EDINBURGH TRANSPLANT UNIT

Annual Report 2013 - 2014

TRANSPLANTATION IN GENERAL

NHS Lothian

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CONTENTS EDINBURGH TRANSPLANT UNIT SCOTTISH ORGAN RETRIEVAL TEAM SCOTTISH LIVER TRANSPLANT UNIT SCOTTISH PANCREAS TRANSPLANT UNIT ISLET TRANSPLANTATION EAST OF SCOTLAND RENAL TRANSPLANTATION SERVICE APPENDICES

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INTRODUCTION There are now more than 5000 patients living in Scotland with a transplant representing every region and every Health Board. The success of organ transplantation and the benefits that it brings to individuals and society is of course entirely dependent on the support of the population in terms of organ donation. 40% of the Scottish population are currently registered on the Organ Donor Register. This financial year has seen further increases in activity for organ donation in Scotland. The SORT team attended 144 donors and organs were retrieved in 138 instances. The improvements in organ donation have arisen through the generosity of the Scottish population following public campaigns from the Scottish Government and other UK agencies promoting organ donation in Scotland. The support of Clinical Leads in organ donation and specialist link individuals in intensive care units together with the sterling efforts of the network of specialist nurses in organ donation has also driven these increases. The projections for increasing organ donation towards 2020 will require considerable thought and planning and NHSBT have commissioned a major review of organ donation across the UK which should report in May 2015. Interim arrangements at NHS Lothian and NHS Greater Glasgow and Clyde are currently supporting staffing shortfalls in staffing of posts in organ donation until this review has been completed and new contracts can be agreed.

Patient care and quality of outcomes are at the heart of all that is done in the Edinburgh Transplant Unit. Many of the staff involved in the unit are involved in more than one of the 3 National programmes (Liver, Pancreas and Islet) and the regional renal transplant programme. Work continues in partnership with NHS Greater Glasgow and Clyde, the National Services Division and other agencies to explore the benefits and risks of National Commissioning of Renal Transplantation in Scotland. The Edinburgh Transplant Unit has continued to expand and to deliver quality outcomes for patients as measured through National audit and reporting systems. The Liver transplant programme has just been through a major Lean review with the assistance of the modernization team from NHS Lothian in an effort to make our services more patient centred, efficient and effective. The implementation phase is currently in progress and it is planned to repeat this event to cover the National Pancreas Transplant programme and Regional Renal Transplant programmes over the coming 6 months. Quality performance indicators are also being developed in each of the programmes that are more patient centred than conventional outcome reporting. The experimental programme around the development and delivery of normothermic regional perfusion for donation after circulatory death donors has continued and the unit has gained considerable experience in this technique in Maastricht category 3 donors over the past 12 months. The early results suggest a higher number of organs recovered per donation after cardiac death donor and higher rates of primary function of kidneys and lower rates of biliary complications in transplanted livers. The transplant service continues to deliver high quality services with excellent outcomes that are testament to the dedication of the many different staff who contribute at many different levels. The staff all appreciate that there is no room for complacency and that there remain significant unmet demand for transplantation and significant pressures on the services. Professor Stephen J Wigmore Clinical Director Transplantation

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NURSING There have been no further changes to the bed allocation and the Transplant Unit, RIE comprises of 20 inpatient beds in Ward 206. There are plans to increase the bed allocation further and this is being discussed within NHS Lothian Surgical Directorate presently. This is in keeping with the increased donor pool and subsequent increase in patients for transplant as well as those who require to return to the unit post transplant for specialist care. There have been no changes to the four bed Transplant High Dependency Unit, Ward 117 which has the additional funded HDU bed available in the critical care corridor. The plans continue to be progressed for the new combined Renal & Transplant HDU. This will be a 16 bed (funded for 14 beds) HDU. The Nursing Establishment: There have been no changes to the establishment within ward 206 Transplant or 117 HDU although we now consider them to be two separate ward areas under the umbrella of Transplant. The establishments remain as: Band 7- 2.0 WTE Band 6 - 4.78 WTE Band 5 - 32.45 WTE increased by 1.95WTE for the additional beds Band 2 - 7.6 WTE Patient Care/Public Involvement Ward 117 (HDU) participated in a Reflective Practice Project in association with NES. This ran though October and allows staff to raise concerns or highlight successes in care on a daily basis whilst incidents are still fresh. The feedback from this was positive and the staff continue to utilise the structure when they feel it is appropriate Care rounding was introduced to ward 206 Transplant and has been embraced by the staff. The support given to the ward by the facilitator who introduced this and the willingness of the staff to adopt this tool should aid the overall patient experience. This carries on from the work in ward 117 where this is now embedded into every day practice. Nursing Ward 206 Transplant There has been a turnover of staff in the last 6 months, with staff who have been in the Unit for a number of years making the decision that they need to broaden their nursing experience. A few staff secured promotional posts and a few made a life choice to go to areas that do not require weekend and night duty work. Presently there are 2 band 5 staff nurses on maternity leave, one due back in November 2014 and the other due back in January 2015. There are 2.11WTE band 5 staff nurse posts vacant, however they are recruited to and the staff members will take up post in early May. There is a 0.91WTE band 6 post vacant and we are offering our current band 6 staff the opportunity of increasing their hours to full time

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in the first instance. The band 6 in post made a decision to work as a band 5 for health reasons. Ward 117 There has been a turnover of staff since Christmas for very similar reasons to the ward area; however we are now fully established, although there are still 3 staff on maternity leave. The rotation to dialysis continues and also the rotation to renal HDU in preparation for the move to the new combined Renal and Transplant HDU. One member of staff from Ward 117 is currently undertaking the Clinical Decision Making Module and there is a large amount of interest in the next cohort. The staff continue to work through the training for the new classification of drugs and their administration. Staff from both areas have been encouraged to take forward the NES further education modules which were free, as a developmental opportunity. We were pleased that a number of staff took this forward. Through PDP, discussions took place with staff regarding their professional development, promotional opportunities or new positions to broaden their nursing experience. A number of staff took this forward which is beneficial to the continued development of the Unit. Serious Adverse Events Two members of staff received high risk needle stick injuries, both of which were reported through a RIDDOR. At this time they have not resulted in the staff contracting an illness As reported in the mid report a patient’s relative also received a high risk needle stick injury whilst assisting his wife who was an in-patient. NHS Lothian needle stick policy was followed. Nil has resulted from this incident to our knowledge. Concerns Nil Complaints Ward 206 Transplant As previously mentioned earlier in the year, a liver patient raised a number of issues which included the standard of food within the hospital, the cleanliness of the toilets and staff attitude. This was all resolved locally with a written apology to the patient. Nil further NSD funded service patient complaints

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Infection Control We continue to clarify the infection control data before reporting to exclude:

• Instances of double counting • Infections, which originated outwith (but were attributed to) the Transplant Unit

since we obtained the specimens. Ward 206 Transplant Staphylococcus Bacteraemia We have had 3 SABS over the course of the year. 2 of which were imports and one MSSA Hospital Acquired Infection where the patient had multiple admissions to the Unit throughout the year. Clostridium Difficile Over the course of the year we have had 8 CDI within the ward. 2 patients with community acquired CDI 1 patient with known infection and possibly acquired from community 1 patient with a HAI although probable import from another hospital 1 patient admitted with CDI 3 patients HAI from multiple antibiotic use to treat infection and two of those patients had several admissions to the Unit over the course of the year. Ward 117 There were no incidents of Staphylococcus bacteraemia since April 2013. Clostridium difficile One incident of Clostridium difficile since April 13

1) Patient was undergoing care in the oncology unit but was readmitted to the Transplant Unit with severe chest sepsis. The patient received antibiotic therapy (appropriate) and this resulted in a CDI (he had previously been positive).

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Hand Hygiene Ward 206 Transplant The ward has an average of 93% for the year Ward 117 The High Dependency Unit has an average of 95-96% for the year. In ward 206 we introduced an electronic educational tool for hand hygiene for a set period of time. The audits thereafter did show an improvement in hand hygiene. Hand hygiene has to be constantly monitored with reminders to the MDT and re education where required. Mrs Jackie Bradie Clinical Nurse Manager QUALITY OF CARE The Transplant Unit QI team meets every 6 weeks and reports to the General Surgery CMT and distributes information to the unit staff via a newsletter. The team is truly multidisciplinary and includes representatives from gastroenterology, renal medicine, anaesthetics, nursing management, dietetics, OT and PT, pharmacy and transplant coordinators and chaplaincy. Over the last year the following projects should be highlighted: - Review of the Mid Staffordshire enquiry and relevance to patient care within the transplant unit - Review of transition from transplant HDU to main ward to reduce medication errors and patient risk during this transition. -“Going Home Post- Transplant” web site- peer reviewed web site accessible on NHS Lothian intranet and internet sites - Physiotherapy Integrated Care Pathways for post liver and kidney transplant - Reducing risk of prescribing errors- tacrolimus prescribing information added to SLTU letters - Liver Transplant protocols added to NHS Lothian intranet sites The QIP team also has responsibility for the organization of the annual SLTU Protocol Meeting (Appendix 1) John Casey Consultant Transplant Surgeon

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Social Work Staffing Staffing was at full complement up until the 19th May 2014 when the full time social worker went on secondment to a sector team. This is for one year and will come to an end on the 18th May 2015. Recruitment for the vacancy created by this secondment is currently under way. There is currently one part time social worker attached to the SLTU, working twenty five hours per week. Patient Activity Currently the social worker is actively working with 26 cases. From the 1st May 2013 to the 30th April 2014 285 assessments were completed; this figure reflects both duty and pre-transplant assessments. There were 187 specialist assessments and 98 hospital or duty assessments. Red Cross Liver Transplant Support Line (LTSL) The social work service has a continued partnership with the Red Cross Liver Transplant Support Line (LTSL) and attends the steering group quarterly to assist in identifying appropriate partnership activities. The Edinburgh and Fife groups have been closed due to low numbers in attendance. The Glasgow group continues to run with the support of volunteers. Projects Completed In 2013/2014 social workers collated responses from Questionnaires. Staff completed WRAP (Wellness Recovery Action Plan Training) training. With renal social workers, liver transplant social workers joined the Society for Transplant Social Workers and one staff member attended the 2013 Dallas conference. Live Donor social work involvement is ongoing and staff have contributed to the protocol in 2014. An outreach group for patients was successfully arranged and held in Glasgow in 2013. Groupwork on benefits changes, vocational rehabilitation, volunteering and time banking were successfully run on the unit. The SLTU social work website and booklet have been amended. CAB (Citizens Advice Bureau) have been approached for allocated RIE hours. This is ongoing and for further negotiation with senior social workers. Staff have contributed to the Outpatient Protocol document.

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Priorities and Projects Underway The Symptom Targeted Intervention (STI) Pilot is ongoing. Membership of the Society for Transplant Social Workers has been maintained. Information has been gathered about the use of hospital accommodation and patient/relative requests. This is ongoing. The Hospital Buddy scheme is ongoing.      Kate Sheridan Social Worker FINANCE Transplant Unit finance reports have already been forwarded to the NSD. Summaries of the financial reports for liver transplantation, SPK, islet and SORT services are shown in Appendix 2.

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SCOTTISH ORGAN RETRIEVAL TEAM

SCOTTISH ORGAN RETRIEVAL TEAM

Annual Report 2013/14

NHS Lothian

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Organ Retrieval Scottish Organ Retrieval Team The Scottish Organ Retrieval Team (SORT) is the regional retrieval team operating in Scotland, one of the seven National Organ Retrieval Service (NORS) teams. SORT came into being formally on April 1st, 2010. Based at the Royal Infirmary of Edinburgh, and the Golden Jubilee Hospital in Glasgow, SORT provides a multi-organ abdominal and cardiothoracic retrieval team for the Scottish region. Data provided in this report are as accurate as possible, but await final verification by NHSBT in June 2014. Location of Retrieval Operations The hospitals in which the 92 successful liver retrievals were undertaken are shown in Appendix 4. The principal locations were Greater Glasgow (31 donors), Grampian (16 donors), Lothian (15 donors), Northern Ireland (14 donors) and Tayside (10 donors). Transport Arrangements Road transport was used to all donor hospitals in Scotland. This financial year we used MTS for road transport of retrieval teams and unaccompanied livers. They have provided a reliable service, ensuring safe, efficient and timely transport of the team and/or unaccompanied livers. The contract for this service has been extended until the end of 2014 and the contract is put out to tender. During this financial year we were unable to use any scheduled flights. In total we chartered an aircraft on 59 occasions all through Amvale, similar to last year. On 17 occasions we chartered a flight for our retrieval team, 14 of these were to retrieve organs from Northern Ireland as 2nd on call for Newcastle. On 42 occasions we chartered a flight to import a liver. NHSBT continue to use Amvale to provide transport for transplantation in the UK. They are able to provide us with air transport for retrieval and imports and road transportation of unaccompanied livers from centres south of Leeds. Balance of Retrieval Activity Of the 92 livers successfully retrieved by SORT in 2013/14, 43 (47%) were transplanted in Edinburgh. While 49 (53%) were sent to other centres. 18 livers were retrieved by SORT as the 2nd on-call team for NORS. Mobilisations to potential donors Since 2011, SORT has doubled its activity levels. The SORT team were mobilised on 153 occasions from 1st April 2013 until 31st March 2014, which contrasts with the previous financial year, when 119 donors and potential donors were attended over the same time period. This represents an increase in activity since last year of 30%. On 27 occasions in 2013-2014, SORT was required to attend donors outside Scotland, acting as the backup team for another NORS team. On 4 occasions, another NORS team was required to come to a Scottish donor as SORT was already deployed. In April 2013, it was predicted

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that SORT activity would rise to 135-145 donors per annum in two to three years. This increase has taken place over the last 12 months. If we consider the level of donor activity seen in Spain (34 per million population per annum) as the ultimate level possible, this represents approximately 200 actual donors per annum in Scotland. If we include non-progressing donors, this equates to about 250 mobilisations per annum. Clearly, there is the potential for substantial further increases in SORT activity, despite the rapid rise we are currently experiencing. During discussions with NHSBT this year, it emerged that SORT activity as recorded by NHSBT may not be accurate. This is because SORT, as a combined abdominal and cardiothoracic team, may only register as one attendance when retrieving from a cardiothoracic/abdominal donor. In other regions, where abdominal and cardiothoracic teams are separate, two teams would be required for the same donor (two attendances). If this is taken into account, SORT were mobilised on 192 occasions in the last financial year (153 abdominal and 39 cardiothoracic). This figure should be used in any comparisons with NORS teams from other regions. Donors attended, Organs Retrieved 73 potential donors who had died after brain stem death (DBD) and 71 donors identified as potentially suitable for donation after cardiac death (DCD) were attended in the financial year 2012-2013. 9 callouts were stood down before the team arrived at the donor hospitals (153 abdominal mobilisations, 39 cardiothoracic mobilisations). SORT retrieved 226 kidneys, 92 livers, 41 pancreata, 25 hearts and 56 lungs for transplantation, along with 19 hearts for valves. This total of 440 organs for transplant is the highest number we have ever retrieved. This compares with 273 organs retrieved 2 years ago in 2011-2012. Funding Bid to NHSBT SORT has undergone an unprecedented change in activity since 2010. Whilst historical on-call rotas were adequate to support previous activity levels, current intensity means that it is no longer possible to deliver working rotas that are compliant with employment legislation. It was noted that an additional 4 surgical staff (excluding consultants) and 4 theatre staff were required to support the abdominal program, whereas 5 surgical staff were required for the cardiothoracic team. A bid was submitted to NHSBT to reflect these substantial cost pressures. After multiple rounds of negotiation, NHSBT declined to offer support, despite our contractual requirement with NHSBT to provide a team which is continuously available and which is compliant with legislation. Currently, NHS Lothian and The Golden Jubilee National Hospital are supporting the increase in establishment required to provide adequate staffing and compliance. Sustainability remains a concern in this situation. Currently, NHSBT are conducting a national review of organ retrieval services, including an economic assessment. Whilst it is unclear as to how this may translate to increased support for increased organ donation, it provides the raw material for informed debate. This is expected to report in early 2015. Normothermic Regional Perfusion Normothermic Regional Perfusion is a technique to improve the quality and quantity of organs retrieved from DCD donors. Mr Gabriel Oniscu, Consultant Surgeon, along with Mr Ian Currie, Clinical Lead for SORT, is leading the development of this technique in DCD donors. This technique, the results of which are shortly to be published in the American Journal of Transplantation, can improve organ quality and allow detailed assessment of organs prior to use. Both of these qualities lead to a substantial benefit for patients. A national collaboration is in progress between Edinburgh, Birmingham and Cambridge to develop this technique.

