UCH evaluating alternative to open-heart surgery
By Tonya Ewers
Office of Public Relations
The University of Colorado Hospital is participating in a Phase II clinical study, evaluating a new percutaneous heart valve repair system to treat patients with mitral regurgitation (MR), the most common type of heart valve insufficiency. UCH is one of approximately 30 medical centers in North America that has been selected to evaluate the safety and effectiveness of this non-surgical procedure as part of the prospective, randomized, controlled, multi-center study called EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy).
“ Some patients diagnosed with MR may be prescribed medication for their symptoms, but currently there are no medications that can eliminate mitral regurgitation,” said Dr. John Carroll, chief of cardiology at University of Colorado Hospital and principal investigator of the study. “Currently, fewer than 20 percent of patients with significant mitral regurgitation receive treatment, which demonstrates a large, unmet clinical need for less invasive treatment options.”
In patients with MR, blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder. An estimated 4 million people in the United States have MR and approximately 250,000 new cases are diagnosed each year. More than 50,000 of these patients undergo surgery each year. For patients who suffer from moderate to severe or severe MR, open-heart surgery is currently recommended by the American College of Cardiology and the American Heart Association to repair or replace the mitral valve.
“ The goal of any minimally invasive surgical procedure has always been to approach the technical success of surgery while minimizing trauma and recovery time,” Carroll said. “With this new approach, we hope to achieve that goal.”
The new Percutaneous Mitral Repair (PMR) procedure evaluated at University of Colorado Hospital uses the MitraClip™ device – a small implant made by Evalve, Inc. – to help the valve close and reduce MR. The procedure is performed by interventional cardiologists and echocardiologists in a catheterization laboratory under general anesthesia. During the procedure, a catheter – a thin, flexible plastic tube – is introduced through the patient’s skin in the groin area and is guided from the femoral vein to the affected area of the heart.
“ After treatment, patients may return to modified activity within one week,” Carroll added. “In addition to improving blood flow through the heart, the procedure can also relieve symptoms like fatigue and shortness-of-breath that often affect many of these patients.”
To be a candidate for the investigational procedure, patients must meet certain eligibility requirements including:
- have moderate to severe or severe mitral regurgitation and be experiencing symptoms (fatigue, chest pain, shortness of breath);
- or, lacking these symptoms, they must have a weakened left ventricle.
In March, at the 55th Annual Scientific Session of The American College of Cardiology, the most recent acute and longest term follow-up data to date was presented on 70 patients enrolled in the non-randomized arms of the EVEREST studies. Several patients have now been followed for more than two years. The summary of findings in the EVEREST Registry of patients showed that while all patients required surgery prior to the procedure, 76 percent of those who received a clip remain free from open-heart surgery.
Currently the only way for a patient to receive the MitraClip device is by participating in the EVEREST II study. Denver-area residents interested in participating can call (303) 372-6648 for more information. For a comprehensive online resource about MR and the EVEREST II clinical study, please visit www.mitralregurgitation.org.
