Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms: A note of caution based ona 9-year experience

Objective To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. Summary Background Data Recently, the use of endovascular grafts for the tr eatment of AAAs has increased dramatically. However, there is little midter m or long-term proof of their efficacy. Methods During the past 9 years, 239 endovascular graft repairs were perfor med for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29 ), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performe d as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and f ollow-up results were prospectively recorded. Results The major complication and death rates within 30 days of endovascul ar graft repair were 17.6% and 8.5%, respectively. The technical success ra te with complete AAA exclusion was 88.7%. During follow-up to 75 months (me an +/- standard deviation, 15.7 +/- 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and we re surgically repaired, with one death. Other late complications included t ype 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/ste nosis (n = 7), limb separation or fabric tear with a subsequent type 3 endo leak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary interven tion or surgery was required in 23 patients (10%). These included deploymen t of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). Conclusion With longer follow-up, complications occurred with increasing fr equency. Although most could be managed with some form of endovascular rein tervention, some complications resulted in a high death rate. Although endo vascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-t erm surveillance and prospective studies to prove the effectiveness of endo vascular graft repair.