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Treatments for Heart Valve Disease

Heart valves are flaps, or leaflets, of tissue that ensure that blood entering or leaving the heart moves in the proper direction with no backflow. The heart and its great vessels have a total of four valves, the mitral valve, tricuspid valve, aortic valve, and pulmonic valve. Valvular disease can affect any of these four valves, and can interfere with the normal flow of blood through the heart.

Balloon Valvuloplasty

For appropriate cases, cardiologists at NewYork-Presbyterian offer minimally invasive options for the treatment of aortic, mitral, or pulmonary stenosis – conditions in which the opening of the valve is narrowed (stenotic) and restricts blood flow. Balloon valvuloplasty is a procedure in which the narrowed heart valve is stretched open without open-heart surgery. For select patients with aortic stenosis and for the majority of patients with pulmonic stenosis or mitral stenosis, valvuloplasty is a preferred alternative to open heart surgery.

During this procedure, a small incision is made in the skin and a catheter is inserted into an artery or vein in the leg using a local anesthetic and conscious sedation (relaxing medications). A balloon-tipped catheter is advanced into the heart and across the narrowed valve. When in place, the balloon is expanded to open the valve, resulting in improved blood flow across the diseased valve. While individual circumstances vary, patients may be discharged as soon as the following day.

Investigational Studies: Percutaneous Valve Replacement

Everest II

NewYork-Presbyterian Hospital/Weill Cornell Medical Center and NewYork-Presbyterian Hospital/Columbia University Medicl Center are conducting investigational studies – through the Everest II Clinical Trial – of a new device for repair of mitral valve regurgitation (leakage). This device helps to prevent backflow of blood from the left ventricle to the left atrium of the heart by holding together parts of the mitral valve leaflets that form an abnormally large opening. Placement of the investigational device does not require surgery; a catheter is inserted into a blood vessel in the leg through a small incision, and is guided to the heart where the device is positioned. After ensuring that the correct placement has been achieved, the catheter is removed. The patient remains under general anesthesia throughout the procedure and may be discharged within 48 hours. There is no surgical wound – just a small adhesive strip where the catheter was placed.

Partner Trial

The Partner Trial is a multi-center, randomized study to determine the safety and efficacy of the Edwards SAPIEN Transcatheter Heart Valve in high risk, symptomatic patients with severe aortic stenosis. Following evaluation by a cardiologist and a cardiac surgeon patients are determined to be either surgical or non-surgical candidates. Surgical candidates are randomized to undergo either transcatheter aortic valve implantation or surgical aortic valve replacement. Non-surgical candidates are randomized to undergo either transcatheter aortic valve implantation or medical management, which may include balloon valvuloplasty. The randomization which determines study assignment is performed by a computer (like flipping a coin).

The study device is a catheter-delivered heart valve combining a balloon expandable stent and bioprosthetic valve leaflets made of bovine pericardium. Patients enrolled in the Partner Trial have clinical follow-up at 1, 6, and 12 months post- procedure and annually for 5 years.