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Feasibility, safety, and utility of brain MRI for patients with non-MRI-conditioned CIED

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Abstract

Feasibility, safety, and utility of brain MRI for patients with non-MRI-conditioned cardiac implantable electrical devices (CIEDs) remains controversial. While a growing number of studies have shown safe employment in select patients under strict protocols, there is an increasing clinical need for further off-label investigations. To assess the feasibility and utility of brain MRI in neurological and neurosurgical patients with non-MRI-conditioned CIEDs using off-label protocol. We retrospectively evaluated 126 patients with non-MRI-conditioned CIEDs referred to our hospital between 2014 to 2018 for MRI under an IRB-approved protocol. A total of 126 off-label brain MRI scans were performed. The mean age was 67.5 ± 13.0. Seventy percent of scans were performed on female patients. Indications for MRI are neurosurgical (45.2%), neurological (51.6%), and others (3.2%). MRI utilization for tumor cases was highest for tumor cases (68.3%), but employment was valuable for vascular (12.7%), deep brain stimulators (3.2%), and other cases (15.9%). In the tumor category, (37.2%) of the scans were performed for initial diagnosis and pre-surgical planning, (47.7%) for post-intervention evaluation/surveillance, (15.1%) for stereotactic radiosurgery treatment (CyberKnife). No clinical complications were encountered. No functional device complications of the CIED were identified during and after the MRI in 96.9% of the studies. A 49.6% of the off-label brain MRI scans performed led to a clinically significant decision and/or intervention for the patients. A 42.9% of obtained MRI studies did not change the plan of care. A 7.9% of post-scan decision-making data was not available. We demonstrate that off-label brain MRI scans performed on select patients under a strict protocol is feasible, safe, and relevant. Almost 50% of scans provided critical information resulting in clinical intervention of the patients.

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Funding

During the initial part of the development (initial cohort data collection phase), Dr. Daniel Kramer was supported by a Paul B. Beeson Career Development Awards in Aging Research program (award no. K23AG045963) and the Greenwall Faculty Scholars Program, and he is a consultant to Circulatory Systems Advisory Panel of the Food and Drug Administration.

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Authors and Affiliations

  1. Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    Julie Mayeku

  2. Cardiovascular Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    Daniel Kramer & Koenraad J. Mortele

  3. Department of Radiology, Geisinger Medical Group, Danville, PA, USA

    Anand Mahadevan

  4. Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    Rafael Rojas & Rafeeque Bhadelia

  5. Neurosurgical Service, McMaster University and Hamilton Health Services, Hamilton, ON, Canada

    Ekkehard M. Kasper

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  1. Julie Mayeku
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  2. Daniel Kramer
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  3. Anand Mahadevan
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  4. Rafael Rojas
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  5. Rafeeque Bhadelia
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  6. Koenraad J. Mortele
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  7. Ekkehard M. Kasper
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Correspondence to Ekkehard M. Kasper.

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Conflict of interest

Dr. Daniel Kramer is also a consultant to Circulatory Systems Advisory Panel of the Food and Drug Administration.

Ethical approval

Our study has full Institutional Review Board approval. (IRB was approved by IRB review team at Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA USA).

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Patients described in this article provided consent for the use of their medical information and imaging.

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Mayeku, J., Kramer, D., Mahadevan, A. et al. Feasibility, safety, and utility of brain MRI for patients with non-MRI-conditioned CIED. Neurosurg Rev 43, 1539–1546 (2020). https://doi.org/10.1007/s10143-019-01149-6

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  • DOI: https://doi.org/10.1007/s10143-019-01149-6

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