US Transplant Programs Research Articles

Should Antimicrobial Resistance Limit Access to an Organ Transplant?

Burkholderia cenocepacia (B cenocepacia) is a gram-negative bacteria associated with significant morbidity and mortality following lung transplantation. Most US transplant programs consider B cenocepacia colonization to be an absolute contraindication to transplantation. This article argues that, if clinicians have good clinical reasons to expect poor outcomes for patients with B cenocepacia, then offering transplantation anyway is an abrogation of clinicians' fiduciary duties. This article also discusses other fiduciary obligations transplant programs might have to patients with B cenocepacia, such as referring to another transplant center, considering novel treatment options, and investigating how the infection's virulence factors stratify that patient's risk for poor transplant outcomes.

Kidney Transplant Practice in Pandemic Times: Lessons Learned for the Future.

Kidney Transplant Practice in Pandemic Times: Lessons Learned for the Future.

OPTN/SRTR 2020 Annual Data Report: Living Donor Collective

The first successful solid organ transplant was a living donor kidney transplant in 1954. Since then, living donation has been an important source of organs for kidney and liver transplants in the United States. Unfortunately, the demand for organs has not kept pace with the supply, and unlike deceased donor transplant, there has been little growth in the number of living donor transplants over the past decade. To better understand possible barriers to living donation and long-term risks attributable to donation, the Health Resources and Services Administration (HRSA) directed the Scientific Registry of Transplant Recipients (SRTR) to establish a national registry of all living donor candidates and donors evaluated at US transplant programs to acquire lifetime follow-up information. Other goals include understanding the factors associated with candidate approval and variation in approval practices across centers. A pilot program was conducted from June 2018 through September 2020 to inform baseline data collection and registration processes. In September 2020, the registry began recruiting additional sites evaluating candidates for living donation. Here, we describe candidates registered at participating living donor kidney and liver programs, from June 2018 through the end of 2020. Not all programs submitted data throughout the whole period. Data for kidney and liver living donor candidates are presented separately.

Factors Having an Impact on Relapse and Survival in Transplant Recipients With Alcohol-Induced Liver Disease.

ObjectiveTo assess the impact of standardized pretransplant alcohol abstinence and treatment guidelines on liver transplant outcomes.MethodsThis study assessed the posttransplant relapse and survival associated with a pretransplant guideline mandating alcohol abstinence, addiction treatment, and Alcoholics Anonymous (AA) attendance. This retrospective cohort study included liver recipients with alcohol-induced liver disease transplanted between January 1, 2000, and December 31, 2012, at a Midwest transplant center. Cox regression models tested for associations between pretransplant treatment, demographic and clinical characteristics, and outcome measures.ResultsOf 236 liver recipients (188 [79.7%] male; 210 [89%] white; mean follow-up, 88.6±55.0 months), 212 (90.2%) completed pretransplant treatment and 135 (57.2%) attended AA weekly. At 5 years, 16.3% and 8.2% had relapsed to any alcohol use and to high-dose drinking, respectively. Smoking during the 6 months before transplant was associated with any relapse (P=.0002) and high-dose relapse (P<.0001), and smoking at transplant was associated with death (P=.001). High-dose relapse was associated with death (hazard ratio, 3.5; P<.0001).ConclusionA transplant center with a guideline requiring abstinence, treatment, and AA participation experienced lower posttransplant relapse rates from those previously reported in comparable large US transplant programs. Smoking cessation may further improve posttransplant outcomes.

A National Survey of Practice Patterns for Accepting Living Kidney Donors With Prior COVID-19

IntroductionA critical question facing transplant programs is whether, when, and how to safely accept living kidney donors (LKDs) who have recovered from COVID-19 infection. The purpose of the study is to understand current practices related to accepting these LKDs.MethodsWe surveyed US transplant programs from 3 September through 3 November 2020. Center level and participant level responses were analyzed.ResultsA total of 174 respondents from 115 unique centers responded, representing 59% of US LKD programs and 72.4% of 2019 and 72.5% of 2020 LKD volume (Organ Procurement and Transplantation Network-OPTN 2021). In all, 48.6% of responding centers had received inquiries from such LKDs, whereas 44.3% were currently evaluating. A total of 98 donors were in the evaluation phase, whereas 27.8% centers had approved 42 such donors to proceed with donation. A total of 50.8% of participants preferred to wait >3 months, and 91% would wait at least 1 month from onset of infection to LD surgery. The most common reason to exclude LDs was evidence of COVID-19−related AKI (59.8%) even if resolved, followed by COVID-19−related pneumonia (28.7%) and hospitalization (21.3%). The most common concern in accepting such donors was kidney health postdonation (59.2%), followed by risk of transmission to the recipient (55.7%), donor perioperative pulmonary risk (41.4%), and donor pulmonary risk in the future (29.9%).ConclusionPractice patterns for acceptance of COVID-19−recovered LKDs showed considerable variability. Ongoing research and consensus building are needed to guide optimal practices to ensure safety of accepting such donors. Long-term close follow-up of such donors is warranted.

