Transcatheter closure of "Surgical" ostium secundum atrial septal defects with GORE® Cardioform ASD Occluder

Objective To evaluate the GORE (R) Cardioform ASD Occluder (GCA)(WL Gore & Associates) device for closure of ostium secundum atrial septal defects (ASDs) with predicted indication for surgical correction. Background Closure of large ASD in small children by transcatheter approach is still challenging. This study evaluated the results of GCA in this subset of patients in a tertiary referral center. Methods Between January 2020 and March 2022, 97 children underwent transcatheter ASD closure at our Institution. Of them, 38 had a large defect (diameter/weight > 1.2 or diameter/body surface area > 20 mm/m(2)), predicted suitable for surgery and underwent closure with GCA. Procedure results and midterm outcome are reported. Results Patients' age and weight were 5.5 +/- 1.5 years and 19.7 +/- 4.7 kg, respectively. Absolute and relative ASD size was 21.5 +/- 3.6 mm, 1.1 +/- 0.2 mm/kg, and 27.7 +/- 4.6 mm/m(2), respectively, resulting in QP/QS of 2.0 +/- 0.8. Three patients were sent to surgery after balloon sizing. Four of the remaining 35 patients who underwent device deployment, needed rescue or elective surgery due to device embolization (n = 1), device instability (n = 2) or new-onset tricuspid valve regurgitation (n = 1). Procedure feasibility was 88.6%. Major complications were recorded in two patients (5.7%). Minor complications were recorded in five patients (14.3%). Complete closure at discharge was 90.3% (28/31 pts) rising to 100% at the last follow-up evaluation. Wireframe fracture rate at the 6 months examination was 52%, without clinical and instrumental consequences. Conclusions Percutaneous treatment with GCA device is effective and safe in a high percentage of ASD children with predicted indications for surgical correction.