Quality of Life in the Canadian Implantable Defibrillator Study
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 ≥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.
In patients with a history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), treatment with an implantable cardioverter defibrillator (ICD) is superior to antiarrhythmic drug therapy in prolonging survival. Questions about the effect of ICD on quality of life have yet to be resolved. The prevalence of mood disturbance is high in patients with an ICD; however, because these studies are not randomized comparisons, it is not known whether the prevalence of mood disturbance is higher in patients treated with an ICD than in patients with life-threatening arrhythmias who are treated solely with drugs.
The purpose of this study was to compare quality-of-life outcome between patients randomized to ICD therapy and patients randomized to amiodarone treatment in the Canadian Implantable Defibrillator Study (CIDS). CIDS was a multicenter, randomized clinical trial. The mortality results have been published. A secondary aim of this study was to evaluate the effects of receiving shocks from the device on quality of life.
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 ≥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.
In patients with a history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), treatment with an implantable cardioverter defibrillator (ICD) is superior to antiarrhythmic drug therapy in prolonging survival. Questions about the effect of ICD on quality of life have yet to be resolved. The prevalence of mood disturbance is high in patients with an ICD; however, because these studies are not randomized comparisons, it is not known whether the prevalence of mood disturbance is higher in patients treated with an ICD than in patients with life-threatening arrhythmias who are treated solely with drugs.
The purpose of this study was to compare quality-of-life outcome between patients randomized to ICD therapy and patients randomized to amiodarone treatment in the Canadian Implantable Defibrillator Study (CIDS). CIDS was a multicenter, randomized clinical trial. The mortality results have been published. A secondary aim of this study was to evaluate the effects of receiving shocks from the device on quality of life.
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