Midterm results of a precuffed expanded polytetrafluoroethylene graft for above knee femoropopliteal bypass in a multicenter study

INTRODUCTION: Above knee (AK) femoropopliteal bypass remains a sufficient and durable therapy for long occlusions of the superficial femoral artery in the era of endovascular repair. A novel, precuffed expanded polytetrafluoroethylene (ePTFE) graft that was designed for AK femoropopliteal bypass (Dynaflo, Bard Peripheral Vascular Inc, Tempe, Ariz) has been available for clinical use since March 2005, promising better patency rates by optimizing the hemodynamic patterns within the distal anastomosis.

METHODS: A prospective, multicenter, nonrandomized study was performed to investigate the clinical results of the Dynaflo graft. Primary end points were patency rates, limb salvage, and complications.

RESULTS: Between March 2005 and August 2007, the Dynaflo graft was used in 135 AK bypasses in 134 patients (110 men) with a mean age of 66 years. Indication for revascularization was claudication in 99 (73%) and critical ischemia in 36 (27%). With a mean follow-up of 18 months the 6-, 12- and 24-month primary patency rates were 90%, 83% and 72.5% and the secondary patency rates were 93%, 88.6% and 82.2%, respectively. The cumulative limb salvage rate at 24 months was 95%. Complications were observed in 39 patients (29%), with bypass failure (29 cases) and significant thrombus accumulation at the distal anastomosis (4 cases) being the most severe.

CONCLUSION: This study presents the first clinical results of a novel ePTFE graft for supragenicular revascularization. The implantation of the Dynaflo graft seems to be safe and feasible for AK bypass, achieving acceptable medium-term patency rates. Nevertheless, long-term results have to be awaited, and prospective comparative studies are warranted.