In revised recommendations, the American Academy of Neurology (AAN) states that catheter-based closure should not be routinely recommended for people who have had a stroke and also have patent foramen ovale. The practice advisory, which updates a previous AAN guideline, has been published in Neurology. Guideline author Steven R Messé (Perelman School of Medicine, the University of Pennsylvania, Philadelphia, USA) says that the evidence is support of PFO closure is limited.
He comments: “Compared with other ways to prevent a second stroke, such as medications to reduce blood clots, the devices used to close a patent foramen ovale have limited evidence to support their use. It is still uncertain how effective these devices are in reducing stroke risk, and the procedure is associated with uncommon but potentially serious complications.”
Additionally, Messé notes that the devices used for PFO closure are not available for routine use in the USA and, therefore, the procedure must be done off-label with a device approved for treating a similar heart defect or with another device that does not have strong evidence regarding its use. At the time of publication, the FDA is currently reviewing the one device that has the best evidence regarding closure. “People should know that having a PFO is common—one in four people have one—and the risk of having a second stroke is low,” he comments.
When the AAN developed the earlier guideline on this topic in 2004, not enough evidence was available to make a recommendation on whether closing a PFO was effective in reducing stroke risk. The advisory also recommends that aspirin or other antiplatelet drugs be used to prevent blood clots instead of anticoagulant drugs such as warfarin and heparin, also known as blood thinners, unless there is another reason to use blood thinners, such as a person with a history of blood clots in the legs or lungs. The practice advisory was supported by the American Academy of Neurology.