Abstract

Background Heart rhythm disorders, especially atrial fibrillation (AF), are increasing global health challenges. Conventional diagnostic tools for assessment of rhythm disorders suffer from limited availability, limited test duration time, and usability challenges. There is also a need for out-of-hospital investigation of arrhythmias. Therefore, the Norwegian ECG247 Smart Heart Sensor has been developed to simplify the assessment of heart rhythm disorders. The current study aimed to evaluate the diagnostic accuracy and usability of the ECG247 Smart Heart Sensor compared to conventional Holter monitors. Methods Parallel tests with ECG247 Smart Heart Sensor and a Holter monitor were performed in 151 consecutive patients referred for out-of-hospital long-term ECG recording at Sorlandet Hospital Arendal, Norway. All ECG data were automatically analysed by both systems and evaluated by hospital physicians. Participants were asked to complete a questionnaire scoring usability parameters after the test. Results A total of 150 patients (62% men, age 54 (±17) years) completed the study. The ECG quality from both monitors was considered satisfactory for rhythm analysis in all patients. AF was identified in 9 (6%) patients during the period with parallel tests. The diagnostic accuracy for automatic AF detection was 95% (95% CI 91–98) for the ECG247 Smart Heart Sensor and 81% (95% CI 74–87) for the Holter system. The proportion of false-positive AF was 4% in tests analysed by the ECG247 algorithm and 16% in tests analysed by the Holter algorithm. Other arrhythmias were absent/rare. The system usability score was significantly better for ECG247 Smart Heart Sensor compared to traditional Holter technology (score 87.4 vs. 67.5, p < 0.001). Conclusions The ECG247 Smart Heart Sensor showed at least comparable diagnostic accuracy for AF and improved usability compared to conventional Holter technology. ECG247 allows for prolonged monitoring and may improve detection of AF. This trial is registered with https://clinicaltrials.gov/ct2/show/NCT04700865.

Highlights

  • Heart rhythm disorders are common and may be associated with serious complications

  • One atrial fibrillation (AF) episode was missed by the Holter algorithm and by the hospital physician. is AF episode was detected by the ECG247 Smart Heart Sensor. e proportion of falsepositive tests identified as having AF was 4% (6 of 137) in tests analysed by the ECG247 algorithm and 16% (26 of 142) in tests analysed by the Holter algorithm

  • Discussion is diagnostic accuracy study included 151 parallel tests with ECG247 Smart Heart Sensor and a traditional Holter system for a mean duration of 33 hours and demonstrated at least comparable ability to detect frequent arrhythmias and significantly improved usability of the ECG247 Smart Heart Sensor compared to a conventional Holter system

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Summary

Introduction

A 12-lead electrocardiogram (ECG) is the gold standard for the diagnosis of rhythm disorders but can only provide a snapshot of the heart’s electrical signals Some frequent arrhythmias, such as atrial fibrillation (AF), may be missed due to its intermittent nature [1, 2]. Conventional diagnostic tools for assessment of rhythm disorders suffer from limited availability, limited test duration time, and usability challenges. E current study aimed to evaluate the diagnostic accuracy and usability of the ECG247 Smart Heart Sensor compared to conventional Holter monitors. E diagnostic accuracy for automatic AF detection was 95% (95% CI 91–98) for the ECG247 Smart Heart Sensor and 81% (95% CI 74–87) for the Holter system. E ECG247 Smart Heart Sensor showed at least comparable diagnostic accuracy for AF and improved usability compared to conventional Holter technology. ECG247 allows for prolonged monitoring and may improve detection of AF. is trial is registered with https://clinicaltrials.gov/ct2/ show/NCT04700865

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