Three-year outcomes of endovascular repair of descending thoracic aortic lesions with a single-branched endograft for left subclavian artery preservation.

Abstract

Zone 2 thoracic endovascular aortic repair with a single-branched endograft (GORE TAG Thoracic Branch Endoprosthesis [TBE], W.L. Gore & Associates, Inc) was approved by the Food and Drug Administration in May 2022 on the basis of 1-year results from a pivotal trial. This report presents 3-year trial outcomes in patients with nondissection descending thoracic aortic lesions requiring zone 2 proximal landing zone. In this prospective, nonrandomized cohort study across 40 US sites, 106 adults underwent thoracic endovascular aortic repair using the TBE device, which includes a side-branch for left subclavian artery perfusion. Three cohorts were evaluated: aneurysm (AN; n = 84), traumatic aortic injury (TAI; n = 9), and other isolated lesions (OL; n = 13). Mean ages were AN 70 ± 11, TAI 42 ± 19, and OL 65 ± 13 years; male patients comprised 63%, 89%, and 46%, respectively. At 36 months, all-cause mortality was 14% overall (AN 13%, TAI 0%, OL 31%) with 1 lesion-related death (1%). Late (>30 days) stroke occurred in 5%. Core laboratory-adjudicated imaging follow-up revealed 8% type I/III endoleaks and 99% left subclavian artery branch patency. Aortic enlargement (>5 mm) was observed in 5% (all in AN cohort; none requiring reintervention), with no instances of aortic rupture, device migration, or wire fracture reported. Late reinterventions were required in 7% of patients, all in the AN group. At 3 years, the TBE device demonstrated durable outcomes for nondissection descending thoracic aortic disease, with high branch patency, low lesion-related mortality, and minimal complications across diverse pathology cohorts. These results support its role as a safe, effective alternative to surgical revascularization in anatomically suitable zone 2 cases.