摘要目的 报道经导管介入治疗常见先天性心脏病中国23家医疗中心注册登记研究的结果.方法 通过回顾性登记研究的方法,收集全国14个省市的23家医疗中心接受介入治疗的常见先天性心脏病患者的临床资料和信息.自2008年1月1日至2010年12月31日,共收集了常见先天性心脏病介入治疗患者的病例资料5808例,其中动脉导管未闭(PDA) 1600例、房间隔缺损(ADS)1847例、室间隔缺损(VSD)1885例和肺动脉瓣狭窄(PS)476例.结果 介入治疗总成功率98.5％(5720/5808),其中PDA、ASD、VSD封堵术成功率分别为99.5％、98.8％和97.4％,PS的经皮球囊肺动脉瓣成形术(PBPV)成功率98.5％.多因素logistic回归分析显示:PDA直径和手术时间、ASD年龄和手术时间、VSD距主动脉瓣距离分别是影响PDA、ASD、VSD封堵术成功率的因素.在完成手术的所有病例中,共有306例出现各种类型的早期并发症,总发生率5.3％( 306/5720),但严重并发症发生率仅为0.6％(36/5720),其中封堵器脱落或移位7例(0.1％)(PDA 2例,ASD 4例,VSD 1例),严重主动脉瓣反流5例(0.3％),严重三尖瓣反流4例(0.3％),三尖瓣狭窄2例(0.1％),房室传导阻滞13例(0.2％)(ASD 2例,VSD 11例),心包填塞2例(ASD 1例,PS 1例),溶血3例(VSD 2 例,PDA 1例).所有介入治疗均未出现死亡病例.影响PDA、ASD、VSD封堵术及PBPV并发症的因素分别为:PDA直径和手术时间、ASD最大径、手术时间和封堵器直径、年龄和PS程度.平均随访15个月(1～36个月),截止到研究结束,PDA、ASD及VSD完全闭合率均达到了100％,PBPV 跨瓣压差进一步降低至正常范围.随访期间发生各类并发症共15例(0.2％),4例需要外科手术干预.结论 经导管介入治疗常见先天性心脏病疗效确切,是一种安全有效的治疗方法.近、远期并发症发生率低,但应注意严重并发症,尤其是远期并发症的发生.加强和完善长期随访十分重要.

abstractsObjective To report the results of transcatheter interventional therapy (TIT) of congenital heart disease (CHD) register from 23 medical centers in China.Method In this retrospective multicenter registry study,clinical data from 5808 patients who underwent TIT between January 2008 to December 2010 in 23 Chinese medical centers in 14 cities were analyzed.Results Procedure was successful in 5720 cases (98.5％),success rate was 99.5％ for PDA,98.8％ for ASD,97.4％ for VSD and 98.5％ for pulmonary stenosis (PS).Multivariate regression analysis showed that PDA size and procedure time,age and procedure time,distance from VSD to AV were significantly associated with the procedure success rate of PDA,ASD and VSD closure,respectively.Early complications occurred in 306 cases (5.3％),36 cases (0.6％) experienced major complications including device embolization in 7 cases, scrious aorta regurgitation in 5 cases,serious tricuspid regurgitation in 4 cases,tricuspid stenosis in 2 cases,heart block (HB) in 13 cases (2 in ASD and 11 in VSD),cardiac tamponade in 2 cases (1 ASD and 1 PS) and hemolysis in 3 cases.Procedure time and PDA size,ASD size,device size,age and PS degree were risk factors related to the occurrence of the early complications for PDA,ASD and VSD closure and PBPV respectively.The median follow-up time was 15 months (range 1-36 months).The complete closure rate during follow up was 100％ for ASD,PDA and VSD and the pressure gradient in PS decreased to normal range in all PS patients.Late complications occurred in 15 cases (0.2％),of which 3 cases needed surgery intervention and permanent pacemaker was implanted in 1 patient.There was no death during procedure and at follow-up period.Conclusions TIT of CHD offers encouraging results in China.Follow up is warranted to monitor the occurrence of serious complications,especially late complications.