Abstract
OBJECTIVES: To report procedural outcome and short-term follow-up data for the Gore septal occluder (GSO), a new device for closure of patent foramen ovale (PFO). BACKGROUND: Transcatheter closure of PFO is an established treatment modality but no current device provides a perfect solution. The GSO has a number of design features, which make it potentially attractive for closure of defects in the atrial septum. METHODS: Data from 9 centers in the United Kingdom implanting the GSO device, submitted to an electronic registry for evaluation. RESULTS: Two hundred twenty-nine patients undergoing PFO closure from June 2011 to October 2012 were included. Indications for closure were secondary prevention of paradoxical cerebral emboli (83.4%), migraine (2.1%), platypnoea orthodeoxia (3.9%), and other (10.5%). Median PFO size was 8 mm and 34 and 39%, respectively, had long tunnel anatomy or atrial septal aneurysms. A GSO was successfully implanted in all cases. A single device was used in 98% but in 4 patients the initial device was removed and a second device required. Procedural complications occurred in 3% and later complications (e.g., atrial fibrillation, atrial ectopics, and device thrombus) in 5.7% of cases. All patients have undergone clinical and echocardiographic follow-up and all devices remain in position. Early bubble studies (median 0 months) with Valsalva maneuver in 67.2% were negative in 89%. CONCLUSIONS: The GSO is an effective occlusion device for closure of PFO of all types. Longer-term follow-up particularly to document later closure rates are required.