Thoracic aortic aneurysm repair with an endovascular stent graft: The "first generation"

Objective The feasibility and efficacy trial of an endovascular stent-graft ing system for the treatment of aneurysms of the descending thoracic aorta was investigated. Methods. After Institutional Review Board approval, 103 patients (mean age 69 years) underwent stent graft repair of a descending thoracic aortic aneu rysm between July 1992 and November 1997. The stent graft was fabricated us ing self-expanding "Z" stents covered by a woven Dacron tube graft. Follow- up, which averaged 22 months, was 100% complete. Simultaneous open abdomina l aortic aneurysm repair was performed in 19 patients. Results, Complete aneurysm thrombosis was achieved in 86 patients (83%). Ea rly mortality, defined as a death during the same hospitalization or in les s than 30 days, was 9 +/- 3%, and was significantly associated with preoper ative cerebrovascular accident (CVA) or myocardial infarction. Major periop erative morbidity occurred in 31 patients, and included paraplegia in 3, CV A in 7, and respiratory insufficiency in 12 patients each. Actuarial surviv al was 81 +/- 4% at 1 year, and 73 rt 5% at 2 years. Treatment failure (inc luding all late, sudden, unexplained deaths) occurred in 38 patients, and o nly 53 +/- 10% of patients were free of treatment failure at 3.7 years. Fiv e patients required late operative therapy for endoleaks associated with an eurysm enlargement. Conclusions. Satisfactory results were achieved using this "first-generatio n" homemade stent graft device. Mortality and morbidity occurred frequently , but may have been associated with the high-risk character of this patient population. Medium-term results were acceptable, but continued aortic enla rgement, with the late development of endoleaks, is a significant concern. Second-generation devices with commercial development, coupled with this in itial experience, should allow improved clinical results in the future. Lon ger term follow-up is still necessary to fully define the efficacy of this endovascular approach. (C) 1999 by The Society of Thoracic Surgeons.