Sex-based differences in outcomes with transcatheter aortic valve therapy: TVT registry from 2011 to 2014
Journal of the American College of Cardiology, 2016•jacc.org
Background: A differential impact of sex has been observed in transcatheter aortic valve
replacement (TAVR) outcomes from small observational studies and subgroup analyses of
randomized trials. Objectives: The goal of this study was to compare the in-hospital and 1-
year outcomes in male and female subjects from the US nationwide TAVR registry. Methods:
National data from the Society of Thoracic Surgeons/American College of Cardiology
Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked …
replacement (TAVR) outcomes from small observational studies and subgroup analyses of
randomized trials. Objectives: The goal of this study was to compare the in-hospital and 1-
year outcomes in male and female subjects from the US nationwide TAVR registry. Methods:
National data from the Society of Thoracic Surgeons/American College of Cardiology
Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked …
Background
A differential impact of sex has been observed in transcatheter aortic valve replacement (TAVR) outcomes from small observational studies and subgroup analyses of randomized trials.
Objectives
The goal of this study was to compare the in-hospital and 1-year outcomes in male and female subjects from the U.S. nationwide TAVR registry.
Methods
National data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Multivariable logistic regression adjustment was performed for in-hospital outcomes. Fine-Gray models were used for nonfatal 1-year outcomes to account for the competing risk of death.
Results
From 2011 to 2014, a total of 11,808 (49.9%) women and 11,844 (51.1%) men underwent TAVR. Compared with male patients, female patients were older, with a lower prevalence of coronary artery disease, atrial fibrillation, and diabetes but a higher rate of porcelain aorta, lower glomerular filtration rate, and higher mean Society of Thoracic Surgeons score (9.0% vs. 8.0%; all p < 0.001). Women were treated more often by using nontransfemoral access than men (45.0% vs. 34.0%). Despite using smaller device sizes, women achieved valve cover index ≥8% more often than men (66% vs. 54%). In-hospital vascular complications were higher in women (8.27% vs. 4.39%; adjusted hazard ratio [HR]: 1.70; 95% CI: 1.34 to 2.14; p < 0.001) and a trend toward higher bleeding (8.01% vs 5.96%; adjusted HR: 1.19; 95% CI: 0.99 to 1.44; p = 0.06) was observed; however, 1-year mortality was lower (21.3% vs. 24.5%; adjusted HR: 0.73; 95% CI: 0.63 to 0.85; p < 0.001) in women than in men.
Conclusions
Female patients undergoing TAVR had a different risk profile compared with male patients. Notwithstanding a greater adjusted risk for in-hospital vascular complications, 1-year adjusted survival was superior in female patients.
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