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1.
N Engl J Med ; 386(17): 1615-1626, 2022 04 28.
Article in English | MEDLINE | ID: mdl-35476650

ABSTRACT

BACKGROUND: Respiratory syncytial virus (RSV), a major cause of illness and death in infants worldwide, could be prevented by vaccination during pregnancy. The efficacy, immunogenicity, and safety of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine in pregnant women and their infants are uncertain. METHODS: In a phase 2b trial, we randomly assigned pregnant women, at 24 through 36 weeks' gestation, to receive either 120 or 240 µg of RSVpreF vaccine (with or without aluminum hydroxide) or placebo. The trial included safety end points and immunogenicity end points that, in this interim analysis, included 50% titers of RSV A, B, and combined A/B neutralizing antibodies in maternal serum at delivery and in umbilical-cord blood, as well as maternal-to-infant transplacental transfer ratios. RESULTS: This planned interim analysis included 406 women and 403 infants; 327 women (80.5%) received RSVpreF vaccine. Most postvaccination reactions were mild to moderate; the incidence of local reactions was higher among women who received RSVpreF vaccine containing aluminum hydroxide than among those who received RSVpreF vaccine without aluminum hydroxide. The incidences of adverse events in the women and infants were similar in the vaccine and placebo groups; the type and frequency of these events were consistent with the background incidences among pregnant women and infants. The geometric mean ratios of 50% neutralizing titers between the infants of vaccine recipients and those of placebo recipients ranged from 9.7 to 11.7 among those with RSV A neutralizing antibodies and from 13.6 to 16.8 among those with RSV B neutralizing antibodies. Transplacental neutralizing antibody transfer ratios ranged from 1.41 to 2.10 and were higher with nonaluminum formulations than with aluminum formulations. Across the range of assessed gestational ages, infants of women who were immunized had similar titers in umbilical-cord blood and similar transplacental transfer ratios. CONCLUSIONS: RSVpreF vaccine elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns. (Funded by Pfizer; ClinicalTrials.gov number, NCT04032093.).


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus Vaccines , Respiratory Syncytial Virus, Human , Viral Fusion Proteins , Aluminum Hydroxide/adverse effects , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , Female , Humans , Infant , Pregnancy , Respiratory Syncytial Virus Infections/immunology , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus Vaccines/adverse effects , Respiratory Syncytial Virus Vaccines/immunology , Respiratory Syncytial Virus Vaccines/therapeutic use , Respiratory Syncytial Virus, Human/immunology , Vaccination , Viral Fusion Proteins/immunology
2.
Am J Transplant ; 24(1): 134-140, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37748555

ABSTRACT

Numerous United States transplant centers require solid organ transplantation candidates to be vaccinated against the coronavirus disease of 2019 to be active on the United Network for Organ Sharing waiting list. This study examined characteristics of adult patients on one center's kidney transplantation waiting list whose status was inactivated due to a lack of coronavirus disease 2019 vaccination by July 1, 2022, and who did not subsequently provide proof of vaccination by August 31, 2022 (cases). Patients in the control group were retrospectively matched to patients in the case group in a 4-to-1 fashion according to age, sex, and "active" status on the waiting list. Multivariable logistic regression was performed, with race/ethnicity, primary language, health insurance, education, and Vaccine Equity Metric (VEM, a measure of health equity at the zip code level) quartile as covariates. Results revealed that patients from zip codes in the lowest VEM quartile (odds ratio [OR] 1.89; P = .02) and those insured by governmental payors (Medicare: OR, 2.00; P < .01 and Medicaid: OR, 2.89; P < .01) had higher odds of being inactivated than those from zip codes that make up the highest VEM quartile and those insured by commercial payors, respectively. These findings serve as a cautionary tale regarding universal pretransplantation vaccination requirements, which may raise equity concerns that should be considered upon policy implementation.


