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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 15  |  Issue : 3  |  Page : 205-210

Our renal transplant protocols during COVID-19 times – A prospective study from high-volume tertiary center of North India


Depatment of Urology, Mahatma Gandhi Medical College, Jaipur, Rajasthan, India

Date of Submission20-Mar-2021
Date of Decision06-Jun-2021
Date of Acceptance05-Jul-2021
Date of Web Publication30-Sep-2021

Correspondence Address:
Dr. Ketul Patel
Mahatma Gandhi Medical College, Jaipur, Rajasthan
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijot.ijot_30_21

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  Abstract 

Introduction: There is a strong temporal association between the increase in coronavirus disease-2019 (COVID-19) infections and a striking reduction in overall solid-organ transplantation procedure. 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. Our current communication shares a protocol for donor and transplant recipient selection during the COVID-19 pandemic to continue lifesaving kidney transplantation. 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 severe acute respiratory syndrome coronavirus 2 and how it affects organ donors and transplant recipients. Objectives: In this study, we aimed to review the published literature and compare it with our kidney transplantation is done in 115 patients in our hospital from July 2020 to February 2021 in the time of COVID-19 and what protocols we follow before transplant to reduce the risk of COVID-19 infection. This article also contains currently available immunosuppressive strategies. Methods: A prospective study was done in Mahatma Gandhi Hospital Jaipur for the transplant done from July 2020 to February 2021. A total of 115 patients from 20th July to 28th February were considered for the study. Results: All 115 patients who were COVID negative on reverse transcriptase–polymerase chain reaction assay and high-resolution computed tomography were considered for the transplant. COVID status on discharge for all 115 recipients was negative. During workup, two donors were found COVID-19 positive and were shifted to COVID center for treatment and their transplant postpone. Out of 115 renal transplant patients, only 1 patient became COVID-19 positive after 5 days of operation. Conclusions: Every transplant center should put its local policy about transplantation depending on the state of the epidemic in the country. Nowadays, transplantation programs should be limited to urgent cases. We suggest lowering the threshold for diagnosis of COVID-19 among renal transplant recipients.

Keywords: COVID-19, ESRD, kidney transplantation, organ transplantation


How to cite this article:
Sadasukhi N, Patel K, Sadasukhi T C, Gupta M, Gupta H L, Sharma A, Malik S. Our renal transplant protocols during COVID-19 times – A prospective study from high-volume tertiary center of North India. Indian J Transplant 2021;15:205-10

How to cite this URL:
Sadasukhi N, Patel K, Sadasukhi T C, Gupta M, Gupta H L, Sharma A, Malik S. Our renal transplant protocols during COVID-19 times – A prospective study from high-volume tertiary center of North India. Indian J Transplant [serial online] 2021 [cited 2021 Dec 5];15:205-10. Available from: https://www.ijtonline.in/text.asp?2021/15/3/205/327392


  Introduction Top


Coronavirus disease-2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV2).[1] The disease was initially confirmed in China and then rapidly spread worldwide with more than 2 million infected individuals and over 200,000 deaths worldwide.[2] This disease is especially fatal in elderly patients (patients older than 70 years) with comorbidities.[3] Data about demographics, characteristics, and clinical presentations of COVID-19 in kidney transplant recipients are scarce.[4]

Since December 2019, a series of unexplained pneumonia cases have been reported in Wuhan, China. On 12 January 2020, the World Health Organization temporarily named this new virus like the 2019 novel coronavirus.[5]

COVID-19 is caused by a single-stranded RNA virus called SARS-CoV-2. The first human case was reported in Wuhan, Hubei province of China, in December 2019. The first case of COVID was reported in India on January 30, 2020.

Kidney transplantation is a lifesaving procedure in ESRD. During the lockdown, transplantation was suspended because of the risk of COVID-19 transmission to immunocompromised recipients.

India is now heading for unlocking down and more and more people are getting immunity. Testing capacity of India has increased tremendously. Guidelines for the prevention and treatment of COVID-19 have also been refined.

Kidney transplantation is a lifesaving procedure with proper precautions that has also been recommended by various authorities.

Respiratory symptoms, which can range from mild to critically ill requiring mechanical ventilation, are the most common clinical feature of COVID-19; however, patients who are immunocompromised may present atypically.[6],[7]

This transplant protocol had three 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.

