CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, vol.82, no.1, pp.116-121, 2013 (SCI-Expanded)
Aim: We sought to investigate the safety and efficacy of Cardio-O-Fix septal occluder
(CSO) in percutaneous closure of atrial septal defects (ASD) as compared to the Amplatzer
septal occluder (ASO). Methods: A consecutive of 351 patients received transcatheter
ASD closure with CSO or ASO from July 2004 to October 2010 were studied. The ASDs
were divided into simple- (isolated defects
<26 mm) or complex-types (isolated defect 26
mm, double or multifenestrated defects). The procedures were guided by fluoroscopy and
transthoracic or transesophageal echocardiography. Clinical and echocardiographic follow-
ups were arranged before discharge, at 1 month and then every 6-month after implantation.
Results: During the study period, 185 (125 males, aged 18.5
6 15.6 years) and 166
(103 males, aged 21.0
6 15.7 years) patients attempted CSO and ASO implants, respectively.
The CSO group had similar ASD and device sizes, prevalence of complex lesions (17
vs. 16%,
P 5 0.796), procedural times and success rates (97% vs. 96%, P 5 0.635) as compared
to the ASO group. Acute residual shunts were less prevalent in CSO than ASO group
and most shunts closed spontaneously at 6-month follow-ups. The average equipment
cost per patient was lower in CSO group (US$ 4,100 vs. US$ 5,900,
P < 0.001). The prevalence
of device embolization and atrial arrhythmia (all
<2%) were similar in both patient
groups. Conclusion: Transcatheter ASD occlusion with CSO is safe and effective and it
appeared to be an attractive alternative to ASO in closing simple-type ASD because of its
relatively low cost.