Primary sclerosing cholangitis

More than 1600 Americans have received adult-to-adult living donor liver transplants. As the number of patients with end-stage liver disease is expected to grow significantly in the next 20 years due to hepatitis C infection, living donor liver transplantation has become a promising solution to the shortage of donor organs. The use of living donors provides organs in an environment of scarcity, allows patients to receive transplants when medically optimized, and produces liver segments with minimal ischemic damage. The donor complications most frequently cited in the medical literature include bile leaks and strictures, biloma, hepatic encephalopathy, wound infection, and pressure sores. In the wake of 2 donor deaths in the United States and subsequent media publicity, there have been new efforts by the transplant community to describe the risks and outcomes for donors, and establish safeguards to protect them from excessive pressure to donate. (Progress in Transplantation. 2005;15:36-44)

The national increase in patients with end-stage liver disease has led to a transplant waiting list that has grown annually from 1993 to 2001.1 Despite national campaigns to persuade families to consent to organ donation, the supply of cadaveric livers has not increased steadily; it lags far behind demand. Living donor liver transplantation (LDLT), the partial removal of a healthy donor's liver for transplantation, has been developed as one solution to the organ shortage. For the recipient, the donated lobe provides significantly better liver function. For the donor, the remaining liver portion regenerates to approximate preoperative size and function within weeks to months. Although LDLT was first developed for pediatric recipients, transplant centers now offer adult-to-adult living donor liver transplantation (AALDLT), which commonly involves the donation of liver segments 5 to 8, the right hemiliver.2

In 2001, 9% (408 of 4588) of adult liver transplants in the United States came from living donors.3 According to Emre,4 AALDLT could increase the adult liver donor pool by up to 40% to 50%. Until recently, it appeared that AALDLT was a promising answer to the organ shortage; more than 1600 procedures have been reported in the United States, most of them since 1998.3 However, the rapid proliferation of the procedure, deaths of healthy donors,5,6 and mass media coverage has led some in the medical and lay press to call for the certification of LDLT centers and mandatory outcomes reporting to a comprehensive database. Transplant coordinators and other nurses can play a vital role in implementing such changes and educating potential donors.

Regulation of Liver Transplantation

In 1984, the US Congress passed the National Organ Transplant Act. The bill authorized the Department of Health and Human Services (DHHS) to establish the Organ Procurement and Transplantation Network (OPTN), to be administered by a private, nonprofit organization under federal contract. The purpose of the OPTN was to create a unified national transplant network. The first OPTN contract was awarded to the United Network for Organ Sharing (UNOS) in 1986, which has been the contract's sole administrator since that time. (The terms UNOS and OPTN are often used interchangeably by transplant professionals; strictly speaking, OPTN is the permanent entity, whereas UNOS is the current administrator of the OPTN contract.)

OPTN develops policies for organ allocation, administers the organ matching list, and makes data reported by transplant centers available to the public. For many years, UNOS has certified cadaveric transplantation programs by stipulating detailed criteria for physician experience and institutional qualifications. However, to date there has been no additional certification process for centers that perform LDLT.7

All transplant centers must be members of OPTN to receive Medicare funds; other OPTN members include organ procurement organizations, professional societies, and patient advocacy organizations interested in transplantation.8 Under requirement by the DHHS, the OPTN Board of Directors is composed of approximately 50% transplant surgeons or physicians and at least 25% transplant candidates, recipients, donors, and family members.9 OPTN has further designated in its bylaws that at least 2 transplant coordinators shall serve on its Board of Directors.10

Waiting List and Organ Availability

Since UNOS began maintaining the organ matching list, the number of waiting list registrations increased annually until 2002, when the number of registrations dropped by 6%.1 UNOS attributes this decrease to the institution of the MELD (Model for End-Stage Liver Disease) system, used to predict mortality and establish eligibility for transplantation. Although more than 58000 Americans have received liver transplants since 1988, this number is far exceeded by the number of patients in need of organs.3 Table 1 illustrates the most recent decade of liver waiting list outcomes.

During 2002, more than 25 000 adults were registered on the waiting list for a new liver at some point during the year; 18.5% received cadaveric donations, and 1.1% received living donations. During the same period, 6.8% died awaiting a transplant, and 2.7% deteriorated enough to be deemed too sick to receive a transplant.11 The remaining 62% of patients were still waiting at the end of 2002.

