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

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-h...

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Autores principales:	Edvard Liljedahl Sandberg, Bjørnar Leangen Grenne, Trygve Berge, Jostein Grimsmo, Dan Atar, Sigrun Halvorsen, Rune Fensli, Jarle Jortveit
Formato:	article
Lenguaje:	EN
Publicado:	Hindawi Limited 2021
Materias:	Medicine (General) R5-920 Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/f6a1c8aaafd9461bac109b262ee8de05
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spelling	oai:doaj.org-article:f6a1c8aaafd9461bac109b262ee8de052021-11-15T01:20:04ZDiagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology2040-230910.1155/2021/5230947https://doaj.org/article/f6a1c8aaafd9461bac109b262ee8de052021-01-01T00:00:00Zhttp://dx.doi.org/10.1155/2021/5230947https://doaj.org/toc/2040-2309Background. 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.Edvard Liljedahl SandbergBjørnar Leangen GrenneTrygve BergeJostein GrimsmoDan AtarSigrun HalvorsenRune FensliJarle JortveitHindawi LimitedarticleMedicine (General)R5-920Medical technologyR855-855.5ENJournal of Healthcare Engineering, Vol 2021 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine (General) R5-920 Medical technology R855-855.5
spellingShingle	Medicine (General) R5-920 Medical technology R855-855.5 Edvard Liljedahl Sandberg Bjørnar Leangen Grenne Trygve Berge Jostein Grimsmo Dan Atar Sigrun Halvorsen Rune Fensli Jarle Jortveit Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
description	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.
format	article
author	Edvard Liljedahl Sandberg Bjørnar Leangen Grenne Trygve Berge Jostein Grimsmo Dan Atar Sigrun Halvorsen Rune Fensli Jarle Jortveit
author_facet	Edvard Liljedahl Sandberg Bjørnar Leangen Grenne Trygve Berge Jostein Grimsmo Dan Atar Sigrun Halvorsen Rune Fensli Jarle Jortveit
author_sort	Edvard Liljedahl Sandberg
title	Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
title_short	Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
title_full	Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
title_fullStr	Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
title_full_unstemmed	Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology
title_sort	diagnostic accuracy and usability of the ecg247 smart heart sensor compared to conventional holter technology
publisher	Hindawi Limited
publishDate	2021
url	https://doaj.org/article/f6a1c8aaafd9461bac109b262ee8de05
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Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology

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