title: Should women receive left ventricular assist device support?: findings from INTERMACS.
abstract: BACKGROUND
  Small studies have reported women to have worse outcomes and more adverse events after implantation of mechanical circulatory support device compared with men. To further evaluate sex differences in outcome, we used the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).
  
  
  RESULTS
  There were 401 women (pulsatile devices=78) and 1535 men (pulsatile devices=402) from 89 institutions who were prospectively enrolled into the INTERMACS database for primary implantation of a left ventricular assist device (LVAD) between June 23, 2006, and March 31, 2010. Extensive preimplantation and outcome data were collected on all patients. With a mean follow-up of 7 months, 67 females (17%) died and 250 males (16%) died. There was no statistically significant sex difference in mortality for either pulsatile-flow (P=0.82) or continuous-flow (P=0.95) devices in adjusted and unadjusted models. There were also no statistically significant sex differences with time to first infection, bleeding, or device malfunction. However, female sex was associated with an increased hazard of first neurological event (adjusted hazard ratio, 1.44; 95% CI, 1.05-1.96; P=0.020).
  
  
  CONCLUSIONS
  There were no significant sex differences in mortality, time to first infection, bleeding, or device malfunction with either pulsatile- or continuous-flow LVADs. However, women had an increased risk of first neurological event. For urgent/emergent mechanical support, the benefit of LVAD support likely outweighs the risk, but it remains less clear for women undergoing elective LVAD implantation.
authors.affiliation: College of Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. hsiche@ccf.org
authors.forename: Eileen M
authors.initials: EM
authors.lastname: Hsich
authors.forename: David C
authors.initials: DC
authors.lastname: Naftel
authors.forename: Susan L
authors.initials: SL
authors.lastname: Myers
authors.forename: Eiran Z
authors.initials: EZ
authors.lastname: Gorodeski
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Grady
authors.forename: Darlene
authors.initials: D
authors.lastname: Schmuhl
authors.forename: Karen L
authors.initials: KL
authors.lastname: Ulisney
authors.forename: James B
authors.initials: JB
authors.lastname: Young
mesh_terms: D017677:Age Distribution; D003657:Decision Making; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D017678:Sex Distribution; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016277:Ventricular Function, Left