Normothermic Machine Perfusion (NMP) For Human Liver Transplantation in the United States

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Abstract

Introduction

Lifebanc and the Cleveland Clinic entered into a collaborative partnership in 2015 to explore the potential benefits of recovering livers from donors for ex-vivo transplants. The study evaluates safety and feasibility of Normothermic Machine Perfusion (NMP) preservation in human liver transplantation.

Methods

Lifebanc provided the resources to recover and coordinate transportation for 32 Standard Criteria Donor livers. To date, 13 livers have been recovered and showed the ability to be preserved much longer than cold storage preservation. This method has the potential to advance the use of marginal donors after brain death (DBD), including donors after cardiac death (DCD), and may lead to less discards and more lives saved. The length of NMP will be about 4-18 hours.

Results

We transplanted 13 livers after NMP to test the safety and feasibility of NMP on a device developed in our institution. Livers included 8 from DBD and 5 after DCD. Cold ischemia time before NMP was 1hrs32mins to 3hrs 57mins. NMP time was 3hrs20mins to 7hrs52mins. Livers were perfused through portal vein and hepatic artery in physiologic flow rates and pressures with perfusate based on matched human packed red blood cells and fresh frozen plasma. During NMP, bile production was 3-13 ml/hr of DBD livers and 1-6ml/hr of DCD livers. All livers displayed lactate clearance [figure1].

Results

The alanine and aspartate aminotransferase (ALT, AST) in perfusate at the end of NMP had correlation (both p=0.001) to their peak values in the first 7 post-operative days (POD) [figure2].

Results

NMP livers were compared to historic liver transplant controls preserved by cold storage (CS) matched (1:4 on DBD, 1:2 on DCD) by donor and recipient age, donor risk index, MELD score, total preservation time. Early allograft dysfunction (EAD) was defined as total bilirubin>10mg/dL or International Normal Ratio (INR)>1.6 at POD7, or peak ALT or AST>2000 U/L until POD7. EAD ratio was 23% in NMP group (3 DCD liver) but was 33% of the controls (p=0.02). NMP group had significant difference compared to the controls on peak AST (p=0.001) and ALT (p=0.001) of DBD livers, but not DCD livers (p>0.05). All DCD-NMP livers had AST decreased rapidly (>1000U/L) within 1 day after peak compared to only half of DCD-CS livers.

Conclusion

Early results indicate the potential benefits of NMP preservation on predicting liver function. This promising method could decrease high risk complications for those who have received a transplant and increase future viable livers for transplantation.

Conclusion

Staff of Lifebanc and The Cleveland Clinic.

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