Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions

Khaled Awad, John Griffin, Thomas C. Crawford, S. Lane Cox, Kevin J. Ferrick, Alexander Mazur, Rafael E. Pena, Steven G. Lloyd, Justin Michalski, Whitney Johnson, William M. Bailey

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. Methods Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. Results One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. Conclusion These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.

Original languageEnglish (US)
Article number6301
Pages (from-to)2155-2161
Number of pages7
JournalHeart Rhythm
Volume12
Issue number10
DOIs
StatePublished - Oct 1 2015

Fingerprint

Implantable Defibrillators
Spine
Thorax
Magnetic Resonance Imaging
Safety
Equipment and Supplies
Ventricular Fibrillation
Multicenter Studies

Keywords

  • Clinical trial
  • Iforia
  • Implantable cardioverter-defibrillator
  • Magnetic resonance imaging
  • Safety
  • Tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. / Awad, Khaled; Griffin, John; Crawford, Thomas C.; Lane Cox, S.; Ferrick, Kevin J.; Mazur, Alexander; Pena, Rafael E.; Lloyd, Steven G.; Michalski, Justin; Johnson, Whitney; Bailey, William M.

In: Heart Rhythm, Vol. 12, No. 10, 6301, 01.10.2015, p. 2155-2161.

Research output: Contribution to journalArticle

Awad, K, Griffin, J, Crawford, TC, Lane Cox, S, Ferrick, KJ, Mazur, A, Pena, RE, Lloyd, SG, Michalski, J, Johnson, W & Bailey, WM 2015, 'Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions', Heart Rhythm, vol. 12, no. 10, 6301, pp. 2155-2161. https://doi.org/10.1016/j.hrthm.2015.06.002
Awad, Khaled ; Griffin, John ; Crawford, Thomas C. ; Lane Cox, S. ; Ferrick, Kevin J. ; Mazur, Alexander ; Pena, Rafael E. ; Lloyd, Steven G. ; Michalski, Justin ; Johnson, Whitney ; Bailey, William M. / Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. In: Heart Rhythm. 2015 ; Vol. 12, No. 10. pp. 2155-2161.
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abstract = "Background Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. Methods Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed {"}off{"} before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50{\%} from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. Results One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7{\%} cardiac, 74.3{\%} thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. Conclusion These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.",
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AU - Mazur, Alexander

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N2 - Background Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. Methods Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. Results One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. Conclusion These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.

AB - Background Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. Methods Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. Results One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. Conclusion These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.

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