing a surgical career: As I mentioned above, the casual and more laid-back environment allows a chance to break the ice with many people you look up to from afar. This opened the doors for me to be involved in various collaborations, get invitations to various conferences, and, in general, have a wider audience of people I called friends and peers across the country.

On opportunities from VESS worth highlighting for younger surgeons and trainees: The trainee programs are really great. Great topics, good opportunities to get to know each other and start the process of getting to know a lot of the other members of this amazing society! Honestly, it’s the relationships and friendships that come from this meeting that make VESS the amazing society that it is. As Dr. Smeds has outlined, we want you in VESS.

Matthew Corriere

Matthew Corriere

Reflections on VESS from a mid-career vascular surgeon: My first VESS meeting was in 2004, and I was a general surgery resident at the time. Back then, the society was a bit smaller and called the PVSS. I had been to a few other academic conferences by then, but it was clear on the first morning

that this one was different in several wonderful ways. The attire was informal, and the interaction was more personal and relaxed. I could see the presenters’ faces without the need for big-screen projection. The queue at the microphone seemed almost inviting—the people in the question line did more smiling than scowling, and some of them even had natural hair that was not yet gray. Faculty, trainees and families mingled between sessions, and the discussions seemed unexpectedly pleasant. People were getting re-acquainted on more than just work. “What gives?” I thought. Some of these folks were the same successful vascular surgeons I had previously encountered elsewhere in more sterile meeting environments. They were up-and-comers in the field whose names could be found on prominent textbook chapters and journal articles.

At VESS, however, the vibe was different. With everyone sporting resort wear and surrounded by snow-covered peaks, there was a curious lack of politics, power lunches, or jockeying for position. I wondered if it might be a group case of altitude sickness, but it turned out that people were just relaxed and having fun.

Attending VESS for the first time: Speaking of altitude, my first VESS meeting was also my first trip to Steamboat Springs, Colorado. My mentor and lab predecessors had alerted me to anticipate wonderful outdoor recreation opportunities. I had to borrow my gear from a fellow resident who did not need it that week (fortunately, he was pursuing another specialty that will go unnamed but frowns on informal dress and seldom appreciates the concept of fun outside the hospital).

As it turns out, both fun and laughter ensue when well-rested vascular surgeons convene in a beautiful place while separated from pagers, the emergency room (ER), vascular emergencies, and other interruptions. Under these circumstances, one might take advantage of opportunities to laugh directly at attendings over circumstances that seldom arise at work, such as being out of shape, becoming a “yard-sale” (a term I learned after unknowingly demonstrating it to an esteemed New Englander colleague), or even publicly displaying hat-head hair chaos. As a young resident scraping by each month to put food on the table and pay the mortgage, I never would have made that first trip without the presentation opportunity. I left feeling energized and incredibly grateful.

Great science coupled with great relaxation: Reflecting on my experiences with VESS over the past 17 years, I have acquired gray hair of my own. Other more pleasant epiphanies also come to mind. I have lost count of how often I have returned with my wife and kids (who are now adults), who caught on quickly and began reminding me on the trip home each year to earmark abstracts for next time. The meeting is no longer a secret— VESS has outgrown some of the smaller venues and hotel demand consistently exceeds supply.

Correspondingly, the submissions are increasingly competitive, and it is never a given that a high-quality abstract will make the program (case in point: the Corriere lab got skunked this year, demonstrating absence of bias favoring the immediate past president).

Beyond the meeting, VESS has blossomed into a vibrant society working year-round on issues dear to young vascular surgeons like clinical practice, diversity, education and career development.

The networking, committee and leadership opportunities VESS creates are unparalleled, and seldom available elsewhere for early-career surgeons. I am also enjoying the swap from presenting at the podium myself to getting trainees and students up there for the first time. So, become a member; sign up here: www.vesurgery.org/my-vess.

Christopher Audu, MD is a vascular surgery resident at the University of Michigan in Ann Arbor, Michigan. Laura Marie Drudi, MD, is a vascular surgeon at Centre Hospitalier de L’Universite de Montréal.

FDA approves two pediatric venous thromboembolism indications for rivaroxaban

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FDA approves two pediatric venous thromboembolism indications for rivaroxaban
Xarelto liquid suspension contents

The Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.

According to the Janssen Pharmaceutical Companies of Johnson & Johnson, rivaroxaban is the only direct oral anticoagulant (DOAC) FDA approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients.

“Historically, there has been limited guidance and options for healthcare providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children,” said Andrew Van Bergen, MD, pediatric cardiologist at Advocate Children’s Hospital in Oak Lawn and Park Ridge, Illinois. “We have had to adjust adult doses of standard anticoagulation therapies, which are both burdensome and uncomfortable for patients, and require frequent monitoring. Now that Xarelto is FDA approved with weight-based dosing options, either as tablets or liquid formulation, a convenient option is available allowing flexibility to tailor the treatment for my patients. This is a major advancement in antithrombotic care for those patients under the age of 18.”

The oral suspension formulation will be administered through a color-coded dosing device that was designed to help minimize dosing errors and is expected to become available in the U.S. for pediatric patients in mid-January 2022. The oral tablets are currently available in the U.S. for appropriate pediatric patients.

“When a child is experiencing health challenges, learning that they are also at risk for a blood clot can feel overwhelming for the patient, and also their parents or caregivers,” said Andrea Baer, executive Director of The Mended Hearts, a patient advocacy organization whose program Mended Little Hearts serves patients and families with congenital heart disease. “Knowing that there is now an FDA-approved oral treatment option to reduce the risk of blood clots that is easy and may be more comfortable than injections to administer may help ease that burden.”

CLI at a crossroads: Which direction now?

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CLI at a crossroads: Which direction now?
Michael Belkin speaks during WVS 2021

Vascular surgery once again finds itself at a crossroads, Michael Belkin, MD, chief of the division of vascular and endovascular surgery at Brigham and Women’s Hospital in Boston, told the Western Vascular Society (WVS) annual meeting (Oct. 16–19) in Jackson Hole, Wyoming, during a presidential guest lecture on the art and science of critical limb ischemia (CLI).

“Again, it’s an existential crossroads,” he told attendees. “We made the right decision last time, years ago, when we adopted interventional therapies as part of what we do as vascular surgeons, and I think, again, we now have to embrace all our tools.” Belkin was discussing bypass surgery and the question of whether it would be a lost art, and whether endovascular-first would become endovascular-only.

“The question is: Can we reproduce the results of PREVENT III? PREVENT III was done by a generation of surgeons who were bypass-first,” Belkin said. Will those be reproduced by the current BASIL and BEST-CLI trials? He has his doubts: “The art of bypass surgery, I think, is threatened.”

So, to the crossroads: “With endo, we have to leverage the technology and advanced technical skills we have to get the best results, but we have to use it in an evidence-based application,” he argued. “And we have to maintain our open skills so that we can offer patients the best therapy for them.

“To those of us who are privileged to train the next generation of surgeons: it’s on us to make sure that our trainees are exposed to the technical aspects—judgmental aspects—of bypass surgery so that they can carry this on in the future.”

Nominate ‘giver, doer’ for Excellence in Community Service Award

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Nominate ‘giver, doer’ for Excellence in Community Service Award
Three recipients of the 2020 and 2021 Excellence in Community Service Awards were honored during VAM in San Diego last year. From left are Daniel McDevitt, Russell Samson, William Shutze and Daniel McGraw

The Society for Vascular Surgery (SVS) is asking members to consider who among the many excellent vascular surgeons they may know in community practice might be worthy of nomination for the 2022 SVS Excellence in Community Service Award.

Applications for the honor—open only to those who practice in the community setting—are due Feb. 1, 2022.

It may be hard for some to define the qualities that denote “excellence” among their community practitioner colleagues. To help get those thoughts going, here are some of the actions of past recipients, who give and do much:

  • Mentored students, from high school to medical school and beyond
  • With partners, were early champions of “best practices” that included standardized group protocols and new technologies
  • Volunteered on mission trips
  • Active in SVS or local and state vascular surgery organizations
  • Helped create a network of rural satellite clinics, plus a mobile vascular lab that took care to patients’ homes
  • Written more than 100 peer-reviewed articles on improving ways to deliver patient care
  • Elevated the profile of vascular surgery with regular scientific presentations at state and local levels
  • In collaboration with a local community college, assisted in developing one of the first accredited training programs for Registered Vascular Technologists in the country
  • Instrumental in bringing modern vascular surgery to a rural community
  • Developed practice guidelines for preventive screenings and follow-up of high-risk vascular patients, leading to tracking and outreach programs to improve the quality of the vascular care for patients proactively

To be considered, applicants must be community practitioners and have been in practice as a vascular surgeon for at least 20 years. They also must have been an SVS member for at least five years, as well as demonstrate evidence of impact on vascular care or community health.

Learn more at vascular.org/CommunityServiceAward.

Explaining the No Surprises Act

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Explaining the No Surprises Act
The No Surprises Act aims to address surprise medical billing at the federal level

The vast scope of the No Surprises Act—legislation signed into law in late 2020—may mean some Society for Vascular Surgery (SVS) members are not aware of its provisions.

The No Surprises Act is part of the Consolidation Appropriateness Act of 2021 to address surprise medical billing at the federal level. In 2021, the Department of Health and Human Services (HHS) published interim final rules, “Requirements related to Surprise Billing” parts I and II. The underlying premise is to protect patients from surprise bills for emergency services and certain scheduled services provided by out-of-network clinicians at in-network facilities while providing greater transparency for healthcare costs. The act, which took effect on Jan. 1, 2022, outlines professional reimbursements for out-of-network services and establishes an independent dispute resolution process to help facilitate provider reimbursement from health plans.

What’s in the act? Let’s start with emergency services. Under this new legislation, patients will not be subject to bills by out-of-network providers at in-network facilities beyond those expected if the care had been completely in-network. The health plan must reimburse the provider directly rather than bill through the patient. The patient’s share, often the “surprise bill,” will be based on a cost-sharing obligation (co-pay/deductible for emergency services) at his or her existing in-network rate. But what is the actual out-of-network rate? The new rate for professional reimbursement will be based on the “recognized amount” and “qualifying amount.” Under these concepts, the reimbursement is determined by specified state law or All Payer Model agreement, if applicable. If neither apply, as in most cases, then the out-of-network rate is determined by an agreement between the provider and the payer but will most likely default to the qualifying payment amount (QPA). The QPA will be based on the health plan’s median in-network rate for the same or similar services. Therefore, the provider will receive an “out-of-network” reimbursement based on any state laws (i.e., all-payer rate-setting model), a rate agreed upon by the payer and provider, or the QPA.

What about non-emergency services performed by out-of-network providers at in-network facilities (i.e., the provider sees a hospital consult but is out-of-network while the hospital is in-network)? The patient will pay the same as expected had the provider been in-network. The provider will be reimbursed based on the QPA and may not balance-bill (charge patients the difference) for certain services unless they meet the notice and consent for out-of-network services guidelines.

However, certain provisions can affect reimbursement for our services. What happens if there is a dispute between the health plan and the provider? The No Surprises Act provides legal recourse through arbitration. The independent dispute resolution (IDR) is a binding process to settle these differences and has been described as a “baseball style” arbitration where each party submits their case and expected payment. While the IDR can consider other factors such as level of training, patient acuity and teaching status, among others, they have been directed that the QPA is the most significant factor when deciding between offers. This raises concerns as it deviates from the original guidelines for determining reimbursement. In particular, if a physician or group fails to agree on reimbursement rates and subsequently does not contract with the health plan, they are considered out-of-network—even if the facility is in-network. According to the No Surprise Act, the health plan would reimburse these clinicians based on the QPA (the plan’s median in-network rate), essentially bypassing any prior negotiations and potentially adversely affecting any other negotiations going forward.

