Review

Robotics in invasive cardiac electrophysiology Expert Review of Medical Devices Downloaded from informahealthcare.com by Nanyang Technological University on 04/26/15 For personal use only.

Expert Rev. Med. Devices 11(4), 375–381 (2014)

Mohammed Shurrab*1, Richard Schilling2, Eli Gang3, Ejaz M Khan4 and Eugene Crystal1 1 Arrhythmia Services, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada 2 Cardiology Research Department, Queen Mary University of London and St. Bartholomew’s Hospital, Dominion House, West Smithfield, London, UK 3 Electrophysiology Section, Division of Cardiology, Cedars-Sinai Medical Centre, Los Angeles, CA, USA 4 Clinical Research Department, Winchester Medical Center, Winchester, VA, USA *Author for correspondence: Tel.: +1 416 480 6100; extn. 7091 Fax: +1 416 480 6172 [email protected]; [email protected]

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Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones. KEYWORDS: ablation • automation • cardiac electrophysiology • efficacy and safety • electromagnetic • electromechanical • magnetic • mapping

Since the initial surgical ablation of cardiac arrhythmia in 1977 [1], many efforts have been applied to improve this treatment modality, resulting in the transition of ablation techniques from open heart surgery to beating heart surgery, to manual catheter ablation; and most recently, the introduction of the robotic systems in 2003 [2]. The use of robotic systems has expanded significantly in numerous fields of invasive cardiology, especially in catheter ablation for complex arrhythmia [3,4]. Current robotics can be grouped by their underlying concept as: manual catheter manipulators, similar in concept to the manual technique: Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA, USA) and AMIGO remote catheter system (Catheter Robotics Inc., Mount Olive, NJ, USA); system-specific catheter manipulators, which use specific deployed forces (magnetic/ electromagnetic) to manipulate the catheters: Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO, USA) and Catheter Guidance Control and Imaging (Magnetecs Corp., Inglewood, CA, USA) and finally mixed systems (Stereotaxis with V-drive; V-sono platform). All existing robotic systems aim to achieve procedural efficacy outcomes (both acute and long-term) similar or superior to the manual technique. However, to compete with the well-established current manual technique on 10.1586/17434440.2014.916207

which thousands of active electrophysiology (EP) operators are trained, robotic systems should also be able to achieve at least one of the following: better (than manual) safety profile for patients and operators, as measured by complication rates and/or radiation exposure; expand the number of patients who are amenable for catheter ablation with either challenging arrhythmia substrates or those who failed manual technique; improved efficiency, that is, allow operators to perform more ablation procedures by minimizing time or physical stress and be economically neutral or beneficial for the healthcare system. In the next section, we will review existing robotic systems with emphasis on the above-mentioned characteristics needed for the success in the clinical field. Niobe magnetic navigation system

Stereotaxis (STXS) system is the most common robotic system used worldwide. Introduced in 2003, the company reported more than 160 active installations globally, with over 50,000 treated patients as of September 2012 [3]. The system allows navigation of the ablation catheters using a combination of magnetic steering and mechanical pulling/pushing. Two external magnets located on either side of the patient generate a magnetic field (0.08 or 0.1 T) (FIGURE 1). The operator can alter the vector of the magnetic field from the control

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Figure 1. Niobe magnetic navigation system has been reproduced with the permission of Stereotaxis.

room or from the bedside. The system requires a specific catheter that incorporates magnets in its floppy distal portion. These small magnets align along the magnetic field vector, allowing remote steering, while precise (1 mm increment) forward and backward movements are created by mechanical pushing and pulling. At present, at least two manufacturers (Biosense-Webster, J&J Medical Companies Inc. and Biotronik GmbH) are providing magnetically enabled catheters, both irrigated and non-irrigated. While soft and flexible, the mechanical forward pressure of these catheters is able to reach 26.8 g/cm2 [5]. Three generations with enhanced features have been introduced to the initial version of STXS system. STXS has recently introduced their thirdgeneration system called EPOCH, installed in several centers since its introduction. The response of the catheter to the magnetic field vector changes has been enhanced and a significant amount of automation features were developed and refined such as bull’s eye, which allows navigation around a central axis and automatically directed movements. STXS system operates with the most common mapping systems (CARTO and ENSITE), although full integration is only available with CARTO. Advantages