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.[8],[9],[10],[11],[12] Screening questionnaires and nasopharyngeal (NP) swab test available at this time,both have limitation and low sensitivity.[13] We have incorporated radiographic imaging of the chest using CT of both potential donors and transplant candidates to improve sensitivity. Over half of asymptomatic patients will show changes on CT and the sensitivity of CT chest findings increases as the COVID-19 progresses.[14],[15],[16],[17],[18],[19],[20],[21] Based on the data available, a noncontract 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 the onset of infection. This is described by Ai et al. in a report of 1014 cases in China, which describes the sensitivity of chest CT imaging for COVID-19 at 97% for those suspected of having COVID-19, 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 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 for that it will dictate eligibility of surgery and inform the 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.

Very little data are currently available regarding the optimal medical management of renal transplant patients testing positive for SARS-CoV-2 including strategies for reducing or modifying immunosuppression.[7],[26],[27],[28],[29],[30],[31],[32],[33],[34],[35],[36] Corticosteroids are a cornerstone of many immunosuppressive regimens; however, their use in SARS-CoV-2 is controversial.[37],[38],[39],[40],[41]


  Methods Top


The objective of our study was to analyze the current scenario and results of renal transplants. A prospective study was done in Mahatma Gandhi Hospital, Jaipur, for the transplant done from July 2020 to February 2021.

On hospital entry, thermal scanning, and hand sanitation were done for each and every patient. If positive, then the patient shifted to the isolation area for further workup. If negative, the patient is asked to fill COVID-19 pro forma at the gate. If any of the points found positive, the patient again shifted to the isolation area for further workup. If negative, the patient now proceeds to OPD.

In outpatient department (OPD), staff and doctor wear N95 mask without valve with face shield. Doctors and staff have to wear disposable gloves changed after seeing every single patient. Hand sanitizers are used frequently. Strict social distancing was maintained.

The patient after all basic OPD basis workup of transplant done is now admitted for transplantation. The patient has been explained about the hazards of transplantation during COVID-19. Proper consent was obtained. On admission, both donor and recipient underwent RT-PCR COVID-19 test and high-resolution CT (HRCT). Preoperative workup was done. Patient and donor isolated with only one attendant with them 15 days before the operation. No other relatives of patients are allowed to meet them to prevent the infection of COVID-19. A separate dialysis unit was also established in which a patient who is going to be operated is only allowed for dialysis without any extra expenditure. The day before the transplant, donor and recipient again underwent COVID-19 RT-PCR. There is not any additional cost for the transplant during COVID-19 times.

OT staff involved in kidney transplants was strictly not allowed to get involved in any other surgical procedure. The minimum movement was allowed in and out of OT during transplant. PPE kit was a must for anyone staying in during transplant.

Kidney transplant unit staffs were kept minimum. Just before their entry to the unit, they underwent COVID-19 RT-PCR. Staffs worked continuously for 10 days on a shift basis and were not allowed to leave KTU for 10 days. Staff then changed after 10 days. Ward boy also worked continuously for 10 days on a shift basis and was not allowed to leave KTU for 10 days.

Transplant donor as well as recipient transferred to KTU. Recipient discharged after 7–10 days with COVID-19 status negative on discharge.

Open donor nephrectomy was done with flank 11th rib cutting incision. The kidney was perfused with standard HTK solution. Recipient renal bed prepared with Gibson incision. Donor kidney anastomosed to recipient external iliac vessels end side. Ureter anastomosed to bladder over 5 Fr DJ with Lich–Gregoir technique. A single drain tube was placed.

In posttransplant recipients, the risk of acute rejection is highest in 1st months after transplantation (induction phase) and diminishes afterward (maintenance phase). Immunosuppression should be at the highest level in the early period and reduced for long-term therapy. At present, conventional immunosuppressive protocols consist of triple therapy: A calcineurin inhibitor, an antiproliferative agent, and corticosteroids. The development of new immunosuppressive drugs is aimed not only at improving short-term outcomes but also achieving better safety, less nephrotoxicity, and minimal side effects.

