One-year results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease

Objective: The purpose of this study was to assess the 1-year patency rates of heparin-bonded covered stents in the treatment of chronic occlusive disease of the superficial femoral artery (SFA). Methods: All patients treated with a heparin-bonded endograft between April 2009 and October 2010 for chronic occlusive disease of the SFA were prospectively gathered in a database and retrospectively analyzed. Primary, primary-assisted, and secondary patency rates, assessed by ultrasound scanning, were analyzed at 1-year, as were the complication rates and mortality. Results: A total of 56 limbs were treated with a heparin-bonded covered stent in 53 patients for chronic ischemia Rutherford category 3 (n = 36), 4 (n = 5), 5 (n = 11), and 6 (n = 1). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC)-2-B (n = 9), C (n = 14), and D (n = 33), and the mean treated lesion length was 18.5 +/- 7.7 cm. Postoperative complications occurred in 7.5%, including hematoma (n = 1), edema (n = 1), pneumonia (n = 1), and urinary retention (n = 1), and the 30-day mortality rate was 0%. The mean follow-up was 413 +/- 208 days. At 1 year, the primary patency was 76%, the primary-assisted patency 82%, and the secondary patency 89%. The limb salvage rate was 100%. Conclusion: Heparin-bonded covered stents seem to provide a valid alternative to surgical treatment of long occlusive lesions in the SFA. Randomized trials and long-term data are required before considering the technique as a new standard of care. (J Vasc Surg 2012;)