The 12-lead electrocardiogram (ECG) is a first-line diagnostic tool for patients with cardiac symptoms. As observed during the COVID-19 pandemic, the ECG is essential to the initial patient evaluation. The novel KardioPal three-lead-based ECG reconstructive technology provides a potential alternative to a standard ECG, reducing the response time and cost of treatment and improving patient comfort. Our study aimed to evaluate the diagnostic accuracy of a reconstructed 12-lead ECG obtained by the KardioPal technology, comparing it with the standard 12-lead ECG, and to assess the feasibility and time required to obtain a reconstructed ECG in a real-life scenario. A prospective, nonrandomized, single-center, adjudicator-blinded trial was conducted on 102 patients during the COVID-19 pandemic at the Dedinje Cardiovascular Institute in Belgrade. The KardioPal system demonstrated a high feasibility rate (99%), with high specificity (96.3%), sensitivity (95.8%), and diagnostic accuracy (96.1%) for obtaining clinically relevant matching of reconstructed 12-lead compared to the standard 12-lead ECG recording. This novel technology provided a significant reduction in ECG acquisition time and the need for personnel and space for obtaining ECG recordings, thereby reducing the risk of viral transmission and the burden on an already overwhelmed healthcare system such as the one experienced during the COVID-19 pandemic.
Keywords: COVID-19; electrocardiogram; medical devices; pandemic; signal processing; telemedicine.