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Organ Donation in the Emergency Department Over 2013-2014, SORT has participated in a collaboration with the Emergency Department and with Specialist Nurses in Organ Donation to realise the potential for organ donation from the Emergency Department. Focussing on those potential donors who have recorded their wishes on the donor register, the program seeks to utilise Normothermic Regional Perfusion to preserve organs temporarily after death. This permits the time required to gain family authorisation and to assemble an organ retrieval team. Approximately 9 potential donors have been identified over the year. Whilst some had medical contraindications to donation, others died at a time where the retrieval team was already deployed and so could not attend. On other occasions, both consultant surgeons who contribute to the program were operating, and could not be freed up to attend the donor, or were out of the hospital on leave or at clinics/meetings. The logistical difficulties in the provision of this program have been significant, given that the program is running in addition to normal clinical commitments. A review of this pilot is to be conducted within the next two months. Performance Psychology SORT is a large clinical team, comprised of members of different seniority and experience, fulfilling different roles. The recent increases in workload and expansion in staff have brought new stresses to the team. It is well recognised from industry and the sporting world that the performance of such groups can deteriorate as a result of rapid changes, such as we have experienced. To address this issue, a collaboration with Edinburgh University Performance Psychology has been developed. Although at an early stage, this seeks to identify and manage team and individual characteristics which can improve team performance, and so optimise our performance under the challenging conditions we face. Conclusion SORT looks forward to increasing donor activity in Scotland, and to providing good quality grafts for seriously ill transplant candidates in Scotland and throughout the UK. Novel techniques underpin the progress which we are making in organ retrieval, maintaining the leading position of the Scottish Organ Retrieval Team in UK retrieval practice. Ian Currie Lead Clinician for SORT Transplant Surgeon

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SCOTTISH LIVER TRANSPLANT UNIT

Annual Report 2013/14

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Section A: Service Programme A2 Aim/Purpose/Mission Statement/Date of Designation SLTU aims to provide an equitable service for the population of Scotland to:

1. Assess the need for liver transplantation in patients with chronic liver disease. 2. Assess the need for liver transplantation and treat patients with acute liver failure. 3. To provide excellence in transplantation surgery including split liver transplantation,

donation after cardiac death transplantation and living donor liver transplantation. 4. To provide after care and long term follow up for patients who have undergone

transplantation. Introduction The past financial year has seen continued growth in terms of activity in the Scottish Liver Transplant Unit. 185 patients were assessed reflecting the increasing demand for liver transplantation. Estimates suggest that this does not reflect the scale of need for transplantation assessment in Scotland and that many patients are still not being referred. Previously identified anomalies in regional referral for assessment appear to have been addressed but there is a need for continuing education of referring clinicians to ensure that current guidelines for referral are widely disseminated throughout Scotland. It is intended to formally begin outpatient assessment of patients for liver transplantation with around a third of patients being estimated to be suitable for this approach. It is envisaged that this will improve the quality of patient experience and also assist with ward bed occupancy and patient flow through the Transplant Unit. The Unit continues to transplant a high proportion of adult split liver transplants although last year more splitting procedures were performed in paediatric centres because of a change in regulation over this issue. A recent report from the Liver Advisory Group showed that there was no difference in outcome of livers in either paediatric or adult recipients dependent on whether the liver was split by a paediatric or an adult surgeon however adult patients may be being disadvantaged by longer cold ischemic times when livers are split at the paediatric centre rather than the adult centre. The size of the waiting list for liver transplantation has been sitting at around 40-50 patients for the past year despite the unit performing 95 liver transplants. 6 patients died on the waiting list for liver transplantation and 13 were removed predominantly because of deterioration of clinical condition. Waiting times remain short for Top Band patients but are still long particularly for blood group O patients with less severe liver disease. The unit is developing experience transplanting livers form donors were normothermic reperfusion has been used and early experiences are very encouraging. Early experience with NRP suggests that it may lead to increasing use of livers from Maastricht category 3 donors (50% of DCD donors with NRP go on to have liver transplanted compared with 27% without NRP) and by reducing the need for retransplant by preventing ischemic biliary injury in DCD donors.

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Almost 2000 follow up clinic visits were undertaken by SLTU with around 7% of these being outreach clinics. Expansion of the outreach service is considered a desirable feature of the programme in terms of improving equity of access and patient convenience but is limited to an extent by the number of specialist transplant hepatology sessions. Professor Stephen J Wigmore Clinical Director Transplantation

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A3 Description of Patient Pathway A3a) Target Group for Service or Programme The Scottish population with chronic liver failure requiring specialist management including assessment for and treatment by liver transplantation. Perioperative and postoperative specialist care. Liaison and provision of advice to referring clinicians regarding suitability for assessment, specialist interventions and post transplant care of patients with liver disease.s A3b) Abbreviated Care Pathway for Service or Programme

Patient referred by hepatologist

Admission to SLTU for assessment

Listed for transplant

Management on the waiting list

Admission to SLTU for Transplant

Yes

Follow up post transplant

No

Chronic liver disease

SLTU or shared

care

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Section B: Quality Domains B1 Efficient B1a) Report of Actual v Planned Activity Analysis of Activity Assessment for chronic liver disease and elective transplantation: During the year 1 April 2013 - 31 March 2014, 185 patients with chronic liver disease were admitted for consideration for elective liver transplantation. Of these 185 patients, 111 were placed on the waiting list and 83 subsequently underwent liver transplantation. 15 of the 83 were transplanted from the NLA Top Band waiting list. The causes of chronic liver disease leading to elective liver transplantation are shown in Appendix 3. Alcoholic liver disease on its own and combined with another liver disease was the most common indication for referral for assessment 90 (47%). The second most common referral was hepatocellular carcinoma plus other diseases 53 (29%). Non alcoholic fatty liver disease was the third most common indicator at 38 (20%). Of the 47% of patients referred with alcoholic liver disease plus another liver disease, 48% were accepted for listing for transplantation, this percentage remains consistent. Details of the Unit’s activity are summarised in an activity report Appendix 3. Re-transplantation 15 patients were listed for re-transplantation, 3 for disease recurrence, 3 for graft cirrhosis, 2 for chronic rejection, 2 for primary non function, 2 for hepatic artery thrombosis, 1 for ischaemic cholangiopathy, 1 for veno occlusive disease and 1 for secondary biliary cirrhosis. Of the 15 patients listed, 7 have been transplanted, 1 patient died, 1 patient was removed and 6 remain active on the waiting list. Emergency Transplantation Of the 51 patients referred for management of fulminant hepatic failure, 15 were listed for super urgent transplantation. 12 of these patients received a transplant within 1-4 days (see Appendix 3). 1 patient died on the super urgent waiting list, and 2 patients were removed from the list as their condition deteriorated and subsequently died. Donor Liver Offers to SLTU From 1 April 2013 to 31 March 2014 a total of 684 donor livers were offered to SLTU which is an increase of 16% (Appendix 4). 95 were accepted and 589 were declined. On average each month 57 actual donor liver offers were made. Of the 589 livers declined, 335 were from DCD donors. This is a 7% increase from last year. 254 were from DBD donors, an increase of 36% from the previous year. The main reasons for not accepting DCD livers was clinical 165 (48%), age 92 (27%) and logistics 39 (11%). The main reason for not accepting DBD livers was clinical 103 (40%), blood group 36 (14%) and logistic 32 (12%).

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Other Operations/Procedures 4 patients underwent hepatico-jejunostomy. Results During the year, there were no intra-operative deaths. 5 patients died post-operatively, within 30 days of surgery. 3 from the elective waiting list and 2 from the super urgent waiting list. (Appendix 3). Mrs D Hill and Ms Wendy Herries Liver Transplant Co-ordinators Live Donor Liver Transplantation SLTU continues to offer live donor liver transplantation (LDLT) to patients registered on the elective liver transplant waiting list. Uptake remains low despite repeated approaches from transplant co-ordinators and medical/surgical staff. Indeed in the financial year 2013/14 of 99 patients listed for elective liver transplantation approaches were made to 93 recipients and LDLT discussed. Of those approached in only 6 instances did the recipients have a potential live donor that approached the unit for assessment. The most common reasons for not identifying a potential live donor continue to be reluctance of the recipient to consider LDLT and the recipient undergoing early transplantation. Whether patient attitudes in Scotland to LDLT will change, or indeed can be changed, is not clear, but with increasing deceased donor liver transplant rates nationally it may well be that waiting times will reduce which may constitute a further negative influence on the uptake of LDLT. Although the projected increase in chronic liver disease may well negate the effects of increasing donor rates; indeed the national deceased donor waiting list reached an all time end of financial year high on 31st March 2014 with 521 patients on the waiting list despite 899 liver transplant being performed that year. It must however by noted that the issues facing the LDLT program within Scotland are not unique. Activity remains low across the United Kingdom (3.1% of all transplants) and this coupled with a live liver donor in another unit suffering major complications, has led to review within the liver transplant community. This has consisted of a UK-wide consensus conference organised jointly by the British Transplant Society and NHS Blood and Transplant and held on the 22nd November 2013, and an on-going review of LDLT commissioning within England. The final document from the consensus meeting is awaited. The on-going review of commissioning of LDLT in England is being undertaken by a Fixed-Term Working Unit within the Liver Advisory Group at the direction of the NHS England. Although this review does not consider the LDLT programme within Scotland, any recommendations regarding minimum standards and volumes may have relevance to the Scottish Programme. Risk Assessment The LDLT programme received a letter from Malcolm Chisholm MSP regarding one of his constituents who is on the elective liver transplant waiting list. The constituent was concerned about the apparent lack of progress with the assessment of a possible live donor. The unit had been initially informed of the possibility that the recipient’s brother who lived in Italy was willing to be considered as a live liver donor. A completed live donor

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health questionnaire was returned to SLTU following which the LDLT co-ordinators attempted to contact the potential live liver donor in Italy but no response was forthcoming. Following receipt of the letter from Malcolm Chisholm it transpired that the recipient had filled out the form himself and had returned it to the unit. Contact has now been established with the possible live liver donor and assessment is on-going. 1 http://www.organdonation.nhs.uk/statistics/downloads/united_kingdom_mar14.pdf James Powell Consultant Surgeon

SCOTTISH LIVER TRANSPLANT UNIT ROYAL INFIRMARY OF EDINBURGH NHS TRUST Comment LIVE DONOR LIVER TRANSPLANTATION NATIONAL SPECIALIST SERVICE – Annual Activity Report Year Report 2013 - 14 STATEMENT OF ACTIVITY Activity Financial Year 1. Recipient Families Approached 93 No formal approach was

made when there was obvious Recipient contraindications.

Outcome 2a. Did not progress 87

Family did not identify / refused potential donor 37 Recipient refused unit approach to family 3 Transplanted soon after listing 24 Listed Top Band 12 Registered UKELD above 62

Recipient unsuitable clinical 7 Recipient Removed unwell 2 Family medically contraindicated 2 Assessments 2. Donor Family Assessments 6 Recipient Received OLT 1 Clinical – Fatty liver / LFT’s 2 Ongoing 3

Acute Liver Failure Programme The number of patients admitted to the SLTU in the last year with acute liver failure increased again to 50 cases. The unit continues to provide telephone advice to physicians around Scotland on at least three times as many cases as these. Paracetamol overdose remains the most common cause of acute liver failure admitted to the unit. Currently there is a review of the listing criteria for acute liver failure in the UK, the Kings College criteria continue to be applied to determine poor prognosis. The transplant rates and non-transplant survival are broadly similar to recent experience. 12 patients were considered candidates for transplantation with 10 (80%) surviving to discharge.

Kenneth Simpson Consultant Physician

50 patients 37POD 13NonPOD

18 Met KCC Criteria 11 POD 7 NonPOD

32 Did not meet KCC Criteria 26 POD 6 NonPOD

12 Transplant Candidates 5 POD 7 NonPOD

6 PODs Not Transplant Candidates

10 Survived WITH Transplant 4 POD 6 NonPOD

1 Survived NO Transplant

32 Survived No Transplant 26 POD 6 NonPOD

KEY: POD – Paracetamol Overdose NonPOD –Other causes Acute Liver Failure KCC – Kings College Criteria

1 Non POD Died NO Transplant

5 Died NO Transplant

1 POD Died with Transplant

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B1b) Resource Use Analysis of Trends, Demands and Referral Patterns The growth in liver transplant activity in Scotland seen in recent years has been maintained in 2013-14. The actual number of transplants was up slightly to 95. There was a 12% rise in the number of patients assessed for liver transplant, with the highest ever number of elective transplant assessments (185 in 2013-14). The 3 commonest indications for the liver transplants performed remain unchanged with liver disease related to alcohol being the principal reason in 43 patients, of whom 12 also had hepatocellular carcinoma (HCC). Hepatitis C virus (HCV) and non-alcoholic fatty liver disease (NAFLD) are the other 2 major aetiologies with 34 patients having a contribution of HCV to their disease and 19 for NAFLD. These patterns continue to reflect the demographics of liver disease in Scotland with alcohol, obesity and viral hepatitis the major killers. Cirrhosis results in death from either liver failure or liver cancer, and the increasing numbers of patients transplanted for HCC reflects both the rising rates of cirrhosis and the successful detection of HCCs at an early, curable stage. It is very likely that these indications will continue to dominate the demand for liver transplantation in Scotland for the foreseeable future although the new treatments becoming available in the next 12 months for HCV are likely to have some impact within the next 5 years. The number of those on the list not surviving to transplantation remains around 10-15 % of the total number of transplants indicating the continued need for an increase in suitable donors. Andrew Bathgate Consultant Physician Indications for Liver Transplantation within SLTU – April 1992 to March 2014

