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Clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators for arrhythmias: A systematic review and economic evaluation

Published online by Cambridge University Press:  18 January 2007

Jackie Bryant
Affiliation:
University of Southampton
Hakan Brodin
Affiliation:
University of Southampton
Emma Loveman
Affiliation:
University of Southampton
Andrew Clegg
Affiliation:
University of Southampton

Abstract

Objectives: The clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators (ICD) for arrhythmias was assessed.

Methods: A systematic review of the literature of systematic reviews and randomized controlled trials that reported mortality outcomes associated with implantable cardioverter defibrillators compared with antiarrhythmic drug therapy in people at risk of sudden cardiac death due to arrhythmias was undertaken. Economic evaluations were also sought. Inclusion criteria, data extraction, and quality assessment were undertaken by standard methodology. A decision analytic model was constructed using best available evidence to determine cost-effectiveness in a UK setting.

Results: Eight randomized controlled trials, two systematic reviews, and a meta-analysis met the inclusion criteria and were of variable quality. Evidence suggests that ICDs reduce mortality in both secondary and primary prevention, although the magnitude of benefit depends on baseline risk for sudden cardiac death. Incremental cost per quality-adjusted life year ranged from £52,000 ($98,000) to over £200,000 ($379,000), depending on mortality risk and assumptions made.

Conclusions: Evidence suggests that ICDs reduce total mortality but may be cost-effective only in some subgroups of patients at high risk of ventricular arrhythmias. Further research is needed on risk stratification of patients in whom ICDs are most likely to be clinically and cost-effective.

