WIN-TAVI Registry Homes in on TAVR Outcomes Unique to Female Patients

PARIS, France—Data from WIN-TAVI, the first-ever TAVR registry dedicated to women, are providing sex-specific information on which factors are associated with better outcomes in female patients.

The goal of the study, said investigator Alaide Chieffo, MD (San Raffaele Hospital, Milan, Italy), is to specifically identify what matters most for women undergoing TAVR, as opposed to drawing comparisons with men.

The findings were presented today at EuroPCR and simultaneously published online ahead of print in JACC: Cardiovascular Interventions.

A growing number of studies, including one recently published in Annals of Internal Medicine, have shown a long-term survival advantage for women versus men after TAVR, despite female patients initially having a higher risk of complications.

Device, Patient Characteristics Predict Outcome

For the WIN-TAVI analysis, Chieffo and colleagues studied the 30-day outcomes of 1,019 female patients enrolled at 18 centers across Europe and one in the United States between 2013 and 2015. Mean age was 83 years, and 90% were at high surgical risk. Nearly two-thirds were considered frail. The most commonly implanted valve was the CoreValve prosthesis (Medtronic) at 39%.

By 30 days, 14.0% of the women had experienced a Valve Academic Research Consortium (VARC)-2 early safety event (primary endpoint; mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Rates of all-cause mortality, stroke, major vascular complications, and VARC life-threatening bleeding were 3.4%, 1.3%, 7.7%, and 4.4%, respectively. A new permanent pacemaker was implanted in 12.1% of women by 30 days.

On multivariate logistic regression analysis, independent predictors of the primary endpoint were age (OR 1.04; 95% CI 1.00-1.08), prior stroke (OR 2.02; 95% CI 1.07-3.80), LVEF < 30% (OR 2.62, 95 % CI 1.07-6.40), and device generation (OR 0.59; 95 % CI 0.38-0.91).

During her presentation, Chieffo stressed that the aim of the registry was to analyze what characteristics specific to women might have an influence on early outcomes.

The researchers found that almost three-quarters (72%) of the female patients had a history of pregnancy and that women who had at one point been pregnant were less likely than those who had never been pregnant to experience a primary endpoint event (adjusted OR 0.57; 95% CI 0.37-0.85). Analyzed by number of pregnancies, only those who had been pregnant once or more than twice had a reduced risk, whereas the risk for women with two pregnancies only showed a nonsignificant trend.

History of breast or gynecological cancer, age at menopause, and history of osteoporosis did not appear to influence outcome.

Not a Study of Sex Disparities

In the discussion following Chieffo’s presentation, session cochair Alain Cribier, MD (Hôpital Charles Nicolle, Rouen, France), suggested that the smaller femoral arteries and smaller valve annuli might partially account for why women had different results from men in previous mixed-gender cohorts. Cribier asked whether investigators planned to conduct a propensity-matched analysis of women versus men, attempting to match device, annulus, and sheath sizes.

In response, Chieffo reiterated that the aim of the study was to look at characteristics unique to women, not to conduct a comparison with men. “As a group we agreed that this is a different population,” she said. Women have, for example, fewer comorbidities, better LVEF, and smaller femoral arteries compared with their male counterparts, she said. “It’s not the plan of the group to do a comparison with men, because we think this is a different entity [and should be studied as such]. No other study has collected what really is characteristic of the female population.”

It will be interesting, Chieffo continued, “to see whether what we found at 30 days is confirmed with longer follow-up.”

A subsequent analysis will look at whether outcomes in women differ according to valve type. Roughly half of the women in the study received a first-generation device, while the rest received newer-generation devices, including some not yet approved in the United States.

Mentioning a number of caveats, including the observational design and lack of systemic neurological evaluation, Chieffo concluded, “Randomized assessment of TAVR versus [surgical aortic valve replacement] in intermediate-risk women with severe [aortic stenosis] is warranted to determine the optimal treatment strategy.”

Worth noting, she said, is that the patients enrolled in WIN-TAVI “were at intermediate-to-high risk compared to women in prior TAVR studies.” This was despite the fact that “high risk” was listed by nine out of 10 heart teams as the primary reason for choosing TAVR for any given patient. In fact, EuroSCORE I was 17.8 and STS score 8.3 in this cohort, suggesting that operators were using other markers of frailty not captured in the standard risk scores.

Note: Study coauthor Roxana Mehran, MD (Mount Sinai Hospital, New York, NY), is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.

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