article156

VEST

"Wearable Cardioverter-Defibrillator after Myocardial Infarction"
The New England Journal of Medicine.
Article DOI: N/A
ClinicalTrials.gov number, NCT01446965.
PubMed - Full text - PDF

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 Outcomes
8.2 Secondary Outcomes
9 Criticisms
10 Funding
11 Further Reading

Clinical Question

Among patients with recent myocardial infarction and an ejection fraction of 35% or less, does a wearable cardioverter–defibrillator reduce the incidence of sudden death during the high-risk period before an implantable cardioverter-defibrillator (ICD) is indicated?

Bottom Line

In patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter–defibrillator did not significantly reduce the primary outcome of arrhythmic death compared with guideline-directed medical therapy alone during the first 90 days post-infarction.

Major Points

Guidelines

As of the last knowledge update for this summary, there were no specific guideline recommendations reflecting the trial's results regarding the wearable cardioverter–defibrillator post-myocardial infarction.

Design

Multicenter, randomized, controlled trial.

Population

2302 participants with acute myocardial infarction and an ejection fraction of 35% or less.

Inclusion Criteria
- Hospitalized with an acute myocardial infarction
- Ejection fraction of 35% or less assessed ≥8 hours after myocardial infarction or ≥48 hours after coronary-artery bypass grafting

Exclusion Criteria
- Implanted cardioverter–defibrillator or unipolar pacemaker
- Significant valve disease, long-term hemodialysis, inappropriate chest circumference for the device, pregnancy, or extended nursing facility stay

Baseline Characteristics
- Mean ejection fraction: 28%
- Majority underwent PCI during index_gpt hospitalization

Interventions

Participants randomized 2:1 to wearable cardioverter–defibrillator plus guideline-directed therapy or guideline-directed therapy alone.

Outcomes

Primary Outcomes
- Composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death)

Secondary Outcomes
- Death from any cause
- Nonarrhythmic death
- Hospitalization for various cardiac conditions

Criticisms

- Misclassification of the adjudicated cause of death may have reduced power for the primary outcome.
- Device adherence less than anticipated, potentially diminishing the power to show the wearable cardioverter–defibrillator's effectiveness.
- Primary endpoint was changed from all-cause mortality at 60 days to arrhythmic death at 90 days.
- Continued funding by device manufacturer could introduce potential bias.

Funding

National Institutes of Health and Zoll Medical. Zoll Medical had no role in trial design, data analysis, or publication decisions but did participate in site monitoring.