Key result
A wearable automated mHealth arrhythmia monitoring system using a single-lead heart belt ECG achieved 97.5% accuracy, 100% sensitivity, and 95.4% specificity for detecting atrial fibrillation.
Why the study?
AF detection is clinically challenging due to its asymptomatic and intermittent nature, and consumer-grade mHealth products could enable long-term ECG monitoring.
Does a wearable automated mHealth arrhythmia monitoring system accurately detect atrial fibrillation compared to a 3-lead Holter ECG in emergency department patients?
Observational (n=159)
Does a wearable automated mHealth arrhythmia monitoring system accurately detect atrial fibrillation compared to a 3-lead Holter ECG in emergency department patients?
A consumer-grade, single-lead ECG heart belt with AI analysis provides highly accurate detection of atrial fibrillation and is preferred by patients over traditional Holter monitoring.
Supports wearable single-lead ECG AI for AF detection in ED; extends validation data but leaves open need for prospective trials.
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. CLINICALTRIAL ClinicalTrials.gov NCT03507335; https://clinicaltrials.gov/ct2/show/NCT03507335
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Santala et al. (2021) conducted an observational in Atrial fibrillation (n=159). Wearable automated mHealth arrhythmia monitoring system (single-lead heart belt ECG) vs. 3-lead ECG (Holter) was evaluated on Accuracy of AF detection with automatic AI arrhythmia detection from the heart belt ECG recording. A wearable automated mHealth arrhythmia monitoring system using a single-lead heart belt ECG achieved 97.5% accuracy, 100% sensitivity, and 95.4% specificity for detecting atrial fibrillation.
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