Accuracy of smartphone based electrocardiogram for the detection of rhythm abnormalities in limb lead: a cross sectional study, non-randomised, single blinded and single-center study

Background: For the identification of arrhythmia and abnormal instances, researchers are examining the reliability of the interpretation offered by smartphone-based portable ECG monitors. The indicator of an unclear alteration in the electrical activity of the heart is a cardiac abnormality. As a result, its early and accurate identification can avoid myocardial infarction and even sudden cardiac death. Objectives of this study were to evaluate and validate the Spandan 12 lead ECG interpretation for accuracy in detection of the cardiac arrhythmias in comparison to the cardiologist diagnosis, and to evaluate the accuracy of the arrhythmia detection of Spandan ECG in comparison to the 12 lead ECG machine. Methods: This cross-sectional study, non-randomised, single blinded and single-center study was carried out at Shri Mahant Indresh Hospital (SMIH), Dehradun, Uttarakhand, India from 1st August 2022 to 31st January 2023. All patients (n=312) visiting the electrocardiogram (ECG) room at the department of cardiology of the SMIH, Dehradun with the prescription of ECG screening during the study period were included in the study were included in the study. Results: In total, 1528 patients with or without a history of cardiovascular disease were enrolled from outpatient and emergency departments of cardiology. A final total of 312 participants considered for accuracy of interpretation of cardiac arrhythmias detected by the standard 12 lead ECG and smartphone ECG in comparison to cardiologists’ diagnosis. Mean age (SD) was 53.90±14.52 years. The male gender (68.78%) showed the maximum frequency than female gender. True Positive cases derived from confusion matrix for 12 lead standard ECG and smartphone ECG in comparison to cardiologist diagnosis was 264 as compared to 273 from 12 lead gold standard. Sensitivity of smartphone Spandan ECG (81.23%) was comparable to gold standard 12 Lead ECG (81.49%). And, specificity, PPV and NPV of smartphone Spandan ECG was recorded to be better than gold standard 12 Lead ECG. Arrhythmia was detected correctly in 403 (70.8%) cases and 431 (61.86%) cases by smartphone ECG and 12 lead gold standards, respectively. Conclusions: Spandan ECG device scored a high accuracy and sensitivity and high specificity. The overall accuracy of smartphone ECG in detecting the rhythm abnormalities increase by 9%, the significance rises in accuracy of computer interpretation when compared to the cardiologist’s diagnosis.