Assessing the risks associated with MRI in patients with a pacemaker or defibrillator

Robert J. Russo, Heather S. Costa, Patricia D. Silva, Jeffrey L. Anderson, Aysha Arshad, Robert W.W. Biederman, Noel G. Boyle, Jennifer V. Frabizzio, Ulrika Birgersdotter-Green, Steven L. Higgins, Rachel Lampert, Christian E. Machado, Edward T. Martin, Andrew L. Rivard, Jason C. Rubenstein, Raymond H.M. Schaerf, Jennifer D. Schwartz, Dipan J. Shah, Gery F. Tomassoni, Gail T. Tominaga & 3 others Allison E. Tonkin, Seth Uretsky, Steven D. Wolff

Research output: Contribution to journalArticle

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Abstract

BACKGROUND 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 cardioverter- defibrillator (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.

Original languageEnglish (US)
Pages (from-to)755-764
Number of pages10
JournalNew England Journal of Medicine
Volume376
Issue number8
DOIs
StatePublished - Feb 23 2017

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Defibrillators
Magnetic Resonance Imaging
Implantable Defibrillators
Equipment and Supplies
Registries
Cardiac Arrhythmias
Atrial Flutter
United States Food and Drug Administration
Magnetic Fields
Electric Impedance
Atrial Fibrillation

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Russo, R. J., Costa, H. S., Silva, P. D., Anderson, J. L., Arshad, A., Biederman, R. W. W., ... Wolff, S. D. (2017). Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. New England Journal of Medicine, 376(8), 755-764. https://doi.org/10.1056/NEJMoa1603265
Russo, Robert J. ; Costa, Heather S. ; Silva, Patricia D. ; Anderson, Jeffrey L. ; Arshad, Aysha ; Biederman, Robert W.W. ; Boyle, Noel G. ; Frabizzio, Jennifer V. ; Birgersdotter-Green, Ulrika ; Higgins, Steven L. ; Lampert, Rachel ; Machado, Christian E. ; Martin, Edward T. ; Rivard, Andrew L. ; Rubenstein, Jason C. ; Schaerf, Raymond H.M. ; Schwartz, Jennifer D. ; Shah, Dipan J. ; Tomassoni, Gery F. ; Tominaga, Gail T. ; Tonkin, Allison E. ; Uretsky, Seth ; Wolff, Steven D. / Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 8. pp. 755-764.
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abstract = "BACKGROUND 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 cardioverter- defibrillator (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.",
author = "Russo, {Robert J.} and Costa, {Heather S.} and Silva, {Patricia D.} and Anderson, {Jeffrey L.} and Aysha Arshad and Biederman, {Robert W.W.} and Boyle, {Noel G.} and Frabizzio, {Jennifer V.} and Ulrika Birgersdotter-Green and Higgins, {Steven L.} and Rachel Lampert and Machado, {Christian E.} and Martin, {Edward T.} and Rivard, {Andrew L.} and Rubenstein, {Jason C.} and Schaerf, {Raymond H.M.} and Schwartz, {Jennifer D.} and Shah, {Dipan J.} and Tomassoni, {Gery F.} and Tominaga, {Gail T.} and Tonkin, {Allison E.} and Seth Uretsky and Wolff, {Steven D.}",
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Russo, RJ, Costa, HS, Silva, PD, Anderson, JL, Arshad, A, Biederman, RWW, Boyle, NG, Frabizzio, JV, Birgersdotter-Green, U, Higgins, SL, Lampert, R, Machado, CE, Martin, ET, Rivard, AL, Rubenstein, JC, Schaerf, RHM, Schwartz, JD, Shah, DJ, Tomassoni, GF, Tominaga, GT, Tonkin, AE, Uretsky, S & Wolff, SD 2017, 'Assessing the risks associated with MRI in patients with a pacemaker or defibrillator', New England Journal of Medicine, vol. 376, no. 8, pp. 755-764. https://doi.org/10.1056/NEJMoa1603265

Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. / Russo, Robert J.; Costa, Heather S.; Silva, Patricia D.; Anderson, Jeffrey L.; Arshad, Aysha; Biederman, Robert W.W.; Boyle, Noel G.; Frabizzio, Jennifer V.; Birgersdotter-Green, Ulrika; Higgins, Steven L.; Lampert, Rachel; Machado, Christian E.; Martin, Edward T.; Rivard, Andrew L.; Rubenstein, Jason C.; Schaerf, Raymond H.M.; Schwartz, Jennifer D.; Shah, Dipan J.; Tomassoni, Gery F.; Tominaga, Gail T.; Tonkin, Allison E.; Uretsky, Seth; Wolff, Steven D.

In: New England Journal of Medicine, Vol. 376, No. 8, 23.02.2017, p. 755-764.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Assessing the risks associated with MRI in patients with a pacemaker or defibrillator

AU - Russo, Robert J.

AU - Costa, Heather S.

AU - Silva, Patricia D.

AU - Anderson, Jeffrey L.

AU - Arshad, Aysha

AU - Biederman, Robert W.W.

AU - Boyle, Noel G.

AU - Frabizzio, Jennifer V.

AU - Birgersdotter-Green, Ulrika

AU - Higgins, Steven L.

AU - Lampert, Rachel

AU - Machado, Christian E.

AU - Martin, Edward T.

AU - Rivard, Andrew L.

AU - Rubenstein, Jason C.

AU - Schaerf, Raymond H.M.

AU - Schwartz, Jennifer D.

AU - Shah, Dipan J.

AU - Tomassoni, Gery F.

AU - Tominaga, Gail T.

AU - Tonkin, Allison E.

AU - Uretsky, Seth

AU - Wolff, Steven D.

PY - 2017/2/23

Y1 - 2017/2/23

N2 - BACKGROUND 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 cardioverter- defibrillator (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.

AB - BACKGROUND 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 cardioverter- defibrillator (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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DO - 10.1056/NEJMoa1603265

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Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RWW et al. Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. New England Journal of Medicine. 2017 Feb 23;376(8):755-764. https://doi.org/10.1056/NEJMoa1603265