Early Experience

Early Experience with the FoxHollow SilverHawk Plaque Excision System in the Treatment of Infra-inguinal Peripheral Arterial Disease.

David P. Lorenz, Adam A. Skolnick, Lawrence A. Garcia
Beth Israel Deaconess Medical Center, Boston, MA.

Background: Optimal endovascular therapy for treatment of infra-inguinal peripheral arterial disease (PAD) are not well established. We report our initial experience and peri-procedural outcomes with a novel endovascular plaque excision (PE) device for treatment of peripheral arterial disease without need for adjunctive balloon dilation or stent placement.

Methods: Fifty-four infra-inguinal interventions were performed on superficial femoral artery (n=32) and popliteal/tibial (n=22) vessels in patients with chronic peripheral arterial disease or those with threatened limb ischemia. All patients had symptomatic claudication, (n=49) or had rest pain or ulceration (n=5). All patients were treated with PE using the Silverhawk® (FoxHollow, Redwood City, CA) system.

Results: The pre-procedure average ankle-brachial index (ABI) was 0.6 (range 0.16-0.8). Four patients underwent PE for restenosis. The pre-procedure lesion stenosis by quantitative angiography was 86.1% and the mean lesion length was 5.6 cm. Ten vessels were totally occluded at the time of treatment. Successful PE occurred in all patients. Following PE, mean diameter stenosis was reduced from 86.1% to 11.8%. Eighteen patients underwent adjunctive angioplasty (PTA) at the index procedure. Acute complications included emboli (n=2) and perforation (n=1). ABI's improved 30.3% (5-114%) in the follow-up period (average 114 days). No limb loss occurred in the peri-procedural period or follow-up. Clinical restenosis requiring treatment only occurred in those patients undergoing adjunctive PTA or stenting (17%) compared with none treated with stand-alone PE (p<0.05).

Conclusions: Treatment with the SilverHawk® PE system appears safe and effective in the treatment of infra-inguinal atherosclerotic disease for both symptomatic claudication and limb salvage. These data suggest that adjunctive use of PTA and/or stent may lead to increased risk of restenosis when compared with stand-alone PE. Plaque excision without adjunctive balloon or stenting therapy appears effective in the treatment of infra-inguinal and infra-popliteal peripheral vascular lesions. These data require confirmation in randomized clinical trials.