Wearable Cardioverter–Defibrillator after Myocardial Infarction

Abstract

BACKGROUND Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindi-cated until 40 to 90 days after myocardial infarction. Whether a wearable cardio- verter-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. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965.)

Eplerenone in patients with myocardial infarction and “mid‐range” ejection fraction: An analysis from the EPHESUS trial

“…Notwithstanding, based on the findings depicted herein, MRAs could be considered in patients with a MI and an EF around 40%. The event rate reduction is marked in the first few months of therapy initiation (and may be maintained thereafter), this is of particular relevance because MRAs may reduce the risk of sudden death in this “high‐risk” post‐MI period were defibrillators are not indicated . The ongoing Colchicine and Spironolactone in Patients With STEMI/SYNERGY Stent Registry (CLEAR‐SYNERGY) trial (http://clinicaltrials.gov Identifier: NCT03048825) may help in assessing the potential effect of MRAs in patients with MI and an EF ≥ 40%.…”

Potential cost‐effectiveness of wearable cardioverter‐defibrillator for patients with implantable cardioverter‐defibrillator explant in a high‐income city of China

“…Data from the Prospective Registry of Patient Using the Wearable Defibrillator (WEARIT‐II) Registry demonstrated a high rate (3% for 3 months) of sustained ventricular tachyarrhythmia at high‐risk patients, and suggested WCD to be safe and effective in protecting patients at risk of SCA . The Vest Prevention of Early Sudden Death Trial was a recent multicenter, randomized, controlled trial, and it also demonstrated that WCD reduced all‐cause death rate when comparing to the control group without WCD (3.1% vs 4.9%; P < .05) …”

Characterization of cardiac acoustic biomarkers in patients with heart failure

“…A noninvasive monitoring strategy such as CABs that can be shown to guide medical therapies in such a manner that rehospitalizations are reduced would provide significant value to patients and to the healthcare system. In such a case, addition of CAB measurements to WCDs would provide additional incentives for patients to comply with WCD use; it comes as no surprise that compliance with WCD is key to its ability to prevent sudden cardiac death (Olgin et al, ; Reek et al, ) and limits the potential benefit for some patients.…”