As many as 26 percent of us have holes in our hearts.
This hole, found in the wall between the heart's two upper chambers, is called a patent foramen ovale, or PFO, and most of the time, it isn't a cause for concern. But sometimes, a PFO can be the cause of a stroke.
In about 40 percent of strokes, patients don't have heart arrhythmias, blood clots or any other identifiable cause. In these patients, PFOs may be to blame.
The question of whether or not doctors should close PFOs in patients who have had strokes has been a hot-button issue for cardiologists and neurologists treating stroke patients for years. But a new study called the CLOSURE trial suggests that closing PFOs may be no better in preventing future strokes than treating patients with medication, a treatment route that is less costly and without the inherent risks of a medical procedure.
The study, published today in the New England Journal of Medicine, looked at 909 patients between the ages of 18 and 60 who had a PFO and had suffered a stroke without another apparent cause, called a cryptogenic stroke. About half of the patients went on medical therapy. The other half took medication and had their PFOs closed -- doctors threaded a catheter through a vein to the heart and plugged the hole with a small device called a STARFlex.
When researchers compared the two groups, they found that the risk of having another stroke was almost equal for both groups. Within two years of the procedure, 2.9 percent of the patients with closed PFOs had a stroke, compared with 3.1 percent of patients taking medication alone.
Dr. Anthony Furlan, the study's lead author and chairman of neurology at University Hospitals Case Medical Center in Cleveland, said the evidence just isn't there to support a PFO closure procedure over simply giving patients medication.
"We're not saying there are no patients who should have the hole closed, but we are saying the selection criteria have to be radically refined," he said. Ideally, a patient would be under age 45, have a very large hole in their heart and a heart defect called an atrial septal aneurysm.
So if both treatments are equally effective, what's wrong with closing PFOs? Furlan said the procedure is costly and poses some risks for patients. According to the study, 13 patients had major vascular complications in the two years after their procedures, and 23 had atrial fibrillation, a heart arrhythmia that can be dangerous if left untreated. Only three patients taking medication alone had atrial fibrillation.
Many doctors welcomed the results of the CLOSURE trial, saying it provides real evidence about the choices doctors can give their patients.
"It has been taught and practiced for years that closing PFOs in patients with cryptogenic strokes is helpful," said Dr. Colin Barker, an assistant professor of cardiovascular medicine at the University of Texas Health Science Center. "This study shows the lack of benefit of this intervention."
"Hopefully it will significantly reduce the number of PFO closures that are being done off-label," said Dr. Amie Hsia, Medical Director of the Stroke Center at MedStar Washington Hospital Center in Washington, D.C.
But the study is drawing fire from other doctors who say the trial had several flaws.