Gary Green of Marquette was the first patient in the U.S. with an implanted MRI-safe defibrillator to undergo an MRI scan. He was also the first patient in the nation to be implanted with the device. Both are part of a clinic trial being conducted at MGH, as well as 275 other sites across the world.
Marquette General Hospital became the first hospital in the nation to scan a patient with a defibrillator that is compatible with full-body magnetic resonance imaging (MRI). MGH was also the first in the nation to implant the MRI-safe defibrillator in the patient earlier this year. Both are part of a clinical trial by Medtronic, recognized world leader in medical technology.
More than two million Americans depend on pacemakers or defibrillators to help regulate their heart conditions. While these implanted devices can save lives, they can also eliminate the possibility of utilizing MRI scans – which is another life-saving tool that detects tumors, bleeding, injuries, blood vessel diseases or infections. This is because the powerful magnet of the MRI can interrupt, move or overheat the defibrillator.
Minneapolis-based Medtronic seeks to change this with the Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. Evera MRI is the first ICD system to be evaluated in the U.S. that allows for MRI scans positioned on any region of the body. The Evera MRI was recently approved for use in Europe.
With an estimated 63 percent of ICD patients needing an MRI within 10 years of receiving a device, the Medtronic trial is of great interest to patients and physicians, alike.
“The study tests the Medtronic Evera MRI ICD when patients who have this system have an MRI scan,” said Rudy Evonich, MD, principal investigator at Marquette General for the Evera MRI study.
Gary Green of Marquette was the first patient in the U.S. to receive the Evera MRI™ SureScan®, and to have an MRI scan with it in. At 55 years old, Green was having difficulties managing his heart condition despite weight loss, medication and close monitoring by his cardiologist. Green’s family history of heart disease and the fact he had suffered a heart attack in 2010 prompted his cardiologist to recommend an ICD implant. Green also has back and hip issues, which requires periodic MRI scans.
Evera MRI is the first ICD system to be evaluated in the U.S. that allows for MRI scans positioned on any region of the body.
During Gary’s first scan, his EKG was continuously monitored by a nurse who has been specially trained in both MRI safety and cardiac device management. Following the MRI, his defibrillator was retested to ensure that no damage to the device occurred during the MRI procedure, and the original device settings are restored.
“Medtronic representatives are on hand during each patient’s MRI to monitor the ICD throughout the scanning process. Results are then compared to devices in a control group,” said Dr. Evonich.
Currently, about 275 subjects are taking part in this study. There are up to 45 sites in various countries, including the United States, Canada, Western Europe, Middle East and Africa, Greater China, India, and Latin America. MGH, the only Michigan hospital participating in the study and one of only 24 in the U.S., hopes to enroll two to three qualified patients into the study per month.
MGH has teamed with Medtronic on clinic trials for the last nine years as part of an ongoing mission to provide patients around the world with the best possible heart care. Dr. Evonich, cardiovascular research director Beth King and cardiovascular research team members Jodi Nease, RN, Jane Anderson, LPN, Adele Price, LPN, Lori Piggott and Michelle Duquaine have worked closely with Medtronic representatives in preparation to conduct the study here at MGH.
If you or a loved one is a candidate for an ICD, ask your doctor for more information about the Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System trial.