Minutes of the Liver Transplant Advisory Committee

Transcription

1 Minutes of the Liver Transplant Advisory Committee Date: 3 December 2012 Venue: Qantas Club Room, Sydney Airport Attendees Jonathan Fawcett (Chair) QLD Michael Crawford NSW Bob Jones VIC/TAS Michael Fink VIC/TAS John Chen SA/NT Mark Brooke-Smith (proxy for Rob Padbury) SA/NT Michael Stormon (Proxy for Winita) Paediatric Rep Libby John ATCA Rep Diana Aspinall Consumer Rep Glenda Balderson Liver Registry Winita Hardikar (teleconference re small bowel) Henry Pleass (small bowel segment) Guest Richard Allen (small bowel segment) Guest Apologies: Rob Padbury Ed Gane Stephen Munn Luc Delriviere Gary Jeffrey Geoff McCaughan Graeme Macdonald SA NZ NZ WA WA NSW QLD 1. Welcome The Chair welcomed all to the meeting. Diana Aspinall s position was confirmed as a Consumer Rep on the Liver Advisory Committee (Liver AC); she agreed to help recruit a community rep. 2. Conflict of Interest No conflict of interest was declared. 3. Confirmation of the Agenda The Agenda for the meeting was confirmed but the order was changed for the convenience of invited guests. 1

2 4. Confirmation of the Minutes The minutes of the previous Liver AC meeting held in Canberra on 26June 2012 were approved unanimously. 5. Matters Arising from the Minutes 5.1 Paediatric Donor The meeting discussed weight and age characteristics and other considerations with a view to defining a paediatric donor. It was agreed that less than 18 years be used as the standard definition and that ATCA be informed. Actions a. Inform ATCA of the new definition of paediatric donor. b. Include the new definition in the Donor Liver Allocation section in the Consensus Statement (CS) 5.2 Medicare Item Number for Liver Transplant The Chair advised that pursuing this matter may not be advantageous at this point and therefore he had not taken any action. 5.2 Share 25 The Chair noted that he had not progressed this matter which is complex and will require funding support for a meeting which the Authority has declined. Participants agreed to discuss this matter at the next meeting. Action a. Include Share 25 in the agenda for the next meeting. 5.3 UW Solution The Chair informed the meeting that he had written to the Authority proposing that it takes up the central purchasing agency role for UW solution. The proposal was declined on the grounds that it did not fit with their remit Combined Liver Kidney Transplant. The meeting noted that patients requiring both kidney and liver transplantation should logically receive both grafts from the same donor as a combined liver-kidney transplant. With increasing numbers of patients presenting for re-transplantation of their liver, there is likely to be an increased demand for such combination transplants. The explanation for this is that liver transplant patients sustain chronic damage to their own kidneys from the long term administration of some immunosuppressive drugs (calcineurin antagonists). There is often also an immediate, and permanent, reduction in kidney function associated with liver transplant surgery especially when the operation has been difficult. Thus, a common scenario occurs when a liver transplant patient with stably impaired kidney function presents for retransplantation of their liver. Since they are not in end-stage kidney failure, they do get a kidney allocated from the donor from whom they receive the second liver. In a significant proportion of such patients, their kidney function deteriorates in the early (1 6 month) post-transplant period to the point that permanent dialysis is required. Current kidney allocation practices do not take into account such patients and there is also an understandable reluctance to allocate kidneys to liver transplant patients who may, in fact, have 2

