Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator

Primary Results of a Randomized Study

Michael R. Gold, Torsten Sommer, Juerg Schwitter, Ahmed Al Fagih, Timothy Albert, B. Merkely, Michael Peterson, Allen Ciuffo, Sung Lee, Lynn Landborg, Jeffrey Cerkvenik, Emanuel Kanal

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Abstract Background Magnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated. Objectives This multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90% freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude. Methods Subjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function. Results In 42 centers, 275 patients were enrolled (76% male, age 60.4 ± 13.8 years). The safety endpoint was met with 100% freedom from the composite endpoint (p <0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100% MRI vs. 98.8% control, noninferiority p <0.0001) or a ≤50% decrease in R-wave amplitude (99.3% MRI vs. 98.8% control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment. Conclusions This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414).

Original languageEnglish
Article number21310
Pages (from-to)2581-2588
Number of pages8
JournalJournal of the American College of Cardiology
Volume65
Issue number24
DOIs
Publication statusPublished - Jun 23 2015

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Implantable Defibrillators
Magnetic Resonance Imaging
Ventricular Fibrillation
Safety
Random Allocation

Keywords

  • implantable cardioverter-defibrillator
  • magnetic resonance imaging

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator : Primary Results of a Randomized Study. / Gold, Michael R.; Sommer, Torsten; Schwitter, Juerg; Al Fagih, Ahmed; Albert, Timothy; Merkely, B.; Peterson, Michael; Ciuffo, Allen; Lee, Sung; Landborg, Lynn; Cerkvenik, Jeffrey; Kanal, Emanuel.

In: Journal of the American College of Cardiology, Vol. 65, No. 24, 21310, 23.06.2015, p. 2581-2588.

Research output: Contribution to journalArticle

Gold, MR, Sommer, T, Schwitter, J, Al Fagih, A, Albert, T, Merkely, B, Peterson, M, Ciuffo, A, Lee, S, Landborg, L, Cerkvenik, J & Kanal, E 2015, 'Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study', Journal of the American College of Cardiology, vol. 65, no. 24, 21310, pp. 2581-2588. https://doi.org/10.1016/j.jacc.2015.04.047
Gold, Michael R. ; Sommer, Torsten ; Schwitter, Juerg ; Al Fagih, Ahmed ; Albert, Timothy ; Merkely, B. ; Peterson, Michael ; Ciuffo, Allen ; Lee, Sung ; Landborg, Lynn ; Cerkvenik, Jeffrey ; Kanal, Emanuel. / Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator : Primary Results of a Randomized Study. In: Journal of the American College of Cardiology. 2015 ; Vol. 65, No. 24. pp. 2581-2588.
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abstract = "Abstract Background Magnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated. Objectives This multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90{\%} freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude. Methods Subjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function. Results In 42 centers, 275 patients were enrolled (76{\%} male, age 60.4 ± 13.8 years). The safety endpoint was met with 100{\%} freedom from the composite endpoint (p <0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100{\%} MRI vs. 98.8{\%} control, noninferiority p <0.0001) or a ≤50{\%} decrease in R-wave amplitude (99.3{\%} MRI vs. 98.8{\%} control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment. Conclusions This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414).",
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AU - Al Fagih, Ahmed

AU - Albert, Timothy

AU - Merkely, B.

AU - Peterson, Michael

AU - Ciuffo, Allen

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AU - Cerkvenik, Jeffrey

AU - Kanal, Emanuel

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N2 - Abstract Background Magnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated. Objectives This multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90% freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude. Methods Subjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function. Results In 42 centers, 275 patients were enrolled (76% male, age 60.4 ± 13.8 years). The safety endpoint was met with 100% freedom from the composite endpoint (p <0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100% MRI vs. 98.8% control, noninferiority p <0.0001) or a ≤50% decrease in R-wave amplitude (99.3% MRI vs. 98.8% control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment. Conclusions This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414).

AB - Abstract Background Magnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated. Objectives This multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90% freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude. Methods Subjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function. Results In 42 centers, 275 patients were enrolled (76% male, age 60.4 ± 13.8 years). The safety endpoint was met with 100% freedom from the composite endpoint (p <0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100% MRI vs. 98.8% control, noninferiority p <0.0001) or a ≤50% decrease in R-wave amplitude (99.3% MRI vs. 98.8% control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment. Conclusions This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414).

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