Digital recruitment and compliance to treatment recommendations in the Norwegian Atrial Fibrillation self-screening pilot study.

Aims: Atrial fibrillation (AF) is prevalent, undiagnosed in approximately one-third of cases, and is associated with severe complications. Guidelines recommend screening individuals at increased risk of stroke. This report evaluated the digital recruitment procedure and compliance with the follow-up recommendations in participants with screen-detected AF in the Norwegian Atrial Fibrillation self-screening pilot study. Methods and results: Norwegians ≥65 years were invited through Facebooks posts, web pages, and newspapers to participate in the study. Targeted Facebook posts promoted over 11 days reached 84 208 users and 10 582 visitors to the study homepage. This accounted for 51% of the total homepage visitors (n = 20 704). A total of 2118 (10%) of the homepage visitors provided digital consent to participate after they met the inclusion criteria. The mean (standard deviation) age of the participants was 70 (4) years, and the majority [n = 1569 (74%)] were women. A total of 1849 (87%) participants completed the electrocardiogram self-screening test, identifying AF in 41 (2.2%) individuals. Of these, 39 (95%) participants consulted a general practitioner, and 34 (83%) participants initiated anticoagulation therapy. Conclusion: Digital recruitment and inclusion in digital AF screening with a high rate of initiation of anticoagulation therapy in AF positive screening cases are feasible. However, digital recruitment and inclusion may introduce selection bias with regard to age and gender. Larger studies are needed to determine the efficacy and cost-effectiveness of a fully digital AF screening. Trial registration: Clinical trials: NCT04700865.

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.

High Diagnostic Accuracy of Long-Term Electrocardiogram Interpretation by General Practitioners.

Aims: Traditional long-term ECG monitoring systems have primarily been used by cardiologist. New remote and wearable easy-to-use devices have led to increased use of ECG recordings also outside cardiology clinics. The aims of this study were to assess the feasibility and diagnostic accuracy of interpretation of the one-lead ECG recordings from a patch ECG device (ECG247 Smart Heart Sensor system) by general practitioners (GP). Methods: Norwegian GPs were invited to digitally assess 10 long-term ECG recordings with different arrhythmias performed by the ECG247 Smart Heart Sensor system. For all ECG examinations, the presence/absence of different arrhythmias was registered. Results: A total of 40 GPs accepted the invitation and assessed all the 10 long-term ECG recordings. All the tests were assessed as interpretable by all the GPs. Arrhythmias (atrial fibrillation/flutter, supraventricular tachycardia, and ventricular tachycardia) were correctly identified in most cases, with sensitivity of 98% (95% CI 95-99%), specificity of 75% (95% CI 68-82%), and diagnostic accuracy of 89% (85-92%). Incorrect automatic system algorithm interpretations were rarely corrected by the GPs. Conclusion: GPs interpreted one-lead recordings by the ECG247 Smart Heart Sensor system with high diagnostic accuracy for common arrhythmias. However, in cases with rare arrhythmias, we recommend consulting a cardiologist to confirm the diagnosis before treatment is initiated. 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.

Heart rhythm assessment in elite endurance athletes: A better method?

Introduction: Arrhythmias also occur among elite endurance athletes. Conventional diagnostic tools for assessment of arrhythmias suffer from limited availability and usability challenges, particularly under the demanding training conditions of an elite athlete. Among endurance athletes, there is a need for out-of-hospital monitoring to enhance detection of arrhythmias under conditions that are relevant and potentially provocative of underlying pathology. The Norwegian patch ECG247 Smart Heart Sensor has been developed to simplify the assessment of heart rhythm disorders. The current study aimed to evaluate the ECG247 Smart Heart Sensor function and usability in an elite athlete environment. Methods: A total of 13 professional cyclists from the UNO-X Pro Cycling Team were examined with the ECG247 Smart Heart Sensor during training camp in Spain, December 2021. All ECG data were analyzed by cardiologists at Sorlandet Hospital Arendal, Norway. The athletes also completed a brief questionnaire registering their training (from on-bike monitoring units) and provided self-assessment of usability parameters after the test. Results: In 8 of 13 athletes (69% male, age 23 ± 4 years), two test periods were performed with different ECG patches, resulting in a total of 21 tests with continuous ECG monitoring. Average total ECG test duration per athlete was 144 ± 47 h (89 ± 24 h/patch). Athletes performed an average of 15 ± 5 training h during each test. The ECG quality from all tests was considered satisfactory for rhythm analysis-also during exercise. The reported usability of the ECG247 Smart Heart Sensor was high, and no athletes reported trouble sleeping or training with the sensor. The automatic arrhythmia algorithm reported episodes of possible arrhythmias in 5 (24%) tests; 2 atrial flutter, 2 supraventricular tachycardia and 1 bradycardia (heart rate <30/min). Manual assessment by physicians verified the episode of bradycardia but revealed normal sinus rhythm in all other tests. No false negative events were identified in over 1,800 h of ECG collection. Conclusion: The ECG247 Smart Heart Sensor allowed for high quality ECG monitoring with high usability during intensive exercise in athletes.

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.