OPTN lists the most commonly reported diagnoses for LDLT recipients under broad categories. These include noncholestatic cirrhosis (such as viral hepatitis or Laennec cirrhosis), cholestatic cirrhosis (primary biliary cirrhosis or primary sclerosing cholangitis), and malignancies.1 The number of patients needing liver transplants is expected to grow markedly because of an increase in hepatitis C virus (HCV) rates. Armstrong et al12 estimate that the number of persons infected with HCV for more than 20 years could increase significantly before peaking in 2015. Based on these numbers, Shiffman et al13 estimated that more than 500 000 people will be added to the transplant waiting list in the next decade as they develop cirrhosis from HCV infections.

History of LDLT procedure

The University of Chicago Hospitals performed the first successful LDLT, from an adult to pediatric recipient, in 1989. Before the first procedure, the physicians involved published a manuscript in the New England Journal of Medicine describing institutional review board approval, the protocol for donor and recipient selection, anticipated risks and benefits, and the use of an independent donor advocate and ethicist.14 By announcing the protocol before the procedure was introduced, the researchers created the opportunity for public and professional dialogue. In contrast, the procedure for adult recipients has never been studied in a formal protocol.13

For the first decade of LDLT, the adult-to-adult procedure developed slowly in comparison to pediatric LDLT, but has been used extensively since (Table 2). Only 34 adult-to-adult procedures were performed from 1991 through 1998, but that number jumped to 1374 from 1999 through 2003.15 Sixty-three percent of LDLT recipients to date have been adults. Of note, 71% of all AALDLT cases have taken place since the beginning of 2001.

The growth of AALDLT since 1998 can be attributed to several factors: first, the liver transplant waiting list grew significantly during the 1990s without a concomitant growth in organ donation, creating an increased need for organs. Over the last quarter century, hepatic resection for solid tumors has been demonstrated to carry minimal morbidity and mortality in otherwise healthy patients,16 and the surgical procedures used to perform such resections have paved the way for similar transplant resections.17 In 1998, Wachs et al18 published case reports of 2 elective AALDLT procedures, which opened the door for other groups to perform the surgery under nonemergent conditions. In the following year, Marcos et al19 published the results of 25 AALDLT procedures. The researchers reported no significant donor complications, with 3 recipient deaths due to sepsis; all 3 patients had functional grafts.

Over time it became apparent that the surgical procedure used to recover a liver segment for adult recipients is significantly different than for pediatric recipients. The technique used is driven by the need to provide an adequate mass for both donor and recipient.13 For pediatric recipients, the left lobe or segments totaling up to 40% of the donor's liver mass are used.4 In contrast, most AALDLT cases necessitate use of the larger right hemiliver, a more technically challenging operation. Malago et al20(p922) emphasize that the "LDLT procedure has changed from the low-risk operation needed for children to a high-risk hepatectomy needed to serve adults, especially those unlikely to receive a liver from the cadaveric allocation system."

Advantages and Disadvantages of LDLT

For the recipient, LDLT offers several advantages over cadaveric donation. It allows a patient to receive a transplant while in optimal physical condition before severe decompensation from end-stage liver failure. LDLT allows more time for donor evaluation, and can be scheduled on an elective rather than emergent basis. Because organ ischemic time is decreased, there is the opportunity for better and more rapid return of normal hepatic function.

LDLT recipients may not require as much immunosuppression as cadaveric transplant recipients; in addition, some LDLT recipients can be weaned off immunosuppressant agents entirely,21 because the majority of LDLT transplants come from family members, whose genetic information may be similar enough so that the recipient recognizes the donor material as self.

Russo and Brown22 suggest that studies comparing the cost of LDLT versus cadaveric transplantation have not demonstrated benefits for either procedure; however, these studies are difficult to design to include costs to society such as loss of work time or disruption to family functioning. To fully calculate costs, researchers should compare (1) patients who receive nonsurgical management, (2) patients who receive LDLT, and (3) patients who receive cadaveric transplants. The first group incurs significant costs resulting from complications of portal hypertension, such as hospitalization for bleeding esophageal varices. The second group may avoid those costs if receiving transplants while relatively healthy, but incurs costs through donor evaluation (including rejected donors), donor complications, and some additional recipient costs for treatment of bile leaks and strictures, which are more common because of the partial liver graft. The third group incurs only a single cadaveric donor evaluation cost and is less likely to incur surgical complications, but may be more ill at the time of transplantation.

