Review

Continuing Medical EducationNature Clinical Practice Cardiovascular Medicine (2008) 5, 148-156
doi:10.1038/ncpcardio1095  
Received 13 September 2007 | Accepted 16 November 2007 | Published online: 5 February 2008

Technology Insight: magnetic navigation in coronary interventions

Steve Ramcharitar, Mark S Patterson, Robert Jan van Geuns, Carlos van Meighem and Patrick W Serruys*  About the authors

Correspondence *Thoraxcenter, Building Ba583a, Dr Molerwaterplein 40, 3015–GD Rotterdam, The Netherlands

Email
 p.w.j.c.serruys@erasmusmc.nl

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Medscape Continuing Medical Education online
Medscape, LLC is pleased to provide online continuing medical education (CME) for this journal article, allowing clinicians the opportunity to earn CME credit. Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide CME for physicians. Medscape, LLC designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. All other clinicians completing this activity will be issued a certificate of participation. To receive credit, please complete the post-test.

Learning objectives

Upon completion of this activity, participants should be able to:

  1. Describe recent areas of growth in interventional cardiology.
  2. Describe the history of development of electro–magnets as guidewires for use in interventional cardiology.
  3. Identify components of a magnetic navigational system (MNS).
  4. Describe the efficacy of the MNS as a primary intervention and a secondary intervention after failed percutaneous coronary intervention.
  5. Describe currently available strategies for crossing chronic total occlusions using MNS.

Competing interests

The authors declared no competing interests. Désirée Lie, the CME questions author, declared no relevant financial relationships.

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Summary

Magnetic navigation is rapidly emerging as a useful technology in the field of interventional cardiology. Precise control of the direction of a guide wire or a device in three-dimensional space offers a means to access vessels and areas of the heart that are often challenging to access with conventional methods. In this comprehensive Review, we detail the development of magnetic navigation technology and how this tool has been adapted for use during percutaneous coronary intervention. We aim to provide an up-to-date analysis of what is currently possible with this technology and an insight into what the future holds, particularly with respect to chronic occluded arteries and cell transplantation.

Review criteria

Stereotactic magnetic navigation is a new technology; the references used in this Review were chosen to highlight the development of this technology and its extension to the field of interventional cardiology. We did not include the use of magnetic navigation in electrophysiological cardiac studies or neuroradiology. The selected papers used were all full-text papers and were published in English. The PubMed search terms used were: "magnetic navigation", "percutaneous intervention", "new technologies" and "stem-cell implantation".

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Introduction

The growth of interventional cardiology has led to numerous technological developments:1 the development of metallic and biodegradable stents that elute novel bioactive molecules;2 specialized guidewires with subtle differences for accessing different types of lesion;3 and various new pharmacological agents.4 One area that has not seen substantial progress thus far is the technology used to precisely guide a wire across a lesion. In most instances, crossing a lesion still relies heavily on both the skills of the interventional cardiologist performing the procedure and the mechanical properties of the guidewire. The Niobe® Magnetic Navigation System (MNS; Stereotaxis Inc., St Louis, MO) is a novel technology that can precisely control the tip of a magnetically enabled wire or device in vivo.5 Preliminary data suggest that the MNS could be useful in tortuous vessels or in complex lesions such as bifurcations, in which the initial bend placed on the wire might not be ideal for crossing tandem lesions.6 Magnetic navigation also means the wire is less likely to deviate into side branches, therefore, reducing radiation exposure and the amount of contrast required.7 The combination of dedicated magnetically enabled devices with three-dimensional (3D) imaging methodologies such as multislice CT (MSCT) and the NOGA® mapping system (Cordis Corporation, Miami Lakes, FL), can increase the accuracy in targeting chronic total occlusions (CTOs) and stem-cell implantation.

To date, the transition of this technology into interventional cardiology has been slow. In many centers the MNS was first used in cardiac electrophysiological procedures, for which the benefits are well established; only now are centers extending the use of this technology to the interventional setting, despite the obvious advantages that the MNS offers. This somewhat cautionary approach stems from the fact that no randomized clinical trials have currently compared the MNS with older, more-established techniques. This issue clearly needs addressing, with future developments in both the software and hardware designs being investigated in timely clinical trials. At present, the expenses incurred in setting up an MNS will also influence its popularity. This Review discusses some of the major technological developments in the context of interventional cardiology and provides an insight into what is currently possible and what might be possible with this novel technology in the future.

