Long-Term Outcome of the GORE EXCLUDER AAA Endoprosthesis for Treatment of Infrarenal Aortic Aneurysms.
OBJECTIVE
To evaluate long-term outcome of GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) for elective treatment of infrarenal aortic aneurysms and to evaluate performance of different generations of the device.


METHODS
A retrospective analysis was performed of 248 patients undergoing elective endovascular aneurysm repair with the GORE EXCLUDER between January 2000 and December 2015 in 2 hospitals. Primary endpoint was reintervention-free survival. Secondary endpoints were technical success, overall survival, rupture-free survival, endoleaks, sac diameter change (> 5 mm), limb occlusion, and migration (> 5 mm). Median follow-up time was 26 months (range, 1-190 months).


RESULTS
Assisted primary technical success was 96.8%. Reintervention-free survival for 5 and 10 years was 85.2% and 75.6%, respectively. Independent risk factors for reintervention were technical success (P < .001), type I endoleak (P < .001), and type II endoleak (P = .003). Late adverse events requiring reintervention included rupture (0.4%), limb occlusion (0.4%), and stent migration (0.4%). Type Ia (4.8%), Ib (2.8%), II (35.9%), and V (6.5%) endoleaks were reported throughout follow-up. Sac growth was more prevalent with the original GORE EXCLUDER compared with the low permeability GORE EXCLUDER (P = .001) and in the presence of type I, II, and V endoleaks (P < .05). Three conversions (1.2%) were performed. Overall survival at 5 and 10 years was 68.4% and 49.0%, with no reported aneurysm-related deaths.


CONCLUSIONS
Treatment with the GORE EXCLUDER is effective with acceptable reintervention rates in the long-term and few device-related adverse events or ruptures up to 10 years. Observed late adverse events and new-onset endoleaks emphasize the need for long-term surveillance.
Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands; University of Maastricht, Maastricht, The Netherlands.
Claire G
CG
Poublon
Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands.
Suzanne
S
Holewijn
Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands.
Steven M M
SMM
van Sterkenburg
Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Ignace F J
IFJ
Tielliu
Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Clark J
CJ
Zeebregts
Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands. Electronic address: mmpj.reijnen@gmail.com.
Michel M P J
MMPJ
Reijnen
D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D012086:Reoperation; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome