MRI SureScan pacemakers & ICDs what you need to know
Many variables can affect the device patient s likelihood of risks w/ an MRI Type of imaging sequence Type of scanner MRI scan duration Strength of RF field Pacemaker and lead materials and design Length and orientation of pacing leads Blood flow in lead-tip region Patient factors and medical history All of these were researched and drove the design & clinical validation of these products
Medtronic SureScan products Pacemakers Revo MRI Advisa MRI SR / DR Micra TPS Pacing leads 5086 or 5076 MRI Implantable Cardiac Monitors LINQ Reveal XT Reveal DX No abandoned or capped leads; no other leads ICDs & CRT Evera VR & DR ICD; Visia AF MRI Amplia & Compia CRT-D ICD leads (ventricle) 6947M (55 & 62 cm) 6935M (55 & 62 cm) Pacing leads (atrium) 5086 or 5076 MRI LV leads 4196, 4296, 4396 4298, 4398, 4598
What was done in pacemakers & ICDs to make them MRI conditional? Designed to manage how they will respond to MRI fields Minimized ferromagnetic content Removed switches that are sensitive to magnetic fields Changed input circuits to avoid picking up gradient fields & relaying those signals to the heart Placed additional filters on the telemetry circuits to ensure high energy fields do not damage circuits
What was done in the leads? Lead tip heating can vary greatly, based on lead construction, length, & path in body & heart Acceptable pacing leads have been engineered to picking up RF energy (making them a poor heat transmitter) Testing has validated that certain ICD leads also perform appropriately (are poor heat transmitters) % of maximum Lead heating comparison 100 90 80 70 60 50 40 30 20 10 0 0 5 10 15 20 25 30 35 40 45 50 Lead Path Standard MRI
What was done in the software? Medtronic created SureScan mode Programmed ON before every scan Checks for system integrity Makes device ignore MRI signals Locks into a safe pacing mode SureScan is turned OFF by Medtronic rep at end of scan
Therefore, Revo, Advisa, & Evera MRI are FDA labeled MR Conditional MR Conditional Under specific conditions of use, there are no known hazards or risks Device conditions Cardiology conditions Radiology conditions
What are the conditions for a scan? (FDA labeling) Device conditions Cardiology conditions Radiology conditions
Device conditions: SureScan pacing system = ONLY Revo MRI pacemaker, or Advisa MRI pacemaker + 5086 or 5076 MRI pacing leads OR, Micra (transcatheter pacing system) which has no leads (no other abandoned leads, or remnants of leads)
Device conditions: SureScan ICD system = ONLY Evera DR MRI, or Evera VR MRI, or Visia AF MRI + 6947M or 6935M ICD leads; 5086 or 5076 MRI pacing leads (no other abandoned leads, or remnants of leads)
Device conditions: SureScan CRTD system = ONLY Amplia MRI, or Compia MRI + 6947M or 6935M ICD leads; 5086 or 5076 MRI atrial pacing leads 4196, 4296, 4396; or 4298, 4398, or 4598 LV leads (no other abandoned leads, or remnants of leads)
How can you identify what hardware is in the patient? Ask the patient who their cardiologist is ( who cares for your pacemaker or ICD ) and call that office to verify the system & to get an order for programming Or, call Medtronic at (800) 551-5544 to verify the patient s current implanted system Or, use the patient s ID card to identify the device and leads implanted, then verify MR conditional at http://www.mrisurescan.com
Patient s ID card will state if they have a complete MRI system
Cardiology conditions: cardiologist s written order (fax to the office who cares for the patient s device before the scan so you have it on hand when we come to program the device)
Cardiology conditions: SureScan programming SureScan is programmed ON before MRI (details prescribed by cardiologist) SureScan is programmed OFF after MRI This is typically done by the Medtronic rep, so you need to plan for this in your scheduling (this does NOT need to be the cardiologist)
Radiology conditions training A health professional who has completed radiology SureScan training must be present during the MRI scan (this is NOT the cardiologist or the Medtronic rep) Training can be found at www.mrisurescan.com Take the training and print your certificates for the hospital training records If you have done this before, you need to revisit it and update your training now! 16
Radiology conditions, page 1 (for example) Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used Some products are recently labeled for 3T; you need to update your training on this! Gradient systems with maximum gradient slew rate performance per axis of 200 Tesla per meter per second (T/m/s) must be used The scanner must be operated in Normal Operating Mode: The whole body averaged SAR must be 2.0 watts per kilogram (W/kg). The head SAR must be < 3.2 W/kg.
Radiology conditions, proper patient monitoring (by designated hospital staff) During a scan, ICD detections and therapies are disabled
Radiology conditions, page 2 Continuous patient monitoring The methods include visual and verbal contact with the patient, electrocardiography, or pulse oximetry. Strongly advise oximetry, as EKG is disrupted by some scan sequences Your hospital needs to plan for who will be monitoring the patient. Most hospitals utilize Radiology or Cath Lab nurses This does NOT need to be the cardiologist
Training requirement www.mrisurescan.com
If you ve trained before, it s likely you re receiving this email...
Follow MRI scanning checklist