DECLARATIONS OF INTEREST IN RELATION TO THE AGENDA - CTAG(16)H1
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1 NHS BLOOD AND TRANSPLANT ORGAN DONATION AND TRANSPLANTATION DIRECTORATE THE SEVENTH MEETING OF THE NHSBT CTAG HEART ADVISORY GROUP ON WEDNESDAY 13 TH APRIL 2016, 15:00 17:00 IN THE CANTERBURY SUITE, THISTLE HOTEL, CARDINGTON STREET, EUSTON, LONDON NW1 2LP PRESENT: Mr S Tsui, Chair Mr N Al-Attar, Surgeon, Golden Jubilee Hospital, Glasgow Mr J Asher, Clinical Lead Medical Informatics (ODT) Dr N Banner, Cardiologist, Harefield Hospital, Middlesex Prof M Burch, Cardiologist, Great Ormond Street Hospital, London Mr S Clark, Surgeon, Freeman Hospital, Newcastle Prof J Dark, National Clinical Lead for Governance, ODT Ms R Hogg, Statistics and Clinical Studies, NHSBT Dr S Lewis, Acting Medical Director, Welsh Health Specialised Services Ms L Logan, Regional Manager, Organ Donation Services, ODT Mr J Mascaro, Surgeon, Queen Elizabeth Hospital, Birmingham Dame J McVittie, Lay Member Representative Dr, Statistics & Clinical Studies, NHSBT Dr J Parameshwar, Cardiologist, Papworth Hospital, Cambridge Mrs C Riotto, Recipient Transplant Co-ordinator Representative, Papworth Hospital Mr R Venkateswaran, Surgeon, Wythenshawe Hospital, Manchester Ms S Watson, Commissioner, NHS England Dr M Winter, (NSD) National Services Division - Scotland IN ATTENDANCE: Mrs D McGuckin, Senior Commissioning Manager, ODT Ms J Newby, ODST Team Manager, ODT Observer Ms A Scales, Paediatric Specialist Nurse Organ Donation Mr C Wheelans, NSD Scotland - Observer Mrs K Zalewska, Clinical & Support Services, ODT APOLOGIES: Mrs T Baker, Transplant Business Manager, Harefield Hospital, Middlesex Prof D Collett, Associate Director of Statistics & Clinical Studies, NHSBT Prof J Forsythe, Associate Medical Director, ODT Prof S Fuggle, Scientific Advisor, ODT Mr A Hasan, Paediatric Surgeon, Freeman Hospital, Newcastle Dr E Jessop, Medical Adviser, NHS England Mr M Knight, Lay Member Representative Mrs J Nuttall, Recipient Co-ordinator Lead, Wythenshawe Hospital, Manchester Ms A Sheldon, Head of Referral & Offering, ODT Mr A Simon, Director of Transplantation, Harefield Dr J Smith, BSHI representative Mr M Stokes, ODT Duty Office Services Manager, NHSBT Dr J Townend, Cardiologist, Queen Elizabeth Hospital, Birmingham Apologies and welcome Action 1 DECLARATIONS OF INTEREST IN RELATION TO THE AGENDA - CTAG(16)H1 There were no declarations of interest.
