Background
In healthcare systems, ECG processing software is increasingly used to expedite clinical workflow and support decision-making. As wearable ECG devices emerge as convenient, non-intrusive tools for cardiac monitoring, validating their automated outputs to ensure accuracy in diverse scenarios is imperative.
Chest strap monitors are a suitable alternative to monitoring physiologic data compared to traditional wrist-worn smartwatches due to their lightweight, unobtrusive design promoting added comfort, as well as electrodes placed firmly on the skin in proximity to the heart that leads to an increase in ECG signal clarity¹. The potential for chest strap monitors as an alternative to ambulatory Holter monitoring for arrhythmic monitoring is also emerging. Compared to traditional Holter monitors, chest strap ECG devices are significantly less expensive, making them more accessible for widespread screening and home monitoring¹.
The Challenge
While chest strap monitors can provide long-term ECG monitoring, such monitors are limited to single-lead ECG acquisition that records the heart at a singular angle. The gold standard methodology of ECG remains the 12-lead system, recording the ECG across multiple leads gives an extensive overview of the heart². Given the limitation of single-lead ECG, ensuring the accuracy of automated arrhythmia detection software within such devices is critical for reliable diagnosis.
Study Aims
B-Secur, in collaboration with Fourth Frontier³, conducted this study to evaluate the rhythm interpretation accuracy of a single-lead ECG chest strap (FX+) embedded with HeartKey Core software4.
Study Design
During the study, two consecutive sets of 2 x 30-second ECGs were acquired on 82 adult patients at an outpatient cardiology clinic. In the first set, ECGs were simultaneously recorded on the FX+ and a standard hospital 12-lead ECG, and in the second, on the FX+ alongside a KardiaMobile device (KM)5. The accuracy of automated rhythm outputs from HeartKey Core, including normal sinus rhythm (NSR), atrial fibrillation (AF), bradycardia, and tachycardia, were calculated against a cardiologist’s manual interpretation of the ECG on each of the respective devices.
Findings
Conclusions
This study has demonstrated the high accuracy of the HeartKey Core software in detecting cardiac arrhythmias when compared to a reference 12-lead ECG interpreted by a cardiologist, showcasing its utility when integrated into a chest strap monitor capable of monitoring the ECG long-term. Overall, the results highlight the promise of such form factors for arrhythmia detection when coupled with robust ECG processing software.
References
[1] Movesense (2022). 5+1 Benefits of Movesense Chest Strap ECG Monitor vs. Holter Devices. https://www.movesense.com/news/2022/06/benefits-of-movesense-chest-strap-ecg-monitor-vs-holter-devices/
[2] Etiwy M, Akhrass Z et al (2019). Accuracy of wearable heart rate monitors in cardiac rehabilitation. Cardiovascular Diagnosis and Therapy. https://cdt.amegroups.org/article/view/25572/24196
[3] Fourth Frontier. https://uk.fourthfrontier.com/
[4] H. Easlea, J. Wiseman, J. Diven, P. Joseph, S. Reddy, M. Bhushan, ID: 4116646 Clinical Validation of the Arrhythmia Detection Functionality in a Single-Lead ECG Chest Strap Device, Heart Rhythm, Volume 21, Issue 9, Supplement, 2024, Page S779, ISSN 1547-5271, https://doi.org/10.1016/j.hrthm.2024.07.050.
[5] KardiaMobile. AliveCor. https://store.alivecor.co.uk/products/kardiamobile?srsltid=AfmBOopEF8mONw_TyKUiBytj4dQcZLhNxRx34O3FXmfTYX9X8s1_gh8N