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

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.