Search

The American Transplant Congress (ATC) is the largest national transplant meeting in the United States jointly sponsored by the American Society of Transplantationand the American Society of Transplant Surgeons. The 2024 ATC was held in Philadelphia, Pennsylvania during which a number of peer-reviewed scientific abstracts were censored from the program by the Health Resources and Services Administration. These abstract presentations were redacted from the program for perceived conflict with current government policy effectively restricting dissemination of highly rated findings and discussion in a scientific forum. In this viewpoint, we describe the content of the abstracts that were withdrawn from the annual ATC meeting and the implications of this censorship by the Health Resources and Services Administration. We further consider the ramifications of this action for the prospective evaluation of government policy and the relationship of the contract agency with the transplant community in the context of ongoing discussions of modernizing the transplant system which has previously been critiqued for lack of transparency.

IMPORTANCE: Ischemic cold storage (ICS) of livers for transplant is associated with serious posttransplant complications and underuse of liver allografts. OBJECTIVE: To determine whether portable normothermic machine perfusion preservation of livers obtained from deceased donors using the Organ Care System (OCS) Liver ameliorates early allograft dysfunction (EAD) and ischemic biliary complications (IBCs). DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial (International Randomized Trial to Evaluate the Effectiveness of the Portable Organ Care System Liver for Preserving and Assessing Donor Livers for Transplantation) was conducted between November 2016 and October 2019 at 20 US liver transplant programs. The trial compared outcomes for 300 recipients of livers preserved using either OCS (n = 153) or ICS (n = 147). Participants were actively listed for liver transplant on the United Network of Organ Sharing national waiting list. INTERVENTIONS: Transplants were performed for recipients randomly assigned to receive donor livers preserved by either conventional ICS or the OCS Liver initiated at the donor hospital. MAIN OUTCOMES AND MEASURES: The primary effectiveness end point was incidence of EAD. Secondary end points included OCS Liver ex vivo assessment capability of donor allografts, extent of reperfusion syndrome, incidence of IBC at 6 and 12 months, and overall recipient survival after transplant. The primary safety end point was the number of liver graft–related severe adverse events within 30 days after transplant. RESULTS: Of 293 patients in the per-protocol population, the primary analysis population for effectiveness, 151 were in the OCS Liver group (mean [SD] age, 57.1 [10.3] years; 102 [67%] men), and 142 were in the ICS group (mean SD age, 58.6 [10.0] years; 100 [68%] men). The primary effectiveness end point was met by a significant decrease in EAD (27 of 150 [18%] vs 44 of 141 [31%]; P = .01). The OCS Liver preserved livers had significant reduction in histopathologic evidence of ischemia-reperfusion injury after reperfusion (eg, less moderate to severe lobular inflammation: 9 of 150 [6%] for OCS Liver vs 18 of 141 [13%] for ICS; P = .004). The OCS Liver resulted in significantly higher use of livers from donors after cardiac death (28 of 55 [51%] for the OCS Liver vs 13 of 51 [26%] for ICS; P = .007). The OCS Liver was also associated with significant reduction in incidence of IBC 6 months (1.3% vs 8.5%; P = .02) and 12 months (2.6% vs 9.9%; P = .02) after transplant. CONCLUSIONS AND RELEVANCE: This multicenter randomized clinical trial provides the first indication, to our knowledge, that normothermic machine perfusion preservation of deceased donor livers reduces both posttransplant EAD and IBC. Use of the OCS Liver also resulted in increased use of livers from donors after cardiac death. Together these findings indicate that OCS Liver preservation is associated with superior posttransplant outcomes and increased donor liver use. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02522871

Supplemental Digital Content is available in the text.

