title: Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms: a note of caution based on a 9-year experience.
abstract: OBJECTIVE
  To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992.
  
  
  BACKGROUND
  Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy.
  
  
  METHODS
  During the past 9 years, 239 endovascular graft repairs were performed 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 performed 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 follow-up results were prospectively recorded.
  
  
  RESULTS
  The major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean +/- standard deviation, 15.7 +/- 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3).
  
  
  CONCLUSIONS
  With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Montefiore Medical Center and the Albert Einstein College of Medicine, New York, New York 10467, USA. takohki@msn.com
authors.forename: T
authors.initials: T
authors.lastname: Ohki
authors.forename: F J
authors.initials: FJ
authors.lastname: Veith
authors.forename: P
authors.initials: P
authors.lastname: Shaw
authors.forename: E
authors.initials: E
authors.lastname: Lipsitz
authors.forename: W D
authors.initials: WD
authors.lastname: Suggs
authors.forename: R A
authors.initials: RA
authors.lastname: Wain
authors.forename: M
authors.initials: M
authors.lastname: Bade
authors.forename: M
authors.initials: M
authors.lastname: Mehta
authors.forename: N
authors.initials: N
authors.lastname: Cayne
authors.forename: J
authors.initials: J
authors.lastname: Cynamon
authors.forename: J
authors.initials: J
authors.lastname: Valldares
authors.forename: J
authors.initials: J
authors.lastname: McKay
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections