title: Sex-Based Differences in Outcomes With Transcatheter Aortic Valve Therapy: TVT Registry From 2011 to 2014.
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.
  
  
  OBJECTIVE
  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.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Jaya
authors.initials: J
authors.lastname: Chandrasekhar
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York; Prince of Wales Hospital, Sydney, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Yu
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Sreekanth
authors.initials: S
authors.lastname: Vemulapalli
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Sunil
authors.initials: S
authors.lastname: Suchindran
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Amit N
authors.initials: AN
authors.lastname: Vora
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D012720:Severity of Illness Index; D017678:Sex Distribution; D012737:Sex Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: long-term outcomes; sex-based differences; transcatheter aortic valve replacement