Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure
Open accessAbstract
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.
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Some studies have found no significant differences in overall quality of life between ICD patients and other cardiac patients, pacemaker patients, or the general population.
“Some studies have found no significant differences in overall QOL between ICD patients and other cardiac patients, 2,3 PM patients, or the general population.4”
From Managing with pacemakers and implantable cardioverter defibrillators (2013) · cites this paper as [3]
The Results (Quality of Life Outcomes; page unavailable) found no significant difference between ICD and placebo patients in self-rated overall health at 30 months. But ICD patients rated their overall health significantly higher at 3 and 12 months, so an unqualified claim of no significant difference overstates this study. The citation placement associates this source with the comparison to other cardiac patients, not the comparisons to pacemaker patients or the general population. (LLM, conf=0.86)
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- Authors
- Mark, D. B., Anstrom, K. J., Sun, J. L., Clapp-Channing, N. E., Tsiatis, A. A., Davidson-Ray, L., Lee, K. L., & Bardy, G. H.
- Affiliations
- Duke Medical Center (US)
- Duke Clinical Research Institute (US)
- North Carolina State University (US)
- University of Washington (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-09-04
- Volume
- 359
- Issue
- 10
- Pages
- 999-1008
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC2823628
- OpenAlex
- W2117271182
- Cited by
- 260
- References
- 19
- Citations by year
- 2026: 6 · 2025: 10 · 2024: 8 · 2023: 1 · 2022: 10 · 2021: 11 · 2020: 6 · 2019: 6 · 2018: 13 · 2017: 18 · 2016: 16 · 2015: 20 · 2014: 16 · 2013: 19 · 2012: 22
- FWCI
- 18.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Heart, Lung, and Blood Institute (U01 HL55496, U01 HL55766, U01-HL55297), U01HL055297, U01HL055766, U01HL055496)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Keywords
- implantable cardioverter-defibrillator, amiodarone, heart failure, quality of life, psychological well-being, physical function, ICD shocks, sudden cardiac death, depressed left ventricular function, primary prevention
- MeSH terms
- Activities of Daily Living, Adult, Amiodarone, Anti-Arrhythmia Agents, Drug Therapy, Combination, Female, Follow-Up Studies, Heart Failure, Humans, Male, Quality of Life, Survival Analysis, Defibrillators, Implantable
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