The Auxiliary Diagnostic Value of a Novel Wearable Electrocardiogram-Recording System for Arrhythmia Detection: Diagnostic Trial

Background: AMAZFIT(®), a novel wearable electrocardiogram (ECG)-recording system is used for the measurement, acquisition, and storage of single-lead cardiac waveforms for adults. The aim of the study was to evaluate the accuracy of AMAZFIT(®) for diagnosing arrhythmia in older patients. Methods: From May to December 2019, we recruited 291 elderly individuals with an average age of 78±10 years old, and 41.9% women. All cardiac waveforms were obtained from the AMAZFIT(®) which included limb and chest leads. Two trained technicians reviewed all ECG data to determine cardiac rhythm using standard diagnostic criteria. We evaluated the accuracy of AMAZFIT(®) for identifying arrhythmia by comparing the sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), and positive and negative likelihood ratios with those of a standard 12-lead ECG. Results: Of the 291 participants, 197 older adults had arrhythmias, including AF (n = 119), first-degree AVB (n = 28), PACs (n = 25), and PVCs (n = 28). Three of these participants had arrhythmias of AF and PVCs. Chest lead data from 100% and limb lead data from 4.7% of the participants were analyzed. An evaluation of AMAZFIT(®) for atrial fibrillation (AF) reported a sensitivity, specificity, PPV, NPV PLR, and negative likelihood ratio (NLR) of 93.28, 95.35, 93.28, 95.35, 20.06, and 0.07%, respectively. AMAZFIT(®) also demonstrated excellent sensitivity for premature atrial contractions (PACs) (84.00%) and premature ventricular contractions (PVCs) (89.29%). However, the device demonstrated a low sensitivity for first-degree atrioventricular block (32.14%). Conclusions: The AMAZFIT(®) showed significantly higher sensitivity and specificity for AF, PACs, and PVCs. This portable ECG-recording device based on an algorithm has a potential auxiliary diagnostic value for identifying arrhythmia compared with a standard 12-lead ECG device.