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Randomized Controlled Trial
. 2008 Sep 4;359(10):999-1008.
doi: 10.1056/NEJMoa0706719.

Quality of life with defibrillator therapy or amiodarone in heart failure

Daniel B Mark  1 , Kevin J Anstrom, Jie L Sun, Nancy E Clapp-Channing, Anastasios A Tsiatis, Linda Davidson-Ray, Kerry L Lee, Gust H Bardy; Sudden Cardiac Death in Heart Failure Trial Investigators
Affiliations
Randomized Controlled Trial

Quality of life with defibrillator therapy or amiodarone in heart failure

Daniel B Mark et al. N Engl J Med. .

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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Figures

Figure 1
Figure 1
Graphic display of completeness of quality-of-life data collection according to follow-up anniversary. Major reasons for missing data are provided. Follow-up for vital status was 100% complete. QOL = quality of life.
Figure 2
Figure 2
Comparisons of two principal quality-of-life measures by intention-to-treat. Cardiac physical functioning is represented in 2A by the Duke Activity Status Index (DASI), which ranges from 0 (worst) to 58 (best). Psychological well-being is represented in 2B by the Short Form-36 Mental Health Inventory (SF-36 MHI-5), which ranges from 0 (worst) to 100 (best). Tables below the figures show medians with 25th and 75th percentiles, means with standard deviations, and 95% confidence intervals around the difference in means (active treatment minus placebo) at each time point. Comparisons with bolded values were statistically significant at a p≤ 0.05 level. ICD = implantable cardioverter-defibrillator; AMIO = amiodarone.
Figure 2
Figure 2
Comparisons of two principal quality-of-life measures by intention-to-treat. Cardiac physical functioning is represented in 2A by the Duke Activity Status Index (DASI), which ranges from 0 (worst) to 58 (best). Psychological well-being is represented in 2B by the Short Form-36 Mental Health Inventory (SF-36 MHI-5), which ranges from 0 (worst) to 100 (best). Tables below the figures show medians with 25th and 75th percentiles, means with standard deviations, and 95% confidence intervals around the difference in means (active treatment minus placebo) at each time point. Comparisons with bolded values were statistically significant at a p≤ 0.05 level. ICD = implantable cardioverter-defibrillator; AMIO = amiodarone.
Figure 3
Figure 3
Effect of ICD shocks on Short Form-36 quality-of-life domains. Patients in the ICD arm who had an ICD shock within 1 month following a scheduled quality-of-life follow-up assessment were compared with ICD patients without an ICD shock. Change scores for the ICD shock group were calculated as the post-shock value minus the most recent pre-shock value. Change scores for the comparison group were the 3 month quality of life values minus baseline. When we used other follow-up contacts (12 months, 24 months) to construct the “no shock” change scores, results were unaltered.
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References

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