Running head: ETHICAL ISSUES SURROUNDING LIVER RETRANSPLANTATION
Ethical Issues Surrounding Liver Retransplantation
Krystal Morris, RN, BSN, CCRN
Washburn University
1700 SW College Ave
Topeka, KS 66621-117
krystal.morris@washburn.edu
Abstract Word Count: 99
Text Word Count:
November 3, 2010
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ETHICAL ISSUES SURROUNDING LIVER RETRANSPLANTATION
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Abstract
Liver retransplantation accounts for 5 to 20% of all liver transplants performed in the
United States today (1). According to the Organ Procurement and Transplantation Network, as
of October 22, 2010, there are 16,026 candidates for liver transplant. Of these candidates, 554
individuals are listed as needing liver retransplantation (2). Primary graft failure, recurrence of
HCV cirrhosis, hepatic artery thrombosis (4), infections postoperatively, bleeding complications,
along with acute and chronic rejection episodes (7) are among the primary reasons that repeat
liver transplantation occurs. This topic presents many controversial ethical, medical, and social
considerations.
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Ethical Issues Surrounding Liver Retransplantation
Introduction
Liver retransplantation accounts for 5% to 20% of all liver transplants performed in the
United States today (1),. In order to be a candidate for transplantation, each patient is placed on
the national donor list, managed by the United Network of Organ Sharing (UNOS) which works
in conjunction with the Organ Procurement and Transplantation Network (OPTN) (2).
According to OPTN, as of October 22, 2010, there are 16,026 candidates for liver transplant. Of
these candidates, 554 people are listed as needing liver retransplantation (3).
Primary graft failure, recurrence of Hepatitis C Virus (HCV) cirrhosis, hepatic artery
thrombosis (4), postoperative infections, bleeding complications, technical problems with
surgery, such as biliary complications (5,6), along with acute and chronic rejection episodes (7)
are among the primary reasons that repeat liver transplantation is necessary.
The waiting list ranks patients based on the severity of their liver disease. Bilirubin,
prothrombin time, and creatinine are utilized in a calculation that provides the transplant team
with a Model of End Stage Liver Disease (MELD) score. This score ranges from 6 to 40, with
higher scores placing patients as the highest priority. Each person’s score indicates the urgency
for needing a liver transplant within the next three months (2). Liver retransplantation presents
many controversial ethical, medical, and social considerations. Literature supporting and
opposing liver retransplantation, legalities of retransplantation, and patient case reviews will be
analyzed throughout the content of this text, highlighting recommendations for nursing.
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Discussion
Supportive Literature
Current literature suggests that 5% to 20% of all patients undergoing liver transplantation
will require retransplantation (8). The success rate of those retransplanted is approximately 62%
to 82%. Over the past decade, surgical techniques have improved, and additional research on
appropriate immunosuppression therapy and donor evaluation has increased survival rates (5). In
the early years of liver transplantation, technical complications of the surgery and chronic
rejection from inadequate immuonsupressive drug dosages were among the primary reasons for
retransplantation (1).
Success of liver retransplantation has increased as an increasing number of surgeons have
gained expertise (12). Proficiency comes with expertise, which in turn reduces cold ischemic
times, yielding more successful transplantations (24). Hospitals performing larger volumes of
transplant cases have been shown to lower the mortality risk one year following surgery (12).
Additional success can be attributed to the process of care that hospitals put into place. Larger
hospitals with a higher volume to transplants often have a Transplant Intensive Care Unit that
specializes in the care of patients with select types of organ transplantation. With this type of
implementation, nursing staff receives focused training and orientation in caring for this
specialized patient population. Nurses are the primary care providers for the patient
postoperatively, therefore importance is stressed on early identification of signs and symptoms of
complications to aide in facilitating prompt communication with the surgical staff. Protocols
and standards of practice have been set in place to assist with this process.
A large metropolitan hospital in the Midwest, for example, has developed a standardized
order set that is initiated in the Transplant Intensive Care Unit (TICU) for postoperative liver
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transplants to ensure that appropriate nursing interventions are completed, and
immunosuppressive medications are properly ordered and administered. Following surgery,
liver transplant patients are transferred to the TICU to receive one on one nursing care for four
hours, and if necessary, longer to ensure that the nurse is able to adequately focus on the patient
and communicate with collaborating physicians as necessary. Once a patient’s condition is
considered stable, he or she is transferred to a Transplant Progressive Care Unit where the staff
has also received an extensive transplant orientation and specialize in caring for these patients.
