Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure
Daniel B. Mark, M.D., M.P.H., Kevin J. Anstrom, Ph.D., Jie L. Sun, M.S., Nancy E. Clapp-Channing, R.N., M.P.H., Anastasios A. Tsiatis, Ph.D., Linda Davidson-Ray, M.A., Kerry L. Lee, Ph.D., Gust H. Bardy, M.D., for the Sudden Cardiac Death in Heart Failure Trial Investigators
Background Implantable cardioverter–defibrillator (ICD)therapy significantly prolongs life in patients at increasedrisk for sudden death from depressed left ventricular function.However, whether this increased longevity is accompanied bydeterioration in the quality of life is unclear.
Methods In a randomized trial, we compared ICD therapy or amiodaronewith state-of-the-art medical therapy alone in 2521 patientswho had stable heart failure with depressed left ventricularfunction. We prospectively measured quality of life at baselineand at months 3, 12, and 30; data collection was 93 to 98% complete.The Duke Activity Status Index (which measures cardiac physicalfunctioning) and the Medical Outcomes Study 36-Item Short-FormMental Health Inventory 5 (which measures psychological well-being)were prespecified primary outcomes. Multiple additional quality-of-lifeoutcomes were also examined.
Results Psychological well-being in the ICD group, as comparedwith medical therapy alone, was significantly improved at 3months (P=0.01) and at 12 months (P=0.003) but not at 30 months.No clinically or statistically significant differences in physicalfunctioning among the study groups were observed. Additionalquality-of-life measures were improved in the ICD group at 3months, 12 months, or both, but there was no significant differenceat 30 months. ICD shocks in the month preceding a scheduledassessment were associated with a decreased quality of lifein multiple domains. The use of amiodarone had no significanteffects on the primary quality-of-life outcomes.
Conclusions In a large primary-prevention population with moderatelysymptomatic heart failure, single-lead ICD therapy was not associatedwith any detectable adverse quality-of-life effects during 30months of follow-up.
Source Information
From the Outcomes Research Group (D.B.M., K.J.A., N.E.C.-C., L.D.-R.), Duke Clinical Research Institute (J.L.S., K.L.L.), and the Departments of Medicine (D.B.M.) and Biostatistics and Bioinformatics (K.J.A., K.L.L.), Duke University Medical Center, Durham, NC; the Department of Statistics, North Carolina State University, Raleigh (A.A.T.); and the Seattle Institute for Cardiac Research, University of Washington, Seattle (G.H.B.).
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