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1.
Transplant Direct ; 8(3): e1298, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35368987

ABSTRACT

With the rapid and widespread expansion of smartphone availability and usage, mobile health (mHealth) has become a viable multipurpose treatment medium for the US healthcare system. Methods: The purpose of this review is to identify posttransplant mHealth applications that support patient self-management or a patient-provider relationship and aim to improve clinical outcomes. The interventions were then analyzed and evaluated to identify current gaps and future needs of mHealth apps in solid organ transplantation. Results: The authors found a nearly universal dichotomy between perceived utility and sustained use, with most studies demonstrating significant attrition during the course of the intervention. In addition, interoperability continues to be a challenge. Conclusions: The authors present potential methods for mitigating the identified barriers and gaps in mHealth apps for solid organ transplant recipients.

2.
Ann Pharmacother ; 56(6): 685-690, 2022 06.
Article in English | MEDLINE | ID: mdl-34496669

ABSTRACT

BACKGROUND: Medication safety issues have detrimental implications on long-term outcomes in the high-risk kidney transplant (KTX) population. Medication errors, adverse drug events, and medication nonadherence are important and modifiable mechanisms of graft loss. OBJECTIVE: To describe the frequency and types of interventions made during a pharmacist-led, mobile health-based intervention in KTX recipients and the impact on patient risk levels. METHODS: This was a secondary analysis of data collected during a 12-month, parallel-arm, 1:1 randomized clinical controlled trial including 136 KTX recipients. Participants were randomized to receive either usual care or supplemental, pharmacist-driven medication therapy monitoring and management using a smartphone-enabled app integrated with telemonitoring of blood pressure and glucose (when applicable) and risk-based televisits. The primary outcome was pharmacist intervention type. Secondary outcomes included frequency of interventions and changes in risk levels. RESULTS: A total of 68 patients were randomized to the intervention and included in this analysis. The mean age at baseline was 50.2 years; 51.5% of participants were male, and 58.8% were black. Primary pharmacist intervention types were medication reconciliation and patient education, followed by medication changes. Medication reconciliation remained high throughout the study period, whereas education and medication changes trended downward. From baseline to month 12, we observed an approximately 15% decrease in high-risk patients and a corresponding 15% increase in medium- or low-risk patients. CONCLUSION AND RELEVANCE: A pharmacist-led mHealth intervention may enhance opportunities for pharmacological and nonpharmacological interventions and mitigate risk levels in KTX recipients.


Subject(s)
Kidney Transplantation , Pharmacists , Humans , Male , Medication Adherence , Medication Errors , Medication Reconciliation , Risk Assessment
3.
Am J Transplant ; 21(10): 3428-3435, 2021 10.
Article in English | MEDLINE | ID: mdl-34197699

ABSTRACT

This was an economic analysis of a 12-month, parallel arm, randomized controlled trial in adult kidney recipients 6 to 36 months posttransplant (NCT03247322). All participants received usual posttransplant care, while the intervention arm received supplemental clinical pharmacist-led medication therapy monitoring and management, via a smartphone-enabled mHealth app, integrated with risk-based televisits. Hospitalization charges were captured from the study institution accounts payable and non-study institution hospitalization charges were estimated using multiple imputation. Multivariable modeling was used to assess the impact of the intervention on charges. The intervention significantly reduced rates of hospitalization (1.08 per patient-year in the control arm vs 0.65 per patient-year in the intervention arm, p = .007). The control arm had estimated hospitalization costs of $870,468 vs $390,489 in the intervention arm. Modeling demonstrated a 49% lower hospitalization charge risk in the intervention arm (RR 0.51, 95% CI 0.28-0.91; p = .022). From a payer or societal perspective, the net estimated cost savings, after accounting for intervention delivery costs, was $368,839, with a return on investment (ROI) of $4.30 for every $1 spent. These results demonstrate that a mHealth-enabled, pharmacist-led intervention significantly reduced hospitalization costs for payers over a 12-month period and has a positive ROI.


