SCD-HeFT

Sudden Cardiac Death in Heart Failure Trial

ClinicalTrials.gov: 

NCT00000609

Patient Population:

  • 2,521 patients with chronic stable heart failure
  • 18 yrs or older
  • New York Heart Association class II or III
  • Left ventricular ejection fraction less than or equal to 35%

Trial Design: Randomized clinical trial

Intervention: amiodarone, single-chamber (VVI) implantable cardioverter defibrillator (ICD) programmed to shock-only mode

Primary Endpoint: All-cause mortality

Sponsors: NIH, NHLBI

Economic Substudy

Principal Investigator:

Daniel B. Mark, MD

Primary Measures:

  • Resource use
  • Cost effectiveness

SCD-HeFT: ECONOMIC STUDY

Daniel Mark, MD presents the results of the quality of life substudy in the Trial to Assess Chelation Therapy.

Overview

This study examined the economic and quality of life outcome with the use of implantable cardioverter defibrillators for primary prevention of death in moderately symptomatic heart failure patients (both ischemic and non-ischemic).

Results

Cost-effectiveness of defibrillator therapy or amiodarone in chronic stable heart failure: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Mark DB, Nelson CL, Anstrom KJ, Al-Khatib SM, Tsiatis AA, Cowper PA, Clapp-Channing NE, Davidson-Ray L, Poole JE, Johnson G, Anderson J, Lee KL, Bardy GH; SCD-HeFT Investigators.

Circulation. 2006 Jul 11;114(2):135-42.

PMID: 16818817 Free Article

Abstract

BACKGROUND:

In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), implantable cardioverter-defibrillator (ICD) therapy significantly reduced all-cause mortality rates compared with medical therapy alone in patients with stable, moderately symptomatic heart failure, whereas amiodarone had no benefit on mortality rates. We examined long-term economic implications of these results.

METHODS AND RESULTS:

Medical costs were estimated by using hospital billing data and the Medicare Fee Schedule. Our base case cost-effectiveness analysis used empirical clinical and cost data to estimate the lifetime incremental cost of saving an extra life-year with ICD therapy relative to medical therapy alone. At 5 years, the amiodarone arm had a survival rate equivalent to that of the placebo arm and higher costs than the placebo arm. For ICD relative to medical therapy alone, the base case lifetime cost-effectiveness and cost-utility ratios (discounted at 3%) were dollar 38,389 per life-year saved (LYS) and dollar 41,530 per quality-adjusted LYS, respectively. A cost-effectiveness ratio < dollar 100,000 was obtained in 99% of 1000 bootstrap repetitions. The cost-effectiveness ratio was sensitive to the amount of extrapolation beyond the empirical 5-year trial data: dollar 127,503 per LYS at 5 years, dollar 88,657 per LYS at 8 years, and dollar 58,510 per LYS at 12 years. Because of a significant interaction between ICD treatment and New York Heart Association class, the cost-effectiveness ratio was dollar 29,872 per LYS for class II, whereas there was incremental cost but no incremental benefit in class III.

CONCLUSIONS:

Prophylactic use of single-lead, shock-only ICD therapy is economically attractive in patients with stable, moderately symptomatic heart failure with an ejection fraction < or = 35%, particularly those in NYHA class II, as long as the benefits of ICD therapy observed in the SCD-HeFT persist for at least 8 years.

DOI: 10.1161/CIRCULATIONAHA.105.581884

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This research has been cited in the NICE Guidance on Implantable cardioverter defibrillators and cardiac resynchronization therapy for arrhythmias and heart failure.

SCD-HeFT Publications

SCD-HeFT: Use of R-R interval statistics for long-term risk stratification for arrhythmic sudden cardiac death.

Au-Yeung WT, Reinhall PG, Poole JE, Anderson J, Johnson G, Fletcher RD, Moore HJ, Mark DB, Lee KL, Bardy GH.

