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Healing a Hole in the Heart

Closure of a patent foramen oval using a septal occluder.
Closure of a patent foramen oval using a septal occluder.
Closure of a patent foramen oval using a septal occluder.

One in four people is born with a small hole in the heart, such as a patent foramen ovale (PFO). For many, a PFO does not cause symptoms or disease; few people are even aware they have the condition. However, when a patient has a stroke for an unknown reason (i.e., cryptogenic), PFO is a likely contributor. It’s twice as prevalent in patients who experience a cryptogenic stroke.

Closing PFOs using a septal occluder reduced the risk of recurrent stroke in patients who had experienced a cryptogenic stroke, according to study findings reported in the September 14, 2017 issue of the New England Journal of Medicine (doi: 10.1056/ NEJMoa1707404).

John F. Rhodes, M.D., a pediatric and adult congenital interventional cardiologist at MUSC Children’s Health, was one of the national principal investigators for the REDUCE study (NCT00738894), a multinational, multicenter study to lower the risk of recurrent stroke for patients who have previously experienced cryptogenic stroke. Participants in the study had no other probable reason for their stroke, aside from PFO.

The controlled, open-label REDUCE study compared antiplatelet therapy on its own with transcatheter closure of a PFO using a septal occluder (the GORE® CARDIOFORM Septal Occluder or its predecessor, the GORE® HELEX® Septal Occluder; W.L. Gore & Associates; Newark, DE), along with antiplatelet therapy. The research involved 644 patients ages 18 to 59; they will be followed for five years. Locations included 63 sites in the U.S., Denmark, Sweden, Norway, United Kingdom, Finland and Canada.

In the initial analysis published in the New England Journal of Medicine, the average risk of cryptogenic stroke decreased by 77 percent with use of a septal occluder compared to medical therapy alone.

“This is pretty compelling evidence that closure is the better treatment, especially in someone under 60 who has no indication for stroke, aside from a PFO,” says Rhodes.

Disclosure: The study was funded by W.L. Gore & Associates. As a national principal investigator, Rhodes was compensated for his time by the sponsor and serves as a paid consultant.

Source: Progressnotes Summer 2018


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