Randomized, Controlled Evaluation Of Safety And Effectiveness Of Ceramic Membrane Occluder

Objective:To discuss the effectiveness and safety of a newly kind of occluder which is covered with ceramic membrane in the transcatheter occlusion of congenital heart disease.Method:Patients with congenital heart disease(contains Atrial Septal Defect,Ventricular Septal Defect and Patent Ductus Arteriosus) who had their free will in ZhongShan Hospital from Dec.2008 to Apr.2009 were collected and divided into two groups.One is trial group, and the other is contrast group. The patients in trial group used the occluders covered with ceramic membrane and others in contrast group used the formerly occluders which were already used in the transcatheter occlusion of congenital heart disease.To observe the successful rate right after the transcatheter occlusion and value the safety and effectiveness through the examinations such as electrocardiogram, X-ray for chest, echocardiography at the time 30 days,90 days,180days after the occlusion.Results:Forty patients of congenital heart disease were included in this research.20 patients were of ASD,8 patients were of VSD,12 were of PDA. The successful rates of two occluders right after the transcatheter occlusion were same.Two occluders had no difference in the safety up to 180 days after the transcatheter occlusion. Two adverse events happened in the research and one was in trial group and the other in contrast group which both were foreign to devices.No death cases.Conclusion:Occluders covered with ceramic membrane had high effectiveness and safety in the transcatheter occlusion of congenital heart disease which were equivalent to formerly occluders in short-dated follow-up.