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Donor and transplant candidate selection for solid organ transplantation during the COVID‐19 pandemic
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June 10 2020 - Am J of Transplantation - N. Thao N. Galvan1*| Nicolas F. Moreno2*| Jay E. Garza2| Susan Bourgeois1|Marion Hemmersbach-Miller3| Bhamidipati Murthy3| Katherine Timmins3|Christine A. O’Mahony1| James Anton4| Andrew Civitello3| Puneet Garcha3|Gabe Loor1| Kenneth Liao1| Alexis Shaffi1| John Vierling1,3| Rise Stribling1,3|Abbas Rana1| John A. Goss1
We have performed 7 heart (including 1 heart/lung and 1 heart/kidney patient), 3 lung, 2 kidney, and 15 liver transplantations between March 24, 2020 and May 11, 2020 utilizing this protocol with 100% survival and no evidence of SARS‐CoV‐2 infection in our recipients at the time of this submission. Our hope is that this protocol will serve as the foundation for further discussion on working transplant protocols to continue transplantation in the midst of a modern worldwide pandemic.
Our current communication shares a protocol for donor and transplant recipient selection during the coronavirus disease 2019 (COVID‐19) pandemic to continue lifesaving solid organ transplantation for heart, lung, liver, and kidney recipients.
Balancing the risks and competing demands using the most current data available, we created a practical protocol that allows us to continue treating life‐threatening end‐organ disease safely for our patients in the context of a virulent pandemic that can infect our donors, health care workers, and our transplant candidates. Using guidance from various international transplant societies, the ASTS, US Department of Defense, and Centers for Disease Control and Prevention, and the clinical expertise of the authors, we have created the Transplant Donor and Transplant Candidate COVID‐19 Screening and Assessment Protocol to ensure the safety of and minimization of risks to our transplant candidates and our health care system at large in the midst of a pandemic. The vetting of our donors and transplant candidates is paramount considering the true risk of donor‐derived transmission of SARS‐CoV‐2 remains unclear. Data are limited at this time, both in amount and sample size but suggests that patients with COVID‐19 who undergo surgery suffer a significant mortality.26 Extrapolating these data to our transplant population would suggest a much higher mortality that would be catastrophic if there were no mechanism to screen for and prevent further transmission. Considering the extraordinary amount of resources involved in every single transplantation, including intensive care beds, ventilators, blood products, personal protective equipment, nurses, intensivists, surgeons, and other health care workers and of course the donor organs themselves, we are obligated as professionals to perform due diligence and proper stewardship to protect our precious few donors, their organs, and the patients they would serve.
Abstract
Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2), a novel coronavirus responsible for a worldwide pandemic has forced drastic changes in medical practice in an alarmingly short period of time. Caregivers must modify their strategies as well as optimize the utilization of resources to ensure public and patient safety. For organ transplantation, in particular, the loss of lifesaving organs for transplantation could lead to increased waitlist mortality. The priority is to select uninfected donors to transplant uninfected recipients while maintaining safety for health care systems in the backdrop of a virulent pandemic. We do not yet have a standard approach to evaluating donors and recipients with possible SARS‐CoV‐2 infection. Our current communication shares a protocol for donor and transplant recipient selection during the coronavirus disease 2019 (COVID‐19) pandemic to continue lifesaving solid organ transplantation for heart, lung, liver, and kidney recipients. The initial results using this protocol are presented here and meant to encourage dialogue between providers, offering ideas to improve safety in solid organ transplantation with limited health care resources. This protocol was created utilizing the guidelines of various organizations and from the clinical experience of the authors and will continue to evolve as more is understood about SARS‐CoV‐2 and how it affects organ donors and transplant recipients.