Heart Rhythm. 2015 Oct;12(10):2058-66. doi: 10.1016/j.hrthm.2015.06.030. Erratum in: Heart Rhythm. 2015 Dec;12(12):2520.

PMID: 26096609 Free PMC Article

Survival benefit of the primary prevention implantable cardioverter-defibrillator among older patients: does age matter? An analysis of pooled data from 5 clinical trials.

Hess PL, Al-Khatib SM, Han JY, Edwards R, Bardy GH, Bigger JT, Buxton A, Cappato R, Dorian P, Hallstrom A, Kadish AH, Kudenchuk PJ, Lee KL, Mark DB, Moss AJ, Steinman R, Inoue LY, Sanders G.

Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):179-86. doi: 10.1161/CIRCOUTCOMES.114.001306. PMID: 25669833 Free PMC Article

Reply: circadian variations of ventricular arrhythmias and sleep-disordered breathing in HF patients.

Patton KK, Hellkamp AS, Lee KL, Mark DB, Johnson GW, Anderson J, Bardy GH, Poole JE; SCD-HeFT Investigators..

J Am Coll Cardiol. 2014 Nov 4;64(18):1968-9. doi: 10.1016/j.jacc.2014.08.022. No abstract available. PMID: 25444153 Free Article

Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.

Steinberg BA, Al-Khatib SM, Edwards R, Han J, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Steinman R, Dorian P, Hallstrom A, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Inoue LY, Sanders GD.

JACC Heart Fail. 2014 Dec;2(6):623-9. doi: 10.1016/j.jchf.2014.06.007. PMID: 25306452 Free PMC Article

Unexpected deviation in circadian variation of ventricular arrhythmias: the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

Patton KK, Hellkamp AS, Lee KL, Mark DB, Johnson GW, Anderson J, Bardy GH, Poole JE; SCD-HeFT Investigators..

J Am Coll Cardiol. 2014 Jun 24;63(24):2702-8. doi: 10.1016/j.jacc.2013.11.072. PMID: 24747100 Free PMC Article

Use of the 6-min walk distance to identify variations in treatment benefits from implantable cardioverter-defibrillator and amiodarone: results from the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

Fishbein DP, Hellkamp AS, Mark DB, Walsh MN, Poole JE, Anderson J, Johnson G, Lee KL, Bardy GH; SCD-HeFT Investigators..

J Am Coll Cardiol. 2014 Jun 17;63(23):2560-8. doi: 10.1016/j.jacc.2014.02.602. PMID: 24727258 Free Article

Implantable cardioverter-defibrillators for primary prevention of sudden cardiac death in CKD: a meta-analysis of patient-level data from 3 randomized trials.

Pun PH, Al-Khatib SM, Han JY, Edwards R, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Steinman R, Dorian P, Hallstrom A, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Hess PL, Inoue LY, Sanders GD.

Am J Kidney Dis. 2014 Jul;64(1):32-9. doi: 10.1053/j.ajkd.2013.12.009. PMID: 24518128 Free PMC Article

Thyroid function in heart failure and impact on mortality.

Mitchell JE, Hellkamp AS, Mark DB, Anderson J, Johnson GW, Poole JE, Lee KL, Bardy GH.

JACC Heart Fail. 2013 Feb;1(1):48-55. PMID: 24159562 Free PMC Article

Reply: rapid rate nonsustained ventricular tachycardia found on ICD interrogation: relationship of RR-NSVT to outcomes in the SCD-HeFT trial.

Chen J, Johnson G, Hellkamp AS, Anderson J, Mark DB, Lee KL, Bardy GH, Poole JE.

J Am Coll Cardiol. 2013 Nov 19;62(21):2028-9. doi: 10.1016/j.jacc.2013.07.061. No abstract available. PMID: 23994409 Free Article

No benefit of a dual coil over a single coil ICD lead: evidence from the Sudden Cardiac Death in Heart Failure Trial.

