title: Sex differences in device therapy for heart failure: utilization, outcomes, and adverse events.
abstract: BACKGROUND
  Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies.
  
  
  METHODS
  We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information.
  
  
  RESULTS
  Ninety percent of the studies evaluated included ≤ 35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT.
  
  
  CONCLUSIONS
  Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex.
authors: Center for Devices and Radiological Health, United States Food and Drug Administration , Silver Spring, Maryland.
authors: Naomi D
authors: ND
authors: Herz
authors: Joseph
authors: J
authors: Engeda
authors: Robbert
authors: R
authors: Zusterzeel
authors: William E
authors: WE
authors: Sanders
authors: Kathryn M
authors: KM
authors: O'Callaghan
authors: David G
authors: DG
authors: Strauss
authors: Samantha B
authors: SB
authors: Jacobs
authors: Kimberly A
authors: KA
authors: Selzman
authors: Ileana L
authors: IL
authors: Piña
authors: Daniel A
authors: DA
authors: Caños
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects / Q000706:statistics & numerical data*; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D020127:Recovery of Function; D012727:Sex Characteristics; D012737:Sex Factors; D015996:Survival Rate; D016896:Treatment Outcome