Subject(s)
Kidney Transplantation , Telemedicine , Adult , Cost Savings , Hospitalization , Humans , Pharmacists
4.
Clin J Am Soc Nephrol ; 16(5): 776-784, 2021 05 08.
Article in English | MEDLINE | ID: mdl-33931415

ABSTRACT

BACKGROUND AND OBJECTIVES: Medication safety events are predominant contributors to suboptimal graft outcomes in kidney transplant recipients. The goal of this study was to examine the efficacy of improving medication safety through a pharmacist-led, mobile health-based intervention. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a 12-month, single-center, prospective, parallel, two-arm, single-blind, randomized controlled trial. Adult kidney recipients 6-36 months post-transplant were eligible. Participants randomized to intervention received supplemental clinical pharmacist-led medication therapy monitoring and management via a mobile health-based application, integrated with risk-guided televisits and home-based BP and glucose monitoring. The application provided an accurate medication regimen, timely reminders, and side effect surveys. Both the control and intervention arms received usual care, including serial laboratory monitoring and regular clinic visits. The coprimary outcomes were to assess the incidence and severity of medication errors and adverse events. RESULTS: In total, 136 kidney transplant recipients were included, 68 in each arm. The mean age was 51 years, 57% were male, and 64% were Black individuals. Participants receiving the intervention experienced a significant reduction in medication errors (61% reduction in the risk rate; incident risk ratio, 0.39; 95% confidence interval, 0.28 to 0.55; P<0.001) and a significantly lower incidence risk of Grade 3 or higher adverse events (incident risk ratio, 0.55, 95% confidence interval, 0.30 to 0.99; P=0.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates of hospitalizations (incident risk ratio, 0.46; 95% confidence interval, 0.27 to 0.77; P=0.005). CONCLUSIONS: We demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health-based intervention.


Subject(s)
Drug Monitoring , Kidney Transplantation , Mobile Applications , Pharmacology, Clinical , Professional Role , Telemedicine , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method
5.
Am J Health Syst Pharm ; 78(14): 1287-1293, 2021 07 09.
Article in English | MEDLINE | ID: mdl-33821958

ABSTRACT

PURPOSE: Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies. METHODS: This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care. RESULTS: Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time. CONCLUSION: This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.


Subject(s)
Kidney Transplantation , Telemedicine , Adult , Graft Rejection/epidemiology , Graft Rejection/prevention & control , Humans , Immunosuppressive Agents , Pharmacists , Tacrolimus
6.
Ther Drug Monit ; 43(3): 401-407, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33560095

ABSTRACT

BACKGROUND: High tacrolimus intrapatient variability (tac IPV) is associated with poor outcomes in kidney transplantation, including rejection, donor-specific antibodies, and graft loss. A common cause of high tac IPV is related to patient nonadherence, but this is yet to be conclusively demonstrated. METHODS: This was a longitudinal cohort study comprising adult kidney recipients, who received transplants between 2015 and 2017, with follow-ups through February 2020. The goal of this study was to identify the most common etiologies of tac levels outside the typical range, which lead to high tac IPV, and assess the etiology-specific associations between high tac IPV and graft outcomes. Multivariate Cox regression was used to assess time-to-event analyses. RESULTS: In total, 537 adult kidney recipients were included; 145 (27%) were identified as having a high tac IPV (>40%) 3-102 months post-transplant. Common etiologies of tac levels significantly outside the standard goal range (6-12 ng/mL) leading to high tac IPV included patient nonadherence (20%), infections (19%), tac-related toxicities (17%), and undocumented issues (27%). In multivariable Cox modeling, those with high tac IPV because of nonadherence had a 3.5 times higher risk of late acute rejection (P = 0.019) and 2.2 times higher risk of late graft loss (P = 0.044). No other etiologies in the typical tac level range were significantly associated with either acute rejection or graft loss. CONCLUSIONS: Although high tac IPV has many causes, only high tac IPV caused by nonadherence is consistently associated with poor allograft outcomes.


Subject(s)
Immunosuppressive Agents , Kidney Transplantation , Tacrolimus , Adult , Aged , Female , Graft Rejection/epidemiology , Graft Rejection/prevention & control , Graft Survival , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/pharmacokinetics , Longitudinal Studies , Male , Middle Aged , Tacrolimus/administration & dosage , Tacrolimus/pharmacokinetics , Transplant Recipients
7.
Ann Pharmacother ; 54(12): 1185-1193, 2020 12.
Article in English | MEDLINE | ID: mdl-32506922

ABSTRACT

BACKGROUND: Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss. OBJECTIVE: The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability. METHODS: A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm. RESULTS: At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs (P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. CONCLUSION AND RELEVANCE: High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.