The STXS system has proved to be as effective as the manual technique, with possibly better safety profile in ablating various ablation substrates [3,6]. The magnetic catheter is soft without an excessive contact force potentially reducing the risk of mechanical complications [3,5]. The cases of cardiac tamponade reported with STXS usage are more likely the result of excessive localized delivery of ablation energy. Catheter flexibility and stable contact force provides good catheter tip tissue contact and results in a precise ablation lesion [7–10], and adequate control of the catheter tip temperature when needed to minimize complications (e.g., to mitigate esophageal injury during ablation of the posterior left atrial wall) [11]. A recent survey reported no cases of esophageal fistula in 3637 patients who had atrial fibrillation ablation with the use of STXS [12]. More so, the catheter may reach difficult anatomical substrates (mitral valve accessory pathways) and remain stable during ablation. The maneuverability of the STXS catheter may be superior to manual access in some extraordinary 376

anatomical circumstances [13–15], although in certain situations supporting sheaths are necessary to reliably transfer forward/ backward movements of the catheter over the long or tortuous distances. Use of STXS catheter also prevents both mechanical suppression of clinical arrhythmia (usually caused by mechanical trauma of the stiff manual catheter to the site of interest) and catheter-induced arrhythmia as shown in outflow tract arrhythmia ablations [16]. The use of STXS in mapping and ablation of ischemic ventricular tachycardia (VT) is promising. The preliminary results of the Study to Obliterate Persistent VT trial showed an ability to ablate the target VT and remain non-inducible in 90.9% of the patients [17]. STXS use has reduced significantly the fluoroscopy time in both complex and standard ablation procedures, with and without use of a concomitant non-x-ray mapping system. This may be due to operator comfort in advancing the catheter without the need of continuous fluoroscopy (as the catheter is floppy and simply bends in response to excessive forward pressure). Also, since the magnetic catheter is stable, operators may feel more comfortable ablating without the use of fluoroscopy as the catheter is unlikely to move during ablation. A significant decrease in radiation exposure has clinical relevance for both operators and patients undergoing ablation procedures [18–20]. The role of the STXS system to place the coronary sinus left ventricular (LV) lead in cardiac resynchronization therapy has shown initial promise but failed to capture cardiac resynchronization therapy market [21]. The use of STXS system for mapping and ablation of cardiac arrhythmias is generally safe in patients with implanted cardiac arrhythmia devices [22]. Limitations

STXS operators can only manipulate the magnetically enabled ablation catheter; however, all additional catheters (pacing/ mapping catheters, intracardiac echocardiogram [ICE], etc.) must be moved manually form the patients’ bedsides. This may lengthen the ablation procedure time as operators may need to rescrub frequently, or have to use an assistant operator. This might be resolved to a substantial extent with the recent introduction of the new Vdrive platform that allows operators to manipulate other catheters remotely [23]. The length of the procedure while using STXS remains a major concern. It may be partially related to the substantial (50–75 cases) learning curve required to master the skill of manipulating the catheters remotely. A recent meta-analysis showed that a reasonable fraction of the STXS procedure time is utilized during the actual ablation; however, a larger unaccounted time is likely related to system set up and catheter maneuvering [3]. STXS has recently introduced an enhanced version to minimize time lag related to maneuvering the magnets, yet the impact on the procedural time needs to be demonstrated [24]. The set up of the STXS system remains complex when integration with CARTO is needed. Sensei robotic navigation system

Hansen system was introduced in 2007 [25], and has about 160 installations worldwide with 13,000 cases being performed. Expert Rev. Med. Devices 11(4), (2014)

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Hansen uses electromechanically manipulated sheaths to control catheters remotely; it is achieved by using a robotic arm, which is fixed at the patient’s table. The robotic arm is connected to the steerable sheath (Artisan) through which mapping and ablation catheters can be positioned within the heart. The Artisan sheath consists of an inner (10.5 F) and an outer (14 F) sheath. Operators can navigate the steerable sheath and catheters remotely from the workstation using the motion controller (FIGURE 2) [26,27]. Hansen is compatible with available 3D mapping systems. In theory, all available standard ablation (either irrigated or not) and mapping catheters, which fit with the size of the inner lumen of the Artisan sheath, can be used and navigated remotely. In reality, those catheters that use a metallic strip rather than a wire to deflect the catheter do not perform as well in this sheath. This is because the catheter will only bend in one direction and this therefore limits the degrees of freedom available using any steerable sheath including the Artisan. Advantages

