Journal article
A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest
Journal of the American College of Cardiology, Vol.84(6), pp.525-536
08/06/2024
DOI: 10.1016/j.jacc.2024.04.063
Abstract
For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch–wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA.
This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD.
The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d.
A total of 305 patients (mean age: 57.9 years; 30.2% female, 27.9% non-White) were enrolled, of which 290 had available device data. The clinically significant cutaneous adverse device effect rate was 2.30% (upper 1-sided 98% CI: 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d.
The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495)
Details
- Title: Subtitle
- A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest
- Creators
- John Hummel - The Ohio State University Wexner Medical CenterMahmoud Houmsse - The Ohio State University Wexner Medical CenterGery Tomassoni - Central Baptist HospitalDevi Nair - Bernard (Czechia)Jorge Romero - Brigham and Women's HospitalJoe Hargrove - Cardiology and Medicine Clinic, Little Rock, Arkansas, USAKiran Mathews - Element Science, Inc, San Francisco, California, USAAnjali B. Thakkar - University of California, San FranciscoSteven Ullery - NAMSA (France)Zubin J. Eapen - Element Science, Inc, San Francisco, California, USAUday N. Kumar - Element Science, Inc, San Francisco, California, USARoxana Mehran - Icahn School of Medicine at Mount SinaiJaved Butler - Research Institute of DallasJoseph Surber - Centricity Research, Columbus, GABruce Goldner - Northwell HealthGery Tomassoni - Central Baptist HospitalJames Stone - North Mississippi Medical CenterFaisal Wahid - ACRC Trials (EDC)/ Texas Institute of Cardiology, McKinney, TXMikhael El-Chami - Emory UniversitySteve Zweibel - Hartford HospitalBrett Atwater - Inova Fairfax HospitalKavita Krishnasamy - Piedmont Atlanta HospitalZayd Eldadah - MedStar Georgetown University HospitalDilesh Patel - TriHealthRafael Cavalcanti - Novant HealthSandeep Singh - Crystal Run HealthcareSunil Sinha - Johns Hopkins HospitalRobert Long - University of Mississippi Medical CenterRobert Pickett - Saint Thomas Research Institute, Nashville, TNChandhiran Rangaswamy - University of LouisvilleKaustubha Patil - Northwestern UniversitySteven Bailin - University of IowaCharles Joyner - Virginia Cardiovascular Specialists/Chippenham Hospital, Richmond, VATheofanie Mela - Massachusetts General HospitalJonathan Shirazi - Parkview Mirro Center for Research and InnovationGioia Turitto - Texas Health DallasRobert Gordon - NorthShore University HealthSystemLuigi Di Biase - Montefiore Medical CenterYehoshua Levine - University of Tennessee Health Science CenterJewel IDE Study Investigators
- Resource Type
- Journal article
- Publication Details
- Journal of the American College of Cardiology, Vol.84(6), pp.525-536
- DOI
- 10.1016/j.jacc.2024.04.063
- ISSN
- 0735-1097
- eISSN
- 1558-3597
- Publisher
- Elsevier Inc
- Grant note
Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll. All other authors have re-ported that they have no relationships relevant to the contents of this paper to disclose.International, Novartis, NovoNordisk, Peer View Institute for Medical Education, TERUMO Europe N.V., Vectura, VoxMedia, WebMD, IQVIA, Radcliffe, and TARSUS Cardiology. Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardio cell, Car-dior, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards, Element Sci-ence, Faraday, Foundry, G3P, Inno life, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharma-cosmos, Pharmain, Pfizer, Prolaio, Regeneron, Renibus, Roche,Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll. All other authors have re-ported that they have no relationships relevant to the contents of this paper to disclose.r International, Novartis, NovoNordisk, Peer View Institute for Medical Education, TERUMO Europe N.V., Vectura, VoxMedia, WebMD, IQVIA, Radcliffe, and TARSUS Cardiology. Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardio cell, Car-dior, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards, Element Sci-ence, Faraday, Foundry, G3P, Inno life, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharma-cosmos, Pharmain, Pfizer, Prolaio, Regeneron, Renibus, Roche,r Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll. All other authors have re-ported that they have no relationships relevant to the contents of this paper to disclose.
- Language
- English
- Date published
- 08/06/2024
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984658253802771
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