Safety of magnetic resonance imaging in patients with cardiac devices

Saman Nazarian, Rozann Hansford, Amir A. Rahsepar, Valeria Weltin, Diana McVeigh, Esra Gucuk Ipek, Alan Kwan, Ronald D Berger, Hugh Calkins, Albert C. Lardo, Michael A Kraut, Ihab R Kamel, Stefan Zimmerman, Henry R Halperin

Research output: Contribution to journalArticle

Abstract

BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials. gov number, NCT01130896.) BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported.

Original languageEnglish (US)
Pages (from-to)2555-2564
Number of pages10
JournalNew England Journal of Medicine
Volume377
Issue number26
DOIs
StatePublished - Dec 28 2017

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Magnetic Resonance Imaging
Safety
Equipment and Supplies
Implantable Defibrillators
Defibrillators
United States Food and Drug Administration
Magnetic Fields
Tachycardia
Thorax
Outcome Assessment (Health Care)
Prospective Studies
Confidence Intervals
National Institutes of Health (U.S.)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Nazarian, S., Hansford, R., Rahsepar, A. A., Weltin, V., McVeigh, D., Ipek, E. G., ... Halperin, H. R. (2017). Safety of magnetic resonance imaging in patients with cardiac devices. New England Journal of Medicine, 377(26), 2555-2564. https://doi.org/10.1056/NEJMoa1604267

Safety of magnetic resonance imaging in patients with cardiac devices. / Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A.; Weltin, Valeria; McVeigh, Diana; Ipek, Esra Gucuk; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C.; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan; Halperin, Henry R.

In: New England Journal of Medicine, Vol. 377, No. 26, 28.12.2017, p. 2555-2564.

Research output: Contribution to journalArticle

Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Ipek EG et al. Safety of magnetic resonance imaging in patients with cardiac devices. New England Journal of Medicine. 2017 Dec 28;377(26):2555-2564. https://doi.org/10.1056/NEJMoa1604267
Nazarian, Saman ; Hansford, Rozann ; Rahsepar, Amir A. ; Weltin, Valeria ; McVeigh, Diana ; Ipek, Esra Gucuk ; Kwan, Alan ; Berger, Ronald D ; Calkins, Hugh ; Lardo, Albert C. ; Kraut, Michael A ; Kamel, Ihab R ; Zimmerman, Stefan ; Halperin, Henry R. / Safety of magnetic resonance imaging in patients with cardiac devices. In: New England Journal of Medicine. 2017 ; Vol. 377, No. 26. pp. 2555-2564.
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title = "Safety of magnetic resonance imaging in patients with cardiac devices",
abstract = "BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed {"}MRI-conditional{"} devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58{\%}) or an implantable cardioverter-defibrillator (42{\%}) that was not considered to be MRI-conditional (termed a {"}legacy{"} device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4{\%}; 95{\%} confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50{\%} change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1{\%} of the patients. At long-term follow-up (results of which were available for 63{\%} of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4{\%} of the patients), increases in atrial capture threshold (4{\%}), increases in right ventricular capture threshold (4{\%}), and increases in left ventricular capture threshold (3{\%}). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials. gov number, NCT01130896.) BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed {"}MRI-conditional{"} devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58{\%}) or an implantable cardioverter-defibrillator (42{\%}) that was not considered to be MRI-conditional (termed a {"}legacy{"} device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4{\%}; 95{\%} confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50{\%} change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1{\%} of the patients. At long-term follow-up (results of which were available for 63{\%} of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4{\%} of the patients), increases in atrial capture threshold (4{\%}), increases in right ventricular capture threshold (4{\%}), and increases in left ventricular capture threshold (3{\%}). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported.",
author = "Saman Nazarian and Rozann Hansford and Rahsepar, {Amir A.} and Valeria Weltin and Diana McVeigh and Ipek, {Esra Gucuk} and Alan Kwan and Berger, {Ronald D} and Hugh Calkins and Lardo, {Albert C.} and Kraut, {Michael A} and Kamel, {Ihab R} and Stefan Zimmerman and Halperin, {Henry R}",
year = "2017",
month = "12",
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doi = "10.1056/NEJMoa1604267",
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TY - JOUR

T1 - Safety of magnetic resonance imaging in patients with cardiac devices

AU - Nazarian, Saman

AU - Hansford, Rozann

AU - Rahsepar, Amir A.

AU - Weltin, Valeria

AU - McVeigh, Diana

AU - Ipek, Esra Gucuk

AU - Kwan, Alan

AU - Berger, Ronald D

AU - Calkins, Hugh

AU - Lardo, Albert C.

AU - Kraut, Michael A

AU - Kamel, Ihab R

AU - Zimmerman, Stefan

AU - Halperin, Henry R

PY - 2017/12/28

Y1 - 2017/12/28

N2 - BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials. gov number, NCT01130896.) BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported.

AB - BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials. gov number, NCT01130896.) BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system. No long-term clinically significant adverse events were reported.

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