Hansen system showed encouraging efficacy results in complex ablation procedures [26]. Hansen was effective in reducing fluoroscopy time significantly during catheter ablation procedures [26,28]. The Hansen system provides significant catheter stability related to the usage of external sheath resulting in improved electrogram attenuation during ablation of paroxysmal atrial fibrillation [29]. The system has also been used in the left ventricle for VT [30], and a recent report has highlighted the fact that Hansen system may provide superior catheter stability in the left ventricle. This is related to the fact that the catheter is rigid when not being manipulated, unaffected by blood flow or cardiac motion [31]. This indeed is applicable to any target within the heart with high flow forces or profound instability. Hansen system has shown superior (to the manual technique) outcomes when used with irrigated catheters in right-sided typical atrial flutter ablation, likely related to enhanced catheter contact [32]. Also, Hansen system may be beneficial for left-sided isthmus ablation [33]. A worldwide survey including the results from 1728 atrial fibrillation ablation procedures that were performed at 12 centers utilizing the Hansen robotic navigation technology showed overall complication rate of 4.7% with a success rate of 67.1% after 18 ± 4 months of follow-up. The study concluded that Hansen usage is associated with similar complication rate and efficacy in comparison to conventional manual technique. Importantly, the results of this survey represented high-end centers of large volume and expert operators [34]. Hansen system has the advantage of being the only robotic system that offers full remote navigation of any of the catheters used in ablation and mapping. This may eventually lead to additional reduction of fluoroscopy especially to operators by decreasing the time needed to rescrub to manipulate the mapping catheters. The introduction of contact force sensors (IntelliSense) may allow the operators to achieve better safety profile related to mechanical movements of catheters within the heart. Unlike STXS, which informahealthcare.com

Figure 2. Sensei robotic navigation system.

requires continuous alteration of the magnetic vector, with Hansen a continuous uninterrupted motion of the ablation catheter can be achieved with the use of the controller [35]. Better assessment of the efficacy and safety of Hansen system is provided by 2 randomized controlled trials, the first a singlecenter study from one of the authors (RS) and the second the Man and Machine trial, comparing Hansen with manual technique in atrial fibrillation ablation [36]. Limitations

As Hansen system provides superior (to the manual technique) catheter stability and a precise ablation lesion, mechanical complication is possible. Furthermore, the ability of a system to create a large lesion may impact radiofrequency lesion-related complications. This trade-off between success and safety is well recognized and contact force and power settings should be monitored carefully; otherwise mechanical complications such as cardiac perforation leading to pericardial effusion/tamponade might be excessive [26,27,37,38]. The rate of esophageal injury in particular seems to be high with Hansen system in comparison to manual or STXS technique [11,39]. A recent study has looked at the risk of esophageal injury with Hansen in comparison to the manual technique and while the same power of radiofrequency energy was delivered during ablation of the posterior wall of the left atrium, an excessive esophageal injury was noted with Hansen. The major reason for this difference, as suggested by the authors, was probably the higher contact force when Hansen was used compared with a manual procedure at the 377

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Figure 3. AMIGO remote catheter system.

same power setting [39]. This effect was minimized when a lower power was used with Hansen. While one might expect improved safety profile with the usage of the contact force sensors, this will only be true if operators recognize that the catheter stability afforded by these systems means that the power and duration of radiofrequency application needs to be adjusted accordingly, particularly on vulnerable areas like the posterior wall of the left atrium. Although previously there was concern that sheath size may cause excessive vascular complications [38], in the authors’ experience this is not borne out in practice or in randomized trials. Although the Hansen system is a full navigation system, transseptal needle cannot be manipulated remotely. During manipulation of the robotic sheath into the LV, transient interference with mitral valve function has been documented; this is easily corrected [31]. The sheath size has limited the use of Hansen in cases where epicardial access is needed. The usage of Hansen in simple/standard ablation procedure is still not well established [40], and the cost of using such systems is probably not justified for such cases.

