Position Statement
Canadian Heart Rhythm Society and Canadian Association of Radiologists Consensus Statement on Magnetic Resonance Imaging With Cardiac Implantable Electronic Devices

https://doi.org/10.1016/j.cjca.2014.07.010Get rights and content

Abstract

Magnetic resonance imaging (MRI) has historically been considered contraindicated for individuals with cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable defibrillators. Magnetic resonance scanners produce magnetic fields that can interact negatively with the metallic components of CIEDs. However, as CIED technology has advanced, newer MRI conditional devices have been developed that are now in clinical use and these systems have had demonstrated safety in the MRI environment. Despite the supportive data of such CIED systems, physicians remain reluctant to perform MRI scanning of conditional devices. This joint statement by the Canadian Heart Rhythm Society and the Canadian Association of Radiologists describes a collaborative process by which CIED specialists and clinics can work with radiology departments and specialists to safely perform MRI in patients with MRI conditional CIED systems. The steps required for patient and scanning preparation and the roles and responsibilities of the CIED and radiology departments are outlined. We also briefly outline the risks and a process by which patients with nonconditional CIEDs might also receive MRI in highly specialized centres. This document supports MRI in patients with MRI conditional CIEDs and offers recommendations on how this can be implemented safely and effectively.

Résumé

L’imagerie par résonance magnétique (IRM) a traditionnellement été contre-indiquée chez les individus porteurs d’un dispositif cardiaque électronique implantable (DCEI) comme les stimulateurs cardiaques et les défibrillateurs implantables. Les appareils d'imagerie par résonance magnétique produisent des champs magnétiques pouvant interagir de façon négative avec les composants métalliques des DCEI. Cependant, à mesure que la technologie des DCEI avançait, de plus récents dispositifs magnétocompatibles ont été conçus et sont maintenant utilisés en clinique. De plus, ces systèmes se sont avérés sécuritaires dans un environnement d’IRM. En dépit des données qui appuient ces systèmes de DCEI, les médecins se montrent réticents à réaliser l’examen d’IRM chez les porteurs de dispositifs magnétocompatibles. Cet énoncé de position commune de la Société canadienne de rythmologie et de l’Association canadienne des radiologistes décrit un processus de collaboration qui permet aux spécialistes et aux cliniques de DCEI de travailler avec les départements et les spécialistes en radiologie pour réaliser l’IRM en toute sécurité chez les patients porteurs de DCEI magnétocompatibles. Nous exposons les grandes lignes des étapes nécessaires à la préparation du patient et de l’examen, ainsi que les rôles et les responsabilités des départements de DCEI et de radiologie. Aussi, nous soulignons brièvement les risques et un processus qui permettrait aux patients porteurs de DCEI non magnétocompatibles de subir l’IRM dans des centres hautement spécialisés. Ce document appuie l’IRM chez les patients porteurs de DCEI magnétocompatibles et présente des recommandations pour une mise en place sécuritaire et efficace.

Section snippets

Potential Risks of MR Imaging in Patients With CIEDs

The presence of a CIED system has traditionally been considered a contraindication to performing an MR examination. MR scanners generate a powerful static magnetic field combined with a switching gradient magnetic field and pulsed radiofrequency fields to generate images. Risks associated with MR scanning in patients with CIEDs generally arise from 3 sources: the static magnetic field, gradient magnetic fields, and radiofrequency fields.5, 6 These sources can induce several responses in the

MR-Conditional CIED Technology

The first MR-conditional pacemaker system was introduced in Europe by Biotronik in 2010 (Berlin, Germany), closely followed by Health Canada and then with US Food and Drug Administration approval in January 2011 for Medtronic's MR-conditional pacemaker (Minneapolis, MN). At the moment, selected pacemakers and implantable loop recorders (ILRs) have received MR-conditional labelling in North America. Currently, no implantable cardioverter defibrillator (ICD) system is approved as MR-conditional

Patient selection: Who might be eligible for an MR-conditional CIED?

When selecting potential recipients of MR-conditional CIED systems, the risk-benefit ratio of implanting an MR-conditional CIED must be considered. The following issues should be addressed. First, the long-term reliability and performance of MR-conditional devices are unknown. Second, some MR-conditional leads are stiffer and larger than standard leads. In some reports, their use was associated with higher rates of dislodgment, repeated surgery, and perforation, although this was not

Scanning Patients With MR-Conditional CIEDs: A Collaborative Process

To properly perform MR imaging for patients with an MR-conditional device, a collaborative process must be established among the CIED clinic, cardiologists with CIED expertise, MR suite, MR radiologists, and administrators. A team of radiologists, cardiologists, MR technologists, technicians, and nurses, with defined responsibilities must be created in advance of providing this specialized imaging service. Where there is a physicist with expertise in MR, he or she should be considered a member

Monitoring Requirements for the CIED Patient Undergoing MR With an MR-Conditional Device

To date, there are no formalized recommendations with regard to the optimal method to monitor the vital status of CIED patients undergoing MR scanning. Currently, 3 modes of monitoring are often used: ECG monitoring, pulse oximetry, and intermittent verbal communication. The advantages and limitations of each modality are summarized in Table 3.

All forms of patient monitoring should be available in the imaging facility, although it is not required that all 3 need to be used at the same time.

MR Scanning of Patients With Non–MR-Conditional CIED Systems: Considerations

MR scanning of patients with non–MR-conditional CIED systems is considered “off-label” and is not endorsed by regulatory agencies (eg, Health Canada, US Food and Drug Administration), joint published guidelines from cardiovascular and radiology societies, and CIED manufacturers.2, 26, 27, 28, 29 As such, MR imaging of a patient with a non–MR-conditional CIED system is not routinely performed and is not considered to be standard of practice. However, the writing committee recognizes the

Conclusions

Patients with MR-conditional CIED systems might undergo MR scanning with minimal risks, provided that well-defined imaging and monitoring protocols are established. In addition, the scanning protocol should adhere to the recommended settings as specified by the CIED manufacturer. Scanning of MR-conditional CIEDs can and should be done at centres meeting the conditions outlined in this document. The fundamental basis of a successful MR scanning program for CIED patients is borne from a

Recommendations: Executive Summary

Full recommendations, including “Values and Preferences,” in Grading of Recommendations Assessment, Development and Evaluation (GRADE) format can be found in Supplemental Appendix S1.

Recommendation

  • 1.

    We recommend that MR imaging of MR-conditional CIEDs can be performed with a low risk of life-threatening complications provided that patients and their CIEDs are properly evaluated before imaging and the scanning protocol be within the specified labelling for that CIED model (Strong Recommendation,

Disclosures

Drs Verma and Exner report research grants from Medtronic Inc. Dr Essebag reports speaker fees from Medtronic and St Jude Medical Inc. There are no other significant disclosures to report.

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