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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.

Original publication

DOI

10.1002/ccd.25063

Type

Journal article

Journal

Catheter Cardiovasc Interv

Publication Date

15/02/2014

Volume

83

Pages

467 - 473

Keywords

cerebrovascular accident, congenital heart, disease in adults, patent foramen ovale/atrial septal defect, Adolescent, Adult, Aged, Cardiac Catheterization, Echocardiography, Transesophageal, Foramen Ovale, Patent, Humans, Male, Middle Aged, Prosthesis Design, Registries, Retrospective Studies, Septal Occluder Device, Time Factors, Treatment Outcome, United Kingdom, Young Adult