Prospective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors.

Organs from hepatitis C virus (HCV)-viremic donors have been used in HCV-uninfected recipients (D+/R-), but the optimal treatment approach has not been defined. We evaluated the kinetics of HCV infection following transplant in D+/R- kidney-transplant (KT) and liver-transplant (LT) recipients when a preemptive antiviral strategy was used. Six US transplant programs prospectively treated D+/R- primary LT and KT recipients with sofosbuvir-velpastasvir for 12weeks starting once viremia was confirmed following transplant and the patients were judged to be clinically stable, including estimated glomerular filtration rate >30mL/min. Primary endpoints were sustained virologic response at 12weeks following transplant and safety (assessed by proportion of treatment-related adverse and serious adverse events). Of the 24 patients transplanted (13 liver, of whom 2 had prior-treated HCV infection; 11 kidney), 23 became viremic after transplant. The median (interquartile range) time from transplant to start of antiviral therapy was 7.0 (6.0, 12.0) versus 16.5 (9.8, 24.5) days, and the median (interquartile range) HCV-RNA level 3days after transplant was 6.5 (3.9, 7.1) versus 3.6 (2.9, 4.0) log10 IU/mL in LT versus KT recipients, respectively. By week 4 of treatment, 10 of 13 (77%) LT, but only 2 of 10 (20%) KT, had undetectable HCV RNA (P=0.01). At the end of treatment, all LT recipients were HCV RNA-undetectable, whereas 3 (30%) of the kidney recipients still had detectable, but not quantifiable, viremia. All achieved sustained virologic response at 12weeks following transplant (lower 95% confidence interval bound: 85%). Serious adverse events considered possibly related to treatment were antibody-mediated rejection, biliary sclerosis, cardiomyopathy, and graft-versus-host disease, with the latter associated with multiorgan failure, premature treatment discontinuation, and death. Despite differing kinetics of early HCV infection in liver versus non-liver recipients, a preemptive antiviral strategy is effective. Vigilance for adverse immunologic events is warranted.

Care of international living kidney donor candidates in the United States: A survey of contemporary experience, practice, and challenges.

The evaluation and care of non-US citizen, non-US residents who wish to come to the United States to serve as international living kidney donors (ILKDs) can pose unique challenges. We surveyed US transplant programs to better understand practices related to ILKD care. We distributed the survey by email and professional society list-servs (Fall 2018, assessing 2017 experience). Eighty-five programs responded (36.8% program response rate), of which 80 considered ILKD candidates. Only 18 programs had written protocols for ILKD evaluation. Programs had a median of 3 (range: 0,75) ILKD candidates who initiated contact during the year, from origin countries spanning 6 continents. Fewer (median: 1, range: 0,25) were approved for donation. Program-reported reasons for not completing ILKD evaluations included visa barriers (58.6%), inability to complete evaluation (34.3%), concerns regarding follow-up (31.4%) or other healthcare access (28.6%), and financial impacts (21.4%). Programs that did not evaluate ILKDs reported similar concerns. Staff time required to evaluate ILKDs was estimated as 1.5-to-3-times (47.9%) or >3-times (32.9%) that needed for domestic candidates. Among programs accepting ILKDs, on average 55% reported successful completion of 1-year follow-up. ILKD evaluation is a resource-intensive process with variable outcomes. Planning and commitment are necessary to care for this unique candidate group.

Survey of US Living Kidney Donation and Transplantation Practices in the COVID-19 Era

