Assessment of intracardiac magnetic navigation system Niobe®, systematic review
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Dec 12, 2010
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Abstract
Introduction and objective: Current methods of ablation involving manual navigation systems and cardiac ablation have some limitations. The aim of this study was to evaluate the efficacy and safety of intracardiac magnetic navigation systems.
Methods: Systematic review in MedLine, Embase, Cochrane Library, Center for Review and Dissemination, ECRI, Hayes and HTA databases was performed. The used Mesh terms were: “electrophisiologic techniques”, “magnetic”, “stereotaxic techniques”, “heart catheterization”, and “catheter ablation”. Inclusion criteria were studies whose populations were adults with cardiac lesions. The intervention was intracardiac magnetic navigation system Niobe ® versus manual cardiac navigation techniques and manual ablation. The outcomes were total procedure time, fluoroscopy time, time of catheter positioning, mapping and ablation time. Quality of studies was assessed by CASPe and STROBE.
Results: 467 references were found and 14 were included: two clinical trials of moderate quality and 10 observational studies with low-moderate quality. The two trials had a total time of procedure by magnetic navigation systems equal or higher than conventional time (151 and 113 Vs. 151 and 77.2 minutes), whereas fluoroscopy times were lower (17.8 and 10.6 Vs. 27.1 and 15.0 minutes). Observational studies showed the total time intervention that ranged between 59 and 243 minutes for magnetic systems compared to 57-332 minutes using conventional techniques. All papers showed magnetic techniques are safe, with no serious adverse effects.
Conclusions: We could conclude that no evidence with high quality has been located to claim that intracardiac magnetic navigation systems clearly improve conventional systems.
Keywords
stereotaxic techniques, atrial fibrillation, ablation, técnicas estereotáxicas, fibrilación auricular, ablación,
References
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8. Ernst S. Robotic approach to catheter ablation. Curr Opin Cardiol. 2008; 23:28-31.
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11. Baumann M, Mahnken A, Floren M, Günther RW, Müller-Schulte D, Schmitz-Rode T. First results with catheter and magnetically guided and detached polymerized ferromagnetic particle filaments and heat-induced particle release using the Stereotaxis Niobe system. Rofo. 2006;178:911-7.
12. Ernst S, Ouyang F, Linder C, Hertting K, Stahl F, Chun J, et al. Initial experience with remote catheter ablation using a novel magnetic navigation system. Circulation. 2004;109:1472-5.
13. Thornton AS, Janse P, Thenus DAMJ, Scholten MF, Jordanes LJ. Magnetic navigation in AV nodal re-entrant tachycardia study: Early results of ablation with one- and three-magnet catheters. Europace. 2006;8:225-30.
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17. Vollmann D, Lüthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009;2:
18. Gallagher P, Martín L, Angel L, Tomassoni G. Initial clinical experience with a cardiac resynchronization therapy utilizing a magnetic navigation system. J Cardiovasc Electrophysiol. 2007; 2:174-80.
19. Pappone C, Vicedomini G, Manguso F, Mazzone P, Gugliotta F, Sala S, et al. Robotic magnetic navigation for atrial fibrillation ablation. J Am Coll Cardiol. 2006;47:1390-400.
20. Buergler JM, Alam S, Spencer W, Kleiman NS, Melendez Y, Franklin J, et al. Initial experience with alcohol septal ablation using a novel magnetic navigation system. J Interv Cardiol. 2007;20:559-63.
21 Kim AM, Turakhia M, Lu J, Badhwar N, Lee BK, Lee RJ, et al. Impact of remote magnetic catheter navigation on ablation fluoroscopy and procedure time. Pacing Clin Electrophysiol. 2008;31:1399-404.
22. Katsiyiannis WT, Melby DP, Matelski JL, Ervin VL, Laverence KL, Gornick CC. Feasibility and safety of remotecontrolled magnetic navigation for ablation of atrial fibrillation. Am J Cardiol. 2008;102:1674-6.
23. Ijsselmuiden AJ, Patterson MS, van Nooijen FC, Tangelder GJ, Dirksen MT, Amoroso G, et al. Magnetically navigated percutaneous coronary intervention in distal and/or complex lesions may improve procedural outcome and material consumption. Eurointerv. 2008;4:517-23.
24 Kerzner R, Sánchez JM, Osborn JL, Chen J, Faddis MN, Gleva MJ, et al.
Radiofrequency ablation of atrioventricular nodal reentrant tachycardia
using a novel magnetic guidance system compared with a conventional approach. Heart Rhythm. 2006;3:261-7.
25. Kiemeneij F, Patterson MS, Amoroso G, Laarman G, Slagboom T. Use of the Stereotaxis Niobe magnetic navigation system for percutaneous coronary intervention: Results from 350 consecutive patients. Catheter
Cardiovasc Interv. 2008;71:510-6.
