title: Figulla ASD occluder versus Amplatzer Septal Occluder: a comparative study on validation of a novel device for percutaneous closure of atrial septal defects.
abstract: OBJECTIVE
  Occlutech Figulla ASD Occluder (FSO) is an alternative device to Amplatzer Septal Occluder (ASO) with some structural innovations including increased flexibility, minimizing the amount of material implanted, and absence of the left atrial clamp. We aimed to report our experiences with FSO and compare the outcomes of this novel device versus ASO.
  
  
  METHODS
  Between December 2005 and February 2009, 75 patients diagnosed with secundum atrial septal defects underwent transcatheter closure. The FSO device was used in 33 patients, and the ASO was used in 42.
  
  
  RESULTS
  Patient characteristics, stretch size of the defect, device left disc size, procedure, and fluoroscopy time were similar between the groups. However, the difference between device waist size and stretched diameter of the defect was significantly higher, and device delivery sheath was significantly larger in FSO group and device left disc size was significantly lower in the FSO group. In all subjects, the residual shunt was small to trivial during follow-up and the reduction in prevalence of residual shunt with time was similar in both groups (P = 0.68). We found no differences in complication rate between the two devices; however, device embolization to the pulmonary bifurcation in one patient was recorded as major complication in FSO device group.
  
  
  CONCLUSIONS
  Both devices are clinically safe and effective in ASD closure. FSO device has similar outcomes when compared to ASO device. Difficulties in selecting the correct device size in larger defects and larger venous sheath requirement need to be evaluated in further studies.
authors.affiliation: From the Clinic of Pediatric Cardiology, Turkiye Yuksek Ihtisas Education and Research Hospital, Ankara, Turkey. aysepac@gmail.com
authors.forename: Aysenur
authors.initials: A
authors.lastname: Pac
authors.forename: Tugcin Bora
authors.initials: TB
authors.lastname: Polat
authors.forename: Ilker
authors.initials: I
authors.lastname: Cetin
authors.forename: Mehmet Burhan
authors.initials: MB
authors.lastname: Oflaz
authors.forename: Sevket
authors.initials: S
authors.lastname: Balli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002404:Catheterization / Q000295:instrumentation* / Q000379:methods; D002648:Child; D002675:Child, Preschool; D017023:Coronary Angiography; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D055989:Septal Occluder Device; D016896:Treatment Outcome; D055815:Young Adult