Subject(s)
Drug Monitoring/methods , Graft Rejection/prevention & control , Immunosuppressive Agents/administration & dosage , Kidney Transplantation , Medication Adherence/statistics & numerical data , Tacrolimus/administration & dosage , Adult , Drug Monitoring/statistics & numerical data , Electronic Health Records , Female , Graft Rejection/epidemiology , Humans , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Prospective Studies , Reminder Systems/statistics & numerical data , Risk Factors , Tacrolimus/therapeutic use , Telemedicine
8.
Am J Transplant ; 20(8): 1969-1983, 2020 08.
Article in English | MEDLINE | ID: mdl-32406604

ABSTRACT

Tacrolimus (Tac) is widely used to prevent rejection and graft loss in solid organ transplantation. A limiting characteristic of Tac is the high intra and interpatient variability associated with its use. Routine therapeutic drug monitoring (TDM) is necessary to facilitate Tac management and to avoid undesirable clinical outcomes. However, whole blood trough concentrations commonly utilized in TDM are not strong predictors of the detrimental clinical outcomes of interest. Recently, researchers have focused on Tac intrapatient variability (Tac IPV) as a novel marker to better assess patient risk. Higher Tac IPV has been associated with a number of mechanisms leading to shortened graft survival. Medication nonadherence (MNA) is considered to be the primary determinant of high Tac IPV and perhaps the most modifiable risk factor. An understanding of the methodology behind Tac IPV is imperative to its recognition as an important prognostic measure and integration into clinical practice. Therapeutic interventions targeting MNA and reducing Tac IPV are crucial to improving long-term graft survival.


Subject(s)
Kidney Transplantation , Tacrolimus , Graft Rejection/drug therapy , Graft Rejection/etiology , Graft Rejection/prevention & control , Graft Survival , Humans , Immunosuppressive Agents/therapeutic use
9.
Clin Transplant ; 34(4): e13844, 2020 04.
Article in English | MEDLINE | ID: mdl-32092187

ABSTRACT

Medication non-adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once-daily immunosuppression regimen of Extended-release-tacrolimus (LCP-tac), everolimus, and prednisone vs LCP-tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post-transplant, patients were randomized to receive LCP-tac and everolimus once daily or LCP-tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well-tolerated, and medication side effect burden tended to be less severe in the intervention group. Self-reported high medication adherence decreased in the control arm from baseline to 6 months (80%-59%), while remaining the same in the intervention arm throughout the study (45%-47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once-daily immunosuppression regimen. The impact of this once-daily regimen on medication adherence requires a larger long-term study.


Subject(s)
Kidney Transplantation , Adult , Aged , Drug Administration Schedule , Female , Graft Rejection/drug therapy , Graft Rejection/etiology , Graft Rejection/prevention & control , Humans , Immunosuppression Therapy , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Pilot Projects , Tacrolimus
10.
HPB (Oxford) ; 22(1): 102-108, 2020 01.
Article in English | MEDLINE | ID: mdl-31405777

ABSTRACT

BACKGROUND: Measures of skeletal muscle abnormalities are rapidly emerging as independent predictors of outcomes after liver transplantation (LT). We describe a simple, novel assessment of myosteatosis acquired prior to liver transplantation using Magnetic Resonance Imaging (MRI) derived fat fraction. METHODS: A retrospective longitudinal cohort study included clinical and biochemical data from patients who underwent liver transplantation at our institution between Feb 2008 and Aug 2014. Patients transplanted for a diagnosis of hepatocellular carcinoma were excluded from the study. The fat fraction of erector spinae muscles was estimated using MRI at the level where muscle volume was highest, with myosteatosis defined at a cut-off value of 0.8. RESULTS: 180 patients were included. At baseline, those with myosteatosis were, on average, older, more likely to be female, and more likely to receive a multi-organ transplant (p < 0.05). Patients with pre-transplant myosteatosis, as delineated by MRI derived fat fraction, also had increased length of hospital stay. CONCLUSION: This preliminary study suggests myosteatosis, as measured by fat fraction on MRI prior to LT, may be associated with increased graft loss and mortality after transplant.


