Initial status and 3-month results relating to the use of biodegradable nitride iron stents in children and the evaluation of right ventricular function

Ling Sun, Jun-Jie Li, Yu-Kai Xu, Yu-Mei Xie, Shu-Shui Wang, Zhi-Wei Zhang, Ling Sun, Jun-Jie Li, Yu-Kai Xu, Yu-Mei Xie, Shu-Shui Wang, Zhi-Wei Zhang

Abstract

Background: Pulmonary artery stenosis is often associated with congenital heart disease. The aim of the study was to evaluate the efficacy and safety of stenting for branch pulmonary artery stenosis using a biodegradable nitride iron stent (IBS® Angel™) and right ventricular systolic and diastolic function.

Methods: From July 2021 to February 2022, a total of 11 cases (ages ranged from 36 to 86 months old) were included in this pre and post-intervention, prospective, cohort and preclinical study. All cases underwent transthoracic echocardiographic (TTE), chest radiography, along with computed tomography (256-slice scanner, multiple-detector) and right heart catheterization. Different types of biodegradable nitride iron stents were implanted. TTE was performed serially 1 day, 1 month and 3 months after the procedure to evaluate the rate of restenosis and right ventricular function.

Results: Stenting was successful in 11 patients. There were no major adverse cardiovascular events related to the device or to the procedure. Blood perfusion in the branch pulmonary artery was improved immediately. At follow-up, there was no significant restenosis that required re-intervention. None of the patients suffered from in-stent thrombosis, vascular embolism, stent displacement or heart failure. Compared with normal values, there were statistical with regards to FAC, E/A and E'/A'. Furthermore, we found that TAPSE correlated significantly with pulsed Doppler S wave (p = 0.008) and left ventricular ejection fraction (p < 0.01). The early trans-tricuspid inflow velocities E/E' (tissue doppler at the lateral tricuspid annulus) correlated significantly with E'/A' (p = 0.009). FAC and E'/A' were statistically different from those prior to stenting (p = 0.041 and p = 0.035) when tested one month postoperatively. At three months postoperatively, only E/A showed a statistical difference (p = 0.015).

Conclusion: Our analysis suggests that biodegradable nitride iron stents are feasible, safe, and effective in children. Some small improvements were observed in right ventricular systolic and diastolic function after successful transcatheter intervention, although change was not statistically significant due to the small sample number. (A clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis (IRIS); NCT04973540).

Keywords: biodegradable stent; children; nitride iron stents; pulmonary artery stenosis; right ventricular function.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Sun, Li, Xu, Xie, Wang and Zhang.

Figures

FIGURE 1
FIGURE 1
IBS® Angel™ Stent system.
FIGURE 2
FIGURE 2
The distributions of congenital heart diseases in 11 patients.
FIGURE 3
FIGURE 3
MDCT images of cases. (A): case 1 had PA/VSD, LPS; (B): case 8 had TOF, LPS; (C): case 3 had VSD, LPS; (D): case 5 had TGA, RPS.
FIGURE 4
FIGURE 4
3D images of branch pulmonary artery. (A): PA/VSD group; (B): TOF group; (C): VSD/PS group; (D): TGA group.
FIGURE 5
FIGURE 5
The DSA images of before and after pulmonary artery stenting. (A): case 1 had PA/VSD, LPS and implanted IBS; (B): case 8 had TOF, LPS and implanted IBS; (C): case 3 had VSD, LPS and implanted IBS; (D): case 5 had TGA, RPS and implanted IBS.
FIGURE 6
FIGURE 6
The boxplots of echocardiographic parameters. (A): The boxplots of S’ and TAPSE in different groups; (B): The boxplots of LVEF and FAC in different groups; (C): The boxplots of E/A, E′/A′ and E/E′ in different groups; (D): The boxplots of RVDA and RVD2 in different groups.
FIGURE 7
FIGURE 7
Echocardiographic parameters correlated analysis. (A): the correlation analysis of TAPSE and S’; (B): the correlation analysis of TAPSE and LVEF; (C): the correlation analysis of E/E′ and E′/A′; (D): the correlation analysis of RA and RVD1; (E): the correlation analysis of RA and RVD2; (F): the correlation analysis of RVD1 and RVD2.

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