In this article, the authors present an overview of the Stereotaxis Vdrive robotic catheter manipulation system and provide a detailed summary of the first case in the world performed with this new technology.
Use of remote magnetic catheter navigation is becoming established and accepted in electrophysiology procedures. Many published reports have shown the clinical utility of the magnetic navigation system (MNS) in routine electrophysiology catheter ablation procedures, including specific reports describing its use in atrioventricular nodal reentrant tachycardia,1 atrioventricular reentrant tachycardia,2 right ventricular outflow tract tachycardia,3 and parahisian accessory pathways.4 More recently, there have been multiple published studies that have demonstrated the usefulness of the system in more complex arrhythmia ablation procedures such as ventricular tachycardia5,6 and atrial fibrillation (AF).7-11
These recent publications on remote magnetic navigation for ablation of atrial fibrillation7-11 represent a total of 321 patients with an average of 1.1 years of follow-up data. Both paroxysmal and persistent AF patients are included in these studies. The efficacy data is consistent with published outcomes for non-magnetic AF ablation, with a freedom from AF at follow-up ranging from 59–76%. The safety record in these publications is exceptional, with a 0% tamponade rate and a general reduction in patient and operator fluoroscopy exposure. The studies that provided comparison data to non-magnetic AF cases9-11 showed that average case times can be longer with magnetic navigation (34–59%). While some of this increase in time can be explained by the learning curve for the system, the data does indicate the need for technologies to assist with magnetic AF ablation procedures and workflow efficiency.
Current magnetic AF ablation procedures that are completed with a circular mapping catheter for confirmation of electrogram abatement generally require a modification of the operator’s clinical approach and technique. Physicians must interrupt the remote workflow to gown, glove and enter the procedure room to reposition the circular mapping catheter. This happens on average up to 5 times per procedure, each time causing a disruption to the work at hand and adding time to the procedure. In some instances, an additional clinician is required to manage the circular mapping catheter throughout the procedure. The need for additional technology to remotely navigate circular mapping catheters during magnetic procedures is clear.
The Vdrive™ Robotic Catheter Manipulation System (Vdrive, Stereotaxis, Inc., Saint Louis, MO), is the world’s first and only robotic navigation system designed specifically for diagnostic devices, allowing physicians to employ clinical techniques that leverage therapeutic and specialized diagnostic catheters in an integrated remote interface (Figure 1). The first available remote manipulator for Vdrive is designed specifically to navigate the Lasso 2515 and Lasso NAV 2515 circular mapping catheters (Lasso, Biosense Webster, Inc., a Johnson & Johnson company, Diamond Bar, CA).
Vdrive consists of a robotic catheter drive unit, a remote controller (Figure 2), and a tableside controller (Figure 3). A custom-designed disposable mounts to the drive unit of the Vdrive system and accepts the Lasso catheter handle without modification (Figure 4). This custom-designed disposable provides catheter shaft support and transmits commands to the catheter handle, thus allowing for fully remote manipulation of the Lasso. There is an emergency “E-Stop” in the procedure room as well as in the control room which provides the ability to stop any motions of the Vdrive. The system may be positioned away from the patient when not in use.
Setup of the Vdrive system is simple and straightforward. The system is draped with a custom drape and the sterile disposable handle clamps are placed onto the unit. The Lasso catheter is fed through a catheter support tube and is then inserted through a standard sheath to the level of the left superior pulmonary vein (LSPV). The Lasso catheter handle is aligned and locked into the handle clamp tray. The catheter support tube is then attached to the Vdrive system and to the transseptal sheath hub. The tubes and handle clamps are locked and the Vdrive adjustable arm is locked into place. Navigation of the Lasso can then take place from the remote controller in the control room.
The Vdrive system is controlled through and fully integrated with the Stereotaxis Navigant version 3.2 software interface and is designed to work in concert with the Niobe® Magnetic Navigation System (Stereotaxis, Inc.). The Vdrive system is compatible with multiple electroanatomic mapping systems, although the Navigant software is most fully integrated with Biosense Webster’s Carto™ RMT System. Vdrive may also be integrated with Odyssey™ Vision system (Stereotaxis, Inc.). Installation of the Vdrive into an EP lab takes approximately 1.5 days with no lab modifications required.
