Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.
10.1097/CM9.0000000000001865
- Author:
Kai YANG
1
;
Jian-Hua LYU
1
;
Hai-Bo HU
1
;
Wen-Hui WU
2
;
Ge-Jun ZHANG
1
;
Jing-Lin JIN
1
;
Yu-Hao LIU
3
;
Yuan FENG
4
;
Li-Ming WANG
5
;
Shi-Hua ZHAO
6
;
Shi-Liang JIANG
7
;
Wei LI
8
;
Xiang-Bin PAN
1
Author Information
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 Interventional Diagnosis and Treatment, Anzhen Hospital, Capital Medical University, Beijing 100011, China.
3. Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou University, Zhengzhou, Henan 450000, China.
4. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
5. Department of Cardiac Surgery, Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital, Xining 810012, China.
6. 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.
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.
- Publication Type:Randomized Controlled Trial
- MeSH:
Cardiac Catheterization;
Heart Septal Defects, Atrial/surgery*;
Humans;
Polymers;
Prospective Studies;
Prosthesis Design;
Septal Occluder Device/adverse effects*;
Treatment Outcome;
Xylenes
- From:
Chinese Medical Journal
2021;134(22):2685-2691
- CountryChina
- Language:English
-
Abstract:
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.
