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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.
- Source :
-
Heart rhythm [Heart Rhythm] 2015 Oct; Vol. 12 (10), pp. 2155-61. Date of Electronic Publication: 2015 Jun 03. - Publication Year :
- 2015
-
Abstract
- Background: Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI).<br />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.<br />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.<br />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.<br />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.<br /> (Copyright © 2015 Heart Rhythm Society. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Contraindications
Equipment Design
Equipment Safety
Female
Follow-Up Studies
Humans
Magnetic Resonance Imaging methods
Male
Middle Aged
Prospective Studies
Risk Factors
Spinal Diseases complications
Ventricular Fibrillation complications
Young Adult
Defibrillators, Implantable
Heart Ventricles pathology
Magnetic Resonance Imaging, Cine methods
Spinal Diseases diagnosis
Thoracic Vertebrae pathology
Ventricular Fibrillation therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1556-3871
- Volume :
- 12
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Heart rhythm
- Publication Type :
- Academic Journal
- Accession number :
- 26049048
- Full Text :
- https://doi.org/10.1016/j.hrthm.2015.06.002