Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter–defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter–defibrillator would reduce the incidence of sudden death during this high-risk period is unclear.
We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter–defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death.
Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock.
Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter–defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control.
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Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965.
Supported by grants (U01HL089458 and U01HL089145) from the National Institutes of Health and by Zoll Medical.
Dr. Olgin reports receiving consulting fees from Novartis; Dr. Morin, receiving lecture fees from Zoll Medical, Biotronik, and Medtronic and grant support from Boston Scientific; Dr. Zweibel, receiving lecture fees and consulting fees from Medtronic; Dr. Buxton, receiving grant support from Medtronic and Biosense Webster and honoraria from Boston Scientific; Dr. Chung, receiving consulting fees from AliveCor; Dr. Rashba, receiving grant support from Medtronic, Boston Scientific, St. Jude Medical, and Biotronik and lecture fees from Pfizer and Bristol-Myers Squibb; and Ms. Maguire, receiving travel support from Zoll Medical.
A complete list of the VEST investigators is provided in the Supplementary Appendix, available at NEJM.org.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Olgin, Jeffrey E.; Pletcher, Mark J.; Vittinghoff, Eric; Wranicz, Jerzy; Malik, Rajesh; Morin, Daniel P.; Zweibel, Steven; Buxton, Alfred E.; Elayi, Claude S.; Chung, Eugene H.; Rashba, Eric; Borggrefe, Martin; Hue, Trisha F; Maguire, Carol; Lin, Feng; Simon, Joel A.; Hulley, Stephen; Lee, Byron K.; and VEST Investigators, "Wearable Cardioverter-Defibrillator After Myocardial Infarction" (2018). Gill Heart & Vascular Institute Faculty Publications. 14.