Download Liver Transplantation In Egypt - Suez Canal University Medical Journal

Suez Canal Univ Med J
.-
Val. 3 No. 2, October, 2000
157-167
Liver Transplantation In Egypt: "Better Late Than Never"
Hatem Khalaf I , Abdel Hamid Sewah,' Darius Mirza j , Ahmed El-L.ubban,' El-Sayed El-Zayat,'
Elwyn Elias jand Paul McMaster 3.
Departments of Surgery l ~ u s Canal
z
University, Internal ~ s d i c i n e ' Suez Canal University. Liver Unit, Queen Elizabeth Hospital.
Birmingham University, United Kingdom 3.
Introduction
HCV infection with genotype 4a was proved
to
be the main cause of severe chronic liver
E
~ there
~ is no
~ doubt
~ that
, chronic
disease in Egypt, and it was highly associated
liver disease is a major health concern.
Schistosomiasis, viral hepatitis, or a
with s~histosomiasis~~~.
Schistosomiasis might
be
a
possible
factor
among
others that enhance
combination of both are the most common
HCV
transmission
in
the
Egyptian
population
aetiologies for chronic liver disease in Egypt
1' . Furthermore, the morbidity and mortality
(I). The prevalence of hepatitis C virus among
persons representing the general population of
associated with viral hepatitis itself is
Egypt was strikingly high, ranging between
increased
when
schistosomiasis
was
5.2% to as high as 33.4% in one s t ~ d y ( ~ - ~ ) .s~perimposed("-'~).The apparently high
Hatem Khalaf et al.
158
prevalence of viral hepatitis in Egypt is of
importance because of its potential adverse
impact on the public health in Egypt. Other
than liver transplantation, there is no effective
medical or surgical treatment for those who
have reached the end-stage of their illness.
Currently in Egypt, liver transplant
candidates have only one hope for cure, that is
to travel to Europe or North America to
undergo cadaveric liver transplantation
abroad. Although, Egypt was the first country
to perform a living related liver transplant in
the Middle East(14), this program did not
survive all the technical and logistic problems
encountered.
In this work we have studied a group
Egyptian liver transplant candidates regarding
the indications and outcome with and without
liver transplantation. We also tried to predict
and discuss all difficulties involved in
developing our own liver transplant programs
in Egypt and whether it is possible to
overcome all the hurdles?
Material and Methods
Study population and design: Two groups
of Egyptian liver transplant candidates were
included in this study. The first group
included twelve Egyptian liver transplant
candidates who had the chance to get
transplanted at the Queen Elizabeth hospital in
Birmingham, UK and they were followed up
for median follow up of 20 months (ranging
between 14 to 54 months). The second group
of patients included 46 Egyptian liver
transplant candidates for whom liver
transplantation was not a feasible option and
they were followed up here in Egypt for one
year, they were considered as a
delayed-intervention control group.
Patients Selection: The indication for
including patients in this study was endstage
liver disease.
Paediatrics, fulminants, and
patients
with
advanced
hepatobiliary
malignancy were excluded from this study.
Methods:
Twelve
patients
were
transplanted at the Queen Elizabeth hospital in
Birmingham, UK. This small group of patients
were referred to Birmingham by different
treating physicians in Egypt. On arrival to the
transplant centre, and before being placed on
the waiting list, all patiens had to go through
the Birmingham's liver transplantation
assessment protocol, and they had to fulfil the
pre-set selection criteria for listing. After
being listed, all patients had to wait inside the
UK until a suitable liver became available.
Priority on the waiting list was always given
to British nationals. Egyptian patients were
listed on the basis that they receive organs not
immediately required for UK nationals, and
this was fully explained and outlined to them
in detail. All liver grafts were obtained from
brain dead heart beating donors. Orthotopic
whole liver transplantation was the standa..d
operative technique. Cyclosporine combined
with Azathioprine and Prednisolone were
used, initially, in all patients. In almost all
patients, Prednisolone was tapered over a
period of 3 month. In patients with hepatitis B
virus, and to guard against the high risk of
recurrence, three patients were treated with
HBV-specific immuno globulin (HBIg) while
Lamivudine was used in one patient only.
As for the second group of patients for
whom liver transplantation was not a feasible
option. They were selected here in Egypt by
the liver team at Suez Canal University
Hospital. All patients in this group had to
fulfil the pre-set selection criteria for
transplantation before being included in this
study. They were followed up here in Egypt
for one year without having a liver transplant
operation.
They were considered as a
delayed-intervention control group.
