Peer-reviewedCC BY-NCBMJ connections. Surgery
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.
25 affiliations
- 1Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham Health System, Birmingham, Alabama, USA.
- 2Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
- 3Weill Cornell Medicine, New York City, New York, USA.
- 4Population Health Sciences, Weill Cornell Medicine, New York City, New York, USA.
- 5Vascular Surgery, University of Florida Health, Gainesville, Florida, USA.
- 6Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.
- 7Dartmouth Hitchcock Medical Center Heart & Vascular Center, Lebanon, New Hampshire, USA.
- 8Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
- 9Division of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University Hospital, Aarhus, Central Denmark Region, Denmark.
- 10W L Gore & Associates Inc, Newark, Delaware, USA.
- 11Cook Medical LLC, Bloomington, Indiana, USA.
- 12Medtronic, Minneapolis, Minnesota, USA.
- 13Swissvasc Registry Department of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Winterthur, Switzerland.
- 14Australian and New Zealand Society for Vascular Surgery, East Melbourne, Victoria, Australia.
- 15Department of Vascular Surgery, Abdominal Center, HUS Helsinki University Hospital, Helsinki, Finland.
- 16Semmelweis University Heart and Vascular Centre, Budapest, Hungary.
- 17Vascular and Endovascular Department and Residency Program, University of Siena Faculty of Medicine and Surgery, Siena, Italy.
- 18Department for Vascular Surgery, St Olavs Hospital Trondheim University Hospital Brøset Department, Trondheim, Norway.
- 19Cambridge Vascular Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
- 20Department of Vascular Surgery, Keele University School of Medicine, Keele, UK.
- 21Lund University Hospital, Lund, Sweden.
- 22Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.
- 23Department of Vascular Surgery, Waikato Hospital, Hamilton, New Zealand.
- 24Medical and Scientific Director, German Institute for Vascular Research (DIGG), Berlin, Germany.
- 25Surgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Abstract
Iintroduction
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.
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BibTeX
@article{banks2026evaluation,
title = {{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.}},
author = {Charles Banks and Kevin Mani and Xinyan Zheng and Jialin Mao and Salvatore Scali and Art Sedrakyan and Jack Cronenwett and Grace Wang and Martin Bjorck and Jacob Budtz-Lilly and Dorthy Ann Johnson and Christina Isaia and Jennifer A Brown and Scott D Williams and Melissa Hasenbank and Thomas Lattman and Barry Beiles and Maarit Venermo and Zoltan Szeberin and Carlo Setacci and Martin Altreuther and Jonathan Boyle and Arun Pherwani and Katarina A Bjoerses and Magnus Jonsson and Manar Khashram and Christian-Alexander Behrendt and Adam Beck},
journal = {BMJ connections. Surgery},
year = {2026},
month = sep,
doi = {10.1136/bmjcsurg-2026-000028},
url = {https://europepmc.org/article/MED/42968921},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - 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.
AU - Charles Banks
AU - Kevin Mani
AU - Xinyan Zheng
AU - Jialin Mao
AU - Salvatore Scali
AU - Art Sedrakyan
AU - Jack Cronenwett
AU - Grace Wang
AU - Martin Bjorck
AU - Jacob Budtz-Lilly
AU - Dorthy Ann Johnson
AU - Christina Isaia
AU - Jennifer A Brown
AU - Scott D Williams
AU - Melissa Hasenbank
AU - Thomas Lattman
AU - Barry Beiles
AU - Maarit Venermo
AU - Zoltan Szeberin
AU - Carlo Setacci
AU - Martin Altreuther
AU - Jonathan Boyle
AU - Arun Pherwani
AU - Katarina A Bjoerses
AU - Magnus Jonsson
AU - Manar Khashram
AU - Christian-Alexander Behrendt
AU - Adam Beck
PY - 2026
DA - 2026/09/01
JO - BMJ connections. Surgery
DO - 10.1136/bmjcsurg-2026-000028
UR - https://europepmc.org/article/MED/42968921
AB - Iintroduction 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.
SN - 2978-1809
ER -