Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients

Abstract

There are few reports on head-to-head comparisons of electrocardiogram (ECG) monitoring between adhesive single-lead and Holter devices for arrhythmias other than atrial fibrillation (AF). This study aimed to compare 24 h ECG monitoring between the two devices in patients with general arrhythmia. Twenty-nine non-AF patients with a workup of pre-diagnosed arrhythmias or suspicious arrhythmic episodes were evaluated. Each participant wore both devices simultaneously, and the cardiac rhythm was monitored for 24 h. Selective ECG parameters were compared between the two devices. Two cardiologists independently compared the diagnoses of each device. The two most frequent monitoring indications were workup of premature atrial contractions (41.4%) and suspicious arrhythmia-related symptoms (37.9%). The single-lead device had a higher noise burden than the Holter device (0.04 ± 0.05% vs. 0.01 ± 0.01%, p = 0.024). The number of total QRS complexes, ventricular ectopic beats, and supraventricular ectopic beats showed an excellent degree of agreement between the two devices (intraclass correlation coefficients = 0.991, 1.000, and 0.987, respectively). In addition, the minimum/average/maximum heart rates showed an excellent degree of agreement. The two cardiologists made coherent diagnoses for all 29 participants using both monitoring methods. In conclusion, the single-lead adhesive device could be an acceptable alternative for ambulatory ECG monitoring in patients with general arrhythmia.

Comparison Between the 24-hour Holter Test and 72-hour Single-Lead Electrocardiogram Monitoring With an Adhesive Patch-Type Device for Atrial Fibrillation Detection: Prospective Cohort Study

“…In addition, they are small and convenient to use [ 5 ]; however, one disadvantage is that most APDs can only record single-lead ECG signals. Consequently, if a patient has P waves that are low in amplitude along with the vector between the device’s electrodes, there is a possibility of misdiagnosing atrial arrhythmias, including AF [ 6 , 13 ]. However, in this study, both the Holter test and the APD showed equivalent AF detection rates during the first 24 hours.…”

“…The MC-100 has a built-in memory of 256 kilobytes, which can store ECG data for up to 2-3 minutes if it is disconnected from the smartphone. During validation of the ECG measurements using the MC-100 for the population with non-AF cardiac arrhythmias, the device showed a diagnostic performance comparable to that of a conventional Holter test [ 13 ].…”

Methodology for the nocturnal cardiac arrhythmia ancillary study of the ADVENT-HF trial in patients with heart failure with reduced ejection fraction and sleep-disordered breathing

“…In addition, distinguishing between PVC and PAC seems to be more difficult using single-lead ECG monitoring (patch monitoring) compared to three-lead ECG Holter monitoring in some cases [41] , [42] . In any event, we found excellent inter-observer agreement using single-lead ECGs from PSGs.…”

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

“…A recently developed wearable device for the detection of arrhythmia, the adhesive single-lead ECG patch (mobiCARE-MC100 TM, Seers Technology, Seongnam-si, Gyeonggi-do, Republic of Korea), which comprises a light chest patch weighing 9.2 g without any other additional parts, allows long-term continuous ECG monitoring and is relatively more comfortable than standard Holter monitoring ( Figure 2A ). In a study comparing this single-lead patch monitor and Holter by wearing them simultaneously for 24 h, most patients did not feel discomfort with single-lead patch monitor ( 17 ). Based on these results, it is thought that the single-lead patch was more comfortable than the Holter.…”

“…Furthermore, this device has an advantage in terms of signal accuracy because it has excellent ability to remove motion artifacts that may be mistaken for a heartbeat. According to a comparative study where a Holter monitor and the abovementioned single-lead ECG patch were simultaneously attached to non-arrhythmic patients, the intraclass correlation coefficients for total QRS complexes, ventricular ectopic beats, and supraventricular ectopic beats of the two devices were 0.991, 0.999, and 0.966, indicating that the performance of the two devices did not differ significantly ( 17 ).…”