Azram Mohammad, Ahmed Noura, Leese Lucy, Brigham Matthew, Bowes Robert, Wheatcroft Stephen B, Ngantcha Marcus, Stegemann Berthold, Crowther George, Tayebjee Muzahir H
Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Great George Street, Leeds General Infirmary, Leeds LS1 3EX, UK.
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Eur Heart J Digit Health. 2021 Sep 28;2(4):643-648. doi: 10.1093/ehjdh/ztab083. eCollection 2021 Dec.
Handheld electrocardiogram (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 6L is a novel handheld ECG monitor which can produce a 6-lead ECG. In this study, we compare the 6L ECG against the 12-lead ECG.
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. Electrocardiograms from the recorders were compared by the following statistical methods: linear regression, Bland-Altman, receiver operator curve, and kappa analysis. 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 (AUC) 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).
Several parameters recorded by the Kardia 6L (QT interval in all six leads, rhythm detection, PR interval, QRS duration, and cardiac axis) perform closely to the gold standard 12-lead ECG. However, that consistency weakens for left ventricular hypertrophy, QRS amplitudes (Lead I and AVL), and ischaemic changes.
医护人员和患者越来越多地使用手持式心电图（ECG）监测仪来诊断心律失常。目前缺乏针对手持式设备与标准12导联心电图的使用验证研究。Kardia 6L是一款新型手持式ECG监测仪，可生成6导联心电图。在本研究中，我们将6L心电图与12导联心电图进行比较。
这是一项前瞻性研究，纳入了利兹教学医院国民保健服务信托基金未选定的心脏科住院患者和门诊患者。所有参与者均接受了12导联和6导联心电图检查。所有心电图参数均采用标准方法模板进行分析，以确保独立观察者之间的一致性。通过以下统计方法比较记录仪的心电图：线性回归、布兰德-奥特曼分析、受试者操作特征曲线和kappa分析。共招募了1015名患者。记录仪之间PR、QRS、心电轴的平均差异较小，受试者操作分析曲线下面积（AUC）>80%。QT和QTc（记录仪之间）的平均差异也较小，QT导联的AUC>75%，QTc导联的AUC>60%。布兰德-奥特曼分析的主要发现表明总体一致性可接受，异常值实例较少（<6%，布兰德-奥特曼分析）。
Kardia 6L记录的几个参数（所有六个导联的QT间期、心律检测、PR间期、QRS时限和心电轴）与金标准12导联心电图表现相近。然而，对于左心室肥厚、QRS波振幅（I导联和AVL导联）和缺血性改变，这种一致性会减弱。
