Wearable Defibrillator Protects Children at Risk

Weighing less than one kilogram, the device consists of two main components: an electrode belt and vest-like garment that surround the patient’s chest, and a monitor that the patient wears around the waist. The pediatric device is intended only for children weighing at least 18 kg and with a chest size of 66 cm or more, which is about the size of an average eight year old.

The device continuously monitors the patient's heart using dry, non-adhesive sensing electrodes that detect abnormal heart rhythms. If such a life-threatening cardiac rhythm is detected, the device alerts the patient prior to delivering a shock, thus allowing a conscious patient to postpone the treatment shock. If, on the other hand, the patient is unconscious, the device releases a special gel over the therapy electrodes and delivers an electrical shock to restore normal rhythm.

The LifeVest Wearable Cardioverter Defibrillator is a product of Zoll Medical Corporation (Zoll; Chelmsford, MA, USA), and has been approved by the US Food and Drug Administration (FDA) for children who are at risk for sudden cardiac arrest, but are not candidates for an ICD due to certain medical conditions or lack of parental consent. The device was previously approved in 2001 for patients 18 years of age and older.

“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” said Vasum Peiris, MD, MPH, chief medical officer of pediatrics and special populations in the FDA Center for Devices and Radiological Health (CDRH). “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”

Ventricular fibrillation (VF) and ventricular tachycardia (VT) are life-threatening abnormal heart rhythms that are the most common cause of sudden cardiac arrest (SCA), according to the US National Heart, Lung and Blood Institute (Bethesda, MD, USA). Certain diseases and conditions that can lead to SCA include heart disease, inherited disorders, and structural changes in the heart due to infection or congenital heart disease. Most people who have SCA die from it, often within minutes. Rapid treatment with a defibrillator can save lives.

Related Links:
Zoll Medical Corporation
US National Heart, Lung and Blood Institute