In this single-center, retrospective cohort study, we aimed to elucidate simple metabolic markers or surrogate indices of β-cell function that best predict long-term insulin independence and goal glycemic HbA1c control (HbA1c ≤ 6.5%) after total pancreatectomy with islet autotransplantation (TP-IAT). Patients who underwent TP-IAT (n= 371) were reviewed for metabolic measures before TP-IAT and for insulin independence and glycemic control at 1, 3, and 5 years after TP-IAT. Insulin independence and goal glycemic control were achieved in 33% and 68% at 1 year, respectively. Although the groups who were insulin independent and dependent overlap substantially on baseline measures, an individual who has abnormal glycemia (prediabetes HbA1c or fasting glucose) or estimated IEQs/kg < 2500 has a very high likelihood of remaining insulin dependent after surgery. In multivariate logistic regression modelling, metabolic measures correctly predicted insulin independence in about 70% of patients at 1, 3, and 5 years after TP-IAT. In conclusion, metabolic testing measures before surgery are highly associated with diabetes outcomes after TP-IAT at a population level and correctly predict outcomes in approximately two out of three patients. These findings may aid in prognostic counseling for chronic pancreatitis patients who are likely to eventually need TP-IAT.

In this single‐center, retrospective cohort study, we aimed to elucidate simple metabolic markers or surrogate indices of β‐cell function that best predict long‐term insulin independence and goal glycemic HbA1c control (HbA1c ≤ 6.5%) after total pancreatectomy with islet autotransplantation (TP‐IAT). Patients who underwent TP‐IAT (n= 371) were reviewed for metabolic measures before TP‐IAT and for insulin independence and glycemic control at 1, 3, and 5 years after TP‐IAT. Insulin independence and goal glycemic control were achieved in 33% and 68% at 1 year, respectively. Although the groups who were insulin independent and dependent overlap substantially on baseline measures, an individual who has abnormal glycemia (prediabetes HbA1c or fasting glucose) or estimated IEQs/kg < 2500 has a very high likelihood of remaining insulin dependent after surgery. In multivariate logistic regression modelling, metabolic measures correctly predicted insulin independence in about 70% of patients at 1, 3, and 5 years after TP‐IAT. In conclusion, metabolic testing measures before surgery are highly associated with diabetes outcomes after TP‐IAT at a population level and correctly predict outcomes in approximately two out of three patients. These findings may aid in prognostic counseling for chronic pancreatitis patients who are likely to eventually need TP‐IAT. This single‐center series of total pancreatectomy and islet autotransplantation shows that preoperative metabolic measures were highly associated with postoperative long‐term insulin independence and goal glycemic HbA1c control at a population level.

Supplemental Digital Content is available in the text

The recent identification of an outbreak of 2019‐ novel Coronavirus is currently evolving, and the impact on transplantation is unknown. However, it is imperative that we anticipate the potential impact on the transplant community in order to avert severe consequences of this infection on both the transplant community and contacts of transplant patients. Given the current spread of a novel coronavirus, transplant infectious disease experts discuss the impact of emerging infections on the transplant community and suggest current management strategies.

Supplemental digital content is available in the text.

Quality metrics have a long history in the field of kidney transplantation. These metrics are highly visible, with significant ramifications to transplantation centers based on their use in regulatory review and other stakeholders. In this perspective, we review the history of quality metrics in this field, discuss the perceptions and empirical evidence evaluating the impact of metrics on care delivery, and summarize the current landscape of quality oversight. Based on the research findings and opinions of the transplantation community, we suggest that significant reforms are needed for the evaluation of quality in the field based on more appropriately aligning metrics with optimizing patient outcomes. Moreover, there are vast potential uses of the current data that should be emphasized in a learning environment rather than a highly punitive system. In our view, these reforms would enhance care delivery, improve patient care, and better align incentives for providers of care that treat transplantation patients.

Single-center studies have demonstrated regional organ procurement collaboration to reduce travel redundancy and improve procurement efficiency. We studied deceased donor kidney, liver, and pancreas transplants performed in the United States between 2002 and 2014 using the Scientific Registry of Transplant Recipients (SRTR). We compared graft failure (GF), death-censored graft failure (DCGF), and patient death (PD) between organs procured by surgeons from the recipient’s center (transplant procurement team [TPT]) versus surgeons from a different center (NTPT). Primary nonfunction (PNF) was assessed for liver and kidney and delayed graft function (DGF) for kidney using mixed-effects logistic modeling. There were 64 906 liver (61.6% TPT), 118 152 kidney (26.1% TPT), 10 832 simultaneous pancreas kidney (SPK; 56.6% TPT), and 4378 solitary pancreas (SP; 34.0% TPT) transplants. When compared to NTPT, DCGF for organs procured by TPT was significantly less for liver (adjusted HR: 0.93; 95% CI: 0.88-0.98) and marginally significant for kidney (0.97; 0.93-1.00) and SPK (0.90; 0.82-1.00), and not significant for SP (0.98; 0.86 -1.11). DGF for TPT kidney was significantly lower (adjusted OR 0.91; 0.87-0.95). Albeit modest, our findings demonstrate a difference between locally procured organs and those procured by the implanting team. Elucidating the etiology of these differences will enhance regional organ procurement collaboration.

