J Grohmann1, R Höhn, T Fleck, C Schmoor, B Stiller. 1. Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
Abstract
OBJECTIVES: Device closure of atrial septal defects (ASD II) is an alternative to surgery. ASD morphology and intracardiac relationships may influence device selection. Biocompatibility, techniques for closing large or multiple defects, and the risk of erosion are main issues in children BACKGROUND: The GORE® Septal Occluder (GSO) is a non-self-centering device with a flat and conformable nitinol-frame covered with expanded polytetrafluoroethylene. We hereby evaluate our initial experience in children to demonstrate feasibility, efficacy, and safety. METHODS: Single-center retrospective intention-to-treat analysis of GSO procedures in children and adolescents with hemodynamically significant ASD. All procedures were conducted under general anesthesia, fluoroscopy and transesophageal echocardiography. All defects were sized using stop-flow-technique. GSOs of 20-30 mm disc-diameter were implanted. RESULTS: GSO implantation was attempted in 45 with technical success in 41 patients, median age 6 (range 3-17) years, bodyweight 19 (12-95) kg. Median balloon-sized diameter was 13 (8-19) mm resulting in a GSO-to-ASD-ratio of 2 (1.7-2.5). Deficient retro-aortic rims (<3 mm) were found in 12 patients, and 10 of these 12 defects could be closed. We observed no complications. Four extensive or multiple ASDs were not treated successfully with GSO. After retrieval, one was closed with a different device; three patients needed surgical therapy. The median follow-up of four (range 0.2-22) months was uneventful in all patients CONCLUSIONS: We found the GSO device closure of ASDs in children to be effective. However, our initial experience is limited to short- and mid-term-follow-up of a low number of patients.
OBJECTIVES: Device closure of atrial septal defects (ASD II) is an alternative to surgery. ASD morphology and intracardiac relationships may influence device selection. Biocompatibility, techniques for closing large or multiple defects, and the risk of erosion are main issues in children BACKGROUND: The GORE® Septal Occluder (GSO) is a non-self-centering device with a flat and conformable nitinol-frame covered with expanded polytetrafluoroethylene. We hereby evaluate our initial experience in children to demonstrate feasibility, efficacy, and safety. METHODS: Single-center retrospective intention-to-treat analysis of GSO procedures in children and adolescents with hemodynamically significant ASD. All procedures were conducted under general anesthesia, fluoroscopy and transesophageal echocardiography. All defects were sized using stop-flow-technique. GSOs of 20-30 mm disc-diameter were implanted. RESULTS:GSO implantation was attempted in 45 with technical success in 41 patients, median age 6 (range 3-17) years, bodyweight 19 (12-95) kg. Median balloon-sized diameter was 13 (8-19) mm resulting in a GSO-to-ASD-ratio of 2 (1.7-2.5). Deficient retro-aortic rims (<3 mm) were found in 12 patients, and 10 of these 12 defects could be closed. We observed no complications. Four extensive or multiple ASDs were not treated successfully with GSO. After retrieval, one was closed with a different device; three patients needed surgical therapy. The median follow-up of four (range 0.2-22) months was uneventful in all patients CONCLUSIONS: We found the GSO device closure of ASDs in children to be effective. However, our initial experience is limited to short- and mid-term-follow-up of a low number of patients.