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1.
Pharmacogenet Genomics ; 33(3): 59-65, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36877088

ABSTRACT

OBJECTIVES: LCP tac has a recommended starting dose of 0.14 mg/kg/day in kidney transplant. The goal of this study was to assess the influence of CYP3A5 on perioperative LCP tac dosing and monitoring. METHODS: This was a prospective observational cohort study of adult kidney recipients receiving de-novo LCP tac. CYP3A5 genotype was measured and 90-day pharmacokinetic and clinical were assessed. Patients were classified as CYP3A5 expressors (*1 homozygous or heterozygous) or nonexpressors (LOF *3/*6/*7 allele). RESULTS: In this study, 120 were screened, 90 were contacted and 52 provided consent; 50 had genotype results, and 22 patients expressed CYP3A5*1. African Americans (AA) comprised 37.5% of nonexpressors versus 81.8% of expressors (P = 0.001). Initial LCP tac dose was similar between CYP3A5 groups (0.145 vs. 0.137 mg/kg/day; P = 0.161), whereas steady state dose was higher in expressors (0.150 vs. 0.117 mg/kg/day; P = 0.026). CYP3A5*1 expressors had significantly more tac trough concentrations of less than 6 ng/ml and significantly fewer tac trough concentrations of more than 14 ng/ml. Providers were significantly more likely to under-adjust LCP tac by 10 and 20% in CYP3A5 expressors versus nonexpressors (P < 0.03). In sequential modeling, CYP3A5 genotype status explained the LCP tac dosing requirements significantly more than AA race. CONCLUSION: CYP3A5*1 expressors require higher doses of LCP tac to achieve therapeutic concentrations and are at higher risk of subtherapeutic trough concentrations, persisting for 30-day posttransplant. LCP tac dose changes in CYP3A5 expressors are more likely to be under-adjusted by providers.


Subject(s)
Cytochrome P-450 CYP3A , Kidney Transplantation , Tacrolimus , Adult , Humans , Cytochrome P-450 CYP3A/genetics , Genotype , Prospective Studies , Tacrolimus/administration & dosage
2.
Clin Transplant ; 37(12): e15149, 2023 12.
Article in English | MEDLINE | ID: mdl-37788162

ABSTRACT

Outcomes analyzing conversion from IR-tacrolimus (IR) to LCP-tacrolimus (LCP) in obesity are limited. This was a retrospective longitudinal cohort study of patients converted from IR to LCP from June 2019 to October 2020. Primary outcomes were conversion ratios for weight-based dose at a steady-state therapeutic level and identification of appropriate dosing weight. Other outcomes included tacrolimus coefficient of variation (CV), time in therapeutic range (TITR), adverse events, infections, donor specific antibodies (DSAs), and acute rejection. A total of 292 patients were included; 156 and 136 patients with a BMI < 30 and BMI ≥ 30 kg/m2 , respectively. Baseline characteristics were similar, except for pancreas transplant, diabetes, and HLA mismatch. IR to LCP conversion ratio ranged from .73 to .79. Mean LCP dose was similar (.08 vs. .07 mg/kg/day for BMI < 30 and BMI ≥ 30 kg/m2 , respectively); there was a significant difference in IR and LCP mg/kg dosing at steady state with TBW (.11 mg/kg vs.09 mg/kg and .08 mg/kg vs. .06 mg/kg, respectively). The most appropriate dosing weight was adjusted body weight (AdjBW), consistent across IR and LCP steady-state doses, and might yield more accurate steady-state dosing requirements. In multivariable modeling, BMI was a significant predictor of steady state mg/kg dosing at therapeutic goal for total body weight (TBW), but not ideal body weight (IBW) or AdjBW.


Subject(s)
Kidney Transplantation , Tacrolimus , Humans , Tacrolimus/therapeutic use , Immunosuppressive Agents/therapeutic use , Kidney Transplantation/adverse effects , Retrospective Studies , Longitudinal Studies , Delayed-Action Preparations , Drug Administration Schedule , Obesity/drug therapy , Obesity/surgery , Obesity/etiology , Transplant Recipients , Graft Rejection/drug therapy , Graft Rejection/etiology
3.
Clin Transplant ; 37(5): e14941, 2023 05.
Article in English | MEDLINE | ID: mdl-36809653

