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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 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. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

SUBMITTER: Olgin JE

PROVIDER: S-EPMC6276371 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Wearable Cardioverter-Defibrillator after Myocardial Infarction.

Olgin Jeffrey E JE Pletcher Mark J MJ Vittinghoff Eric E Wranicz Jerzy J Malik Rajesh R Morin Daniel P DP Zweibel Steven S Buxton Alfred E AE Elayi Claude S CS Chung Eugene H EH Rashba Eric E Borggrefe Martin M Hue Trisha F TF Maguire Carol C Lin Feng F Simon Joel A JA Hulley Stephen S Lee Byron K BK

The New England journal of medicine 20180901 13

<h4>Background</h4>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.<h4>Methods</h4>We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or l ...[more]

PMID: 30280654

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Project description:BackgroundPatients with cardiac sarcoidosis are at increased risk of ventricular tachycardia/fibrillation.ObjectiveWe tested the hypothesis that the wearable cardioverter defibrillator can be used to mitigate the risk of sudden cardiac death among cardiac sarcoidosis patients.MethodsA retrospective review of the commercial database identified cardiac sarcoidosis patients who wore the wearable cardioverter defibrillator. Evidence for cardiac sarcoidosis diagnosis as well as demographic, co-morbidity and left ventricular ejection fraction were provided by patient clinical records. Clinical data also included daily wearable cardioverter defibrillator wear, shock treatment and survival information.ResultsThe wearable cardioverter defibrillator was worn by 46 cardiac sarcoidosis patients, 24 (52%) male. The median age was 48 years and median left ventricular ejection fraction was 30%. The wearable cardioverter defibrillator was worn a median of 23.6 hours each day. There were 11 ventricular tachycardia/fibrillation episodes occurring in 10 (22%) patients. Ventricular tachycardia/fibrillation occurred over a range of 1 to 79 days, median 24 days. First-shock success for conversion of ventricular tachycardia/fibrillation was 100%. Patient survival 24 hours after shock treatment was 100%. Follow up to determine the reason for discontinuing wearable cardioverter defibrillator use indicated that among shocked patients 7 received an implantable cardioverter defibrillator, 1 patient was admitted to the hospital ending in death 2 weeks after discontinuing wearable cardioverter defibrillator use, and 2 patients were lost to follow up. Among the not shocked patients, there were 16 who received an implantable cardioverter defibrillator while 7 achieved improved left ventricular ejection fraction.ConclusionManagement of sudden cardiac death among cardiac sarcoidosis patients was aided by the wearable cardioverter defibrillator resulting in successful termination of ventricular tachycardia/fibrillation upon delivery of shock.

Project description:Background: The wearable cardioverter-defibrillator (WCD) is available for patients at high risk for sudden cardiac death (SCD) when immediate implantable cardioverter-defibrillator (ICD) implantation is not possible or indicated. Patient selection remains challenging especially in primary prevention. Long-term data on these patients is still lacking. 153 patients were included in this study. They were prescribed the WCD between April 2012 and March 2019 at the University Medical Center, Mannheim, Germany. The mean follow-up period was 36.2 ± 15.6 months. Outcome data, including all-cause mortality, were analyzed by disease etiology and ICD implantation following WCD use. We analyzed 56 patients with ischemic cardiomyopathy, 70 patients with non-ischemic cardiomyopathy, 16 patients with prior need for ICD/CRT-D (device for cardiac resynchronization therapy with defibrillator) explanation, 8 patients with acute myocarditis and 3 patients with congenital diseases. 58% of the patients did not need ICD/CRT-D implantation after WCD use. 4% of all patients suffered from appropriate WCD shocks. 2 of these patients (33%) experienced appropriate ICD shocks after implantation due to ventricular tachyarrhythmias. Long-term follow-up shows a good overall survival. All-cause mortality was 10%. There was no significant difference between patients with or without subsequent ICD implantation (p = 0.48). Patients with ischemic cardiomyopathy numerically showed a higher long-term mortality than patients with non-ischemic cardiomyopathy (14% vs. 6%, p = 0.13) and received significantly more ICD shocks after implantation (10% of ischemic cardiomyopathy (ICM) patients versus 3% of non-ischemic cardiomyopathy (NICM) patients, p = 0.04). All patients with ventricular tachyarrhythmias during WCD use or after ICD implantation survived the follow-up period. Following WCD use, ICD implantation could be avoided in 58% of patients. Long-term follow-up shows good overall survival. The majority of all patients did not suffer from WCD shocks nor did receive ICD shocks after subsequent implantation. Patient selection regarding predictive conditions on long-term risk of ventricular tachyarrhythmias needs further risk stratification.

Project description:The wearable cardioverter-defibrillator (WCD) has a built-in accelerometer, which allows tracking of patients' physical activity by remote monitoring. It is unclear whether WCD-measured physical activity, step count, and heart rate correlate with established tools for the assessment of cardiopulmonary fitness such as the 6-min walk test (6MWT). To correlate measurements of patient physical activity through the WCD with a supervised 6MWT during in-patient cardiac rehabilitation (CR) and to allow their use as surrogate parameters of cardiopulmonary fitness in an out-patient setting. Consecutive patients with a history of WCD use treated at our center and an in-patient CR following an index hospitalization were included. Baseline characteristics, measurements of WCD accelerometer (median daily step count, median daily activity level), median daily heart rate, and clinically supervised 6MWT at admission and discharge of CR were obtained. Forty-one patients with a mean age of 55.5 (±11.5) years were included. Thirty-five patients (85.4%) were male and 28 patients (68%) had a primary prophylactic WCD-indication. The most common underlying heart diseases were ischemic heart disease (24 patients 58.6%) and dilated cardiomyopathy (13 patients, 31.7%). Median CR duration was 20 (IQR 19.75-26.25) days. 6MWT distance increased from a mean of 329 m (±107) to 470 m (±116) during CR (p < 0.0001). The median daily step count and activity level increased significantly, from 5542 steps (IQR 3718-7055) to 8778 (IQR 6229-12,920, p < 0.0001) and median 117 × 106 (IQR 96 × 106-142 × 106) threshold value exceedance (TVE) to 146 × 106 TVE (IQR 110 × 106-169 × 106, p < 0.0001), respectively. The median heart rate was 74.9 bpm (IQR 65.8-84.5) and 70.2 (IQR 64.1-77.3, p = 0.09) at admission and discharge, respectively. Of all three parameters, median daily step count showed the best correlation to the results of the 6MWT at admission and discharge (r = 0.32, p = 0.04 and 0.37, p = 0.02, respectively). Remote monitoring of median daily step count as assessed by the WCD's accelerometer showed positive correlation with the 6MWT and could serve as a surrogate for cardiopulmonary exercise capacity. Assessment of daily step count and activity level measured remotely by the WCD could help to tailor optimal exercise instruction for patients not attending CR.

Dataset Information

Wearable Cardioverter-Defibrillator after Myocardial Infarction.

Publications

Wearable Cardioverter-Defibrillator after Myocardial Infarction.

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