Current Patient Management Issues, Clinical Trial Design Challenges, and the Pathway Forward
Following the diagnosis and acute treatment of ischemic strokes, patients routinely undergo testing to classify the stroke in terms of potential causes. Ischemic strokes in the setting of a detected PFO may be differentiated into two major categories: (1) the negatively-defined cryptogenic category (i.e. the lack of a definitive cause with detection of a PFO) and (2) the cardio-embolic category where additional evidence supports a potential causal relationship with a paradoxical embolism related to PFO.
Uncertainty is common, both in determining the etiology of ischemic stroke and the management of patients with ischemic stroke who are found to have a PFO. Observational and some randomized clinical trial data provide supportive but not definitive data on the added benefits of PFO closure in secondary stroke prevention of select patients. Patients can be stratified as those most likely to benefit from PFO closure, those least likely, and those in whom uncertainty of the benefit of closure remains. The clinician must therefore provide an individualized approach to therapy in secondary stroke prevention strategies.
Clinical trials investigating the efficacy of PFO closure in the setting of secondary stroke prevention have faced numerous challenges, but the lessons learned have nonetheless been valuable. Additional focused research should lead to greater clarity as to the role of PFO closure.
KeywordsPatent foramen ovale Ischemic stroke Device closure Secondary prevention Paradoxical embolism TIA Venous thrombo-embolic disease
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