ABSTRACT

BACKGROUND: The influence of converting to once daily, extended-release LCP-Tacrolimus (Tac) for those with high tacrolimus variability in kidney transplant recipients (KTRs) is not well-studied. METHODS: Single-center, retrospective cohort study of adult KTRs converted from Tac immediate release to LCP-Tac 1-2 years post-transplant. Primary measures were Tac variability, using the coefficient of variation (CV) and time in therapeutic range (TTR), as well as clinical outcomes (rejection, infections, graft loss, death). RESULTS: A total of 193 KTRs included with a follow-up of 3.2 ± .7 years and 1.3 ± .3 years since LCP-Tac conversion. Mean age was 52 ± 13 years; 70% were African American, 39% were female, 16% living donor and 12% donor after cardiac death (DCD). In the overall cohort, tac CV was 29.5% before conversion, which increased to 33.4% after LCP-Tac (p = .008). In those with Tac CV >30% (n = 86), conversion to LCP-Tac reduced variability (40.6% vs. 35.5%; p = .019) and for those with Tac CV >30% and nonadherence or med errors (n = 16), LCP-Tac conversion substantially reduced Tac CV (43.4% vs. 29.9%; p = .026). TTR significantly improved for those with Tac CV >30% with (52.4% vs. 82.8%; p = .027) or without nonadherence or med errors (64.8% vs. 73.2%; p = .005). CMV, BK, and overall infections were significantly higher prior to LCP-Tac conversion. In the overall cohort, 3% had rejection before conversion and 2% after (p = NS). At end of follow-up, graft and patient survival were 94% and 96%, respectively. CONCLUSIONS: In those with high Tac CV, conversion to LCP-Tac is associated with a significant reduction in variability and improvement in TTR, particularly in those with nonadherence or medication errors.


Subject(s)
Kidney Transplantation , Tacrolimus , Adult , Humans , Female , Middle Aged , Aged , Male , Tacrolimus/therapeutic use , Immunosuppressive Agents/therapeutic use , Retrospective Studies , Transplant Recipients , Graft Rejection/drug therapy , Graft Rejection/etiology
4.
Clin Transplant ; 37(5): e14944, 2023 05.
Article in English | MEDLINE | ID: mdl-36794749

ABSTRACT

Diabetes (DM) is a common comorbidity in transplant patients with known effects on gastrointestinal (GI) motility and absorption; however, DM's impact on immediate release (IR) tacrolimus to LCP-tacrolimus (LCP) conversion ratios has not been studied. This multivariable analysis of a retrospective longitudinal cohort study included kidney transplant recipients converted from IR to LCP between 2019 and 2020. The primary outcome was IR to LCP conversion ratio based on DM status. Other outcomes included tacrolimus variability, rejection, graft loss, and death. Of the 292 patients included, 172 patients had DM and 120 did not. The IR:LCP conversion ratio was significantly higher with DM (67.5% ± 21.1% no DM vs. 79.8% ± 28.7% in DM; P < .001). In multivariable modeling, DM was the only variable significantly and independently associated with IR:LCP conversion ratios. No difference was observed in rejection rates. Graft (97.5% no DM vs. 92.4% in DM; P = .062) and patient survival (100% no DM vs. 94.8% in DM; P = .011) were lower with DM. The presence of DM significantly increased the IR:LCP conversion ratio by 13%-14%, compared to patients without DM. On multivariable analysis, DM was the only significant predictor of conversion ratios, potentially related to GI motility or absorption differences.


Subject(s)
Diabetes Mellitus , Tacrolimus , Humans , Tacrolimus/therapeutic use , Immunosuppressive Agents/therapeutic use , Retrospective Studies , Longitudinal Studies , Delayed-Action Preparations , Graft Rejection/etiology , Diabetes Mellitus/drug therapy
5.
Am J Transplant ; 22(8): 1958-1962, 2022 08.
Article in English | MEDLINE | ID: mdl-35451211

ABSTRACT

During the early wave of the COVID-19 pandemic, the Scientific Registry of Transplant Recipients (SRTR) designated a "black out" period between March 12, 2020, and June 12, 2020, for transplant outcomes reporting. We discuss the implications and potential bias it has introduced as it may selectively favor the outcomes for certain regions and harm other regions due to varied effects of different waves of COVID-19 infections across the United States.


