Abstract 16587: Safety and Efficacy of the Solysafe Septal Occluder Compared to Amplatzer PFO Occluder 25mm for Percutaneous Closure of Patent Foramen Ovale — First Clinical Experience.
Introduction: The Solysafe® Septal Occluder (SSO) is a novel device for percutaneous closure of interatrial communications. Its self-centering characteristics make it attractive for closure of large patent foramen ovales (PFOs) and PFOs with atrial septal aneurysms (ASA). The goal of this study was to compare efficacy and safety of the SSO device with the Amplatzer 25 mm PFO occluder (Amp25) for closure of PFOs with and without ASAs.
Methods: Patients (pts) undergoing percutaneous PFO closure with an Amp25 or SSO device were enrolled in a prospective registry. All patients had a transesophageal echocardiography (TEE) with saline contrast injection at baseline and at 6 months follow up. A large interatrial right to left shunt was defined as passage of >20 bubbles. Residual shunts at follow up, periprocedural complications and complications during follow up were compared between the 2 devices.
Results: From 2002 to 2009 197 pts underwent percutaneous PFO occlusion. For most pts the indication was paradoxical embolism (97%). In 177 pts the Amp25 and in 20 pts the SSO device was used. Both, the presence of an ASA (Amp25: 51% vs. SSO: 55% p=ns) and the presence of a large shunt at baseline (Amp25: 32% vs. SSO: 40%, p=ns) was similar between the two device groups. Procedural success was achieved in all cases. However, one procedure in the Amp25 group was complicated by device embolization. Percutaneous retrieval was successful and the PFO could be closed with a larger device during the same procedure. In 2 pts of the SSO group, self-limiting pulmonary bleeding occurred due to guide-wire perforation of lung veins. During follow-up 2 pts in the SSO group developed a thrombus on the device, complicated by a major stroke in one of these patients. In the Amp25 group one patient had a TIA 2 months after device closure. At six months follow up rates of any residual shunt (Amp25: 11% vs. SSO: 15%, p =ns) and large residual shunts (Amp25: 2% vs. SSO: 5%, p =ns) were not significantly different.
Conclusions: Compared to the Amplatzer® PFO 25 occluder, the Solysafe® Septal Occluder showed similar effectiveness of complete PFO occlusion at 6 months. In this series, there was however a high rate of periprocedural lung vein perforation and thrombus formation during follow up which may be of concern.
- © 2010 by American Heart Association, Inc.