Chinese expert guidelines for the prevention of patent foramen ovale-associated stroke
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摘要: 卵圆孔未闭（PFO）发生率高，约1/4的成年人均存在PFO。随着4项经导管封堵PFO和药物治疗相对比的随机对照研究结果的相继发表，各国相继更新了PFO相关指南或共识。我国关于PFO治疗的推荐仍停留在2017年的“卵圆孔未闭预防性封堵术中国专家共识”上，鉴于PFO人群基数庞大，为规范PFO封堵术的临床应用，在借鉴国内外最新研究的基础上，结合我国具体情况，国内本领域专家形成了卵圆孔未闭相关卒中预防中国专家指南，以供参考。Abstract: The incidence of patent foramen ovale (PFO) is high, and PFO is present in approximately one-quarter of adults. As the results of randomized controlled trials comparing transcatheter PFO closure and drug therapy have been updated, countries have successively updated PFO guidelines or consensus. China′s recommendation for PFO treatment only stays on the 2017 “Chinese expert consensus on preventive closure of patent foramen ovale”. In view of the large population of PFO, in order to standardize the clinical application of PFO closure, we learnt from the latest research at domestic and abroad, combined with the specific situation of China, experts in this field have developed a Chinese expert guidelines for the prevention of patent foramen ovale-associated stroke for reference.
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Key words:
- patent foramen ovale /
- closure /
- stroke
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表 1 经导管封堵PFO vs. 药物治疗的RCT研究
研究 患者数 随访时间
（月）主要终点 跟踪样本量
计算（年）平均随访
时间（年）观测事件率
（封堵vs.药物）预期事件
（封堵vs.药物）CLOSURE I 2012[7] 909 48 卒中/TIA和神经源性死亡 2 2 5.5% vs. 6.8% 3.0 % vs. 6.0% PC 2013[8] 414 48 死亡，卒中，TIA，外周栓塞 4.5 4.1 3.4% vs. 5.2% 4.5% vs. 13.5% RESPECT 2013[9]，2017[5] 980 84 卒中，TIA，死亡 2 5.9 1.9% vs. 3.3% 1.05% vs. 4.3% REDUCE 2017[4] 664 38 随机化后24个月发生卒中或影像学证实的TIA 2 3.2 1.4% vs. 5.4% 3.6% vs. 8% CLOSE 2017[3] 473 64 致命性或非致命性卒中 3 5.4 0% vs. 6.2% 5.3% vs. 10.5% DEFENSE 2018[6] 120 24 卒中，血管源性死亡和TIA 2 2.8 0% vs. 12.9% 4% vs. 15% 
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表 3 ESUS的诊断标准
经头颅CT和（或）MRI检测排除腔隙性缺血性卒中a 经MRA和（或）CTA排除供应缺血脑组织的动脉存在≥50%管腔狭窄程度的颅内外动脉粥样硬化 无心源性栓塞的高危风险b 对（18～45）岁青年卒中患者及伴其他系统特征的卒中患者需排除其他少见病因，如血管炎、动脉夹层、偏头痛/血管痉挛、药物滥用等 a腔隙性梗死定义为皮质下梗死灶MRI中最大直径≤2 cm（CT≤1.5 cm），位于深部小血管供血区。b包括持续性和阵发性房颤、持续性房扑、心脏内血栓、人工心脏瓣膜、心房黏液瘤或其他心脏肿瘤、二尖瓣狭窄、4周内的心肌梗死、左室射血分数<30%的心力衰竭、瓣膜赘生物或感染性心内膜炎等。
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表 4 PFO相关卒中筛查关键点
年龄<55岁 CT/MRI显示多发缺血性病灶高危PFO 临床栓塞事件复发者 DVT/PE病史或易栓症者 Valsalva动作相关血栓栓塞事件 呼吸睡眠暂停 长途旅行/静止状态下相关临床事件 同时发生体循环/肺循环栓塞 RoPE评分>6分者
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