This advertorial is sponsored by Laminate Medical Technologies.
At the 2024 Charing Cross (CX) International Symposium (April 23–25) in London, England, the Vascular Access Masterclass Controversies session delved into the question, “We have new technology, but do we need it?” Among the notable presentations, Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Hospitals in Raleigh, North Carolina, ignited discourse on whether extravascular support should redefine the standard of care in surgical fistula creation. Advocating for the adoption of the VasQ extravascular nitinol support by Laminate Medical, Dillavou underscored its potential to address numerous prevalent challenges in fistula creation, positioning it as a pivotal innovation in dialysis access.
“Sometimes, it is difficult to see a change in the standard of care as it happens,” Dillavou said as she began her presentation, acknowledging the gradual evolution of medical standards and drawing parallels with the transformative impact of guidelines such as those set forth by the Kidney Disease Outcomes Quality Initiative (KDOQI) in the United States. “We can look back in the U.S. and see that the KDOQI guidelines emphasizing fistula use definitely changed the way we practiced. [They] made more fistulas available for standard use, but it came with costs like increased catheter use, more procedures per usable fistula and a decrease in primary patency results.”
Dillavou emphasized the need for enhanced access solutions with fewer interventions, lower infection rates, and faster maturation, highlighting that “the VasQ device can solve a lot of these problems” by mitigating common issues encountered in standard fistulas, such as stenosis and aneurysmal dilation by “keeping the fistula at an optimal angle and offering support to that dissected area of the vein to counteract the shear stress.”
Central to her argument were compelling datasets supporting VasQ’s efficacy. Referencing studies including a randomized controlled trial by Nikolaos Karydis, MD, assistant professor in general and transplant surgery at the University of Patras in Patras, Greece, and research by Robert Shahverdyan, MD, head of vascular access at Asklepios Klinik Barmbek in Hamburg, Germany, Dillavou showcased consistent improvements in maturation rates and primary patency with VasQ utilization. Furthermore, she presented findings from an ongoing study comparing VasQ to conventional methods, indicating superior functionality and patency outcomes with the device and pointed to Shahverdyan’s long-term success using the device as standard of care.
“When [Shahverdyan’s] practice shifted to using VasQ as part of his standard of care, he had a drastic reduction in primary failures and an increase in primary patency at six months,” said Dillavou, who also referred to a study that she had contributed to that compared VasQ to historic controls. “In the U.S., when we contrasted VasQ fistulas to historic controls, we found increased functionality at three and six months, and increased primary patency at all time-points. When we look at the body of literature in historic unsupported fistulas versus VasQ, we see a clear trend towards enhanced patient outcomes when they are externally supported.”
Beyond immediate postoperative benefits, Dillavou emphasized the long-term advantages of VasQ providing permanent structural support. Drawing from retrospective analyses, she illustrated reduced catheter days, decreased infection-related hospitalizations, and diminished incidences of complications such as steal syndrome and aneurysm formation. “This global view shows that patients have fewer catheter days and have fewer infection-related hospitalizations at one year. We also see that two years after creation with an external support device, we are seeing fewer instances of steal, and we’re seeing less aneurysmal formation,” said Dillavou.
Addressing concerns regarding costs, Dillavou highlighted substantial cost savings estimated based on the existing clinical data. The potential for significant healthcare expenditure reduction with VasQ integration has been replicated in multiple countries, such as the United Kingdom, Italy, Germany and the U.S. She also highlighted that VasQ has now reached Asia with Yong Enming, MD, and Zhang Li, MD, both from Tan Tock Seng Hospital in Singapore, underscoring global interest in exploring both the clinical and economic implications of VasQ adoption.
Following Dillavou’s presentation, audience participation was invited, leading to inquiries delving into technical considerations and comparative efficacy, with insights provided by panelists including experienced VasQ users like Shahverdyan and Nicholas Inston, MBBS, a consultant surgeon at University Hospitals Birmingham in Birmingham, England.
Speaking to Vascular Specialist regarding the role that VasQ has to play in the future of arteriovenous fistulas (AVFs), Inston, the session’s moderator, said: “The signal coming from multiple global studies consistently shows that VasQ has better outcomes than those in traditional surgical studies. If we strive to improve the outcomes of AVFs, we need to take these data seriously.”
Shahverdyan also shared his thoughts on the device, saying: “Looking at our experience of over six years with almost 300 VasQ implants—mostly for radiocephalic AVF creation, which historically have shown to fail more commonly—and the existing evidence throughout the globe on the outcomes of VasQ device, it consistently demonstrates significantly better outcomes in dialysis patients with extremely low safety concerns: we have observed zero cases of infection, steal or juxta-anastomotic aneurysms. Hence, it is justified to say that we as caregivers should provide our patients with best possible treatment options and consider the application of the VasQ device as standard of care.”
The discourse surrounding VasQ at the CX Symposium underscores a paradigm shift in dialysis access management, with mounting evidence and key experts heralding its potential role as a transformative standard of care. Of course, skepticism still exists based on the bulk of VasQ’s evidence from observational studies, especially compared to the numerous randomized controlled studies for technologies like drug-coated balloons (DCBs).
In response to comments regarding the level of evidence for VasQ in comparison to DCBs, Dillavou closed out the discussion by stating that “there’s more agreement in the VasQ device than there is for DCBs.” This statement highlights that the strength of the VasQ data has been in the consistent clinical benefit across multiple studies that is not typically observed for many new technologies.
Learn more about VasQ at laminatemedical.com.
