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Sacred Heart Participates in Revolutionary Heart Valve Trial

June 11, 2011

New technology treats aortic heart valve disease without surgery

Spokane, WA—Providence Sacred Heart Medical Center & Children’s Hospital announces its first patients have received replacement artificial aortic valves implanted through a catheter placed in the leg as part of the Medtronic CoreValve® U.S. Clinical Trial. Sacred Heart is one of 40 hospitals across the U.S. and the only hospital in the Pacific Northwest to be selected to participate in the trial evaluating a revolutionary non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery.

Potential candidates for the procedure are patients who suffer from severe aortic stenosis, which prevents the heart’s aortic valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. Untreated, aortic valve stenosis leads to serious heart problems and eventual death. As aortic stenosis is a condition that develops with age, the need for this procedure will continue to grow, even among people who are otherwise healthy.

“There is significant need for new treatment options and we’re proud that Sacred Heart’s team can be part of evaluating this revolutionary new alternative in our own community,” says Leland Siwek, MD, a cardiac surgeon at Sacred Heart. “Because the risks of open-heart surgery can be significant for many patients, we’re excited to offer this less-invasive option.

In the U.S., 100,000 people have been diagnosed with this condition, and approximately one-third of these patients are considered to have too high a risk for open-heart surgery.

In the clinical trial, physicians channel a catheter (thin tube) with a prosthetic valve (from a pig heart) attached through a small opening in the patient’s femoral artery to reach the heart. The physician guides the CoreValve System to the aortic valve, where it self-expands to replace the diseased aortic valve. The procedure is completed while the heart continues to beat without open-heart surgery or surgical removal of the native valve.

“Essentially we can change the valve with the engine running, without popping the hood,” says Michael Ring, MD, an interventional cardiologist who is part of the CoreValve Team at Sacred Heart.

In the U.S., the CoreValve System will not be commercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA). It has been approved for use in Europe since 2007.

For more information about the CoreValve trial, see www.aorticstenosistrial.com.

About Aortic Stenosis

Aortic stenosis, which is most prevalent in the elderly population, inhibits blood flow between the heart and the body and causes symptoms such as shortness of breath, chest pain, fatigue and fainting spells. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and eventual death. Other than surgery, patients with this condition have had few, if any, successful treatment options.