Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla

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• dc.contributor.author Dacher, Jean-Nicolas
• dc.contributor.author Langguth, Patrick
• dc.contributor.author Adam, David
• dc.contributor.author Winkler, Walther-Benedikt
• dc.contributor.author Martí-Almor, Julio
• dc.contributor.author Prenner, Günther
• dc.contributor.author Trucco, María Emilce
• dc.contributor.author Kol, Amir
• dc.contributor.author Xiang, Meixiang
• dc.contributor.author Melissano, Donato
• dc.contributor.author Fawaz, Hanan
• dc.contributor.author Lau, Dennis H.
• dc.date.accessioned 2024-03-04T07:17:48Z
• dc.date.available 2024-03-04T07:17:48Z
• dc.date.issued 2023
• dc.description.abstract Objectives: To evaluate at 1.5 and 3 T MRI the safety and performance of trademarked ENO®, TEO®, or OTO® pacing systems with automated MRI Mode and the image quality of non-enhanced MR examinations. Methods: A total of 267 implanted patients underwent MRI examination (brain, cardiac, shoulder, cervical spine) at 1.5 (n = 126) or 3 T (n = 141). MRI-related device complications, lead electrical performances stability at 1-month post-MRI, proper functioning of the automated MRI mode and image quality were evaluated. Results: Freedom from MRI-related complications at 1 month post-MRI was 100% in both 1.5 and 3 T arms (both p < 0.0001). The stability of pacing capture threshold was respectively at 1.5 and 3 T (atrial:: 98.9% (p = 0.001) and 100% (p < 0.0001); ventricular: both 100% (p < 0001)). The stability of sensing was respectively at 1.5 and 3 T (atrial: 100% (p = 0.0001) and 96.9% (p = 0.01); ventricular: 100% (p < 0.0001) and 99.1% (p = 0.0001)). All devices switched automatically to the programmed asynchronous mode in the MRI environment and to initially programmed mode after the MRI exam. While all MR examinations were assessed as interpretable, artifacts deteriorated a subset of examinations including mostly cardiac and shoulder ones. Conclusion: This study demonstrates the safety and electrical stability of ENO®, TEO®, or OTO® pacing systems at 1 month post-MRI at 1.5 and 3 T. Even if artifacts were noticed in a subset of examinations, overall interpretability was preserved. Clinical relevance statement: ENO®, TEO®, and OTO® pacing systems switch to MR-mode when detecting magnetic field and switch back on conventional mode after MRI. Their safety and electrical stability at 1 month post MRI were shown at 1.5 and 3 T. Overall interpretability was preserved. Key points: • Patients implanted with an MRI conditional cardiac pacemaker can be safely scanned under 1.5 or 3 Tesla MRI with preserved interpretability. • Electrical parameters of the MRI conditional pacing system remain stable after a 1.5 or 3 Tesla MRI scan. • The automated MRI mode enabled the automatic switch to asynchronous mode in the MRI environment and to initial settings after the MRI scan in all patients.
• dc.format.mimetype application/pdf
• dc.identifier.citation Dacher JN, Langguth P, Adam D, Winkler WB, Martí-Almor J, Prenner G, Trucco ME, Kol A, Xiang M, Melissano D, Fawaz H, Lau DH. Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla. Eur Radiol. 2023 Oct;33(10):6948-58. DOI: 10.1007/s00330-023-09650-9
• dc.identifier.doi http://dx.doi.org/10.1007/s00330-023-09650-9
• dc.identifier.issn 0938-7994
• dc.identifier.uri http://hdl.handle.net/10230/59312
• dc.language.iso eng
• dc.publisher Springer
• dc.relation.ispartof Tesla Eur Radiol. 2023 Oct;33(10):6948-58
• dc.rights © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Artificial
• dc.subject.keyword Cardiac pacemaker
• dc.subject.keyword Magnetic fields
• dc.subject.keyword Magnetic resonance imaging
• dc.title Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion