TSANZ

The Transplantation Society of Australia and New Zealand

Liver Protocol

ORGAN DONORS' SUITABILITY CRITERIA

General organ donor criteria

Required Information for allocation

1. Blood group
2. Body weight
3. Approximate height
4. Approximate girth
5. Laboratory tests	-	as in General organ donor criteria for viral studies. HIV, Hep BsAg, Hep C Ab, CMV and HBV core Ab It should be noted that donors who are HbsAg positive should be offered to units with urgent cases listed for transplant or with recipients who are Hepatitis B surface Antigen. All HBsAg+ donor livers should be biopsied to exclude significant (>Stage 1) fibrosis.
	-	In contrast, donors who are HBsAg negative but anti-HBcore positive can be used in any of the following situations: (i) HBsAg positive recipient. Needs combination prophylaxis post-transplant (ii) anti-HBs positive (via either vaccine or natural immunity). Needs no prophylaxis post-transplant (iii) any other patient who accepts long-term lamivudine prophylaxis
	-	Donors who are anti-HCV positive should be offered to units with elective anti-HCV+ cases listed for transplant, provided these potential recipients are known to be HCV RNA+. All anti-HCV+ donor livers should be biopsied to exclude significant (>Stage 1) fibrosis.
6. Known liver disease

GENERAL: RECIPIENT SUITABILITY CRITERIA

1.	Accepted indication for listing:
	-	life threatening acute or chronic liver disease not amenable to alternative therapy.
	-	extrahepatic manifestations of inborn error of metabolism (FAP, GSD, hyperlipidaemia).
2.	Transplant to improve quality of life but not life expectancy (ie palliative transplant) is not accepted indication.
3.	Accepted onto the waiting list by a recognised liver transplant unit.
4.	Absence of contra-indications, e.g.:
	-	life threatening non-hepatic illness considered to preclude successful liver transplantation;
	-	persisting alcohol or substance abuse;
	-	inability to co-operate with life long medical supervision;
	-	the presence of significant malignancy (except for hepatocellular cancer, see below).
	-	severe neurologic or developmental impairment.

Currently recognised Liver Transplant Units

Qld	-	Princess Alexandra Hospital Paediatric Service - Royal Childrens Hospital
NSW	-	Royal Prince Alfred Hospital Paediatric Service - New Children's Hospital, Westmead
VIC	-	Austin Hospital Paediatric Service - Royal Children's Hospital
SA	-	Flinders Medical Centre
WA	-	Sir Charles Gairdner Hospital
NZ	-	Auckland City Hospital

 

Background

Each liver transplant Unit has a list of patients who are waiting for liver transplant.
The criteria for being placed on the list include terminal liver disease, hepatocellular cancer fulfilling “San Francisco” criteria and severe symptomatic liver disorders such as polycystic liver disease.

Examples of general guidelines for selection for specific disease are:

1. Hepatocellular Cancer
   
      San Francisco criteria:
   
   • Single tumour ≤ 6.5cm in maximum diameter
   • Multiple tumours ≤ 3cm in number) with the largest diameter being ≤ 4.5cm and a total tumour diameter of ≤ 8.0cm
   • No extra-hepatic spread
      
      
2. Cirrhosis (all forms)
   • Decompensated liver disease
   • Correctable extrahepatic manifestations of cirrhosis e.g. hepatopulmonary syndrome, failure of growth and/or neurodevelopment
      
3. Metabolic disorders
   • Life threatening conditions curable by liver transplantation
   • Severe uncontrolled symptomatic disease
      
4. Alcoholic Liver Disease
    
   Liver failure following -
   • 6 months abstinence
   • Considered at low risk for continued alcohol abuse
      
5. HIV positive patients
   are acceptable candidates for transplant providing the individual prognosis from HIV infection is acceptable. In patient receiving HAART at the time of listing, HIV should be fully suppressed (HIV RNA undetectable and CD4 >100). In patients unable to tolerate HAART because of liver failure, there should be evidence of fully suppressible HIV (absence of multiresistance) prior to HAART withdrawal.
    
6. Retransplant
   Is considered only in patients with an acceptable predicted survival (>50-% at 5 years).
    
7. Exclusions
   Included
   • Metastic liver disease (non – neuroendocrine)
   • Significant co-morbidities impacting on life expectancy
   • Persisting alcohol and/or substance abuse
     

ORGAN RETRIEVAL MECHANISM

The unit accepting the liver offer is responsible for arranging the surgical procedure either using a team from their hospital or by arrangement with another appropriate team from one of the other recognised liver transplant unit.

The unit accepting the liver is responsible for liaison with the relevant donor co-ordinator to achieve a surgical starting time mutually acceptable to the donor hospital and all involved donor surgical teams.

The unit accepting the liver offer is responsible for ensuring that the liver and, if retrieved by the liver unit other intra-abdominal organs, meet medical standards for organ donation and are delivered in a safe and appropriate manner to the recipient unit's hospital, or in the case of non- hepatic intra-abdominal organs, to the donor co-ordinator.
 

ORGAN ALLOCATION AND DISTRIBUTION

The recognised Liver Transplant Unit in the State (including all Australian States and New Zealand) of the donor's hospital is offered the donation as detailed below. They have 20 minutes to respond to the offer.

