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

Objective

The aim of this study was 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 and thoracoabdominal aortic aneurysms. There is limited long-term data on FB-EVAR.

Methods

All consecutive patients enrolled in a prospective, non-randomized study of FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms between 2013 and 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, defined as a composite of aortic-related mortality, aortic rupture, conversion to open repair, and type I or III endoleak. Secondary endpoints included physical and mental component QoL scores.

Results

Among 342 patients, 159 (70% male; median age, 74 years [interquartile range, 69-79 years]) 5-year survivors were analyzed. Median follow-up was 63 months (interquartile range, 59-82 months). Cumulative incidence of aortic repair failure at 5 years was 5.0% (95% confidence interval [CI], 2.4%-9.2%). Cumulative incidence of aortic rupture was 1.3% (95% CI, 0.0%-3.1%) and of 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. Physical component QoL scores declined post-procedure then improved but remained below baseline at 5 years. There was no change in mental component QoL scores. The 8-year survival rate among patients who survived the first 5 years was 58.9% (95% CI, 47.4%-73.3%).

Conclusions

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.