NEW ORLEANS – Last week, the U.S. Food and Drug Administration approved the first transcatheter aortic heart valve that can be implanted without open heart surgery -- and Ochsner Medical Center was one of only 22 sites in the United States for this landmark clinical trial.
The FDA’s approval of the Edwards SAPIEN heart valve gives patients who are considered non-operable for conventional open heart valve surgery new hope for longer life and relief from symptoms. Annually, some 300,000 people in the U.S. need a new heart valve.
Transcatheter aortic valve replacement (TAVR) involves a catheter carrying a tissue valve built into a metal frame a half an inch in diameter being threaded up the artery from the leg to the aortic valve, where it positions the new valve within the damaged one. This procedure is performed in a state-of-the-art cath lab on a "beating heart," without the need for bypass machine, which can pose additional risks.
“The Edwards SAPIEN valve offers a new lease on life for patients with severe aortic stenosis through a minimally invasive procedure which can reduce morbidity and recovery time," said Ochsner’s Stephen Ramee, M.D., FACC, Medical Director of the John Ochsner Heart & Vascular Institute Heart Valve Program. “We are seeing patients in their 80s and 90s who were bedridden before the procedure participating in their daily activities again just a month later. It is extremely gratifying for the doctors and for the patients.”
Regionally, this procedure is available only through the John Ochsner Heart & Vascular Institute’s Heart Valve Program. “Between Dallas and Miami and up to Atlanta, Ochsner is the only hospital that has the ability to perform the transcatheter aortic valve replacement,” said Ramee.
Ochsner was chosen for the trial due to its expertise in valve replacement surgery and vast experience in interventional procedures. "This is an interdisciplinary study in which Ochsner's Cardiovascular Medicine, Cardiothoracic Surgery, Anesthesia, Pulmonology and Nephrology departments are working collaboratively, using the best techniques from all specialties, to advance the standard of care for our patients," said Ramee.
For more information on Ochsner’s Heart Valve Program, please call toll free 1-855-842-3724 or email heartvalve@ochsner.org.
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