0 0 02 3 2

5 5 58 8

58

10 9

18

11 10

22

0

5 5 6 7 8

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9

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97

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0 0 0 1 14 5 4 5 5 5 4

79

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128

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1992/9

393/9

494/9

595/9

696/9

797/9

898/9

999/0

0

2000/0

1

2001/0

2

2002/0

3

2003/0

4

2004/0

5

2005/0

6

2006/0

7

2007/0

8

2008/0

9

2009/1

0

2010/1

1

2011/1

2

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3

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14

Hep CALDHCC / OtherPBCNAFLD

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Analysis of bed occupancy In spite of attempts to improve patient flow the pressure on beds remains very high, partly because of the large increase in transplant assessments and the increasing pool of patients requiring readmission from all of the different components of transplantation in Edinburgh. The bed occupancy rate of 95% -105% is very high and places unacceptable pressures on organization and flow for the senior nursing staff. Resolution of issues around establishing outpatient liver transplant assessment is approaching conclusion and it is anticipated that this will ease pressure on ward beds. It may also be possible to use space in this facility to avoid admission to the ward for patients attending for relatively simple treatments or investigations. Investment has been made in care assistant posts to facilitate these transplant patients attending DOSA. Critical care bed occupancy remains at an acceptable level however intensive care unit occupancy figures remain high but this may partly reflect the mixed level 2 and level 3 constitution of Ward 118. All of the services are constantly reviewed to make bed usage as safe and efficient as possible. B1c) Finance and Workforce Delays in appointment of a number of key posts resulted in an underspend last year however these posts are now in place and this situation is unlikely to recur. Investment from NHS Lothian has occurred outside of the normal NHSBT SORT contract to support additional posts in theatre nursing staff and organ retrieval medical staff in the short term to ensure that rotas for both groups are European Working Time Directive compliant. B1d) Key Performance Indicators (KPIs) and HEAT targets There are currently no KPI or HEAT targets set around liver transplantation in Scotland. As mentioned elsewhere patient centred Quality Performance Indicators re currently being developed. B2 Effective B2a) Clinical Audit Programme The unit contributes actively to National audit statistics concerning liver transplantation and submits data on a routine basis on every case that passes through the unit. B2b) Clinical Outcomes/complications rates/external benchmarking SLTU is subject to external audit and is benchmarked against other UK transplant centres through the Royal College of Surgeons of England Liver Transplant Audit (Appendix 5). The unit registers patients with a higher illness severity (MELD) score than other UK units and maintains consistently high performance in short and long term graft ad patient survival outcomes compared with the other UK centres. Outcomes in terms of patients and graft survival are updated monthly via CUSUM plots which demonstrate our current

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performance compared with previous performance and monitor maintenance of standards of quality and patient safety. B2c) Service Improvement We have instituted bimonthly Directorate meetings Chaired by Professor Wigmore to which an open invitation is extended to all staff. Under the aegis of this meeting a number of service improvements have been made and the service continues to undergo re-design and remodelling to improve efficiency, effectiveness and to improve value for money. A major review of administration and clerical procedures has been initiated and a number of changes to process have been made. Other areas of activity will be highlighted over the coming year in particular liver transplant assessment and whether there is scope to undertake limited assessments on an outpatient basis. As mentioned above, outpatient assessment of suitable liver transplant assessment patients is being initiated within the DOSA facility which will improve quality of experience for those patients while reducing the burden on inpatient ward beds. Investment has been made through slippage monies into the Vital Data electronic patient record system which will supersede Proton. Groups from within the unit are working to create and design the new interfaces for the patient record system. B2d) Research This has been another good year for research in the Scottish Liver Transplant Unit with a large number of papers and significant grants. This research has been undertaken in collaboration with the University of Edinburgh and holds great potential for significant advances in the area of liver failure and transplantation over the next few years. Ever since opening over 20 years ago the Scottish Liver Transplant Unit has considered clinical research, audit and more recently research in basic science to be an important component of the Unit’s activity. Since opening the Unit has developed numerous links with other Departments within the Hospital and University and other Institutions which have enabled inter-departmental research to be successfully carried out. These departments include: Hepatology, Surgery, Anaesthetics, Psychological Medicine, Nephrology, Nursing, Haematology, Pathology, Radiology and Cardiology. Research links with Clinical Psychology at Stirling University continues to be fruitful. Important links have also fostered with the Clinical Research Facility. The Unit acts as a National referral focus for a large variety of patients with acute and chronic liver disease and this has allowed larger databases of patients liver problems to be established which have been invaluable in allowing high quality audit of the Unit. These have led to numerous presentations at National and International meetings and publications in high quality journals. SLTU continues to have both a National and International profile for liver research. The main research projects are outlined below. Over the last 12 months or so DRs Jonathan Fallowfield and Neil Henderson have been successful in obtaining senior fellowships in liver research and John Plevris was awarded an Honorary professorship with the University for his work on the bioartificial liver.

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Acute liver failure The Scottish Liver Transplant Unit is the primary referral site for patients in Scotland with acute liver failure. Each year approximately 50 patients with acute liver injury are transferred to the Unit and the most common cause for this injury is Paracetamol poisoning. A large database has been developed and Dr Kenneth Simpson along with Dr Darren Craig continue to publish in this area.. A recent study looking at monocytes in acute liver injury holds promise as being prognostically accurate. Cellular therapy A major interest of the Unit for a number of years is the possibility of using stem cells in the area of transplantation including their use to generate hepatocytes for bioartificial liver devices. Professor Stuart Forbes has been working in the Unit for a number of years and has an International reputation for liver stem cell research. He has recently obtained a grant from the Sir Jules Thorn Fund for over one million pounds and funding from the Medical Research Council to look at the possibility of using stem cells to treat liver disease. Studies have also been set up in conjunction with the Transplant Unit in Birmingham and recruitment in the Liver Unit is well under way in Edinburgh with the appointment of Dr Joanna Moore. Professor Stuart Forbes along with Professor John Iredale and a large team of clinical research fellows are not only undertaking highly acclaimed research work, but also helping clinically to support the Unit. The opening of the MRC Centre for Regenerative Medicine in the Business Park next to the hospital in the near future we hope will increase our capacity to undertake translational research and benefit patients with liver disease in Scotland. Cardiovascular risk in liver transplantation A large prospective study of patients being assessed for liver transplant was recently undertaken in the Unit recruiting approximately 200 patients who at the time of assessment had a wide range of tests undertaken to try and identify cardiovascular risk. Data from this cohort is presently being analysed and publications are expected in 2013/14. Bioartificial Liver Development The large European grant in association with Amsterdam to develop a bioartificial liver has progressed well this year but the clinical phase is still some time off. Use of a different system, the ELAD will be trialled in the RIE this year. As mentioned above Dr Plevris who leads this was promoted in 2013 to Professor Plevris. Grants 2011 – 2013 CSO A randomised controlled trial to test if a simple anticipated regret manipulation leads to a significant increase in organ donor registrations. Professor R O’Carroll, Professor E Ferguson and Professor P C Hayes £162,650 2007–2013 Sir Jules Thorn Charitable Trust Stem cell therapy for cirrhosis. Professor S Forbes, Professor P C Hayes, Professor J Iredale, Dr C Bellamy. £1.1 million 2011-2015 MRC-MRF Establishment of a resource for long term study of hepatitis C virus infection in the UK. Multicentre study. 1.9 million

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2011-2014 Wellcome Trust/Scottish Translational Medicine and Therapeutics Initiative. Relaxin as a therapeutic haemodynamic modulator in liver disease. V Snowdon, J Fallowfield, Hayes P, Iredale J £244,706 2012- 2015 Development of a bioartificial liver therapy in acute liver failure. European Commisssion Grant FP7. Professor Chameleon in Amsterdam. PI in Edinburgh Dr J Plevris, Co-applicant Euro 6.3 million 2012-2014 CSO Tissue engineering of 3d human hepatic organotypic model using novel cell, biomatrix and bioreactor enabling technologies for pharmaceutical applications PI John Plevris. Co-applicants L Nelson and Professor P C Hayes £280, 550 2013-2014 Novartis-sponsored Phase II Clinical Trial NCT01640964 (J Fallowfield: CI). Ulrich M, Bush C, Severin T, Dongre N, Semple S, Hayes P, Fallowfield J. An exploratory study to investigate the haemodynamic effects of serelaxin in patients with compensated cirrhosis and portal hypertension. 360,000. Status: recruiting 2014-2016 Technology Strategy Board (Enhancing In Vivo Imaging for Stratified Medicine) (J Fallowfield: co-PI). LiverMultiscan with MRI replacing liver biopsy. £229,024 to Edinburgh (total grant award £1.22 million to Perspectum Diagnostics, University of Edinburgh and University of Birmingham) Publications Nelson LJ, Treskes P, Howie AF, Walker SW, Hayes PC, Plevris JN. Profiling the Impact of Medium Formulation on Morphology and Functionality of Primary Hepatocytes in vitro. Scientific Reports 2013 Sep 24;3:2735.

Manousou P, Cholongitas E, Samonakis D, Tsochatzis E, Corbani A, Dhillon AP, Davidson J, Rodríguez-Perálvarez M, Patch D, O'Beirne J, Thorburn D, Luong T, Rolles K, Davidson B, McCormick PA, Hayes P, Burroughs AK. Reduced fibrosis in recurrent HCV with tacrolimus, azathioprine and steroids versus tacrolimus: randomised trial long term outcomes. Gut. 2013 Oct 16. doi: 10.1136/gutjnl-2013-305606. to go in cv Moore JK, Love E, Craig DG, Hayes PC, Simpson KJ. Acute kidney injury in acute liver failure: a review. Expert Rev Gastroenterol Hepatol. 2013 Oct 17. in press to go in cv Tripathi D, Hayes P. Beta blockers in portal hypertension: new developments and controversies. Liver Int. 2013 Oct 17 in press to go in cv Craig DG, Lee P, Pryde EA, Hayes PC, Simpson KJ. Serum neopterin and soluble CD163 as markers of Macrophage activation in paracetamol (acetaminophen) – induced human acute liver injury. AP & T 2013;38:1395-1404 Morling J, Fallowfield J, Williamson R, Nee L, Jackson A, Glancy S, Reynolds R, Hayes P, Guha I, Strachan M, Price J. Non-invasive hepatic biomarkers (ELF and CK18) in people with type 2 diabetes: the Edinburgh Type 2 Diabetes Study. Liver Int. 2013 Nov 15. doi: 10.1111/liv.12385.

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Walton H, Masterton G, Hayes P. An epidemiological study of the association of coffee with chronic liver disease. Scott Med J. 2013 Nov;58(4):217-22. Review article: J.A. Leithead, P.C. Hayes, J.W. Ferguson. Advances in the management of patients with cirrhosis and portal hypertension-related renal dysfunction Alimentary Pharmacology and Therapeutics Feb 2014: 39(7):699-711 Review article: 2014 UK consensus guidelines - hepatitis C management and direct-acting anti-viral therapy. Miller MH, Agarwal K, Austin A, Brown A, Barclay ST, Dundas P, Dusheiko GM, Foster GR, Fox R, Hayes PC, Leen C, Millson C, Ryder SD, Tait J, Ustianowski A, Dillon JF.Aliment Pharmacol Ther. 2014 Apr 22. doi: 10.1111/apt.12764. [Epub ahead of print]

Attendance at specialist hepatitis clinics and initiation of antiviral treatment among persons chronically infected with hepatitis C: examining the early impact of Scotland's Hepatitis C Action Plan. McDonald SA, Hutchinson SJ, Innes HA, Allen S, Bramley P, Bhattacharyya D, Carman W, Dillon JF, Fox R, Fraser A, Goldberg DJ, Kennedy N, Mills PR, Morris J, Stanley AJ, Wilks D, Hayes PC. J Viral Hepat. 2014 May;21(5):366-76. doi: 10.1111/jvh.12153. Epub 2013 Sep 2. Markedly Increased High-Mobility Group Box 1 Protein in a Patient with Small-for-Size Syndrome. Craig DG, Lee P, Pryde EA, Hidalgo E, Hayes PC, Wigmore SJ, Forbes SJ, Simpson KJ. Case Rep Transplant. 2014;2014:272498. doi: 10.1155/2014/272498. Epub 2014 Jan 29.Mobasher MA, González-Rodriguez A, Santamaría B, Ramos S, Martín MÁ, Goya L,Rada P, Letzig L, James LP, Cuadrado A, Martín-Pérez J, Simpson KJ, Muntané J,Valverde AM. Protein tyrosine phosphatase 1B modulates GSK3β/Nrf2 and IGFIRsignaling pathways in acetaminophen-induced hepatotoxicity. Cell Death Dis. 2013 May 9;4:e626. doi: 10.1038/cddis.2013.150. PubMed PMID: 23661004; PubMed Central PMCID: PMC3674359. 2: Moore JK, Craig DG, Pryde EA, Walker SW, Beckett GJ, Hayes PC, Simpson KJ.Persistently elevated troponin I in paracetamol hepatotoxicity: association with liver injury, organ failure, and outcome. Clin Toxicol (Phila). 2013 Aug;51(7):532-9. doi: 10.3109/15563650.2013.816853. Epub 2013 Jul 5. PubMed PMID:23829708. Peter Hayes Professor of Hepatology

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3 Safe B3a) Risk Register Waiting list patients- A written list of all patients on the waiting list for liver transplantation is maintained by the unit and reviewed on a weekly basis by the whole unit in the Liver Assessment meeting. This list is used to update the team on the weekly status of patients awaiting liver transplantation, to document specific areas for concern relating to technical issues and to indicate patient choice for example with respect to split or DCD liver transplantation. B3b) Clinical Governance SLTU is an active participant in many aspects of clinical governance including internal audit, morbidity and mortality meetings, representation on the QIP team and external audit as mentioned previously through the Royal College of Surgeons Liver Transplantation Audit. The Unit is also represented by a consultant physician and surgeon on the UK Liver Advisory Group which is a forum for discussion of all aspects of liver transplantation in the UK many of which pertain directly to patient safety and clinical governance. B3c) Healthcare Associated Infection (HAI) and Scottish Patient Safety Programme (SPSP) The SLTU is fully engaged with SPSP and HAI programmes and monthly infection and incident rates are posted on the ward under the supervision of our Charge Nurse. The Unit has a good patient safety record and considering the complexity of the surgery and the immunosuppressed nature of our patients a good HAI record. Our daily ward rounds are frequently attended by a Consultant microbiologist who advises on individual and unit policies regarding HAI. B3d) Adverse Events Adverse events are discussed at the Morbidity and Mortality section of our weekly multidisciplinary team meeting on Friday afternoon. Cases such as near misses, serious adverse events and the outcomes of all patients presenting with acute liver failure are discussed and a minute of the discussion and action points raised is kept. SLTU also complies with NHS Lothian policy on adverse events and harm and all serious events are escalated professionally and operationally within the Acute Division and are investigated and managed utilising same procedures as all other serious events. B3e) Complaints/Compliments The unit receives a large number of compliments from patients and their families and very few complaints. Any complaints are dealt with promptly and in compliance with NHS Lothian policy for complaints.

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B4 Timely (Access) B4a) Waiting/Response Times

(i) Waiting Times/Response Times Targets Assessment This year 185 patients with chronic liver disease were assessed for liver transplantation. The median waiting time between referral and assessment was 3-4 weeks. There is no set target for waiting time for assessment in the UK but it has been the Unit policy to attempt to keep this period less than 4 weeks. Urgent referrals are seen more rapidly and the greatest limitation to assessment is beds and time/resources to undertake assessments. Appendix 4 Blood group B and small blood group O patients continue to have the longest waiting times and this is similar in other centres across the UK. Waiting List This year there were 6 deaths on the elective liver transplant waiting list and 3 on the super urgent waiting list. In addition 13 patients were removed from the elective waiting list. On five occasions this was because the patient’s condition was improving. The other 9 patients were removed due to their condition deteriorating, or they became outwith criteria. 3 patients were removed from the super urgent waiting list, 2 as the patient’s condition improved and 1 as they were too sick. Waiting times are shown in Appendix 3.

