Screening for Atrial Fibrillation by Digital Health Technology in Older People in Homecare Settings: A Feasibility Trial.

Aims: Users of homecare services are often excluded from clinical trials due to advanced age, multimorbidity, and frailty. Atrial fibrillation (AF) is a common and frequently undiagnosed arrhythmia in the elderly and is associated with severe mortality, morbidity, and healthcare costs. Timely identification prevents associated complications through evidence-based treatment. This study is aimed at assessing the feasibility of AF screening using new digital health technology in older people in a homecare setting. Methods: Users of homecare services ≥ 65 years old with at least one additional risk factor for stroke in two Norwegian municipalities were assessed for study participation by nurses. Participants performed a continuous prolonged ECG recording using a patch ECG device (ECG247 Smart Heart Sensor). Results: A total of 144 individuals were assessed for study participation, but only 18 (13%) were included. The main reasons for noninclusion were known AF and/or anticoagulation therapy (25%), severe cognitive impairment (26%), and lack of willingness to participate (36%). The mean age of participants performing the ECG test was 81 (SD ± 7) years, and 9 (50%) were women. All ECG tests were interpretable; the mean ECG monitoring time was 104 hours (IQR 34-338 hours). AF was detected in one individual (6%). Conclusion: This feasibility study highlights the challenges of enrolling older people receiving homecare services in clinical trials. However, all included participants performed an interpretable and prolonged continuous ECG recording with a digital ECG patch device. This trial is registered with NCT04700865.

Fully digital self-screening for atrial fibrillation with patch electrocardiogram.

AIMS: Atrial fibrillation (AF) is the most common arrhythmia worldwide. The AF is associated with severe mortality, morbidity, and healthcare costs, and guidelines recommend screening people at risk. However, screening methods and organization still need to be clarified. The current study aimed to assess the feasibility of a fully digital self-screening procedure and to assess the prevalence of undetected AF using a continuous patch electrocardiogram (ECG) monitoring system. METHODS AND RESULTS: Individuals ≥65 years old with at least one additional risk factor for stroke from the general population of Norway were invited to a fully digital continuous self-screening for AF using a patch ECG device (ECG247 Smart Heart Sensor). Participants self-reported clinical characteristics and usability online, and all participants received digital feedback of their results. A total of 2118 individuals with a mean CHA2DS2-VASc risk score of 2.6 (0.9) were enrolled in the study [74% women; mean age 70.1 years (4.2)]. Of these, 1849 (87.3%) participants completed the ECG self-screening test, while 215 (10.2%) did not try to start the test and 54 (2.5%) failed to start the test. The system usability score was 84.5. The mean ECG monitoring time was 153 h (87). Atrial fibrillation was detected in 41 (2.2%) individuals. CONCLUSION: This fully digitalized self-screening procedure for AF demonstrated excellent feasibility. The number needed to screen was 45 to detect one unrecognized case of AF in subjects at risk for stroke. Randomized studies with long-term follow-up are needed to assess whether self-screening for AF can reduce the incidence of AF-related complications. CLINICAL TRIALS: NCT04700865.

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-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.