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Early developments

Vascular studies using magnetic navigation first began over 50 years ago when Llander,8 and later Tillander,9 used magnetic fields to guide an articulated steel-tip catheter in rabbit aorta. After these initial investigations, small external permanent magnets were used to stereotactically direct iron particles for thrombosis of intracranial aneurysms,10, 11, 12 later, rotating electromagnets were used, enabling better control.13 In 1991, Ram and Meyer performed the first magnetically guided angiography in a human. They successfully used a magnetized catheter controlled with external permanent magnets in a neonate with anatomically complex congenital heart disease.14 Despite initial success, further development was hampered by low field strengths, the need for large magnets and the lack of precise 3D control.15, 16 In order for stereotactic localization and computer-controlled vector guidance to be possible, considerable advances in both medical physics and magnet design were required.17 Further advancements in these areas and the use of MRI coregistered with real-time fluoroscopy enabled the navigation of both a small object in a canine brain18 and magnetically enabled catheters in pig brains.19 These experiments led to the MNS first being used in interventional radiology and cardiac electrophysiology, and now in interventional cardiology.20, 21, 22 Across these disciplines there are now more than 100 systems installed worldwide. It should be noted, however, that applying this technology in interventional cardiology presents a greater challenge than in more established indications such as neurosurgery. Unlike the brain, the heart is a dynamic structure, and the patient's chest moves with respiration.

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The MNS and intervention: what is currently possible?

Patent coronary arteries

Tortuous and severely angulated coronary arteries are associated with reduced procedural success rates and a raised incidence of CABG surgery.30 A guidewire must be maneuvered without causing complications such as dissection or perforation. Several phantom studies in hepatic celiac arteries and the cerebral arteries have demonstrated higher procedural success using the MNS than with manual manipulation, and shown that the MNS is easier, more accurate and faster even when used by inexperienced operators.31, 32, 33 Studies in a coronary phantom, however, reported longer crossing times with the MNS than with a standard wire, although fluoroscopic times were significantly reduced.34 The longer crossing times could have been related to the use of first generation Cronus® (Stereotaxis Inc., St Louis, MO) magnetic wires—subsequent generations have been easier to track. Indeed, a recent 2D phantom study using five increasingly tortuous vessel models found that as vessel complexity increased the newer generation wires—Titan® and Pegasus® (Stereotaxis Inc., St Louis, MO) —were significantly better in reducing both the crossing and fluoroscopy times than were conventional wires.35 Moreover, in some of the phantom models, prior experience of magnetic navigation was not a prerequisite for successful crossing. Overall wire usage was significantly reduced with the MNS.

A seminal paper by Atmakuri et al. showed the effectiveness of magnetic navigation during percutaneous coronary intervention (PCI) in native coronary arteries that would have been difficult to cross with conventional methods because of severe tortuousity.36 In this study of 68 lesions in 59 patients, successful MNS crossings were achieved in 85% of cases. More importantly perhaps, magnetically guided intervention was successful in 9 (63%) of the 13 patients in whom PCI with a conventional wire had previously failed. The procedural success rates for magnetically guided intervention as the primary intervention and following failed conventional PCI ('secondary' intervention) were 84% and 62%, respectively, with longer median fluoroscopy and crossing times observed in secondary procedures. Similar success was reported in a study of 21 consecutive diseased coronary arteries, although guidewire navigation with the MNS was found to be slower than manual navigation.37 The patients enrolled in this study did, however, have simple, straightforward lesions indicating that the MNS could be more suitable for use in complex coronary lesions and as a secondary procedure following failed conventional wire placement. This theory is exemplified further by the successful results seen when the MNS was used following an unsuccessful alcohol septal ablation that failed because of severe angulation (130°),38 and when used to cross a crushed stent of a bifurcation that was complicated by dissection.39 At present it is not clear how wide the applicability of magnetic-assisted navigation is likely to be in patent vessels. In order to evaluate this issue, our group has been assessing prolonged conventional crossing times to characterize the lesions and vessels that might be appropriate for magnetic navigation.

Occluded coronary arteries

CTOs have been described as one of the last frontiers in interventional cardiology.40 Despite advances in technology and the development of specialized devices and dedicated wires, the rate of successful crossings is still unsatisfactory.41 An attractive strategy for treatment of CTOs was postulated by Serruys in 2006.1 The first stage of this strategy involves magnetic navigation to steer a guidewire through the occlusion. Second, optical coherence tomography, intravascular ultrasonography or MSCT cross sections are employed to 'look forward' within the vessel to ensure that the wire is ideally positioned in the true lumen. Finally, ablative power at the tip of the wire is used to recanalize the CTO.42 The first successful study to demonstrate the feasibility of MSCT angiography and magnetic-enabled PCI used a system that 'looked forward' at the occlusion—the bull's eye view—making the search pattern for microchannels through the occlusion more uniform by avoiding repetitions.43 Although mapping the occluded segments was easily accomplished, the bulky 2–3 mm magnetic tips used were a notable limitation. Furthermore, the fact that navigation was performed using a fixed roadmap (centerline) rather than a dynamic one gated to the electrocardiogram meant that there was discordance between the live fluoroscopy image and the centerline—another limitation. Ordinarily, when navigating through a patent vessel this discordance is not a problem as the wire is contained within the vessel's lumen, so that when the heart moves with each beat the wire can still follow the trajectory of the predetermined vectors. In CTOs, however, the lack of a patent lumen means that as the heart moves, the tip of the wire can be perpendicular to the vascular wall and when pushed can protrude. Hence, it is of paramount importance to develop technologies that allow dynamic road mapping (centerline) to be superimposed on the live fluoroscopy image, especially when considering magnetic-enabled radiofrequency ablation. Paieon Inc. is developing a dynamic road-mapping system based on their software that can recognize systolic and diastolic phases on fluoroscopic images. This system might have a role in patent vessels or those with subtotal occlusion, but not necessarily in CTOs because contrast media is needed to demarcate the vessel contours.

Much more appealing are methods aimed at electrocardiographic phase gating of the MSCT-derived centerline to the live fluoroscopic image following alignment to recognizable landmarks such as spinous processes and the catheter tip. This technique ensures that at a designated point in the cardiac cycle both the centerline and the live fluoroscopic image of the vessel are superimposed, enabling safe advancement of the ablating wire. Development of the magnetic-enabled wire with radiofrequency ablation functionality is nearing completion (Figure 6). This device is composed of a 0.014 inch wire with a small radiofrequency electrode at its tip and three small magnets embedded proximally. An external generator supplies the radiofrequency energy needed for ablation. A safety and feasibility pilot study of this wire in 'within-stent' CTOs is planned for early 2008 at the Thoraxcenter, Rotterdam, The Netherlands.

Figure 6 A diagrammatic representation of the magnetically enabled radiofrequency ablating wire for chronic total occlusions.
Figure 6 : A diagrammatic representation of the magnetically enabled radiofrequency ablating wire for chronic total occlusions. Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

 

Full figure and legend (10K)Figures & Tables indexDownload PowerPoint slide (216K)

Stem-cell injection

Intramyocardial injection of bone-marrow-derived stem cells is a novel technology that has the potential to induce myocardial regeneration and improvement in left ventricular function.44 Currently, electromechanically guided injection is the preferred mode of delivery in patients with chronic myocardial ischemia.45 Indeed, clinical studies have shown that transendocardial injections of stem cells using the NOGA® mapping system are feasible and safe46 In this system, once the mapping electrode makes a good contact with the myocardium and the operator recognizes the appropriate electrical signal strengths, stem cells are injected through a needle linked to the device. One major drawback with this system is the difficulty of reaching remote areas of the left ventricle with manual manipulation of the catheter. This drawback can be addressed by using the magnetically enabled MNS-guided NOGA® electromechanical mapping catheter (Stereotaxis Inc.; Figure 7). The guiding can be performed remotely to reduce operator radiation exposure. Moreover, the magnetic momentum at the catheter tip precludes the need for shaft support, allowing the use of a softer catheter that is less likely to penetrate the myocardium and cause a perforation. By using MSCT or MRI to identify the infarcted area, relevant data can be integrated into Navigant® to further augment the accuracy of target localization.

Figure 7 A diagrammatic representation of magnetically enabled cell injection catheter following an automatic map in the myocardium.
Figure 7 : A diagrammatic representation of magnetically enabled cell injection catheter following an automatic map in the myocardium. Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

 

Full figure and legend (12K)Figures & Tables indexDownload PowerPoint slide (218K)

A recent animal study showed the preclinical feasibility of Stereotaxis-compatible NOGASTAR mapping and MYOSTAR® injection catheters (Cordis Corporation, Miami Lakes, FL) both equipped with a small permanent magnet at the tip.47 Remote NOGA® mapping was possible with a computer-controlled catheter advancement system (Cardiodrive unit; Stereotaxis Inc., St Louis, MO). The introduction of the NOGA® map into Navigant® provided 3D vectors for the navigation of a magnetically enabled MYOSTAR® catheter. The combination of these technologies resulted in a 95.8% success rate of magnetic-guided injection of mesenchymal precursor cells into the myocardium. When labeled, cells were detected in all but one segment on histology.

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What does the future hold?

