Quality of life with defibrillator therapy or amiodarone in heart failure

被引:169
作者
Mark, Daniel B. [1 ,3 ]
Anstrom, Kevin J. [1 ,4 ]
Sun, Jie L. [2 ]
Clapp-Channing, Nancy E. [1 ]
Tsiatis, Anastasios A. [5 ]
Davidson-Ray, Linda [1 ]
Lee, Kerry L. [2 ,4 ]
Bardy, Gust H. [6 ]
机构
[1] Duke Univ, Med Ctr, Outcomes Res Grp, Durham, NC 27710 USA
[2] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA
[3] Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
[4] Duke Univ, Med Ctr, Dept Biostat & Bioinformat, Durham, NC 27710 USA
[5] N Carolina State Univ, Dept Stat, Raleigh, NC 27695 USA
[6] Univ Washington, Seattle Inst Cardiac Res, Seattle, WA 98195 USA
关键词
D O I
10.1056/NEJMoa0706719
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:999 / 1008
页数:10
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