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EARLY OUTCOMES OF OFF-THE-SHELF THORACOABDOMINAL MULTIBRANCH ENDOPROSTHESIS DURING PRE VS POST-MARKET APPROVAL PERIOD
Kenneth Han, BA, Alyssa Pyun, MD, Imani McElroy, MD, Elizabeth Miranda, MD, Miguel Manzur, MD, Gregory A. Magee, MD, Fred A. Weaver, MD, MMM, Sukgu M. Han, MD, MS.
Keck Medical Center of USC, Los Angeles, CA, USA.
OBJECTIVES: The Gore Thoracoabdominal Multibranch Endoprosthesis(TAMBE) is the first off-the-shelf four-vessel inner branched endograft to obtain commercial approval for complex abdominal and thoracoabdominal aortic aneurysms(TAAA). While the trial results are excellent, there is a paucity of data on the commercial use of TAMBE. Here, we present our early outcomes of patients who received TAMBE during pre and post-market approval periods, including off-label application of TAMBE.
METHODS: Consecutive patients who received TAMBE at a single institution from April 2020 to September 2024 were reviewed. Baseline characteristics including underlying aortic pathology, extent, urgency of repair, and off-label usage were compared between those during pre and post-market period. Intraoperative metrics and 30-day outcomes were compared.
RESULTS: Total of 35 patients were included, with 13 during pre and 22 during post-market period. Extent I~III TAAA were more commonly treated during post-market period (2/13 vs 12/22). Compassionate, off-label TAMBE was performed in 2 patients (previous failed endograft, chronic aortic dissection) during the pre-market period, while 15 patients were repaired using TAMBE in off-label fashion during the post-market period. Off-label uses during post-market period include chronic dissection(2), previous failed endograft(4), combination with Thoracic Branch Endoprosthesis or Iliac Branch Endoprosthesis(5), contained rupture(1), and total transfemoral implantation(5). There were no significant differences in operative time (273 vs 256 min, P=0.493), fluoroscopy time (49 vs 48 min, P=0.907), and contrast (112 ml vs 121 ml, P=0.495) during the pre vs post-market period groups. Technical success was 100% during pre and 95.5% during post-market. 30-day mortality was 0% for both groups, major adverse events(MAE) were seen in 7.7%, and 4.6% during pre and post-market periods. At median follow-up of 966 days for pre and 59 days for post-market, 15.4% of pre-market and 9.1% of post-market patients experienced target vessel instability, with 38.5% and 13.6% re-interventions for pre and post-market groups respectively.
CONCLUSIONS: Commercial approval of TAMBE was followed by increased application of the device beyond its instructions for use, without increased 30-day MAE. While this indicates that TAMBE is a promising technology with wider applicability, robust follow-up data through post-market multicenter registry is critical for defining its future role.
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