Texas Heart® Institute at St. Luke’s Episcopal Hospital Among First in Texas to Offer Pacemaker that Allows Patients to Safely Undergo MRI Procedures
Texas Heart® Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) is among the first in Texas using newly approved pacemaker technology to safely overcome barriers, which previously blocked patients fitted with pacemakers from access to Magnetic Resonance Imaging (MRI) machines for medical diagnosis. The new technology, known as the Revo MRI™ Sure Scan pacing system, received FDA approval in February 2011.
THI-affiliated cardiac electrophysiologist John J. Seger, MD, was the first in a four-state region of Texas, Oklahoma, New Mexico and Arizona to implant the device. The patient who received the new pacemaker in October 2009 was a 76-year-old cancer patient who needed the device to treat a slow heart beat, but also needed an MRI on a regular basis to ensure that his cancer had not returned or spread. Although the FDA had not yet approved the device at that time, it allowed SLEH to implant the pacemaker based on compassionate use.
“Up to one in three people will undergo an MRI in their lifetime,” Seger said. “This new technology gives flexibility for those who also need a pacemaker.”
There is a 50 to 75 percent probability that patients with cardiac devices such as a pacemaker will need an MRI over the lifetime of their devices, according to the developer of the new pacemaker. Furthermore, more than 200,000 patients in the United States have to forego an MRI scan because they have a pacemaker. The Revo MRI Sure Scan helps address this unmet patient need.
Mark Skolkin, MD, chief of radiology for SLEH, added that until now patients with pacemakers, who required advanced imaging, have had computed tomography (CT) scans.
“Unfortunately, in many cases – such as in the brain, spine and orthopedic applications – the information obtained is not equivalent to MRI studies,” Skolkin said. “For patients with chronic diseases requiring repeated scans, MRI exams are often preferred to limit lifetime radiation exposure and possible side effects of contrast that is injected for the CT studies.”
The FDA approved the Revo MRI Sure Scan as MR-Conditional, meaning that it can be used in conjunction with MRI under certain conditions, such as a particular type of MRI scanner and scanner settings. Previously, patients with pacemakers were advised to avoid MRIs because the relatively high magnetic and radio-frequency fields produced during the scan could interfere with a pacemaker’s therapy. The device could fail to pace the heart, or the metal tip of the lead that connects to the device’s circuitry to the heart might heat up and burn heart tissue.