Subject(s)
COVID-19 , Waiting Lists , Adult , Humans , Aged , United States/epidemiology , Case-Control Studies , Retrospective Studies , Medicare , COVID-19/epidemiology , COVID-19/prevention & control , Vaccination
3.
Ann Surg ; 279(1): 104-111, 2024 01 01.
Article in English | MEDLINE | ID: mdl-37522174

ABSTRACT

OBJECTIVE: To evaluate long-term oncologic outcomes of patients post-living donor liver transplantation (LDLT) within and outside standard transplantation selection criteria and the added value of the incorporation of the New York-California (NYCA) score. BACKGROUND: LDLT offers an opportunity to decrease the liver transplantation waitlist, reduce waitlist mortality, and expand selection criteria for patients with hepatocellular carcinoma (HCC). METHODS: Primary adult LDLT recipients between October 1999 and August 2019 were identified from a multicenter cohort of 12 North American centers. Posttransplantation and recurrence-free survival were evaluated using the Kaplan-Meier method. RESULTS: Three hundred sixty LDLTs were identified. Patients within Milan criteria (MC) at transplantation had a 1, 5, and 10-year posttransplantation survival of 90.9%, 78.5%, and 64.1% versus outside MC 90.4%, 68.6%, and 57.7% ( P = 0.20), respectively. For patients within the University of California San Francisco (UCSF) criteria, respective posttransplantation survival was 90.6%, 77.8%, and 65.0%, versus outside UCSF 92.1%, 63.8%, and 45.8% ( P = 0.08). Fifty-three (83%) patients classified as outside MC at transplantation would have been classified as either low or acceptable risk with the NYCA score. These patients had a 5-year overall survival of 72.2%. Similarly, 28(80%) patients classified as outside UCSF at transplantation would have been classified as a low or acceptable risk with a 5-year overall survival of 65.3%. CONCLUSIONS: Long-term survival is excellent for patients with HCC undergoing LDLT within and outside selection criteria, exceeding the minimum recommended 5-year rate of 60% proposed by consensus guidelines. The NYCA categorization offers insight into identifying a substantial proportion of patients with HCC outside the MC and the UCSF criteria who still achieve similar post-LDLT outcomes as patients within the criteria.


Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Liver Transplantation , Adult , Humans , Liver Transplantation/methods , Living Donors , Neoplasm Recurrence, Local/etiology , Patient Selection , North America , Retrospective Studies , Treatment Outcome
4.
Med Care ; 62(8): 521-529, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38889200

ABSTRACT

BACKGROUND: Recent efforts to increase access to kidney transplant (KTx) in the United States include increasing referrals to transplant programs, leading to more pretransplant services. Transplant programs reconcile the costs of these services through the Organ Acquisition Cost Center (OACC). OBJECTIVE: The aim of this study was to determine the costs associated with pretransplant services by applying microeconomic methods to OACC costs reported by transplant hospitals. RESEARCH DESIGN, SUBJECTS, AND MEASURES: For all US adult kidney transplant hospitals from 2013 through 2018 (n=193), we crosslinked the total OACC costs (at the hospital-fiscal year level) to proxy measures of volumes of pretransplant services. We used a multiple-output cost function, regressing total OACC costs against proxy measures for volumes of pretransplant services and adjusting for patient characteristics, to calculate the marginal cost of each pretransplant service. RESULTS: Over 1015 adult hospital-years, median OACC costs attributable to the pretransplant services were $5 million. Marginal costs for the pretransplant services were: initial transplant evaluation, $9k per waitlist addition; waitlist management, $2k per patient-year on the waitlist; deceased donor offer management, $1k per offer; living donor evaluation, procurement and follow-up: $26k per living donor. Longer time on dialysis among patients added to the waitlist was associated with higher OACC costs at the transplant hospital. CONCLUSIONS: To achieve the policy goals of more access to KTx, sufficient funding is needed to support the increase in volume of pretransplant services. Future studies should assess the relative value of each service and explore ways to enhance efficiency.


Subject(s)
Kidney Transplantation , Waiting Lists , Humans , Kidney Transplantation/economics , Kidney Transplantation/statistics & numerical data , United States , Male , Female , Middle Aged , Eligibility Determination , Adult , Tissue and Organ Procurement/economics , Health Care Costs/statistics & numerical data
5.
Am J Transplant ; 23(12): 1980-1989, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37748554