3 recoverable renal function. This is more typical, though, in first-time recipients who have hepatorenal syndrome. Although the number of combined liverkidney transplants is currently small, around 5%, there was a general understanding that the matter is sufficiently important to warrant a dialogue with the renal transplant community. To this end, the Committee agreed to collect data from all jurisdictions on actual outcomes of combined liver-kidney transplants and outcomes in liver transplant patients with kidney impairment at the time they received a new liver. Mark Stevens, a liver and kidney transplant surgeon who has just completed training and who has worked in three states recently, and an interested renal physician were to be approached to collect data for sharing with renal clinicians. Action a. Convene a research team comprising Mark Stevens and a renal physician to collect data on outcomes of combined liver-kidney transplant, and patients with impaired kidney function undergoing liver transplantation. 5.4 Consensus Statement (CS) A draft revision of Appendix H Donor Liver Allocation - of the Consensus Statement was presented to the Committee. The revisions were made in response to the need to format suitability criteria in line with the Appendices concerning other donor organs. The committee was in accord that the revision was acceptable but also took the opportunity to review the content as well. It was decided that there have been changes made in assessing the suitability of donor livers for transplantation. The Chairman agreed to re-word the contents of the Appendix to reflect current practice. Actions a. Redraft the Liver Section of the CS incorporating the suggestions made at the meeting. b. Seek feedback from members on the revised version. c. Submit final version of the text for endorsement by TSANZ Council. 6. Small Bowel Transplant This was the main item of new business at the Liver AC meeting. Professor Bob Jones (Victoria) presented an update on the current state of practice in small bowel transplantation and how the new service in Victoria is to be configured. The criteria for suitable donors for small bowel grafts were presented and it was noted that they very strictly define a group of donors in there is likely to be the very minimum of organ injury and the best prospects of successful function after transplantation. The reasoning behind this is that the small bowel in organ donors is very susceptible to injury, such as ischaemia caused by the use of inotropic drugs in the donor, and this may compromise the success of a small bowel transplant. It was also noted that patients with intestinal failure frequently develop associated liver disease. As a result, a third to a half of patients may require concomitant liver transplant. It is organ allocation for this group of recipients that required careful discussion because transplanting them will deprive a recipient waiting on the liver transplant waiting list of an opportunity to be transplanted. As is common with other multivisceral organ transplants, the severity of individual organ dysfunction that reaches a threshold for requiring transplant is different (and generally lower) than the severity of organ dysfunction for a patient presenting for a single organ transplant. Thus, a patient needing a combined liver and intestinal transplant may not have a 3

4 MELD score of more than 14 (which is the threshold for liver-alone transplantation) but is nonetheless as seriously ill as a patient with a high MELD score. Currently, the estimation of equivalence between liver-intestine and liver-only recipients is empirical. With these factors in mind, extensive discussion took place about how to establish a fair and effective allocation system of livers between liver-intestine and liver-only recipients on the waiting list. The following points emerged: i. There was immediate consensus that the Victoria unit is providing a service for the whole country and that they should not be expected to find all of the suitable donors from within their own state donor pool and that this was a national issue. ii. iii. iv. A key component in making a system work was adequate discussion between the unit in the home state and the Victoria unit when a suitable donor was available. That if a unit had a patient on their waiting list awaiting liver transplantation who was very sick it would not be justified to give up a liver to the Victoria unit for liver-intestine transplant because of the risk of that liver recipient dying before another donor became available. In the light of previous data presented to the Committee, the threshold MELD score for identifying the very sick patient waiting for a liver transplant was 25. In order to achieve maximum utility, it was noted that it would still be feasible to split a liver destined for combined liver-intestine transplant so that child could still receive a segment II/III graft from such donors. v. Given the very tightly defined donor parameters for intestinal transplantation (including those combined with liver transplants), it would be helpful if all the units were circulated with the adult and paediatric waiting list for intestinal transplant in order that suitable recipients in the Victoria unit could be easily identified. The committee decided on a new category of urgent, nationally listed, patients to encompass those waiting for liver-intestine transplant to be called 2(c). In the event of a donor becoming available that would meet the criteria for liver-intestine transplantation in a patient on the 2(c) list, then it would be mandatory for the home state to discuss allocation of that donor with the Victoria unit UNLESS they already had a patient on their liver transplant waiting list with a MELD score of 25 or greater, in which case they were at liberty to proceed with liver transplantation in that sick patient without discussion. There was unanimous agreement among those present to this proposal. There was further discussion about the logistics of the service with regard to donor organ procurement. The acceptable cold ischaemia time for intestinal grafts is only 6 hours and the Victoria unit will plan to send their own procurement personnel to retrieve the intestinal grafts. If the liver is not allocated to the Victoria unit, then the home state will need to send their own personnel to retrieve the liver. The reason for this is that the Victoria unit will be working to strict time limitations and they will not have time to complete the liver procurement for the home state. There may, though, be some prospect of each team sending a limited number of personnel because they would be able to work together. There was also discussion about referral and follow-up arrangements for the patients transplanted by the Victoria unit. Ultimately, they will be return to their home state 4

