Early Clinical Results

Early Clinical Results with the SilverHawk Plaque Excision Device for
Infrainguinal Revascularization - A Single Center Experience

Venkatesh Ramaiah, MD, Edward Diethrich, MD,Joseph Cardenas, MD
Arizona Heart Institute and Hospital, Phoenix, Arizona

Purpose: To evaluate the safety, efficacy and early short term results with plaque excision for infrainguinal revascularization.

Methods: 202 lesions in 181 patients were treated with the SilverHawk System at a single center from June 2003 to June 2004. Immediate procedural and angiographic success, lesion revascularization and patency were studied. Patients were followed with Duplex and/or ABI's at 3, 6, 9 and 12 months.

Results: All but 8 lesions (4%) were treated successfully (residual stenosis <15% ) with the SilverHawk (96% technical success ). 59% were males and the average age was 72 years. 107 lesions (53%) belonged to categories 1, 2 and 3. (Rutherford-Becker scores) and 95 lesions (47%) were in categories 4, 5 and 6. Lesion distribution was as shown in Table 1 with 39% being below-the-knee. Moderate to severe calcification was seen in 62% of lesions. 46% of patients had a single vessel run-off, 32% had 2 vessel run-off and 22% had 3 vessel run-off. Occlusions accounted for 26% of the lesions. Combined occlusions and stenosis reached 48%. 24% of patients were treated for in-stent restenosis. Mean increase in ABI'S was 0.24 (range 0.21-0.38). The average tissue collected was 140mg (range 40-410mg) and the average length of stay was 1.2 days. There was one perforation treated with a Viabahn graft. Minor complication rate was 4% and included groin hematomas, renal failure and minor dissections. Distal embolization was not seen in our series. Adjunctive balloon angioplasty was used in 44 lesions (22%) and stents were placed in 14 lesions (6.9%). 92 patients (45%) have completed 6 months follow-up . Primary patency was 96% and assisted primary patency was 100%. These 12 patients underwent re-excision/balloon angioplasty and two had stents placed.

Conclusions: Percutaneous plaque excision with the SilverHawk System has emerged as a safe and effective method for the treatment and revascularization of infrainguinal disease with high rates of angiographic and clinical success. Short-term clinical results are very encouraging and stent utilization in these challenging locations has decreased. However long term follow-up and patency will be a key factor in determining the full impact of this promising technology.