Real-World Outcomes of the Gore Thoracic Branch Endoprosthesis in Aortic Arch Zones 0–2, with a Zone 2 Comparison to TEVAR With Carotid–Subclavian Bypass

OBJECTIVES: This study reports real-world outcomes of zone 0 and 1 thoracic branch endoprosthesis (TBE) after US Food and Drug Administration approval and compares zone 2 TBE with thoracic endovascular aortic repair (TEVAR) with left subclavian artery bypass (LSAB). METHODS: We retrospectively reviewed consecutive patients undergoing zone 0 to 2 TBE at a single center. Additionally, we performed a sub-analysis comparison with zone 2 TEVAR + LSAB. Outcomes were assessed using multivariate regression and Cox proportional hazards models adjusting for intervention type, indication, urgency, prior aortic surgery, number of zones covered, and proximal device diameter. RESULTS: We included75 patients (median age, 69.5 years; 71.1% male) who underwent zone 0 to 2 TBE. Of these, 50 patients (66.7%) were performed for zone 2, 13.3% zone 1, and 20% zone 0, with 28% performed in an urgent/emergent fashion; 37.3% had prior ascending/arch repair and 13.3% prior TEVAR. Indications were 16% aneurysm, 66.7% dissection, and 17.3% penetrating aortic ulcer or intramural hematoma. Approximately one-half (51.4%) used the 12-mm portal configuration, and 48.6% used the 8-mm portal configuration. Proximal cuffs were needed in 14.7%. The 30-day outcomes showed a significantly higher incidence of permanent cerebrovascular accident in zone 0 (20%) and higher myocardial ischemia in zone 1 (20%) compared with the other zones. One-year outcomes showed an 80.4% overall survival rate, 1.3% type IA endoleak, 60% sac regression, 100% false lumen thrombosis at 1 year, and 100% branch patency. When focusing on the zone 2 TBE only (n = 50) and comparing on multivariate-adjusted outcomes with zone 2 TEVAR + LSAB performed at the same institution (n = 94), zone 2 TBE was associated with lower rates of postoperative acute kidney injury (odds ratio OR, 0.23; 95% confidence interval CI, 0.04-0.99; P = .048) and myocardial ischemia (OR, 0.12; 95% CI, 0.01-0.98), shorter length of stay (β -1.7 days; 95% CI, -2.4 to -1.1; P < .001), reduced procedure time (β-54 minutes; 95% CI, -71 to -38; P = .001) and less contrast use (β-42 mL; 95% CI, -61 to -23 mL; P < .001), and greater 1-year sac regression (OR, 7.48; 95% CI, 1.43-12.27; P = .02). Adjusted Cox analysis showed TBE had greater freedom from reintervention (hazard ratio, 0.26; 95% CI, 0.6-0.92; P = .015). CONCLUSIONS: TBE in the real world is safe and effective for zone 0 to 2 repairs with low mid-term morbidity. Compared with TEVAR + LSAB, zone 2 TBE in particular results in shorter hospitalizations, fewer complications, and lower reintervention rates, supporting its use as the preferred strategy in suitable anatomy. Further comparative studies are needed for zones 0 and 1 treatment.