Subject(s)
COVID-19 , Organ Transplantation , Tissue and Organ Procurement , Transplants , COVID-19/epidemiology , Humans , Pandemics , Registries , Transplant Recipients , United States/epidemiology
6.
Am J Kidney Dis ; 80(6): 707-717, 2022 12.
Article in English | MEDLINE | ID: mdl-35301050

ABSTRACT

RATIONALE & OBJECTIVE: The national kidney allocation system (KAS) implemented in December 2014 in the United States redefined the start of waiting time from the time of waitlisting to the time of kidney failure. Waitlisting has declined post-KAS, but it is unknown if this is due to transplant center practices or changes in dialysis facility referral and evaluation. The purpose of this study was to assess the impact of the 2014 KAS policy change on referral and evaluation for transplantation among a population of incident and prevalent patients with kidney failure. STUDY DESIGN: Cohort study. SETTING & PARTICIPANTS: 37,676 incident (2012-2016) patients in Georgia, North Carolina, and South Carolina identified within the US Renal Data System at 9 transplant centers and followed through December 2017. A prevalent population of 6,079 patients from the same centers receiving maintenance dialysis in 2012 but not referred for transplantation in 2012. EXPOSURE: KAS era (pre-KAS vs post-KAS). OUTCOME: Referral for transplantation, start of transplant evaluation, and waitlisting. ANALYTICAL APPROACH: Multivariable time-dependent Cox models for the incident and prevalent population. RESULTS: Among incident patients, KAS was associated with increased referrals (adjusted HR, 1.16 [95% CI, 1.12-1.20]) and evaluation starts among those referred (adjusted HR, 1.16 [95% CI, 1.10-1.21]), decreased overall waitlisting (adjusted HR, 0.70 [95% CI, 0.65-0.76]), and lower rates of active waitlisting among those evaluated compared to the pre-KAS era (adjusted HR, 0.81 [95% CI, 0.74-0.90]). Among the prevalent population, KAS was associated with increases in overall waitlisting (adjusted HR, 1.74 [95% CI, 1.15-2.63]) and active waitlisting among those evaluated (adjusted HR, 2.01 [95% CI, 1.16-3.49]), but had no significant impact on referral or evaluation starts among those referred. LIMITATIONS: Limited to 3 states, residual confounding. CONCLUSIONS: In the southeastern United States, the impact of KAS on steps to transplantation was different among incident and prevalent patients with kidney failure. Dialysis facilities referred more incident patients and transplant centers evaluated more incident patients after implementation of KAS, but fewer evaluated patients were placed onto the waitlist. Changes in dialysis facility and transplant center behaviors after KAS implementation may have influenced the observed changes in access to transplantation.


Subject(s)
Kidney Failure, Chronic , Kidney Transplantation , Humans , United States/epidemiology , Kidney Failure, Chronic/diagnosis , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/surgery , Cohort Studies , Waiting Lists , Referral and Consultation , Kidney
7.
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
8.
Am J Transplant ; 20(8): 2113-2125, 2020 08.
Article in English | MEDLINE | ID: mdl-31981441

ABSTRACT

Variability in transplant access exists, but barriers to referral and evaluation are underexplored due to lack of national surveillance data. We examined referral for kidney transplantation evaluation and start of the evaluation among 34 857 incident, adult (18-79 years) end-stage kidney disease patients from 690 dialysis facilities in the United States Renal Data System from January 1, 2012 through August 31, 2016, followed through February 2018 and linked data to referral and evaluation data from nine transplant centers in Georgia, North Carolina, and South Carolina. Multivariable-adjusted competing risk analysis examined each outcome. The median within-facility cumulative percentage of patients referred for kidney transplantation within 1 year of dialysis at the 690 dialysis facilities in Network 6 was 33.7% (interquartile range [IQR]: 25.3%-43.1%). Only 48.3% of referred patients started the transplant evaluation within 6 months of referral. In multivariable analyses, factors associated with referral vs evaluation start among those referred at any time differed. For example, black, non-Hispanic patients had a higher rate of referral (hazard ratio [HR]: 1.22; 95% confidence interval [CI]: 1.18-1.27), but lower evaluation start among those referred (HR: 0.93; 95% CI: 0.88-0.98), vs white non-Hispanic patients. Barriers to transplant varied by step, and national surveillance data should be collected on early transplant steps to improve transplant access.


