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

  1. Sana M. Al-Khatib, MD, MHS;
  2. Kevin J. Anstrom, PhD;
  3. Eric L. Eisenstein, DBA;
  4. Eric D. Peterson, MD, MPH;
  5. James G. Jollis, MD;
  6. Daniel B. Mark, MD, MPH;
  7. Yun Li, MS;
  8. Christopher M. O'Connor, MD;
  9. Linda K. Shaw, MS; and
  10. Robert M. Califf, MD
  1. From the Duke Clinical Research Institute, Durham, North Carolina.

    Abstract

    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.

    Article and Author Information

    • 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.

    Responses to this article

    • Cost-Effectiveness of ICD therapy
      • Sana M. Al-Khatib and
      • Daniel B. Mark and Robert M. Califf
      Ann Intern Med published online October 26, 2009
    • Cost Effectiveness of Therapy With Abnormal LV Function Post-MI
      • William S Weintraub
      Ann Intern Med published online October 26, 2009
    • Defibrillators Cost Effective - Only for the Developed West !
      • Fahim H. Jafary
      Ann Intern Med published online October 26, 2009

    Summary for Patients

    • Summaries for Patients:What Are the Clinical and Economic Implications of Following MADIT-II Criteria for Surgically Implanting Automatic Cardiac Defibrillators? Ann Intern Med April 19, 2005 142:I-39
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