June 23, 2008Physicians at Northeast Georgia Medical Center (NGMC) and Northeast Georgia Heart Center, PC, have begun enrolling patients in a clinical study of the first pacemaker system designed for safe use in Magnetic Resonance Imaging (MRI) environments under specified scanning conditions.
"We are the first Georgia hospital to participate in this study," says Tom Edwards, director of Cardiac Services at NGMC. "This study’s results could impact so many people, and we are very excited to be a part of it."
Pacemaker technology has extended the lives of millions of patients with heart rhythm conditions, and each year nearly 1 million pacemakers are implanted in patients worldwide. The first Medtronic EnRhythm MRI™ SureScan™ pacing system recently was implanted in a 79 year-old male patient of Robert C. Ferguson, MD by Jay Joseph, MD, FACC. Karthik Ramaswamy, MD, FACC, implanted the second system in a 74-year-old male patient of Narasimhulu Neelagaru, MD. The EnRhythm MRI SureScan pacing system consists of the dual-chamber EnRhythm MRI™ SureScan™ pacemaker and CapSureFix MRI™ SureScan™ pacing leads (Model 5086MRI).
The clinical trial is a prospective, randomized, controlled, unblinded, multi-center study, involving 470 individuals. All patients in the trial will receive an EnRhythm MRI SureScan pacing system, and two-thirds of the participants will receive MRI scans. The expected study duration and follow up time is approximately 30 months.
"We are dedicated to the advancement of medical technology and providing northeast Georgia residents with the most innovative and advanced treatment options available," Dr. Ramaswamy says. "Participating in clinical trials such as EnRhythm MRI provides us with the means to accomplish this."
MRI lets doctors see internal organs, blood vessels, muscles, joints, tumors, areas of infection and more, 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. However, the magnets used for MRI can interrupt the pacing and inhibit the output of pacemakers.
"Patients with medical devices such as pacemakers are prevented from undergoing medically necessary procedures such as MRIs. We are excited about this study as it presents new opportunities for patients to receive the medical care they need," says Dr. Joseph.
Extensive research and design efforts went into the EnRhythm MRI SureScan pacing system to address and mitigate interactions between the pacing system and the MR environment. The system includes modified hardware to minimize the level of energy transmitted through the lead/device connection point, and new programming features. The device and leads also contain radiopaque marks, viewable via X-ray, to indicate that the system is MR-Conditional (a term identifying a device that may be used during an MRI under specified scanning conditions). The leads are designed to decrease the risk of overheating during an MRI scan without limiting the ability to conduct therapy.
NGMC has been rated number one in Georgia for Overall Cardiac Care for the third year in a row by Healthgrades, the nation’s leading independent healthcare ratings company.