Subject(s)
Kidney Failure, Chronic , Kidney Transplantation , Adult , Humans , Kidney Failure, Chronic/surgery , North Carolina/epidemiology , Referral and Consultation , Renal Dialysis , United States
9.
Clin Transplant ; 34(9): e13983, 2020 09.
Article in English | MEDLINE | ID: mdl-32639652

ABSTRACT

There is a high rate of Emergency Department (ED) utilization in kidney recipients post-transplant; ED visits are associated with readmission rates and lower survival rates. However, utilization within and outside transplant centers may lead to different outcomes. The objective was to analyze ED utilization patterns at transplant and non-transplant centers as well as common etiologies of ED visits and correlation with hospitalization, graft, and patient outcomes. This was a longitudinal, retrospective, single-center cohort study in kidney transplant recipients evaluating ED utilization. Comparator groups were determined by ED location, time from transplant, and disposition/readmission from ED visit. 1,106 kidney recipients were included in the study. ED utilization dropped at the transplant center after the 1st year (P < .001), while remaining at a similar rate at non-transplant centers (0.22 vs 1.06 VPPY). Infection and allograft complications were the most common causes of ED visits. In multivariable Cox modeling, an ED visit due to allograft complication at a non-transplant center >1 year post-transplant was associated with higher risk for graft loss and death (aHR 2.93 and aHR 1.75, P < .0001). The results of this study demonstrate an increased risk of graft loss among patients who utilize non-transplant center emergency departments. Improved communication and coordination between transplant centers and non-transplant centers may contribute to better long-term outcomes.


Subject(s)
Graft Survival , Kidney Transplantation , Cohort Studies , Emergency Service, Hospital , Humans , Kidney , Kidney Transplantation/adverse effects , Retrospective Studies , Transplant Recipients
10.
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
11.
Transpl Int ; 33(4): 414-422, 2020 04.
Article in English | MEDLINE | ID: mdl-31930584

ABSTRACT

The number of adults with heart failure (HF) will increase by ~50% between 2012 and 2030. Among kidney transplant recipients, HF accounts for 16% of all post-transplant admissions. We describe the burden of HF and predictors of healthcare utilization following kidney transplantation. We retrospectively identified adults who underwent kidney transplantation at our institution (01/2007-12/2017). Data were acquired from electronic health records, with healthcare utilization obtained from a statewide database. The HF incidence rate and prevalence were estimated for each year, total charges for HF and non-HF patients were compared, and logistic regression was employed for a 3-year predictive model of healthcare utilization associated with HF. Among 1731 kidney transplant recipients, the post-transplant HF incidence rate ranged from 1.91 (year 3) to 6.80 (year 10) per 100 person-years, while the prevalence increased from 31.7% (year 1) to 48.1% (year 10). Median charges were $75 837 (HF) compared to $42 940 (non-HF) per person-year (P < 0.001). Pretransplant HF [odds ratio (OR) = 3.12] and an eGFR < 45 (OR = 4.73) were the strongest predictors of HF encounters (P < 0.05 for both). We observed a high and increasing prevalence of HF, which was associated with twice the costs. Kidney transplant recipients would benefit from interventions aimed at mitigating HF risk factors.


Subject(s)
Heart Failure , Kidney Transplantation , Adult , Costs and Cost Analysis , Glomerular Filtration Rate , Heart Failure/epidemiology , Hospitalization , Humans , Kidney Transplantation/adverse effects , Retrospective Studies
12.
Am J Transplant ; 19(11): 2973-2978, 2019 11.
Article in English | MEDLINE | ID: mdl-31199562

ABSTRACT

Identifying and supporting specific organ procurement organizations (OPOs) with the greatest opportunity to increase donation rates could significantly increase the number of organs available for transplant. Accomplishing this is complicated by current Scientific Registry of Transplant Recipients/Centers for Medicare & Medicaid Services metrics of donation rates and OPO performance that rely on eligible deaths. These data are self-reported and unverifiable and have been shown to underestimate potential organ donors. We examine the limitations of current OPO performance/donation metrics to inform discussions related to strategies to increase donation. We propose changing to a simple, verifiable, and uniformly applied donation metric. This would allow the transplant community to (1) better understand inherent differences in donor availability based on geography and (2) identify underperforming areas that would benefit from systems improvement agreements to increase donation rates.


Subject(s)
Death , Organ Transplantation/standards , Registries/statistics & numerical data , Resource Allocation/standards , Tissue Donors/supply & distribution , Tissue and Organ Procurement/standards , Benchmarking , Efficiency, Organizational , Humans , Tissue Donors/statistics & numerical data
14.
Am J Public Health ; 109(9): 1273-1279, 2019 09.
Article in English | MEDLINE | ID: mdl-31318603

ABSTRACT

Objectives. To evaluate the effectiveness of video messaging on adolescent organ donor designation rates.Methods. We randomized adolescent driver education classes in Massachusetts, between July 2015 and February 2018, to receive 1 of 3 organ donation video messaging interventions (informational, testimonial, or blended). Adolescents completed questionnaires before and after the intervention and at 1-week follow-up; we compared their registration status at time of obtaining driver's license with that of a regionally matched historical comparison group.Results. Donor designation rates were higher for those exposed to video messaging than for the historical comparison group (60% vs 50%; P < .001). Testimonial (64%) and blended messaging (65%) yielded higher donor designation rates than informational messaging (51%; P = .013). There was a statistically significant messaging × time interaction effect for donation knowledge (P = .03), with blended and informational messaging showing more gains in knowledge from before to after the intervention (P < .001; d = 0.69 and P < .001; d = 0.45, respectively), compared with testimonial messaging (d = 0.09; P = .22).Conclusions. Testimonial messaging is most effective in producing a verifiable and demonstrable impact on donor designation rates among adolescents, and driver education classes are an efficient venue for disseminating organ donation messaging to youths.Trial Registration. ClinicalTrials.gov; identifier: NCT03013816.


Subject(s)
Tissue Donors/statistics & numerical data , Adolescent , Adolescent Behavior , Automobile Driving/education , Female , Humans , Male , Massachusetts/epidemiology , Random Allocation
15.
Clin Transplant ; 33(5): e13522, 2019 05.
Article in English | MEDLINE | ID: mdl-30861180

ABSTRACT

Reducing acute care utilization is a means of improving long-term patient outcomes. We sought to assess high inpatient (IP) admission and standalone emergency department (ED) utilization within a 9-month period post-kidney transplantation and to identify mutable factors to reduce utilization. In this ten-year retrospective study, 1599 adult kidney transplant recipients were identified. A previous transplant, graft loss, or death within 3 months post-transplantation excluded 319 patients. Comprehensive resource utilization data were obtained from a statewide database. Those with ≥2 IP admissions or standalone ED visits 4-12 months post-transplantation were classified as high utilizers. Multivariable logistic regression models were used for examining associations of predictors with high IP or ED utilization. Of 1280 kidney recipients, 209 and 183 were categorized as IP and ED high utilizers, respectively. Factors significantly associated with high IP utilization included valvular disease, body mass index ≥35, and IP or ED use <3 months post-transplantation; while factors associated with high ED utilization included IP or ED use <3 months post-transplantation, younger age, female, smoker, congestive heart failure, depression, and IP or ED use 1 year pre-transplantation. Inpatient and standalone ED utilization within a 9-month period after kidney transplantation is high and associated with sociodemographic factors, mutable comorbidities, and healthcare utilization.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Hospitalization/statistics & numerical data , Kidney Failure, Chronic/surgery , Kidney Transplantation/methods , Patient Acceptance of Health Care/statistics & numerical data , Adult , Female , Follow-Up Studies , Glomerular Filtration Rate , Graft Survival , Humans , Kidney Function Tests , Male , Middle Aged , Prognosis , Retrospective Studies , Risk Factors
16.
Clin Transplant ; 33(10): e13701, 2019 10.
Article in English | MEDLINE | ID: mdl-31461791

ABSTRACT

INTRODUCTION: Transplant nurse (RN) coordinators review tacrolimus levels frequently and would be capable of making dose adjustments autonomously if not limited by their license. Collaborative practice agreements could be an answer; thus, the aim of this evaluation was to determine if an RN-driven protocol could be used safely and effectively to manage tacrolimus in ambulatory kidney transplant (KTX) recipients. METHODS: This was a retrospective review of all solitary adult KTX recipients between August 1, 2016, and July 29, 2017. The primary objective was to evaluate protocol adherence and frequency of use, and secondary objectives were to evaluate the utility of the protocol both overall and based on ethnicity. RESULTS: A total of 173 patients were included in the evaluation (59% African American [AA], 41% non-African American [non-AA). RN coordinators followed the protocol for 75% of tacrolimus adjustments; however, they only responded to 27% of the overall levels. There was no difference in 180-day tacrolimus-associated readmission (15% AA vs 5% non-AA, P = .06), biopsy-proven acute rejection (4% AA vs 7% non-AA, P = .363), or hyperkalemia (34% AA vs 32% non-AA, P = .87) between groups. CONCLUSIONS: Transplant nurse coordinators are capable of accurately following a protocol for tacrolimus dosage adjustment in a large, racially diverse kidney transplant center.


