Researchers Study Device That May Help Patients Avoid Open-heart Surgery

Murray, UT (1/21/2008) — Cardiac researchers at Intermountain Medical Center in Murray are studying a new device that may help patients avoid open-heart surgery to repair a defect that affects as many as one in five people over the age of 55.

Mitral regurgitation is a condition in which the heart's mitral valve doesn't close tightly, allowing blood to flow backward into the left atrium of the heart with each heartbeat. When the mitral valve doesn't function properly, blood can't move through the heart or to the rest of the body very efficiently. This can leave patients fatigued and short of breath and lead to serious cardiac problems such as an enlarged ventricle.

Researchers at Intermountain Medical Center are seeking patients throughout the Intermountain West who have moderate to severe mitral regurgitation and are experiencing symptoms such as fatigue, chest pain, or shortness of breath, or those patients who may be asymptomatic but still have a weakened left ventricle.

Intermountain Medical Center is one of only 40 hospitals in the nation — and the only center in Utah — participating in the national phase II clinical trial of the MitraClip device, which is inserted by interventional cardiologists in the cath laboratory. The MitraClip brings the leaflets of the mitral valve together, helping the valve to close properly.

The randomized study, known as the EVEREST II clinical trial, is designed to evaluate the safety and effectiveness of the procedure in patients with moderate to severe mitral regurgitation, as compared to open-heart surgical valve replacement or repair.

An estimated four million people in the United States have significant mitral regurgitation, with about 250,000 new patients diagnosed each year. Researchers estimate that only about 20 percent of patients, or 50,000 people, undergo surgery annually to repair or replace the valve.

"This means about 80 percent of patients with significant mitral regurgitation currently go untreated, representing a large unmet clinical need that may be addressed by less invasive treatment options like the MitraClip device," says Brian Wisenant, M.D., interventional cardiologist and principal investigator of the study at Intermountain Medical Center.

Mitral regurgitation is usually caused by conditions that weaken the heart muscle or damage the mitral valve. Common causes of mitral regurgitation in adults are heart attack due to coronary artery disease, degeneration of the valve tissue, and cardiomyopathy.

For more information about enrollment, call Intermountain Medical Center at (801) 507-7000 and ask for the Utah Heart Clinic and The Everest II study.