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PFO stands for Patent Foramen Ovale, which translated means “open hole (in the heart) shaped like an oval.” It is estimated that about 25 percent of all people have PFOs, but to the people on the street, it is a term that is completely off their radar screen.
As common as PFOs are, they are still somewhat a mystery to the medical community. Some physicians treat patients with PFOs with blood thinning medications such as aspirin or Coumadin, while other physicians opt for a procedure to close the hole.
One area of concern in the medical community is that people with PFOs who have had a stroke might be at increased risk for a recurrent stroke.
That’s why researchers at UNMC are participating in a national study to try to determine the best treatment to reduce the risk of a recurrent stroke in people with PFOs.
The randomized clinical trial — called RESPECT — is being conducted by the AGA Medical Corporation in 26 states and 60 medical centers around the country. UNMC is the only site in Nebraska involved in the study.
Evidence indicates there may be a connection between PFOs and cryptogenic stroke — a stroke where no known cause can be determined, said Pierre Fayad, M.D., Reynolds Centennial Professor and Chairman of Neurological Sciences at UNMC and medical director of the stroke center at The Nebraska Medical Center.
“PFOs certainly have the potential of being dangerous,” said Dr. Fayad, who is the principal investigator for the UNMC portion of the clinical trial. “But, we’re not sure. The study is trying to answer that question, as well as trying to see whether closing the holes can relieve the danger and if it is worth the risk of closing the hole to possibly prevent a stroke.”
Nationwide, the clinical trial hopes to enroll 500 patients. In Nebraska, UNMC will try to enroll 10-20 patients.
On Thursday, David Thaler, M.D., Ph.D., one of the four physicians on the steering committee for the national clinical trial, gave a grand rounds presentation for the department of neurological sciences as a visiting professor.
“We are working on the best way to prevent the next stroke in people with PFOs,” said Dr. Thaler, who is a neurologist and director of the comprehensive stroke center at Tufts-New England Medical Center in Boston. “We don’t know what’s the best way of preventing the next stroke. We’re equally balanced between the two options — closing the hole mechanically or thinning the blood with medicine.”
The purpose of the RESPECT clinical trial is to see if there is a difference between the two treatments, he said.
Dr. Thaler said that some physicians have been closing the PFOs by systemically running devices to the patient’s heart by going through the groin or arm.
“Unfortunately, there are no devices approved by the FDA for this problem,” he said. “If a physician wants to close one of these holes, they’re doing it with devices designed for different holes. They might be able to use a device that will close a PFO, but we don’t know that it fits right and that it’s not going to cause its own problems.
“That’s why I would encourage physicians, who recommend closure for their patients with PFOs, to refer these patients to the clinical trial. By doing this, they will have a 50 percent chance of getting the right device rather than a 100 percent chance of getting a device that is designed for a different indication.”
To be eligible for the clinical trial, Dr. Fayad said patients must be between age 19 and 60, have had a cryptogenic stroke and a documented PFO.
Patients, who meet these criteria, will be randomly selected to have either a closure procedure done or to receive medical management in the form of antiplatelets or anticoagulants. If they receive the closure procedure, a device called the Amplatzer PFO Occluder will be used. This device is manufactured by AGA Medical Corporation and is specially designed to close PFOs.
Patients will receive follow-up care at one month, six months, 18 months, 24 months and annually for up to six years. The cost of tests and procedures performed solely for study purposes will be paid for by the study. However, patients will be responsible for the cost of any antiplatelet or anticoagulant medication that is prescribed for them.
For more information on the clinical trial, contact Mary Adolphson, a research nurse coordinator for The Nebraska Medical Center, at 552-2247 or madolphson@nebraskamed.com.