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Mergental H, Laing RW, Hodson J, et al. Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers. Liver Transpl. 2021;doi: 10.1002/lt.26326.
Mergental, H., Laing, R. W., Hodson, J., Boteon, Y. L., Attard, J. A., Walace, L. L., Neil, D. A. H., Barton, D., Schlegel, A., Muiesan, P., Abradelo, M., Isaac, J. R., Roberts, K., Perera, M. T. P. R., Afford, S. C., & Mirza, D. F. (2021). Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers. Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, . https://doi.org/10.1002/lt.26326
Mergental, Hynek, et al. "Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers." Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society vol. (2021). doi: https://doi.org/10.1002/lt.26326
Mergental H, Laing RW, Hodson J, Boteon YL, Attard JA, Walace LL, Neil DAH, Barton D, Schlegel A, Muiesan P, Abradelo M, Isaac JR, Roberts K, Perera MTPR, Afford SC, Mirza DF. Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers. Liver Transpl. 2021 Oct 07; doi: 10.1002/lt.26326. Epub 2021 Oct 07. PMID: 34619014.
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Liver Transpl. 2021 Oct 07; doi: 10.1002/lt.26326. Epub 2021 Oct 07.

Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers.

Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society

Hynek Mergental, Richard W Laing, James Hodson, Yuri L Boteon, Joseph A Attard, Laine L Walace, Desley A H Neil, Darren Barton, Andrea Schlegel, Paolo Muiesan, Manuel Abradelo, John R Isaac, Keith Roberts, M Thamara P R Perera, Simon C Afford, Darius F Mirza

Affiliations

  1. Liver Unit, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
  2. National Institute for Health Research, Birmingham Biomedical Research Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
  3. Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom.
  4. Department of Statistics, Institute for Translational Medicine, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
  5. Department of Cellular Pathology, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
  6. D3B Team, Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.

PMID: 34619014 DOI: 10.1002/lt.26326

Abstract

Normothermic machine perfusion (NMP) allows objective assessment of donor liver transplantability. Several viability evaluation protocols have been established, consisting of parameters such as perfusate lactate clearance, pH, transaminase levels, and the production and composition of bile. The aims of this study were to assess 3 such protocols, namely, those introduced by the teams from Birmingham (BP), Cambridge (CP), and Groningen (GP), using a cohort of high-risk marginal livers that had initially been deemed unsuitable for transplantation and to introduce the concept of the viability assessment sensitivity and specificity. To demonstrate and quantify the diagnostic accuracy of these protocols, we used a composite outcome of organ use and 24-month graft survival as a surrogate endpoint. The effects of assessment modifications, including the removal of the most stringent components of the protocols, were also assessed. Of the 31 organs, 22 were transplanted after a period of NMP, of which 18 achieved the outcome of 24-month graft survival. The BP yielded 94% sensitivity and 50% specificity when predicting this outcome. The GP and CP both seemed overly conservative, with 1 and 0 organs, respectively, meeting these protocols. Modification of the GP and CP to exclude their most stringent components increased this to 11 and 8 organs, respectively, and resulted in moderate sensitivity (56% and 44%) but high specificity (92% and 100%, respectively) with respect to the composite outcome. This study shows that the normothermic assessment protocols can be useful in identifying potentially viable organs but that the balance of risk of underuse and overuse varies by protocol.

Copyright © 2021 The Authors. Liver Transplantation published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.

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