Franciscan St. Francis Health surgeon authored scientific study
leading to FDA ruling
INDIANAPOLIS
– Patients who have received On-X® mechanical aortic heart valves at Franciscan
St. Francis Heart Center may soon be able to reduce their regular blood-thinning
medication regimen, according to a recent expanded labeling claim granted by
the U.S. Food and Drug Administration.
While
all mechanical heart valve patients must continuously take anticoagulant
medication (warfarin), the FDA’s decision makes the On-X valve the only one in
the world that allows patients to be managed at a substantially lower dose,
beginning three months after their surgeries.
“The
On-X valves are designed with breakthrough technology that causes less blood
cell damage than traditional mechanical valves and are the only valves with a
pure carbon coating,” said Marc W. Gerdisch, MD, chief of
cardiovascular and thoracic surgery at Franciscan St. Francis Heart
Center. “This development is significant for patients. It enables many to lower
their blood-thinning dosage dramatically and experience an enhanced quality of
life, with a 65 percent decrease in risk of medication-related bleeding
complications.”
Dr.
Gerdisch is the co-medial director of the Franciscan St. Francis Heart Valve
Center.
In 2013, he was the first surgeon in the nation to implant the On-X Aortic
Prosthetic Valve with Anatomic Sewing Ring in a 35-year-old male from
Ellettsville, Ind. “This design innovation facilitates implantation and avoids
trauma to the heart, further expanding the advantages of the On-X valve,” he
said.
“At
Franciscan St. Francis Heart Valve Center, we have used the On-X mechanical
valves since 2006 and have implanted hundreds,” said Dr. Gerdisch, a senior
partner with Cardiac Surgery Associates. “It represents only a
fraction of our valve surgeries, but it plays a crucial role in our ability to
provide superior results for our patients. It provides the opportunity for a
younger patient to have a single valve for life, with reduced risk. I find many
patients who have had tissue valves implanted while they were young choose an
On-X as their second valve because they have no desire to have a third.”
Studies
have shown that up to 50 percent of untreated patients with severe aortic
valve disease will not survive beyond an average of two years after the
onset of symptoms. Common signs are shortness of breath and increased
fatigue. Fortunately, surgery to replace the valve can extend their lives.
Click
HERE to view a patient’s
experience with heart valve surgery and the Franciscan St. Francis Heart Center
team who treated him.
