Women undergoing percutaneous transcatheter edge-to-edge repair (TEER) of mitral regurgitation (MR) with the MitraClip System may have lower one-year all-cause mortality but similar composite cardiovascular outcomes, compared with men undergoing the procedure, according to a study published Nov. 16 in Circulation: Cardiovascular Interventions.

Pedro A. Villablanca, MD, MSc, FACC, et al., used STS/ACC TVT Registry data to look at sex-based differences in outcomes among patients undergoing TEER for MR. The researchers linked registry data with Centers for Medicare and Medicaid Services claims data to assess one-year outcomes.

The study comprised 5,295 patients, including 2,523 women (47.6%), who underwent TEER between 2011 and 2017. At baseline women had a lower prevalence of coronary artery disease and coronary intervention and were less likely than men to have diabetes, peripheral artery disease and end-stage renal disease.

After one year, there were no sex-based differences in the unadjusted primary composite outcome of mortality, stroke or any bleeding. However, women had a higher unadjusted cumulative incidence rate of stroke at one year vs. men. (3%; Confidence Interval [CI]: 2.4%-3.8% vs. 2.1%; CI: 1.6%-2.7%; p=0.008). After adjusting for demographics and comorbidities, women had a lower adjusted one-year risk of all-cause mortality (adjusted hazard ratio, 0.80 CI: 0.68-0.94) vs. men, but the adjusted one-year risk of stroke or bleeding did not differ by sex.

The results also show that female patients were less likely to receive more than one clip, compared with men. Procedural success was lower in women (adjusted odds ratio [aOR], 0.78; p<0.05), driven by a lower rate of achieving a mitral valve gradient <5 mm Hg post implant (aOR, 0.54; p<0.05).

According to the researchers, women undergoing TEER with the MitraClip system for severe MR “have a different risk profile compared with male patients.” Compared with men, women had lower odds of procedural success and higher rates of complications but lower adjusted one-year all-cause mortality, they conclude.

“Taken at face value, having a patient subgroup with less device success, higher rates of procedural and in-hospital complications and fewer patients discharged home should not necessarily translate to lower all-cause mortality at one year,” write Saif Anwaruddin, MD, FACC, and Anita W. Asgar, MD, FACC, in a related editorial comment. Reconciling this, they write, relies on an understanding of the baseline differences between the two populations. Future research should seek to better understand why men and women with MR present so differently.

Clinical Topics: Cardiac Surgery, Valvular Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and VHD, Mitral Regurgitation

Keywords: Surgical Instruments, Diabetes Mellitus, Kidney Failure, Chronic, Peripheral Arterial Disease, Stroke, Registries, Medicare, Prevalence, Mitral Valve Insufficiency, Mitral Valve, Confidence Intervals, Centers for Medicare and Medicaid Services, U.S., Odds Ratio, Coronary Artery Disease, National Cardiovascular Data Registries, STS/ACC TVT Registry

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