Finally, for those uninsured/self-pay patients, or those who pursue self-payment if services are denied by their health plans, the “convening” provider (primary provider) will be required to provide a Good Faith Estimate for all scheduled services (>3 days out), or upon request by the patient. This estimate will provide expected charges for all services, both professional (including co-providers or any other clinician that will be providing billable services) and facility-based. For a surgical procedure, these charges should include the surgery, any labs or tests, and anesthesia care. While the co-provider provision has been delayed until Jan. 1, 2023, all other services and their associated charges and discounts must be provided in an itemized fashion for the patient’s review prior to any intervention. There are rigid timeline requirements and penalties, as well as recourse, if actual costs are higher than estimates (currently ≥$400 difference can trigger an appeal). This will require coordination between provider(s) and medical facilities to ensure appropriate estimates and subsequent reimbursement. Lastly, this rule does not impact any bills generated when both the provider and facility are out-of-network.

This bill covers numerous other issues such as batch claims, audit processes, price comparison tools, continuity of care, etc., which are well beyond the scope of this article. We advise all providers to converse with their medical facility and/or group practice managers to help formulate a plan. Clinicians should also utilize resources provided by national organizations such as the American Hospital Association (AHA) and American Medical Association (AMA) to ensure up-to-date information.

References:

  1. https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-116HR133SA-RCP-116-68.pdf
  2. https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-ii-interim-final-rule-comment-period

Francesco Aiello, MD, is a member of the SVS Coding Committee, a professor of surgery at the University of Massachusetts Medical School, and chief medical officer of Revenue Management, UMass Memorial Health. Angela L. Confoey, MHA, is associate vice president in the Hospital Central Billing Office at UMass Memorial Health.

‘Leveraging multiple teams and cardiovascular specialists’

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‘Leveraging multiple teams and cardiovascular specialists’
Young Erben

This quarter’s Leadership Corner features Young Erben, MD, interviewing Charles B. Ross, MD, chief of vascular and endovascular services at Piedmont Heart Institute, Piedmont Hospital, Atlanta, since 2012.

I am highlighting the innovative work of Dr. Ross, current medical leader of the Southeastern Vascular Study Group (SEVSG) and president of the Georgia Vascular Society. Dr. Ross is an advocate for vascular service providers and a well-respected vascular surgeon within his region. He understands the unique stresses placed on systems for vascular care and the providers and teams who must provide that care “in the trenches.” Many of us are certainly reminded when we highlight Dr. Ross of the daily challenges we face while trying to juggle the needs of the patient, hospital system and of all providers involved within a hospital system.

Dr. Ross was recruited from the University of Louisville to the Piedmont Heart Institute, Piedmont Hospital, in 2012. The Institute was experiencing tremendous growth and development of all facets of its cardiovascular service line. Dr. Ross recognized the synergistic advantages of development of a system to care for all non-coronary vascular emergencies for the institute, the hospital and the healthcare system, and introduced the concept of a level one cardiovascular emergency program. Dr. Ross was teamed with Dr. William Morris Brown, Piedmont Heart Institute chief of cardiac surgery, to lead this effort. Dr. Ross gives credit to Drs. Michael Dalsing, Gary Lemmon, Arthur Coffey and the team at IU-Methodist in Indianapolis who mentored the Piedmont team.

He said, “Basically, we adapted the groundbreaking IU-Methodist level one system to the needs of Piedmont and its metro Atlanta and north Georgia community—incorporating not just acute aortic syndromes, acute limb ischemia and ‘other’ vascular emergencies like acute mesenteric ischemia and venous catastrophes, but also acute pulmonary embolism response.” This required leveraging multiple teams and cardiovascular specialists as well as supporting consultants. The Piedmont Level I Cardiovascular Emergency Program went “live” on July 1, 2014, and has since served over 1,300 major emergencies.

Several questions come to mind when we encounter unique leaders like Dr. Ross.

Charles B. Ross

What inspires you?

CR: Patients and teammates inspire me. The bravery of patients facing life- and limb-threatening situations is never lost on me. Daily inspiration may also come from a special nurse who provides critical and compassionate care, a perfusionist incredibly tired from overwork who works extra hours to support the ECMO program, or an advanced practice provider (APP) who spots an important piece of data that meaningfully changes a plan. Or watching my partners plan a complex aortic endovascular reconstruction, or observing them develop a vascular service line at a satellite hospital—seeing progress in action. Everyone in the trenches being the best they can be—little things that sometimes no one else seems to see—inspire me.

What keeps you passionate about what you do?

CR: Vascular surgery as a specialty is the source of my passion. It is the history of vascular surgery, my everlasting appreciation of those who trained me, and my desire for the whole world to appreciate the miracles we produce, or contribute to, every single day. Turning passion to productive works, involvement with regional vascular societies, the PERT Consortium, and Society for Vascular Surgery (SVS) have been key for me. Failure pushes me forward as well. The present “fireman” struggle that all vascular leaders are facing has been particularly difficult for me. Piedmont is a large hospital with one of the highest acuity ratings of all “community hospitals” in this country. And, we have a large system of satellite hospitals unable to provide advanced vascular care much of the time. My partners and I live the role of “firemen of the hospital and system,” often multiple times daily. We do so in absence of resident and fellow support. Despite the attention offered by our SVS to this issue, I have been unable to achieve recognition and tangible support for my team for our contributions to the mission of the hospital and healthcare system as a whole. I am continuing to work with our administrative team to quantify and gain credit for our efforts.

What about collaboration—you are known as someone who values multispecialty involvement. Can you elaborate?

CR: Collaboration works best when there is mutual respect, concern and empathy among team members. This was highlighted by Drs. Ali AbuRahma and Mark Bates in a special session at the Vascular Annual Meeting (VAM) this year. I felt as if my Piedmont colleague in interventional cardiology-vascular medicine, Dr. Andrew Klein, and I could have given the same talk with the same message. If an acute pulmonary embolism presents to me on call and I am in a case, it is seamless for me to call Drew and ask him to take it, and vice versa. The taxonomy of our specialties does not matter.

The same is true for interventional management of acute limb ischemia. Another major example of Piedmont Heart and Vascular Institute collaborative effort is our cardiac and vascular surgery teamwork in offering comprehensive management of all acute aortic syndromes and complex aortic elective surgery.

Issues do arise that can be very destructive to collaboration, but they are imposed at higher levels than the trenches in which we provide patient care. Differential payment based on specialty taxonomy for identical work is demoralizing. Marketing that favors one specialty above another and provides misleading messages that can change practice patterns is also troubling. These actions undermine collaboration.

Multispecialty collaboration in absence of incentives to support such activities creates winners and losers. For example, a hospital may wish for its vascular surgeons to support other services. But, if the hospital fails to recognize the opportunity lost by having a vascular surgeon on standby for six hours, without any billable service, what it is really asking is for vascular surgery to underwrite the other service. Of course, the vascular surgeon wants nothing but good care for patients, and vascular surgery wants to contribute to programs that are good for the hospital. But, in relative value unit (RVU)-driven compensation plans, or, worse still, private practice, vascular surgeons personally take a loss for participation. There are innumerable such examples, and we cannot be “shamed” into not speaking up. In my experience, for complex reasons, including historic undervaluation for vascular procedures as compared to others, vascular surgery ends up on the short end of the stick much of the time.

What keeps you grounded?

CR: My colleagues and my family. I am so fortunate to have the most supportive and stable vascular partnership at Piedmont, and in the greater vascular surgical community in Georgia as a whole. Moreover, the national support I have felt has been so appreciated. The ability to pick up the phone, and call mentors and colleagues for advice on administrative problems and manpower has been a great advantage. SVS membership has been foundational for me. More than anything, my participation in the SVS reminds me that I am not alone. Colleagues in the PERT Consortium also represent important sources of counsel and gravitas for me. The PERT community, both here in metro Atlanta and nationally, basically defines a multispecialty, multi-institutional effort with a singular mission—to reduce mortality and morbidity of acute pulmonary embolism. The chance to be part of an effort to have a measurable, positive impact on a frequently fatal disease process has been one of the most rewarding activities in which I have ever engaged. But, most importantly, it is my wife of 41 years, Kim, who tolerates burdensome Epic activity, multiple conference calls resulting in late dinners, and other academic and nonclinical duties which tend to consume weekends.

It is also our children, all hard workers and successful in their own early careers. Everything hinges on Kim and family.

Young Erben participated in the 2020 Society for Vascular Surgery (SVS) Leadership Development Program and is one of the recipients of the 2021 Leadership Mastery Grant. She has been able to use her skills learned during the course to bring multi-disciplinary teams together to address several vascular needs in her community. The Mastery Grant permitted her to take the Career Advancement and Leadership Skills for Women in Healthcare course offered by Harvard Medical School and directed by Julie Silver, MD, a renowned innovator at supporting healthcare change and working to improve disparities in the medical workforce.

TCAR affords greater quality-adjusted life years than carotid endarterectomy, cost-effectiveness model finds

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TCAR affords greater quality-adjusted life years than carotid endarterectomy, cost-effectiveness model finds
Mahmoud Malas

A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularization (TCAR) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY).

The study was published in the December 2021 issue of the Journal of Vascular Surgery.

According to principal author Mahmoud Malas, MD from the University of California San Diego, San Diego, California, “TCAR was developed to address the deficiencies associated with both CEA and TFCAS [transfemoral carotid artery stenting]. Several studies have shown that TCAR has one-half the stroke rate of TFCAS. Further, it has similar stroke and death outcomes compared with CEA while reducing the incidence of cranial nerve injury and myocardial infarction.”

“Although the clinical benefits of TCAR have been clearly established, there is little data comparing its cost-effectiveness with CEA,” continues Malas. “The purpose of this study was to compare the quality of life, efficacy, and cost-effectiveness among patients undergoing TCAR versus CEA.”

As reported in JVS, the San Diego group led by Malas created a model that simulated the outcomes of 10,000 symptomatic patients undergoing either TCAR or CEA. QALY was defined as the product of time and patient quality of life (scale 0–1). Cost-effectiveness was assessed with an incremental cost-effectiveness ratio (ICER) calculated as the incremental costs divided by incremental QALYs. Cost-effectiveness was defined as an ICER <US$150,000/QALY.

The team found the five-year costs per procedure to be $8,821 per 2.85 QALY for CEA and $19,154 per 2.92 QALY for TCAR.

The calculated ICER for TCAR was $152,229 over five years. Based on a nationally accepted standard used by the authors, TCAR was considered cost-effective 49% of the time.

“The present study utilizes microsimulation models to compare the cost, efficacy and cost-effectiveness of TCAR versus CEA in symptomatic patients, said Malas, in discussing the study results. Although the five-year costs for TCAR were approximately US$11,000 greater than those for CEA, it afforded greater QALYs and may be cost-effective in the long term.”

New technology in patient care may be associated with a significant cost when introduced. It is likely the clinical benefits of TCAR will also prove to be cost-effective as the use of the procedure becomes more common and its costs gradually decrease, the authors conclude.

