Cath Lab Procedure Could Replace Heart Surgery in Some Patients with Leaking Valves

Toronto (Nov. 30, 2005) - In a Canadian first, Toronto General Hospital used a new percutaneous or "through the skin" valve repair system to treat a patient with a "torrential" leaking mitral valve without open-heart surgery.  Currently, open-heart surgery with cardiopulmonary bypass is the only effective treatment for a leaking mitral heart valve.

The patient, a 79-year-old woman, was a candidate for surgical treatment of the leaking mitral valve. Instead, she was treated without a surgical incision using a new percutaneous procedure with a catheter on Tuesday November 15, 2005 at the Peter Munk Cardiac Centre at Toronto General Hospital (TGH), University Health Network under general anesthesia while her heart was beating. She is doing well. The "torrential" leaking of her valve was reduced to mild to moderate, a degree of leakage that occurs in many people and usually does not cause symptoms.

Mitral valve regurgitation (MR), a common heart valve problem, is a condition in which the two leaflets or "swinging doors" of the one-way mitral valve fail to close completely as the heart contracts, allowing blood to leak backwards (regurgitation) into the atrium, the heart's upper chamber. As a result, the blood flow to the body (cardiac output) is decreased, and the heart tries to compensate by beating more forcefully. In severe cases, MR causes shortness of breath, fatigue and palpitations.

"Repairing a valve on a beating heart without surgery was inconceivable only a few years ago. We are at the beginning of an era that will see explosive growth in the non surgical treatment of valvular heart disease," said Dr. Eric Horlick, the lead interventional cardiologist at TGH who performed the first percutaneous Edge-to-Edge procedure in Canada. Dr. Horlick is also an Assistant Professor of Medicine at University of Toronto.

"This new device gives us a potential tool to help selected patients who would otherwise have to undergo open-heart surgery", said Dr. Leonard Schwartz, cardiologist at TGH and Professor of Medicine at University of Toronto, who is the Principal Investigator at TGH of the multicentre investigational trial (EVEREST II) comparing the mitral valve implant (MitraClip TM device; Evalve, Inc., Menlo Park, CA, USA) to surgical mitral valve treatment. "This is break-through technology allowing a procedure that is less invasive than open-heart surgery and, in the future, may provide another option to patients who are in need of mitral valve surgery."

During the procedure, a catheter or tube is threaded from the groin through a vein to the left atrium of the heart, just above the valve. A small delivery catheter which holds the clip is slipped into this tube and advanced through the valve in an open position. The clip is positioned at the area where the leak originates, and is then retracted to grasp and close on the valve leaflets.  When the clip is closed, it brings the two leaflets together to seal the leak, thereby reducing MR. The procedure is monitored by a sophisticated, real-time echocardiogram, which displays the beating heart, including the chambers, the mitral valve, and the major blood vessels, helping the cardiologist to accurately guide and place the clip and assess the effect of placement on MR. Dr. Melitta Mezody, echocardiologist at University Health Network and Mount Sinai, and Assistant Professor of Medicine at the University of Toronto performed the echocardiogram. The team was also assisted by an ECHO certified cardiac anesthesiologist, Dr. Jane Heggie, and cardiac anesthesia fellow, Dr. Max Meineri.

Once the clip is positioned to adequately reduce MR, the clip is released from the catheter and left attached to the valve leaflets. The catheters are then removed.

Depending on the anatomy and severity of MR, some patients may require two clips. Patients are placed on blood thinners for six months.

The multidisciplinary team of interventional cardiologists, surgeons, nurses, technologists, echocardiologists and anesthesiologists at the Peter Munk Cardiac Centre at TGH used the Evalve Inc.'s percutaneous E2E™ mitral valve repair system, as part of an ongoing clinical trial in North America at centres such as The Cleveland Clinic Foundation and Columbia University Medical Center. EVEREST II is a comparison with surgical mitral valve repair or replacement. This will be a collaborative study by cardiologists Drs. Schwartz, Horlick and Mezody and cardiovascular surgeons, Drs. Tirone David and Michael Borger of the Peter Munk Cardiac Centre at TGH; and co-ordinated by research nurse Rachael Ramsamujh.

About Toronto General Hospital

Toronto General Hospital is a partner in the University Health Network, along with the Toronto Western Hospital and the Princess Margaret Hospital. These teaching hospitals are affiliated with the University of Toronto. The scope of research at Toronto General Hospital has made this institution a national and international source for cardiovascular discovery, education and patient care, as well as for its innovations in transplantation, surgical innovation, infectious diseases, diabetes and genomic medicine. In addition, the Peter Munk Cardiac Centre at Toronto General Hospital trains more cardiologists and cardiovascular surgeons than any hospital in Canada.

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