Subject(s)
Adipose Tissue/diagnostic imaging , End Stage Liver Disease/diagnostic imaging , End Stage Liver Disease/surgery , Liver Transplantation , Magnetic Resonance Imaging , Paraspinal Muscles/diagnostic imaging , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Graft Survival , Humans , Infant , Longitudinal Studies , Male , Middle Aged , Reproducibility of Results , Retrospective Studies , Sensitivity and Specificity , Treatment Outcome , Young Adult
11.
Clin Transplant ; 33(10): e13695, 2019 10.
Article in English | MEDLINE | ID: mdl-31421062

ABSTRACT

BACKGROUND: Diabetes mellitus (DM) is associated with increased post-operative complications in various surgeries. Little data exist regarding the impact of long-standing DM (>25 years) on outcomes in pancreas transplantation (PTX). The objectives of our study were to determine if long-standing pre-transplant DM (>25 years) was associated with inferior outcomes following PTX. METHODS: Using a 13-year (April, 2000-May, 2012) retrospective analysis, we examined demographic and transplant factors, complications, and outcomes in patients without (Group A) and with (Group B) long-standing (>25 years) pre-PTX DM. RESULTS: Mean follow-up was 4.2 years. Of 214 consecutive PTX performed, 137 (105 simultaneous PTX (SPK), 25 PTX after kidney (PAK), 7 PTX alone (PTA)) had pre-PTX duration of DM recorded, including 65 in Group A and 72 in Group B. There were no differences between cohorts with respect to demographics. There were no differences in post-PTX surgical/medical complications. There were no differences in outcomes between cohorts (ie, rejection, graft loss or death). CONCLUSIONS: This large-scale analysis demonstrated that PTX can be performed in patients with long-standing DM with excellent patient and graft outcomes. Long-standing DM did not lead to an increased post-PTX infections or complications. Our study suggests that duration of DM should not impact PTX candidacy.


Subject(s)
Diabetes Mellitus, Type 1/surgery , Diabetes Mellitus, Type 2/surgery , Graft Rejection/etiology , Graft Survival , Pancreas Transplantation/adverse effects , Pancreas Transplantation/statistics & numerical data , Postoperative Complications/etiology , Adult , Female , Follow-Up Studies , Humans , Male , Pancreas Transplantation/methods , Prognosis , Retrospective Studies , Risk Factors , Young Adult
12.
Am J Health Syst Pharm ; 76(15): 1143-1149, 2019 Jul 18.
Article in English | MEDLINE | ID: mdl-31361870

ABSTRACT

PURPOSE: The development, testing, and preliminary validation of a technology-enabled, pharmacist-led intervention aimed at improving medication safety and outcomes in kidney transplant recipients are described. SUMMARY: Medication safety issues, encompassing medication errors (MEs), medication nonadherence, and adverse drug events (ADEs), are a predominant cause of poor outcomes after kidney transplantation. However, a limited number of clinical trials assessing the effectiveness of technology in improving medication safety and outcomes in transplant recipients have been conducted. Through an iterative, evidence-based approach, a technology-enabled intervention aimed at improving posttransplant medication safety outcomes was developed, tested, and preliminarily validated. Early acceptability and feasibility results from a prospective, randomized controlled trial assessing the effectiveness of this system are reported here. Of the 120 patients enrolled into the trial at the time of writing, 60 were randomly assigned to receive the intervention. At a mean ± S.D. follow-up of 5.8 ± 4.0 months, there were 2 patient dropouts in the intervention group, resulting in a retention rate of 98%, which was higher than the expected 90% retention rate. CONCLUSION: The development and deployment of a comprehensive medication safety monitoring dashboard for kidney transplant recipients is feasible and acceptable to patients in the current healthcare environment. An ongoing randomized controlled clinical trial is assessing whether such a system reduces MEs and ADRs, leading to improved patient outcomes.


