Percutaneous endoprosthesis for treatment of aortic aneurysms.

The purpose of this study was to define the clinical utility of stent-grafts for endoluminal treatment of infrarenal abdominal aortic aneurysms (AAAs). In a prospective study involving three centers, bifurcated stent-grafts for endovascular repair of infrarenal AAAs were implanted in 295 patients. Patient selection was based on anatomic suitability. For analysis of the initial and follow-up results the patients were divided in three subgroups. Group 1 included patients treated between August 1994 and April 1996 with use of the original stent-graft device; group 2 comprised patients treated between May 1996 and December 1997 with the refined stent-graft device, and group 3 comprised patients treated with a newly designed bifurcated stent-graft device. In group 1 (n = 111) the primary technical success was 82%. The procedure had to be converted to surgery in four patients. Endoleaks immediately after the procedure were observed in 16 patients. The initial technical success in subgroup 2 (n = 159) was 96%. One patient required surgical repair, and five others had immediate perigraft flow due to reperfusion via lumbar arteries. For group 3 (n = 28) the primary technical success rate was 89%. Endoleaks due to back-bleeding via lumbar arteries were demonstrated in three patients. Minor and major complications related to the intervention, including two perioperative deaths, were observed in 24 patients (8%). Serious problems such as distal migration or disconnection of the stent-graft were detected during follow-up in five patients. Delayed aortic rupture occurred in three patients who survived after successful surgical repair. Based on the initial results and a limited follow-up of 35 months, we believe endoluminal repair of infrarenal AAA with use of bifurcated endografts may be a feasible alternative to conventional surgery, especially for patients at high surgical risk. However, at the present time there are major concerns with respect to the structural integrity of stent-graft material and the fate of the proximal aortic cuff in the long-term time frame.