SEATTLE, June 24, 2004 - Last week a 72-year-old man from Lewiston, Idaho became only the second person west of the Mississippi to receive a less-invasive alternative to open-heart surgery - with the Evalve® percutaneous mitral-valve repair system - to treat mitral-valve regurgitation (MR). Physician-scientists with the Swedish Heart Institute are conducting a Phase-I clinical trial of the investigational system. At present, surgery is the only effective treatment method 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 an interventional cardiologist to place a small implant that may help the mitral valve to properly close. 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 provide an alternative to open-heart surgery in appropriate cases," said William Gray, M.D., director of Endovascular Care for the Swedish Heart Institute (SHI) and a principal partner with Swedish Cardiovascular Research - a SHI-affiliated clinic located at Swedish Medical Center/First Hill Campus.
"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," said Mark Reisman, M.D., director of Swedish Cardiovascular Research and of the Cardiac Catheterization Lab at Swedish Medical Center/First Hill Campus.
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 in the hospital for three to five days, 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 investigational 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 in the atrium, it is advanced into the ventricle. 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 generally return home within 48 hours.
Currently, the Evalve percutaneous mitral-valve repair system is the only device for valve repair in clinical trials in the United States. Swedish Medical Center is one of only seven hospitals in the world participating in EVEREST I (Endovascular Valve Edge-to-Edge Repair Study) and the only one west of the Mississippi. The six other sites include The Cleveland Clinic Foundation; Emory University Hospital, Atlanta; Columbia University Medical Center, New York; Washington Hospital Center, Washington, DC; Evanston Northwestern Hospital; and Hospital of The University of Pennsylvania.
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 bypass
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," said Dr. Reisman. "With this approach, we hope to fully achieve just that goal."
"Today, we are known as pioneers in the research and early adoption of minimally invasive heart and vascular treatments at Swedish," said Dr. Gray. "Now we are once again pushing the boundaries of non-invasive care."
The trial is being conducted under an approved Investigational Device Exemption and is sponsored by Evalve Inc. of Redwood City, Calif.
For more information, call Swedish Cardiovascular Research at 206-386-6191 or visit www.evalveinc.com
Swedish Heart Institute (SHI) encompasses all of Swedish Medical Center's cardiac-care services, which includes more than 60 physicians at hospitals and clinics across the Puget-Sound region. SHI offers a broad spectrum of cardiac services - from surgical and interventional procedures to the latest advances in heart-disease prevention, diagnosis and cardiac rehabilitation. SHI includes 18 member clinics and four medical-center affiliates, including: Swedish Medical Centers at First Hill, Ballard and Providence; Stevens Hospital in Edmonds; Highline Community Hospital in Burien; Valley Medical Center in Renton; Ballard Cardiology; Summit Cardiology; Swedish Cardiovascular Research; Highline Cardiologists; Minor & James Cardiologists; Pacific Cardiology in Aberdeen; Physicians Anesthesia Service Inc., P.S.; The Polyclinic Cardiologists; Seattle Heart Clinic; Stevens Cardiology; Summit Cardiology - Ballard; Summit Cardiology - Northwest; Summit Cardiology - Stevens; Swedish Cardiac Surgery; Swedish Cardiology, P.S.; Swedish Cardiovascular Consultants; Swedish Pediatric Specialty Care (Cardiology); and Valley Internal Medicine Cardiologists. For more information, visit www.swedish.org
- To read the transcript of a HealthLink story that KING 5 Television (channel 5 in Seatle; NBC) ran about this trial on June 25, 2004 click here.