5 and will be followed up by the liver transplant units there (both liver-intestine and intestine-only transplant patients). However, this may not be the same hospital that referred those patients for intestinal transplantation. Ideally, the home state liver transplant unit should see all patients destined for intestinal transplant in Victoria before they go there. Beyond this, a case can be made for a more formal hub and spoke structure for the relationship between the Victoria unit and the liver transplant units around the country - these logically could be a basis for state-based intestinal failure units. The care of intestinal failure patients has historically been compromised by ad hoc management in individual hospitals. Given that intestinal transplant is still a new area of solid organ transplantation, it is proposed that progress in the intestinal transplantation in Australia and New Zealand will be a standing agenda item for the Liver AC indefinitely. The arrangements that are set out above can be reviewed and modified according to developing experience and need at any time by the Liver AC. Actions a. Revise the intestinal section in the Consensus Statement. b. Include Category 2(c) for liver-small bowel transplant under the liver section in the Consensus Statement. c. Compile a national list of Category 2c patients awaiting liver-small bowel transplant. d. Include intestinal transplantation as a standing agenda item for the Liver AC meetings. 7. Heart-Lung-Liver Transplant Prioritisation This item of business was submitted in light of review of experience with combined liver and thoracic transplantation in New South Wales. To date, no patient in New South Wales has proceeded with combined liver and thoracic organ transplantation because they have all died waiting for a suitable donor. There was general discussion about the difficulties in transplanting this very small group of patients in whom Cystic Fibrosis would be the commonest underlying disease but there are some others and Familial Amyloid Polyneuropathy (FAP) was the underlying disease in the patient in New South Wales who most recently succumbed while waiting for a suitable donor. Echoing the discussion regarding the assessment of disease severity in patients requiring combined liver-intestine transplantation, it was highlighted that the patient in New South Wales with FAP didn t appear as sick as other patients on the cardiac transplant waiting list and therefore was passed over when suitable donors were available in favour of patients requiring heart-only transplantation who were more obviously unwell in advance heart failure. Nonetheless, the patient with FAP was in a very advance state of decline and finally died on the waiting list. When the further obstacles to transplant are considered the allocation of multiple donor organs to a single rather than multiple patients and the stricter donor suitability criteria (e.g. tighter size matching and tissue cross-matching) it is not surprising that these patients are difficult to get to transplant. In Queensland, 6 patients have received combined heart-lung-liver transplantation (in every case the recipient heart was successfully domino transplanted into another patient). Five of these patients waited over a year for their transplant and the only one that died post-operatively had waited nearly three years by which time, in retrospect, they were actually untransplantable. 5

