Objective To investigate the safety and efficacy of patent foramen ovale ( PFO ) closure with Left-disk-coated PFO occluder. Methods The device was implanted in patients with PFO under the guidance of fluoroscopy and transthoracal echocardiography using a 10-12 French delivery sheath via femoral vein approach. Aspirin (100 mg/d for 6 months) was administered post procedure. Patients were followed clinically and echocardiographically at 24 hours, 1 month, 3months, 6 months, and 12 months after device implantation and yearly thereafter. Results Permanent device implantation failed in one patient (4% ) and succeed in the remaining 24 patients (96% ) . There were no major in-hospital-adverse events or complications ( thromboembolism, occluder dislodgement, infection or myocardial infarction). Seven patients developed transient atrial premature beats or atrial tachycardia during implantation and stopped without medication post procedure. Follow-up [(25 ±12) months] results showed that all occluders were in position and there were no residual shunt, arrhythmia and cerebral vessel events post procedure. Conclusion Left-disk-coated PFO occluder is safe and effective for PFO closure.%目的 探讨经皮导管左盘外包膜卵圆孔封堵器治疗卵圆孔未闭的安全性和疗效.方法 在X线透视和超声心动图引导下经股静脉,通过10～12 F长鞘,采用左盘外包膜卵圆孔封堵器对有指征的卵圆孔未闭患者行介入治疗.术后口服阿司匹林(100 mg/d)6个月.术后24 h、1个月、3个月、6个月和1年分别行临床和超声心动图随访,以后每年随访1次.结果 共有25例卵圆孔未闭患者行卵圆孔封堵术,成功率为96%.没有发生院内不良事件和封堵器血栓形成、感染、心肌梗死等并发症.7例患者在术中出现频发性房性早搏或阵发性房性心动过速,术后很快终止.随访6～42(25±12)个月,封堵器位置正常,无房水平残余分流,未出现新发的心律失常和脑血管事件.结论 经皮导管左盘外包膜卵圆孔封堵器治疗卵圆孔未闭安全、有效.
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