medwireNews: The results of a US registry study suggest that women undergoing transcatheter aortic valve replacement (TAVR) are at greater risk of in-hospital vascular complications than men, but have better 1-year survival outcomes.
Major in-hospital vascular complications occurred in 8.27% of 11,808 women and 4.39% of 11,844 men undergoing TAVR between 2011 and 2014, translating into a significant hazard ratio (HR) of 1.70 after adjustment for potentially confounding factors.
However, after 1 year, mortality risk was significantly lower among women than men, with rates of 21.3% versus 24.5% (adjusted HR=0.73), as was the incidence of major adverse cardiac events, at 25.3% versus 28.1% (adjusted HR=0.80).
Compared with male patients, female patients were in general older, with a lower prevalence of pre-existing coronary artery disease, atrial fibrillation, and diabetes, but were more likely to have a lower glomerular filtration rate, porcelain aorta, and a higher average Society of Thoracic Surgeons score.
“These findings underscore the need for rigorous TAVR-specific and female-specific risk assessments in decision-making for the most optimal treatment option in patients with significant aortic valve disease,” say study authors Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) and colleagues.
As reported in the Journal of the American College of Cardiology, the team analyzed data from 348 centers across the USA from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, “one of the largest [registries] of valve patients to date.” TAVR was performed for degenerative aortic valve disease in the majority (94.5%) of patients.
In an accompanying commentary, Molly Szerlip (The Heart Hospital Baylor Plano, Texas, USA) highlights that although the study results confirm randomized trial findings, “it remains a subject of speculation as to why there is a survival difference benefiting female patients undergoing TAVR, especially because this outcome is exactly the opposite of [surgical aortic valve replacement] outcomes according to sex.”
The commentator cautions that the study findings are only applicable to the population studied, and “should not necessarily be extrapolated to lower risk populations or to patients who receive newer generation valves.”
The study authors agree, noting that they did not examine “differences in outcomes according to TAVR time period or adjust for device types.”
And they conclude: “A comparative sex-based analysis in warranted in patients undergoing TAVR with newer generation devices to examine for temporal changes in procedural complications and long-term outcomes.”
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