2 2 MINUTES OF THE MEETING HELD ON THURSDAY 24 th SEPTEMBER CTAG H(M)(15)2 2.1 Accuracy The minutes were approved as a correct record. 2.2 Action points - CTAG H(AP)(16)1 AP1 Heart Allocation Working Group : In hand AP2 VAD database issues: It was agreed that reference should be made to IMACS to establish what fields they collect that are not currently stored in the VAD database. These should be added to the UK VAD database. AP3 Audit of components of ischaemia time in adult heart transplantation: No further comments were received so the proposal for data collection was agreed and adopted. The NORS team will be responsible for collection of the data and reporting of timings until the organ leaves the operating rooom. The recipient centre team will be responsible for recording the data from the time the organ enters the recipient transplant operating room AP4 Heart related clinical governance incidents: Completed AP5 Clinical characteristics of urgent patients: to work with M Stokes to establish whether the relevant information is being received for patients registered under the other urgent heart category. AP6 GOSH paediatric access to heart transplantation : Refer to minute 7 below. AP7 DCD Heart donation: Completed Action 2.3 Matters arising, not separately identified There were no other matters arising. 3 GOVERNANCE ISSUES 3.1 Non-compliance with heart allocation There were no instances of non-compliance to report. 3.2 Heart incidents for review Clinical Governance report - CTAG(16)H2 Between September 2015 and March 2016 there were 38 incidents reported which related to the heart, 17 of which related to retrieval. Incidents of particular concern were: Pulmonary valve damage: In this 6 month period there were no less than 10 reported instances of pulmonary valve damage when the heart was not being used and valves were being despatched to the Tissue Banks. Primarily this relates to the approach taken when retrieving donor lungs, the process for which has previously been circulated to retrieval teams. Paediatric heart retrieval by an adult team: A heart was retrieved from a paediatric donor weighing 30kg by an adult team, as per the current agreement. Concerns were expressed about the training of the retrieval surgeon and, following discussion at NRG, it was suggested that CTAG increases the size threshold for sending a paediatric retrieval team to donors weighing up to 40kg or consider changing to a height threshold, say 145cm. It was estimated this change would not impact on paediatric teams significantly. Members agreed in principle to raise the threshold for the size of donors in order to allow designated paediatric teams to retrieve. In order to reach a decision on any change to a height threshold, was asked to provide data on the number of paediatric donors over the last 3 years from which organs were retrieved, split by height, ie less than 130 cm, cm, cm, cm, cm.
3 Loss of heart and lungs due to misplaced catheter: Retrieval teams are reminded of the importance of standard approaches to central vein cannulation. Delay in departure of packed heart due to inability of abdominal team to procure spleen and lymph nodes during a difficult retrieval: NRG have accepted that abdominal teams should be asked to take these specimens during the perfusion phase of their retrieval. 3.3 Summary of CUSUM monitoring of 30 day outcomes following heart transplantation - CTAG(16)H3 No CUSUM signals in heart transplantation were reported since the last CTAG meeting. 4 DCD HEARTS SERVICE EVALUATION CTAG(16)H4 D McGuckin updated the meeting on the DCD Heart Retrieval evaluation, summarising activity since the programme started in February 2015 and since the NHSBT agreed evaluation began on 1 st December Since 1 st December 2015 there have been 7 additional retrievals, 6 at Papworth and 1 at Harefield. In total there have been 22 DCD hearts retrieved since the programme began in February 2015, which have resulted in 20 additional heart transplants. Funding is not available for the evaluation beyond the end of March 2016 and both Papworth and Harefield are keen to continue with their clinical programme in 2016/17 therefore it is likely that the teams will pursue internal funding to continue until such time as a business case can be considered by the Departments of Health. S Tsui proposed a working group meeting take place involving all centres in the process to move this forward. D McGuckin agreed to take back to the DCD steering group a request from Manchester to explore the expansion of the programme to other interested centres. 5 AMENDMENTS TO URGENT HEART SCHEME 5.1 Long Waiting Times CTAG(16)H5 The urgent heart scheme has no restriction on the maximum duration that a patient can remain on the list. Over the past year there were around recipients on the scheme at any one time, with the maximum being as high as 52. A proposal was received that when an urgent/super-urgent heart patient reaches 6 months waiting time on the urgent heart list, the registering centre must provide an update to the CTAG Adjudication Panel justifying the patient s inclusion on the list. Members endorsed the proposal and was asked to develop a process for reminding centres approximately 2 weeks before the 6 month limit is reached. If the centre requests the patient remains on the scheme this will be referred to the adjudication panel for a decision within 72 hours. If the panel agrees then the patient will stay on the scheme to be reviewed again in 6 months time; if not, the patient will be transferred to the routine list. This process will be reviewed with the possibility of changing the timing for referral to the panel to 3 months for those on the super-urgent list. 5.2 Weekly update forms It was previously agreed, when the urgent heart scheme was implemented, that when centres list urgent patients the centre provides a weekly update. Few centres are doing this so the process is being adjusted to make it more workable. It is proposed that returns are provided monthly with less information being requested. C & SS D McGuckin