(ii) Slippage

(iii) Exceptional Circumstances Affecting Targets

B4b) Review of Clinical Pathway

(i) Review and Changes to Clinical Pathway

There have been no major changes to the patient clinical pathway. Minor changes have been discussed at the Liver unit protocol meeting and are documented in the unit protocol.

(ii) Improvements to Local Delivery of Care B5 Person Centred

B5a) Patient Carer/Public Involvement B5b) Better Together Programme Involvement B5c) User Surveys

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B6 Equitable B6a) Fair for all: Equality & Diversity All policies and procedures within Transplant assessment, allocation and delivery comply with NHS Lothian Equality & Diversity policies. We have a full assessment undertaken on all patients referred to the unit. Assessment and transplant criteria is based on medical need and is not in any way influenced by age, sex, religion, colour or economic status. Full psychological screening and assessment is undertaken and complies with UK transplant standards. B6b) Geographical Access The SLTU accepts referrals from every corner of Scotland. More than 950 patients who have previously received liver transplants are alive and living in every region of Scotland There is an active programme of outreach clinics from hepatologists visiting all of the major centres in Scotland to assess and review potential patients. In addition to formal referrals the Unit acts as a reference point for advice regarding complex issues around acute and chronic liver disease in Scotland. Details of patients referring Health Boards are given in Appendix 3 Section H. The previously reported anomalies in referral rates from different health boards based on population have now been addressed and resolved. Section C: Looking Ahead/Expected

Change/Developments Northern Liver Alliance The Northern Liver Alliance was established in August 2006 as a collaboration between Edinburgh, Newcastle and Leeds Liver Transplant Units. The main purpose of the NLA was to reduce mortality on the liver transplant waiting list in Scotland and in the North of England. The three transplant units within the NLA have been sharing their deceased donor pools in order to give priority to sick patients on the waiting list who are at greater risk of dying. The collaboration has been enthusiastically supported by all staff, has operated in a remarkable spirit of mutual trust and has been admired by the remaining four liver transplant units in the U.K. In the last three years Liver Selection Allocation Working Party (LSAWP) at NHSBT has separately been working towards development of a new National Allocation Scheme for deceased donor liver grafts in the U.K. A new allocation system (if it entails a single national waiting list) may ultimately make the NLA prioritisation obsolete. M Akyol from Edinburgh has chaired the NLA since its inception, until 2013. At the Autumn 2012 meeting of the NLA, a proposal to rotate the chair of NLA on an annual basis between Edinburgh, Leeds and Newcastle was accepted. In 2013 the chair passed to Leeds and the current chairperson is Mr Ernest Hidalgo.

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NLA, has been an important factor in the increased liver transplant activity in Edinburgh. Its participants also firmly believe that it has prevented deaths on the waiting list in Scotland and in the North of England. Murat Akyol Consultant Surgeon Liver Allocation Working Group NHSBT continues to develop UK policy and guidelines for liver transplantation supported by the Liver Advisory Group (LAG) and its Liver Selection and Allocation Working Party (LSAWP) subgroup. SLTU has representation on both LAG and LSAWP.

The following are the major areas that have concerned LAG and LSAWP over the last 12 months –

Changes to the Solid Organ Advisory Groups:Liver Advisory Group. The Solid Organ Advisory Groups support NHSBT in developing UK policy and guidelines for transplantation. Following an external review in 2012 changes to the structures of the Solid Organ Advisory Groups were implemented in 2013. The changes included the addition of two competitively appointed lay representatives and two patient support group representatives to the Liver Advisory Group (LAG), the abolition of the Liver Selection and Allocation Working Party (LSAWP) and the formation of a Core Working Group with responsibility for pursuing objectives defined by LAG. The LAG continues to have 2 representatives from SLTU. The Core Working Group consists of 6 individuals, one of whom is from SLTU, but these individuals do not act as representatives of individual units rather they act at the direction of LAG. In addition, a number of Fixed-Term Working Groups have been established to review specific aspects of liver transplantation (individuals from SLTU are involved in these groups). Furthermore, following competitive interview Professor John O’Grady from King’s College Hospital was appointed Chair of LAG in place of Dr Alex Gimson who had completed his terms of office. Liver Allograft Distribution and Allocation. NHSBT remains committed to the development of a transparent, objective, equitable and effective liver transplant allocation scheme. The 2010-11 SLTU Annual Report documented the initial development of a new liver transplant allocation scheme with subsequent Annual Reports describing the difficulties encountered in progressing this work. The 2012-13 Annual Report also documented changes required by NHSBT with regard to the ordering of the elective liver transplant waiting list within transplant units according disease severity, as defined by UKELD, and the requirement to consider allocation of brain stem dead donor (DBD) allografts to those with highest ranking; donation after cardiac death (DCD) allografts were excluded from this stipulation. These changes were however deemed to be temporary measures brought in to increase transparency, objectivity and to standardise practice across UK units, and that a definitive allocation scheme remained imperative. Following appointment of the new Chair of LAG and the introduction of a new LAG workplan, the core working group with support from the FTWUs have been tasked with providing a proposed new liver allocation scheme by September 2014, for consideration by key stakeholders before introduction. This work has

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a number of aspects some of which are continuations of those undertaken by the LSAWP, but others are new. Although a deadline of September 2014 has been set for a proposed new scheme considerable work remains before meeting the challenge of introducing major and possibly controversial change. Liver Allocation Zones. The size of the liver allocation zone for each liver transplant unit and hence number of donor liver allografts available for transplantation, is linked to the annual number of elective registrations by each unit. NHSBT through LAG undertakes annual analysis of the number of elective liver recipient registrations and recalculates liver allocation zones if there are significant differences between unit registrations and allocation zone size. Analysis in November 2013 did not require any changes to donor allocation zones to be made. Further review will be undertaken in November 2014. Liver Transplantation in Severe Acute Alcoholic Hepatitis (SAAH). Previous Annual Reports have detailed the history of a proposal for a service development analysis of liver transplantation for severe acute alcoholic hepatitis. This service development analysis was initially proposed following publication in 2011 of a series of patients undergoing liver transplant for SAAH in France. Given that transplantation for SAAH might prove highly controversial, and indeed has divided opinion within LAG/LSAWP, the proposal has been subject to wide discussion within NHSBT before agreement from the NHSBT Board was granted in March 2014 to proceed with the service development analysis wherein liver transplantation would be undertaken in 20 patients with SAAH according to a strict nationally agreed protocol. Following careful dissemination to media of the NHSBT Board decision, SAAH was established as an indication under the heading of service development. However, only 5 of the 7 liver transplant units within the UK have stated that they will participate in the service development analysis; SLTU and Birmingham have indicated that they will not participate in the service development analysis; SLTU and Birmingham have indicated that they will not participate. This decision was made based on the opinion of a broad range of specialists in liver transplantation working within the SLTU based on concerns that this was an unevidenced service development rather than a formal clinical trial and that patients currently on the waiting list would be disadvantaged by our participation. It was acknowledged that patients with acute alcoholic hepatitis in Scotland might potentially be disadvantaged by the non-participation of SLTU in this study. NSD were informed of this decision informally Criteria for Listing of Patients with HCC. Selection of patients with hepatocellular carcinoma onto the elective liver transplant waiting list remains under review within LAG. This has resulted in changes to the currently agreed UK national listing criteria. These changes have lowered the threshold for a tumour marker (AFP) above which listing for liver transplantation is not allowed. Changes were made because of analyses demonstrating poor outcome following liver transplantation for HCC in patients with very high levels of AFP. The changes to listing criteria have been disseminated through the Scottish National Hepato Pancreatico Biliary National Managed Clinical Network to clinicians involved in the care of patients with HCC. Further changes to selection criteria for HCC were considered at a UK consensus conference on 17th January 2014 and form the remit for a Fixed Term Working Unit under LAG. It is likely that further modification of selection criteria will occur and that these will require wide dissemination within Scotland. Development and Improved Understanding of Measures of Liver Transplant Performance. NHSBT remains committed to reducing inequity of access to and variation in transplantation within the UK. Analysis undertaken within NHSBT at the direction of LAG has demonstrated variation in a number of recorded measures between liver transplant

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units (e.g. rates of liver allograft acceptance/utilisation, waiting list size and waiting list times). However it is not known whether the observed differences are appropriate with units adhering to best practice or whether variation is due to poor practice and as such are clinical governance concern. Consequently LAG is developing improved metrics of liver transplant unit performance in addition to continued work that attempts to determine the relevance of any observed variation. Novel measures of liver transplant unit performance would supplement currently published data including those contained within NHSBT Annual Reports, NHSBT CUSUM monitoring and the annual UK and Ireland Liver Transplant Audit. Finally, as part of the NHS England Commissioning for Quality and Innovation (CQIN) payment framework LAG is developing a number of measures that may be adapted for use by SLTU as measures of patient care that can be included in the SLTU annual report. UK and Ireland Liver Transplant Unit Meeting. A meeting of the UK and Ireland liver transplant units has been organised annually on a rotating basis by the 8 transplant units. This meeting has provided an informal but robust forum for the liver transplant units to discuss issues relevant to liver transplantation within the UK. This meeting has been funded by donations from industry allowing units to send any member of the liver transplant team and not just clinicians. However after NHSBT and NHS England suggested that the meeting was not fit for purpose in its present format a decision was made to establish a British Liver Transplant Group under the auspices of the British Association for the Study of the Liver (BASL). The British Liver Transplant Group will hold a meeting alongside the BASL annual meeting. The inaugural meeting of the British Liver Transplant Group will occur on the 18th September in Newcastle. Although the intention is to provide a more formalised meeting the potential exists that by allying the meeting to BASL, which is for the most part attending by physicians, the effect may be to reduce participation by all individuals involved in liver transplantation. Review of Adult to Adult Live Donor Liver Transplantation (LDLT) in England. As discussed in the section regarding the SLTU LDLT programme, at the direction of NHS England LAG is undertaking a review of LDLT in England. The outcome of this review may be that adult to adult LDLT programmes are limited to units undertaking paediatric LDLT (King’s College Hospital, St James’ Hospital Leeds and Queen Elizabeth Birmingham). At the present time all 6 liver transplant units in England are commissioned to undertake LDLT. Although uptake has been low in all units, in adult only transplant units the number of individuals undergoing LDLT is negligible. The current review does not consider the SLTU LDLT programme but any conclusions from the review may have relevance to the programme in Scotland.

James Powell Consultant Transplant Surgeon

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Split Liver Transplantation (SLT) SLTU continues to undertake split liver transplantation. Indeed, based on NHSBT figures presented at the May 2014 LAG meeting, SLTU has undertaken the 3rd largest number of adult split liver transplants since 1st April 2006.

In the financial year 2013-14 SLTU undertook 11 split liver transplants. In 2 cases the liver splitting process was undertaken in Edinburgh whilst in the remaining 9 the liver was split at one of the 3 paediatric liver transplant units with the graft being imported for transplant by SLTU. Unfortunately, unlike in previous years where outcome following split liver transplant has been good, results during 2013-14 are of concern. Of the 11 patients undergoing split liver transplantation 1 patient has died of ischaemic cholangiopathy and sepsis, 1 patient has been re-transplanted for hepatic artery thrombosis and 1 patient is currently active on the elective liver transplant list awaiting re-transplantation because of hepatic artery thrombosis. Of the 11 individuals undergoing split liver transplant there have been 4 patients with biliary complications and 3 patients with hepatic artery complications (2 patients had both biliary and arterial complications). Given that 5 of 11 patients had major biliary/arterial complications an internal review of the split liver transplants performed in 2013-14 will be undertaken the results of which will be made available at the NSD Annual Performance Review. James Powell Consultant Transplant Surgeon

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Section D: Summary of Highlights (Celebration and Risk) Edinburgh continues to enjoy very high standards of performance in all domains of transplantation and organ retrieval activity. This high level of performance is a testament to the hard work and dedication of staff performing all sorts of different tasks within the SLTU programme. Key elements such as infection control, which are the responsibility of every member of the team, have been particularly well delivered. Pressures remain on inpatient beds and waiting times for liver transplant assessment but pathways of care are under constant review and revision to maintain the best possible service. Equity of access has been a cause for concern in relation to one or two health boards and these issues appear to have been addressed with a significant increase in numbers of referrals and transplants from those health boards in question. The recent LEAN event in liver transplantation will be repeated in renal and pancreas transplantation and we hope that implementation of recommendations from these events will further drive changes in patient-centred care with greater efficiency and effectiveness. The establishment of a room for relatives with furniture funded by patient donations through the endowments funds has improved the quality of the care that the unit can offer to families of transplant recipients particularly in the peri-transplant period where long waits are made easier by a relaxing environment. Endowment funds have also been used to support a number of important clinical research projects within the unit which will drive development and innovation in care of transplant patients.

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SCOTTISH PANCREAS TRANSPLANT UNIT

SCOTTISH PANCREAS KIDNEY

TRANSPLANT UNIT

Annual Report 2013/14

NHS Lothian

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Introduction The annual activity and outcome data for pancreas transplantation needs to be interpreted differently to liver transplantation and kidney transplantation because of smaller overall activity levels. 20 Simultaneous kidney and pancreas transplants (SPK) and 1 pancreas after kidney transplant (PAK) were performed in 2013/14 financial year. Eighteen patients transplanted (86%) were Scottish residents. Notable aspects of the pancreas transplant activity and outcome in 2013/14 were as follows:

• The 20 kidney transplants performed, as part of the 20 SPK transplants constitutes 16% of our overall kidney transplant activity.

• The National Pancreas Allocation Scheme has now been running for 40 months. It has reached maturity. The prediction of its potential influence in pancreas transplantation, based on simulations, has transpired to be accurate across the UK. Waiting time to transplant has reduced further in this financial year.

• Fifteen (71%) of our 21 transplants were performed using imported grafts.

• Two of the 4 pancreas graft failures observed this year happened with grafts which

came from donors aged > 45.

• Retrieval damage to pancreas grafts continues to be a UK wide problem. Damage to grafts and other factors relating to graft quality result in appreciable number of admissions, which do not result in transplantation.

• Patients from Northern Ireland continue to be referred, registered and transplanted

in Scotland. In October 2013 we were invited to Belfast to provide an update of the pancreas transplant programme. The feedback we received was gratifying.

Murat Akyol Consultant Surgeon Clinical Lead for Pancreas Transplantation

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Section A: Service Programme A1 Aim/Purpose/Mission Statement/Date of Designation The Scottish Pancreas Transplantation programme aims to provide assessment for and delivery of pancreas and kidney transplantation to suitable patients with diabetes and with end stage renal disease in Scotland. In addition the programme offers pancreas alone transplantation for selected diabetic individuals. The programme aims to provide equal opportunity and excellent quality of care to all referred patients in Scotland. A2 Description of Patient Pathway A3a) Target Group for Service or Programme Figure 1

Refrral Centres for New Assessments in 2013/14 n= 43

0 2 4 6 8 10 12

Greater Glasgow & Clyde

Northern Ireland

Lothian

Dumfries & Galloway

Ayrshire & Arran

Tayside

Highlands & Islands

Lanarkshire

Grampian

Referrals for SPK transplantation continue to be received from all Health Board areas in Scotland. Number of referrals per population in different parts of Scotland has been variable in each financial year. This is more likely to be due to the small numbers referred per annum from each region and not an indication of systematic under-utilisation of pancreas transplantation in any one region. 21% of patients referred in 2013/14 were resident in Northern Ireland. This compares to 19% in the previous year.

