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ARTICLE

Clinical and Economic Implications of the Multicenter Automatic Defibrillator Implantation Trial-II

Sana M. Al-Khatib, MD, MHS; Kevin J. Anstrom, PhD; Eric L. Eisenstein, DBA; Eric D. Peterson, MD, MPH; James G. Jollis, MD; Daniel B. Mark, MD, MPH; Yun Li, MS; Christopher M. O'Connor, MD; Linda K. Shaw, MS; and Robert M. Califf, MD

19 April 2005 | Volume 142 Issue 8 | Pages 593-600

Background: The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II demonstrated that implantable cardioverter defibrillators (ICDs) save lives when used in patients with a history of myocardial infarction (MI) and an ejection fraction of 0.3 or less.

Objective: To investigate the cost-effectiveness of implanting ICDs in patients who met MADIT-II eligibility criteria and were enrolled in the Duke Cardiovascular Database between 1 January 1986 and 31 December 2001.

Design: Cost-effectiveness analysis.

Data Sources: Published literature, databases owned by Duke University Medical Center, and Medicare data.

Target Population: Adults with a history of MI and an ejection fraction of 0.3 or less.

Time Horizon: Lifetime.

Perspective: Societal.

Interventions: ICD therapy versus conventional medical therapy.

Outcomes Measures: Cost per life-year gained and incremental cost-effectiveness.

Results: Compared with conventional medical therapy, ICDs are projected to result in an increase of 1.80 discounted years in life expectancy and an incremental cost-effectiveness ratio of $50 500 per life-year gained. Cost-effectiveness varied dramatically with changes in time horizon: The cost-effectiveness ratio increased to $67 800 per life-year gained, $79 900 per life-year gained, $100 000 per life-year gained, $167 900 per life-year gained, and $367 200 per life-year gained for 15-year, 12-year, 9-year, 6-year, and 3-year time horizons, respectively. Changing the frequency of follow-up visits, complication rates, and battery replacements had less of an effect on the cost-effectiveness ratios than reducing the cost of ICD placement and leads.

Limitations: The study was limited by the completeness of the data, referral bias, difference in medical therapy between the Duke cohort and the MADIT-II cohort, and not addressing potential upgrades to biventricular devices.

Conclusions: The economic expense of defibrillator implantation in all patients who meet MADIT-II eligibility criteria is substantial. However, in the range of survival benefit observed in MADIT-II, ICD therapy for these patients is economically attractive by conventional standards.

Editors' Notes Context The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II has shown that implantable cardioverter defibrillators (ICDs), compared with conventional therapy, appreciably improve survival in patients who have had a myocardial infarction and have an ejection fraction of 0.3 or less. However, the cost of following these recommendations has not been adequately assessed. Contribution Implantable cardioverter defibrillators are projected to improve survival by 1.80 discounted years, with an incremental cost-effectiveness ratio of $50 500 per life-year gained. Sensitivity analysis shows that the cost of replacing ICD batteries and leads exerts greater effect on cost-effectiveness ratios than other factors. Implications The large number of patients eligible for ICDs under MADIT-II criteria may strain societal ability to perform and pay for these procedures. –The Editors

 

Author and Article Information

From the Duke Clinical Research Institute, Durham, North Carolina.

The results of this study were presented at the American College of Cardiology 52nd Annual Scientific Session, Chicago, Illinois, 30 March–2 April 2003.

Acknowledgments: The authors thank Kerry Lee, PhD, for critical review of the manuscript and Maqui Ortiz for editorial assistance and manuscript preparation.

Grant Support: In part by Guidant Corporation.

Potential Financial Conflicts of Interest: Consultancies: S.M. Al-Khatib (Guidant Corp.), D.B. Mark (Medtronic Inc.), C.M. O'Connor (Guidant Corp., Medtronic Inc.), R.M. Califf (Guidant Corp., Medtronic Inc.); Honoraria: S.M. Al-Khatib (Medtronic Inc., Guidant Corp.), D.B. Mark (Medtronic Inc.), C.M. O'Connor (Guidant Corp., Medtronic Inc.), R.M. Califf (Guidant Corp., Medtronic Inc.); Stock ownership or options (other than mutual funds): R.M. Califf (Guidant Corp., Medtronic Inc.); Grants received: S.M. Al-Khatib (Guidant Corp., Medtronic Inc.), D.B. Mark (Medtronic Inc.), R.M. Califf (Guidant Corp., Medtronic Inc.); Grants pending: D.B. Mark (Medtronic Inc.), R.M. Califf (Guidant Corp., Medtronic Inc.); Royalties: R.M. Califf (Guidant Corp., Medtronic Inc.).

Requests for Single Reprints: Sana M. Al-Khatib, MD, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27715.

Current Author Addresses: Drs. Al-Khatib, Anstrom, Peterson, Jollis, Mark, O'Connor, and Califf; Mr. Li; Mr. Eisenstein; and Ms. Shaw: Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27715.

Author Contributions: Conception and design: S.M. Al-Khatib, K.J. Anstrom, E.L. Eisenstein, J.G. Jollis, C.M. O'Connor, R.M. Califf.

Analysis and interpretation of the data: S.M. Al-Khatib, K.J. Anstrom, E.L. Eisenstein, E.D. Peterson, J.G. Jollis, D.B. Mark, Y. Li, C.M. O'Connor, L.K. Shaw.

Drafting of the article: S.M. Al-Khatib, K.J. Anstrom, E.L. Eisenstein, D.B. Mark.

Critical revision of the article for important intellectual content: K.J. Anstrom, E.L. Eisenstein, E.D. Peterson, J.G. Jollis, D.B. Mark, Y. Li, C.M. O'Connor, L.K. Shaw, R.M. Califf.

Final approval of the article: S.M. Al-Khatib, K.J. Anstrom, E.D. Peterson, J.G. Jollis, D.B. Mark, Y. Li, C.M. O'Connor, L.K. Shaw, R.M. Califf.

Provision of study materials or patients: E.D. Peterson.

Statistical expertise: K.J. Anstrom, E.D. Peterson, Y. Li, L.K. Shaw.

Obtaining of funding: S.M. Al-Khatib, R.M. Califf.

Administrative, technical, or logistic support: R.M. Califf.

Collection and assembly of data: S.M. Al-Khatib, K.J. Anstrom, Y. Li, L.K. Shaw.

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