Parylene涂层封堵器治疗儿童先天性心脏病疗效观察

Efficacy of Parylene coating occluder in the treatment of children with congenial heart disease

摘要:

目的：探讨Parylene涂层封堵器（Parylene coating occluder）治疗儿童先天性心脏病（congenial heart diseases，CHD）的临床安全性、有效性及阻断镍离子释放入血的效果。方法：将待实施介入治疗的CHD患儿23例按照随机分组原则分为派瑞林组（A组）及传统组（B组），均为北京华医圣杰医疗器械公司产品。A组12例，其中室间隔缺损（ventricular septal defects，VSD）4例，动脉导管未闭（patent ductus arteriosus，PDA）8例，B组11例，其中VSD 3例，PPA 8例。所有患儿均由其监护人签署知情同意书。2组均在X线、心脏彩超及心电图监测下完成经导管介入封堵治疗，于术前，术后1 d、1月、3月、6月随访观察临床症状体征、肝肾功、血常规、心电图、心脏彩超、胸片及血镍浓度变化情况。结果：2组介入封堵治疗均成功，成功率均为100%（23/23）；A组中有1例术后即刻有少量残余分流，随访至术后6月时残余分流消失。无机械性溶血、封堵器脱落、移位、心律失常等并发症发生。随访各时间点2组之间在临床症状体征、肝肾功能（分别为P＝0.819、P＝0.418、P＝0.991、P＝0.828）、血常规（分别为P＝0.521、P＝0.239、P＝0.088）、心电图、心脏彩超（分别为P＝0.249、P＝0.239、P＝0.213、P＝0.071、P＝0.397）、胸片（P分别为0.537、0.114）和血液镍离子浓度（P=0.797）方面均无统计学意义。结论：小儿CHD介入治疗中，Parylene涂层封堵器在有效性、安全性及阻断镍离子释放入血方面与传统封堵器无显著差异。

Abstract:

Objective：To explore clinical safety and efficacy of Parylene coating occluder in the treatment of children with congenial heart diseases（CHD） and in the block of nickel release into blood. Methods：A total of 23 patients with CHD who would done tran－scatheter closure were divided into parylene goup（A group） and traditional group（B group）. The devices of both group were supplied by Beijing Huayi Medical Equipment Company. There were 12 cases in A group，including 4 cases of ventricular septal defects（VSD） and 8 cases of patent ductus arteriosus（PDA） and there were 11 cases in B group，including 3 cases of VSD and 8 cases of PDA. All patients were informed consent form signed by his guardian. All cases in both groups completed percutaneous transcatheter closure therapy under X-ray，electrocardiography and transthoracic echocardiography，and were followed-up regarding clinical symptoms，hepatic and renal function，blood routine，echocardiography，electrocardiography，chest X-ray and nickel concentration before therapy，1 d post therapy，1 month post therapy，3 months post therapy and 6 months post therapy respectively. Results：All treatments in both parylene group and tradional group were successful，with successful rate of 100%（23/23）. Little residual shunt was observed in one case in parylene group just after the treatment but disappeared at 6 month after the treatment. No case had complications of mechani－cal hemolysis，devices shifting and falling off and arrhythmia. There was no significant difference between two groups in clinical symptoms and signs，hepatic and renal function（P=0.819，P=0.418，P=0.991，P=0.828），routine blood examination（P=0.521，P=0.239，P=0.088），echocardiography，transthoracic electrocardiography（P=0.249，P=0.239，P=0.213，P=0.071，P=0.397），chest X-ray（P=0.537 and P=0.114） and nickel concentration（P=0.797） at each follow-up time point. Conclusion：There is no significant difference between Parylene coating occluder and traditional occluder in effectiveness and safety in the treatment of child CHD and in the block of nickel release into blood.