Ex-situ machine perfusion devices for liver transplants

People identified as needing a liver transplant are placed on a waiting list for a donor liver. The waiting time for a suitable liver can vary quite a lot: the average waiting time for a liver transplant for adults in the UK is 4 months (NHS B&T). Previously static cold storage (SCS) was the gold standard preservation strategy. This involves the donor liver being flushed with cold organ preservation solution and placed in a sterile bag in a cold storage icebox for up to 4 hours, aiming to minimise liver degradation. This is done by a specially trained team before being transferred to the selected hospital for transplant as soon as possible, to minimise ischaemic damage to the organ. Whilst this approach is still used, increasingly preservation strategies are also being used to try and utilise donor organs and meet rising demand. As a result machine perfusion devices are currently in use across all 7 specialist liver transplant centres by special arrangement only, funded charitably in all cases. Arrangements of which devices, how and when they are used varies across centres with great disparity in access currently. Machine perfusion devices provide the opportunity to carry out functional viability testing of the liver for clinicians to determine if it is appropriate to transplant for positive outcomes for the recipient. Machine perfusion devices also support preservation for an extended period of time (up to 24 hours), enhancing donor organ sharing by removing geographical and transportation barriers with the potential to reduce discarded organs and inequity of access.

Status:

In progress

Technology type:

Device

Decision:

Selected

Reason for decision:

Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources

Description:

In the UK, more than 11,000 people die due to liver disease each year, and numbers are rising (British Liver Trust 2023). Liver transplantation is an effective treatment option for people with end-stage liver disease and some types of liver cancer. A liver transplant is surgery to remove a diseased liver and replace it with a healthy one from another person (donor). People identified as needing a liver transplant are placed on a waiting-list for a donor liver. Demand for liver transplants is high and some people die on the waiting-list or are removed due to ill health before receiving a donor liver (NHS Blood and transplant 2023). Livers are usually stored in ice between removal from a donor and transplant, to minimise damage. In the UK, many donor livers are discarded because clinicians are concerned about giving potentially lower quality livers to people. These decisions are based on the characteristics of the donor and the appearance of the liver because it is not possible to assess how well the liver is functioning during cold storage. Ex-situ machine perfusion devices preserve the donor liver outside the body. The aims of these devices include increasing the number of livers suitable for transplant, extending how long the liver can be stored for to enable more flexibility in the timing of transplant operations and improving the outcomes of transplant recipients. Perfusion machines vary in many ways including the temperature at which they keep the donor liver. Some also allow assessment of liver function during preservation to help the surgeon decide if the liver is appropriate to transplant. This topic has been identified by NICE for early value assessment (EVA). The purpose of this assessment is to review the evidence that is available and assess the potential clinical and cost-effectiveness of the technologies, identify evidence gaps to help direct evidence generation in the future, and inform recommendations on the possible conditional use of these technologies in the NHS while further evidence is generated.

Project Team

Project lead

Toni Gasse

Email enquiries

If you have any queries please email [email protected]

External Assessment Group:

Centre for Reviews and Dissemination and Centre for Health Economics, University of York

Timeline

Key events during the development of the guidance:

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