Two-year results after directional Atherectomy of infrapopliteal arteries with the SilverHawk device

Purpose: To report the 12- and 24-month results after directional atherectomy (DA) of below-the-knee (BTK) arterial lesions with the SilverHawk device. Methods: Forty-nine BTK lesions in 36 patients (58% men; mean age 70 +/- 11 years) with peripheral occlusive disease of the lower limbs were treated with DA; 19 (53%) of the limbs were classified with Rutherford-Becker 4 or 5 ischemia. Target lesions were in the popliteal artery (n=6, 12%), tibioperoneal trunk (n=25, 51%), peroneal artery (n=10, 20%), anterior tibial artery (n=5, 10%), and posterior tibial artery (n=3, 6%). Nine (18%) lesions were located in a stent. Twelve lesions extended to 2 artery segments. The average degree of diameter stenosis was 89%+/- 10% (range 70%-100%); there were 11 (22%) occlusions. The mean lesion length was 48 28 mm. Results: Sixteen (33%) lesions were treated after predilation; 33 (67%) lesions were treated with primary DA. All but 1 (2%) lesion could be treated with DA. In 19 (39%) lesions, additional balloon angioplasty was performed, and 2 (4%) lesions required stent implantation as a result of dissection. The mean stenosis diameter after DA was 12%+/- 18% (range 0%-100%). After additional therapy, the mean stenosis diameter was 8%+/- 9% (range 0%-100%). A residual stenosis <= 30% was achieved in 48 (98%) lesions. The mean ankle-brachial index significantly increased from 0.48 +/- 0.26 to 0.81 +/- 0.32 (p<0.05) before discharge and remained improved during follow-up. Primary and secondary patency rates were 67% and 91% after 1 year and 60% and 80% after 24 months. The 12-and 24-month cumulative event-free survival rates (primary patency) by Kaplan-Meier analysis were 58%+/- 8% and 46%+/- 9%; at the same time intervals, the cumulative survival rates (secondary patency) were 88%+/- 6% and 73%+/- 9%, respectively. Conclusion: BTK lesions can be treated successfully and safely with DA. Midterm clinical results are encouraging.