Abstract
Background: A substantial proportion of cardiac arrhythmias are paroxysmal in nature, and 12-lead electrocardiography (ECG) and Holter monitoring often fail to detect paroxysmal arrhythmias. We designed and evaluated a watch-type, electrocardiograph-recording, wearable device (w-ECG) to overcome the limitations of 12-lead ECG and Holter monitoring. Methods: We prospectively enrolled 96 patients with symptoms assumed to be related to cardiac arrhythmias. Electrocardiography recording was performed with both the w-ECG and Holter monitoring. Detection of any arrhythmia was the primary outcome endpoint and was compared between the w-ECG and Holter monitoring. Results: Any arrhythmia was detected in 51 (53.1%) and 27 (28.1%) patients by the w-ECG and Holter monitoring, respectively (odds ratio (OR) = 2.9, p < 0.001). The w-ECG was superior to Holter monitoring for the detection of clinically significant arrhythmias (excluding atrial premature contraction, ventricular premature contraction, and non-sustained atrial tachyarrhythmia) (OR = 2.34, p = 0.018). In 27 (28.1%) patients, cardiac arrhythmias were detected only by the w-ECG, with atrial fibrillation being the most frequent case (13 patients). Based on ECGs recorded by using the w-ECG, 17 patients (17.7%) received therapeutic interventions, including radiofrequency catheter ablation. Conclusions: The w-ECG is capable of recording ECGs of good quality, with a discernable P wave and distinguishable QRS morphology. The ability of the w-ECG to detect cardiac arrhythmias was significantly better than that of Holter monitoring, and a significant proportion of patients received therapeutic intervention based on ECGs recorded by the w-ECG.