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Future Outlook for Organ Transplantation and Disability
The workshop discussions covered the complexity of organ transplantation and recovery and the added challenges of incorporating this knowledge into the world of SSA disability determinations and ongoing reviews. Sara Rosenbaum of The George Washington University and James Bowman of the Health Resources and Services Administration moderated a final discussion, allowing for reflection and expert perspectives across topics. Panelists included Aditi Gupta, University of Kansas Medical Center; Erika Lease, University of Washington; Jignesh Patel, Cedars-Sinai Medical Center; and Tanjala Purnell, JHU.
Bowman summarized what the speakers covered during the workshop sessions, first noting that there is no typical transplant patient, as each one is unique and has a different and varied experience. This can relate to many QOL expectations and the goals clinicians might have for themselves or their patients. Decades ago, he said, if a clinician kept a patient alive and they had a functioning organ, the clinician had succeeded. But at this point, the field has grown and improved and now gone beyond those expectations, so it is necessary to really listen to what patients want out of life afterward. Related to this, Bowman said, is that the U.S. health “system” is really many systems, requiring high levels of case coordination, which can leave patients vulnerable to gaps in care and services during the handoffs across systems. He added that dedicated case management can improve many of the challenges for transplant recipients.
In addition, Bowman remarked that COVID-19 has shown the vast potential for using technologies such as telehealth and remote appointments, and it compelled providers and systems to adapt to approaches that successfully manage patients from miles away. Lastly, Bowman commented on the issue of disparities in transplantation and spoke of a need to target patients and populations more precisely to better provide solutions, ideally mitigating some of the poor outcomes related to disparities.
COVID-19-RELATED CONCERNS FOR TRANSPLANT PATIENTS
Bowman posed a question of whether evidence exists regarding the interaction of recipients who have recovered from COVID-19 but still have residual effects in organ function—more systematically or for either their transplant organ or long-term recovery. Lease responded that there are two ways of viewing this question—thinking about those who have yet to undergo transplant and those who have received a new organ. In a handful of cases where transplant recipients had COVID-19, while the acute infection resolved, they never fully recovered and then developed acute respiratory distress syndrome.1 Another cohort is emerging of patients who may recover enough to leave the hospital but have permanent lung damage requiring a future transplant. However, clarity about other systemic effects of COVID-19 is still lacking, she said, and how it might affect the ability to even get to transplantation or do well after transplantation. Researchers are also trying to understand how COVID-19 affects recipients, and some registries are trying to collect this data right now. Researchers still do not know a great deal, said Lease, but a lot of people are looking at these questions and hope to have more answers.
Patel responded that even before transplantation, patients acquiring COVID-19 faced challenges, as they may test positive for several weeks after the initial infection, but it is unknown how safe it is yet for them to proceed with the transplant and immunosuppressive medications regimen, he said. Another problem is that many potential donors now have a history of COVID-19, died from it, or tested positive prior to organ procurement. As Lease mentioned, whether it is safe to receive organs from such donors is still unknown, but it is an area of active investigation. Numerous recipients have also been infected with COVID-19 after transplantation, and
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1 At the time of the workshop in March 2021.
the data from the past year show that transplant patients do not do very well. Mortality rates have been as high as 25 percent once a patient is hospitalized, Patel stated. But he highlighted a large registry being built at the University of Washington for all solid organ transplant patients who have contracted COVID-19, so they are continuing to learn from that data. His final issue was that of vaccines; though they have been proven very effective at preventing hospitalization and death in the normal healthy population, evidence is increasing that transplant recipients may not mount the same antibody response, causing anxiety and concern among patients.
Gupta mentioned the complexity of managing acute COVID-19 in the transplant population given their intentional immunosuppression. COVID-19, she said, can induce an inflammatory cascade, and the immunosuppressive medications could actually slow the cascade. But additional questions remain surrounding how to direct or continue treatments during an active infection. Commenting on vaccines, she discussed the plasmapheresis that can occur as part of the treatment for rejection. Vaccinated patients who receive plasmapheresis will probably have their antibodies removed, she said, but experts are not sure if these patients should receive another dose of vaccine.
