Vest Prevention of Early Sudden Death Trial - VEST
Contribution To Literature:
A WCD does not reduce SCD, but reduces all-cause mortality up to 90 days among patients with moderate to severe LV dysfunction immediately post-MI compared with controls.
Description:
The goal of the trial was to compare the efficacy of a wearable cardioverter-defibrillator (WCD) in reducing sudden cardiac death (SCD) among post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF) ≤35%.
Study Design
Immediate post-MI patients with low EF were randomized in a 2:1 fashion to either WCD + optimal medical therapy (OMT) (n = 1,524) vs. OMT alone (n = 778).
- Total number screened: 13,774
- Total number of enrollees: 2,302
- Duration of follow-up: 90 days
- Mean patient age: 61 years
- Percentage female: 27%
Inclusion criteria:
- ≤7 days of hospital discharge for acute MI
- EF ≤35% assessed:
- ≥8 hours after MI
- ≥8 hours after percutaneous coronary intervention (PCI)
- ≥48 hours after coronary artery bypass grafting (CABG)
- Existing implantable cardioverter-defibrillator (ICD)
- Significant valve disease
- Unipolar pacing system
- Chronic hemodialysis
- Chest too small/large for WCD
- Discharge to skilled nursing facility for >7 days
- Pregnancy
- Prior MI 25%, prior CHF 18%
- Mean LVEF: 28.2%
- During index MI hospitalization, PCI: 84%, thrombolytics: 8%, CABG: 1%
- Cardiac arrest/ventricular fibrillation: 10%
- Cardiogenic shock: 10%
Exclusion criteria:
Other salient features/characteristics:
Principal Findings:
The primary outcome, SCD + ventricular tachyarrhythmia death, for WCD + control, was 1.6% vs. 2.4%, p = 0.18.
Secondary outcomes:
- Nonsudden death: 1.4% vs. 2.2%, p = 0.15, including stroke death: 0% vs. 0.5%, p = 0.01
- All-cause mortality: 3.1% vs. 4.9%, p = 0.04
- All-cause rehospitalization: 31% vs. 33%, p = 0.51
In the WCD group, hours/day WCD worn: 14.1; appropriate shocks: 1.4%, inappropriate shocks: 0.6%, aborted shocks: 4.6%.
Interpretation:
The results of this trial indicate that a WCD does not reduce SCD up to 90 days among patients with moderate to severe LV dysfunction immediately post-MI compared with controls. However, there was a significant reduction in all-cause mortality with WCD use during this time frame. There was a fairly high rate of cross-over (~20%) and compliance with WCD use diminished with time. With the caveats of this being an open-label trial with a negative primary endpoint, it seems reasonable to consider WCD use among eligible patients based on the reduction observed in all-cause mortality in this trial.
It will be helpful to understand the cost-effectiveness of this strategy, as well as methods to risk-stratify the patients most likely to benefit from WCD use (e.g., patients presenting with cardiac arrest, severe LV dysfunction, nonsustained ventricular tachycardia in the hospital, etc.).
References:
Olgin JE, Pletcher MJ, Vittinghoff E, et al., on behalf of the VEST Investigators. Wearable Cardioverter–Defibrillator After Myocardial Infarction. N Engl J Med 2018;379:1205-15.
Editorial: Field ME, Page RL. Another Shock for Sudden Death Prevention After Myocardial Infarction. N Engl J Med 2018;379:1274-5.
Presented by Dr. Jeffrey E. Olgin at the American College of Cardiology Annual Scientific Session (ACC 2018), Orlando, FL, March 10, 2018.
Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and ACS
Keywords: ACC18, ACC Annual Scientific Session, Acute Coronary Syndrome, Arrhythmias, Cardiac, Coronary Artery Bypass, Cost-Benefit Analysis, Death, Sudden, Cardiac, Defibrillators, Heart Failure, Myocardial Infarction, Percutaneous Coronary Intervention, Secondary Prevention, Stroke, Stroke Volume
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