Is scanning traditional pacemaker patients safe?

Despite theoretical and actual risks of MRI to patients with pacemakers, defibrillators, and other cardiac devices, the safety debate continues.

• Testing has been limited and studies too small and insufficient to extrapolate results to the larger population
• Patient safety cannot be guaranteed by extrapolating findings from these limited studies
• The American College of Radiology (ACR) and the Radiological Society of North America (RSNA) warn that medical devices may malfunction or cause problems during an MRI exam⁶
• Contraindications against MRI scans for people with implantable cardiac devices are found on the websites of all the main manufacturers of implantable cardiac devices^7-11
• Patients are at risk of serious side effects or death in the absence of a pacing system approved for MRI use^4,5,12
• Safety is proven only by more rigorous scientific testing and regulatory review
• Clinicians must carefully balance the potential benefits and risks to patients

Hazards and Risks

MRI and Implantable Pacing Systems — The risks were prohibitive for your patients, until SureScan^® pacing systems.

Three powerful fields present during an MRI scan provide sources of electromagnetic interference (EMI):

• Static magnetic field
• Gradient magnetic field
• Pulsed radiofrequency (RF)

Either alone or in combination, these fields have the potential to induce hazardous effects on patients and their implantable cardiac devices.

Potential Hazard3,4	Risks for Patient and Device
Force, Torque, Vibration	Surrounding tissue damage Lead dislodgement System damage Patient discomfort
Induced Voltage by Gradient and RF Fields	Cardiac arrhythmias Accelerated pacing beyond rate limit Inhibition of pacing support Damage to mechanical integrity
Lead Tip Heating	Tissue damage Loss of sensing and/or pacing capture Subsequent threshold changes Patient discomfort
Device Malfunction	Loss of therapy Pacing mode change Device reset Erroneous diagnostic data

A staggering combination of variables affect the magnitude of risk for patients:

Because of these risks, MRI scans are unsafe and off limits for millions of patients with implantable cardiac devices.

With the exception of the SureScan^® Pacing Systems with MR Conditional approval, current pacing systems cannot be used safely in an MRI environment. Testing has been limited and studies too small and insufficient to extrapolate results to the larger population.

Numerous adverse events involving pacemaker patients undergoing MRI scans have been reported by the FDA and in medical journals.^3,5