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dc.contributor.authorRusso, Robert J.
dc.contributor.authorCosta, Heather S.
dc.contributor.authorSilva, Patricia D.
dc.contributor.authorAnderson, Jeffrey L.
dc.contributor.authorArshad, Aysha
dc.contributor.authorBiederman, Robert W.W.
dc.contributor.authorBoyle, Noel G.
dc.contributor.authorFrabizzio, Jennifer V.
dc.contributor.authorBirgersdotter-Green, Ulrika
dc.contributor.authorHiggins, Steven L.
dc.contributor.authorLampert, Rachel
dc.contributor.authorMachado, Christian E.
dc.contributor.authorMartin, Edward T.
dc.contributor.authorRivard, Andrew L.
dc.contributor.authorRubenstein, Jason C.
dc.contributor.authorSchaerf, Raymond H.M.
dc.contributor.authorSchwartz, Jennifer D.
dc.contributor.authorShah, Dipan J.
dc.contributor.authorTomassoni, Gery F.
dc.contributor.authorTominaga, Gail T.
dc.contributor.authorTonkin, Allison E.
dc.contributor.authorUretsky, Seth
dc.contributor.authorWolff, Steven D.
dc.date.accessioned2017-04-04T22:50:57Z
dc.date.available2017-04-04T22:50:57Z
dc.date.issued2017-02-23
dc.identifier.citationAssessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator 2017, 376 (8):755 New England Journal of Medicineen
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.pmid28225684
dc.identifier.doi10.1056/NEJMoa1603265
dc.identifier.urihttp://hdl.handle.net/10150/623014
dc.description.abstractBACKGROUND The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverterdefibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). METHODS Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. RESULTS MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. CONCLUSIONS In this study, device or lead failure did not occur in any patient with a non-MRIconditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol.
dc.description.sponsorshipSt. Jude Medical; Biotronik; Boston Scientific; Hewitt Foundation for Medical Researchen
dc.language.isoenen
dc.publisherMASSACHUSETTS MEDICAL SOCen
dc.relation.urlhttp://www.nejm.org/doi/10.1056/NEJMoa1603265en
dc.rightsCopyright © 2017 Massachusetts Medical Society.en
dc.rights.urihttp://rightsstatements.org/vocab/InC/1.0/
dc.titleAssessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillatoren
dc.typeArticleen
dc.contributor.departmentUniv Arizona, Dept Entomolen
dc.identifier.journalNew England Journal of Medicineen
dc.description.note6 month embargo; first published: February 23, 2017en
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
refterms.dateFOA0017-08-24T00:00:00Z
html.description.abstractBACKGROUND The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverterdefibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). METHODS Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. RESULTS MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. CONCLUSIONS In this study, device or lead failure did not occur in any patient with a non-MRIconditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol.


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