Percutaneous Viabahn-assisted Subintimal Recanalization for Severe Superficial Femoral Artery Occlusive Disease

Purpose: To evaluate Viabahn-assisted subintimal recanalization (VASIR) in long recanalizations of the superficial femoral artery (SFA). Material and Methods: Twenty-eight patients (15 men, 13 women; mean age, 70.6 years ± 11.2) were studied. Comorbidities were hypertension (n = 24), coronary disease (n = 16), and diabetes (n = 11). Presenting symptoms were disabling claudication (n = 14), rest pain (n = 6), and tissue loss (n = 8). Lesions were angiographically severe (TransAtlantic Intersociety Consensus [TASC] class D, n = 18; TASC class C, n = 8; TASC class B, n = 2); four of the 28 patients had no continuous run-off vessels. The SFA was recanalized percutaneously with standard subintimal techniques and then repaved with Viabahn stent-grafts. The ankle-brachial index (ABI) was obtained and duplex imaging performed at 1 month and then every 3 months. Results: Technical success was achieved in all 28 patients without complications. The mean ABI of 0.47 ± 0.18 before the procedure increased to 0.88 ± 0.20 after the procedure. Seventeen of the 28 patients developed palpable foot pulses. The mean follow-up was 8.2 months ± 3.6 (range, 1-13 months). Twelve recanalizations failed 1 day to 8 months after the procedure. Four patients underwent successful salvage, five underwent bypass, two chose no further therapy, and one required amputation. Thus, life-table primary patency is only 44% ± 16 but secondary patency is 57% ± 17. There was no correlation between failure and symptoms, lesion severity, or run-off status, but in eight of 12 failures, in which stents went from the adductor canal to just short of the SFA origin, stenosis occurred at the ends of the stent-grafts, which suggests that deformational forces from knee flexion may play an important role. Conclusions: VASIR shows considerable promise as a primary treatment for SFA occlusions, with diligent follow-up and aggressive repeat intervention. When failure mechanisms are better understood, VASIR may be considered as a substitute for vein bypass in suitable patients.