26. Rivero-Ayerza M, Thornton AS, Theuns D, Scholten MF, Mekel JM, Res J, et al. Left ventricular lead placement within a coronary sinus side branch using remote magnetic navigation of a guidewire: a feasibility study. J Cardiovasc Electrophysiol. 2006;2: 27. Niobe® magnetic navigation guidance system for percutaneous coronary interventions in patients with cardiac arrhytmias. National Horizon Scanning Unit. Horizon scanning priorisiting summary. Australia and New Zealand Horizon Scanning Network. (Update 2007). Abril, 2005;9(1).
28. Advanced Electrophysiologic Mapping Systems. Health Technology Policy Assessment. Ontario, Canadá. Marzo 2006.
29. Tsuchida K, García-García HM, van der Giessen W, McFadden EP, van der Ent M, Sianos G, et al. Guidewire navigation in coronary artery estenosis using a novel magnetic navigation system: First clinical experience. Catheter Cardiovasc Interv. 2006;67:356-63.
30. Moreno J, Archondo T, Barrios R, Pérez-Castellano N, Porro R, García J, et al. La ablación de taquicardia intranodal con sistema de navegación remota Stereotaxis® precisa menores parámetros de temperatura y potencia por mejoría del contacto tisular. Rev Esp Cardiol. 2009;62:1001-11.
31. Canales EI, Córdova J, Escaned J, Hernández-Antolín R. Estereotaxis: una nueva alternativa para el tratamiento de lesiones con angulación y tortuosidad extrema que previamente se han fallado con técnicas convencionales. Rev Esp Cardiol. 2009;62:942-4.
32. Di Biase L, Fahmy TS, Patel D, Bai R, Civello K, Wazni OM, et al. Remote Magnetic Navigation. Human Experience in Pulmonary vein ablation. J Am Coll Cardiol. 2007;9:868-74.
33. Aryana A, d´Avila A, Heist EK, Mela T, Singh JP, Ruskin JN, et al. Remote magnetic navigation to guide endocardial and epicardial catheter mapping of scarrelated ventricular tachycardia. Circulation. 2007;115:1191-200.
2. Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: The Framingham Study. N Engl J Med. 1982;306:1018-22.
3. Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural
history of atrial fibrillation: Incidence, risk factors, and prognosis in the
Manitoba follow-up study. Am J Med. 1995;98:476-84.
4. Onundarson PT, Thorgeirsson G, Jonmundsson E, Sigfusson N,
Hardarson T. Chronic atrial fibrillationepidemiologic features and 14 year
follow-up: a case control study. Eur Heart J. 1987;8:521-7.
5. Álvarez M, Tercedor L. Epidemiología de las arritmias en España. Situación actual para su tratamiento, en Pérez-Villacastín J, editor. Arritmias: manejo práctico. Madrid: Sociedad Española de Cardiología. 2007;1-16.
6. Cea-Calvo L, Redón J, Lozano JV, Fernández-Pérez C, Martí-Canales JC, Llisterri JL, et al. Prevalencia de fibrilación auricular en la población
española de 60 ó más años de edad. Estudio PREV-ICTUS. Rev Esp Cardiol. 2007;60:616-24.
7. Schmidt B, Chun KR, Tilz RR, Koektuerk B, Ouyang F, Kuck KH. Remote navigation systems in electrophysiology. Europace. 2008;10(Suppl.3):iii57-61.
8. Ernst S. Robotic approach to catheter ablation. Curr Opin Cardiol. 2008; 23:28-31.
9. Darge A, Reynolds MR, Germano JJ. Advances in atrial fibrillation ablation. J Invasive Cardiol. 2009;21:247-54.
10. Pappone C, Santinelli V. Ablación de la fibrilación auricular: ¿dónde estamos? Rev Esp Cardiol. 2009;62:1087-91.
11. Baumann M, Mahnken A, Floren M, Günther RW, Müller-Schulte D, Schmitz-Rode T. First results with catheter and magnetically guided and detached polymerized ferromagnetic particle filaments and heat-induced particle release using the Stereotaxis Niobe system. Rofo. 2006;178:911-7.
12. Ernst S, Ouyang F, Linder C, Hertting K, Stahl F, Chun J, et al. Initial experience with remote catheter ablation using a novel magnetic navigation system. Circulation. 2004;109:1472-5.
13. Thornton AS, Janse P, Thenus DAMJ, Scholten MF, Jordanes LJ. Magnetic navigation in AV nodal re-entrant tachycardia study: Early results of ablation with one- and three-magnet catheters. Europace. 2006;8:225-30.
14. Critical Appraisal Skills Programme Español. Programa de lectura crítica CASPe. Entendiendo la evidencia sobre la eficacia clínica. 11 preguntas para entender un ensayo clínico. Consultado el 19 de mayo de 2010. Disponible en: http://www.redcaspe.org/herramientas/lectura/11ensayo.pdf.
15. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; Iniciativa STROBE. Declaración de la Iniciativa STROBE (Strengthening the Reporting of Observational studies in
Epidemiology): directrices para la comunicación de estudios observacionales. Gac Sanit. 2008;22:144-50.