Subject(s)
Black or African American/statistics & numerical data , Graft Rejection/drug therapy , Graft Survival/drug effects , Kidney Transplantation/adverse effects , Nursing Care/statistics & numerical data , Postoperative Complications/drug therapy , Tacrolimus/administration & dosage , Adult , Aged , Delivery of Health Care, Integrated/statistics & numerical data , Disease Management , Female , Follow-Up Studies , Glomerular Filtration Rate , Graft Rejection/epidemiology , Graft Rejection/etiology , Graft Rejection/pathology , Humans , Immunosuppressive Agents/administration & dosage , Incidence , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/surgery , Kidney Function Tests , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/pathology , Prognosis , Retrospective Studies , Risk Factors , South Carolina/epidemiology , Young Adult
17.
Transpl Int ; 32(1): 84-94, 2019 01.
Article in English | MEDLINE | ID: mdl-30176087

ABSTRACT

An improved understanding of the impact of clinical surrogates on disparities in African-American (AA) kidney transplantation (KTX) is needed. We conducted a 10-year retrospective longitudinal cohort study of electronically abstracted clinical data assessing the impact of surrogates on disparities in KTX. Clinical surrogates were assessed by posttransplant year (1, 2, 3 or 4) and defined as acute rejection (Banff ≥1A), mean SBP >140 mmHg, tacrolimus variability (CV) >40%, mean glucose >160 mg/dl and mean hemoglobin <10 g/dl. We utilized landmark methodology to minimize immortal time bias and logistic and survival regression to assess outcomes; 1610 KTX were assessed (54.2% AAs), with 1000, 468, 368 and 303 included in the year 1, 2, 3 and 4 complete case analyses, respectively. AAs had significantly higher odds of developing a clinical surrogate, which increased in posttransplant years three and four [OR year 1 1.99 (1.38-2.88), year 2 1.77 (1.20-2.62), year 3 2.35 (1.49-3.71), year 4 2.85 (1.72-4.70)]. Adjusting for the five clinical surrogates in survival models explained a significant portion of the higher risks of graft loss in AAs in post-transplant years three and four. Results suggest focusing efforts on improving late clinical surrogate management within AAs may help mitigate racial disparities in KTX.


Subject(s)
Healthcare Disparities , Kidney Failure, Chronic/ethnology , Kidney Failure, Chronic/surgery , Kidney Transplantation , Transplant Recipients , Adult , Black or African American , Aged , Female , Graft Rejection , Graft Survival , Health Status Disparities , Humans , Immunosuppressive Agents , Longitudinal Studies , Male , Middle Aged , Retrospective Studies , Tacrolimus , Time Factors , Treatment Outcome
18.
Nephrology (Carlton) ; 24(8): 855-862, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30198104

ABSTRACT

AIM: Identifying kidney transplant patients at highest risk for graft loss prior to loss may allow for effective interventions to improve 5 years survival. METHODS: We performed a 10 years retrospective cohort study of adult kidney transplant recipients (n = 1747). We acquired data from electronic health records, United Network of Organ Sharing, social determinants of health, natural language processing data extraction, and real-time capture of dynamically evolving clinical data obtained within 1 year of transplant; from which we developed a 5 years graft survival model. RESULTS: Total of 1439 met eligibility; 265 (18.4%) of them experienced graft loss by 5 years. Graft loss patients were characterized by: older age, being African-American, diabetic, unemployed, smokers, having marginal donor kidneys and cardiovascular comorbidities. Predictive dynamic variables included: low mean blood pressure, higher pulse pressures, higher heart rate, anaemia, lower estimated glomerular filtration rate peak, increased tacrolimus variability, rejection and readmissions. This Big Data analysis generated a 5 years graft loss model with an 82% predictive capacity, versus 66% using baseline United Network of Organ Sharing data alone. CONCLUSION: Our analysis yielded a 5 years graft loss model demonstrating superior predictive capacity compared with United Network of Organ Sharing data alone, allowing post-transplant individualized risk-assessed care prior to transitioning back to community care.


