FRIDAY, Sept. 28, 2018 (HealthDay News) — Wearing a cardioverter-defibrillator does not reduce arrhythmic death in patients with acute myocardial infarction and an ejection fraction of 35 percent or less, according to a study published in the Sept. 27 issue of the New England Journal of Medicine.
Jeffrey E. Olgin, M.D., from the University of California in San Francisco, and colleagues randomized patients with acute myocardial infarction and an ejection fraction of 35 percent or less to receive wearable cardioverter-defibrillator plus guideline-directed therapy (device group) or to receive only guideline-directed therapy (control group) (1,524 and 778 patients, respectively).
The researchers found that arrhythmic death occurred in 1.6 and 2.4 percent of participants in the device and control groups, respectively (relative risk, 0.67; 95 percent confidence interval, 0.37 to 1.21; P = 0.18). Death from any cause occurred in 3.1 and 4.9 percent of participants in the device and control groups, respectively (relative risk, 0.64; 95 percent confidence interval, 0.43 to 0.98; uncorrected P = 0.04); non-arrhythmic deaths occurred in 1.4 and 2.2 percent, respectively (relative risk, 0.63; 95 percent confidence interval, 0.33 to 1.19; uncorrected P = 0.15).
“Among patients with a recent myocardial infarction and an ejection fraction of 35 percent or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control,” the authors write.
Several authors disclosed financial ties to pharmaceutical and medical device companies, including Zoll Medical, which manufactures the LifeVest used in the study and funded the study.
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