Early Procedural and Clinical Outcomes

Early Procedural and Clinical Outcomes for a Novel Method of Revascularization in Critical Limb Ischemia: Limb Salvage with SilverHawk Plaque Excision

David E. Kandzari, Atul Chopra, Roger Gammon
Duke Clinical Research Institute, Durham, NC; Austin Heart, Austin, TX

Background: Critical Limb Ischemia (CLI, Rutherford-Becker ≥5) in patients with PAD is associated with substantial morbidity and mortality. While many CLI patients undergo limb amputation, fewer than half ever ambulate again with a prosthesis, and 2-year mortality approximates 50%. A novel plaque excision catheter (SilverHawk [SH], FoxHollow Technologies) effectively removes atherosclerotic tissue without plaque displacement, embolization or vessel dilatation. We sought to determine the safety and efficacy of plaque excision in patients undergoing catheter-based revascularization for CLI.

Methods: For patients with CLI (Rutherford-Becker ≥5) and for whom surgical amputation was recommended, percutaneous revascularization using the SH catheter was performed. The study endpoint, post-procedure clinical success, was defined as: (1) freedom from limb amputation, (2) visible healing of ischemic tissue, or (3) 'lesser' amputation than planned before SH procedure. Secondary endpoints included procedural success (<50 % residual stenosis, no major complications) and all-cause mortality.

Results: Plaque excision was performed in 16 patients (34 lesions) (Table 1). Eleven patients had multi-level disease. Lesion locations included: external iliac (3%), common femoral (9%), superficial femoral (35%), profunda (3%), popliteal (15%), anterior tibial (15%), posterior tibial (3%), peroneal (12%), tibio-peroneal trunk (3%), and femoral-popliteal graft (3%). Immediate procedural success was achieved in all 16 patients and for all 34 lesions. Adjunctive therapy was required for less than half of the lesions (15 lesions: 10 PTA, 5 stent) (Table 2). Over a mean follow-up period of 6 weeks (range, 2 to 8 weeks), no patients underwent unplanned amputation, and planned, but less extensive, amputation was performed in 2 patients. Two patients died of cardiac cause unrelated to the procedure.

Conclusions: Plaque excision with the SilverHawk catheter is a safe and effective method for achieving limb salvage in patients with CLI. In this preliminary experience, plaque excision was associated with uniform procedural success and favorable early clinical outcomes. Intermediate and long-term follow-up will be presented. These findings support the use of plaque excision for the treatment of CLI.