MARQUETTE - Marquette General Hospital recently became the first hospital in the country to surgically implant in a patient a defibrillator compatible with magnetic resonance imaging scans.
When Marquette General cardiologist and electrophysiologist Mark Cowan performed the procedure, MGH became the first U.S. hospital - one of only 28 hospitals in the country and 40 worldwide - to begin participating in Minneapolis-based Medtronic's clinical trial to test its Evera MRI SureScan implantable cardioverter-defibrillator system in patients.
"Defibrillators have been around for 20 years," said Rudy Evonich, a cardiac electrophysiologist at MGH and the hospital's principal investigator in the Evera study. "They're important life-saving technology, but previously they've been an absolute contraindication to having an MRI.
Gary Green of Marquette discusses with Marquette General Hospital Cardiovascular Research Director Beth King the details of the procedure he was about to undergo that would implant an MRI-safe defibrillator in his body. Green was the first patient in the U.S. to receive the new defibrillator as part of a clinical trial.
MGH’s Dr. Mark Cowan implanted the MRI-safe defibrillator. (Photos courtesy Marquette General Hospital)
Dr. Rudy Evonich, MGH’s principal investigator for the Minneapolis-based Medtronic’s Evera MRI clinical trials, holds up one of the new devices. (Journal photo by Zach Jay)
"When you're in a magnetic field, a long piece of wire can create a charge that then can damage the heart, and the device itself has magnetic components within it that can be heated and damaged by being within an MRI scanner."
More than two million Americans depend on defibrillators or pacemakers to regulate and monitor their heart conditions, according to an MGH press release about the study. An estimated 63 percent of patients who have an ICD will need an MRI within 10 years of receiving the device. And while in recent years, MRI-compatible pacemakers have been invented, approved and put into use, the technology for a defibrillator that can safely go through an MRI is only now being tested - and Marquette General is at the forefront of this new medical advancement.
The clinical trials will involve 275 patients, and MGH hopes to enroll as many as 28 of its qualified patients in the program - two or three per month. For every three patients who receive the implant, two will go for an MRI scan within nine to 12 weeks of the procedure; the third will be part of the control group, and will not receive a scan.
Doctors as well as representatives from Medtronic will be on hand during the MRI to monitor the ICD, and the results will be compared to devices in the control group.
Who was the first patient in the U.S. to receive the Evera technology? 55-year-old Gary Green of Marquette, whom the MGH release called "a perfect candidate for the trial."
Despite weight loss, medication and close monitoring by his cardiologist, Green was having difficulty managing his heart condition. Having suffered a heart attack in 2010, and with a family history of heart disease, Green's doctor recommended an ICD implant. Also afflicted with back and hip problems, it's likely that Green will need MRIs in the future.
"I have to have the ICD anyway, so if my situation will help by providing information, I'm happy to participate in the study," he said in the release. "Although I'm nervous about having the implant, the technology will be monitoring my heart, and that makes me feel safe."
Evonich said that while many in the area don't think of Marquette General as a hospital on the cutting edge of technology, often traveling to Mayo Clinic in Minnesota or seeking treatment for various health problems downstate or in Wisconsin, MGH was chosen for its strong performance over nine years of previous Medtronic research studies.
"Our enrollment in previous studies was good. Our followup with the patients was good. Our data collection was good," he said. "There's not drop-out. There's not patients that don't do what's asked of them as part of the research study. We have a really active research program, with dedicated coordinators and staff, and so industry looks at us as a good site for doing studies because the data that comes from our site is accurate."
Patients who think they may be a candidate for an ICD are encouraged to ask their doctor for more information about the Evera MRI SureScan ICD System and the clinical trial.
Zach Jay can be reached at 906-486-4401.