New Wearable Defibrillator Highly Successful in Preventing Sudden Cardiac Arrest with Excellent Patient Adherence: Study

The Jewel is an innovative, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) featuring a machine-learning detection algorithm aimed at enhancing both user compliance and protection against SCA.

"The innovative patch-wearable cardioverter-defibrillator is both safe and effective, with excellent patient adherence. There were no fatalities linked to non-compliance, and it achieved a high rate of successful shock conversions," the researchers wrote in the Journal of the American College of Cardiology.

For many patients, the risk of sudden cardiac arrest is heightened temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and address SCA during these critical periods. However, traditional WCDs often come with discomfort, frequent maintenance needs, and limitations such as being unsuitable for use while showering, leading to issues with compliance and preventable SCA-related deaths.

Against the above background, John Hummel, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA, and colleagues aimed to demonstrate the safety and clinical effectiveness of a novel P-WCD.

For this purpose, the researchers enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator in the Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites.

The main safety endpoint was set as less than 15% of patients experiencing clinically significant cutaneous adverse effects from the device, while the primary effectiveness endpoint was fewer than two inappropriate shocks per 100 patient months. Secondary endpoints included achieving at least one successful conversion of ventricular tachycardia or ventricular fibrillation and maintaining a wear time compliance of over 14.1 hours per day.

The following were the key findings of the study:

• Three-hundred and five patients (mean age: 57.9 years; 30.2% female) were enrolled, of which 290 had available device data.
• The clinically significant cutaneous adverse device effect rate was 2.30%; none were severe.
• There were no device-related deaths or serious adverse events.
• The inappropriate shock rate was 0.36/100 patient-months.
• Of 11 shocks in 9 patients, nine shocks were adjudicated to be appropriate.
• Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 h/d.

"This study of a new, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) successfully achieved both primary and secondary effectiveness and safety endpoints. There were no patient deaths or missed episodes that required external rescue, and the high level of patient compliance resulted in a substantial number of successful, life-saving conversions," the researchers concluded.

Reference:

Hummel, J., Houmsse, M., Tomassoni, G., Nair, D., Romero, J., Hargrove, J., Mathews, K., Thakkar, A. B., Ullery, S., Eapen, Z. J., Kumar, U. N., Mehran, R., & Butler, J. (2024). A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. Journal of the American College of Cardiology, 84(6), 525-536. https://doi.org/10.1016/j.jacc.2024.04.063