摘要
Nitinol alloy occluders are widely used in the transcatheter intervention treatment of congenital heart diseases like patent ductus arteriosus（PDA）.However,nitinol alloy contains high levels of nickel,which can lead to toxic effects in the immune and hematopoietic systems if released in sufficient quantities.A new type of single-rivet occluder coated with nano-film has been developed to limit the release of nickel.In total,23 patients were recruited and randomly assigned to the experimental group（n=12） with the new nano-film single-rivet occluders or the control group（n=11） with the traditional occluders.One case in the control group was lost to follow-up.The remaining 22 cases were followed up at 24 h,7 days,1 month,3 months,and 6 months after the procedure.There were no statistically significant differences in routine blood test,alanine aminotransferase,creatinine,and troponin between the experimental and control groups.Serum nickel concentration in both two groups increased at 24 h after the procedure,peaked at 1 month,and returned to preoperative levels at 6 months.Serum nickel levels in the experimental group were significantly lower than in the control group at 24 h,7 days,1 month,and 3 months after the procedure.These data suggested that the nano-film coating effectively prevented nickel release from the new occluders,and therefore has a preferable safety profile.
Nitinol alloy occluders are widely used in the transcatheter intervention treatment of congenital heart diseases like patent ductus arteriosus（PDA）.However,nitinol alloy contains high levels of nickel,which can lead to toxic effects in the immune and hematopoietic systems if released in sufficient quantities.A new type of single-rivet occluder coated with nano-film has been developed to limit the release of nickel.In total,23 patients were recruited and randomly assigned to the experimental group（n=12） with the new nano-film single-rivet occluders or the control group（n=11） with the traditional occluders.One case in the control group was lost to follow-up.The remaining 22 cases were followed up at 24 h,7 days,1 month,3 months,and 6 months after the procedure.There were no statistically significant differences in routine blood test,alanine aminotransferase,creatinine,and troponin between the experimental and control groups.Serum nickel concentration in both two groups increased at 24 h after the procedure,peaked at 1 month,and returned to preoperative levels at 6 months.Serum nickel levels in the experimental group were significantly lower than in the control group at 24 h,7 days,1 month,and 3 months after the procedure.These data suggested that the nano-film coating effectively prevented nickel release from the new occluders,and therefore has a preferable safety profile.
作者
Xiao-ke SHANG
Mei LIU
Hong-jun LI
Rong LU
Shan-shan DING
Bin WANG
Nian-guo DONG
Peng CHEN
尚小珂;柳梅;李红军;卢蓉;丁珊珊;王斌;董念国;陈澍(Department of Cardiovascular Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology;Medical Research Institute,Second Clinical College of Wuhan University;Department of Intensive Care Unit,Wuhan First Hospital;Department of Electroencephalogram,Zhangqiu District Hospital of Traditional Chinese Medicine;Department of Oncololgy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology)
基金
supported by grants from the National Natural Science Foundation of China(No.31330029)
Wuhan Youth Program for Healthcare Scholars(No.201477)
Wuhan Chenguang Program of Science and Technology(No.2016070204010148)