The primary disadvantage of LDLT compared to cadaveric transplantation is an increased complication rate. This can be ascribed to the differences that arise from transplanting the liver in its entirety versus a partial organ.23 Significant anatomical variation in donor biliary and hepatic vascular anatomy is common, which may require varying surgical techniques. The learning curve for transplant surgeons has included the difficulties of creating a graft large enough to support the recipient with appropriate anastomoses, while leaving similar function for the donor. As a result, early biliary leak, late bile duct stricture,24 and hepatic artery thrombosis have been reported more frequently after LDLT than cadaveric transplantation.13 In addition, bacterial and fungal sepsis are more common after LDLT, particularly in patients with advanced decompensated cirrhosis.13

Assessing Donor Outcomes

Numerous factors affect our ability to measure the risks to AALDLT donors. At present, UNOS requires transplant centers to report data on the demographics of living donors, number of procedures performed, and deaths. UNOS collects limited clinical data on LDLT donors, and follows them only to 1 year after discharge. Although some transplant centers have reported their own results, significant variation exists in defining and reporting complications. This information, while useful for basic purposes, is inadequate to make a complete assessment of donor risk.

With the limitations of reporting in mind, Shiffman et al13 estimate the risk of donor mortality for right hepatectomy, the most commonly used approach, at 0.2% to 0.5%. To date, there have been 3 liver donor deaths in this country reported by the mass media, 2 involving AALDLT.6 (One other adult donor committed suicide 2 years after transplantation; most authorities do not consider this unfortunate event to be directly attributable to donation.24) However, because of delays or lack of reporting in the medical literature, the number of donor deaths remains unclear.25 In 1999, Strong26 reported that although only 1 LDLT donor death had been reported in the world, he was personally aware of 5 other occurrences.

Our knowledge of common complications has come primarily from published reports by individual transplant centers or surveys. The donor complications most frequently cited in the medical literature include injury to the biliary tract resulting in bile leaks, biloma, or biliary duct stenosis.13 However, these data are biased by the voluntary nature of reporting, variation in donor evaluation, lack of uniformity in surgical technique, and experience levels of surgeons and transplant centers. Of particular concern is the inability to predict the risk of long-term complications simply because the procedure is so new: Shiffman et al13(p179) raise concern that "bile duct strictures may increase the lifetime risk of the donor for developing secondary biliary cirrhosis, the significance of which may not be realized for several decades."

Current Procedures in Evaluating Donors

Potential LDLT recipients should first meet the UNOS criteria for cadaveric transplantation and be placed on the national waiting list. Even though a living donor is to be used, in the event of immediate postoperative organ failure, the recipient would be eligible for cadaveric transplantation.

The first step in evaluating potential donors should be a physical examination by a hepatologist or internist. Selzner et al27 state that donors should be ABO-compatible with the recipient, in good general health, free of liver disease, and preferably between 20 and 45 years old. The initial evaluation consists of noninvasive testing such as blood chemistries and typing, as well as cardiac and pulmonary function tests.

In the second stage, more expensive and invasive procedures are employed. Computed tomography scan or magnetic resonance imaging is done to establish liver volume, and magnetic resonance angiography or other procedures are used to assess hepatic and biliary anatomy. Also during this stage, a psychosocial examination by psychologist, psychiatrist, or social worker is usually completed. During this evaluation, the individual's motivation for donation is discussed, including pressures from others to consent to donation. This examination should assess emotional stability to rule out inappropriate donors. Although the donor may anticipate psychological gain from donation, he or she must also prepare for the emotional conflict that could occur if the recipient dies postoperatively.

The psychosocial examination is also an appropriate time to discuss finances. Most recipients' third-party payers will cover the costs of donor workup and hospitalization, but may not cover lost income during routine recovery, or costs incurred from temporary or permanent disability. In a survey of 24 donors. Trotter et al28 found that donor families spent a mean of $3660 on nonreimbursed incidentals such as transportation and lodging, incidental medications, and lost wages during donation. The transplant team may advise donors about such potential costs, and suggest obtaining additional disability insurance for financial protection.

Brown et al29 have recently published results of their national survey of LDLT programs. They found that almost all donors are screened preoperatively by a hepatologist, social worker, and psychiatrist or psychologist. However, only half of centers employ an "independent advocate," a physician or ethicist who examines the donor, but has no contact with the recipient. The researchers also report a wide variety of invasive screening procedures, such as liver biopsy, arteriography, or other methods to assess the donor's bile duct anatomy. In total, 45% of individuals who presented for initial evaluation proceeded with donation. Those who did not proceed were ruled out because of medical evaluation or personal choice.

