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

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,...

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Autores principales: Dacher, Jean-Nicolas, Langguth, Patrick, Adam, David, Winkler, Walther-Benedikt, Martí-Almor, Julio, Prenner, Günther, Trucco, María Emilce, Kol, Amir, Xiang, Meixiang, Melissano, Donato, Fawaz, Hanan, Lau, Dennis H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10189234/
https://www.ncbi.nlm.nih.gov/pubmed/37195432
http://dx.doi.org/10.1007/s00330-023-09650-9
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author Dacher, Jean-Nicolas
Langguth, Patrick
Adam, David
Winkler, Walther-Benedikt
Martí-Almor, Julio
Prenner, Günther
Trucco, María Emilce
Kol, Amir
Xiang, Meixiang
Melissano, Donato
Fawaz, Hanan
Lau, Dennis H.
author_facet Dacher, Jean-Nicolas
Langguth, Patrick
Adam, David
Winkler, Walther-Benedikt
Martí-Almor, Julio
Prenner, Günther
Trucco, María Emilce
Kol, Amir
Xiang, Meixiang
Melissano, Donato
Fawaz, Hanan
Lau, Dennis H.
author_sort Dacher, Jean-Nicolas
collection PubMed
description 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.
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spelling pubmed-101892342023-05-19 Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla Dacher, Jean-Nicolas Langguth, Patrick Adam, David Winkler, Walther-Benedikt Martí-Almor, Julio Prenner, Günther Trucco, María Emilce Kol, Amir Xiang, Meixiang Melissano, Donato Fawaz, Hanan Lau, Dennis H. Eur Radiol Magnetic Resonance 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. Springer Berlin Heidelberg 2023-05-17 2023 /pmc/articles/PMC10189234/ /pubmed/37195432 http://dx.doi.org/10.1007/s00330-023-09650-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis 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/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Magnetic Resonance
Dacher, Jean-Nicolas
Langguth, Patrick
Adam, David
Winkler, Walther-Benedikt
Martí-Almor, Julio
Prenner, Günther
Trucco, María Emilce
Kol, Amir
Xiang, Meixiang
Melissano, Donato
Fawaz, Hanan
Lau, Dennis H.
Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title_full Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title_fullStr Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title_full_unstemmed Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title_short Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla
title_sort safety and performance of mr-conditional pacing systems with automated mri mode at 1.5 and 3 tesla
topic Magnetic Resonance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10189234/
https://www.ncbi.nlm.nih.gov/pubmed/37195432
http://dx.doi.org/10.1007/s00330-023-09650-9
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