ABSTRACT

Older compatible living donor kidney transplant (CLDKT) recipients have higher mortality and death-censored graft failure (DCGF) compared to younger recipients. These risks may be amplified in older incompatible living donor kidney transplant (ILDKT) recipients who undergo desensitization and intense immunosuppression. In a 25-center cohort of ILDKT recipients transplanted between September 24, 1997, and December 15, 2016, we compared mortality, DCGF, delayed graft function (DGF), acute rejection (AR), and length of stay (LOS) between 234 older (age ≥60 years) and 1172 younger (age 18-59 years) recipients. To investigate whether the impact of age was different for ILDKT recipients compared to 17 542 CLDKT recipients, we used an interaction term to determine whether the relationship between posttransplant outcomes and transplant type (ILDKT vs CLDKT) was modified by age. Overall, older recipients had higher mortality (hazard ratio: 1.632.072.65, P < .001), lower DCGF (hazard ratio: 0.360.530.77, P = .001), and AR (odds ratio: 0.390.540.74, P < .001), and similar DGF (odds ratio: 0.461.032.33, P = .9) and LOS (incidence rate ratio: 0.880.981.10, P = 0.8) compared to younger recipients. The impact of age on mortality (interaction P = .052), DCGF (interaction P = .7), AR interaction P = .2), DGF (interaction P = .9), and LOS (interaction P = .5) were similar in ILDKT and CLDKT recipients. Age alone should not preclude eligibility for ILDKT.


Subject(s)
Kidney Transplantation , Humans , Aged , Middle Aged , Adolescent , Young Adult , Adult , Kidney Transplantation/adverse effects , Living Donors , Graft Survival , Graft Rejection/etiology , HLA Antigens , Risk Factors
6.
Hepatology ; 75(6): 1579-1589, 2022 06.
Article in English | MEDLINE | ID: mdl-34859474

ABSTRACT

Interest in anonymous nondirected living organ donation is increasing in the United States and a small number of transplantation centers are accumulating an experience regarding nondirected donation in living donor liver transplantation. Herein, we review current transplant policy, discuss emerging data, draw parallels from nondirected kidney donation, and examine relevant considerations in nondirected living liver donation. We aim to provide a consensus guidance to ensure safe evaluation and selection of nondirected living liver donors and a schema for just allocation of nondirected grafts.


Subject(s)
Kidney Transplantation , Liver Transplantation , Tissue and Organ Procurement , Humans , Kidney , Living Donors , United States
7.
Clin Transplant ; 37(10): e15049, 2023 10.
Article in English | MEDLINE | ID: mdl-37329290

ABSTRACT

BACKGROUND: Outcome data for the great majority of liver normothermic machine perfusion (NMP) cases derive from the strict confines of clinical trials. Detailed specifics regarding the intraoperative and early postoperative impact of NMP on reperfusion injury and its sequelae during real-world use of this emerging technology remain largely unavailable. METHODS: We analyzed transplants performed in a 3-month pilot period during which surgeons invoked commercial NMP at their discretion. Living donor, multi-organ, and hypothermic machine perfusion transplants were excluded. RESULTS: Intraoperatively, NMP (n = 24) compared to static cold storage (n = 25) recipients required less peri-reperfusion bolus epinephrine (0 vs. 60 µg; p < .001) and post-reperfusion fresh frozen plasma (2.5 vs. 7.0 units; p = .0069), platelets (.0 vs. 2.0 units; p = .042), and hemostatic agents (0% vs. 24%; p = .010). Time from incision to venous reperfusion did not differ (3.6 vs. 3.1; p = .095) but time from venous reperfusion to surgery end was shorter for NMP recipients (2.3 vs. 2.8 h; p = .0045). Postoperatively, NMP recipients required fewer red blood cell (1.0 vs. 4.0 units; p = .0083) and fresh frozen plasma (4.0 vs. 7.0 units; p = .046) transfusions, had shorter intensive care unit stays (33.5 vs. 58.4 h; p = .012), and experienced less early allograft dysfunction according to both the Model for Early Allograft Function Score (3.4 vs. 5.0; p = .0047) and peak AST within 10 days of transplant (619 vs. 1,181 U/L; p = .036). Liver acceptance for the corresponding recipient was conditional on NMP use for 63% (15/24) of cases. CONCLUSION: Real-world NMP use was associated with significantly lower intensity of reperfusion injury and intraoperative and postoperative care that may translate into patient benefit.


Subject(s)
Liver Transplantation , Reperfusion Injury , Humans , Organ Preservation , Liver , Perfusion
8.
Clin Transplant ; 37(7): e14954, 2023 07.
Article in English | MEDLINE | ID: mdl-36892182

