Long-term follow-up outcomes in a real-world study cohort after percutaneous patent foramen ovale closure

OBJECTIVE
In recent years, percutaneous closure of a patent foramen ovale (PFO) has gained widespread use. This study is an evaluation of the safety and efficacy of the Figulla and Amplatzer devices for PFO closure, including long-term follow-up results.


METHODS
A total of 305 patients (43.6% male; mean age: 43.25±10.98 years) who underwent percutaneous PFO closure between 2003 and 2019 were enrolled. The Risk of Paradoxical Embolism (RoPE) score was calculated to predict the recurrence risk of cerebrovascular events due to PFO. Transthoracic echocardiography was used during the procedure.


RESULTS
The devices were successfully implanted in all patients. The in-hospital periprocedural complications recorded were atrial fibrillation in 1 patient (0.3%), supraventricular tachycardia in 1 patient (0.3%), and femoral hematoma in 3 patients (1%). The procedure time and fluoroscopy time was 21.92±2.93 minutes and 2.19±0.24 minutes, respectively. Recurrent ischemic stroke or transient ischemic attack (TIA) was observed in 7 (2.2%) patients during the median 85.77 months (25th-75th percentile: 10.21–108.00 months) follow-up. The RoPE score was significantly lower in patients with recurrent ischemic cerebral event (stroke or TIA) compared with asymptomatic patients (p<0.001). Kaplan-Meier curve analysis revealed that there was no significant difference between PFO device types (Amplatzer: 2.4% vs. Figulla: 3.3%) in terms of recurrent ischemic cerebral events during follow-up (log-rank; p=0.642).


CONCLUSION
Percutaneous PFO closure was safe, feasible, and effective. Our study confirmed the efficacy and safety of transthoracic echocardiogram guidance during percutaneous closure of PFO, which shortens the procedure time. A lower RoPE score was related to the recurrence risk of ischemic cerebrovascular events.