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Utility of novel nonfluoroscopic 4D navigation technology for catheter ablation
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EDITORIAL COMMENTARY
Utility of novel nonfluoroscopic 4D navigation technology for catheter ablation Hiroshige Yamabe, MD, PhD From the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Japan. To guide catheter ablation procedures during treatment of various forms of tachyarrhythmias, reconstruction of the cardiac chamber using either the CARTO or the EnSite NavX nonfluoroscopic 3-dimensional system has been performed extensively.1,2 Earley et al3 compared the utility of nonfluoroscopic mapping systems, specifically the CARTO and EnSite NavX, with that of conventional mapping in patients referred for catheter ablation of a wide variety of arrhythmias. They found that CARTO and EnSite NavX procedures demonstrated similar effectiveness and safety as a conventional approach; however, they both reduced X-ray exposure, with NavX producing a significantly greater effect than CARTO.3 Estner et al4 investigated the feasibility of performing segmental pulmonary vein isolation guided by the NavX system. They reported that the 3-dimensional visualization of the catheters by NavX system allowed rapid and precise visualization of the mapping and ablation catheters at the pulmonary vein ostia and markedly reduced fluoroscopy time, total X-ray exposure, and procedural duration during pulmonary vein isolation compared with ablation performed under fluoroscopic guidance.4 More recently, Finlay et al5 compared the efficacy of 3-dimensional reconstruction of the left atrium into a cardiac mapping system between the NavX fusion and Cartomerge during atrial fibrillation catheter ablation procedures. They reported that Cartomerge appeared to be faster and used less fluoroscopy to achieve registration than NavX fusion, but overall procedural times and clinical outcomes were similar between the two systems.5 These systems provide static 3-dimensional maps of a chamber in a moving target organ. Because respiratory and cardiac motion affect chamber movement, the inability to show real-time motion of the ablation catheter together with the target atrial or ventricular chamber limits the accurate localization of the target area of the tachyarrhythmia. Recently, a novel sensorbased electromagnetic tracking system (MediGuide Technology, St. Jude Medical Inc, St Paul, MN) has been Address reprint requests and correspondence: Dr. Hiroshige Yamabe, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo Kumamoto City, 860-8556 Japan. E-mail address: [email protected].
1547-5271/$-see front matter B 2013 Heart Rhythm Society. All rights reserved.
introduced. Miniaturized single coil sensors, which are mounted on a diagnostic electrode catheter or ablation catheter, enable real-time tracking of the catheter within a dynamic electromagnetic field provided by a transmitter unit.6,7 Because the transmitter unit is installed within the fluoroscopy detector of a conventional flat-panel X-ray imaging system, sensor-mounted electrode catheters are visualized 3-dimensionally in real time, resulting in 4dimensional visualization within preacquired X-ray cine loops.6,7 In this issue of HeartRhythm, Rolf et al8 examined the usefulness of the MediGuide Technology, a novel sensorbased electromagnetic 4-dimensional navigation system, in catheter ablation of atrial fibrillation. For their purposes, they analyzed procedural parameters required for catheter ablation of atrial fibrillation using a MediGuide Technology–enabled ablation catheter. MediGuide Technology catheters were used in 80 patients presenting with atrial fibrillation who underwent circumferential pulmonary vein isolation accompanied by substrate modification. Isolation of the pulmonary vein was achieved in all patients, and additional substrate modification was performed in 17 patients with a median fluoroscopy time of 4.4 minutes and an irradiation dose of 2115 cGycm2. This is the first report of clinical experience involving atrial fibrillation ablation with MediGuide Technology–enabled ablation catheters. This study demonstrated how this technology is easily integrated into the workflow of atrial fibrillation ablation therapy and high-quality nonfluoroscopic 4-dimensional catheter tracking coupled with very low radiation exposure. In their previous study, Rolf et al9 used MediGuide Technology for the deployment of diagnostic catheters but not for the tracking of ablation catheters in atrial fibrillation catheter ablation. Forty-nine patients received atrial fibrillation ablation therapy utilizing the MediGuide Technology–enabled NavX-EnSite system, and the fluoroscopy time of these patients was significantly reduced compared to the matched control patients ablated with a conventional NavX EnSite system (31 vs 16 minutes; P o .001).9 Furthermore, the irradiation dose of the MediGuide Technology patient group was significantly lower than that of the matched control group (7363 ⫾ 5827 cGycm2 vs 14453 ⫾ 7403 cGycm2; P o .001).9 Median total http://dx.doi.org/10.1016/j.hrthm.2013.05.018
