LSAWP(12)1

NHS BLOOD AND TRANSPLANT LIVER SELECTION AND ALLOCATION WORKING PARTY MINUTES OF MEETING HELD ON 7 SEPTEMBER 2012 AT THE ROYAL COLLEGE OF SURGEONS, LONDON Mr M Akyol Prof A Burroughs Mrs S Charman Dr M Davies Dr A Gimson Mr A Hudson Prof D Manas Mr P Muisan Mr J Powell Dr J Van Der Muelen

Chair, Royal Infirmary of Edinburgh Royal Free Hospital, London Royal College of Surgeons, London St James’s University Hospital, Leeds Addenbrooke’s Hospital, Cambridge NHSBT Freeman Hospital, Newcastle Queen Elizabeth Hospital, Birmingham Royal Infirmary of Edinburgh Royal College of Surgeons, London

Mrs K Huang

Secretary, NHSBT ACTION

Apologies : Prof D Collett and Prof N Heaton. 1.

Declarations of interest in relation to the agenda There were no declarations of interest in relation to the agenda.

2.

Minutes from meeting on 23 May 2012

2.1

Accuracy The minutes were accepted as a true and correct record.

2.2

Action Points – LSAWP(AP)1 Item 1- DCD/DBD outcome analysis Comments have been received by S Charman. The manuscript has been through a final revision and is ready for submission. Action: Completed, no further action. Item 2- Appeals process Changes to the Appeals process documented in the minutes of the LSAWP 23rd May 2012 meeting have been endorsed by LAG. Action: Completed, no further action. Item 3 - Letter from James Neuberger about recording decisions for patients chosen for transplantation No action was taken on this item. The decision taken at the transplant policy review committee on 24th July 2012 superseded the decision recorded at the LSAWP minutes. Refer to item 3.1 on agenda. Action: On Agenda. Item 4 – Transplantation for neuroendocrine tumours The recommendation by LSAWP was discussed and endorsed by LAG. Action: Completed, no further action.

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LSAWP(12)1

ACTION Item 5 – Data release agreement In response to the request from LSAWP, a discussion paper [AGCh(12)4] was prepared by NHSBT in June 2012. Views about the proposed initial data set on this paper were sought. Members discussed this dataset and the letter from M Akyol dated 2nd July 2012 - LSAWP(12)6. The consensus was that the initial dataset proposed was too restricted. More detailed data, including outcome data, would be required to make the database useful. M Akyol will write to J Neuberger. Action: M Akyol. Item 6 – Applications for data Completed. Action: Completed, no further action. Item 7 – Update on proposed Universal Liver Transplant Allocation Scheme Refer to minute 3.1. Action: On Agenda Item 8 – Reasons for removal from the transplant list In progress. Action: C Counter. 3 3.1

M Akyol

C Counter

LTAS Update: Current position and future proposals The report from the consensus conference by Sir Scott Baker has been discussed by the Transplant Policy Review Committee. The report’s recommendations have been accepted. The strategy, also discussed and agreed by the Transplant Policy Review Committee requires: a) development of an interim policy for allocation of liver grafts within transplant units by the end of 2012; b) further work to be done in consultation with all partners and stakeholders to refine the basis for a new allocation and distribution policy. In order to achieve the aim set at paragraph a) above, LSAWP considered a discussion document which outlined several options. It was agreed that “need” should be the primary consideration in the local allocation of organs. A Hudson was asked to perform analyses in order to determine which of the three scores - “MELD, UKELD or modified John O’Neill formula” predicted early mortality on the waiting list. Transplant units agreed to rank their individual waiting lists by the chosen scoring system and to update this weekly. Extensive discussion then took place about how to treat patients with HCC and variant syndromes within this rank order, how to account for donor factors and how to achieve an appropriate donor/recipient matching. It was decided that standardising this process with any easy formula was not possible. The solution proposed was to defer the decision to the judgement of the clinicians involved on each occasion. Action: C Counter A separate discussion then took place about the optimum interim method to determine donation zones. The options were to keep donation zones proportionate to the percentage share of new 2

