"Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction". The New England Journal of Medicine. 2002. 346(12):877-883.

Contents

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
9 Criticisms
10 Funding
11 Further Reading

Clinical Question

Does prophylactic implantation of a defibrillator improve survival among patients with a prior myocardial infarction and reduced left ventricular ejection fraction?

Bottom Line

Prophylactic implantation of a defibrillator in patients with prior myocardial infarction and a left ventricular ejection fraction of 0.30 or less improves survival.

Major Points

Guidelines

Design

- Multicenter, randomized controlled trial
- N=1232 patients with prior MI and ejection fraction ≤0.30
- Intervention: Implantable defibrillator (n=742)
- Control: Conventional medical therapy (n=490)
- Primary outcome: Death from any cause
- Follow-up: Average of 20 months

Population

Inclusion Criteria
- Prior myocardial infarction
- Left ventricular ejection fraction ≤0.30

Exclusion Criteria
- Contraindications for defibrillator
- Recent MI or revascularization
- Advanced non-cardiac diseases

Baseline Characteristics
- Similar between groups
- Medication use at last follow-up was also comparable

Interventions

- Transvenous defibrillator implantation in the intervention group
- Standard medical treatment in the control group

Outcomes

Primary Outcome
- 19.8% mortality in conventional therapy group
- 14.2% mortality in defibrillator group
- Hazard ratio for death: 0.69 (95% CI, 0.51 to 0.93; P=0.016)

Criticisms

- The incidence of heart failure requiring hospitalization was higher in the defibrillator group.
- The cost and resource implications of widespread prophylactic implantation are substantial.

Funding

The study was supported by a research grant from Guidant to the University of Rochester School of Medicine and Dentistry. Some authors disclosed financial relationships with Guidant.

Further Reading

The trial publication and relevant additional literature involve advancements in the field of cardiac electrophysiology and criteria for defibrillator implantation post-MI.