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CIED and MRI: Overcoming Challenges to Meet Patien ...
CIED and MRI: Overcoming Challenges to Meet Patien ...
CIED and MRI: Overcoming Challenges to Meet Patient Needs
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Video Transcription
Video Summary
This session focused on the challenges of obtaining MRIs for patients with cardiac implantable devices. The speakers, including Dr. Russo from Scripps Research Institute, highlighted the risks associated with MRI in patients with devices, such as lead heating, generator damage, and inappropriate device programming. Dr. Russo emphasized the lack of documented adverse events in appropriately managed patients, while identifying an opportunity to improve patient access to MRIs by reassuring the radiology community and removing unnecessary hurdles. Martha Ferrara discussed the clinician's role in obtaining off-label MRIs when traditional policies deny access due to device concerns. She provided examples of successful collaborations which have not resulted in adverse events and argued that such MRIs provide significant clinical value by guiding accurate and targeted treatment. Mark Fellman shed light on the FDA's regulatory considerations, indicating that FDA approval of MRI conditional labeling requires data submission from manufacturers. He noted the challenges in labeling mixed vendor systems and highlighted the practice of medicine's evolution towards using comprehensive guidelines for non-MR conditional scenarios. The session concluded with a discussion on collaborating across specialties to overcome institutional and regulatory barriers, stressing that service to patients should not be denied due to theoretical risks, as highlighted by ongoing data showing safety. The importance of expanded research and advocacy was underscored, particularly for specific patient populations like those with epicardial leads.
Keywords
MRI
cardiac implantable devices
lead heating
generator damage
radiology
off-label MRI
FDA approval
regulatory barriers
patient access
epicardial leads
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