Cited by 260Cardiac pacing and defibrillation studiesHeart Failure Treatment and ManagementCardiac Health and Mental Health

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Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure

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Mark, Daniel B., Anstrom, Kevin J., Sun, Jie L., Clapp-Channing, Nancy E., Tsiatis, Anastasios A., Davidson-Ray, Linda, Lee, Kerry L., Bardy, Gust H.·2008·New England Journal of Medicine

DOI 10.1056/nejmoa0706719PMC PMC2823628

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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.

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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)
ORCID: Mark, Daniel B.
Anstrom, Kevin J.
Sun, Jie L.
Davidson-Ray, Linda
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
DOI: 10.1056/nejmoa0706719
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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Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure

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