Saturday, May 15, 2004

Woman tests heart device


She's the first in global study

By Matt Leingang
The Cincinnati Enquirer

A Tristate woman is the first patient enrolled in a worldwide study to determine why a promising treatment for congestive heart failure works in some people but not others.

The treatment involves a combination of drugs and the next generation of pacemaker technology to improve the way the heart functions.

In March, Audrey L. Hall, 80, of Milan, Ind., was implanted with a biventricular pacemaker at Christ Hospital. The device is designed to synchronize the pumping action of the heart when the right and left ventricles are out of rhythm.

A standard pacemaker works on just the right ventricle of the heart.

About 300 patients are being tapped for the study at medical centers in the United States, Europe and Asia. Medtronic Inc., a Minneapolis-based company that makes the device, confirmed that Hall is the first.

Doctors at the Ohio Heart Health Center are conducting the study locally along with the Lindner Clinical Trial Center. Since March, six other local patients have been fitted with biventricular pacemakers and enrolled in the study.

Biventricular pacemakers were approved by the U.S. Food and Drug Administration in 2001. Doctors are still trying to determine which patients would benefit most from this new technology.

So far, about 70 percent of patients who receive the device report feeling better, said Dr. Eugene Chung, director of the heart failure program at Ohio Heart Health Center.

The mystery is why not all patients respond.

Hall, a retired schoolteacher, said her pacemaker is working well. Before receiving it, Hall was constantly short of breath and battled fatigue. Medications were not working, which is why her cardiologist recommended the study.

"Now I can walk again without getting too run down," Hall said. "This basically was my last option, as far as my life is concerned."

Heart failure is not a specific disease. It is a condition or syjdrome that can be brought on by a variety of health problems, such as high blood pressure, diabetes or damage from a prior heart attack.

E-mail mleingang@enquirer.com




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