Closure of atrial septal defects with the Amplatzer occlusion device: preliminary results

J Am Coll Cardiol. 1998 Apr;31(5):1110-6. doi: 10.1016/s0735-1097(98)00039-4.


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 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.

MeSH terms

  • Adolescent
  • Cardiac Catheterization
  • Child
  • Child, Preschool
  • Echocardiography, Doppler, Color
  • Heart Septal Defects, Atrial / diagnostic imaging
  • Heart Septal Defects, Atrial / surgery*
  • Humans
  • Prostheses and Implants*
  • Prosthesis Design
  • Prosthesis Implantation / methods
  • Treatment Outcome