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P1: Plenary Session 1: William J. von Liebig Forum

RS02 - One year results of the GORE® EXCLUDER® Conformable Endoprosthesis in patients with hostile aortic neck angles (>60˚) in the US pivotal IDE trial

Wednesday, June 19, 2024
9:04 AM – 9:11 AM CT
Location: West Building, Level 3, Skyline Ballroom W375ab

    Presenting Author only(s)

  • Mahmoud Almadani, MD (he/him/his)

    Faculty
    Maimonides Health
    Brooklyn, New York

    • Submitting Author only(s)

  • Robert Rhee

    Chief, Vascular Surgery
    Maimonides Health
    Brooklyn, New York

    • Co-Author(s)

  • DY

    Dai Yamanouchi

    Professor and Chair, Vascular Surgery
    Fujita Health University

  • Gustavo S. Oderich, MD

    Professor of Surgery and Chair of Vascular and Endovascular Surgery
    Department of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, McGovern
    Houston, Texas

  • Sukgu M. Han, MD, MS (he/him/his)

    Associate Professor of Surgery
    University of Southern California
    Los Angeles, California

  • EM

    Erin M. Moore, MD

    Section Cheif, Vascular Surgery
    Baptist Medical Center, Jacksonville
    Jacksonville, Florida

  • JM

    Jon Matsumura

    Division of Vascular Surgery, University of Colorado School of Medicine

Objectives: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) system in the United States (US) regulatory high-neck angulation (HNA) sub-study trial.

Methods: This study is a prospective, multicenter, investigational device exemption (IDE) clinical trial at 35 US sites with core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment included infrarenal aortic neck angulation > 60˚ and ≤ 90˚ with aortic neck length ≥10 mm. Primary safety end points included blood loss > 1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness end points included technical success, absence from Type I and III endoleak, migration (>10mm), sac enlargement (>5mm), sac rupture, and conversion to open repair.

Results: 95 patients were enrolled in the HNA sub-study of the EXCC IDE trial between January 22, 2018 – February 16, 2022. 71/95 patients were male with an average age of 74.4 years. The mean infrarenal proximal aortic neck angle in the sub-study was 71.6˚ with AAA size of 62.9mm. Overall technical success was 97.9%. Freedom from a primary safety endpoint was 96.7% through 30 days, Freedom from the primary effectiveness endpoint at 12 months was 94.8% 18/95 patients in the sub-study had aortic neck lengths < 15mm with no significant difference in outcome compared to the rest of the HNA sub-study group. 4 patients had type 1A endoleak, however did not require intervention after the procedure but no interventions or sac enlargement were noted in these patients. At 1 year, 29 (39.7%) patients experienced a Type 2 endoleak and 1 (1.3%) patient experience AAA sac expansion ≥ 5mm. There were no aneurysm-related deaths, conversions or ruptures at 1 year.

Conclusions: The EXCC IDE study demonstrates safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system in highly angulated necks (60-90 degrees) are preserved at 1 year follow-up.