Premounted stents for branch pulmonary artery stenosis in children: A short term solution

Ooi, Yinn Khurn; Kim, Sung In H.; Gillespie, Scott; Kim, Dennis W.; Vincent, Robert; Petit, Christopher J.

doi:10.1002/ccd.27800

Cited by 18 publications

(8 citation statements)

References 21 publications

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“…With the development of small low profile delivery systems, stents are now deployed in the pulmonary vasculature of the smallest of children 28,29 who theoretically have better lung parenchymal and PA growth potential. Implantation of small stents can be an effective short term solution but this therapeutic strategy is associated with the expected need for catheter reinterventions to accommodate somatic PA growth and with high rates of need for surgical stent interventions 39 . Unlike existing long‐term data when adult PA diameters can be achieved through stenting, 26 there is limited data describing longitudinal outcomes following small diameter stent interventions in the PAs of young children.…”

Section: Discussionmentioning

confidence: 99%

Pulmonary artery and lung parenchymal growth following early versus delayed stent interventions in a swine pulmonary artery stenosis model

Pewowaruk

Hermsen

Johnson

et al. 2020

Cathet Cardio Intervent

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Objectives: Compare lung parenchymal and pulmonary artery (PA) growth and hemodynamics following early and delayed PA stent interventions for treatment of unilateral branch PA stenosis (PAS) in swine. Background: How the pulmonary circulation remodels in response to different durations of hypoperfusion and how much growth and function can be recovered with catheter directed interventions at differing time periods of lung development is not understood. Methods: A total of 18 swine were assigned to four groups: Sham (n = 4), untreated left PAS (LPAS) (n = 4), early intervention (EI) (n = 5), and delayed intervention (DI) (n = 5). EI had left pulmonary artery (LPA) stenting at 5 weeks (6 kg) with redilation at 10 weeks. DI had stenting at 10 weeks. All underwent right heart catheterization, computed tomography, magnetic resonance imaging, and histology at 20 weeks (55 kg). Results: EI decreased the extent of histologic changes in the left lung as DI had marked alveolar septal and bronchovascular abnormalities (p = .05 and p < .05 vs. sham) that were less prevalent in EI. EI also increased left lung volumes and alveolar counts compared to DI. EI and DI equally restored LPA pulsatility, R heart pressures, and distal LPA growth. EI and DI improved, but did not normalize LPA stenosis diameter (LPA/DAo ratio: Sham 1.27 ± 0.11 mm/mm, DI 0.88 ± 0.10 mm/mm, EI 1.01 ± 0.09 mm/mm) and pulmonary blood flow distributions (LPA-flow%: Sham 52 ± 5%, LPAS 7 ± 2%, DI 44 ± 3%, EI 40 ± 2%). Conclusion: In this surgically created PAS model, EI was associated with improved lung parenchymal development compared to DI. Longer durations of L lung hypoperfusion did not detrimentally affect PA growth and R heart hemodynamics. Functional and anatomical discrepancies persist despite successful stent interventions that warrant additional investigation.

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Section: Discussionmentioning

confidence: 99%

Pulmonary artery and lung parenchymal growth following early versus delayed stent interventions in a swine pulmonary artery stenosis model

Pewowaruk

Hermsen

Johnson

et al. 2020

Cathet Cardio Intervent

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“…Short-term data have demonstrated excellent results for bare metal stents or drug eluting stents when implanted in branch pulmonary arteries; however, reintervention is the primary failure method with the extended follow-up. Recent observational studies demonstrated a high rate of reintervention of 60% at 10 years ( 24 ) and 65% at 5 years for permanent stents ( 25 ). Compared with permanent stents, bioresorbable stents are the direction of future research.…”

Section: Discussionmentioning

confidence: 99%

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

Sun

et al. 2022

Front. Cardiovasc. Med.

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BackgroundPulmonary 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.MethodsFrom 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.ResultsStenting 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).ConclusionOur 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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“…Endovascular stents have been used to treat a wide variety of vascular stenoses in children for the past 30 years, however, there currently exists no stent that is: (a) designed for implantation in infants, (b) FDA approved for use in infants and (c) designed to be implanted at infant vessel diameters and expandable to adult dimeters while maintaining structural integrity. Despite this gap in availability of bespoke technologies, numerous studies have demonstrated the benefits of stent implantation in infants 3‐10 . Some of these benefits include: predictable improvement in vessel diameter associated with a reduction in pressure gradients, 3‐10 improved safety compared to angioplasty in the early post‐operative state, 10,11 delay or avoidance of surgical intervention 3,5,6,10 and improved survival when performed in infants requiring ECMO support following cardiac surgery 5 .…”

Section: Discussionmentioning

confidence: 99%

“…Despite this gap in availability of bespoke technologies, numerous studies have demonstrated the benefits of stent implantation in infants. [3][4][5][6][7][8][9][10] Some of these benefits include: predictable improvement in vessel diameter associated with a reduction in pressure gradients, [3][4][5][6][7][8][9][10] improved safety compared to angioplasty in the early post-operative state, 10,11 delay or avoidance of surgical intervention 3,5,6,10 and improved survival when performed in infants requiring ECMO support following cardiac surgery. 5 Abraham et al 5 described 75 catheterizations performed in children on ECMO with a median age of 1.5 months.…”

Section: Discussionmentioning

confidence: 99%

Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions

Zahn

Abbott²,

Tailor

et al. 2021

Cathet Cardio Intervent

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Objectives This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions. Background There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs. Methods This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5). Results Successful deployment occurred in 21/22 attempts. Two instances of post‐deployment migration occurred. Stents were re‐expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re‐dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/− 1.2 mm; final diameter 16.1 mm +/− 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time. Conclusions In this in vivo study of the Minima stent, there was high implant success, predictable re‐dilatability to adult diameters and favorable histopathology. Further study is warranted.

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Premounted stents for branch pulmonary artery stenosis in children: A short term solution

Abstract: PMS is an effective short term solution for BPAS in children. PMS is associated with expected early need for transcatheter reintervention to accommodate for growth, but also has high rates of SSI.

Cited by 18 publications

References 21 publications

Pulmonary artery and lung parenchymal growth following early versus delayed stent interventions in a swine pulmonary artery stenosis model

Pulmonary artery and lung parenchymal growth following early versus delayed stent interventions in a swine pulmonary artery stenosis model

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

Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions

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