Statistical analysis

Data are expressed as mean ± standard deviation. Statistical analysis used Student t test to asses group differences for continuous variable and statistical significance was defined as P < 0.05. The extracted data was tabulated, and Prism GraphPad software (v6) was used for comparative statistical analyses. We used unpaired t-tests for continuous variables, and Fisher's exact tests for categorical variables.

Patient consent

The patient consent has been obtained for participation in the study and for publication of clinical details and images. Patients understand that the names, initials would not be published, and all standard protocols will be followed to conceal their identity.

Ethics statement

The ethical clearance was obtained from MGUMST, Jaipur Ethics Committee on May 31, 2021, with IRB number NO.MGMCH/IEC/JPR/2021/456.

The privacy and confidentiality of each participant were ensured. Written informed consent was obtained from all participants. All participants were given chance to ask questions about organ donation, and relevant information regarding the same was provided. The procedure was carried out in accordance with the Declaration of Helsinki and International Council for Harmonization-Good Clinical Practice (ICH-GCP).


  Results Top


A total of transplant 115 patients from 20th July to 28th February who gave informed consent were considered for the study.

The average age of the recipient was 40 years, 22 females and 93 males. The average age of the donor was 47 years, 57 males and 58 females.

Six transplants were SWAP transplants.

Donors were:

  • Brother – 8
  • Brother-in-law – 1
  • Cousin – 1
  • Sister-in-law – 1
  • Father –15
  • Grandmother – 1
  • Husband – 3
  • Mother – 39
  • Mother in law– 3
  • Sister – 8
  • Uncle – 1
  • Wife – 33.


Accessory renal arteries were anastomosed 24 times.

During workup, two donors were found COVID-19 positive and were shifted to COVID center for treatment and their transplant postpone. The two patient which was found to be COVID-19 positive,after 15 days treatment for COVID-19,both patients become COVID-19 negative,and after 1 month of that both patient undergo successful renal transplant.

One hundred and fifteen patients which were COVID negative on RT-PCR and HRCT were considered for the transplant. COVID status on discharge for all 115 recipients was negative.

Average cold ischemia time was 40 min and anastomoses time was 25 min. The average function of the right kidney was 51.74 ml/min and the left kidney was 48.47 ml/min. Supernumerary renal artery was 5 times in right kidney and 3 times in left kidney. 108 times left kidney was considered for transplant, whereas 7 times right kidney was taken [Table 1].
Table 1: Comparision between right and left kidney taken for transplant

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Even after so much precaution, out of 115 renal transplant patients, only 1 patient became COVID-19 positive after 5 days of operation, and because of this patient doctors and KTU staff became positive, the patient was successfully discharged once became COVID-19 negative after 17 days. Doctors and staff also became COVID-19 negative after 20 days; post transplant, three patients have wound infection which was successfully managed. Posttransplant average serum creatine level on day 1 was 2.7 mg/dl and on day 7 was 1.3 mg/dl [Table 2].
Table 2: Postoperative value of urineoutput and creatine with statistical analysis

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In our center, we use a sequential immunosuppression regimen where an induction agent, either an anti-thymocyte globulin or interleukin-2 receptor antibody, is given at the time of transplantation to prevent early acute rejection which is then followed by a triple immunosuppressive maintenance regimen: a calcineurin inhibitor, an antiproliferative agent, and corticosteroids. Very low rejection rates have been achieved at our transplant center using combinations of these agents.

For one patient who became COVID-19 positive 5 days post transplant, immunosuppression doses were modified in that patient. In that patient, corticosteroid dose was increased and the antimetabolite mycophenolate mofetil dose was decreased. The patient has become COVID-19 negative after 17 days.


  Discussion Top


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.

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 the 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 PPV 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 for 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.[42]

In our institution, a total of 115 renal transplants were performed from July 1, 2021, to 28 February 2021. The average age of the recipient was 40 years, 22 females and 93 males. The average age of the donor was 47 years, 58 males and 57 females. 24 donors have accessory renal artery. Others have a single renal artery. One hundred and fourteen rental recipients were COVID-19 negative post transplant, only 1 recipient after 5 days of transplant became COVID-19 positive, doctor and staff also became COVID-19 positive from that patient also in spite of so much precaution taken. All 115 renal transplant patients were successfully discharged.

Renal transplant immunosuppression

At present, conventional immunosuppressive protocols consist of triple therapy: a calcineurin inhibitor, an antiproliferative agent, and corticosteroids.