C Counter

LSAWP(12)1

ACTION registrations or proportionate to the size of the waiting list. Also emphasised was the need to explain discordant rates of waiting time compared with waiting list mortality in some transplant units. It was felt that using waiting list size as the basis for zones may provide an incentive to decline marginal livers. It was also pointed out that new registrations versus total waiting list size would produce almost identical results at this stage, three years after starting the zonal adjustment. Ultimately the decision was taken to continue with the current system during the interim period. Finally discussion took place on how to monitor compliance with these interim guidelines. As agreed transplant units and clinicians would have the discretion to overrule the ranking, in order to achieve donor/recipient matching or cater for special cases of variant syndromes/HCC. On each occasion they do so, they would produce a document describing the highest priority patient, reason why not transplanted; next prioritised patient/reason why not transplanted …… etc until they reach the patient transplanted on the rank order. The challenging timescale of having this interim policy ready by the end of December 2012 was emphasised. 4

4.1

Deaths and removals from the waiting list It was agreed that a detailed understanding of deaths/removals from waiting list was important to inform decisions about the optimum allocation/distribution method. The codes for recording the causes of death currently used by NHSBT were reviewed. These were considered to be too numerous. Also they had been designed for all types of transplants (hence not liver specific) and were intended to record causes of death in transplant recipients (not those awaiting transplantation on the waiting list). A smaller list of codes specific to liver transplant waiting list patients is required. M Akyol will circulate a draft for a proposed list of codes. As well as the cause of death, the most recent UKELD score prior to death and the place of death will also need to be recorded. Action: M Akyol

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Standardisation of bilirubin, creatinine INR and sodium Measurements Alex Hudson presented an analysis of the influence of serum creatinine of UKELD score based on Leeds data. A. Burroughs gave an oral presentation reviewing the evidence for the variability in the measurement of each of the components of UKELD score. The scope for variability is different for each of the 4 parameters. Normograms or correction factors are not likely to be feasible or effective. Standardising the thromboplastin used for INR measurement would achieve comparability of the calculated INRs between all laboratories. Standardisation of sodium, creatinine and bilirubin measurements will require 3

M Akyol

LSAWP(12)1

ACTION collaboration of clinicians and biochemists from each liver transplant unit. A. Burroughs agreed to lead a project to achieve this. Members were asked to e-mail A. Burroughs with contact details of a biochemist from their own centre. Action: All and A Burroughs 6

6.1

6.2

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7.1

8 8.1

8.2

All A Burroughs

Prospective audit of patient selection for liver transplantation Alex Hudson reported on behalf of D. Collett. The statistical analyses and simulations heavily rely on having updated UKELD score for all patients on the waiting list. It was agreed that the requirement for updating key variables needs to be re-established as a matter of priority. Further simulations on allocation models should await accrual of at least 12 months of updated data. A proposal for a parallel investigation by D. Collett was also discussed. Each time a liver is allocated to a patient, the suggestion is to compare the patient chosen by the clinician with the patient who would have been selected had need or utility based allocation models been employed. It had been envisaged that participation in this parallel study would be optional and M Akyol was asked to write to all units inviting them to take part. In practice when all units are updating UKELD components for their registered patients, this study could be undertaken without additional input from individual transplant units. Action: M Akyol

M Akyol

Sequential data collection The current sequential data collection is updated by completing a single page form. This form was provided as an attachment to the agenda. Unless “need” is defined by a method other than MELD or UKELD score, there will be no need to collect information other than what is recorded on the current data collection form. Action: BLANK AOB Combined cardiothoracic and liver transplantation: A. Gimson presented a paper on behalf of Dr Bill Griffiths outlining a proposal to offer combined cardiothoracic and liver transplantation as a national service based in Cambridge and Newcastle. Members expressed support for this proposal and their thanks to Dr Griffiths for the initiative in developing this programme. It was decided to defer discussion about national allocation priorities to be afforded to combined cardiothoracic liver transplant candidates. The allocation priorities will be determined after the current proposal is discussed at LAG. Action: M Akyol Impact of ethnicity on survival after liver transplantation: J Van Der Meulen spoke about a draft manuscript on this topic. The manuscript had been circulated to the members in advance. J Van Der Meulen thanked members for their feedback and 4

M Akyol

LSAWP(12)1

ACTION 8.3

repeated the invitation for those who want to contribute to the manuscript to contact him. Action: BLANK Data request : Application for data from Mr N Ahmed of St James’s Hospital, Leeds was considered. Members expressed their hesitation and concern about whether the project aims were attainable, mainly because of the difficulty with obtaining follow up data on transplanted recipients. M Akyol agreed to write to N. Ahmed. Action: M Akyol

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M Akyol

Date of next meeting: Wednesday 31st October 2012 from 1.30 pm – 3.00 pm in the Research Board Room at the Royal College of Surgeons, London.

Organ Donation & Transplantation Directorate

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September 2012