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Potential Cost-Effectiveness of Prophylactic Use of the Implantable Cardioverter Defibrillator or Amiodarone after Myocardial Infarction

Gillian D. Sanders, PhD; Mark A. Hlatky, MD; Nathan R. Every, MD, MPH; Kathryn M. McDonald, MM; Paul A. Heidenreich, MD, MS; Lori S. Parsons, BS; and Douglas K. Owens, MD, MS
[+] Article and Author Information

From Stanford University, Stanford, and Veterans Affairs Palo Alto Health Care System, Palo Alto, California; and Seattle Veterans Affairs Medical Center and University of Washington, Seattle, Washington.


Acknowledgments: The authors thank the other investigators in the Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team (CARD PORT) for reviewing the model and data sources. They also thank Lyn Dupré for editorial assistance.

Grant Support: In part by the Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team grant (HS 08362) to Stanford University from the Agency for Health Care Policy and Research. Drs. Owens, Heidenreich, and Every are supported by Career Development Awards from the Veterans Affairs Health Services Research and Development Service.

Requests for Single Reprints: Gillian D. Sanders, PhD, Center for Primary Care and Outcomes Research, 179 Encina Commons, Stanford University, Stanford, CA 94305-6019; e-mail, sanders@stanford.edu.

Current Author Addresses: Drs. Sanders and Owens and Ms. McDonald: Center for Primary Care and Outcomes Research, 179 Encina Commons, Stanford University, Stanford, CA 94305-6019.

Drs. Hlatky and Heidenreich: Department of Health Research and Policy, HRP Building, Stanford University, Stanford, CA 94305-5405.

Dr. Every: Frazier & Co., 601 Union Street, Suite 3300, Seattle, WA 98101.

Ms. Parsons: Ovation Research Group, 805 Fir Place, Edmunds, WA 98020.

Author Contributions: Conception and design: G.D. Sanders, M.A. Hlatky, N.R. Every, K.M. McDonald, P.A. Heidenreich, D.K. Owens.

Analysis and interpretation of the data: G.D. Sanders, M.A. Hlatky, N.R. Every, K.M. McDonald, P.A. Heidenreich, L.S. Parsons, D.K. Owens.

Drafting of the article: G.D. Sanders, M.A. Hlatky, K.M. McDonald, D.K. Owens.

Critical revision of the article for important intellectual content: G.D. Sanders, M.A. Hlatky, N.R. Every, K.M. McDonald, P.A. Heidenreich, D.K. Owens.

Final approval of the article: G.D. Sanders, M.A. Hlatky, N.R. Every, K.M. McDonald, P.A. Heidenreich, L.S. Parsons, D.K. Owens.

Provision of study materials or patients: M.A. Hlatky, N.R. Every.

Statistical expertise: G.D. Sanders, M.A. Hlatky, N.R. Every, L.S. Parsons, D.K. Owens.

Obtaining of funding: M.A. Hlatky, N.R. Every, K.M. McDonald, D.K. Owens.

Administrative, technical, or logistic support: K.M. McDonald.

Collection and assembly of data: G.D. Sanders, M.A. Hlatky, K.M. McDonald, L.S. Parsons.


Ann Intern Med. 2001;135(10):870-883. doi:10.7326/0003-4819-135-10-200111200-00007
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More than 1 million Americans per year have acute myocardial infarction (1). Those who survive to hospital discharge have a 5% to 10% risk for dying suddenly within the first year (27). Prevention of those sudden deaths is an important goal, and several approaches have been used to accomplish it. Secondary prevention with type I antiarrhythmic drugs has been unsuccessful (8). Prophylactic use of amiodarone has significantly reduced death after myocardial infarction in some but not all randomized trials. Quantitative overviews of these studies suggest that amiodarone reduces mortality rates by 10% to 20% (910). Recent studies of the implantable cardioverter defibrillator (ICD) in patients who have no history of sustained arrhythmia have also had mixed results, with positive results in patients with unsustained ventricular tachycardia (1112) and negative results in patients with reduced ejection fraction and positive results on signal-averaged electrocardiography (13). The use of prophylactic ICD has nevertheless attracted great interest because of the demonstrated efficacy of the device in patients who have had a documented episode of ventricular fibrillation or sustained ventricular tachycardia (1416). Although ongoing or planned randomized, controlled trials (1718) will clarify the role of ICDs and amiodarone therapy in patients who have had myocardial infarctions, the results of these trials will not be available until late 2001 at the earliest.

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Figures

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Figure 1.
The decision model.

The square node on the left represents a choice among three alternative treatments: implantable cardiac defibrillator (ICD), amiodarone, and no antiarrhythmic treatment. Circles represent chance nodes. Patients who receive an ICD are at risk for death from the implant procedure. Patients who do not die of ICD implantation and patients who are receiving amiodarone or no treatment enter the Markov tree (denoted by rectangles containing circles and an arrow). The Markov tree represents the clinical events that can occur during each 1-month period as a patient is followed until death. During each 1-month period, a patient may die from arrhythmic or nonarrhythmic cardiac causes and may also die of noncardiac causes. If none of these events occur, the patient remains well for the 1-month period. Patients who have an ICD may have a lead infection or failure that causes them to withdraw from treatment (and to switch to no antiarrhythmic therapy). Patients who receive amiodarone are at risk for amiodarone toxicity. In our analysis, a patient may die of toxicity, withdraw from treatment (and switch to no antiarrhythmic therapy), or have acute toxicity that does not require discontinuation.

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Figure 2.
Sensitivity analysis.

Top. Incremental cost-effectiveness of an implantable cardiac defibrillator (ICD) compared with no antiarrhythmic therapy. Bottom. Incremental cost-effectiveness of amiodarone compared with no antiarrhythmic therapy. EF = ejection fraction; QALY = quality-adjusted life-year.

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Figure 3.
Sensitivity analysis of the incremental cost-effectiveness of an implantable cardiac defibrillator (ICD) compared with amiodarone.

Top. Patients with an ejection fraction of 0.3 or less. Middle. Patients with an ejection fraction of 0.31 to 0.4. Bottom. Patients with an ejection fraction greater than 0.4. QALY = quality-adjusted life-year.

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Figure 4.
Sensitivity analysis of cardiac mortality rate.

Top. Amiodarone compared with no antiarrhythmic therapy. Bottom. Implantable cardioverter defibrillator (ICD) compared with no antiarrhythmic therapy. Arrows indicate base-case estimates for each sensitivity analysis. Both graphs assume an effectiveness of 60% in reduction in arrhythmic mortality with ICD and an 11% reduction in total mortality with amiodarone therapy. EF = ejection fraction; QALY = quality-adjusted life-year.

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Summary for Patients

Cost-Effectiveness of Implantable Defibrillators versus the Drug Amiodarone To Prevent Abnormal Heart Rhythms after Heart Attack

The summary below is from the full report titled “Potential Cost-Effectiveness of Prophylactic Use of the Implantable Cardioverter Defibrillator or Amiodarone after Myocardial Infarction.” It is in the 20 November 2001 issue of Annals of Internal Medicine (volume 135, pages 870–883). The authors are GD Sanders, MA Hlatky, NR Every, KM McDonald, PA Heidenreich, LS Parsons, and DK Owens.

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