Subject(s)
Drug Monitoring/methods , Evidence-Based Pharmacy Practice/organization & administration , Kidney Transplantation/adverse effects , Telemedicine/organization & administration , Transplant Recipients , Adult , Electronic Health Records/statistics & numerical data , Evidence-Based Pharmacy Practice/methods , Female , Graft Rejection/epidemiology , Graft Rejection/prevention & control , Graft Survival , Health Plan Implementation , Humans , Immunosuppressive Agents/therapeutic use , Internet , Male , Medication Adherence , Medication Errors/prevention & control , Mobile Applications , Pharmacists/organization & administration , Professional Role , Program Development , Prospective Studies , Smartphone , Telemedicine/methods , Young Adult
14.
J Surg Res ; 222: 195-202.e2, 2018 02.
Article in English | MEDLINE | ID: mdl-29100587

ABSTRACT

BACKGROUND: There are only a limited number of studies that have sought to identify patients at high risk for medication errors and subsequent adverse clinical outcomes. This study sought to identify risk factors for increased health care resource utilization in kidney transplant recipients based on drug-related problems and self-administered surveys. METHODS: In this prospective observational study, adult kidney transplant recipients seen in the transplant clinic between September and November 2015 were surveyed for self-reported demographics, medication adherence, and health status/outlook. Subsequently, patients were assessed for associations between survey results, pharmacist-derived drug-related problems, and health resource utilization over a minimum 6-mo follow-up period. Based on univariate associations, two risk cohorts were identified and compared for health care utilization using multivariable Poisson regression. RESULTS: A total of 237 patients were included, with a mean follow-up of 8 mo. From the patient survey data, Medicaid insured or self-rated poor health status were identified as a significant risk cohort. From pharmacist assessments, those who received incorrect medication or lacked appropriate follow-up medication monitoring were identified as a significant risk cohort (pharmacy errors). The Medicaid insured or self-rated poor health status cohort experienced 43% more total health care encounters (incident rate ratios [IRR] 1.43, 1.01-2.02) and 35% more transplant clinic visits (IRR 1.35, 1.03-1.77). The pharmacy errors cohort experienced 4.2 times the rate of total health care encounters (IRR 4.17, 1.55-11.2), 4.1 times the rate of hospital readmissions (IRR 4.09, 1.58-10.6), and 2.3 times the rate of transplant clinic visits (IRR 2.31, 1.04-5.11). CONCLUSIONS: Medicaid insurance, self-rated poor health status, and errors in the medication regimen or monitoring were significant risk factors for increased health care utilization in kidney transplant recipients. Further research is warranted to validate these potential risk factors, determine the long-term impact on graft/patient survival, and assess the mutability of these risks through prospective identification and intervention.


Subject(s)
Kidney Transplantation/rehabilitation , Patient Acceptance of Health Care/statistics & numerical data , Adult , Aged , Female , Humans , Kidney Transplantation/statistics & numerical data , Male , Middle Aged , Prospective Studies
15.
Surgery ; 163(2): 430-435, 2018 02.
Article in English | MEDLINE | ID: mdl-29174434

ABSTRACT

BACKGROUND: The incidence and impact of adverse drug events (ADEs) leading to hospitalization and as a predominant risk factor for late graft loss has not been studied in transplantation. METHODS: This was a longitudinal cohort study of adult kidney recipients transplanted between 2005 and 2010 and followed through 2013. There were 3 cohorts: no readmissions, readmissions not due to an adverse drug event, and adverse drug events contributing to readmissions. The rationale of the adverse drug events contribution to the readmission was categorized in terms of probability, preventability, and severity. RESULTS: A total of 837 patients with 963 hospital readmissions were included; 47.9% had at least one hospital readmission and 65.0% of readmissions were deemed as having an ADE contribute. The predominant causes of readmissions related to ADEs included non-opportunistic infections (39.6%), opportunistic infections (10.5%), rejection (18.1%), and acute kidney injury (11.8%). Over time, readmissions due to under-immunosuppression (rejection) significantly decreased (-1.6% per year), while those due to over-immunosuppression (infection, cancer, or cytopenias) significantly increased (2.1% increase per year [difference 3.7%, P = .026]). Delayed graft function, rejection, creatinine, graft loss, and death were all significantly greater in those with an ADE that contributed to a readmission compared the other two cohorts (P < .05). CONCLUSION: These results demonstrate that ADEs may be associated with a significant increase in the risk of hospital readmission after kidney transplant and subsequent graft loss.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Kidney Transplantation/mortality , Patient Readmission/statistics & numerical data , Adult , Aged , Female , Humans , Longitudinal Studies , Male , Middle Aged , Retrospective Studies , South Carolina/epidemiology
17.
Transpl Infect Dis ; 19(6)2017 Dec.
Article in English | MEDLINE | ID: mdl-28921781