Single‐center studies have demonstrated regional organ procurement collaboration to reduce travel redundancy and improve procurement efficiency. We studied deceased donor kidney, liver, and pancreas transplants performed in the United States between 2002 and 2014 using the Scientific Registry of Transplant Recipients (SRTR). We compared graft failure (GF), death‐censored graft failure (DCGF), and patient death (PD) between organs procured by surgeons from the recipient's center (transplant procurement team [TPT]) versus surgeons from a different center (NTPT). Primary nonfunction (PNF) was assessed for liver and kidney and delayed graft function (DGF) for kidney using mixed‐effects logistic modeling. There were 64 906 liver (61.6% TPT), 118 152 kidney (26.1% TPT), 10 832 simultaneous pancreas kidney (SPK; 56.6% TPT), and 4378 solitary pancreas (SP; 34.0% TPT) transplants. When compared to NTPT, DCGF for organs procured by TPT was significantly less for liver (adjusted HR: 0.93; 95% CI: 0.88‐0.98) and marginally significant for kidney (0.97; 0.93‐1.00) and SPK (0.90; 0.82‐1.00), and not significant for SP (0.98; 0.86 ‐1.11). DGF for TPT kidney was significantly lower (adjusted OR 0.91; 0.87‐0.95). Albeit modest, our findings demonstrate a difference between locally procured organs and those procured by the implanting team. Elucidating the etiology of these differences will enhance regional organ procurement collaboration. Organs procured by the implanting transplant team, as compared to those procured by a local surgeon, demonstrate superior outcomes for liver, kidney, and simultaneous pancreas–kidney transplants but not pancreas transplant alone, inciting questions about regional organ procurement collaboration.

In accordance with the National Organ Transplant Act and Department of Health and Human Services’ Final Rule, the Scientific Registry of Transplant Recipients (SRTR) publicly releases biannual program‐specific reports that include analyses of transplant centers’ risk‐adjusted waitlist mortality, organ acceptance ratios, transplant rates, and graft and patient survival.Since the inception of these center metrics, 1‐year posttransplant graft and patient survival have improved, and center variation has decreased, casting uncertainty on their clinical relevance. The SRTRhas recently modified center evaluations by ranking centers into 5 tiers rather than 3 tiers in an attempt to discriminate between programs performing within a tight range, further exacerbating this uncertainty. The American Society of Transplantation/American Society of Transplant Surgeons convened an expert taskforce to examine both the utility and unintended consequences of transplant center metrics. Estimates of center variation in outcomes in adjacent tiers are imprecise and fleeting, but can result in consequential changes in clinician and center behavior. The taskforce has concerns that current metrics, based principally on 1‐year graft and patient survival, provide minimal if any benefit in informing patient choice and access to transplantation, with the untoward effect of decreased utilization of organs and restriction of research and innovation. The AST/ASTS Transplant Metrics Taskforce examines the relevance of current program‐specific reporting for kidney transplantation in the modern era.

In accordance with the National Organ Transplant Act and Department of Health and Human Services’ Final Rule, the Scientific Registry of Transplant Recipients (SRTR) publicly releases biannual program-specific reports that include analyses of transplant centers’ risk-adjusted waitlist mortality, organ acceptance ratios, transplant rates, and graft and patient survival. Since the inception of these center metrics, 1-year posttransplant graft and patient survival have improved, and center variation has decreased, casting uncertainty on their clinical relevance. The SRTR has recently modified center evaluations by ranking centers into 5 tiers rather than 3 tiers in an attempt to discriminate between programs performing within a tight range, further exacerbating this uncertainty. The American Society of Transplantation/American Society of Transplant Surgeons convened an expert taskforce to examine both the utility and unintended consequences of transplant center metrics. Estimates of center variation in outcomes in adjacent tiers are imprecise and fleeting, but can result in consequential changes in clinician and center behavior. The taskforce has concerns that current metrics, based principally on 1-year graft and patient survival, provide minimal if any benefit in informing patient choice and access to transplantation, with the untoward effect of decreased utilization of organs and restriction of research and innovation.

