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Obstacles to implement machine perfusion technology in routine clinical practice of transplantation: Why are we not there yet?

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HEPATOLOGY
卷 -, 期 -, 页码 -

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LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/HEP.0000000000000394

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This article discusses the challenges of implementing machine perfusion of solid organs in practice, including the roles of clinical practitioners, hospitals, regulatory bodies, and industry stakeholders worldwide. It emphasizes the need for strong collaboration between these stakeholders and presents integrated roadmaps to achieve wider implementation. The importance of research development, clear regulatory pathways, and flexible reimbursement schemes is highlighted, along with potential solutions to address relevant hurdles. The article provides an overview of the current landscape of liver perfusion and underscores the role of clinical, regulatory, and financial stakeholders globally.
Machine perfusion of solid human organs is an old technique, and the basic principles were presented as early as 1855 by Claude Barnard. More than 50 years ago, the first perfusion system was used in clinical kidney transplantation. Despite the well-known benefits of dynamic organ preservation and significant medical and technical development in the last decades, perfusion devices are still not in routine use. This article describes the various challenges to implement this technology in practice, critically analyzing the role of all involved stakeholders, including clinicians, hospitals, regulatory, and industry, on the background of regional differences worldwide. The clinical need for this technology is discussed first, followed by the current status of research and the impact of costs and regulations. Considering the need for strong collaborations between clinical users, regulatory bodies, and industry, integrated road maps and pathways required to achieve a wider implementation are presented. The role of research development, clear regulatory pathways, and the need for more flexible reimbursement schemes is discussed together with potential solutions to address the most relevant hurdles. This article paints an overall picture of the current liver perfusion landscape and highlights the role of clinical, regulatory, and financial stakeholders worldwide.

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