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Initial Post-Commercialization Experience Using a Thoracic Branch Endoprosthesis: Broad Application to Real-World

Xiaoying Lou1,2, Patrick R Vargo1,2, Francis Caputo1,3

  • 1Aorta Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH 44195, United States.

European Journal of Cardio-Thoracic Surgery : Official Journal of the European Association for Cardio-Thoracic Surgery
|December 17, 2025
PubMed
Summary

The Gore thoracic branched endovascular (TBE) device shows early safety and versatility for aortic repair in real-world use, including complex cases and off-label indications. Further studies will assess long-term durability.

Keywords:
aortic arch aneurysmaortic arch dissectionbranched endoprosthesisthoracic endovascular aortic repair (TEVAR)

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Area of Science:

  • Vascular Surgery
  • Medical Devices
  • Cardiovascular Research

Background:

  • The Gore thoracic branched endovascular (TBE) device, approved in 2022, offers a new option for thoracic endovascular aortic repair (TEVAR).
  • Initial studies focused on zone 2 deployment for aneurysms, with use in dissections and zones 0/1 remaining investigational.
  • Real-world data is crucial for understanding the device's performance in diverse clinical scenarios.

Purpose of the Study:

  • To evaluate the early clinical outcomes of the Gore TBE device in a real-world patient cohort.
  • To assess the safety and efficacy of TBE device deployment across various aortic pathologies and anatomical zones.
  • To investigate the device's performance in both approved and off-label indications.

Main Methods:

  • A retrospective single-center cohort study of 55 consecutive patients undergoing TBE repair between September 2022 and September 2024.
  • Inclusion of patients with diverse aortic pathologies including aneurysms, dissections, intramural hematomas, and coarctations.
  • Assessment of patient characteristics, procedural details, deployment zones (0, 1, and 2), and postoperative outcomes including endoleaks and re-interventions.

Main Results:

  • Technical success rate was 100% with an operative mortality of 3.6%.
  • No strokes or paralysis occurred; one case of renal failure and one of paraparesis (resolved) were noted.
  • An overall endoleak rate of 16.4% was observed, with 6 out of 9 cases requiring intervention.

Conclusions:

  • The Gore TBE device demonstrates safety and versatility in real-world application for various aortic conditions and deployment zones.
  • Continued follow-up is essential to determine the long-term durability of repairs performed with the TBE device.
  • Emerging investigational devices may offer further improvements in TEVAR outcomes.