ProMRI

ProMRI: MR Conditional Devices


For many years, patients with a pacemaker, ICD or CRT device, have been denied access to MRI. The cardiac devices were not approved for MRI scanning and the influence of magnetic resonance imaging on implanted cardiac systems was not yet tested.

In 2009 BIOTRONIK received, as one of the leading medical device companies, its first approval to label a pacemaker family and the respective leads as MR conditional. Today BIOTRONIK offers in more than 100 countries a comprehensive portfolio of pacemaker-, ICD- and CRT systems and cardiac monitors which are tested and approved to be MR conditional. BIOTRONIK therefore allows patients implanted with these device systems to undergo MRI scans under certain conditions.

Image
Cardiac Patient is able to undergo an MRI scan

General Information
For Cardiologists
For Radiologists
For Hospital Management
General Information

Design Innovations and Testing on Safety

To receive approval for MRI usage, a new set of requirements were added to the design and testing of the cardiac device system. The cardiac devices and the leads are tested individually and as a combined system, as approval is only given for the specific combinations of lead(s) and devices.

Examples of additional requirements are:

  • No significant change in temperature of the lead(s) in the MRI environment. The leads can act as an antenna and dissipate the energy of the radio frequency field as temperature rise to the tip of the lead.
  • Ensure optimal therapy through specific MRI modes of the devices. The MR environment may lead to inadequate sensing of the heart rhythm or unintentional pacing.
  • Withstand electromagnetic interference. The strong static, gradient and RF fields present in the MR environment may affect the electrical operation of the device or its software.

Interaction between MRI fields and body in an MR environment

Image
Image

Approved for MRI

Our efforts in design and the extensive testing of the ProMRI technology in our products have resulted in MR conditional devices in all areas of arrhythmia management:

  • MR conditional cardiac monitors, pacemakers, ICDs, CRT-P and CRT-D systems and their leads
  • Cardiac devices approved for 1.5 Tesla and 3.0 Tesla MRI scanners
  • More than 1.000.000 sold products MRI approved worldwide

To minimize barriers for device patients to undergo the MRI scanning they need, we continue our efforts to have our MR conditional systems approved for 1.5 T and 3.0 T MRI scanners, allowing full-body MRI scanning and streamlining the scanning procedure.

The latest innovation in this field is MRI AutoDetect. Cardiac devices with this feature have a new built-in sensor detecting the MR environment and automatically adapting the therapy mode during the MRI scanning. As a result, the workflow of device programming is improved and the scanning procedure for cardiac device patients is simplified.

MRI Access: A Growing Need

MR imaging is the preferred diagnostic modality for many soft tissue, sometimes life threatening conditions. As many patients with a cardiac device also have other comorbidities, up to 75% of these patients will need an MRI in their lifetime1

In 2012, the overall number of MRI scans in the US reached 30.2 million procedures2. MRI volumes will continue to be driven by growth in brain, musculoskeletal, and spine applications, in addition to newer procedures like cardiac MRI.

The need for MRI scanning is highest in the age group between 55-80 years, patients in this age group are also more likely to receive a cardiac device. As the demographics in many countries show a population growth of elderly people, an increase in demand of MRI scans with patients implanted with cardiac devices is expected as well.

The growing number of patients with an implanted cardiac device and the increased use of MRI to diagnose diseases like cancer or stroke will collide and result in more and more patients missing out on MRI scans. For the US in 2004 alone, it was estimated that 200,000 device patients missed out on MRI scans3. To counteract this problem, BIOTRONIK continuously strives to eliminate these barriers by introducing MR conditional pacemakers, leads and other cardiac devices.

Image
Image

MR conditional: What Does It Mean?

The following terminology applied to implants and devices relative to the MRI environment is being used: 

  • MR safe: an item that poses no known hazards in all MRI environments. E.g a plastic dish. 
  • MR conditional: an item that poses no known hazards in a specific MRI environment with specific conditions of use. 
  • MR unsafe: an item that is known to pose hazards in all MRI environments. E.g a pair of metal scissors. 

All current cardiac devices and their leads approved for MRI scanning are labelled: MR conditional.

Different Types of MRI Scanners

MRI scanners are the gold standard of soft tissue imaging. The most common MRI Scanner has 1.5 tesla which is able to create images with high enough resolution for almost all clinical applications.

The 3.0 tesla MRI Scanner provides even higher quality images and is used when more detailed images are required. E.g. brain scans or tumor Imaging.

