Objective-To assess the efficacy and complications of device occlusion of a
trial septal defects in adults, using the Amplatzer septal occluder (ASO).
Design-A prospective interventional study.
Setting-Paediatric cardiology departments in two European teaching hospital
s.
Patients-The first 20 patients accepted for atrial septal defect device occ
lusion, on the basis of transoesophageal echocardiography. Sixteen patients
had larger defects with right heart dilatation, while the primary indicati
on for closure in four was a history of early paradoxical embolism.
Interventions-Transcatheter atrial septal defect occlusions performed under
transoesophageal echocardiography and fluoroscopic guidance between Decemb
er 1996 and June 1998.
Outcome measures-Success of deployment of ASO devices, procedure and fluoro
scopic times, complications, and symptoms.
Results-The ASO device was successfully implanted in all 20 patients (14 fe
male), median age 44.2 years, with no complications. Of the 16 patients wit
h right heart dilatation, the median Qp:Qs was 2.5:1. Defects measured 11-2
2 mm (median 18) on transoesophageal echocardiography, with balloon sized d
iameter (and device size) of 13-28 mm (median 20). For all 20 patients, the
procedure time ranged from 38-78 minutes (median 61), and fluoroscopy 8.4-
24.7 minutes (median 15.2). There were residual shunts in three patients at
the end of the procedure, which were trivial (less than or equal to 1 mm)
as assessed by transoesophageal echocardiography, and persisted for more th
an six months in only one patient. Follow up ranged from 0.1-1.5 years (med
ian 0.7). There have been no late complications.
Conclusions-The ASO device can be used successfully to close selected oval
fossa defects in adults, with minimal procedural morbidity and excellent ea
rly results.