Robotic positioning of standard electrophysiology catheters: a novel approach to catheter robotics

Abstract

Background: Robotic systems have been developed to manipulate and position electrophysiology (EP) catheters remotely. One limitation of existing systems is their requirement for specialized catheters or sheaths. We evaluated a system (Catheter Robotics Remote Catheter Manipulation System [RCMS], Catheter Robotics, Inc., Budd Lake, New Jersey) that manipulates conventional EP catheters placed through standard introducer sheaths. The remote controller functions much like the EP catheter handle, and the system permits repeated catheter disengagement for manual manipulation without requiring removal of the catheter from the body. This study tested the hypothesis that the RCMS would be able to safely and effectively position catheters at various intracardiac sites and obtain thresholds and electrograms similar to those obtained with manual catheter manipulation.

Methods: Two identical 7 Fr catheters (Blazer II; Boston Scientific Corp., Natick, Massachusetts) were inserted into the right femoral veins of 6 mongrel dogs through separate, standard 7 Fr sheaths. The first catheter was manually placed at a right ventricular endocardial site. The second catheter handle was placed in the mating holder of the RCMS and moved to approximately the same site as the first catheter using the Catheter Robotics RCMS. The pacing threshold was determined for each catheter. This sequence was performed at 2 right atrial and 2 right ventricular sites. The distance between the manually and robotically placed catheters tips was measured, and pacing thresholds and His-bundle recordings were compared. The heart was inspected at necropsy for signs of cardiac perforation or injury.

Results: Compared to manual positioning, remote catheter placement produced the same pacing threshold at 7/24 sites, a lower threshold at 11/24 sites, and a higher threshold at only 6/24 sites (p > 0.05). The average distance between catheter tips was 0.46 +/- 0.32 cm (median 0.32, range 0.13-1.16 cm). There was no difference between right atrial and right ventricular sites (p > 0.05). His-bundle electrograms were equal in amplitude and timing. Further, the remote navigation catheter was able to be disengaged, manually manipulated, then reengaged in the robot without issue. There was no evidence of perforation.

Conclusions: The Catheter Robotics remote catheter manipulation system, which uses conventional EP catheters and introducer sheaths, appears to be safe and effective at directing EP catheters to intracardiac sites and achieving pacing thresholds and electrograms equivalent to manually placed catheters. Further clinical studies are needed to confirm these observations.