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

doi:10.1155/2021/5230947

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

J Healthc Eng. 2021 Nov 2:2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.

Authors

Edvard Liljedahl Sandberg¹, Bjørnar Leangen Grenne^{2

3}, Trygve Berge⁴, Jostein Grimsmo⁵, Dan Atar^{6

7}, Sigrun Halvorsen^{6

7}, Rune Fensli⁸, Jarle Jortveit¹

Affiliations

¹ Sorlandet Hospital, Department of Cardiology, Arendal, Norway.
² Clinic of Cardiology, St. Olavs Hospital, Trondheim, Norway.
³ Centre for Innovative Ultrasound Solutions and Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.
⁴ Vestre Viken Hospital Trust, Baerum Hospital, Department of Medical Research and Department of Internal Medicine, Rud, Norway.
⁵ LHL-Hospital Gardermoen, Department of Cardiac Rehabilitation, Jessheim, Norway.
⁶ Oslo University Hospital Ullevål, Department of Cardiology, Oslo, Norway.
⁷ Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
⁸ Faculty of Engineering and Science, University of Agder, Grimstad, Norway.

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Atrial Fibrillation* / diagnosis
Electrocardiography
Electrocardiography, Ambulatory*
Female
Heart Rate
Humans
Male
Middle Aged
Technology

Associated data

ClinicalTrials.gov/NCT04700865