Magnetic navigation is still in the developmental phase and as such will not revolutionize the way we currently perform PCI. By considering magnetic navigation as an adjunct technique to current practices, however, this technique could be used to beneficial effect in clinical situations that are technically difficult or associated with low procedural success. The development of both software and hardware is, therefore, in the context of adjunct therapy. More powerful magnetic fields (i.e. 0.1–0.12 Tesla, increased from the current 0.08) and software upgrades to further improve the precision of wire control are in development. In terms of CTOs, future developments include dynamic road mapping and appropriate gating of the MSCT images with real-time fluoroscopic images. In addition, alignment between angiographically determined 3D reconstructed nonoccluded segments and the occluded sections obtained through MSCT will be more accurate. Moreover, as MSCT cross-section analysis provides important information on plaque composition and can accurately identify the vessel's border—a 'true' centerline can be reconstructed by 'stacking' the gated cross sections if the center of each cross section (Figure 5b) is determined precisely. Incorporation of this idea in future versions of the Navigant® software is being contemplated, so that a gated wire can be advanced in a frame-like fashion to ensure central wire transit. The unwarranted complexity of several MNS workstations, which can slow processing speed, will be reduced in the future by a new single-screen user interface (Odyssey Network Solutions, Stereotaxis, St Louis, MO) that links diagnostic information from several sources. To further improve the speed of navigation without compromising safety there will, however, need to be improvements in alignment of the centerline to the real-time fluoroscopy image, possibly through dynamic electrocardiographic gating. This improvement would allow the operator to drag the vector with confidence, instead of using 1–5 mm jumps along the centerline. With this development, the MNS could then compete with conventional wires in all lesions, not just complex cases.

New advances in material science have permitted the development of several guidewires with variable degrees of support and flexibility, tailored to individual coronary lesions. The newest generation in wire design—the Pegasus®—is made from a nitinol–stainless steel composite for improved flexibility with minimal deformity. Future wire-related developments will include magnets that can change the stiffness of the wire to improve the delivery of a device, multimagnet configurations to enable smoother transition across the tip, and wires with the ability to feedback their position in space. The ability to accurately identify a wire's position can be useful when combined with a robotic wire advancement system. To date, such systems have been successfully employed in electrophysiological procedures48, 49 but have not yet been extended to MNS-guided PCI. A stand-alone remote navigation system (CorPath®, Corindus Ltd, Haifa, Israel) for wire advancement and stent deployment using a joystick to control the wire's axial (i.e. advance, retract) and rotational movements has been shown to be feasible,50 which opens the possibility of linking such a device to the MNS to achieve full automation.

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Limitations

Even though the concept of directional wire guidance has been effectively realized, the areas in which the system offers a clear advantage over current approaches still need to be identified, which explains the slow market penetration in interventional cardiology. In addition, apart from a few institutional registries, there are limited data on this new technology. The lack of randomized, controlled trials makes comparisons with existing technologies purely speculative. Furthermore, new operators experience a learning phase before achieving an adequate level of competence, irrespective of whether they are a physician or technical staff. Similarly, as the software develops, there is a need for continuing educational updates or seminars to ensure that operators are kept abreast of new developments.

At present, the main limitation with the software remains the alignment of the virtual image to the real-time image. There is also a need for dynamic road mapping of the vessel; at present operators navigate through a static image. The 3D-reconstruction packages used still have limitations with respect to accuracies in tracing the vascular contours from which the central path for navigation is ultimately derived. The physical limitations of magnets attached to the wire tip could hinder advancement in extremely tortuous vessels, highlighting the importance of the multimagnet design that offers a smoother transition. Ultimately, the success of 3D magnetic-enabled procedures still depends heavily on the time it takes to prepare the road map. The time taken can vary enormously depending on the vessel characteristics and must, therefore, be taken into account during procedural planning. The 2D navigation approach is quicker; however, the level of accuracy is compromised.

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Conclusions

Magnetic navigation in coronary intervention is rapidly evolving. State-of-the-art magnetic devices are now competing with conventional nonmagnetically enabled wires and devices. These technological advances are creating new roles for stereotactic magnetic navigation, which in the future will include a wider range of invasive cardiac procedures.

Key points

  • The magnetic navigation system offers complete in vivo omnidirectional guidewire manipulation
  • Precision in guidance is achieved through navigational vectors within a magnetic field
  • To increase accuracy the system integrates three-dimensional imaging modalities and three-dimensional virtual reconstruction software
  • The system can improve clinical success in complex lesion subgroups and can limit the contrast usage
  • A number of recent technological advancements have been successful in targeting chronically occluded vessels, and promising results have been demonstrated with magnetic-aided stem-cell implantation
  • Randomized trials are needed to prove the clinical effectiveness of magnetic navigation

Acknowledgments

Désirée Lie, University of California, Irvine, CA, is the author of and is solely responsible for the content of the learning objectives, questions and answers of the Medscape-accredited continuing medical education activity associated with this article.

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Competing interests

The authors declared no competing interests.

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Subject areas under which this article appears: Intervention