Anonymous Living Liver Donation: Donor Profiles and Outcomes

Donor selection process

All patients that were evaluated as potential live anonymous liver donors between December of 2004 and August of 2009 were included in the study. Our assessment protocol did not substantially change during this period.

Persons with an interest in anonymous donation were given an information packet and a health history questionnaire after initiating contact with our donor office. If no absolute contraindications were identified, potential anonymous live liver donors undergo the same rigorous medical, surgical and psychological evaluation that is undertaken at our center for biologically or emotionally related donors (2).

The assessment process includes evaluation by two transplant surgeons, a social worker, a family physician, a transplant hepatologist, a psychiatrist and an anesthesiologist. Laboratory tests are also performed to determine normal liver function, blood type and absence of viral diseases (hepatitis B, hepatitis C, HIV, HTLV, West Nile virus and syphilis). A formal psychiatric assessment is performed to identify any psychological contraindications to donation, to rule out any inappropriate motives such as financial inducements and to also assess the donors understanding of living liver donation.

At our center, a remote history of substance abuse is not an absolute contraindication to donation provided there is history that the underlying issues that provoked substance abuse have been dealt with and there are no current social or psychological issues. When controversial concerns are identified, additional psychiatric opinions are usually obtained.

The patients undergo multimodal abdominal imaging. An abdominal ultrasound is obtained to survey the liver and to estimate fat content. If there is a question of steatosis, potential donors are referred for a liver biopsy. Liver anatomy is determined by computed tomography (CT) angiogram and magnetic resonance cholangiopancreatography. CT cholangiograms are sometimes performed if additional information is required. An independent medical assessment is performed to ensure that the donor is medically fit for high-risk surgery.

Careful attention was made to the motivation of the donor and their understanding and acceptance of the organ donation process. In addition to our routine requirements for liver donation, the following additional criteria were used to assess anonymous donors: a past history of altruistic acts, a logical rationale for donation that is understandable to the team, no prior major psychiatric or psychosocial issues, strong social supports and a willingness to maintain confidentiality of patient information. Thus, all potential anonymous donors were asked to explain why they had made this choice and whether or not they had also considered options with less risk including blood donation, marrow donation, kidney donation, as well as other volunteer activities. Also, as with all of our live liver donors, anonymous donors must be able to voluntarily consent to donation and have no expectation of unacceptable secondary benefit such as media or public attention or illegal compensation.

Potential donors were required to also undertake to (1) remain anonymous to the recipient for at least 6 months; and (2) have no contact with the recipient without agreement of both the donor and recipient. This verbal ‘no contact agreement’ was devised by an ethicist working with the donor team and was approved by the hospital's Medical Advisory Committee. The waiting time chosen was arbitrary but was felt to provide adequate time for both the donor and recipient to recover and make a thoughtful decision. Anonymous donors were informed of the immediate postoperative outcomes of the transplant but were otherwise not routinely informed of the condition of the recipient. If both parties wanted contact, they had to agree that this would occur under the supervision of a social worker.

Potential donors meet with two different donor surgeons who review the procedure and described the risks in great detail. For nondirected donors, donors are given the option to donate to either a child or an adult. Donors are not questioned nor is any preference given to other recipient characteristics (e.g age, race and cause of liver failure). We recommend left lateral lobe donation because of the presumed lower morbidity and mortality rate when compared with a right lobe resection (5,6). Right lobe donation was offered when (1) it was not anatomically possible to donate the left lateral segment of the liver; or (2) the donation was directed to an adult. Donors are also given a handbook that provides recent data on morbidity rates in our program.

We require a 2-week minimum ‘cooling off’ period to work up donors for elective liver transplants. The work up for anonymous donors usually takes much longer; as it is largely driven by donor availability and the amount of time that the donor requires to provide a fully informed consent. The goal of the evaluation is not only to determine if a potential donor is medically and psychologically fit to undergo donation, but also to gage their understanding of the surgery and the potential risks involved. During the donor assessment process, potential donors are supported by a dedicated donor coordinator and by a family doctor who act as donor advocates. Whenever the potential donor meets with the health care team during the assessment process, they are reminded of the option of opting out at any time.

Nondirected donor recipients are allocated based on blood type and graft size. The recipient with the highest medical necessity (i.e. MELD score and complications related to end stage liver disease such as encephalopathy) is then chosen.

Follow-up is provided at 2, 4 and 12 weeks after the surgery and then annually thereafter for up to 10 years by our program. These scheduled meetings not only screened for postoperative complications, the donor advocates also routinely asked questions about patient satisfaction and quality of life.

All patients in Canada are eligible for short-term disability for 3 months. All health costs are covered by the provincial health care plan and medication is covered by the donor's private insurance. ‘Out of pocket’ expenses (e.g. travel costs, meals lost wages) are partially covered by Ontario's Transplant Patient Expense Reimbursement (TPER) program (see http://www.giftoflife.on.ca for more details).

All potential donors are asked to abstain from alcohol intake, smoking and contraceptive use for 4 weeks prior to surgery.

The scoring system described by Clavien was used to classify all complications, ranked according to five tiers of severity (7).

Donor and excluded donor characteristics

The first potential anonymous donor evaluation started in December 2004; this patient successfully donated a left lateral segment to a pediatric recipient the following year (2). Since that time, over 1000 potential donors have initiated a call to the donor assessment office, often in response to a public appeal. The majority did not respond to our return phone calls or they failed to complete the required living donor health questionnaire. Only 29 people submitted the appropriate documentation to be considered for anonymous donation, passed our initial screening and then underwent further evaluation. The evaluation process was conducted by the same staff members over the 5-year period.

