title: Percutaneous management of a Fontan fenestration: in search for the ideal restriction-occlusion device.
abstract: OBJECTIVE
  Most devices devices available for percutaneous closure of Fontan fenestrations tend to be bulky. The aim of this study was to evaluate a low profile custom made device and assess its efficacy and safety.
  
  
  METHODS
  A 15 mm PFO star was used as the basis. The following modifications were made: removal of the left disc to reduce thrombogenicity in the left atrium, increase the length of the LA legs from 2 by 15 mm to 3 by 20 mm to prevent dislodgement and later adding a pivot between the left and right umbrella. A partial occluder was made by removing two opposite quadrants from the proximal disk.
  
  
  RESULTS
  Device deployment was possible in 93% (63 of 68) patients. In five patients, the device could not be deployed and an alternative device was used. In 45 patients complete closure of the fenestration was obtained and saturations increased from 84% +/- 4% to 95% +/- 2% (P < 001). In 18 high risk patients with suboptimal Fontan circulation, a modified device was used to effect partial occlusion: saturations increased from 79% +/- 7% to 90% +/- 4% (P < 0.001); a residual shunt persisted in most patients for several months. No thrombotic events were recorded during follow-up.
  
  
  CONCLUSIONS
  The modified PFO star device can safely be deployed in Fontan patients to occlude or restrict flow through a fenestration. It has a low profile with minimal foreign material, is non-obstructive and minimally thrombogenic.
authors: Paediatric Cardiology, University Hospitals Leuven, Leuven, Belgium.
authors: Derize E
authors: DE
authors: Boshoff
authors: Stephen C
authors: SC
authors: Brown
authors: Joseph
authors: J
authors: Degiovanni
authors: Oliver
authors: O
authors: Stumper
authors: John
authors: J
authors: Wright
authors: Luc
authors: L
authors: Mertens
authors: Marc
authors: M
authors: Gewillig
mesh_terms: D001530:Belgium; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D003326:Coronary Circulation; D004739:England; D018729:Fontan Procedure; D006330:Heart Defects, Congenital / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008422:Materials Testing; D011474:Prosthesis Design; D011652:Pulmonary Circulation; D011859:Radiography; D055989:Septal Occluder Device; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome