Clinical Validation of ECG Image Epi-Endocardial Mapping Accuracy: Single Center Single-Blind Cross-Sectional Study

Mikhail Chmelevsky1, Margarita Budanova1, Stepan Zubarev2, Danila Potyagaylo3, Tatiana Treshkur1, Dmitry Lebedev1
1Almazov National Medical Research Centre, 2Almazov National Medical Research Center, 3EP Solutions


Abstract

Background. Although ECG imaging technology has been in development for many years, the clinical validation of epi-endocardial ECGI mapping has been performed on relatively small groups of patients. Aim. To validate epi-endocardial ECGI mapping accuracy for different pacings with implanted pacemakers in single center single-blind cross-sectional study Methods. 30 patients (median age 61 years; min-max 27-78 years, 26 male) with previously implanted pacemakers underwent epi-endocardial ECGI mapping using “Amycard 01C EP Lab” system (EP Solutions SA, Switzerland). 240-channell ECG were recorded during right endocardial and left epicardial ventricular pacings followed by torso and ECG-gated cardiac computed tomography. The data obtained from CT was imported into “Amycard 01C EP lab” software in DICOM-format to reconstruct 3D polygonal models of the torso and heart. In this study we consider both epicardial and epi-endocardial 3D models of the heart. Afterwards epi- and endocardial unipolar electrograms as well as isopotential maps were reconstructed using an iterative Tikhonov regularization algorithm. Early activation zone was determined from the isopotential maps by 3 independed investigators (2 blinded and 1 non-blinded with experience from 6 months to 5 years in ECGI). A p-value < 0.01 was considered as statistically significant. Statistical analysis was performed using Statistica v.12 (Statsoft Inc, USA). Results. The mean (SD) geodesic distance between noninvasively reconstructed and the reference pacing sites was 9 (6) mm for the LV epicardial and 12 (5) for the LV epi-endocardial models, 23 (14) for the RV epicardial and 9(4) for the RV epi-endocardial models. There was a significant difference in accuracy for LV epicardial and epi-endocardial models (p=0,007) while no difference for RV models (p=0,039). Conclusions. The study showed sufficient accuracy to use this technology in routine clinical practice for identification of focal arrhythmia sources.