The Patient Care Pathway refers to the process that must be followed from the time a patient is first referred for an MRI scan. To safely perform an MRI scan, SureScan™ must be programmed On prior to receiving an MRI scan. After the scan is performed, SureScan must be programmed Off to return to pre-MRI configuration.
Follow the methods described in the Patient Pre-Screening Process to verify that your patient has a complete SureScan pacing, defibrillation, or CRT-D system.
Use the Cardiology Checklist to ensure that the proper requirements and device settings are in place before a patient with a SureScan System undergoes an MRI.
Consult the SureScan Programming Steps for device programming instructions you need to follow prior to and after an MRI procedure.
Refer to the Radiologist Checklist to find Radiology’s responsibilities for scheduling, prepping, and conducting an MRI scan on a patient with a SureScan pacing, defibrillation, or CRT-D system.
Verify that patient has a complete SureScan pacing, defibrillation, or CRT system, which consists of an approved combination MRI SureScan device with SureScan lead(s) (Note: The model 6725 Pin Plug is MR conditional only for use in the atrial port on CRT devices), using one or more of the following methods:
The following are two optional methods that rely on complete and accurate information being entered:
STEP 1: PATIENT PRESCREENING REQUIREMENTS
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
STEP 3: POST-SCAN PROGRAMMING REQUIREMENTS
Refer to the SureScan Programming Tip Card for more details.
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.
From the Quick Look™ II screen, select "Params" (see red box).
Select "MRI SureScan..." (see red box).
Tip: SureScan settings are also accessible by selecting [Params][Pacing][Additional Features].
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.
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.
Select the desired SureScan Pacing Mode and confirm by closing the window.
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.
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.
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.