Long-term Outcomes After Percutaneous Closure of PFO

Study Overview
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Brief Summary
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International medical centre Medicor from Slovenia has reported 306 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till June 2022. The investigators are going to follow-up the participants clinically and with contrast transthoracic echocardiography (TTE) to define the percentage of functional percutaneous closure. The latter is defined with the number (ten or less) of contrast-bubbles in the left atrium during Valsalva maneuver and contrast (agitated saline) application. The clinical follow-up will show the recurrence of embolic events (cerebrovascular insults, transient ischemic attacks) after percutaneous closure. In addition all of the participants are going to be screened for atrial fibrillation. The patients with moderate residual shunts (more than ten bubbles in the left atrium) will then according to the protocol have a transesophageal echocardiogram (TEE) to show the eventual mechanism of the shunt. If the TEE will not show any signs of a residual shunt, the patients will undergo a computed tomography angiogram (CTA) of the pulmonary circulation to exclude arterio-venous fistulas as a cause of the shunt seen on TTE. The investigators will also show the comparison in functional closure between classic and alternative device occluders.

Official Title
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Long-term Echocardiographic and Clinical Outcomes After Percutaneous Closure of Patent Foramen Ovale

Conditions
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Foramen Ovale, Patent, Echocardiography, Embolic Stroke, Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had a neurological event confirmed by a neurologist. Patients who underwent percutaneous closure of PFO in MC Medicor (Slovenia) from 2006 to 2022. Exclusion Criteria: Patients who had additional congenital heart defects (as is atrial septal defects). Professional divers, who had the percutaneous closure of PFO because of an episode of decompression sickness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVI | Cerebrovascular insult | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. | 
| TIA | Transient ischemic attack | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. | 
| Death | From cardiac and non-cardiac reasons | From date of percutaneous closure until the date of death from any cause. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF | Atrial fibrillation | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patent foramen ovale, transthoracic echocardiography, cerebrovascular insult, transient ischemic attack, atrial fibrillation