IntroductionThe scope of the impact of the coronavirus disease 2019 (COVID-19) pandemic on living donor kidney transplantation (LDKT) practices is not well defined.MethodsWe surveyed US transplant programs to assess practices, strategies, and barriers to living LDKT during the COVID-19 pandemic. After institutional review board approval, the survey was distributed from 9 May 2020 to 30 May 2020 by e-mail and postings to professional society list-servs. Responses were stratified based on state COVID-19 cumulative incidence levels.ResultsStaff at 118 unique centers responded, representing 61% of US living donor recovery programs and 75% of LKDT volume in the prepandemic year. Overall, 66% reported that LDKT surgery was on hold (81% in “high” vs. 49% in “low” COVID-19 cumulative incidence states). A total of 36% reported that evaluation of new donor candidates had paused, 27% reported that evaluations were very much decreased (>0% to <25% typical), and 23% reported that evaluations were moderately decreased (25% to <50% typical). Barriers to LDKT surgery included program concerns for donor (85%) and recipient (75%) safety, patient concerns (56%), elective case restrictions (47%), and hospital administrative restrictions (48%). Programs with higher local COVID-19 cumulative incidence reported more barriers related to staff and resource diversion. Most centers continuing donor evaluations used remote strategies (video, 82%; telephone, 43%). As LDKT resumes, all programs will screen for COVID-19, although timeframe and modalities will vary. Recommendations for presurgical self-quarantine are also variable.ConclusionThe COVID-19 pandemic has had broad impacts on LDKT practice. Ongoing research and consensus building are needed to reduce barriers, to guide optimal practices, and to support safe restoration of LDKT across centers.

The kidney evaluation of living kidney donor candidates: US practices in 2017.

We surveyed US transplant programs to assess practices used to assess kidney health in living kidney donor candidates in 2017; the response rate was 31%. In this report, we focus on the kidney; a companion piece focuses on the metabolic and cardiovascular aspects of candidate evaluation. Compared to 2005, programs have become more stringent in accepting younger candidates and less stringent in accepting older candidates. The 24-hour creatinine clearance remains the mainstay for kidney function assessment, with 74% continuing to use a value below 80mL/min/1.73m2 for exclusion and 22% using age-based criteria. ApoL1 genotyping is obtained routinely or selectively by 45%, half of which use the high-risk genotype as an absolute exclusion criterion. For history of symptomatic stones, 49% accept if there is no current radiographic evidence of stones and urine profile is low risk, 80%-95% consider candidates with unilateral asymptomatic stones, but only 33%-48% consider if stones are bilateral. In addition, 14% use the risk assessment tool developed by Grams et al routinely for decision-making, and 42% use it sometimes. Also, 57% reported not having yet determined a risk threshold for acceptable postdonation risk above which candidates are excluded. Contemporary practice variation underscores the need for better evidence to guide the donor selection process.

Perceptions and Practices Regarding Frailty in Kidney Transplantation: Results of a National Survey.

Given the potential utility of frailty, a clinical phenotype of decreased physiologic reserve and resistance to stressors, to predict postkidney transplant (KT) outcomes, we sought to understand the perceptions and practices regarding frailty measurement in US KT programs. Surveys were emailed to American Society of Transplantation Kidney/Pancreas Community of Practice members and 202 US transplant programs (November 2017 to April 2018). Program characteristics were gleaned from Scientific Registry of Transplant Recipients. The 133 responding programs (response rate = 66%) represented 77% of adult KTs and 79% of adult KT candidates in the United States. Respondents considered frailty to be a useful concept in evaluating candidacy (99%) and endorsed a need to develop a frailty measurement specific to KT (92%). Frailty measurement was more common during candidacy evaluation (69%) than during KT admission (28%). Of the 202 programs, 38% performed frailty assessments in all candidates while 23% performed assessments only for older candidates. There was heterogeneity in the frailty assessment method; 18 different tools were utilized to measure frailty. The most common tool was a timed walk test (19%); 67% reported performing >1 tool. Among programs that measure frailty, 53% reported being less likely to list frail patients for KT. Among US KT programs, frailty is recognized as a clinically relevant construct and is commonly measured at evaluation. However, there is considerable heterogeneity in the tools used to measure frailty. Efforts to identify optimal measurement of frailty using either an existing or a novel tool and subsequent standardization of its measurement and application across KT programs should be considered.

Now is the time for the Organ Procurement and Transplantation Network to change regulatory policy to effectively increase transplantation in the United States; Carpe Diem.

With the Centers for Medicare and Medicaid Services proposing to remove outcome measures from the transplant centers' renewal for Conditions of Participation an exciting opportunity surfaces for the Organ Procurement and Transplantation Network to make an equally bold change and allow for increased transplantation options for patients in the United States.

