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.