Cardiac closure and occlusion devices (E.g devices to treat PFO, PDA, ASD, VSD)

MRI Generic Implant Safety Policy (GISP)

Policy Statement for MRI safety of cardiac closure and occlusion devices to treat congenital heart defects such as Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) and Patent Foramen Ovale (PFO)

Brief summary of known devices

Some closure procedures are carried out using clips e.g. to repair PDA. More often closure or occlusion is performed with umbrella like devices/occlusion devices which have expandable, metal wire frame structures. These are often referred to as devices that repair a hole in the heart.

Device Use

Clips can be used as part of surgical procedures, however, more commonly interventional procedures, using occlusion devices, are used. Once inserted, the umbrella like structures are expanded on either side of the pathology such as to repair the defect.

What this policy does not cover, including notable exceptions

• This policy only covers closure or occlusion devices used in the heart. This policy does not cover coiling or embolization devices. Polices for these devices are covered elsewhere.  

What the policy covers

• Clips, closure and occlusion devices used for the repair of Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) and Patent Foramen Ovale (PFO). These are commonly referred to as repairs for a hole in the heart.  

MR safety policy statement

• Patients with clips, closure, or occlusion devices for the purposes of the repair of PDA, ASD, VSD, and PFO may be safely scanned using 1.5T and 3T MRI in normal operating mode. If first level is required to achieve the desired clinical imaging quality, we believe the risk of scanning is still low, and therefore first level can be used where necessary under this GISP.    

Link to detailed review and risk assessment

Acknowledgement