Organ recovery from deceased donors with prior COVID‐19: A case series

Abstract Although guidance documents have been published regarding organ donation from individuals with a prior history of COVID‐19 infection, no data exist regarding successful recovery and transplantation from deceased donors with a history of or positive testing suggesting a prior SARS‐CoV‐2 infection. Here, we report a case series of six deceased donors with a history of COVID‐19 from whom 13 organs were recovered and transplanted through several of the nation's organ procurement organizations (OPOs). In addition, at least two potential donors were authorized for donation but with no organs were successfully allocated and did not proceed to recovery. No transmission of SARS‐CoV‐2 was reported from the six donors to recipients, procurement teams, or hospital personnel. Although more studies are needed, organ donation from deceased donors who have recovered from COVID‐19 should be considered.


| INTRODUC TI ON
The recognition and subsequent declaration of the COVID-19 as a pandemic has dramatically impacted the landscape of organ donation and transplantation in the United States. Some of the earliest publications on the topic highlighted the importance of developing protocols and screening modalities for potential organ donors, based on lessons from prior pandemics, and recommended against recovering organs from a donor with suspected or confirmed COVID-19, citing risks not only to recipients but also health care and procuring teams. 1,2 Screening of potential organ donors in the United States began in March utilizing both clinical and epidemiologic factors, as laboratories worked to develop specific nucleic acid (NAT) testing. Organ Procurement Organizations (OPOs) followed other countries and began universal testing all potential organ donors given the risk of pre-symptomatic or asymptomatic infection. 3 A report from the Organ Procurement and Transplantation Network (OPTN) identified that 100% of deceased donors underwent NAT testing starting on April 21, 2020. 4 Organ authorization and recovery rates dropped by 11 and 17%, respectively, over the ensuing 90-day period from March to May, as social distancing reduced hospital admissions and traumatic deaths. 5 It was universally accepted that any donor with a current COVID-19 infection would be excluded from donating any organ.
However, as transplant activity resumed in the summer months of 2020, OPOs predictably began to receive referrals for organ donation from patients with evidence of prior SARS-CoV-2 infection.
As no data exist regarding the safety of such patients as organ donors, the purpose of this study is to describe our experience regarding organ donors with evidence or history of prior SARS-CoV-2 infection.

| Case 1
A 32-year-old man was declared neurologically dead in July 2020 following a drug overdose. The donor had a Kidney Donor Profile Index (KDPI) of 10%, and excellent organ function. A standard screening nasopharyngeal (NP) swab for SARS-CoV-2 Polymerase Chain Reaction (PCR) was negative. During allocation, it was discovered that the donor was diagnosed with COVID-19 infection 14 weeks prior, after presenting with cough, fatigue, watery eyes, and diarrhea, and had a positive NP swab at that time. He was never hospitalized and recovered at home. This had not been detected on the initial DRAI, which inquired about exposures in the prior 28 days. The donor underwent a second PCR from bronchoalveolar lavage (BAL) fluid, which was negative. The heart, kidneys, and liver were accepted and transplanted. The donor's archived serum was found to be positive for SARS-CoV-2 IgG antibody post recovery. The liver recipient had no evidence of transmission at hospital discharge. The heart recipient had a smooth course and negative SARS-CoV-2 PCR 6 weeks post-transplant. The left kidney recipient had delayed graft function but has since recovered at home with normal kidney function and two negative SARS-CoV-2 PCR. The right kidney recipient went home with no delayed graft function, and has had no further SARS-CoV-2 testing or signs of transmission.

| Case 2
A 21-year-old woman presented with hemodynamic instability following blunt trauma in July 2020. She was coagulopathic and received massive transfusions. A routine admission NP swab for SARS-CoV-2 was negative. Chart review revealed that the patient had complained of fever and respiratory symptoms 38 days prior to the trauma admission, was diagnosed with COVID-19 by NP swab at that time, and recovered uneventfully at home. Despite normal admission creatinine of 0.93 mg/dL, she developed nonoliguric acute kidney injury, with a terminal creatinine of 4.5mg/ dL. Her KDPI was 27%. After stabilization, she was declared dead by neurologic criteria. A second SARS-CoV-2 PCR was reported as negative on tracheal aspirate. The heart, liver, and kidneys were accepted for transplantation. In the donor OR, the kidneys were found to have acute tubular necrosis and severe thrombotic microangiopathy with intracapillary fibrin thrombi. The kidneys were discarded, and the liver and heart were successfully transplanted.
Post-transplant, hemodiluted donor serum tested negative for SARS-CoV-2 IgG antibody. The liver recipient has recovered uneventfully and was discharged home, with no sign of transmission at 21 days post-transplant and a negative SARS-CoV-2 IgG antibody test. The heart recipient was discharged home and has no sign of transmission.

