Efficacy and safety of a parylene-coated occluder for atrial septal defect:a prospective,multi-center,randomized controlled clinical trial  

作　　者：Kai Yang Jian-Hua Lyu Hai-Bo Hu Wen-Hui Wu Ge-Jun Zhang Jing-Lin Jin Yu-Hao Liu Yuan Feng Li-Ming Wang Shi-Hua Zhao Shi-Liang Jiang Wei Li Xiang-Bin Pan 

机构地区：[1]Center of Structural Heart Disease,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China [2]Department of Magnetic Resonance Imaging,Fuwai Hospital,State Key Laboratory of Cardiovascular Disease,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China [3]Department of Interventional Diagnosis and Treatment,Anzhen Hospital,Capital Medical University,Beijing 100011,China [4]Department of Cardiology,Fuwai Central China Cardiovascular Hospital,Zhengzhou University,Zhengzhou,Henan 450000,China [5]Department of Cardiology,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China [6]Department of Cardiac Surgery,Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital,Xining 810012,China [7]Department of Radiology,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China [8]Medical Research and Biometrics Center,National Center for Cardiovascular Diseases,Fuwai Hospital,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China.

出　　处：《Chinese Medical Journal》2021年第22期2685-2691,共7页中华医学杂志（英文版）

摘　　要：Background:Nitinol-containing devices are widely used in clinical practice.However,there are concerns about nickel release after nitinol-containing device implantation.This study aimed to compare the efficacy and safety of a parylene-coated occluder vs.a traditional nitinol-containing device for atrial septal defect(ASD).Methods:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder(n=54)or the control group to receive a traditional occluder(n=54).The plugging success rate at 6 months after device implantation and the pre-and post-implantation serum nickel levels were compared between the two groups.A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device.The Cochran–Mantel–Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.Results:At 6 months after implantation,successful ASD closure was achieved in 52 of 53 patients(98.11%)in both the trial and control groups(95%confidence interval(CI):[4.90,5.16])based on per-protocol set analysis.The absolute value of the lower limit of the 95%CI was 4.90%,which was less than the specified non-inferiority margin of 8%.No deaths or severe complications occurred during 6 months of follow-up.The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group(P<0.05 vs.baseline).In the trial group,there was no significant difference in the serum nickel level before vs.after device implantation(P>0.05).Conclusions:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder.The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD,especially in patients with a nickel allergy.

关 键 词：Congenital heart disease Atrial septal defect Percutaneous intervention PARYLENE NICKEL 

分 类 号：R654.2[医药卫生—外科学]