ABSTRACT

INTRODUCTION: Living donor liver transplantation (LDLT) is a promising option for mitigating the deceased donor organ shortage and reducing waitlist mortality. Despite excellent outcomes and data supporting expanding candidate indications for LDLT, broader uptake throughout the United States has yet to occur. METHODS: In response to this, the American Society of Transplantation hosted a virtual consensus conference (October 18-19, 2021), bringing together relevant experts with the aim of identifying barriers to broader implementation and making recommendations regarding strategies to address these barriers. In this report, we summarize the findings relevant to the selection and engagement of both the LDLT candidate and living donor. Utilizing a modified Delphi approach, barrier and strategy statements were developed, refined, and voted on for overall barrier importance and potential impact and feasibility of the strategy to address said barrier. RESULTS: Barriers identified fell into three general categories: 1) awareness, acceptance, and engagement across patients (potential candidates and donors), providers, and institutions, 2) data gaps and lack of standardization in candidate and donor selection, and 3) data gaps regarding post-living liver donation outcomes and resource needs. CONCLUSIONS: Strategies to address barriers included efforts toward education and engagement across populations, rigorous and collaborative research, and institutional commitment and resources.


Subject(s)
Liver Transplantation , Tissue and Organ Procurement , Humans , Consensus , Donor Selection , Living Donors/education , United States
9.
Am J Transplant ; 22(1): 177-186, 2022 01.
Article in English | MEDLINE | ID: mdl-34379865

ABSTRACT

Nutritional status is known to strongly predict health outcomes in people with cystic fibrosis (CF), but the prevalence of and consequences for CF children with growth failure and underweight CF adults on the liver transplant (LT) waitlist has not been delineated. We utilized UNOS registry data from 2003 to 2017 to investigate the impact of growth failure and underweight on outcomes in liver transplant candidates with CF. Almost 1 in 3 children and adults with CF had growth failure or were underweight, respectively, at listing. Body mass index under-estimated growth failure compared to height and weight z-scores for children. In multivariate analysis of children, growth failure (HR 2.1, 95% CI 1.7-2.6), and CF (HR 2.7, 95% CI 1.6-4.6, vs. Non-CF) were independent risk factors for waitlist death among children; having both increased death risk almost fourfold (SHR 3.88, 95% CI 1.42-10.58). However, among children who did receive a LT, CF was not associated with death within 1-year post-LT. Underweight adult CF candidates were less likely to receive LT, again suggesting the importance of nutritional evaluation and early intervention in this at-risk cohort.


Subject(s)
Cystic Fibrosis , Liver Transplantation , Adult , Child , Cystic Fibrosis/surgery , Humans , Nutritional Status , Risk Factors , Waiting Lists
10.
Am J Transplant ; 22(6): 1519-1522, 2022 06.
Article in English | MEDLINE | ID: mdl-35352461

ABSTRACT

Living donor liver transplantation has expanded in recent years, particularly in North America. As experience with this procedure has matured over the last 25 years, centers are increasingly faced with potential living donors who are more medically complex. As donors move through the evaluation process, completing the informed consent process continues to be challenged by a paucity of granular data demonstrating long-term outcomes and overall safety specifically in the otherwise "healthy" living liver donor population. Two recently published studies examined long-term outcomes post-living liver donation using Korean registry data and reported similar results, with excellent overall survival when compared to appropriately matched controls. However, the authors of these studies were presented differently, with one reporting an alarmist view based on one aspect of a suboptimal analysis approach using an inappropriate comparator group. Herein, the North American Living Liver Donor Innovation Group (NALLDIG) consortium discusses these two studies and their potential impact on living liver donation in North America, ultimately highlighting the importance of scientific integrity in data presentation and dissemination when using transplant registry data.


Subject(s)
Liver Transplantation , Transplants , Humans , Liver , Living Donors , Registries
11.
Clin Transplant ; 36(10): e14703, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35538019

ABSTRACT

BACKGROUND: There are currently no guidelines pertaining to ERAS pathways in living donor hepatectomy. OBJECTIVES: The aim of this study was to identify whether surgical technique influences immediate and short-term outcomes after living liver donation surgery. DATA SOURCES: Ovid MEDLINE, Embase, Scopus, Google Scholar, and Cochrane Central. METHODS: Systematic review and meta-analysis following PRISMA guidelines and recommendations using the GRADE approach derived from an international expert panel (CRD42021260707). Endpoints were mortality, overall complications, serious complications, bile eaks, pulmonary complications, estimated blood loss and length of stay. RESULTS: Of the 2410 screened articles, 21 articles were included for final analysis; three observational, 13 retrospective cohort, four prospective cohort studies, and one randomized trial. Overall complications were higher with right versus left hepatectomy (26.8% vs. 20.8%; OR 1.4, P = .010). Donors after left hepatectomy had shorter length of stay (MD 1.4 days) compared to right hepatectomy. There was no difference in outcomes after right donor hepatectomy with versus without middle hepatic vein. We had limited data on the influence of incision type and minimally invasive approaches on living donor outcomes, and no data on the effect of operative time on donor outcomes. CONCLUSIONS: Left donor hepatectomy should be preferred over right hepatectomy, as it is related to improved donor short-term outcomes (QOE; Moderate | Grade of Recommendation; Strong). Right donor hepatectomy with or without MHV has equivalent outcomes (QOE; Moderate | Grade of Recommendation; Strong); no preference is recommended, decision should be based on program's experience and expertise. No difference in outcomes was observed related to incision type, minimally invasive vs. open (QOE; Low | Grade of Recommendation; Weak); no preference can be recommended.


