Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited. This single-center registry evaluates the long-term efficacy and safety of percutaneous PFO closure and identifies the clinical, anatomical, procedural and pharmacological factors associated with clinical and echocardiographic outcomes. The registry combines a retrospective cohort of patients treated at Severance Hospital between 2010 and March 2026 with a prospective registry extension that enrolls patients undergoing PFO closure after institutional review board approval, with follow-up for up to 119 months. Clinical outcomes include recurrent ischemic stroke or transient ischemic attack, all-cause death, device-related complications and new-onset atrial fibrillation. Echocardiographic outcomes are assessed by serial agitated saline transthoracic echocardiography, which allows the presence, grade and longitudinal trajectory of residual shunt to be characterized.
Age range
19 Years
Sex
ALL
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Number of participants with recurrent ischemic stroke or transient ischemic attack
Timeframe: From patent foramen ovale closure to the last clinical follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort
Number of participants with residual right-to-left shunt on agitated saline transthoracic echocardiography, by shunt grade
Timeframe: From patent foramen ovale closure to the last follow-up echocardiography: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort