What new data tell us about TAVR in women with a history of early menopause
Women in early menopause face a heightened risk of certain cardiovascular complications, including aortic stenosis (AS). When those patients undergo transcatheter aortic valve replacement (TAVR) later in life, are they more likely to experience an adverse outcome?
An international team of researchers, led by specialists with the Icahn School of Medicine at Mount Sinai in New York City, aimed to find out. The group shared its findings in the American Journal of Cardiology.
The analysis included data from more than 1,000 intermediate- and high-risk female TAVR patients treated from January 2013 to December 2015 in North America or Europe. All data came from the WIN-TAVI registry. Patients were excluded if information about their menopausal age was not available, leading to a final cohort of 732 patients. The group was separated into two cohorts: patients who experienced early menopause (age ≤45 years) and those who did not.
Overall, 23.6% of patients experienced early menopause. These women had a mean age of 81.6 years old when they underwent TAVR and 64.2% were 80 years or older at the time of the procedure. For women who did not experience early menopause, the mean age was 82.7 years old and 71.6% were 80 years or older.
“In our study, there was a trend toward younger age at presentation for TAVR in women who experienced early menopause compared with regular menopause,” wrote first author Madison Edens, MD, a cardiology fellow with the Mount Sinai health system, and colleagues. “Although this difference may not be clinically relevant, it could still point to an impact of menopause age on the pathophysiology of AS.”
Women in the early menopause group also had a significantly lower mean Society of Thoracic Surgery score (6.6 vs. 8.2) and significantly lower serum creatinine levels (1.1 vs. 2.4 mg/100 ml).
TAVR outcomes among women with and without a history of early menopause
A history of early menopause did not appear to make an impact on the periprocedural complication rates or overall TAVR outcomes.
The study’s primary efficacy outcome—a composite of mortality, strokes, myocardial infarctions, hospitalizations for valve-related symptoms, heart failure-related dysfunction or valve-related dysfunction one year after treatment—was seen in 6.4% of patients from the early menopause group and 5.2% of patients from the control group. This was not found to be a significant difference. There also was significant difference in the study’s primary safety endpoint—a composite of mortality, stroke, major vascular complications, life-threatening bleeding events, stage 2 or 3 acute kidney injuries, coronary artery obstruction and repeat procedures one year after treatment—between the two groups.
The next step, according to Edens et al., is to take an even closer look at this subject.
“Future studies are needed to continue to investigate the effects of the menopausal state on the development of AS,” the authors wrote. “Additional large clinical trials dedicated to women who underwent TAVR would allow us to gain more information on some of the hormonally mediated risk factors that can influence patient outcomes. These investigations could contribute to best practices and optimal management strategies that would allow improved care of this unique patient population.”
The full study is available here from ScienceDirect.