Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.
Identifieur interne : 000438 ( PubMed/Curation ); précédent : 000437; suivant : 000439Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.
Auteurs : Michael R. Gold [États-Unis] ; Emanuel Kanal [États-Unis] ; Juerg Schwitter [Suisse] ; Torsten Sommer [Allemagne] ; Hyun Yoon [États-Unis] ; Michael Ellingson [États-Unis] ; Lynn Landborg [États-Unis] ; Tara Bratten [États-Unis]Source :
- Heart rhythm [ 1556-3871 ] ; 2015.
Descripteurs français
- KwdFr :
- Animaux, Défibrillateurs implantables (effets indésirables), Fibrillation ventriculaire (épidémiologie), Humains, Imagerie par résonance magnétique (), Imagerie par résonance magnétique (effets indésirables), Imagerie par résonance magnétique (instrumentation), Maladies cardiovasculaires (), Pacemaker (effets indésirables), Reproductibilité des résultats, Sécurité du matériel ().
- MESH :
- effets indésirables : Défibrillateurs implantables, Imagerie par résonance magnétique, Pacemaker.
- épidémiologie : Fibrillation ventriculaire, Imagerie par résonance magnétique.
- Animaux, Humains, Imagerie par résonance magnétique, Maladies cardiovasculaires, Reproductibilité des résultats, Sécurité du matériel.
English descriptors
- KwdEn :
- Animals, Cardiovascular Diseases (therapy), Defibrillators, Implantable (adverse effects), Equipment Safety (statistics & numerical data), Humans, Magnetic Resonance Imaging (adverse effects), Magnetic Resonance Imaging (instrumentation), Magnetic Resonance Imaging (methods), Pacemaker, Artificial (adverse effects), Reproducibility of Results, Ventricular Fibrillation (epidemiology).
- MESH :
- adverse effects : Defibrillators, Implantable, Magnetic Resonance Imaging, Pacemaker, Artificial.
- epidemiology : Ventricular Fibrillation.
- instrumentation : Magnetic Resonance Imaging.
- methods : Magnetic Resonance Imaging.
- statistics & numerical data : Equipment Safety.
- therapy : Cardiovascular Diseases.
- Animals, Humans, Reproducibility of Results.
Abstract
Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system.
DOI: 10.1016/j.hrthm.2014.12.012
PubMed: 25496984
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Gold</name><affiliation wicri:level="2"><nlm:affiliation>Medical University of South Carolina, Charleston, South Carolina. Electronic address: goldmr@musc.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Sud</region></placeName><wicri:cityArea>Medical University of South Carolina, Charleston</wicri:cityArea></affiliation></author><author><name sortKey="Kanal, Emanuel" sort="Kanal, Emanuel" uniqKey="Kanal E" first="Emanuel" last="Kanal">Emanuel Kanal</name><affiliation wicri:level="2"><nlm:affiliation>University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>University of Pittsburgh Medical Center, Pittsburgh</wicri:cityArea></affiliation></author><author><name sortKey="Schwitter, Juerg" sort="Schwitter, Juerg" uniqKey="Schwitter J" first="Juerg" last="Schwitter">Juerg Schwitter</name><affiliation wicri:level="1"><nlm:affiliation>University Hospital Lausanne, Lausanne, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>University Hospital Lausanne, Lausanne</wicri:regionArea></affiliation></author><author><name sortKey="Sommer, Torsten" sort="Sommer, Torsten" uniqKey="Sommer T" first="Torsten" last="Sommer">Torsten Sommer</name><affiliation wicri:level="1"><nlm:affiliation>German Red Cross Hospital, Neuwied, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Red Cross Hospital, Neuwied</wicri:regionArea></affiliation></author><author><name sortKey="Yoon, Hyun" sort="Yoon, Hyun" uniqKey="Yoon H" first="Hyun" last="Yoon">Hyun Yoon</name><affiliation wicri:level="2"><nlm:affiliation>Medtronic, Inc, Mounds View, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Medtronic, Inc, Mounds View</wicri:cityArea></affiliation></author><author><name sortKey="Ellingson, Michael" sort="Ellingson, Michael" uniqKey="Ellingson M" first="Michael" last="Ellingson">Michael Ellingson</name><affiliation wicri:level="2"><nlm:affiliation>Medtronic, Inc, Mounds View, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Medtronic, Inc, Mounds View</wicri:cityArea></affiliation></author><author><name sortKey="Landborg, Lynn" sort="Landborg, Lynn" uniqKey="Landborg L" first="Lynn" last="Landborg">Lynn Landborg</name><affiliation wicri:level="2"><nlm:affiliation>Medtronic, Inc, Mounds View, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Medtronic, Inc, Mounds View</wicri:cityArea></affiliation></author><author><name sortKey="Bratten, Tara" sort="Bratten, Tara" uniqKey="Bratten T" first="Tara" last="Bratten">Tara Bratten</name><affiliation wicri:level="2"><nlm:affiliation>Medtronic, Inc, Mounds View, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Medtronic, Inc, Mounds View</wicri:cityArea></affiliation></author></analytic><series><title level="j">Heart rhythm</title><idno type="eISSN">1556-3871</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Animals</term><term>Cardiovascular Diseases (therapy)</term><term>Defibrillators, Implantable (adverse effects)</term><term>Equipment Safety (statistics & numerical data)</term><term>Humans</term><term>Magnetic Resonance Imaging (adverse effects)</term><term>Magnetic Resonance Imaging (instrumentation)</term><term>Magnetic Resonance Imaging (methods)</term><term>Pacemaker, Artificial (adverse effects)</term><term>Reproducibility of Results</term><term>Ventricular Fibrillation (epidemiology)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Animaux</term><term>Défibrillateurs implantables (effets indésirables)</term><term>Fibrillation ventriculaire (épidémiologie)</term><term>Humains</term><term>Imagerie