Memorandum by Mr S R Bramhall MD FRCS
Consultant Hepatobiliary and Transplant Surgeon
BACKGROUND
The number of cadaveric donors in the UK has
remained at approximately 12 per million per calendar year for
a number of years now and this is despite medical attempts to
increase donor numbers by taking on more and more what are termed
marginal donors (older donors, donors with diseases that would
traditionally not have been considered for donation and increase
in non-heart beating organ donation). What this means is that
the number of cadaveric heart beating donors, which are the main
stem of organ replacement, has declined dramatically in the last
20 years from more than 800 to just around 600 per year. Over
this time period the waiting list for renal replacement has increased
dramatically and now in excess of 6,000 patients are awaiting
renal transplantation. The liver surgeons have controlled their
waiting list by applying arbitrary guidelines for the inclusion
of patients on the waiting list. The nationally agreed guideline
is that patients should have a 50% chance of five year survival
before they are listed for liver replacement. This is of course
completely arbitrary and many patients who fall out with this
criteria would gain significantly from liver replacement. For
instance the five year survival following the cancer surgery for
GI organs ranges from 25-50% depending on the organ involved.
What this has meant is that referring gastroenterologists control
the number of patients that are referred to liver transplant centres
and act as primary gatekeepers and then liver transplant physicians
also control the number of patients going on the waiting list
according to the national guidelines. Despite this control the
number of patients waiting for liver transplant has dramatically
increased over the last two years and consequently the death on
the waiting list for liver transplantation now runs in the order
of 15% and is rising. I have little doubt that similar controls
are placed on patients waiting for cardiothoracic organ replacement
and that deaths on the cardiothoracic organ waiting list are also
rising.
The national donation rate in the United Kingdom
is now one of the lowest in the developed world. Donation rates
in the US run at 24 donors per million population, in Spain it
is 35 per million population, in Northern Italy it is 25 per million
population, in Austria it is 24 and Belgium 23 per million population.
The UK donation rate mirrors that of Croatia, Slovakia and Greece.
Despite this, there is very good evidence that the types of patient
being admitted to the Intensive Care Unit in all of these countries
is very similar and therefore the potential for organ donation
across all of these countries is similar. It has often been quoted
that the mixed ethnicity of the UK is part of the reason for the
relatively high family refusal rates, although the ethnic mix
in many of the countries quoted above is different from the UK
there is absolutely no reason to suspect that donation rates similar
to theirs could not be achieved.
FINANCIAL COST
There are enormous financial costs to keeping
patients with end stage organ disease alive. The cost for renal
dialysis and the cost benefit of renal replacement therapy is
well recognised and easy to compute. However, this is not the
case for patients with end stage liver disease. In Birmingham
our current waiting list is 75 patients. At any one time 10% of
these patients will be inpatients either here at the University
Hospital Birmingham NHS Trust or in their local referring hospital.
The average stay for these patients is approximately seven days
and this computes to 2,500 bed days per year which costs the NHS
approximately £750,000 per year; in addition 1% of our waiting
list population will be inpatients on Intensive Care Unit which
approximates to 12 patients per year each of them an inpatient
for a minimum of seven days. The cost of this is an additional
£100,000 per year and therefore if this was extrapolated
throughout the UK the cost of keeping patients in hospital who
are currently on waiting lists for liver replacement is in excess
of £3,000,000 per year. It is impossible to get accurate
figures but the cost of keeping patients alive with end stage
liver disease who fall out with the current guidelines for liver
replacement will be at least 10 times this. I have little doubt
that similar figures would apply for cardiothoracic organ replacement.
In addition those countries that do not have legally recognised
brain stem death have developed living related liver replacement
and this has been taken on in some countries because of a shortage
of donor organs. UHB NHS Foundation Trust has recently submitted
a bid to the DoH for funding of living related liver transplantation.