This type of intervention can aide in the success rate of retransplantation through maintaining
continuity of care through the recognition of early patient problems and by providing the
necessary post- operative education to prepare the patient for the transition home and facilitating
the likelihood of a successful retransplantation.
Outcomes of retransplantation are associated with the indication of the surgery. Many
retransplantation surgeries occur within 30 days of initial transplantation, and show an increasing
number of positive results when the procedure occurs in this time frame (5). The exception to
this statement is when patients are urgently retransplanted and clinically unstable prior to
surgery. Improved outcomes have been noted among patients who were retransplanted due to
hepatic artery thrombosis, a common indication for a repeat transplant (10).
Waiting lists for transplant candidates have increased, although there has not been a
significant increase in donors. Many efforts are currently being made to raise awareness about
organ donation to the public. Information regarding donation has been placed on social media
outlets in the past year. Among these groups includes Facebook, YouTube, and twitter. UNOS
has a Facebook corporate page as well as various groups to join for those who have received a
transplant, are awaiting a transplant, or have been affected in some way by a transplant (21).
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Social networking sites have been a growing trend over the past decade. Utilizing this type of
tool could prove beneficial by targeting a larger population of individuals in regards to the
current organ shortage and encourage others to become interested in organ donation.
Donor history is an important factor that transplant teams analyze when making the
decision to accept or deny potential liver transplant donors. Extended criteria donors (ECDs) are
donors that a transplant team will accept that are often more complex cases due to advanced
donor age, donation after cardiac death, and various ischemic donor injuries (23) Currently,
authors are working to develop a standardized tool to serve as a donor risk screening index to
assist with the determination of acceptable organs (17).
Utilizing this population of donors is an attempt to increase the pool of available donors
for the many candidates on the waiting list. In an attempt to expedite the decision to accept an
organ, local procurement by a team other than the receiving transplant team is growing in
popularity. The average cost for travel for organ procurement is approximately $30,000 (23).
Transplant teams are more hesitant to make the flight on a questionable donor due to the risk that
the flight presents to the crew as well as the financial obligation that is associated. Local teams
have begun to take high quality digital photography of the liver once it has been procured to send
to the transplant team who will make the ultimate decision if the liver is acceptable before
beginning the costly process of transporting an organ (23).
Opposing Literature
Liver retransplantation is often the only chance for survival in patients experiencing a
variety of complications leading to failure of the primary liver, also referred to as a hepatic graft
in the literature. The procedure presents a greater risk of morbidity and long term survival than
for persons receiving an initial transplant (1,5,11,12). Allograft failure often occurs due to the
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technical demands of the surgery along with pre-existing comorbities (9). Liver transplant has
become the treatment of choice for many patient conditions such as primary biliary cirrhosis,
alcohol and HCV related liver diseases, and Hepatocellular Carcinoma. Since retransplantation
has become an option, it is the treatment of choice for more patients who meet criteria and have
been placed on the waiting list. Although the number of candidates for transplantation has
increased, there has not been a significant increase in the number of organ donors to meet this
demand (13).
Organ shortage in the United States is one of the many controversial issues surrounding
liver retransplantion. When a patient receives a repeat transplant, many think it is unjust to give
priority over someone who has never received a transplant (13). Currently, 554/16,026 (.035%)
of those nationally listed as candidates for transplantation are listed for retransplantation. The
mortality rate of patients on the initial liver transplantation is approximately 18% (24).
Statistically, this numbers appears of patients awaiting retransplantation are very small, yet can
raise many ethical concerns for the transplant teams, candidates for transplant, and family
members
Patients with Primary Biliary Cirrhosis often rank with a lower MELD score, which will
lead to a longer wait time to receive a transplant. This can raise an ethical concern when patients
with HCV have a higher MELD score and will receive transplantation sooner. Many patients
with HCV have contracted the disease from sexual activity or drug use. Patients with alcoholic
cirrhosis can become transplant candidates once they have completed the necessary rehabilitation
and have been free of alcohol for at least 6 months. One could argue these particular patient
situations should not have priority over patients whose lifestyles have not contributed to their
liver failure.
