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Study Supports Closure Procedure for Stroke Patients with a Hole in the Heart

CardioSmart News

Medication alone may not be optimal for stroke patients with a hole in their heart, based on a recent study that found a minimally-invasive procedure improves outcomes for stroke patients with patent foramen ovale.

Patent foramen ovale (or PFO) is a congenital heart defect that occurs when a small hole between the top two chambers of the heart fails to close at birth. PFO affects an estimated 1 in 4 people and increases risk for stroke—a leading cause of death in the United States.

When patients with PFO suffer stroke, it’s especially important that they take steps to prevent a second heart event. However, what the ideal treatment is for stroke patients with PFO is unclear.

The recent study, which was presented March 12 at the American College of Cardiology Scientific Sessions, tested a new treatment for stroke patients with PFO. The goal was to see whether a procedure plus medication performed better than medication alone in helping prevent future heart events.

The study included 120 stroke patients, all of whom had a high-risk form of PFO. They were treated at two centers in South Korea and randomly assigned to medication plus PFO closure or medication alone.

The PFO closure is a non-invasive procedure that threads a device through a vein in the groin, which is used to close the hole in the heart.

Ultimately, the study was cut short once it became clear that the PFO procedure had significant benefits over medication alone. After following participants for two years, researchers found that seven of the patients on medication only suffered second heart events, while there were no such events in patients with the PFO closure. Based on results, researchers estimate that for every ten closures of PFO, it would prevent one stroke after two years.

“The results suggest that closure is beneficial for those with high-risk PFO,” explains Jae Kwan Song, MD, a cardiologist at Asan Medical Center in Seoul, South Korea and the study’s lead author. The next step, he explains, is to clarify which patients stand to benefit most from the new device. 

"With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer,” says Song. “The key to appropriate use of this medical device is determining how to select optimal candidates for the procedure.”

Authors also add that future trials are needed to compare different medications when used in stroke patients with PFO. In this study, all patients received some form of blood thinner, which helps reduce the formation of blood clots and prevents stroke. Experts wonder if there may be potential benefits of different medications, especially when used in combination with the PFO procedure.

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