Robotic Catheter Research Articles

Atrial Fibrillation Ablation Using a Robotic Catheter Remote Control System: Initial Human Experience and Long-Term Follow-Up Results

We present the initial clinical human experience with the use of a robotic remote navigation system (Hansen Medical, Mountain View, California), to perform left and right atrial mapping and radiofrequency ablation of atrial fibrillation (AF) and atrial flutter (AFL). Catheter ablation is an established curative modality for various arrhythmias. A robotic steerable sheath system (SSS) (Hansen Medical) allows better catheter stability and greater degrees of freedom of catheter movement. A total of 40 patients (mean age 57 years) with antiarrhythmic drug (AAD)-refractory AF (23 had also concomitant documented typical AFL) were studied. Three-dimensional reconstruction of the corresponding atrial chamber anatomy was performed with the CARTO electroanatomic mapping system (Biosense Webster, Diamond Bar, California or the EnSite NavX system (St. Jude Medical, Minneapolis, Minnesota) in combination with the Artisan catheter (Hansen Medical). In patients undergoing AF ablation, 2 transseptal punctures were performed under intracardiac ultrasound (ICE) guidance, with one of the punctures being performed using SSS. Pulmonary vein antrum isolation was performed with a 3.5-mm thermocool catheter manipulated with the use of the SSS and was verified by circular mapping. Patients were followed clinically for recurrence of arrhythmia with an event transmitter and ambulatory holter monitoring. Clinical recurrence of AF/AFL was defined as AF/AFL episodes >1 min in duration. Pulmonary vein antrum isolation was performed in 40 patients, including 23 with concomitant typical AFL ablation. All pulmonary veins, including the superior vena cava, were successfully isolated. In 23 of 40 patients, cavotricuspid ablation was also performed with bidirectional block obtained. At 1-year follow-up, 34 patients (86%) and 5 patients were free from atrial arrhythmia off AADs and on AADs, respectively. This preliminary human experience suggests that mapping and ablation of AFL and AF using this novel robotic catheter with remote control system is feasible with similar results to conventional approach.

A Systematical Analysis of In Vivo Contact Forces on Virtual Catheter Tip/Tissue Surface Contact during Cardiac Mapping and Intervention

While catheter tip/tissue contact has been shown to be an important determinant of ablative lesions in in vitro studies, the impact of contact on the outcomes of mapping and ablation in the intact heart has not been evaluated. Twelve dogs underwent atrial ablation guided by the Senesitrade mark robotic catheter remote control system. After intracardiac ultrasound (ICE) validation of contact force measured by an in-line mechanical sensor, the relationship between contact force and individual lesion formation was established during irrigated-tipped ablation (flow 17 mL/sec) at 15 watts for 30 seconds. Minimal contact by ICE correlated with force of 4.7 +/- 5.8 grams, consistent contact 9.9 +/- 8.6 grams and tissue tenting produced 25.0 +/- 14.0 grams. Conversely, catheter tip/tissue contact by ICE was predicted by contact force. A contact force of 10-20 and > or =20 grams generated full-thickness, larger volume ablative lesions than that created with <10 grams (98 +/- 69 and 89 +/- 70 mm(3) vs 40 +/- 42 mm(3), P < 0.05). Moderate (10 grams) and marked contact (15-20 grams) application produced 1.5 X greater electroanatomic map volumes that were seen with minimal contact (5 grams) (26 +/- 3 cm(3) vs 33 +/- 6, 39 +/- 3 cm(3), P < 0.05). The electroanatomic map/CT merge process was also more distorted when mapping was generated at moderate to marked contact force. This study shows that mapping and ablation using a robotic sheath guidance system are critically dependent on generated force. These findings suggest that ablative lesion size is optimized by the application of 10-20 grams of contact force, although mapping requires lower-force application to avoid image distortions.

