Another Medical/Surgical Advance

"It doesn't apply to the majority of mitral valve disease. It reduces mitral valve leakage for patients who are not deemed surgical candidates or are deemed at very, very high risk for surgical intervention."
"This is a device that doesn't replace an operation; it adds a possibility."
"At this point, we cannot say that it prolongs life. It helps the patient to live better, to have less hospital readmissions, less shortness of breath, fewer symptoms."
"The big advantage of the Heart Institute is that we're always at the forefront of innovation and technology."
Dr. Thierry Mesana, president/CEO, University of Ottawa Heart Institute

That possibility, however, is with the use of a new heart valve treatment, surgery can be avoided for those patients for whom an operation would place existential stress on their survivability. And that constitutes a considerable advantage from any perspective, seen through any lens of medical/surgical competence and potential outcome.

Dr. Mesana was speaking of a new medical device which though having been implanted at least thirty times during clinical trials over the past two years by teams of surgeons and cardiologists at the Ottawa Heart Institute, has only now been approved by Health Canada. The device has been named the MitraClip, developed by Abbott, a global health care company. And it is the first of its kind.

It is meant to be used as a non-surgical alternative for patients with life-threatening leaky mitral valves. Older patients, people with numerous risk factors for surgery, or patients who have previously undergone multiple heart operations are likely candidates for the use of the MitraClip. A cautionary note was issued during an interview by Dr. Mesana that for only relatively few patients is the procedure suitable.

They would be people with degenerative mitral regurgitation at high risk for surgery, which represents the standard condition treatment. The condition itself results in a flow of blood backward in the heart; caused by an anatomical defect in the mitral valve located between the left atrium and left ventricle of the heart, for those who remember their high school pictorials during physiognomy studies in health class.

The condition is not uncommon, affecting roughly one in ten individuals aged 75 and up. The Clip could assist about half of those who are stricken with both leaky valves and end-stage heart failure. Only about ten percent would be candidates for its use among those with leaky mitral valves, but not among those without heart failure included.

The MitraClip is delivered to the heart through the femoral vein (blood vessel in the leg) permitting the heart to pump blood more efficiently and in the process relieving symptoms like shortness of breath. Implanted, the device clips the mitral valve's two leaflets together, creating a second opening in the valve. "That helps close the valve", explained Dr. Mesana.

Patients suffering from mitral valve disease, unable to withstand surgery, could be treated only with drugs up to the present time. The drugs would reduce their symptoms but would not stop the disease progression. The Clip promises an improved quality of life, but it doesn't come cheap, at about $30,000. Since use of the MitraClip reduces the length of hospital stays and cuts hospital readmissions, it helps to pay for itself.

Despite having been approved by Health Canada, it has not yet been given approval for universal coverage under medicare in Canada by any of the provincial governments. Yet even if a province agrees to fund the procedure, the locations at which it could be performed would be limited, and so too the number of procedures each approved centre could perform.

The Heart Institute, while waiting to see which if any of the provinces will eventually pay for the procedure by 2015, plans to continue implanting the MitraClip using its current clinical budget, for a limited number of patients.