Key result
Implantation of biodegradable nitride iron stents in children with pulmonary artery stenosis was successful in all 11 patients, with a 0% incidence of major adverse cardiovascular events at 3 months.
Why the study?
Pulmonary artery stenosis is frequently associated with congenital heart disease, prompting evaluation of the safety and efficacy of biodegradable nitride iron stenting and its impact on right ventricular function.
Does biodegradable nitride iron stent implantation improve vessel patency and right ventricular function in children with branch pulmonary artery stenosis?
Cohort (n=11)
Yes
Does biodegradable nitride iron stent implantation improve vessel patency and right ventricular function in children with branch pulmonary artery stenosis?
Biodegradable nitride iron stents are feasible, safe, and effective for treating branch pulmonary artery stenosis in children, significantly improving vessel diameter and hemodynamics without major adverse events at 3 months.
Supports short-term feasibility of biodegradable stents in pediatric branch pulmonary artery stenosis; leaves open durability, RV effects, and need for randomized trials.
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).
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Sun et al. (2022) conducted a cohort in Pulmonary artery stenosis (n=11). Biodegradable nitride iron stent (IBS Angel) vs. Baseline (pre-intervention) was evaluated on Composite of major adverse cardiovascular events (cardiovascular mortality, in-stent thrombosis, vascular embolism, stent displacement, and heart failure). Implantation of biodegradable nitride iron stents in children with pulmonary artery stenosis was successful in all 11 patients, with a 0% incidence of major adverse cardiovascular events at 3 months.
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