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

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).

Automatic Mobile Health Arrhythmia Monitoring for the Detection of Atrial Fibrillation: Prospective Feasibility, Accuracy, and User Experience Study.

BACKGROUND: Atrial fibrillation (AF) is the most common tachyarrhythmia and associated with a risk of stroke. The detection and diagnosis of AF represent a major clinical challenge due to AF's asymptomatic and intermittent nature. Novel consumer-grade mobile health (mHealth) products with automatic arrhythmia detection could be an option for long-term electrocardiogram (ECG)-based rhythm monitoring and AF detection. OBJECTIVE: We evaluated the feasibility and accuracy of a wearable automated mHealth arrhythmia monitoring system, including a consumer-grade, single-lead heart rate belt ECG device (heart belt), a mobile phone application, and a cloud service with an artificial intelligence (AI) arrhythmia detection algorithm for AF detection. The specific aim of this proof-of-concept study was to test the feasibility of the entire sequence of operations from ECG recording to AI arrhythmia analysis and ultimately to final AF detection. METHODS: Patients (n=159) with an AF (n=73) or sinus rhythm (n=86) were recruited from the emergency department. A single-lead heart belt ECG was recorded for 24 hours. Simultaneously registered 3-lead ECGs (Holter) served as the gold standard for the final rhythm diagnostics and as a reference device in a user experience survey with patients over 65 years of age (high-risk group). RESULTS: The heart belt provided a high-quality ECG recording for visual interpretation resulting in 100% accuracy, sensitivity, and specificity of AF detection. The accuracy of AF detection with the automatic AI arrhythmia detection from the heart belt ECG recording was also high (97.5%), and the sensitivity and specificity were 100% and 95.4%, respectively. The correlation between the automatic estimated AF burden and the true AF burden from Holter recording was >0.99 with a mean burden error of 0.05 (SD 0.26) hours. The heart belt demonstrated good user experience and did not significantly interfere with the patient's daily activities. The patients preferred the heart belt over Holter ECG for rhythm monitoring (85/110, 77% heart belt vs 77/109, 71% Holter, P=.049). CONCLUSIONS: A consumer-grade, single-lead ECG heart belt provided good-quality ECG for rhythm diagnosis. The mHealth arrhythmia monitoring system, consisting of heart-belt ECG, a mobile phone application, and an automated AF detection achieved AF detection with high accuracy, sensitivity, and specificity. In addition, the mHealth arrhythmia monitoring system showed good user experience. TRIAL REGISTRATION: ClinicalTrials.gov NCT03507335; https://clinicaltrials.gov/ct2/show/NCT03507335.