Infrainguinal ePTFE vascular graft with bioactive surface heparin bonding. First clinical results.

AIM: The ultimate aim of improved expanded polytetrafluoroethylene (ePTFE) vascular graft design is to achieve patency rates in femoropopliteal bypass grafting comparable with autologous saphenous vein grafts. Enhanced thromboresistance of the ePTFE material by bioactive surface heparin bonding is one conceivable path toward this goal. This retrospective study was performed to collect the first clinical data for a new ePTFE graft with bioactive surface heparin immobilization.
METHODS: Between March 2003 and February 2004, 43 femoropopliteal or femorocrural ePTFE vascular prostheses with bioactive end-point immobilized heparin (Gore-Tex Propaten Vascular Graft), using the Car-meda BioActive Surface technology, were implanted in 40 patients. Twelve prostheses were implanted in above-knee and 31 in below-knee position. The indication for bypass grafting was limb-threatening ischemia in 88% of the patients. The mean follow-up was 16.6 months.
RESULTS: The primary 1-year patency was 91% for above-knee bypass grafts and 92% for below-knee bypass grafts. The 2-year primary patency rate for above-knee bypass grafts was 68% and 81% for below-knee bypass grafts. Limb salvage was achieved in 98%. The perioperative mortality was 0%, but during follow-up 22% of the patients died with patent bypass grafts.
CONCLUSIONS: While conventional ePTFE grafts, particularly in the below-knee position, have shown poor results even in the short-term, the bioactive heparinized ePTFE graft evaluated in this study provides patency rates comparable with autologous vein grafts. Because the influence of luminal heparin bonding is not only limited to thromboresistance but has impact on, amongst other elements, protein adsorption (thereby improving hemocompatibility), a continuous effect for long-term patency could also be expected.