Jonathan P. Piccini, MD; L. Kristin Newby, MD, MHS
In patients with congestive heart failure (CHF), does implantable cardioverter-defibrillator (ICD) therapy or amiodarone improve quality of life (QOL)?
Randomized controlled trial (RCT) (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]). ClinicalTrials.gov NCT00000609.
Blinded (patients and clinicians, for comparison of amiodarone with placebo).*
Canada, United States, and New Zealand.
2521 patients (mean age 60 y, 77% men) who had New York Heart Association chronic, stable class II or III CHF and left ventricular (LV) ejection fraction ≤ 35%.
State-of-the-art medical therapy with conservatively programmed single-chamber ICD (n = 816), amiodarone (n = 830), or amiodarone placebo (n = 833).
Cardiac physical functioning (Duke Activity Status Index) and psychological well-being (36-item Short-Form Mental Health Inventory 5). Secondary outcomes included QOL measured by SF-36 and Minnesota Living with HF scale (score range 0 to 105, higher scores = worse function).
84% at 12 months; 73% at 30 months.
At 12 months, the ICD group had better psychological well-being and SF-36 scores for pain, general health, and social function than did the placebo group (Table); groups did not differ for cardiac physical functioning (Table), other domains of SF-36 (Table), or scores on the Minnesota Living with HF Scale (median 32 vs 36, P = 0.07). At 12 months, the amiodarone group had better scores on the SF-36 pain scale than did the placebo group, but groups did not differ for any other outcome (Table). The results at 30 months are not presented because follow-up was < 80%.
Implantable cardioverter-defibrillator therapy improved quality of life in congestive heart failure at 12 months; amiodarone did not.
Implantable cardioverter-defibrillator (ICD) vs amiodarone vs placebo in congestive heart failure‡
‡Abbreviations defined in Glossary.
§Score range 0 to 100; higher scores = better function.
||Significant difference between groups.
Piccini JP, Newby LK. Defibrillator therapy improved quality of life in CHF; amiodarone did not. Ann Intern Med. ;150:JC1–10. doi: 10.7326/0003-4819-150-2-200901200-02010
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Published: Ann Intern Med. 2009;150(2):JC1-10.
Cardiology, Rhythm Disorders and Devices.
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