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
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.
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
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