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Clinical Trial Shows On-X Prosthetic Heart Valve, Implanted By St. David's HealthCare Surgeons, Could Eliminate Need for Full Anticoagulant Treatment, Such As Blood Thinners

Tuesday, November 01, 2011

AUSTIN, Texas—A recent clinical trial has shown the On-X® Prosthetic Heart Valve—implanted by physicians within St. David’s HealthCare since 2002—surpasses all other artificial valves on the market in potentially eliminating the need for anticoagulant treatment, such as blood thinners.

There are two types of valves typically used in treating cardiac patients—mechanical valves and tissue valves, or valves from a cow or pig. Tissue valves can last anywhere from 12 to 20 years, while mechanical valves are believed to last indefinitely, a key benefit. Traditionally, mechanical valves require patients to take blood thinners, such as warfarin (Coumadin®), because they have the propensity to develop blood clots. Blood thinners put patients at risk for dangerous bleeding, especially older patients.

In January of 2006, the FDA approved the first and only IDE (Investigational Device Exemption) lowered anticoagulation trial—the Prospective Randomized On-X Valve Reduced Anticoagulation Clinical Trial (PROACT)—for a mechanical valve to be conducted for the On-X Prosthetic Heart Valve. Initial results are promising.

“The On-X prosthesis acts more like a natural valve in its treatment of blood and has the potential to eliminate the need for full anticoagulant treatment,” Faraz Kerendi, M.D., cardiac surgeon at Cardiothoracic and Vascular Surgeons who practices at Heart Hospital of Austin, said. “We are pleased with the preliminary results of the PROACT study.”

The study may find low-risk aortic patients with the On-X Prosthetic Heart Valve can be treated using non-warfarin anticoagulation medication such as clopidogrel (Plavix®) and aspirin, and higher-risk aortic patients may only require reduced levels of warfarin (Coumadin®), in addition to aspirin.

“This valve may provide the long-term benefits of a mechanical valve without the complication of having to take Coumadin, which is significant because this medication has a number of negative side effects, including increased risk of bleeding,” Dr. Kerendi said. “This prosthesis is ideal for younger patients who will have the implanted valve for the rest of their lives. It could eliminate the need for re-operation.”

The On-X valve received full pre-market approval from the FDA in March of 2002. It has been implanted in patients at Heart Hospital of Austin, St. David’s Medical Center, St. David’s South Austin Medical Center and St. David’s North Austin Medical Center.

St. David’s HealthCare
With more than 60 sites across Central Texas, St. David’s HealthCare includes seven of the area’s leading hospitals and is one of the largest health systems in Texas. Known for compassionate, high-quality care, the organization has been recognized with the Texas Award for Performance Excellence, the highest honor bestowed by the State of Texas based upon world-class quality measures. Ranked as one of the Top Workplaces in 2010 by the Austin American-Statesman—as well as the top Austin-area employer among large companies at the Austin Business Journal’s annual “Best Places to Work” event in 2007, 2008 and 2009—St. David’s HealthCare is the third-largest private employer in the Austin area, with more than 7,100 employees. For more information, please visit StDavids.com.

Blood Thinner Anticoagulant Treatment On-X® Prosthetic Heart Valve