On Feb. 14, 2011, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center became the first facility in Texas – and the second in the United States – to implant the new Revo MRI™ SureScan® pacing system since it was approved by the U.S. Food and Drug Administration (FDA).
The Revo MRI SureScan pacing system is the first and only pacemaker in the United States specifically designed for use in a magnetic resonance imaging (MRI) environment under specified scanning conditions.
“Until now, MRI use was not considered safe for patients who required implanted pacemakers,” said Dr. Robert Canby, an electrophysiologist with TCAI at St. David’s Medical Center. “The strong magnetic fields produced by MRI machines can disrupt the electronic pulses created by the pacemaker, delivering an altered pulse that can result in a potentially life-threatening heart arrhythmia. The magnets can also send energy through the leads, increasing the temperature of the leads, which can result in a shock or burning of the heart tissue.”
Each year, an estimated 200,000 pacemaker patients in the United States must forgo MRI scans, which are critical for making a wide range of health diagnoses, due to the potential for serious adverse effects. Access to MRI technology may provide earlier detection and treatment of serious medical conditions such as stroke, cancer and a wide variety of important neurologic and orthopedic conditions.
As the population ages, the use of pacemakers is growing, with approximately five million patients worldwide who require implanted pacemakers or cardioverter-defibrillators.
The use of MRI as a diagnostic tool is also increasing, with approximately 30 million scans completed in 2007. Individuals over the age of 65 are twice as likely to need an MRI as younger patients.
Additionally, 50 to 75 percent of patients with electronic cardiac devices will likely need an MRI over their device’s lifetime.
Revo MRI was designed to address safety concerns surrounding MRI procedures for patients who have implanted pacemakers. The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment.
Since MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment.
MRI lets doctors see internal organs, blood vessels, muscles, joints, tumors and areas of infection without X-rays or surgery and without exposing the patient to any ionizing radiation. The MRI machine creates a magnetic field, sends radio waves through the body, then measures the response with a computer, creating an image of the inside of the body.
In many cases, MRI gives information that cannot be seen on an X-ray, ultrasound or computed tomography (CT) scan.
The Texas Cardiac Arrhythmia Institute at St. David’s Medical Center is one of the world’s preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as atrial fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, M.D., a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures. For more information, visit www.tcainstitute.com.