Device Closure of Patent Foramen Ovale with the St Jude’s Premere Device
The technique of transcatheter patent foramen ovale (PFO) closure, using double occluder type devices, has been well described in the literature,1-5 and in earlier chapters in this book. While the implantation of such a device is generally quite safe, there have been a number of late, device-related complications which continue to cause concern, including device thrombosis,6
atrial arrhythmia,7 device erosion,8-11 and anatomic/ device distortion with residual shunting in a patient with a long, non-compliant PFO tunnel.12,13 The St Jude’s Premere PFO Closure system, a modified double occluder, was designed to minimize these specific risks. Early clinical results are available.14,15
The St Jude’s Premere PFO Closure system (Figure 27.1), like its counterparts, is a self-expanding, dualanchor, occlusion device.The right and left atrial anchors are constructed of Nitinol, with only the right anchor entirely enveloped by a knitted polyester fabric. A flexible polyester braided tether, running through the center of the device, allows the anchors to be locked together after delivery. The final distance separating the two anchors is adjustable.A snare-type release mechanism, as well as the braided tether, allows for device retrieval at any point of the implantation procedure. The device is designed specifically for PFO closure. It is not indicated for atrial septal defects (ASDs), or a multiply fenestrated atrial septum.