TAVR Outcomes for Women Evaluated Using WIN-TAVI Registry

January 2, 2018—Findings from the first WIN-TAVI (Women’s International Transcatheter Aortic Valve Implantation) registry evaluating 1-year clinical outcomes of transcatheter aortic valve replacement (TAVR) in women were reported by Alaide Chieffo, MD, et al online in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The study sought to examine the safety and performance of contemporary TAVR in an exclusive all-women treatment population and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes.

According to the investigators, the WIN-TAVI registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis at 18 sites in Europe and one site in the United States between January 2013 and December 2015.

The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods.

As summarized in JACC: Cardiovascular Interventions, the study enrolled 1,019 intermediate- to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 17.8 ± 11.7%, and mean Society of Thoracic Surgeons score 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% of patients and new-generation devices were used in 42.1% of patients.

The investigators reported that the primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients.

Previous coronary revascularization (hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.17 to 2.52; P = .006) and EuroSCORE I (HR, 1.02; 95% CI, 1.00 to 1.04; P = .027) were independent predictors of the VARC-2 efficacy endpoint.

Similarly, EuroSCORE I (HR, 1.02; 95% CI, 1.00 to 1.04; P = .013), baseline atrial fibrillation (HR, 1.58; 95% CI, 1.07 to 2.33; P = .022), and previous percutaneous coronary intervention (HR, 1.5; 95% CI, 1.03 to 2.19; P = .035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes.

The investigators concluded that intermediate- to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke.