Why the study?
A differential impact of sex had been observed in TAVR outcomes from small observational studies and subgroup analyses of randomized trials.
Do in-hospital and 1-year outcomes differ between female and male patients undergoing transcatheter aortic valve replacement?
Population
11,808 women and 11,844 men undergoing TAVR from the U.S. nationwide TVT registry
Comparison
Female vs male patients
Design
Registry-based observational study
Follow-up
1 year
Key result
Female patients undergoing TAVR had lower 1-year mortality compared with male patients (21.3% vs. 24.5%; adjusted HR 0.73; 95% CI 0.63-0.85; p<0.001), despite higher vascular complications.
Authors
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Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We thought that women had a survival advantage, [but] it may have been that men had a disadvantage and once we leveled the playing field it equalized.”
“These studies can inform future quality improvement initiatives and point to potential adjunctive therapies or interventions that may be administered in a sex-specific manner but with the overall goal of improving quality of life and survival for both sexes.”
“Sex differences in outcomes after TAVR remain incompletely understood. Earlier studies described a 'sex paradox,' with women experiencing more procedural complications, but similar or superior survival compared with men. However, most data derive from earlier device generations, and contemporary evidence is limited.”
May support sex-specific TAVR risk discussions; hypothesis-generating and requires prospective validation before practice change.
Observational (n=23,652)
Yes
Do in-hospital and 1-year outcomes differ between female and male patients undergoing transcatheter aortic valve replacement?
Hazard Ratio: 0.73 (95% CI 0.63–0.85)
Absolute Event Rate: 21.3% vs 24.5%
p-value: p=< 0.001
Female patients undergoing TAVR have a higher risk of in-hospital vascular complications but superior 1-year survival compared to male patients.
Chandrasekhar et al. (2016) conducted an observational in Transcatheter aortic valve replacement (n=23,652). Female sex vs. Male sex was evaluated on 1-year mortality (HR 0.73, 95% CI 0.63 to 0.85, p=< 0.001). Female patients undergoing TAVR had lower 1-year mortality compared with male patients (21.3% vs. 24.5%; adjusted HR 0.73; 95% CI 0.63-0.85; p<0.001), despite higher vascular complications.
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