Abstract
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
Document Type
Article
Publication Date
9-27-2018
Digital Object Identifier (DOI)
https://doi.org/10.1056/NEJMoa1800781
Funding Information
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.
Related Content
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.
Repository Citation
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.
https://uknowledge.uky.edu/heart_facpub/14
Protocol
nejmoa1800781_appendix.pdf (1257 kB)
Supplementary Appendix
nejmoa1800781_disclosures.pdf (290 kB)
Disclosure Forms
Notes/Citation Information
Published in The New England Journal of Medicine, v. 379, no. 13, p. 1205-1215.
From The New England Journal of Medicine, Jeffrey E. Olgin, Mark J. Pletcher, Eric Vittinghoff, Jerzy Wranicz, Rajesh Malik, Daniel P. Morin, Steven Zweibel, Alfred E. Buxton, Claude S. Elayi, Eugene H. Chung, Eric Rashba, Martin Borggrefe, Trisha F. Hue, Carol Maguire, Feng Lin, Joel A. Simon, Stephen Hulley, and Byron K. Lee, Wearable Cardioverter–Defibrillator after Myocardial Infarction, 379, 1205-1215. Copyright © 2018 Massachusetts Medical Society. All rights reserved. Reprinted with permission.