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  • Arvind A
  • Seif El Dahan K
  • Malhotra R
  • Daher D
  • Rich NE
  • et al.
Liver Transpl. 2024 Jun 1;30(6):595-606 doi: 10.1097/LVT.0000000000000357.

Liver transplantation is the curative therapy of choice for patients with early-stage HCC. Locoregional therapies are often employed as a bridge to reduce the risk of waitlist dropout; however, their association with posttransplant outcomes is unclear. We conducted a systematic review using Ovid MEDLINE and EMBASE to identify studies published between database inception and August 2, 2023, which reported posttransplant recurrence-free survival and overall survival among patients transplanted for HCC within Milan criteria, stratified by receipt of bridging therapy. Pooled HRs were calculated for each outcome using the DerSimonian and Laird method for a random-effects model. We identified 38 studies, including 19,671 patients who received and 20,148 patients who did not receive bridging therapy. Bridging therapy was not associated with significant differences in recurrence-free survival (pooled HR: 0.91, 95% CI: 0.77-1.08; I2 =39%) or overall survival (pooled HR: 1.09, 95% CI: 0.95-1.24; I2 =47%). Results were relatively consistent across subgroups, including geographic location and study period. Studies were discordant regarding the differential strength of association by pretreatment tumor burden and pathologic response, but potential benefits of locoregional therapy were mitigated in those who received 3 or more treatments. Adverse events were reported in a minority of studies, but when reported occurred in 6%-15% of the patients. Few studies reported loss to follow-up and most had a risk of residual confounding. Bridging therapy is not associated with improvements in posttransplant recurrence-free or overall survival among patients with HCC within Milan criteria. The risk-benefit ratio of bridging therapy likely differs based on the risk of waitlist dropout.

  • Bellamy COC
  • O'Leary JG
  • Adeyi O
  • Baddour N
  • Batal I
  • et al.
Am J Transplant. 2024 Jun;24(6):905-917 doi: 10.1016/j.ajt.2024.03.008.

The Banff Working Group on Liver Allograft Pathology met in September 2022. Participants included hepatologists, surgeons, pathologists, immunologists, and histocompatibility specialists. Presentations and discussions focused on the evaluation of long-term allograft health, including noninvasive and tissue monitoring, immunosuppression optimization, and long-term structural changes. Potential revision of the rejection classification scheme to better accommodate and communicate late T cell-mediated rejection patterns and related structural changes, such as nodular regenerative hyperplasia, were discussed. Improved stratification of long-term maintenance immunosuppression to match the heterogeneity of patient settings will be central to improving long-term patient survival. Such personalized therapeutics are in turn contingent on a better understanding and monitoring of allograft status within a rational decision-making approach, likely to be facilitated in implementation with emerging decision-support tools. Proposed revisions to rejection classification emerging from the meeting include the incorporation of interface hepatitis and fibrosis staging. These will be opened to online testing, modified accordingly, and subject to consensus discussion leading up to the next Banff conference.

  • Vidnes TK
  • Wahl AK
  • Larsen MH
  • Meyer KB
  • Engebretsen E
  • et al.
Patient Educ Couns. 2024 Jun;123:108207 doi: 10.1016/j.pec.2024.108207.
OBJECTIVE:

This study aimed to evaluate the effect of a new health communication intervention focusing on knowledge management skills on health literacy and medication adherence during the first year following kidney transplantation.

METHODS:

We randomized 195 patients during 2020-2021, to either intervention- or control group. Questionnaires were completed at baseline and at 12 months post-transplantation with a 12-month response rate of 84%. Health literacy was measured by the multidimensional Health Literacy Questionnaire (HLQ) instrument. Medication adherence was measured by the self-reported questionnaire (BAASIS©).

RESULTS:

Results showed that the intervention group had a significant increase in 2 HLQ domains compared to the control group capturing the "ability to appraise health information" Domain 5, (p-value = 0.002) and the "ability to navigate the healthcare system" Domain 7, (p-value <0.04). The effect sizes of SRM were 0.49 (Domain 5) and 0.33 (Domain 7). Medication adherence was comparable in the groups at any measure points.

