Since its recent approval by the U.S. Food and Drug Administration, transcatheter aortic valve replacement (TAVR) has served as a significant new therapy, improving the mortality of inoperable patients with severe, symptomatic aortic stenosis and yielding much of the same outcomes as surgical aortic valve replacement (SAVR). While prior studies have investigated the differences between males and females in pre-existing comorbidities, even looking into the left ventricular response to severe aortic stenosis potentially explaining improved clinical outcomes in females, the impact of sex on long-term outcomes following SAVR has been more uncertain, as have sex specific differences following TAVR or SAVR.

According to a new study published Feb. 19 in the Journal of the American College of Cardiology, new evidence has found that females experience a lower late mortality through TAVR therapy than SAVR, particularly among patients suitable for transfemoral access, suggesting that TAVR may be preferable over surgery in high-risk patients.

The study, led by Mathew Williams, MD, FACC, Columbia University Medical Center/NY Presbyterian Hospital, looked at 699 patients—300 female—were randomized 1:1 to either SAVR or TAVR with a balloon expandable peridcardial tissue valve. The baseline characteristics and two-year outcomes of the treatments were then compared among males and females. Data showed that while all-cause mortality in TAVR and SAVR showed little difference among males at six months (15.0 percent vs. 19.8 percent, p=0.17) and two years (37.7 percent vs. 32.3 percent, HR = 1.15 [95 percent CI: 0.82, 1.61], p=0.42), a significant difference was evident among females at their own six month (12.2 percent vs. 25.8 percent, p<0.01) and two year markers (28.2 percent vs. 38.2 percent; hazard ratio [HR] = 0.67, 95 percent CI: 0.44 to 1.00, p=0.049).

According to Williams these differences in late outcomes may be driven by differences in baseline characteristics. Females were less likely to experience important comorbidities, including coronary artery disease, diabetes, peripheral vascular disease, and renal dysfunction. For females that survive the procedural period, the initial benefit of lower mortality with TAVR is sustained. For males however, any early benefit of lower procedural mortality with TAVR appears to be overtaken by competing risks including baseline factors and post-implant complications, leading to higher mortality in their follow-up.

“That women did considerably better with TAVR than SAVR (half the mortality) while outcomes in men were similar with the two techniques, suggests that we should be weighing the options for aortic valve replacement differently in women than in men,” says study co-author Pamela Douglas, MD, MACC. “In a man, the choice of SAVR vs TAVR is almost a coin toss—results are the same with both. However in a woman this new paper suggests that TAVR is preferred. Hopefully physicians and patients will use this information to make more personalized decisions regarding care.”

Keywords: Heart Valve Prosthesis, Risk, Coronary Artery Disease, Follow-Up Studies, United States Food and Drug Administration, Comorbidity, Diabetes Mellitus, Peripheral Vascular Diseases

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