Heparin-bonded expanded polytetrafluoroethylene vascular graft for femoropopliteal and femorocrural bypass grafting: 1-year results

OBJECTIVE: Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency. METHOD: From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses. RESULTS: All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%. CONCLUSIONS: In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.