Author + information
- Received August 23, 2018
- Revision received November 15, 2018
- Accepted November 20, 2018
- Published online January 30, 2019.
- Ahmad Masri, MDa,∗ (, )
- Ahmed M. Altibi, MDa,
- Sebhat Erqou, MD, PhDb,
- Mohammad A. Zmaili, MDa,
- Ala Saleh, MDa,
- Raed Al-Adham, MDc,
- Karam Ayoub, MDd,
- Moaaz Baghal, MDa,
- Laith Alkukhun, MDa,
- Amr F. Barakat, MDa,
- Sandeep Jain, MDa,
- Samir Saba, MDa and
- Evan Adelstein, MDe
- aHeart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- bDepartment of Medicine, Providence VA Medical Center and Alpert Medical School of Brown University, Providence, Rhode Island
- cDepartment of Medicine, University of Arizona, Phoenix, Arizona
- dDivision of Cardiology, Department of Medicine, University of Kentucky, Lexington, Kentucky
- eDivision of Cardiology, Albany Medical College, Albany, New York
- ↵∗Address for correspondence:
Dr. Masri, Division of Cardiology, Department of Medicine, University of Pittsburgh, 200 Lothrop Street, Scaife Hall, S-553, Pittsburgh, Pennsylvania 15213.
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.
Dr. Masri has received grants from the National Institutes of Health (T32HL129964-02). Dr. Saba has received research support from Medtronic and Boston Scientific. Drs. Jain and Adelstein have received research support from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received August 23, 2018.
- Revision received November 15, 2018.
- Accepted November 20, 2018.
- 2019 American College of Cardiology Foundation
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