A Flexible Multilayered Dry Electrode and Assembly to Single-Lead ECG Patch to Monitor Atrial Fibrillation in a Real-Life Scenario

The aim of this study is to propose a novel flexible dry electrode and assembly to a wearable single-lead ECG patch for continuously monitoring atrial fibrillation (AF) in a real-life scenario. Silver ink was screen-printed on a flexible polyurethane substrate to fabricate the multilayered dry electrode. A wearable recording patch with three dry electrodes was developed to collect single-lead ECG signal, particularly to provide a robust anti-artifact capability by employing a driven right leg electrode as reference. The characterization of the dry electrode based patch was quantified by combing the engineering measurement on raw signal quality and the clinical evaluation of automatical AF detection. A total of 50 patients (age 70 ± 11) were enrolled. Each patient wore one or two patches and a standard Holter simultaneously for a continuous 24 hours ECG recording in a real-life scenario. The averaged R wave peak amplitude, signal-to-noise ratio, and signal-to-artifact ratio were 0.75-1.47 mV, 3-6 dB, and 3-7, respectively. Compared with two different cardiologists' interpretations of the ECGs from dry electrodes, an offline detection algorithm automatically interpreted AF with the overall accuracy 93.57% and 85.94% during the stationary and movement states, respectively. The obtained results demonstrated the ability of using a flexible screen-printed dry electrode and assembly to a wearable patch to effectively record ECG signal in patients even disturbed by body motions, which may establish its clinical validity and applicability.