Flexible Robotic Retrograde Renoscopy: Description of Novel Robotic Device and Preliminary Laboratory Experience

To describe a novel flexible robotic system for performing retrograde intrarenal surgery. Remote robotic flexible ureterorenoscopy was performed bilaterally in 5 acute swine (10 kidneys). A novel 14F robotic catheter system, which manipulated a passive optical fiberscope mounted on a remote catheter manipulator was used. The technical feasibility, efficiency, and reproducibility of accessing all calices were assessed. Additionally, laser lithotripsy of calculi and laser ablation of renal papillae were performed. The robotic catheter system could be introduced de novo in eight ureters; two ureters required balloon dilation. The ureteroscope could be successfully manipulated remotely into 83 (98%) of the 85 calices. The time required to inspect all calices within a given kidney decreased with experience from 15 minutes in the first kidney to 49 seconds in the last (mean 4.6 minutes). On a visual analog scale (1, worst to 10, best), the reproducibility of caliceal access was rated at 8, and instrument tip stability was rated at 10. A renal pelvic perforation constituted the solitary complication. Histologic examination of the ureter showed changes consistent with acute dilation without areas of necrosis. A novel robotic catheter system is described for performing retrograde ureterorenoscopy. The potential advantages compared with conventional manual flexible ureterorenoscopy include an increased range of motion, instrument stability, and improved ergonomics. Ongoing refinement is likely to expand the role of this technology in retrograde intrarenal surgery in the near future.

Robotic catheter ventriculostomy: feasibility, efficacy, and implications

Robotic applications hold great promise for improving clinical outcomes and reducing complications of surgery. To date, however, there have been few widespread applications of robotic technology in neurosurgery. The authors hypothesized that image-guided robotic placement of a ventriculostomy catheter is safe, highly accurate, and highly reproducible. Sixteen patients requiring catheter ventriculostomy for ventriculoperitoneal (VP) shunt or reservoir placement were included in this retrospective study. All patients underwent image-guided robotic placement of a ventricular catheter, using a preoperatively defined trajectory. All catheters were placed successfully in a single pass. There were no catheter-related hemorrhages and no injuries to adjacent neural structures. The mean distance of the catheter tip from the target was 1.5 mm. The mean operative times were 112 minutes for VP shunt placement and 42.3 minutes for reservoir placement. The mean operative times decreased over the course of the study by 49% for VP shunts and by 19% for reservoir placement. The robotic placement of a ventriculostomy catheter using a preplanned trajectory is safe, highly accurate, and highly reliable. This makes single-pass ventriculostomy possible in all patients, even in those with very small ventricles, and may permit catheter-based therapies in patients who would otherwise be deemed poor surgical candidates because of ventricle size. Robotic placement also permits careful preoperative study and optimization of the catheter trajectory, which may help minimize the risks to bridging veins and sulcal vessels.

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

BackgroundA 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.ObjectiveTo report our initial experience using this system for remotely performing catheter ablation in humans.MethodsConsecutive 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.ResultsTen 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 cGycm2 for all ten ablation procedures.ConclusionsSafe 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.Electronic supplementary materialThe online version of this article (doi:10.1007/s10840-007-9184-z) contains supplementary material, which is available to authorized users.

Abstract 3223: Feasibility and Safety of the Integrated 3D Image and Contact Force-Guided Ablation for Atrial Fibrillation with the Hansen Robotic Catheter Sheath System

