Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies

Sophie C. Hofferberth; Timothy Kelley; Aimee K. Armstrong; Christine Heyninck-Jantz; Alaena Maiorano; Michael Colson; Frederick J. Schoen; Changfu Wu; Nicole Ibrahim; Justin T. Tretter; Megan D. Mueller; Richard W. Bianco; John P. Carney; Luc Behr; Christopher K. Breuer; Jason Beith; Martijn Cox; Eric N. Feins; Eric Vang; Larry Wood; Robert T. Tranquillo; D. Scott Lim; Andrew M. Taylor; Andrew Redington; John P. Cheatham; Doff B. McElhinney; Pedro J. del Nido; Ajit Yoganathan

doi:10.1016/j.athoracsur.2024.11.024

Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies

Sophie C. Hofferberth, Timothy Kelley, Aimee K. Armstrong, Christine Heyninck-Jantz, Alaena Maiorano, Michael Colson, Frederick J. Schoen, Changfu Wu, Nicole Ibrahim, Justin T. Tretter, Megan D. Mueller, Richard W. Bianco, John P. Carney, Luc Behr, Christopher K. Breuer, Jason Beith, Martijn Cox, Eric N. Feins, Eric Vang, Larry WoodRobert T. Tranquillo, D. Scott Lim, Andrew M. Taylor, Andrew Redington, John P. Cheatham, Doff B. McElhinney, Pedro J. del Nido, Ajit Yoganathan

Research output: Contribution to journal › Review article › peer-review

Abstract

Background: In October 2022, the Heart Valve Collaboratory and United States Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies. Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers, and scientists were assembled to review the current state of the art, discuss unique challenges in the premarket and postmarket evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease. Results: The workshop highlighted the tremendous clinical need to develop a new framework for developing and evaluating pediatric-specific heart valve therapies. Conclusions: This report summarizes the proceedings of the workshop and outlines the key considerations for developing a new framework for evaluating novel pediatric heart valve therapies.

Original language	English (US)
Pages (from-to)	1326-1339
Number of pages	14
Journal	Annals of Thoracic Surgery
Volume	119
Issue number	6
DOIs	https://doi.org/10.1016/j.athoracsur.2024.11.024
State	Published - Jun 2025

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© 2025 The Society of Thoracic Surgeons

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Hofferberth, S. C., Kelley, T., Armstrong, A. K., Heyninck-Jantz, C., Maiorano, A., Colson, M., Schoen, F. J., Wu, C., Ibrahim, N., Tretter, J. T., Mueller, M. D., Bianco, R. W., Carney, J. P., Behr, L., Breuer, C. K., Beith, J., Cox, M., Feins, E. N., Vang, E., ... Yoganathan, A. (2025). Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies. Annals of Thoracic Surgery, 119(6), 1326-1339. https://doi.org/10.1016/j.athoracsur.2024.11.024

Hofferberth, SC, Kelley, T, Armstrong, AK, Heyninck-Jantz, C, Maiorano, A, Colson, M, Schoen, FJ, Wu, C, Ibrahim, N, Tretter, JT, Mueller, MD, Bianco, RW , Carney, JP, Behr, L, Breuer, CK, Beith, J, Cox, M, Feins, EN, Vang, E, Wood, L, Tranquillo, RT, Lim, DS, Taylor, AM, Redington, A, Cheatham, JP, McElhinney, DB, del Nido, PJ & Yoganathan, A 2025, 'Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies', Annals of Thoracic Surgery, vol. 119, no. 6, pp. 1326-1339. https://doi.org/10.1016/j.athoracsur.2024.11.024

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abstract = "Background: In October 2022, the Heart Valve Collaboratory and United States Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies. Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers, and scientists were assembled to review the current state of the art, discuss unique challenges in the premarket and postmarket evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease. Results: The workshop highlighted the tremendous clinical need to develop a new framework for developing and evaluating pediatric-specific heart valve therapies. Conclusions: This report summarizes the proceedings of the workshop and outlines the key considerations for developing a new framework for evaluating novel pediatric heart valve therapies.",

author = "Hofferberth, {Sophie C.} and Timothy Kelley and Armstrong, {Aimee K.} and Christine Heyninck-Jantz and Alaena Maiorano and Michael Colson and Schoen, {Frederick J.} and Changfu Wu and Nicole Ibrahim and Tretter, {Justin T.} and Mueller, {Megan D.} and Bianco, {Richard W.} and Carney, {John P.} and Luc Behr and Breuer, {Christopher K.} and Jason Beith and Martijn Cox and Feins, {Eric N.} and Eric Vang and Larry Wood and Tranquillo, {Robert T.} and Lim, {D. Scott} and Taylor, {Andrew M.} and Andrew Redington and Cheatham, {John P.} and McElhinney, {Doff B.} and {del Nido}, {Pedro J.} and Ajit Yoganathan",

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month = jun,

doi = "10.1016/j.athoracsur.2024.11.024",

language = "English (US)",

volume = "119",

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AU - Hofferberth, Sophie C.

AU - Kelley, Timothy

AU - Armstrong, Aimee K.

AU - Heyninck-Jantz, Christine

AU - Maiorano, Alaena

AU - Colson, Michael

AU - Schoen, Frederick J.

AU - Wu, Changfu

AU - Ibrahim, Nicole

AU - Tretter, Justin T.

AU - Mueller, Megan D.

AU - Bianco, Richard W.

AU - Carney, John P.

AU - Behr, Luc

AU - Breuer, Christopher K.

AU - Beith, Jason

AU - Cox, Martijn

AU - Feins, Eric N.

AU - Vang, Eric

AU - Wood, Larry

AU - Tranquillo, Robert T.

AU - Lim, D. Scott

AU - Taylor, Andrew M.

AU - Redington, Andrew

AU - Cheatham, John P.

AU - McElhinney, Doff B.

AU - del Nido, Pedro J.

AU - Yoganathan, Ajit

PY - 2025/6

Y1 - 2025/6

N2 - Background: In October 2022, the Heart Valve Collaboratory and United States Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies. Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers, and scientists were assembled to review the current state of the art, discuss unique challenges in the premarket and postmarket evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease. Results: The workshop highlighted the tremendous clinical need to develop a new framework for developing and evaluating pediatric-specific heart valve therapies. Conclusions: This report summarizes the proceedings of the workshop and outlines the key considerations for developing a new framework for evaluating novel pediatric heart valve therapies.

AB - Background: In October 2022, the Heart Valve Collaboratory and United States Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies. Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers, and scientists were assembled to review the current state of the art, discuss unique challenges in the premarket and postmarket evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease. Results: The workshop highlighted the tremendous clinical need to develop a new framework for developing and evaluating pediatric-specific heart valve therapies. Conclusions: This report summarizes the proceedings of the workshop and outlines the key considerations for developing a new framework for evaluating novel pediatric heart valve therapies.

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Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies

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