SVS issues new guidelines covering carotid disease and popliteal aneurysms

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SVS issues new guidelines covering carotid disease and popliteal aneurysms
Ali AbuRahma

The Society for Vascular Surgery (SVS) has released updated clinical practice guidelines for the management of extracranial cerebrovascular disease and popliteal artery aneurysms in a special supplement, “The Care of Patients with Extracranial Cerebrovascular Disease and Popliteal Artery Aneurysms: The Society for Vascular Surgery Clinical Practice Guidelines,” published in the January issue of the Journal of Vascular Surgery (JVS).

The supplement also includes a systematic review supporting the SVS guidelines on managing carotid artery disease, plus a systematic review and meta-analysis of treatment and the natural history of popliteal artery aneurysms.

Ali AbuRahma, MD, SVS president, and Alik Farber, MD, led the respective writing groups in developing the clinical practice documents which offer recommendations to inform the diagnosis, evaluation, treatment options and follow-up of affected patients. “The expert writing groups included world-renowned vascular surgeons who analyzed the most recent evidence and performed systematic reviews to bring forth these clinical practice guidelines (CPGs),” said Ruth Bush, MD, chair, and Marc Schermerhorn, MD, vice chair, of the SVS Document Oversight Committee (DOC).

The carotid guideline includes an update of the 2011 guideline and provides graded evidence-based recommendations that address the following areas of patient care:

  • The role of surgical therapy over medical therapy alone for asymptomatic low-risk patients
  • The role of carotid endarterectomy vs. stenting for symptomatic low-risk patients
  • The optimal timing of interventions after acute stroke
  • Screening for carotid artery stenosis in asymptomatic patients
  • The sequence of carotid and coronary interventions for patients undergoing intervention for diseases in both vascular beds

The guideline “is concise and practical and will be of great use to clinicians for real-time decision-making,” said Bush and Schermerhorn.  Because of the volume of the literature, information, and additional topics with more critical details, the writing group also created a separate implementation document as a supporting companion resource.

The JVS supplement also includes an editorial, “Emerging evidence suggests that patients with high-grade asymptomatic carotid stenosis should be revascularized.”

The clinical practice guidelines on popliteal artery aneurysms present evidence and consensus-based recommendations regarding the evaluation of patients with popliteal aneurysms and size thresholds for repair. They provide recommendations for open surgical repair vs endovascular stent-graft repair for specific patient populations according to life expectancy, plus recommendations for urgent treatment of thrombosed popliteal aneurysms according to the Rutherford acute ischemia stage at presentation.

“This [clinical practice guidelines] is a unique contribution that has amassed the available data and current treatments for this disease process,” said Bush and Schermerhorn.

Since publication of the SVS’ 2011 update of the clinical practice guidelines for carotid artery disease, several pivotal studies comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS) have been published. In addition, the literature has demonstrated a confirmation of the need for optimization of medical therapy. Therefore, the updated SVS guidelines provides graded recommendations that address five very relevant questions: the role of surgical therapy over medical therapy alone in asymptomatic low risk patients, the role of CEA vs. CAS in symptomatic low risk patients, the optimal timing of interventions after acute stroke, screening for carotid artery stenosis in asymptomatic patients, and the sequence of carotid and coronary interventions in patients undergoing intervention for diseases in both vascular territories.

According to AbuRahma, writing group chair, “These guideline recommendations address the latest technology in the management of carotid disease, such as transcarotid artery stenting with flow reversal and how its outcomes compare to transfemoral stenting and the gold-standard, carotid endarterectomy.”

The 2021 SVS guidelines propose that CEA remains the preferred intervention over CAS in low-risk patients with symptomatic and asymptomatic disease.

Evidence suggests that once the perioperative period has elapsed, late ipsilateral stroke (at five and nine years) is no different between CEA and CAS, but 30-day death/stroke is significantly higher after transfemoral CAS vs. CEA, especially in the first seven to 14 days after symptom onset.

This is why the SVS and European Society for Vascular Surgery (ESVS) guidelines retain CEA as the first-line option.

Aneurysms of the popliteal artery are the most common aneurysms outside of the brain and abdominal aorta. Popliteal artery aneurysms can cause limb loss and therefore early diagnosis, careful follow up, and timely treatment of this condition are paramount.

These SVS practice guidelines offer recommendations to inform the diagnosis, evaluation, treatment options, and follow up of patients with popliteal artery aneurysms. Evidence-based recommendations regarding the evaluation of patients with known popliteal aneurysms, as well as size thresholds for repair, are included. Specific circumstances under which aneurysms may be considered for repair at a smaller size are also provided. Recommendations for open versus endovascular repair are given for specific patient populations based on life expectancy, as are recommendations for urgent treatment of thrombosed popliteal aneurysms based on the Rutherford acute ischemia stage at presentation.

World in motion: WFVS seeks to help shape future of global vascular training

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World in motion: WFVS seeks to help shape future of global vascular training

The World Federation of Vascular Societies (WFVS) recently entered a new era of governance with the aim of better disseminating science and best practices for vascular surgeons operating in every corner of the globe. Palma Shaw, MD, the WFVS secretary-general, outlines some of the strides made so far and what plans are in store for future progress in vascular training—including the potential use of simulation and virtual hands-on care.

Task Force to address question: How will we care for pediatric vascular patients?

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Task Force to address question: How will we care for pediatric vascular patients?
3/9/18 Environmental portraits of Surgical Doctors at the NCRC.
Dawn Coleman

Along with the American Pediatric Surgical Association (APSA), the Society for Vascular Surgery (SVS) plans to minimize and close some very real gaps in vascular care—treating pediatric patients.

The two organizations have formed a joint task force on the issue to identify key areas of concentration for collaborative education, guideline development, and potentially training across the vascular and pediatric surgery fields. The end goal of the SVS/APSA Task Force on Pediatric Vascular Surgery Care is advancing the understanding and care of vascular disease among pediatric patients.

“Our residents spend no defined time across programs managing kids,” said Dawn Coleman, MD, task force lead. “There are no training requirements to cover care of pediatric patients. So who will provide care, especially in acute emergencies?”

Coleman’s practice focuses in part on pediatric patients, and she covered the topic in a well-attended postgraduate course at the 2021 Vascular Annual Meeting (VAM). Resultant discussions, plus earlier conversations on the work of the SVS Population Health Task Force, “have identified a very clear gap in the care of children.” John White, MD, who is helping lead the task force effort, has long acknowledged this care gap and has sought to address it. The impetus: a young patient who could not receive the proper care in a major metropolitan area because he, the doctor, was out of town and no other vascular surgeon felt comfortable providing care to this 2-year-old.

Other cases also “really got me thinking” about the knowledge and care gaps, said White. “The fundamental issue is we don’t know how to optimize treatment for vascular problems in pediatric patients and on what basis. Right now, we have more questions than answers.”

Surgeons treating adult patients need not concern themselves with neurological, bone or muscle development, for example, said White. In addition, general physicians are getting farther afield from physical exams, utilizing imaging studies heavily instead. And, distance-walking tests—a mainstay vascular exam for adult patients—don’t provide much information in children’s cases, he pointed out.

Many vascular surgeons acknowledge significant reticence about treating pediatric patients, primarily because of lack of training, particularly in open procedures, said Coleman.

However, in the cases of critical, time-sensitive vascular emergencies, typically trauma cases, she said, “vascular surgeons may not find themselves with the precise team they’d like. This discomfort and lack of knowledge can impact the outcomes in a big way, including life or limb.”

The two doctors suggest the task force can collate clinical and practice resources for surgeons on the front lines presented with emergencies, plus working together through scientific studies to understand the natural history of the problem and care. “Ultimately, the goal from an educational perspective is to share broadly the expertise and resources of both groups,” said White, so that when faced with a pediatric vascular challenge, surgeons are empowered with appropriate resources to optimize care for these unique patients.

“We really need to work very hard and play catch-up ball, with better understanding of what children’s needs are. We need to put together education models, we need to develop brand new areas of guidance and technology, such as for operating on a premature infant.”

Coleman emphasized the importance of leveraging multidisciplinary teams for these children, especially when specialty resources may be limited by hospital constraints. In her own practice, she treats and operates on children with renovascular hypertension, a mainly developmental rare disease. “Our program rests on the expertise of the surgical team alongside pediatric nephrology, interventional radiology, cardiology, neurology, anesthesiology/ critical care and others,” she said.

White hopes the task force will go beyond putting together teams for emergencies. “Let’s get beyond that. Let’s discuss vascular care for kids overall.”

He cited care for young athletes and patient follow-up as two specific needs. “The high school athlete of today is a college athlete of 20 years ago,” he said. “The injuries we see—the vascular needs of these patients—are different now. We have to catch up.”

He regards establishing follow-up with pediatricians and pediatric situations another important priority. Emergency room surgeons rarely do follow-up care, he said. “But in the cases of pediatric vascular emergencies, we want the surgeon to become part of that child’s healthcare team.”

He treats children with congenital vascular anomalies. “Eventually that child will need to transition to both an adult primary care physician and a vascular surgeon who understand the impact of pediatric vascular issues on adult health.”

“We have the chance to do something incredible with this partnership,” said Coleman of the task force. “It will further our understanding of pediatric vascular diseases. Through data reconciliation, education and enhancing collaboration, this task force has the potential to have a powerful impact on not just rare, esoteric pediatric vascular disease, but common and time-sensitive pathology.”

The group will begin meeting in January 2022.

In paying back, Joe Hart pays it forward

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In paying back, Joe Hart pays it forward
Joe Hart

For Joe Hart, MD, a larger donation to the Society for Vascular Surgery (SVS) Foundation this past year is helping him pay back several of his own scholarships and research opportunities from which he benefited.

“I’m someone who’s been fortunate to get scholarships,” he said of his undergraduate and medical school years. “I’m from a big family—I needed the help! So I try to pay things back where I can. I’ve always been involved, but I was able to do something more substantial this year.”

During medical school at Northwestern, he received funding for a research opportunity he feels helped him get started in the right direction. After fellowship, he won an award through the Marco Polo Program to go to Europe for six months for training, research and project work. Now he tries to impact the future of vascular patient care by helping fund research that will affect that care. He calls himself a “hybrid,” working primarily in a clinical practice but also still trying to keep his hand in when it comes to research. He spent six years trying to make it his full-time pursuit. But funding was an issue, as were the difficulties—as many researchers know—balancing research, clinical and patient needs.

Contributions to the SVS Foundation help researchers get that precious time they need to pursue projects to improve patient care, said Hart, currently an associate professor of surgery and radiology at the Medical College of Wisconsin in Milwaukee.

“I know it’s difficult to get funding, I know it’s important. Grants help our people get more funding to keep up their research, without clinical practice getting in the way.”

Hart also gives his time, serving on both the SVS Foundation Board of Directors and the VISTA—Vascular Volunteers In Service To All—Steering Committee.

And after spending more than five years in a relatively rural setting in northern Maine, he also understands and appreciates some of the Foundation’s newer initiatives like VISTA, which is aimed at providing access to vascular care to under-served populations.

He encourages everyone to participate in the Foundation’s work, echoing the sentiments of other Foundation committee members. “Even in my mac-and-cheese days I gave a little,” he said. “And I’m glad I’m in a place in my life where I can do more. It seems like the right thing to do.”

The SVS Foundation has published its 2021 annual report. Read it at vascular.org/FoundationAnnualReport21.

Wei Zhou: Prepared for change—and a more diverse, vocal generation of surgeons

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Wei Zhou: Prepared for change—and a more diverse, vocal generation of surgeons
Wei Zhou

There was something of a different pulse to some of the matters around this year’s Western Vascular Society (WVS) annual meeting, recalls Wei Zhou, MD, a regular attendee over the last decade—particularly during a session dedicated to issues related to diversity, equity and inclusion (DEI).

