Key result
Female sex in TAVI is linked to ~63% higher 30-day but lower 1-year mortality versus males.
Why the study?
Evaluating local TAVI outcomes against international best practice using registry data can provide an evidence base to inform appropriate patient selection in subgroups such as females.
Does sex affect procedural success and mortality outcomes in patients undergoing TAVI?
Observational (n=2,996)
Yes
Does sex affect procedural success and mortality outcomes in patients undergoing TAVI?
Absolute Event Rate: 6.04% vs 3.71%
In a South African TAVI registry, females presented with worse symptoms and had higher early mortality due to vascular complications, but exhibited better long-term survival compared to males.
Higher early female TAVI mortality in South Africa signals vascular access caution; extends sex-outcome data to underrepresented regions but leaves practice change open.
Background TAVI implants have been available for >10years in SA and data has been collected since 2014 in a national registry. Objectives Evaluating local TAVI outcomes against international best practice using data captured in the SHARE TAVI registry, can provide an evidence base to inform appropriate patient selection in subgroups such as females. Method Clinical and demographic data of 4249 Aortic stenosis patients(pts) has been captured into a national web-based prospective registry, outcomes are reviewed at 30d and annually (to 10 years) post-implant (VARC2 definitions). From Sept 2014 – June 2024 2996 of these patients received TAVI implants, aggregated procedural and 30-day outcomes data from all 31 participating sites has been analysed by sex. Results Patient populations and outcomes are similar to other registries and studies (GARY, Corevalve, PARTNER 1) in early TAVI programs. Female pts are less represented in TAVI implant data in SA 41.45% (n=1242/2996), and the percentage of females has gradually dropped from 52.94% in 2014 to 39.9% in 2023. Females are on average slightly older than males 79.964 vs. 78.854 years, have higher STS risk score 6.139% vs 5.329% and are more often frail 28% vs 19% of men. Most comorbidities occur similarly between sexes, exceptions are: Females: Prior CABG 9.18%, Permanent Pacemaker 6.84%, Extracardiac arteriopathy 9.02%, DM 20.13% Males: Prior CABG 27.31%, Permanent Pacemaker 11.97%, Extracardiac arteriopathy 16.99%, DM 26.97% Females have higher Mean gradient across valve (49.25 vs 46.62mmHg), and more pts in NYHA class III+IV (61.22% vs 55.75%) Lower Procedural Success in females (96.86%) vs 97.95% in males is partly due to higher female Intraprocedural mortality 1.93% vs 0.68%, and similarly 30-day mortality 6.04% vs 3.71% is higher in females. The higher female intraprocedural mortality is related to bleeding & vascular complications with larger profile earlier generation valves. Mortality outcomes by 1-year (11.93% vs 12.71%) and 2-year (22.10% vs 23.16%) favour females. Conclusion Differences in baseline Echo measurements, risk scores, comorbidities and periprocedural outcomes between sexes do not always track to obvious changes in longer term outcomes. Women come for treatment later than men, presenting with worse symptoms and aortic stenosis. Poorer procedural outcomes in females were driven by vascular & bleeding complications with larger profile earlier generation valves. Newer generation smaller profile valves result in fewer bleeding and vascular complications related to females' smaller vasculature and anatomy. By 1-year the higher burden of co-morbidities in males drives a relatively higher sex-related mortality difference and mortality outcomes favour females.
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Schaafsma et al. (2025) conducted an observational in Aortic stenosis (n=2,996). Female sex vs. Male sex was evaluated on 30-day mortality. Female patients undergoing TAVI had higher 30-day mortality than males (6.04% vs 3.71%) due to bleeding complications, but 1-year mortality favored females (11.93% vs 12.71%).
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