Time-Driven Activity-Based Costing (TDBAC) Identifies Time and Effort Required for Completion of CIBMTR Forms and Can Assist in Resource Planning for HCT Centers

Purpose US transplant programs are required to report data to the Center for International Blood and Marrow Transplant Research (CIBMTR). There is, however, a lack of published data on time and effort (T/E) for completing CIBMTR Forms. A T/E analysis was performed using a Time-Driven Activity-Based Costing (TDBAC) model to determine hours needed for completion of forms. TDABC involves five distinct steps: identifying resources used for specific procedures, defining costs, estimating practice capacity, calculating cost of personnel per time unit, and determining time units required for completion, which result in the calculation of cost per procedure. Methods The adult and pediatric programs performed separate analyses including the following forms: Transplant Essential Data (TED), Comprehensive Report forms (CRF) and Cellular Therapy Essential Data (CTED). The completion period extended from pre-infusion – 1 year follow-up. Each center developed process maps for form completion and averaged out the cost per minute, per form, compensating for Clinical Research Coordinator (CRC) data entry experience. Time required to complete CIBMTR forms included chart review, data extraction, data entry, and standardized clinical consensus meetings for GVHD/Toxicity assessments, which confirmed grading and staging post-infusion. Results Time for form completion ranged 10 - 240 min, with mean/median times of 85/60, respectively (Figure 1). When analyzed by common transplant indications, total time for all form completion ranged from 933 min (leukemia) to 1083 min (immune deficiency and lymphoma). The separate process maps for adult and pediatric centers did not show notable difference in T/E. Results were then compared to CIBMTR form reimbursement. TDABC calculations determined that the actual cost is approximately up to 5 times reimbursement currently received from CIBMTR, through 1 year CRF form completion for one patient. Discussion Time analysis using TDABC can be an efficacious tool for calculating length of time to complete CIBMTR forms, and for reporting centers to justify increased reimbursement and increases in number of personnel for form completion.

Validation of the american quality assessment model and performance improvement to the brazilian transplant.

Objective:To validate the quality assessment and performance improvement instrument of US transplant programs to the Brazilian reality.Method: Methodological study developed for semantic validation and cultural adaptation of the Quality assessment and Performance Improvement instrument in the following steps: 1) translation; 2) synthesis; 3) back translation; 4) review by expert committee; 5) pretest and 6) content validation. To evaluate the agreement between the five judges, the Kappa coefficient was used and for content validation, the content validation index. Results: Kappa coefficient showed the agreement of the judges for semantic, idiomatic, cultural and conceptual equivalences. Content validation index values for relevance and item sequence of at least 0.80 for all blocks. Conclusion: The instrument of Quality Evaluation and Performance Improvement of Transplantation Programs proved to be valid and reliable. This instrument will contribute to the development of quality assurance programs for transplant teams in Brazil.

Pediatric heart transplantation at adult-specialty centers in the United States: A multicenter registry analysis.

Recent Organ Procurement and Transplantation Network bylaw revisions mandate that US transplant programs have an "approved pediatric component" in order to perform heart transplantation (HT) in patients <18years old. The impact of this change on adolescents, a group known to be at high risk for graft loss and nonadherence, is unknown. We studied all US primary pediatric (age <18years) HT from 2000 to 2015 to compare graft survival between centers organized mainly for adult versus pediatric care. Centers were designated as pediatric- or adult-specialty care according to the ratio of pediatric:adult HT performed and minimum age of HT (pediatric-specialty defined as ratio>0.7; adult-specialty ratio<0.05 and minimum age >8years). In propensity score-matched cohorts, we observed no difference in graft loss by center type (median survival: adult 12.4 years vs pediatric 9.2years, P=.174). Compared to the matched pediatric cohort, adult-specialty center recipients lived closer to their transplant center (31 vs 45 miles, P=.012), and trended toward fewer out-of-state transplants (15 vs 25%, P=.082). Our data suggest that select adolescents can achieve similar midterm graft survival at centers organized primarily for adult HT care. Regardless of post-HT setting, the development of care models that demonstrably improve adherence may be of greatest benefit to improving survival of this high-risk population.

Cultural competency of a mobile, customized patient education tool for improving potential kidney transplant recipients' knowledge and decision-making.

Patients considering renal transplantation face an increasingly complex array of choices as a result of the revised kidney transplant allocation system. Decision aids have been shown to improve patient decision-making through the provision of detailed, relevant, individualized clinical data. A mobile iOS-based application (app) including animated patient education and individualized risk-adjusted outcomes following kidney transplants with varying donor characteristics and DSA waiting times was piloted in two large US transplant programs with a diverse group of renal transplant candidates (N=81). The majority (86%) of patients felt that the app improved their knowledge and was culturally appropriate for their race/ethnicity (67%-85%). Patients scored significantly higher on transplant knowledge testing (9.1/20 to 13.8/20, P<.001) after viewing the app, including patients with low health literacy (8.0 to 13.0, P<.001). Overall knowledge of and interest in living and deceased donor kidney transplantation increased. This pilot project confirmed the benefit and cultural acceptability of this educational tool, and further refinement will explore how to better communicate the risks and benefits of nonstandard donors.

