High-resolution, Real-time, and Nonfluoroscopic Three-Dimensional Cardiac Imaging and Catheter Navigation in Humans Using a Novel Dielectric-Based System.

Abstract

BACKGROUND\nCatheter navigation and 3D cardiac mapping are essential components of minimally invasive electrophysiological procedures.\n\n\nOBJECTIVE\nTo develop a novel 3D mapping system (KODEX - EPD™) that measures changing electrical field gradients induced on intracardiac electrodes to enable catheter localization and real-time three-dimensional cardiac mapping.\n\n\nMETHODS\nWe first validated the accuracy of the system s measurement and localization capabilities by comparing known versus KODEX - EPD™-measured distances and locations at 12 different anatomical landmarks in both the atria and ventricles of four swine. Next, in vivo images of 3D porcine cardiac anatomy generated by KODEX - EPD™ and the widely-used CARTO®3 were compared to gold-standard CT images acquired in the same animals. Finally, 3D maps of atrial anatomy were created in 22 patients with paroxysmal atrial fibrillation (DURABLE-I trial).\n\n\nRESULTS\nFirst, the mean error between known and measured distances was 1.08±0.11 mm (p<0.01), and the overall standard deviation between known and measured location in 12 different areas of the porcine heart was 0.35 mm (p<0.01). Second, 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.\n\n\nCONCLUSION\nThe 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.