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

TL;DR

This paper reports on the early real-world use of a new aortic repair device, showing it is safe and effective for various aortic conditions beyond its initial approval.

Contribution

The study provides real-world clinical data on the use of the Gore TBE device in diverse aortic pathologies and deployment zones.

Findings

The Gore TBE device was used successfully in 55 patients with aortic aneurysms, dissections, and other pathologies.

Technical success was 100%, with a low operative mortality rate of 3.6% and no strokes or paralyses.

Endoleaks occurred in 16.4% of cases, with most managed medically or through intervention.

Abstract

The first thoracic branched endoprosthesis (TBE) device for arch and proximal descending aortic thoracic endovascular aortic repair (TEVAR) became commercially available in the United States in 2022 (WL Gore, Flagstaff, AZ, United States). The pivotal approval study was limited to zone 2 deployment in cases of aortic aneurysm, but its use in aortic dissections and deployment in zones 0 and 1 remain investigational. We describe early results of Gore TBE device deployment in real-world patients and in a variety of clinical settings including off-label indications.

Patient characteristics, procedural details, and postoperative outcomes were assessed in this retrospective single-centre cohort study. Twenty-one patients (38.2%) were not open surgical candidates due to comorbidities. Follow-up evaluations included computed tomography angiography imaging of the device and its branches in addition to out

evaluation at discharge, 3 and 12 months, and then annually thereafter. The rate of endoleaks and re-interventions were assessed over the course of follow-up.

Between September 2022 and September 2024, 55 consecutive patients underwent aortic repair using the Gore TBE endoprosthesis at our institution. Ten (18.2%) cases were performed in an urgent/emergency setting. Indication for TBE repair was arch, descending and/or thoraco-abdominal aortic aneurysm (N = 26 [47.3%]), dissection (N = 27 [49.1%], 6 acute/subacute), intramural haematoma (N = 1 [1.8%]), or aortic coarctation (N = 1 [1.8%)]. Device deployment was performed in aortic zone 0 (N = 16 [29.1%]), zone 1 (N = 5 [9.1%]), or zone 2 (N = 34 [61.8%]). Twenty-four (43.6%) underwent an aortic arch debranching procedure prior to TEVAR, and 23 (41.8%) had preoperative spinal drain placement. Technical success was 100.0% following the index operation. Operative mortality was 3.6% (N = 2). There were no cases of stroke or paralysis and one case of renal failure requiring dialysis. One patient experienced paraparesis treated with spinal drain placement with immediate resolution. Median follow-up was 366 (interquartile range [IQR]: 189, 444) days. The rate of endoleak over the follow-up period was 16.4% (N = 9). Three cases were treated medically with ongoing surveillance, and the remaining 6 underwent intervention: 5 endovascular, 1 open. The linearized all-cause mortality rate was 11.0% per patient-year.

Real-world use of the Gore TBE device demonstrates its safety and versatility in addressing various aortic pathologies and deployment zones. Further follow-up is necessary to assess the durability of repair, and novel investigational devices may improve outcomes.

Since its commercial approval for zone 2 disease in May 2022, the GORE TAG thoracic branch endoprosthesis (TBE: W.L.

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