RESUMEN
BACKGROUND: Catheter navigation and 3-dimensional (3D) cardiac mapping are essential components of minimally invasive electrophysiological procedures. OBJECTIVE: The purpose of this study was to develop a novel 3D mapping system (KODEX - EPD, EPD Solutions, Best, The Netherlands) that measures changing electric field gradients induced on intracardiac electrodes to enable catheter localization and real-time 3D cardiac mapping. METHODS: We first validated the accuracy of the system's measurement and localization capabilities by comparing known and KODEX - EPD-measured distances and locations at 12 anatomical landmarks in both the atria and ventricles of 4 swine. Next, in vivo images of 3D porcine cardiac anatomy generated by KODEX - EPD and widely used CARTO 3 system (Biosense Webster, Inc., Diamond Bar, CA) were compared with gold standard computed tomography images acquired from the same animals. Finally, 3D maps of atrial anatomy were created for 22 patients with paroxysmal atrial fibrillation (Dielectric Unravelling of Radiofrequency ABLation Effectiveness trial). RESULTS: First, the mean error between known and measured distances was 1.08 ± 0.11 mm (P < .01) and the overall standard deviation between known and measured locations in 12 areas of the porcine heart was 0.35 mm (P < .01). Second, an expert comparison of 3D image quality revealed that KODEX - EPD is noninferior to CARTO 3. Third, the system enabled 3D imaging of atrial anatomy in humans, provided real-time images of atrioventricular valves, and detected important anatomical variations in a subset of patients. CONCLUSION: The KODEX - EPD system is a novel 3D mapping system that accurately detects catheter location and can generate high-resolution images without the need for preacquired imaging, specialty catheters, or a point-by-point mapping procedure.