Results of a multicenter trial for the treatment of traumatic vascular injury with a covered stent.

BACKGROUND: The safety and efficacy of endovascular treatment of arterial trauma using the Wallgraft Endoprosthesis was evaluated in a subgroup analysis of a prospective, multicenter, nonrandomized registry trial with a historical control to surgical management. Endpoints were exclusion success at procedure and at 12-months, primary patency and freedom-from-bypass at 12-months, and major adverse events. METHODS: Sixty-two patients were treated for arterial trauma from October 1997 to June 2003. The anatomic locations of the injuries were: iliac (33), subclavian (18), and femoral (11) arteries. Indication for treatment was perforation/rupture (33), acute pseudoaneurysm (10), AV fistula (16), and dissection (3). Exclusion and patency were assessed using arteriography, duplex ultrasound, CT, or MRA at postprocedure and 12-months. Major adverse event and mortality rates were compared with surgical intervention of arterial trauma using literature based objective performance criteria. RESULTS: The Wallgraft Endoprosthesis achieved postprocedure exclusion in 58 of 62 cases (93.5%). One-year exclusion rates were 91.3% iliac, 90.0% subclavian, and 62.3% femoral. One-year primary patency rates were 76.4% iliac, 85.7% subclavian, and 85.7% femoral. Freedom-from-bypass was achieved in 74.3% iliac and 100% femoral and subclavian injuries. The most common adverse events were stenosis (4.8%) and occlusion (6.5% early, 1.6% late). There were no device- or procedure-related deaths. Analysis of the literature revealed the rates and severity of complications are less than those associated with surgical repair. CONCLUSION: The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.

Waligraft endoprosthesis for the percutaneous treatment of femoral and popliteal artery aneurysms.

PURPOSE: To evaluate the safety and efficacy of the Wallgraft Endoprosthesis for the treatment of femoropopliteal artery aneurysms. METHODS: From October 1997 to April 2000, 17 patients (13 men; mean age 73.5 +/- 7.1 years) with 7 femoral and 13 popliteal artery aneurysms underwent percutaneous aneurysm exclusion using the Wallgraft Endoprosthesis as part of a larger clinical trial. The mean aneurysm diameters were 37.6 +/- 12.9 mm and 22.3 +/- 8.7 mm, respectively. RESULTS: Acute procedural success was 100% for femoral aneurysms and 92.3% (12/13) in the popliteal artery owing to one endoleak that resolved after 1 month. There were no complications, and the mean length of stay was 2.2 +/- 3.8 days. Six-month and 1-year aneurysm exclusion rates were 100% for both locations, but 4 (31%) popliteal stent-grafts thrombosed in follow-up. Three were recanalized, but the fourth underwent bypass grafting after 3 thrombotic episodes. The 1-year primary and secondary patency rates were both 100% for the femoral aneurysms and 69% and 92%, respectively, for popliteal repairs. No procedure or device-related deaths occurred. CONCLUSIONS: Treatment of aneurysms in the femoropopliteal segment appears to be safe and effective with the Wallgraft Endoprosthesis, although longer follow-up in a larger patient group will be needed to determine this technique's potential versus surgical repair.