par résonance magnétique ()</term><term>Imagerie par résonance magnétique (effets indésirables)</term><term>Imagerie par résonance magnétique (instrumentation)</term><term>Maladies cardiovasculaires ()</term><term>Pacemaker (effets indésirables)</term><term>Reproductibilité des résultats</term><term>Sécurité du matériel ()</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Defibrillators, Implantable</term><term>Magnetic Resonance Imaging</term><term>Pacemaker, Artificial</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Défibrillateurs implantables</term><term>Imagerie par résonance magnétique</term><term>Pacemaker</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Ventricular Fibrillation</term></keywords><keywords scheme="MESH" qualifier="instrumentation" xml:lang="en"><term>Magnetic Resonance Imaging</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Magnetic Resonance Imaging</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Equipment Safety</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Cardiovascular Diseases</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Fibrillation ventriculaire</term><term>Imagerie par résonance magnétique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Humans</term><term>Reproducibility of Results</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Animaux</term><term>Humains</term><term>Imagerie par résonance magnétique</term><term>Maladies cardiovasculaires</term><term>Reproductibilité des résultats</term><term>Sécurité du matériel</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25496984</PMID><DateCreated><Year>2015</Year><Month>02</Month><Day>23</Day></DateCreated><DateCompleted><Year>2016</Year><Month>01</Month><Day>19</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>04</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1556-3871</ISSN><JournalIssue CitedMedium="Internet"><Volume>12</Volume><Issue>3</Issue><PubDate><Year>2015</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Heart rhythm</Title><ISOAbbreviation>Heart Rhythm</ISOAbbreviation></Journal><ArticleTitle>Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.</ArticleTitle><Pagination><MedlinePgn>631-638</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1547-5271(14)01419-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.hrthm.2014.12.012</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI.</AbstractText><CopyrightInformation>Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gold</LastName><ForeName>Michael R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Medical University of South Carolina, Charleston, South Carolina. Electronic address: goldmr@musc.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kanal</LastName><ForeName>Emanuel</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwitter</LastName><ForeName>Juerg</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University Hospital Lausanne, Lausanne, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sommer</LastName><ForeName>Torsten</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>German Red Cross Hospital, Neuwied, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yoon</LastName><ForeName>Hyun</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Medtronic, Inc, Mounds View, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ellingson</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Medtronic, Inc, Mounds View, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Landborg</LastName><ForeName>Lynn</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Medtronic, Inc, Mounds View, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bratten</LastName><ForeName>Tara</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Medtronic, Inc, Mounds View, Minnesota.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D023362">Evaluation Studies</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>12</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Heart Rhythm</MedlineTA><NlmUniqueID>101200317</NlmUniqueID><ISSNLinking>1547-5271</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002318" MajorTopicYN="N">Cardiovascular Diseases</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017147" MajorTopicYN="N">Defibrillators, Implantable</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004869" MajorTopicYN="N">Equipment Safety</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008279" MajorTopicYN="N">Magnetic Resonance Imaging</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000295" MajorTopicYN="Y">instrumentation</QualifierName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010138" MajorTopicYN="N">Pacemaker, Artificial</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014693" MajorTopicYN="N">Ventricular Fibrillation</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Defibrillator</Keyword><Keyword MajorTopicYN="N">Hazards</Keyword><Keyword MajorTopicYN="N">Implantable cardioverter-defibrillator</Keyword><Keyword MajorTopicYN="N">Lead electrode heating</Keyword><Keyword MajorTopicYN="N">Magnetic resonance imaging</Keyword><Keyword MajorTopicYN="N">Ventricular fibrillation detection</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>09</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>12</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>12</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>1</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25496984</ArticleId><ArticleId IdType="pii">S1547-5271(14)01419-2</ArticleId><ArticleId IdType="doi">10.1016/j.hrthm.2014.12.012</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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