Subject(s)
Laparoscopy , Liver Transplantation , Humans , Retrospective Studies , Prospective Studies , Liver Transplantation/adverse effects , Laparoscopy/methods , Length of Stay , Postoperative Complications/etiology , Living Donors , Hepatectomy/methods , Liver/surgery
12.
Value Health ; 25(12): 2028-2033, 2022 12.
Article in English | MEDLINE | ID: mdl-35690519

ABSTRACT

OBJECTIVES: The aim of this study was to show how the US government could save approximately 47 000 patients with chronic kidney failure each year from suffering on dialysis and premature death by compensating living kidney donors enough to completely end the kidney shortage. METHODS: Supply and demand analysis was used to estimate the number of donated kidneys needed to end the kidney shortage and the level of compensation required to encourage this number of donations. These results were then input into a detailed cost-benefit analysis to estimate the economic value of kidney transplantation to (1) the average kidney recipient and their caregiver, (2) taxpayers, and (3) society in general. RESULTS: We estimate half of patients diagnosed with kidney failure each year-approximately 62 000 patients-could be saved from suffering on dialysis and premature death if they could receive an average of 1½ kidney transplants. However, currently there are only enough donated kidneys to save approximately 15 000 patients. To encourage sufficient donations to save the other 47 000 patients, the government would have to compensate living kidney donors approximately $77 000 (±50%) per donor. The value of transplantation to an average kidney recipient (and caregiver) would be approximately $1.5 million, and the savings from the recipient not needing expensive dialysis treatments would be approximately $1.2 million. CONCLUSIONS: This analysis reveals the huge benefit that compensating living kidney donors would provide to patients with kidney failure and their caregivers and, conversely, the huge cost that is being imposed on these patients and their families by the current legal prohibition against such compensation.


Subject(s)
Kidney Failure, Chronic , Kidney Transplantation , Humans , United States , Cost-Benefit Analysis , Living Donors , Kidney Failure, Chronic/surgery , Renal Dialysis
13.
BMC Med Ethics ; 23(1): 20, 2022 03 05.
Article in English | MEDLINE | ID: mdl-35248038

ABSTRACT

BACKGROUND: The Public Health Service Increased Risk designation identified organ donors at increased risk of transmitting hepatitis B, hepatitis C, and human immunodeficiency virus. Despite clear data demonstrating a low absolute risk of disease transmission from these donors, patients are hesitant to consent to receiving organs from these donors. We hypothesize that patients who consent to receiving offers from these donors have decreased time to transplant and decreased waitlist mortality. METHODS: We performed a single-center retrospective review of all-comers waitlisted for liver transplant from 2013 to 2019. The three competing risk events (transplant, death, and removal from transplant list) were analyzed. 1603 patients were included, of which 1244 (77.6%) consented to offers from increased risk donors. RESULTS: Compared to those who did not consent, those who did had 2.3 times the rate of transplant (SHR 2.29, 95% CI 1.88-2.79, p < 0.0001), with a median time to transplant of 11 months versus 14 months (p < 0.0001), as well as a 44% decrease in the rate of death on the waitlist (SHR 0.56, 95% CI 0.42-0.74, p < 0.0001). All findings remained significant after controlling for the recipient age, race, gender, blood type, and MELD. Of those who did not consent, 63/359 (17.5%) received a transplant, all of which were from standard criteria donors, and of those who did consent, 615/1244 (49.4%) received a transplant, of which 183/615 (29.8%) were from increased risk donors. CONCLUSIONS: The findings of decreased rates of transplantation and increased risk of death on the waiting list by patients who were unwilling to accept risks of viral transmission of 1/300-1/1000 in the worst case scenarios suggests that this consent process may be harmful especially when involving "trigger" words such as HIV. The rigor of the consent process for the use of these organs was recently changed but a broader discussion about informed consent in similar situations is important.


