中国组织工程研究与临床康复2011，Vol.15Issue(34)：6296-6301,6.DOI:10.3969/j.issn.1673-8225.2011.34.007
生物陶瓷膜先天性心脏病封堵器与普通镍钛合金封堵器的比较:随机对照
Comparison between the bioceramic coating occluder and Nitinol occluder in congenital heart disease: A randomized control
方臻飞 1李丽 1沈向前 1胡信群 1唐建军 1吕晓玲 1唐亮1
作者信息
- 1. 中南大学湘雅二医院心内科,湖南省长沙市,410011
- 折叠
摘要
Abstract
BACKGROUND: Studies have demonstrated that the nickel-titanium alloy passive film of common nitinol occluders in congenitalheart disease can be destroyed, its internal nickel ion release increases the blood of nickel in complex organic internal environment,and leads to histocompatibility worse of occlude.OBJECTIVE: To evaluated the safety and effectiveness of the new Cera TM occluder.METHODS: A total of 110 cases with congenital heart disease patients, including 46 cases with atrial septal defect (ASD), 32cases with ventricular septal defect, and 32 cases with patent ductus arteriosus. According to the operation sequence using blockrandomized method, the patients were assigned to experimental group (CeraTM occluder) and control group (HeartRTM). Theincidence of complication and changes of heart function were observed at 24 hours, 1, 3, 6 and 12 months follow-up, includingclinical examination, transthoracic echocardiography, electrocardiography, and chest X-rays results.RESULTS AND CONCLUSION: The occluder of 1 case with ASD desquamated at 20 hours after implantation in control group.Except one patient of ASD in the experimental group, 109 patients were successfully implanted occluders in the institution. Therewas no significant difference in haemodynamics data, procedural data, residual shunt rate and incidence rate of complication, thereduction of cardiac volume overload, and the improvement increased of pulmonary blood flow (P ＞ 0.05). The biocermic coating(CeraTM) has the same clinical safety and effectives, compared with common nitinol occlude (HeartRTM).关键词
生物陶瓷膜/先天性心脏病/镍钛合金/封堵器/介入治疗分类
医药卫生引用本文复制引用
方臻飞,李丽,沈向前,胡信群,唐建军,吕晓玲,唐亮..生物陶瓷膜先天性心脏病封堵器与普通镍钛合金封堵器的比较:随机对照[J].中国组织工程研究与临床康复,2011,15(34):6296-6301,6.
