Quality of life with defibrillator therapy or amiodarone in heart failure.
Quality of life with defibrillator therapy or amiodarone in heart failure.
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DOI：
10.1056/nejmoa0706719
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发表时间：
2008-09-04
期刊：
影响因子：
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通讯作者：
Sudden Cardiac Death in Heart Failure Trial Investigators
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文献类型：
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作者：
Mark DB;Anstrom KJ;Sun JL;Clapp-Channing NE;Tsiatis AA;Davidson-Ray L;Lee KL;Bardy GH;Sudden Cardiac Death in Heart Failure Trial Investigators
植入式心律转复除颤器（ICD）治疗可显著延长因左心室功能下降而心源性猝死风险增加的患者的生命。然而，目前还不清楚这种寿命的延长是否伴随着生活质量的下降。心力衰竭心源性猝死试验（SCD-HeFT）在2521例左心室功能抑制的稳定性心力衰竭患者中比较了ICD治疗或胺碘酮与最新技术水平的药物治疗。生活质量是试验的次要终点，在基线、3、12和30个月进行前瞻性测量，完成率为93%至98%。杜克活动状态指数（测量心脏生理功能）和SF-36心理健康量表（测量心理健康或痛苦）是预先规定的主要生活质量结局。还检查了多个额外的生活质量结局。与单纯药物治疗相比，ICD组的心理健康在3个月（p=0.01）和12个月（p=0.004）时显著改善，但在30个月时没有改善。未观察到各治疗组的身体功能存在临床或统计学显著差异。ICD组的其他一些生活质量指标在3个月和/或12个月时有所改善，但在30个月时无显著差异。在预定评估前一个月内的ICD电击与多个领域的生活质量下降相关。胺碘酮对主要生活质量结局无显著影响。在大量中度症状性心力衰竭的一级预防人群中，单电极导线ICD治疗在30个月的随访中与任何可检测到的不良生活质量影响无关。
Implantable cardioverter defibrillator (ICD) therapy significantly prolongs life in patients at increased risk of sudden cardiac death from depressed left ventricular function. However, it is unclear whether this increased longevity is accompanied by deterioration in quality of life. The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) compared ICD therapy or amiodarone versus state-of-the-art medical therapy alone in 2521 stable heart failure patients with depressed left ventricular function. Quality of life, a secondary end point of the trial, was prospectively measured at baseline, 3, 12, and 30 months and was 93% to 98% complete. The Duke Activity Status Index (which measures cardiac physical functioning) and the SF-36 Mental Health Inventory (which measures psychological well-being or distress) were prespecified principal quality-of-life outcomes. Multiple additional quality-of-life outcomes were also examined. Compared with medical therapy alone, psychological well-being in the ICD arm significantly improved at 3 months (p=0.01) and 12 months (p=0.004) but not at 30 months. No clinically or statistically significant differences in physical functioning by treatment were observed. Some other quality-of-life measures improved in the ICD arm at 3 and/or 12 months but none differed significantly at 30 months. ICD shocks within the month preceding a scheduled assessment were associated with decreased quality of life in multiple domains. Amiodarone had no significant effects on the principal quality-of-life outcomes. 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 over 30 months of follow-up.