Guidelines for the Management of Patients with Patent Ductus Arteriosus (PDA), 
Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), and Patent Foramen Ovale Occluders or Closure Devices Referred for MRI Examinations*
 

Frank G. Shellock, Ph.D., FACR, FISMRM
Adjunct Clinical Professor of Radiology and Medicine
Keck School of Medicine, University of Southern California
www.MRIsafety.com

In the clinical magnetic resonance imaging (MRI) setting, it is often necessary to manage patients with patent ductus arteriosus (PDA), atrial septal defect (ASD), ventricular septal defect (VSD), and patent foramen ovale occluders or closure devices (1-6). MRI labeling information exists for numerous cardiac occluders and closure devices. By following the MRI labeling information (i.e., presented in the Instructions for Use, Product Manual, Patient Identification Card, etc.), patients with cardiac occluders and closure devices have safely undergone MRI examinations, including those performed using MR systems operating at 3-Tesla. Notably, there has never been an adverse event reported in association with performing MRI exams in patients with these implants (4).
 

The standard policy that MRI labeling information is required before allowing the use of MRI in patients with cardiac occluders and closure devices limits access to this important diagnostic imaging modality for those patients for which labeling information is unavailable. Taking into account the peer-reviewed literature and other related information (1-6), it is acceptable to perform MRI examinations in patients with all cardiac occluders and closure devices by following specific guidelines developed by considering the primary safety concerns (i.e., magnetic field-related force, torque, and RF-induced heating) for these implants.

Guidelines: A patient with a cardiac occluder or closure device may undergo MRI using the following guidelines:
 

• 3-Tesla or less
   
• No restriction on the direction of the static magnetic field
   
• No restriction on the value of the spatial gradient magnetic field
   
• For a cardiac occluder or closure devices located inside of the area of the transmitted RF energy, use a whole-body averaged specific absorption rate (SAR) of 2-W/kg (i.e., operating the MR system in the Normal Operating Mode)
   
• For a cardiac occluder or closure device located entirely outside of the area of the transmitted RF energy, a whole-body averaged specific absorption rate (SAR) of 4-W/kg (i.e., operating the MR system in the First Level Controlled Operating Mode) may be used
   
• Maximum imaging time, 15 minutes per pulse sequence, multiple pulse sequences are allowed

*Important Note: The “Guidelines for the Management of Patients with Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), and Patent Foramen Ovale Occluder or Closure Devices Referred for MRI Examinations" should only be implemented for use after the careful review by the supervising radiologist or other physician responsible for the MRI facility and with the adoption of the information as a written policy.

Important Note: Any deviation from the above MRI conditions requires prior approval by the supervising physician.

Important Note: These guidelines must be reviewed on an annual basis to confirm that no  cardiac occluder or closure device has become available that substantially deviates from the above MRI conditions or that is labeled, MR Unsafe.

References
(1) Shellock FG, Morisoli SM. Ex vivo evaluation of ferromagnetism and artifacts for cardiac occluders exposed to a 1.5-Tesla MR system. J Magn Reson Imaging 1994;4:213-215.

(2) Shellock FG, Valencerina S. Septal repair implants: Evaluation of MRI safety at 3-Tesla. Magnetic Resonance Imaging 2005;23:1021-1025.

(3) ACCF/ACR/AHA/NASCI/SCMR 2010 Expert Consensus Document on Cardiovascular Magnetic Resonance A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. J Am Coll Cardiol 2010;55:2614-62.

(4) Cardiac closure and occlusion devices (e.g., devices to treat PFO, PDA, ASD, VSD), NHS GGC MRI Physics, https://www.mriphysics.scot.nhs.uk/implant-safety-policies/cardiac-closure-and-occlusion-devices-e-g-devices-to-treat-pfo-pda-asd-vsd/ Accessed, 08/2025.

(5) Shellock FG. Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2020 Edition. Biomedical Research Publishing Group, Los Angeles, CA, 2020.
 

(6) Shellock FG. Chapter 18, MRI Issues for Implants and Devices. In, MRI Bioeffects, Safety and Patient Management.  FG Shellock and JV Crues, Editors. Biomedical Research Publishing Group, Los Angeles, CA, 2022.
 

8/2025