JENNIFER STEEL (ed.)Living Donor Advocacy2014An Evolving Role Within Transplantation10.1007/978-1-4614-9143-9_7

7. The History of Living Donor Advocacy in Living Donor Transplantation

Talia B. Baker¹ and Helen G. Spicer²

(1)

Department of Transplant Surgery, Northwestern Memorial Hospital, 676 N. St. Clair Street Suite 1900, 60611 Chicago, IL, USA

(2)

Kidney Transplant Services, Henrico Doctors’ Hospital, 1602 Skipwith Road, 23229 Richmond, VA, USA

Talia B. Baker (Corresponding author)

Email: tabaker@nmh.org

Helen G. Spicer

Email: helen.spicer@hcahealthcare.com

Abstract

The history of living donor advocacy importantly highlights the maturation of the field of transplantation. The first successful kidney transplant performed on identical twins in 1954 confirmed the feasibility and efficacy of the surgical procedure. The process that led up to the operation itself set the groundwork for the concepts that would evolve into living donor advocacy. In this chapter, we hope to provide a historical overview of the dynamics that formed the concept of advocacy for living donors including kidney as well as extrarenal donation. As the language of living donor advocacy is now coded into Centers for Medicare and Medicaid Services (CMS) regulations, it is extremely helpful to examine the historical origins of the concept of advocacy in relationship to the development of living donor transplantation.

Keywords

Donor advocacyDonor advocateLiving donorTransplantationImmunosuppressionKidney transplant

People need to be reminded more often than they need to be instructed.

Samuel Johnson, English poet (1709–1784)

In this chapter, we will provide a historical review of the dynamics that have formed the concept of advocacy for living donors . Webster’s definition of an advocate is one who pleads the cause of another and it has its roots in the Latin word advocatus, to summon for counsel [1]. We use the terms “donor advocate” and “advocacy process” interchangeably. These terms include the tasks of ensuring that the donor is able to understand the information and also include exploring the issues by questioning the understanding of information to test the validity of a decision in an effort to improve the quality of the decision made. These concepts are relevant to kidney as well as extrarenal donation (including living donor liver, lung, intestinal, and pancreas transplants).

We will discuss the landmarks that shaped the past and current thinking in efforts to develop organ transplantation . The major challenges were rejection and suitable organ availability. Transplantation was an unprecedented and unique field in that it depended entirely on the availability of human organs for replacement.

In 1954, the successful transplant of identical twins in Boston proved the feasibility of the surgical procedure for kidney transplant . The ability to find a genetically identical living donor provided the basis for understanding and modulating the immunology of the transplant. It also began to set up the standards for informed consent for living donors and the necessity for a multidisciplinary team with specific members assigned to the donor’s care. The ethical psychosocial review in this case set the framework for the discussions that would ultimately be developed into the process of donor advocacy . This included discussions of workup, perioperative and after care of any potential living donor [2].

The decade of the 1960s was remarkable for the development of the tools needed to support the expansion of kidney transplantation from identical twins as donor sources to include human leukocyte antigen (HLA)-mismatched living donors and deceased donors. These efforts included advances in organ preservation, tissue typing, medication discoveries, and organizational efforts to allocate deceased donor organs. It also began to consider measures to improve the collection and review of clinical information that would lead to improving and prolonging human life.

The decade of the 1970s was marked by the development and expansion of deceased donor kidney transplants, specifically. There were legislative efforts to promote organ donation and use in all types of organ replacements. The ultimate goal, many believed, was to not depend on living donors who would have to be exposed to excessive risk. Unfortunately, however, at the end of the decade there was a view that this may not be a reasonable endeavor, as living donor kidneys seemed to have significantly superior long-term graft survival as compared to matched deceased donors.

