Guidelines: Workflow for MR conditional devices
Manufacturer overview: Medtronic (SureScan) - Biotronik (ProMRI) - Bosten Scientific (ImageReady) - St. Jude Medical/Abbott (MRI Ready) - Sorin/LivaNova
All major pacemaker companies have MR conditional devices in their portfolio. However, the condition under which they can be scanned varied strongly. Searching for the right document with all details may be challenging. Therefore I try to collect the most importand documents on this webpage. First with direct links to the manufacturers Webpage (or guidelines how to get there) and partly also with the documents from the manufacturer.
Konsensuspapier der Deutschen Gesellschaft für Kardiologie (DGK) und der Deutschen Röntgengesellschaft (DRG) (3.2017)
T. Sommer, W. Bauer, K. Fischbach, C. Kolb, R. Luechinger, U. Wiegand, J. Lotz, I. Eitel, M. Gutberlet, H. Thiele, H. H. Schild, M. Kelm, H. Quick, J. Schulz-Menger, J. Barkhausen, D. Bänsch
RöFo (Deutsch), RöFo (English); Der Kardiologe: PDF: Deutsch, English
Positionspapier der Deutschen Röntgengesellschaft (DRG) zu MR-Untersuchungen bei Patienten mit Herzschrittmachern (2015)
T. Sommer, R. Luechinger, J. Barkhausen, M. Gutberlet, H. H. Quick, K. Fischbach
RöFo: pdf English version - pdf Deutscher Text
Overview of the labels from the different pacemaker vendors (march 2015). Copy from Positionspapier. Correction: Maximum body size should be minimal body size (see german document!)
http://www.pacemaker.ch/de/fachpersonen/mri.asp (only in German, 2017)
General information:
Medtronic has different pacemaker, ICD CRT-D, loop recorder, with some even older leads approved for MRI. All MR conditional pacemaker and ICD systems (SureScan) can be scanned at 1.5T, with 2W/kg and without an exclusion zone. All systems except EnrythmMRI are allowed at 3T. At 3T there is a zone (below C7) which allows only a B1rms of <2.8uT. Isocenter above C7 (head scans) have no SAR restrictions. Details please check the detailed documents from the manufacturer. Serial number is not needed, but lead length may be of importance. (overview over leads/leadi length which are not approved for MRI) - (Overview over all MR conditional Surescan systems (device+leads)
Webpage for MRI info:
Medtronic has a dedicated webpage with all relevant information on their Surescan devices: http://www.mrisurescan.com. The webpage includes also Drug infusion Systems and Spinal Cord Stimulators.
Webpage to search specific model info:
Search mask to enter device, lead etc.: http://wwwp.medtronic.com/mrc/search/index (select correct country before continue). At that point you get pdf for the different devices.
Summary:
MR conditional pacemaker, ICD, CRT-D, loop recorder (Surescan) systems (device and leads!) can be scanned at 1.5T, with 2W/kg and any body region (no exclusion zone). At 3T all devices except Enrythem MRI are allowed. For head scan without restriction, below C7 only up to a B1rms of 2.8uT
other devices:
Deep Brain Stimulator: http://professional.medtronic.com/mri/surescan-mri-radiologists/index.htm (on that page you find a pdf with a nice summary of the current restrictions of all surescan systems.)
Some deep brain stimulators from Medtronic are approved for MRI at 1.5T. A few for whole body applications, other for head only applications (in some case even with the limitation for the use of a transmit/receive head coil, and and in the worst case only for 0.1W/kg head SAR. To get resonable scantime prepare dedicated sequences in advance. To get lower SAR for TSE sequence use 3T protocols, which use not 180Â refocusing pules.)
General information:
Biotronic has Pacemaker, ICDs, CRT and CRD devices approved for MRI. Depending on the device and/or lead the devices are approved for 1.5T only or 1.5T and 3T. Some have an exclusion zone. SAR is limited to 2W/kg or in some cases to 4W/kg. Only suspine patient position are allowed. For some devices/leads the serial number is important to judge if the system may undergo MRI or not. Biotronik provide one large pdf-document with all devices which may under some conditions undergo MRI.
