CLOSURE OF ATRIAL SEPTAL-DEFECTS WITH THE AMPLATZER OCCLUSION DEVICE - PRELIMINARY-RESULTS

Objectives. This study reports our clinical experience with transcathe ter closure of secundum atrial septal defects (ASDs) in children, usin g the Amplatzer, a new occlusion device. Background. None of the devic es previously used for transcatheter closure of interatrial communicat ions has gained wide acceptance, Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that co nsists of two round disks made of Nitinol wire mesh and linked togethe r by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac c atheterization criteria for transcatheter closure. The Amplatzer's siz e 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 an d deployed under fluoroscopic and ultrasound guidance. Once its positi on was optimal, it was released. Results. The mean ASD diameter by tra nsesophageal echocardiography mas 14.1 +/- 2.3 mm and was significantl y 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 complicatio ns were observed. after deployment of the prosthesis, there was no res idual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disapp eared in two of them at the 3-month follow-up. Conclusions. The Amplat zer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patien ts and a longer follow up period are required before this technique ca n be widely used. (C)1998 by the American College of Cardiology.