Clinical outcomes and quality of life measures among 5-year survivors of fenestrated-branched endovascular aortic repair.

Abstract

Objective: To report clinical outcomes and quality-of-life (QOL) changes among 5-year survivors of fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal (CAAA) and thoracoabdominal aortic aneurysms (TAAA).

Summary background data: There is limited long-term data on FB-EVAR.

Methods: All consecutive patients enrolled in a prospective, non-randomized study of FB-EVAR for CAAAs and TAAAs between 2013-2019 was analyzed (ClinicalTrials.gov NCT01937949 and NCT02089607). Patients who completed 5-year clinical and imaging follow-up were classified as 5-year survivors. Primary endpoint was the cumulative incidence of aortic repair failure (ARF), defined as a composite of aortic-related mortality (ARM), aortic rupture (ARR), conversion to open repair, and type I or III endoleak. Secondary endpoints included physical (PCS) and mental component (MCS) QOL scores.

Results: Among 342 patients, 159 (70% male; median age 74-years (IQR 69-79-years) 5-year survivors were analyzed. Median follow-up was 63-months (IQR 59-82). Cumulative incidence of ARF at 5 years was 5.0% (95% CI 2.4-9.2). Cumulative incidences of ARR was 1.3% (95% CI 0.0-3.1) and type IIIB endoleaks was 2.4% (95% CI 0.0-5.2) at 5-years. There were no conversions to open repair or type IA endoleaks. PCS decline post-procedure improved but remained below baseline at 5-years. There was no change in MCS. The 8-year survival rate among patients who survived the first 5-years was 58.9% (95% CI 47.4-73.3%).

Conclusion: The 5-year risk of FB-EVAR failure is 5% among survivors, with a low risk of aortic rupture or device integrity issues. Early decline in physical QOL scores improves but does not return to baseline values.