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.
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
IntroductionArrhythmias 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.MethodsA 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.ResultsIn 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.ConclusionThe ECG247 Smart Heart Sensor allowed for high quality ECG monitoring with high usability during intensive exercise in athletes.
BackgroundPoor adherence to guideline recommendations for anticoagulation in patients with acute myocardial infarction (MI) and atrial fibrillation (AF) is previously reported. The aim of the present cohort study was to assess time trends in prescription of anticoagulation therapy in a nationwide registry-based cohort of patients with acute MI and AF.MethodsAll patients, registered in the Norwegian Myocardial Infarction Registry (NORMI) between 2013 and 2019 with ECG-verified AF at hospitalisation, were included in the cohort study. The primary outcome was the prescription rate of anticoagulation therapy at hospital discharge and follow-up through 2019.ResultsAF was observed in 8565 (10.9% of 78369) patients registered in the NORMI from 2013 through 2019. The congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65–75, and sex (female) score was ≥2 in 7845 (92%) of the hospitalised patients with AF, and in 7174 (96%) of 7440 patients discharged alive. Only 3704 (47.2%) of these patients were treated with anticoagulation prior to the MI. The prescription rate of anticoagulation therapy at discharge was 55% in 2013, increasing to 78% in 2019 (annual per cent change 6.0 (95% CI 0.7 to 11.6)). Patients prescribed anticoagulation therapy had reduced risk of all types of stroke or death at follow-up compared with patients without prescription of anticoagulation therapy (multivariate-adjusted HR 0.8, 95% CI 0.7 to 0.8, p<0.001).ConclusionsThe prescription rate of anticoagulation therapy in patients with MI and AF increased during the study period, but many patients were still undertreated with respect to stroke prevention.
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