Three-year outcome of the heparin-bonded Viabahn for superficial femoral artery occlusive disease

Abstract

Objective: Self-expanding covered stents for superficial femoral artery (SFA) occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73% to 78% in long lesions. The aim of this study was to present the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease.

Methods: All patients treated with a heparin-bonded Viabahn in three centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes, and duplex ultrasound scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end points of the study were the 3-year primary, primary assisted, and secondary patency rates.

Results: A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study. Fifty-four patients were male (77%), and the mean age was 70.0 ± 9.1 years. The mean lesion length was 17.4 ± 7.0 cm, and 84% were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range, 2-55 months). The 3-year primary, primary assisted, and secondary patency rates were 59%, 71%, and 82%, respectively, with a 3-year freedom from amputation of 100%.

Conclusions: The use of a heparin-bonded Viabahn for SFA occlusive disease is related to patency rates within limits of surgical reconstruction. The procedure is related to low morbidity and amputation rates.