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

背景：研究表明普通镍钛合金先天性心脏病封堵器镍钛合金表面钝化膜可被破坏，在复杂的机体内环境中其内部镍离子释放使血镍增高，导致封堵器的组织相容性恶化。 目的：评价新型生物陶瓷膜先天性心脏病封堵器的安全性与有效性。 方法：先天性心脏病患者110例，其中房间隔缺损46 例，室间隔缺损32例，动脉导管未闭32 例。按手术先后顺序进行区组随机分组，两组病例各占一半，实验组置入陶瓷膜封堵器CeraTM，对照组置入普通镍钛合金封堵器HeartRTM，术后 24 h，1，3，6，12个月随访观察并发症的发生及心功能改变，包括临床体格检查，经胸超声心动图，心电图以及胸片结果。 结果与结论：对照组1 例房间隔缺损置入后20 h封堵器脱落，实验组1 例房间隔缺损封堵失败，其余患者均成功置入封堵器。置入两种不同封堵器患者在血流动力学资料改善，术中导管操作数据，残余分流率，并发症发生率，减少心脏超容量负荷，改善肺血增多等方面差异无显著性意义(P > 0.05)。说明生物陶瓷膜先心病封堵器临床疗效及安全性与普通镍钛合金封堵器无差异。

Comparison between the bioceramic coating occluder and Nitinol occluder in congenital heart disease: A randomized control

BACKGROUND: Studies have demonstrated that the nickel-titanium alloy passive film of common nitinol occluders in congenital heart 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 CeraTM occluder. METHODS: A total of 110 cases with congenital heart disease patients, including 46 cases with atrial septal defect (ASD), 32 cases with ventricular septal defect, and 32 cases with patent ductus arteriosus. According to the operation sequence using block randomized method, the patients were assigned to experimental group (CeraTM occluder) and control group (HeartRTM). The incidence of complication and changes of heart function were observed at 24 hours, 1, 3, 6 and 12 months follow-up, including clinical 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. There was no significant difference in haemodynamics data, procedural data, residual shunt rate and incidence rate of complication, the reduction 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).