Medium-term results of transcatheter closure of patent foramen ovale (PFO) with Amplatzer PFO and Cribriform occluders

Abstract

Background: The use of an Amplatzer Cribriform Septal Occluder (ACSO) for percutaneous patent foramen ovale (PFO) closure (especially in cases with atrial septal aneurysm) has been recently described as superior compared to that of an Amplatzer PFO Occluder (APFO).

Aim: To assess immediate and medium-term clinical outcomes of patients with PFO with paradoxical embolism event (EE) who underwent transcatheter PFO closure with an APFO or an ACSO.

Methods: Overall, 56 consecutive patients underwent percutaneous closure of PFO with an APFO device; the results were compared to those in seven patients treated with ACSO. Deaths due to embolism, stroke or transient ischaemic attack (TIA) were considered recurrent EE. Pre- and 6 month post-intervention right to left shunting (RLS) were evaluated with intravenous contrast injection by transcranial Doppler examination of the middle cerebral artery during Valsalva manoeuvre.

Results: The procedure was successfully completed in all patients in both groups. No procedure-related complications were observed during hospitalisation. Residual RLS was noted at six months in 14/56 (25%) patients in the APFO group and 4/7 (57%) patients in the ACSO group (p <0.05). Recurrent TIA was observed in three patients in the APFO group (one of them had small residual shunt immediately after procedure and at six-month follow-up). Another patient from that group experienced stroke one month after the procedure. No recurrence of EE was recorded in the ACSO group.

Conclusions: Transcatheter PFO closure with both Amplatzer devices is a minimally invasive procedure with high success and low complication rates. Taking in consideration residual RLS in the medium-term period, the application of a Cribriform device is not superior to that of an Amplatzer PFO device. Results of randomised trials are necessary to confirm the effectiveness of transcatheter therapy in patients with PFO and a paradoxical thromboembolic event.