ArticleJAMA surgery2025
Fenestrated and Branched Endovascular Aortic Repair and Mortality at Hospitals Without Investigational Device Trials.
Article in JAMA surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Impact of Single Antiplatelet, Dual Antiplatelet, and Anticoagulation Plus Antiplatelet Therapy on Branch Vessel Patency and Bleeding Risk Following Branched Endovascular Aortic Repair.Cardiovascular drugs and therapy · 2026Article
- Infection after Endovascular Repair of Complex Aortic and Thoracoabdominal Aneurysms with Fenestrated and Branched Devices: A Systematic Descriptive Review.Vascular specialist international · 2026Review
- Large Aneurysm Size is Associated with Increased Short and Long Term Mortality after Branched and Fenestrated Repair for Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms.European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery · 2026Article
- Increased clinical frailty is associated with aortic-related mortality following fenestrated and branched endovascular repair for thoracoabdominal aortic aneurysm.Journal of vascular surgery · 2026Article
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10 authors.
Funding
Abstract
Importance: Fenestrated and branched endovascular aortic repairs (F/BEVAR) have been adopted by many centers. However, national trends of F/BEVAR use remain unclear, particularly at sites who perform them without an US Food and Drug Adminstration (FDA)-approved investigational device exemption (IDE). Objective: To quantify the use of F/BEVAR in the US and to determine if mortality was different at IDE vs non-IDE sites. Design, Setting, and Participants: This retrospective cohort study examined 100% fee-for-service Medicare claims data from 2016 to 2023. Participants were patients who underwent endovascular treatment of the visceral aorta incorporating 2 or more visceral artery endoprostheses. Hospitals with vs without an IDE were identified using hospitals' Employer Identification Number as a time varying exposure. Exposure: F/BEVAR. Main Outcomes and Measures: Trends in the center-level F/BEVAR case volume stratified by IDE status were assessed using cumulative incidence curves. Mortality outcomes at 30 days and 3 years were compared using Kaplan-Meier methods and Cox proportional hazards models with adjustment for baseline patient characteristics. Results: From 2016 to 2023, 8017 patients were treated with F/BEVAR at 549 hospitals. The median (IQR) age was 75.8 (71.3-80.8) years; 5795 patients (72.3%) were male and 2222 (27.7%) female. A total of 2226 F/BEVAR (27.8%) were performed at 22 hospitals with an IDE. The number of patients treated with F/BEVAR increased from 771 in 2016 to 1251 in 2023. The median (IQR) annual case volume per hospital was significantly higher at IDE sites (22.3 [11.0-30.4] vs 1.2 [1.0-2.0] cases/y; P < .001); 18 IDE sites (90.0%) and 20 non-IDE sites (3.7%) completed 9 or more cases per year. The 30-day mortality (3.0% vs 4.9%) but not 3-year mortality (26.0% vs 27.1%) was lower for patients treated at hospitals with vs without an IDE. After risk adjustment, both 30-day (odds ratio, 0.47; 95% CI, 0.32-0.69) and midterm mortality (hazard ratio, 0.81; 95% CI, 0.69-0.95) were lower for patients treated at IDE sites. Conclusions and Relevance: The use of F/BEVAR is increasing across the United States, with the majority of cases being performed outside of IDE studies and at low-volume centers. F/BEVAR performed at non-IDE centers are associated with higher adjusted 30-day and midterm mortality. Transparent outcome reporting and identification of process measures from IDE sites may help achieve more equity in patient outcomes.
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