Closure of atrial septal defects with the Amplatzer occlusion device: preliminary results.
OBJECTIVE
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 was 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.
Thanopoulos
B D
BD
Department of Pediatric Cardiology, Aghia Sophia Children's Hospital, Athens, Greece.
Laskari
C V
CV
Tsaousis
G S
GS
Zarayelyan
A
A
Vekiou
A
A
Papadopoulos
G S
GS
D000293:Adolescent; D006328:Cardiac Catheterization; D002648:Child; D002675:Child, Preschool; D018618:Echocardiography, Doppler, Color; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D016896:Treatment Outcome