title: Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.
abstract: BACKGROUND
  Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting.
  
  
  OBJECTIVE
  To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial.
  
  
  METHODS
  Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894).
  
  
  METHODS
  25 hospitals in the United States, Canada, and Germany.
  
  
  METHODS
  High-risk and inoperable patients (1220 women and 1339 men).
  
  
  METHODS
  TAVR.
  
  
  METHODS
  Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters.
  
  
  RESULTS
  At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001).
  
  
  CONCLUSIONS
  Secondary analysis that included nonrandomized trial data.
  
  
  CONCLUSIONS
  Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis.
  
  
  BACKGROUND
  Edwards Lifesciences.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.forename: Darshan
authors.initials: D
authors.lastname: Doshi
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.forename: Karin H
authors.initials: KH
authors.lastname: Humphries
authors.forename: Vuyisile T
authors.initials: VT
authors.lastname: Nkomo
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.forename: Lars
authors.initials: L
authors.lastname: Svensson
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Martin
authors.initials: M
authors.lastname: Leon
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002423:Cause of Death; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D010359:Patient Readmission; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D012307:Risk Factors; D012737:Sex Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000453:epidemiology