Subject(s)
Graft Survival , Kidney Transplantation , Models, Statistical , Adult , Cohort Studies , Female , Forecasting , Graft Rejection/epidemiology , Graft Rejection/prevention & control , Humans , Male , Middle Aged , Retrospective Studies , Risk Assessment , Time Factors , Transplantation, Homologous
19.
Am J Nephrol ; 47(3): 191-199, 2018.
Article in English | MEDLINE | ID: mdl-29539601

ABSTRACT

BACKGROUND: Several studies have been performed to evaluate surrogate markers of long-term allograft function in renal transplant recipients. These include serum creatinine, estimated glomerular filtration rate (eGFR), slope of eGFR, and more recently eGFR variability. The aim of this study was to measure eGFR slope while assessing the variability of this slope and if high variability occurring at any time post-transplant was predictive of poorer long-term outcomes in a large cohort of kidney transplant recipients. METHODS: Adult solitary kidney transplant recipients transplanted between July 1, 2005 and July 31, 2015 were included. The primary outcome was time to graft loss, defined as return to chronic dialysis, retransplant, or death. Secondary outcomes were death-censored graft loss and acute allograft rejection. Cox regression was utilized for primary and secondary outcomes. Multivariate logistic regression was used to determine baseline factors predictive of high eGFR variability. RESULTS: A total of 1,543 patients were included in the analysis. The percentage of patients who experienced an eGFR coefficient of variation of <30% was 79.6% (1,229/1,543), while 20.4% (314/1,543) patients had high eGFR variability (≥30%). Patients with high eGFR variability tended to be younger, African-American and female. Those with higher eGFR variability, accounting for confounding and other eGFR measures (peak and slope), had significantly lower overall patient and graft survival. CONCLUSION: This study provides a novel analysis of the utility of eGFR variability in a large cohort. The clinical use of the slope of eGFR and eGFR variability may aid in predicting long-term graft outcomes and facilitate early patient discussions to change the trajectory of allograft function.


Subject(s)
Glomerular Filtration Rate , Graft Rejection/epidemiology , Kidney Transplantation/mortality , Adult , Aged , Female , Humans , Incidence , Male , Middle Aged , Retrospective Studies , United States/epidemiology
20.
J Surg Res ; 221: 88-94, 2018 01.
Article in English | MEDLINE | ID: mdl-29229159

ABSTRACT

BACKGROUND: Despite numerous initiatives to increase solid organs for transplant, the gap between donors and recipients widens. There is little in the literature identifying socioeconomic predictors for donation. We evaluate the correlation between socioeconomic factors and familial authorization for donation. METHODS: A retrospective analysis of adult potential donor referrals between 2007 and 2012 to our organ procurement organization (OPO) was performed. Potential donor information was obtained from the OPO database, death certificates, and the US Census Report. Data on demographics, education, residence, income, registry status, cause and manner of death, as well as OPO assessments and approach for donation were collected. End point was familial authorization for donation. RESULTS: A total of 1059 potential donors were included, with an overall authorization rate of 47%. The majority was not on the donor registry (73%). Younger donors (18-39 y: odds ratio [OR] = 4.9, P < 0.001; 40-60 y: OR = 2.1, P < 0.001), higher levels of education (college: OR = 2.5, P = 0.005; graduate studies: OR = 3.9, P = 0.002), prior listing on the donor registry (OR = 10.3, P < 0.001), and residence in counties with lower poverty rates than the US rates (OR = 1.7, P = 0.02) were independently associated with higher authorization rates. Decoupling (OR = 3.1, P < 0.001) and donation first mentioned by the local health care provider (OR = 1.8, P = 0.01) were also independently associated with higher authorization rates. CONCLUSIONS: Donor registration correlated most strongly with the highest authorization rates. These results indicate that public educational efforts in populations with unfavorable socioeconomic considerations may be beneficial in improving donor registration. Collaborations with local providers as well as OPO in-hospital assessments and approach techniques can help with improving authorization rates.


Subject(s)
Tissue and Organ Procurement/statistics & numerical data , Adolescent , Adult , Female , Humans , Male , Middle Aged , Retrospective Studies , Socioeconomic Factors , Young Adult
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