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

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.