Results
Age, sex, and geographic distribution: the
study included 58 Egyptian patients (12
patients transplanted and 46 patients as a
delayed-intervention control group). The age,
sex, and geographic distribution of both
groups are show in table (1). Endstage liver
disease indicating liver transplantation was
more common among middle aged Egyptian
Liver Transplantation In Egypt
159
males living in rural areas. However, all
transplanted patients came from urban areas
which reflects their socio-economic status and
their ability to travel abroad to get a new liver.
patients. In conclusion, schistosomiasis did
not seem to have any negative impact on the
transpIant procedure and did not worsen the
outcome after liver transplantation.
Indications: the indications of candidacy
for liver transplantation in both the
transplanted and the control groups are shown
in tables (2) and (3), respectively.
Viral-related cirrhosis alone (43.1%) or mixed
with schistosomal fibrosis (48.3%) were the
main indications of candidacy for liver
replacement in both groups (Fig. 1).
Waiting Period: In Egyptian recipients, the
mean waiting period to get a new liver was
significantly (P-value ~ 0 . 0 5 )longer than that
for English recipients transplanted at the same
period of time, table (4).
Survival: In the transplanted group, 11
patients (91.7%) survived after a median
follow up of 20 months (range 14 to 54
months). On the other hand, and among the
control group, only 9 patients (19.5%)
survived for one year. This difference in
survival with and without liver transplantation
was statistically highly significant (P-value
<O.OOl).
Post-transplant
complications:
Complications encountered in the transplanted
group are listed in table (5). Major
complications included death at 3.5 years
posttransplant from recurrent HCV in one
patient and re-listing for chronic rejection one
years posttransplant in another patient.
Schistosomiasis: In our study 8 patients had
previous history of schistosomal infestation;
one had pure hepatosplenic schistosomiasis
and 7 were mixed with viral hepatitis.
Compared with non-schistosomal recipients,
schistosomiasis did not significantly affect
either the incidence of rejection or the
Cyclosporine doses needed to achieve the
target trough levels. Schistosomal reinfection
or reactivation were not detected in any of our
Costs: The cost of transplanting overseas
patients at Birmingham is around £50,000.
This includes the costs of pretransplant
assessment and care, the transplant operation.
and the postoperative care and medications
for a three months period. It does not include
accommodation and daily expenses while
waiting outside the hospital which was more
or less around £1000/month for our patients.
On their return to Egypt, the main burden was
the cost of immunosuppressive drugs.
Fortunately, the national health service in
Egypt provides these drugs at reduced prices
(i.e. almost half their price at the UK). For our
patients the costs of medication was more or
less around £150/month. The problem lies in
those patients with hepatitis B virus, who are
in need for HBV-specific immuno globulin
(HBIg), this raises the costs considerably, as
the price of one dose is around £1000 and
usually they require 4-6 doses every year to
keep good HBIg levels in the blood.
Table 1: Age, sex, and geographic distribution of both study groups
General Characteristic:
Age
MaleiFernale ratio
RuralIUrban ratio
Transplanted group (12 pt.)
Control group (46 pt.)
Median = 50 yrs (40 to 57)
1111
1210
Median = 47 yrs (25 to 65)
312
311
.
Hatem Khalaf et al.
160
Table 2: Spectrum of diseases leading to end-stage liver disease in the transplanted group (12 patients).
Disease
No. of patients
Viral Hepatitis
HCV
HBV + HDV
Mixed
HCV + schistosomiasis
HCV + schistosomiasis + small HCC (<4 cm)
HCV + HBV + schistosomiasis
Schistosomiasis
Secondary Biliary Cirrhosis
Total number of patients
%
(3)
2
1
(7)
2
2
3
(1)
(1)
12 patients
Table 3: Spectrum of diseases leading to end-stage liver disease in the control group (46 patients).
Disease
No. of patients
%
Viral related cirrhosis
Hepatitis C virus
Hepatitis B virus (HBV)
HBV + Hepatocellular carcinoma (HCC)
Hepatitis B virus + Hepatitis C virus
Mixed (Cirrhosis + Peri-portal fibrosis)
Hepatitis C virus + schistosomiasis
HBV + HCV + schistosomiasis
Cryptogenic cirrhosis + schistosomiasis
Hepatitis B virus + schistosomiasis
Schistosomiasis (Pure periportal fibrosis)
Cryptogenic
Primary Biliary Cirrhosis
Total number of patients
Table 4: The waiting time on the liver transplantation list (P-value <0.05)
Waiting Period
Egyptians Recipients (n=12)
English Recipients (n=63)
Mean
Range: Min.
126 days
33 days
82 days
One day
Max.
