Diagnostic Value of a Wearable Continuous Electrocardiogram Monitoring Device (AT-Patch) for New-Onset Atrial Fibrillation in High-Risk Patients: Prospective Cohort Study (Preprint)

Abstract

BACKGROUND While conventional electrocardiogram (ECG) monitoring devices are useful for detecting atrial fibrillation, they have considerable drawbacks, including short monitoring duration and invasive device implantation. The use of patch-type devices circumvents these drawbacks and have shown comparable diagnostic capability for the early detection of atrial fibrillation. OBJECTIVE We aimed to determine whether a patch-type device (AT-Patch) applied to patients with a high risk of new-onset atrial fibrillation defined by the CHA2DS2-VASc score had increased detection rates. METHODS In this non-randomized multicenter prospective cohort study, we enrolled 320 adults aged ≥19 years who had never experienced atrial fibrillation and whose CHA2DS2-VASc score was ≥2. The AT-Patch was attached to each individuals for 11 days, and the data were analyzed for arrhythmic events by two independent cardiologists. RESULTS Atrial fibrillation was detected by the AT-Patch in 3.4% (11/320) of patients, as diagnosed by both cardiologists. Interestingly, when participants with or without atrial fibrillation were compared, a previous history of heart failure was significantly more common in the atrial fibrillation group (36.4% versus 5.2%, respectively, P=0.003). When a CHA2DS2-VASc score ≥4 was combined with previous heart failure, the detection rate was significantly increased to 24.4%. Comparison of the recorded ECG data revealed that supraventricular and ventricular ectopic rhythms were significantly more frequent in the new-onset atrial fibrillation group compared with non-atrial fibrillation group (3.4% versus 0.4%, P=0.001; 5.2% versus 1.2%, P<0.001), respectively. CONCLUSIONS This study detected a moderate number of new-onset atrial fibrillations in high-risk patients using the AT-Patch device. Further studies will aim to investigate the value of early detection of atrial fibrillation, particularly in patients with heart failure as a means of reducing adverse clinical outcomes of atrial fibrillation. CLINICALTRIAL ClinicalTrials.gov NCT04857268. Registered on April 22, 2021.