Banner Good Samaritan cardiologist evaluates innovative device to repair mitral valve
Nonsurgical procedure may replace open-heart surgery for mitral valve regurgitation
PHOENIX (April 10, 2006)—Banner Good Samaritan Medical Center, Arizona’s largest provider of health care services, has initiated a Phase II clinical evaluation of a new percutaneous heart valve repair system to treat patients with mitral regurgitation (MR), the most common type of heart valve insufficiency. Banner Good Samaritan is one of 37 potential medical centers in North America that has been selected to evaluate the safety and efficacy of this nonsurgical procedure. Interventional cardiologist Timothy J. Byrne, D.O., recently performed his first procedure at the hospital. At the 30-day follow-up, the patient is doing well.
In patients with MR, blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder. It is a progressive disorder, and an estimated 4 million people in the United States have significant MR, with an annual incidence of 250,000 newly diagnosed patients.
 The MitraClip is implanted by catheter, reducing the need for open chest surgery. When deployed, the clip will bring the valve leafs together to form a double oriface that reduces mitral regurgitation.  |
“The beautiful thing about the MitraClip is that it is a nonsurgical technique for mitral regurgitation,” said Dr. Byrne, the study’s principal investigator and chief of interventional cardiology at Banner Good Samaritan. “Because the procedure is done percutaneously, or under the skin, it doesn’t require us to open the patient’s chest to repair a leaky mitral valve.”
Dr. Byrne is performing percutaneous mitral valve repair as part of the prospective, randomized, controlled, multi-center EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) study. The study will evaluate the safety and efficacy of the technology in patients with moderate to severe or severe MR, as compared to surgical repair or replacement.
Dr. Byrne noted that the current standard remains open-heart surgery to repair the mitral valve or remove and replace the damaged valve. “This device reduces the amount of leaking without all the risks of open-heart surgery and being placed on a bypass machine,” he said. “We know that mitral valve surgery is a big surgery that is associated with significant risk, whereas implanting this nonsurgical technique is similar to implanting a stent. We’re still learning about the long-term results of the device, although we believe it to be permanent. To determine what those results are, we need to compare outcome data for the MitraClip to open-heart surgery and mitral valve replacement and repair.
“What makes this procedure unique is that it doesn’t take away the patient’s ability to have a valve-replacement surgery, if it’s necessary,” Dr. Byrne added. “To further determine the MitraClip’s efficacy compared to the surgical standard, we are collaborating with cardiothoracic surgeon Dr. Pierre Tibi.”
The Phase II study is being conducted under a United States Food and Drug Administration (FDA) approved Investigational Device Exemption. 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 percent 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 percent of those who received a clip remain free from surgery. The devices were developed and manufactured by Evalve, Inc. of Menlo Park, Calif.
The 12-month follow-up results from Phase I indicate that this device reduces MR. “This will provide a percutaneous option for patients who now require mitral valve surgery to treat their MR, and we’re very excited to be a part of this important study that enables cardiologists to treat patients with MR in the cardiac catheterization lab,” Dr. Byrne said. “Currently, less than 20 percent of patients with significant MR receive treatment, which demonstrates the large, unmet clinical need for less invasive treatment options for these patients.”
To be a candidate for the investigational procedure, patients must 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. During the procedure, a catheter (a thin, flexible plastic tube) is introduced through the patient’s skin in the groin area and is then guided through the femoral vein into the affected area of the heart. A smaller delivery catheter that holds the MitraClip device is then introduced through this tube so that the clip can be guided into place and attached to the leaflets (the “swinging doors”) of the mitral valve. Once the clip is securely attached, it is deployed and the catheters are removed. The entire process is monitored with echocardiography. After treatment, patients generally return to normal activity within one week. Currently the only way for a patient to receive the MitraClip device is by participating in the EVEREST II study.
Mitral regurgitation (MR) is the most common type of heart valve insufficiency. It is a debilitating, progressive condition that occurs when the leaflets or “swinging doors" of the mitral valve do not close properly. The mitral valve is a 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. The failure of the mitral valve to properly close leads to a condition in which a portion of the pumped blood flows back, or regurgitates, through the valve into the left atrium during heartbeats. Mitral regurgitation results in reduced cardiac output to the body and causes the heart to pump harder to compensate. If left untreated, the heart becomes damaged and eventually is unable to compensate for the MR, leading to congestive heart failure. Patients with significant MR may become weakened by their condition and require open-heart surgery to replace or repair the leaking mitral valve. The two most common causes of MR are valve “degeneration” (so called “floppy valve”), and heart muscle abnormalities caused primarily by coronary artery disease and cardiomyopathy (referred to as “functional” MR). For more information about mitral regurgitation and treatment options, please visit www.mitralregurgitation.org.
Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices, which enable the percutaneous repair of cardiac valves. The company’s initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. Evalve is based in Menlo Park, CA. For more information about Evalve, Inc., visit www.evalveinc.com.
Banner Good Samaritan Medical Center has been providing medical care to Arizona and the Southwest since 1911. Banner Good Samaritan is owned and operated by Phoenix-based Banner Health, a not-for-profit organization, and is a flagship hospital within the system. The hospital was recently named a Solucient “100 Top Hospitals” for Cardiovascular Care, and recognized as a Magnet facility by the American Nurses Credentialing Center, the highest honor a hospital can earn for its nursing care and practices.
Licensed for 659 inpatient beds, Banner Good Samaritan’s staff is nationally recognized for its expertise in several major services, including cardiology, critical care, neurosciences, obstetrics, oncology, rehabilitation, research, surgery and both solid organ and bone marrow transplant services. Today, more than 3,600 nurses and staff members work with over 1,700 physicians representing nearly 50 specialties staff to provide care to more than 36,000 inpatients each year.
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