The first case in the world completed with Vdrive was performed at our lab during the first week of January 2011. The patient was a 65-year-old male with a history of paroxysmal atrial fibrillation. He had previous cryoablation 12 months prior to presenting to our center for definitive treatment. He remained highly symptomatic during his follow-up period.
Based on the patient’s history and presentation, we decided to proceed with a re-do pulmonary vein isolation (PVI) procedure. Using the Vdrive, we interrogated all four veins with the Lasso catheter remotely from the control room. Upon examination, it was noted that three of the four pulmonary veins were reconducting.
With Biosense Webster's NaviStar RMT ThermoCool catheter, we proceeded to deliver encircling lesion sets to re-isolate the pulmonary veins using a power setting of 25–35 W and a flow rate of 17 ml. We placed the transseptal sheath just on the right atrial side of the septum in order to provide for the greatest flexibility in reaching all targets with the magnetic catheter. Using the Vdrive to navigate the Lasso catheter, we were able to confirm pulmonary vein isolation in all four veins. The patient was in sinus rhythm at the end of the case, and there were no complications related to the procedure.
Allowing the physician to navigate and change the position of the Lasso catheter remotely from the control room maintained an efficient remote workflow throughout the entire case. Driving the Lasso with the Vdrive system eliminated the need to rescrub and enter the treatment room for manual repositioning of the Lasso, thus minimizing the interruptions to the completion of the case. Integration of the Vdrive with the Niobe system enabled a fully remote, single-operator workflow.
During this first case, we noticed that the freedom to easily, frequently, and precisely move the Lasso catheter with remote micromovements facilitated our treatment decisions. We were able to perform gap identification and targeting completely remotely with an efficient workflow when using the integration with the Carto system. It was also apparent during this case that the Vdrive system provided an additional measure of stability for the Lasso, thus enhancing the stability of the electrogram signals. This stability also allowed us to position the Lasso at any location, not just within the pulmonary veins.
Based on our early experience, we plan to adopt the Vdrive as standard for our complex left atrial arrhythmia cases. We believe that the improved remote workflow has the potential to decrease radiation exposure to the entire EP team. In addition, our patients can receive the most advanced procedure available by providing us the versatility to optimize conventional diagnostic techniques remotely while maintaining the safety and efficacy of magnetic procedures.
We believe Vdrive is the next evolution in robotic navigation platform technologies. It adapts traditional electrophysiology products like the Lasso catheter to remote robotic control and fully integrates that control into the interface of the Niobe Magnetic Navigation System. Together, Vdrive and Niobe provide independent remote manipulation of diagnostic catheters and magnetic ablation catheters in a single interface. Future versions may include robotic sheath manipulation, manipulation of intracardiac echocardiography (ICE) catheters, and the potential for the installation of dual Vdrives for multiple applications.
- Ernst S, Ouyang F, Linder C, et al. Initial experience with remote catheter ablation using a novel magnetic navigation system: Magnetic remote catheter ablation. Circulation 2004;109:1472–1475.
- Thornton AS, Rivero-Ayerza M, Knops P, Jordaens LJ. Magnetic navigation in left-sided AV reentrant tachycardias: Preliminary results of a retrograde approach. J Cardiovasc Electrophysiol 2007;18:467–472.
- Thornton AS, Jordaens LJ. Remote magnetic navigation for mapping and ablating right ventricular outflow tract tachycardia. Heart Rhythm 2006;3:691–696.
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- Arya A, Eitel C, Bollmann A, et al. Catheter ablation of scar-related ventricular tachycardia in patients with electrical storm using remote magnetic catheter navigation. Pacing Clin Electrophysiol 2010;33:1312–1318.
- Di Biase L, Santangeli P, Astudillo V, et al. Endo-epicardial ablation of ventricular arrhythmias in the left ventricle with the Remote Magnetic Navigation System and the 3.5-mm open irrigated magnetic catheter: results from a large single-center case-control series. Heart Rhythm 2010;7:1029–1035. Epub 2010 Apr 28.
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- Pappone C, Vicedomini G, Frigoli E, et al. Irrigated-tip magnetic catheter ablation of AF: A long-term prospective study in 130 patients. Heart Rhythm 2011;8:8–15. Epub 2010 Sep 29.
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Editor’s Note: This article underwent peer review by one or more members of EP Lab Digest’s editorial board.