Two compared device closure with antiplatelet treatment alone, and each trial showed a significant benefit of PFO closure. An additional positive did not restrict medical treatment to antiplatelets but did limit eligibility to patients with high-risk anatomic PFO features, including larger shunt size and atrial sep- tal aneurysm. A meta-analysis of all trials561 found that the number needed to treat with device closure to pre- vent 1 recurrent stroke was 131 during 1 person-year of follow-up or 13 during 10 person-years of follow- up, which may be clinically important in this generally young population. Analysis of administrative claims data showed a 4.9% rate of serious periprocedural complica- tion, including AF, in patients 60 years of age.562 RCT data of PFO closure in patients >60 years of age are and the rate of serious periproce- dural complications in this older age group is signifi- cantly higher (10.9%).562 Recommendation-Specific Supportive Text 1. Recommendations for secondary stroke preven- tion in a patient with a PFO should be based on joint input from a neurologist with expertise in vas- cular neurology and a cardiologist with expertise in PFO closure (Figure 5).563,564 Although 1 small trial with 120 patients did include some patients Recommendations for PFO (Continued) COR LOE Recommendations CLINICAL STATEMENTS AND GUIDELINES Kleindorfer >60 years of age, this should not be construed as randomized clinical trial evidence of benefit in this age group; therefore, this procedure should rarely be performed in older patients and only in very unusual clinical circumstances. It is essential that a thorough evaluation has been completed and that there is no alternative cause of the stroke. All that showed benefit from PFO clo- sure excluded lacunar strokes. Thus, the require- ment that the stroke be cryptogenic is equivalent to nonlacunar stroke of undetermined source, or ESUS. 