The Federal Drug Administration recently approved a new heart valve called the Trifecta, but three years ago Sis Doumite, 73, was the first in Texas to receive the valve in a clinical trial.
Doumite took the risk with reassurance from Dr. Joseph Coselli, chief of adult cardiac surgery for Texas Heart Institute at St. Luke's Hospital. He said, "this device had been implanted in thousands and thousands of patients overseas before it was ever implanted here."
Still, Doumite said she was not thrilled about having open heart surgery. Doctors discovered her aortic valve was not functioning properly after she was rushed to the emergency room suffering from shortness of breath.
"The thought of them cutting my chest open you know was scary, but I know it had to be done," said Doumite.
The aortic valve allows blood to flow from the left ventricle, the main pumping chamber of the heart, to the body's main artery, the aorta. According to Dr. Coselli, a malfunctioning valve could be deadly.
"Disease and deterioration of the aortic valve that leads to heart failure and in many cases death," said Dr. Coselli.
He asked Doumite to participate in a clinical trial for the Trifecta valve and Doumite agreed making her the first in Texas receive the device.
"In the clinical trial itself there were over a thousand of these valves put in the patients who were followed carefully," explained Dr. Coselli.
The titanium and tissue valve was implanted on a Monday in 2008 and by Friday, Doumite said, she was up and going again.
"My daughter and I walked. In fact, she made me slow down because I was feeling good," said Doumite.
"Everybody was shocked that I was dressed and had my makeup on," continued Doumite.
The Trifecta valve now has the FDA's seal of approval and with an estimated 90,000 heart valve replacements annually Dr. Coselli said it will become more widely available in the coming years.
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