Clinical Controversy

Despite theoretical and actual risks of MR scanning to patients with cardiac devices, the safety debate continues.

• Limited studies have documented safe procedures and "no adverse events"
• Patient safety cannot be guaranteed by extrapolating findings from limited studies that documented no adverse events. Safety is proven only by more rigorous scientific testing and regulatory review.
• Clinicians must carefully balance the potential benefits and risks to patients
• No implantable cardiac device is currently labeled for use in the MR environment

...failing to identify an adverse event is not equivalent to demonstrating safety-especially when only a limited number of patients are studied...¹

J. Rod Gimbel, MD, FACC
Emanuel Kanal, MD, FACR

Recently Published Articles: The Safety Debate Surrounding MRI and Implantable Cardiac Devices.

References

1. Gimbel J and Kanal E. Can patients with implantable pacemakers safely undergo magnetic resonance imaging? J Am Coll Cardiol. 2004;43:1325-1327.

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