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Comparative Study
. 2024 Oct;33(10):1465-1474.
doi: 10.1016/j.hlc.2024.05.008. Epub 2024 Jul 8.

Accuracy of a Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias Compared Against Cardiac Electrophysiology Study

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Free article
Comparative Study

Accuracy of a Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias Compared Against Cardiac Electrophysiology Study

Samual Turnbull et al. Heart Lung Circ. 2024 Oct.
Free article

Abstract

Background: Single-lead electrocardiogram (ECG) devices may allow detection and diagnosis of cardiac rhythms. However, data on their accuracy for detecting cardiac arrhythmias beyond atrial fibrillation are limited. We aimed to determine the accuracy of the AliveCor KardiaMobile (AC) (AliveCor Inc, Mountain View, CA, USA) for the diagnosis of arrhythmias against gold standard cardiac electrophysiology study (EPS).

Method: Patients undergoing clinically indicated EPS underwent simultaneous rhythm recording with an AC, standard 12-lead ECG, and EP catheters for intracardiac electrograms. Rhythms recorded during EPS were classified based on electrogram, 12-lead ECG, and clinical findings. Blinded reviewers provided differential diagnoses for the single-lead AC tracings; a separate reviewer compared diagnoses made between the AC tracings and EPS findings.

Results: In 49 patients, 843 cardiac rhythms were captured during 502 AC recordings. Analysis of tracings containing sinus rhythm (n=273) returned an overall accuracy of 92%, with sensitivity and specificity values of 93% and 92%, respectively. Accuracy for tracings per rhythm was atrial fibrillation 91% (n=51); supraventricular tachycardia accuracy was 89% (n=191), ventricular tachycardia 91% (n=198), ventricular fibrillation 98% (n=11), and asystole 100% (n=5). Accuracy for supraventricular ectopy was 93% (n=28) and for premature ventricular complexes was 91% (n=86). Overall accuracy was 94% for solitary rhythms and 93% in tracings from patients with baseline bundle branch block.

Conclusions: When compared against the gold standard EPS diagnosis, the interpretation of arrhythmias recorded by an AliveCor single-lead ECG device had reasonable diagnostic accuracy.

Keywords: Arrhythmia; Atrial fibrillation; Electrophysiology; Single-lead ECG; Ventricular tachycardia.

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Conflict of interest statement

Conflicts of Interest No authors have financial interest in the KardiaMobile or distributor of the KardiaMobile. Dr Kumar has received funding and/or consulting fees from Abbott Medical, Biosense Webster, Biotronik and Medtronic, and has received honoraria from Abbott Medical, Biosense Webster, Biotronik, and Sanofi Aventis. Dr Mahajan has served on the advisory board of Abbott and Medtronic. The University of Adelaide reports receiving, on behalf of Dr Mahajan, research funding from Abbott, Bayer, and Medtronic, and lecture and/or consulting fees from Abbott, Bayer, Biotronik, Medtronic, and Pfizer. The remaining authors have nothing to disclose.

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