In the authors' multivariable models, the recent changes in the kidney allocation system is associated with increased cold ischemia time, delayed graft function rates, length of stay, and transplant related costs.

Time limits on organ viability from retrieval to implantation shape the US system for human organ transplantation. Preclinical research has demonstrated that emerging biopreservation technologies can prolong organ viability, perhaps indefinitely. These technologies could transform transplantation into a scheduled procedure without geographic or time constraints, permitting organ assessment and potential preconditioning of the recipients. However, the safety and efficacy of advanced biopreservation with prolonged storage of vascularized organs followed by reanimation will require new regulatory oversight, as clinicians and transplant centers are not trained in the engineering techniques involved or equipped to assess the manipulated organs. Although the Food and Drug Administration is best situated to provide that process oversight, the agency has until now declined to oversee organ quality and has excluded vascularized organs from the oversight framework of human cells, tissues, and cellular-based and tissue-based products. Integration of advanced biopreservation technologies will require new facilities for organ preservation, storage, and reanimation plus ethical guidance on immediate organ use versus preservation, national allocation, and governance of centralized organ banks. Realization of the long-term benefit of advanced biopreservation requires anticipation of the necessary legal and ethical oversight tools and that process should begin now.

This review confirms that while mortality and graft related outcomes are frequently reported in trials in kidney transplantation, surrogate outcomes, life-threatening complications and patient-reported outcome are uncommon, suggesting the need to establish core outcomes to improve clinical decision-making. Supplemental digital content is available in the text.

Total pancreatectomy (TP) is a treatment option for patients experiencing chronic pancreatitis (CP) refractory to medical management. Patients who are candidates for TP benefit from islet autotransplantation (IAT), which preserves available β-cell mass and thereby reduces the risk of brittle diabetes. Malignancy is an absolute contraindication for IAT to prevent the transplantation of occult malignant cells. We present the case of a patient with CP who was approved to undergo TP with IAT (TPIAT) but was intraoperatively discovered to have a pancreatic neuroendocrine tumor. The case illustrates a number of important surgical decision-making considerations for patients undergoing TPIAT and should help guide surgeons should they be presented with this clinical scenario. We stress the importance of vigilance for possible malignancy and to consider an intraoperative biopsy to further investigate unexpected findings that might represent an occult pancreatic malignancy in patients with CP undergoing TPIAT.

Since 2012, the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has required transplant centers to record the citizenship residency status of patients undergoing transplantation in the United States. This policy replaced the 5% threshold of the non–US citizen/nonresidents (NC/NR) undergoing organ transplantation that could result in an audit of transplant center activity. Since April 1, 2015, the country of residence for the NC/NR on the waitlist has also been recorded. We analyzed the frequency of NC/NR deceased donor organ transplants and waitlist registrations at all US transplant centers by data provided by UNOS for that purpose to the UNOS Ad Hoc International Relations Committee. During the period of 2013 to 2016, 1176 deceased donor transplants (of all organs) were performed in non–US citizen/non–US resident (NC/NR) candidates (0.54% of the total number of transplants). We focused on high-volume NC/NR transplant centers that performed more than 5% of the deceased donor kidney or liver transplants in NC/NR or whose waitlist registrants exceeded 5% NC/NR. This report was prepared to fulfill the transparency policy of UNOS to assure a public trust in the distribution of organs. When viewed with a public awareness of deceased donor organ shortages, it suggests the need for a more comprehensive understanding of current NC/NR activity in the United States. Patterns of organ specific NC/NR registrations and transplantations at high-volume centers should prompt a review of transplant center practices to determine whether the deceased donor and center resources may be compromised for their US patients.The authors analyze the UNOS data regarding citizenship and residency status of all organ recipients within the USA. On top of getting current and accurate data, the authors discuss the potential deleterious consequences for US residents and the applicability to all other countries facing the same issue.