This has involved a detailed financial evaluation and an overall
cost to UHB of assessing and providing organs from a living related
donor will come in at £23,000 per donor. It is interesting
to note that in the US five years ago living related liver transplantation
was performed in approximately 400 patients per year; over the
last five years since the donation rate in the US has increased
from 12 per million to 24 per million the number of patients undergoing
living related liver transplants has now reduced to under 200
per year. In addition living related liver transplantation is
barely practised at all in Spain which has the highest donor rates
anywhere in the world.
MODELS OF
ORGAN PROCUREMENT
In the United States transplantation is overseen
by the Organ Procurement and Transplantation Network (OPTN) which
is a government funded body contracted to the United Network for
Organ Sharing (UNOS) and operates under a federal mandate and
in line with a number of federal laws related to organ transplantation.
The OPTN monitors and regulates transplant activity and oversees
the activity of 58 Organ Procurement Organisations (OPO) within
11 regions. The OPO is a not for profit organisation which charges
recipient hospitals for services obtaining organs. All of the
above is backed up by legislation and hospitals have a legal obligation
to perform death tests where brain stem death is suspected and
report all deaths and potential donors to the OPO. This is regularly
audited by the OPO staff and hospitals are penalised if they do
not meet the requirements. In addition each hospital is financially
remunerated for the costs to that organisation for the donation
process.
The Spanish system uses medically qualified
transplant coordinators in every hospital with an ITU and these
doctors are proactive in identifying potential donors and discussing
them with clinicians to optimise donor identification and organ
retrieval. Since the inception of this system in Spain donation
rates have rocketed, pressure on the waiting lists have relieved
and organ donation is the highest in the world.
In the late 1990's organ donation in Italy was
at an all time low with many patients seeking organ replacement
outside Italy; however, a legal framework for transplantation
was introduced into the Northern Italian Procurement Organisation
in the late 1990's, they introduced the Spanish model and donation
rates in Northern Italy have increased from approximately eight
per million to numbers approaching that of the Spanish donation
rates.
In the UK organ donation is entirely a voluntary
process and is highly dependent on the interests and motivation
of the clinicians working on the Intensive Care Units. It is well
recognised anecdotally that many patients who are suspected of
being brain stem dead never have the tests performed and it has
also been recognised anecdotally that many patients confirmed
as being brain stem dead are not referred. It is entirely dependent
on the level of interest of the clinician and in addition religious
and cultural differences also influence referral. There is a constant
battle within Intensive Care Units for ITU beds, there is no doubt
that the donation process will delay discharge from an Intensive
Care Unit by several hours, there is also conflict in providing
operating theatre space for the donation process to carry on and
hospitals do not receive any remuneration for the process of organ
donation. It is usually perceived that organ donation is a favour
to the transplant unit rather than an aspect of good patient care
and in addition the option of donation may actually help bereaved
families.
POTENTIAL DONOR
AUDIT
UK Transplant has been performing a potential
donor audit and the 30 month data from this audit has recently
been published by UK Transplant. All deaths on an Intensive Care
Unit have been audited by transplant coordinators and over this
30 month period this has led to an audit of 57,972 deaths. The
data is fascinating and demonstrates three areas where there is
very significant leakage of potential donors.
1. Performing brain stem death tests
The audit demonstrated that over the 30 month
period 5,072 patients died with brain stem death being a likely
diagnosis. This amounts to 2,028 patients per year. Of these patients
brain stem death tests were only performed in 3,519 (1,408 patients
per year), therefore brain stem death tests were not performed
in approximately 620 patients per year. The data also shows that
when brain stem death tests were performed brain stem death was
confirmed in almost 97% of cases. There is therefore more than
600 patients per year who could be potential donors were brain
stem death tests performed and this is a very difficult group
of patients to access. Clinicians will produce a variety of excuses
as to why brain stem death tests were not performed and it is
very difficult under these circumstances to argue.
