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Women have lower mortality risk than men after TAVR
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Women who underwent transcatheter aortic valve replacement had a higher incidence of postprocedural bleeding and vascular complications, but improved 1-year survival compared with men, according to a secondary analysis of the PARTNER trial.
The secondary, as-treated analysis focused on the randomized and nonrandomized portions of the PARTNER trial. Susheel Kodali, MD, and colleagues examined sex-specific differences in 2,559 high-risk and inoperable patients (1,220 women) who underwent TAVR (Sapien, Edwards Lifesciences) in the trial.
Susheel Kodali
At baseline, women were less likely than men to report a history of diabetes, hyperlipidemia, renal disease or smoking, had a lower EuroSCORE (25.1 vs. 27.7) and had a higher STS-PROM score (11.9% vs. 11.1%).
After TAVR, women had a higher rate of vascular complications (17.3% vs. 10%; P < .001), major bleeding (10.5% vs. 7.7%; P = .012) and unplanned arterial procedures (13.9% vs. 7.2%; P < .001) compared with men. Women had a lower frequency of mild paravalvular leak (35% vs. 47%) and moderate/severe paravalvular leak (6% vs. 14.3%; P < .001 for both).
At 30-day follow-up, the researchers found no difference in rates of all-cause mortality (women, 6.5% vs. men, 5.9%; P = .52), cardiac mortality (4.8% vs. 3.9%; P = .23) or death/rehospitalization (12% vs. 12.5%; P = .75). At 1 year, the rate of unadjusted all-cause mortality was 19% in women vs. 25.9% in men (P < .0001). Women also had a lower 1-year rate of rehospitalization (15.8% vs. 18.9%; P = .043). The researchers observed no difference between men and women in the incidence of stroke.
Access site used during TAVR did not appear to influence the sex-specific differences at 1 year (P = .91). For women who underwent TAVR via transfemoral access, the rate of mortality at 1 year was 17.4% vs. 24% for men (P = .004). For women who underwent TAVR via transapical access, the rate of mortality at 1 year was 20.8% vs. 28.8% for men (P = .004).
“These findings for TAVR directly contrast with the abundant literature on aortic valve surgery, in which female sex has been shown to be an established risk factor for adverse prognosis after surgical AVR, as reflected in the most recent STS risk model,” Kodali, director of the Heart Valve Program and director of the interventional cardiology fellowship program at Columbia University Medical Center/New York-Presbyterian Hospital, and colleagues wrote.
According to the researchers, the lower 1-year mortality rates after TAVR among women could be related to a lower burden of comorbid conditions, small annulus sizes, greater pre-TAVR ejection fraction and less aortic regurgitation after the procedure.
“These results, in conjunction with prior published work, indicate that the approach to sex-specific risk in TAVR should be the opposite of that in surgical AVR, for which female sex is regarded as predictive of adverse prognosis,” the researchers wrote. – by Jennifer Byrne
Disclosure: Kodali reports receiving personal fees from Edwards Lifesciences and nonfinancial support from Medtronic. See the full study for a list of the other researchers’ relevant financial disclosures.
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