As 1.5 and 3.0 tesla MRI Scanner differ in their magnetic fields and therefore in their effect on the cardiac device, specific testing has to be done in order to receive approval for both scanner types. Even approval of a cardiac device system for 3.0 tesla MRI scans does not automatically imply that the cardiac system is also MR conditional for 1.5 tesla MRI machines.

Image
For Cardiologists

ProMRI: Safety Information for the Cardiologist

In order to ensure the safety of a patient with a BIOTRONIK MR conditional cardiac system during the MRI procedure, specific conditions have to be met and checked by the cardiologist prior, during and after the MRI procedure.

As new BIOTRONIK products become available or current cardiac systems receive additional MR conditional approval, the conditions for MRI scanning may change over time for a device – lead combination. It is therefore important to be informed about the latest approval status of such a system in your region.

This website gives you quick access to all the information you need.

Image
Image

Verify Whether The Implanted System is MR Conditional Approved

Make sure the combination of the device and its leads are approved as MR conditional. As the approval status may vary between countries, there might be differences in the MRI conditions for the implanted system between certain countries.

  • To check if the implanted system is MR conditional visit the ProMRI®System Check Website.
  • For conditions and combinations of ProMRI device systems, also check the ProMRI manual, available on the BIOTRONIK manual library.
  • To configure an MR conditional system for implant visit the ProMRI®Configurator.

ProMRI Scanning Checklist

Only when all conditions are fulfilled, the MR conditional system can be used in an MR environment. There are separate checklists for devices approved for full-body or for MRI scanning with an exclusion zone of the chest area.

Download the ProMRI Checklist for a short overview of the conditions or the ProMRI manual for all Details.

ProMRI: Workflow for MR Conditional Devices

Patients with an MR conditional cardiac monitor, pacemaker, ICD or CRT system the following measures must be taken before, during and after the scan:

1. Patient visits cardiologist prior to an MRI scan.

2. The cardiologist checks if scanning is allowed and programs the device to a specific MRI setting.

3. The MRI scan is performed according ProMRI conditions by a radiologist.

4a. The cardiologist programs the device to its previous settings and a follow up is being performed.

4b. If the system has the MRI AutoDetect function, programming back to previous settings is done automatically (if the device has Home Monitoring activated, a follow up is being performed via Home Monitoring).

5. Patient continues as usual with regular follow ups.

MRI AutoDetect: MRI Access Simplified

The cardiac devices with the MRI AutoDetect feature have a built-in sensor for detecting the MR environment. When the patient is near the MRI scanner, the device is automatically programmed to the predefined MRI setting. Leaving the MRI scanner, the previous setting becomes active again.

  • Only during the actual duration of the scanning procedure, the patient is in the MRI Mode with limited therapy functionality (asynchronous pacing, Tachy detection OFF)
  • Once the MRI AutoDetect functionality is active, no additional programming is required when a patient undergoes (multiple) MRI scans
  • The activation of the MRI mode through the MRI AutoDetect sensor is programmable for a window of up to 14 days.
  • After an MRI scan, a report with all details is transmitted by Home Monitoring within 24 hours.
Image

MRI Auto Detect Video

For Radiologists

ProMRI: Safety Information for Radiologists

For patients with a cardiac device, MRI has been a contraindication for many years. Today BIOTRONIK offers in more than 100 countries, a comprehensive portfolio of MR conditional cardiac devices and leads which are approved for usage in the MR environment. In order to allow the patient to undergo an MRI scan, specific conditions have to be met. To perform the MR procedure, the radiologist must make sure that these specific ProMRI conditions are adhered to.

The sharing of information between cardiologist and radiologist is also important to make sure the MRI scanning takes place within the boundaries of the ProMRI conditions. Here you can find the information you need to scan patients with a BIOTRONIK MR conditional cardiac monitor, pacemaker, ICD or CRT system.

Image
Image

MRI Scanning Checklist

Only when all conditions are fulfilled, the MR conditional system can be used in an MR environment. There are separate checklists for devices approved for full-body or for an MRI scanning procedure with an exclusion zone of the chest area.

Download the ProMRI Checklist for a short overview of these conditions and the ProMRI manual for all the safety information details.

Before MRI Scanning

Before the patient can undergo the MRI scan, the patient first needs to have a follow up by a cardiologist. During this follow up, the cardiologist will check if the system is approved as MR conditional and program the device to the MRI mode. The MRI mode is specifically designed to allow MRI scanning, but offers limited device therapy. For instance the tachy arrhythmia therapy in ICD devices is switched to off. The timing of the device programming by the cardiologist and MRI scanning should therefore be carefully planned.

