FDA Ruling Allows Heart Valve Patients to Limit Blood-thinning Medication
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.