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  • Clinical Outcomes WEARIT France
    • zoll-life-vest

    Clinical Outcomes: WEARIT France

    Multi-centered, observational study of more than 1,000 French patients evaluated WCD efficacy and patient experience in real-world setting.

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    Cardiologist sitting and talking with a LifeVest wearable cardioverter defibrillator patient

    Use of and Compliance with the Wearable Cardioverter Defibrillator with Transient Risk of Sudden Cardiac Death

    Purpose

    • This post-market, multicentric, observational national study was designed to provide contemporary real-world data on wearable cardioverter defibrillator (WCD) use, not only in terms of efficacy, but also compliance and adherence.

    Methods

    • 1,157 patient analysis across 88 French centers
      • Retrospective analysis of patients who used the WCD between May 2014 and December 2016.
      • Prospective analysis of patients fit with the WCD from January 2017 through March 2018.
    • Included patients with ischemic cardiomyopathy (82.1%), after implantable cardioverter defibrillator explant (10.3%), and before heart transplantation (7.6%).
    • All patients received systematic education session through a standardized program across France at the time of initiation of WCD therapy and were systematically enrolled in the ZOLL® online patient data management system.

     
    Graph showing patient ratings on a variety of health status statements

    Adherence to WCD and impact on perceived health status

    • The median daily WCD wear time was 23.4 hours in the overall population.
    • Overall, the use of WCD was generally positively associated with health and lifestyle benefits as shown in the table.
    Table displaying the arrhythmic events experienced, including number of patients, number of events, and event rate per 100 patient years

    Key Results

    • The sustained VT/VF event rate was high, with 3.1% of patients who had a VT/VF event of whom more than half were treated by the WCD.
    • 62% of the ventricular tachyarrhythmias occurred during the 30 first days and 38% after the 30 first days.
    • Almost all patients who received a treatment shock had their VT/VF episode successfully terminated after one treatment.
      • 1 patient required 2 shocks to terminate the arrythmia.
    • Rate of survival post shock: 100%.
      • All patients who were admitted to the hospital following an appropriate shock survived to hospital discharge.
    • There was a low occurrence of inappropriate therapy (0.7%).
    Graph showing improvement of LVEF, showing 32.5% improvement in the general population and 46.6% improvement in the ischemic population

    Results continued

    In the general population, upon termination of WCD use, EF improved in 32.5% of patients to the point that an ICD was no longer indicated, while 50.6% of patients required permanent implantation of an ICD. In the ischemic population that represented 82% of enrolled patients, 46.6% of patients had an EF improved and no longer needed an ICD.

    Conclusion

    • These findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high risk in selected patients.

    Source: Garcia R, Combes N, Defaye P, et al. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. EP Europace. 2020;23(1):73-81. doi:10.1093/europace/euaa268

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