Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices

MRI is the preferred imaging modality for both acute and elective evaluation of many
conditions. For example, for many diseases of the central nervous system, no other imaging
modality provides the requisite soft tissue resolution to support critical care elements such
as neurosurgical planning or assessment of intracranial malignancies.

Historically, MRIs were considered contraindicated for patients with CIEDs including PMs and
ICDs. However, studies have demonstrated very high utilization of MRIs among patients
eligible for CIEDs. In many cases, alternative imaging is either insufficient or, as with
CT-myelography, poses substantial risks or procedural hurdles that may be less favorable than
the potential risks of an MRI.

In recent years, a growing literature has suggested that MRIs can be performed safely in the
setting of CIEDs if certain precautions are taken. Additionally, guidance documents have been
released by professional societies including the American Heart Association (AHA) and the
American College of Radiology (ACR) outlining recommended safety measures that can be taken
to minimize risk and maximize benefit for patients in need of imaging. However, there are
fewer data on performing MRIs in pacemaker-dependent patients with ICDs, who were excluded
from the largest published study as well as the MagnaSafe Registry. Thus, demonstrating the
safety and clinical utility of performing MRIs in this context is of high importance.

In response to urgent clinical considerations, Beth Israel Deaconess Medical Center has
established a clinical protocol to provide safe MRIs in cases of compelling clinical
indications, with close supervision and oversight from Radiology and Cardiac
Electrophysiology staff. Thus, the investigators now propose a prospective study to evaluate
safety and clinical outcomes for patients treated under this clinical protocol.

Specifically, this study proposes to perform a prospective clinical trial in patients with
CIEDs that have a clinical need for MRI as outpatients to determine:

1. Safety according to the incidence rates of acute major and minor adverse events
according to pre-specified definitions.

2. Clinical outcomes and scan utility affecting patients' survival and quality of life and
treatment, including acute and longitudinal changes in device parameters, the need for
system revision, and proportion of MRI findings influencing clinical management
including medical or surgical interventions, and diagnostic or prognostic changes.

Inclusion Criteria:

- Patients have a medically/clinically indicated need for an MRI

- Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000

- Patients are willing and able to sign consent and HIPAA authorization or an authorized
representative of the patient is willing to sign consent for the patient

*The following factors are considered relative contraindications to the clinical
protocol at BIDMC, and will similarly be considered exclusion criteria for the study.
Exceptions on a case-by-case basis for circumstances of dire, life-threatening need
may be considered.

- Leads implanted <6 weeks prior to the MRI

- Presence of any capped/abandoned leads

- Presence of nontransvenous epicardial leads

Exclusion Criteria:

- Other contraindications to MRI (e.g. other non-MRI-conditional implants)

- Pacemaker or ICD implanted prior to the year 2000

- Leads and/or generator implanted within 6 weeks of the proposed MRI

- CIED that is FDA approved as MRI conditional

- Pregnant women