NorthShore Cardiologist Dr. Ted Feldman Presents Results of EVEREST II Trial
Watch: Dr. Feldman discusses MitraClip at ACC
NorthShore University HealthSystem (NorthShore) interventional cardiologist, Ted Feldman, MD , presented data 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. Only 20 percent of MR patients undergo surgery, leaving many of the remaining patients to be impacted everyday by the condition that causes their heart to work harder. The MitraClip is designed to help these patients on a case-by-case basis.
Patients participating in the EVEREST II trial experienced improvements in heart function, quality of life and the ability to engage in normal physical activity. Patients, like Arlene Beyna of Mount Prospect, Illinois were able to get back to the basics of being physically active within days of the procedure.
"[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."
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 were selected for treatment with the MitraClip device if they met the criteria for surgical intervention from the 1998/2006 American College of Cardiology (ACC)/ American Heart Association (AHA) Joint Task Force Recommendations regarding therapy for valvular heart disease. 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.