Comparison of contemporary devices used for transcatheter patent foramen ovale closure.

Background: Transcatheter patent foramen ovale (PFO) closure can be performed with various devices. However, their handling, safety, presence of residual shunt and impact on recurrent thromboembolic events (TEs) are rarely compared with one another. Our goal was to compare the clinical performance of contemporary devices designed for PFO closure.

Methods: PFO closure with the Cardia PFO occluder (n = 405), Intrasept (n = 301) and Amplatzer PFO occluder (n = 89) was attempted in 795 patients with presumed paradoxical embolism.

Results: The procedure was successful in all patients. The periprocedural complication rate of 1.8% was comparable among the three groups. Residual shunting immediately following the procedure was higher in patients treated with the Cardia PFO occluder (24% vs. 14% [Intrasept] and 16% [Amplatzer]; p = 0.004). After a mean follow-up period of 26 months, no difference in residual shunting was seen (8% [Cardia] vs. 7% [Intrasept] vs. 8% [Amplatzer]; p = 0.736). The annual incidence of recurrent TE was 1.4%, which was not affected by the presence of a residual shunt or the type of device used. New-onset atrial fibrillation (AF) following PFO closure was the only predictor of recurrent TE and was more common in patients treated with the Amplatzer (10% vs. 5% [Cardia]) and 5% [Intrasept]; p = 0.057).

Conclusions: The clinical performance of the three PFO occluders evaluated in this study seems comparable. Device design does not seem to impact the success of the PFO closure procedure. AF was the only predictor of recurrent TEs, underscoring the importance of aggressive therapy for atrial arrhythmias early following PFO closure.