High SCA treatment rates despite contemporary GDMT in 19,000+ consecutive LifeVest® patient study

ESC Heart Failure Late Breaker: Largest single LifeVest® WCD study of NICM and MI/CAD patients shows high appropriate treatment rates during early period of contemporary GDMT

Caitlyn Doyle ZOLL Medical Corporation +1 (412) 334-4501 [email protected]

May 19, 2025 — CHELMSFORD, MASS. — ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced results from SCD-PROTECT, a nationwide analysis of LifeVest® wearable cardioverter defibrillator (WCD) patients in Germany, presented on May 18, 2025 as a late-breaking clinical trial at the European Society of Cardiology (ESC) Heart Failure 2025 conference.

Key findings across 19,598 consecutive patients:1

  • Despite high overall use of contemporary GDMT, incidences of appropriate LifeVest treatments were high in both NICM and MI/CAD patients:
    • 6.53 appropriate treatments per 100 patient-years in NICM
    • 9.18 appropriate treatments per 100 patient-years in MI/CAD
  • The rate of appropriate LifeVest treatments in SCD-PROTECT was higher than the ICD treatment rate reported in studies of chronic patients, indicating that results of ICD trials may not be applicable to the early period of GDMT.
  • Median LifeVest Wear Time® per day was 23.4 and 23.5 hours in NICM and MI/CAD patients respectively.
  • Inappropriate treatments were rare with an overall rate of 0.5% of patients.

“Most notable in this study is the high rate of SCA among LifeVest patients despite wide use of GDMT, highlighting high short-term SCD risk and the need to protect these patients,” said Peter Brady, MD, FRCP, FACC, FHRS, Vice President, Medical and Clinical Affairs for ZOLL Cardiac Management Solutions. “We should be thinking about LifeVest and GDMT as complementary approaches to manage SCD in the short-term.”

The SCD-PROTECT study adds to the body of evidence supporting LifeVest. Only LifeVest has >95% first shock success in peer-reviewed publications and real-world use,2-5 96% one-year survival data,6 and a wealth of published research covering more than 120,000 patients.2,5,7-11

“ZOLL is committed to advancing clinical research to support data-driven decision making for patients at high risk for SCD,” added Brady. “Only LifeVest has been proven safe and effective in multiple peer-reviewed studies as well as real-world experience. When sudden cardiac death is on the line, patients deserve solutions backed by rigorous evidence.”

More than one million women and men have been protected by LifeVest, the WCD that offers robust coverage for Medicare, Medicaid, veterans and commercial patients. For more information, visit www.LifeVestInnovation.com.

About the SCD-PROTECT Study

The study titled "Sudden cardiac arrest in patients with newly diagnosed non-ischemic cardiomyopathy or myocardial infarction/coronary artery disease – Nationwide analysis of more than 19,000 patients with a wearable cardioverter-defibrillator" was presented by Johann Bauersachs and is authored by David Duncker, Eloi Marijon, Marco Metra, Olivier Piot, Marat Fudim, Uwe Siebert, Norbert Frey, Lars Siegfried Maier, and Johann Bauersachs. All patients who received a WCD from December 2021 to May 2023 in Germany were included in this epidemiological, observational, multicenter study, evaluating the SCA/SCD incidence in patients with NICM or MI/CAD during the early high-risk period before an ICD is indicated. For more information, visit clinicaltrials.gov.

About ZOLL

ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit www.asahi-kasei.com/sustainability/.

1 Duncker D, Marijon E, Metra M, Piot O, Fudim M, Siebert U, Frey N, Maier LS, Bauersachs J. Sudden cardiac arrest in patients with newly diagnosed non-ischemic cardiomyopathy or myocardial infarction/coronary artery disease – Nationwide analysis of more than19.000 patients with a wearable cardioverter-defibrillator. Presented by Johann Bauersachs as Late-Breaking Clinical Trial at European Society of Cardiology Heart Failure 2025. May 18, 2025.
2 Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: Data from the prospective registry of patients using the wearable cardioverter defibrillator (WEARIT-II Registry). Circulation 2015;132(17):1613–1619.
3 Data on file, 90d0241_a01. Report of AArD Performance during 2019.
4 Data on file, 90a0061_a01_revb. Clinical Evaluation Report for LifeVest Wearable Defibrillator, Model 4000, 2021.
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6 Kutyifa V, Moss A, Klein H, et al. One-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry). Pacing Clin Electrophysiol. 2018;1–7. https://doi.org/10.1111/pace.13448.
7 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.
8 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.
9 Waessnig N, Guenther M, Quick S, et al. Experience with the wearable cardioverter-defibrillator in patients at high risk for sudden cardiac death. Circulation 2016;134:635–643.
10 Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post myocardial infarction. J Am Coll Cardiol. 2013;62(21):2000–2007.
11 Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:117–128.

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