Evaluation of devices used for endovascular repair of ruptured abdominal aortic aneurysms in the international consortium of vascular registries: an international, retrospective, multicentre, single-arm, open-label performance goal study

Introduction The purpose of this study was to pilot a new concept for device appraisal—leveraging international real-world data (RWD) from the International Consortium of Vascular Registries (ICVRs) to assess aggregate endovascular aortic repair (EVAR) performance against a conservative performance goal (PG) derived from open surgical repair (OSR), with the intention of helping refine device labelling in collaboration with industry and the US Food and Drug Administration. Research Design and Methods International retrospective, multicentre, single-arm cohort, open-label clinical PG-based study within the ICVRs. Because OSR patients may not have been anatomically EVAR-eligible, the OSR cohort used for PG derivation was restricted to smaller diameters (<6.5 cm men; <5.5 cm women) to include patients eligible for EVAR. Analyses performed at Weill Cornell Medicine (MDEpiNet Center). Results OSR PG cohort: 932 patients (72±9 years average; 83.8% men) with 30% in-hospital mortality. EVAR cohort: 219 patients (75±10 years average, 83.1% men) with larger aneurysms (EVAR 7.3±2.0 cm vs OSR 5.3±1.3 cm; p<0.001). In-hospital mortality after EVAR was 18% (upper 95% CI 13% to 23%), exceeding the PG (p<0.001). EVAR showed lower dialysis (10.6% vs 15.7%; p=0.02), bowel ischaemia (1.8% vs 7.5%; p<0.001) and reoperation for bleeding (2.7% vs 7.1%; p=0.004). Conclusions This proof-of-concept study shows harmonised international RWD can evaluate device performance in ruptured abdominal aortic aneurysm. Despite a comparator biased to favour OSR, EVAR met/exceeded the PG and reduced complications, supporting regulatory discussions to align instructions for use with guideline-endorsed EVAR-first strategies