Abstract
Some of the recently released smartwatch products feature a single-lead electrocardiogram (ECG) recording capability. The reliability of obtaining 3-lead ECG with smartwatches is yet to be confirmed in a large study. This study aimed to assess the feasibility and reliability of smartwatch to obtain 3-lead ECG recordings, the classical Einthoven ECG leads I-III compared to standard ECG. To record lead I, the watch was worn on the left wrist and the right index finger was placed on the digital crown for 30 s. For lead II, the watch was placed on the lower abdomen and the right index finger was placed on the digital crown for 30 s. For lead III, the same process was repeated with the left index finger. Spearman correlation and Bland-Altman tests were used for data analysis. A total of 300 smartwatch ECG tracings were successfully obtained. ECG waves’ characteristics of all three leads obtained from the smartwatch had a similar duration, amplitude, and polarity compared to standard ECG. The results of this study suggested that the examined smartwatch (Apple Watch Series 4) could obtain 3-lead ECG tracings, including Einthoven leads I, II, and III by placing the smartwatch on the described positions.
Highlights
The 12-lead electrocardiogram (ECG) is the most widely used tool for early diagnosis of heart diseases [1]
The Leipzig Apple Heart Rhythm Study is a prospective, nonrandomized, adjudicator-blinded trial aiming to confirm the feasibility and reliability of ECGs generated by smartwatches for the diagnosis of cardiac arrhythmias, which has been registered on ClinicalTrials.gov (NCT04092985)
This is not the first report on the ability of handheld ECG recorders to record leads other than lead I, the following features distinguish it from other studies: 1. This was the first study to quantitatively assess the similarity of lead I, II, and III tracings recorded by the smartwatch with those obtained from the standard ECG, and the first to show strong correlation in every three leads and no clinical difference between the values obtained for each segment
Summary
The 12-lead electrocardiogram (ECG) is the most widely used tool for early diagnosis of heart diseases [1]. Standard 12-lead ECG is a process that requires trained personnel and specialized equipment and cannot be performed without patients’ presence in health centers [2]. One of the products of these advances is handheld/wearable single-lead ECG recorders [6]. The latest development in this area is the inclusion of single-lead ECG in smartwatches, which are getting more popular every day [7]. One of the smartwatch products with this capability is the Apple Watch Series 4, which can record single-lead ECG in 30 s using two positive and negative electrodes. The Apple Watch Series 4 was the first smartwatch with the capability of single-lead ECG recording that received a de novo Food and Drug Administration (FDA) clearance in August 2018 [8]. Doubts about the quality of ECG signals generated by smartwatches and the fact that they are limited to one lead (similar to lead I) have largely limited their clinical
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