CONCLUSIONS:

This study contributes to important knowledge about how a health communication intervention focusing on knowledge translation using motivational interviewing techniques positively strengthens health literacy in kidney transplant recipients.

PRACTICAL IMPLICATIONS:

Current patient education practice may benefit from focusing on knowledge translation in combination with motivational interview technique.

  • Czigany Z
  • Putri AJ
  • Michalski CW
  • Mehrabi A
Hepatology. 2024 Jun 1;79(6):E165-E166 doi: 10.1097/HEP.0000000000000811.
  • Kumar N
  • Fitzsimons MG
  • Iyer MH
  • Essandoh M
  • Kumar JE
  • et al.
J Heart Lung Transplant. 2024 Jun;43(6):931-943 doi: 10.1016/j.healun.2024.02.1458.
BACKGROUND:

Vasoplegic syndrome (VS) is a common occurrence during heart transplantation (HT). It currently lacks a uniform definition between transplant centers, and its pathophysiology and treatment remain enigmatic. This systematic review summarizes the available published clinical data regarding VS during HT.

METHODS:

We searched databases for all published reports on VS during HT. Data collected included the incidence of VS in the HT population, patient and intraoperative characteristics, and postoperative outcomes.

RESULTS:

Twenty-two publications were included in this review. The prevalence of VS during HT was 28.72% (95% confidence interval: 27.37%, 30.10%). Factors associated with VS included male sex, higher body mass index, hypothyroidism, pre-HT left ventricular assist device or venoarterial extracorporeal membrane oxygenation (VA-ECMO), pre-HT calcium channel blocker or amiodarone usage, longer cardiopulmonary bypass time, and higher blood product transfusion requirement. Patients who developed VS were more likely to require postoperative VA-ECMO support, renal replacement therapy, reoperation for bleeding, longer mechanical ventilation, and a greater 30-day and 1-year mortality.

CONCLUSIONS:

The results of our systematic review are an initial step for providing clinicians with data that can help identify high-risk patients and avenues for potential risk mitigation. Establishing guidelines that officially define VS will aid in the precise diagnosis of these patients during HT and guide treatment. Future studies of treatment strategies for refractory VS are needed in this high-risk patient population.

  • Mortensen LA
  • Jespersen B
  • Helligsoe ASL
  • Tougaard B
  • Cibulskyte-Ninkovic D
  • et al.
Clin J Am Soc Nephrol. 2024 Jun 1;19(6):755-766 doi: 10.2215/CJN.0000000000000439.
  • Kim J
  • Joh JW
  • Lee KW
  • Choi DL
  • Wang HJ
Ann Hepatobiliary Pancreat Surg. 2024 May 31;28(2):238-247 doi: 10.14701/ahbps.23-129.
CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: Kim et al in this small RCT have found an unexpected counter to the classical narrative that prolonged steroid use is associated with NODAT. In the per protocol patients, the NODAT rate was 32.4% in the cohort who had early withdrawal of steroids (2 weeks) compared to only 10% in those that had a standard steroid regimen of 3 months (p=0.029). They found no significant differences in outcomes related to acute rejection, CKD, infection rate, graft failure, or death between the two groups. Suggesting, in this study, that if it were not for the increased risk of NODAT it is safe to withdraw steroids early. While the findings are interesting, they have limited generalisability for several reasons. Only 58% of the patients randomised were included in the analysis, with over a third of patients discontinuing their steroids early, which has limited the power of the study. The RCT was not blinded, which given that it would have been straightforward to provide a placebo for the steroids after early discontinuation and blind both patient and clinician. Finally, the study was performed in a very specific population, a single centre in Korea, in which race, diet, genetic background, and primary liver disease aetiology differ significantly from other parts of the world. Given the contrast to RCTs of Western and Indian populations in the incidence of NODAT relating to steroid use and duration, a larger, multicentre, blinded study should be conducted in this population with a longer follow-up duration to ensure the manifestation of cardiovascular events, graft loss and mortality are captured.
Aims: To assess if early steroid withdrawal after liver transplantation influences the rate of new onset diabetes after transplant (NODAT).
Interventions: Intervention group underwent early steroid withdrawal at 2 weeks, compared to standard care who underwent withdrawal at 3 months.
Participants: 115 adult (aged 20-70) liver transplant recipients from deceased or living donors.
Outcomes: The primary outcome measure was NODAT in the 12 months following transplant, secondary outcomes were: biopsy proven acute rejection, time to episode of rejection, failure of rejection treatment, the occurrence of chronic kidney disease (CKD), graft failure, and/or patient mortality.
Follow Up: 12-months following liver transplantation.
BACKGROUNDS/AIMS:

Prolonged use of steroids after liver transplantation (LT) significantly increases the risk of diabetes or cardiovascular disease, which can adversely affect patient outcomes. Our study evaluated the effectiveness and safety of early steroid withdrawal within the first year following LT.

METHODS:

This study was conducted as an open-label, multicenter, randomized controlled trial. Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation. This study included participants aged 20 to 70 years who were scheduled to undergo a single-organ liver transplant from a living or deceased donor at one of the four participating centers.

RESULTS:

Between November 2012 and August 2020, 115 patients were selected and randomized into two groups, with 60 in Group 1 and 55 in Group 2. The incidence of new-onset diabetes after transplantation (NODAT) was notably higher in Group 1 (32.4%) than in Group 2 (10.0%) in the per-protocol set. Although biopsy-proven acute rejection, graft failure, and mortality did not occur, the median tacrolimus trough level/dose/weight in Group 1 exceeded that in Group 2. No significant differences in safety parameters, such as infection and recurrence of hepatocellular carcinoma, were observed between the two groups.

CONCLUSIONS:

The present study did not find a significant reduction in the incidence of NODAT in the early steroid withdrawal group. Our study suggests that steroid withdrawal three months posttransplantation is a standard and safe immunosuppressive strategy for LT patients.

  • Bates A
  • Letton ME
  • Arnold R
  • Lambert K
J Ren Care. 2024 May 28; doi: 10.1111/jorc.12497.
BACKGROUND:

Exercise has the potential to reduce the susceptibility to comorbidity and cardiovascular disease in kidney transplant recipients. However, kidney transplant recipients report lower levels of exercise compared to the general population, prompting an investigation into the barriers and enablers to exercise in this transplant cohort.

OBJECTIVES:

This systematic review aimed to explore and map the barriers and enablers to exercise in kidney transplant recipients.

METHODS:

Seven electronic databases were systematically searched. Themes were synthesised and then deductively categorised using the Theoretical Domains Framework.

RESULTS:

Eleven studies were included in the review. Commonly reported barriers to exercise were lack of exercise guidance (n = 9 studies), physical limitations (n = 5 studies) and a fear of harming the kidney (n = 7 studies). Enablers were a desire to return to normality (n = 5 studies), physical and mental benefits (n = 3 studies), goal setting and tracking improvements (n = 3 studies). At the local level, barriers identified by kidney transplant recipients were a lack of knowledge, fear of injuring the kidney, bad weather and physical limitations. Perceived enablers were already living an active lifestyle, mental benefits, exercise preferences and social support.

CONCLUSION:

Key findings of this research were an increased demand for specific/explicit exercise information regarding type and intensity, and personalised guidance and support for kidney transplant recipients after transplantation. These findings can be used to inform the development of exercise resources and interventions for kidney transplant recipients and their health care professionals within the local community and at a greater level.

  • Mayer KA
  • Schrezenmeier E
  • Diebold M
  • Halloran PF
  • Schatzl M
  • et al.
N Engl J Med. 2024 May 25; doi: 10.1056/NEJMoa2400763.
BACKGROUND:

Antibody-mediated rejection is a leading cause of kidney-transplant failure. The targeting of CD38 to inhibit graft injury caused by alloantibodies and natural killer (NK) cells may be a therapeutic option.

