Care of Living Donors
Dianne LaPointe Rudow, ANP-BC, DNP, CCTC
I. INTRODUCTIONA. The history of living organ donation
The first successful living donor transplant was performed in 1954 in Boston, Massachusetts, United States, between identical twin brothers.1
The hospital created a separate live donor team to advocate on the live organ donor’s behalf.
The advent of immunosuppressant drugs in the 1970s facilitated transplantation from nonidentical family members and a subsequent increase in organ transplantation from deceased donors.
As more candidates met transplantation criteria and the number of deceased donors declined, the number of live kidney donors exceeded the number of deceased donor transplants in 2004. Currently, the number of live donors is slowly declining.2
Numerous studies have shown that kidney donation is safe and that most donors lead normal lives with a single kidney and have minimal risk of end-stage renal disease (ESRD) providing they lead a healthy lifestyle.3,4,5
Live liver donation has been performed for children since the late 1980s and adults since 1998. The largest volume of procedures occurs in centers where there are limited numbers of deceased donors. This may be due to donor shortages in certain areas of the world or certain countriesl who do not utilize deceased donors at all. Medical outcomes have been studied, and although liver donation portends a higher risk than kidney donation, it is still believed to be safe enough to perform at experienced centers.6,7
The benefits for the recipient of a living donor transplant are clear.
The organ is from a (typically) young healthy person who has undergone an intense medical evaluation.
Data indicate that patients with ESRD benefit significantly with pre-emptive kidney transplantation and less time on dialysis.8
The surgery can be planned when the recipient’s medical status is stable and, in the case of liver donation, before a liver transplant candidate becomes too sick to undergo transplantation.
The cold ischemic time is reduced, as the time the organ is without a blood supply is very short compared to the time involved in deceased donor transplantation.
The negative aspects of live donation for the recipient include
Having a family member or close friend undergo major surgery, which they themselves do not medically require or benefit from, on behalf of the recipient
In the case of liver donation, receiving a partial graft that is often initially smaller than needed
B. Ethical issues in living donor transplantation
The following ethical principles may be applied to the living donor9:
Autonomy: The right to act intentionally, with understanding and without internal or external controlling influences
Beneficence: The duty to provide benefits to others and to balance benefits, risks, and costs so as to obtain the best overall results.
Nonmaleficence: The duty not to intentionally create a harm or injury through acts of either commission or omission
Justice: The duty to act fairly, including the allocation of scarce resources
Each duty is a prima facie duty, which means that it is binding or obligatory unless it is overridden by another moral duty.
In clinical practice, an ethics consult can facilitate complex decision making when ethical conflicts arise.
The risks and benefits of living donor transplantation need to be carefully balanced as many ethical issues may be raised.
The act of living donation is a unique situation—exposing one individual to potential harm for the benefit of another.10
The potential living donor is considering a surgery and subsequent risk that is not medically necessary, will temporarily disable him or her, and will expose him or her to some risk of morbidity and mortality.
The Hippocratic Oath, which states primum non nocere—“firstly, do no harm”11—must be considered when determining donor suitability. Additionally, donor benefits may need to be considered, that is, saving a loved one’s life.
A broader ethical view may be argued that an increase in living donation reduces the number of individuals waiting on the transplant list.
Informed consent. Respect for an individual’s autonomy is the central reason that each person has the right to consent to or refuse living donation.
Individuals must be given the necessary information about the choices available and understand the potential consequences of each course of action, hence the term “informed consent.”
While potential donors may be given an appropriate, detailed description of the benefits and risks of donation, it is unclear how much information is actually retained and how this plays in the decisions to choose to move forward with donation. Studies on successful approaches to informed consent are needed.
There is a well-described tendency for some people to decide at an early stage, even before presenting to the transplant program, that they wish to donate and then to be impervious to any suggestion that they should make a more informed decision in the light of further education about the process, risks, and long-term outcomes.12
Knowing that the potential recipient has end-stage organ failure and can die can be, in fact, coercive and interfere with true informed consent.
Key principles of informed consent
Potential living donors should be approached “neutrally,” in other words in an unbiased manner.
Education about the risks and benefits should be provided at an appropriate educational and health literacy level; cultural background must be taken into consideration.
Potential donors should be fully informed about risks, benefits, and alternatives as early as possible.
Coercive internal and external pressures should be probed for and detected wherever possible.
The potential living donor should be provided an opportunity to discreetly withdraw from further consideration.
