The New England Journal of Medicine publishes positive results from NorthShore's EVEREST II trial

Apr 5 2011

NorthShore University HealthSystem (NorthShore) interventional cardiologist, Ted Feldman, MD, presented positive results from the EVEREST II trial (Endovascular Valve Edge-to-Edge REpair STudy), that were concurrently published in The New England Journal of Medicine. Principal investigator of the study, Dr. Feldman presented the results today at the American College of Cardiology annual scientific sessions.  New results demonstrate the MitraClip, a novel, first-in-class catheter-based device, continues to be a safe and effective alternative to open heart surgery for select patients with mitral regurgitation two years after treatment.  

"This is a major advance in heart valve therapy, especially for patients with high risk for mitral valve surgery," said Dr. Feldman, 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. "This is the first catheter-based therapy for a mitral valve problem to complete a randomized trial, and has transformed the lives of patients suffering from moderate to severe mitral regurgitation (MR)."

Over eight million people in the U.S. and Europe have 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.

"This clearly defines another treatment option, because most patients do well and if they fail with the clip, they can still have surgery. For patients at high risk for surgery this provides an option where none existed before," said John Alexander, MD, Chief of Cardiothoracic Surgery at NorthShore. "We have seen many patients experience life-changing results with the MitraClip. Relief from shortness of breath and other MR symptoms has given these patients their lives back and the ability to engage in normal physical activity."

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's vascular division. 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 leaflets to hold them together. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. That feasibility trial, to determine safety, was judged a success, and led to EVEREST II, in which 279 patients were randomized 2:1 to receive the MitraClip device vs. undergo standard open-heart surgery.

The results of Phase II, announced today, are very promising. Two years following treatment, the MitraClip procedure demonstrated a clinical success rate of 51.7 percent for patients randomized to treatment with the MitraClip device, compared to a clinical success rate of 66.3 percent for surgery patients. Surgery was avoided in 78 percent of patients randomized to the MitraClip device. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes.

SOURCE NorthShore University HealthSystem