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Heart Failure2018New England Journal of Medicine

VEST

Vest Prevention of Early Sudden Death Trial

Sample Size
2,302
Study Design
Multicenter, randomized, unblinded, controlled trial
Year Published
2018
Category
Heart Failure

Clinical Question

Does a wearable cardioverter-defibrillator (WCD) reduce arrhythmic death in patients with a reduced ejection fraction early after myocardial infarction?

Population

Patients within 7 days of acute myocardial infarction with an LVEF ≤35% at 108 sites in the United States, Europe, and India.

Intervention

Wearable cardioverter-defibrillator (LifeVest WCD 4000) plus guideline-directed medical therapy

Control

Guideline-directed medical therapy alone

Primary Endpoint

Sudden death or death from ventricular tachyarrhythmia at 90 days

Key Findings

1

The primary endpoint of arrhythmic death occurred in 1.6% of WCD patients vs 2.4% of control patients (relative risk reduction 35.5%; p=0.18).

2

All-cause mortality was significantly lower in the WCD group (3.1% vs 4.9%; relative risk reduction 36%; p=0.04).

3

The WCD delivered appropriate shocks in 1.4% of patients and inappropriate shocks in 0.6% of patients.

4

Device compliance was suboptimal: median daily wear time was 18.0 hours among WCD patients, with 10.7% of patients not wearing the device at all.

5

Most sudden deaths in the WCD group occurred when patients were not wearing the device.

Impact on Clinical Practice

VEST addressed a critical clinical gap: the vulnerability period for sudden cardiac death in the first 90 days after myocardial infarction, before patients meet guideline criteria for a permanent implantable cardioverter-defibrillator (ICD). Current guidelines mandate a 40-90 day waiting period before ICD implantation to allow for potential LV recovery. While the primary endpoint was not statistically significant, the trial revealed important clinical insights. The reduction in all-cause mortality suggested a potential benefit, but the failure to reach significance on arrhythmic death was likely driven by poor device compliance. Many of the sudden deaths in the WCD group occurred when patients were not wearing the device. VEST highlighted the real-world challenges of wearable therapy, where patient adherence significantly impacts outcomes. It also reinforced the high-risk nature of the early post-MI period and the need for close monitoring and optimization of medical therapy in patients with newly reduced ejection fractions.

Guideline Impact

VEST informed the 2018 ACC/AHA/HRS guideline update, which gave a Class IIb recommendation for WCD in selected patients with newly diagnosed LV dysfunction at risk for sudden cardiac death when ICD implantation is not yet indicated.

Limitations

The primary endpoint did not reach statistical significance, making the mortality benefit a secondary finding that requires cautious interpretation.

Suboptimal device compliance (median 18 hours/day) likely diluted the treatment effect and limits conclusions about WCD efficacy when worn consistently.

Unblinded design may have influenced clinical management differently between groups.

Reviewed by Rahul R. Handa, MD
Cardiovascular & Thoracic Surgeon

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