The clinical team caring for the living donor must incorporate ethical principles into practice as well. The living donor team must
Ensure that “The person who gives consent to be a live organ donor should be competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, and fully informed of the risks, benefits, and alternative treatment available to the recipient.”13
Maintain the confidentiality of the donor and ensure that medical records are not accessible to the recipient.
Support a donor who decides not to donate; assist the donor to remove him- or herself from further consideration.
Ensure that donors who are found to be unsuitable for donation for medical or psychosocial reasons receive support and appropriate referrals for care.
Payment for organs
Per the World Health Assembly resolution WHA63.22, “cells, tissues, and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues, or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.”14
The Declaration of Istanbul defines “transplant commercialism” as “a policy or practice in which an organ is treated as a commodity, including by being bought or sold or used for material gain.”15
It is illegal in the United States and most countries worldwide to pay for or receive any financial benefit from being a live organ donor. All donors considering living donation must be informed that, if it is determined that they received any financial compensation, they may be criminally prosecuted.
C. Regulatory oversight of living donor practices
As both the number of living donor kidney transplants and the number of extrarenal transplants increased, much national and global attention was given to the care and regulatory oversight of the living organ donor. Previous live donors expressed dissatisfaction with their care and follow-up and transplant centers’ practice and resources varied. Many consensus conferences were held to standardize the approach to live donor care and various regulatory bodies gained oversight to the care of the living donor.
In November 2002, the Advisory Council on Organ Transplant (ACOT) made recommendations to the Secretary of Health and Human Services that each institution that performs living donor transplantation provide an independent donor advocate (ILDA) to ensure that informed consent standards are adhered to and ethical principles are applied to practice.16
Effective June 28, 2007, the Center for Medicare Services (CMS) Conditions of Participation regulated live donor care for the first time.17 These regulations include the following:
Living donor selection must be consistent with the general principles of ethics.
Assurance that a prospective living donor receives a medical and psychosocial evaluation prior to donation.
Documentation in the living donor’s medical records the living donor’s suitability for donation.
Documentation that the living donor has given informed consent.
Specification of components of informed consent required during the education process.
Blood type verification for living donor transplantation immediately before removal of the organ and prior to implantation.
Centers must have a live donor postoperative management policy.
An ILDA or team must evaluate all live donors.
Policies surrounding aspects of paired kidney donation.
Live donor program Quality Assurance Process Improvement Program.
In September 2007, the Organ Procurement and Transplantation Network (OPTN) was given oversight of living donation in the United States. The OPTN has developed policies that transplant programs that perform living donation are required to follow.18 Policies currently exist in the following areas:
Requirements for protocols that hospitals who recover live donor organs must follow
ILDA requirements
Informed consent requirements
Medical evaluation requirements
Psychosocial evaluation requirements
Registration and blood type verification of living donors before donation
Placement of living donor organs
Packaging, labeling, and transporting living donor organs, vessels, and tissue-typing material.
Reporting requirements including 2-year live donor follow-up
The initial regulatory requirements continue to evolve as evidence in the literature changes and the transplant community analyzes practice and provides suggestions for improvement. Recent revisions to policies surrounding the care of the living organ donor have been made based on significant contributions from worldwide consensus conferences and published in the literature.19,20,21,22,23,24,25,26 These include the following topics:
Care of the kidney donor
Care of the extrarenal donor
Ethical issues in live donation
Psychosocial evaluation of living donors
Transplant program quality and surveillance
Paired kidney donation
Living donor follow-up
Best practices in living kidney donation
II. THE LIVING DONOR EVALUATIONThe living donor evaluation typically involves many phases including the referral or screening process, the evaluation process, and the live donor team decision process. A multidisciplinary team of health care professionals experienced in living donation is involved in the entire process. Care must be taken that potential donors are not pressured or coerced by the recipient or other family members. The donor should be seen separately, in the absence of the prospective recipient and the family, and should be reassured that his or her views with respect to donation, as well as his or her medical and social history, will be kept confidential.
