国产与进口封堵器介入治疗小儿室间隔缺损导致的心律失常和残余分流分析

目的 了解进口和国产膜部窜间隔缺损(VSD)封堵器封堵小儿先天性膜周部VSD术后心律失常和残余分流的改变和差异.方法 2003年1月至2008年6月在本院成功封堵的膜周部VSD患儿396例,应用进口膜部VSD封堵器和装置封堵膜周部VSD组186例;国产膜部VSD封堵器和装置封堵膜周部VSD组210例.术中严密监测心电图(ECG)改变,术后常规持续心电监测3～7 d,必要时1～2周.观察ECG各波段的变化,分析各组心律失常和残余分流的发生率及评价重度心律失常病例的临床转归.结果 膜部瘤样VSD较其他类型膜周部VSD更容易发生心律失常和残余分流(48.8%比29.1%,X~2=5.21,P<0.05;12.5%比0.9%,X~2=23.31,P<0.01);进口封堵器封堵膜部瘤样VSD均较封堵其他类型膜周部VSD易于导致心律失常和残余分流(68.2%比28.0%,X~2=14.18,P<0.01;36.4%比1.2%,X~2=40.44.P<0.01);封堵膜部瘤样VSD进口封堵器较国产者更易导致心律失常和残余分流(68.2%比41.4%,X~2=4.60,P<0.01;36.4%比3.4%,X~2=15.60,P<0.01),而封堵其他类型膜周部VSD心律失常和残余分流发生率差异并无统计学意义.国产封堵器封堵膜部瘤样VSD和其他膜周部VSD导致心律失常和残余分流则无差异.进口和国产2组各出现3例Ⅲ度房窜传导阻滞(Ⅲ度AVB)或间歇Ⅲ度AVB.出现Ⅲ度AVB的6例中除1例应用进口封堵器者为膜周部VSD,其他5例均为膜部瘤样VSD.结论 进121和国产封堵器封堵膜周部VSD均可导致Ⅲ度AVB等严重心律失常发生.但国产封堵器封堵膜部瘤样VSD发生心律失常和残余分流较进口封堵器少.术中和术后应密切观察ECG的改变.

Arrhythmia and residual shunt in children with ventricular septal defect arising from interventional treatment using homemade vs imported occluder devices

Objective To investigate the changes and differences of arrhythmia and residual shunt arising from interventional treatment in children with congenital perimembranous ventricular septal defect (PMVSD) using homemade and imported occluder devices. Methods Between January 2003 and June 2008, 396 PMVSD children were successfully treated with occluder devices in our hospital, comprising 186 with imported products and 210 with homemade ones. Close observation on ECG was made during the procedures and was sustained as a routine until 3 to 7 days after treatment, or 1 to 2 weeks if indicated, to identify the changes in each ECG lead. Incidences of arrhythmia and residual shunt in both groups were recorded and clinical outcome of children with severe arrhythmia was evaluated. Results Arrhythmia and residual shunt were observed more in bulging-type than in other types of PMVSD (48.8% vs 29.1%, X~2=5.21, P<0.05; 12.5% vs 0.9%, X~2=23.31, P<0.01), as were more likely to occur after use of imported devices (68.2% vs 28.0%, X~2=14.18, P<0.01; 36.4% vs 1.2%, X~2=40.44, P<0.01). Imported devices resulted in more arrhythmia and residual shunt than did homemade products after treatment of bulging-type PMVSD (68.2% vs 41.4%, X~2=4.60, P<0.01 ; 36.4% vs 3.4%, X~2=15.60, P<0.01), but such an observation was not significant when the both were used for other types of PMVSD. Homemade devices were not found to induce more cases of arrhythmia and residual shunt than other types of PMVSD. The complete or recurrent third-degree atrioventricular block ( Ⅲ°AVB) occurred in 3 cases of each group using homemade or imported devices. Among them, one was with usual PMVSD and the other 5 were with bulging- type PMVSD. Conclusions While arrhythmia and residual shunt can be observed with treatment of PMVSD using either homemade or imported occluder devices, homemade products may result in lower incidence in bulging-type VSD than do imported devices. Close monitoring of ECG during and after treatment should be mandatory.