VEST

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The Vest Prevention of Early Sudden Death Trial

 
Purpose

  • This randomized controlled trial was designed to study the use of the WCD and its effect on sudden death and total mortality measured at three months following myocardial infarction among patients who have ventricular dysfunction

 
Methods

  • Randomized controlled trial of 2,302 post-MI, EF ≤ 35% patients (mean age of 60.9 ± 12.6 years; mean EF of 28.2% ± 6.1%) randomized 2:1 to receive the WCD plus guideline-directed medical therapy or guideline-directed medical therapy alone
  • Inclusion criteria included post-MI patients with or without revascularization, EF ≤ 35%, and age ≥ 18 years who were enrolled within 7 days of hospital discharge
  • Primary outcome: sudden cardiac death and death due to ventricular arrhythmias at 90 days
  • Key secondary outcomes:
    • Total mortality
    • Non-sudden death (i.e. non-arrhythmic)
  • Outcomes were adjudicated through use of hospitalization records, autopsy reports, death certificates and narratives of accounts from witnesses of the events (or circumstances of last being seen). Data from the WCD were not used in the adjudication of outcomes.

 
Key Results

  • Mortality is high in the 90 days following an MI
    • 1 in 20 low-EF (EF ≤ 35%) patients die in the 90 days following an MI
  • The intention-to-treat (ITT) analysis produced the following results:
    • Reduction in sudden death, however this endpoint did not reach statistical significance
    • Reduction in total mortality by 36% (1.8% ARR; uncorrected p=0.04) at 90 days
      • Total mortality was 3.1% in the device group, as compared to 4.9% in the control group (uncorrected p=0.04)

VEST Sudden Death or Death from VT and Death from Any Cause

  • In an as-treated analysis that compared patients who chose to wear the WCD with those who did not, there was a:
    • 57% reduction in the rate of sudden death (uncorrected p=0.03) at 90 days
    • 74% reduction in the rate of total mortality (uncorrected p<.001) at 90 days
  • Wear time in the as-treated analysis was high at an average daily wear of 23.2 hours/day

VEST As Treated Analysis

 
Conclusions

  • Study results confirm that the WCD is safe and effective in protecting post-MI patients with a low ejection fraction (≤ 35%) from death
  • Post-MI patients have a high risk of mortality in the 90 days after their MI
  • The VEST Trial results underscore the need for shared decision-making conversations with patients at risk of SCD

 

Click here to read the full publication
Olgin JE, Pletcher MJ, Vittinghoff E, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018;379(13):1205–1215.

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