Accuracy assessment of catheter guidance technology in electrophysiology procedures: a comparison of a new 3D-based fluoroscopy navigation system to current electroanatomic mapping systems.

Background: With increasing complexity in electrophysiology (EP) procedures, the use of electroanatomic mapping systems (EAMS) as a supplement to fluoroscopy has become common practice. This is the first study that evaluates spatial and point localization accuracy for 2 current EAMS, CARTO3(®) (Biosense Webster, Diamond Bar, CA, USA) and EnSite Velocity(®) (St. Jude Medical Inc., St. Paul, MN, USA), and for a novel overlay guidance (OG) software (Siemens AG, Forchheim, Germany) in a phantom experiment.

Methods And Results: A C-arm CT scan was performed on an acrylic phantom containing holes and location markers. Spatial accuracy was assessed for each system using distance measurements involving known markers inside the phantom and properly placed catheters. Anatomical maps of the phantom were acquired by each EAMS, whereas the 3D-based OG software superimposed an overlay image of the phantom, segmented from the C-arm CT data set, onto biplane fluoroscopy. Registration processes and landmark measurements quantitatively assessed the spatial accuracy of each technology with respect to the ground truth phantom. Point localization performance was 0.49 ± 0.25 mm in OG, 0.46 ± 0.17 mm in CARTO3(®) and 0.79 ± 0.83 mm in EnSite(®) . The registration offset between virtual visualization and reality was 1.10 ± 0.52 mm in OG, 1.62 ± 0.77 mm in CARTO3(®) and 2.02 ± 1.21 mm in EnSite(®) . The offset to phantom C-arm CT landmark measurements was 0.30 ± 0.26 mm in OG, 0.24 ± 0.21 mm in CARTO3(®) and 1.32 ± 0.98 mm in EnSite(®) .

Conclusions: Each of the evaluated EP guidance systems showed a high level of accuracy; the observed offsets between the virtual 3D visualization and the real phantom were below a clinically relevant threshold of 3 mm.