title: A multicentre, comparative study of Cera septal occluder versus AMPLATZER Septal Occluder in transcatheter closure of secundum atrial septal defects.
abstract: OBJECTIVE
  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).
  
  
  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.
authors.affiliation: Department of Cardiology, Erciyes University School of Medicine, Kayseri, Turkey.
authors.forename: Mehmet Gungor
authors.initials: MG
authors.lastname: Kaya
authors.forename: Mahmut
authors.initials: M
authors.lastname: Akpek
authors.forename: Ahmet
authors.initials: A
authors.lastname: Celebi
authors.forename: Turkay
authors.initials: T
authors.lastname: Saritas
authors.forename: Murat
authors.initials: M
authors.lastname: Meric
authors.forename: Korhan
authors.initials: K
authors.lastname: Soylu
authors.forename: Hekim
authors.initials: H
authors.lastname: Karapinar
authors.forename: Yat-Yi
authors.initials: YY
authors.lastname: Lam
mesh_terms: D000293:Adolescent; D000328:Adult; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D006801:Humans; D008297:Male; D055989:Septal Occluder Device / Q000706:statistics & numerical data*; D055815:Young Adult