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Treatment Effects in Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale
To the Editor In a recent study, Dr Kent and colleagues used previously developed scoring systems to estimate the risk of recurrent ischemic stroke in patients with patent foramen ovale (PFO) and concluded that the risk reduction for recurrent ischemic events with device closure varied across groups classified by their probabilities that the stroke was causally related to the PFO. Although these findings are interesting, they should be considered cautiously because other than right-to-left shunt and atrial septal aneurysm, no groups were stratified using anatomical and/or functional PFO variables. However, the magnitude of the right-to-left shunt, length of PFO tunnel, presence of prominent eustachian valve, and eventual left atrial dysfunction are related to stroke risk as outlined by a recent European position paper on management of patients with PFO. Therefore, the lack of stratification using these variables may have underestimated the risk of ischemic stroke. A rigorous individualized decision about PFO closure should include evaluation of both the morphological and functional characteristics of a PFO.
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