This advertorial is sponsored by Penumbra, Inc.
Adam Reichard, MD, discusses the use of Lightning Bolt 7® computer-assisted vacuum thrombectomy (CAVTTM) as a first-line option across a wide spectrum of challenging lower extremity acute limb ischemia (ALI) cases, including patients with Rutherford classification IIb ALI.
Two cases stick out for Reichard where he used Lightning Bolt 7 (Penumbra) CAVT as his first-line therapy for patients who require urgent management for lower extremity ALI. Both patients were diagnosed with Rutherford IIb lower extremity acute limb ischemia. And both saw clinical improvement following use of the Lightning Bolt 7 device, notes the vascular surgeon in the TriHealth hospital system based in Cincinnati, Ohio.
For Reichard, the specter of Rutherford IIb cases is a key point of contention. The level of threat to the limb is so great, open surgery would be the traditional approach. Yet, as Reichard has observed in recent years, the landscape has shifted. In these patients, an endovascular-first approach is increasingly the go-to option. For evidence, he points to the STRIDE study, which looked at 30-day outcomes after first-line use of the Indigo and Lightning portfolios in cases of ALI, including Rutherford I, IIa and IIb patients.
“If you’re talking to vascular surgeons who treat this disease pathology, they would agree that it is routine to start with an endovascular approach in someone who has Rutherford I or IIa ischemia, but, when you get into IIb territory, and you know it’s a more threatened limb, then people might be a little more reluctant,” Reichard explains. “However, the STRIDE study did a great job showing that, even in patients with Rutherford IIb ALI, at 30 days you’re going to salvage more limbs and mortality is going to be lower if you start with percutaneous thrombectomy, including computer-assisted vacuum thrombectomy technology, as opposed to open surgery.”
Thirty-day outcomes from STRIDE—a prospective, single-arm observational study carried out at 16 international sites among 119 patients with lower extremity ALI—showed rates of 98.2% for limb salvage, 89.4% for patency, 3.4% for mortality and 4.2% for periprocedural major bleeding.1 This compares to rates of 83.1% (limb salvage),2 78.6% (patency),3 13.2% (mortality),4 and 21% (major bleeding)5 in the setting of open surgery, as recorded in the literature.
During his fellowship years, Reichard watched as endo-first took hold. “When I first started in practice, it wasn’t too long after the Lightning Bolt 7 catheter had been released,” he says. “I got the opportunity to use it in training, as some of my mentors had embraced endovascular-first for lower extremity ALI, and I saw how effective it was. When I went out into practice, I told myself that was going to be my practice pattern when it was appropriate.”
Reichard recalls of those first two patients he treated, both Rutherford IIb: “They
had pain, sensory dysfunction and motor dysfunction, and traditionally we would have taken them to the operating room for a cutdown and open embolectomy or thrombectomy.”
In the first case, a female patient with a prior aortobifemoral graft, Reichard explains, a Lightning Bolt 7 catheter was used in her leg from the common femoral artery down to her foot. “At the end of that case, she had palpable pulses and, a few hours after that, when I went to check on her, she said that her leg and foot felt much better, and it looked much better clinically too,” he says. “That is someone who traditionally probably would have ended up—at least—with a groin incision and a femoral dissection, but probably with a below-the-knee popliteal artery cutdown and dissection.”
The second patient, a male in his 80s with a prior endovascular aneurysm repair (EVAR), underwent a femoral dissection and cutdown to directly access his superficial femoral artery. A Lightning Bolt 7 catheter was similarly used to thrombectomize his leg.
In this case, Reichard acknowledges a possible paradox. “People could argue that if you’re already open, and you already have the femoral vessels exposed, why not just pass a Fogarty balloon embolectomy catheter. However, my issue with that is that you’re sending a balloon catheter blindly down the leg and looking for back bleeding. You do your on-table angiogram at the end of the case to see what your outflow looks like. More often than not, you’re going to end up doing adjunctive endovascular procedures trying to touch that up.”
Reichard argues that, in this case, taking an endovascular-first approach from an open exposure provided visibility on the outflow vessels, ultimately proving to be “more effective and efficient.”
The gravity and complexity of an ALI diagnosis weigh heavily. In-hospital and 30-day mortality rates are up to 9% and 15%, respectively, Reichard points out. Amputation rates can reach 15% at discharge and 25% at 30 days, he continues.
“Something that is most important to consider is that if a patient comes in with ALI, mortality at five years is almost 50%, so obviously there is a lot of morbidity and mortality associated with this issue.”
The safety and effectiveness of endovascular devices mean the shift to endo-first practice patterns like the one adopted by him and his colleagues at TriHealth are increasing, Reichard says. “We know that about 86% of patients with ALI that go for an open embolectomy or thrombectomy end up needing additional endovascular work while you are in the operating room.”
The rapid development of CAVT has led to greater clinical gains as new iterations of the technology have rolled out, Reichard observes. “When the Lightning devices came out, that really mitigated blood loss during procedures. At that point, I think people were a lot less reluctant to use those devices first-line.”
As a vascular surgeon with the skills to pivot to open surgery should the need arise, Reichard says the endo-first approach infrequently leads to the need for bailout procedures. “These devices are so effective at clearing thrombus, even in the tibial vessels, that it has really minimized the need for open surgery for tibial thrombectomies. Also, if a Rutherford IIb lower extremity ALI patient comes in and you are able to de-bulk the majority of that thrombus endovascularly, when we’re still endo, more often than not, we have the option of adjunctive catheter-directed thrombolysis, which we don’t often need to do. Once we’re open, that is taken off the table.”
Lightning Bolt 7 occupies an intriguing position in the shift toward endo-first, Reichard adds. “The fact that the device uses a dual clot detection algorithm—pressure and flow based—is important in these cases, allowing for quicker clot detection and patent flow. What we want in these cases is effective thrombus removal, but we also want to try to mitigate blood loss. This catheter, its algorithm, effectiveness and safety are what makes it more effective in managing these patients.”
References
- Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584–592.e5. doi:10.1016/j.jvs.2023.10.062
- Veenstra EB, van der Laan MJ. Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. 2020 Feb;71(2):654–668.e3. doi:10.1016/j.jvs.2019.05.031
- Grip O. Wanhainen A, Michaëlsson K, Lindhagen L, Björc M. Open or endovascular revascularization in the treatment of acute lower limb ischemia. Br J Surg. 2018 Nov;105(12):1598–1606. doi:10.1002/bjs.10954
- Taha AG, Byrne RM, Avgerinos ED, et al. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg. 2015 Jan;61(1):147–157. doi:10.1016/j.jvs.2014.06.109
- Kolte D, Kennedy KF, Shishehbor MH, et al. Endovascular versus surgical revascularization for acute limb ischemia: a propensity-score matched analysis. Circ Cardiovasc Interv. 2020;13(1):e008150
This interview was sponsored by Penumbra, Inc. Adam Reichard is a consultant for Penumbra.
Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.
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