Aoukar PS, Poole JE, Johnson GW, Anderson J, Hellkamp AS, Mark DB, Lee KL, Bardy GH.

Heart Rhythm. 2013 Jul;10(7):970-6. doi: 10.1016/j.hrthm.2013.03.046. PMID: 23562699

Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

Chen J, Johnson G, Hellkamp AS, Anderson J, Mark DB, Lee KL, Bardy GH, Poole JE.

J Am Coll Cardiol. 2013 May 28;61(21):2161-8. doi: 10.1016/j.jacc.2013.02.046. PMID: 23541974 Free PMC Article

Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.

Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, Anstrom KJ, Curtis J, Al-Khalidi H, Curtis LH, Heidenreich P, Peterson ED, Sanders G, Clapp-Channing N, Lee KL, Moss AJ.

JAMA. 2013 Jan 2;309(1):55-62. doi: 10.1001/jama.2012.157182. PMID: 23280225 Free PMC Article

Mortality benefits from implantable cardioverter-defibrillator therapy are not restricted to patients with remote myocardial infarction: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Piccini JP, Al-Khatib SM, Hellkamp AS, Anstrom KJ, Poole JE, Mark DB, Lee KL, Bardy GH.

Heart Rhythm. 2011 Mar;8(3):393-400. doi: 10.1016/j.hrthm.2010.11.033. PMID: 21109025 Free PMC Article

Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial.

Packer DL, Prutkin JM, Hellkamp AS, Mitchell LB, Bernstein RC, Wood F, Boehmer JP, Carlson MD, Frantz RP, McNulty SE, Rogers JG, Anderson J, Johnson GW, Walsh MN, Poole JE, Mark DB, Lee KL, Bardy GH.

Circulation. 2009 Dec 1;120(22):2170-6. doi: 10.1161/CIRCULATIONAHA.109.853689. Erratum in: Circulation. 2010 Feb 16;121(6):e39. PMID: 19917887 Free PMC Article

Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population.

Levy WC, Lee KL, Hellkamp AS, Poole JE, Mozaffarian D, Linker DT, Maggioni AP, Anand I, Poole-Wilson PA, Fishbein DP, Johnson G, Anderson J, Mark DB, Bardy GH.

Circulation. 2009 Sep 8;120(10):835-42. doi: 10.1161/CIRCULATIONAHA.108.816884. PMID: 19704100 Free PMC Article

Ejection fraction assessment and survival: an analysis of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Gula LJ, Klein GJ, Hellkamp AS, Massel D, Krahn AD, Skanes AC, Yee R, Anderson J, Johnson GW, Poole JE, Mark DB, Lee KL, Bardy GH.

Am Heart J. 2008 Dec;156(6):1196-200. doi: 10.1016/j.ahj.2008.08.007. PMID: 19033019 Free PMC Article

Role of microvolt T-wave alternans in assessment of arrhythmia vulnerability among patients with heart failure and systolic dysfunction: primary results from the T-wave alternans sudden cardiac death in heart failure trial substudy.

Gold MR, Ip JH, Costantini O, Poole JE, McNulty S, Mark DB, Lee KL, Bardy GH.

Circulation. 2008 Nov 11;118(20):2022-8. doi: 10.1161/CIRCULATIONAHA.107.748962. PMID: 18955671 Free PMC Article

No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Anderson J, Chung K, Wong WS, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

J Am Coll Cardiol. 2008 Aug 12;52(7):551-6. doi: 10.1016/j.jacc.2008.04.051. PMID: 18687249 Free Article

Implantable cardioverter defibrillator therapy in patients with prior coronary revascularization in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Al-Khatib SM, Hellkamp AS, Lee KL, Anderson J, Poole JE, Mark DB, Bardy GH; scd-heft investigators..

