Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial

M. Bral; B. Gala-Lopez; D. Bigam; N. Kneteman; A. Malcolm; S. Livingstone; A. Andres; J. Emamaullee; L. Russell; C. Coussios; L. J. West; P. J. Friend; A. M.J. Shapiro

doi:10.1111/ajt.14049

Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial

M. Bral, B. Gala-Lopez, D. Bigam, N. Kneteman, A. Malcolm, S. Livingstone, A. Andres, J. Emamaullee, L. Russell, C. Coussios, L. J. West, P. J. Friend, A. M.J. Shapiro

Research output: Contribution to journal › Article › peer-review

175 Citations (Scopus)

Abstract

After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3–22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.

Original language	English
Pages (from-to)	1071-1080
Number of pages	10
Journal	American Journal of Transplantation
Volume	17
Issue number	4
DOIs	https://doi.org/10.1111/ajt.14049
Publication status	Published - Apr 1 2017
Externally published	Yes

Bibliographical note

Funding Information:
M.B. is the recipient of the American Society of Transplant Surgeons (ASTS) 2015 Scientist Scholarship. B.G. is supported through an Alberta Innovates Healthcare Solutions (AIHS) Clinician Fellowship, and the Canadian National Transplant Research Program (CNRTP). A.M.J.S. holds a Canada Research Chair in Transplantation Surgery and Regenerative Medicine, and a Senior Clinical Scholarship from Alberta Innovates Healthcare Solutions. L.J.W. holds a Canada Research Chair in Cardiac Transplantation. Funding for this trial is gratefully acknowledged from the following: University Hospital Foundation at the University of Alberta, the Canadian National Transplant Research Program—Project 1 (CLF Alberta Liver Research Fund and CNTRP Trust Fund), the Alberta Transplant Institute, and Astellas Pharma Canada, Inc. We further acknowledge the significant support provided from OrganOx Ltd. for their in kind contribution of metra, on site training in the UK and Canada, and partial cost recovery for disposable perfusion circuits and perfusion solutions. Medical illustration for Figure was kindly provided by Michiko Maruyama.

Publisher Copyright:
© 2016 The American Society of Transplantation and the American Society of Transplant Surgeons

ASJC Scopus Subject Areas

Immunology and Allergy
Transplantation
Pharmacology (medical)

Access to Document

10.1111/ajt.14049

Cite this

Bral, M., Gala-Lopez, B., Bigam, D., Kneteman, N., Malcolm, A., Livingstone, S., Andres, A., Emamaullee, J., Russell, L., Coussios, C., West, L. J., Friend, P. J., & Shapiro, A. M. J. (2017). Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial. American Journal of Transplantation, 17(4), 1071-1080. https://doi.org/10.1111/ajt.14049

Bral, M, Gala-Lopez, B, Bigam, D, Kneteman, N, Malcolm, A, Livingstone, S, Andres, A, Emamaullee, J, Russell, L, Coussios, C, West, LJ, Friend, PJ & Shapiro, AMJ 2017, 'Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial', American Journal of Transplantation, vol. 17, no. 4, pp. 1071-1080. https://doi.org/10.1111/ajt.14049

@article{8d67432db8064237bbbb3597e33a2f66,

title = "Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial",

abstract = "After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3–22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.",

author = "M. Bral and B. Gala-Lopez and D. Bigam and N. Kneteman and A. Malcolm and S. Livingstone and A. Andres and J. Emamaullee and L. Russell and C. Coussios and West, {L. J.} and Friend, {P. J.} and Shapiro, {A. M.J.}",

note = "Funding Information: M.B. is the recipient of the American Society of Transplant Surgeons (ASTS) 2015 Scientist Scholarship. B.G. is supported through an Alberta Innovates Healthcare Solutions (AIHS) Clinician Fellowship, and the Canadian National Transplant Research Program (CNRTP). A.M.J.S. holds a Canada Research Chair in Transplantation Surgery and Regenerative Medicine, and a Senior Clinical Scholarship from Alberta Innovates Healthcare Solutions. L.J.W. holds a Canada Research Chair in Cardiac Transplantation. Funding for this trial is gratefully acknowledged from the following: University Hospital Foundation at the University of Alberta, the Canadian National Transplant Research Program—Project 1 (CLF Alberta Liver Research Fund and CNTRP Trust Fund), the Alberta Transplant Institute, and Astellas Pharma Canada, Inc. We further acknowledge the significant support provided from OrganOx Ltd. for their in kind contribution of metra, on site training in the UK and Canada, and partial cost recovery for disposable perfusion circuits and perfusion solutions. Medical illustration for Figure was kindly provided by Michiko Maruyama. Publisher Copyright: {\textcopyright} 2016 The American Society of Transplantation and the American Society of Transplant Surgeons",

year = "2017",

month = apr,

day = "1",

doi = "10.1111/ajt.14049",

language = "English",

volume = "17",

pages = "1071--1080",

journal = "American Journal of Transplantation",

issn = "1600-6135",

publisher = "Wiley-Blackwell",

number = "4",

}

TY - JOUR

T1 - Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion

T2 - Results of a Clinical Trial

AU - Bral, M.

AU - Gala-Lopez, B.

AU - Bigam, D.

AU - Kneteman, N.

AU - Malcolm, A.

AU - Livingstone, S.

AU - Andres, A.

AU - Emamaullee, J.

AU - Russell, L.

AU - Coussios, C.

AU - West, L. J.

AU - Friend, P. J.

AU - Shapiro, A. M.J.

N1 - Funding Information: M.B. is the recipient of the American Society of Transplant Surgeons (ASTS) 2015 Scientist Scholarship. B.G. is supported through an Alberta Innovates Healthcare Solutions (AIHS) Clinician Fellowship, and the Canadian National Transplant Research Program (CNRTP). A.M.J.S. holds a Canada Research Chair in Transplantation Surgery and Regenerative Medicine, and a Senior Clinical Scholarship from Alberta Innovates Healthcare Solutions. L.J.W. holds a Canada Research Chair in Cardiac Transplantation. Funding for this trial is gratefully acknowledged from the following: University Hospital Foundation at the University of Alberta, the Canadian National Transplant Research Program—Project 1 (CLF Alberta Liver Research Fund and CNTRP Trust Fund), the Alberta Transplant Institute, and Astellas Pharma Canada, Inc. We further acknowledge the significant support provided from OrganOx Ltd. for their in kind contribution of metra, on site training in the UK and Canada, and partial cost recovery for disposable perfusion circuits and perfusion solutions. Medical illustration for Figure was kindly provided by Michiko Maruyama. Publisher Copyright: © 2016 The American Society of Transplantation and the American Society of Transplant Surgeons

PY - 2017/4/1

Y1 - 2017/4/1

N2 - After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3–22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.

AB - After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3–22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.

UR - http://www.scopus.com/inward/record.url?scp=85006790239&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85006790239&partnerID=8YFLogxK

U2 - 10.1111/ajt.14049

DO - 10.1111/ajt.14049

M3 - Article

C2 - 27639262

AN - SCOPUS:85006790239

SN - 1600-6135

VL - 17

SP - 1071

EP - 1080

JO - American Journal of Transplantation

JF - American Journal of Transplantation

IS - 4

ER -

Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial

Abstract

Bibliographical note

ASJC Scopus Subject Areas

Access to Document

Other files and links

Fingerprint

Cite this