Subject(s)
HIV Infections , Organ Transplantation , Tissue and Organ Procurement , Humans , Informed Consent , Tissue Donors , Waiting Lists
14.
Am J Transplant ; 21(4): 1633-1636, 2021 04.
Article in English | MEDLINE | ID: mdl-33171017

ABSTRACT

Living donor liver transplantation (LDLT) enjoys widespread use in Asia, but remains limited to a handful of centers in North America and comprises only 5% of liver transplants performed in the United States. In contrast, living donor kidney transplantation is used frequently in the United States, and has evolved to commonly include paired exchanges, particularly for ABO-incompatible pairs. Liver paired exchange (LPE) has been utilized in Asia, and was recently reported in Canada; here we report the first LPE performed in the United States, and the first LPE to be performed on consecutive days. The LPE performed at our institution was initiated by a nondirected donor who enabled the exchange for an ABO-incompatible pair, and the final recipient was selected from our deceased donor waitlist. The exchange was performed over the course of 2 consecutive days, and relied on the use and compliance of a bridge donor. Here, we show that LPE is feasible at centers with significant LDLT experience and affords an opportunity to expand LDLT in cases of ABO incompatibility or when nondirected donors arise. To our knowledge, this represents the first exchange of its kind in the United States.


Subject(s)
Liver Transplantation , Living Donors , ABO Blood-Group System , Blood Group Incompatibility , Canada , Humans , North America
15.
Am J Transplant ; 21(9): 3014-3020, 2021 09.
Article in English | MEDLINE | ID: mdl-33421310

ABSTRACT

Kidney transplantation reduces mortality in patients with end stage renal disease (ESRD). Decisions about performing kidney transplantation in the setting of a prior cancer are challenging, as cancer recurrence in the setting of immunosuppression can result in poor outcomes. For cancer of the breast, rapid advances in molecular characterization have allowed improved prognostication, which is not reflected in current guidelines. We developed a 19-question survey to determine transplant surgeons' knowledge, practice, and attitudes regarding guidelines for kidney transplantation in women with breast cancer. Of the 129 respondents from 32 states and 14 countries, 74.8% felt that current guidelines are inadequate. Surgeons outside the United States (US) were more likely to consider transplantation in a breast cancer patient without a waiting period (p = .017). Within the US, 29.2% of surgeons in the Western region would consider transplantation without a waiting period, versus 3.6% of surgeons in the East (p = .004). Encouragingly, 90.4% of providers surveyed would consider eliminating wait-times for women with a low risk of cancer recurrence based on the accurate prediction of molecular assays. These findings support the need for new guidelines incorporating individualized recurrence risk to improve care of ESRD patients with breast cancer.


Subject(s)
Breast Neoplasms , Cancer Survivors , Kidney Failure, Chronic , Kidney Transplantation , Breast Neoplasms/surgery , Female , Humans , Kidney Failure, Chronic/surgery , Neoplasm Recurrence, Local , Surveys and Questionnaires , United States
16.
Am J Transplant ; 21(11): 3694-3703, 2021 11.
Article in English | MEDLINE | ID: mdl-33884757

ABSTRACT

A potential solution to the deceased donor organ shortage is to expand donor acceptability criteria. The procurement cost implications of using nonstandard donors is unknown. Using 5 years of US organ procurement organization (OPO) data, we built a cost function model to make cost projections: the total cost was the dependent variable; production outputs, including the number of donors and organs procured, were the independent variables. In the model, procuring one kidney or procuring both kidneys from double/en bloc transplantation from a single-organ donor resulted in a marginal cost of $55 k (95% confidence interval [CI] $28 k, $99 k) per kidney, and procuring only the liver from a single-organ donor results in a marginal cost of $41 k (95% CI $12 k, $69 k) per liver. Procuring two kidneys for two candidates from a donor lowered the marginal cost to $36 k (95% CI $22 k, $66 k) per kidney, and procuring two kidneys and a liver lowers the marginal cost to $24 k (95% CI $17 k, $45 k) per organ. Economies of scale were observed, where high OPO volume was correlated with lower costs. Despite higher cost per organ than for standard donors, kidney transplantation from nonstandard donors remained cost-effective based on contemporary US data.


