Initial clinical results with the Amplatzer septal occluder - a self-centering double-disc device for the occlusion of atrial septal defects

In recent years many different systems for transcatheter closure of an atrial septal defect (ASD) have been developed and tested. However, all systems presently available have some special disadvantages. The recently introduced Amplatzer Septal Occluder (ASO), though, appears promising. It is a self-expanding and self-centering double disc made from a Nitinol mesh, which is tightly woven to give mechanical strength. Both discs are separated by a connecting cylindrical portion. Its diameter may be chosen, so that it corresponds to that of the ASD. Discs of polyester patches are sewn into the retention discs as well as into the cylindrical portion of the device in order to augment thrombogenicity. After measuring the diameter of the ASD with a balloon, an appropriate ASO is selected and advanced into the left atrium through a 7 or 8 French sheath. Then the distal disc and part of the connecting cylindrical portion is developed in the left atrium and pulled against the atrial septum, so that the cylindrical portion is occluding the ASD. Thereafter, proximal disc is deployed and the delivery cable disconnected. As long as the cable is connected to the device repositioning is easily achieved by pulling the device back into the sheath. Within a time period of 4 months in 29 out of 31 patients (median age: 12.1 years, median weight: 45.0 kg) complete closure of the ASD with a mean diameter of 11.0 mm (6-20 mm) was achieved without complications, the average fluoroscopy time being 8.3 min (2.9-21.5 min). Mean Qp:Qs was 1.5 (0.9-2.2). During a mean follow-up period of 2.1 months post implantation fixed seating of the ASO without residual shunt, arrhythmias, thrombembolic events and impairment of A-V valves was observed in all patients. Conclusion: The Amplatzer septal occluder allows quick, safe, and complete closure of atrial septal defects without complications if one adheres to strict implantation criteria. For a final judgement, however, long-term follow-up studies are necessary.