That might’ve had something to do with the presence of a contingent of voluble, young faculty. Crucially, this emerging generation is one that contains more women, greater diversity and a louder voice, Zhou muses. It is a new tenor that excites her—for the future it might portend, for the trails it might set for others. “I think the society wants to make a change,” says Zhou. “It’s time to be inclusive, it’s time to embrace new ideas.”

Zhou, an immigrant to the United States after high school, knows what extra obstacles can lie in the way of people with demographic characteristics such as hers. She knows what it has taken to reach her latest career milestone: During the recent WVS meeting in Jackson Hole, Wyoming, she was unveiled as the society’s president-elect. As just the second woman to enter the presidential line, as well as the second Asian, she speaks of an element of surprise at the election, as much due to her relative youth as the ascension itself. “I’m still trying to digest the news,” Zhou tells Vascular Specialist in an interview shortly before her first WVS Executive Council meeting. “But there are more early-career vascular surgeons who are women, who are diverse, and I have really embraced the change. As a society, we need to embrace change. I think, as a leader, you really need to embrace what’s going on with the pipeline.”

Zhou’s own career has followed a particular trajectory. Since vascular fellowship, she has remained committed to academia, considering herself primarily a clinician-scientist.

“I enjoy the stimulating part of the science—though I’m a busy clinician I still enjoy the science part,” she says. “I have been lucky enough to have grant fundings from the VA [Veterans Affairs], NIH [National Institutes of Health] and the American Heart Association [AHA], from the American College of Surgeons [ACS] over the years. I still have a research lab—stood-over-the-benchtop research.” Meanwhile, Zhou’s clinical research interests have evolved. While at Stanford, where she operated for 10 years, she had a particular interest in neurocognition, and how carotid disease and carotid intervention—particularly micro-embolization—affect cognitive function.

Now based in Arizona, where she serves as chief of the division of vascular and endovascular surgery at University of Arizona College of Medicine-Tucson, her role has altered. There, part of her attention has turned to bringing together vascular surgery and podiatry, focusing on limb salvage, which she says represents “a huge” part of her group’s practice. “I embrace my podiatry colleagues and embrace the collaboration between podiatry and vascular,” Zhou explains. “That has continued to develop the program, and I think that’s important because they’re both integral equally to our practice. Along with that, there’s lots of work, research and clinical questions that we can ask to improve our care for patients with diabetes and diabetic foot ulcers, and for limb salvage in the southwest.”

In that vein, different types of vascular practice also merit consideration in the crucible of diversity, Zhou continues. “We’re not just an academic society; we’re a society that encompasses all types of vascular surgeons in the Western region. People in private practice, people in large group practice, and academia. We also need to embrace our young early-career faculty and students who are lots more diverse. Outreach is definitely on my agenda.” That’s a vision she shares with current WVS President Vincent Rowe, MD, who took over from Michael Conte, MD, in Jackson Hole.

Zhou points to a survey conducted by the society’s new DEI committee. It showed that 30% of the membership who responded had plans to retire. “That raises a pipeline issue for our society,” she says.

The more vocal, up-and-coming generation were particularly impressive during a DEI committee breakout session at the meeting, Zhou points out. “I’m considered more of a mid-career senior faculty surgeon, so in my role I recognize the diversity, and I want to change but not only are [the younger faculty] diverse— their voices seem louder. Not only do they recognize the need for change, but they definitely have a desire to make the change happen.

“I was actually inspired by our early-career faculty members, especially women faculty and women members in our society. They’re extremely accomplished and very vocal. They inspire me to be more vocal regarding this aspect of our society.”

When serving on the WVS program committee, Zhou describes how the group would organize a diversity network session where such issues would be raised and discussed.

“That was it,” she recalls. There was industry interest and support, but the mode of the session was not as well received as that which emerged at the most recent meeting, Zhou adds.

“This year it was a different pulse,” Zhou explains. “The DEI committee was formed this year and the new young surgeon committee was formed this year, and lots of our young faculty members are women. They are not just realizing the need for change, they demand change. Not only from the society but also from industry.”

Venous disease: SVS DEI Committee seeks survey participants

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Venous disease: SVS DEI Committee seeks survey participants
Doctors and medical staff wearing surgical masks, they are standing together, coronavirus prevention concept
The SVS DEI committee seeks respondents for a venous practice-focused survey

The Society for Vascular Surgery (SVS) Diversity, Equity and Inclusion (DEI) Committee is calling on vascular surgeons to complete a survey focused on patterns of practice in venous disease. Responses are due by Friday, Dec. 31.

The committee seeks respondents to complete the survey—expected to take 5 minutes—as it explores venous disease workload and the perspectives of surgeons on their practice.

“We invite all practicing vascular surgeons—irrespective of whether you perform venous interventions—to fill out the survey and help us in our efforts to improve our understanding of current venous practice patterns,” the committee said.

The survey can be completed here.

Planning underway for next VAM

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Planning underway for next VAM
VAM 2022 follows quickly on the heels of VAM 2021, held in August

One of the innovations—livestreaming— introduced at the 2021 Vascular Annual Meeting (VAM), is influencing the 2022 schedule.

“The streaming option, particularly for international members, was a big hit,” said Andres Schanzer, MD, chair of the Society for Vascular Surgery (SVS) Program Committee, which oversees VAM educational programming.

This year, SVS offered a livestreaming option for those who for whatever reason were not able to attend VAM in person. Seventeen sessions were livestreamed—including all plenary sessions, named lectures, a number of international sessions and the two presidential addresses, by Kim Hodgson, MD, and Ronald L. Dalman, MD.

Because of the popularity of the international sessions, as well as the time zone differences, for 2022, planners have moved the international sessions to early morning. “This lets our international attendees who are livestreaming to watch the sessions geared toward them during the day, and not late at night,” said Schanzer.

The move also allows the Postgraduate Education Committee to schedule additional educational content in the afternoons, in the form of concurrent sessions and those planned with particular audiences in mind.

Schanzer stressed the section sessions will be educational in nature, planned in close collaboration with the section leaders and the committee, and focus on cutting-edge topics relevant to each section. “Of course, we’re still in the planning stages for all sessions,” he said. “But the Postgraduate Education Committee wants to offer content that is timely, relevant and specifically focused to the members of those particular sections.”

VAM will be held June 15 to 18, 2022, in Boston, with educational programming across all four days. Exhibits will be open June 16 to 17, and the SVS Foundation Gala will be the evening of Friday, June 17. Learn more at vascular.org/VAM.

Collaborative effort key to investigating potential biomarker of acute aortic syndrome

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Collaborative effort key to investigating potential biomarker of acute aortic syndrome
Maaz Syed at VSASM 2021

Research indicates that plasma desmosine has the potential to act as a biomarker of acute aortic syndrome and could, in the future, be used as a diagnostic tool for the condition in the acute setting.

Presenting the findings of a British Heart Foundation-funded study during the Sol Cohen Prize Session at the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021) held Dec. 1–3, in Manchester, England, Maaz Syed, a medical student at the University of Edinburgh, Edinburgh, Scotland, concluded that a multicenter, collaborative effort is needed to propel future investigation. The British Heart Foundation-funded study, published as an abstract in Heart, was a collaborative effort between the University of Edinburgh and Anna Maria Choy, MBBS, and her team at the University of Dundee, Dundee, Scotland.

Acute aortic syndrome “poses challenges in diagnosis, is unpredictable and is catastrophic,” Syed told the VSASM audience. It is known that patients with abdominal aortic aneurysms (AAAs) have raised desmosine, but, according to Syed, it has never been tested in patients with acute aortic syndrome before. Therefore, the research team set out to compare plasma desmosine concentrations in patients with acute aortic syndrome compared to healthy controls, with the primary aim of determining whether desmosine concentrations change with respect to phase of disease.

The investigators analyzed plasma desmosine concentrations in 53 patients with acute aortic syndrome and compared them to 106 controls, Syed relayed. The presenter noted that the groups were “reasonably well matched,” although patients in the acute aortic syndrome group were slightly older on average, more likely to be male and had lower blood pressures than the patients in the control group as they were on antihypertensive therapy.

“As we had hypothesized, plasma desmosine concentration was increased in patients with acute aortic syndrome compared to controls,” the presenter informed VSASM attendees. He added that this was true across all three sub-pathologies: aortic dissections, intramural hematomas and penetrating aortic ulcers.

The researchers were mainly interested in phase of disease, Syed detailed, noting that the majority of patients the team recruited belonged to the acute, subacute and chronic groups. The team started noticing a trend: “It looked like the closer you got to the event, the higher the plasma desmosine we observed.”

In light of this finding, Syed and colleagues then collected blood from the three patients who had presented with chest pain and later gone on to develop acute aortic syndrome or be diagnosed with acute aortic syndrome. “We thought that their plasma desmosine would be higher, but we were not expecting to see such a high level,” he remarked.

The team developed a simple linear regression model to check that it was not a change in baseline demographics that was influencing the levels of plasma desmosine. “Plasma desmosine presentation had a three-fold increase compared to 106 healthy controls independent of their age, their sex and their smoking status, and this was statistically significant,” he explained.

The presenter detailed that, while the phase of disease helps clinicians work out morphologically how the aorta is going to behave, it does not necessarily reflect the pathobiological properties of the aorta with respect to time. Therefore, the team also wanted to see how plasma desmosine concentrations differed with respect to time as a continuous variable. One of their key findings was that plasma desmosine level peaked at presentation and gradually decreased with respect to time, but that even patients who are many years out of the initial event had a raised desmosine level.

Finally, Syed and colleagues wanted to determine if plasma desmosine can influence the prediction of longitudinal outcomes. They developed another linear regression model, this time fitting aortic growth against desmosine and conventional clinical predictors. “Desmosine outperformed things like aortic diameter and the age of the dissection or the intramural haematoma,” he reported.

A possible diagnostic tool

“We have demonstrated not only that plasma desmosine is increased in patients with acute aortic syndrome, but that it is detectable within 24 hours of symptom onset,” Syed summarized, stressing that this has implications for the use of plasma desmosine as a potential diagnostic tool in the emergency department. Plasma desmosine also appears to be associated with aortic expansion independent of things like aortic diameter, the presenter added.

Discussion following Syed’s presentation delved further into the findings, with Richard Gibbs, MBChB, a consultant vascular surgeon at Imperial College Healthcare NHS Trust, London, England, keen to know if the researchers had data on plasma desmosine levels in patients with connective tissue disorders. Syed noted that in the one patient they assessed who had Marfan syndrome, the team noticed a five- to six-fold increase in his plasma desmosine. Two weeks later, the patient developed a dissection. “It is very hard to capture something like this, we were lucky,” the presenter commented, “but it was findings such as this that made us think maybe this is an important biomarker in patients with acute aortic syndrome, and we are now systematically testing plasma desmosine in patients with connective tissue disorders for that reason.”

Closing his presentation, Syed was keen to emphasize the importance of the research. He explained that when the findings were published earlier this year, the team was approached by the Aortic Dissection Charitable Trust. “The trust was set up in 2015 by a group of MPs who had sadly experienced loss of life in young members of their families due to this catastrophic disease, and one of the benefits of presenting research such as this in this forum is that we can gauge interest among the vascular community in developing a biomarker to diagnose acute aortic syndrome and improve risk stratification.” He continued: “Clearly, work needs to be done to take this forward, and that is going to require a multicenter, collaborative effort.”

