• Mortality is high in the 90 days following an MI.
  • 1 in 20 low-EF (EF ≤ 35%) patients died in the 90 days following an MI.
• In an Intent-to-Treat (ITT) analysis¹:
  • WCD use in post-MI patients with an EF ≤35% resulted in a reduction in the sudden death endpoint, although this did not reach statistical significance at 90 days.
  • WCD use resulted in a significant reduction of 36% in total mortality (1.8% ARR; uncorrected p=0.04) at 90 days.
  • There was a low rate of inappropriate therapies at <0.6%.
• A per-protocol analysis confirms that when worn, WCD use resulted in significant reductions in sudden death and total mortality²:
  • WCD use resulted in a significant reduction of 62% in arrhythmic death (p=0.02).
  • WCD use resulted in a significant reduction of 75% in total mortality (p<0.001).
  • Among the patients who choose to wear the WCD, median use was high at >22 hours/day.

• 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.
• Investigators performed an initial intent-to-treat analysis and subsequent per-protocol analysis.

Sources:

1. Olgin JE, Pletcher MJ, Vittinghoff E, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction . N Engl J Med. 2018;379(13):1205–1215.
2. Olgin JE, Lee BK, Vittinghoff E, et al. Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses . J Cardiovasc Electrophysiol 2020;1–10. https://doi.org/10.1111/jce.14404 .