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 19 years or older
Percutaneous patent foramen ovale closure
Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography
Prospective cohort: closure performed after institutional review board approval, with written informed consent
Atrial septal defect closure (defect other than patent foramen ovale)
Device embolization or device removal
Echocardiographic image quality inadequate for assessment of shunt
Prospective cohort: refusal of informed consent
Consecutive adults who underwent percutaneous patent foramen ovale closure at a single tertiary referral center in Seoul, Republic of Korea. The retrospective cohort comprises patients treated between 2010 and March 2026 who had at least one post-procedural agitated saline transthoracic echocardiography. The prospective cohort comprises patients undergoing closure after institutional review board approval who provide written informed consent. The population reflects routine clinical practice, and treatment is not assigned by protocol.
Cohort
Other
Not listed
Number of participants with recurrent ischemic stroke or transient ischemic attack
First recurrent ischemic stroke or transient ischemic attack after closure, identified from medical records and classified by event type and TOAST criteria. Reported as the number of participants with an event and as the event rate per 100 patient-years.
Number of participants with residual right-to-left shunt on agitated saline transthoracic echocardiography, by shunt grade
Residual right-to-left shunt is defined as the appearance of microbubbles in the left heart within three cardiac cycles after right atrial opacification. Shunt grade is assigned from the maximum microbubble count: small (1 to 10), moderate (11 to 30) or large (more than 30). Reported as the number of participants in each grade.
Number of participants who die from any cause
Death from any cause, ascertained from medical records.
Number of participants with device-related complications
Device embolization, device thrombus, erosion, reintervention or surgical device removal.
Number of participants with new-onset atrial fibrillation
Atrial fibrillation newly documented on electrocardiography, Holter monitoring or event recorder, classified as paroxysmal, persistent or permanent.
Number of participants with the composite of recurrent ischemic stroke or transient ischemic attack, all-cause death, or device-related complications
Composite of recurrent ischemic stroke or transient ischemic attack, all-cause death, and device-related complications, analyzed as time to first event.
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