Lessons learned from the long-term follow-up of a first-generation aortic stent graft

Objective: Endovascular repair (EVR) of abdominal aortic aneurysm (AAA) is being performed with increasing frequency worldwide. No studies have a complete follow-up of more than 4 years. Our study objective was to assess the long-term results and the durability of a first-generation stent graft with complete 7-year follow-up. Methods: Between March 1994 and May 1995, 23 consecutive patients underwent treatment with the Clutter stent graft at a single center. All patients underwent computed tomographic scan before discharge, at 3 and 6 months, and annually thereafter. The data were prospectively collected on all patients. The median follow-up period was 72.5 months (range, 0.2 to 91 months). None of the patients were lost to follow-up. Results:. Among these 21 men and two women with a median age of 69 years (range, 52 to 85 years), 11 (47.8%) were at high risk. The 30-day technical success rate was 87%. Acute (30-day) complications were one graft deployment failure (4.3%) that necessitated an immediate conversion, 20 intraoperative graft limb kinks (87%), all of which needed additional Wallstent (Schneider, Minneapolis, Minn) placement, four renal failures (17.4%), one type: Ia endoleak complicated with AAA rupture (4.3%), and three perioperative deaths (13%). Late complications were eight type I or 11 endoleaks (34.8%) after a mean delay of 23.9 months (range, 3 to 69 months), 13 proximal stent migrations (56.5%) after a mean delay of 29.6 months (range, 7 to 58 months), six graft limb thromboses (26.1%) after a mean delay of 38.7 months (range, 3 to 71 months), one AAA rupture (4.3%), and 11 deaths (47.8%), with five AAA-related deaths (21.7%). The 3-year, 5-year, and 7-year cumulative endoleak rates were 34%, 41%, and 49%, respectively; the cumulative migration rates were 66%, 75%, and 75%, respectively; and the cumulative open surgery rates were 30%, 50%, and 50%, respectively. At the same intervals, the cumulative survival rates for any death were 69%, 56%, and 49%, respectively; the cumulative survival rates for AAA-related deaths were 82%, 82%, and 73%, respectively; and the cumulative secondary, success rates were 54%, 28%, and 28%, respectively. Conclusion: This studies emphasizes the need for close lifelong surveillance of AAAs treated with EVR. Despite the small population of this series, a long-term follow-up highlights that the first-generation homemade stent graft evaluated in this study failed to adequately protect the patient from AAA-related death and that most of the serious complications were related to a late failure of the aortic neck attachment. Better proximal fixation of the aortic stent graft is essential to improve the durability of EVR.