16. Wood MA, Orlov M, Ramaswamy K, Haffajee C, Ellenbogen K; Stereotaxis Heart Study Investigators. Remote magnetic versus manual catheter navigation for ablation of supraventricular tachycardias: A randomized, multicenter trial. Pacing Clin Electrophysiol. 2008;31:
1313-21.
17. Vollmann D, Lüthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009;2:
18. Gallagher P, Martín L, Angel L, Tomassoni G. Initial clinical experience with a cardiac resynchronization therapy utilizing a magnetic navigation system. J Cardiovasc Electrophysiol. 2007; 2:174-80.
19. Pappone C, Vicedomini G, Manguso F, Mazzone P, Gugliotta F, Sala S, et al. Robotic magnetic navigation for atrial fibrillation ablation. J Am Coll Cardiol. 2006;47:1390-400.
20. Buergler JM, Alam S, Spencer W, Kleiman NS, Melendez Y, Franklin J, et al. Initial experience with alcohol septal ablation using a novel magnetic navigation system. J Interv Cardiol. 2007;20:559-63.
21 Kim AM, Turakhia M, Lu J, Badhwar N, Lee BK, Lee RJ, et al. Impact of remote magnetic catheter navigation on ablation fluoroscopy and procedure time. Pacing Clin Electrophysiol. 2008;31:1399-404.
22. Katsiyiannis WT, Melby DP, Matelski JL, Ervin VL, Laverence KL, Gornick CC. Feasibility and safety of remotecontrolled magnetic navigation for ablation of atrial fibrillation. Am J Cardiol. 2008;102:1674-6.
23. Ijsselmuiden AJ, Patterson MS, van Nooijen FC, Tangelder GJ, Dirksen MT, Amoroso G, et al. Magnetically navigated percutaneous coronary intervention in distal and/or complex lesions may improve procedural outcome and material consumption. Eurointerv. 2008;4:517-23.
24 Kerzner R, Sánchez JM, Osborn JL, Chen J, Faddis MN, Gleva MJ, et al.
Radiofrequency ablation of atrioventricular nodal reentrant tachycardia
using a novel magnetic guidance system compared with a conventional approach. Heart Rhythm. 2006;3:261-7.
25. Kiemeneij F, Patterson MS, Amoroso G, Laarman G, Slagboom T. Use of the Stereotaxis Niobe magnetic navigation system for percutaneous coronary intervention: Results from 350 consecutive patients. Catheter
Cardiovasc Interv. 2008;71:510-6.
26. Rivero-Ayerza M, Thornton AS, Theuns D, Scholten MF, Mekel JM, Res J, et al. Left ventricular lead placement within a coronary sinus side branch using remote magnetic navigation of a guidewire: a feasibility study. J Cardiovasc Electrophysiol. 2006;2: 27. Niobe® magnetic navigation guidance system for percutaneous coronary interventions in patients with cardiac arrhytmias. National Horizon Scanning Unit. Horizon scanning priorisiting summary. Australia and New Zealand Horizon Scanning Network. (Update 2007). Abril, 2005;9(1).
28. Advanced Electrophysiologic Mapping Systems. Health Technology Policy Assessment. Ontario, Canadá. Marzo 2006.
29. Tsuchida K, García-García HM, van der Giessen W, McFadden EP, van der Ent M, Sianos G, et al. Guidewire navigation in coronary artery estenosis using a novel magnetic navigation system: First clinical experience. Catheter Cardiovasc Interv. 2006;67:356-63.
30. Moreno J, Archondo T, Barrios R, Pérez-Castellano N, Porro R, García J, et al. La ablación de taquicardia intranodal con sistema de navegación remota Stereotaxis® precisa menores parámetros de temperatura y potencia por mejoría del contacto tisular. Rev Esp Cardiol. 2009;62:1001-11.
31. Canales EI, Córdova J, Escaned J, Hernández-Antolín R. Estereotaxis: una nueva alternativa para el tratamiento de lesiones con angulación y tortuosidad extrema que previamente se han fallado con técnicas convencionales. Rev Esp Cardiol. 2009;62:942-4.
32. Di Biase L, Fahmy TS, Patel D, Bai R, Civello K, Wazni OM, et al. Remote Magnetic Navigation. Human Experience in Pulmonary vein ablation. J Am Coll Cardiol. 2007;9:868-74.
33. Aryana A, d´Avila A, Heist EK, Mela T, Singh JP, Ruskin JN, et al. Remote magnetic navigation to guide endocardial and epicardial catheter mapping of scarrelated ventricular tachycardia. Circulation. 2007;115:1191-200.
How to Cite
Ruiz-Aragón, J., Molina-Linde, J. M., Márquez-Pelaéz, S., & Rodríguez-López, R. (2010). Assessment of intracardiac magnetic navigation system Niobe®, systematic review. Universitas Medica, 52(2), 191–2016. https://doi.org/10.11144/Javeriana.umed52-2.esnm
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Section
Short Reviews