ABSTRACT

BACKGROUND: With the advent of effective antivirals against cytomegalovirus (CMV), use of CMV hyperimmune globulin (HIG) has decreased. Although antiviral prophylaxis in patients at high risk for CMV is effective, many patients still have late infection, never developing antibodies sufficient to achieve immunity. Utilizing a combination of antiviral and CMV HIG may allow patients to achieve immunity and decrease late CMV infections. METHODS: This was a prospective randomized, open-label, pilot study comparing valganciclovir (VGCV) prophylaxis for 200 days vs VGCV for 100 days followed by CMV HIG in abdominal transplant recipients at high risk for CMV. The primary outcome was a comparison of late CMV disease. RESULTS: Forty patients were randomized to VGCV for 200 days (n = 20) or VGCV for 100 days followed by 3 doses of monthly CMV HIG (n = 20). Numerically, more overall CMV infections occurred in the CMV HIG group (45 vs 20%, P = .09). No differences in overall CMV infections or late CMV disease were seen between groups (20% vs 15%, P = 1.00 and 0 vs 0, P = 1.00). All CMV disease occurred within 200 days, with 63% occurring while patients were on VGCV. No differences were found in toxicities, graft function, or rejection between groups. Patients with CMV infection at any time had a higher body weight than those who did not have an infection (82 vs 95 kg, P = .049). CONCLUSION: Use of CMV HIG sequentially with prophylaxis may be an effective and affordable prophylactic regimen in abdominal transplant recipients at high risk for CMV, and warrants larger prospective study. Increased monitoring for patients with obesity may be warranted.


Subject(s)
Antibiotic Prophylaxis/methods , Antiviral Agents/therapeutic use , Cytomegalovirus Infections/prevention & control , Ganciclovir/analogs & derivatives , Immunoglobulins/therapeutic use , Kidney Transplantation/adverse effects , Liver Transplantation/adverse effects , Adult , Antiviral Agents/administration & dosage , Combined Modality Therapy/methods , Cytomegalovirus/immunology , Cytomegalovirus Infections/immunology , Drug Administration Schedule , Female , Ganciclovir/administration & dosage , Ganciclovir/therapeutic use , Graft Rejection/epidemiology , Humans , Immunization, Passive/methods , Immunoglobulins/administration & dosage , Immunoglobulins, Intravenous , Male , Middle Aged , Pilot Projects , Prospective Studies , Time Factors , Transplant Recipients , Valganciclovir
18.
Transplantation ; 101(12): 2931-2938, 2017 12.
Article in English | MEDLINE | ID: mdl-28658199

ABSTRACT

BACKGROUND: Low tacrolimus concentrations have been associated with higher risk of acute rejection, particularly within African American (AA) kidney transplant recipients; little is known about intrapatient tacrolimus variabilities impact on racial disparities. METHODS: Ten year, single-center, longitudinal cohort study of kidney recipients. Intrapatient tacrolimus variability was assessed using the coefficient of variation (CV) measured between 1 month posttransplant and the clinical event, with a comparable period assessed in those without events. Pediatrics, nontacrolimus/mycophenolate regimens, and nonrenal transplants were excluded. Multivariable Cox regression models were used to analyze data. RESULTS: One thousand four hundred eleven recipients were included (54.4% AA) with 39 521 concentrations used to assess intrapatient tacrolimus CV. Overall, intrapatient tacrolimus CV was higher in AAs versus non-AAs (39.9 ± 19.8 % vs 34.8 ± 15.8% P < 0.001). Tacrolimus variability was a significant risk factor for deleterious clinical outcomes. A 10% increase in tacrolimus CV augmented the risk of acute rejection by 20% (adjusted hazard ratio, 1.20, 1.13-1.28; P < 0.001) and the risk of graft loss by 30% (adjusted hazard ratio, 1.30, 1.23-1.37; P < 0.001), with significant effect modification by race for acute rejection, but not graft loss. High tacrolimus variability (CV >40%) was a significant explanatory variable for disparities in AAs; the crude relative risk of acute rejection in AAs was reduced by 46% when including tacrolimus variability in modeling and reduced by 40% for graft loss. CONCLUSIONS: These data demonstrate that intrapatient tacrolimus variability is strongly associated with acute rejection in AAs and graft loss in all patients. Tacrolimus variability is a significant explanatory variable for disparities in AA recipients.


