New findings from first all-female TAVR registry

Paris – A history of pregnancy did not protect against adverse outcomes at 1 year in the Women’s International Transcatheter Aortic Valve Implantation Registry (WIN-TAVI), even though it did within the first 30 days, Alaide Chieffo, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

One year ago, at EuroPCR 2016, she reported that in WIN-TAVI, a history of pregnancy – albeit typically more than half a century previously – was independently associated with a 43% reduction in the Valve Academic Research Consortium-2 (VARC-2) 30-day composite endpoint, including death, stroke, major vascular complications, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat transcatheter aortic valve replacement (TAVR) done because of valve-related dysfunction. Those early findings, first reported in this publication, were later published (JACC Cardiovasc Interv. 2016 Aug 8;9[15]:1589-600).

At 1 year of follow-up, however, the rate of the VARC-2 composite endpoint was no longer significantly different in women with or without a history of pregnancy. Nor was a history of pregnancy associated with a significantly reduced risk of the secondary endpoint of death or stroke: The 27% reduction in risk of this secondary endpoint in women with a history of pregnancy, compared with that of nulliparous women, didn’t achieve statistical significance in multivariate analysis, according to Dr. Chieffo of the San Raffaele Scientific Institute in Milan.

She speculated that pregnancy earlier in life provided strong protection against poor 30-day outcomes and a similar trend – albeit not statistically significant – at 1 year because women without children may have less family support.

“They are old women, left alone, without the family taking care of them. This is socially important, I think, because we are investing quite a lot of money in a procedure, and then maybe we’re adding adverse events because these patients are not properly taken care of when they are out of the hospital,” the interventional cardiologist said.

Neither of the other two female-specific characteristics evaluated in WIN-TAVI – having a history of osteoporosis or age at menopause – turned out to be related to the risk of bad outcomes at 1 year, she added.

WIN-TAVI is the first all-female registry of patients undergoing TAVR for severe aortic stenosis. The prospective, observational registry includes 1,019 women treated at 19 highly experienced European and North American TAVR centers. They averaged 82.5 years of age with a mean Society of Thoracic Surgeons score of 8.3%, putting them at intermediate or high surgical risk. A percutaneous transfemoral approach was used in 91% of cases. TAVR was performed under conscious sedation in 28% of the women and under local anesthesia in another 37%. Of the women in the registry, 42% received a newer-generation device.

In addition to the lack of significant impact of prior pregnancy on 1-year outcomes, another noteworthy finding at 1 year of follow-up was that preprocedural atrial fibrillation was independently associated with a 58% increase in the risk of death or stroke (P = .02). Prior percutaneous coronary intervention and EuroSCORE (European System for Cardiac Operative Risk Evaluation) were the only other independent predictors.

This observation suggests the need for a women-only randomized trial of TAVR versus surgical aortic valve replacement in women with intermediate surgical risk, Dr. Chieffo suggested. It will be important to learn whether the ability to surgically ablate preoperative atrial fibrillation in women during surgical valve replacement results in a lower 1-year risk of death or stroke than is achieved with TAVR.

Overall, the 1-year clinical outcomes seen in WIN-TAVI are “very good,” she noted. The VARC-2 composite endpoint occurred in 16.5% of women, all-cause mortality in 12.5%, cardiovascular mortality in 10.8%, and stroke in 2.2%. Only 3.2% of women were hospitalized for heart failure or valve-related symptoms. A new pacemaker was implanted in 12.7% of participants. At baseline 74% of women were New York Heart Association functional class III or IV; at 1 year, only 8.1% were. Moderate paravalvular aortic regurgitation was present in 6% of patients at 6 months and in 9.7% at 1 year

The WIN-TAVI registry is entirely self-funded. Dr. Chieffo reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom.com