Digital Electrocardiographic Complex for Risk Stratification of Paroxysmal Atrial Fibrillation

The aim of the study was to develop and clinically test a hardware and software system capable of identifying the predictors of the hidden forms of atrial fibrillation (AF) using 12-lead ECG data in sinus rhythm.

There was developed the hardware and software system "Intecard 8.1" to assess a set of markers for atrial electrical instability by 3-5-minute ECG recordings in sinus rhythm. The markers include P-wave amplitude in lead II <0.1 mV, P-wave duration >120 ms, advanced interatrial block, the area of the biphasic P-wave terminal part <-4 mV·ms, and MVP (morphology-voltage- P-wave duration) score >3 points.The clinical testing of "Intecard 8.1" system was carried out on 120 patients with ischemic heart disease or dilated cardiomyopathy. The patients' average age was 57.9±13.1 years.

P-wave detection is a challenging task due to a low signal amplitude, noise, high error probability in atrioventricular block or T-wave and P-wave superposition in case of marked tachycardia. To improve detection, a phase transformation method was used, according to which there was studied its phase component arctg[x(n)/Rv], where x(n) - ECG signal samples, Rv - a constant. We developed an identification algorithm implemented in "Intecard 8.1" software, its clinical trials being conducted.During the 12 [6; 22] month observation period, AF episodes were recorded in 22 from 120 patients (18.3%). The patients with AF episodes exhibited a significant decrease in P-wave amplitude (p=0.029), its duration increase (p<0.001), and a significantly high MVP score (p<0.01). The MVP score with a cut-off point >3 points is of the highest prognostic significance. The area under the ROC curve AUC was 0.988 with a 95% confidence interval: 0.975-0.999 (p<0.001). The prediction model of hidden AF paroxysms has sensitivity and specificity: 92 and 89%, respectively.

The digital electrocardiographic complex "Intecard 8.1" when analyzing 3-5-minute ECG recordings with sinus rhythm enables to identify the patients with high risk or with hidden AF forms. The dynamic assessment of P-wave parameters offers an opportunity to personalize heart rhythm control in this patient cohort.