Early clinical experience with use of the ‘Amplatzer Septal Occluder’ device for atrial septal defect

Abstract

Device closure of oval fossa atrial septal defects with the Amplatzer Septal Occluder was performed in 26 patients ranging in age from 0.89 to 60.44 years. In eight additional patients no device implant was performed because of the presence of multiple defects or because the defect was of a size unsuitable for closure with the devices currently available. The stretched diameter of the defects that were closed ranged from 4 to 23 mm (mean 14+/-5.4 mm) and device sizes ranged from 4 to 24 mm. Two devices were unstable, of which one embolized to the right atrium after release. Both devices were retrieved at the same procedure. One of these patients subsequently underwent a successful device closure of his defect using a larger (24-mm) device. Three patients had multiple defects, which were successfully closed with a single device. At 1-month follow-up 23/26 (88%) and at 3-month follow-up 22/24 (92%) patients had complete closure of their defects, while two had residual shunts. One further patient who had complete closure of his defect at 1-month post-implant had his device removed and his atrial septal defect patched surgically 8 weeks after device closure. This was done as a result of the development of a vegetation affecting the device after an episode of septicaemia, which was not related to the cardiac problems. There was no procedure-related morbidity or mortality and all patients remain well at the present time.

Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal Occluder. A Japanese Clinical Trial.

“…Although there are some concerns about the large profile of the device obtained immediately after deployment, it is reported that the thickness of the device significantly decreases after 6 months. 28 One complication observed in our study was a transient second-degree AVB and 8 other studies have reported 10 complications (3.1%) out of 325 procedures: [20][21][22][23][24][25][26][27] 5 in 3 cases the devices were taken out by catheter. Even though serious complications are less frequent with the ASO than with other devices, precise and careful manipulation and sufficient anticoagulation during the procedure are necessary, especially to avoid device displacement and embolism by air or thrombus.…”

“…Moreover, the membrane inside the disks and waist facilitates thrombosis and occlusion. These features result in a high rate of closure success: 94.1% in our study and 91.7-98.7% in others, [20][21][22][23][24][25][26][27] despite the high rate of residual shunt immediately after implantation. The residual shunt is observed mainly through the connecting waist and between 2 disks, but disappears with thrombus formation on membranes inside the device.…”

Transcatheter closure of double atrial septal defects with a single Amplatzer device

“…In contrast to other patch-type prostheses, closure of the defect is accomplished by stenting the communication by the 4 mm long waist containing polyester material that induces thrombosis. The immediate and short-term occlusion rate was exceedingly high [13,14,17], surpassing all other devices. Double atrial septal defects could safely be closed with a single Amplatzer septal occluder in the majority of our patients.…”

Improvement in Exercise Capacity in Asymptomatic and Mildly Symptomatic Adults After Atrial Septal Defect Percutaneous Closure

“…A minimum margin of 5 mm between these structures and the ASD had to be present for the procedure to be initiated. 9 The pulmonary artery, RV, and right and left atrial pressures were obtained with standard fluid-filled catheters. With oxygen uptake measured at rest, the Qp:Qs flow ratio was calculated by oxymetry using the Fick principle.…”