TSANZ

The Transplantation Society of Australia and New Zealand

Heart Protocol

RECIPIENT SUITABILITY CRITERIA

Introduction

Heart transplantation is a highly effective treatment for advanced heart disease, however its use is limited by the scarcity of suitable donor organs(1, 2). For this reason, heart transplantation is offered only to patients who have end-stage heart disease and who have exhausted all alternative treatment options(3, 4).  This includes patients whose survival is dependent on mechanical circulatory support, although not all of these patients will be potential candidates for organ transplantation. A decision to offer transplantation should be based on the expectation of low peri-operative mortality, a post-operative life expectancy of at least 5 years and reasonable prospect of returning to an active life-style(3, 4).

INCLUSION CRITERIA:

1. End-stage heart disease may be manifested as:

(i) Cardiogenic shock eg complicating acute myocardial infarction
(ii)Intractable symptomatic heart failure (NYHA Class III-IV) despite maximally tolerated evidence-based medical therapy
(iii)Need for permanent mechanical cardiac support
(iv)Frequent repeated discharges from an implanted AICD device
(v) Intractable angina despite optimal medical, interventional and surgical treatment

2. Age < 70 years

EXCLUSION CRITERIA:

  1. Any condition(s) which results in an expected 5 year survival after transplantation of less than 50% or which precludes active rehabilitation after transplantation.(3, 4)
  2. Active malignancy(3)
  3. Irreversible dysfunction of other organs – combined organ transplant (eg heart/lung, heart/kidney, heart/liver) may be a consideration (1, 5-7)
  4. Irreversible degeneration/damage of other organ systems that precludes rehabilitation after heart transplantation eg advanced neurodegenerative disease, advanced rheumatoid arthritis, severe peripheral vascular disease not amenable to revascularisation(3, 4)
  5. Uncontrolled infection
  6. Morbid obesity (BMI > 30 or >140% ideal body weight)(8, 9)
  7. Inability to comply with complex medical therapy eg chronic cognitive or neuropsychiatric deficits in the absence of a carer capable of taking on this role.(10, 11)
  8. Active substance abuse including smoking, alcohol and illicit drug use (12, 13)

SPECIAL CIRCUMSTANCES/CONSIDERATIONS:

Heterotopic Heart Transplantation

Historically, the vast majority of heart transplants have been performed orthotopically.
Heterotopic heart transplantation may be considered in two clinical settings:

  1. Patients who meet the above criteria for heart transplantation and who have fixed pulmonary hypertension as evidenced by a transpulmonary gradient > 15 mmHg after vasodilator challenge(14). Paediatric patients with a high pulmonary vascular resistance may be considered for orthotopic transplantation, based on the presence of acute reactivity, expected regression post-transplantation, the magnitude of the peri-operative risk and the availability of other treatment options.
  2. Extended criteria donor in which donor heart function is judged to be suboptimal for orthotopic transplantation (but potentially recoverable) may be considered for heterotopic transplantation subject to informed consent of the potential recipient(15).

Combined Organ Transplantation (Heart/Lung, Heart/Liver, Heart/Kidney)

Combined organ transplantation can be carried out with the expectation of a similarly low peri-operative mortality and reasonable life expectancy as heart-alone transplantation in carefully selected individuals (5, 6) (7). Patients being considered for combined heart/other organ transplantation need to meet all standard criteria for heart transplantation plus

  1. have evidence of advanced irreversible dysfunction of the other organ and meet standard criteria for transplantation of that organ eg Eisenmenger Syndrome secondary to complex congenital heart disease (heart-lung transplantation), end-stage renal failure (heart-kidney transplantation).
  2. have evidence that heart transplantation alone will result in a poor life expectancy unless the other organ is also transplanted eg combined heart-liver transplantation for end-stage ischaemic heart disease in association with homozygous hypercholesterolaemia or cardiac amyloidosis in association with familial autonomic neuropathy.

Evaluation of patients for combined organ transplantation requires detailed assessment and agreement by both organ transplant teams that the patient meets eligibility criteria.

The decision to allocate cadaveric organs for combined transplantation needs to take into consideration the implications for individuals who are on waiting lists for single organs.

Heart retransplantation

Recent data from the registry of the International Society for Heart & Lung Transplantation indicate that carefully selected patients undergoing cardiac re-transplantation following irreversible failure of the initial cardiac allograft can achieve excellent short- and long-term survival, although still less than what can be expected for a patient receiving a first cardiac allograft(2). The decision to accept a patient for retransplantation must take into account both the survival prospects of the recipient and the potential implications for other individuals who are on the waiting list for heart transplantation.

DONOR HEART ALLOCATION

ORGAN DONORS' SUITABILITY CRITERIA

Standard Criteria

  1. General Organ Donor Criteria
  2. Age to 60 years
  3. No known significant cardiac disease (if in doubt contact heart transplant unit)
  4. Not dependent upon high dose inotropes (noradrenaline < 0.2 ug/kg/min or equivalent)

Extended criteria donors (donor characteristics that are associated with increased short and/or long-term morbidity and mortality after heart transplantation):

  1. Anticipated ischaemic time > 360 minutes.  There is a progressive increase in the risk of death after heart transplantation as the donor heart ischaemic time increases above 240 minutes. Donor heart ischaemic time > 360 minutes is associated with a 30% increase in the relative risk of death at one year post-heart transplant. (16)
  2. Donor requiring high-dose inotropic support (17)
  3. Donor graft dysfunction on Echo (LVEF < 50%, major wall motion abnormality, LVH > 13 mm)(18)
  4. Donor co-morbidities  –  eg Donor positive for Hep B or Hep C (18, 19).

