Key result
Female sex links to lower 1-year TAVI mortality but more 30-day major vascular complications.
Why the study?
Although women account for nearly half of patients undergoing TAVI and have a clinical profile distinct from men, they remain underrepresented in clinical research, and large-scale real-world data comparing sex differences in TAVI remain scarce.
Does female sex compared to male sex affect clinical outcomes and VARC-3 adverse events in patients undergoing transcatheter aortic valve intervention (TAVI)?
Cohort (n=6,866)
Yes
Does female sex compared to male sex affect clinical outcomes and VARC-3 adverse events in patients undergoing transcatheter aortic valve intervention (TAVI)?
In a large nationwide TAVI cohort, women experienced higher rates of 30-day major vascular complications while men had higher rates of 30-day permanent pacemaker implantation and unadjusted 1-year all-cause mortality.
Sex differences in TAVI complications and unadjusted 1-year mortality merit procedural consideration; leaves open whether associations persist after adjustment or in trials.
Background Transcatheter aortic valve intervention (TAVI) has become an established treatment for patients with severe aortic stenosis. Although nearly half of the patients are female, women remain underrepresented in clinical research. The clinical profile differs from that of men, with a higher prevalence of small aortic annulus and increased risk of bleeding complications. Large scale real-world data comparing sex- differences in TAVI remain scarce. Purpose This study aims to describe sex-differences in characteristics and clinical outcomes of patients receiving TAVI from a large, contemporary, nationwide cohort. Methods We included data from the Netherlands Heart Registration between 2019-2024. We described differences between women and men in terms of patient- and procedural characteristics as well as VARC-3 adverse-events using the Mann-Whitney U test and chi-squared test. We calculated odds-ratios using logistic regression. We described differences in all-cause mortality using unadjusted cox-regressions and Kaplan-Meier mortality curves. Results Of 6866 patients undergoing TAVI in the Netherlands between 2019-2024, 3070 (44.7%) were female. Female patients were older and had a higher EuroSCOREII. Valve-sizes in women were significantly smaller compared to men’s. More women received a self-expanding valve. Major vascular complications at 30 days occurred more often in women, while men more often had a new permanent pacemaker-implantation at 30 days. Median follow-up was 501 days. While there was no difference in 30-day unadjusted all-cause mortality risk, men had a higher one-year unadjusted all-cause mortality risk compared to women. Patient characteristics and clinical outcomes per sex are presented in Table 1 and Figure 1. Conclusions 44.7% of the patients undergoing TAVI in the Netherlands is female. In a purely descriptive manner, unadjusted one-year mortality risk was higher for men compared to women. Women more often had major vascular complications, whereas men more often required new permanent pacemaker implantation. These findings underscore the need for more research regarding factors impacting sex-based differences in clinical outcomes in TAVI.
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Voorham et al. (2026) conducted a cohort in Severe aortic stenosis undergoing transcatheter aortic valve intervention (TAVI) (n=6,866). Female sex vs. Male sex was evaluated on 1-year unadjusted all-cause mortality and 30-day VARC-3 adverse events. Women (44.7% of 6,866 TAVI patients) had lower unadjusted 1-year all-cause mortality and fewer new pacemakers, but more 30-day major vascular complications than men.
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