Two-year outcomes of endovascular repair of isolated thoracic aortic lesions using a single-branch thoracic endograft with left subclavian artery preservation.
BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become the preferred management strategy for most pathologies involving the descending aorta. When left subclavian artery (LSA) coverage is required during TEVAR to achieve an adequate proximal landing zone (PLZ), revascularization is recommended. Branched endografts represent an alternative to surgical revascularization. METHODS: Across 34 investigative sites, 13 adult patients with isolated lesions (nonaneurysm, nondissection, nontrauma) of the descending thoracic aorta requiring a zone 2 PLZ were enrolled in a prospective, nonrandomized study of a single-branched thoracic aortic endograft (GORE TAG Thoracic Branch Endoprosthesis [TBE]; WL Gore and Associates). The TBE incorporates a single side branch for LSA perfusion in zone 2. RESULTS: The mean patient age was 65 ± 13 years, and 54% were female. Pathologies included intramural hematoma in 23% (n = 3), penetrating aortic ulcer in 39% (n = 5), and other isolated lesions in 39% (n = 5). The technical success rate of the procedure was 100%; 31% (n = 4) of the patients required distal TEVAR in addition to the TBE device for complete exclusion of their aortic pathology. The median procedure time was 142 minutes (range, 66-357 minutes). No 30-day/in-hospital mortality, stroke, paraparesis/paraplegia, or new dialysis occurred. Through 24-month core laboratory adjudicated imaging follow-up, there have been no type I/III endoleaks, LSA branch patency loss, reinterventions, or aortic enlargement (>5 mm). CONCLUSIONS: Two-year results from this multicenter, prospective, nonrandomized cohort study using an investigational single-branched thoracic endograft for maintaining LSA perfusion in patients with isolated lesions of the descending thoracic aorta demonstrate excellent perioperative and early mid-term outcomes in patients with suitable anatomy.
