Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population. Extensive research has demonstrated an association between PFO and neurological conditions such as cryptogenic stroke, migraine, and sleep apnea syndrome, and it is even considered a potential root cause of these disorders. However, the mechanisms by which PFO contributes to neurological diseases remain unclear. In our preliminary clinical work, we have observed a strong correlation between PFO and epilepsy, and PFO closure has shown some efficacy in reducing seizure frequency. The aim of this study is to further investigate the efficacy and safety of PFO closure in patients with drug-resistant epilepsy.
Age between 18 and 60 years, with no gender restrictions;
Diagnosis of epilepsy in accordance with the International League Against Epilepsy (ILAE) criteria (2014 edition);
Drug-resistant epilepsy, defined as failure to achieve sustained seizure freedom despite appropriate selection and tolerability of at least two antiseizure medications (monotherapy or combination therapy) for a minimum of six months;
Diagnosis of patent foramen ovale (PFO) meeting the criteria established by the American Society of Echocardiography (ASE) and the Society for Cardiovascular Angiography and Interventions (SCAI) (2015 edition), with right-to-left shunting (RLS) of grade II or higher upon Valsalva maneuver, as assessed by contrast-enhanced echocardiography;
Patients diagnosed with epilepsy of a known etiology, including infectious, metabolic, immune, genetic, or structural causes;
History of stroke or psychogenic nonepileptic seizures (PNES);
History of epilepsy surgery or implantable neurostimulation therapy, or planned epilepsy surgery, neurostimulation therapy, ketogenic diet therapy, or other antiseizure interventions during the study period;
Presence of structural cardiac abnormalities other than patent foramen ovale (PFO), such as moderate or severe valvular regurgitation or pulmonary hypertension;
Parallel
patent foramen ovale closure
Devicepatent foramen ovale closure
Percentage decrease in seizure frequency compared to baseline period
Percentage decrease in seizure frequency compared to baseline period
Percentage decrease in mean duration of seizures from baseline period
Percentage decrease in mean duration of seizures from baseline period
Percentage of decrease from baseline in Epilepsy Severity
Percentage of decrease from baseline in Epilepsy Severity Scale score (NHS3)
Percentage improvement from baseline in Quality of Life for Patients with Epilepsy
Percentage improvement from baseline in Quality of Life Rating Scale for Patients with Epilepsy (QOLIE-31)
The maximum number of observation days without sustained epileptic seizures during the follow-up observation period
The maximum number of observation days without sustained epileptic seizures during the follow-up observation period
Scores of Hamilton Anxiety Scale (HAMA)
The severity of anxiety
Scores of Hamilton Depression Scale (HAMD)
The severity of depression
Scores of MMSE
The severity of cognitive decline
Scores of MoCA
The severity of cognitive decline
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