By M Azram et al
Taken directly from European Heart Journal – Digital Health
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. This prospective study compared the 6 L ECG against the 12 lead ECG.
- Unselected cardiac inpatients and outpatients
- 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.
There were 1015 patients were 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).
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.
Read full article here: https://academic.oup.com/ehjdh/advance-article/doi/10.1093/ehjdh/ztab083/6377335
Mohammad Azram, Noura Ahmed, Lucy Leese, Matthew Brigham, Robert Bowes, Stephen B Wheatcroft, Marcus Ngantcha, Berthold Stegemann, George Crowther, Muzahir H Tayebjee, Clinical Validation and Evaluation of the novel six lead handheld ECG recorder compared to the 12 lead ECG in unselected cardiology patients (EVALECG Cardio), European Heart Journal – Digital Health, 2021;, ztab083, https://doi.org/10.1093/ehjdh/ztab083