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Female gender predicted late survival in TAVR
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Women experienced improved late survival despite increased vascular complications after transcatheter aortic valve replacement compared with men, according to findings from a recent meta-analysis.
The researchers culled the MEDLINE, Embase and Cochrane Library databases for patient-level time-to-event data on the effect of gender on early and late mortality, along with safety, in TAVR. All-cause mortality served as the primary endpoint for the analysis, with 30-day major vascular complications, bleeding events and stroke as safety endpoints.
Data from 11,310 patients from five studies were included. All patients had severe, symptomatic aortic stenosis and were ineligible or at high risk for surgery, according to the researchers. The cohort was 48.6% women, and women were less likely to have comorbidities than men.
Major vascular complication rates were 6.3% among women and 3.4% among men (P < .001). Similarly, 30-day rates of major bleeding events (10.5% vs. 8.5%; P = .003) and stroke (4.4% vs. 3.6%; P = .029) were also significantly higher among women. Aortic incompetence of at least grade 2 was reported in 19.4% of women and 24.5% of men (P < .001).
Procedural mortality rates (death within 72 hours of the procedure) were 2.6% for women and 2.2% for men (P = .24). Thirty-day mortality rates were also similar between women and men (6.5% vs. 6.5%; P = .93). However, follow-up data over a median of 387 days (interquartile range, 192-730 days) from the index procedure indicated that female gender was independently associated with better survival (adjusted HR = 0.79; 95% CI, 0.73-0.86). This reduced risk for all-cause mortality persisted regardless of valve type and intervention access route. In addition, age was predictive of mortality in men but not women, according to the results.
Jay Giri
Joseph E. Bavaria, MD, of the cardiovascular surgery division and Jay Giri, MD, MPH, of the cardiovascular medicine division, both from the University of Pennsylvania Perelman School of Medicine, suggested in an accompanying editorial that the design of the current meta-analysis allows “more granular assessment of potential predictors of post-TAVR outcomes than that of a traditional meta-analysis.”
However, they said, “Despite these methodological strengths, the study design remains observational, and the analysis is potentially victim to treatment-selection bias.”
They also raised the question of whether lower-risk women are systematically chosen for inclusion in such trials.
“Clearly, characterizing the influence of sex upon TAVR outcomes is not straightforward,” they wrote. “Sex is an immutable trait, hence treatment-selection bias cannot be mitigated through randomization. As such, the best way to determine effects of sex on TAVR outcomes will be to develop a TAVR-specific long-term mortality risk model utilizing a truly unselected patient population.” – by Rob Volansky
Disclosure: The researchers report associations with a number of device and pharmaceutical companies. Please see the full study for a list of all other authors’ relevant financial disclosures. Bavaria reports serving as co-principal investigator on the PARTNER trials, sponsored by Edwards Lifesciences and the SURTAVI trial, sponsored by Medtronic Inc.; and was on the steering committee for the REPRISE III Trial, sponsored by Boston Scientific. Giri reports serving as a sub-investigator on the PARTNER trials and the SURTAVI trial.
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