Barriers to Implementing Protocols for Kidney Paired Donation and Desensitization: Survey of US Transplant Programs

Special types of kidney transplant exist for patients who have willing but incompatible donors. Two types of transplants that circumvent donor-recipient incompatibility are "kidney paired donation" and "desensitization." Lack of access to these protocols limits living donations and shortens the life span of patients with willing but incompatible donors. To understand potential barriers to implementing kidney paired donation and desensitization, as well as attitudes toward nondirected donation and compatible type O donation, which would maximize the number of kidney paired donation transplants performed via chains. We created a 56-question Web-based survey to elicit information from US transplant program directors about 24 potential barriers to implementing these protocols. Of 166 programs contacted, 96 responded, including 88 complete and 8 partial responses. After pediatric-only programs and multiple responses from the same program were removed, 84 total (78 complete) remained. Respondents were asked to designate each barrier as "major," "minor," or "not a barrier". Availability of dedicated nurse coordinators and the United Network for Organ Sharing's variance request process (although kidney paired donation does not actually require a variance) were significant barriers to kidney paired donation. Most respondents (54%, 42/78) would prefer to participate in a regional rather than a national protocol for kidney paired donation. Risk of complications was the most significant barrier to desensitization. University affiliation, region, and training (nephrologist vs surgeon) had little effect on perception of barriers. Most (92%, 71/78) would evaluate nondirected donations; 53% (41/78) would encourage compatible type O donors to enter kidney paired donation.

Barriers to implementing protocols for kidney paired donation and desensitization: survey of US transplant programs

Special types of kidney transplant exist for patients who have willing but incompatible donors. Two types of transplants that circumvent donor-recipient incompatibility are "kidney paired donation" and "desensitization." Lack of access to these protocols limits living donations and shortens the life span of patients with willing but incompatible donors. To understand potential barriers to implementing kidney paired donation and desensitization, as well as attitudes toward nondirected donation and compatible type O donation, which would maximize the number of kidney paired donation transplants performed via chains. We created a 56-question Web-based survey to elicit information from US transplant program directors about 24 potential barriers to implementing these protocols. Of 166 programs contacted, 96 responded, including 88 complete and 8 partial responses. After pediatric-only programs and multiple responses from the same program were removed, 84 total (78 complete) remained. Respondents were asked to designate each barrier as "major," "minor," or "not a barrier". Availability of dedicated nurse coordinators and the United Network for Organ Sharing's variance request process (although kidney paired donation does not actually require a variance) were significant barriers to kidney paired donation. Most respondents (54%, 42/78) would prefer to participate in a regional rather than a national protocol for kidney paired donation. Risk of complications was the most significant barrier to desensitization. University affiliation, region, and training (nephrologist vs surgeon) had little effect on perception of barriers. Most (92%, 71/78) would evaluate nondirected donations; 53% (41/78) would encourage compatible type O donors to enter kidney paired donation.

Evaluating Living Kidney Donors: Relationship Types, Psychosocial Criteria, and Consent Processes at US Transplant Programs

We conducted a survey of 132 US kidney transplant programs to examine how they evaluate and select potential living kidney donors, focusing on donor-recipient relationships, psychosocial criteria, and consent processes. There is heterogeneity in donor-recipient relationships that are considered acceptable, although most programs (70%) will not consider publicly solicited donors. Most programs (75%) require a psychosocial evaluation for all potential living donors. Most programs agree that knowledge of financial reward (90%), active substance abuse (86%), and active mental health problems (76%) are absolute contraindications to donation. However, there is greater variability in how other psychosocial issues are considered in the selection process. Consent processes are highly variable across programs: donor and recipient consent for the donor evaluation is presumed in 57% and 76% of programs, respectively. The use of 13 different informed consent elements varied from 65% (alternative donation procedures) to 86% (description of evaluation, surgery and recuperative period) of programs. Forty-three percent use a 'cooling off' period. Findings demonstrate high variability in current practice regarding acceptable donor-recipient relationships, psychosocial criteria, and consent processes. Whether greater consensus should be reached on these donor evaluation practices, especially in the context of more expansive use of living donor kidney transplantation, is discussed.

Cross Border Shopping: How Much for Your Heart?

No one has described the fiscal disparity that arises as a result of Canada/United States (US) cross border organ transactions. Canadian healthcare cannot continue to subsidize US transplant programs while paying their inflated organ acquisition fees. Canadian hospitals should bill US transplant programs for all costs associated with procuring organs.