A new study from investigators in Finland found a single-lead ECG in a necklace could aid in diagnosis of AF.
While the phrase “wearables” often conjures images of Apple Watches and other wrist-worn devices, new research suggests an electrocardiogram (ECG) necklace could be the future of wearable diagnostics.
Using a single lead ECG, the necklace was able to produce interpretable ECG recordings that allowed clinicians to diagnose atrial fibrillation (AF) with greater than 95% sensitivity and an automatic algorithm detected AF with 94.7% specificity.
“The necklace ECG is simple to use and allows repetitive self-monitoring of heart rhythm, thereby improving the likelihood of detecting atrial fibrillation,” said investigator Elmeri Santala, a medical student at the University of Eastern Finland, in a statement. “The ESC recommends screening for atrial fibrillation in people over 65 years of age and in those at high risk of stroke; automated analysis by the necklace ECG is well suited for this purpose. Diagnosis of atrial fibrillation should always be confirmed by a physician using the ECG report.”
Highlighted as part of the European Society of Cardiology (ESC)’s EHRA Essentials 4 You, the study was performed by Santala and a team of colleagues from the Kuopio University Hospital in Finland. Using patients from the hospital’s emergency department, investigators identified 145 adult volunteers for inclusion in their study, which was designed to assess the suitability and reliability of a novel, single-lead ECG worn around the neck.
A total of 145 patients were included in the study, of which 66 had AF and 79 were in sinus rhythm, according to a diagnosis done using simultaneous 3-lead ECG performed for reference.
The ECG used in the study was embedded into a pendant on the necklace. The necklace pendant was designed to be used with a smartphone application and held either between the palms of the patient’s hands or between their palm and chest for 30 seconds.
Data gathered from the readings was sent to a cloud service and assessed for AF using an artificial intelligence algorithm. Subsequently, the application will display results and an ECG reported is generated for physicians to confirm the diagnosis.
All ECG recordings from the necklaces and 3-lead ECGs were analyzed by a pair of cardiologists who were blinded to the initial rhythm—referred to as doctor 1 and doctor 2 in the study.
Results of the analysis indicated the necklace-ECG created interpretable ECG records in 91.0% and 86.2%, according to doctor 1 and doctor 2, respectively. When analyzed by the automatic analysis service, 93.1% of recording were interpretable (98.7% of patients in sinus rhythm, 86.4% of AF patients).
When evaluating necklace-ECG recordings, sensitivity for diagnosis of AF was 98.2% for doctor 1 and 96.3% for doctor 2 while specificity was 100% for both doctors. Results from the automatic arrhythmia algorithm indicated a sensitivity of 94.7% and a specificity of 100% for diagnosing AF.
“The wearable necklace-ECG provides a new and easy method for detecting an abnormal heart rhythm called atrial fibrillation, which is a fast-growing public health problem,” Santala said, in the aforementioned statement.
This study, “Wearable ECG embedded in a necklace enables reliable detection of atrial fibrillation,” was presented as part of EHRA Essentials 4 You, a scientific platform of the ESC.