Webpage for MRI info: Main Webpage about ProMRI: https://www.biotronik.com/en-us/products/services/promri
Search the specific device and leads:
ProMRI System Check (Select country -- Select Device and Select one or two leads
Document with all info but less easy to search:
Link to the Manual: Biotronik Manual Library (Select country -- Select ProMRI under Product Group -- Select ProMRI under Product)
General information:
Bosten Scientific have pacemaker and ICD system on the market. Depending on the device and/or lead the devices are approved for 1.5T only or 1.5T and 3T. All MR conditional system have no exclusion zone. SAR is limited to 2W/kg or to 4W/kg.
Webpage for MRI info: Main Webpage ImageReady: http://www.bostonscientific.com/imageready/en-EU/home.html
Webpage includes also Neurostimulators. You can find documents for radiologist in different languages with a summary of the restrictions etc.
General information:
St. Jude Medical has pacemaker on the market which are approved for 1.5T. Some systems (device and leads) are approved for wbSAR 4W/kg, others are only for 2W/kg and in this case with an exclusion zone (warning there exists two exclusion zones (L4-C1 and L4- 10cm superior to C1)).
Webpage for MRI info: Infos in english auf Deutsch
Webpage to search specific model info:
Webpage with list of devices and leads: http://mri.merlin.net/
Hint: Direct link to MRI Ready System Manuals does not work. (you have to type in country and language and search than for MRI-ready).
other devices:
Webpage for Neuromodulation products: https://www.neuromodulation.abbott/us/en/hcp/provider-resources/mri-support.html
Pacemaker part moved over to Microport (head quater in China) and is no longer available under the LivaNova name. The brand Sorin is still in use.
General information:
Microport has different devcies and leads labeled for MRI. The latest models are for 1.5T and 3T (whole body) in normal operating mode. The Kora pacemaker are only approved for 1.5T. The exclusion zone has been removed. An automode is available for some devices.
Webpage for MRI info:Main Webpage about autoMRI: https://www.crm.microport.com/automri/de/
Manuals for the devices:
https://www.microportmanuals.com/
Select language - Yes - Cardiac Rhythm Management (CRM) - Europe & Other Countries - Search - MRI Solutions - pacemaker - MRI Solutions - select the correct model - select your Language - select manual version
Proposed workflow for patient with a MR conditional device. Copy from Positionspapier.
IF a pacemaker lead is not connected to a device, the patient should not undergo a MRI. This is independent if the electrode is labeled as MR conditional (if used in a system) or not. Therefore removing a device to allow a MRI scan is the worst thing which can made, since heating is very likely much higher compared to the same lead connected to a device.
field gradient: A field gradient of for example 19T/m (1900Gauss/cm) indicate how fast the magnetic field of the main magnetic field maximal may drop. This is a given value for each magnet (and not gradient system) and it can not be changed. However, in general this vaules are not limiting the possible MR systems. Typical values for a 1.5T are 2-3T/m and for a 3T in the range of 4-6T/m. This field gradient has nothing to do with the gradients for spatial encoding.
whole body SAR vs head SAR: For patients without any implants, the whole body SAR is limited for the normal operating mode to 2W/kg and for the first level control mode to 4W/kg. For the head SAR the limit is for both modes 3.2W/kg. Depending on the MR device and software release, different values will be shown and used to limit the RF power.
For the pacemaker/ICD in most case the whole body SAR is limited (to for example 2W/kg). If the limitation is normal operating mode, than for head scan, no changes are needed, since any scan will be within the normal operating mode. However, if only 2W/kg is given and your device shows whole body SAR, than you have to check that it will be within the 2W/kg.
Limit SAR on different scanners:
Philips: If the scanner switch to first level control mode for SAR, a small red indication will appear next to the scan name in the scan list. In you start the scan you have in addition to confirm that you will use first level control mode, which is in most case not allowed. Go to contrast and there for SAR mode. If you change that parameter to low, SAR is limited to 2W/kg. Other limites (even lower once) can be adjusted with user defined.
Rel 5.3+ ScanWise: With the Rel 5.3 and the ScanWise feature, during the patient registration all safety relevant infos can be entered and the system will be locked to the restriction!
GE: During entering patient data, you can also select normal operating mode for SAR.
Siemens: If a scan with a SAR above normal operating mode is selected, a window appears and there will be to option to select an adapted sequence with a SAR within normal operating mode.
If you find any outdated document or a no longer working link, please let me know: Roger Luechinger
This webpage includes document which are valid for Europe only. In other countries different restriction may apply and the link may not point to the right webpage in those cases. On the other hand side if you search documents over google etc. be check always if you got the correct document!
Last modified: 31 May 2023
Roger Luechinger