Safety and Efficacy of Patent Foramen Ovale Device Closure: Evaluation of Outcomes in a Tertiary Referral Center

Recent randomized controlled trials have demonstrated the benefit of patent foramen ovale (PFO) device closure over medical therapy alone for secondary prevention of cryptogenic stroke in carefully selected patients. In the current study, we sought to investigate the outcomes and complications of PFO device closure in our referral tertiary cardiovascular center.

In this retrospective study, 155 adult patients who underwent PFO device closure between 2006 and 2021 were included. Patient characteristics, recurrent neurologic events, and procedure-related complications were evaluated.

The follow-up period was 2.3 ± 1.2 years. The average age of the participants was 41.3 ± 10 years, and 59.4% were male. Six patients(3.9%) suffered recurrent cerebrovascular events in the follow‑up. No procedure‑related complications were reported in our study population. Two patients (1.3%) with recurrent stroke had developed newly diagnosed atrial fibrillation (AF).

PFO device closure is a safe and effective method for the prevention of recurrent ischemic stroke in patients with no other detectable etiology. Patients, particularly those with cardiovascular risk factors, should be meticulously investigated for the asymptomatic episodes of AF as the contributing factor with prolonged Holter monitoring or use of loop recorders.