Evalve® Cardiovascular Valve Repair System Currently Being Evaluated in Phase I Trial
Apr 28, 2004
A 61-old man was the first in the New York City-area to receive a new, less-invasive alternative to open-heart surgery with the Evalve® Cardiovascular Valve Repair System (CVRS) to treat mitral valve regurgitation (MR). Physician-scientists at NewYork-Presbyterian Hospital/Columbia are conducting a Phase I clinical trial of the new treatment. At present, surgery is the only effective method of treatment for severe chronic MR, a defect in which the heart's mitral valve fails to close properly, resulting in abnormal flow of blood, weakening of the heart, and potentially leading to congestive heart failure.
The technology enables the physician to place a small implant that helps the mitral valve to close properly. In addition to improving blood flow through the heart, the procedure may lessen the fatigue and shortness-of-breath that afflicts patients with chronic significant MR.
We expect that patients' quality of life may be improved and we hope the procedure will prevent the need for open-heart surgery, says Dr. Hal Wasserman, Associate Director of the Interventional Cardiology Center at NewYork-Presbyterian Hospital/Columbia and Associate Clinical Professor of Medicine at Columbia University College of Physicians Surgeons.
This procedure is the next step in the evolution of mitral valve repair for regurgitation from open heart surgery to minimally invasive approaches to robotic valve repair and now a non-surgical solution, says Dr. Allan Schwartz, Chief of the Division of Cardiology at NewYork-Presbyterian Hospital/Columbia and Harold Ames Hatch Professor of Medicine at Columbia University College of Physicians Surgeons. No one should undergo mitral valve surgery without first being evaluated for this clinical trial.
Four million Americans are estimated to suffer from mitral valve regurgitation, with nearly 250,000 additional Americans diagnosed each year. In turn, approximately 50,000 Americans undergo surgery for mitral valve regurgitation annually.
The condition occurs when the leaflets or flaps of the mitral valve, a one-way valve that connects the left atrium to the left ventricle of the heart, fail to shut completely as the heart pumps blood into the aorta, causing backflow (regurgitation) through the valve during each heartbeat. This flow reversal can cause the heart and lungs to swell. Signs and symptoms may include an audible heart murmur, shortness of breath, fatigue and heart palpitations.
At present, the only way to correct MR is through mitral valve repair or mitral valve replacement, both of which require open-heart surgery with cardiopulmonary bypass. Patients typically remain three to five days in the hospital, including intensive care and experience a lengthy recovery period at home. Nationally, patients undergoing isolated mitral valve surgery face a 1.5 percent mortality rate for repair and a 6.0 percent mortality rate for replacement.
In the new procedure, a catheter holding the implant is threaded from the groin area through the femoral vein to the heart. After positioning the clip over the midsection of the mitral valve it is advanced past the leaflets that open and shut as the heart pumps blood. The clip, located at the tip of the catheter, is then attached near the center of both valve leaflets, holding them together. The entire procedure is monitored by an echocardiogram and x-rays. Prior to deployment the clip can be repositioned to obtain maximum reduction of MR.
Once a satisfactory placement is achieved, the clip is detached from the catheter and the catheter is removed. The patient remains under general anesthesia throughout the procedure and can return home within 48 hours.
This technology offers patients a less-invasive procedure with a virtually nonexistent recovery. It's a major paradigm shift from surgery to a non-surgical endovascular approach, says Dr. Wasserman.
Currently, the CVRS is the only device for valve repair in clinical trials in the United States. NewYork-Presbyterian/Columbia is one of only seven premier centers in the world participating in EVEREST I (Endovascular Valve Edge-to-Edge Repair Study).
To qualify for the EVEREST I trial, individuals must:
- Have moderately severe to severe mitral valve regurgitation with symptoms or with evidence of left ventricular dysfunction
- Qualify as a candidate for mitral valve surgery including cardiopulmonary by pass
Eligibility can be determined through a brief medical history in conjunction with an echocardiogram.
The goal of any minimally invasive surgical procedure has always been to achieve the technical success of surgery while minimizing trauma and recovery time, says Dr. Michael Argenziano, Director of Minimally Invasive and Robotic Cardiac Surgery at NewYork-Presbyterian/Columbia and Assistant Professor of Surgery at Columbia University College of Physicians Surgeons. With this approach, we hope to fully achieve just that goal.
Today, we are known as pioneers in minimal access surgery and robotic surgery at Columbia, says Dr. Mehmet C. Oz, Director of the Cardiovascular Institute at NewYork-Presbyterian/Columbia and Professor of Surgery at Columbia University College of Physicians Surgeons. Now we are once again pushing the boundaries of non-invasive care.
The trial is being conducted under an FDA approved Investigational Device Exemption and is sponsored Evalve, Inc. of Redwood City, CA.
For more information, call 212-746-1122.