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MR safety assessment of active implantable medical devices

MR-Sicherheitsbewertung von aktiven implantierbaren medizinischen Geräten. Englische Version

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Abstract

Background

Increasing numbers of patients with active implantable medical devices (AIMDs) require magnetic resonance (MR) examinations. The manufacturers are continuing to improve the MR compatibility of their AIMDs. To this end, a variety of measurement methods and numerical simulations are used to evaluate the risks associated with magnetic resonance imaging (MRI).

Objective

In this article, test methods used to investigate interactions between AIMDs with radio frequency fields and time-varying magnetic gradient fields are reviewed.

Materials and methods

A literature review of known test methods for radio frequency and gradient field exposure of AIMDs with leads, in particular for neurostimulators, cochlear implants, and implanted infusion pumps, is presented. The state of the art and promising methods are discussed.

Results

ISO/TS 10974 describes the design of high frequency and gradient injection setups to test conductive materials. A large number of sensor designs have been published to measure the induced voltages and currents through radio frequency and gradient fields and for monitoring AIMDs during MR examinations in in vitro tests.

Conclusion

The test methods should be planned to be as conservative as possible to cover the worst case scenario. However, in vitro measurements and computer simulation are far from being able to cover all possible configurations in their complexity and uniqueness. For safer MR examinations, current research recommends in vivo testing prior to MR, parallel radiofrequency transmission techniques, and new sequences with reduced energy input in the presence of AIMDs.

Zusammenfassung

Hintergrund

Immer mehr Patienten mit aktiven implantierbaren medizinischen Geräten (AIMDs) benötigen Magnetresonanz(MR)-Untersuchungen. Die Hersteller sind dabei, die MR-Kompatibilität ihrer AIMDs zu verbessern. Dafür werden verschiedenste Messmethoden und numerische Simulationen durchgeführt, um die Risiken in Bezug auf die Magnetresonanztomographie (MRT) zu evaluieren.

Ziele

Dieser Beitrag gibt einen Überblick über die verwendeten Testmethoden, welche die Interaktionen zwischen AIMDs mit Hochfrequenzfeldern und zeitveränderlichen magnetischen Feldgradienten untersuchen.

Material und Methoden

Ein Literaturüberblick über die bekannten Testmethoden für Feldgradienten- und Hochfrequenzexposition von AIMDs mit Anschlussleitungen, insbesondere bei Neurostimulatoren, Cochlea-Implantaten und implantierten Arzneimittelpumpen, wird präsentiert. Der Stand der Technik und vielversprechende Verfahren werden diskutiert.

Ergebnisse

ISO/TS 10974 beschreibt das Design von Hochfrequenz- und Gradienteninjektionsaufbauten für konduktive Materialtests. Zur Messung der induzierten Spannungen und Ströme durch Hochfrequenz- und Gradientenfelder sowie zur Überwachung der AIMDs während MR-Untersuchungen bei In-vitro-Tests wurde eine Vielzahl von Sensordesigns publiziert.

Schlussfolgerung

Die Testmethoden sind so konservativ wie möglich ausgelegt und müssen den ungünstigsten Fall abdecken. Allerdings sind In-vitro-Messungen und Computersimulation weit davon entfernt, jede mögliche Konfiguration in ihrer Komplexität und Einzigartigkeit zu erfassen. Für sicherere MR-Untersuchungen werden in der rezentesten Forschung In-vivo-Testung vor der MR-Untersuchung, parallele Hochfrequenzsendetechniken und neue Sequenzen mit reduziertem Energieeintrag in der Anwesenheit von AIMDs vorgeschlagen.

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Authors and Affiliations

  1. IADI, U1254, INSERM, Université de Lorraine, CHRU de Nancy Brabois, Bâtiment Recherche (anciennement EFS), Rez-de-Chaussé, Rue du Morvan, 54511, Nancy, France

    Sarra Aissani & Jacques Felblinger

  2. CIC 1433 Innovation Technologique, INSERM, CHRU Nancy Brabois, Nancy, France

    Jacques Felblinger

  3. Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria

    Elmar Laistler

  4. MR Centre of Excellence, Medical University of Vienna, Vienna, Austria

    Elmar Laistler

Authors
  1. Sarra Aissani
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  2. Elmar Laistler
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Correspondence to Jacques Felblinger.

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Conflict of interest

J. Felblinger is a shareholder in Healtis. This has no effect on the content of the current publication. S. Aissani and E. Laistler declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

The supplement containing this article is not sponsored by industry.

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Aissani, S., Laistler, E. & Felblinger, J. MR safety assessment of active implantable medical devices. Radiologe 59 (Suppl 1), 40–45 (2019). https://doi.org/10.1007/s00117-019-0541-6

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