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Figure 2. Patients Added to SPK Waiting List by NHS Board 2010 to 2014 n = 83

0 1 1 2

1 000

1 2 2 1

1 7 1 5

1 000

1 2 0 6

2 1 2 1

2 4 00

6 5 2 1

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0 5 10 15 20 25

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Lothian

Ayrshire & Arran

Tayside

Dumfries & Galloway

Lanarkshire

Grampian

Highlands & Islands

Fife

2013/142012/132011/122010/11

The number of patients registered for pancreas transplantation from each Scottish Health Board area has been variable over the last 4 years. The registrations from N Ireland have continued to increase, reaching 7 new patients in 2013/14 from 4 in 2010/11. 30 % of new patients added to the SPK transplant waiting in 2013/14 were residents of Northern Ireland. A3b) Abbreviated Care Pathway for Service or Programme Section B: Quality Domains B1 Efficient The time taken from referral to outpatient assessment for pancreas transplantation has been longer then we would have liked in the past. In 2013/14 the overall median time was 54 days, with a range of 8–100 days. Five patients waited for >84 days for an appointment In each of these cases the delay was as a result of either patient choice or patient being unavailable (hospitalised in parent unit). In the second half of the year the median waiting time has reduced to 43 days, with a range of 8–71 days.

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Figure 3 Number of Assessments, Transplants and post-Transplant re-admissions over the last 4 financial years

0

50

100

150

200

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2010/11 2011/12 2012/13 2013/14

All Assessments

Post Transplant Readmissions

Transplants

Clinics

The trends for increasing referrals, increasing transplant activity and fewer post-transplant readmissions are welcome. The reduction in the outpatient activity seen in the last financial year has been a consequence of a deliberate policy of earlier devolution of care to parent units and less frequent returns to Edinburgh for patients with stable graft function in the long-term. Deaths on the Waiting List No patients died on the waiting list in 2013/14. However 4 patients were removed from the waiting list due to deterioration in clinical condition, hence becoming unsuitable for pancreas transplantation. Patients Transplanted in 2013/14 that had previously undergone pancreas transplantation: No previously transplanted patient returned to the pancreas transplant waiting list in 2013/14 and no patient received pancreas re-transplantation. One patient who had suffered SPK graft failure following transplantation in 2007 received a kidney alone transplant in 2013/14. Another patient, removed from SPK list in 2013/14 due to ill-health, received a live donor kidney transplant.

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Original Transplant Graft Failed Outcome

SPK 14.06.07 Pancreas + Kidney Kidney Transplant 31.07.13 SPK 09.06.13 Kidney Live donor kidney 14.04.14 Pancreas Retrievals and Offers Figure 4. Retrievals in Scotland

Scottish Pancreas Retrieval Locations (n=36)

0 2 4 6 8 10 12

Victoria Hospital Kirkcaldy

Royal Infirmary Edinburgh

Dumfries & Galloway

Perth

Glasgow Royal Infirmary

Wishaw

Western Infirmary Glasgow

St Johns

Aberdeen

Royal Alexandra Paisley

Ninewells

Southern General Glasgow

Western Generl Edinburgh

In 2013/14 financial year 36 pancreata were retrieved from Scottish donors.

• 14 (38%) of the 36 pancreata retrieved in Scotland were exported for vascularised transplantation. 3 of the exported grafts were not transplanted.

• 8 (22%) of the 36 pancreata retrieved in Scotland were retained for vascularised transplantation in Scotland and 6 were transplanted. The 2 pancreata not used for transplantation were used in the islet lab for research, education and training.

• 10 of the 36 pancreata were used for islet isolation in Scotland. The isolates were exported to other islet transplanting centres. Only 3 of the 10 isolates were transplanted. The other 7 pancreata had sub-optimal islet yields. They were used for research or education and training.

• 4 of the 36 pancreata were accepted for islet transplantation and isolated in Scotland. One Scottish islet recipient received one islet transplant. The islets from the remaining 3 pancreata were not used for transplantation due to poor yield on one occasion and on two occasions no suitable islet recipient was available.

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Transplanted Pancreas Grafts – Imported n= 15

Fifteen of the 21 (71%) pancreas transplants performed were done using imported pancreas grafts from hospitals outside Scotland. This is in contrast to the era before the introduction of the National Allocation Scheme, when most pancreas transplants were performed using grafts form Scottish Donors. The increase in transplantation using imported grafts has not been accompanied by increased ischaemia times and the outcome has been equally good. The trend towards greater numbers of imported grafts is welcome, since it avoids simultaneous liver and pancreas transplants and eases the pressure on the surgical team, theatre staff, critical care and others. A further 8 pancreata were imported but not transplanted in Edinburgh. Six of these 8 pancreata were sent to the islet lab for isolation, for research and education. One pancreas was discarded and one was transplanted by another centre. Donor Age

2011/12 2012/13 2013/14 Donor age No. of Txs No. of Txs No. of Txs

50 – 57 years 5 1 3 45 – 49 years 5 5 1 20 – 44 years 4 12 15 < 20 years 3 2 2 Total Transplants 17 20 21

The number and proportion of pancreas transplants from deceased donors older than 45 have reduced in the last two financial years. Out of the 4 pancreas grafts that were lost in the peri-operative period in this financial year, 2 were from donors aged > 45. In 20011/12 all of the grafts that failed had come from donors > 45 yrs and in 2012/13 50% of pancreas grafts that came from donors > 45 yrs had failed.

Hospital Number Royal London Hospital (Whitechapel) 2 Sheffield Children’s Hospital 1 Newcross Hospital, Wolverhampton 1 Royal Bolton Hospital 1 Royal Victoria Infirmary Newcastle 1 Royal Hallamshire Hospital, Sheffield 1 Royal Berkshire Hospital, Reading 1 Royal Victoria Hospital, Belfast 1 Stockton-on-Tees University Hospital 1 University Hospital, North Staffordshire, Stoke on Trent 1 John Radcliffe Hospital, Oxford 1 Royal Albert Edward Infirmary, Wigan 1 Norfolk & Norwich University Hospital 1 Chesterfield & North Derbyshire University Hospital 1

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Pancreas Offers Declined 403 pancreas offers were declined in 2013/14, compared with 306 declined offers in 2012/13. Of the 403 declined pancreas offers in 2013/14:

• The majority of offers (90%) were made on a named patient basis. Only 10% were offered via the national pancreas fast-track system.

• 96 (24%) offers were for a named patient active on the islet transplant waiting list. Figure 5 Declined offers in 2013/14

Decline Pancreas n=403

225

44

19

20

9

9

741

4

4

6

2

2

2

1

1

7

PMH

Other

Long CIT

Age

Pancreas Fatty

Poor Islet Yield

Poor organ perfusion

Workload

No suitable recipient

Damaged Organ

Long WIT

Organ Fibrotic

Poor Islet Viability

Poor islet purity

Poor Organ Function

Tumour

Anatomical

Figure 5 shows reasons for decline in 2013/14. These include offers for simultaneous kidney and pancreas transplantation, pancreas alone transplantation, islet transplantation and the offers via the fast-track scheme.

• 61 % of the offers were declined due to donor medical history and/or donor age

• On 41 occasions (10%) workload was one of the factors in the decision to decline. - 18/41 of these grafts were accepted and transplanted by other centres - 16/41 were declined by all centres - 7/41 were accepted by other centres but found unsuitable and not transplanted

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Pancreas offers accepted but not used for transplantation 17 patients were admitted on 23 occasions when pancreas transplantation did not

proceed. Reasons for Transplant not proceeding

Donor History 9 Pancreas Fatty 8 Damaged pancreas 2 Damage due to Trauma 1 DCD - prolonged WIT 1 Workload 1 Recipient not fit/donor marginal 1

The occasion marked as workload represents the first and only time when 2 different surgeons on-call for pancreas and liver transplantation simultaneously accepted offers of a liver and a pancreas for transplantation. We have since introduced safeguards to prevent this occurring. The remaining cases represent either incomplete information received from the retrieving centre at the time of the offer, assessment of organ quality by implanting surgeon (at variance with the retrieving surgeon) or the change in the donor’s condition after the offer had been accepted. Outcome Data

Four of the 20 patients who received SPK transplantation in 2013/14 were pre-dialysis at the time of transplant. One other patient received a pancreas after kidney transplant. Only one patient suffered early kidney graft loss following SPK transplantation. 19 of the 21 patients transplanted were discharged with a functioning kidney transplant, with a median creatinine of 111 (range 67 – 252). Median creatinine was 96 (range 57– 153) at 3 months post transplant. 16 of the 21 patients transplanted had a functioning pancreas graft at time of discharge with a median blood glucose of 5.1 mmol/l, independent of insulin.

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Acute Rejections

No patient underwent biopsy of the pancreas graft in 2013/14. 12 kidney biopsies were carried out in 9 recipients. • One patient underwent biopsy on 3 occasions and was treated for rejection on one

occasion. • One patient underwent biopsy twice and was treated for rejection on one occasion. • Six patients underwent biopsies once only. None had acute rejection.

The acute rejection rate of 9.5% (2/21) in pancreas transplantation in 2013/14 is considerably lower than the incidence of rejection observed in earlier years of pancreas transplantation in Edinburgh. A similar trend has been observed in other UK pancreas transplant centres and internationally.

Reason for pancreas graft loss: Four patients (19%) suffered pancreas graft loss in 2013/14. The reasons were as follows: • pelvic abscess and abdominal bleeding • fat necrosis / peritonitis • arterial thrombosis • duodenal necrosis and bile leakage

Operative and Post Operative Complications

Seven of the 21 patients who underwent transplantation in 2013/14 suffered surgical complications.

Total number of interventions: • 1 recipient required 3 laparotomies: -

- Re-exploration of kidney following renal artery stenosis (day 2) - Transplant nephrectomy due to kidney necrosis (day 6) - Laparoscopic fenestration of lymphocele (day 47)

• 3 recipients required 2 laparotomies: -

- 1 graft pancreatitis / washout (day 3) - 1 pancreatectomy (day 10) - 1 repair of duodenal anastomosis (day 3) - 1 pancreatectomy due to necrosis (day 9)

- 1 wound dehiscence / bleeding / pelvic abscess (day 12) - 1 pancreatectomy (day 18)

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• 3 recipients required one laparotomy: -

- 1 pancreatectomy due to enteric leak (day 23) - 2 repairs of wound dehiscence (day 25 and day 28)

• 1 recipient developed haematuria as a result of an AV malformation. This

recipient also developed pulmonary embolism. The patient has now been discharged home with functioning kidney and pancreas grafts.

• 1 recipient developed thrombosis of one limb of the Y graft pancreatic arterial

anastomosis, which was successfully treated.

Post Operative Readmissions A total of 14 pancreas transplant patients were readmitted on 22 occasions during 2013/14. Graft Survival: Pancreas transplants carried out in 2013/14 4 pancreas grafts and one kidney graft were removed during 2013/14. • 1 pancreas graft removed on day 9 as a result of fat necrosis/pancreatitis • 1 pancreas graft removed on day 10 as a result of arterial thrombosis • 1 pancreas graft removed on day 18 as a result of pelvic abscess/ bleeding • 1 pancreas graft removed on day 23 as a result of a leak of the duodenal

anastomosis • 1 kidney graft removed on day 6 as a result of renal artery thrombosis.

Deaths in the 2013/2014 financial year During 2013/14 financial year one patient died in the peri-operative period, on day 11 following cardiac arrest. This patient died with a functioning pancreas graft. 4 other patients, who had undergone previous SPK transplantation, died in 2013/14 financial year: • 1 patient died 12 years after transplantation due to lymphoma. He died with

functioning kidney and pancreas transplants. • 1 patient died 11 years after SPK transplantation due to myocardial infarction. This

patient was insulin dependent at the time of her death. Her kidney graft had failed in 2009 and she had received a kidney transplant alone in March 2011. She died with a functioning kidney transplant.

• 2 patients died from sepsis. One 9 years and the other 11 years after SPK

transplantation. Both patients had returned to dialysis and were insulin dependent prior to their death.

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Outcome Measures Reported by PAG

Continuous monitoring of pancreas transplant outcomes is undertaken by NHSBT to agreed standards. They are reported regularly and reviewed bi-annually by the Pancreas Advisory Group.

The CUSUM plots see Appendix 8 pages 15 – 24 and 63 - 70 display graft and patient survival following pancreas transplantation in the UK pancreas transplant units. As well as comparing outcome in the UK transplant units, CUSUM plots also compare each individual unit’s current results with their previous outcome and provide a benchmark for the maintenance of patient safety and quality of programme delivery. NHSBT also undertook a review of graft and patient survival at 1, 5 and 10 years after transplantation for all solid organ transplants throughout the UK. This recent analysis took account of both crude and risk adjusted survival. In deceased donor kidney transplantation, the only statistically significant difference observed was inferior long term outcome following kidney transplantation in some units (19% difference between the best and worst survival 10 years after kidney transplantation). All UK pancreas transplant centres, apart from one English unit, had crude and risk adjusted early pancreas graft survival and patient survival rates within 95% confidence intervals of the mean.

B1b) Resource Use B1c) Finance and Workforce

Details of the Pancreas transplant programme resources and finance are given in Appendix 2.

B1d) Key Performance Indicators (KPIs) and HEAT targets

There are currently no KPI or HEAT targets set around pancreas transplantation in Scotland

B2 Effective B2a) Clinical Audit Programme

The unit contributes actively to the national transplantation database and submits data for every case. Key clinical outcome measures such as graft and patient survival, acute rejection rate, causes of graft loss are regularly reviewed at the pancreas transplant MDT and appropriate changes to the pancreas transplantation protocol are introduced.

B2b) Clinical Outcomes/complications rates/external benchmarking

SPTU is subject to external audit and is benchmarked against other UK transplant centres through the NHSBT and the Royal College of Surgeons of England Transplant Audits. Appendix 8 pages 15 – 24 and 63 - 70

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B2c) Service Improvement

The weekly pancreas MDT provides a multi-disciplinary forum for the consideration of all patients undergoing assessment for their suitability for transplantation, allows a more structured opportunity for discussion for complex pre-transplant (and sometimes post-transplant) issues, standardises and streamlines the assessment process and it has been welcomed by all staff. We have also introduced a classification for standard and high risk patients on the waiting list, to allow more intensive and frequent follow-up of those in the high risk category.

B2d) Research

There is an active programme of research in pancreas transplantation with current focus on outcome of patients referred for pancreas transplant.

B3 Safe B3a) Risk Register

Waiting list patients – A written list of all patients on the waiting list for simultaneous pancreas kidney transplantation is continually reviewed and maintained by the transplant co-ordinators. The waiting list kept at NHSBT Bristol is also sent to us regularly by registered mail, which provides an additional opportunity to check the accuracy of the list. The Unit discusses and reviews the status of patients on the SPK waiting list regularly at the weekly pancreas MDT transplant meeting.

B3b) Clinical Governance

SPTU is an active participant in many aspects of clinical governance including internal audit, morbidity and mortality meetings, representation on the QIP team and external audit as mentioned previously through the National Pancreas Transplantation Audit. The Unit is also represented by a consultant surgeon on the UK Pancreas Advisory Group which is a forum for discussion of all aspects of pancreas transplantation in the UK many of which pertain directly to patient safety and clinical governance.

B3c) Healthcare Associated Infection (HAI) and Scottish Patient Safety

Programme (SPSP)

The SPTU is fully engaged with SPSP and HAI programmes and monthly infection and incident rates are posted on the ward under the supervision of our Charge Nurse. The Unit has a good patient safety record. Considering the complexity of the surgery and the immunosuppressed nature of our patients our HAI record is also remarkably good. Our daily ward rounds are frequently attended by a Consultant microbiologist who advises on individual patient management and on unit policies regarding HAI.

