title: Early single clinical experience with the new Figulla ASD Occluder for transcatheter closure of atrial septal defect in adults.
abstract: BACKGROUND
  Recently, the Occlutech Figulla ASD Occluder (FSO) has been introduced for transcatheter closure of atrial septal defects. This device can be used for transcatheter closure of small as well as large atrial septal defects.
  
  
  OBJECTIVE
  To evaluate the feasibility and short-term results of transcatheter closure of secundum type atrial septal defects using the FSO device in adult patients.
  
  
  METHODS
  Seventy-four consecutive adult patients were referred for transcatheter closure of secundum large atrial septal defects ("stretched" diameter>20mm and/or invasive pulmonary/systemic flow [Qp/Qs] ratio>1.5) using the FSO device.
  
  
  RESULTS
  The FSO device was successfully implanted in 68 patients (mean±SD [range] age: 31.8±12.3 [17-64] years; weight: 71.5±18.4 [49-98]kg). All patients had right atrial and ventricular volume overload with a mean Qp/Qs ratio of 2.5±0.6 (range 1.5-3.8). Mean atrial septal defect diameter was 22.3±4.8 (range 12-33)mm and the size of the implanted FSO was 24.1±4.9 (range 12-36)mm. Two patients had trivial (jet width<1mm in diameter) residual shunts and one patient had a small (1-2mm) residual shunt. There were no moderate or severe residual shunts. No device embolization or other serious complication occurred during either the procedure or the follow-up.
  
  
  CONCLUSIONS
  The present study found that transcatheter closure of isolated secundum atrial septal defects using the novel design of the FSO device was safe, effective, and had an excellent outcome during the 6month follow-up period.
authors.affiliation: Faculty of Medicine, Inonu University, Malatya, Turkey. mcansel34@hotmail.com
authors.forename: Mehmet
authors.initials: M
authors.lastname: Cansel
authors.forename: Hasan
authors.initials: H
authors.lastname: Pekdemir
authors.forename: Julide
authors.initials: J
authors.lastname: Yağmur
authors.forename: Hakan
authors.initials: H
authors.lastname: Tasolar
authors.forename: Necip
authors.initials: N
authors.lastname: Ermis
authors.forename: Ertugrul
authors.initials: E
authors.lastname: Kurtoglu
authors.forename: Nusret
authors.initials: N
authors.lastname: Acıkgoz
authors.forename: Halil
authors.initials: H
authors.lastname: Atas
authors.forename: Ramazan
authors.initials: R
authors.lastname: Ozdemir
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey; D055815:Young Adult