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Four-Dimensional Computed Tomography-Guided Valve Sizing for Transcatheter Pulmonary Valve Replacement
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Preclinical Evaluation of a Growth-Accommodating Transcatheter Pulmonary Valve System for Young Children

Nnaoma Agwu1, Daryl Chau1, Gregory S Kelley1

  • 1Department of Biomedical Engineering University of California Irvine CA USA.

Journal of the American Heart Association
|June 18, 2025
PubMed

Insights

A novel origami-inspired transcatheter pulmonary valve, the IRIS Valve, shows promise for early treatment in children weighing as little as 8kg. This innovation addresses pulmonary regurgitation and prevents right ventricle dysfunction in pediatric congenital heart defect patients.

Area of Science:

  • Cardiovascular Research
  • Biomedical Engineering
  • Pediatric Cardiology

Background:

  • Congenital heart defects (CHDs) impact ~1% of births, with many children requiring interventions for right ventricular outflow tract abnormalities.
  • Pulmonary valve regurgitation is common, often necessitating eventual valve replacement to prevent right ventricle failure.
  • Current transcatheter pulmonary valve replacement is limited to patients ≥20kg, leaving smaller children at risk of ventricular dilation.

Purpose of the Study:

  • To develop a transcatheter pulmonary valve (IRIS Valve) suitable for earlier implantation in pediatric patients (≥8kg).
  • To address the limitations of existing transcatheter pulmonary valve replacement in treating progressive pulmonary valve regurgitation in younger children.

Main Methods:

  • The IRIS Valve, inspired by origami, was designed for growth accommodation and transcatheter delivery.
  • Finite element analysis and fracture testing validated the stent's mechanical properties.
  • Implantation in Yucatan mini pigs (8-17kg) was performed using a 12-Fr system for a 6-month study period.

Main Results:

  • Mechanical testing confirmed the stent's ability to crimp to 3mm and expand to 20mm without fracture.
  • Animal studies demonstrated successful integration within the pulmonary valve annulus.
  • The implanted valves maintained integrity with a favorable tissue response over 6 months.

Conclusions:

  • The IRIS Valve represents a significant advancement for earlier treatment of pulmonary valve disease in pediatric CHD patients.
  • This technology has the potential to improve long-term outcomes by preventing right ventricle dysfunction in a vulnerable population.
Abstract

Keywords:
IRIS valveTPVRcongenital heart diseasepulmonary valve regurgitationtranscatheter pulmonary valve replacement

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