"Wearable Cardioverter-Defibrillator after Myocardial Infarction" The New England Journal of Medicine. Article DOI: N/A ClinicalTrials.gov number, NCT01446965. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
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 Outcomes 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
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?
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.
Implantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality when implanted months to years after myocardial infarction. However, ICDs are not recommended until 40 to 90 days post-infarction. The Vest Prevention of Early Sudden Death Trial (VEST) aimed to determine whether a wearable cardioverter–defibrillator could protect against sudden death during this vulnerable period.
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.
Multicenter, randomized, controlled trial.
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 hospitalization
Participants randomized 2:1 to wearable cardioverter–defibrillator plus guideline-directed therapy or guideline-directed therapy alone.
Primary Outcomes - Composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death)
- Death from any cause - Nonarrhythmic death - Hospitalization for various cardiac conditions
- 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.
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.
- Full text of the original article at NEJM.org. - ClinicalTrials.gov identifier: NCT01446965.