Suggested statements to use when describing risk during consent for patients with different non-MR Conditional CIEDs
| Intervention | Recommended risk statement to discuss with the patient. The MRI procedure, benefits and alternatives should also be discussed with the patient with the opportunity for them to have additional queries addressed by an appropriate clinician. |
| Intermediate-risk and higher-risk scenarios (formal written consent required) | |
| MRI with MR Unlabelled CIED (without additional higher-risk scenarios) | You have been referred for a MRI scan. Your pacemaker/defibrillator has not been formally approved to undergo MRI scanning by the manufacturer. The decision to perform the MRI scan has been made after discussing the possible benefits, risks and alternatives with your referring doctor. Serious complications related to MRI occur in <1 in every 2000 patients (about 0.05%) with these devices overall. These include, but are not limited to:
Emergency or urgent replacement of the cardiac device may be needed and will be performed if required. |
| Additional intermediate-risk and higher-risk scenarios (formal written consent required) | |
| MRI with MR Unlabelled CIED generators implanted prior to 2005 | (in addition to above) Due to the age of your device, the risk may be slightly higher—with approximately a 2% risk of (generally temporary) programme changes to ‘factory settings’. |
| MRI with MR Unlabelled CIEDs implanted prior to 2000 | (in addition to above) There is less evidence for scanning patients with old devices that were implanted before the year 2000. We also know that the older technology used in these devices mean that they are more sensitive to MRI and therefore the risk is likely to be higher. |
| MRI with abandoned lead(s) | (in addition to above) Having a pacemaker or defibrillator lead which is not attached to a generator may result in heating at the end of the lead in your heart, which could theoretically cause tissue damage. To date, there have been no reported problems in patients being scanned with these leads, although the number of these patients is relatively small. We would ask that you inform staff immediately if you feel any discomfort. |
| Lower-risk scenarios (formal written consent is not required, and the risks can be discussed verbally) | |
| MRI following recent CIED implantation (typically <6 weeks post implant) | Your cardiac device manufacturer recommends that you wait for a period of time after implantation (commonly 6 weeks) before having an MRI scan. There have been no problems reported in patients having scans earlier than this, however formal testing has not been performed to guarantee that this is safe. |
| MRI in patients with ‘mismatched’ CIEDs with MR Conditional generators | The generator in your device has been formally tested and approved for MRI, however the leads have not. Studies have found no increased risk of MRI with devices like yours when compared with MRI in patients with device systems that are fully approved. There is however a potential risk of undergoing an MRI, but this will be small and considerably lower than <1 in every 2000 patients, which is the overall risk of MRI in patients with devices not approved for MRI. |
These statements should be used in addition to discussing the MRI procedure, potential benefits and alternatives. This list is intended for common scenarios, and not as an exhaustive list. ‘Mismatched’ CIEDs have MR Conditional generators and MR Unlabelled leads; or MR Conditional components from different manufacturers.
*For lower risk scenarios, see table 3.
CIED, cardiac implantable electronic device.