Patient Care Pathway MRI Access

STEP 1: PATIENT PRESCREENING REQUIREMENTS

• The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
• The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance history. (Note: For Advisa MRI™ and Ensura MRI™ pacemakers, the lead impedance value is ≥ 200 ohms (Ω) and ≤ 1,500 Ω.)
• The SureScan system is implanted in the left or right pectoral region.
• The SureScan system is post-lead maturation period (approximately 6 weeks). 
• The SureScan device is operating within the projected service life.
• For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan mode is programmed to On, no diaphragmatic stimulation is present when the paced leads have a pacing output of 5.0 V and a pulse width of 1.0 ms.

Caution: It is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms for pacemaker-dependent patients. A higher pacing capture threshold may indicate an issue with the implanted lead.

STEP 2: PRESCAN PROGRAMMING REQUIREMENTS

• A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan mode. Take the training now.
• Provide a doctor’s order for pacing support needed and the appropriate pacing rate during SureScan operation.
  • For patients who require pacing support, the MRI pacing mode must be set to DOO, AOO, or VOO while the MRI SureScan feature is programmed On.
  • Tip: If an asynchronous pacing mode is selected, an appropriate MRI SureScan pacing rate must be selected to avoid competitive pacing during the operation of MRI SureScan.
  • Note: For pacemakers and CRT-P systems, Atrial and RV pace polarities must be set to bipolar to program MRI SureScan mode to On.
  • Note: For CRT systems, when MRI SureScan mode is programmed to On, the patient receives no CRT support. This lack of CRT support might cause dizziness or shortness of breath.
  • For patients who do not require pacing support, the MRI pacing mode should be set to ODO (OVO, for single chamber devices) while the MRI SureScan feature is programmed On.

STEP 3: POST-SCAN PROGRAMMING REQUIREMENTS

• Program SureScan mode Off after the MRI procedure; device returned to previous settings.
  • Note: Do not leave the device in MRI SureScan mode after the scan is complete. For CRT-D and ICD devices, while the MRI SureScan mode is programmed to On, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased. 
  • Note: For CRT Systems, while the MRI SureScan mode is programmed to On, the patient receives no CRT support. This lack of CRT support might cause dizziness or shortness of breath.
• Check the pacing thresholds to ensure that there is a proper safety margin.

Prior to the MRI procedure

1. After accessing the Parameters screen, navigate to the MRI SureScan feature.
2. Select the check box in the upper-left corner to indicate all items on the MRI SureScan checklist are satisfied.
3. Select MRI SureScan programming field to On. Note: When MRI SureScan is programmed to On, all device diagnostic measurements and collection are suspended; the ICD or CRT-D system does not detect tachyarrhythmias and does not deliver tachyarrhythmia therapy.
4. From here, you will need to:
   • Program a mode (DOO, VOO, AOO, ODO, or OVO)
   • Program a rate (for asynchronous modes only)
   • Touch [PROGRAM] to complete the steps
   • Touch [Print...] for documentation

Refer to the SureScan Programming Tip Card for more details.

After the MRI procedure

1. Interrogate the device, and you will be automatically brought to the SureScan programming screen.
2. Program SureScan Off. Pre-scan parameters are automatically restored.
3. Check the pacing capture threshold to ensure that there is a proper safety margin.

Follow these steps to program MRI SureScan Mode to “ON”

Note: The screens may vary slightly.

Warning: Do not scan a patient without first programming MRI SureScan to On. Scanning the patient without programming MRI SureScan to On may result in patient harm or damage to the SureScan system.

Step 1

From the Quick Look™ II screen, select "Params" (see red box).

Step 2

Select "MRI SureScan..." (see red box).

Tip: SureScan settings are also accessible by selecting [Params][Pacing][Additional Features].

Step 3

Select the check box in the upper-left corner if all items on the MRI SureScan Checklist are satisfied for the patient (see red box).

Select "OK". The MRI SureScan window appears.

Step 4

Program MRI SureScan to “On” (see red box).

An external defibrillator must be immediately available while the device is programmed to MRI SureScan mode for patients with a defibrillator or CRT-D system; for pacemaker and CRT-P patients while they are in the MRI scanner.

Step 5

Select the desired SureScan Pacing Mode and confirm by closing the window.

Step 6

If asynchronous pacing mode is needed, select the desired SureScan Lower Rate.

Tip: If an asynchronous pacing mode is selected, an appropriate MRI SureScan pacing rate must be selected to avoid competitive pacing during the operation of MRI SureScan.

Note: While MRI SureScan is programmed to On, the patient receives no CRT support. This may cause dizziness or shortness of breath. Be sure to program MRI SureScan to Off as soon as the scan is complete.

Step 7: Select "Program"

The status of MRI SureScan and programmed parameters may be confirmed by printing the MRI SureScan parameter screen.

Note: CRT patients receive no CRT support during SureScan mode; patient should be monitored for dizziness and shortness of breath

No other programming is available until MRI SureScan is programmed to Off.

Tips

After SureScan is programmed On, notice that tachyarrhythmia detection and therapies are off for defibrillator and CRT-D systems. Diagnostic data is not collected. This is not programmable. 

SureScan Timeout in defibrillation and CRT systems is a safety feature to ensure patients are not sent home without programming MRI SureScan Off. When programmed into SureScan mode the 6-hour timeout is activated; when this timeout period ends, the device automatically returns to the pre-scan settings. Before you program MRI SureScan to On, ensure that the MRI scan will be completed before this 6-hour timeout occurs. Please note that this Tip Card does not cover Micra™ Transcatheter Pacing System; refer to the dedicated SureScan Tip Card for Micra TPS programming recommendations.

A customizable word document that cardiologists can use to supply patient implant information and programming instructions for any patient with a SureScan System. The form may then be faxed to any MRI site before the patient undergoes an MRI.