Background: Current technologies to fully “register” surrogate maps onto 3D CT (CartoMerge, NavxMerge) or 3D ICE images (CartoSound) have emerged to guide ablation. The feasibility of navigation with the Hansen Robotic Catheter Sheath System (HRCS) has also been reported. Integrated 3D Image and contact force sensor with this robotic system may allow for feasibility and safety for guiding complex anatomic-based ablation. Methods: Circumferential pulmonary vein (PV) ablation with the robotic system guided by integrated 3D images (CartoMerge, NavxMerge or CartoSound) (n=3), were done and compared to manual manipulation guided by the integrated 3D images (CartoSound) (n=8). Each ablation was performed using contact force ranges of 10 –20 grams (20W, 17 ml/min flow, 30 seconds). Accuracy of PV ablation was assessed by comparing distance from the PV ostia (specific 4 sites) to the ablative points on the 3D image structures, and the corresponding distances of the actual ablative lesions at pathologic exam. Results: Using three integrated 3D image systems, circumferential PV ablation was successfully guided in 6 PVs (3 RSPVs and 3 LSPVs) with the robotic system. During all ablations with contact forces of 10 –20 grams, no impedance rises, pops or type 2 microbubbles were seen. Accuracy of the PV ablation was 0.22±0.84 mm (range 0 –2). The PV rings were 100% circumferential by electroanatomic mapping, yielding an 86±7% (range 80 –98%) uninterrupted circumferential ablative ring around each PV with 1.1 ± 0.4 gaps (3.0 ± 0.9 mm). These resulting parameters were equal to those in the integrated 3D image-based manual navigation (Accuracy: 0.5±0.9 (range 0 –2.5) mm, Gaps:1.3 ± 0.9 ( 2.6 ± 0.9 mm), circumferential lesions 88 ± 10% (range 70 –100). Conclusions: This feasibility study demonstrated successful integrated 3D image and contact force-guided robotic ablation. Contact sensor guided 3D volume construction and real time 3D images accurately replicated atrial and venous anatomy, resulting in successful circumferential ablation.

View-Synchronized Robotic Image-Guided Therapy for Atrial Fibrillation Ablation

A robotic catheter navigation system has been developed that provides a significant degree of freedom of catheter movement. This study examines the feasibility of synchronizing this robotic navigation system with electroanatomic mapping and 3-dimensional computed tomography imaging to perform view-synchronized left atrial (LA) ablation. This study consisted of a porcine experimental validation phase (9 animals) and a clinical feasibility phase (9 atrial fibrillation patients). Preprocedural computed tomography images were reconstructed to provide 3-dimensional surface models of the LA pulmonary veins and aorta. Aortic electroanatomic mapping was performed manually, followed by registration with the corresponding computed tomography aorta image using custom software. The mapping catheter was remotely manipulated with the robotic navigation system within the registered computed tomography image of the LA pulmonary veins. The point-to-surface error between the LA electroanatomic mapping data and the computed tomography image was 2.1+/-0.7 and 1.6+/-0.1 mm in the preclinical and clinical studies, respectively. The catheter was remotely navigated into all pulmonary veins, the LA appendage, and circumferentially along the mitral valve annulus. In 7 of 9 animals, circumferential radiofrequency ablation lesions were applied periostially to ablate 11 pulmonary veins. In patients, all of the pulmonary veins were remotely electrically isolated in an extraostial fashion. Adjunctive ablation included superior vena cava isolation in 6 patients, cavotricuspid isthmus ablation in 5 patients, and ablation of sites of complex fractionated activity and atypical LA flutters in 3 patients. This study demonstrates the safety and feasibility of an emerging paradigm for atrial fibrillation ablation involving the confluence of 3 technologies: 3-dimensional imaging, electroanatomic mapping, and remote robotic navigation.

Novel Robotic Catheter Remote Control System: Feasibility and Safety of Transseptal Puncture and Endocardial Catheter Navigation

