The heart’s valves consist of leaflets that open to allow blood to flow forward through the heart and close tightly to prevent backflow of blood in the heart. Mitral regurgitation (MR) occurs when the leaflets of the mitral valve do not close properly. MR causes blood to leak backward across the valve. When the leak is severe, the heart has to pump stronger to force the blood out to the body, causing the heart to enlarge and weaken.
Traditionally, severe mitral regurgitation has been treated with heart surgery. Although minimally invasive surgery has decreased the size of the incision, researchers are hoping to develop a non-surgical option to treat this condition.
Two new investigational procedures are being tested at the Miller Family Heart & Vascular Institute at Cleveland Clinic that may change the future of heart valve surgery:
The first procedure is performed in the cardiac catheterization laboratory in consenting patients, with the aid of echocardiography. A special catheter with a very small clip-like device is inserted into the femoral vein, in the groin, and advanced to the heart. With precise controlled movements, and guided by echocardiography, the cardiologist attaches the clip to the leaflets of the mitral valve, and the catheter is removed. Scar tissue forms over the clip and holds the valve leaflets in their new position, which limits the leakage.
Other medical centers involved in this study include: Evanston Northwestern Healthcare, Emory University, University of Pennsylvania, Swedish Medical Center, and Washington Hospital Center.
A second procedure is currently being tested in the operating room by a cardiologist and a cardiothoracic surgeon on consenting patients who are having mitral valve surgery, to determine the safety of the device. Mitral valve regurgitation can be caused by a dilated annulus, the tough fibrous ring that supports the mitral valve leaflets and a floppy posterior mitral valve leaflet. This technology focuses on reshaping the valve annulus and posterior mitral valve leaflet. A delivery catheter is inserted into the subclavian or internal jugular vein in the neck and advanced to the heart. The device remodels, or pushes the annulus back into shape, stopping the leak. Transesophageal echocardiography is used to ensure the device is in place and the appropriate outcomes are achieved. The device and catheter are removed at the end of the procedure. Eventually, this procedure also will be performed in the catheterization laboratory.
Both procedures are Phase I clinical trials, which means they are in their earliest clinical research phase, being tested in a small group of consenting patients for the first time to evaluate safety. (See Understanding Clinical Trials*) for more information on the phases of Clinical Trials).
Currently percutaneous procedures (valvotomy) are performed, in many patients, to treat mitral valve stenosis (a stiff inflexible valve) and highly selected patients for aortic stenosis. The preliminary results suggest that the new percutaneous devices could help to treat mitral valve regurgitation. This would be especially beneficial to patients with congestive heart failure and mitral regurgitation, and possibly, in those who may face more than one surgery in their lifetime. Although investigators are still cautious about these devices, they are hopeful new technology can offer further options for patients with mitral valve regurgitation in the future.
For questions or more information, you may contact us by email, using the Contact Us Form. Please state "Miller Family Heart & Vascular Institute" in the Question or Comment Section. You may also call the Miller Family Heart & Vascular Institute Resource and Information Center Nurse at 216/445-9288 or toll-free 866/289-6911.
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© Cleveland Clinic, 12/03
