New Heart Device Saves Lives

Following recent government approval of the device that reduces stroke risk by closing a small hole in the heart, a Scripps Health patient has become the first on the West Coast to be implanted with the gadget.

On Nov. 11, Scripps Clinic interventional cardiologist Matthew Price, M.D., placed the device, called an Amplatzer PFO Occluder, in a female patient during a 45-minute procedure in a laboratory in the Scripps Clinic on the campus of Scripps Memorial Hospital La Jolla.

The implant involves a relatively low-risk, minimally invasive procedure, during which the patient is awake the entire time. 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 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,” Dr. Price said. “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.”

The Amplatzer PFO Occluder is currently the only device approved in the United States for PFO closure.