ArticleJournal of the American Heart Association2025
Preclinical Evaluation of a Growth-Accommodating Transcatheter Pulmonary Valve System for Young Children.
Article in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- One Anatomy, Multiple Valve Choices: Interobserver Agreement in Selecting Transcatheter Pulmonary Valve.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundCongenital heart defects affect approximately 1% of births in the United States and Europe, with >1 million children in the United States living with congenital heart defects. Many experience abnormalities in the right ventricular outflow tract, often necessitating surgical intervention early in life. However, the initial repairs typically are temporary solutions as many patients will eventually need pulmonary valve replacement to address pulmonary valve regurgitation and prevent right ventricle failure. Addressing progressive pulmonary valve regurgitation, ideally in patients weighing 8 to 10 kg, is critical to prevent right ventricle dysfunction. Transcatheter pulmonary valve replacement currently treats patients weighing at least 20 kg. Unfortunately, smaller children must wait for valve replacement and risk right ventricular dilation.
methodsTo address this challenge, we have developed the IRIS Valve, a growth-accommodating transcatheter pulmonary heart valve inspired by origami targeting implantation in at least 8 kg children. The valve stent underwent finite element analysis with validation by fracture testing. Using a 12-Fr transcatheter system, the IRIS valve was implanted into 8 to 17 kg Yucatan mini pigs for 6 months.
resultsBenchtop fracture testing and finite element analysis confirmed the stent's ability to be crimped to a 3-mm diameter for loading into a 12-Fr transcatheter system and expanded to 20 mm without fracture. Animal studies successfully demonstrated excellent integration within the pulmonary valve annulus, intact valve integrity, and favorable tissue response.
conclusionsThe IRIS Valve offers a promising solution for earlier treatment of heart valve disease in pediatric patients with congenital heart defects, potentially improving outcomes in this vulnerable population.
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