Validation and clinical use of a novel diagnostic device for screening of atrial fibrillation

Abstract

AimsPatients with asymptomatic and undiagnosed atrial fibrillation (AF) are at increased risk of heart failure and ischaemic stroke. In this study, we validated a new diagnostic device, the MyDiagnostick, for detection of AF by general practitioners and patients. It records and stores a Lead I electrocardiogram (ECG) which is automatically analysed for the presence of AF.Methods and resultsIn total, 192 patients (age 69.4 ± 12.6 years) were asked to hold the MyDiagnostick for 1 min, immediately before a routine 12-lead ECG was recorded. Atrial fibrillation detection and ECGs stored by the MyDiagnostick were compared with the cardiac rhythm on the 12-lead ECG. In a second part of the study, the MyDiagnostick was used to screen for AF during influenza vaccination in the general practitioner's office. Atrial fibrillation was present in 53 out of the 192 patients (27.6%). All AF patients were correctly detected by the MyDiagnostick (sensitivity 100%; 95% confidence interval 93–100%). MyDiagnostick AF classification in 6 out of 139 patients in sinus rhythm was considered false positive (specificity 95.9%; 95% confidence interval 91.3–98.1%). During 4 h of influenza vaccination in 676 patients (age 74 ± 7.1 years), the MyDiagnostick correctly diagnosed AF in all 55 patients (prevalence 8.1%). In 11 patients (1.6%), AF was not diagnosed before, all with a CHA2DS2VASc score of >1.ConclusionThe high AF detection performance of the MyDiagnostick, combined with the ease of use of the device, enables large screening programmes for detection of undiagnosed AF.

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…Powtarzana codzienna rejestracja EKG zwiększała szansę wykrycia niemego klinicznie, bezobjawowego napadowego AF w nieselekcjonowanej szwedzkiej populacji osób w wieku > 75 lat [120,135]. Kilka urządzeń obsługiwanych przez pacjenta [136,137] oraz przedłużone ciągłe monitorowanie EKG za pomocą rejestratorów z elektrodą przyklejaną do skóry [138] uzyskały walidację jako metody wykrywania napadowego AF (dodatkowa ryc. 1) [139].…”

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…120 Repeated daily ECG recordings increased the detection of silent, asymptomatic paroxysmal AF in an unselected Swedish population aged .75 years. 120,135 Several patient-operated devices 136,137 and extended continuous ECG monitoring using skin patch recorders 138 have been validated for the detection of paroxysmal AF (Web Figure 1). 139 The detection of asymptomatic AF by new technologies, such as smartphone cases with ECG electrodes, smart watches, and blood pressure machines with AF detection algorithms, has not yet been formally evaluated against an established arrhythmia detection method.…”

Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation

“…22 AliveCor technology is already widely used for the remote detection of AF and common arrhythmias in routine clinical practice, having several attractive features, including the quality of the trace, a validated AF reporting algorithm, remote access for clinicians over a secure server, and Health Insurance Portability and Accountability Act compliance. However, other validated technologies are available, [36][37][38][39][40] suggesting a need for comparative studies evaluating their relative effectiveness and acceptability.…”