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Posttransplant biopsy risk for stable long-term pediatric liver transplant recipients: 451 percutaneous biopsies from two multicenter immunosuppression withdrawal trials.

ABSTRACT: Although liver biopsy is the gold standard for assessing allograft health, its attendant risk has deterred its use in routine monitoring of stable liver transplant recipients during long-term follow-up. We utilized prospectively collected data on adverse events from 2 clinical trials of immunosuppression withdrawal to quantify the risk of liver biopsy in pediatric liver transplant recipients. The trials included 451 liver biopsies in 179 children. No biopsies led to bleeding requiring transfusion or intervention, suggesting a clinically significant bleeding risk of <0.8%. Complications were reported in 5.5% of biopsies (95% CI 3.6%-8.1%): 5.8% (21/363) of protocol biopsies and 4.5% (4/88) of for-cause biopsies (P = .80). Mild complications occurred in 1.8% of biopsies, moderate in 1.8%, and severe in 2.0%. The majority of complications (89%) resolved within 1 week. Six of 9 (67%) severe complications were related to biliary issues; 5 were episodes of cholangitis. Biopsy-related cholangitis occurred only in children with underlying biliary strictures. Overall, biopsy-related complications were infrequent and resolved quickly. Severe complications were rare, with occult biliary stricture as the dominant driver. Our study provides evidence for clinicians who are considering the risk vs benefit of surveillance liver biopsies in pediatric liver transplant recipients.

SUBMITTER: Perito ER

PROVIDER: S-EPMC6482080 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Posttransplant biopsy risk for stable long-term pediatric liver transplant recipients: 451 percutaneous biopsies from two multicenter immunosuppression withdrawal trials.

Perito Emily R ER Martinez Mercedes M Turmelle Yumirle P YP Mason Kristen K Spain Katharine M KM Bucuvalas John C JC Feng Sandy S

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 20190204 5

Although liver biopsy is the gold standard for assessing allograft health, its attendant risk has deterred its use in routine monitoring of stable liver transplant recipients during long-term follow-up. We utilized prospectively collected data on adverse events from 2 clinical trials of immunosuppression withdrawal to quantify the risk of liver biopsy in pediatric liver transplant recipients. The trials included 451 liver biopsies in 179 children. No biopsies led to bleeding requiring transfusio ...[more]

PMID: 30614623

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Project description:Background and aimsAs conversion from calcineurin inhibitor to sirolimus (SRL), a mechanistic target of rapamycin inhibitor (mTOR-I), has been shown to enhance immunoregulatory profiles in liver transplant (LT) recipients (LTRs), mTOR-I therapy might allow for increased success of immunosuppression (IS) withdrawal. Our aim was to determine if operational tolerance could be observed in LTRs withdrawn from SRL and if blood/graft tolerance biomarkers were predictive of successful withdrawal.Approach and resultsWe performed a prospective trial of SRL monotherapy withdrawal in nonimmune, nonviremic LTRs > 3 years post-LT. SRL was weaned over ~6 months, and biopsies were performed 12 months postweaning or at concern for acute rejection. Twenty-one LTRs consented; 6 were excluded due to subclinical acute rejection on baseline biopsy or other reasons, and 15 underwent weaning (age 61.3 ± 8.8 years; LT to SRL weaning 6.7 ± 3 years). Eight (53%) achieved operational tolerance (TOL). Of the 7 who were nontolerant (non-TOL), 6 had mild acute rejection on biopsy near the end of weaning or at study end; 1 was removed from the trial due to liver cancer recurrence. At baseline preweaning, there were statistically increased blood tolerogenic dendritic cells and cell phenotypes correlating with chronic antigen presentation in the TOL versus non-TOL groups. A previously identified biopsy gene signature accurately predicted TOL versus non-TOL in 12/14 LTRs before weaning. At study end, biopsy staining revealed statistically significant increases in antigen-presenting cell:leukocyte pairings, FOXP3+ /CD4+ T cells, Tbet+ /CD8+ T cells, and lobular dendritic cells in the non-TOL group.ConclusionsThis study evaluated IS withdrawal directly from mTOR-I therapy in LTRs and achieved > 50% operational tolerance. Preweaning gene expression and peripheral blood mononuclear cell profiling may be useful as predictors of successful mTOR-I therapy withdrawal. NCT02062944.

Project description:Rationale & objectivePosttransplant diabetes mellitus (DM) after kidney transplantation increases morbidity and mortality, particularly in older and obese recipients. We aimed to examine the impact of immunosuppression selection on the risk of posttransplant DM among both older and obese kidney transplant recipients.Study designRetrospective database study.Setting & participantsKidney-only transplant recipients aged ≥18 years from 2005 to 2016 in the United States from US Renal Data System records, which integrate Organ Procurement and Transplantation Network/United Network for Organ Sharing records with Medicare billing claims.ExposuresVarious immunosuppression regimens in the first 3 months after transplant.OutcomesDevelopment of DM >3 months-to-1 year posttransplant.Analytical approachWe used multivariable Cox regression to compare the incidence of posttransplant DM by immunosuppression regimen with the reference regimen of thymoglobulin (TMG) or alemtuzumab (ALEM) with tacrolimus + mycophenolic acid + prednisone using inverse propensity weighting.Results12.7% of kidney transplant recipients developed posttransplant DM with higher incidences in older (≥55 years vs <55 years: 16.7% vs 10.1%) and obese (body mass index [BMI] ≥ 30 kg/m2 vs BMI < 30 kg/m2: 17.1% vs 10.9%) patients. The incidence of posttransplant DM was lower with steroid avoidance [TMG/ALEM + no prednisone (8.4%) and IL2rAb + no prednisone (9.7%)] than TMG/ALEM with triple therapy (13.1%). After adjustment for donor and recipient characteristics, TMG/ALEM with steroid avoidance was beneficial for all groups [age < 55 years: adjusted HR (aHR), 0.63 (95% confidence interval [CI], 0.54-0.72); age ≥ 55 years: aHR, 0.69 (95% CI, 0.60-0.79); BMI < 30 kg/m2: aHR, 0.69 (95% CI, 0.60-0.78); BMI ≥ 30 kg/m2: aHR, 0.67 (95% CI, 0.57-0.79)]. However, IL2rAb with steroid avoidance was beneficial only for older patients (aHR, 0.76; 95% CI, 0.58-0.99) and for those with BMI < 30 kg/m2 (aHR, 0.63; 95% CI, 0.46-0.87).LimitationsRetrospective study and lacked data on immunosuppression levels.ConclusionsThe beneficial impact of steroid avoidance using tacrolimus on posttransplant DM appears to differ by patient age and induction regimen.

Dataset Information

Posttransplant biopsy risk for stable long-term pediatric liver transplant recipients: 451 percutaneous biopsies from two multicenter immunosuppression withdrawal trials.

Publications

Posttransplant biopsy risk for stable long-term pediatric liver transplant recipients: 451 percutaneous biopsies from two multicenter immunosuppression withdrawal trials.

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