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Psychosocial evaluations are part of the transplant process. In order for a patient to be
listed as a candidate, social workers and transplant coordinators evaluate the support system that
is in place for the patient. It is important to make sure there is a strong foundation of support, as a
liver transplant is a life changing experience that will require a commitment of taking an
immunosuppressive regimen, follow up laboratory work, and follow up appointments.
Immunosuppressive regimens often include taking an oral anti-rejection medication two times a
day. Following discharge from the hospital, patients are required to stay in the vicinity of the
transplant facility for several weeks, occasionally longer, in order for laboratory work to be
obtained and analyzed, to target postoperative complications early on. Patients are allowed to
return home once laboratory work has stabilized, but are often required to get blood drawn
weekly or biweekly for a period of time, and eventually monthly. The life change that a liver
transplant brings requires a desire for success through compliance with all regimens by the
patient, which is often facilitated and encouraged through their support system.
Occasionally liver transplant candidates are denied due to lack of a support system to
help them follow the rigorous regimen previously discussed. The ethical issue that this presents
is the fairness in denying someone a life-saving transplant because they do not have a support
system in place. Some individuals no longer have family ties and prefer to keep to themselves.
Does this mean that they are not an appropriate candidate? Lack of a support system does not
always mean that a patient will have compliance issues with a new organ, although research
indicates better success rates with it in place.
Although the primary goal of organ retransplantation is the optimal health of the patient,
it is realistic to analyze the financial considerations behind the procedure. The high costs of
retransplantation have been well documented (6,10). The cost of a retransplantation is twice that
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of the primary one (6). In general, patients who are retransplanted have a higher degree of illness
than those receiving a primary transplant (10). Longer stays in the Intensive Care Unit can be
financially demanding due to the level of care that is necessary along with the additional
diagnostic testing that is involved. As of 2005, it was estimated that the cost of an adult liver
transplant is approximately $146,069. If a patient requires retransplantation, the cost of a late
retransplant is about $331,943, while retransplantation earlier on is $442,092 (6). Finances are a
driving force in our society, which presents the ethical question behind the value of life? Is it
ethically correct to place monetary value on human life when deciding if a procedure is too
expensive?
Legal Aspects
On February 15, 2007 Donna Hollingshead filed a suit against Blue Cross and Blue
Shields (BCBS) of Oklahoma, HMO. Hollingshead had Primary Sclerosing Cholangisitis (PSC)
that led to cirrhosis and liver failure. Prior to transplant, she met the criteria set forth by BCBS in
that she had a life expectancy of 18 months or less without a liver transplant, she had PSC,
normal functioning kidneys, no concurrent extrahepatic malignancy, and had a psychologically
stable, supportive, social environment. Hollingshead underwent her primary liver transplant and
was discharged from the hospital with a functioning liver and in stable condition. Eleven days
later, her new liver failed, and she underwent a second transplant to save her life (14).
BCBS states in its policy that the company “denies any benefit for transplants of more
than one organ of the same type” (14). Since her primary liver transplant failed, the company
was not willing to cover Hollingshead on her retransplantation surgery. Hollingshead sued in
regards to the refusal to cover her second surgery. Her argument was that the policy should cover
one successful liver transplant. The primary liver transplant was not successful in that it failed
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within 11 days of surgery. Dr. Richard Gilroy’s letter written on her behalf, stated that “Three
percent of liver transplants do not function and retransplant is mandatory in those situations;
otherwise the patient will die. We consider this part of the original transplantation process”(14).
In the end, BCBS of Oklahoma refused to cover Hollingshead retransplantation surgery based on
the criteria that she received more than one organ of the same type.
Donna Hollingshead’s case presents an important ethical dilemma in regards to the
financing of liver retransplantation. She had worked for a hospital that carried BCBS insurance,
therefore she had paid monthly for insurance up until the time of her illness. Her primary
transplant failed, as 3% off all transplants do. How is it fair that she had to carry the financial
burden because her new organ did not work? It would seem reasonable that BCBS would cover
her throughout one successful transplant, which hers was not. Without retransplantation, she
would have died. The cost of retransplantation could have cost this patient more than $400,000.
