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. Copyright 2009 Wiley-Liss, Inc.
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. Copyright 2009 Wiley-Liss, Inc.
Authors: Ganesh K Gnanappa; David S Celermajer; Gary F Sholler; Tom Gentles; David Winlaw; Yves d'Udekem; Julian Ayer Journal: Pediatr Cardiol Date: 2016-10-27 Impact factor: 1.655
Authors: Christopher E Greenleaf; Zhia Ning Lim; Wen Li; Damien J LaPar; Jorge D Salazar; Antonio F Corno Journal: Front Pediatr Date: 2022-10-04 Impact factor: 3.569