| Case 3
A 54-year-old with end-stage kidney disease, hypertension, diabetes, prior stroke, and multiple previous amputations was admitted following a cardiac arrest during routine hemodialysis. The patient was a nursing home resident who had been tested for coronavirus 3 months prior to this event and was negative at that time by NP swab. On this admission, screening NP swab was negative for coronavirus. The patient was declared neurologically dead and deemed a suitable donor, with no known history of coronavirus. During donor evaluation 3 days later, a second NP PCR was positive for SARS-CoV-2. On that same day, both stool and BAL PCRs were negative.
Antibody testing showed that the donor was SARS-CoV-2-IgM negative but IgG positive. The next day, the liver was recovered and transplanted. No other organ was deemed suitable for transplant.
The liver recipient died of multisystem organ failure 1 month posttransplant and never left the hospital. SARS-CoV-2 PCR testing was done pre-mortem three times in the post-operative period and was negative on post-transplant days 1, 3, and 23.

| Case 4
A 46-year-old with a history of hypertension and obesity was declared dead by neurological criteria after suffering a stroke. Chart review found that the patient had been diagnosed with an asymptomatic SARS-CoV-2 infection 48 days prior by NP swab. Following the stroke, the admission SARS-CoV-2 NP swab was negative but IgG level was positive at 25.9 AU/mL. Repeat PCR testing found a second negative NP swab and a negative BAL. The liver was transplanted, the recipient tested negative for SARS-CoV-2 post-transplant and was still recovering in the hospital 2 weeks later.

| Case 5
A 52-year-old with end-stage liver disease suffered a stroke and neurologic death. The patient had been admitted to a hospital three times between April 9 and June 29 with complications of cirrhosis. On all three admissions, COVID-19 was listed as a confounding diagnosis. On another hospitalization in July 2020 related to cirrhosis, the patient's NP swab was negative and two SARS-CoV-2 IgGs were positive with a level of 26.7 AU/mL.

| Case 6
A 22-year-old with a history of epilepsy suffered cardiac arrest caused by seizure and was declared dead by neurologic criteria.
Admission SARS-CoV-2 NP swab was negative, and the donor had no known history of coronavirus infection. On hospital day 2, a SARS-CoV-2 PCR from the BAL was negative. The heart, liver, and kidneys were allocated and during their recovery on hospital day 3, a SARS-CoV-2 stool PCR came back positive but a repeat NP swab was negative. The heart recipient was already in the operating room when the tests resulted. The liver transplant was aborted, but heart and kidneys were successfully recovered and transplanted. The In addition to the donor and recipient information, these six recoveries involved nine procurement teams, including five teams local to the donation service area and four visiting teams. No transmission to any member of the procurement, operating room, or hospital teams was reported. The demographic factors and testing data for these donors and recipients are summarized in Table 1.

| D ISCUSS I ON
Coronavirus was declared a pandemic on March 11, 2020, and changed organ and tissue donation dramatically. The calendar year 2019 saw a record-breaking 11,870 deceased donors in the United States, 6 representing nearly 40% increase from just 5 years prior.
Prior to March 11, the nation was recovering more than 250 deceased donors per week, on pace again for a record year. After the announcement, organ recovery rates in the United States mimicked the decline previously seen in Italy and plummeted by more than 25%, as transplant hospitals recognized the risks of immunosuppression, resource utilization, and staff deployment in the face of an overwhelmed medical system. [7][8][9] By late April, these rates slowly began to increase as centers and OPOs began to navigate resource availability and risk-benefit analysis. Operational changes for OPO's included limited onsite presence at partner hospitals, telephone approaches for authorization, and increases in local recovery and centralized recovery centers. 2 Authorization rates declined as did overall donation and transplantation rates. 5,10 Patients referred as potential organ donors undergo epidemiologic and clinical screening and any confirmed diagnosis of COVID-19, whether current or in the prior 28 precludes donation. 3 Laboratories developed rapid turnaround testing availability and OPO's began universal screening of all consented donors, generally by NP swab, given provider exposure risks with other methods. 11 Later, it has been common to also perform BAL testing. However, even in the face of negative testing, there have been continued concerns about the safety of donation. In particular, there have been concerns that the screening tests may be insufficiently sensitive, that donors may still be in the asymptomatic phase of infection before virus is detectable, and concerns exist regarding nosocomial spread during donor workup. In the epicenter of Wuhan, deceased donors are quarantined in intensive care for at least 7 days during the workup period and must undergo two negative NAT and antibody tests prior to donating. 12 Organ donors with respiratory viruses such as influenza and the pandemic H1N1 2009 influenza virus have had organs successfully recovered and transplanted, however, the systemic nature of COVID-19 manifestations raised questions as to whether SARS-CoV-2 involvement of organs and tissues beyond the respiratory tract would complicate donation of non-lung organs from such donors. 13,14 Early studies from the virus epicenter described the initial cluster of 41 known COVID-19 patients, only 15% had viremia. 15 Another study examined more than 1000 tissue specimens from 200 COVID-19 patients and found that while 29% had virus in the GI tract, very few had detectable virus in blood or urine. 16

CO N FLI C T O F I NTE R E S T
The authors declare no conflicts of interest.