Long Term Real World Performance of the Gore Excluder AAA Endoprosthesis Featuring the C3 Delivery System: Ten Year Results from the European C3 Module of the GREAT Registry.

Abstract

This study aimed to report the ten year data for patients treated with the Gore Excluder AAA Endoprosthesis featuring the C3 Delivery System for infrarenal aortic disease, as recorded in the European C3 module of the Gore Global Registry for Endovascular Aortic Treatment. The European C3 module included patients from 13 centres who underwent endovascular aortic aneurysm repair between August 2010 and December 2012. Outcomes were assessed using descriptive statistics and Kaplan-Meier survival analysis with 95% confidence intervals (CIs). At module closure, 396 patients (87.1% men; mean age ± standard deviation 73.9 ± 7.8 years) were available for analysis, with a mean follow up duration ± standard deviation of 6.4 ± 3.2 years. Of these, 94.4% underwent elective endovascular aortic aneurysm repair for infrarenal aortic aneurysm, and 16.9% (67 of 396) were treated outside the instructions for use. At ten years, the all cause mortality rate was 46.0% with 182 deaths: five aortic related, 120 non-aortic related, and 57 of unknown cause. Freedom from aortic related death was 98.6% (95% CI 96.7 - 99.4%). Freedom from any re-intervention and device related re-intervention was 77.3% (95% CI 71.8 - 81.8%) and 80.6% (95% CI 75.3 - 84.9%), respectively. Freedom from type 1 endoleak was 95.4% (95% CI 92.3 - 97.5%), with type 2 endoleaks accounting for 82% (41 of 50) of all endoleaks. Structural complications were rare: two cases of migration (0.5%), one case of compression (0.3%), and no cases of device fractures. Nine patients (2.3%) required conversion, and secondary rupture occurred in three cases (0.8%). The Gore C3 Excluder shows long term safety and durability for infrarenal aortic disease, with low rates of aortic related death and major aortic events. These findings support its effectiveness in a real world setting. However, surveillance adherence remains challenging in daily practice.