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fluoroscopy time of 4.4 minutes and median irradiation dose of 2115 cGycm2 in the present report8 were much more lower than those reported in their previous study.9 These reductions in fluoroscopy time and irradiation dose seem to be caused by the additional use of MediGuide Technology–enabled ablation catheters; however, this is not necessarily evident because catheter ablation procedures in their previous study9 were more complex (ie, box isolation and mitral isthmus ablation) compared with the current report.8 It would appear to be prudent, therefore, to perform a broader comparison of the procedural parameters between different groups with and without the use of MediGuide Technology–enabled ablation catheters to further confirm the usefulness of MediGuide Technology–guided catheter ablation therapy for atrial fibrillation. Also, a randomized trial comparing standard vs 4-dimensional navigation would allow crucial comparisons with regard to safety and clinical efficacy. Recently, the same group reported that MediGuide Technology allowed successful ablation procedures with short fluoroscopy times in typical atrial flutter cases.10 In 10 patients who underwent catheter ablation of typical atrial flutter, anatomic cavotricuspid isthmus reconstruction was performed using 2 sensorequipped MediGuide catheters within the EnSite NavX system. Ablation procedures were performed with a conventional 8-mm-tip ablation catheter. Noteworthy, successful anatomic cavotricuspid isthmus reconstruction was achieved, and complete cavotricuspid isthmus block was documented in all patients. Use of the MediGuide Technology system resulted in a fluoroscopy time of 2.5 ⫾ 2 minutes.10 Furthermore, they also showed that the MediGuide Technology contributed to a drastic reduction in radiation exposure when used for several different types of supraventricular tachycardias.11 Catheter ablation was performed using the MediGuide Technology system in 24 patients with supraventricular tachycardia. In all patients, diagnostic catheters and/or ablation catheters with a special sensor were used.11 Fluoroscopy time and median fluoroscopy dose in the MediGuide Technology system group both were significantly lower than those in a conventionally ablated group (0.5 ⫾ 1.4 minutes vs 10.2 ⫾ 9.6 minutes; P o .001; and 187 ⫾ 554 cGycm2 vs
Heart Rhythm, Vol 0, No 0, Month 2013 996 ⫾ 2593 cGycm2; P o .05).11 These results support the usefulness of this novel sensor-based electromagnetic 4-dimensional navigation system. These findings open the door to safer and therefore more effective potential future applications of this technology during invasive cardiac electrophysiology. Further application of this technology to the sheath or multipolar electrode catheters associated with shaft visualization would allow safer and more effective catheter ablation procedures for various types of tachyarrhythmias.
References 1. Khongphatthanayothin A, Kosar E, Nademanee K. Nonfluoroscopic threedimensional mapping for arrhythmia ablation: tool or toy? J Cardiovasc Electrophysiol 2000;11:239–243. 2. Novak PG, Macle L, Thibault B, Guerra PG. Enhanced left atrial mapping using digitally synchronized NavX three-dimensional nonfluoroscopic mapping and high-resolution computed tomographic imaging for catheter ablation of atrial fibrillation. Heart Rhythm 2004;1:521–522. 3. Earley MJ, Showkathali R, Alzetani M, et al. Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 2006;27:1223–1229. 4. Estner HL, Deisenhofer I, Luik A, et al. Electrical isolation of pulmonary veins in patients with atrial fibrillation: reduction of fluoroscopy exposure and procedure duration by the use of a non-fluoroscopic navigation system (NavX). Europace 2006;8:583–587. 5. Finlay MC, Hunter RJ, Baker V, et al. A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial. J Interv Card Electrophysiol 2012;33:161–169. 6. Piorkowski C, Hindricks G. Nonfluoroscopic sensor-guided navigation of intracardiac electrophysiology catheters within prerecorded cine loops. Circ Arrhythm Electrophysiol 2011;4:e36–e38. 7. Fenici R, Brisinda D. From 3D to 4D imaging: is that useful for interventional cardiac electrophysiology? Conf Proc IEEE Eng Med Biol Soc 2007;2007: 5996–5999. 8. Rolf S, John S, Gaspar T, et al. Catheter ablation of atrial fibrillation supported by novel nonfluoroscopic 4D navigation technology. Heart Rhythm 2013;10:000– 000. 9. Rolf S, Sommer P, Gaspar T, et al. Ablation of atrial fibrillation using novel 4-dimensional catheter tracking within autoregistered left atrial angiograms. Circ Arrhythm Electrophysiol 2012;5:684–690. 10. Sommer P, Wojdyla-Hordynska A, Rolf S, et al. Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter tracking system. Europace 2013;15:578–581. 11. Sommer P, Piorkowski C, Gaspar T, et al. MediGuide in supraventricular tachycardia: initial experience from a multicentre registry. Europace 2013; doi:10.1093/europace/eut090.