A. The Interdisciplinary Team Utilized to Care for the Living Organ Donor
The physician is a trained transplant nephrologist/hepatologist (depending on organ being donated) who is responsible for the medical evaluation of the potential living donor and carefully evaluates the donor, assists in the donor decision-making process, and may be available for postoperative care. This physician
Performs a full history and physical for potential donors
Determines the need for additional testing for risk stratification, the identification of systemic disease, or likelihood of developing systemic disease
Interprets diagnostic tests results
Assists with the education of potential and actual donors
Follows donors postoperatively as needed
A board-certified surgeon who has successfully completed training and has experience in the living donor organ procurement. The surgeon’s role is to
Assess the potential living donor for surgical suitability
Determine surgical feasibility given the donor and recipient anatomy
Participate in the live donor team meetings to determine suitability
Consider the ILDA’s recommendation regarding the donor’s suitability
Participate in the education process for all potential donors
The live donor coordinator is a licensed registered nurse who coordinates the care of the live organ donors. The coordinator is responsible for
Structuring the process of the evaluation, education, and consent for living donation
Screening potential donors by telephone
Obtaining consent for the donor evaluation
Determining blood type compatibility
Ensuring confidentiality of the donor record
Assisting in the coordination of the medical evaluation
Facilitating additional medical testing of the potential donor
Explaining medical information in terms that the donor can understand
Educating the donor about the process of evaluation, the risks involved, organ allocation, and the intended recipient’s medical condition
Participating in the living donor team meetings to determine candidacy
Supporting the donor if they choose not to donate or if they are declined by the medical team
Providing pre-, peri-, and postoperative care and education.
The social worker is involved in the evaluation and care of potential and actual live organ donors. The social worker’s role is to
Conduct a clinical psychosocial assessment of the living donor and his/her support system
Participate in living donor team’s collaborative decision-making process regarding the appropriateness of the candidate with the living donor team
Educate and counsel the candidate about living donation with written information and through individual, family, and group meetings
Provide advocacy and emotional and concrete support to the donor and his/her family during the inpatient stay
Coordinate discharge planning orders of the medical team
Offer postdischarge counseling and donor recognition
The financial coordinator counsels the donor regarding the finances of living donation, particularly with regard to insurance coverage. Specifically, the financial coordinator
Verifies available benefits for living donation with the intended recipient’s insurance company and obtains any preauthorizations required for the comprehensive donor evaluation
Explores alternative options in the event that coverage for living donation is denied by the recipient’s insurance company
Informs the living donor of the possibility of future health problems related to donation that may not be covered by the recipient’s insurance
Provides education regarding the living donor’s potential difficulty in obtaining health, life, or disability insurance and risk of increased costs of health, life, or disability insurance.
The ILDA ensures protection of the rights of living donors and prospective living donors.17,18,27,28,29,30,31 The role of the ILDA can be performed by one person or by a team. The ILDA
Functions independently of the candidate’s team and must not be involved in transplantation activities on a routine basis.
Must demonstrate knowledge of living organ donation, transplantation, medical ethics, informed consent, and the potential impact of family and external pressures on the living donor’s decision to donate.
May be a nurse, social worker, physician, clergy, ethicist, or psychologist. Some programs use nonclinicians in this role.31
Must follow the transplant program’s written protocols and grievance process when necessary to protect the rights and best interests of the living donor.17,18
Must determine whether the living donor has received information on each of the following areas and assist the donor in obtaining additional information from other professionals as needed about18,27,28,29,30:
The informed consent process
The evaluation process
The surgical procedure
Potential medical risks
Potential psychosocial risks
Follow-up requirements and the benefit and need for obtaining follow-up care
The psychiatrist/psychologist is often involved in the assessment of the living organ donor, especially those with a psychiatric history, questionable competence, and distant relationship with the recipient or questionable motives. The psychiatrist/psychologist will
Screen for underlying psychiatric illness
Determine how pre-existing psychiatric illness may impact donation
Make recommendation for pre- and postdonation mental health interventions
Assess the potential donor’s understanding of the risks and benefits of donation
Assess the potential donor’s ability to give informed consent
Assess for any internal and/or external coercion
B. The Referral Process
Potential living donors may learn about the opportunity to be a live donor from many sources, including
The potential recipient
The potential recipient’s medical team or dialysis center
The potential recipient’s friends or family members
The Internet/social media (Facebook, Twitter, etc.)
Donor solicitation websites (e.g., matchingdonors.com)
Billboards/media campaigns
Regardless of how potential donors learn about living donation, they should be encouraged to make the first inquiry to the transplant center to start the donation evaluation process. This can help ensure that the donor is making an independent choice to be evaluated.
The referral process involves the following:
A medical screening questionnaire done in person, by phone, in writing, or via the Internet. This can rule out any obvious contraindications to donation.
