![]() Patient sex, date of birth, height, weight, and cardiac history were obtained through chart review. Inclusion criteria were as follows: 1) age 10-18kg, Group C) >18-32kg, and Group D) >32kg. Louis Children’s Hospital or scheduled for outpatient visits in a Pediatric Cardiology Clinic were recruited into one of two study arms: 1) ECG and pulse oximetry or 2) pulse oximetry only. Informed written consent was obtained from a parent/guardian and assent was obtained from pediatric patients ≥ 8 years of age when developmentally appropriate. Louis, a prospective study was undertaken. The aim of this study is to assess the feasibility and accuracy of the pulse oximetry estimation, ECG algorithm auto-interpretation, and ECG data from the AW6 as compared to clinical standard of care in a diverse cohort of pediatric cardiology patients.Īfter obtaining approval from the Institutional Review Board (IRB) at Washington University in St. During an oxygen saturation estimation, the watch emits red and green LED and infrared light, while photodiodes measure the amount of reflected light. Apple Watch Series 6 (AW6) is distinct from previous versions in that it also functions as a pulse oximeter to estimate blood oxygen saturation on-demand. It has been studied in adults and has received FDA clearance to detect atrial fibrillation in adults 22 years or older. The Apple Watch Series 4 and subsequent generations added the ability to obtain on-demand recording of a single lead electrocardiogram (ECG). Given the increased usage of these technologies, there has been an appropriate increase in questions of how to interpret these data in pediatric patients. In the pediatric community, there has been an increase in use of wrist-worn wearable devices, including Apple Watch and Fitbit, though the prevalence has not been rigorously quantified. Cardiac electrophysiology remains at the forefront of these technologies, with much of the testing and algorithm development focusing on adult patients with atrial fibrillation.Ĭhildren represent an important population to consider for the use of these devices, with 42% of young children owning their own tablet device and 53% of children owning a smart phone by age 11 (a number that increases to 84% by teenage years). Devices that can be purchased over the counter will undoubtedly have wide reaching consequence beyond the intended use. Each of these devices have specific indications for use and targeted use populations. This unprecedented access to data raises questions of regulation, testing, and perhaps most importantly, validity of the data. This data paves the way for further studies and use of the AW6 in medical care of pediatric patients.Ĭardiac wearable digital health devices have become common in the general population with some devices requiring physician prescription, and others being marketed direct to consumer. The AW6 pulse oximetry was accurate when compared to standard hospital pulse oximetry, but did produce some notable outliers, so this data must be used with caution and verified by medical grade pulse oximetry. We found that the AW6 produces good quality single-lead ECGs that can be accurately interpreted by pediatric cardiologists, but the watch’s automated rhythm interpretation is not reliable in children, particularly those with abnormal ECGs. This study aimed to study the AW6 ECG and pulse oximetry functions in pediatric patients with and without heart disease. Additionally, the Apple Watch Series 6 (AW6) has a function to get on-the-spot and background measurements of blood oxygen saturation which has not been studied yet. The Apple Watch Series 4 and newer have the capability to produce an on-the-spot single lead electrocardiogram (ECG) that is intended to detect atrial fibrillation in adult patients. These devices are often being used without doctor prescription or guidance so there is increasing need to understand how to interpret and use the data they provide. Wearable health devices are becoming more commonly available to the general public.
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