Some studies suggest that PFO may be present in as high as 27% of the population. It is diagnosed on transthoracic and transoesphageal echocardiography with demonstrable significant right to left shunting (evidence for blood going from right to left chambers).
However, not all PFOs need to be closed. The PFO device was approved in 2016 by the US Food and Drug Administration (FDA) based on 10 year resuts of a randomized study which involved patients <60 years old with PFO and cryptogenic stroke (of unknown cause). It compared patients treated with PFO device plus blood thinning medications with patients treated with blood thinning medications alone and found a 50 percent reduction in new strokes in patients with PFO device. Other less common indications for closure include decompression illness in professional divers, cyanosis (mixing of deoxygenated [blue] blood in the left chambers causing breathlessness especially with certain posture.
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