Percutaneous management of a Fontan fenestration: in search for the ideal restriction-occlusion device.

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. Patients and 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. © 2009 Wiley-Liss, Inc.