Department of Cardiology, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, United Kingdom.
Catheter Cardiovasc Interv. 2013 Mar;81(4):660-5. doi: 10.1002/ccd.24405. Epub 2012 Aug 1.
A number of devices are available for percutaneous closure of a clinically significant patent foramen ovale (PFO). The new GORE(®) septal occluder (GSO) is a nonself-centering device consisting of an expanded polytetrafluoroethylene tube supported by a frame of nitinol wire conforming into a double disk. This study reports the first clinical GSO implantation experience.
GSO implantation in 20 consecutive patients is reported. Inclusion criteria were all patients referred with a significant PFO implicated in paradoxical embolism or transient right to left shunting causing desaturation. Procedures were performed under local anaesthesia and intracardiac echocardiography (ICE) in addition to fluoroscopy. Procedural data, acute and early closure rates were examined.
All patients underwent successful day-case device implantation. Eleven patients had previous stroke, five had transient ischemic attacks, two had a history suspicious of PFO-related desaturation, and two had a history suspicious of PFO-related peripheral thromboembolism. Acute closure rates on IVC injection bubble testing were 100% at implant and 100% (14/14) at 1 month. Average PFO balloon size was 8.0 ± 3.6(range 2.0-16.7) mm, mean fluoroscopic implantation time 3.0 ± 1.7(range 0.7-6.3) min, radiation dose 283 ± 340 (range 6-1,431) μGym(2), and total procedural time 34.8 ± 8.0 (range 22-53) min. 5 × 20 mm(2), 7 × 25 m(2), 8 × 30 mm(2) GSO devices were implanted, aiming for device size at least twice balloon PFO size. Cases included aneurysmal septums with up to 30 mm deviation and tunnels up to 12 mm long. Removal and repositioning of two devices was performed on two occasions after uncertainty about device locking. At 1 month follow-up, two patients had brief self-terminating episodes of suspected atrial fibrillation, all had normal resting ECGs. No thromboembolic/neurological events were reported.
The GSO can be implanted under local anaesthesia and ICE with low procedural and fluoroscopy times with high procedural success as a day case. No residual shunts were seen. This initial experience suggests that it is a safe and effective device for PFO closure.
目前有多种设备可用于经皮闭合临床上有意义的卵圆孔未闭（PFO）。新型戈尔（GORE）分隔器（GSO）是非自定心装置，由膨体聚四氟乙烯管组成，由顺应性双盘的镍钛诺丝框架支撑。本研究报告首例 GSO 植入经验。
报告了 20 例连续 GSO 植入患者的情况。纳入标准为所有因反常栓塞或短暂右向左分流导致低氧血症而转介的有显著 PFO 患者。在局部麻醉和心内超声（ICE）以及透视下进行手术。检查了手术过程数据、即刻和早期闭合率。
所有患者均成功进行了日间手术装置植入。11 例患者有既往卒中，5 例有短暂性脑缺血发作，2 例有可疑与 PFO 相关的低氧血症病史，2 例有可疑与 PFO 相关的外周血栓栓塞病史。IVC 注射气泡试验的即刻闭合率为植入时 100%（14/14），1 个月时 100%（14/14）。平均 PFO 球囊大小为 8.0±3.6（范围 2.0-16.7）mm，平均透视植入时间为 3.0±1.7（范围 0.7-6.3）min，辐射剂量为 283±340（范围 6-1431）μGy m²，总手术时间为 34.8±8.0（范围 22-53）min。植入了 5×20mm²、7×25mm²和 8×30mm²的 GSO 装置，目标是装置尺寸至少是球囊 PFO 尺寸的两倍。病例包括最大达 30mm 偏差的瘤样间隔和最大 12mm 长的隧道。由于对装置锁定存在不确定性，两次对两个装置进行了取出和重新定位。1 个月随访时，2 例患者出现短暂自终止的疑似心房颤动发作，所有患者静息心电图均正常。无血栓栓塞/神经事件报告。
GSO 可在局部麻醉和 ICE 下植入，手术过程时间和透视时间短，手术成功率高，可作为日间手术。未见残余分流。初步经验表明，该装置是一种安全有效的 PFO 闭合装置。
