Now is the time for the Organ Procurement and Transplantation Network to change regulatory policy to effectively increase transplantation in the United States; Carpe Diem

With the Centers for Medicare and Medicaid Services proposing to remove outcome measures from the transplant centers’ renewal for Conditions of Participation an exciting opportunity surfaces for the Organ Procurement and Transplantation Network to make an equally bold change and allow for increased transplantation options for patients in the United States.     

Eudaimonia: An Aristotelian approach to transplantation

Despite extraordinary achievements in over the past 20 years, the field of transplantation remains hindered by relatively narrow metrics for success. Eudaimonia is an Aristotelian concept that refers to flourishing, or achieving the best conditions possible, in every sense. The vast amounts of patient data that are collected throughout the transplant care continuum, ranging from social determinants of health to genomic profiles and patient-reported outcomes, afford us unprecedented opportunity to enhance our definition of success for our transplant patients. We must engage the technologies available for data integration and analysis and apply them in an insightful way, such that our clinical practice evolves beyond patient and graft survival and toward a more comprehensive state of wellness.     

Seeking new answers to old questions about public reporting of transplant program performance in the United States

The Scientific Registry of Transplant Recipients (SRTR) is mandated by the National Organ Transplant Act, the Final Rule, and the SRTR contract with the Health Resources and Services Administration to report program‐specific information on the performance of transplant programs. Following a consensus conference in 2012, SRTR developed a new version of the public website to improve public reporting of often complex metrics, including changing from a 3‐tier to a 5‐tier summary metric for first‐year posttransplant survival. After its release in December 2016, the new presentation was moved to a “beta” website to allow collection of additional feedback. SRTR made further improvements and released a new beta website in May 2018. In response to feedback, SRTR added 5‐tier summaries for standardized waitlist mortality and deceased donor transplant rate ratios, along with an indicator of which metric most affects survival after listing. Presentation of results was made more understandable with input from patients and families from surveys and focus groups. Room for improvement remains, including continuing to make the data more useful to patients, deciding what additional data elements should be collected to improve risk adjustment, and developing new metrics that better reflect outcomes most relevant to patients.     

Ethical and logistical concerns for establishing NRP‐cDCD heart transplantation in the United States

Controlled heart donation after circulatory determination of death (cDCD) is well established internationally with good outcomes and could be adopted in the United States to increase heart supply if ethical and logistical challenges are comprehensively addressed. The most effective and resource‐efficient method for mitigating warm ischemia after circulatory arrest is normothermic regional perfusion (NRP) in situ. This strategy requires restarting circulation after declaration of death according to circulatory criteria, which appears to challenge the legal circulatory death definition requiring irreversible cessation. Permanent cessation for life‐saving efforts must be achieved to assuage this concern and ligating principal vessels maintains no blood flow to the brain, which ensures natural progression to cessation of brain function. This practice—standard in some countries—raises unique concerns about prioritizing life‐saving efforts, informed authorization from decision‐makers, and the clinician's role in the patient's death. To preserve public trust, medical integrity, and respect for the donor, the donation conversation must not take place until after an un‐coerced decision to withdraw life‐sustaining treatment made in accordance with the patient's treatment goals. The decision‐maker(s) must understand cDCD procedure well enough to provide genuine authorization and the preservation/procurement teams must be kept separate from the clinical care team.     

Pretransplant solid organ malignancy and organ transplant candidacy: A consensus expert opinion statement

Patients undergoing evaluation for solid organ transplantation (SOT) often have a history of malignancy. Although the cancer has been treated in these patients, the benefits of transplantation need to be balanced against the risk of tumor recurrence, especially in the setting of immunosuppression. Prior guidelines of when to transplant patients with a prior treated malignancy do not take in to account current staging, disease biology, or advances in cancer treatments. To develop contemporary recommendations, the American Society of Transplantation held a consensus workshop to perform a comprehensive review of current literature regarding cancer therapies, cancer stage-specific prognosis, the kinetics of cancer recurrence, and the limited data on the effects of immunosuppression on cancer-specific outcomes. This document contains prognosis based on contemporary treatment and transplant recommendations for breast, colorectal, anal, urological, gynecological, and nonsmall cell lung cancers. This conference and consensus documents aim to provide recommendations to assist in the evaluation of patients for SOT given a history of a pretransplant malignancy.     

Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States

Every 6 months, the Scientific Registry of Transplant Recipients (SRTR) publishes evaluations of every solid organ transplant program in the United States, including evaluations of 1‐year patient and graft survival. The Centers for Medicare & Medicaid Services (CMS) and the Organ Procurement and Transplantation Network (OPTN) Membership and Professional Standards Committee (MPSC) use SRTR's 1‐year evaluations for regulatory review of transplant programs. Concern has been growing that the regulatory scrutiny of transplant programs with lower‐than‐expected outcomes is harmful, causing programs to undertake fewer high‐risk transplants and leading to unnecessary organ discards. As a result, CMS raised its threshold for a “Condition‐Level Deficiency” designation of observed relative to expected 1‐year graft or patient survival from 1.50 to 1.85. Exceeding this threshold in the current SRTR outcomes report and in one of the four previous reports leads to scrutiny that may result in loss of Medicare funding. For its part, OPTN is reviewing a proposal from the MPSC to also change its performance criteria thresholds for program review, to review programs with “substantive clinical differences.” We review the details and implications of these changes in transplant program oversight.     