Ethical Issues

The issues that face organ donors often center on 3 healthcare ethics principles: autonomy, beneficence/nonmaleficence, and justice.30 Autonomy for the donor involves our respect for his or her capacity to act intentionally and without coercion. In the case of transplantation, beneficence (doing good) and nonmaleficence (not inflicting harm) are in competition; in this case, we seek to minimize needless harm to the healthy donor. Justice weighs the fairness of treatments for individuals and the larger society.

Arguments over donor autonomy in AALDLT generally center on 2 issues: the right of the donor to choose what may be a high-risk donation, and the elements of informed consent. Historically, surgeons have ruled out potential donors on the basis of their assessment of excessive clinical risk. But a donor determined to undertake a particularly risky procedure may not be able to assess his or her own emotional competency, financial burden, or the impact on his or her extended family. This safeguard may be an appropriate function for the independent advocate, with authority to overrule a patient's decision to donate.31

The principle of informed consent is critical for the donor, and goes beyond explanation of the surgical procedure. First, the physician obtaining consent should explain the limits of current knowledge; that is, statistics are influenced by the short history of the procedure, variety and changes in technique, and self-reporting bias. Once these limitations are clearly established, the physician should explain transplant center and national data regarding deaths, complications, and most frequent patient complaints.

The last feature is critical; particularly for healthy individuals who have never been seriously ill, there is a tendency preoperatively to underestimate the amount of pain, fatigue, and other disability they will experience after major abdominal surgery. It is critical that health professionals not minimize what we consider to be routine postoperative discomforts. Beavers et al32 found that liver donors frequently reported unexpected pain, a larger surgical scar than anticipated, or delayed normal bowel function, even though 94% of respondents reported they had a clear understanding of the complications before giving consent. Donors in that study experienced a mean time to complete recovery of 12 weeks; one third of donors reported it took more time than expected to completely recover.

Although professionals agree in general that potential donors should be protected from undue pressure to consent, the methods to do so vary. Many institutions use the psychological interview to determine if a potential donor is being coerced to donate. However, others believe that a transplant team focused on the recipient's illness cannot remain objective about donor suitability. The New York State Transplant Council,31 the DHHS Advisory Committee on Organ Transplantation33 and others5 have recommended that an advocate uninvolved the recipient's care should be part of the donor selection process.

In organ donation, the obligation of nonmaleficence does not dictate that absolutely no harm may be done to the patient, but allows for some degree of injury as long as there is an intended benefit to another. It is incumbent on transplant centers to minimize that harm by carefully screening potential donors, and to err on the side of safety in assessing their risk. There must be an acceptable level of success for the procedure in general, and the recipient in particular. It is appropriate for a donor to be aware of the recipient's expected morbidity and mortality as well as his or her own.

The implementation of LDLT programs improves the opportunity for realizing the principle of utility, the creation of the greatest good for the largest number of people. LDLT increases the donor pool, potentially allowing additional patients to receive transplants. The procedure has also stood up to the test of justice, in this case the equitable allocation of cadaveric organs. There has not been a significant need for retransplantation because of recipient organ failure5; in those instances, recipients would be granted regional priority for a retransplantation, which would cause cadaveric organs to be allocated out of sequence.

Finally, in applying these ethical principles, we should recognize that the cultural backgrounds of patient, potential donor, and practitioner can significantly affect decision making. LDLT presents special dilemmas because of the potentially competing interests of the donor and recipient. The degree to which those interests are valued may become especially significant when patients and healthcare professionals are from different cultures.

