Placement of hemobahn stent-grafts in femoropopliteal arteries:: Early experience and midterm results in 18 patients

PURPOSE: To determine the outcome of a new polytetrafluoroethylene (PTFE)-covered scent-graft in the treatment of occlusive lesions of the femoropopliteal arteries. MATERIALS AND METHODS: Eighteen patients with intermittent claudication (Fontaine stages IIb-IV; Rutherford classes I/2-III/5) and occlusive lesions of the superficial femoral and/or popliteal artery were treated with use of a new PTFE-covered stent-graft (Hemobahn). Indication for scent-graft insertion was an unsatisfactory result after balloon dilation. RESULTS: Successful stent-graft placement was achieved in 17 patients (94%). In one patient, additional insertion of a Palmaz stent was necessary because of a stent-graft wrinkle. Mean ankle-brachial index increased from 0.72 +/- 0.15 preoperatively to 0.94 +/- 0.17 postoperatively (P = .028). Fifteen patients (83%) experienced an initial improvement of at least one clinical stage. Primary patency was 61% +/- 11% at 3 months and 49% +/- 12% at 6 months. Stent-graft occlusion was observed in 13 patients (72%). In four patients, the scent-graft was reopened percutaneously by balloon angioplasty (n = 2) and/or rotational thrombectomy (n = 2). Therefore, the secondary patency rate was 67% +/- 11% at 3 months and 61% +/- 11% at 6 months. Patency rates proved to be significantly lower for stent-grafts longer than 10 cm (P = .03). Intimal hyperplasia at the proximal or distal end of the stent-graft was observed in seven patients (39%). Complications such as access site hematoma (n = 3), distal thromboembolism (n = 2), and abscess formation around the stent-graft (n = 1) were observed. CONCLUSION: Despite excellent initial angiographic results, the patency rate in lesions treated with the Hemobahn stent-graft in this small study was unsatisfactory. Use of scent-grafts longer than 10 cm and the occurrence of intimal hyperplasia proved to be major factors in the reduction of long-term patency rates.