EVANSTON, Ill., March 14 /PRNewswire/ -- NorthShore University HealthSystem (NorthShore) interventional cardiologist, Ted Feldman, MD, presented data today at the American College of Cardiology annual scientific sessions from the EVEREST II trial (Endovascular Valve Edge-to-Edge REpair STudy) demonstrating the MitraClip, a novel, first-in-class catheter-based device, is a safe and effective alternative to open heart surgery for select patients with mitral regurgitation.
"This is a major advancement in cardiac care," said Ted Feldman, MD, principal investigator of the trial and director of NorthShore's Cardiac Catheterization Laboratory where he became the first physician in the U.S. to use any method for non-surgical repair of leaking mitral valves. "It's the first catheter-based therapy for a mitral valve problem to complete a trial, and has transformed the lives of patients suffering from moderate to severe mitral regurgitation."
Over eight million people in the US and Europe have Mitral Regurgitation (MR), a condition in which the mitral valve leaflets do not seal tightly. This valvular defect allows blood to flow backward into the heart and is often referred to as a "leaking heart valve". The condition can cause shortness of breath, fatigue, coughing, heart palpitations, swollen feet or ankles and heart murmur. If left untreated, MR's progressive nature could lead to heart failure, stroke, heart attack or death. The MitraClip is designed to help these patients on a case-by-case basis, and is currently under review by the FDA.
Patients participating in the EVEREST II trial experienced improvements in heart function, quality of life and the ability to engage in normal physical activity. "[Before the procedure] I had a hard time walking up the stairs. I would have to stop several times and sometimes sit down to catch my breath," said Beyna, an EVEREST II trial participant and NorthShore patient. "Now it's different. I don't get out of breath and I can do the things I couldn't do before."
In Phase I of the trial, started in 2003, 107 patients had their mitral valves repaired with the MitraClip, a 4 mm-wide, polyester-covered device developed by Abbott Vascular, Inc. Under general anesthesia, the clip (or sometimes two) is inserted via catheter through an artery in the groin, threaded up to the heart and clamped to the mitral valve's two edges to hold them together. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine.
The results of Phase II, announced today, are very promising. A one-year follow-up showed that only 9.6 percent of the 279 MitraClip patients had safety issues associated with the procedure vs. 57 percent of open-heart patients. In terms of effectiveness, 72.4 percent of MitraClip patients had successful reduction of MR vs. 87.8 of surgical patients. Importantly, patients treated with the MitraClip could still have traditional surgery if needed.
About the EVEREST II Trial
The EVEREST II pivotal trial is a multi-center, randomized clinical trial of 279 patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation who were candidates for mitral valve surgery. The mean age for patients was 68 years, and patients in the trial tended to have more co-morbidities, such as hypertension and congestive heart failure, than the average surgical patient as defined by the 2008 Society for Thoracic Surgery (STS) Database. Patients had at least moderate-to-severe functional or degenerative mitral regurgitation and were either symptomatic or asymptomatic with evidence of compromised left ventricular function, atrial fibrillation, or pulmonary hypertension. The echocardiography core laboratory at the University of California, San Francisco (UCSF) reviewed the trial's echocardiograms based on the American Society of Echocardiography (ASE) criteria for assessment of MR and left ventricular function.
About NorthShore University HealthSystem
Headquartered in Evanston, NorthShore University HealthSystem (NorthShore) is a comprehensive, fully integrated, healthcare delivery system that serves the Chicago Region. The system includes four hospitals in Evanston, Glenview (Glenbrook Hospital), Highland Park and Skokie. Further, NorthShore supports teaching and research as the principal teaching affiliate for the University of Chicago Pritzker School of Medicine. The NorthShore Research Institute focuses on clinical and translational research, including leadership in outcomes research and clinical trials. The NorthShore University HealthSystem Foundation is a leading philanthropic entity of NorthShore. It raises charitable contributions, engages volunteer friends and invests in community partnerships.
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