Public and Professional Response

The rapid growth of the AALDLT procedure and accompanying ethical challenges has been prominently featured in Newsday,6 The New York Times,34 Wall Street Journal,35 and on the television program 60 Minutes II.36 Two widows of donors have publicly challenged the decision-making processes for donor screening and safeguards used in their spouses' cases.6,37 Furthermore, one widow has alleged negligence in the postoperative care her husband received. The subsequent investigation by the New York State Department of Health resulted in heavy fines and the temporary cessation of Mount Sinai Hospital's AALDLT program, one of the largest in the country.38,39

The medical community has also reacted to concerns about the rapid growth of AALDLT. Transplant centers have reexamined their procedures; this accounts at least in part for the decline in cases since 2001. The New York State Transplant Council31 and the American Society of Transplant Surgeons40 have issued recommendations specific to living liver donation, and the DHHS Advisory Committee on Organ Transplantation,33 and the Live Organ Donor Consensus Group41 have published broader proposals for all living organ donors. Among these are recommendations on informed consent, donor advocates, a living donor registry, and sample consent forms for living donor procedures.41 Further, the National Institutes of Health has launched a 7-year multicenter AALDLT study to examine donor outcomes.42

The nursing community has also responded to the concerns over living donors. The North American Transplant Coordinators Organization has issued a policy statement on living donor transplantation for all organs covering donor evaluation, informed consent, and donor follow-up.43 According to Benner,44 transplant centers have special obligations to ensure that adequate financing and institutional support are given to protect living donors.

The implementation of improved screening and consent processes and long-term data collection are positive steps toward informing and protecting healthy donors. However, the results of such activities will not be seen for at least several years; until then, what is the role of nursing in educating and safeguarding donors?

Nursing Implications

To be effective patient educators, transplant nurse coordinators must be able to explain scientific data and clinical routines. In the case of AALDLT, nurses must also be prepared to answer donors' questions and dispel myths arising from mass media coverage. Transplant coordinators should be familiar with the major studies on LDLT, UNOS data, and their own center's data. They can direct donors to the UNOS Web site for further information comparing centers.

In particular, patients may be interested in data regarding the transplant center's experience. Medical ethicist Arthur Caplan45(p494) summarized a prominently held view: "Living donation of lobes of liver should still be viewed as an innovative procedure not to be undertaken at institutions that do not have extensive experience with other forms of transplantation." However, in a survey by Brown et al,29 14 of 42 centers accounted for 80% of AALDLT procedures.29 In addition,32 other institutions stated they planned to offer the procedure within the next 12 months. Thus, many centers with limited experience may be performing AALDLT. Transplant coordinators are in a position to help donors understand that a variety of features in addition to surgeon experience can be important factors in patient outcomes; such factors include nurse-to-patient ratios, staff education, systems for error prevention, and resident supervision.

Nursing has a critical role to play in patient education. Transplant coordinators are vital in educating patients about the stages of the transplant workup, the patient's role in maximizing preoperative health through diet and exercise as tolerated, the transplant surgery itself, postoperative recovery, and complex medication regimens for recipient immunosuppression. The transplant coordinator should also prepare both the donor and recipient for potential complications of either party. Statistics on morbidity and mortality for each procedure should be provided to each person clearly.

Nursing has a critical role to play in developing written materials for potential donors that reflect the currently available data in a clear format. Although the sample consent forms published by the DHHS Advisory Committee on Organ Transplantation are an excellent template,46,47 nurses at transplant centers can provide further expertise in developing patient education materials that are attractive and comprehensible to lay readers.

As team members who are a consistent presence through the preoperative and postoperative continuum, transplant coordinators spend significant time assessing and coaching families. The educational emphasis on viewing the patient as part of his or her environment makes nurses experts in assessing the support systems of donors. Nurse coordinators can help patients make a realistic assessment of their ability to return to work and resume family roles based on their unique circumstances, and prepare them for the loss of work time or income that donation might cause.

Finally, as part of the transplant team, nurse coordinators can promote the addition of an independent donor advocate to the assessment process. Based on our extensive contact with families, coordinators can play a vital role in educating those advocates about common concerns donors experience.

Future Actions

In June 2003, the UNOS Board of Directors endorsed a series of measures affecting living donor transplantation. They approved the creation of a certification process for LDLT programs that will prescribe experience requirements for surgeons. They endorsed detailed reporting forms for long-term donor follow-up, and approved the creation of a standardized educational tool for living donors and recipients.48 Of note, UNOS has not made recommendations regarding nursing issues such as staffing ratios or continuing education requirements. The future involvement of nurses in implementing improvements in patient and staff education, data collection, and the donation process can significantly enhance the care we provide, and the choices we offer to donors and recipients.

Acknowledgment

This work was supported in part by Health Resources and Services Administration contract 231-00-0115. The content is the responsibility of the author alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.

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Claire Curran, RN, MSN, CCRN

University of North Carolina Hospitals, Chapel Hill, NC

Copyright North American Transplant Coordinators Organization Mar 2005
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