Patent foramen ovale with complex anatomy: Comparison of two different devices (Amplatzer Septal Occluder device and Amplatzer PFO Occluder device 30/35).

BACKGROUND: Patent foramen ovale (PFO) closure after a cryptogenic cerebral ischemic event is a routinely procedure. The most used device is Amplatzer™ PFO Occluder 25 mm, but PFOs with complex anatomy require larger device for closure. We compared Amplatzer™ Septal Occluder (ASO) device versus Amplatzer™ PFO Occluder 30 or 35 mm (A-PFO 30/35) about the safety of procedure and the presence of residual shunt during the follow-up.

METHODS: From June 2002 to July 2016, 355 patients (pts) with PFO undergone closure at our institution. Among these ones, 70 pts (19.7%) had a PFO with complex anatomy and a single device with greater diameter was implanted. In these cases, the following devices were used: Gore® Septal Occluder (GSO) in 4 pts; ASO device in 33 pts (group I) and A-PFO 30/35 in 33 pts (group II). Patients treated with GSO device were excluded by our analysis.

RESULTS: Comparing group I and group II, there weren't complications during the procedures. Two patients of group II were lost at follow-up. At last follow-up, 1 pt of group I (3%) and 10 pts of group II (32.3%) had a residual shunt (p < 0.01). 7 of 10 pts of group II and the only 1 of group I with residual shunt underwent a complete closure by Amplatzer™ Vascular Plug (AVP) devices.

CONCLUSIONS: ASO devices and A-PFO 30/35 devices are both safe to close complex PFO; but A-PFO 30/35 is associated with a more incidence of residual shunt.