title: Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety.
abstract: BACKGROUND
  The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6-month follow-up.
  
  
  METHODS
  All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included.
  
  
  RESULTS
  Implantation success was 100%. The in-hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow-up (n = 79), no major complications or reoccurrences of cerebral thrombo-embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%).
  
  
  CONCLUSIONS
  The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure.
authors.affiliation: Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands. b.van.den.branden@antoniusziekenhuis.nl
authors.forename: Ben J L
authors.initials: BJ
authors.lastname: Van Den Branden
authors.forename: Martijn C
authors.initials: MC
authors.lastname: Post
authors.forename: Herbert W M
authors.initials: HW
authors.lastname: Plokker
authors.forename: Jurriën M
authors.initials: JM
authors.lastname: Ten Berg
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Suttorp
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation*; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000628:therapy; D006344:Heart Septal Defects, Atrial / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D055989:Septal Occluder Device / Q000706:statistics & numerical data*; D016896:Treatment Outcome