Long-term Patency and Clinical Outcome of the Viabahn Stent-Graft for Femoropopliteal Artery Obstructions

Abstract

To assess the long-term patency of the Viabahn stent-graft after placement for the treatment of occlusive disease of the femoropopliteal artery (FPA). Viabahn stent-grafts were placed into 87 limbs in 76 patients for the treatment of atherosclerotic occlusive disease of the FPA. Mean lesion length was 14.2 cm (range, 2.8-40 cm), with 80 of 87 lesions (92%) at least 7 cm in length. Patients were followed by duplex ultrasound (US), resting ankle brachial index (ABI) measurement, and clinical status at 6 months, 1 year, and yearly thereafter for a maximum of 8.5 years. A systolic velocity ratio greater than 2.0 on duplex US anywhere in the FPA was defined as a loss of primary vessel patency. Primary, primary assisted, and secondary vessel patency rates were 76%, 87%, and 93%, respectively, at 1 year and 55%, 67%, and 79%, respectively, at 4 years. Mean resting ABI improved from 0.70 before the procedure to 0.90 as of the most recent follow-up (P<.001). Mean Rutherford-Becker classification improved from 3.4 before the procedure to 0.68 as of the most recent follow-up (P<.001). Eighty-eight percent of limbs showed a maintained improvement in clinical status. Primary patency was independent of lesion length and type but dependent on device diameter (P=.001). The primary vessel patency rate in devices of at least 7 mm (n=21) was 82% at 4 years. No stent fractures were observed despite the use of multiple overlapping stent-grafts in 36.8% of limbs (n=32). This study demonstrates durable vessel patency to 4 years for long Transatlantic Inter-Society Consensus class C and D lesions treated with the Viabahn stent-graft. Results were independent of lesion length and type but dependent on device diameter. This study helps confirm the durability and clinical utility of this device in the treatment of FPA occlusive disease.