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MADIT II

Frequently Asked Questions

Prophylactic Implantable Cardioverter Defibrillator (ICD) Therapy

What were the relative and absolute all-cause mortality risk reduction figures for the MADIT II patient population?

The patient population of the MADIT II trial was assigned in a 3:2 ratio to receive Guidant implantable cardioverter defibrillator (ICD) therapy and conventional medical therapy, as directed by a physician, or conventional therapy alone. MADIT II results demonstrated a 31% relative risk reduction in the Guidant ICD therapy group.1

Were patients required to have a history of arrhythmias before participating in the trial? Was an electrophysiology (EP) study required or performed?

No. Patients were not required to have a history of arrhythmias in order to participate. A documented prior MI and an ejection fraction (EF) <30% were the only cardiac entry criteria. Nevertheless, a subpopulation of patients participating in MADIT II underwent an EP study as part of a secondary objective — namely, to determine if ventricular tachycardia (VT) induced during an EP study as part of the ICD implantation procedure is associated with a higher appropriate discharge rate during follow-up than non-inducibility.

How do the results of the MADIT II trial impact current sudden cardiac death (SCD) prevention practices?

The results of MADIT II definitively demonstrate that initializing post-myocardial infarction (MI) patients for prophylactic ICD therapy, based on an EF <30%, can significantly reduce their risk of death.1

What economic impact would increased use of ICD therapy have on US healthcare expenditures?

There is a misconception among some healthcare professionals that increased use of ICD therapy will disproportionately increase national healthcare expenditures (NHE). In fact, even if ICD therapy were to triple by 2005, it would still account for less than 1% of total NHE.2,3 When compared with other lifesaving interventions, using a standard measure of cost per life-years saved, ICD therapy has been shown to be cost-effective.4,5 One study, in fact, concluded that prophylactic ICD therapy became increasingly cost-effective when used early, as first-choice therapy in post-MI patients with VT or ventricular fibrillation (VF).6


References

  1. Moss AJ, Zareba W, Hall WJ, et al, for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
  2. HCFA National Health Expenditures Projections 2000-2010.
  3. Data on file. Guidant Corporation
  4. Kupersmith J, Holmes-Rovner M, Hogan A, Gardiner J. Cost-effectiveness analysis in heart disease, part III: ischemia, congestive heart failure, and arrhythmias. Prog Cardiovasc Dis. 1995;37:307-346.
  5. Kuppermann M, Luce BR, McGovern B, Podrid PJ, Bigger T Jr, Ruskin JN. An analysis of the cost effectiveness of the implantable defibrillator. Circulation. 1990;81:91-100.
  6. Wever EFD, Hauer RNW, Schrijvers G, et al. Cost-effectiveness of implantable defibrillator as first-choice therapy versus electrophysiologically guided, tiered strategy in postinfarct sudden death survivors: a randomized study. Circulation. 1996;93:489-496.

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