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

Author:

Kwun Ju-SeungORCID,Lee Jang HoonORCID,Park Bo EunORCID,Park Jong SungORCID,Kim Hyeon JeongORCID,Kim Sun-HwaORCID,Jeon Ki-HyunORCID,Cho Hyoung-wonORCID,Kang Si-HyuckORCID,Lee WonjaeORCID,Youn Tae-JinORCID,Chae In-HoORCID,Yoon Chang-HwanORCID

Abstract

BACKGROUND

While conventional electrocardiogram monitoring devices are useful for detecting atrial fibrillation, they have considerable drawbacks, including a short monitoring duration and invasive device implantation. The use of patch-type devices circumvents these drawbacks and has 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 congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke, vascular disease, age 65-74 years, sex scale (CHA<sub>2</sub>DS<sub>2</sub>-VASc) score had increased detection rates.

METHODS

In this nonrandomized multicenter prospective cohort study, we enrolled 320 adults aged ≥19 years who had never experienced atrial fibrillation and whose CHA<sub>2</sub>DS<sub>2</sub>-VASc score was ≥2. The AT-Patch was attached to each individual for 11 days, and the data were analyzed for arrhythmic events by 2 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 (n=4/11, 36.4% vs n=16/309, 5.2%, respectively; <i>P</i>=.003). When a CHA<sub>2</sub>DS<sub>2</sub>-VASc score ≥4 was combined with previous heart failure, the detection rate was significantly increased to 24.4%. Comparison of the recorded electrocardiogram data revealed that supraventricular and ventricular ectopic rhythms were significantly more frequent in the new-onset atrial fibrillation group compared with nonatrial fibrillation group (3.4% vs 0.4%; <i>P=</i>.001 and 5.2% vs 1.2%; <i>P&lt;</i>.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; https://classic.clinicaltrials.gov/ct2/show/NCT04857268

Publisher

JMIR Publications Inc.

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