Clinical validation and evaluation of a novel six-lead handheld electrocardiogram recorder compared to the 12-lead electrocardiogram in unselected cardiology patients (EVALECG Cardio)

Abstract

Introduction Handheld ECG monitors are increasingly used by both healthcare workers and patients to diagnose cardiac arrhythmias. There is a lack of studies validating the use of handheld devices against the standard 12 lead ECG. The Kardia 6 L is a novel handheld ECG monitor which can produce a 6 lead ECG. In this study we compare the 6 L ECG against the 12 lead ECG. Methods A prospective study consisting of unselected cardiac inpatients and outpatients at Leeds Teaching Hospital NHS Trust. All participants had a 12 and 6 Lead ECGs. All ECG parameters were analysed by using a standard method template for consistency between independent observers. ECGs from the recorders were compared by the following statistical methods: linear regression, Bland Altman, receiver operator curve and kappa analysis. Results There were 1015 patients recruited. The mean differences between recorders were small for PR, QRS, cardiac axis, with receiver operator analysis area under the curve of > 80%. Mean differences for QT and QTc (between recorders) were also small, with AUCs for QT leads of > 75% and AUCs for QTc leads of > 60%. Key findings from Bland-Altman analysis demonstrate overall an acceptable agreement with few outliers instances (<6%, Bland Altman analysis). Conclusion Several parameters recorded by the Kardia 6 L (QT Interval in all six leads, rhythm detection, PR Interval, QRS duration, cardiac axis) perform closely to the gold standard 12 lead ECG. However, that consistency weakens for left ventricular hypertrophy, QRS amplitudes (Lead I & AVL) and ischaemic changes.

Clinical Validation of Automated Corrected QT-Interval Measurements From a Single Lead Electrocardiogram Using a Novel Smartwatch

“…It was more challenging for the algorithm to obtain interval measurements in abnormal ECGs, therefore impeding clinical application in patients at risk. In another study ( 6 ) using a multilead handheld device, it was shown, that QTc could be obtained by the device most frequent in lead II. Changing of the Scanwatch’s position for recording might lead to more usable data.…”

“…To obtain a SW-ECG, patients were instructed to hold the stainless steel ring on the top case of the SW continuously for 30 s. Readings from the automated SW-algorithm (HR, PR-, and QT-interval plus QTc) were recorded and a PDF-file of the 30 s single-lead (lead I) SW-ECG was saved. QT-interval on the corresponding 12-lead ECG was manually interpreted by two blinded, independent cardiologists applying the tangent-method ( 8 ), using lead II or V5/V6 as suggested in previous work ( 6 , 8 , 9 ). Bazett’s formula was used to calculate QTc ( 10 ).…”

Use of a smartphone electrocardiogram to diagnose arrhythmias during exercise in athletes: a case series

“… 10 Pilot data for the six-lead device have recently shown high levels of agreement with 12-lead ECGs in athletes for rhythm analysis, but not ischaemia. 11 , 12 …”

The Relationship between Body Composition and ECG Ventricular Activity in Young Adults

“…In addition, this ECG recording variant is useful for obtaining information on cardiac rhythm and electrical intervals for patients who have difficulty achieving the classic 12-lead ECG, such as the existence of mental health diseases [ 36 ]. In contrast, these methods are less reliable for determining left ventricular hypertrophy, QRS wave amplitudes, or ischemic changes [ 37 ].…”