Objective The aim of this study was to evaluate the safety and efficacy of the GORE® Septal Occluder (GSO) at 1-, 6-, and 12-month follow-up in patients with a clinical indication for patent foramen ovale (PFO) closure. Background Limited data are available regarding the safety and efficacy of the GSO for PFO closure. Methods Sixty consecutive patients with an embolic event, migraine, or risk of decompression sickness were enrolled. Transesophageal or transthoracic echocardiography and clinical follow-up were performed at 1, 6 and 12 months after implantation. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Results Procedures were technically successful in 98.3% (59/60). In one case, the anterior interatrial septal rim proved too short to allow safe GSO implantation and, instead, a different occluder was implanted. One patient developed transient neurological symptoms during the procedure without evidence for a stroke by magnetic resonance imaging. At 6-month follow-up, the closure rate was 86.6% (52/60). The complete closure rate after 1 year was 93.3% (56/60). Stroke, thrombus formation and atrial fibrillation (AF)/flutter occurred in 1 (1.7%), 1 (1.7%), and 5 (8.3%) patients, respectively. Conclusion PFO closure with the GSO is accompanied by a high technical success rate and closure rates similar to other currently used devices. The incidence of AF was higher than reported with most other devices. This may be a chance finding but warrants further investigation in larger trials.
- congenital heart disease in adults (CHDA)
- embolization (EMBO)
- patent foramen ovale/atrial septal defect (PFO)