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Necklace-embedded electrocardiogram for the detection and diagnosis of atrial fibrillation.


ABSTRACT:

Background

Atrial fibrillation (AF) is the major cause of stroke since approximately 25% of all strokes are of cardioembolic-origin. The detection and diagnosis of AF are often challenging due to the asymptomatic and intermittent nature of AF.

Hypothesis

A wearable electrocardiogram (ECG)-device could increase the likelihood of AF detection. The aim of this study was to evaluate the feasibility and reliability of a novel, consumer-grade, single-lead ECG recording device (Necklace-ECG) for screening, identifying and diagnosing of AF both by a cardiologist and automated AF-detection algorithms.

Methods

A thirty-second ECG was recorded with the Necklace-ECG device from two positions; between the palms (palm) and between the palm and the chest (chest). Simultaneously registered 3-lead ECGs (Holter) served as a golden standard for the final rhythm diagnosis. Two cardiologists interpreted independently in a blinded fashion the Necklace-ECG recordings from 145 patients (66 AF and 79 sinus rhythm, SR). In addition, the Necklace-ECG recordings were analyzed with an automatic AF detection algorithm.

Results

Two cardiologists diagnosed the correct rhythm of the interpretable Necklace-ECG with a mean sensitivity of 97.2% and 99.1% (palm and chest, respectively) and specificity of 100% and 98.5%. The automatic arrhythmia algorithm detected the correct rhythm with a sensitivity of 94.7% and 98.3% (palm and chest) and specificity of 100% of the interpretable measurements.

Conclusions

The novel Necklace-ECG device is able to detect AF with high sensitivity and specificity as evaluated both by cardiologists and an automated AF-detection algorithm. Thus, the wearable Necklace-ECG is a new, promising method for AF screening.

Clinical trial registration

Study was registered in the ClinicalTrials.gov database (NCT03753139).

SUBMITTER: Santala OE 

PROVIDER: S-EPMC8119818 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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<h4>Background</h4>Atrial fibrillation (AF) is the major cause of stroke since approximately 25% of all strokes are of cardioembolic-origin. The detection and diagnosis of AF are often challenging due to the asymptomatic and intermittent nature of AF.<h4>Hypothesis</h4>A wearable electrocardiogram (ECG)-device could increase the likelihood of AF detection. The aim of this study was to evaluate the feasibility and reliability of a novel, consumer-grade, single-lead ECG recording device (Necklace-  ...[more]

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