应用国产封堵器介入治疗小儿动脉导管未闭的远期疗效

目的分析经导管国产封堵器治疗小儿动脉导管未闭（patent duetus arteriosus，PDA）远期随访资料，评价其远期疗效、安全性及影响疗效的因素。方法PDA患儿接受国产封堵器治疗302例，病例均随访至2006年12月，进行回顾性队列研究。结果PDA最窄处直径在2．0～16（4．1±1．3）mm，其中直径超过12mm10例（3．3％）。成功植入4／6～22／24mm大小的封堵器298例（98．6％）。完成了随访244例，随访率为81％，随访时间24～82个月。需要再次接受治疗4例（1．3％），其中接受介入治疗3例（0．9％），包括因残余分流而溶血2例；因封堵器移位接受外科治疗1例（0．3％）。1年和5年无事件发生率为98．0％。残余分流率在1d，1个月，6个月，12个月，24个月和36个月分别为10．4％，3．7％，2．1％，0．8％，0．5％和0。10例巨大PDA应用大型封堵器封堵成功。结论应用国产封堵器治疗小儿PDA远期疗效确切．安全性好。

Long-term follow-up results of transcatheter closure of patent ducts arterious using domestic device in children

Objectives To document the long-term follow-up results of transcatheter domestic device occlusion of patent ductus arteriosus （PDA） in children and to assess the safety and effectiveness of this method for PDA closure. Methods Between January 2000 and November 2004, 302 consecutive patients had isolated PDA underwent percutaneous closure using domestic device. All patients were followed-up until December 2006. A retrospective cohort study was completed in all patients. Results The PDAs were measured from 2.0 to 16 mm （median 4.1 mm） at the narrowest diameter, of which 10 PDAs were larger than 12 mm （3.3%）. All PDAs were occluded with 4/6-22/24 mm devices through 6F or 9F sheaths. Devices were successfully implanted in 298 patients （98.6%）. All shapes of the PDA could be closed. Follow-up after device implantation was accomplished in 244 patients （81%）. Three patients （0.9%） required re-intervention to treat residual shunt with or without hemolysis and one patient （0.3%） underwent surgical treatment due to the malposition of the device. Event-free rates were 98.0% at one year and five years. The incidence of residual shunt reduced at different follow-up period, namely 10.4%, 3.7%, 2.1%, 0.8%, 0.5% and o at ld, 1, 6, 12, 24 and 36 months after device occlusion, respectively. Large devices were successfully implanted in 10 patients with large PDA. Conclusions This large number of patients and long-term follow-up results confirm the safety and effectiveness of domestic device closure of PDAs in children.