2. Brain stem death tests performed not referred
The audit also reveals that of the 3,400 patients
in whom brain stem death was diagnosed (1,360 per year) 99% of
them were medically suitable for organ donation but 514 of these
patients (205 per year) were not considered for organ donation
with no approach to the family being made or no consideration
of solid organ donation. It is possible to influence this group
of patients because the diagnosis of brain stem death has been
made but again ensuring these patients are referred for organ
donation is paramount.
3. Family refusal rate
Over the course of the 30 month period 1,158
families refused organ donation when approached (463 per year)
giving a family refusal rate of approximately 40%. There is no
doubt that family refusal rate can be influenced in a number of
ways, this has been ably demonstrated in the US, Spain and small
areas within the UK. Family refusal rates are improved when collaborative
requesting is carried out (requesting by a trained transplant
coordinator in conjunction with ITU staff). The family refusal
rate is also dramatically reduced in families where the potential
donor is on the organ donor register.
SUMMARY
The 30 month data from the PDA has demonstrated
that over this period 1,536 solid organ heart beating donors donated
organs (614 per year), however, the total scope for donation was
2,228 which means that 1,288 patients per year who were potentially
suitable for organ donation did not come to fruition. If even
half of this excess were turned into donors then the UK would
have no waiting list for renal replacement in 10 years, death
on the waiting list for liver replacement would be eliminated
and many more patients who are subsequently offered liver replacement
could be considered. If even 50% of the 1,288 potential donors
per year that are currently lost through leakage in the system
were converted into donors then the organ donor rates in the UK
would mirror that of the US and would become close to the rates
achieved in Northern Italy and Spain. This adds further weight
to the argument that there is the potential in the UK for significantly
increasing organ donation with an appropriate approach.
CURRENT INITIATIVES
UK Transplant has recently merged with the Blood
Transfusion Service to become part of NHS BT. The strategy for
solid organ donation is currently being considered by UKT and
if successful will certainly help to address some of the issues
of family refusal rates and possibly address some of the potential
untapped source for organ donors where brain stem death tests
are performed and referral is not made. The strategy for UK Transplant
over the next three years should be to centrally employ coordinators.
Currently coordinators are employed by the host NHS Trust, there
is little management of these individuals and certainly no performance
management simply because the local trusts have no experience
of organ donation. In addition many of the coordinators around
the country still perform dual organ donor and organ recipient
roles which are clearly unacceptable in the current climate and
centralised employment will address many of these issues. In addition
extra funding is being sought by UK Transplant as part of its
strategy to place in-house coordinators in all of the larger ITUs
throughout the country (80% of organ donors come from 20% of UK
ITUs): this is similar to the Spanish model although the in-house
coordinators from the UK will be from a nurse background rather
than a medical background. The 2003 10 year transplant plan whilst
clearly failing at the moment aims to have 16,000,000 people on
the organ donor register by the end of the plan and this is well
ahead of schedule with more than 13,000,000 people on the ODR
currently. Provided that the strategy put in place by UK Transplant
is fully funded the family refusal rates in the UK should start
to come down and potentially the patients in whom brain stem death
is confirmed but who are not referred will also slowly start to
be influenced.
REMAINING PROBLEM
The most significant remaining problem therefore
is in the patients in whom brain stem death tests are not performed
currently. The number of potential patients per year that fall
into this group is equivalent to the number of actual heart beating
donors. This clinical practice is clearly bad medical practice
and needs to be addressed. It is good medical practice to perform
brain stem death tests in patients in whom brain stem death is
performed for a number of reasons but not least that if brain
stem death is confirmed then continued management on an Intensive
Care Unit is futile; in addition it is good medical practice to
ensure that where brain stem death tests are performed and confirmed
that the families of the deceased are offered the option of organ
donation at a time of great sadness. These two problems have been
addressed in the US by legislation, it is a requirement for clinicians
to perform brain stem death tests were brain stem death is suspected
and in addition where brain stem death is confirmed to the requirement
for such patient to be referred to the OPO. Such a system in the
UK, even with current family refusal rates, would lead to a further
495 solid organ donors per year and an extra 1,240 solid organ
transplants per year.
16 July 2007
| 