270 days
360 days
Liver Transplantation In Egypt
161
Table 5: Post-transplant complications in 12 Egyptian recipients
Complication
No.
Initial Poor Function (ZPF):
Acute Renal Failure:
Rejection:
Early acute:(moderate or severe)
Late acute rejection
Chronic rejection
Vascular complications:
Venous outflow o b s t r u c t i o n
Biliary complications:
Anastornotic s t r i c t u r e
Zmmunsuppressives Related:
Sepsis:
Cyclosporine A:
Nephrotoxicity
Neurotoxicity
Azathioprine:
Myelotoxicity
Hepatic venous congestion
Recurrent Disease:
HCV (in HCV patients n = 10)
Management & Negative Outcome
%
Recovered after 3 weeks
CVVDl (9days) + I V V D ~(3rnonths)
High dose steroids
one patient converted to Tacrolimus
Relisted one year posttransplant
Cavogram + Balloon dilatation
ERCP~+ endoscopic stenting
Dose reduction + antibiotics
Responded to dose reduction
One patient converted to FK506
Reduced (5 pt.) or Stopped (1 pt.)
Stopped
One died 3.5 years post-transplant
-
-
-
'continous Veno-Venous Dialysis
'~ntermittent Veno-Venous Dialysis
3~ndoscopicRetrograde Cholangio-Pancreatography
Mixed
48.3%
Viral
Figure 1: Indications of candidacy for liver transplantation in 58 Egyptian patients
(12 transplanted
+ 46 control)
-
162
Discussion
Although liver transplantation was never
assessed in a controlled clinical trial, given the
excellent
outcome
following
liver
transplantation, a controlled trial evaluating
the efficacy of transplantation will probably
never be performed. However, in Egypt, there
is still a great national debate regarding
developing our own liver transplant programs.
Many questions raised, yet answers to it are
among the least well defined. Is there a need
for liver transplantation in Egypt? What is the
impact of the peculiar patterns of liver disease
in Egypt on the transplant process? How will
we solve the donor problem? Should a few
patients benefit from liver transplantation
when there are many children who do not
receive
vaccination
against
common
childhood diseases? Although these are
complex, interrelated questions that are easier
to ask than to answer, we will try in the view
of our results to clarify some of them.
Not a long time ago, schistosomiasis was
the leading cause of chronic liver disease in
Egypt(15), end-stage liver failure was rarely
seen and the leading cause of death was
recurrent variceal haemorrhage with preserved
hepatocyte function(16). Nowadays, the
situation is much different, viral hepatitis
whether alone or mixed with schistosomiasis
has replaced schistosomiasis as the leading
cause of liver disease in Egypt('J7). This
change in pattern of liver disease in Egypt has
led to more patients presenting with
decompensated liver disease and has created a
definite need for liver transplant programs.
In our study, this peculiar pattern of liver
disease in Egypt had little impact on the
transplant process: In patients with hepatitis
C virus, recurrence was usually mild with
good outcome, however, long term outcome
remains to be seen. In patients with hepatitis
B virus, the need for immunoprophylaxis, will
increase the costs of the procedure. In Egypt,
as elsewhere, HCV and HBV infections were
linked to the development of hepatocellular
carcinoma(18), this, if not excluding liver
Hatem Khalaf et al.
transplantation, will affect the timing of the
procedure. Schistosomiasis did not affect
either the incidence of acute and chronic
rejection or the eventual graft and patient
outcome within follow up period. These
results coincide with those obtained by the
Ghoneim's group while investigating the
impact of schistosomiasis on kidney
transplantati~n('~,~~).
This may signify that
schistosomiasis does not affect the host
immune response to the graft, which
contradicts previous studies indicating that
schistosomal patients are immunosuppressed
(13,21,22).
This might be explained by the work
of Ottesen and his colleagues in 1978, who
concluded that despite the progressive loss of
the host cellular immune response to
schistosoma mansoni when infection became
chronic, this loss is not a manifestation of a
state of generalised cellular immune
depression; it is rather limited to a response to
schistosoma antigen(23). In contrast to the
results obtained by Ghoneim's group on
kidney
transplantati~n(~~),schistosomal
recipients in our study did not require
significantly greater doses of Cyclosporine to
achieve the target trough levels compared with
non- schistosomal recipients. This could be
due to the improved absorption of
Cyclosporine, which is bile dependent,
following liver transplantation. Schistosomal
reinfection or reactivation were not detected in
any of our patients, while in Ghoneim's study
schistosomal reinfection was observed in 23%
of their cases, but because all the reinfected
patients had a history of contact with
potentially infective water, the authors believe
that it was probably reinfection rather than
reactivation of adult worms(20).The issue of
reactivation of surviving sterile worms is an
interesting one which needs further
investigation.
