Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 16, 2023
Open Peer Review Period: Jan 16, 2023 - Mar 13, 2023
Date Accepted: Aug 10, 2023
(closed for review but you can still tweet)
Diagnostic value of the AT-Patch, a wearable continuous electrocardiogram monitoring device, for new-onset atrial fibrillation in high-risk patients (ESTRENO-AF): a prospective cohort study
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. Clinical Trial: ClinicalTrials.gov NCT04857268. Registered on April 22, 2021.
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