Subject(s)
Kidney Transplantation , Tissue and Organ Procurement , Cost-Benefit Analysis , Humans , Kidney , Tissue Donors
17.
Am J Transplant ; 21(4): 1612-1621, 2021 04.
Article in English | MEDLINE | ID: mdl-33370502

ABSTRACT

Incompatible living donor kidney transplant recipients (ILDKTr) have pre-existing donor-specific antibody (DSA) that, despite desensitization, may persist or reappear with resulting consequences, including delayed graft function (DGF) and acute rejection (AR). To quantify the risk of DGF and AR in ILDKT and downstream effects, we compared 1406 ILDKTr to 17 542 compatible LDKT recipients (CLDKTr) using a 25-center cohort with novel SRTR linkage. We characterized DSA strength as positive Luminex, negative flow crossmatch (PLNF); positive flow, negative cytotoxic crossmatch (PFNC); or positive cytotoxic crossmatch (PCC). DGF occurred in 3.1% of CLDKT, 3.5% of PLNF, 5.7% of PFNC, and 7.6% of PCC recipients, which translated to higher DGF for PCC recipients (aOR = 1.03 1.682.72 ). However, the impact of DGF on mortality and DCGF risk was no higher for ILDKT than CLDKT (p interaction > .1). AR developed in 8.4% of CLDKT, 18.2% of PLNF, 21.3% of PFNC, and 21.7% of PCC recipients, which translated to higher AR (aOR PLNF = 1.45 2.093.02 ; PFNC = 1.67 2.403.46 ; PCC = 1.48 2.243.37 ). Although the impact of AR on mortality was no higher for ILDKT than CLDKT (p interaction = .1), its impact on DCGF risk was less consequential for ILDKT (aHR = 1.34 1.621.95 ) than CLDKT (aHR = 1.96 2.292.67 ) (p interaction = .004). Providers should consider these risks during preoperative counseling, and strategies to mitigate them should be considered.


Subject(s)
Kidney Transplantation , Delayed Graft Function/etiology , Graft Rejection/etiology , Graft Survival , Humans , Kidney Transplantation/adverse effects , Living Donors , Retrospective Studies , Risk Factors
18.
J Hepatol ; 74(4): 829-837, 2021 04.
Article in English | MEDLINE | ID: mdl-33188904

ABSTRACT

BACKGROUND & AIMS: It has been suggested that patients with hepatocellular carcinoma (HCC) at high risk of wait-list dropout would have done poorly after liver transplantation (LT) because of tumour aggressiveness. To test this hypothesis, we analysed risk of wait-list dropout among patients with HCC in long-wait regions (LWRs) to create a dropout risk score, and applied this score in short (SWRs) and mid-wait regions (MWRs) to evaluate post-LT outcomes. We sought to identify a threshold in dropout risk that predicts worse post-LT outcome. METHODS: Using the United Network for Organ Sharing database, including all patients with T2 HCC receiving priority listing from 2010 to 2014, a dropout risk score was created from a developmental cohort of 2,092 patients in LWRs, and tested in a validation cohort of 1,735 patients in SWRs and 2,894 patients in MWRs. RESULTS: On multivariable analysis, 1 tumour (3.1-5 cm) or 2-3 tumours, alpha-fetoprotein (AFP) >20 ng/ml, and increasing Child-Pugh and model for end-stage liver disease-sodium scores significantly predicted wait-list dropout. A dropout risk score using these 4 variables (C-statistic 0.74) was able to stratify 1-year cumulative incidence of dropout from 7.1% with a score ≤7 to 39.5% with a score >23. Patients with a dropout risk score >30 had 5-year post-LT survival of 60.1% vs. 71.8% for those with a score ≤30 (p = 0.004). There were no significant differences in post-LT survival below this threshold. CONCLUSIONS: This study provided evidence that patients with HCC with the highest dropout risk have aggressive tumour biology that would also result in poor post-LT outcomes when transplanted quickly. Below this threshold risk score of ≤30, priority status for organ allocation could be stratified based on the predicted risks of wait-list dropout without significant differences in post-LT survival. LAY SUMMARY: Prioritising patients with hepatocellular carcinoma for liver transplant based on risk of wait-list dropout has been considered but may lead to inferior post-transplant survival. In this study of nearly 7,000 patients, we created a threshold dropout risk score based on tumour and liver-related factors beyond which patients with hepatocellular carcinoma will likely have poor post-liver transplant outcomes (60% at 5 years). For patients below this risk score threshold, priority status could be stratified based on the predicted risk of wait-list dropout without compromising post-transplant survival.


