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  • LifeVest
  • Takeaways from HRS 2026

    • Defining sudden cardiac death risk and wearable defibrillator performance: Takeaways from HRS 2026

    At Heart Rhythm 2026, the latest research was highlighted around newly diagnosed heart failure patients with reduced ejection fraction (HFrEF), including outcomes during the early period of four-pillar guideline directed medical therapy (GDMT).  

     
    Chart showing medical therapy rates at discharge

    Sudden Cardiac Death (SCD) Risk from Two Major Studies

    SCD-PROTECT, a nationwide epidemiological, observational study of nearly 20,000 consecutive LifeVest WCD patients, evaluated the risk of SCD during the early phase of GDMT initiation in newly diagnosed NICM and MI/CAD patients. Four-pillar GDMT use was widespread in both populations (figure 1).1  

     
    Graph showing cumulative SCA and SCD incidence per 100 patient-years in NICM and MI patients

    Despite the use of GDMT, the cumulative incidence of SCA/SCD was high, at 6.10 events per 100 patient-years (NICM) and 8.64 events per 100 patients-years (MI/CAD) (figure 2).1 Results were reported in 100 patient-years to allow comparison to trials covering chronic patient populations. Study authors concluded the incidence of SCA/SCD per 100 patient-years was considerably higher than seen in ICD trials in chronic HFrEF patients.1 These results were validated with an additional study of 20,000 patients presented at AHA 2025, which confirmed this high rate of SCD in a WCD patient population.2  

     

    Measures for WCD Comfort and Safety

    In SCD-PROTECT, secondary outcomes were determined to evaluate WCD performance across a large, consecutive patient population. Patients in the study were prescribed a modern version of the LifeVest wearable cardioverter defibrillator.

    The device was well tolerated by patients with a median wear time of 23.4 hours per day (MI/CAD) and 23.5 hours per day (NICM) respectively over 62 days of median wear.1 Inappropriate treatments were experienced in 0.5% of patients, the lowest rate reported in contemporary WCD literature.1 Patients also experienced an extremely low rate of discontinuation due to skin irritation (0.3% of patients).1

    Dr. Peter Brady, Chief Medical Officer for ZOLL Cardiac Management Solutions explained, "Compliance is one straightforward way to measure comfort. The modern LifeVest is informed by 20+ years of continuous innovation designed to optimize comfort and usability without compromising safety or efficacy. That commitment bears out in real-world and peer-reviewed data showing effective SCD treatment with high compliance and low inappropriate treatments."

    LifeVest Garment

    Real World Outcomes of WCD Innovations

    ZOLL has introduced numerous innovations and education initiatives into the WCD category to enhance the patient experience and optimize wear times. 

    Three generations of garment innovations over the past five years have delivered the most comfortable LifeVest to date, preferred by patients for greater comfort and ease of use.3 The modern LifeVest includes lightweight, athleisure fabrics and the largest range of garment sizes, fitting chest measurements of 26”-56” (figure 3).

    An AI-enhanced algorithm introduced in 2018 has led to zero median false alarms at 90 days, validated in a study of 96,000 real-world patients.4

    Med Prof_LifeVest_ESC HF 2026

    Clinical results demonstrate a meaningful impact in patient outcomes. During this decade, LifeVest has delivered #1 patient compliance in real-world and peer-reviewed data, validated most recently with SCD-PROTECT (figure 4).1,5,6

    Learn more about innovations behind the modern LifeVest.

     

    References


    1. David Duncker, Eloi Marijon, Marco Metra, Olivier Piot, Marat Fudim, Uwe Siebert, Norbert Frey, Lars Siegfried Maier, Johann Bauersachs, Sudden cardiac death in newly diagnosed non-ischaemic or ischaemic cardiomyopathy assessed with a wearable cardioverter-defibrillator: the German nationwide SCD-PROTECT study, European Heart Journal, 2025;, ehaf668, https://doi.org/10.1093/eurheartj/ehaf668
    2. MedAxiom. (2025, November 10). Largest real-world study of wearable defibrillators confirms strong effectiveness and safety performance of Kestra’s ASSURE Device. MedAxiom.  https://www.medaxiom.com/news/2025/11/10/news/Largest-Real-World-Study-of-Wearable-Defibrillators-Confirms-Strong-Effectiveness-and-Safety-Performance-of-Kestra-s-ASSURE-Device/ 
    3. Data on file, 20c1184_a01. Garment Comparative Wear Test.
    4. Arkles J, Delaughter C, D’Souza B. A novel artificial intelligence based algorithm to reduce wearable cardioverter-defibrillator alarms. J Interv Cardiac Electrophysiol. 2023.  https://doi.org/10.1007/s10840-023-01497-w 
    5. 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 
    6. Data on file, 90d0258_a01. 2021 Commercial Compliance Analysis.

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