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EDITORIAL COMMENTARY
Utility of novel nonfluoroscopic 4D navigation technology for catheter ablation Hiroshige Yamabe, MD, PhD From the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Japan. To guide catheter ablation procedures during treatment of various forms of tachyarrhythmias, reconstruction of the cardiac chamber using either the CARTO or the EnSite NavX nonfluoroscopic 3-dimensional system has been performed extensively.1,2 Earley et al3 compared the utility of nonfluoroscopic mapping systems, specifically the CARTO and EnSite NavX, with that of conventional mapping in patients referred for catheter ablation of a wide variety of arrhythmias. They found that CARTO and EnSite NavX procedures demonstrated similar effectiveness and safety as a conventional approach; however, they both reduced X-ray exposure, with NavX producing a significantly greater effect than CARTO.3 Estner et al4 investigated the feasibility of performing segmental pulmonary vein isolation guided by the NavX system. They reported that the 3-dimensional visualization of the catheters by NavX system allowed rapid and precise visualization of the mapping and ablation catheters at the pulmonary vein ostia and markedly reduced fluoroscopy time, total X-ray exposure, and procedural duration during pulmonary vein isolation compared with ablation performed under fluoroscopic guidance.4 More recently, Finlay et al5 compared the efficacy of 3-dimensional reconstruction of the left atrium into a cardiac mapping system between the NavX fusion and Cartomerge during atrial fibrillation catheter ablation procedures. They reported that Cartomerge appeared to be faster and used less fluoroscopy to achieve registration than NavX fusion, but overall procedural times and clinical outcomes were similar between the two systems.5 These systems provide static 3-dimensional maps of a chamber in a moving target organ. Because respiratory and cardiac motion affect chamber movement, the inability to show real-time motion of the ablation catheter together with the target atrial or ventricular chamber limits the accurate localization of the target area of the tachyarrhythmia. Recently, a novel sensorbased electromagnetic tracking system (MediGuide Technology, St. Jude Medical Inc, St Paul, MN) has been Address reprint requests and correspondence: Dr. Hiroshige Yamabe, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo Kumamoto City, 860-8556 Japan. E-mail address: [email protected].
1547-5271/$-see front matter B 2013 Heart Rhythm Society. All rights reserved.
introduced. Miniaturized single coil sensors, which are mounted on a diagnostic electrode catheter or ablation catheter, enable real-time tracking of the catheter within a dynamic electromagnetic field provided by a transmitter unit.6,7 Because the transmitter unit is installed within the fluoroscopy detector of a conventional flat-panel X-ray imaging system, sensor-mounted electrode catheters are visualized 3-dimensionally in real time, resulting in 4dimensional visualization within preacquired X-ray cine loops.6,7 In this issue of HeartRhythm, Rolf et al8 examined the usefulness of the MediGuide Technology, a novel sensorbased electromagnetic 4-dimensional navigation system, in catheter ablation of atrial fibrillation. For their purposes, they analyzed procedural parameters required for catheter ablation of atrial fibrillation using a MediGuide Technology–enabled ablation catheter. MediGuide Technology catheters were used in 80 patients presenting with atrial fibrillation who underwent circumferential pulmonary vein isolation accompanied by substrate modification. Isolation of the pulmonary vein was achieved in all patients, and additional substrate modification was performed in 17 patients with a median fluoroscopy time of 4.4 minutes and an irradiation dose of 2115 cGycm2. This is the first report of clinical experience involving atrial fibrillation ablation with MediGuide Technology–enabled ablation catheters. This study demonstrated how this technology is easily integrated into the workflow of atrial fibrillation ablation therapy and high-quality nonfluoroscopic 4-dimensional catheter tracking coupled with very low radiation exposure. In their previous study, Rolf et al9 used MediGuide Technology for the deployment of diagnostic catheters but not for the tracking of ablation catheters in atrial fibrillation catheter ablation. Forty-nine patients received atrial fibrillation ablation therapy utilizing the MediGuide Technology–enabled NavX-EnSite system, and the fluoroscopy time of these patients was significantly reduced compared to the matched control patients ablated with a conventional NavX EnSite system (31 vs 16 minutes; P o .001).9 Furthermore, the irradiation dose of the MediGuide Technology patient group was significantly lower than that of the matched control group (7363 ⫾ 5827 cGycm2 vs 14453 ⫾ 7403 cGycm2; P o .001).9 Median total http://dx.doi.org/10.1016/j.hrthm.2013.05.018
