Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children
Background Congenital 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 interventio...
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Wiley
2025-07-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.125.041932 |
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| author | Nnaoma Agwu Daryl Chau Gregory S. Kelley Tanya Burney Ekaterina Perminov Christopher Alcantara Michael R. Recto Arash Kheradvar |
| author_facet | Nnaoma Agwu Daryl Chau Gregory S. Kelley Tanya Burney Ekaterina Perminov Christopher Alcantara Michael R. Recto Arash Kheradvar |
| author_sort | Nnaoma Agwu |
| collection | DOAJ |
| description | Background Congenital 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. Methods To 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. Results Benchtop 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. Conclusions The 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. |
| format | Article |
| id | doaj-art-a3cf85633ba04566b1f4e075e3ff9d0d |
| institution | DOAJ |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-a3cf85633ba04566b1f4e075e3ff9d0d2025-08-20T02:46:24ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-07-01141310.1161/JAHA.125.041932Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young ChildrenNnaoma Agwu0Daryl Chau1Gregory S. Kelley2Tanya Burney3Ekaterina Perminov4Christopher Alcantara5Michael R. Recto6Arash Kheradvar7Department of Biomedical Engineering University of California Irvine CA USADepartment of Biomedical Engineering University of California Irvine CA USADepartment of Biomedical Engineering University of California Irvine CA USADepartment of Biomedical Engineering University of California Irvine CA USADepartment of Biomedical Engineering University of California Irvine CA USAChildren’s Hospital of Orange County Orange CA USAChildren’s Hospital of Orange County Orange CA USADepartment of Biomedical Engineering University of California Irvine CA USABackground Congenital 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. Methods To 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. Results Benchtop 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. Conclusions The 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.https://www.ahajournals.org/doi/10.1161/JAHA.125.041932congenital heart diseaseIRIS valvepulmonary valve regurgitationTPVRtranscatheter pulmonary valve replacement |
| spellingShingle | Nnaoma Agwu Daryl Chau Gregory S. Kelley Tanya Burney Ekaterina Perminov Christopher Alcantara Michael R. Recto Arash Kheradvar Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease congenital heart disease IRIS valve pulmonary valve regurgitation TPVR transcatheter pulmonary valve replacement |
| title | Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children |
| title_full | Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children |
| title_fullStr | Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children |
| title_full_unstemmed | Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children |
| title_short | Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children |
| title_sort | preclinical evaluation of a growth accommodating transcatheter pulmonary valve system for young children |
| topic | congenital heart disease IRIS valve pulmonary valve regurgitation TPVR transcatheter pulmonary valve replacement |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.125.041932 |
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