title: Quality of life with defibrillator therapy or amiodarone in heart failure.
abstract: BACKGROUND
  Implantable cardioverter-defibrillator (ICD) therapy significantly prolongs life in patients at increased risk for sudden death from depressed left ventricular function. However, whether this increased longevity is accompanied by deterioration in the quality of life is unclear.
  
  
  METHODS
  In a randomized trial, we compared ICD therapy or amiodarone with state-of-the-art medical therapy alone in 2521 patients who had stable heart failure with depressed left ventricular function. We prospectively measured quality of life at baseline and at months 3, 12, and 30; data collection was 93 to 98% complete. The Duke Activity Status Index (which measures cardiac physical functioning) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being) were prespecified primary outcomes. Multiple additional quality-of-life outcomes were also examined.
  
  
  RESULTS
  Psychological well-being in the ICD group, as compared with medical therapy alone, was significantly improved at 3 months (P=0.01) and at 12 months (P=0.003) but not at 30 months. No clinically or statistically significant differences in physical functioning among the study groups were observed. Additional quality-of-life measures were improved in the ICD group at 3 months, 12 months, or both, but there was no significant difference at 30 months. ICD shocks in the month preceding a scheduled assessment were associated with a decreased quality of life in multiple domains. The use of amiodarone had no significant effects on the primary quality-of-life outcomes.
  
  
  CONCLUSIONS
  In a large primary-prevention population with moderately symptomatic heart failure, single-lead ICD therapy was not associated with any detectable adverse quality-of-life effects during 30 months of follow-up.
authors.affiliation: Outcomes Research Group, Duke University Medical Center, Durham, NC, USA.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.forename: Jie L
authors.initials: JL
authors.lastname: Sun
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Clapp-Channing
authors.forename: Anastasios A
authors.initials: AA
authors.lastname: Tsiatis
authors.forename: Linda
authors.initials: L
authors.lastname: Davidson-Ray
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
authors.forename: Gust H
authors.initials: GH
authors.lastname: Bardy