title: Long-term use of a left ventricular assist device for end-stage heart failure.
abstract: BACKGROUND
  Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated.
  
  
  METHODS
  We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure.
  
  
  RESULTS
  Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group.
  
  
  CONCLUSIONS
  The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.
authors.affiliation: College of Physicians and Surgeons, Columbia University, New York, NY, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Rose
authors.forename: A C
authors.initials: AC
authors.lastname: Gelijns
authors.forename: A J
authors.initials: AJ
authors.lastname: Moskowitz
authors.forename: D F
authors.initials: DF
authors.lastname: Heitjan
authors.forename: L W
authors.initials: LW
authors.lastname: Stevenson
authors.forename: W
authors.initials: W
authors.lastname: Dembitsky
authors.forename: J W
authors.initials: JW
authors.lastname: Long
authors.forename: D D
authors.initials: DD
authors.lastname: Ascheim
authors.forename: A R
authors.initials: AR
authors.lastname: Tierney
authors.forename: R G
authors.initials: RG
authors.lastname: Levitan
authors.forename: J T
authors.initials: JT
authors.lastname: Watson
authors.forename: P
authors.initials: P
authors.lastname: Meier
authors.forename: N S
authors.initials: NS
authors.lastname: Ronan
authors.forename: P A
authors.initials: PA
authors.lastname: Shapiro
authors.forename: R M
authors.initials: RM
authors.lastname: Lazar
authors.forename: L W
authors.initials: LW
authors.lastname: Miller
authors.forename: L
authors.initials: L
authors.lastname: Gupta
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
authors.forename: P
authors.initials: P
authors.lastname: Desvigne-Nickens
authors.forename: M C
authors.initials: MC
authors.lastname: Oz
authors.forename: V L
authors.initials: VL
authors.lastname: Poirier
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D002423:Cause of Death; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006333:Heart Failure / Q000145:classification / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016019:Survival Analysis