Closure of atrial septal defects with the amplatzer occlusion device: Preliminary results

Objectives. This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device. Background. None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance, Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer's size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released. Results. The mean ASD diameter by transesophageal echocardiography mas 14.1 +/- 2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8 +/- 2.4 mm), The mean device diameter was 16.6 +/- 2.3 mm. No complications were observed. after deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up. Conclusions. The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow up period are required before this technique can be widely used. (C)1998 by the American College of Cardiology.