Joseph R. Schneider1, Michael J. Verta, Jr.2, Marc J. Alonzo3, David Hahn3, Nilseh H .Patel1, Stanley Kim1
1Central DuPage Hospital, Winfield, IL; 2St. Mary's Good Samaritan Hospital, Mount Vernon, IL; 3Northshore University Healthcare, Evanston, IL
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: Thirteen males and fourteen females, mean age 73±11 years underwent 28 VASIR for severe (TASC C 8/28, TASC D 20/28; 4/28 no continuous infrapopliteal run-off artery) SFA disease. Indications were claudication (14/28 limbs), ischemic rest pain (6/28), and tissue loss (8/28). VASIR 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 ABI and duplex scan at 1 month, then every 3 months after VASIR.
RESULTS: VASIR was technically successful in all. ABI averaged .47±.17 pre-procedure, .89±.20 post-procedure, and increased by .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, two with patent grafts, none from causes related to VASIR, all more than 30 days post-VASIR. Estimated one 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 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 two have failed (one thrombosed, one required preemptive balloon angioplasty). 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 suffer early failure. VASIR is an acceptable alternative to vein bypass in selected patients with severe SFA disease. Warfarin may be valuable to reduce the risk of failure after VASIR.
AUTHOR DISCLOSURES: J.R. Schneider, None; M.J. Verta, None; M.J. Alonzo, None; D. Hahn, None; N.H. Patel, None; S. Kim, None.