The decade of the 1980s started with a major scientific discovery of the drug cyclosporine. The discovery of this novel immunosuppressant changed the landscape of transplantation , both of renal and of extrarenal organs [3]. Deceased donor kidney transplant 1-year success rates improved from 50 to 89 % [4]. With this improved graft survival, however, the transplant community was suddenly faced with a shortage of deceased donor organs. This, in turn, created a need for a central distribution system for the available organs. Living donation emerged as an important and essential means to provide the needed organs.

The decade of the 1990s brought an increase in the general understanding and distribution of knowledge for improving organ survival and patient survival. There were many efforts to increase the use of all deceased donor organs, including expanding the acceptance criteria for both donors and candidates for organ transplant. The gap in the need for organs continued to be filled with living donation, now including living donor transplantation of liver, lung, and intestines. There were concomitant developments in novel complex protocols to reduce the incidence of rejection in highly sensitized patients. By the end of the decade, one in five organs transplanted were from living donors. In 1999, the National Kidney Foundation launched their End the Wait campaign. One goal was to increase the use of living donors in a preemptive kidney transplant scenario [5].

The last decade was a time to take stock of the current status of living donor care. The transplant societies published many consensus papers indentifying best practices in the care of the living donor . The concept of living donor teams and an independent living donor advocate was emerging. The living donor care provider is identified among multiple disciplines and is in the process of developing into a subspecialty. In 2010, the American Foundation for Donation and Transplantation (former South-Eastern Organ Procurement Foundation, SEOPF) began offering training programs for living donor team members. In 2012, The American Society of Transplantation organized a community of practice for the living donor team members. Furthermore, several unfortunate and highly publicized donor deaths attracted the attention of the regulatory agencies. This resulted in regulations at the federal level and, in some cases, at the state level that mandated the inclusion of living donor advocates and living donor teams .

Currently, the role of the living donor advocate is coded into Centers for Medicare & Medicaid Services (CMS) regulations. The Department of Health and Human Services Centers for Medicare and Medicaid Services issued the Conditions of Participation for Organ Transplant programs to be in effect from June, 2007.

The regulations that define the role and responsibility of the living donor advocate are listed in Appendix 7.1, at the end of this chapter.

Kidney transplant from a living donor was first performed successfully in 1954, marking the beginning of the modern era for transplantation . It is instructive to review in detail the social and political contexts that preceded and followed this event. This is a story of the American entrepreneurial spirit that fosters innovation. Once the processes mature, they are recommended for standardization as the best practices and from there they are brought forward to be codified by regulators for compliance. This is clearly the direction that health care is taking as we move to develop accountable care organizations in an effort to define appropriate care for specific disease states and the limits to this care. Transplantation as a discipline, therefore, offers a 50-year history that can help inform our current health-care debates.

1947–1959

To fully understand the unique set of forces that led to the development of transplantation in America, it is necessary to begin in the years after World War II. There were many medical discoveries that were seeds to medical advances that occurred in the next two decades. The American cultural changes were rapid and equally dramatic. The role of the physician, the entrepreneurial spirit that was encouraged in the use of public funds for medical research, the coverage of medical care, the right to the understanding of medical procedures—risks and benefits—and the concept of right to health care in the midst of national political debate on the role of government regulations provide a uniquely American story [6].

At the end of World War II, several clinical discoveries were influential in developing kidney transplantation . Dr. Wilhelm Kolff developed the hemodialysis technology during his confinement by the Germans during World War II [2]. Dr. Peter Medawar worked out details on first and second set reactive antibodies that began the science of immunology and the pharmacology of immunosuppressant medications .

In the book, Surgery of the Soul: Reflections on a Curious Career, Dr. Joseph Murray details the issues that were addressed in the early days of the experimental years of developing the clinical reality of kidney transplantation . The success of the deceased donor transplant was not possible. This had been demonstrated by the understanding of the body’s innate ability to reject foreign protein. It had been known that skin grafts from identical twins would not reject. Therefore, it made sense that the beginning of the experiment of kidney transplantation would require an identical twin pair.