Utilisation of extended criteria donors is at the discretion of the heart transplant unit. Allocation should be based on the same principles as standard criteria donors.

Required Information for allocation

1. Blood group

2. Body weight

3. Body height

4. Laboratory tests

-

General Organ Donor Criteria for viral studies
HIV, HepBsAg, HepBcab,  Hep C, CMV

5. Investigations

-

Current chest X-ray the ECG done after brain death

-

Echocardiogram is desirable

CURRENTLY RECOGNISED HEART TRANSPLANT UNITS

QLD

-

Princes Charles Hospital

NSW

St Vincent's Hospital

VIC

-
-

Alfred Hospital
Paediatric - Royal Children's Hospital

WA

-

Royal Perth Hospital

NZ

-

Auckland Public Hospital

ORGAN RETRIEVAL MECHANISM

The unit accepting the heart 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 heart transplant units.

The unit accepting the heart offer 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 heart offer is responsible for ensuring that the heart, and if retrieved the lungs, meet medical standards for organ donation and are delivered in a safe and appropriate manner to the recipient unit's hospital.

ORGAN ALLOCATION AND DISTRIBUTION

The recognised Heart Transplant Unit in the state 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

Heart Transplant Unit

QLD

-

QLD

NSW, ACT

-

NSW

VIC, TAS

-

VIC 

WA

-

WA

If the home state declines the offer, then the heart donation offer is made to the non-home state recognised heart transplant units, with a 20 minute response time. In Victoria the donor co-ordinators keep a record of the rotation between the 2 units. 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 state in strict turn. If the first non-home state declines the offer, the next is asked until all units have been asked.

Donor heart offers from South Australia and the Northern Territory will be offered on the same rotation as for non-home state offers.

New Zealand Organ Donor Offers

New Zealand heart donor offers that are declined by the New Zealand Heart Transplant Unit may be offered by New Zealand to the Eastern State recognised Heart Transplant Units. The rotation of offers to those units is held by the New Zealand Donor Co-ordinators.

INDIVIDUAL PATIENT ALLOCATION

Donor hearts will be allocated according to the following criteria:

1. ABO compatibility*
except paediatric patients aged less than 12 months

2. Size & weight compatibility*
+/_ 15% of donor body weight
Greater variability in the ratio of donor:recipient weight may be acceptable depending on the age of donor and recipient especially in paediatric cases

3. Negative lymphocytotyoxic crossmatch*      
Sensitised paediatric recipientsfor whom there are no other options may require transplantation in the setting of positive T and B cell cross-match, followed by augmented immune suppression.

4. Urgent Status**

5. ABO identity

6. Recipient Waiting Time

7. Logistics***

The decision about each individual offer and waiting list management are the responsibility of each recognised Heart Transplant Unit.

Explanatory Notes

* Items 1-3 are absolute requirements for adult patients

** Urgent Status for Heart Transplantation

Most patients with heart failure that is so severe that it poses an immediate threat to life (eg cardiogenic shock) will be implanted with some form of mechanical device (eg LVAD or BVAD) and rehabilitated prior to active listing for heart transplantation. Occasionally, such transplant candidates are unsuitable for mechanical support or develop life-threatening complications while on support eg severe sepsis or mechanical device failure. Under these circumstances, when the patient’s survival is estimated to be days or weeks without transplantation, the patient may be placed on an Urgent List, in which case the next compatible donor heart arising anywhere in Australia and New Zealand will be offered for that individual.

Urgent listing for heart transplantation is at the discretion of the Transplant Unit Director. It will be the responsibility of the Transplant Unit Director (or his or her nominee) to notify all other Cardiothoracic Transplant Units in Australia and New Zealand, and to notify the organ donor co-ordinators in all jurisdictions when a patient is placed on (and removed from) the Urgent Waiting List.

It is expected that the majority of individuals placed on the Urgent Waiting List will either die or be transplanted within two weeks of notification.  Each Transplant Unit will be allowed a maximum of 3 Urgent listings within any 12 month period. The operation of the Urgent Waiting List will be subject to annual audit and review by the Cardiac Standing Committee of TSANZ.

***Logistical considerations include:

Operation type (orthotopic, heterotopic or domino)
Time of retrieval: operation room availability
Location of recipients &/or donor: (local, interstate)
Type (i.e. road or air) and availability of transport to bring recipient to the transplant centre and to take retrieval team to donor hospital
Availability of required team members for the retrieval and trasplant
Availability of I.C.U beds
Donor instability

It is recognised that logistical considerations may override criteria 4 through 6 (eg if there are transport problems that prevent the selected recipient from being transported to the transplant hospital in time).  In instances where logistics override higher criteria, this needs to be recorded as well as the specific logistical issue eg transport.

Domino Hearts

Domino hearts donated by a recipient of a heart/lung transplant should be donated according to the relevant jurisdication's laws on living donation and allocated to a medically appropriate recipient in the waiting list of that Heart/Lung Transplant Unit.

Click here to view references.

Date of protocol: August 2002

Updated October 2006
Updated January 2008
Updated December 2008
Revised 1st June 2009