BACKGROUND Recent published trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) for preventing recurrent cryptogenic cerebrovascular events. However, the risk of recurrent cerebrovascular events (rCVEs) is up to 5.7%, and the etiology is unclear. OBJECTIVE This study aimed to investigate the risk factors for rCVEs after closure of PFO during long-term follow-up. METHODS In our center, 282 consecutive patients underwent PFO closure because of a cryptogenic cerebrovascular event between 2006 and 2014. Their Risk of Paradoxical Embolism (RoPE) score was calculated retrospectively. We followed up with the patients by telephone, using hospital records to identify those who suffered from rCVEs. Patients with rCVEs were matched with two control patients of the same sex and RoPE score without rCVEs who underwent PFO closure at approximately the same time. The patients with rCVEs and controls participated in a clinical examination, including contrast transthoracic echocardiography (TTE) and Holter electrocardiography, to investigate the possible cause of rCVEs compared with controls. RESULTS Fourteen (5%) out of the 282 consecutive patients who underwent PFO closure suffered from rCVEs during a mean follow-up of 8.4 years (1.7 rCVEs per 100 patient-years). The median RoPE score of the patients was 7. Recurrent CVE occurred in 3.2 patients per 100 patient-years in patients with residual shunting compared with 0.8 patients per 100 patient-years in those without residual shunt. These patients were on antiplatelet treatment or without any effective anticoagulant treatment at the time rCVE occurred. The risk ratio of rCVEs in patients with residual shunting was 2.9-times higher than in patients without residual shunting (95% CI: 1.4-6.1) at follow-up visit. Four patients who had the BioSTAR device implanted suffered from an rCVE despite lack of residual shunting. CONCLUSIONS This study indicates that residual shunting and choice of the device may be the major reasons for rCVEs.

中文翻译：

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经皮闭合卵圆形未闭孔后患者的反复脑血管事件。

背景技术最近发表的试验表明，经卵圆形未闭孔（PFO）的经导管闭合对于预防复发性隐源性脑血管事件的功效。然而，复发性脑血管事件（rCVEs）的风险高达5.7％，病因尚不清楚。目的本研究旨在探讨长期随访中PFO关闭后rCVE的危险因素。方法在我们中心，2006年至2014年间，由于隐源性脑血管事件，连续282例患者进行了PFO封闭治疗。他们的悖论性栓塞（RoPE）评分风险进行了回顾性计算。我们通过电话随访患者，使用医院记录来识别患有rCVE的患者。患有rCVE的患者与两名具有相同性别和RoPE评分且无rCVE的对照患者相匹配，这些患者在大约同一时间进行了PFO封闭。患有rCVE和对照的患者参加了临床检查，包括对比经胸超声心动图（TTE）和Holter心电图检查，以研究与对照相比rCVE的可能原因。结果在282例接受PFO封堵的连续患者中，有14例（5％）在平均8.4年的随访中患有rCVE（每100个患者年1.7 rCVEs）。患者的RoPE评分中位数为7。具有残余分流的患者中，每100个患者年中有3.2例患者发生了复发性CVE，而没有残余分流的患者中，每100个患者年中有0.8例发生了CVE。这些患者在发生rCVE时正在接受抗血小板治疗或未进行任何有效的抗凝治疗。随访时，残余分流患者的rCVEs风险比是无残余分流患者的rCVEs的2.9倍（95％CI：1.4-6.1）。尽管缺乏残余分流，但四名植入BioSTAR装置的患者仍患有rCVE。结论这项研究表明残余分流和设备的选择可能是导致rCVE的主要原因。