This report presents the Japanese status of organ procurement from deceased donors for organ transplantation in 2020 just within the COVID-19 pandemic in Japan. The Act on Organ Transplantation was established in July 1997 and amended in June 2009. After the enforcement of the amended Act on Organ Transplantation in July 2010, the number of brain-dead donors vastly increased. But the total numbers of deceased donors for organ transplantation were almost the same from 2015 to 2018. In 2019 the total number increased to 125. But within COVID-19 pandemic, the number decreased to 77. In this situation, the number of brain-dead donors in 2020 was kept almost the same from 2015 to 2018. The Japanese Society for Transplantation would like to express its deepest gratitude to those who have expressed their willingness to donate their organs despite the difficult circumstances, to the families who have agreed to donate their organs, and to the medical staff, other related people, and transplant coordinators who have been involved in organ donation in order to respond to their wishes.

A total of 1,711 kidney transplants including 1,570 from living donors, 17 from non-heart-beating donors and 124 from heart-beating donors were performed in 2020 in Japan. The data obtained from the Japanese Renal Transplant Registry are shown and analyzed in this annual report. The characteristics of recipients and donors such as relationships, original diseases, duration of dialysis therapy, blood transfusion, status of viral antigens and antibodies, pretransplant complications, causes of death of deceased donors, ischemic time and histocompatibilities are described. In addition, immunosuppressants used initially and other treatments are analyzed. We also report the results of a follow-up survey for recipients and living donors.

As of December 31, 2020, a total of 10,418 liver transplants had been performed in 70 institutions in Japan. There were 658 deceased donor transplants (655 from heart-beating donors and 3 from non-heart-beating donors) and 9,760 living-donor transplants. The annual total of liver transplants in 2020 was 380. Deceased-donor transplants decreased to 63 in 2020 from 88 in 2019, probably due to the COVID-19 pandemic. The most frequent indication was cholestatic disease, followed by hepatocellular disease and neoplastic disease. As for hepatocellular disease in 2020, alcoholic cirrhosis and non-alcoholic steatohepatitis were the most common. Patient survival following transplantation from heart-beating donors (655 transplants: 1-year 89.4%, 3-year 86.6%, 5-year 83.2%, 10-year 76.3%, 15-year 66.9%, 20-year 56.2%) was similar to that from living-donors (9,760 transplants: 1-year 85.5%, 3-year 81.7%, 5-year 79.2%, 10-year 74.1%, 15-year 69.6%, 20-year 65.6%, 25-year 62.9%, 30-year 60.4%). Graft survival was very much the same as patient survival (heart-beating donor: 1-year 88.9%, 3-year 86.2%, 5-year 82.8%, 10-year 75.8%, 15-year 66.5%, 20-year 55.8%; living-donor: 1-year 84.9%, 3-year 80.7%, 5-year 78.1%, 10-year 72.5%, 15-year 67.5%, 20-year 62.1%, 25-year 60.2%, 30-year 57.6%). Survival data are reported according to age and sex of recipient, indication, graft type, age and sex of donor, ABO-compatibility, and other factors. Cause of death of living liver donors is also reported.

Since the Organ Transplantation Law was passed in October 1997, a total of 566 heart transplantations (HTx) had been performed in Japan as of December, 2020. Of those, 597 HTx were performed after activation of a revised Transplant Act, and 84 were performed in 2019, but the number fell to 54 due to the COVID-19 pandemic. Most recipients had dilated cardiomyopathy; and the waiting condition of all patients was status 1 at HTx. The mean waiting time as status 1 continually increased to 1,625 days in 2020 from 892 days in 2014 in adults. After approval of the use of an implantable continuous flow ventricular assist device (cf-LVAD) for bridge-to-transplant (BTT) since 2011, BTT, especially using the cf-LVAD increased. In 2020, 46 of 49 adult cases were supported by several types of cf-LVADs. Fifty-five children underwent HTx and 42 (76%) of them were BTT cases (8 in Nipro VAD, 17 in EXCOR VAD, 9 in Jarvik 2000 and 8 in other cf-VADs). Most patients received a modified bicaval method of operation with Celsior for cardiac preservation, and all recipients were administered triple therapy with a calcineurin inhibitor (cyclosporine or tacrolimus), mycophenolate mofetil, and a steroid as an initial immunosuppressive regimen. Patient survival at 5, 10 and 20 years was 90.5%, 79.5% and 75.5%, respectively, which is superior to that of the international registry. This surveillance documented that the results of HTx in Japan were excellent despite a severe shortage of donors and long waiting times with LVAD as BTT.

