Heart Valve Provides Life-Saving Alternative to Open-Heart Surgery

VANCOUVER, BRITISH COLUMBIA - According to recent study result published in the New England Journal of Medicine (NEJM), a new aortic heart valve replacement procedure, called trans-catheter aortic-valve implantation (TAVI) has shown to be a viable life-saving option for patients who are unable to undergo open heart surgery.

The study, which is part of the Partner Trial (Placement of AoRTic TraNscathetER Valve), compared the health outcomes of patients who underwent TAVI using the investigational Edwards SAPIEN trans catheter valve to those who received standard therapy. All patients in the study had severe aortic stenosis and were considered not to be suitable candidates for surgery. The conclusions stated that TAVI, as compared with standard therapy, significantly reduced the rates of death for these patients.

Severe aortic steno-sis is a progressive and life-threatening disease, and patients who do not undergo surgical valve replacement of their diseased aortic valve have no effective treatment option to prevent or delay their disease progression. Without treatment, previous studies indicate 50 per cent of patients will not survive more than two to three years.

Heart valve replacement surgery usually requires a long incision in the center of the chest to enable surgeons to expose the heart, which is temporarily stopped while the valve is replaced and sutured in place. A heart-lung bypass machine is used to keep the patient's blood circulating until the heart function is restored. Using the TAVI procedure, the Edwards SAPIEN valve (a collapsible aortic heart valve) can be inserted in two ways: through a small incision in the ribs (trans-apical) or threaded up to the patient's heart through the circulatory system using a catheter inserted in the patient's groin (trans-femoral). The NEJM study focused on the trans-femoral procedure.

In 2005 a team of specialists at the Heart Centre in St. Paul's Hospital, Vancouver, BC (one of the partner sites in the trial) and University of British Columbia, were the first world's first to successfully perform trans arterial procedures (pioneered by the St. Paul's Heart Center team) and the world's first to successfully perform a trans apical aortic valve replacement. The Heart Center began with 17 procedures in 2005 and have now done over 200 trans femoral procedures and over 150 trans apical. The team has also trained over 50 other programs around the world, with over 10,000 procedures now done worldwide.

"The world-renowned research and clinical innovation in the Heart Centre at St. Paul's Hospital continue to position British Columbia as a leader in cardiac sciences," says Hon. Kevin Falcon, Minister of Health Services.

"The research and cardiac services at St. Paul's have a rich 50-year history of excellence, and I'm confident this tradition – and breakthrough improvements to patient care -- will continue through St. Paul's Hospital's leading contributions and collaborations with BC's health authorities, Cardiac Services BC, universities and other research partners."

St. Paul's world-renowned interventional cardiologist, Dr. John Webb is co-author of the study and a member of the executive committee for the trial's design. He was also the first interventional cardiologist in North America to perform a successful per cutaneous aortic valve replacement.

"The results from the trial to date are very encouraging," says Dr. Webb, McLeod Family Professor in Valvular Heart Disease Intervention at the University of British Columbia. "We hope that this will eventually become a standard treatment option. Not only is it less invasive than traditional open-heart surgery, but this procedure provides patients who are not candidates for surgery with an option that has so far proven to have better health outcomes than standard treatment."

At St. Paul's Hospital, the procedure is currently provided on compassionate grounds for patients who are too frail to survive open-heart valve replacement surgery.

These findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 scientific symposium held in Washington, DC, this week.

source: marketwire

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