Herz-Kreislauf-Erkrankungen und Diagnose

Comparison of Accuracy and Diagnostic Validity of a Novel Non-Invasive Electrocardiographic Monitoring Device with a Standard 3 Lead Holter Monitor and an ECG Patch over a 24 hours Period

Abstract

Barr C

Conventional 24-hour Holter monitoring is the most widely used ambulatory electrocardiographic (ECG) monitoring method to detect cardiac arrhythmias. However, such devices are cumbersome to wear, with multiple wires and patches which limit patients during daily activities.

In a study of 31 participants, we evaluated the effectiveness of QardioCore, a novel electro-cardiographic monitoring device with a convenient design without leads and patches, in generating rhythm strip data that fulfill the requirements of clinical quality and accuracy when evaluated against two comparison devices: A standard three lead Holter monitor (sub-group 1) and an ECG patch (sub-group 2), over 24-hour period.

Contrasting the ECG recordings taken with the QardioCore ECG Monitor and the comparison devices has not highlighted any differences considered clinically relevant or statistically significant. The regression analysis of the RR intervals between QardioCore and the Holter monitor and ECG patch reported a correlation of 0.95 (p<0.05) with a R-squared of 0.90. Patient gender and age did not affect the relative performance of the QardioCore ECG monitor with the two comparison devices. Within sub-group 1, the R-squared of the RR intervals between QardioCore and the Holter monitor was 0.87, while within sub-group 2, the R-squared of the RR intervals between QardioCore and the ECG patch was 0.96.

This study demonstrated that the QardioCore ECG monitor, a small, comfortable and easy to use ECG recording system, is a clinically valid tool that can be used to accurately identify rhythm disorders compared to a standard Holter monitor and ECG patch.