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News — Very promising one-year results from the first study of a new minimally invasive procedure that uses a small clip to help properly close the leaflets of the mitral valve in patients with mitral regurgitation (MR), were presented at the Cardiovascular Research Foundation's (CRF) Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in Washington, D.C. Using an approach adapted from an established surgical technique, the MitraClip demonstrated it could reduce MR severity from moderate-severe or severe to moderate or lower. Importantly, the MR reduction achieved at 30 days is maintained at one year in 93% of patients and 74% of all patients treated have avoided open heart surgery.

Mitral valve regurgitation, the most common type of heart valve insufficiency, is a progressive disorder in which the mitral valve in the heart does not close properly, allowing blood to flow backward into the heart and causing fatigue and shortness of breath. The mitral valve is the one-way, blood flow regulator that separates the left atrium, the heart chamber that collects blood, from the left ventricle, the chamber of the heart that pumps blood out to the body.

Left unchecked, severe MR can lead to congestive heart failure or serious heart rhythm irregularities. The MitraClip (Evalve, Menlo Park, Calif.) is an investigational device that holds together a portion of the two "swinging doors" or leaflets of the mitral valve to facilitate closure of the valve. The percutaneous valve repair procedure is performed by interventional cardiologists in the catheterization laboratory under general anesthesia on a beating heart. In addition to improving blood flow through the heart, the procedure may also improve left-ventricular function and relieve symptoms such as the fatigue and shortness-of-breath that often affect patients with chronic significant MR.

The EVEREST I trial (Endovascular Valve Edge-to-Edge REpair STudy) included 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms (fatigue, shortness of breath, chest pain) or had a weakened left ventricle. Results showed that 93% of those patients who experienced a significant MR reduction at one month maintained the reduction at 6 months. MR severity did not increase from six to 12 months in any of the patients with completed 12-month follow-up. Of the group of patients who received a clip, 83% remained free from surgery.

"This is a very exciting study because the only option currently available for patients with moderate to severe MR is open-heart surgery," said EVEREST principal investigator Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Hospital in Evanston, IL. "These initial results are very encouraging in that not only did we observe a reduction in MR at six months, but the durability of the repair has held up in those patients who have completed 12-month follow up."

Dr. Feldman will present these results on Thurs., Oct. 20, at 1:28 p.m. EDT in Room 151AB of the Washington Convention Center at the TCT Symposium. His presentation is entitled: Edge-to-Edge Mitral Valve Repair Using the Percutaneous Evalve MitraClip: One-Year Results of the EVEREST Phase I Clinical Trial.

"Based on these encouraging results, our next step in evaluating this potential alternative to open-heart surgery is completion of a larger randomized, multi-center Phase II trial that compares the percutaneous MitraClip to surgery," added Dr. Feldman. Involving approximately 30 medical centers in North America, EVEREST II is now enrolling patients and is designed to further demonstrate the safety and effectiveness of this non-surgical procedure.

For patients who suffer from moderate-to-severe or severe MR, the American College of Cardiology and the American Heart Association recommends open-heart surgery to repair or replace the mitral valve, and approximately 50,000 patients undergo open-heart surgery each year to treat mitral regurgitation. An estimated 4 million people in the U.S. have significant MR, with an annual incidence of 250,000 newly diagnosed patients.

About CRF and TCTThe Cardiovascular Research Foundation is dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine. By establishing the safe use of new technologies and pharmacologic agents, CRF has played a major role in the remarkable advances in survival and quality of life for patients with cardiovascular disease. CRF is the sponsor of the 17th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, one of the largest interventional vascular medicine meetings in the world. For more information, please visit .