Objectives
To investigate 4‐year, post‐transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real‐world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve.
Background
Previous TAVI investigations of first‐generation devices demonstrated an early‐ to mid‐term survival advantage in women compared with men.
Methods
SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post‐approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan–Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model.
Results
At 4 years, women had lower all‐cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75–1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79–1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality.
Conclusions
In this large, real‐world cohort, all‐cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.