Viabahn-Assisted Subintimal Recanalization (VASIR) of Superficial Femoral Artery Occlusions

Objective: To evaluate VASIR in long recanalizations of the superficial femoral artery (SFA).
Materials: Twenty three patients (11 males, 12 females), mean age 70.1+10.9 years, were studied. Comorbidities were hypertension (20/23), coronary disease (14/23), and diabetes (11/23). Presenting symptoms were disabling claudication (10/23), rest pain (6/23), and tissue loss (7/23). Lesions were angiographically severe (TASC D 16/23, TASC C 5/23, TASC B 2/23); 4/23 had no continuous run-off vessels.
Methods: The SFA was recanalized percutaneously with standard subintimal techniques, then repaved with Viabahn stent grafts. Patients were followed with ABIs and duplex imaging at 1 month, then every 3 months.
Results: Technical success was achieved in 23/23 without complications. Mean pre-procedural ABI of 0.43+0.16 rose to 0.86+0.22 post-procedure. 13/23 patients developed palpable foot pulses. Median follow-up is 6 months (range 1-10 months).
Eight recanalizations failed from 1 day to 8 months post-procedure. Five were successfully rescued, two required urgent bypass, and one required amputation. Thus primary patency is only 65% but secondary patency is 87%.
There was no correlation between failure and symptoms, lesion severity, or run-off status, but in 4/8 failures, where stents went from adductor canal to just short of the SFA origin, stenosis occurred at the ends of the stent-grafts, suggesting deformational forces from knee flexion may play an important role.
Conclusion: VASIR shows considerable promise as a primary treatment for SFA occlusions, with diligent follow-up and aggressive re-intervention. Until failure mechanisms are better understood, it should not be routinely substituted for vein bypass in suitable patients.