This is a case of a middle class worker whose life style did not contribute to the need for a liver
transplant. It could be merely impossible for a middle class working individual to ever pay off
their medical debt. This case is one of the many ethical financial dilemmas that are present in
transplantation.
Case Reviews
Ethical principles of justice, beneficence, and non-maleficence are highlighted in
following case studies analyzing retransplantation.
Patient A is a male in his late 30s who received a transplant for cirrhosis related to HCV.
His primary transplant was not effective for a number of reasons. Donor factors play a significant
role in the success of the surgery. There is an increased risk of failure when the age of the donor
is greater than 50 years with additional risks when the age of the donor is over 60 (15). The
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length of cold ischemic time of the organ is an important factor in the success as well. Transport
time from another other facility, or out of state is a contributing factor to cold ischemic time.
Ischemic reperfusion injury and biliary complications are among the primary reasons that
liver transplantations fail. Early biliary complications associated with liver transplantation
include biliary leaks, and in the later postoperative period, biliary strictures are often an issue.
Biliary concerns arise in 9 to 35% of liver transplant recipients (17). Patients often times have
signs of rejection and immunosuppression therapy is not appropriately managed.
Patient A experienced all of the complications that were mentioned in the above section,
and underwent a secondary liver transplant. Repeat organ transplantations have lower success
rates than the initial one, which proved true to this particular patient. He had prolonged times in
the Intensive Care Unit and underwent a number of tests and procedures post-transplant. This
particular patient was able to return home, yet has been readmitted to the hospital on several
occasions related to postoperative complications from his secondary transplant.
In this patient’s case, he had at least four of the many factors that contribute to primary
graft failure. The ethical question to address in regards to this particular situation is if it was right
to give this patient a secondary transplant. This patient was critically ill prior to the procedure,
therefore presenting with an increased risk of intra-procedural complications along with an
extended recovery. With his clinical presentation prior to being relisted, is there justice in
passing other people on the transplant waiting list who have never received a transplant to
provide a liver to this patient with so many risk factors?
When analyzing the other side of this case, the patient did not have any control over the
type of donor that he received, nor did he have control over where the donor came from, which
was a primary factor in the cold ischemic time of his primary transplant. Non-malficience is a
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goal of every physician, but harm was caused to this patient. Based on this ethical principle, did
this patient deserve a secondary transplant because harm occurred to him? According to several
sources, transplant teams have begun to widen the criteria for acceptable organ criteria due to the
increasing number of patients on the wait list and the advances that have occurred in the surgical
process (18, 19). In 2009, an article was published that analyzed extended criteria of donors in
liver transplantation. The findings in this articles suggest that increased donor age greater than 50
years old can play a significant role in graft failure of HCV positive patients presenting with
higher MELD scores. When using marginal donors, decreased success with the surgery has been
noted (19). The prolonged ischemic time led to ischemia reperfusion injury which could have
played a role in is biliary complications as well.
Patient B was a male in his 40s with end stage liver disease secondary to HCV. There are
many shared factors between this patient’s case and the case that was previously highlighted.
During his primary transplant, the liver experienced prolonged ischemic time. Following surgery,
he was placed in immunosuppression therapy for an extended period of time. Many of the
immunosuppression drugs have shown to be nephrotoxic, leading to acute renal failure in many
transplant patients. Immunosuppressive therapy presents with a risk of metabolic disorders,
cardiovascular risk factors as well the renal dysfunction (20), which is what occurred with this
particular patient. Immunosuppression protocols have been developed and are constantly being
refined to better meet the needs of transplant recipients. Patient B ended up requiring Continuous
Renal Replacement Therapy (CRRT) prior to and following his secondary transplant.
In this particular case, proper immunosuppressive therapy adjustments could have aided
in preventing multisystem organ failure that he experienced prior to receiving a new organ.
Maleficence unintentionally occurred to this patient. Ethical issues such as proper education and
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closer monitoring by pharmacy and nursing staff to identify this problem earlier on could have
prevented the need for a secondary liver transplantation.
Recommendations
Conclusion
Liver retransplantation will most likely always raise ethical concerns for the transplant
community, although it is necessary to sustain life in patients whose primary transplant has
failed.
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