SS19 - F/BEVAR is increasing throughout the United States and associated with increased mortality when performed at hospitals without an investigational device exemption

Friday, June 21, 2024

10:24 AM – 10:35 AM CT

Location: West Building, Level 3, Skyline Ballroom W375ab

Presenting Author only(s)

Sara L. Zettervall, MD

Assistant Professor
University of Washington
Seattle, Washington

Co-Author(s)

Chen Dun, MS

PhD Student
Johns Hopkins University School of Medicine
Baltimore, Maryland
JC

Jesse A. Columbo

Vascular Surgeon
Dartmouth Hitchcock Medical Center
Lebanon NH, New Hampshire
Bernardo C. Mendes, MD

Associate Professor of Surgery
Division of Vascular and Endovascular Surgery, Mayo Clinic
Rochester, Minnesota
PG

Philip P. Goodney, MD, MS

Vascular Surgeon
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
Andres Schanzer, MD (he/him/his)

Professor
University of Massachusetts Chan Medical School
Worcester, Massachusetts
Marc L. Schermerhorn, MD (he/him/his)

Chief of Vascular and Endovascular Surgery
Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
Boston, Massachusetts
MM

Martin A. Makary

Professor of Surgery
Johns Hopkins University School of Medicine
Baltimore, Maryland
James H. Black, III, MD

Professor and Chief
Johns Hopkins University School of Medicine
Baltimore, Maryland

Senior Author(s)

Caitlin W. Hicks, MD, MS (she/her/hers)

Associate Professor of Surgery
Johns Hopkins University
Baltimore, Maryland

Objectives: Fenestrated and branched endovascular aortic repair (F/BEVAR) has been adopted by many centers. However, national trends of F/BEVAR, particularly at sites who perform them without an FDA-approved Investigational Device Exemption (IDE), remain unclear. We aimed to quantify the use of F/BEVAR in the US, and to evaluate the association of F/BEVAR with case volume and mortality at IDE vs non-IDE sites.

Methods: We used 100% fee-for-service Medicare claims data to identify patients who underwent endovascular treatment of the visceral aorta incorporating two or more visceral artery endoprostheses from 2014-2022. The hospital’s Employer Identification Number and the corresponding start and end dates for IDE studies were used to identify cases performed at IDE vs non-IDE centers. Aneurysm extent and number of target vessels were compared. Trends in the center-level F/BEVAR case volume stratified by IDE status were assessed using cumulative incidence curves. The 30-day and 3-year mortality were compared using Kaplan-Meier methods and Cox proportional hazards models after adjusting for patient comorbidities.

Results: Between 2014-2022, 7977 patients were treated with F/BEVAR (median age 75.8 years, 72.6% male, 91.4% White) at 551 hospitals, of which 25% (n=1967) were performed at 20 hospitals with an IDE (Figure 1). The median annual case volume per hospital was significantly higher at IDE sites (24 cases/year vs. 2 cases/year, P< 0.001); 24% of IDE sites and 93% of non-IDE sites completed ≤9 cases per year. The number of target vessels treated (4 vessel: 61% at IDE vs 21% at non-IDE, P< 0.001) and indication for repair (thoracoabdominal aneurysms: 44% at IDE vs. 80% at non-IDE, P< 0.001) varied by IDE status. The 30-day (3.1% vs. 4.9%, P< 0.001) and 3-year (25% vs. 28%, P=0.03) mortality were improved for patients treated at hospitals with vs. without an IDE. After risk adjustment, both 30-day (OR 0.48, 95%CI 0.32-0.71) and mid-term mortality (HR 0.83, 95%CI 0.71-1.0) was lower for patients treated at IDE sites.

Conclusions: The utilization of F/BEVAR is increasing dramatically across the United States, with the majority of cases being performed outside of IDE studies, at low volume centers, and to treat 4-vessels or thoracoabdominal aneurysms. These findings emphasize the need for access to commercially available devices and transparent outcome reporting to ensure optimal patient outcomes.