Association between sex and transcatheter aortic valve replacement outcome for bicuspid and tricuspid aortic stenosis

Abstract Introduction Little is known on sex-stratified outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS). Purpose To compare TAVR outcomes between sexes in bicuspid vs tricuspid aortic stenosis. Methods In this cohort study based on the Society of Thoracic Surgeons (STS) /American College of Cardiology Transcatheter Valve Therapies Registry, consecutive TAVR procedures in native AS patients using contemporary devices from January 2012 to September 2023 were included. Simple matching was performed between sex based on age, surgical risk, period of procedure, ejection fraction, and renal function. Primary outcome was mortality. Secondary outcomes included stroke, composite of death and stroke, aortic valve reintervention, new permanent pacemaker implantation, and re-admission. Results The overall cohort included 530328 patients with a mean age of 79.3±8.5 years and STS score of 5.6±4.8 % (27759 bicuspid AS; 502569 tricuspid AS), and matching cohort had 10047 bicuspid and 188015 tricuspid female-male pairs (Figure 1). Unlike in tricuspid patients, rates of death in bicuspid AS were comparable between males and females at 30 days (before matching: 1.8% vs 1.7%; P = 0.825; after matching: 1.7% vs 1.6%; P = 0.678), but became higher in males at 1 year (before matching: 6.5% vs 5.3%; P = 0.0003; after matching: 6.5% vs 4.8%; P 0.0001) (Figure 2). In the matched cohort, no significant interaction of aortic valve morphology and sex on mortality was seen at 30-day (P for interaction 0.417) or 1-year (P for interaction 0.302). When looking at cumulative incidence, female sex was associated with lower risk of death at 30 days (adjusted odds ratio OR 0.81, 95% confidence interval CI 0.76-0.87, P0.0001) and 1 year (adjusted hazard ratio HR 0.69, 95%CI 0.66-0.71, P0.0001). At 1 year, females had a higher risk of stroke (adjusted HR 1.07, 95%CI 1.01-1.13, P=0.015), but were less prone to aortic valve reintervention (adjusted HR 0.65, 95%CI 0.55-0.78, P0.001), pacemaker implantation (adjusted HR 0.82, 95%CI 0.79-0.84, P0.001), and re-admission (adjusted HR 0.95, 95%CI 0.94-0.97, P0.001). Conclusions In this national registry of AS patients treated with TAVR, bicuspid valve morphology did not modify the relationship between sex and clinical outcomes at both 30 days and 1 year. Females showed a survival benefit but faced a higher risk of stroke, whereas males were more likely to require pacemaker implantation and valve reintervention. These differences in TAVR outcomes suggest the need for tailored post-procedural monitoring and management strategies based on patient sex.