Abstract:

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).