J Cardiovasc Electrophysiol. 2008 Oct;19(10):1059-65. doi: 10.1111/j.1540-8167.2008.01191.x. PMID: 18479330

Primary prevention with defibrillator therapy in women: results from the Sudden Cardiac Death in Heart Failure Trial.

Russo AM, Poole JE, Mark DB, Anderson J, Hellkamp AS, Lee KL, Johnson GW, Domanski M, Bardy GH.

J Cardiovasc Electrophysiol. 2008 Jul;19(7):720-4. doi: 10.1111/j.1540-8167.2008.01129.x. PMID: 18373605

Syncope predicts the outcome of cardiomyopathy patients: analysis of the SCD-HeFT study.

Olshansky B, Poole JE, Johnson G, Anderson J, Hellkamp AS, Packer D, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

J Am Coll Cardiol. 2008 Apr 1;51(13):1277-82. doi: 10.1016/j.jacc.2007.11.065. PMID: 18371559 Free Article

Outcome in African Americans and other minorities in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Mitchell JE, Hellkamp AS, Mark DB, Anderson J, Poole JE, Lee KL, Bardy GH; SCD-HeFT Investigators..

Am Heart J. 2008 Mar;155(3):501-6. doi: 10.1016/j.ahj.2007.10.022. PMID: 18294487 Free PMC Article

Where patients with mild to moderate heart failure die: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Olshansky B, Wood F, Hellkamp AS, Poole JE, Anderson J, Johnson GW, Boineau R, Domanski MJ, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

Am Heart J. 2007 Jun;153(6):1089-94. PMID: 17540216

Preventing tomorrow’s sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy.

Sanders GD, Al-Khatib SM, Berliner E, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis AB, Curtis JP, Domanski M, Fain E, Gersh BJ, Gold MR, Goldberger J, Haghighi-Mood A, Hammill SC, Harder J, Healey J, Hlatky MA, Hohnloser SH, Lee KL, Mark DB, Mitchell B, Phurrough S, Prystowsky E, Smith JM, Stockbridge N, Temple R; Expert panel participating in a Duke Center for the Prevention of Sudden Cardiac Death-sponsored conference..

Am Heart J. 2007 Jun;153(6):951-9. PMID: 17540195

Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Freudenberger RS, Hellkamp AS, Halperin JL, Poole J, Anderson J, Johnson G, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

Circulation. 2007 May 22;115(20):2637-41. PMID: 17485579 Free Article

Absence of bilateral vision loss from amiodarone: a randomized trial.

Mindel JS, Anderson J, Hellkamp A, Johnson G, Poole JE, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

Am Heart J. 2007 May;153(5):837-42. Erratum in: Am Heart J. 2007 Jul;154(1):53. PMID: 17452162 Free PMC Article

Statin use was associated with reduced mortality in both ischemic and nonischemic cardiomyopathy and in patients with implantable defibrillators: mortality data and mechanistic insights from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Dickinson MG, Ip JH, Olshansky B, Hellkamp AS, Anderson J, Poole JE, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

Am Heart J. 2007 Apr;153(4):573-8. PMID: 17383296

Role of amiodarone or implantable cardioverter/defibrillator in patients with atrial fibrillation and heart failure.

Singh SN, Poole J, Anderson J, Hellkamp AS, Karasik P, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators..

Am Heart J. 2006 Nov;152(5):974.e7-11. PMID: 17070171

Cost-effectiveness of defibrillator therapy or amiodarone in chronic stable heart failure: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Mark DB, Nelson CL, Anstrom KJ, Al-Khatib SM, Tsiatis AA, Cowper PA, Clapp-Channing NE, Davidson-Ray L, Poole JE, Johnson G, Anderson J, Lee KL, Bardy GH; SCD-HeFT Investigators..

Circulation. 2006 Jul 11;114(2):135-42. PMID: 16818817 Free Article

Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure.

Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators..

N Engl J Med. 2005 Jan 20;352(3):225-37. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. PMID: 15659722 Free Article