Outcomes of patients receiving solid organ transplants in the United States are systematically aggregated into bi‐annual Program‐Specific Reports (PSRs) detailing risk‐adjusted survival by transplant center. Recently, the Scientific Registry of Transplant Recipients (SRTR) issued 5‐tier ratings evaluating centers based on risk‐adjusted 1‐year graft survival. Our primary aim was to examine the reliability of 5‐tier ratings over time. Using 10 consecutive PSRs for adult kidney transplant centers from June 2012 to December 2016 (n = 208), we applied 5‐tier ratings to center outcomes and evaluated ratings over time. From the baseline period (June 2012), 47% of centers had at least a 1‐unit tier change within 6 months, 66% by 1 year, and 94% by 3 years. Similarly, 46% of centers had at least a 2‐unit tier change by 3 years. In comparison, 15% of centers had a change in the traditional 3‐tier rating at 3 years. The 5‐tier ratings at 4 years had minimal association with baseline rating (Kappa 0.07, 95% confidence interval [CI] ‐0.002 to 0.158). Centers had a median of 3 different 5‐tier ratings over the period (q1 = 2, q3 = 4). Findings were consistent for center volume, transplant rate, and baseline 5‐tier rating. Cumulatively, results suggest that 5‐tier ratings are highly volatile, limiting their utility for informing potential stakeholders, particularly transplant candidates given expected waiting times between wait listing and transplantation. The SRTR 5‐tier ratings used to depict transplant center performance fluctuate frequently over time, limiting their utility for stakeholders, particularly for transplant candidates. See Greenwald's editorial on page 1303.

Outcomes of patients receiving solid organ transplants in the United States are systematically aggregated into bi-annual Program-Specific Reports (PSRs) detailing risk-adjusted survival by transplant center. Recently, the Scientific Registry of Transplant Recipients (SRTR) issued 5-tier ratings evaluating centers based on risk-adjusted 1-year graft survival. Our primary aim was to examine the reliability of 5-tier ratings over time. Using 10 consecutive PSRs for adult kidney transplant centers from June 2012 to December 2016 (n = 208), we applied 5-tier ratings to center outcomes and evaluated ratings over time. From the baseline period (June 2012), 47% of centers had at least a 1-unit tier change within 6 months, 66% by 1 year, and 94% by 3 years. Similarly, 46% of centers had at least a 2-unit tier change by 3 years. In comparison, 15% of centers had a change in the traditional 3-tier rating at 3 years. The 5-tier ratings at 4 years had minimal association with baseline rating (Kappa 0.07, 95% confidence interval [CI] -0.002 to 0.158). Centers had a median of 3 different 5-tier ratings over the period (q1 = 2, q3 = 4). Findings were consistent for center volume, transplant rate, and baseline 5-tier rating. Cumulatively, results suggest that 5-tier ratings are highly volatile, limiting their utility for informing potential stakeholders, particularly transplant candidates given expected waiting times between wait listing and transplantation.

Partial liver resections are routinely performed in living donor liver transplantation and to debulk tumours in liver malignancies, but surgical decisions on vessel reconstruction for adequate inflow and outflow are challenging. Pre-operative evaluation is often limited to radiological imaging, which fails to account for post-resection haemodynamic alterations. Substantial evidence suggests post-surgical increase in local volume flow rate enhances shear stress, signalling hepatic regeneration, but excessive shear stress has been postulated to result in small for size syndrome and liver failure. Predicting haemodynamic alterations throughout the liver is particularly challenging due to the dendritic architecture of the vasculature, spanning several orders of magnitude in diameter. Therefore, we developed a mathematical lumped parameter model with realistic heterogeneities capturing inflow/outflow of the human liver to simulate acute perfusion alterations following surgical resection. Our model is parametrized using clinical measurements, relies on a single free parameter and accurately captures established perfusion characteristics. We quantify acute changes in volume flow rate, flow speed and wall shear stress following variable, realistic liver resections and make comparisons with the intact liver. Our numerical model runs in minutes and can be adapted to patient-specific anatomy, providing a novel computational tool aimed at assisting pre- and intra-operative surgical decisions for liver resections.

Rapid steroid withdrawal, under the protection of rabbit antilymphocyte induction, leads to fewer complications with no decrease in patient or graft survival or graft function compared to protracted and high dose steroids at 15 years post kidney transplant.

