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)

    Exclusion criteria:

    • 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

    Other salient features/characteristics:

    • 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%

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:

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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