Jaya Chandrasekhar1, George Dangas1, Jennifer Yu2, Sreekanth Vemulapalli3, Sunil Suchindran3, Amit N Vora3, Usman Baber1, Roxana Mehran4. 1. Icahn School of Medicine at Mount Sinai, New York, New York. 2. Icahn School of Medicine at Mount Sinai, New York, New York; Prince of Wales Hospital, Sydney, Australia. 3. Duke Clinical Research Institute, Durham, North Carolina. 4. Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.
Abstract
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.
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.
Authors: Zakeih Chaker; Vinay Badhwar; Fahad Alqahtani; Sami Aljohani; Chad J Zack; David R Holmes; Charanjit S Rihal; Mohamad Alkhouli Journal: J Am Heart Assoc Date: 2017-09-21 Impact factor: 5.501