Study probes lower dose drugs for artificial heart valve patients

INDIANAPOLIS – Chris Connelly was aware he would eventually need surgery to correct a calcified valve in his heart, but what he didn’t suspect was that he might be living on borrowed time.

While attending a recent heart health seminar at St. Francis Hospital & Health Centers, Connelly, a father of three, learned about a new Food and Drug Administration-approved clinical trial under way at the St. Francis Heart Center. He inquired and was accepted into the study.

The study tests the safety and effectiveness of using lower dosages of blood-thinning drugs in conjunction with the On-X heart valve, a device manufactured by On-X Life Technololgies of Austin, Texas.

The study is conducted by Cardiac Surgery Associates (CSA ) at St. Francis and other major heart centers nationally. The 33-year-old Connelly received an On-X valve and uses a home monitoring device to help control the anticoagulant therapy he is receiving.

“The On-X valve could become the first mechanical heart valve approved for use with lower doses of anticoagulants such as Coumadin (warfarin) or even antiplatelet therapy (aspirin and Plavix) alone,” said investigator Marc Gerdisch, M.D., CSA medical director and director of cardio-thoracic surgery at St. Francis Heart Center.

“Ultimately, this means a better quality of life for our patients,” Gerdisch added.

Anticoagulants are used to slow down or stop the formation of blood clots. When a prosthetic device replaces the native tissue cardiac valve, it introduces foreign material into the blood stream, which can stimulate clotting. Mechanical heart valves have been around for years but require lifetime coagulation therapy at high dosages.

Biologic tissue valves do not require anticoagulants, but typically require replacement after 8-15 years and therefore another operation.

What makes the On-X unique is its carbon-based material coating combined with superb blood flow performance and an innovative hinge design, allowing the device to perform more like a normal tissue valve.

Candidates seeking the requirements to participate in the study can call 317-851-2582.

To learn more about the services and programs at the St. Francis Heart Center, go to www.stfrancishospitals.org/Heart.