How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Are the population and subgroups appropriate and described correctly?

  • Question on Consultation

    Are the interventions described correctly?

  • Question on Consultation

    Are there any other technologies that should be included in the assessment?

  • Question on Consultation

    Have the care pathway and comparator been appropriately described?

  • Question on Consultation

    Is the place of the technologies in the pathway described appropriately?

  • Question on Consultation

    Are livers typically split at paediatric liver transplant centres?

  • Question on Consultation

    Are all of the outcomes suitable for inclusion in the assessment?

  • Question on Consultation

    Are there any additional outcomes which should be included, particularly for children and young people?

  • Question on Consultation

    Which outcomes are most relevant to children and young people?

  • Question on Consultation

    Are there any other patient issues that should be considered?

  • Question on Consultation

    Are there any other issues for the implementation and adoption of ex-situ machine technologies for liver transplants?

  • Question on Consultation

    Are there any changes that need to be made to the scope to eliminate unlawful discrimination and promote equality?

  • Question on Consultation

    Are there any additional potential equality or discrimination issues associated with this topic that need to be considered?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Ex-situ machine perfusion devices for deceased donor liver transplants

Closed for comments This consultation ended on at   Request commenting lead permission

9 Decision problem

The key decision questions for this assessment are:

  • What is the clinical effectiveness of using ex-situ machine perfusion technologies for liver transplant?

  • What is the cost effectiveness of using ex-situ machine perfusion technologies for liver transplant?

  • What evidence is available to support the value proposition of ex-situ machine perfusion devices outlined in the scope, i.e.:

  • increasing the number of livers suitable for transplant?

  • extending preservation time to allow more flexibility in the timing of the transplant operation?

  • improving the clinical outcomes of transplant recipients?

  • Are there any gaps in the evidence base?

Table 2: Decision problem

Populations

People active on the UK waiting list for liver transplantation from deceased donors.

Sub-groups

Where data permits, subgroups will be considered based on:

  • Higher risk donors for adult recipients. These might include extended criteria donors (particularly with steatotic livers) and donors following circulatory death. If possible, use of NRP of livers donated after circulatory death will also be considered.

  • Complex adult recipients. These might include people who have previously had a transplant or abdominal surgery, or those with advanced comorbidities and haemodynamic instability.

  • Logistical considerations for adults. These might include complex multi-organ transplants, challenging explant surgery, split livers (i.e., transport of right lobe for adult recipient) or other cases where it may be predicted that transport, allocation or in-hospital logistics would lead to cold ischaemia times too long to proceed with transplantation without the use of ex-situ machine perfusion.

  • Higher risk donors for children and young person (CYP) recipients. These might include extended criteria donors and donors following circulatory death. If possible, use of NRP of livers donated after circulatory death will also be considered. If possible, use of ex-situ machine perfusion during liver splitting will also be considered.

  • Complex CYP recipients. These might include people who have previously had a transplant or abdominal surgery. If possible, use of ex-situ machine perfusion during liver splitting will also be considered.

  • Logistical considerations for CYP recipients. These might include complex multi-organ transplants, challenging explant surgery or other cases where it may be predicted that transport, allocation or in-hospital logistics would lead to cold ischaemia times too long to proceed with transplantation without the use of ex-situ machine perfusion. If possible, use of ex-situ machine perfusion during liver splitting will also be considered.

Interventions

Ex-situ machine perfusion devices initiated on arrival at the hospital of the person having the transplant after the liver has been transported using conventional static cold storage.

The following ex-situ machine perfusion devices will be considered:

  • Liver Assist (XVIVO B.V.)

  • Organ Care System (OCS) Liver (TransMedics)

  • metra (OrganOx Ltd)

  • PerLife (Aferetica Srl)

  • VitaSmart Hypothermic Oxygenated Machine Perfusion System (Bridge to Life Ltd)

Where possible, the assessment will also consider potential changes to the national liver transplantation pathway, in line with proposals by NHS Blood and Transplant, including the use of ex-situ machine perfusion technologies during transportation of donor organs, as applicable.

Comparator

Static cold storage (SCS) of donated livers.

Healthcare setting

Secondary and tertiary care, including retrieval and transportation of organs from donors to recipient hospitals.

Outcomes (may include but are not limited to)

Clinical outcomes:

  • Transplant utilisation (proportion of donor organs that proceeded to transplant rather than being discarded)

  • Size and duration of liver transplant waiting list

  • Mortality on liver transplant waiting list

  • Overall participant survival at 1 year and maximum follow-up

  • Graft survival at 1 year and maximum follow-up

  • Re-transplantation at 1 year and maximum follow-up

  • Biliary complications at 1 year and maximum follow-up (total and if data permits separately for biliary leakage, anastomotic biliary strictures and non-anastomotic biliary strictures)

  • Primary non-function of the graft (defined as irreversible graft dysfunction leading to recipient death or emergency retransplant within 7 days, excluding due to hepatic artery thrombosis)

  • Hepatic artery thrombosis within 28 days (total and if data permits separately for hepatic artery thrombosis leading to recipient death and emergency retransplant)

  • Acute kidney injury post transplantation (defined as stage 2 or 3 on the Acute Kidney Injury Network classification system)

  • Post-operative requirement for renal replacement therapy (total and if data permits separately for dialysis and kidney transplantation)

  • Early allograft function, measured with a validated model (7 days) (e.g., Early Allograft Dysfunction or Model for Early Allograft Function criteria)

  • Transaminase release during the first week post-transplant (participant serum) (until 7 days)

  • Mechanical failure of machine perfusion technology

  • Serious adverse events (e.g., Clavien-Dindo classification, grade III or higher), including bowel perforation, post-transplant lymphoproliferative disorder, bleeding and infections (both donor-related and surgical infections)

  • Device related adverse events

Patient-reported outcomes:

  • Health related quality of life, assessed using any validated scale (also from carer and/or family perspective)

Other

  • Healthcare professional satisfaction and/or wellbeing

Costs and resource use:

  • Cost of technology, including purchase costs/lease fee, consumable costs and cost of training, including cost of transplants that do not proceed to surgery

  • Cost of organ retrieval and transplant surgery (encompassing cases that do not proceed to transplantation), including:

    • hospital length of stay (including ICU)

    • management of complications and adverse events (including dialysis, rehospitalisation and retransplantation)

    • transportation of organs (including method of transport and whether ex-situ machine perfusion was used)

  • Cost of returning perfusion devices

  • Cost of managing condition on the transplant waiting list, including hospitalisation episodes

  • Staff time and cost according to specialism and level of pay, including theatre staff

  • Proportion of daytime transplant procedures

Economic analysis

  • The cost-effectiveness of interventions should be expressed in terms of incremental cost per quality adjusted life year.

  • Costs will be considered from an NHS and Personal Social Services perspective. The availability of any commercial arrangements for the interventions or comparator will be taken into account.

Time horizon

The time horizon for estimating clinical and cost effectiveness will be sufficiently long to reflect potential for differences in costs or outcomes between the technologies being compared.