INTRODUCTION
The world faces an unprecedented pandemic in modern times wrought by the novel coronavirus. Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) was first reported in Wuhan, China in late December 2019 and has since spread worldwide, including the United States. This virus is particularly contagious, with each infected person estimated to infect 1‐3 others with a 20% rate of hospitalization and a case fatality rate of 1% up to as high as 16.4%.1, 2 The World Health Organization declared an international pandemic on March 11, 2020, which led to a proclamation of national emergency in the United States on March 12, 2020 and a local stay‐at‐home order by March 24, 2020, all in an effort to prevent widespread nosocomial and community spread. At the time of this submission, 1 339 819 positive cases are documented in the United States, among over 4 152 670 positive cases worldwide.3
At this time there are 112 207 patients on the United Network for Organ Sharing waitlist with end‐stage organ disease facing the competing risk of waitlist mortality.4 In the effort to navigate this pandemic in a pragmatic way, while mitigating the risks to our hospital inpatients and staff, and ultimately maximizing lifesaving transplantation, we have devised a protocol implemented at our institution on March 24, 2020 to select donors and transplant candidates for solid organ transplantation during the coronavirus disease 2019 (COVID‐19) pandemic. This has allowed the continued possibility of transplantation for those who do not have the option to wait, adhering to the Centers for Medicare & Medicaid Services (CMS) “Adult Elective Surgery and Procedures Recommendations,” which designated transplants as “tier 3b” (high acuity surgery/unhealthy patients) with the consecutive action directive to not postpone surgery.5
The American Society of Transplant Surgeons (ASTS) COVID‐19 Strike Force Guidance published online on March 24, 2020 advised against transplanting from donors infected with SARS‐CoV‐2.6, 7 As such, this protocol was devised on the premise that SARS‐CoV‐2 testing be performed on all donors and transplant candidates universally, whether symptomatic or not. This is especially relevant to the pandemic where asymptomatic individuals can shed the virus and continue to infect others.8 This transplant protocol had 3 priorities: (1) avoiding infected deceased donor allografts, (2) avoiding admission of potentially infected transplant candidates, and (3) avoiding transplantation of currently hospitalized infected transplant candidates. This protocol combines the history, physical exam, SARS‐CoV‐2 reverse transcriptase polymerase chain reaction assay (RT‐PCR) testing, radiographic imaging of the chest using computed tomography (CT), and transplant infectious disease consultation that allows for informed and consistent decisions that minimize risks to all of our patients and health care workers.
The fundamental questions that our protocol was designed to address were the following (as adapted from Chen et al9):
1 Is the donor infected with SARS‐CoV‐2?
2 Can we obtain adequate donor screening, that is, assessment of exposure risk and clinical risk?
3 Is the transplant candidate infected with SARS‐CoV‐2?
4 Can we prevent the potential of bringing a transplant candidate infected with SARS‐CoV‐2 into the hospital, increasing the likelihood of infecting other patients and health care workers?
5 Can we assure that the transplant procedure would not expose our health care staff (eg, procurement team, anesthesiologists, surgeons, operating room staff, and intensive care unit staff) to unnecessary risk?
This protocol is timely because there is no established policy to assess donors and transplant candidates for transplantation. We developed this screening tool based on the data available regarding the pathophysiology of the virus and professional task forces assembled to confront the pandemic.6, 7, 10-12 Given the constraints of screening questionnaires, especially as it pertains to deceased donors, and the limited sensitivity of the nasopharyngeal swab test available at this time,13 we have incorporated radiographic imaging of the chest using CT of both potential donors and transplant candidates to improve sensitivity. This is based on the understanding that over half of asymptomatic patients will show changes on CT and the sensitivity of CT chest findings increases as the COVID‐19 progresses.14-21 Based on the data available, a noncontrast chest CT used for diagnosis of COVID‐19 may serve as an important complement to RT‐PCR testing, as published data have found that CT imaging of the chest may show changes associated with COVID‐19 before or coinciding with onset of infection. This is described by Ai et al in a report of 1014 cases in China, which describes sensitivity of chest CT imaging for COVID‐19 at 97% for those suspected of having COVID‐19, a higher sensitivity than the RT‐PCR testing (71%).
