Title:
Remote controlled robot assisted cardiac navigation: feasibility assessment and validation in a porcine model.

Abstract:
Despite the recent advances in catheter design and technology, intra-cardiac navigation during electrophysiology procedures remains challenging. Incorporation of imaging along with magnetic or robotic guidance may improve navigation accuracy and procedural safety. In the present study, the in vivo performance of a novel remote controlled Robot Assisted Cardiac Navigation System (RACN) was evaluated in a porcine model.
The navigation catheter and target sensor were advanced to the right atrium using fluoroscopic and intra-cardiac echo guidance. The target sensor was positioned at three target locations in the right atrium (RA) and the navigation task was completed by an experienced physician using both manual and RACN guidance. The navigation time, final distance between the catheter tip and target sensor, and variability in final catheter tip position were determined and compared for manual and RACN guided navigation.
The experiments were completed in three animals and five measurements recorded for each target location. The mean distance (mm) between catheter tip and target sensor at the end of the navigation task was significantly less using RACN guidance compared with manual navigation (5.02 ± 0.31 vs. 9.66 ± 2.88, p = 0.050 for high RA, 9.19 ± 1.13 vs. 13.0 ± 1.00, p = 0.011 for low RA and 6.77 ± 0.59 vs. 15.66 ± 2.51, p = 0.003 for tricuspid valve annulus). The average time (s) needed to complete the navigation task was significantly longer by RACN guided navigation compared with manual navigation (43.31 ± 18.19 vs. 13.54 ± 1.36, p = 0.047 for high RA, 43.71 ± 11.93 vs. 22.71 ± 3.79, p = 0.043 for low RA and 37.84 ± 3.71 vs. 16.13 ± 4.92, p = 0.003 for tricuspid valve annulus. RACN guided navigation resulted in greater consistency in performance compared with manual navigation as evidenced by lower variability in final distance measurements (0.41 vs. 0.99 mm, p = 0.04).
This study demonstrated the safety and feasibility of the RACN system for cardiac navigation. The results demonstrated that RACN performed comparably with manual navigation, with improved precision and consistency for targets located in and near the right atrial chamber.