This created the immediate ethical dilemma: “First, do no harm.” The balance between doing well and having to outweigh the potential harm was at the core of medical ethics. The only way to perform a living donor kidney transplant was to obtain a kidney from a suitable living person. There was clearly no medical gain for the donor while the potential for harm was significant.

The story of the living donor transplant at the Brigham and Women’s Hospital is an appropriate starting point for the understanding of the origins of donor advocacy in transplant care.

Ronald and Richard Herrick were twins. Ronald’s brother was diagnosed with glomerulonephritis at age 21. He was admitted to Peter Bent Brigham Hospital in October, 1954. He was disoriented and extremely uncooperative. The psychiatrist noted in the chart “Impression: toxic psychosis reaction superimposed on paranoid personality….I feel the patient will recover from his psychosis with the use of medications and the removal of toxic agents by dialysis” [2].

Dr. Murray relates the processes required to ensure that they were indeed identical twins. This included fingerprinting, genetic testing, and, finally, reciprocal skin grafting. The skin grafts showed no signs of rejection after 4 weeks. This was proof of the genetic identity [2].

Before offering the option of transplantation to Richard, Ronald, and their family, the medical and surgical team consulted experienced physicians inside and outside the University, clergy of all denominations, and legal counsel. Dr. Murray describes several meetings with the family to review the details of preparations for surgery, anesthesia, surgical procedure, possible complications, and anticipated results of the transplant. There were several meetings over time. The family was encouraged to ask any question [2].

Ronald, the identical twin donor, relates: “I had heard of such things, but they seemed to be in the realm of science fiction.” He describes feeling excitement as well as fear. The thought of being cut open and having an organ removed was, in his words, “shocking” [2]. Henry Fox, Chief of Psychiatry, noted, “I think we have to be careful not to be too much swayed by our eagerness to carry out a kidney transplant successfully for the first time…seems to be whether we as physicians have the right to put the healthy twin under the pressure of being asked whether he is willing to make this sacrifice. I do not feel that we have this right in view of the potential danger to the healthy twin as well as the uncertainty of the outcome for this patient” [2].

At the last preoperative family conference, Ronald asked whether the hospital would assume responsibility for his health care for the rest of his life. Dr. Harrison (the donor surgeon) replied, “Of course not.” However, he immediately followed this declaration with a question: “Ronald, do you think anyone in this room would ever refuse you care if you needed help?” Ronald paused, and then realized that his future health care depended upon our own sense of professional responsibility rather than on legal assurances [2].

The processes described within the account by Dr. Murray set up the professional standards that represent the donor advocacy functions that have been coded into regulations today.

There was a team approach to the care of the donor and the recipient.

There were multiple meetings with the entire family to outline in detail the procedures and potential outcomes. The donor was present to hear about the reality of the success of this procedure for the recipient.

There were psychiatric evaluations for both the donor and the recipient.

There were ethical discussions related to the risk to the donor and whether it was right to ask him to take this risk.

The donor was able to seek counsel from team members, some of whom agreed and some who did not.

There was a separate medical and surgical team for the donor and the recipient. The donor and recipient surgeons were in communication in the operating room. They viewed this process as a continuum: from the donor removal to the recipient implantation, a well-orchestrated procedure that would ensure the success of the procedure. Every detail was important.

The final note is the long-term follow-up of the living donor: Who would not be willing to care for the donor if he needed care?

This account of the deliberations and the issue of long-term care for the donor are relevant to our 2013 professional and regulatory debates.

1960–1969

This decade’s theme song could be Bob Dylan’s “the times they are a changing.” The election of John F. Kennedy signaled a country embarking on changes in every aspect of American life. Under the Kennedy and later under the Johnson administrations, there was an array of political and social changes. The passage of Medicare health-care coverage in 1965 for those over 65 provided the first steps toward greater access to health-care coverage for all citizens.

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