【Objective】 To scrutinize the status of lung transplantation in Japan, the Japanese Society of Lung and Heart-Lung Transplantation started to collect and present registry data in 2005. This is the 17th official registry report of Japanese lung transplantation.

【Design and Methods】 The data of cadaveric lung transplantation and living-donor lobar lung transplantation performed by the end of 2020 were registered in the database and analyzed with respect to the number of transplants, recipient survival rates, recipient functional and working statuses, and causes of death after transplantations. Survival rates were calculated by the Kaplan-Meier method.

【Results】 A total of 584 cadaveric lung transplantation (306 single, 278 bilateral), 251 living-donor lobar lung transplantation and 3 heart-lung transplantation procedures were performed by the end of 2020. The number of cadaveric lung transplantations in 2020 was lower than in 2019 due to the pandemic of COVID-19. Five-year and 10-year survival rates of cadaveric lung transplantations were 73.0% and 60.7%, which were superior to those in the international registry. Five-year and 10-year survival rates of living-donor lobar transplantations were similar to those of cadaveric lung transplantation with 73.3% and 61.6%. The 3 recipients of heart-lung transplantation are all alive. The functional status of approximately 80% of recipients was restored to grade 0 or 1 of the mMRC scale after lung transplantations. The mMRC of the 3 heart-lung transplant recipients was grade 0. Infection has been the leading cause of death after lung transplantation. The number of deaths from chronic lung allograft dysfunction, malignancy and post-transplantation lymphoproliferative disease have been increasing in recent years.

【Conclusion】 The outcomes of Japanese lung transplantation are so far satisfactory. The modified Japanese transplantation law has been enforced since July 2010, and an increase in the number of cadaveric organ transplantations was achieved thereafter. The number of cadaveric lung transplantation in 2020 seems to have been affected by the pandemic of COVID-19. The Japanese Society of Lung and Heart-Lung Transplantation will continue to present annual reports of Japanese lung transplantations.

A total of 465 cases of pancreas transplantation from deceased and living-related donors were performed in 18 institutions in Japan between April 2000 and the end of 2020. The following donor- and recipient-related factors were analyzed: age and gender of donor and recipient, cause of death, history of diabetes and hemodialysis, waiting period, total cold ischemic time, operative procedure, immunosuppression and survival rates of patient and graft. Based on the analyses, the current status of pancreas transplantation in Japan was described. The patient survival after the transplantation was 95.8%, 94.9% and 92.9% at 1, 3, and 5 years, respectively. The pancreas graft survival in cases with simultaneous pancreas and kidney transplantation (SPK) was 87.0%, 84.6%, and 82.8% at 1, 3, and 5 years, respectively. The pancreas graft survival in cases with pancreas after kidney transplantation (PAK) (82.0%, 66.6%, and 53.2% at 1, 3, and 5 years, respectively) and pancreas transplantation alone (PTA) (66.7%, 42.4%, and 33.9% at 1, 3, and 5 years) was significantly poorer than for SPK. The main cause of pancreas graft loss was graft thrombus in SPK cases, while it was chronic rejection in PAK and PTA cases. In conclusion, we demonstrated the current status of pancreas transplantation in Japan. While the posttransplant outcome was favorable, it is necessary to overcome graft thrombus in SPK cases and chronic rejection in PAK and PTA cases in order to improve the posttransplant outcomes.

The Phase Ⅱ study, a multicenter clinical trial of islet transplantation in Japan using anti-thymocyte globulin induction, was started in 2012. In the first islet transplantation anti-thymocyte globulin was used as induction therapy and in the second and third islet transplantation if needed, Anti CD 25 antibody was used as induction therapy. Calcineurin inhibitors and mycophenolate mofetil were used as maintenance immunosuppressive therapy. The primary endpoint of this clinical trial was the proportion of subjects with HbA1c levels less than 7.4% and who are free of severe hypoglycemic events from day 90 to one year after the first islet cell infusion. As the result of the interim analysis of this clinical study, the primary endpoint of this study to keep HbA1c level less than 7.4% was achieved with 75% of the patients with no episode of severe hypoglycemia as well. And islet graft survival remained better than in the previous era, so far with about 80% at 4 years after islet transplantation. Additionally, there was no surgical complication when the islet cells were infused. In April 2020, according to these successful results of the clinical trial, islet transplantation was covered by health insurance in Japan.

Thirty-five intestinal transplants were performed since 1996 in 6 institutions. There were 22 deceased-donor and 13 living-donor transplants. The primary causes of intestinal transplants were short gut syndrome (n=15), intestinal mobility function disorder (n=15), retransplantation (n=4) and others (n=1). One-year patient survival was 90%, and 10-year patient survival was 56%. They were excellent results for a standard therapeutic option for intestinal failure if patients fail to maintain total parental nutrition.

