{ "abstract": "Iintroduction\n\nThe 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\n\nInternational 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\n\nOSR 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\n\nThis 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.", "abstract_shown": true, "affiliations": [ "Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham Health System, Birmingham, Alabama, USA.", "Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.", "Weill Cornell Medicine, New York City, New York, USA.", "Population Health Sciences, Weill Cornell Medicine, New York City, New York, USA.", "Vascular Surgery, University of Florida Health, Gainesville, Florida, USA.", "Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.", "Dartmouth Hitchcock Medical Center Heart & Vascular Center, Lebanon, New Hampshire, USA.", "Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.", "Division of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University Hospital, Aarhus, Central Denmark Region, Denmark.", "W L Gore & Associates Inc, Newark, Delaware, USA.", "Cook Medical LLC, Bloomington, Indiana, USA.", "Medtronic, Minneapolis, Minnesota, USA.", "Swissvasc Registry Department of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Winterthur, Switzerland.", "Australian and New Zealand Society for Vascular Surgery, East Melbourne, Victoria, Australia.", "Department of Vascular Surgery, Abdominal Center, HUS Helsinki University Hospital, Helsinki, Finland.", "Semmelweis University Heart and Vascular Centre, Budapest, Hungary.", "Vascular and Endovascular Department and Residency Program, University of Siena Faculty of Medicine and Surgery, Siena, Italy.", "Department for Vascular Surgery, St Olavs Hospital Trondheim University Hospital Brøset Department, Trondheim, Norway.", "Cambridge Vascular Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.", "Department of Vascular Surgery, Keele University School of Medicine, Keele, UK.", "Lund University Hospital, Lund, Sweden.", "Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.", "Department of Vascular Surgery, Waikato Hospital, Hamilton, New Zealand.", "Medical and Scientific Director, German Institute for Vascular Research (DIGG), Berlin, Germany.", "Surgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA." ], "article_type": "research article", "arxiv": null, "author_total": 28, "authors": [ { "affs": [ 0 ], "name": "Charles Banks", "orcid": "0000-0003-2284-2826" }, { "affs": [ 1 ], "name": "Kevin Mani" }, { "affs": [ 2 ], "name": "Xinyan Zheng" }, { "affs": [ 3 ], "name": "Jialin Mao" }, { "affs": [ 4 ], "name": "Salvatore Scali" }, { "affs": [ 5 ], "name": "Art Sedrakyan" }, { "affs": [ 6 ], "name": "Jack Cronenwett" }, { "affs": [ 7 ], "name": "Grace Wang" }, { "affs": [ 1 ], "name": "Martin Bjorck" }, { "affs": [ 8 ], "name": "Jacob Budtz-Lilly" }, { "affs": [ 9 ], "name": "Dorthy Ann Johnson" }, { "affs": [ 9 ], "name": "Christina Isaia" }, { "affs": [ 10 ], "name": "Jennifer A Brown" }, { "affs": [ 10 ], "name": "Scott D Williams" }, { "affs": [ 11 ], "name": "Melissa Hasenbank" }, { "affs": [ 12 ], "name": "Thomas Lattman" }, { "affs": [ 13 ], "name": "Barry Beiles", "orcid": "0000-0001-5026-1661" }, { "affs": [ 14 ], "name": "Maarit Venermo" }, { "affs": [ 15 ], "name": "Zoltan Szeberin" }, { "affs": [ 16 ], "name": "Carlo Setacci" }, { "affs": [ 17 ], "name": "Martin Altreuther" }, { "affs": [ 18 ], "name": "Jonathan Boyle" }, { "affs": [ 19 ], "name": "Arun Pherwani" }, { "affs": [ 20 ], "name": "Katarina A Bjoerses" }, { "affs": [ 21 ], "name": "Magnus Jonsson" }, { "affs": [ 22 ], "name": "Manar Khashram" }, { "affs": [ 23 ], "name": "Christian-Alexander Behrendt", "orcid": "0000-0003-0406-3319" }, { "affs": [ 24 ], "name": "Adam Beck", "orcid": "0000-0002-5474-3833" } ], "bibtex": "https://research.draconitic.com/paper/52v1qyg8qqzm9.bib", "cited_by": 0, "doi": "10.1136/bmjcsurg-2026-000028", "fulltext_url": "https://europepmc.org/articles/PMC13723777", "id": "52v1qyg8qqzm9", "issns": [ "2978-1809" ], "landing_url": "https://europepmc.org/article/MED/42968921", "language": "eng", "licence": "CC-BY-NC", "licence_label": "CC BY-NC", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "1506" ], [ "heading", "Original Research" ], [ "openalex", "2740|Aortic aneurysm repair treatments" ] ], "openalex": "W7204951791", "pdf_url": "https://europepmc.org/articles/PMC13723777?pdf=render", "pmcid": "PMC13723777", "pmid": "42968921", "published": "2026-09-01", "publisher": "BMJ Publishing Group", "ris": "https://research.draconitic.com/paper/52v1qyg8qqzm9.ris", "sources": [ { "first_seen": "2026-11-03T15:20:53Z", "native_id": "MED:42968921", "source": "europepmc", "url": "https://europepmc.org/article/MED/42968921" }, { "first_seen": "2026-11-04T12:22:21Z", "native_id": "PMC13723777", "source": "pmc", "url": "https://doi.org/10.1136/bmjcsurg-2026-000028" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2740|Aortic aneurysm repair treatments", "subfield": "general" } ], "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.", "title_text": "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.", "type": "peer-reviewed", "updated_at": "2026-11-05T12:20:32Z", "url": "https://research.draconitic.com/paper/52v1qyg8qqzm9", "venue": "BMJ connections. Surgery", "versions": [] }