Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla

J. Rod Gimbel, David Bello, Matthias Schmitt, B. Merkely, Juerg Schwitter, David L. Hayes, Torsten Sommer, Edward J. Schloss, Yanping Chang, Sarah Willey, Emanuel Kanal

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

Background: Magnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system. Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk. The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI. Objective: To confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions. Methods: Primary eligibility criteria included standard dual-chamber pacing indications. Patients (n = 263) were randomized in a 2:1 ratio to undergo 16 chest and head scans at 1.5 T between 9 and 12 weeks postimplant (n = 177) or to not undergo MRI (n = 86) post-implant. Evaluation of the pacemaker system occurred immediately before, during (monitoring), and after MRI, 1-week post-MRI, and 1-month post-MRI, and similarly for controls. Primary end points measured the MRI-related complication-free rate for safety and compared pacing capture threshold between MRI and control subjects for effectiveness. Results: There were no MRI-related complications during or after MRI in subjects undergoing MRI (n = 148). Differences in pacing capture threshold values from pre-MRI to 1-month post-MRI were minimal and similar between the MRI and control groups. Conclusions: This randomized trial demonstrates that the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective in the 1.5 T MRI environment without positioning restrictions for MRI scans or limitations of body parts scanned.

Original languageEnglish
Pages (from-to)685-691
Number of pages7
JournalHeart Rhythm
Volume10
Issue number5
DOIs
Publication statusPublished - May 2013

Fingerprint

Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Thorax
Safety
United States Food and Drug Administration
Human Body

Keywords

  • 5086MRI
  • Advisa MRI
  • CapSureFix MRI
  • Chest scan
  • EnRhythm MRI
  • Magnetic resonance imaging
  • Pacemaker
  • Revo MRI
  • Safety
  • SureScan

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Rod Gimbel, J., Bello, D., Schmitt, M., Merkely, B., Schwitter, J., Hayes, D. L., ... Kanal, E. (2013). Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm, 10(5), 685-691. https://doi.org/10.1016/j.hrthm.2013.01.022

Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. / Rod Gimbel, J.; Bello, David; Schmitt, Matthias; Merkely, B.; Schwitter, Juerg; Hayes, David L.; Sommer, Torsten; Schloss, Edward J.; Chang, Yanping; Willey, Sarah; Kanal, Emanuel.

In: Heart Rhythm, Vol. 10, No. 5, 05.2013, p. 685-691.

Research output: Contribution to journalArticle

Rod Gimbel, J, Bello, D, Schmitt, M, Merkely, B, Schwitter, J, Hayes, DL, Sommer, T, Schloss, EJ, Chang, Y, Willey, S & Kanal, E 2013, 'Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla', Heart Rhythm, vol. 10, no. 5, pp. 685-691. https://doi.org/10.1016/j.hrthm.2013.01.022
Rod Gimbel, J. ; Bello, David ; Schmitt, Matthias ; Merkely, B. ; Schwitter, Juerg ; Hayes, David L. ; Sommer, Torsten ; Schloss, Edward J. ; Chang, Yanping ; Willey, Sarah ; Kanal, Emanuel. / Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. In: Heart Rhythm. 2013 ; Vol. 10, No. 5. pp. 685-691.
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AU - Hayes, David L.

AU - Sommer, Torsten

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N2 - Background: Magnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system. Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk. The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI. Objective: To confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions. Methods: Primary eligibility criteria included standard dual-chamber pacing indications. Patients (n = 263) were randomized in a 2:1 ratio to undergo 16 chest and head scans at 1.5 T between 9 and 12 weeks postimplant (n = 177) or to not undergo MRI (n = 86) post-implant. Evaluation of the pacemaker system occurred immediately before, during (monitoring), and after MRI, 1-week post-MRI, and 1-month post-MRI, and similarly for controls. Primary end points measured the MRI-related complication-free rate for safety and compared pacing capture threshold between MRI and control subjects for effectiveness. Results: There were no MRI-related complications during or after MRI in subjects undergoing MRI (n = 148). Differences in pacing capture threshold values from pre-MRI to 1-month post-MRI were minimal and similar between the MRI and control groups. Conclusions: This randomized trial demonstrates that the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective in the 1.5 T MRI environment without positioning restrictions for MRI scans or limitations of body parts scanned.

AB - Background: Magnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system. Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk. The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI. Objective: To confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions. Methods: Primary eligibility criteria included standard dual-chamber pacing indications. Patients (n = 263) were randomized in a 2:1 ratio to undergo 16 chest and head scans at 1.5 T between 9 and 12 weeks postimplant (n = 177) or to not undergo MRI (n = 86) post-implant. Evaluation of the pacemaker system occurred immediately before, during (monitoring), and after MRI, 1-week post-MRI, and 1-month post-MRI, and similarly for controls. Primary end points measured the MRI-related complication-free rate for safety and compared pacing capture threshold between MRI and control subjects for effectiveness. Results: There were no MRI-related complications during or after MRI in subjects undergoing MRI (n = 148). Differences in pacing capture threshold values from pre-MRI to 1-month post-MRI were minimal and similar between the MRI and control groups. Conclusions: This randomized trial demonstrates that the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective in the 1.5 T MRI environment without positioning restrictions for MRI scans or limitations of body parts scanned.

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