Notably, in the subgroup initially found negative on RT‐PCR who then converted to positive on serial testing, 67% were found to show initial CT imaging suggestive of COVID‐19 before the initial negative RT‐PCR test and 93% had positive CT imaging suggestive of COVID‐19 preceding or in parallel to the eventual positive RT‐PCR by a median of 8 days.22 Although these data are based on symptomatic patients, an eventual meta‐analysis suggests that although chest CT scans have a low positive predictive value (PPV) range of 1.5%‐30.7%, the negative predictive value was 95.4%‐99.8%.23 That is, the probability that an individual with a negative test has a very high likelihood of not actually having the disease. Added to this finding is the fact that nasopharyngeal (NP) swabs taken for RT‐PCR of SARS‐CoV‐2 have varying sensitivity and specificity within the clinical setting, depending on how the swab was acquired.24 A well‐collected NP swab is essential to ensure a reliable test and is necessary in that it will dictate eligibility of surgery and inform administration of immunosuppressive therapy, as prescribed by the Infectious Disease Society of America and its Guidelines on the Diagnosis of COVID‐19.24, 25 Notwithstanding the limitations of our current testing strategies to screen and detect SARS‐CoV‐2, those reasons serve as the rationale for including CT chest imaging to complement RT‐PCR testing in our algorithm. Furthermore, it is an easily obtainable, efficient study that nearly all of our donors have already undergone during their donor workup. These practicalities are predicated on our intent to prevent transplantation with a donor organ infected with SARS‐CoV‐2 or transplantation of a candidate with COVID‐19 during the COVID‐19 pandemic, which shows no signs of abating in the near future. Although the risk of declining a donor or deferring a transplant for a patient who does not actually have COVID‐19 exists, transplanting a donor organ or transplant recipient with SARS‐CoV‐2 could be devastating for the recipient, the transplant program, and the donor family. This protocol combines the history, physical exam, SARS‐CoV‐2 RT‐PCR testing, CT chest imaging, and transplant infectious disease consultation that allows for informed and consistent decisions that minimize risks to all of our patients and health care workers.
DISCUSSION
Balancing the risks and competing demands using the most current data available, we created a practical protocol that allows us to continue treating life‐threatening end‐organ disease safely for our patients in the context of a virulent pandemic that can infect our donors, health care workers, and our transplant candidates. Using guidance from various international transplant societies, the ASTS, US Department of Defense, and Centers for Disease Control and Prevention, and the clinical expertise of the authors, we have created the Transplant Donor and Transplant Candidate COVID‐19 Screening and Assessment Protocol to ensure the safety of and minimization of risks to our transplant candidates and our health care system at large in the midst of a pandemic. The vetting of our donors and transplant candidates is paramount considering the true risk of donor‐derived transmission of SARS‐CoV‐2 remains unclear. Data are limited at this time, both in amount and sample size but suggests that patients with COVID‐19 who undergo surgery suffer a significant mortality.26 Extrapolating these data to our transplant population would suggest a much higher mortality that would be catastrophic if there were no mechanism to screen for and prevent further transmission.
Considering the extraordinary amount of resources involved in every single transplantation, including intensive care beds, ventilators, blood products, personal protective equipment, nurses, intensivists, surgeons, and other health care workers and of course the donor organs themselves, we are obligated as professionals to perform due diligence and proper stewardship to protect our precious few donors, their organs, and the patients they would serve.
Limitations of this work include the constantly evolving understanding of the transmission and pathophysiology of this virus and its effects on our patients, varying degrees of negative predictive value of chest CT imaging based on the prevalence of disease, and our sample size. There is also a risk that we may be especially selective at this point, considering the low positive predictive value of chest CT imaging and the varying sensitivity of RT‐PCR dependent on its collection,24 there may be some donors and candidates who are deferred for transplantation. However, we feel that this is the most pragmatic way to approach donor and candidate selection, in the backdrop of limited medical supplies, personnel, hospital resources, and evolving understanding of this virulent disease. A working transplant protocol is important because the careful selection of donors and transplant candidates is necessary in the COVID‐19 pandemic to attenuate risk and ensure appropriate utilization of resources, and ultimately to continue life‐saving transplantation for our patients with end‐organ disease who face very real and well‐documented waitlist mortality. This is especially true considering the public health consensus is that SARS‐COV‐2 will require a coordinated and pragmatic framework including widespread testing that will take this pandemic well into the future27 during which time our patients continue to face a significant waitlist mortality. In preparing this manuscript, a review of Transplant Society Recommendation Consensus was published that outlined the recommendations of 22 transplant societies internationally.12 This consensus supports our algorithm in requiring clinical screening, donor testing, excluding those infected or suspected of SARS‐CoV‐2 infection, candidate RT‐PCR testing, resolution of symptoms with negative RT‐PCR assay before transplantation, and a CT imaging of the chest of candidates prior to transplantation.12
We have performed 7 heart (including 1 heart/lung and 1 heart/kidney patient), 3 lung, 2 kidney, and 15 liver transplantations between March 24, 2020 and May 11, 2020 utilizing this protocol with 100% survival and no evidence of SARS‐CoV‐2 infection in our recipients at the time of this submission. Our hope is that this protocol will serve as the foundation for further discussion on working transplant protocols to continue transplantation in the midst of a modern worldwide pandemic.
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