Key result
Female sex is not associated with 1-year mortality differences after transfemoral TAVI vs. male sex.
Why the study?
Anatomical, pathophysiological, and clinical differences between women and men may influence outcomes following TAVI, motivating an evaluation of the association between sex and post-procedural mortality and complications in a real-world cohort.
Does biological sex (female vs. male) affect 1-year all-cause mortality and procedure-related complications in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI?
Cohort (n=1,065)
No
Does biological sex (female vs. male) affect 1-year all-cause mortality and procedure-related complications in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI?
Hazard Ratio: 1.07 (95% CI 0.69–1.66)
Absolute Event Rate: 11.4% vs 11.9%
p-value: p=0.772
In this real-world cohort of 1,065 patients undergoing transfemoral TAVI, short- and 1-year mortality did not differ between sexes despite women presenting with older age, greater frailty, and higher surgical risk scores, whereas men had a significantly higher independent risk of new permanent pacemaker implantation.
No independent link between female sex and 1-year TAVI mortality; leaves open sex-specific risk stratification in larger prospective cohorts.
Background Severe aortic stenosis is one of the most prevalent valvular heart diseases in the ageing population, and transcatheter aortic valve implantation (TAVI) has become an effective and less invasive therapeutic alternative. Anatomical, pathophysiological, and clinical differences between women and men may influence outcomes following the procedure. This study aimed to evaluate the association between sex and mortality and procedure-related complications after TAVI in a real-world cohort from the Vigo Health Area. Methods We conducted a retrospective, single-center observational study including 1,065 patients with severe aortic stenosis who underwent transfemoral TAVI between 2010 and 2023. The primary endpoint was all-cause mortality at 1 year. Secondary endpoints included bleeding, vascular complications, and new permanent pacemaker implantation. Time-to-event analyses were censored at 365 days; multivariable models used complete-case analysis. Results Women were older and had greater frailty and higher surgical risk scores than men. In-hospital and 1-year mortality were similar between sexes. Date-based 30-day mortality was 2.4% in men and 3.7% in women ( p = 0.225), and female sex was not independently associated with 30-day mortality after adjustment for age and STS score (adjusted OR 1.79, 95% CI 0.80–3.98; p = 0.154). Female sex was not independently associated with 1-year mortality (adjusted HR 1.07, 95% CI 0.69–1.66; p = 0.772). Women had more bleeding in unadjusted analyses, but female sex was not significantly associated with any bleeding after adjustment (adjusted OR 1.61, 95% CI 0.92–2.81; p = 0.093). Male sex remained associated with higher odds of new permanent pacemaker implantation (adjusted OR 1.49, 95% CI 1.03–2.17; p = 0.036). Conclusions Sex was not independently associated with short- or 1-year mortality after TAVI. Women had a higher unadjusted incidence of bleeding, whereas men had a higher incidence of new permanent pacemaker implantation that persisted after adjustment. These findings describe sex-related differences in procedural risk profiles but should be interpreted in the context of the observational design and the long study period.
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Táboas et al. (2026) conducted a cohort in Severe symptomatic aortic stenosis undergoing transfemoral TAVI (n=1,065). Female sex vs. Male sex was evaluated on All-cause mortality at 1 year (adjusted HR 1.07, 95% CI 0.69-1.66, p=0.772). Female sex was not independently associated with 1-year all-cause mortality compared to male sex after transfemoral TAVI (adjusted HR 1.07, 95% CI 0.69-1.66; p=0.772).
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