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B3d) Adverse Events

Adverse events are discussed at the monthly Morbidity and Mortality meetings and records of outcomes and action points relating to morbidity and mortality are maintained. SPTU also complies with NHS Lothian policy on adverse events and harm. All serious events are raised within the Acute Division and are investigated and managed employing established procedures.

B3e) Complaints/Compliments

The unit receives a large number of compliments from patients and their families and very few complaints. Any complaints are dealt with promptly and in compliance with NHS Lothian policy for complaints. There have been no complaints in 2013/14. A previous complaint (2012/13) from a patient is still under investigation.

. B4 Timely (Access) B4a) Waiting/Response Times

(i) Waiting Times/Response Times Targets

Waiting list information On the 31st March 2014 there were 35 people registered on the SPTU SPK transplant waiting list. These include 11 suspended patients (31%). The waiting list comprises 20 patients with blood group ‘O’, 12 with blood group ‘A’ and 3 with blood group ‘B’. All of these patients are registered for SPK transplant. Ten patients (28%) on the waiting list reside in Northern Ireland. SPTU waiting list makes up 14.8% of the UK pancreas transplant waiting list on 31 March 2014. Figure 6 illustrates the blood group profile of the patients awaiting pancreas transplantation in Scotland and in the overall UK waiting list.

Scotland & the UK - SPK Patients on the Waiting List by Blood Group 31st March 2014

55%8%

33%

4%

57%9%

34%0

0% 10% 20% 30% 40% 50% 60%

Scotland

UK

O

B

A

AB

Figure 6

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Referral Letter to First Consultant Appointment (days) Oct - Apr 2011/2012 2012/2013 2013/2014 2013/14 Mean 63 days 56 days 52 days 40 days Median 65 days 53 days 54 days 43 days Range 5 – 128 days 13 – 142 days 8 – 100 days 8 – 71 days In the financial year 2013/14, 131 patients were seen in the transplant assessment clinics. This number includes 43 new patients assessed for pancreas transplantation and 47 patients seen for secondary review. A further 41 patients who were registered on the waiting list were also reviewed. Since the 2013/14 mid-year review the unit has worked hard to reduce the time from referral to first consultant appointment. As a result the median waiting time in the second half of 2013/14 period has reduced from 54 days to 43 days. We are determined to continue to improve this aspect of the service provision in the year ahead. Patients who waited > 84 days were reviewed (n=4). On all occasions the appointments were deferred at the patients’ request or due to their inability to attend (hospitalised in parent unit). Waiting Time

Length of Time on Waiting List – for patients transplanted 2013/14 n= 21

Days on Waiting List

0

100

200

300

400

500

600

700

800

900

2009/10 2010/11 2011/12 2012/13 2013/14

Blood Group O

Non Blood Group O

Figure 7

Fig 7 depicts the time spent (median time in days) on the waiting list for patients who received pancreas transplantation for each of the last 4 years. Patients on the SPK waiting list continue to wait a considerable period of time for transplantation. However there has been a small reduction in waiting time in the last year. Blood group O patients now have a median waiting time of 619 days compared to 743 in 2012/13. Non-blood group O patients median waiting in 2013/14 is 547 days compared to 557 days in 2012/13.

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B6b) Geographical Access

Patients continue to be referred, registered for transplantation and transplanted from all renal units in Scotland. In the past year 9 new patients have been referred from Northern Ireland. This has increased the number of repeat appointments for Northern Ireland referrals with 10 second appointments and a further 5 reviews of patients on the waiting list. Patients referred from Tayside, Grampian and the Highlands are seen locally for their first consultation with a transplant unit consultant. They then attend the Royal Infirmary of Edinburgh for an anaesthetic assessment and a second surgical review.

kirsty.martin � 2/6/2014 09:25Deleted: - I ... [1]

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SCOTTISH ISLET TRANSPLANT PROGRAMME

Annual Report 2013/14

NHS Lothian

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A1- Scottish National Islet Transplant Service Annual Report

2013/14 A2- Aim of Service The purpose of this service is to provide an islet transplant programme for Scottish patients who fulfil the following criteria:

1. Insulin sensitive patients with Type I diabetes and normal renal function who experience recurrent severe hypoglycaemia despite optimised specialist management.

2. Insulin sensitive patients with a renal allograft who are unable to maintain HbA1c <7.0% despite optimised specialist management.

The primary end point of islet transplantation is to achieve abrogation of hypoglycaemic unawareness with the secondary end points of improved glycaemic control and insulin independence (expected in the minority of patients). A3- Description of Patient Pathway Referrals for assessment for islet transplantation are accepted from all over Scotland and Northern Ireland. Patients are assessed by a multi disciplinary team comprising a Consultant Transplant Surgeon, Consultant Diabetologist, transplant coordinator, dietician with a specialist interest in type I diabetes and a clinical nurse specialist with an interest in diabetes. Formal psychological assessment is carried out if required. Assessment is a lengthy process using a format agreed by the UK Islet Transplant Consortium (UKITC) and includes out patient continuous glucose monitoring and radiological assessment of the liver in preparation for islet implantation. The islet transplant begins with referral of a donor pancreas for a named patient as per the new national sharing scheme (NPAS). The pancreas is the transported to the islet isolation laboratory at SNBTS where the isolation process takes place over the following 8-12 hours. The preparation of islets is then placed in culture for the next 24-48 hours and during this time the graft recipient is admitted to the transplant unit and prepared for transplantation as per the unit protocol (Appendix 9). Over the last year we have also accepted and successfully transplanted islets prepared at one of the other UK isolation centres. If the preparation of islets meets safety release criteria and is a sufficient number, the patient is taken to the radiology suite and the islets brought to the Royal Infirmary by the SNBTS isolation staff. Islets are then infused into the portal vein of the recipient under local anaesthetic and sedation by a Consultant Hepatobiliary Radiologist. The patient is then returned to the transplant high dependency unit for a median of 2 days to allow for the intensive blood sugar monitoring required and then transferred to the main ward for a further 2-3 days to allow for stabilisation of insulin dose and self medication education. Patients are then followed up at out patient clinics initially 2-3 times per week, gradually reducing as clinical condition allows. Normally 2 islet grafts (sequentially, depending on donor offers) are required to complete the treatment process although 3 patients have achieved insulin independence after single islet transplants. John Casey Clinical Lead for Islet Transplantation

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Section B Quality Domains B1 Efficient Islet Isolation Laboratory Staffing

• Vacant band 8a and 5 posts successfully filled in May 2014 & Sept 2014 respectively.

• Training of Islet staff in Tissue and stem cell duties (in order that all staff can participate in all work areas in a reciprocal arrangement) progressing very well.

• Training of Tissues & Cells staff in Islet cell isolations still progressing well. • Discussions around the out of hours on-call service is ongoing due to non-

compliance with the European Working Time Directive.

Organs Offered - Appendix 7

• Offered (Pancreas offered from any site in any condition/ischaemic time): 48 • Accepted (pancreas accepted and received for ay purpose, including training): 40 • Acceptable & Processed (isolation completed): 30 • Successful product (all parameters for clinical use achieved): 16 • Transplanted: 13

• Discrepancy between no. offered and no. accepted – this is due to decisions made

by the clinician, laboratory already isolating/transplanting, donors not deteriorating in specified time frame (DCD).

• Islet lab has 53% success rate in producing islet cells suitable for transplant – conversion rate to transplant is 43%. These figures are inclusive of both DBD and DCDs.

• Of the 13 transplants performed, 3 were exported to Newcastle, with the remaining 10 being carried out in Edinburgh.

Research & Training Activity

• Continue to support various research projects – send cells and residual tissue which are not suitable for transplant to Aberdeen, Newcastle, Cambridge, SNBTS and Edinburgh Uni.

In addition to moving all our cell therapy development projects to the new GMP facility at Scottish Centre for Regenerative Medicine, we have taken over an area of the lab which will be used as a training laboratory. This area will be used to train existing members of Tissues & Cells in the isolation process without compromising our ability to take clinical pancreata and also to develop the isolation process. This ‘research’ lab will be managed by Neil McGowan.

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Routine GMP Requirements

• Weekly cleaning & monitoring of facility and associated equipment. • Weekly stock checking of consumables and reagents. • PPM of all equipment. • Document control, review, incident reporting, change control.

Regulatory • Tissues & Cells inspected by Human Tissue Authority (HTA) in March 2014 –

HTA license maintained. Excellent outcome, with no comments.

Equipment • Capital funding received from NSD for the purchase of a second microscope – this

has reduced the isolation time, allowing 2 samples to be counted at the same time and has also helped with the training of staff members.

Clinical Service The islet programme has now evolved from a new service to an established clinical programme and the service was recognised with a Scottish Health Award in 2013. 24 new patients were assessed in this financial year and 50 patients reassessed. Patient referrals are being received from all over Scotland though we still see a centre effect with most referrals from Lothian. Ten islet transplants were carried out (6 first infusions and 4 second). We carried out our first islet after kidney transplant (IAK) and this patient achieved insulin independence after a single islet infusion. Out patient follow up clinics continue to expand (179 vs 164). In addition to this, patients are encouraged to contact the team by phone and we are in the process of setting up a dedicated email address to facilitate contact with both patients and referring practitioners and GP’s. NHSBT ODT data (below) shows that the Scottish islet programme continues to be the leading UK unit in activity, listing of new patients and in utilisation of DCD donors

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B2- Effective Reversal of hypoglycaemic unawareness has been achieved in 100% of patients. In addition, glycaemic control has been significantly improved in all patients (as measured by continuous glucose monitoring and HbA1c). Although insulin independence is not a clinical end point in the UK, over 60% of patients in our programme consistently achieve insulin independence for a period of time (a predictor of good long term graft function) and one patient has achieved long term insulin independence after a single islet infusion and 2 further patients have achieved transient insulin independence after single infusions. The clinical data from the programme was presented both independently and as part of the UK programme at the International Pancreas and Islet Transplant Association meeting in September 2013. The islet isolation laboratory has continued to produce consistently high quality islet preparations on a par with the best islet labs world wide and is now an integral part of the UK “hub and spoke” islet transplant programme. The Scottish programme exported 9 islet preps last year and continues to achieve a high rate of conversion to transplantation (43%). All patient and laboratory data are submitted to the NHSBT ODT database and the first meaningful data are being produced from this (Appendix 8) The unit continues to fully participate in the UKITC and research output from this organisation includes data from the Scottish programme. The following clinical abstracts have been published/presented in the last year: Outcomes in subjects with Type 1 diabetes following islet transplantation in the Scottish islet transplant programme. Forbes, S.; McGilvray, T.; Davidson, J.; Duncan, K.; Jansen, C.; Barclay, J.; Anderson, D.; McGowan, N.; Casey, J. Diabetes UK Annual meeting 2013

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Reduction in body weight, fat mass and waist circumference secondary to reduced calorific intake following islet transplantation in subjects with Type 1 diabetes in Scotland. Anderson, D.; Duncan, K.; Barclay, J.; Jansen, C.; McGilvary, T.; Davidson, J.; McGowan, N.; Casey, J.; Forbes, S. Diabetes UK Annual meeting 2013. Islet Activity and Outcomes in The United Kingdom. Lisa L Mumford MSc, James AM Shaw FRCP PhD, Paul Johnson FRCS, Gareth Jones FRCP, Neil Parrott FRCS, Stephanie Amiel FRCP, Richard M Smith FRCP PhD, Neil W A McGowan Ph D, Stephen Hughes PhD, Guo Cai Huang PhD, John Casey FRCS PhD. IPITA 2013 Improved glycaemic control with concurrent reduction in calorific intake and fat mass following islet transplantation in subjects with Type 1 diabetes from islets donated after circulatory death (DCD) and brain death (DBD) in the Scottish islet transplant programme. Shareen Forbes1,2,3, Debbie Anderson¹, Kirsty Duncan², Calum Gray4, Janet Barclay¹, Tammie McGilvary², Donna Mitchell5, Alan Timpson5, Lora Irvine5, Peter Henry5, Laura Bailey5, George Galea5 Neil McGowan5 and John Casey. IPITA 2013 Access to Islet Transplantation at a single Health Service funded National Centre. S Forbes, K Duncan, J Barclay, D Anderson, T McGilvray, N McGowan, J Casey. IPITA 2013. Publications Outcomes in subjects with Type 1 diabetes following islet transplantation in the Scottish islet transplant programme. Forbes, S.; McGilvray, T.; Davidson, J.; Duncan, K.; Jansen, C.; Barclay, J.; Anderson, D.; McGowan, N.; Casey, J. Diabetic Medicine2013(30): 87. Reduction in body weight, fat mass and waist circumference secondary to reduced calorific intake following islet transplantation in subjects with Type 1 diabetes in Scotland. Anderson, D.; Duncan, K.; Barclay, J.; Jansen, C.; McGilvary, T.; Davidson, J.; McGowan, N.; Casey, J.; Forbes, S. In: Diabetic Medicine 2013 (30):15 Access to Islet Transplantation at a single health service funded National Centre. S Forbes, K Duncan, J Barclay, D Anderson, T McGivray, N McGowan, J Casey. Transplantation 2013;96:64 Improved glycaemic control with concurrent reduction in calorific intake and fat mass following islet transplantation in subjects with type I diabetes from islets donated after circulatory death and brain death in the Scottish Islet Transplant Programme. S Forbes, D Anderson, C Gray, J Barclay, T McGilvray, D Mitchell, A Timpson, L Irvine, P Henry, L Bailey, G Galea, N McGowan, J Casey. Transplantation 2013:96:90. Islet Activity and Outcomes in the United Kingdom. L Mumford, J Shaw, P Johnson, G Jones, N Parrott, M Rutter, S Amiel, R Smith, N Mcgowan, S Hughes, G Huang, J Casey. Transplantation 2013;96:120 Lessons from a 13 year cohort of the First UK Pancreas transplant Programme. C Jansen, V Lee, L Mumford, JJ Casey, M Akyol, G Oniscu. Transplantation 2013;96:47.

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Attainment of metabolic goals in the integrated UK islet transplant program with locally isolated and transported preparations. 1Augustin M Brooks MRCP; 2Neil Walker MRCP, DPhil; 1Ali Aldibbiat MRCP, PhD 2Stephen Hughes PhD; 3Gareth Jones FRCP; 3Julian de Havilland PhD 4Pratik Choudhary FRCP; 4Guo Cai Huang PhD; 5Neil Parrott FRCS; 6Neil W A McGowan PhD; 6John Casey FRCS, PhD; 7Lisa Mumford MSc; 8Peter Barker MSc; 8Keith Burling MPhil; 8Roman Hovorka PhD; 1Mark Walker FRCP; 9Richard M Smith FRCP, PhD; 6Shareen Forbes FRCP, PhD; 10,11Martin K Rutter FRCP; 4Stephanie Amiel FRCP; 3Miranda J Rosenthal PhD; 2Paul Johnson FRCS; 1James AM Shaw FRCP, PhD. American Journal of Transplantation.(in Press) Finance Finance and resources allocated and used by islet isolation and transplantation are given in Appendix 2. B3- Safe The islet transplant programme is fully integrated into the Transplant Unit at the Royal Infirmary, and as such is subject to the clinical governance and SPSP processes of the unit. An annual protocol and service review is an integral part of the programme. To date there have been no serious adverse events in relation to the islet programme and no complaints. A number of verbal compliments have been made. B4- Timely Referred patients are assessed by a multi disciplinary team at the weekly islet transplant clinic. Follow up patients are also seen at this clinic. Additional clinics are utilised as necessary for follow up patients and ward reviews organised if required. Increasing numbers of new and follow up patients have resulted in increasing times from referral to listing. As more patients are listed for islet transplantation in the UK, waiting times from listing to transplantation are increasing. B5- Patient Centred The transplant unit QIP team has developed information for both patients and relatives using the transplant unit and the islet programme is part of this. In addition we have contributed to the development of a UK wide patient information booklet for islet transplantation which is in the final stages of preparation. We ensure that patients have easy, direct access to islet programme staff so that any problems and concerns are dealt with promptly. B6 Equitable The programme continues to receive referrals from all over Scotland. We have given presentations at a variety of Scottish diabetes meetings with a view to increasing awareness of the success of the islet transplant programme in Scotland so that all appropriate patients are referred regardless of the geography of their referring unit. The pancreas allocation scheme in the UK ensures that islets are offered to patients in an equitable and transparent way.

