Facilitators and Barriers of Ex Situ Heart Perfusion (ESHP) in Pediatric Donation

Abstract

Purpose Despite medical advances, pediatric heart transplant (HTx) candidates are at significant risk for morbidity and mortality. Ex Situ Heart Perfusion (ESHP) is a method for continuous perfusion of the donor heart, allowing for extended out-of-body time and functional assessment of the organ. Currently available devices are targeted to adults and have been used in the context of neurological and circulatory determination of death. Pediatric-specific devices are in development, but before adoption, knowledge of stakeholder attitudes towards ESHP is needed. The aim of this study was to explore pediatric HTx stakeholders’ understanding and perspectives of ESHP. Methods A virtual focus group study was conducted international pediatric HTx stakeholders. Data was analyzed using qualitative content analysis. Results There were 17 participants from 12 institutions representing 3 countries. Findings were organized under the topics of: general knowledge, indications, risks, adoption/barriers, and pediatric-specific considerations. Knowledge ranged from limited grasp of the technology to first-hand experience in clinical practice. Discussions encircled the current use of ESHP in adult-sized HTx candidates, and potential future uses in infants and young children. In all focus groups, it was discussed that risks need to be considered regarding ESHP itself, including the potential of damaging the donor heart, subjecting recipients to unquantified risks, and potential adverse impacts on pediatric HTx programs if poor outcomes occur. Concerns surrounding the material costs and human resources associated with ESHP were also discussed. While all discussions highlighted the need for pediatric ESHP devices, participants emphasized the need for rigorous research and implementation oversight of ESHP to navigate ethical issues, program administration, and support best practices in the context of technological innovation. Conclusion For stakeholders to become adopters of ESHP, they must understand the goals, benefits, and risks. This project represents the first step in the adoption of new technology, and the knowledge gained will form the basis for future education, clinical trial design, and rollout of pediatric ESHP technologies. Despite medical advances, pediatric heart transplant (HTx) candidates are at significant risk for morbidity and mortality. Ex Situ Heart Perfusion (ESHP) is a method for continuous perfusion of the donor heart, allowing for extended out-of-body time and functional assessment of the organ. Currently available devices are targeted to adults and have been used in the context of neurological and circulatory determination of death. Pediatric-specific devices are in development, but before adoption, knowledge of stakeholder attitudes towards ESHP is needed. The aim of this study was to explore pediatric HTx stakeholders’ understanding and perspectives of ESHP. A virtual focus group study was conducted international pediatric HTx stakeholders. Data was analyzed using qualitative content analysis. There were 17 participants from 12 institutions representing 3 countries. Findings were organized under the topics of: general knowledge, indications, risks, adoption/barriers, and pediatric-specific considerations. Knowledge ranged from limited grasp of the technology to first-hand experience in clinical practice. Discussions encircled the current use of ESHP in adult-sized HTx candidates, and potential future uses in infants and young children. In all focus groups, it was discussed that risks need to be considered regarding ESHP itself, including the potential of damaging the donor heart, subjecting recipients to unquantified risks, and potential adverse impacts on pediatric HTx programs if poor outcomes occur. Concerns surrounding the material costs and human resources associated with ESHP were also discussed. While all discussions highlighted the need for pediatric ESHP devices, participants emphasized the need for rigorous research and implementation oversight of ESHP to navigate ethical issues, program administration, and support best practices in the context of technological innovation. For stakeholders to become adopters of ESHP, they must understand the goals, benefits, and risks. This project represents the first step in the adoption of new technology, and the knowledge gained will form the basis for future education, clinical trial design, and rollout of pediatric ESHP technologies.