Rosenbaum, shifting to the topic of outcomes, posed a question with two dimensions in mind—technique and equity. She asked what the biggest impediments are to improving survival times and functional ability for transplant recipients. Specifically, she said, this should not only include the technical breakthroughs, but, given the discussion around disparities, should also consider the access to such breakthroughs and what that may look like for different populations. Purnell responded that the 5- to 10-year mark after transplant is when they start to see greater gaps in disparities. She noted that historically, this is also around the time when people have lost their Medicare coverage for immunosuppressive medications. Purnell expressed excitement about new legislation being considered that would improve longer-term coverage for those drugs but mentioned the reason to think about other basic human needs. For example, COVID-19 has inspired a lot of emphasis on keeping a safe distance from others who may present more of a risk for the virus, but she asked what that means for patients who do not have homes where they can safely isolate. Additionally, Purnell stated that returning to work may illuminate important questions about protections in place for transplant recipients who want to contribute to society. This needs to go beyond written policies, she said, to also include operational guidance for employees, such as whom they should call if they
feel they are not able to safely perform their job duties. Not everyone can work remotely, so what are the consequences in the case of patients who may be lower-wage essential workers, she asked.
EMERGING TECHNOLOGIES TO WATCH
Rosenbaum asked what emerging technologies people are following closely and what kind of timeline people should expect for new and promising features in the field to become standard practice. Patel highlighted the challenges of conducting clinical trials because the number of patients with certain conditions is small and each program has a limited set of patients. Despite advances in certain areas that have been shown to be effective, getting patients covered by insurance has been a big challenge. Therapies from other areas, such as autoimmune diseases, are potentially useful, but researchers are still looking at this transition to see how it might best work. Patel called attention to the need for better monitoring for rejection without being invasive, such as through blood tests, which is an area of active investigation. Finally, he noted the evolution that the field is continuing to undergo, especially in terms of genetically engineering animals to provide a source of organs for humans. While this has been an area of research for decades, it may become reality in the next few years. Gupta noted the time differences in innovations; research on drugs and artificial organs may take longer, but other practical changes and developments could be moved along more quickly—such as exercise and nutrition programs. She also pointed to medications and more systemic barriers, saying if financial and other access barriers can be broken, some patients could see immediate benefit.
Lease described the field of lung transplantation as much smaller and with less volume of transplants. The field has tried to borrow from other organ research, such as kidney studies. Not all organ transplant recipients are the same, and interventions across organ types are not easily generalizable, so some interventions that may work for one type may not work for another. She agreed with the importance of innovations that are less invasive and that can be done from afar, without requiring travel to the transplant center. Lease also noted that because lung transplant patients require so much immunosuppression compared to other organ recipients, they are limited by the complications due to these medications. Purnell also highlighted the advances in reimbursement for virtual visits over the past year. She explained that they have been able to close some gaps in care coordination and figure out very quickly how to get experts to speak at grand rounds
nationwide to be sources of information virtually. From an equity standpoint, she was hopeful that patients who live far from their transplant center or may face other difficulties in getting to appointments can now be more engaged with their providers. Purnell advocated for thinking of ways to continue to revolutionize the field, prioritizing building trust with patients and their caregivers, which could help to improve long-term outcomes.
Rosenbaum recounted the number of times throughout the workshop that speakers had highlighted the differences in immune responses among different ethnic groups, and asked how the transplant medical community accounts for those differences in planning for both the procedure and recovery. Are differences tracked separately in studies looking at transplant outcomes? Purnell replied by highlighting the variability among transplant center practices, so answers will often be different depending on setting. Most of what is known comes from the national registries, which include numerous types of information, but they all use standard risk adjustment models as well to control for certain factors.
FINAL THOUGHTS
Finally, Rosenbaum called for comments and reflections from speakers, wanting to ensure they were heard by SSA and the public. Lease commented that the discussions throughout the workshop highlighted the variety of issues many transplant patients face, many of which are nonmedical, such as accessing care or continuing strict adherence to difficult protocols. Gupta emphasized this concept as well, saying that each transplant recipient or candidate is different from the next, creating a need to target policy solutions to address the specific needs of individuals from different backgrounds. She called attention to the numerous barriers patients encounter when merely trying to get on the transplant list, so simplifying the process overall would be hugely beneficial. Tying in diversity, Gupta said many transplant patients do not trust the system because things are so complex, and they may have had negative experiences in the past—so she called for getting these patients more engaged and empowered to have more successful outcomes. Patel concluded, noting the need to address disincentives associated with disability and health care coverage. He explained that if transplant patients were to become more active and start to work, they might lose their health care coverage, which would threaten their access to critical immunosuppressive medications. While there has been progress on this front over the past few years, Patel acknowledged, such issues need to be addressed more directly.
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