Thursday, July 16, 2009

Saint Joseph's Joins Landmark Study of Percutaneous Mitral Repair with the Mitraclip System

Saint Joseph’s Hospital has become a new clinical trial site for EVEREST II to evaluate the Evalve® MitraClip® system for the treatment of mitral regurgitation (MR). Cardiologists participating in the EVEREST II trial seek to repair the mitral valve non-surgically by using a catheter to place a tiny clip on the valve leaflets. A serious heart condition, MR can lead to arrhythmias, congestive heart failure, stroke and increased risk of sudden death if left untreated.

The mitral valve is a one-way valve that connects the left atrium to the left ventricle of the heart. With MR, the valve does not seal completely and blood leaks back into the left atrium. This reverse flow can cause the heart and lungs to become overloaded with fluid. Symptoms may include an audible heart murmur, shortness of breath and heart palpitations. It is estimated that four million Americans suffer from mitral valve regurgitation, with nearly 250,000 Americans diagnosed each year. According to the Society of Thoracic Surgeons, 40,000 Americans undergo surgery for MR annually.

“The MitraClip device is a natural progression of research treatment options from minimally-invasive approaches, such as robotic surgery, to non-surgical valve repair for patients with MR,” says Louis Heller, MD, interventional cardiologist and Principal Investigator for EVEREST II at Saint Joseph’s Hospital.

For most patients, traditional mitral valve repair requires a surgical procedure called a sternotomy which involves making an incision in the center of the chest to reach the heart. Patients must also undergo cardiopulmonary bypass using a heart lung machine to have their valve repaired or replaced with a tissue or mechanical substitute. The open procedure typically requires a three to five day hospital stay and a lengthy recovery period following hospital discharge.

Saint Joseph’s is one of the country’s leading hospitals for robotic-assisted mitral valve repair, under the leadership of pioneering cardiothoracic surgeon, Douglas Murphy, MD. Minimally-invasive robotic-assisted surgery allows surgeons to repair the mitral valve via four or five dime-size incisions avoiding the sternotomy. Recovery is significantly faster resulting in a shorter hospital stay and a faster return to normal activities. However, patients still must be placed on cardiopulmonary bypass during the robotic procedure.

“We are moving to more minimally-invasive procedures for patients and this trial may take us a step closer to non-invasive procedures,” says Dr. Murphy. “From a patient’s view, success of the EVEREST trial may eventually offer a less invasive approach with a shortened recovery period.”

In October 2007, preliminary results were released for the initial cohort of 107 patients enrolled in the non-randomized arms of the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) studies. Results demonstrated ongoing effectiveness and durability up to 36 months of follow-up (N=81), with 76 percent of patients with one or more Clips implanted experiencing a reduction to ≤ Grade 2+ MR as assessed by the Independent Core Laboratory and graded per the American Society of Echocardiography guidelines (N=107). Statistically significant reverse remodeling of the left ventricle was reported in patients with matched data 12 months after a successful MitraClip procedure (N=54). In April 2008, results from the initial EVEREST Functional MR cohort (N=23) were reported. Results demonstrated 79 percent freedom from death, surgery for valve dysfunction and MR > 2+ at 1-year with preservation of surgical options and clinical improvement in 75 percent of patients with matched data (n=12), with 58percent of patients in NYHA Class I at 1-year. EVEREST II, the Phase II safety and efficacy trial, was recently approved by the IRB at Saint Joseph’s.

With the MitraClip system, the cardiologist guides a catheter (tube) through the vascular system from the groin to the heart's mitral valve, using echocardiographic and fluoroscopic imaging to show the way. The MitraClip device, located on the tip of the catheter, is then placed on the central portion of the valve leaflets, holding them together. The heart beats normally throughout the procedure. (This percutaneous technique is based upon an open surgical method known as the edge-to-edge surgical repair or Alfieri technique, in which a surgeon sutures the valve leaflets together at the location of the leak to reduce MR). During the procedure, the physician can evaluate the clip's effectiveness in reducing MR and can reposition the device as needed.

Once satisfactory MR reduction is achieved, the clip is deployed and the catheter system removed. The patient remains under general anesthesia throughout the procedure and is usually discharged home 1-2 days later. There is no surgical wound —just a Band-Aid over the incision where the catheter was placed. Patients take clopidogrel for a month and aspirin for six months; there is usually no need for a blood thinner, such as Warfarin.

Currently, the MitraClip device is the only device in clinical trials in the United States for percutaneous valve repair. Eligible patients will be invited to participate in the EVEREST II REALISM research study which will collect additional safety and effectiveness data to support the Pre market approval application.

“Today, Saint Joseph’s is recognized as a pioneer in minimally-invasive, robotic-assisted mitral valve repair,” says Dr. Murphy. “The MitraClip system moves us closer to becoming a leader in non-invasive care.”

For more information about the EVEREST II trial, call the Saint Joseph’s Research Institute clinical coordinator at 678-843-6165 or visit
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