Clinical trials report a variety of clinical, surrogate, or patient-reported outcomes. This article describes the results of novel methods using iterative Delphi Surveys of not only health professionals but patients and caregivers to determine the most important clinical trial outcome endpoints among both groups. Supplemental digital content is available in the text.

Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) convened 2 international consensus workshops in Boston and Hong Kong with patients/caregivers and health professionals to discuss the development and implementation of core outcome domains for trials in kidney transplantation. Supplemental digital content is available in the text.

This OPTN review shows that more than 20% of all deceased organ donors in the US were identified as increased risk for acquiring HIV, HBV and HCV according to new Public Health Service 2013 criteria, negatively impacting the utilization of high-quality organs.

This study shows that of 20 HIV+ brain-dead donors, 80% had a CD4 count less than normal and no recipient had a recognized donor-associated adverse event suggesting that CD4 absolute numbers should not be used to determine potential HIV+ donor status

OBJECTIVES:Total pancreatectomy with islet autotransplantation (TPIAT) is increasingly performed with remote islet cell processing and preparation, i.e., with islet cell isolation performed remotely from the primary surgical site at an appropriately equipped islet isolation facility. We aimed to determine whether TPIAT using remote islet isolation results in comparable long-term glycemic outcomes compared with TPIAT performed with standard local isolation.METHODS:We performed a retrospective cohort study of adult patients who underwent TPIAT at three tertiary care centers from 2010 to 2013. Two centers performed remote isolation and one performed local isolation. Explanted pancreata in the remote cohort were transported ∼130 miles to and from islet isolation facilities. The primary outcome was insulin independence 1 year following transplant.RESULTS:Baseline characteristics were similar between groups except the remote cohort had higher preoperative hemoglobin A1c (HbA1c; 5.43 vs. 5.25, P=0.02) and there were more females in the local cohort (58% vs. 76%, P=0.049). At 1 year, 27% of remote and 32% of local patients were insulin independent (P=0.48). Remote patients experienced a greater drop in fasting c-peptide (−1.66 vs. −0.64, P=0.006) and a greater rise in HbA1c (1.65 vs. 0.99, P=0.014) at 1-year follow-up. A preoperative c-peptide >2.7 (odds ratio (OR) 4.4, 95% confidence interval (CI) 1.6–14.3) and >3,000 islet equivalents/kg (OR 11.0, 95% CI 3.2–37.3) were associated with one-year insulin independence in the local group.CONCLUSIONS:At 1 year after TPIAT, patients undergoing remote surgery have equivalent rates of long-term insulin independence compared with patients undergoing TPIAT locally, but metabolic control is superior with local isolation.

Fear of diabetes and major surgery may prohibit referral of young children severely affected by pancreatitis for total pancreatectomy with islet autotransplant (TPIAT). We evaluated outcomes in our youngest TPIAT recipients, 3 to 8 years of age at surgery. Medical records were reviewed for 17 children (9 girls) ages 8 years or younger undergoing TPIAT from 2000 to 2014. Most (14/17) had genetic risk factors for pancreatitis. Since 2006, TPIAT recipients were followed prospectively with health questionnaires including assessments of pain and narcotic use, and scheduled hemoglobin A1c (HbA1c) and mixed-meal tolerance tests (6 mL/kg Boost HP) before surgery, and at regular intervals after. Patients are 1 to 11 years post-TPIAT (median 2.2 years). Data are reported as median (25th, 75th percentile). All had relief of pain, with all 17 patients off narcotics at most recent follow-up. Hospitalization rates decreased from 5.0 hospitalization episodes per person-year of follow-up before TPIAT, to 0.35 episodes per person-year of follow-up after TPIAT. Fourteen (82%) discontinued insulin, higher than the observed insulin independence rate of 41% in 399 patients older than 8 years of age undergoing TPIAT over the same interval (P= 0.004). Median post-TPIAT HbA1c was 5.9% (5.6%, 6.3%), and within patient post-TPIAT mean HbA1c was ?6.5% for all but 2 patients. Young children with severe refractory chronic pancreatitis may be good candidates for TPIAT, with high rates of pain relief and insulin independence, and excellent glycemic control in the majority.

Supplemental Digital Content is available in the text