One-year outcomes for recanalization of long superficial femoral artery chronic total occlusions with the Viabahn stent graft.

OBJECTIVE

The treatment of long superficial femoral artery (SFA) chronic total occlusions (CTOs) remains controversial. There are several percutaneous treatment options available for the recanalization of these lesions. Percutaneous transluminal angioplasty (PTA) alone, nitinol stents, and expanded PTFE-lined nitinol stents are all viable treatment alternatives to femoral-popliteal bypass surgery. There are, however, limited data on outcomes of patients with SFA CTOs undergoing endovascular treatment. This study was performed to evaluate the safety, efficacy and 1-year patency rates of the Viabahn (WL Gore and Associates, Flagstaff, Arizona) e-polytetrafluoroethylene (e-PTFE) stent grafts at a major medical center in Phoenix, Arizona.

METHODS

Thirty patients (32 limbs) were prospectively treated for activity- limiting claudication after failing medical therapy. These patients received traditional angioplasty and stenting techniques using the Viabahn e-PTFE stent graft. Follow-up ankle-brachial index (ABI) examinations and duplex surveillance were completed at 6 and 12 months in all patients.

RESULTS

The mean age of the patients was 58.4 years. There were 12 women (40%) and 18 men (60%). Five of the patients (16.67%) were diabetics. The procedural success rate was 100%, with no in-hospital morbidity or mortality. The mean preprocedural ABI was 0.54 and the mean SFA occlusion length was 15.4 cm. The mean stented length was 24.6 cm. The median stent diameter was 6 mm. One patient (3.3%) did have subacute stent thrombosis at 4 months. On follow-up testing, the mean post-procedure ABI at 1 year was 0.76 with a primary patency rate of 80% and a primary assisted patency rate of 86%. Silent asymptomatic occlusions were noted in 10% (3/30) of the patients. Restenosis was a prespecified endpoint and was defined as being significant if the proximal peak velocity ratio (PVR) exceeded 2.4 on duplex interrogation. This endpoint was detected in 6.6% of the patient population (2/30) (proximal peak velocity ratio is the ratio of the maximum intrastenotic PSV and the maximum prestenotic PSV).

CONCLUSIONS

Percutaneous e-PTFE stent-grafting with the Viabahn stent graft is a viable treatment option for TASC D occlusions in the SFA in claudicants and patients with critical limb ischemia. Primary and primary assisted patency rates at 1 year are comparable to historical surgical outcomes using PTFE grafts as bypass conduits. Longterm data (> 5 years) in a larger patient cohort are necessary before definite conclusions can be drawn.