Clinical assessment of a non-invasive wearable MEMS pressure sensor array for monitoring of arterial pulse waveform, heart rate and detection of atrial fibrillation

Abstract

There is an unmet clinical need for a low cost and easy to use wearable devices for continuous cardiovascular health monitoring. A flexible and wearable wristband, based on microelectromechanical sensor (MEMS) elements array was developed to support this need. The performance of the device in cardiovascular monitoring was investigated by (i) comparing the arterial pressure waveform recordings to the gold standard, invasive catheter recording (n = 18), (ii) analyzing the ability to detect irregularities of the rhythm (n = 7), and (iii) measuring the heartrate monitoring accuracy (n = 31). Arterial waveforms carry important physiological information and the comparison study revealed that the recordings made with the wearable device and with the gold standard device resulted in almost identical (r = 0.9-0.99) pulse waveforms. The device can measure the heart rhythm and possible irregularities in it. A clustering analysis demonstrates a perfect classification accuracy between atrial fibrillation (AF) and sinus rhythm. The heartrate monitoring study showed near perfect beat-to-beat accuracy (sensitivity = 99.1%, precision = 100%) on healthy subjects. In contrast, beat-to-beat detection from coronary artery disease patients was challenging, but the averaged heartrate was extracted successfully (95% CI: -1.2 to 1.1 bpm). In conclusion, the results indicate that the device could be useful in remote monitoring of cardiovascular diseases and personalized medicine.