Blood type and, in kidney donation, histocompatibility testing.
Basic vital signs, height, weight, and blood pressure.
Basic education about the donation process and risks/benefits of donation.
C. Types of Living Donors
Traditionally, living donors were biologically related to the recipient, for example siblings, parents, children, and cousins. Over the past decade, as surgical innovations developed, laparoscopic kidney donation was introduced and immunosuppression agents improved, and the relationship of the donor and recipient became less important.
Transplant programs now consider both emotionally and nonemotionally related individuals as potential donors, that is, spouses, life partners, friends, and strangers.
Certain religious and community groups are working together to pair donors and recipients.
Increased participation in social media has fostered the development of relationships based on the purpose of living donation.
This is more common with kidney donation than extrarenal donation and is likely related to
The availability of long-term data on kidney donation
The minimal invasiveness of laparoscopic nephrectomy
The lower morbidity and mortality of live kidney donation compared to liver or lung donation
Paired kidney donation (PKD) is an option that is increasing for ABO-incompatible pairs and transplant candidates who are highly sensitized.32
D. Selection of the Living Donor18
Age >18 years old
Completed a comprehensive medical and surgical evaluation
Completed a psychosocial evaluation by a qualified health care professional
Education about all elements of donation and transplant; informed consent obtained
E. Exclusion Criteria for Living Donor
Transplant center protocols vary in terms of inclusion and exclusion criteria based on center culture, experience, and amount of risk the center is willing to accept. That being said, per OPTN policy, all live donor programs must exclude all donors with any of the following exclusion criteria18:
A donor who is both <18 years old and mentally incapable of making an informed decision
HIV infection
Active malignancy or incompletely treated malignancy
High suspicion of donor coercion
Belief that an illegal financial exchange has occurred between the donor and recipient
Evidence of acute symptomatic infection (until resolved)
Uncontrolled, diagnosable psychiatric conditions requiring treatment before donation, including any evidence of suicidality
Kidney donor exclusion criteria:
Uncontrollable hypertension or hypertension with evidence of end-organ damage
Diabetes mellitus
Liver donor exclusion criteria:
Hepatitis C virus RNA positive
Hepatitis B surface antigen positive
Donors with ZZ, Z-null, null-null, and S-null alpha-1 antitrypsin phenotypes and untypable phenotypes
Expected donor remnant volume <30% of native liver volume (based on radiological imaging)
History of previous living liver donation
The donor must confirm (typically in writing) that he or she
Is willing to donate
Is free from inducement and coercion
Has been informed that he or she can decline to donate at any time
Understands that it is a federal crime to offer to donate any human organ for anything of value including, but not limited to, cash, property, and vacations
The clinicians educating the donor must disclose
Any alternate procedures or treatment for the recipient, including deceased donor transplantation
The fact that deceased donor organ may become available for the candidate before the living donor’s evaluation occurs
There should be a disclosure that any transplant candidate may have risk factors for increased morbidity or mortality that are not disclosed to the donor.
The donor’s personal health information obtained during the donor evaluation is subject to the same regulations as all medical records and could reveal conditions that must be reported to local, state, or federal public health authorities.
The transplant program that performs the donor nephrectomy is responsible for reporting living donor follow-up information specifically to the OPTN.34
As part of the predonation education and consent process, the donor must commit to postoperative follow-up testing coordinated by the live donor program.
Any infectious disease or malignancy pertinent to acute recipient care that is discovered during the donor’s first 2 years of follow-up care.
May need to be reported to local, state, or federal public health authorities
Will be disclosed to the recipient’s transplant center
Will be reported through the OPTN Improving Patient Safety Portal
Any transplant program may refuse a living donor. If this occurs, the donor must be informed that different transplant programs may have different selection criteria and the donor can seek a second opinion elsewhere.
The live donor should be informed that there are risks to the donor evaluation. They include18
Allergic reactions to contrast dye
Identification of reportable infections
Diagnosis of serious medical conditions
Identification of adverse genetic findings unknown to the donor
Discovery of certain abnormalities that will require more testing at the donor’s expense
Death
Scars, hernia, wound infection, blood clots, pneumonia, nerve injury, pain, fatigue, and other consequences typical of any surgical procedure.
Abdominal symptoms such as bloating and nausea and potential bowel obstruction.
Donor morbidity and mortality may be impacted by obesity, hypertension, or other pre-existing donor-specific conditions.
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