Safe cardiac mapping and catheter ablation using a novel remote catheter manipulator

The use of robotically-guided electrophysiology (EP) catheters has been recently proposed. To date, NIOBETM magnetic navigation system (Stereotaxis Inc., St. Loius, MO, USA) and SenseiTM robotic navigation system (Hansen Medical, CA, USA) are commercially available systems to enable remote control of electrophysiology (EP) catheters. However, the issue of providing a safe and effective way to perform remotely what commonly electrophysiologists carry out manually during EP procedures remains unsolved: one of the main concerns with the Sensei system is the risk of cardiac tamponade, as almost the full length of the catheter is encased in a rigid steerable sheath; ablation lesions produced with NIOBE system resulted less effective than those applied conventionally, as the maximal endocardial force exerted by the magnetically-guided catheter is generally lower than that applied by conventionally controlled catheters. The aim of this feasibility study on sheep was to demonstrate safety and efficacy of a novel Remote Catheter Manipulator (RCM) (Tre Esse Progettazione Biomedica srl, Bologna, Italy) which allows remote manipulation of standard steerable EP catheters, with no need of dedicated catheters or sheaths. The RCM preserves the safe buckling property of a standard EP catheter, entering the vasculature through commercially-available sheath-introducer. It is also equipped with a force feedback sensor-based mechanism to control the resistance encountered by the catheter while advancing, alerting the operator when a threshold force is exceeded.