title: Ten years of experience with the GORE EXCLUDER® stent-graft for the treatment of aortic and iliac aneurysms: outcomes from a single center study.
abstract: OBJECTIVE
  This study was designed to assess the long-term outcome of selected patients with aortic, aortoiliac, and isolated common iliac aneurysms treated with the GORE EXCLUDER® stent-graft.
  
  
  METHODS
  Between December 1998 and June 2010, 121 nonconsecutive patients underwent insertion of a GORE EXCLUDER® stent-graft to treat an aortic (n=80; 66%), aortoiliac (n=25; 21%), or isolated common iliac (n=16; 13%) aneurysm. Procedural and follow-up data were collected prospectively. Primary endpoints are overall survival, intervention-free survival, and freedom from aneurysm rupture. Secondary endpoints are device- and procedure-related complications, including all types of endoleaks or endotension, and reintervention.
  
  
  RESULTS
  The mean follow-up is 4.98 years (standard deviation, 3.18; median follow-up, 4.05 years). The estimated percentage overall survival (with 95% confidence interval) after respectively 5 and 10 years of follow-up is 74.5% (65.8; 81.3) and 57.8% (47.7; 66.7). The estimated intervention-free survival after respectively 5 and 10 years is 90% (84.3; 96.1) and 77.7% (67; 88.4). There was no aneurysm rupture during follow-up. Early postoperative complications occurred in 16 patients (13%); none were fatal. Late reinterventions were performed in 18 patients (15%). Finally, throughout the follow-up period, endoleaks were identified: type I (n=4; 3%); type II (n=39; 32%); type III (n=0; 0%); endotension was seen in 11 patients (9%).
  
  
  CONCLUSIONS
  Aneurysm exclusion with use of the GORE EXCLUDER® stent-graft is durable through a mean follow-up of nearly 5 years. There was no postprocedural aneurysm rupture. Complications occurred throughout the follow-up period, requiring continued clinical and radiological surveillance.
authors.affiliation: Department of Radiology, University Hospitals Leuven, and Department of Biostatistics and Statistical Bioinformatics, Catholic University of Leuven, Herestraat 49, 3000, Leuven, Belgium. geert.maleux@uzleuven.be
authors.forename: G
authors.initials: G
authors.lastname: Maleux
authors.forename: H
authors.initials: H
authors.lastname: Claes
authors.forename: A
authors.initials: A
authors.lastname: Van Holsbeeck
authors.forename: R
authors.initials: R
authors.lastname: Janssen
authors.forename: A
authors.initials: A
authors.lastname: Laenen
authors.forename: S
authors.initials: S
authors.lastname: Heye
authors.forename: S
authors.initials: S
authors.lastname: Houthoofd
authors.forename: I
authors.initials: I
authors.lastname: Fourneau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001014:Aortic Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D001807:Blood Vessel Prosthesis; D057510:Endovascular Procedures / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017543:Iliac Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D015641:Radiography, Interventional; D018570:Risk Assessment; D015607:Stents; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome