Occlusive and aneurysmal peripheral arterial disease: assessment of a stent-graft system.

PURPOSE: To assess the use of a recently developed stent-graft system for treatment of occlusive lesions and aneurysms in the iliac and femoropopliteal arteries. MATERIALS AND METHODS: The stent-graft consisted of a nitinol stent framework covered by a thin-walled polyester fabric. The device was used in 105 patients with symptomatic peripheral vascular disease. Implant locations were iliac artery (n = 38), femoral artery (n = 62), and popliteal artery (n = 5). RESULTS: Initial technical success was achieved in all patients except one with occlusive disease and one with aneurysmal disease. Residual stenosis after stent-graft implantation was 0.5% +/- 3. Mean ankle-brachial index increased from 0.53 to 0.98. Complications were hematoma (n = 3), pseudoaneurysm (n = 2), puncture site thrombosis (n = 1), early graft thrombosis (n = 8), graft misplacement (n = 1), distal embolization (n = 2), delayed thrombosis (n = 14), pain and fever (n = 27). At the iliac level, primary patency was 97% and secondary patency was 100%. At the femoral level, primary patency was 59% and secondary patency was 81%. CONCLUSION: Endoluminal bypass with a percutaneously delivered stent-graft is feasible. Technical results are good, and the number of complications is few at the iliac level. At the femoropopliteal level, patency is not as good and the number of complications is higher.