Type
GENERAL ESSAYS
Copyright
© 2007 Cambridge University Press

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References

A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. 1997 The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med. 337: 15761583.
Anonymous. 2002 State-specific mortality from sudden cardiac death—US 1999. MMWR Morb Mortal Wkly Rep. 51: 123126.
Bansch D, Antz M, Boczor S, et al. 2002 Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: The Cardiomyopathy Trial (CAT). Circulation. 105: 14531458.Google Scholar
Bardy GH, Lee KL, Mark DB, et al. 2005 Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 352: 225237.Google Scholar
Bigger JT Jr. 1997 Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. 337: 15691575.Google Scholar
Bristow MR, Saxon LA, Boehmer J. 2004 Cardiac resynchronisation therapy with or without an implantable cardioverter defibrillator in advanced chronic heart failure. N Engl J Med. 350: 21402150.Google Scholar
Bryant J, Brodin H, Loveman E, et al. 2005 The clinical effectiveness and cost effectiveness of implantable cardioverter defibrillators: Arrhythmias. Health Technol Assess. 9: 36.Google Scholar
Buxton AE, Lee KL, Fisher JD. 1999 A randomized study of the prevention of sudden cardiac death in patients with coronary artery disease. N Engl J Med. 341: 18821890.Google Scholar
Buxton MJ, Caine N, Chase D, et al. A review of the evidence on the effects and costs of implantable cardiac defibrillators (ICD) therapy in different patient groups, and modelling of cost-effectiveness and cost-utility for these groups in a UK context (project number 99/23/04). Health Technol Assess. In press.
Connolly SJ, Gent M, Roberts RS. 2000 Canadian Implantable Defibrillator Study (CIDS) A randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation. 101: 12971302.Google Scholar
Connolly SJ, Hallstrom AP, Cappato R, et al. 2000 Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator Study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J. 21: 20712078.Google Scholar
de Vreede-Swagemakers JJ, Gorgels AP, Dubois-Arbouw WI, et al. 1997 Out-of-hospital cardiac arrest in the 1990's: A population-based study in the Maastrict area on incidence, characteristics and survival. J Am Coll Cardiol. 30: 15001505.Google Scholar
Drummond MF, Jefferson TO. 1996 Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ. 313: 275283.Google Scholar
Ezekowitz JA, Armstrong PW, McAlister FA. 2003 Implantable cardioverter defibrillators in primary and secondary prevention: A systematic review of randomized, controlled trials. Ann Intern Med. 138: 445452.Google Scholar
Hlatky M. 2004 Evidence-based use of cardiac procedures and devices. N Engl J Med. 350: 21262128.Google Scholar
Irvine J, Dorian P, Baker B, et al. 2002 Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 144: 282289.Google Scholar
Jadad AR, Moore A, Carroll D. 1996 Assessing the quality of reports of randomised clinical trials: Is blinding necessary? Control Clin Trials. 17: 112.Google Scholar
Joint Submission to NICE by ABHI CRM Special Interest Section (Biotronik, ELA, Guidant, Medtronic, St Jude). October 2003.
Kadish A, Dyer A, Daubert JP, et al. 2004 Prophylactic defibrillator implantation with nonischemic dilated cardiomyopathy. N Engl J Med. 350: 21512158.Google Scholar
Kuck KH, Cappato R, Siebels J, et al. 2000 Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: The Cardiac Arrest Study Hamburg (CASH). Circulation. 102: 748754.Google Scholar
Kupersmith J, Hogan A, Guerrero P, et al. 1995 Evaluating and improving the cost-effectiveness of the implantable cardioverter-defibrillator. Am Heart J. 130 (Pt 1): 507515.Google Scholar
Kuppermann M, Luce BR, McGovern B. 1990 An analysis of the cost effectiveness of the implantable defibrillator. Circulation. 81: 91100.Google Scholar
Larsen G, Hallstrom A, McAnulty J, et al. 2002 Cost-effectiveness of the implantable cardioverter-defibrillator versus antiarrhythmic drugs in survivors of serious ventricular tachyarrhythmias: Results of the Antiarrhythmics Versus Implantable Defibrillators (AVID) economic analysis substudy. Circulation. 105: 20492057.Google Scholar
Larsen GC, Manolis AS, Sonnenberg FA, et al. 1992 Cost-effectiveness of the implantable cardioverter-defibrillator: Effect of improved battery life and comparison with amiodarone therapy. J Am Coll Cardiol. 19: 13231334.Google Scholar
Lee DS, Green LD, Liu PP, et al. 2003 Effectiveness of implantable defibrillators for preventing arrhythmic events and death: A meta-analysis. J Am Coll Cardiol. 41: 15731582.Google Scholar
Moss AJ, Fadl Y, Zareba W, et al. 2001 Defibrillator Implantation Trial Research Group. Survival benefit with an implanted defibrillator in relation to mortality risk in chronic coronary heart disease. Am J Cardiol. 88: 516520.Google Scholar
Moss AJ, Hall WJ, Cannom DS, et al. 1996 Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 335: 19331940.Google Scholar
Moss AJ, Zareba W, Hall WJ, et al. 2002 Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 346: 877883.Google Scholar
Mushlin AI. 1998 The cost-effectiveness of automatic implantable cardiac defibrillators: Results from MADIT. Circulation. 25: 21292135.Google Scholar
Namerow PB, Firth BR, Heywood GM, et al. 1999 Quality-of-life six months after CABG surgery in patients randomized to ICD versus no ICD therapy: Findings from the CABG Patch Trial. Pacing Clin Electrophysiol. 22: 13051313.Google Scholar
National Institute for Clinical Excellence. 2000. Guidance on the use of implantable cardioverter defibrillators for arrhythmias. London: National Institute for Clinical Excellence (NICE)
National Statistics. 2002. Mortality statistics: Cause. Review of the Registrar General on deaths by cause, sex and age in England and Wales in 2001. London: Office for National Statistics; No. DH2 no. 28.
NHS Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness: CRD guidelines for those carrying out or commissioning reviews. 1999. No. CRD Report 4.
O'Brien BJ, Buxton MJ, Ruskin JN. 1992 Cost effectiveness of the implantable cardioverter-defibrillator: A preliminary analysis. Br Heart J. 68: 241245.Google Scholar
O'Brien BJ, Connolly SJ, Goeree R, et al. 2001 Cost-effectiveness of the implantable cardioverter-defibrillator: Results from the Canadian Implantable Defibrillator Study (CIDS). Circulation. 103: 14161421.Google Scholar
O'Brien BJ, Heyland D, Richardson WS, et al. 1997 Users' guides to the medical literature. XIII. How to use an article on economic analysis of clinical practice. B. What are the results and will they help me in caring for my patients? Evidence-Based Medicine Working Group. JAMA. 277: 18021806.Google Scholar
Owens DK, Sanders GD, Harris RA, et al. 1997 Cost-effectiveness of implantable cardioverter defibrillators relative to amiodarone for prevention of sudden cardiac death. Ann Intern Med. 126: 112.Google Scholar
Owens DK, Sanders GD, Heidenreich PA, et al. 2002 Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator. Am Heart J. 144: 440448.Google Scholar
Sanders GD, Hlatky MA, Every NR, et al. 2001 Potential cost-effectiveness of prophylactic use of the implantable cardioverter defibrillator or amiodarone after myocardial infarction. Ann Intern Med. 135: 870883.Google Scholar
Schilling RJ, Kaye G. 1998 Epidemiology and management of failed sudden cardiac death. Hosp Med. 59: 116119.Google Scholar
Schron EB, Exner DV, Yao Q, et al. 2002 Quality of life in the antiarrhythmics versus implantable defibrillators trial: Impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation. 105: 589594.Google Scholar
Seidl K, Senges J. 2003 Worldwide utilisation of implantable cardioverter defibrillators now and in the future. Card Electrophysiol Rev. 7: 513.Google Scholar
Technology Evaluation Center. 2004 Special report: Cost-effectiveness of implantable cardioverter-defibrillators in a MADIT-II population. Technol Eval Cent Asses Program Exec Summ. 19: 12.
Wever EF, Hauer RN, Schwetz KM. 1996 Cost-effectiveness of implantable defibrillator as first-choice therapy versus electrophysiologically guided, tiered strategy in postinfarct sudden death survivors. Circulation. 93: 489496.Google Scholar