Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation

RESTORE Investigators Group

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

BACKGROUND: Organ waste is a major cause of the donor liver shortage. Roughly 67% of recovered organ donors have liver utilization annually. A new technology called normothermic machine perfusion (NMP) offers a way to recover marginal and declined livers for transplant. We report interim results of the RESTORE trial (FDA investigational drug exemption trial NCT04483102) that aims to transplant NMP-treated livers that would otherwise be discarded. STUDY DESIGN: Declined livers were screened for NMP eligibility (eg donation after circulatory death [DCD] grafts with warm ischemic time <40 minutes, donation after brain death [DBD] grafts with cold ischemic time <8 hours). Livers meeting pre-NMP eligibility criteria received NMP using the OrganOx metra device for a minimum of 4 hours. All NMP-treated livers meeting the viability criteria were transplanted to consented recipients. RESULTS: Over 22 months, 60 declined livers from three organ procurement organizations (OPOs; 40 DCD and 20 DBD donor livers) were offered, and 22 livers (10 DCD and 12 DBD livers) met the pre-NMP eligibility. After NMP, 16 of 22 livers passed viability testing and were transplanted into needy recipients (median Model for End-Stage Liver Disease [MELD] score of 8, range 6 to 24), resulting in a 72.7% rescue rate (50% DCD, 91.7% DBD). The rate of early allograft dysfunction was 31.3%, but there were no graft-related deaths, primary nonfunction, or instances of nonanastomotic biliary strictures. CONCLUSIONS: Interim results of the RESTORE trial suggest that a sizable number of declined livers can be reclaimed. They are safe for transplantation and can enable lower MELD patients at high risk of morbidity and mortality to receive lifesaving grafts while offering OPOs a way to allocate more livers and reduce organ waste.

Original languageEnglish (US)
Pages (from-to)614-625
Number of pages12
JournalJournal of the American College of Surgeons
Volume236
Issue number4
DOIs
StatePublished - Apr 1 2023

Funding

This work was funded by Mid-America Transplant Foundation grant 07201901 from OrganOx Ltd. Dr Chapman is on the board of directors of the Mid-America Transplant Foundation. Dr Doyle is an endowed chair at the Mid-America Transplant Foundation. Dr Gao receives funding support from the National Institutes of Health. Support: This work was funded by Mid-America Transplant Foundation grant 07201901 from OrganOx Ltd. Dr Chapman is on the board of directors of the Mid-America Transplant Foundation. Dr Doyle is an endowed chair at the Mid-America Transplant Foundation. Dr Gao receives funding support from the National Institutes of Health.

ASJC Scopus subject areas

  • General Medicine

Fingerprint

Dive into the research topics of 'Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation'. Together they form a unique fingerprint.

Cite this