Purpose: To evaluate the safety and efficacy of endovascular abdominal aortic aneurysm (AAA) repair with a commercial modular stent-graft.
Methods: Between February 1998 and May 2000, 66 consecutive patients (56 men; mean age 70 years, range 51-87) were recruited for a single-center study to examine the safety and efficacy of the Excluder stent-graft for endovascular AAA repair. The patients were predominantly asymptomatic (2 symptomatic) and categorized as ASA III or IV (62, 94%), with aneurysms that ranged from 35 to 89 mm in diameter (mean 56). Surveillance included clinical examination and computed tomographic aortography at discharge, 6 weeks, and at 6, 12, and 24 months.
Results: All endoprostheses were implanted as intended, but 1 patient succumbed to an intraprocedural brainstem infarction (1.5% 30-day mortality rate). The major and minor morbidity rates were 21% and 4.5%, respectively. Primary technical success at discharge was 68% (45/66), largely as the result of a 30% (20/66) endoleak rate. The aneurysm exclusion rate at 30 days was 88%. During the mean 5.8-month follow-up, no device migration, limb kinking, aneurysm rupture, or limb thrombosis was observed.
Conclusions: Endoluminal AAA repair with the bifurcated Excluder stent-graft is safe and efficacious in the short term. Longer surveillance will have to demonstrate if the excellent early results can be maintained over the years.