European Heart Journal publishes SCD-PROTECT study, addressing evidence gap in early SCD risk in the context of four-pillar GDMT for both NICM and MI/CAD patients

ZOLL^®, an Asahi Kasei company that manufactures medical devices and related software solutions, is highlighting the recent European Heart Journal publication of SCD-PROTECT, an independent clinical trial designed to specifically evaluate the risk of sudden cardiac death (SCD) in the early post-MI/CAD and new NICM period with four-pillar guideline-directed medical therapy (GDMT).

Key findings across 19,598 consecutive LifeVest WCD patients:¹

• There was very high utilization of four-pillar GDMT medications at discharge:
  • 81.7% of patients were on an SGLT2 inhibitor
  • 74.7% of patients were on an ARNI
  • 95.1% of patients were on a beta-blocker
  • 83.1% of patients were on an MRA
• Despite high use of GDMT, the rate of appropriate LifeVest treatments was high:
  • NICM: 6.10 appropriate treatments per 100 patient-years
  • MI/CAD: 8.64 appropriate treatments per 100 patient-years
• The rate of appropriate LifeVest treatments in SCD-PROTECT was significantly higher than treatment rates reported in ICD studies of chronic patients, indicating that results of ICD trials may not be applicable to the early period of GDMT.

“Four-pillar GDMT has shown strong outcomes, but these findings illustrate that there remains a vulnerable early period, where SCD risk remains high despite comprehensive use of GDMT therapy,” said Marat Fudim, MD, MHS, an author of the SCD-PROTECT study.

“SCD-PROTECT is a landmark study that reshapes our understanding of SCD risk in the context of modern GDMT,” Fudim continued. “These data support the LifeVest WCD as an effective tool for protecting newly diagnosed heart failure and post-MI patients with reduced EF during this high-risk window.”

SCD-PROTECT is an independent study. See the publication here and for additional details visit www.SCDProtection.com.

SCD-PROTECT adds to the body of evidence reinforcing the effectiveness of the LifeVest WCD. In this cohort of 19,598 consecutive real-world patients, median LifeVest Wear Time^® per day was 23.4 and 23.5 hours in NICM and MI/CAD patients respectively.¹ Inappropriate treatments were rare with an overall rate of 0.5% of patients.¹

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

More than one million women and men have been protected by LifeVest, the only WCD with in-network coverage for >98% of commercially covered lives.¹² For more information, visit www.LifeVestInnovation.com.

About the SCD-PROTECT Study

The study titled "Sudden cardiac death in newly diagnosed non-ischaemic or ischaemic cardiomyopathy assessed with a wearable cardioverter-defibrillator: the German nationwide SCD-PROTECT study" 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 LifeVest 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 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. Its healthcare operations include devices and systems for critical care, products and services for the manufacture of biotherapeutics, and a growing portfolio of specialty pharmaceuticals. 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 https://www.asahi-kasei.com/sustainability/.

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. 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.
5. Chung MK, Szymkiewicz SJ, Shao M, et al. Aggregate national experience with the wearable cardioverter-defibrillator: Event rates, compliance, and survival. J Am Coll Cardiol. 2010;56(3):194–203.
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.
12. Based on commercial data as of March 2025

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