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Meta-Analysis
. 2019 Feb;5(2):152-161.
doi: 10.1016/j.jacep.2018.11.011. Epub 2019 Jan 30.

Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis

Affiliations
Meta-Analysis

Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis

Ahmad Masri et al. JACC Clin Electrophysiol. 2019 Feb.

Abstract

Objectives: This study sought to synthesize the available evidence on the use of the wearable cardioverter-defibrillator (WCD).

Background: Observational WCD studies for the prevention of sudden cardiac death have provided conflicting data. The VEST (Vest Prevention of Early Sudden Death) trial was the first randomized controlled trial (RCT) showing no reduction in sudden cardiac death as compared to medical therapy only.

Methods: We searched PubMed, EMBASE, and Google Scholar for studies reporting on the outcomes of patients wearing WCDs from January 1, 2001, through March 20, 2018. Rates of appropriate and inappropriate WCD therapies were pooled. Estimates were derived using DerSimonian and Laird's method.

Results: Twenty-eight studies were included (N = 33,242; 27 observational, 1 RCT-WCD arm). The incidence of appropriate WCD therapy was 5 per 100 persons over 3 months (95% confidence interval [CI]: 3.0 to 6.0, I2 = 93%). In studies on ischemic cardiomyopathy, the appropriate WCD therapy incidence was lower in the VEST trial (1 per 100 persons over 3 months; 95% CI: 1.0 to 2.0) as compared with observational studies (11 per 100 persons over 3 months; 95% CI: 11.0 to 20.0; I2 = 93%). The incidence of inappropriate therapy was 2 per 100 persons over 3 months (95% CI: 1.0 to 3.0; I2 = 93%). Mortality while wearing WCD was rare at 0.7 per 100 persons over 3 months (95% CI: 0.3 to 1.7; I2 = 94%).

Conclusions: The rate of appropriately treated WCD patients over 3 months of follow-up was substantial; higher in-observational studies as compared with the VEST trial. There was significant heterogeneity. More RCTs are needed to justify continued use of WCD in primary prevention.

Keywords: death; meta-analysis; shock; systematic review; wearable cardioverter-defibrillator.

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Conflict of interest statement

Conflict of interest: Samir Saba has research support from Medtronic and Boston Scientific. Sandeep Jain and Evan Adelstein have research support from Medtronic. Other co-authors have no conflict of interest to declare.

Figures

Figure 1.
Figure 1.
Pooled incidence rate per 1 person over 3 months of appropriately treated patients while wearing the wearable cardioverter-defibrillator. The vertical line represents the summary pooled estimate across all studies shown. Multiply rate by a 100 to get incidence rate per 100 persons over 3 months. ICMP: ischemic cardiomyopathy; NICMP: non-ischemic cardiomyopathy; mixed: mixed indication for the wearable cardioverter-defibrillator; CI: confidence interval. Event rates could not be estimated for studies with zero events (Bhaskaran 2015, Kao 2012, Saltzberg 2012 PPCMP), thus, these studies did not contribute to the pooled estimate within each outcome.
Figure 2.
Figure 2.
Pooled incidence rate per 1 person over 3 months of appropriately and inappropriately treated patients, appropriate and inappropriate shock, failed shock, and death while wearing the wearable cardioverter-defibrillator, stratified by type of cardiomyopathy into ischemic cardiomyopathy, non-ischemic cardiomyopathy, and mixed indications. Multiply rate by a 100 to get incidence rate per 100 persons over 3 months. Rx: treatment; ICMP: ischemic cardiomyopathy; NICMP: non-ischemic cardiomyopathy; mixed: mixed indication for the wearable cardioverter-defibrillator; WCD: wearable cardioverter-defibrillator; CI: confidence interval; n_studies: number of studies included; n_cases: total number of events in the included studies.
Figure 3.
Figure 3.
Pooled incidence rate per 1 person over 3 months of appropriately and inappropriately treated patients, appropriate and inappropriate shock, failed shock, and death while wearing the wearable cardioverter-defibrillator, stratified by primary prevention, secondary prevention, and internal cardioverter-defibrillator explant. Multiply rate by a 100 to get incidence rate per 100 persons over 3 months. Rx: treatment; prev: prevention; ICD: internal cardioverter-defibrillator; WCD: wearable cardioverter-defibrillator; CI: confidence interval; n_studies: number of studies included; n_cases: total number of events in the included studies.

References

    1. https://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.Pdf. Accessed Nov 13th, 2018.
    1. Al-Khatib SM, Stevenson WG, Ackerman MJ et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation 2017. - PubMed
    1. Barraud J, Pinon P, Laine M et al. Ventricular Arrhythmia Occurrence and Compliance in Patients Treated With the Wearable Cardioverter Defibrillator Following Percutaneous Coronary Intervention. Heart Lung Circ 2017. - PubMed
    1. Barsheshet A, Kutyifa V, Vamvouris T et al. Study of the wearable cardioverter defibrillator in advanced heart-failure patients (SWIFT). J Cardiovasc Electrophysiol 2017;28:778–784. - PubMed
    1. Beiert T, Malotki R, Kraemer N et al. A real world wearable cardioverter defibrillator experience - Very high appropriate shock rate in ischemic cardiomyopathy patients at a European single-center. J Electrocardiol 2017;50:603–609. - PubMed

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