Saint Alphonsus Selected to Participate in International Clinical Trial

Major Study Investigates New Minimally-Invasive Heart Valve Replacement Procedure

A major international clinical trial of a new, minimally-invasive heart valve replacement procedure is now available to patients at Saint Alphonsus Regional Medical Center in Boise. The Saint Alphonsus Heart Institute, under the guidance of Dr. Robert Farivar, Cardiothoracic Surgery Medical Director, is one of approximately 80 hospitals in the United States, Canada and Europe participating in the Tendyne Mitral Valve System clinical trial.

The mitral valve is one of four valves in the heart that opens to let blood flow forward and closes to prevent the backflow of blood. When the valve fails, it results in a condition known as mitral regurgitation, a common and serious form of heart disease where the mitral valve does not close properly, causing blood to flow back into the heart and not out to the rest of the body. Over time, the leakage leads to heart stress and strain, because the heart must work harder to pump the blood to the body. If not treated, over time the heart can become enlarged or weaken, and patients can experience irregular heart rhythm.

“Many patients may have mitral regurgitation and not even know it and may not require any medical intervention. But in more severe cases, the patient could experience fatigue, shortness of breath, leg swelling, dizziness, and an overall lack of energy. And left untreated, over time the heart can become enlarged or weaken, and patients can experience irregular heart rhythms,” said Dr. Farivar. “It’s a great compliment to our cardiothoracic team that Saint Alphonsus is the only hospital in the region offering this major clinical trial to its patients.”

“This clinical trial is significant because it’s testing a method to replace the mitral valve without requiring a traditional open-heart surgery or having the patient connected to a heart-lung machine,” he added.

A small incision is made in the left side of the patient’s chest, and a catheter is placed in the heart. Through this catheter, the replacement valve is inserted and opened, much like a flower. It functions like a healthy mitral valve. Once inside the heart, the catheter is withdrawn, and the incision is closed. The procedure typically takes about 45 minutes to complete, and the patient can go home within a few days.

Patients exhibiting moderate-to-severe mitral regurgitation or severe mitral annular calcification and those for whom open-heart procedures would be risky are eligible to participate in the trial. Patients should consult their cardiologist for more information on possible enrollment in the trial.

“It’s because of Dr. Farivar and his team that we are able to offer this exciting clinic trial to patients in Idaho and Oregon. Dr. Farivar is truly a pioneer in new heart surgery advancements, and his expertise has helped make the Saint Alphonsus Heart Institute the most advanced in the region,” said Odette Bolano, President and CEO of Saint Alphonsus Health System.

Saint Alphonsus joins a prestigious list of hospitals and medical centers participating in the trial, including Stanford Health Care, University of California at San Francisco, University of Southern California University Hospital, University of Michigan, the Cleveland Clinic, Providence Heart and Vascular (Portland), University of Virginia Medical Center, and Swedish Medical Center (Seattle).