OBJECTIVES: Many investigators including TransAtlantic Inter-Society Consensus (TASC) recommend against primary endovascular treatment for severe (TASC C and D) superficial femoral artery (SFA) disease. Vein bypass is preferable but may not be appropriate due to comorbidities or lack of suitable vein. This study reviews our results with Viabahn stent graft-assisted subintimal recanalization (VASIR) for TASC C and D SFA atherosclerosis. METHODS: In all, 13 males and 14 females, mean age 72 ± 11 years underwent 28 VASIR for severe (TASC C 8 of 28, TASC D 20 of 28, and 5 of 28 no continuous infrapopliteal runoff artery) SFA disease. Indications were claudication (14 of 28 limbs), ischemic rest pain (6 of 28), and tissue loss (8 of 28). Viabahn stent graft-assisted subintimal recanalization was chosen instead of bypass due to comorbidities or lack of vein. Patients received aspirin and, if not already taking warfarin, they also received clopidogrel. Patients were examined with Ankle-brachial Index (ABI) and duplex scan at 1 month, then every 3 months after VASIR. RESULTS: Viabahn stent graft-assisted subintimal recanalization was technically successful in all. Ankle-brachial Index averaged 0.47 ± 0.17 preprocedure, 0.89 ± 0.20 postprocedure, and increased by 0.15 or more in every case. Median follow-up is 20 months. There were 3 perioperative (<30 days) and 7 later failures including revision prior to any thrombosis. One patient required amputation. Four have died, 2 with patent grafts, none from causes related to VASIR, all more than 30 days post-VASIR. Estimated 1-year primary and secondary patency were 70% ± 11% and 73% ± 10%. Failure was not significantly associated with indications, comorbidities, or runoff status. There was a clear distinction between patients with early failure and the rest of the patients. None of the 8 patients with failure in the first 8 months after surgery has a patent graft. However, of 17 grafts primarily patent at 8 months, only 2 have failed (1 thrombosed and 1 required preemptive balloon angioplasty). There was a strong trend toward better patency with 6 and 7 mm diameter compared to 5 mm diameter stent grafts. Furthermore, although warfarin was not prescribed as part of the protocol, no patient taking warfarin before and who resumed warfarin after VASIR (n=4) suffered failure. CONCLUSIONS: Despite significant early failures, we found VASIR to be durable in those who did not have early failure. Viabahn stent graft-assisted subintimal recanalization is an acceptable alternative to vein bypass in selected patients with severe SFA disease. Smaller arterial or stent graft diameter may be associated with poorer results. Warfarin may be valuable to reduce the risk of failure after VASIR.
OBJECTIVES: Many investigators including TransAtlantic Inter-Society Consensus (TASC) recommend against primary endovascular treatment for severe (TASC C and D) superficial femoral artery (SFA) disease. Vein bypass is preferable but may not be appropriate due to comorbidities or lack of suitable vein. This study reviews our results with Viabahn stent graft-assisted subintimal recanalization (VASIR) for TASC C and D SFA atherosclerosis. METHODS: In all, 13 males and 14 females, mean age 72 ± 11 years underwent 28 VASIR for severe (TASC C 8 of 28, TASC D 20 of 28, and 5 of 28 no continuous infrapopliteal runoff artery) SFA disease. Indications were claudication (14 of 28 limbs), ischemic rest pain (6 of 28), and tissue loss (8 of 28). Viabahn stent graft-assisted subintimal recanalization was chosen instead of bypass due to comorbidities or lack of vein. Patients received aspirin and, if not already taking warfarin, they also received clopidogrel. Patients were examined with Ankle-brachial Index (ABI) and duplex scan at 1 month, then every 3 months after VASIR. RESULTS: Viabahn stent graft-assisted subintimal recanalization was technically successful in all. Ankle-brachial Index averaged 0.47 ± 0.17 preprocedure, 0.89 ± 0.20 postprocedure, and increased by 0.15 or more in every case. Median follow-up is 20 months. There were 3 perioperative (<30 days) and 7 later failures including revision prior to any thrombosis. One patient required amputation. Four have died, 2 with patent grafts, none from causes related to VASIR, all more than 30 days post-VASIR. Estimated 1-year primary and secondary patency were 70% ± 11% and 73% ± 10%. Failure was not significantly associated with indications, comorbidities, or runoff status. There was a clear distinction between patients with early failure and the rest of the patients. None of the 8 patients with failure in the first 8 months after surgery has a patent graft. However, of 17 grafts primarily patent at 8 months, only 2 have failed (1 thrombosed and 1 required preemptive balloon angioplasty). There was a strong trend toward better patency with 6 and 7 mm diameter compared to 5 mm diameter stent grafts. Furthermore, although warfarin was not prescribed as part of the protocol, no patient taking warfarin before and who resumed warfarin after VASIR (n=4) suffered failure. CONCLUSIONS: Despite significant early failures, we found VASIR to be durable in those who did not have early failure. Viabahn stent graft-assisted subintimal recanalization is an acceptable alternative to vein bypass in selected patients with severe SFA disease. Smaller arterial or stent graft diameter may be associated with poorer results. Warfarin may be valuable to reduce the risk of failure after VASIR.