The Gore Septal Occluder (GSO) for Multiple Indications in Children – An Intention to Treat Analysis

Abstract

To assess the safety and efficacy of all uses of the Gore septal occluder (GSO) (WL Gore and Associates, Flagstaff, AZ, USA) in a tertiary children's hospital. The GSO is widely used in atrial septal communication closure in the adult population. Usage in the paediatric population is expanding. Device design potentially confers some benefits in this population. Single centre retrospective data review over 6 years to July 2019 in a tertiary paediatric cardiac centre. All instances of intended GSO use were identified. Outcome measures were closure rates and procedural complications. Fifty-four (54) patients with median age 7.9 years (3-17 years) and weight 26.5 kg (12.6-76 kg) underwent attempted GSO implantation. Indications were atrial septal defect (ASD) with volume loading (39); abolition of right to left shunt (8); stroke prevention (3) and Fontan fenestration (4). Successful GSO deployment in 46/50 (92%) of the ASD/PFO group and 100% of the Fontan group. Occlusion rate was assessed at 24 hours and at medians of 1.4 months (IQR 1.1 mo), 9 months (IQR 8.3 mo) and 25.4 months (IQR 28.1 mo). Complete occlusion documented at these points was 91%, 87%, 93% and 98% respectively. Major complications prevented GSO implantation in four patients. Two (2) patients had transient rhythm disorder. There was no incidence of erosion, further arrhythmia, venous access complications or death during follow-up. The GSO can be safely deployed in both the atrial septum and Fontan fenestration with a low rate of complications. Trivial residual shunt is present in a number of cases early after deployment, although improves with time. Delivery sheath size was not a cause of significant complications in this patient cohort.