Medical device

A new device approved by the Food and Drug Administration has been deployed for the first time in Texas to repair a hole in the heart of a Grandbury woman.

The new AMPLATZER PFO Occluder, a double-umbrella-shaped titanium plug, was implanted in the heart of Heidi Easley, an art teacher and mom from Granbury, on Nov. 15 at Baylor Scott & White All Saints Medical Center in Fort Worth.

The device was developed to plug a “patent foramen ovale” (PFO). A PFO is a small hole between the two upper chambers of the heart (right and left atrium) through which blood clots sometimes escape and travel to the brain, causing strokes.

Easley, 37, was experiencing searing headache pain and vision loss when her neurologist confirmed that she had suffered a mini-stroke due to an undiagnosed PFO the size of a pencil eraser.

“It is a very common congenital heart defect,” said Dr. Farhan Ali, the interventional cardiologist who performed the procedure at Baylor Hamilton Heart and Vascular Hospital at Baylor Scott & White All Saints. “About one in four, 25 percent of adults, have a PFO, but it is usually not even detected unless they have a stroke and no other cause can be determined.”

The holes are closed to prevent recurring strokes.

“Everyone has a hole in his heart before birth,” Ali said. “The opening allows oxygenated blood from the placenta to bypass the lungs and get to the developing organs of the fetus.”

The flap-like opening normally closes immediately after birth when the lungs take over that job. When the flap remains open or “patent,” it is referred to as a PFO.

“Closing the holes is not new. I probably close 60 to 100 a year and have been doing that with off-label devices for seven years in Texas and for three or four years before that in Detroit. What is new is that we finally have an FDA-approved device for closing them,” Ali said.

The new devices are implanted through a catheter inserted in the leg in an outpatient procedure without general anesthesia. It takes only 5 to 10 minutes to deploy the device and 30 minutes total for the procedure, Ali said.

For about the last 10 years, PFOs have been repaired with devices that were developed to plug atrial septal defects (ASDs) and used off-label for PFOs. However those devices sometimes do not fit perfectly and insurance companies have been reluctant to cover off-label use, he said.

“ASDs are usually larger and shaped a little different, but we were using septal occluders to close PFOs because we had no other choice. Nothing had been approved for PFOs until now. This is the first device that’s made to fit the anatomy of a PFO, which is more like a tunnel 10 to 15 mms [millimeters] wide than a simple hole,” Ali said.

PFOs are usually detected through an echocardiogram or ultrasound procedure when a “cryptogenic” stroke – a stroke of unknown origin – is diagnosed.

The American Heart Association says that each year about one-third of the ischemic strokes in the United States (about 200,000) are classified as cryptogenic.

The AMPLATZER PFO Occluder is designed to plug the unwanted hole and reduce the risk of follow-up strokes.

The landmark clinical trial that lead the FDA to approve the new device found that patients who received it and continued established medical treatment with mild blood thinners such as aspirin had a 45 percent reduced risk of stroke compared with patients receiving established medical therapy alone.

PFOs are almost never closed surgically anymore, usually only in tandem with open-heart bypass surgery for severe blockages and with heart valve repairs.

They are often treated medically with blood thinners in older patients, but that can present a bigger problem for younger people ages 18 to 60 who are very active and don’t want to be on heavy-dose blood thinners all their lives, Ali said. Blood thinners can interfere with active lifestyles and sports as well as pregnancy.

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