Assessment Of MRI In Patients With Implanted Cardiac Devices
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2017 |
| Start Date: | October 12, 2017 |
| End Date: | October 2019 |
| Contact: | Bobby Kalb, MD |
| Email: | bkalb@radiology.arizona.edu |
| Phone: | 520-626-9444 |
The research goal is to continue to add to the extensive body of peer-reviewed evidence that
demonstrates MRI may be safely performed in patients with cIEDs, after they have been
evaluated and cleared by cardiology. This study will allow the researchers to collect data
from the facilities ongoing clinical practice regarding the number and types of any adverse
clinical reactions, and also to document any changes in the implanted cardiac device that may
have occurred during the MRI scan. The researchers will also be assessing the results of the
MRI and how the imaging findings impact patient care and the clinical outcome of the patient.
This data will then be presented to the FDA and the Centers for Medicare and Medicaid
Services to further influence federal guidelines and payment structures.
demonstrates MRI may be safely performed in patients with cIEDs, after they have been
evaluated and cleared by cardiology. This study will allow the researchers to collect data
from the facilities ongoing clinical practice regarding the number and types of any adverse
clinical reactions, and also to document any changes in the implanted cardiac device that may
have occurred during the MRI scan. The researchers will also be assessing the results of the
MRI and how the imaging findings impact patient care and the clinical outcome of the patient.
This data will then be presented to the FDA and the Centers for Medicare and Medicaid
Services to further influence federal guidelines and payment structures.
Cardiac implantable electronic devices (cIEDs) generally refer to implanted pacemakers and
defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously,
cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans,
with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED.
However, this is a major healthcare issue, as approximately 50-75% of patients with implanted
cIEDs are expected to need a future MRI as part of their clinical care. The inability to get
such a test may negatively impact the ability to diagnose and treat future diseases.
However, many of the initial concerns regarding the capability of performing MRI in patients
with cIED have likely been overstated. There is peer-reviewed literature dating back to the
1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain
protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al
from Johns Hopkins University published a study on 438 patients with cIED that received MRI.
There were no adverse clinical effects from this study. In fact, the American College of
Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer
listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are
still regarded as a relative contraindication to performing MRI at some centers. In addition,
performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid
Services. Continued accrual of data regarding the safety of performing MRI in patients with
cIEDs is needed, including outcomes studies that document the clinical impact of improved
diagnostics provided by the MRI on patient care.
defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously,
cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans,
with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED.
However, this is a major healthcare issue, as approximately 50-75% of patients with implanted
cIEDs are expected to need a future MRI as part of their clinical care. The inability to get
such a test may negatively impact the ability to diagnose and treat future diseases.
However, many of the initial concerns regarding the capability of performing MRI in patients
with cIED have likely been overstated. There is peer-reviewed literature dating back to the
1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain
protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al
from Johns Hopkins University published a study on 438 patients with cIED that received MRI.
There were no adverse clinical effects from this study. In fact, the American College of
Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer
listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are
still regarded as a relative contraindication to performing MRI at some centers. In addition,
performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid
Services. Continued accrual of data regarding the safety of performing MRI in patients with
cIEDs is needed, including outcomes studies that document the clinical impact of improved
diagnostics provided by the MRI on patient care.
Inclusion Criteria:
- All patients that require an MRI as part of the normal course of their medical care
that also have a cIED and are candidates for MRI .
Exclusion Criteria:
- patient does not require an MRI for their medical care
- patient does not have a cIED
- patient has not been seen or approved by cardiology to be a candidate for MRI
- patients under the age of 18
- pregnant patients
- prisoners
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