4 6 HEART SELECTION & ALLOCATION POLICIES 6.1 Review of current policies CTAG(16)H6 a & b Members reviewed the current policies. No comments were received apart from the possibility of changes in relation to the issue of paediatric access to heart transplantation discussed at minute 7 below. 7 Access to heart transplantation for larger paediatric patients at GOSH - CTAG(16)H7 A paper submitted to the previous CTAG heart meeting showed strong statistical evidence of a difference in the proportion of patients transplanted within 6 months of registration at GOSH and Newcastle. Contributing factors for this difference were thought to be: the issue of larger paediatric patients requiring adult sized hearts meaning this cohort of patients at GOSH wait longer than at Newcastle because GOSH will only ever appear below all adult centres in the heart matching run GOSH is the only heart transplant centre without a dedicated allocation zone meaning it will never be the first centre to receive a non-urgent offer of a paediatric donor heart. Members were asked to consider draft proposals to alleviate this issue. It was agreed that a working group meeting be set up on the same day as the working group for DCD Hearts in minute 4 above in order to get agreement on how to address this imbalance. C & SS 8 VAD UPDATE S Watson reported on progress with destination therapy VADs where an evidence review is to be taken forward to develop a policy in 2016/17. Discussions need to include the impact on VAD numbers of the DCD heart programme. 9 STATISTICS & CLINICAL STUDIES REPORT 9.1 Access to heart transplant by blood group CTAG(16)H8 Members received a report on access to heart transplant by recipient blood group over the last two years. Although blood group O patients continue to wait longer than others for non-urgent heart transplant and six month transplant rates differ significantly between the blood groups, little else can be done to direct blood group O donor hearts without affecting the urgent scheme. Under the new impending heart allocation scheme, due to be implemented in summer 2016, blood group prioritisation rules will change and running this analysis when the new scheme has been implemented will provide an insight on whether the new scheme addresses this issue. It was agreed that this paper would not be needed in future as the concluding message is the same each year and there is little that can be done about it under the current scheme. 9.2 GOSH 20cm donor-recipient size match rule CTAG(16)H9 A paper was received analysing the impact of the 20cm size matching limit for GOSH accepting adult donor hearts for use in non-urgent paediatric recipients. The rule was introduced with the aim of restricting the number of adult hearts being used by GOSH as adult patients were being disadvantaged. Between 1 January 2015 and 31 December 2015 there was one transplant involving an adult donor heart to a non-urgent paediatric recipient. A breach of the rule occurred in July and is being investigated. The child involved breached the rule at time of listing but grew from 138 cm at the time of listing to 141cm at the time of transplant. It was agreed to discuss in more detail whether to adjust the 20cm rule at the working group meeting referred to in minute 7 above. S Tsui
5 9.3 Prolonged heart registrations CTAG(16)H10 Members noted a summary of prolonged heart registrations and suspensions by centre as at 1 March It was agreed that it would be useful for centres to receive this information, including patient names, on a 6 monthly basis to allow them to check that the information held by NHSBT is valid. It would also be useful to show which patients are or are not on VADs. 9.4 Updated post-heart transplant survival models CTAG(16)H11 A paper showing newly developed risk adjusted heart post-transplant survival models for patient survival times was received. These will be used annually to estimate post-transplant survival in the Annual Report on Cardiothoracic Transplantation and will form the basis for any research project looking at the factors that influence post-transplant survival. Concerns were expressed about adopting a model that does not account for ischaemia time. It was suggested that the data could be analysed with both the old and the new models and compared. OCS patients would need to be considered separately and agreed to investigate the issue of OCS usage and its influence on other factors. This would involve looking at different models: OCS for DBD hearts; OCS for DCD hearts; and non-ocs DBD hearts. 10 Any other business There were no other items of business. 11 Date of next meeting: Tuesday 27 th September 2016, 10.00am - 12 noon London venue tbc Post meeting note: The next meeting has been rescheduled to an alternative date in October 2016 actual date to be confirmed. Organ Donation & Transplantation Directorate April 2016
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