Scripps Clinic Cardiologist First on West Coast To Implant New FDA-Approved Heart Device

A Scripps Health patient has become the first on the West Coast to be implanted with the Amplatzer PFO Occluder, which reduces stroke risk by closing a small hole in the heart, following government approval of the device.

Scripps Clinic interventional cardiologist Matthew Price, MD, placed the tiny device in a female patient Nov. 11 during a 45-minute procedure in a catheterization laboratory in the Scripps Clinic John R. Anderson V Medical Pavilion on the campus of Scripps Memorial Hospital La Jolla.

The minimally invasive procedure came just two weeks after the Food and Drug Administration cleared the device for use in the United States.

As many as 30 percent of Americans have a patent foramen ovale (PFO), a small connection in the heart muscle separating the right atrium from the left atrium, that in most people spontaneously closes after birth. In almost all cases, the defect is not a problem and does not require treatment.

But it appears this hole may play a role in certain types of strokes that have no other identifiable cause, like high blood pressure, atrial fibrillation or atherosclerosis. In such strokes, called “cryptogenic”, the PFO might provide a path for a blood clot to pass through the heart and travel to the brain where it causes a stroke.

“Patients who experience a cryptogenic stroke tend to be younger than patients who suffer other types of strokes, and recurrent stroke is something we want to avoid at all costs,” said Dr. Price. “For cryptogenic stroke patients with a PFO, we can now offer the Amplatzer PFO Occluder implant as a treatment to greatly reduce the chances of a follow-on stroke.”

Low-risk procedure

Alternative treatments include taking blood thinners or clot blocking medications, or undergoing open-heart surgery to close the PFO, but those options come with numerous risks.

The implant, on the other hand, involves a relatively low-risk procedure.

“The patient is awake the entire time,” Dr. Price said. “Using local anesthesia, the interventional cardiologist threads the device through a catheter introduced through a needle hole in a vein in the leg and up to the heart.”

Once the tip of the catheter is positioned in the hole, a pair of mesh and polyester fabric discs are unfolded and clasped together, closing the opening.

The Amplatzer PFO Occluder, made by St. Jude Medical, is currently the only device approved in the United States for PFO closure.

In an eight-year randomized clinical study that paved the way for FDA approval, 499 patients aged 18 to 60 years old were treated with the device plus blood-thinning medication, while 481 patients in a control group only received the medication. The implant group experienced a 50 percent reduction in the rate of new strokes when compared to the control group.

“Cryptogenic stroke is a terrible thing, and there is nothing worse than suffering a second stroke,” Dr. Price said. “Now we have a relatively safe procedure that clearly reduces the risk of having another stroke in these patients compared with medical therapy alone.”

Friday’s procedure was the latest example of the leading role Scripps plays in the development and use of innovative cardiology treatments and technologies.

Scripps is the only heart care provider in the region consistently recognized by U.S. News & World Report as one of the best in the country. In 2015, U.S. News & World Report ranked Scripps’s heart program 19 in the nation, the highest rated program in San Diego County.

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