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

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.