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fluoroscopy time of 4.4 minutes and median irradiation dose of 2115 cGycm2 in the present report8 were much more lower than those reported in their previous study.9 These reductions in fluoroscopy time and irradiation dose seem to be caused by the additional use of MediGuide Technology–enabled ablation catheters; however, this is not necessarily evident because catheter ablation procedures in their previous study9 were more complex (ie, box isolation and mitral isthmus ablation) compared with the current report.8 It would appear to be prudent, therefore, to perform a broader comparison of the procedural parameters between different groups with and without the use of MediGuide Technology–enabled ablation catheters to further confirm the usefulness of MediGuide Technology–guided catheter ablation therapy for atrial fibrillation. Also, a randomized trial comparing standard vs 4-dimensional navigation would allow crucial comparisons with regard to safety and clinical efficacy. Recently, the same group reported that MediGuide Technology allowed successful ablation procedures with short fluoroscopy times in typical atrial flutter cases.10 In 10 patients who underwent catheter ablation of typical atrial flutter, anatomic cavotricuspid isthmus reconstruction was performed using 2 sensorequipped MediGuide catheters within the EnSite NavX system. Ablation procedures were performed with a conventional 8-mm-tip ablation catheter. Noteworthy, successful anatomic cavotricuspid isthmus reconstruction was achieved, and complete cavotricuspid isthmus block was documented in all patients. Use of the MediGuide Technology system resulted in a fluoroscopy time of 2.5 ⫾ 2 minutes.10 Furthermore, they also showed that the MediGuide Technology contributed to a drastic reduction in radiation exposure when used for several different types of supraventricular tachycardias.11 Catheter ablation was performed using the MediGuide Technology system in 24 patients with supraventricular tachycardia. In all patients, diagnostic catheters and/or ablation catheters with a special sensor were used.11 Fluoroscopy time and median fluoroscopy dose in the MediGuide Technology system group both were significantly lower than those in a conventionally ablated group (0.5 ⫾ 1.4 minutes vs 10.2 ⫾ 9.6 minutes; P o .001; and 187 ⫾ 554 cGycm2 vs
Heart Rhythm, Vol 0, No 0, Month 2013 996 ⫾ 2593 cGycm2; P o .05).11 These results support the usefulness of this novel sensor-based electromagnetic 4-dimensional navigation system. These findings open the door to safer and therefore more effective potential future applications of this technology during invasive cardiac electrophysiology. Further application of this technology to the sheath or multipolar electrode catheters associated with shaft visualization would allow safer and more effective catheter ablation procedures for various types of tachyarrhythmias.
References 1. Khongphatthanayothin A, Kosar E, Nademanee K. Nonfluoroscopic threedimensional mapping for arrhythmia ablation: tool or toy? J Cardiovasc Electrophysiol 2000;11:239–243. 2. Novak PG, Macle L, Thibault B, Guerra PG. Enhanced left atrial mapping using digitally synchronized NavX three-dimensional nonfluoroscopic mapping and high-resolution computed tomographic imaging for catheter ablation of atrial fibrillation. Heart Rhythm 2004;1:521–522. 3. Earley MJ, Showkathali R, Alzetani M, et al. Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 2006;27:1223–1229. 4. Estner HL, Deisenhofer I, Luik A, et al. Electrical isolation of pulmonary veins in patients with atrial fibrillation: reduction of fluoroscopy exposure and procedure duration by the use of a non-fluoroscopic navigation system (NavX). Europace 2006;8:583–587. 5. Finlay MC, Hunter RJ, Baker V, et al. A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial. J Interv Card Electrophysiol 2012;33:161–169. 6. Piorkowski C, Hindricks G. Nonfluoroscopic sensor-guided navigation of intracardiac electrophysiology catheters within prerecorded cine loops. Circ Arrhythm Electrophysiol 2011;4:e36–e38. 7. Fenici R, Brisinda D. From 3D to 4D imaging: is that useful for interventional cardiac electrophysiology? Conf Proc IEEE Eng Med Biol Soc 2007;2007: 5996–5999. 8. Rolf S, John S, Gaspar T, et al. Catheter ablation of atrial fibrillation supported by novel nonfluoroscopic 4D navigation technology. Heart Rhythm 2013;10:000– 000. 9. Rolf S, Sommer P, Gaspar T, et al. Ablation of atrial fibrillation using novel 4-dimensional catheter tracking within autoregistered left atrial angiograms. Circ Arrhythm Electrophysiol 2012;5:684–690. 10. Sommer P, Wojdyla-Hordynska A, Rolf S, et al. Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter tracking system. Europace 2013;15:578–581. 11. Sommer P, Piorkowski C, Gaspar T, et al. MediGuide in supraventricular tachycardia: initial experience from a multicentre registry. Europace 2013; doi:10.1093/europace/eut090.
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