The aims of this study were to demonstrate the safety and the feasibility of the robotic catheter remote control system (CCS) in endocardial navigation in all cardiac chambers, as well as facilitation of the transseptal puncture. CCS has been developed to facilitate control and precise positioning of catheters within the cardiovascular system. CCS consists of a remote catheter manipulator, a set up joint, a physician workstation, and a steerable guide catheter (SGC) and sheath. A conventional 4-mm tip catheter was inserted through the SGC to perform mapping of five predefined targets in each cardiac chamber. Seven mongrel dogs were used in this study. Intracardiac echocardiography and three-dimensional (3-D) electroanatomical mapping were integrated with CCS to facilitate catheter manipulation and to guide transseptal puncture. The time to complete the transseptal puncture and the time to complete access to the predefined targets in each cardiac chamber were measured. Gross and microscopic examinations of the accessed and ablation sites were performed to evaluate safety. Transseptal puncture was performed successfully in all animals with a mean time of 7 +/- 3 minutes. Procedure times to access the five targets in the right atrium, right ventricle, left atrium, and left ventricle were 5.6 +/- 1.7, 4.6 +/- 1.5, 13.5 +/- 11.0, 7.0 +/- 2.9 minutes, respectively. There were no intracardiac damages associated with catheter manipulation noted in the excised hearts. Endocardial catheter navigation and mapping using the robotic catheter remote control is safe and feasible. Moreover, the CCS could be used to perform transseptal puncture and left atrial instrumentation.

AB44-2: Human pulmonary vein and flutter ablation using the robotic catheter control system and real-time integration of CT imaging with electroanatomical mapping

AB44-2: Human pulmonary vein and flutter ablation using the robotic catheter control system and real-time integration of CT imaging with electroanatomical mapping

Novel robotic catheter remote control system: Safety and accuracy in delivering RF lesions in all 4 cardiac chambers

Objectives: The aims of this study were to demonstrate that the robotic catheter remote control system is effective and safe in delivering radiofrequency lesions in all 4 cardiac chambers in addition to facilitating transseptal puncture.

Porcine pulmonary vein ablation using a novel robotic catheter control system and real-time integration of CT imaging with electroanatomical mapping

Porcine pulmonary vein ablation using a novel robotic catheter control system and real-time integration of CT imaging with electroanatomical mapping

Pre-clinical canine testing of 3D electroanatomical mapping system developed for a robotic catheter maneuvering system for left atrial mapping

The purpose was to test in dogs a new 3D electroanatomical mapping system (CARTO-RMT, Biosense Webster) developed for use with a robotic magnetic catheter maneuvering system (MMS) (Niobe, Stereotaxis-Siemens) in mapping and ablation of the left atrium (LA) and pulmonary veins (PV). MMS uses 2 computer controlled magnets to generate a magnetic field (MF) in any direction. The MF directs a flexible catheter with a small magnet in the tip, while a screw-drive device advances/withdraws the catheter.

Preliminary human experience using a novel robotic catheter remote control

Preliminary human experience using a novel robotic catheter remote control

Early Experience with a Computerized Robotically Controlled Catheter System

Recently, the use of robotic assisted surgery has been utilized in cardiac surgical procedures. The use of robotics may offer benefits in precision, stability and control of instruments remotely. We report early experience with a novel remote robotic catheter control system (CCS). We used a computerized robotically controlled catheter system that enables the user to remotely manipulate the tip of a catheter precisely in three dimensions. We tested the robotic catheter control systems ability to navigate within the heart and to make precise, rapid and repeatable movements. We compared the CCS with the ability of a standard quadripolar steerable ablation catheter placed in a deflectable sheath to navigate and make precision movements. Twelve ex-vivo porcine hearts were utilized to permit accurate measurements of navigation and precision. Eight targets were selected for navigation and precision testing. Time was measured for the catheter to reach the predefined target from a specific starting point to test navigation. In addition, time was measured to contact a discrete 0.8 mm target in order to test precision. The use of the CCS reduced the time needed for both navigation (8.5 +/- 13.9 sec vs. 22.7 +/- 26.7 sec, p = 0.002) and significantly decreased the time for precision targeting (10.1 +/- 6.9 sec vs. 29.6 +/- 26.4 sec, p < 0.001) in the specific RA and LA sites in the ex-vivo hearts. The use of a computerized robotically assisted catheter control system is feasible and shows promise in rapid precision movement of the catheter. Further study is needed to elucidate the role of such a system in-vivo and in patient specific catheter ablation and mapping.