abstract
- BACKGROUND: The primary aim of this study was to compare quality-of-life outcome between patients randomized to implantable cardioverter defibrillator (ICD) therapy and patients randomized to amiodarone treatment in the Canadian Implantable Defibrillator Study (CIDS). A secondary aim was to evaluate the effects on quality-of-life outcomes of receiving shocks from the device. METHODS: Quality of life was assessed in 317 English-speaking participants by use of the Rand Corporation's 38-item Mental Health Inventory (MHI) and the Nottingham Health Profile (NHP). Assessments were done in the hospital at baseline and with mailed questionnaires after 2, 6, and 12 months of follow-up. Sixty-two percent of patients completed the follow-up assessments at 6 and 12 months. RESULTS: Repeated measures analysis of variance revealed significant time by treatment group interaction effect on total MHI and the psychological distress and psychological well-being sub-scales, and on 5 of the 7 NHP scales (energy, physical mobility, emotional reactions, sleep disturbance, and lifestyle impairment) (P <.05). Emotional and physical health scores were shown to improve significantly in the ICD group and were either unchanged (emotional health) or deteriorated (energy and physical mobility) in the amiodarone-treated group by means of post-hoc comparisons. Quality of life did not improve in the subgroup of patients in the ICD-treated group who received > or =5 shocks from their device. CONCLUSION: Quality of life is better with ICD therapy than with amiodarone therapy. The beneficial quality-of-life effects from an ICD are not evident in patients who receive numerous shocks from their device.