Long-Term Outcomes of Gore's Excluder for Infrarenal Aortic Aneurysms Studied in The Netherlands

March 22, 2017—A study conducted at two centers in The Netherlands evaluated the long-term outcome of the Excluder abdominal aortic aneurysm (AAA) endoprosthesis (Gore & Associates) for elective treatment of infrarenal aortic aneurysms and the performance of different generations of the device. Claire G. Poublon, BSc, et al published the findings online ahead of print in Journal of Vascular and Interventional Radiology (JVIR).

The investigators performed a retrospective analysis of 248 patients undergoing elective endovascular aneurysm repair with the Excluder AAA device between January 2000 and December 2015 at the University Medical Center Groningen in Groningen, the Netherlands, and Rijnstate Hospital in Arnhem, The Netherlands. 

As reported In JVIR, the study's 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).

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 Excluder device compared with the low-permeability Excluder device (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%, with no reported aneurysm-related deaths.

The investigators concluded that treatment with the Excluder device 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, advised the investigators in JVIR.