VRIC 2022 to be held May 11 in Seattle

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VRIC 2022 to be held May 11 in Seattle

The Society for Vascular Surgery’s 2022 Vascular Research Initiatives Conference (VRIC) will return to its spring timeframe of the past several years.

Abstract submission for VRIC closes at 6 p.m. Central Time Tuesday, Jan. 11, 2022. Registration opens Feb. 10, 2022; look out for information on early-bird rates that will be available before then.

The conference will be held May 11, 2022, in Seattle, the day before—and in the same place—as the American Heart Association (AHA) “Vascular Discovery: From Genes to Medicine” Scientific Sessions from May 12–14, 2022.

The COVID-19 pandemic forced cancellation of the live VRIC in the spring of 2020, and a pivot to a virtual meeting that fall. In 2021, with the AHA not holding live sessions, VRIC joined the Vascular Annual Meeting (VAM) with a shortened program of four hours, over two days.

VRIC focuses broadly on emerging vascular science and translational research relevant to vascular patients. Collaboration is key, with audience-presenter discussion that helps motivate participants to discover solutions to vascular disease issues.

The conference brings together vascular surgeons, vascular biologists, physicians with an interest in vascular problems, vascular surgery trainees and research trainees focused on cardiovascular biology.

Highlights include the Alexander W. Clowes Distinguished Lecture, typically delivered by a noted scientist/researcher, and the always-popular translational panel and discussion. This year, the theme is “Translational Immunology and Cardiovascular Disease.” There will be four abstract sessions broadly focused on:

  • Arterial remodeling and discovery science for venous disease
  • Vascular regeneration, stem cells and wound healing
  • Atherosclerosis and the role of the immune system
  • Aortopathies and novel vascular devices

“VRIC allows us to identify important breakthroughs in understanding the mechanisms of vascular pathology that allow for development of therapies to prevent and treat common vascular diseases,” said Katherine Gallagher, MD. She chairs the SVS Basic and Translational Research Committee, which plans the conference; she herself is a longtime VRIC presenter and mentor to other presenters.

“This meeting is an excellent venue for research/ surgical trainees who focus on translational research in vascular disease. The discussions surrounding the presentations often lead to collaborations and new directions for many in our vascular research community.”

VRIC presents some of the research at the ground-floor level in many ways, she said. This is research that “affects future treatment and management of vascular disease, and the care our members eventually will provide patients.” For more information on VRIC—to be held at the Sheraton Grand Seattle Hotel—visit vascular.org/VRIC22.

Vascular Specialist–December 2021

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Vascular Specialist–December 2021

In this issue:

*This issue went to press before Congress moved to address cuts to Medicare due to kick in Jan. 1, 2022.

  • “Countdown to the cuts” (p. 1 and 7)
  • “One simple trick can tone your abs and identify fake news!” Medical editor Malachi Sheahan, MD, tackles the second part of a two-part editorial on science denial amid the pandemic (p. 2 and 4)
  • Interview: Wei Zhou, MD, discusses becoming Western Vascular Society (WVS) president-elect, progress on diversity, equity and inclusion issues, and the emerging generation of young surgeons (p. 15)
  • Young Erben, MD, interviews Charles B. Ross, MD, in this month’s leadership column (p. 18)
  • Corner Stitch: Christopher Audu, MD, and Laura Marie Drudi, MD, place  Vascular and Endovascular Surgery Society (VESS) membership under the microscope (p. 22–23)
  • A roundup of new science and associated news from meetings taking place across the fall (p. 25)

Smoking status ‘should not deter nor delay’ endovascular intervention in femoropopliteal vessels

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Smoking status ‘should not deter nor delay’ endovascular intervention in femoropopliteal vessels

Smoking does not seem to affect reocclusion rates, interval to reintervention and the total number of interventions in peripheral arterial disease (PAD) patients with stents in the femoropopliteal segment, new research showed.

These were among the findings delivered by Sascha Wodoslawsky, BA, a medical student at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia during the Eastern Vascular Society (EVS) annual meeting (Sept. 23–26) in Charleston, South Carolina.

Wodoslawsky and colleagues set out to assess the relationship between smoking status and various different variables, probing three groups: current smokers, former smokers and never smokers.

They were operating against a backdrop of two decades’ worth of published studies showing “completely polarizing views,” she said—from those indicating that smoking 10 or more cigarettes was beneficial in reducing the rate of restenosis, to a more conventional view around smoking increasing the risk of graft failure or increased restenosis rates.

The 10-year retrospective chart review looked at the records of 287 patients, 36.6% of whom were current smokers, 48.8% former smokers and 14.5% never smokers.

The researchers found no significant difference in the likelihood of reintervention for in-stent restenosis, total number of reinterventions and interval to stent reocclusion between the three smoking status categories. Furthermore, they detected no significant association between the number of pack-years smoked and the interval to stent reocclusion.

“So, although there are many benefits of smoking cessation, and of course we should actively work with our patients to encourage smoking cessation, patient smoking status should not deter nor delay endovascular intervention,” Wodoslawsky concluded.

Referring to similar findings established by a research team on which he was senior author, Alan Dietzik, MD, chief of vascular and endovascular surgery at Danbury Health Systems in Danbury, Connecticut, commented: “What we also found was that when you intervened on these patients, and improved their quality of life, they’re actually more likely to quit smoking.”

Surgeons must stay skilled in femorotibial/pedal bypass surgery, Paris audience hears

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Surgeons must stay skilled in femorotibial/pedal bypass surgery, Paris audience hears
Peter Schneider delivers his talk

At Paris Vascular Insights (PVI) 2021 (Oct. 21–23, Paris, France), Peter Schneider, MD, University of California San Francisco, San Francisco, emphasized the need for trainees to learn both open and endovascular techniques in a talk on how to remain skilled in femorotibial/pedal bypass.

Schneider recalled that an “extremely important question” when he was a trainee was “how will we learn endovascular?” A couple of decades later, “the shoe is completely on the other foot,” he said, noting that the question now is ‘how will the trainees learn femorotibial bypass or pedal bypass and/or how will we maintain those skills?’

“Bypass is not disappearing,” the presenter declared, referring to a graph showing a downward trend but then a stabilization, at least of cases in the U.S. Instead, bypass is evolving, Schneider stated. “We are going to more distal targets, we are going after endovascular failure, and we are treating patients with worse disease morphology, and worse tissue damage in the foot.”

In addition to this evolution, Schneider noted that “we know a few things about how to get good results from bypass,” giving the example of better wound healing when there is a bypass targeting a specific angiosome.

Turning to the key question of how to remain skilled in bypass surgery, Schneider believes that this should be addressed from a programmatic standpoint that “really depends on the size of your program and the number of bypasses being done.”

PTFE crural bypasses: ‘Very acceptable patency, excellent limb salvage is obtainable with a fairly aggressive approach’

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PTFE crural bypasses: ‘Very acceptable patency, excellent limb salvage is obtainable with a fairly aggressive approach’
Gregg Landis

“The mantra I always use with fellows is bad vein, bad bypass.” Those were the words of Gregg Landis, MD, system chief of vascular surgery at Northwell Health in New York, as he presented an 18-year experience of polytetrafluoroethylene (PTFE) bypasses to tibial and pedal arteries for limb salvage.

Landis was responding to a comment from the floor at the Eastern Vascular Society (EVS) annual meeting (Sept. 23–26) in Charleston, South Carolina, that had pondered the utility of compromised vein bypasses and the “magic solution” to maintaining PTFE bypasses. They “rarely fail because they have a proximal stenosis or distal outflow; they just have failed whether you follow them closely or not,” the questioner said. The bypasses that fail abruptly, commented Landis, fail early. The ones that tend to stay open are seen in patients “who rarely come in.” Perhaps the early failures are down to patient-associated clinical factors, he added.

The study at hand was comprised of two parts: a single-center experience with 118 consecutive patients followed for up to five years from 2013 to 2018 at Landis’ own institution and 32 bypasses derived from five institutions. Among the single-center group, a large percentage were still active smokers at the time of their bypass, Landis pointed out.

Further, 64% of the cases received a direct-to-artery anastomosis, while 36% had a vein patch. Landis showed that bypass patency was 69% at one year and 40% out to five years, while the corresponding limb salvage rates were 72% and “a very, very respectable 53%.” Twenty-one patients required reinterventions to maintain graft patency and limb salvage.

In terms of the multicenter group of patients, Landis explained that the research team looked at patients who had ultra-long-term patency, amassing 32 patients who all had “angiographically proven patency.” Patency ranged from four to 13 years, with a mean of almost six years and many requiring multiple reinterventions, he said.

“Despite their poor current reputation, PTFE crural bypasses are worthwhile for patients facing imminent amputation without other therapeutic options. Mid-, long-, and ultra-long-term patency and limb salvage for such grafts are often achievable,” Landis and colleagues concluded.

Designated discussant Philip Paty, MD, of Vascular Health Partners of Community Care Physicians, in Glens Falls, New York, placed the findings into context, saying: “For critical limb ischemia, autogenous single-piece greater saphenous vein is the conduit of choice for bypass. Sometimes, major leg amputation is the only reasonable option in the compromised patient. But before this point, most of us would agree that, do we use either interventional techniques, or non-autogenous conduits to obtain salvage?”

Previous papers, Paty continued, have shown that patency of prosthetic bypasses, “although poor, are still attended by limb salvage.” In the PREVENT III trial, one-year patency of single-vein greater saphenous vein was 61%, he elaborated. “Has prothetic bypass evolved to explain these improved patency results?” Paty asked. Landis said he did not believe PTFE bypasses have evolved greatly, but rather his data exhibits the efficacy of old technology allied with a “fairly aggressive approach toward surveillance.”

Another question from the floor queried what appeared to be the “cherry-picked” nature of the multicenter group of patients. Landis agreed, explaining the difficulty in obtaining decade-long-type cases. “But I think the common theme in all of these patients was the aggressive approach toward reintervention,” he said.

Senate passes bill to halt 2022 Medicare cuts

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Senate passes bill to halt 2022 Medicare cuts

Last night, the Senate passed legislation to halt Medicare physician payment cuts that were scheduled to take effect on January 1. President Joe Biden is expected to sign the bill into law.

Highlights of the physician payment provisions include a delay in resuming the 2% Medicare sequester for three months (Jan. 1–March 31, 2022), followed by a reduction to 1% for three months (April 1–June 30, 2022); a one-year increase over the final Medicare Physician Fee Schedule Conversion Factor of 3% (0.75% less than the conversion factor “patch” provided for 2021); a one-year delay in the cuts to the clinical lab fee schedule; and a one-year delay in the Medicare radiation oncology demonstration

Additionally, the bill will erase the 4% Medicare PAY-GO cut and prevent any additional PAY-GO cuts through 2022. The SVS Medicare Cuts Task Force has been working to educate legislators and regulators, meeting with members of Congress, writing daily letters, growing the PAC, and more to help fight the cuts.

Matthew Sideman, MD, chair of the SVS Medicare Cuts Task Force said, “Thank you to the many SVS members who wrote, called, and donated to the PAC. Your efforts were essential. Congress doesn’t always move quickly, but yesterday they took a big step in the right direction of remedying the cuts and preserving patient access to care.”  “There is still a lot of work to be done to reach a permanent solution. The care that vascular surgeons provide is valuable, life-saving work, and we will not rest until our healthcare system recognizes that value with real, long-term solutions to reimbursement.”   The SVS CMS Cuts Task Force plans to continue its mission into the new year, working towards ending automatic cuts and establishing a systematic solution that recognizes the incredible value of vascular care in all settings.

New attending call model aimed at fatigue mitigation produces ‘stable’ workflow

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New attending call model aimed at fatigue mitigation produces ‘stable’ workflow
operation in hospital
Operation in hospital

A “paradigm shift” in attending call staffing with a focus on fatigue mitigation can be undertaken in a vascular surgery practice without disruption to clinical productivity, a study presented at the New England Society for Vascular Surgery (NESVS) annual meeting (Oct. 15–17) in Cape Neddick, Maine, demonstrated.

A research team implemented an attending call model similar to a resident “night float” in 2018 with the intention of limiting the number of continuous hours of coverage undertaken. “Attending wellness should be the aim of further interventions and study,” Elizabeth Blazick, MD, a vascular surgeon at Maine Medical Center in Portland, Maine, and colleagues concluded.

They had carried out a comparison of operative work relative value unit (wRVU) productivity before and after implementation of a weekly night call model among attending vascular surgeons at a single tertiary vascular surgery practice.

A total of 10 attending surgeons participated in the model during the three-year study period, NESVS heard. “The total inpatient wRVUs were stable during the year of implementation compared with the previous year, and had increased significantly in the year after implementation,” the researchers reported.

Similar trends were noted in the wRVU/clinical full-time equivalent and total operating room cases, they added.

Amplifi vein dilation system demonstrates ‘encouraging’ clinical results in hemodialysis access

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Amplifi vein dilation system demonstrates ‘encouraging’ clinical results in hemodialysis access

Artio Medical announced that full results from its first-in-human clinical study of the Amplifi vein dilation system were presented at the 2021 VEITHSymposium (Nov. 16–20, Orlando) by Surendra Shenoy, MD, associate professor of surgery in the Washington University School of Medicine at Barnes-Jewish Hospital, St Louis.

“Data from the first five patients treated with the Amplifi system demonstrated more than a doubling of forearm and upper arm cephalic vein diameters following a mean treatment period of 8.6 days,” said Shenoy. “We were able to successfully create an arteriovenous fistula (AVF) using treated veins in all patients and observed rapid and robust AVF maturation. These data are very encouraging, and I believe this technology has the potential to offer a much-needed solution for increasing AVF suitability and reducing maturation failure.”

The Amplifi vein dilation system is designed to stimulate arm vein enlargement prior to AVF creation to make more patients requiring vascular access for hemodialysis eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation rates.

“In this study, three of the five patients had pre-existing problems in the cephalic vein, which were made more apparent by Amplifi system treatment,” Shenoy added.

“In one patient, an AVF was made more proximally and, in another, angioplasty was performed, and both patients went on to have successful AVF maturation and use.”

Review the year in SVS Foundation annual report

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Review the year in SVS Foundation annual report

In a year prominently defined once more by COVID-19, the SVS Foundation nonetheless took some big steps forward, with new initiatives and a big increase in the number of donors (28%) as well as the percentage of Society for Vascular Surgery (SVS) Active members who contributed (26%).

The Foundation is, as the title of its annual report proclaims, “Opening Doors to New Horizons.” Read the report for:

  • Financial highlights
  • The major impact—a 9.5- fold return—of a major SVS Foundation research award program
  • How mentorship influences the profession’s future
  • A donor’s story of why he gives
  • The SVS Foundation’s “honor roll” of donors
  • How to give to the SVS Foundation

Please contribute to the SVS Foundation’s annual appeal today to help it continue to impact patient care and to continue to open doors to new tomorrows in healthcare.

In appreciation, contributors’ names will be included in an “honor roll” of donors on the Foundation website, on the SVS Foundation recognition board at the 2022 Vascular Annual Meeting (VAM) and in the FY22 SVS Foundation annual report.

VSIGs increase early exposure to vascular surgery in med school

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VSIGs increase early exposure to vascular surgery in med school

This month, we are focusing on medical student recruitment into vascular surgery. In many medical schools, students do not get any exposure to the field of vascular surgery (or to vascular surgeons) during the preclinical years, and even during the clinical years, vascular surgery can sometimes be a late find. The introduction of Vascular Surgery Interest Groups (VSIGs) aims to change this “initial exposure” problem.

Here’s my story: I am currently a third-year medical student at the University of Michigan, an executive board member of the vascular surgery interest group (VSIG) on campus, with aims to apply to vascular surgery residency programs.

My involvement in VSIG was quite coincidental. As I mention above, vascular surgery isn’t highlighted in pre-medical training in undergraduate study and only sparsely mentioned in medical school compared to other fields. I came into medical school thinking I wanted to go into a procedural field and work with the circulatory system—which I have always found fascinating. My plan therefore, was to explore fields related to those two criteria. I had no idea that there was an entire field solely devoted to surgery and the circulatory system. Well, I quickly came across interventional radiology, cardiology and cardiothoracic surgery. One day, a friend from my class reached out inviting me (and other M1s) to join the VSIG executive board. That email started a chain of events leading to my exploration of vascular surgery and eventually becoming an active member of the club.

VSIG-UMich helped me learn what vascular surgery really was during my first and second years, when I had limited exposure to vascular surgeons. I remember attending a technology day that was hosted during my MS1 year where company representatives brought stents and simulators, and walked us through their use, indications and deployment. Events like these, as well as panel events, career day presentations, and case walkthroughs were integral for my exposure to the field. VSIG also allowed me to interact with vascular residents, fellows and faculty, and solidify my career choice.

I was lucky to have a VSIG and an engaged section of vascular surgery at my medical school. However, if someone wanted to establish a VSIG in their medical school, there are two key components that I can envision being extremely helpful. The first is a faculty mentor to sponsor the club, and the second is reaching out to an established club at another institution. The faculty mentor can provide resources and input from the department, and the outside club can provide event ideas and a framework to build off. Once the club is started, reach out to the vascular residents! They are closest to medical students in training and often have invaluable advice and contacts to help further your club along.

The great thing about vascular surgery is that the faculty and residents are often very personable and willing to help. VSIGs increase the early exposure to vascular surgery in medical school and if you need assistance starting one, please reach out.

Akul Arora, BS, is a medical student at the University of Michigan Medical School in Ann Arbor, Michigan.

Canadian Vascular: Spin in RCTs

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Canadian Vascular: Spin in RCTs
decline in open surgery aaa
Open repair

A large proportion of statistically nonsignificant randomized controlled trials (RCTs) yielded interpretations that were inconsistent with their results, according to an analysis of 31 manuscripts covering research comparing carotid endarterectomy (CEA) to carotid artery stenting (CAS) for carotid stenosis and endovascular aneurysm repair (EVAR) to open repair for abdominal aortic aneurysms (AAAs).

That was the main finding presented by Allen Li, a medical student at the University of Ottawa, Canada, during the Canadian Society for Vascular Surgery (CSVS) 2021 annual meeting (Sept. 24–25), held virtually. Li et al probed all phase-three RCTs with nonsignificant primary outcomes comparing open repair to EVAR or CEA to CAS.

Spin was identified in nine abstracts and 13 main texts among 18 AAA articles, and seven abstracts and 10 main texts across 13 carotid stenosis studies. For both, “spin was most likely to be found in the manuscript discussion section,” the authors found, and increasing journal impact factor was associated with a statistically significant lower likelihood of grade A spin, or spin in the title or abstract conclusions. No significant association could be found with funding source, they added.

Learn by doing at February SVS PAD workshop

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Learn by doing at February SVS PAD workshop

The Society for Vascular Surgery (SVS) Peripheral Arterial Disease (PAD) Workshop in February will feature four hours of hands-on surgical skills training, on 10 different facets of PAD treatment.

“We are offering the chance for surgeons to be trained by surgeons, by people accomplished in the appropriate surgical techniques and well versed in possible complications and their management,” said Vikram Kashyap, MD. He is directing the workshop with Patrick Geraghty, MD, with assistance from Daniel McDevitt, MD, chair of the SVS Community Practice Section Executive Committee.

Registration opened in early November for the course, which is limited to 75 participants to assure each attendee receives plenty of individual attention. The course will be Feb. 11 and 12, 2022, in Rosemont, Illinois, minutes from Chicago’s O’Hare International Airport.

This hands-on educational workshop represents the start of a new era for the Society, said Kashyap. “Our members have long sought—and SVS leadership has wanted to provide—this kind of hands-on skills training. This is definitely not a standard workshop or conference.”

The 1.5-day workshop features overviews, guidelines, standards of care and case discussions, as well as the skills training. It is geared primarily at younger surgeons who want to learn or practice PAD techniques and procedures. Topics include national trends in open and endovascular therapies, the team approach for limb salvage, imaging, device access, therapies, working in an office-based lab (OBL) versus an ambulatory surgery center and more.

Attendees will practice and perfect hands-on skills in simulations, some using cadavers and some using models, taught by expert faculty. Hands-on training topics include ergonomics and radiation safety, access of pedal vessels (cadaver vs. simulator), closure devices, endovascular embolectomy/thrombectomy, PTA and stent choices, endovascular deep venous arterialization, atherectomy choices and axial imaging. In groups of five, attendees will spend 20 minutes on each topic in two, two-hour sessions.

The faculty will also present information on gaps in outcomes data for chronic limb-threatening ischemia and how to generate viable research steps to address these gaps. For more information and to register visit vascular.org/PADCourse22.

Course organizers call the assembled faculty “world-class and representing a broad cross-section of SVS members,” said Kashyap. “These surgeons are excited to be involved in this first-of-its-kind workshop and to teach what they know to our members,” he said.

Faculty members include Danielle Bajakian, MD, Venita Chandra, MD, Dan Clair, MD, Brian DeRubertis, MD, Bryan Fisher, MD, Elizabeth Genovese, MD, Steve Henao, MD, Vipul Khetarpaul, MD, Norm Kumins, MD, Miguel Montero-Baker, MD, Pat Muck, MD, Inkyong Parrack, MD, Darren Schneider, MD, Peter Schneider, MD, and Eric Scott, MD.

New ACS president aims to sow seeds of hope for enhanced recovery amid pandemic

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New ACS president aims to sow seeds of hope for enhanced recovery amid pandemic

Former Society for Vascular Surgery (SVS) President Julie A. Freischlag recently took over the presidential reins of the American College of Surgeons (ACS). Here she talks to Vascular Specialist about her journey as a vascular surgeon and leader both at the institutional and societal level, what she means by “enhanced recovery” in the aftermath of COVID-19, and the social media campaign she is pushing: #SurgeonsSowingHope.

‘Do not blame the legal system for the present state of medical malpractice’

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‘Do not blame the legal system for the present state of medical malpractice’
O. William Brown

I read with both interest and disappointment Dr. Andrew J. Meltzer’s guest editorial regarding medical malpractice published in the October issue of Vascular Specialist. He unfortunately chose the often traveled, but dead-end road of blaming the legal system for the current state of the medical malpractice system. This approach neglects the basic tenets of medical malpractice law.

To file a medical malpractice lawsuit, an attorney must show that the defendant physician had a physician-patient relationship with the patient, violated the standard of care, that the violation was responsible for the damages, and that the plaintiff did, in fact, suffer damages. The critical component of these requirements, in almost all cases, is the testimony of an expert witness who establishes the violation of the standard of care. This testimony is provided by a physician, not an attorney. Yes, one of our “colleagues.”

In our October print issue guest editorial, Andrew J. Meltzer, MD, took aim at medical liability in vascular practice

If there is no expert, as a matter of law, the case must fail. Do you really believe attorneys can determine whether the standard of care has been violated? They rely on physicians. It is true that attorneys may shop around for a physician who will support their case, but, like it or not, that is their job.

An attorney who has an injured client, and is informed by an appropriately credentialed physician that the injury was the result of negligence by the treating physician, must either file a lawsuit or explain why they are not filing the suit and suggest the client seek another legal opinion. He/ she cannot tell the client that there is no case. To do so would constitute legal malpractice.

For many years, I have encouraged my colleagues to report marginal testimony to the appropriate authorities or societies. However, to my disappointment, this is rarely done. I have suggested that deposition testimony be presented as part of the program of the national society meetings but have been told that to “shame” these doctors would be inappropriate. I disagree. A physician should be willing to defend his/her testimony to their colleagues, or perhaps should not testify.

Do not blame the legal system for the present state of medical malpractice. Physicians need only look in the mirror to find the real source of the problem.

Unfortunately, Dr. Meltzer, you have no case.

O. William Brown, MD, is a professor of surgery at Oakland University/William Beaumont School of Medicine, Auburn Hills, Michigan, and an adjunct professor of law at Michigan State University College of Laws, East Lansing, Michigan.

Rise in cardiovascular disease, vascular surgeon burnout presents a public health crisis, Western Vascular Society hears

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Rise in cardiovascular disease, vascular surgeon burnout presents a public health crisis, Western Vascular Society hears
Michael Conte

Cases of cardiovascular disease are rising across the U.S., with large disparities seen in ethnic groups and poorer geographical areas. In combination with increased burnout in the vascular workforce, this has led to a public health crisis that requires immediate action. These were among the main takeaways from a presidential address delivered by Michael S. Conte, MD, at the 2021 Western Vascular Society (WVS) annual meeting in Jackson Hole, Wyoming (Oct. 16–19).

Ensuring the vascular health of patients is crucial to ensure freedom from pain, disability, physical limitations, emotional stress, and limb loss, to name a few, Conte explained. It is vital patients experience freedom from both mortality due to vascular issues, and escape the treatment burden, to manage quality of life, the outgoing WVS president said. Time away from the hospital is vital to facilitate this; however, vascular health harbors many different perspectives, including patient preference, the primary healthcare provider, the government, and public health agencies, he continued. It is important to consider that the social determinants of health contribute greatly to vascular health.

Determinants include patient income status, education, food security, and social environment. Although this is widely known by healthcare professionals and the general public, there is a lack of information regarding vascular health in circulation, Conte communicated.

The number of cases of heart disease and stroke across the U.S. is rising. In 2010, the American Heart Association (AHA) developed Life’s Simple Seven (LS7), as a measure of cardiovascular health. The seven indicators are smoking, diet, physical activity, body mass index (BMI), blood pressure, total cholesterol, and fasting glucose.

Conte presented data relating to these indicators in the U.S. population. The U.S. performed well with smoking, with numbers at an ideal rate. In contrast, the majority of the population performed extremely poorly compared to those performing ideal or intermediate, explaining that “BMI and physical activity were poorer in adults, significantly impacting cardiovascular health.”

Healthcare disparities

“It is apparent physical activity that BMI, diabetes, and smoking rates are all increasing, according to past trends, with smoking rates presenting the highest in the U.S., compared to all indicators. This rise in indicators will therefore hold impacts on future health and requires attention,” explained Conte. Peripheral vascular disease affects one in 18 adults (25+ years) worldwide, and 8.5 million Americans.

One-third of diabetic Americans over 50 years old also have peripheral arterial disease (PAD), with up to half not displaying symptoms. Of these individuals, one in three will die within five years following diagnosis, with one in three admitted to hospital for myocardial infarction (MI) or stroke, with low ankle-brachial index (ABI).

There are large vascular health disparities among ethnic groups, with African Americans and Native Americans particularly affected. “Amputation in Black Americans sits at two-to-three times higher than the national average,” stated Conte.

Patients with PAD are also commonly overlooked, he said. It is indicated that in comparison to MI or stroke, in patients with PAD, following the event (30 days) fewer patients received statins and less aggressive medical care, despite ongoing research. Not only does this impact ethnic groups, but females and the older population (80+ years) are also highly affected, Conte said.

In May last year, Lizzie Presser of ProPublica shed light on the present amputation epidemic faced by Black Americans in the realm of the mainstream press, Conte noted. Presser detailed a finding that “Hispanic and Black patients experience a greater disease severity at clinical presentation (n=834),” with one in four experiencing amputation following hospitalization from PAD, compared to one in seven in non-Hispanic white patients (n>140,000).

Across all Americans, the rate of diabetes is increasing, with around 10% diagnosed. Conte further pointed out that lower-extremity amputation rates reduced in the 2000s, increasing in 2010, with 60,000 patients receiving toe amputation in 2015. When analyzing amputation patterns across geographical locations, in California, there is a positive relationship between lower-extremity amputation rates and poorer areas, he said. Conte pointed out that in areas “with increased poverty levels, amputation rates are higher.” Additionally, in areas of the U.S. where more Black individuals reside, amputation rates are higher, indicating a clear health inequality. Research also found that Black Americans with vascular disease are less likely to receive revascularization, with white Americans receiving treatment at a higher rate. In this light, Conte concluded there is a positive “strong relationship between Black individuals, lower-income and increased amputation risk.”

‘Lend a hand, save a leg’

To tackle this disparity, the Society for Vascular Surgery (SVS) launched the Vascular Volunteers in Service to All (VISTA) initiative, with the catchphrase, “lend a hand, save a leg,” Conte continued. VISTA launched pilot programs across underserved areas of the country like the state of Oklahoma in an attempt to drill into the underlying issues.

There have been several initiatives that aim to work with these vascular health disparities. The WVS Diversity, Equity and Inclusion Committee launched a program in 2021, based on “healthcare disparities in vascular surgery: identifying inequalities and improving outcomes,” Conte said.

The Society for Vascular Surgery (SVS) has also taken steps to tackle this issue, with member numbers currently increasing. However, only half of these members are practicing vascular surgeons in the U.S.

Conte reported a public health crisis of physician burnout: It is predicted that until 2040, the U.S. will face a shortage of surgeons, leading to increased cases of burnout, he said—echoing a theme reported at other recent regional meetings.

More than 50% of U.S. physicians self-reported burnout, highlighting the extent of the problem.

With the increasing prevalence of cardiovascular disease, burnout in vascular surgeons presents a growing public health concern, due to the impact on the adequacy of the vascular surgery workforce, he added.

Re-emerging from the pandemic: ‘What truly motivates us?’

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Re-emerging from the pandemic: ‘What truly motivates us?’
Alan Dardik

How to find “flow” and motivation through goal setting, and reacquainting with “intrinsic priorities” on the other side of the COVID-19 pandemic, formed the basis of the presidential address delivered by Alan Dardik, MD, at the New England Society for Vascular Surgery (NESVS) annual meeting in Cape Neddick, Maine (Oct. 15–17).

Dardik spoke of how the virus had highlighted the necessity of humility and actually harbored two pandemics: one of SARS-CoV-2 itself, the other “ignorance, stupidity and denial.”

Yet, as the pandemic rumbles on into the distant future, the Yale School of Medicine, New Haven, Connecticut, professor of vascular surgery posed the question of how to restart?

“How do we carry on?” Dardik asked the NESVS gathering. “How do we establish our new normal? Indeed, what is normal now? How do we get back to our lives? Do we want to go back to our previous lives? How do we determine what are our new lives and habits? How do we restart?”

Quoting the book Drive by Daniel Pink, Dardik pondered its practical lessons for life in a post-COVID-19 world. “We must set our own goals and remember our own intrinsic priorities,” he said. “For us, New England vascular surgeons, I believe this is relatively straight forward: Be the best surgeon you can be. Do not focus on your compensation, but remember why you entered this noble, revered, sacred profession: to help others and advance the art and science of healing for patients with vascular disease. In these paths, nothing has changed during the pandemic; we need to continue to focus on our goals and direct our own lives; this is autonomy. We need to extend and expand our capabilities, mastery. And we need to live a life of purpose.”

Dardik turned to the concept of “flow,” describing it as a state of being “totally invested” in an experience without consciousness of time—such that “if you have lost track of the time during this address, then you are in flow right now,” he told those gathered.

“As surgeons we all feel flow when the operation goes, and seven hours pass without a thought or an attention to the phone ringing or even an urge to eat or pee; it is why we are all terrible judges of the time we spend in the case,” Dardik explained. “It is what we all hope to feel, and what my father told me is the best part of the day. I also tell my students that operating is truly an escape from the outside world and a sincere pleasure. My wife can tell from the look on my face when I come home what I was doing that day; being a surgeon in the operating room, in flow, helping another person through their vascular issues, saving limb and life. This is why we all do this.”

To the question of restarting then? He offers not an answer but a suggestion: Get into the operating room and get lost in flow. “If you do not spend much time in the operating room or with patients, as some career directions sometimes evolve, then find your activities that give you flow,” Dardik said.

“Identify when you are naturally in your flow state. Learn how to get into it by working backwards. Understanding the benefits of flow can reinforce the habit. And start trying to shift into your flow state on purpose. Time is our most precious commodity. We cannot invent more of it. We can make more money, exercise to gain strength, even make or adopt or marry into more family members. We can buy another home and certainly fill it with more ‘stuff.’ We can learn a new skill. But we cannot make more time.”

The quest to continually reinvent vascular surgery to provide empathetic, patient-oriented, and personalized care to patients carries on regardless, Dardik added. “We can restart our lives not after the pandemic, but right now, as the pandemic continues. We can achieve flow and all else will follow.”

Clinical evaluation of robotic-assisted peripheral artery intervention in human completed

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Clinical evaluation of robotic-assisted peripheral artery intervention in human completed

Aopeng Medical’s Allvas endovascular intervention surgical robot has successfully carried out a first-in-human clinical evaluation of a robot-assisted peripheral artery intervention of an iliac artery in the department of vascular surgery at Changhai Hospital in Shanghai, China.  

The procedure was performed by Qing-Sheng Lu, MD, and colleagues. The endovascular intervention surgical robot, combined with digital subtraction angiography (DSA), precisely evaluated the target lesion and location, and completed a refined operation process to better ensure the safety of the procedure, reduce iatrogenic injury, and reduce the incidence of complications and postoperative reintervention rate, a press release from Aopeng Medical reports.

According to Aopeng Medical, the Allvas endovascular intervention surgical robot is the first platform-robot in peripheral artery intervention with independent intellectual property rights in China. Its core technology covers robot architecture design, robotic arm and actuator process design, force feedback mechanism, software algorithm and automated surgery, and system integration. Aopeng Medical claims that the Allvas is the world’s first universal peripheral artery interventional robot. Early this year, the company completed what it asserts to be world’s first in-human clinical trial of robot-assisted endovascular aortic repair of thoracic aortic aneurysm and abdominal aortic aneurysm. 

The traditional surgical treatment has numerous side effects, such as high trauma, high risk, difficulty and multiple complications. In comparison, Aopeng Medical alleges that its endovascular intervention surgical robot, Allvas, can achieve precise positioning through digital technology, which meets specific needs from the individual patient. The company adds that Allvas is also expected to reduce the radiation dose received by the operator by more than 90% and improve the precision of surgical manipulation, thus helping physicians to achieve higher efficiency and more satisfactory effects in clinical practice. 