Subject(s)
Immunosuppressive Agents/pharmacokinetics , Kidney Transplantation , Renal Insufficiency/surgery , Tacrolimus/pharmacokinetics , Adolescent , Adult , Black or African American , Drug Administration Schedule , Electronic Health Records , Female , Graft Rejection , Graft Survival , Healthcare Disparities , Humans , Immunosuppressive Agents/therapeutic use , Longitudinal Studies , Male , Middle Aged , Proportional Hazards Models , Renal Insufficiency/ethnology , Risk Factors , Tacrolimus/therapeutic use , Time Factors , United States , Young Adult
19.
Transpl Infect Dis ; 19(5)2017 Oct.
Article in English | MEDLINE | ID: mdl-28644910

ABSTRACT

The potential for transmission of Babesia microti by blood transfusion is well recognized. Physicians may be unaware that products used for transfusion may be collected from geographically diverse regions. We describe a liver transplant recipient in South Carolina who likely acquired B. microti infection from a unit of blood collected in Minnesota.


Subject(s)
Babesia/isolation & purification , Babesiosis/blood , Babesiosis/microbiology , Blood Transfusion , Liver Transplantation/adverse effects , Anti-Bacterial Agents/therapeutic use , Antimalarials/therapeutic use , Blood Donors , Clindamycin/therapeutic use , Exchange Transfusion, Whole Blood , Humans , Male , Middle Aged , Quinidine/analogs & derivatives , Quinidine/therapeutic use
20.
Ann Surg ; 266(3): 450-456, 2017 09.
Article in English | MEDLINE | ID: mdl-28654544

ABSTRACT

OBJECTIVE: Determine the impact of cytolytic versus IL-2 receptor antibody (IL-2RA) induction on acute rejection, graft loss and death in African-American (AA) kidney transplant (KTX) recipients. BACKGROUND: AAs are underrepresented in clinical trials in transplantation; thus, there is controversy regarding the optimal choice of perioperative antibody induction in KTX to improve outcomes. METHODS: National cohort study using US transplant registry data from January 1, 2000 to December 31, 2009 in adult solitary AA KTX recipients, with at least 5 years of follow-up. Multivariable logistic and Cox regression were utilized to assess the outcomes of acute rejection, graft loss, and mortality, with interaction terms to assess effect modification. RESULTS: Twenty-five thousand eighty-four adult AAs receiving solitary KTX were included, 16,927 (67.5%) received cytolytic induction and 8157 (32.5%) received IL-2RA induction. After adjustment for recipient sociodemographics, donor, and transplant characteristics, the use of cytolytic induction therapy reduced the risk of acute rejection by 32% (OR 0.68, 0.62-0.75), graft loss by 9% (HR 0.91, 0.86-0.97), and death by 12% (HR 0.88, 0.83-0.94). There were a number of significant effect modifiers, including public insurance, panel reactive antibody, delayed graft function, and steroid withdrawal; in these groups, cytolytic induction substantially improved clinical outcomes. CONCLUSIONS: These data demonstrate that cytolytic induction therapy, as compared with IL-2RA, reduces the risk of rejection, graft loss, and death in adult AA KTX recipients, particularly in those who are sensitized, receive public insurance, develop delayed graft function, or undergo steroid withdrawal.


Subject(s)
Black or African American , Graft Rejection/prevention & control , Immunosuppressive Agents/therapeutic use , Induction Chemotherapy/methods , Kidney Transplantation/mortality , Adolescent , Adult , Aged , Aged, 80 and over , Alemtuzumab , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antilymphocyte Serum/therapeutic use , Basiliximab , Daclizumab , Female , Follow-Up Studies , Graft Rejection/ethnology , Graft Rejection/mortality , Humans , Immunoglobulin G/therapeutic use , Logistic Models , Male , Middle Aged , Muromonab-CD3/therapeutic use , Proportional Hazards Models , Recombinant Fusion Proteins/therapeutic use , Registries , Retrospective Studies , Treatment Outcome , United States , Young Adult
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