Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results.

Objective: Many patients with peripheral arterial occlusive disease who require a lower-limb bypass have no available autologous saphenous vein (ASV) for the procedure and thus require a prosthetic graft. Expanded polytetrafluoroethylene (ePTFE) grafts are commonly used, but results with these prostheses have varied, especially when the distal anastomosis is below the knee. However, there is increasing evidence that ePTFE grafts to which heparin has been bound with use of covalent endpoint linkage provide better results. This nonrandomized study compared the performance of these grafts with that of ASV conduits in the largest clinical series of heparin-bonded ePTFE graft implantations reported so far.

Methods: The records of 350 patients who underwent a lower-limb bypass procedure that used either a heparin-bonded ePTFE graft (n = 240) or an ASV graft (n = 110) were reviewed, and preoperative, operative, and follow-up data were recorded. Kaplan-Meier analyses were used to calculate primary patency and limb salvage rates in the two graft groups; results were compared by using log-rank testing.

Results: The primary patency rates at 1 year for the heparin-bonded ePTFE grafts were 92% for above-knee femoropopliteal (AK FP) bypasses, 92% for below-knee femoropopliteal (BK FP) bypasses, and 79% for femorocrural (FC) applications. The corresponding 2-year rates were 83%, 83%, and 69%, respectively. In the ASV group, the 1-year primary patency rates for AK FP, BK FP, and FC bypasses were 91%, 72%, and 69%, respectively; the 2-year rates were 80%, 72%, and 64%, respectively. There were no significant differences in patency when AK FP, BK FP, or FC procedures were considered separately. Two-year limb salvage rates in the heparin-bonded ePTFE graft group were 92%, 98%, and 87%, respectively, for AK FP, BK FP, and FC bypasses; in the ASV group, the rates were 100%, 91%, and 96%, respectively. Two infections occurred in patients given a heparin-bonded ePTFE graft.

Conclusion: In this large retrospective study, heparin-bonded ePTFE grafts had 1- and 2-year primary patency results that were not significantly different from those for ASV grafts. Results in BK FP and FC applications were especially promising. Randomized studies comparing the use of heparin-bonded ePTFE and ASV grafts in the treatment of peripheral arterial disease are needed to substantiate our results.