Subject(s)
End Stage Liver Disease , Graft Survival , Liver Transplantation , Patient Dropouts/statistics & numerical data , Postoperative Complications , Waiting Lists , Carcinoma, Hepatocellular/pathology , End Stage Liver Disease/blood , End Stage Liver Disease/diagnosis , End Stage Liver Disease/epidemiology , End Stage Liver Disease/surgery , Female , Humans , Liver Neoplasms/pathology , Liver Transplantation/adverse effects , Liver Transplantation/methods , Liver Transplantation/mortality , Male , Middle Aged , Neoplasm Staging , Outcome Assessment, Health Care , Postoperative Complications/diagnosis , Postoperative Complications/mortality , Risk Assessment/methods , Risk Factors , Severity of Illness Index , Tissue and Organ Procurement/organization & administration , United States/epidemiology , alpha-Fetoproteins/analysis
19.
Eur Radiol ; 31(2): 764-774, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32862291

ABSTRACT

PURPOSE: To identify post-liver transplant CT findings which predict graft failure within 1 year. MATERIALS AND METHODS: We evaluated the CT scans of 202 adult liver transplants performed in our institution who underwent CT within 3 months after transplantation. We recorded CT findings of liver perfusion defect (LPD), parenchymal homogeneity, and the diameters and attenuations of the hepatic vessels. Findings were correlated to 1-year graft failure, and interobserver variability was assessed. RESULTS: Forty-one (20.3%) of the 202 liver grafts failed within 1 year. Graft failure was highly associated with LPD (n = 18/25, or 67%, versus 15/98, or 15%, p < 0.001), parenchymal hypoattenuation (n = 20/41, or 48.8% versus 17/161, or 10.6%, p < 0.001), and smaller diameter of portal veins (right portal vein [RPV], 10.7 ± 2.7 mm versus 14.7 ± 2.2 mm, and left portal vein [LPV], 9.8 ± 3.0 mm versus 12.4 ± 2.2 mm, p < 0.001, respectively). Of these findings, LPD (hazard ratio [HR], 5.43, p < 0.001) and small portal vein diameters (HR, RPV, 3.33, p < 0.001, and LPV, 3.13, p < 0.05) independently predicted graft failure. All the measurements showed fair to moderate interobserver agreement (0.233~0.597). CONCLUSION: For patients who have CT scan within the first 3 months of liver transplantation, findings of LPD and small portal vein diameters predict 1-year graft failure. KEY POINTS: •Failed grafts are highly associated with liver perfusion defect, hypoattenuation, and small portal vein. •Right portal vein < 11.5 mm and left portal vein < 10.0 mm were associated with poor graft outcome. •Liver perfusion defect and small portal vein diameter independently predicted graft failure.


Subject(s)
Liver Transplantation , Adult , Humans , Liver/diagnostic imaging , Living Donors , Portal Vein/diagnostic imaging , Tomography, X-Ray Computed
20.
Clin Transplant ; 35(8): e14292, 2021 08.
Article in English | MEDLINE | ID: mdl-33749935

ABSTRACT

To predict whether the COVID-19 pandemic and transplant center responses could have resulted in preventable deaths, we analyzed registry information of the US end-stage renal disease (ESRD) patient population awaiting kidney transplantation. Data were from the Organ Procurement and Transplantation Network (OPTN), the US Centers for Disease Control and Prevention, and the United States Renal Data System. Based on 2019 OPTN reports, annualized reduction in kidney transplantation of 25%-100% could result in excess deaths of wait-listed (deceased donor) transplant candidates from 84 to 337 and living donor candidate excess deaths from 35 to 141 (total 119-478 potentially preventable deaths of transplant candidates). Changes in transplant activity due to COVID-19 varied with some centers shutting down while others simply heeded known or suspected pandemic risks. Understanding potential excess mortality for ESRD transplant candidates when circumstances compel curtailment of transplant activity may inform policy and procedural aspects of organ transplant systems allowing ways to best inform patients and families as to potential risks in shuttering organ transplant activity. Considering that more than 700 000 Americans have ESRD with 100 000 awaiting a kidney transplant, our highest annual estimate of 478 excess total deaths from postponing kidney transplantation seems modest.


Subject(s)
COVID-19 , Kidney Failure, Chronic , Tissue and Organ Procurement , Humans , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/surgery , Living Donors , Pandemics , SARS-CoV-2 , United States/epidemiology , Waiting Lists
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