METHODS:

In this phase 2, double-blind, randomized, placebo-controlled trial, we assigned patients with antibody-mediated rejection that had occurred at least 180 days after transplantation to receive nine infusions of the CD38 monoclonal antibody felzartamab (at a dose of 16 mg per kilogram of body weight) or placebo for 6 months, followed by a 6-month observation period. The primary outcome was the safety and side-effect profile of felzartamab. Key secondary outcomes were renal-biopsy results at 24 and 52 weeks, donor-specific antibody levels, peripheral NK-cell counts, and donor-derived cell-free DNA levels.

RESULTS:

A total of 22 patients underwent randomization (11 to receive felzartamab and 11 to receive placebo). The median time from transplantation until trial inclusion was 9 years. Mild or moderate infusion reactions occurred in 8 patients in the felzartamab group. Serious adverse events occurred in 1 patient in the felzartamab group and in 4 patients in the placebo group; graft loss occurred in 1 patient in the placebo group. After week 24, resolution of morphologic antibody-mediated rejection was more frequent with felzartamab (in 9 of 11 patients [82%]) than with placebo (in 2 of 10 patients [20%]), for a difference of 62 percentage points (95% confidence interval [CI], 19 to 100) and a risk ratio of 0.23 (95% confidence interval [CI], 0.06 to 0.83). The median microvascular inflammation score was lower in the felzartamab group than in the placebo group (0 vs. 2.5), for a mean difference of -1.95 (95% CI, -2.97 to -0.92). Also lower was a molecular score reflecting the probability of antibody-mediated rejection (0.17 vs. 0.77) and the level of donor-derived cell-free DNA (0.31% vs. 0.82%). At week 52, the recurrence of antibody-mediated rejection was reported in 3 of 9 patients who had a response to felzartamab, with an increase in molecular activity and biomarker levels toward baseline levels.

CONCLUSIONS:

Felzartamab had acceptable safety and side-effect profiles in patients with antibody-mediated rejection. (Funded by MorphoSys and Human Immunology Biosciences; ClinicalTrials.gov number, NCT05021484; and EUDRACT number, 2021-000545-40.).

  • Panicker AJ
  • Prokop LJ
  • Hacke K
  • Jaramillo A
  • Griffiths LG
J Heart Lung Transplant. 2024 May 23; doi: 10.1016/j.healun.2024.05.012.
BACKGROUND:

Current monitoring after heart transplantation (HT) employs repeated invasive endomyocardial biopsies (EMB). Although positive EMB confirms rejection, EMB fails to predict impending, sub-clinical, or EMB-negative rejection events. While non-HLA antibodies have emerged as important risk factors for antibody-mediated rejection (AMR) after HT, their use in clinical risk stratification has been limited. A systematic review of the role of non-HLA antibodies in rejection pathologies has potential to guide efforts to overcome deficiencies of EMB in rejection monitoring.

METHODS:

Databases were searched to include studies on non-HLA antibodies in HT recipients. Data collected included: number of patients, type of rejection, non-HLA antigen studied, association of non-HLA antibodies with rejection, and evidence for synergistic interaction between non-HLA antibodies and HLA-DSA responses.

RESULTS:

A total of 56 studies met the inclusion criteria. Strength of evidence for each non-HLA antibody was evaluated based on the number of articles and patients in support vs. against their role in mediating rejection. Importantly, despite previous intense focus on the role of anti-MHC class I chain-related gene A (MICA) and anti-angiotensin II type I receptor (AT1R) antibodies in HT rejection, evidence for their involvement was equivocal. Conversely, strength of evidence for other non-HLA antibodies supports that differing rejection pathologies are driven by differing non-HLA antibodies.

CONCLUSION:

This systematic review underscores the importance of identifying peri-HT non-HLA antibodies. Current evidence supports the role of non-HLA antibodies in all forms of HT rejection. Further investigations are required to define the mechanisms of action of non-HLA antibodies in HT rejection.