Robotic donor hepatectomy: A major breakthrough in living donor liver transplantation

Living donation in many countries is the main resource of organs. Healthy, volunteering individuals deserve the highest safety standards possible in addition to the least invasive technique to procure the organs. Since the introduction of living donor liver transplantation, many efforts have been made to minimize the surgical trauma inherent to living donor surgery. The journey started with a large Mercedes incision and evolved to reverse L-shaped and small upper midline incisions before the introduction of minimally invasive laparoscopic techniques originated. The technical difficulties of the laparoscopic approach due to suboptimal instrumentation, challenging ergonomics, and the long learning curve limited the application of the fully laparoscopic approach to a few centers. The recent introduction of the robotic platform with its superb optical system and advanced instruments allows for the first time, a genuine emulation of open donor surgery in a closed abdomen, thus allowing all liver donors to benefit from minimally invasive surgery (better cosmesis, less pain and morbidity, and better quality of life) without compromising donor safety. This attribute in combination with the ubiquitous presence of the robot in major transplant centers may well lead to the desired endpoint of this technology, namely, the widespread dissemination of minimally invasive donor surgery.     

Greater access to transplantation should be a priority: A view of the Dialysis PATIENTS Demonstration Act

Fragmentation of care has been cited as a rationale toward moving to new care models with care coordination and a focus on value‐based care delivery. This trend is gathering momentum in end‐stage renal disease (ESRD) care given evident care gaps and the variety of healthcare entities that touch patients with ESRD in the course of their treatment. Although care models supported by chronic condition special needs plans and ESRD seamless care organizations (ESCOs) have advanced care and cost‐effectiveness, their shortcomings limit their ability to support larger patient populations. New care models and potential organizational structures, such as those proposed in the Dialysis Patient Access To Integrated‐care, Empowerment, Nephrologists, Treatments, and Services (PATIENTS) Demonstration Act, provide another approach toward reducing fragmentation of care, increasing patient health, and helping define better approaches to care for patients with ESRD so that they have the opportunity to be better transplant candidates. We recognize that this type of innovation represents change without certainty. We also believe that multiple levels of accountability, ongoing support for transplantation, and continued freedom of access to transplant professionals who participate in Medicare would prioritize patient health, quality of life, and choice with regard to transplantation with this care model.     

Moving past “think local,act global”: A perspective on geographic disparity

The transplant community has debated the necessity and merits of broader organ distribution for several years, but the debate has been fundamentally shaped by inaccurate assessments of donor supply and demand. The possible legal requirements of distribution must be balanced with (a) the moral and statutory imperatives to reduce inequities resulting from socioeconomic disparity, and (b) the shortcomings of MELD in predicting mortality risk in rural areas. In this viewpoint, we use the example of liver transplantation to discuss the drivers of geographic disparity as a direct consequence of donation rates, local organ use, wealth, and poverty. Seen in this light, strategies seeking to equalize MELD at transplant across the United States risk severely exacerbating existing inequalities in access to health care.     

Access to transplantation for persons with intellectual disability: Strategies for nondiscrimination

Disqualifying patients with intellectual disabilities (ID) from transplantation has received growing attention from the media, state legislatures, the Office of Civil Rights, and recently the National Council on Disability, as well as internationally. Compared with evidence‐based criteria used to determine transplant eligibility, the ID criterion remains controversial because of its potential to be discriminatory, subjective, and because its relationship to outcomes is uncertain. Use of ID in determining transplant candidacy may stem partly from perceived worse adherence and outcomes for patients with ID, fear of penalties to transplant centers for poor outcomes, and stigma surrounding the quality of life for people with ID. However, using ID as a contraindication to solid organ transplantation is not evidence‐based and reduces equitable access to transplantation, disadvantaging an already vulnerable population. Variability and lack of transparency in referral and evaluation allows for gatekeeping, threatens patient autonomy, limits access to lifesaving treatment, and may be seen as unfair. We examine the benefits and harms of using ID as a transplant eligibility criterion, review current clinical evidence and ethical considerations, and make recommendations for transplant teams and regulatory agencies to ensure fair access to transplant for individuals with ID.     

C4 article: Implications of COVID-19 in transplantation

A novel coronavirus has had global impact on individual health and health care delivery. In this C4 article, contributors discuss various aspects of transplantation including donor and recipient screening, management of infected patients, and prevention of coronavirus disease (COVID). Donor screening with SARS-CoV-2 nucleic acid testing (NAT) close to the time of procurement is recommended. Many programs are also screening all potential recipients at the time of admission. The management of COVID has evolved with remdesivir emerging as a new potential option for transplant recipients. Dexamethasone has also shown promise and convalescent plasma is under study. Prevention strategies for transplant candidates and recipients are paramount. Pediatric-specific issues are also discussed. Strategies for the psychological well-being of patients and providers are also imperative, in addition to future research priorities for transplantation.