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Section C- Looking Ahead/Developments The islet transplant programme in Scotland has continued to be the most active unit in the UK and activity in the islet lab and clinical programme has continued to increase. The challenges for the clinical programme are to maintain a high quality patient centred service in the face of a large increase in activity. This will require an increase in out patient facilities and staff, particularly to deal with the large numbers of post transplant patients. The field of islet transplantation is changing on an international basis and it is clear that newer immunosuppression regimens such as using Etanercept have a beneficial effect on longterm graft survival. The islet lab is now established as a leading laboratory in the UK and is an integral part of the UK isolation programme. Islet isolation activity is increasing and becoming more challenging with the increase in DCD organs being offered and formal UK wide regionalisation of islet isolation will be introduced in the near future. Maintaining a full quota of islet staff is therefore paramount and an increase in the number of core staff will be required. Research and development continues to be a high priority for the islet programme and a number of clinical and basic science research grants have been awarded and are in the process of review. We plan to staff a separate isolation lab for research isolations which will allow optimal utilisation of donated pancreata in Scotland and also provide a training facility for staff involved in the clinical programme. The following major research collaborations are in progress: MRC TSCRC - £550,000 (August 2012-2015). Reprogramming of redundant human exocrine tissue to endocrine tissue for transplantation in the treatment of type I diabetes. Suppression of Epithelial to Mesenchymal Transitioning Enhances Ex-Vivo Reprogramming of Human Exocrine Pancreatic Tissue Toward Functional Insulin-Producing beta- like cells. M Lima; K Muir; H Docherty; R Drummond; N McGowan; Y Heremans; S Forbes; I Houbracken; J Ross; S J Forbes; P Ravassard; H Heimberg; J Casey; K Docherty. Diabetes. 2013; 62:2821-33. Wellcome Trust- £350,000 (August 2013-2016). (Collaboration with Professor JA Bradley, Cambridge University) The alloimmune response to human induced pluripotent stem cells and their differentiated progeny in a humanised mouse model Diabetes UK - £280,000 (January 2014-2017). Optimising Islet cell Engraftment for long term function. Shareen Forbes, Stuart Forbes, John Casey, Neil McGowan Medical Research Scotland- £125,000. (Jan 2014-2018). PhD Studentship. 3D Cell Printing for Scalable, In-vitro Production of Functional, Microencapsulated Pancreatic Islets for the treatment of type I Diabetes Mellitus. W. Shu, J Casey Chief Scientist Office- £280,000 (Jan 2014-2017). MESENCHYMAL STROMAL CELLS FOR CO-TRANSPLANTATION WITH PANCREATIC ISLETS TO IMPROVE GRAFT FUNCTION IN TYPE-1 DIABETES

61

Section D: Summary of Highlights The Scottish Islet Transplant Service is now an established national programme providing a high quality treatment for patients with life threatening hypoglycaemic unawareness. The islet team received a Scottish Health Award for Care of the Chronically Ill and the Scottish Islet Programme was cited as a leading UK cell therapy programme in the recent House of Lords document on regenerative medicine in the UK. The programme now has a national and international profile thanks to the dedication and team working of the staff involved in both the clinical side of the service and the isolation lab. The programme is leading the way in the UK in utilisation of DCD organs without a loss in clinical effectiveness. The research and development aspect of the programme has attracted over £1.5 million in research funding over the past 18 months and has produced significant academic output(Appendix..). The UK Cell Therapy Catapult is now a collaborator in the islet reprogramming research and further collaborative grant applications are being submitted to UKSCF, Diabetes UK, and the Technology Strategy Board.

62

Scottish Islet Transplant Programme – Lothian University Hospital NHS Division Royal Infirmary of Edinburgh National Services Division – Annual Activity Report 2013 – 14 1. Activity Financial Year

Assessed 24 Re-assesed 50 Transplants 10 3 patients received 1st & 2nd

transfusion

Assessments NHS Board of Referral New Assessments Re-Assessed Lothian 7 17 Dumfries & Galloway 3 3 Highlands 3 3 Fife 3 11 Greater Glasgow & Clyde 2 6 Lanarkshire 2 2 Tayside 2 3 Ayrshire & Arran 1 1

Borders 1 1 Northern Ireland 0 2 Forth Valley 0 1 TOTAL 24 50

Time for Referral to Assessment, n - 24

Mean 51 Median 49 Range 19 – 74 days

Islet Waiting List Patients Accepted 1st Transfusion 2nd Transfusion Lothian 2 1

Highlands & Islands 2 1 Fife 1 0

Northern Ireland 1 1 Forth Valley 1 1 Dumfries & Galloway 1 0 Lanarkshire 1 0 TOTAL 9 4 Mean Waiting Times to Transplant by Blood Group Blood Group No. No. Days No. of Days * 3 patients Patients (1st Tx) (2nd Tx) received 2 transplants

A 3 156 days 56 days O 4 260 days 91 days

63

Islet Transfusions Patients Transplanted 1st Transfusion 2nd Transfusion Fife 1 1

Forth Valley 1 1 Highlands & Islands 1 0 Greater Glasgow & Clyde 1 0 Ayrshire & Arran 1 0 Northern Ireland 1 1 Lothian 0 1 TOTAL 6 4

Length of Inpatient Stay – Islet Transplant n = 10

Ward HDU Mean 4 2 Median 3 2 Range 2 - 6 2 - 3

Financial Year Deaths on Islet Waiting List 0 Deaths during assessment 0 Removed from Waiting List 1 *Lothian pt - removed as too well Graft Failure 0 Post Transplant Re-admissions 1

Clinics Post Islet Transplant Review Clinic 179 Review Clinic – DNA’s 11 Islet Retrievals Scottish pancreas retrievals 16 Transplant 4 Scottish 1, English 3, Poor yield 8, other 4 Imported (including 2 islets isolated 16 At Kings for Scottish recipients Transplant 9 Poor Yield 7

Scottish Isolations for other centres Newcastle 4 (3 transplant) Manchester 3 (0 transplant) Oxford 1 (0 transplant)

Scottish Isolation Outcomes

Imported Pancreata 9 Local Pancreas 1 Successful total Isolations 16 Transplanted total 13 Isolations not transplanted 3 1 patient unfit 1 yield not suitable for recipient 1 sent to Newcastle – not used Islets used for Education & Training Purposes 10 Poor Yield 10 Not Transplanted – other 3

64

Scottish Islet Transplant Programme – Lothian University Hospital NHS Division Royal Infirmary of Edinburgh National Services Division – Annual Activity Report 2013 – 14

Assessments / Re-assessments - 2013 / 14 - n – 74

7 1

16 35

28 35

30 54

24 50

0 10 20 30 40 50 60 70 80 90

2013/14

2012/13

2011/12

2010/11

2009/10

AssessedRe-assessed

Islet Assessments by NHS Board - 2013 / 14

0 1

0 21 11 1

2 3

2 2

2 63 11

3 3

3 3

717

0 5 10 15 20 25

Lothian

Dumfries & Galloway

Highlands

Fife

Greater Glagsow & Clyde

Lanarkshire

Tayside

Ayrshire & Arran

Borders

Northern Ireland

Forth Valley

AssessedRe-assessed

65

Scottish Islet Transplant Programme – Lothian University Hospital NHS Division Royal Infirmary of Edinburgh

Patients Accepted to Islet Waiting List by Transfusion - 2010 to 2014

3

5

109

1

5

1

4

0

1

2

3

4

5

6

7

8

9

10

1st Transfusion 2nd Transfusion

2010/112011/122012/132013/14

Islet Transfusions 2010 to 2014 n = 30

1 1

5

3

5 5

6

4

0

1

2

3

4

5

6

2010/11 2011/12 2012/13 2013/14

First TransplantSecond Transplant

Post Islet Transplant Review Clinic - 2010 to 2014

15

110

164

179

0

20

40

60

80

100

120

140

160

180

200

2010/11 2011/12 2012/13 2013/14

66

APPENDICES

Appendix 1 Transplant Unit QIT Annual Report 2013 – 14 Appendix 2 Financial Statements 2013 – 14 Appendix 3 SLTU Activity Report 2013 – 14 Appendix 4 SLTU Charts 2013 – 14 Appendix 5 NHSBT – A Centre Specific Review Presentation Appendix 6 SPK Transplant Activity Report 2013 – 14 Appendix 7 Islet Organs Offered 2013 – 14 Appendix 8 Pancreas and Islet Advisory Group Papers Appendix 9 Islet Protocol

67

EAST OF SCOTLAND RENAL TRANSPLANTATION SERVICE

Annual Report 2013/14

NHS Lothian

CONTENTS

Introduction Nursing Report Renal Recipient Transplant Co-ordinator’s Report Living Donor Kidney Transplantation Histocompatibility and Immunogenetics Laboratory Report Waiting List Statistics Donor Statistics Kidney Transplant Statistics Post Transplant Outpatient Activity

69

Introduction The renal transplant unit has had an excellent year with the most productive year in the history of the unit to date in living donor renal transplantation with 35 transplants taking place within the financial year all of which are working with good function. The fortunes of the living donor programme reflect a great deal of hard work and also greater support for living donor renal co-ordination which is key to the success of any living donor programme. The appointment of Lorna Henderson with her special interest in more complex transplant immunology has also supported the ABO and HLA incompatible transplant work as well as more aggressive responses to antibody mediated rejection of grafts. The unit are grateful to the executive management team of NHS Lothian who have supported the use of the expensive but highly effective drug ecluzimab on a number of occasions at very short notice enabling the team to rescue grafts that might otherwise have been lost. Cadaveric renal transplantation has also been very busy and we have gained in experience with NRP kidneys with pleasingly low rates of delayed graft function. Members of the unit have contributed to a group investigating the risks and benefits of National Commissioning of renal transplantation in Scotland and we hope that this work will lead to greater cohesion with colleagues in the West of Scotland and greater standardization of care for renal transplantation across the country. Prof Stephen J Wigmore on behalf of Miss Lorna Marson Dr Jane Goddard

70

NRP During 2013 – 2014 a programme of in-situ normothermic regional perfusion for donation after circulatory death was introduced in the Unit. This is part of a wider national programme in conjunction with Cambridge and Birmingham exploring normothermic perfusion and reconditioning of the organs in situ prior to cold perfusion. It is anticipated that this approach could lead to an increase in the number of organs recovered per donor and better functioning organs following transplantation. The initial Scottish experience includes 9 DCD donors attended. From those donors we recovered and transplanted 5 livers, 17 kidneys and 1 pancreas that was isolated for islets (subsequently transplanted in Newcastle). The kidney graft function is very good. We have noted a reduction in the delayed graft function (defined as the need for dialysis) from 50% national rate to 30%. Furthermore the true delayed graft function defined as the need for dialysis other than for hyperkalaemia was 18%. The kidney function at 3 months and 12 months, based on the combined Edinburgh, Cambridge and Birmingham experience shows a mean creatinine of 117 umol/L and 115 umol/L at 3 months and 12 months respectively. Overall we have achieved an organ recovery rate of 3 organs per donor, which represents an increase from the current national average of 2.6 organs per donor. Although this is a preliminary experience, the early results are encouraging and warrant further investigation and development of the approach over the coming years. Mr G Oniscu Consultant Transplant Surgeon

71

Nursing Report There have been no further changes to the bed allocation and the Transplant Unit, RIE comprises of 20 inpatient beds in Ward 206. There are plans to increase the bed allocation further and this is being discussed within NHS Lothian Surgical Directorate presently. This is in keeping with the increased donor pool and subsequent increase in patients for transplant as well as those who require to return to the unit post transplant for specialist care. There have been no changes to the four bed Transplant High Dependency Unit, Ward 117 which has the additional funded HDU bed available in the critical care corridor. The plans continue to be progressed for the new combined Renal & Transplant HDU. This will be a 16 bed (funded for 14 beds) HDU. The Nursing Establishment: There have been no changes to the establishment within ward 206 Transplant or 117 HDU although we now consider them to be two separate ward areas under the umbrella of Transplant. The establishments remain as: Band 7- 2.0 WTE Band 6 - 4.78 WTE Band 5 - 32.45 WTE increased by 1.95WTE for the additional beds Band 2 - 7.6 WTE Patient Care/Public Involvement Ward 117 (HDU) participated in a Reflective Practice Project in association with NES. This ran though October and allows staff to raise concerns or highlight successes in care on a daily basis whilst incidents are still fresh. The feedback from this was positive and the staff continue to utilise the structure when they feel it is appropriate Care rounding was introduced to ward 206 Transplant and has been embraced by the staff. The support given to the ward by the facilitator who introduced this and the willingness of the staff to adopt this tool should aid the overall patient experience. This carries on from the work in ward 117 where this is now embedded into every day practice. Nursing Ward 206 Transplant There has been a turn over of staff in the last 6 months, with staff who have been in the Unit for a number of years making the decision that they need to broaden their nursing experience. A few staff secured promotional posts and a few made a life choice to go to areas that do not require weekend and night duty work. Presently there are 2 band 5 staff nurses on maternity leave, one due back in November 2014 and the other due back in January 2015.

72

There are 2.11WTE band 5 staff nurse posts vacant, however they are recruited to and the staff members will take up post in early May. There is a 0.91WTE band 6 post vacant and we are offering our current band 6 staff the opportunity of increasing their hours to full time in the first instance. The band 6 in post made a decision to work as a band 5 for health reasons. Ward 117 There has been a turnover of staff since Christmas for very similar reasons to the ward area; however we are now fully established, although there are still 3 staff on maternity leave. The rotation to dialysis continues and also the rotation to renal HDU in preparation for the move to the new combined Renal and Transplant HDU. One member of staff from Ward 117 is currently undertaking the Clinical Decision Making Module and there is a large amount of interest in the next cohort. The staff continue to work through the training for the new classification of drugs and their administration. Staff from both areas have been encouraged to take forward the NES further education modules which were free, as a developmental opportunity. We were pleased that a number of staff took this forward. Through PDP, discussions took place with staff regarding their professional development, promotional opportunities or new positions to broaden their nursing experience. A number of staff took this forward which is beneficial to the continued development of the Unit. Serious Adverse Events Two members of staff received high risk needle stick injuries, both of which were reported through a RIDDOR. At this time they have not resulted in the staff contracting an illness As reported in the mid report a patient’s relative also received a high risk needle stick injury whilst assisting his wife who was an in-patient. NHS Lothian needle stick policy was followed. Nil has resulted from this incident to our knowledge. Concerns Nil

73

Complaints Ward 206 Transplant As previously mentioned earlier in the year, a liver patient raised a number of issues which included the standard of food within the hospital, the cleanliness of the toilets and staff attitude. This was all resolved locally with a written apology to the patient. Nil further NSD funded service patient complaints Infection Control We continue to clarify the infection control data before reporting to exclude:

• Instances of double counting • Infections, which originated out with (but were attributed to) the

Transplant Unit since we obtained the specimens. Ward 206Transplant Staphylococcus Bacteraemia We have had 3 SABS over the course of the year. 2 of which were imports and one MSSA Hospital Acquired Infection where the patient had multiple admissions to the Unit throughout the year. Clostridium Difficile Over the course of the year we have had 8 CDI within the ward. 2 patients with community acquired CDI 1 patient with known infection and possibly acquired from community 1 patient with a HAI although probable import from another hospital 1 patient admitted with CDI 3 patients HAI from multiple antibiotic use to treat infection and two of those patients had several admissions to the Unit over the course of the year. Ward 117 There were no incidents of Staphylococcus bacteraemia since April 2013. Clostridium difficile One incident of Clostridium difficile since April 13

2) Patient was undergoing care in the oncology unit but was readmitted to the Transplant Unit with severe chest sepsis. The patient received antibiotic therapy (appropriate) and this resulted in a CDI (he had previously been positive)

74

Renal Recipient Transplant Co-ordinator’s Report The focus for the coming year is to further improve and develop the service we give to both assessment and transplant patients. Achievements in 2013/14

• The introduction of a traffic light system for all patients currently on the waiting list in Lothian, Borders and Fife to indicate the required frequency of review to ensure they are fit to remain on the transplant list.

• A weekly MDT to discuss patients currently on the waiting list

• The nurse led annual review clinic DNA rate has improved by 3% to 12%

• Alison Glover is now the renal recipient transplant coordinator representative

on the national Kidney Advisory Group (KAG)

• A Scotland wide renal recipient meeting held in Edinburgh

• The introduction of the Going Home and Keeping Healthy website for post transplant patients www.nhslothian.scot.nhs.uk/renaltransplant

Aims for 2014/15

• To pilot an on line annual review service for those patients who attend Victoria Hospital and Queen Margaret Hospital

• To audit the assessment process to ensure patients are listed in a timely and

efficient manner

• To organise a further Scottish renal recipient meeting to encourage increased communication and joint collaboration

We also look forward to eSERPA being introduced to streamline our documentation and allow greater access to relevant information Renal Recipient Coordinators

75

Living Donor Kidney Transplantation There were 35 living donor transplants carried out between 1st April 2013 and 31st March 2014, the highest number of live donor transplants performed in a financial year in Edinburgh. All grafts are functioning. 6 patients were pre-emptive, 23 haemodialysis and 6 peritoneal dialysis patients were transplanted.

Kidney alone transplant

Living Donor - 35Deceased Donor - 65

Live Donor Transplant by recipient centre.

Aberdeen Dundee Lothian Fife Highlands Other Borders 7 8 9 3 6 1 1

Paired exchange; ABOi and altruistic donors Altruistic donor kidneys exported

Altruistic donor kidneys imported

3-way exchange

Altruistic donor chain (inc one HLA incompatible)

2-way exchanges

HLAi Domino donation

10 3 1 4 3 1 1

76

Live donor operation by type

Live donor transplant(direct donation)Altruistic donor

3-way exchange

Altruistic donor chain

2-way exchange

HLAi

Domino donation

Laparoscopic nephrectomy All donors underwent laparoscopic nephrectomy,

Side of nephrectomy

0

5

10

15

20

25

30

Left Right

Assessment time From data available the assessment time ranged from 24 – 88 weeks, with a median of 44 weeks. A robust database is now in place to capture prospective data concerning local assessment times.

77

Transplant outcome

One- and five-year graft survival estimates (unadjusted) following living donor kidney transplant – adults only, at Edinburgh Survival period Year of

transplant No. in analysis Survival 95%

confidence int. One year 2008 – 2012 124 96% 90-98% Five years 2004 – 2008 89 89% 80-94% One- and five-year patient survival estimates (unadjusted) following first living donor kidney transplant – adults only, at Edinburgh Survival period Year of

transplant No. in analysis Survival 95%

confidence int. One year 2008 – 2012 106 98% 92-100% Five years 2004 – 2008 80 93% 86-98% Programme Developments

• The team were delighted to welcome Kath Brown and Lynne McCutcheon as Live Donor Co-ordinators. Kath brings a wealth of experience from the Transplant Unit in Glasgow and Lynne has transferred her hospital management skills and is moving forward with the team.

• Nurse-led clinics have now been introduced to utilise clinic times more effectively. Initial feedback appears to be very positive and it is hoped this can be expanded in the future.

• The new patient information booklets are in progress and due for completion in the near future.

• The Independent Assessors continue to offer great support to the team

Future Developments

• The team are looking forward to working with the BBC with the Transplant Tales documentary. Potential live donor pairs have been identified and approached, along with altruistic and paired exchange stories.

• The Live Donor Co-ordinator team are working closely with Mr Oniscu and Ms Marson on developing and improving the live donor transplant pathway.

• An event is planned to raise awareness of altruistic donation, building on the success of this year’s programme - Edinburgh is now 5th in the country out of 23 centres for altruistic donor numbers.

78

Histocompatibility and Immunogenetics (H&I) Laboratory Report Between April 2013-March 2014 the H&I laboratory supported a total of 135 kidney (105), SPK (19), pancreas (1) and islet (10) transplants performed at the Edinburgh Transplant Unit. HLA matching Out of 66 deceased donor kidney transplants (DBD and DCD), 9 were Level 1 (000) mismatches, 11 were Level 2 (0 DR and 0/1 B) mismatches and 42 were Level 3 mismatches (0 DR and 2 B or 1 DR and 0/1 B). Only 4 patients received poor Level 4 mismatches (1 DR and 2 B or 2 DR). However in SPK and islet transplants 12/19 and 5/10 patients respectively received Level 4 mismatches. Virtual crossmatching Out of 67 deceased donor kidney transplants (DBD and DCD), 53 (80.3%) were undertaken following virtual crossmatching (vXM), i.e. without waiting for the results of the prospective crossmatch. Of these 53 vXMs, 16 were undertaken in patients with known HLA antibodies. The rate of vXM for SPK transplants was 95%. Transplanting sensitised patients 75/135 (55.6%) patients who received a transplant in 2013/14 had no HLA antibodies at the time of transplant. 31 patients were sensitised only for class I, 4 only for class II and 25 for both. Six patients had significant donor specific HLA antibodies at the time of transplant and were classed as HLA incompatible transplants. HLA typing of deceased donors The following table shows the number of deceased donor HLA class I and II types undertaken for ODT in 2013/14. For DCD donors, a significant proportaion of the types undertaken did not lead to transplant.

April 2013 to March 2014 Proceeded to Transplant

Yes No Total Number Deceased Donors HLA Typed (n=74) (12/13=65)

56 18

DCD Donors (n=41) 25 16 DBD Donors (n=33) 31 2

79

Waiting List and Renal Transplant Statistics

UK active waiting list at 31 st March – all organs (except kidney)

2010 to 2014

122 129166 176

221253

212 215 225269

12 13 16 16 15

357

491513

461505

48 55 40 39 35

275251

197 213 203

20 2650 42 48

0

100

200

300

400

500

600

2010 2011 2012 2013 2014

Heart Lung Heart/Lung Liver Pancreas Kidney/Pancreas Other multiorgan

UK waiting list as at 31 st March – kidney only (active) 2010 to 2014

68926599 6415

61125660

0

1000

2000

3000

4000

5000

6000

7000

8000

2010 2011 2012 2013 2014

80

Total number of kidney patients on the waiting list for East of Scotland as at 31 st March 2014

24

7140

118

473

0

50

100

150

200

250

300

350

400

450

500

Inverness Aberdeen Dundee Edinburgh Scotland

81

Edinburgh Transplant Assessment clinic appointments

76 73

51

68

88106

84

117

0

20

40

60

80

100

120

140

New Patient Return Patient

2008/092010/112011/122012/132013/14

Clinics are run by both surgeon and co-ordinator – total number of 66 clinics run In last financial year.

DNA rates for Transplant Assessment Clinic for 2013/14 NP appointments 9.1% RP appointments 9.16%

82

Patients added (kidney only, as active or suspended) to the East of Scotland waiting list 1 st April 2009 to 31st March 2014

120 115

87

146 150

0

25

50

75

100125

150

175

2009/10 2010/11 2011/12 2012/13 2013/14

Number of patients who died or were removed from Kidney Transplant Waiting List 1 st April 2013 - 31 st March 2014 Dialysis centre Died on list Removed from list Inverness - - Aberdeen 1 - Edinburgh 4 - Dundee 1 - Total 6 0

83

Donor statistics

Deceased solid organ donors in Scotland April 2009 – March 2014

Solid organ donors Donating hospital 2009/2010 2010/2011 2011/2012 2012/13 2013/14 Kilmarnock 1 2 0 2 0 Ayr 3 0 0 3 2 Borders 0 0 1 0 0 Greenock 0 0 1 6 1 Paisley 1 3 5 4 5 Kirkcaldy 0 0 1 2 5 Dunfermline 5 3 6 0 0 Glasgow 16 13 11 16 28 Inverness 2 2 2 4 1 Aidrie 0 1 1 3 0 Wishaw 2 1 3 5 2 East Kilbride 3 0 1 2 1 Aberdeen 5 4 3 8 14 Edinburgh 18 27 24 19 28 Dundee 2 6 10 7 8 Livingstone 0 2 5 4 4 Perth 2 1 2 3 2 Falkirk (Larbert) 0 0 2 3 3 Stirling 1 1 1 0 0 Dumfries and Galloway 2 1 2 3 2 Scotland 63 67 81 94 106

84

Table below shows proportion of DBD versus DCD deceased donors in Scotland 1st April 2009 to 31st March 2014

47 49 53 56 62

16 1828

3844

0

20

40

60

80

100

120

2009/2010 2010/2011 2011/2012 2012/2013 2013/2014

DBD DCD

Proportion of DBD versus DCD kidney transplants in East of Scotland 1 st April 2009 to 31 st March 2014

0%

20%

40%

60%

80%

100%

120%

2009/10 2010/11 2011/12 2012/13 2013/14

DBDDCD

*2012/13 data includes 1 liver kidneys and 1 islet after kidney

85

UK and Ireland figures for deceased solid organ donors 1st April 2009 to 31st March 2014

1030 10561155

12681374

0

500

1000

1500

2009/2010 2010/2011 2011/2012 2012/2013 2013/2014

UK and Ireland figures for deceased solid organ donors 1st April 2013 – 31st March 2014

Donor Type

England Scotland Wales N Ireland Republic of Ireland*

Total

DBD 654 62 33 32 51 832 DCD 460 44 21 14 3 542 Total 1114 106 54 46 54 1374 *Data for Republic of Ireland not complete

Kidney Transplant Statistics

Kidney transplant offers declined

292

68 62 61 830

5 010 015 02 0 02 5 03 0 03 5 0

2 0 0 9 /10 2 0 10 /11 2 0 11/12 2 0 12 /13 2 0 13 /14

Kidney/pancreas transplant offers declined

158254

422 474411

0

10 0

2 0 0

3 0 0

4 0 0

5 0 0

2 0 0 9 /10 2 0 10 /11 2 0 11/12 2 0 12 /13 2 0 13 /14

Deceased donor kidney transplants per million population by region, April

2009 to March 2014

0

10

20

30

40

50

60

70

80

L o t h i a n B o r d e r s F i f e T a y s i d e G r a m p i a n H i g h l a n d

2009/102010/112011/122012/132013/14

87

Number of kidney transplants* carried out in Edinburgh and Scotland April 2009 – March 2014

160

132

163 161

192

8368

8065

87

49 4655

71

26 28 24 29 35

80

0

20

4060

80

100

120

140160

180

200

2009/10 2010/11 2011/12 2012/13 2013/14

Cadaveric Scotland Cadaveric Edinburgh Live Scotland Live Edinburgh

* includes kidney/pancreas and liver/kidney transplants Edinburgh cadaveric 09/10 includes 12 SPK, 1 liver/kidney, 70 kidney Edinburgh live 09/10 includes two altruistic and 2 paired/pooled donors Edinburgh cadaveric 10/11 includes 6 SPK, 1 liver/kidney, 61 kidney Edinburgh live 10/11 includes two paired/pooled donors Edinburgh cadaveric 11/12 includes 17 SPK, 2 liver/kidney, 61 kidney Edinburgh cadaveric 12/13 includes 20 SPK, 1 liver/kidney, 44 kidney Edinburgh live 12/13 includes four altruistic and three paired/pooled donors Edinburgh cadaveric 13/14 includes 20 SPK, 67 kidney

Edinburgh live 13/14 includes 5 altruistic and 6 paired/pooled donors

88

Deceased donor kidney transplant recipient age group 1 st April 2009 to 31 st March 2014

0

5

10

15

20

25

11-20 21-30 31-40 41-50 51-60 61-70 70+

2009/10 2010/11 2011/12 2012/13 2013/14

Number of DR mismatches for all renal transplants

0

1

2

2009/10

44

57

8

2010/11

44

38

7

2011/12

41

38

8

2012/13

38

30

6

2013/14 34 55 8

89

Dialysis treatment prior to deceased donor kidney transplant

Hospital haemodialysis

CAPD / APD

Pre-dialysis

Home haemodialysis

2009/10

58

21

4

0

2010/11

40

18

1

2

2011/12

45

9

6

3

2012/13

35

5

2

3

2013/14

53

9

4

1

All kidney patients transplanted showing graft number 1 st April 2009 to 31 st March 2014

90

18

1 0

76

11

2 0

73

850 1

63

830 0

78

15

2 2 00

10

20

30

40

50

60

70

80

90

2009/10 2010/11 2011/12 2012/13 2013/14

1st

2nd

3rd

4th

5th

90

Length of stay for all kidney transplant patients from 1 April 2013 to 31 March 2014

Mean Range Ward 10 days 3 – 50 days HDU 4 days 1 – 15 days ITU – 3 patients 4 days 2 – 5 days

One- and five-year kidney graft and patient survival

estimates (unadjusted) deceased donor transplants

One- and five-year graft survival estimates following first deceased kidney-only transplant – adults only, at Edinburgh Survival period Year of

transplant No. in

analysis

Survival rate 95%

confidence int.

1 year 2008 – 2012 250 93% 88-96% 5 years 2004 – 2008 167 84% 76-88% One- and five-year patient survival estimates following first deceased kidney-only transplant – adults only, at Edinburgh Survival period Year of

transplant No. in

analysis Survival rate 95%

confidence int.

1 year 2008 – 2012 250 96% 92-98% 5 years 2004 – 2008 167 86% 80-90%

91

Post Transplant Outpatient Activity

Post transplant outpatient activity year on year is shown in the graph below. This consists of patients attending outpatient Consultant and Registrar clinics at the Royal Infirmary of Edinburgh, Borders General and St John’s Hospital. The nurse-led annual review clinics also include the Royal Infirmary of Edinburgh, Queen Margaret Hospital Dunfermline, Victoria Hospital Kirkcaldy and St John’s Hospital.

31583188

3454 3454

3157

30003050310031503200325033003350340034503500

2009/10 2010/11 2011/12 2012/13 2013/14*

Figures for 2012/13 includes 426 patients who attended the ward for outpatient appointments * Figures for 2013/14 do not include patients who attended the ward for outpatient appointments

DNA rate for clinic 2013/2014 is 8.8%