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

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.

[Effects of nitrogen deposition and management intensity on stoichiometry of leaf litter in Moso bamboo forest.] / 氮沉降和经营强度对毛竹林凋落叶生态化学计量特征的影响.

In this study, a field experiment was conducted to estimate the effects of simulated nitrogen (N) deposition (low-N: 30 kg N·hm-2·a-1, moderate-N: 60 kg N·hm-2·a-1, high-N: 90 kg N·hm-2·a-1) on ecological stoichiometry of leaf litter in Moso bamboo forest under conventional management (CM) and intensive management (IM) practices. The results showed that compared with CM, IM significantly increased C, N and P concentrations of leaf litter by 9.3%, 32.4% and 22.7%, respectively, but significantly decreased C:N, C:P and N:P ratios by 17.4%, 54.3% and 44.6%, respectively. In CM Moso bamboo plots, low- and moderate-N deposition significantly increased C, N and P concentrations of leaf litter but decreased C:N, C:P and N:P, high-N deposition significantly increased C, N concentrations, C:P and N:P, but decreased P concentration. In IM Moso bamboo plots, low-N deposition significantly increased P concentration but decreased C concentrations, C:P and N:P, moderate-N deposition significantly increased N and P concentrations but decreased C concentration, C:N, C:P and N:P, high-N deposition significantly increased C:N, C:P and N:P but decreased P concentration. The interaction of management intensity and N deposition significantly influenced stoichiometry of leaf litter, except for C:N. The P concentration of leaf litter was significantly correlated with P concentration in soils.