State of donor Hospital		Liver Transplant Unit
Qld	-	Qld
NSW, ACT	-	NSW
VIC, TAS	-	VIC
SA, NT	-	SA
WA	-	WA
NZ	-	NZ

If the `home state" (the state of the donor hospital as above) refuses the offer then the liver donation offer is made to the non-home state recognised liver transplant units, with a 20 min response time-limit. The non-home state offer is based upon a rotation kept by each state donor co-ordination team, such that the first non- home state offer is rotated through each of the states in strict turn, unless by mutual agreement of all units a decision to prioritise specific patients has been made. If the first non-home state refuses the offer, the next is asked until all units have been asked. If all recognised units refuse the initial offer it is then rotated through units with non-ANZ Nationals awaiting transplantation.

If a combined transplant e.g. liver, kidney transplant is required from an interstate donor then prior local transplant committee and relevant interstate committee approval is required.

Accountability and record keeping

All states are responsible for recording donor offers and outcomes accessible for open inspection and regular publications.

SPECIFIC ALLOCATION OF DONOR LIVERS:

Elective list for liver transplantation

Within each liver transplant Unit the decision to allocate a particular donor liver to an individual patient is based on the following variables:

• donor and recipient blood group
• size donor/size of recipient of liver
• suitability of donor liver for split liver donation
• severity of liver disease. This is based on objective criteria such as Childs Pugh Score/or MELD score
• matching of functional status of donor with severity of liver disease and predicted outcome post transplant. e.g. a “marginal” donor may not be as suitable for a very sick and unstable patient. The status of the donor liver will depend on liver function and anticipated ischemic time
• Hepatitis B and C status of donor and recipient 

Guidelines for split liver donation

Every liver donation is considered for splitting between an adult and child. General suitability for splitting is age <40 years, normal liver enzymes, non-steatotic, non-ionotroph dependent. If a liver donation is suitable for splitting, and there is not a ‘local’ paediatric recipient, then there is a national paediatric waiting list and the liver should be split for a national suitable recipient.

"Urgent" List for Liver Transplantation

A recognised Liver Transplant Unit may notify transplant co-ordinators of urgent cases with the following minimum information, (which is necessary to access the "Urgent" list):

1. State;
2. Age;
3. Sex;
4. Weight;
5. ABO group;
6. Diagnosis;
7. Whether the patient is being ventilated.

The donor co-ordinator will notify all state (including New Zealand) donor co-ordinators, who will in turn notify their own state recipient co-ordinators (where such a role exists). Each co-ordinator will be given the minimum clinical information above.

These cases will be in 2 categories:

Category 1: Super Urgent.
These patients will have acute liver failure and are being ventilated. In this situation the "home state unit" (including New Zealand) will waive a donor offer to the unit with the Category 1: super urgent patient. Re-listing required every 3 days.

Category 2A: Urgent. These patients will (but not exclusively) be patients with:

• acute liver failure fulfilling Kings criteria but not ventilated
• hepatic artery thrombosis or primary non function post transplant
• paediatric (particularly biliary atresia) patients on a ventilator

Re-listing required every 3 days.

Category 2B: Semi-urgent paediatric
Paediatric patients with severe metabolic disorders or hepatoblastoma for whom a limited time period exists during which liver transplantation is possible. Re-listing required every 7 days.

Living Donor Liver Transplantation

Principles

• Live liver donation should only be performed if the risk to the donor is justified by the expectation of an acceptable outcome in the recipient.  The patient and graft survival of a live donor transplant should approximate the expected outcome for a recipient with the same disease aetiology undergoing a deceased donor transplant.

• The indications for live donor liver transplantation should be the same as those established for deceased donor transplantation with the exception of ethically and institutionally-approved protocol studies that consider liver donor transplantation in patients that do not otherwise qualify for liver transplantation from a deceased donor.

• Live donor liver transplantation should offer an overall advantage to the recipient when compared to waiting for an acceptable deceased donor organ to become available for transplantation.  The decision to proceed with a live donor liver transplant should be made after a careful analysis of the recipient risk to benefit ratio as it relates to the severity of liver failure, quality of life and expected wait list time for a deceased donor.

• The donor evaluation should be accomplished in a staged protocol that includes comprehensive medical, surgical, radiological and psychosocial assessments by appropriately trained individuals. An independent donor advocate must be part of the donor assessment team.

• The psychosocial/psychiatric evaluation of the donor should be conducted by a mental health care professional such as a psychiatrist, psychologist or social worker with appropriate expertise.

Practice

• Right lobe, left lobe and left lateral segment grafts are all possible options for live donor liver transplantation.  In general, removal of the left lobe or left lateral segment is less hazardous for the donor.  The priority is always to leave sufficient functioning liver parenchyma in the donor (≥ 35% of total liver volume) while providing an adequately-sized segment for the recipient (a graft-to-recipient weight ratio (GRWR ≥ 0.8% is recommended, however volume required depends on multiple factors including severity of liver failure, portal hypertension, and adequacy of venous outflow for the graft

• Donor liver biopsies are not mandatory

• International guidelines suggest an upper age limit of 60 years.  The lower age limit is determined by the age of majority in the jurisdiction

• A body-mass index of <30 is recommended

• Compatible donor ABO blood type is recommended

DATE OF PROTOCOL: August 2002
Updated: November 2004
Updated: February 2007