Experience of robotic catheter ablation in humans using a novel remotely steerable catheter sheath

Abstract

Background: A novel remotely controlled steerable guide catheter has been developed to enable precise manipulation and stable positioning of any eight French (Fr) or smaller electrophysiological catheter within the heart for the purposes of mapping and ablation.

Objective: To report our initial experience using this system for remotely performing catheter ablation in humans.

Methods: Consecutive patients attending for routine ablation were recruited. Various conventional diagnostic catheters were inserted through the left femoral vein in preparation for treating an accessory pathway (n = 1), atrial flutter (n = 2) and atrial fibrillation (n = 7). The steerable guide catheter was inserted into the right femoral vein through which various irrigated and non-irrigated tip ablation catheters were used. Conventional endpoints of loss of pathway conduction, bidirectional cavotricuspid isthmus block and four pulmonary vein isolation were used to determine acute procedural success.

Results: Ten patients underwent remote catheter ablation using conventional and/or 3D non-fluoroscopic mapping technologies. All procedural endpoints were achieved using the robotic control system without manual manipulation of the ablation catheter. There was no major complication. A radiation dosimeter positioned next to the operator 2.7 m away from the X-ray source showed negligible exposure despite a mean cumulative dose area product of 7,281.4 cGycm(2) for all ten ablation procedures.

Conclusions: Safe and clinically effective remote navigation of ablation catheters can be achieved using a novel remotely controlled steerable guide catheter in a variety of arrhythmias. The system is compatible with current mapping and ablation technologies Remote navigation substantially reduces radiation exposure to the operator.

Fig. 1

The remote catheter manipulator (RCM) (left) is attached to the steerable guide catheter (Artisan™) through which a mapping catheter can be positioned within the heart. The physician’s workstation (right) navigates the steerable guide catheter remotely

Fig. 2

The Instinctive Motion Controller (top left) used with a control panel on the physician’s workstation (bottom left) remotely guides the steerable guide catheter which can be seen on the central “control view” display (right). Real-time data on catheter orientation, catheter-tip pressure, fluoroscopic views as well as intracardiac echocardiography are shown

Fig. 3

The Artisan control catheter and its components. SIG Steerable inner guide, SOG steerable outer guide

Fig. 4

Examples of the use of the remotely controlled catheter sheath in conventional electrophysiological procedures. LAO projection of a left free wall accessory pathway ablation (left) and PA projection of segmental right upper pulmonary vein isolation (right). (SGC steerable guide catheter, Abl ablation catheter tip)

Fig. 5

Non-fluoroscopic mapping system images created using the remotely controlled steerable guide catheter. Anteroposterior view of the left and right atrial geometry using NavX™ (top left) and posteroanterior view of the left atrium during wide area circumferential ablation using CARTO™ (top right). Posteroanterior view of the left atrium (bottom left) and cross-sectional view of the left sided pulmonary veins (bottom right) during segmental pulmonary vein isolation using CARTOMERGE™. (Ablation lesions in red)

Fig. 6

The Intellisense system display (close-up edited view). Coaxial forces sensed at the catheter tip are displayed as a realtime waveform strip chart and gauge. On the strip chart there is a “warning level” threshold which is set by the operator. When forces exceed this level, the tip of the animated catheter changes colour (from white to yellow), and the strip chart plot line changes colour as well