Hematopoietic stem cell transplantation (HSCT) offers potentially curative treatment for a wide range of otherwise fatal hematologic disorders, and the number of HSCTs has continued to increase over the last 30 years; more than 5,000 allogeneic and autologous HSCTs have been performed annually in recent years. A constant increase of allogeneic HSCTs for older (aged over 50) patients, and an increase in the variety of donor/stem cell sources such as cord blood from unrelated donors have led to this constant increase of HSCT in Japan. The transplant survival outcome also continues to improve and the assets for the improvement include better supportive care, innovative transplant approaches, and the considerable contribution of a well-established transplant outcome registry to a variety of clinical studies.

【Objective】 This study aimed to describe nursing care and its intention considered by nurses for the brain-dead patient’s family until the decision making on brain death organ donation.

【Design】 This study was qualitative study.

【Methods】 Semi-structured interviews were conducted with seven nurses having the experience of caring for brain-dead organ donors and their families. The components involved in decision support were identified from the interviews and qualitatively analyzed.

【Results】 The results revealed four main features of nursing practice for supporting families making decisions on brain death organ donation in the emergency department as follows: (1) Following and respecting family members’ emotions and hopes in the decision-making process; (2) Care for the family to realize the unchanged dignity of the brain-dead patient; (3) Being on the side of the family but keeping a certain distance psychologically and grasping the overall picture of the family to maintain the family as they are; and (4) Following the system of support for families deciding on brain death organ donation.

【Conclusion】 These findings suggested that in order to enhance care for the families until decision-making on brain death organ donation, the nurses nestled the family’s grief process and showed continuing respect for patient’s dignity, by relying on the multi-professional team.

【Background】 We calculated donor-recipient Eplet mismatch (EpMM) based on HLA class II genotyping results (DRB1, DPB1, DQB1) and retrospectively investigated the relationship between prognosis and renal transplant prognosis.

【Methods】 The subjects consisted of 273 patients who underwent renal transplantation at our hospital and were genotyped for the six antigens of HLA-A, B, C, DR, DP, and DQ. Epitope mismatch (antibody validated) were calculated using HLA Matchmaker. The analysis was performed by dividing the subjects into 6 groups: Group 1 (G1) (0<EpMM>2), Group 2 (G2) (3<EpMM>5), Group 3 (G3) (6<EpMM>8), Group 4 (G4) (9<EpMM>11), Group 5 (G5) (12<EpMM>14), and Group 6 (G6) (15≤EpMM).

【Results】 The average EpMM was 7.2. Group 3 has the most, accounting for 32%. It has been suggested that there is a close relationship between EpMM and the incidence of CAMR and dnDSA. CAMR was observed in 33.3% of G6 and 6.3% of G1. The incidence of dnDSA was 41.7% in G6 and 12.5% in G1. However, the eGFR was not significantly different between G1 and G6 up to 10 years after transplantation.

【Conclusion】 The results of this study show that as EpMM increases, the incidence of CAMR and dnDSA increases. Our findings suggest that patients with an HLA-DPB1, DQB1, or DRB1 EpMM of 6 or higher are at increased risk.

A lymphocele after renal transplantation can cause a deterioration in renal function and cause a local infection. We report three cases of post-renal transplant lymphoceles managed successfully by inguinal lymphangiography with Lipiodol^®.

【Case 1】 A man aged in his forties received CT-guided drainage for a lymphocele on the 18th day of kidney transplantation; however, the volume of drainage did not decrease. Inguinal Lipiodol^® lymphangiography was performed 25 days after the transplant; the lymphocele was imaged and resulted in the lymphatic discharge stopping four days later.

【Case 2】 A woman aged in her sixties received CT-guided drainage for a lymphocele on the 50th day of kidney transplantation; however, the volume of drainage did not decrease. Inguinal lymphangiography was performed 62 days after the transplant. Despite most of the injected Lipiodol^® leaking into the adjacent subcutaneous tissue because of the small size of the lymph node, the discharge stopped three days after lymphangiography.

【Case 3】 A man aged in his thirties received CT-guided drainage for a lymphocele on the 12th postoperative day. Because the volume of drainage did not decrease, inguinal lymphangiography was performed on the 19th postoperative day. The lymphatic discharge continued after the first session of Lipiodol lymphangiography and therefore a second session was performed. Lymphatic discharge stopped 6 days after the second session.

No recurrence of lymphocele occurred in any of the three cases. Based on these clinical outcomes, we conclude that Lipiodol^® lymphangiography for lymphocele after renal transplantation is a minimally invasive and effective procedure.