A multicentre, comparative study of Cera septal occluder versus AMPLATZER Septal Occluder in transcatheter closure of secundum atrial septal defects

Abstract

Aims: To evaluate the safety and efficacy of the new Cera septal occluder (CSO) for atrial septal defect (ASD) closure as compared to the AMPLATZER Septal Occluder (ASO). Methods and results: A total of 405 ASD patients receiving CSO or ASO were studied. The ASDs were classified into simple defects (isolated defects <26 mm) or complex defects (isolated defects >26 mm, large defects with a deficient rim, double or multi-fenestrated defects). Clinical and echocardiographic findings were collected before discharge, at one month, and every six months after implantation. Two hundred and five (133 females, aged 30 +/- 13 years) and 200 (135 females, aged 28 +/- 14 years) patients received CSO and ASO implants, respectively. The CSO group had similar ASD and device sizes, prevalence of complex lesions, procedural times and success rates as compared to the ASO group. Echocardiographic follow-up at one and six months showed similar residual shunts between devices. Both groups had similar rates for device embolisation and atrial arrhythmia. The average equipment cost per patient was lower in the CSO group than in the ASO group (US$3,500 vs. US$5,600, p<0.001). Conclusions: Transcatheter ASD closure with CSO is safe and effective. It appears to be an attractive alternative to ASO because of its relatively low cost.