Long-term outcomes following patent foramen ovale device closure: A single-center experience

Abstract

Background

Patent foramen ovale (PFO) transcatheter closure is recommended for carefully selected patients with cryptogenic stroke and transient ischemic attack (TIA). It has also been associated with significant improvement in the severity of refractory migraine headaches.

Objective

To report long-term outcome after PFO closure for patients with stroke, TIA, and refractory migraine.

Methods

This retrospective study represents a single-center experience including patients undergoing PFO transcatheter closure for stroke, TIA, or refractory migraine. Patients were followed at 1 and 6 months, one year, and then annually for at least 5 years after closure. After that, patients either attended annually or were followed by telephone interviews. Holter monitoring was done 1–3 months after closure, then selectively according to patient symptoms.

Results

We enrolled 480 patients undergoing PFO transcatheter closure between March 2001 and July 2020. 432 patients completed follow-up through August 2024. The follow-up duration ranged from (4–23) years. PFO closure was successful in all patients without complications. New onset atrial fibrillation (AF) occurred in 6 patients (1.39 %), typically later during follow-up (14.0 ± 4.1 years), all with cardiovascular risk factors. Cerebrovascular events recurred 0.31 events/100 person/years. Using the Log-rank test, event recurrence was more observed in patients >40 years in the presence of other cardiovascular risk factors and AF. Regarding Migraine, (82.4 %) of patients experienced complete resolution of symptoms, and (17.6 %) reported mild symptoms (Migraine Disability Assessment Questionnaire (MIDAS) grade I). The mean MIDAS score significantly improved; the mean before closure was 28.3 ± 7.23 and 0.83 ± 1.82 after closure (P = 0.001). The migraine persistence rate was 1.9 events per 100 person-years.

Conclusions

Percutaneous PFO closure is a safe and effective long-term intervention for preventing recurrent cerebrovascular events and significantly improves migraine symptoms.