Baptist Medical Center Jacksonville first in region to use new heart device approved for use with MRI scans
October 5, 2015 | Jacksonville, FL
Baptist Heart Hospital at Baptist Medical Center Jacksonville is now offering patients the first implantable cardioverter defibrillator (ICD) system approved for use with magnetic resonance imaging (MRI) scans.
Scott Lee, MD, cardiac electrophysiologist and director of Electrophysiology services for Baptist Health, was the first to implant the new device in Northeast Florida and Southeast Georgia.
Many patients rely on implantable defibrillators to detect irregular heartbeats and deliver life-saving therapy to restore a normal heartbeat. However, until now, patients have not been able to receive MRI scans for evaluating other medical conditions such as stroke because of potential interactions between the MRI and the device function, which might result in risk to patients. These MRI restrictions have resulted in a critical unmet need as data have shown that, within four years, more than one-third of patients with these defibrillators are likely to need an MRI.
“Because it is impossible to determine whether or not a patient will ever need an MRI scan for other medical conditions, being able to place an MRI safe ICD in them to treat dangerous heart rhythm disorders is just one less restriction on their future medical care,” said Dr. Lee. “We are pleased to again be able to offer our patients and the community the latest and most advanced treatments available as part of our comprehensive arrhythmia service.”
Shirley Goodman, 60, who has two children and 10 grandchildren, was the first patient at Baptist Jacksonville and in the region to receive the new device this week. She’s had heart problems for about 15 years and strokes.
“It’s very comforting,” Goodman said. “I’m so appreciative of everybody.”
“The defibrillator gives us the assurance to know if she needs medical help, there is some hope she can survive,” added her husband, Jesse. “It calms my fears some. And if she needs an MRI, she will be able to get it.”
Dr. Lee said Goodman was perfectly suited for an MRI safe implantable cardiac defibrillator since she came into the hospital before the device was implanted with an acute stroke that could only be diagnosed with an MRI. To continue to monitor her health, she may need MRIs in the future.
The implantable cardioverter defibrillator system is a small implantable heart device that is placed under the skin typically just below the collarbone on the left side of the chest. The defibrillator system may be prescribed to continuously monitor heart rate and deliver an electrical shock to correct a life-threatening heart rate for patients at risk for cardiac arrhythmia or sudden cardiac arrest.
MRI is an imaging test used regularly for a wide range of diagnoses including conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and back pain, all which are prevalent among older adults.
The Evera MRI™ SureScan® ICD System from Medtronic has been FDA approved to allow for MRI scans on any part of the body. The system includes design enhancements from previous generation devices that allow it to safely undergo full-body MRIs, while maintaining the same longevity, proven shock reduction and physical size and shape of the original defibrillator. The device is paired with the Sprint Quattro® Secure MRI SureScan® DF4 leads, backed by more than 10 years of proven performance with active monitoring, now tested for safe use during an MRI, according to Medtronic.
The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the randomized, controlled Evera MRI Clinical Trial that demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.