Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology

Edvard Liljedahl Sandberg, Bjørnar Leangen Grenne, Trygve Berge, Jostein Grimsmo, Dan Atar, Sigrun Halvorsen, Rune Fensli, Jarle Jortveit, Edvard Liljedahl Sandberg, Bjørnar Leangen Grenne, Trygve Berge, Jostein Grimsmo, Dan Atar, Sigrun Halvorsen, Rune Fensli, Jarle Jortveit

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://ichgcp.net/clinical-trials-registry/NCT04700865.

Conflict of interest statement

ES has received speaking fees from Pfizer. BLG has received speaking fees from BMS, Pfizer. He acts as scientific advisor to Appsens AS. TB has received speaking fees from Bayer, Boehringer Ingelheim, and BMS/Pfizer. JG has received speaking fees from Bayer. DA has received speaking fees from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, MSD, Novartis, Pfizer, and Sanofi. He acts as scientific advisor to Appsens AS. SH has received speaking fees from Boehringer Ingelheim, BMS, Pfizer, and Sanofi. RF is a shareholder in Appsens AS and is employed by the company. JJ has received speaking fees from Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Novartis, Pfizer, and Sanofi. He is a shareholder in Appsens AS and is employed by the company.

Copyright © 2021 Edvard Liljedahl Sandberg et al.

Figures

Figure 1
Figure 1
The ECG247 Smart Heart Sensor system: sensor with real-time arrhythmia detection, smartphone application, back-end cloud service with postprocessing arrhythmia analyser, and web portal.
Figure 2
Figure 2
The ECG247 Smart Heart Sensor placed over the sternum, screenshots from the ECG247 mobile application, and a screenshot from the ECG247 web portal for healthcare professionals.
Figure 3
Figure 3
Parallel tests with ECG247 Smart Heart Sensor and Medilog AR4 Holter monitor.

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Source: PubMed

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