Seventeen assessments were terminated because of patient decisions (7/29), medical concerns (5/29), anatomical unsuitability (3/29) or breech of anonymity (2/29). The reason behind termination secondary to patient decision was usually due to concerns about the risks of the procedure. This decision is immediately accepted without discussion. By protocol, we do not ask detailed questions about the reasons for this decision in order to avoid any perception of coercion by the program. One breech of anonymity occurred when the potential donor went public and proclaimed they were going to ‘save’ a particular child. Another breech in anonymity occurred when a potential donor attempted to contact the hospital ward the night before planned donation to obtain information on the recipient. Both of these potential donors were immediately disqualified following these actions.

The 12 donors included six women and six men with ages ranging from 20 to 54 years (Table 1). Occupations included product developer, accountant, student, housekeeper, computer consultant, executive assistant, secretary, pediatric nurse, line worker and commercial driver. One donor was retired at the time of donation. Four donations were directed toward individuals that had had public appeals through the media. Two donors were required to lose weight before they were able to donate. Five of the donors had remote minor psychiatric issues including transient, stress induced secondary depression (1/12) and mild anxiety provoked by specific life events (4/12); none had any major, recent or current psychiatric issues.

The majority of donors had learned about anonymous donation through the media regarding organ donation (Table 2). This initial interest in donation was then typically followed by several months of research into the area prior to coming forward to volunteer to donate. All successful donors had a significant history of altruistic activity acting as blood donors, bone marrow registrants and volunteers at both a local and international level. Approximately 60% of the donors also knew someone (either family or friend) whose life had been positively impacted by receiving a solid organ transplant. All potential nondirected anonymous donors were advised of other lower risk donor options including anonymous kidney donation, but none obliged. The time from start of evaluation to donation ranged from 53 days to almost 1 year.

Donor surgery, complications and outcomes

Five patients donated their left lateral segment to a pediatric recipient and seven underwent a right hepatectomy for an adult recipient (Table 1). All had a history of at least one minor or major surgery. To minimize the risk of inadvertent contact, donor and recipient families were asked to use separate waiting rooms; and the donor and recipient were assigned rooms in separate areas of the hospital. No donors required allogeneic blood transfusions during the procedure or their ensuing hospital stay. The mean length of stay was 6 days (5.8 days for the left lateral segment group and 6 days for right hepatectomy group) with a range of 4–8 days.

The overall complication rate for the cohort was 40% (Table 3). There was no difference in complications between the right hepatectomy donors and the left lateral segment donors. Only four complications (33%) were Grade II or above. One patient developed a Clostridium-difficile infection and was treated with metronidazole. Another patient developed a urinary tract infection and was treated with oral antibiotics. A pulmonary embolus was diagnosed in one patient on postoperative day 2 after an episode of shortness of breath. This particular patient was later discharged home on therapeutic low molecular weight heparin with later institution of warfarin for a total of 6 months. Unfortunately, one graft was lost secondary to bleeding from the intraoperative rupture of a hemangioma in the liver caused by surgical manipulation. The hepatectomy was completed but the graft was not usable. This donor's hospital stay was uncomplicated. None of these complications resulted in any permanent disability.

The only grade III complication was an intraoperative pneumothorax during a right hepatectomy, which was managed by the intraoperative placement of a small chest tube that was removed on postoperative day 2. This complication did not alter the patient's hospital stay; the patient was discharged on the fifth postoperative day. Of note, this donor subsequently donated a kidney to another anonymous recipient.

All but one donor returned to his/her previous occupation without limitations by a mean time of 8 weeks (range 2–12 weeks). One patient was retired. At postoperative visits, with a mean follow-up of 24.2 months (range of 2.6–47.6 months), none of the donors have expressed regret about their decision.

Six donors elected for contact with their recipient or recipient's family; all of who agreed. Contact was by anonymous letters only in two cases. Face to face meetings occurred in four cases. One of the recipients died several months after transplantation and the donor has met and maintained close contact with the family. One donor met with the family directly without any initial paper correspondence. All donors had contact with the recipient or their family more than 1 year after donation except for the last anonymous-directed donor who met up with the recipient shortly after surgery. This was an anonymous-directed donor who knew the patient within their community and arranged to meet the patient through the patient's wife without notification of the transplant team. Most have kept close ties with the recipient and their families. Two donors contacted the media with the team's permission about their experience with anonymous donation 1 year after donating stating they wanted to increase awareness about organ donation. No life altering adverse events took place (e.g. divorce) after donation. One patient went on to get married, and one patient is writing a novel about the experience of live liver donation.

Recipient outcomes

To date, three patients have been transplanted for biliary atresia, one for hepatoblastoma, one for urea cycle deficiency, one for primary biliary cirrhosis (PBC), one for primary sclerosing cholangitis (PSC), two for hepatitis C virus (HCV), two for alcohol-related steatohepatitis (ASH) and one patient had both ASH and HCV. None of the recipients had fulminant hepatic failure and none were transplanted urgently. The PELD scores for the pediatric recipients ranged between 7 and 26. The MELD score range for adults was 12–36. The adult patient with the MELD score of 12 was plagued by difficulty with sodium balance and frequent admissions for encephalopathy and therefore was selected as the recipient. Of the 12 recipients, 10 patients (83%) are currently alive at a mean of 2.2 years posttransplant. One recipient died approximately 6 months after transplantation from Pneumocystis carinii pneumonia. The other recipient death occurred approximately 3 months after transplantation and was due to overwhelming sepsis.