Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies: A retrospective observational study

Abstract

Objective: The t-Branch, a standardized off-the-shelf multi-branched stent graft has been used for the treatment of elective and urgent cases in aortic disease. The aim of this study was to assess the early outcomes in terms of technical success, mortality, and morbidity in >500 patients being treated with the t-Branch device. Methods: A two-center retrospective observational study was undertaken including patients treated using the t-Branch (Cook Medical, Bloomington, IN) in elective or urgent settings for complex abdominal aortic aneurysm and thoraco-abdominal aortic aneurysm between 2014 and 2019 (early experience 2014-2016; late experience 2017-2019). Primary endpoints were technical success and early (30-day) mortality, and secondary endpoints were early morbidity, endoleak, and target vessel patency rates. Multivariable regression models were used to determine the independent association of risk factors with (1) mortality and (2) spinal cord ischemia. Results: A total of 542 patients (mean age, 70.5 ± 8.5 years; 388 men [72%]; mean aneurysm diameter, 7.5 ± 2.5 cm) were included (63% elective; 90% thoraco-abdominal aortic aneurysm). The technical success rate was 97% (526/542) (elective, 96.7% [328/339] vs urgent, 97.6% [208/213]). The total 30-day mortality rate was 12.3% (8.5% in elective, 15% in symptomatic, and 30% in contained rupture). After multivariate regression analysis, the mortality rate was associated with older age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.11; P