The interatrial shunt device. Courtesy Scripps Clinic

Scripps Clinic cardiologists announced Friday they enrolled the first San Diego County patient in an international trial meant to test a device created to relieve heart failure symptoms.

The unnamed woman was enrolled in the randomized study this week by interventional cardiologist Matthew Price at the Scripps Memorial Hospital La Jolla’s cardiac catheterization laboratory.

Qualifying for the trial involves “ejection fraction,” a measurement of the amount of blood that leaves the heart with each beat. Heart failure patients have “preserved ejection fraction” when their hearts pumps too much blood from the left ventricle with each beat.

More conventional heart failure treatments, such as beta blockers and other medications, aren’t typically effective in heart failure patients with preserved ejection fraction, Scripps cardiologists said. That’s where the experimental device comes into play.

“When a patient can’t be helped with medications, or still has symptoms despite medications, this simple procedure and device can potentially improve the quality of their life in a safe and long-lasting way,” Price said.

The experimental “interatrial shunt” device is implanted within the atrial septum, which is the wall of tissue separating the hearts upper chambers: the right and left atria. In heart failure, blood pressure builds up in the left atrium, which leads to breathlessness and fatigue — particularly during exercise — as well as water retention.

The device, a small scaffold of metal wire, holds open a small hole to allow blood to flow from the left atrium to right atrium, which improves symptoms by lowering blood pressure in the left atrium as well as arteries and capillaries found in the lungs, according to Scripps.

Scripps cardiologists plan to enroll more patients over the next year in the randomized, controlled and blinded clinical trial, with the aim of testing the device in 380 patients in the U.S. and 11 other countries.

“This trial represents an interdisciplinary approach to heart care which has become more common in recent years,” said Scripps Clinic heart failure specialist Rajeev Mohan, principal investigator for the La Jolla study site. “It is also the first of its kind to help treat patients with normal ejection fraction heart failure where treatment options are lacking.”

If the device is proven to work, the manufacturer likely would seek Food and Drug Administration approval to sell the product commercially.

In an earlier study, participants examined a month after implantation of the device had lower blood pressure in arteries and capillaries found in the lungs. No safety issues related to the device were reported, Scripps officials said.

Heart failure is the third leading cause of death attributable to cardiovascular disease in the United States, according to the American Heart Association. About 6.5 million Americans currently live with heart failure.

–City News Service

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