Two drug classes are used for “induction:” polyclonal antibodies (anti-thymocyte globulins) and interleukin-2 receptor antagonist (basiliximab). Basiliximab may be preferred in low-risk patients and rATG in high-risk patients. Recently, alemtuzumab has shown promise in low-risk patients. Future research is warranted with alefacept.

“Maintenance” immunosuppressives consist of calcineurin inhibitors, mTOR inhibitors, antimetabolites, and corticosteroids. Today, tacrolimus is the most commonly used calcineurin inhibitor. Prolonged-release tacrolimus provides once-daily dosing of this product and hopefully will simplify a complex posttransplant immunosuppressive regimen. At this point in the clinical trials, voclosporin, a cyclosporine analog, has not shown superior efficacy outcomes, but perhaps an improvement in the safety profile (namely new-onset diabetes after transplant) will secure its place in transplant immunotherapy. Although calcineurin inhibitors have significantly lowered acute rejection rates, they are direct nephrotoxins and chronic allograft nephrotoxicity still persists. A potential alternative to the calcineurin inhibitor-based regimens are mTOR-inhibitors, sirolimus, and everolimus. The use of mTOR inhibitors group of drugs (afinitor, torisel ) has been associated with many adverse effects and it appears the mTOR group of drugs is only successful in a some group of patients. Whether calcineurin inhibitor-free/sparing regimens using mTOR-I maintenance therapy is efficacious in the long term remains unknown. Currently, there are three antimetabolites on the market: azathioprine, mycophenolate mofetil, and mycophenolate sodium. It is still unclear whether enteric-coated mycophenolate sodium has a gastrointestinal side effect benefit over mycophenolate mofetil. These perceived benefits should be weighed with the cost savings benefit associated with generic mycophenolate mofetil. Three maintenance agents with novel mechanisms of action to watch include sotrastaurin, a protein kinase C inhibitor; belatacept, a recently approved costimulation blocker; and tofacitinib, a JAK 3 inhibitor. Belatacept, the first immunosuppressive to demonstrate a renal benefit over a calcineurin inhibitor-based regimen, may prove beneficial to the immunosuppressive maintenance regimens.

Treatment regimens for humoral rejection may include one or more of the following: plasmapheresis, intravenous immunoglobulin, and rituximab. Investigations of bortezomib and eculizumab have been hindered by small, nonrandomized trials. Although results are encouraging, larger studies and long-term follow-up are needed.

While awaiting further advances in the immunosuppressive armamentarium, we should be able to improve the functional life of most renal allografts by tailoring our available agents for induction and maintenance therapy.

The National Health Service of England guidelines recommend physicians to exercise caution when starting patients on immunosuppressive medications during the pandemic and to use the lowest possible dose of immunosuppression.[43] The British Society of Rheumatology recommends for transplant recipients who are well and on immunosuppression therapy to continue with their medications with appropriate social distancing and infection control measures.[44] Despite theoretical evidence of increased risk of COVID-19 severity and mortality for patients on immunosuppression, to date, various studies have shown immunosuppression per se carry no significant added risk.[45],[46]

There is no consensus regarding modification in the immunosuppressive regimen of transplant recipients with COVID-19. The dose adjustment has to balance the infection control and the organ rejection. The modification in the immunosuppressive regimen of transplant recipients with COVID-19 is to stop antimetabolite drugs and decrease calcineurin inhibitors by 50%. Steroids should be continued on the same doses (Massachusetts General Hospital COVID-19 Treatment Guidance).[47]

Limitation

It was a single centre study.


  Conclusions Top


Every transplant center should put its local policy about transplantation depending on the state of the epidemic in the country. Nowadays, transplantation programs should be limited to urgent cases. We suggest lowering the threshold for diagnosis of COVID-19among renal transplant recipient. Handling and manipulation of immunosuppressants duringCOVID-19 infection is an art, and it is the key for recovery from infection with preservation of graft function. There is no consensus regarding modification in the immunosuppressive regimen of transplant recipients with COVID-19. Renal transplant recipients with moderate oxygen requirements may be able to be managed successfully with steroid-sparing modifications to immunosuppression including modest reductions in calcineurin inhibitor trough concentrations and antiproliferative dosing.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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