Microincision vessel preparation system effective in patients with PAD
A vessel preparation system involving microincisions used before endovascular treatment for peripheral artery disease was associated with good outcomes at 1 year, researchers reported.
“Long, complex lesions benefit from continuous, controlled-depth, circumferential microincisions” with the system (FLEX Vessel Prep System, VentureMed Group), Thomas Zeller, MD, PhD, associate professor of angiology at Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany, said during a presentation at the virtual Leipzig Interventional Course. He presented the data on behalf of the physician investigators at HFR-Hôpital Cantonal Fribourg, Switzerland.
For the retrospective, investigator-initiated study, the researchers analyzed 65 patients (mean age, 72 years; 60% men; mean lesion length, 196 mm) treated with the system who were Rutherford class 2 to 6 and had de novo lesions with at least 70% stenosis in the superficial femoral or popliteal arteries. All patients had the microincisions before treatment with an uncoated balloon, a paclitaxel-coated balloon (Freeway, Eurocor) or a stent.
“Proper vessel preparation mitigates adverse effects of balloon-based angioplasty such as dissections and vessel recoil,” Zeller said during the presentation. “In addition, it addresses barriers to drug transfer in lesions with mixed or complex lesion or plaque morphologies, including calcification. The device is designed to induce microincisions. The first step of the procedure is crossing the lesion with a guidewire to advance the device distal to the lesion and then to expose its three blades to the vessel wall. These surgical microblades are self-sizing and the retrograde pullback of the dynamic struts allows continuous engagement along the entire length of the lesions. Microincision blades create circumferential, controlled-depth, continuous microincisions and release circumferential tension, improving vessel compliance, enabling luminal gain and minimizing vessel trauma and complications.”
The procedural success rate was 100%, procedure-related adverse events occurred in 4.6% of patients and 16.9% of patients received stents, Zeller said.
At 1 year, 93.7% of patients were free from target lesion revascularization, there were no cases of major amputation and the mean reduction in Rutherford class was 2, Zeller said, noting there were two non-procedure-related deaths, one at 1 month in a patient aged 87 years and one at 3 months in a patient aged 95 years.
“Plaque modification with microincisions may improve acute outcomes that lead to better long-term outcomes in peripheral artery disease patients,” Zeller said during the presentation. “Further prospective study is warranted.”
Editor’s Note: This article was updated on Feb. 9, 2021 to reflect modifications to the data and other changes requested by Dr. Zeller.
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Zeller T, et al. Clinical trial updates – SFA. Presented at: Leipzig Interventional Course; Jan. 25-29, 2021 (virtual meeting).
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