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P4: Plenary Session 4

SS11 - 30-Day Outcomes from the Pivotal Trial of a Four Branch Off-The Shelf Solution to Treat Complex Aortic Aneurysms

Thursday, June 20, 2024
10:55 AM – 11:06 AM CT
Location: West Building, Level 3, Skyline Ballroom W375ab

    Submitting & Presenting Author(s)

  • Mark A. Farber, MD

    Professor of Surgery, Chief of Division
    University of North Carolina
    Chapel Hill, North Carolina

    • Co-Author(s)

  • JM

    Jon Matsumura

    Division of Vascular Surgery, University of Colorado School of Medicine

  • Sukgu M. Han, MD, MS (he/him/his)

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

  • Michel S. Makaroun, MD

    Chair in Vascular Surgery; Professor of Surgery
    University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania

  • Bjoern D. Suckow, MD, MS

    Assistant Professor of Vascular Surgery
    Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire

  • Carlos H. Timaran, MD, MS

    Associate Professor
    Department of Vascular Surgery UT Southwestern Medical Cente
    Dallas, Texas

  • Bernardo C. Mendes, MD

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

    • Senior Author(s)

  • 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

Objectives:

Objective: This study reports the 30-day outcomes of the Thoracoabdominal Branched Endoprosthesis (TAMBE) pivotal trial for complex aortic aneurysm repair.

Methods:

Methods: This was a nonrandomized, two-armed prospective study of TAMBE across 35 investigative sites. The primary arm of the study (reported here) included type IV TAAA and pararenal aneurysms who met the inclusion criteria from June 2019 to December 2021. The secondary arm (not reported) included subjects with type I-III TAAA. Technical success was analyzed per the SVS guidelines. ClinicalTrials.gov: NCT03728985.

Results:

Results: There were 102 subjects who underwent TAMBE in the primary arm, consisting of 84 males (82.4%) with a mean age 73+6.4 years (range 58-82) and a mean BMI of 28.3+5.0. Fifty-nine (57.8%) subjects were treated for type IV, and 43 (42.2%) for pararenal aneurysms. A cerebral spinal fluid drain was used in 10 (9.8%) patients. Technical success was achieved in 99% of patients with the single failure due to unsuccessful cannulation of the left renal artery target vessel. Mean procedure time was 315+103 minutes (range 163-944), mean estimated blood loss 300+296 ml (range 10-2000) and contrast administration of 153.6+73.5 ml (range zz-aa). The ICU length of stay was 58.7+52.7 hours (83 patients range 1-288). Additional endovascular components were deployed in 32 (31.4%) of subjects to manage procedural complications, including aortic and target vessel dissections, and injuries. There were 407 target vessels incorporated with a mean of 1.6 (Range 1~4) VBX stent grafts per vessel. There was one adverse event related to femoral access and seven subjects with non-serious adverse events related to access (3 upper extremity, 5 lower extremity). Post-op transfusion was required in 14 (13.7%) of patients. Major adverse events occurred in seven (6.9%) patients (Table I) through 30 days and included respiratory failure-2, disabling stroke-1, new onset renal failure requiring dialysis-2, and paraplegia–2 (including one subject with intra-operative rupture). At 30-days, there were no type I/III endoleaks, severe bowel ischemia, or lesion-related/all-cause mortality. There were no cases of wire fracture or device kinking through one month. The Core Lab reported patency was 100% in the aortic component, stented SMA and celiac arteries, 95.9% in the left renal, and 99% in the right renal through one month of follow-up. Reinterventions, all minor, at 30-days were performed in 9/96 (9.4%) of subjects.

Conclusions:

Conclusions: Early TAMBE outcomes demonstrate a high technical success rate, no 30-day mortality and low safety events rate within 30 days of the index procedure.