title: Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure. Multicenter clinical experience.
abstract: OBJECTIVE
  The Ceraflex atrial septal defect occluder is an alternative device to the Amplatzer septal occluder with some structural innovations including flexible connection, increased flexibility, and minimized amount of implant material. We evaluated the efficiency and safety of the Ceraflex septal occluder device in percutaneous closure of secundum atrial septal defects.
  
  
  METHODS
  This was a prospective, nonrandomized, multicenter study of patients undergoing transcatheter closure for an atrial septal defect with the Ceraflex and the Amplatzer septal occluder devices. A clinical evaluation and follow-up transthoracic echocardiography were performed at 1, 6, and 12 months.
  
  
  RESULTS
  Between 2010 and 2014, 125 patients underwent atrial septal defect closure with the Ceraflex septal occluder (n = 58) and the Amplatzer septal occluder (n = 67) under transesophageal echocardiography guidance. Patient characteristics, the stretched size of the defect, device size, and fluoroscopy time were similar between the groups. The immediate and follow-up complete occlusion rates for both groups were 100%. There was no device embolization, procedure-related stroke, or pericardial effusion.
  
  
  CONCLUSIONS
  The Ceraflex septal occluder is a safe and efficient device for closure of secundum atrial septal defects with no procedural complications. The Ceraflex has similar outcomes when compared with the Amplatzer septal occluder device. The advantage of the Ceraflex septal occluder device is that it can be deployed without the tension of the delivery catheter.
authors: Department of Cardiology, Evliya Celebi Training and Research Hospital, Kutahya, Turkey, maliastarcioglu@hotmail.com.
authors: M A
authors: MA
authors: Astarcioglu
authors: M
authors: M
authors: Kalcik
authors: T
authors: T
authors: Sen
authors: A C
authors: AC
authors: Aykan
authors: T
authors: T
authors: Gokdeniz
authors: O M
authors: OM
authors: Gursoy
authors: S
authors: S
authors: Karakoyun
authors: S
authors: S
authors: Kulahcioglu
authors: S
authors: S
authors: Gunduz
authors: C
authors: C
authors: Kilit
authors: M
authors: M
authors: Oylumlu
authors: B
authors: B
authors: Amasyali
mesh_terms: D000328:Adult; D015984:Causality; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis* / Q000453:epidemiology / Q000601:surgery*; D006801:Humans; D015994:Incidence; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology* / Q000517:prevention & control; D012307:Risk Factors; D055989:Septal Occluder Device / Q000145:classification / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014421:Turkey / Q000453:epidemiology