used to position catheters throughout the right side of the heart with good tissue contact and considerably short learning curve [42]. The first clinical study evaluated the Amigo system in the clinical setting of cavo-tricuspid isthmus ablation. The study concluded that amigo is safe and effective for cavotricuspid isthmus ablation [41]. The short learning curve and familiar catheters seem to be the most important advantages of this system, as the handle mimics the manual catheter operators are already used to it. The Amigo system is compatible with various catheters and 3D mapping systems. The system has not been tested in complex ablation procedures. One may wonder if simplicity would be an advantage or rather a challenge in complex ablation procedures where the desired substrate is complex. Amigo does provide very reliable tissue contact and is currently been evaluated with new pressure sensing catheters. With pressure sensor feedback, Amigo may become the cutting edge technology electrophysiologists wish for. In complex ablation, the maneuverability has been a challenge to any robotic technology. With a new generation of Amigo, two catheters can be manipulated at the same time. There is a limited clinical experience with the Amigo system as highlighted by the scarcity of publications reporting its clinical use. Catheter guidance control & imaging

Magnetecs has eight electromagnets focused in a semi-spherical pattern around the patient’s chest (FIGURE 4). Near instantaneous changes in polarity and current strength result in a dynamic magnetic field focused within the region of the heart with a maximum strength of 0.14 T [43]. Any magnetic-tipped catheter can be aligned almost instantaneously with the magnetic vector changes. The system offers magnetic navigation of the catheter, which can be either user driven via a 3D joystick (‘magnetic manual mode’) or the catheter can travel in an ‘automatic’ mode to designated lesion sites, hence, pre-designed lesion sets can be created and ablative energy delivered to designated sites such as PV antra. Advantages & limitations

AMIGO remote catheter system (Catheter Robotics Inc.)

The system consists of a robotic arm fixed on the patient’s table and a remote controller connected to the robot remotely (FIGURE 3) [41,42]. Amigo is an open platform system, which can accommodate many available catheters. The catheter is manipulated by a standard handle designed for manual work ‘controller’, which may be up to 100 ft (30 m) away from the patient [42]. The remote controller mimics the handle of a standard EP catheter. Advantages & limitations

Amigo system has been introduced to the field of EP as a simple robotic system that is affordable, easy to operate and ostensibly requires a very short learning curve. The catheter can be removed from the robotic arm for manual manipulation and can also be re-attached to the robot without breaking sterility [41]. A recent feasibility study showed that Amigo could be 378

Unlike STXS, Magnetecs system uses electromagnetic forces with enhanced maximal generated magnetic field forces (0.14 T). The magnetic field can be changed instantaneously, which lead to faster catheter real-time response (milliseconds), hence eliminate time loss and eventually achieve shorter procedure time. This may also improve catheter tip stability and maintain catheter position on a desired target with little effect of external forces related to blood flow and cardiac motion. The system uses a 7 F size catheter and thus vascular complications are not likely to be an issue. The unique steel structure that contains the electromagnets virtually eliminates stray electromagnetic radiation beyond the confines of the system, so no additional room shielding is necessary and no interference with metallic tools outside of the confines of the sphere is seen [43]. A recent feasibility study on mapping accuracy for predefined sites within the right and left cardiac chambers showed reasonable results (RICTAM trial). Preliminary data in patients Expert Rev. Med. Devices 11(4), (2014)

Robotics in invasive cardiac electrophysiology

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with paroxysmal atrial fibrillation as well as left atrial flutter are also promising [GANG E, UNPUBLISHED DATA]. Magnetecs was fast and accurate with the use of the operator mode or the automatic mode without severe adverse events. The additional electrical forces may lead to a faster response. Although the features of Magnetecs sound promising, the true value of this system should be further evaluated in large clinical trials.

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Obstacles to the wider adoption of robotics in EP

