Remote and wearable ECG devices with diagnostic abilities in adults: A state-of-the-science scoping review

Abstract

The electrocardiogram (ECG) records the electrical activity in the heart in real time, providing an important opportunity to detecting various cardiac pathologies. The 12-lead ECG currently serves as the "standard" ECG acquisition technique for diagnostic purposes for many cardiac pathologies other than arrhythmias. However, the technical aspects of acquiring a 12-lead ECG are not easy. and its usage currently is restricted to trained medical personnel, which limits the scope of its usefulness. Remote and wearable ECG devices have attempted to bridge this gap by enabling patients to take their own ECG using a simplified method at the expense of a reduced number of leads, usually a single-lead ECG. In this review, we summarize the studies that investigated the use of remote ECG devices and their clinical utility in diagnosing cardiac pathologies. Eligible studies discussed Food and Drug Administration-cleared, commercially available devices that were validated in an adult population. We summarize technical logistics of signal quality and device reliability, dimensional and functional features, and diagnostic value. Our synthesis shows that reduced-set ECG wearables have huge potential for long-term monitoring, particularly if paired with real-time notification techniques. Such capabilities make them primarily useful for abnormal rhythm detection, and there is sufficient evidence that a remote ECG device can be superior to the traditional 12-lead ECG in diagnosing specific arrhythmias such as atrial fibrillation. However, this review identifies important challenges faced by this technology and highlights the limited availability of clinical research examining their usefulness.

Keywords: Atrial fibrillation; Device; Diagnosis; Electrocardiogram; Remote; Wearable.

Fig. 1:. ECG acquisition method and tracing.

(a) Frontal ECG leads; (b) Precordial ECG leads acquisition methods.; (c) An example of a standard 10-second 12-lead ECG from a 60-year-old male evaluated for acute chest pain. The header of the ECG page shows global measurements of the ECG waveforms (left), diagnostic statements made by the machine and an overall automated interpretation (center), and the corresponding decision criteria (right). WCT: Wilson’s central terminal.

Fig. 2:. Commercialized remote ECG devices and their placement.

(d) the placement of the two sensors of (a), (b) and (c); (f) the placement of the three sensors of (e); (h) the placement of the three sensors of (g); (j) the placement of the sensors of (i); and (m) the placement of the sensors of (l) and (k) to record the ECG signal.

Fig. 3:. Comparison of the features of standard vs. remote ECG monitoring systems.

Fig. 4:. Summary of the diagnostic accuracy of remote ECG devices for AF detection.

This figure summarizes the reported sensitivity and specificity metrics for detecting AF using a wearable device. Error bars indicate the 95% confidence interval as reported by parent study. Metrics without error bars indicate parent study did not report such values or the independent reviewer computed these metrics from data extracted from the parent study.