Dr. Peter Fail, director of cardiac catheterization laboratories and interventional research for Cardiovascular Institute of the South (CIS) is among a selected group of physicians around the world to implant the MitraClip™ device, an implant designed to repair the mitral valve of the heart using a catheter-based procedure that is less invasive than traditional surgical methods.

The procedure was performed on November 10, 2005 in the cardiac catheterization laboratory at Terrebonne General Medical Center (TGMC) in Houma, La. as part of a clinical evaluation of the heart valve repair system (Evalve, Inc, Menlo Park, CA) for patients with mitral regurgitation (MR), the most common type of heart valve problem. It was only the 16th procedure to be performed as part of the Phase II study.

Dr. Eric Engeron, a CIS staff cardiologist also involved in the study, is evaluating the echocardiographic data and assisted in the procedure, as well as Gary Chaisson, RT(R) RCIS, director of cardiac catheterization laboratories for both CIS and TGMC.

The trial, known as EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), is designed to evaluate the safety and effectiveness of this non-surgical, catheter-based procedure as compared to open heart surgery: the current standard of care for the treatment of significant MR.

Patients with MR often experience fatigue and shortness-of-breath due to a backward flow of blood through the mitral valve. If left untreated, MR damages the heart and can lead to congestive heart failure. An estimated 4 million people in the United States are affected, and approximately 50,000 patients undergo open heart surgery annually.

Dr. Fail, chief of staff at TGMC and the study’s principal investigator at CIS, praised the procedure, “The MitraClip device showed great promise in the initial studies. This catheter-based procedure is less invasive and may allow for a shorter recovery time.”

An earlier Phase I study, EVEREST I, was conducted to determine safety and feasibility in patients with moderate to severe or severe MR. The EVEREST I feasibility study has enrolled 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms or had a weakened left ventricle. Only 4% of the 47 patients enrolled experienced a significant adverse event at 30 days. The first 27 patients treated have reached one-year follow-up. Ninety-three percent of those patients who experienced a significant reduction in MR at one month following treatment have maintained that improvement at one year. While all patients required surgery prior to the MitraClip procedure, 75% of those who received a clip remain free from surgery.

“The goal of the EVEREST II study is to determine whether this technology should be offered to patients with moderate to severe or severe MR as an alternative to open heart surgery,” said Dr. Fail. “Cardiovascular Institute of the South is known around the world as a leader in the development of new technologies. I’m pleased that CIS was chosen as one of only 37 sites in North America to bring this leading edge procedure to our patients.”

The study is being conducted under an FDA approved IDE and the devices were developed and manufactured by Evalve, Inc. of Menlo Park, CA.

For more information about mitral regurgitation, visit www.mitralregurgitation.org. For more information about Cardiovascular Institute of the South, call 1-800-425-2565 or visit our Web site at www.cardio.org.