What is the clinical evidence from this study?

Study design: Observational. Population: Severe aortic stenosis (n=2588). Intervention: Female sex vs. Male sex. Primary outcome: Cumulative long-term all-cause mortality (HR 0.615, 95% CI 0.512-0.738, p=<0.001).

April 26, 2021Open Access

Effect of Sex on Mortality and Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation

Q: What are the key findings of this study?

Female sex was independently associated with a 38.5% reduction in cumulative long-term all-cause mortality (HR 0.615) compared to male sex after transcatheter aortic valve implantation.

Key Result

Female sex was independently associated with a 38.5% reduction in cumulative long-term all-cause mortality (HR 0.615) compared to male sex after transcatheter aortic valve implantation.

Study Design

Type

Observational (n=2,588)

Multicenter

Yes

Structured PICO

Does female sex improve survival and affect left ventricular remodeling after transcatheter aortic valve implantation?

Population

2,588 patients undergoing transcatheter aortic valve implantation (TAVI), 69.3% female, from the OCEAN-TAVI Japanese multicenter registry.

Intervention

Female sex

Comparator

Male sex

Outcome

All-cause mortality, cardiovascular mortality, and changes in left ventricular mass index (LVMI)hard clinical

Female sex is independently associated with lower long-term mortality after TAVI, with survival advantages particularly evident in patients experiencing left ventricular mass regression at 1 year.

Main Result

Effect estimate: HR 0.615 (95% CI 0.512-0.738)

Absolute Event Rate: 9.3% vs 13.2%

p-value: p=<0.001

Limitations

Retrospective analysis of a non-randomized registry
Balloon expandable valves were used in most patients (87%), with few new-generation devices
Echocardiographic data were not analyzed by an independent core laboratory
Left ventricular mass was determined only by 2D linear echocardiography, not MRI or CT
Exact number of patients with a history of myocardial infarction was unknown
No exclusion criteria for uncontrolled hypertension, thyroid disease, or other heart valvular diseases

Abstract

BACKGROUND: The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown. METHODS AND RESULTS: This study included 2,588 patients (1,793 69.3% female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P<0.001 for both). Multivariate analysis showed that female sex was independently associated with lower cumulative long-term mortality (hazard ratio 0.615; 95% confidence interval 0.512-0.738; P<0.001). Regression in the LVMI was observed in both sexes, and there was no significant difference in the percentage LVMI regression from baseline to 1 year after TAVI between women and men. Women had a survival advantage compared with men among patients with LVMI regression at 1 year, but not among patients with no LVMI regression. CONCLUSIONS: We found that female sex is associated with better survival outcomes after TAVI in a large Japanese registry. Although LVMI regression was observed in women and men after TAVI, post-procedural LV mass regression may be related to the sex differences in mortality.

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