Scripps Enrolls First Local Patient for Heart Failure Device Trial

Scripps Clinic cardiologists this week enrolled the first San Diego County patient in an international clinical trial of an experimental interatrial shunt device designed to relieve symptoms from heart failure.

The female patient was enrolled in the randomized study by interventional cardiologist Matthew Price, MD, in the cardiac catheterization laboratory at the John R. Anderson V Medical Pavilion on the campus of Scripps Memorial Hospital La Jolla.

The interatrial shunt device is implanted within the atrial septum, the wall of tissue separating the heart’s 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 within this wall. As a result, blood flows from the left atrium to right atrium, which in turn lowers the blood pressure in the left atrium and lungs. This helps to improve heart failure symptoms.

The device and procedure specifically target heart failure patients with preserved (or normal) ejection fraction, which relates to the amount of blood that leaves the heart with each beat. More conventional treatments such as beta blockers and other medications are largely ineffective in heart failure patients with preserved ejection fraction.

“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,” Dr. Price said.

“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, MD, who is the 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.”

The Scripps cardiologists are looking to enroll more patients over the next year in this prospective, randomized controlled, blinded clinical trial, which is seeking to test the device in 380 patients in the United States and 11 other countries.

If results from the trial are positive, the device manufacturer will seek permission from the Food and Drug Administration to make the device commercially available in the United States.

In an earlier study of the device, participants who were examined a month after implant had lower blood pressure in their lungs, and no safety issues were reported in association with the device.

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 are living with heart failure.

The interatrial shunt device is the latest example of Scripps’ leadership and innovation in cardiology.

Ranked No. 1 for heart care in San Diego County by U.S. News and World Report, Scripps Health is the largest provider of heart care in the region, caring for more than 76,000 cardiovascular patients every year. Its Prebys Cardiovascular Institute in La Jolla brings together leading researchers, physicians, staff and technologies in the most advanced center dedicated to heart care on the West Coast.

Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.