Paediatric Cardiology, University Hospitals Leuven, Leuven, Belgium.
Catheter Cardiovasc Interv. 2010 Jan 1;75(1):60-5. doi: 10.1002/ccd.22275.
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.
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.
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.
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.
大多数可用于经皮关闭 Fontan 窗的装置往往体积庞大。本研究旨在评估一种低剖面定制装置，并评估其疗效和安全性。
以 15mm 的 PFO 星为基础。进行了以下修改：去除左盘以减少左心房的血栓形成，将 LA 腿的长度从 2×15mm 增加到 3×20mm，以防止移位，并在左伞和右伞之间增加一个枢轴。通过从近端盘上移除两个相对的象限来制作部分封堵器。
在 93%（63/68）的患者中可以进行装置部署。在 5 名患者中，无法部署该装置，因此使用了替代装置。在 45 名患者中，完全关闭了窗孔，饱和度从 84%±4%增加到 95%±2%（P<0.001）。在 18 名 Fontan 循环情况不理想的高危患者中，使用改良装置进行部分封堵：饱和度从 79%±7%增加到 90%±4%（P<0.001）；大多数患者在几个月内仍存在残余分流。在随访期间没有记录到血栓形成事件。
改良的 PFO 星装置可安全地用于 Fontan 患者，以闭塞或限制窗孔的血流。它具有低剖面、最小的异物、非阻塞性和最小的血栓形成性。