6 There are no regulations that can be imposed or other solution to this problem that can be offered by the LAC. It seems essential, though, that if a patient is to be listed for combined solid organ transplantation, then all the stakeholders in the process have to buy in to the recognised need for the procedure and importance of identifying, prioritising and allocating suitable donors to these patients. There is nothing to be gained by listing patients for these complex procedures, the results of which are very good, unless there is a definite intention to proceed with it. As a final observation, it was noted that the use of domino heart transplants from a heart-lungliver recipient means that, in effect, they have only taken a liver and lungs from the donor pool. With the increasing availability of donor lungs, as a result of take-up in DCD lung transplantation, there is probably less pressure on lung transplant waiting lists and this should reduce the impost of combined heart-lung-liver transplantation. Henry Pleass (NSW) also raised similar issues around combined kidney-pancreas transplantation. On occasions around Australia, suitable donor organs for combined kidney-pancreas transplantation have not been allocated to patients on the waiting list and instead have gone to kidney-only patients in the home state of the donor for locally argued reasons. Again, while the Liver AC strongly supports the principle of adherence to nationally developed protocols, it is recognised that on occasions it is possible that there could be legitimate reasons for deviating from them. It is necessary to promote the strength of the arguments underpinning the national protocols to reduce the occurrence of such deviations. Action a. Write to TSANZ President requesting greater transparency, including documentation of decision making, in respect to heart allocation decisions. b. Raise the issue of obtaining kidneys for the needy pancreas transplant patients with RTAC. 8. PJP Prophylaxis in Heart Lung Transplantation The Chair informed the meeting that he had recently participated in a workshop on PJP Prophylaxis in Heart Lung Transplantation and that he had been asked by TSANZ President to provide information on treatment regimes employed by different transplant units. He invited views of participants on what they were doing and what they might do in future to combat this virulent strain of Pneumocystis jirovecii which had predominantly inflicted the eastern seaboard. Notably, the outbreak occurred in Westmead Hospital in 2010, followed by another in Infection had spread to other hospitals in NSW, SA, VIC and QLD; NZ and WA have so far not been infected. Of the total 72 identified cases, 10 deaths have occurred. He encouraged participants to undertake a DNA analysis of the virus if a new case was discovered. The Committee was of the view that different jurisdictions were dealing with the issue in their own ways and therefore it does not warrant any further medical intervention. The Chair agreed to advise the TSANZ President accordingly. Action a. Write to TSANZ President outlining practices of different jurisdiction and advising that no special medical intervention is necessary. 9. Religious Prohibitions on Use of Blood Products This item of business was tabled by Michael Crawford (NSW) in order to explore approaches and attitudes to liver transplantation in this group of patients. Various points were raised in discussion: 6

7 i. Liver transplant surgery can be very difficult and associated with massive blood loss. Equally, though, modern experience shows that many liver transplants can be performed with low, or no, transfusion requirements. ii. iii. iv. It can be difficult to predict in advance how much blood, and blood products, a patient will require. There is variation between Jehovah s Witness patients in what blood or blood products they would be willing to accept. Some will accept cell-salvaged red cells, some won t, and some will accept non-red cell products such as FFP. There are reports in the literature of successful liver transplants in Jehovah s Witness patients including a combined publication from the liver transplant units in New Zealand and Western Australia. Unfortunately, no representatives from either of these units were able to attend the Liver AC meeting. v. In the event of a Jehovah s Witness liver transplant recipient dying in the perioperative period, because they would not accept blood products, then effectively they have denied another patient receiving a successful liver transplant. The Liver AC acknowledges the difficulties posed by this group of patients and the need to treat them equitably by comparison with other Australian and New Zealand citizens. However, the Liver AC cannot impose measures that may be seen as going against safe clinical practice in individual situations. 10. Assessing Future Transplant Resources. The Chair advised that the Authority is undertaking a high level assessment of resources required for transplantation of organs premised on achieving a higher donation rate of 25 dpmp, compared with 14.9 in Chairs of TSANZ Advisory Committees present at the Transplant Liaison Reference Group (TLRG) agreed to conduct the assessment pertaining to their own transplant areas and feedback to TLRG which meets in March He referred to a number of tables populated with NSW data prepared by TSANZ Project Officer and invited comments on what data should be collected and the mechanism for collating the data. The meeting agreed to capture data on downstream activities as well which will invariably be affected by increased transplant throughput. Actions a. Formulate a simpler user friendly template to collect data. b. Send the template to jurisdictions to input data c. Collate data received from jurisdictions d. Send collated data to all members and obtain their feedback e. Submit data to TLRG in the March 2013 meeting. 11. Uploading Minutes of the Committee Meeting on TSANZ website The TSANZ Project Officer advised that the minutes of the Liver AC meetings, upon their approval by the Committee, will be uploaded on the TSANZ website which can be accessed by TSANZ members only. Action a. Upload Minutes of Liver AC on TSANZ website 7

