Objectives: Endovascular options for the treatment of lower extremity peripheral arterial disease are typified with diminished patency. A novel alternative to standard angioplasty and stent is the excision of the obstructing arterial plaque using a minimally invasive technique, the Silverhawk Atherectomy device. Methods: A prospective database was maintained of SilverHawk procedures from 2004 to 2007. A total of 579 lesions were treated in 275 patients (claudication 101 patients (36.7%) and critical limb ischemia (CLI) in 174 patients (63.3%). Noninvasive laboratory evaluation was performed at 1, 3, and 6 months, and yearly. Stand-alone atherectomy was attempted, and adjunct therapy was used for residual stenosis. Results: Mean age was 70.0 years (range, 37-102) (62.5% male, 46.2% smokers, 67.6% diabetes mellitus). Lesion characteristics were 199 superficial femoral arteries, 110 popliteal, 218 tibials, and 52 multilevel. Thirty-day perioperative mortality was 1.8%. Mean follow-up was 12.5 months (range, 0.5-48.2). 18-month primary and secondary patency for all lesions was 52.7% +/- 2.8 and 75.0% +/- 2.4 (P < 0.0001). Eighteen-month primary and secondary patency for claudicants was 58.0% +/- 4.3 and 82.5% +/- 3.5 (P < 0.0001) and for CLI was 49.4% +/- 3.7 and 69.9% +/- 3.2 (P < 0.0001), respectively. The reintervention rate was 25.3% in claudicants and 30.1% for CLI. Limb salvage was 100% in claudicants and overall limb salvage was 92.4% per patient at 18 months and only 4.4% required bypass. Conclusion: This is the largest reported series with the longest follow-up showing the SilverHawk device as an effective endovascular therapy for patients with claudication and CLI with a low mortality, low complications rate, low amputation rate, and rare need for conversion to surgical bypass. The majority of reintervention was performed with endovascular techniques.
