Real-World Patent Foramen Ovale (PFO) Closure in Japan　― 30-Day Clinical Outcomes From the Amplatzer^TM PFO Occluder Japan Post-Marketing Surveillance Study ―

Abstract

found that in patients who had experienced a PFO-associated stroke, transcatheter PFO closure combined with medical therapy reduced the risk of recurrent PFO-associated stroke by 75% compared with medical therapy alone. 6 The Amplatzer TM PFO Occluder, a transcatheter PFO closure device, received Conformité Européenne (CE) approval in 1998 and US Food and Drug Administration (FDA) approval in 2016, and has been used to treat over 180,000 patients worldwide. This analysis presents early A patent foramen ovale (PFO) is a congenital flaplike opening between the right and left atria that is present in approximately 15-25% of adults. 1,2 Although in most cases it is benign and requires no treatment, in some individuals it can be a cause of ischemic stroke via paradoxical embolism, commonly referred to as a PFO-associated stroke. In fact, this mechanism is likely responsible for approximately 5% of all ischemic strokes. 3-5 A patient-level analysis of 6 randomized controlled trials

Morphological Features of Patent Foramen Ovale Compared Between Older and Young Patients With Cryptogenic Ischemic Stroke

“…16 Indeed, in the clinical setting, almost one-third of transcatheter PFO closures were performed in patients >60 years in the Amplatzer TM PFO Occluder Japan Post-Marketing Surveillance study. 17 Therefore, preoperative evaluation of the morphology of the PFO may be important when considering the indication of transcatheter closure, especially in older patients with a history of CS. Therefore, because the morphological features of PFO in older patients with a history of CS are comparatively unknown our aim in the present study was to rectify this deficiency in the data.…”