8 12. Schedule of Meeting It was agreed to hold the next meeting a day before the ILTS Sydney meeting June Consequently there will be no meeting at the TSANZ ASM in Canberra as usual. Among items to be discussed are: Donor audit, outcome of urgent listing, Small bowel and Share 25. Michael Crawford agreed to find a venue after discussing the matter with Geoff McCaughan. Actions a. Find a venue for the meeting in Sydney b. Make meeting arrangements 13. Closure The meeting closed at approximately 2:40pm. The Chair thanked everyone for attending the meeting. 8

9 Action List Subject Reference Action Who When Status # Community Rep /01 Assist in finding a suitable community rep D Aspinall 11/06/13 Definition of /02-a Write to ATCA President J Fawcett 11/06/13 Paediatric Donor advising the new definition of paediatric donor /02-b Include the new definition in the revised version of the J Fawcett 11/06/13 Donor Liver Allocation section in the Consensus Statement (CS) Share /03 Include Share 25 in the I Ali 04/04/13 agenda for the next meeting. Combined Liver Kidney Transplant /04-a Set up a research team comprising Mark Steven and a renal researcher to collect data on outcomes of combo J Fawcett 24/12/12 (liver-kidney) transplant, both actual and potential /04-b Oversee/supervise research J Fawcett 11/06/ /04-c Present data at the next M Steven 11/06/13 Consensus Statement (CS) Small Bowel Transplant Heart-Lung-Liver Transplant Prioritisation /05-a Meeting Redraft the Liver Section of the CS incorporating the suggestions made at the meeting /05-b Seek feedback from members on the revised version /05-c Submit final version of the text for endorsement by TSANZ Council /05-a Revise the intestinal section in the CS /05-b Include Category 2c for liver-small bowel transplant under the liver section in the CS /05-c /05-d Compile a national list of Category 2c patients awaiting liver-small bowel transplant. Raise the issue of obtaining kidneys for the needy pancreas transplant patients with RTAC Chair /06 Reply to TSANZ President s letter, requesting greater transparency in documentation of decision making in respect to heart J Fawcett 24/12/12 I Ali 04/02/13 J Fawcett 05/03/13 J Fawcett 24/12/12 J Fawcett 21/12/12 All 11/06/13 J Fawcett 11/06/13 J Fawcett 4/03/13 9

10 PJP Prophylaxis in Heart Lung Transplantation Religious Prohibitions on Use of Blood Products Assessing Future Transplant Resources. Uploading Minutes on TSANZ website Schedule of Meeting allocation decisions /07 Write to TSANZ President J Fawcett 24/12/12 outlining practices of different jurisdiction and advising that no special medical intervention is necessary /08 Document approaches and J Fawcett 24/12/12 attitudes to liver transplantation for the group of patients affected by religious prohibitions on use of blood products /09-a Formulate a simpler user I Ali 18/12/12 friendly template to collect data /09-b Send the template to I Ali 21/12/12 jurisdictions to input data /09-c Collate data received from I Ali 20/01/13 jurisdictions /09-d Send collated data to all I Ali 30/01/13 members and obtain their feedback /09-e Submit data to TLRG J Fawcett 03/ /10 Upload Minutes approved by I Ali 24/12/12 the Liver AC on TSANZ website /10-a Advise TSANZ Project M 18/12/12 Officer of a suitable date for Crawford the Sydney meeting coinciding with the ILTS event /10-b Make meeting arrangements I Ali 30/01/13 in consultation with the Chair 10