BIOTRONIK devices may have the MRI AutoDetect feature. In this device a built-in sensor detects the MR environment and automatically programs the device in the preset MRI mode. To activate the sensor and program the MRI mode, a visit to the cardiologist prior to the MRI is still required.

Image

Image

Ask for Patient ID Card

The Patient ID card will indicate if the cardiac system is MR conditional.

Note: If all specific conditions of the scanning procedure are met, the device system can be used in the MR environment.


Communication between Radiologist and Cardiologist is Key

Consult the patients cardiologist and the ProMRI manual if you have questions regarding the implanted systems MR conditionality and/ or its conditions. At ProMRIcheck.com you can check if a device– lead combination has been approved in a country.

Using the individual QR code in the documentation of your patient gives a quick overview of the MR conditionality of the patients device.

Image

ProMRI: Workflow for MRI conditional Devices

Patients with an MR conditional cardiac monitor, pacemaker, ICD or CRT system the following measures must be taken before, during and after the scan:

1. Patient visits cardiologist prior to an MRI scan.

2. The cardiologist checks if scanning is allowed and programs the device to a specific MRI setting.

3. The MRI scan is performed according ProMRI conditions by a radiologist.

4a. The cardiologist programs the device to its previous settings and a follow up is being performed.

4b. If the system has the MRI AutoDetect function, programming back to previous settings is done automatically (if the device has Home Monitoring activated, a follow up is being performed via Home Monitoring).

5. Patient continues as usual with regular follow ups.

Imaging Artefacts

The MRI scan of a patient having an MRI conditional device, can be distorted by artefacts caused by the device system. The closer the implanted device is near the scanned area, the risk of artefacts increases. In most cases however, the implanted cardiac devices do not limit the clinical diagnostic value of the MRI image.

For Hospital Management

ProMRI: Enabling Access to MRI

The value of BIOTRONIK ProMRI technology lays in the increased access to MRI of cardiac device patients. Design innovations and extensive testing, have resulted in MR conditional approved cardiac systems in all areas of cardiac rhythm management: cardiac monitors, pacemakers, ICD and CRT systems and their leads.

MRI has been proven to offer superior diagnostic value in a number of serious health conditions. MRI is especially valuable for neurological (brain) and musculoskeletal conditions as well as cancer, as it offers unique visualization allowing better therapy decisions in these often life threatening diseases.

As three out of four device patients will need an MRI during their lifetime, the ProMRI technology contributes highly effectively to optimal patient care.

Image
Image

The Need for MRI Increases with Age

The population of patients with an implanted device is usually older than 55 years of age. As age increases, more patients suffer from comorbidities which might require an MRI scan to be diagnosed or monitored.

Patients with a cardiac device have a probability of up to 75% for needing a MRI scan during their lifetime due to comorbidities. This means that the patients implanted with a conventional non-MR conditional device system might not be able to undergo a scan even though they actually need it. As MR imaging is not only a one-off necessity but, depending on the condition, might be required repeatedly, these patients may miss out on necessary diagnostics more often.

Avoiding Risks by Off Label Use

For imaging of soft tissue diseases which can be life threatening (tumors e.g.), MRI is the imaging modality of choice. The availability of MR conditional devices reduces the potential for off-label situations which routinely occur if patients with conventional devices undergo MRI scanning.

MRI Access for All

MRI is accepted as a beneficial and cost-effective diagnostic tool, it should therefore be available to all patients in need – including the increasing population of patients with a cardiac device.

Image

MRI AutoDetect Simplifies the MRI Workflow

BIOTRONIK devices with the unique built-in sensor detects the MR environment and automatically switches the device to the predefined MRI setting. As a result:

  • Less programming is required by a medical professional (cardiologist) as part of the MRI procedure, which saves costs.
  • More flexibility in scheduling patient appointments which increases efficiency of the cardiology and radiology departments and simplifies the workflow
  • Before and after the scanning procedure no supervision by a medical professional is needed, as the patient remains in optimal therapy mode during that time. As a result, additional costs can be avoided.

1 Kalin R, Stanton MS. Current Clinical Issues for MRI Scanning of Pacemaker and Defibrillator Patients. PACE. 28, 326-328. 2005.

2 Magnetica Ltd. Todays MRI market. 2014. Eagle Farm, QLD, Australia, Magnetica Ltd. 11-12-2014.

3 Kalin R, Stanton MS. Current Clinical Issues for MRI Scanning of Pacemaker and Defibrillator Patients. Pacing and Clinical Electrophysiology. 2005; 28: 326–328.