Open repair: In good hands?

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Open repair: In good hands?

The twin issues of center volumes for open AAA repair as well as training implications came under the spotlight at two recent regional vascular conferences.

The volume of elective open abdominal aortic aneurysm (AAA) repairs that medical centers perform directly correlates with the outcome measure “failure to rescue,” or in-hospital death after a patient experiences a complication—with a nearly 10% decreased risk evident for each additional five cases per year an institution performs, the New England Society for Vascular Surgery (NESVS) annual meeting (Oct. 15–17) in Cape Neddick, Maine heard.

The findings were part of an analysis of all elective open AAA repair procedures included in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) between 2003 and 2020.

Against a backdrop of debate over the annual center volume-mortality relationship and varying minimum procedure volume recommendations, the researchers behind the VQI study identified failure to rescue as “an attractive alternative outcome measure” due to the fact it judges overall team and hospital system performance, and is a composite measure, therefore “is less sensitive to risk-adjustment errors and may further improve discriminations for inter-hospital quality comparisons.”

The work was led by senior author David H. Stone, MD, a professor of surgery and program director at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and Salvatore Scali, MD, a professor of surgery and program director at the University of Florida in Gainesville, Florida, who delivered the findings before the NESVS meeting.

The team set out to measure the impact of failure to rescue on elective open AAA repair outcomes and its association with center volume, as well as to determine the factors associated with failure to rescue. The analysis was performed on data from 218 VQI hospitals. Some 9,700 open repairs were retrieved, with 32% found to have at least one postoperative in-hospital complication recorded. Among the 3,176 patients experiencing a complication, 10% died in hospital—representing the failure-to-rescue cohort, Scali explained.

“We determined that older patients, and women, as well as subjects with higher comorbidity burden, larger AAA diameters, and any history of prior aortic surgery were all significantly more likely to be present among the failure-to-rescue cohort,” Scali told those gathered. Technical differences were also noted between the two groups, he added. Recommended adjuncts including decreased epidural use occurred in the failure-to-rescue cohort, while variables associated with greater operative complexity and greater blood loss were more common among the same group.

Unadjusted analysis showed center volume was inversely associated with failure-to-rescue rates: There was a 9% decrease in risk for each additional five procedures per year a center performed, Scali said. Some 73% of VQI centers performed less than 10 open repairs per year—the current SVS-endorsed volume threshold. Yet, Scali pointed out, they accounted for around a third of all open AAA repairs nationally.

“When adjusting for demographics, comorbidities and procedure-related factors, patients undergoing elective open AAA repair at centers performing more than 10 AAA repairs per year had a 50% reduction in the likelihood of experiencing failure to rescue,” he continued.

When exploring the association between the number of postoperative complications and subsequent probability of failure to rescue, “significant differences” were detected. For example, if a patient experienced two postoperative complications, they had a more than three-fold likelihood of experiencing failure to rescue compared to a patient suffering a single complication, the researchers found.

“This difference is further amplified when looking at patients experiencing two vs. three or more complications,” Scali said. “Specifically, a seven-fold increase in predicted risk of failure to rescue occurred in patients experiencing three or more complications when compared to those cataloged as having two complications. Finally, the difference between a single complication and three or more complications was exponential, with a 24-fold relative risk increase being present.”

In terms of specific types of complications and the predicted risk of failure to rescue, Scali and colleagues found that renal complications had the lowest predicted rate. By comparison, a postoperative cardiac complication had a nearly three-fold higher risk, while a return trip to the operating room (OR) for bleeding was associated with a nearly 12-fold increased risk compared to a renal complication.

“Center volume does appear to be an effective proxy for quality given its strong association with failure to rescue,” Scali concluded. “A majority of centers fail to meet SVS-endorsed volume thresholds, which may have implications for outcome reporting and inter-hospital comparisons. Crude volume-based comparisons alone may be suboptimal in discerning high-quality AAA care among centers nationally.”

Context of failure to rescue

In an interview with Vascular Specialist, Scali said the varying open repair volume thresholds posed for optimal care begged the question: “Is there a better way?” Regionalization of aortic care, while worthy, works in small countries with single-payor systems and “relatively monochromatic societies,” but less so in continental-sized countries and markets in the form of the U.S., he said.

Furthermore, there are low-volume centers “that perform well, that don’t meet the thresholds” but on average can deliver quality care, Scali continued. “How do you align so that when you go to a lower-volume hospital, you know you are going to get high-quality care? How do you make the lower-volume centers look like the higher-volume centers?”

That’s where failure to rescue comes in, Scali said. “There are so many ancillary services required, and, most importantly, that postoperative care—the surveillance that occurs both in-hospital and out-of-hospital—and having robust processes of care are probably the biggest determinants of the outcome.” Surgeon-level factors, too are important, “but if you really want to align these lower-volume hospitals with higher-volume hospitals you have to target metrics that measure team performance.”

These new results help characterize patterns of complications—particularly those deemed high risk, Scali added. “Where [our study] sheds new light—yes, the volume-outcome relationship is known—is that failure to rescue further validates this based on our dataset. But, more importantly, if low-volume centers are going to continue to do this work, they might want to develop processes of care that target very high-impact complications, for one.

“As we’ve shown in our work, things like a return to the OR for bleeding, or patients who have a postoperative pulmonary complication, to name a couple of high-profile complications; those are key patients that, when those complications occur, are at the highest risk of having a downstream event that leads to failure to rescue and in-hospital death. So, you would want to do everything you can to reduce the risk of those events. And if those events did occur, those are where the resources in these low-volume hospitals need to be focused.”

Future of open aortic education

At the Western Vascular Society (WVS) annual meeting (Oct. 16–19) in Jackson Hole, Wyoming, meanwhile, a research team from Stanford University, California, presented data on the future of open aortic education, finding that with the incidence of open AAA repair decreasing nationally, practice shifting toward teaching hospitals, and opportunities for training declining amid the continuing adoption of endovascular aneurysm repair (EVAR), “open aortic reconstruction for aortoiliac occlusive disease is rising among trainees.”

Delivering the results, Stanford vascular surgery chief resident Elizabeth George, MD, told WVS attendees: “Just from our back-of-the-envelope calculations and looking at national volumes, these aortic volumes, at least from those at teaching hospitals, are adequate to meet graduation requirements. However, strategies to maintain and maximize the education as well as the experience from these cases should be top priority for vascular surgery program directors.”

George and colleagues set out to explore how evolving endovascular technology has transformed open aortic surgical education. To do so, they probed the National Inpatient Sample (NIS) for open AAA repair as well as aortoiliac occlusive disease estimates between 2006 and 2017. They also looked at Accreditation Council for Graduate Medical Education (ACGME) case volumes for the same procedures among vascular surgery residents and fellows graduating during the same time period. In the NIS, George and colleagues found significant decreases in volume for both total open aortic repair volume and open AAA, with open repair for aortoiliac reconstruction seeing a far less steep decline. Meanwhile, the ACGME data showed that in 2006, graduating fellows could claim an average of 19 open AAA repairs, George reported. However, this figure had dropped to 11 by 2017. On the other hand, the equivalent statistic for aortoiliac occlusive disease increased over the same time span, she said. Data derived for those in integrated vascular surgery residency told a similar story, she added.

‘Refreshing’ data

Designated discussant Benjamin W. Starnes, MD, the vascular surgery chief at the University of Washington in Seattle, called the data presented by George and colleagues a “refreshing” interlude amid previous forecasts spelling out “doom and gloom” in light of vascular trainees not gaining enough open surgical experience in order to achieve competency. “Facing an increase in vascular disease, an aging population and the silver tsunami, better cancer therapies and patients surviving longer to develop vascular disease, and more minimally invasive methods to treat these patients, we’ve now grown at the University of Washington from six to 16 vascular surgeons in just 15 years,” he said. “Our open experience has only increased for our trainees rather than decreased.”

Starnes placed this into context with data from his institution for the last year: He found that 38% of the aortic cases with which he was personally involved were open repairs, and went on to ask George how other types of exposures should be counted toward open aortic surgery for the ACGME.

“Since vascular surgery itself has evolved over the past 20 or 30 years, I think the metrics with which we measure our trainees should also change in kind,” she said.

‘Female sex predicts reintervention after elective EVAR for AAA’

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‘Female sex predicts reintervention after elective EVAR for AAA’
William Beckerman at the EVS 2021 podium

Females were found to be at greater risk of reintervention following elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) at both the one- and five-year mark following their initial procedure, researchers in New Jersey discovered.

The retrospective chart review conducted by first-named author Taylor Corsi, BS, a medical student at Rutgers Robert Wood Johnson Medical School in New Brunswick, senior author William Beckerman, MD, a vascular surgeon at Robert Wood Johnson University Hospital, and colleagues showed freedom from reintervention rates of 86% for females vs. 96% for males at one year (p=0.02) and 69% (female) vs. 86% (male) at five years (p=0.03).

Delivering the data at the recent Eastern Vascular Society (EVS) annual meeting (Sept. 23–26; Charleston, South Carolina), Beckerman told attendees the findings “support recent conclusions that, despite similar one- and five-year mortality, females do have a higher rate of early and long-term postoperative morbidity such as reintervention.

“This refutes the suggestion that comparable outcomes using a single device and trial inclusion criteria can be applied broadly.”

The Rutgers data, from 2011 to 2016, include 185 patients—75% of them men, with 25% women. The research team looked at primary outcomes of survival along with freedom from reintervention at one and five years. Secondary outcomes analyzed were postoperative intensive care unit (ICU) stay and 30-day readmission.

The researchers found no statistically significant difference in postoperative ICU stay or 30-day readmission rates between the sexes but a trend toward significance in terms of more females requiring an ICU stay after their initial operation. Similarly, they did not detect a statistically significant difference in one- and five-year survival rates.“Looking at reintervention, we did see a difference at both one and five years in terms of freedom from reintervention between males and females, with females having a greater risk of reintervention at both of these time points,” Beckerman explained.

“With the reinterventions, there was a little bit of a drop right from the beginning, which was associated with more access site complications in females, whether that was in the iliac artery in terms of dissections, thrombosis or from the common femoral access, whether percutaneous or open. As time went on, it mostly trended toward an endoleak intervention as a cause for reintervention in these patients.” On multivariate analysis, female sex alone predicted increased five-year risk of reintervention (p=0.02), Beckerman added.

He concluded: “Female sex was independently associated with one- and five-year reintervention and not survival. We did find that there were sex-specific factors that contributed to greater surgical morbidity after elective EVAR. This is one of the only studies to our knowledge that utilizes the full depth of institution-specific data with five-year follow-up. And it provides real-world evidence in support of a need to study devices in a more heterogenous population, especially getting more women enrolled in trials for these devices.”

Beckerman conceded limitations, including the fact the data were drawn from a few hundred patients at a single tertiary care center. He said the research team intends to study more recent patients to account for the development of smaller devices and also plans to collaborate with non-tertiary care centers “to better evaluate representative outcomes.”

Speaking from the audience, incoming EVS President Robert Y. Rhee, MD, pointed out the preponderance of men in investigational device exemption (IDE) trials, which, depending on the subset, can consist of 80–90% men, he said. Beckerman added: “No one is expecting a 50-50 split just because there is not a 50-50 split in terms of aneurysms being treated in women vs. men but it would be nice to see, at the very least, a study population that is equivalent to the population that is being treated.”