Long-term outcomes of thoracic endovascular aortic repair for descending thoracic aortic aneurysms based on pooled results from FDA clinical trials.

Abstract

Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for descending thoracic aortic aneurysms, but long-term data are limited. This study assessed long-term results of TEVAR in early recipients of TEVAR devices who were enrolled in US Food and Drug Administration investigational device exemption clinical trials for aneurysm. This was a single-center retrospective study including 179 patients enrolled in 14 clinical trials for TEVAR for descending thoracic aortic aneurysm between 2000 and 2019. The primary outcome was 10-year mortality. Secondary outcomes included a 30-day composite of death or a neurologic event, endoleak, reintervention, and aortic diameter on follow-up imaging. Descriptive statistics, Kaplan-Meier survival analysis, Cox proportional hazards models, and cumulative incidence functions with competing risk were used for analysis. The median patient age was 74 years and median follow-up was 5.5 years. Aneurysm morphology was fusiform (n = 100 [55.9%]) or saccular (n = 70 [39.1%]), with median preoperative diameter of 60.0 mm. Survival at 1, 5, and 10 years was 91.1%, 62.8%, and 31.4%. Endoleak was observed in 58 patients (32.4%), and reintervention in 44 patients (24.6%). Neither endoleak nor reintervention was associated with all-cause mortality at 10 years. Increasing age and preoperative aneurysm diameter were independent predictors of mortality. A majority of patients (73.8%) had stable aneurysm sac at 5 years. Although overall survival at 10 years was limited, early outcomes were favorable and most patients had stable aneurysm sac at 5 years. Endoleak and reintervention were not linked to long-term mortality, whereas age and preoperative aortic diameter predicted worse survival. In this older patient cohort, the durability of TEVAR remains a concern.