The incremental capital costs remain a major challenge that is facing most of the robotic systems [44]. However, potential cost benefit from short- and long-term outcomes should be taken into consideration including success and complications rates. These may only be tested in large studies. The adoption of this technology requires significant time and training efforts. The set up time of some of robotic systems may be also time consuming and involves a significant learning curve not only for primary operator but also for the whole team [34,45]. Industry representatives are often needed to facilitate the usage of these systems. These obstacles may make operators reluctant to use robotic systems given the pressure of limited lab time and the increasing demand for ablation procedures. Most of these systems are present in teaching centers where involvement of trainees is substantial. Many trainees will face difficulty adapting this technology during their short training, or acquiring skills, which may be irrelevant to their future practice. One may speculate that more specific preparatory training might be needed to master the skills required for specific robotic systems. The use of some of these systems is still limited or uncertain in some specific procedures (Hansen in LV/epicardial ablations or non-complex arrhythmia). Most of the enhanced solutions implanted in these systems are directed toward complex ablation procedures (i.e., atrial fibrillation and VT). However, standard/simple arrhythmia substrate category is still occupying about a half of the lab volumes in most of developed entities [46,47]. Manufacturers should direct more efforts toward enhancing their platforms to better serve simple ablation procedures; the current results of robotic systems in ablation of standard arrhythmia are either limited or less promising [6]. Existing robotics systems are designed to follow a point-bypoint ablation concept, the most versatile in terms of ablation targets. This concept is increasingly challenged by multielectrode ablation techniques progressively prevalent for ablation of atrial fibrillation. The next most important step for these systems may become the development of the multipolar ablation instruments. The ideal robotic system

The ideal robotic system would be the one that combines the advantages of both magnetic and mechanical manipulators. This ideal system should use the magnetic or electromagnetic field (STXS/Magnetecs) in manipulating a soft and flexible magnetically enabled ablation catheter. The homogenous informahealthcare.com

Figure 4. Catheter guidance control and imaging.

magnetic/electromagnetic field with a reasonable contact force will provide superior stability and precise ablation lesion formation while minimizing mechanical complications encountered with excessive contact forces of other systems. Also it should include the mechanical/electromechanical forces (Hansen/Amigo) needed to manipulate mapping and ICE catheters in order to reach full manipulation of all catheters remotely. This system would theoretically enable remote manipulation of the ablation/mapping/ICE catheters; reduce the need to rescrub for positioning catheters, reduce radiation exposure, especially for operators and eventually provides precise movement of catheters. A small sheath size is needed to minimize vascular complications. The recent platform from STXS, the Vdrive with V-Sono Platform provides some conceptual glimpse on how the system may work. A robotic arm is being added to the current STXS system that will allow to mechanically manipulate the mapping and ICE catheters remotely. A recent study on the Vdrive system represented the initial experience with this system. The Vdrive system enabled fully remote navigation procedures with minimal need for manual crossover. This has been achieved with a reasonable procedure and fluoroscopy time [23]. Multicenter and large prospective studies are required to assess this concept in both standard and complex ablation procedures. Expert commentary & five-year view

Since their introduction in early 2000s, robotic systems have impacted the field of clinical cardiac EP. Only a minority (2–3 hundred) of cardiac EP labs at present are equipped with these systems. Clinically approved robotic systems offer similar efficacy profile in comparison to the manual technique, while some demonstrate better safety outcomes. The introduction (i.e., STXS) or optimization (i.e., Hansen medical) of contact force sensors may minimize the differences in mechanical 379

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complication rates among various robotic systems and in comparison to the manual technique. Outcomes comparison among various robotic systems requires large multicenter trials and major financial support. In the view of the current health economic challenges, it is important to access economical value of these systems. Such assessment is a complex exercise, both efficacy and safety outcomes should be taken into consideration. Robotic systems may have particular value in complex ablations, where success and complication rates that variable using a manual approach are largely dependent on individual operator skill. With more research involving robotic systems, operators may be able to offer patients not only better and uniform success rates, but also lower complication rates. The future will

be in favor of a robotic system that combines the advantages of both mechanical and magnetic forces. The learning curve of operators might be improved with the future use of computerized simulations to master the skills needed for those robotized devices. Financial & competing interests disclosure

E Gang owns shares in Magnetecs Corp. E Khan is a paid consultant for Catheter Robotics, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Key issues • Robotics in cardiac electrophysiology has expanded since initially introduced 10 years ago. • Each robotic system has advantages and limitations related to the underlying manipulation mechanism and related tools. • Robotics has possibly similar efficacy outcomes in comparison to manual technique, but likely superior safety outcomes. • Efficacy and safety of each robotic system is variable based on the operating platform. • Economic evaluation is needed to assess the true value of these systems. • Robotics with combination of magnetic and mechanical manipulation seems to be the most promising platform. • More research is needed to assess the true value of these systems.

meta-analysis. Expert Rev Cardiovasc Ther 2013;11(7):829-36

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Robotics in invasive cardiac electrophysiology.

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine st...
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