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 stent-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 stent-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 stent-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 stent-grafts longer than 10 cm and the occurrence of intimal hyperplasia proved to be major factors in the reduction of long-term patency rates.