Transcatheter closure of "Surgical" ostium secundum atrial septal defects with GORE® Cardioform ASD Occluder. Issue 10 (28th July 2022)

• Record Type: Journal Article
• Authors: Santoro, Giuseppe; Pizzuto, Alessandra; Cuman, Magdalena; Haxhiademi, Dorela; Marchese, Pietro; Franchi, Eliana; Marrone, Chiara; Pak, Vitali; Assanta, Nadia; Cantinotti, Massimiliano
• Is Part Of: Journal of cardiac surgery. Volume 37:Issue 10(2022)
• Page Start: 3200
• Page End: 3206
• Publication Date: 2022-07-28
• Subjects: atrial septal defect -- device -- interventional cardiac catheterization -- low‐weight child; Heart -- Surgery -- Periodicals; 617.412005
• DOI: 10.1111/jocs.16786
• Languages: English
• ISSNs: 0886-0440

Abstract

Abstract: Objective: To evaluate the GORE® 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.