One of the main obstacles to liver
transplantation in Egypt is the availability of
donor organs. Most centres rely on the use of
heart-beating brain dead cadaveric donors.
However, in some countries, including Egypt,
cadaveric organ donation is either illegal or
Liver Transplantation In Egypt
163
socially unacceptable. Since 1959 many
Islamic Fatwas and sanctions were issued
allowing organ and tissue transplantation,
however, the most important of which is the
historical decree issued in 1986 equating brain
death with cadaveric and respiratory death
25). This decree has paved the way for liver
transplant programs to be launched many
Arabic countries including Saudi Arabia,
Kuwait and
but surprisingly
Egypt is still lagging behind!
(247
Alternatives to heart beating donors
cadaveric include living related liver
transplantation (LRLT), non heart beating
donors, and xenotransplantation. Living
donation offers liver grafts of excellent quality
which can be transplanted with optimal timing
and under elective conditions and is
associated extremely high success rates(300").
However, it generates many ethical debates, is
it ethical to ask a mother to donate a liver lobe
to a sick child? and can a parent truly give
informed consent under such circumstances?
Is it ethical to subject a healthy person a major
operation with a potential morbidity and
mortality to save the life of a child dying from
endstage liver disease? Segmental liver
donation is a dangerous procedure and must
not be undertaken lightly. Although donor
mortality is very rare, but it has been reported
(33),and it is an unacceptable catastrophe. One
other limitation to LRLT is its feasibility in
adults, which constitute the main problem in
Egypt. Although, a successful living-related
partial transplantation to an adult has been
reported (34, 35),it is not yet established and
remains to be seen(36).
If it was possible to harvest and use livers
after cardiac arrest, this would help to
alleviate the shortage of organ for
transplantation, and would also be of
enormous benefit to patients from countries
where brain death is not accepted such as
Egypt. But unfortunately the mechanisms of
the damage in warm ischaemia are not yet
well understood and the consequences of
transplanting a liver that is unable to provide
immediate life-support are unacceptable.
Although successful liver transplantation was
reported using non-heart-beating donord3'),
now it is generally accepted that livers, like
hearts, can be successfully used only if
harvested prior to cardiac a~-rest(~~-~O),
or from
controlled non-heart-beating donors (i.e.
arrested in the operating room after
life-sustaining treatment was ~ t o p p e d ) ( ~ l , ~ ~ ) .
Xenotransplantation remains a research tool at
present, but perhaps it is not too optimistic to
hope that will ease some of the pressure in the
next century.
Costs is another major concern in Egypt,
and it has been argued whether the good
outcome with liver transplantation,justifies its
high costs. Studies elsewhere have shown the
liver transplantation can be cost-effective in
comparison with other accepted health care
service^(^^.^^). However, these .results needs to
be reproduced in Egypt, bearing in mind that
medical
treatment
without
liver
transplantation, will only lead to the survival
of a critically ill patient who will most
certainly be admitted again to the hospital for
yet another complication or a reoccurrence of
the same problem, or to die. Therefore, in liver
transplant candidates, the treatment of
symptoms and complications becomes a "lost
investment". It should be also remembered
that, currently, there are a large number of
Egyptian patients travelling abroad to undergo
cadaveric liver transplantation in Europe or
North America. Where, in addition to the very
high costs, there is no guarantee that they will
get a new liver in time because of the rules
governing the use of the available organs in
patients from another country. We believe that
the money already spent annually to send
those patients abroad plus personal donations
will be enough to cover the expenses of
developing and maintaining a national liver
transplant program.
In Egypt, there are still many legal and
cultural difficulties regarding organ donation
following brain death that require much
thought and discussion by both individuals
Hatem Khalaf et al.
and society as a whole. Although many
campaigns were launched, the assessment of
there effect will have to await the legalisation
of the procedure by the Egyptian authorities.
Finally, considering the good outcome after
liver transplantation in Egyptian recipients
and the increasing need for the procedure by
many other patients, we believe that
developing a liver transplant program in
Egypt became a necessity and strong efforts
should be made to overcome all the hurdles
whether religious, legal, economical, or
cultural. Although it is
Figure 1: Indications of candidacy for liver
transplantation in 58 Egyptian patients (12
transplanted + 46 control)
9
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Correspondence to:
Dr. Hatem KhalaJ Department of General Surgery,
Suez Canal UniversityHospital.
Ismailia Egypt.
Fax: 002 064 328543
E-mail: Hatem -Khalaf@ Hotmial.com
Liver Transplantation In Egypt
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