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BACKGROUND: Recent surveys highlight gross workforce shortage of dietitians in global kidney health and significant gaps in renal nutrition care, with disparities greater in low/low-middle income countries. OBJECTIVE: This paper narrates ground experiences gained through the Palm Tocotrienols in Chronic Hemodialysis (PaTCH) project on kidney nutrition care scenarios and some Asian low-to-middle-income countries namely Bangladesh, India, and Malaysia. METHOD: Core PaTCH investigators from 3 universities (USA and Malaysia) were supported by their postgraduate students (n = 17) with capacity skills in kidney nutrition care methodology and processes. This core team, in turn, built capacity for partnering hospitals as countries differed in their ability to deliver dietitian-related activities for dialysis patients. RESULTS: We performed a structural component analyses of PaTCH affiliated and nonaffiliated (Myanmar and Indonesia) countries to identify challenges to kidney nutrition care. Deficits in patient-centered care, empowerment processes and moderating factors to nutrition care optimization characterized country comparisons. Underscoring these factors were some countries lacked trained dietitians whilst for others generalist dietitians or nonclinical nutritionists were providing patient care. Resolution of some challenges in low-to-middle-income countries through coalition networking to facilitate interprofessional collaboration and task sharing is described. CONCLUSIONS: We perceive interprofessional collaboration is the way forward to fill gaps in essential dietitian services and regional-based institutional coalitions will facilitate culture-sensitive capacity in building skills. For the long-term an advanced renal nutrition course such as the Global Renal Internet Course for Dietitians is vital to facilitate sustainable kidney nutrition care.
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Estado Nutricional , Nutricionistas , Humanos , Atenção à Saúde , Inquéritos e Questionários , Diálise Renal , RimRESUMO
BACKGROUND: Calcineurin inhibitors (CNIs) are often associated with abnormalities in glucose and lipid metabolism. Tacrolimus is the most potent CNI which is nowadays used almost universally as a part of triple-drug immunosuppression after kidney transplantation. Tacrolimus can cause islet cell damage and decrease in insulin secretion which can lead to post-transplant diabetes mellitus and rarely diabetic ketoacidosis. Although rare, acute pancreatitis has also been implicated by a few case reports to be associated with tacrolimus. However, tacrolimus-induced acute pancreatitis has not been reported in pediatric kidney transplant recipient till date. CASE DESCRIPTION: We report the first case of tacrolimus-induced acute pancreatitis in association with hypertriglyceridemia and DKA in a child early after kidney transplant. The patient was managed with supportive treatment, and tacrolimus was stopped for three days and then switched to cyclosporine-based regimen. The patient became euglycemic within 8 weeks of switching to cyclosporine and did not have any recurrence of pancreatitis. CONCLUSION: Tacrolimus-induced pancreatitis is rare in the setting of kidney transplants and prompt diagnosis and management can lead to a successful outcome.
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Cetoacidose Diabética/induzido quimicamente , Imunossupressores/efeitos adversos , Transplante de Rim , Pancreatite/induzido quimicamente , Tacrolimo/efeitos adversos , Adolescente , Terapia Combinada , Cetoacidose Diabética/diagnóstico por imagem , Cetoacidose Diabética/terapia , Humanos , Masculino , Pancreatite/diagnóstico por imagem , Pancreatite/terapia , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. METHODS: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points. RESULTS: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). CONCLUSIONS: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).
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Insuficiência Cardíaca/terapia , Coração Auxiliar , Desenho de Prótese , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Coração Auxiliar/efeitos adversos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Reoperação/estatística & dados numéricos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Trombose/etiologia , Resultado do Tratamento , Teste de CaminhadaRESUMO
BACKGROUND: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial's 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. METHODS: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non-device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. RESULTS: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P=0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P=0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P<0.001) and stroke (HM3: 2.8% versus HMII: 11.3%; P=0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P<0.001) and similar in either bridge to transplant or destination therapy intent. CONCLUSIONS: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.
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Atenção à Saúde/economia , Insuficiência Cardíaca/terapia , Coração Auxiliar/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Custos e Análise de Custo , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/patologia , Transplante de Coração , Coração Auxiliar/efeitos adversos , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia , Trombose/etiologia , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Peritoneal dialysis (PD) is the preferred modality of dialysis among children with end-stage renal disease. METHODS: To study the incidence of technique failure and survival among children with end-stage renal disease on continuous ambulatory peritoneal dialysis (CAPD), we included children younger than 18 years of age who commenced and continued PD for more than 3 months as their primary form of dialysis between 1st January 2005 and 31st December 2016. Kaplan-Meier survival analysis was applied to analyze the CAPD outcomes. RESULTS: A total of 68 Tenckhoff (58 double cuffs, and ten single cuffs) catheters were inserted in 66 patients (mean age 12.3 ± 3.91 years) during the study period. Of the 66 children, 31 (47%) experienced 45 episodes of peritonitis. The total duration on CAPD was 107.58 years with a peritonitis rate of 0.42 episodes per year. Overall, the mean patient survival was 41 (95% confidence interval (CI) 29-54) months, with mean patient survival of 72% at 12 months, declining to 30% at 36 months and then remaining stable until the end of follow-up (106 months). The overall mean technique survival was 55 (95% CI 40-69) months, with mean technique survival of 69% at 12 months, declining to 44% at 36 months and then remaining stable until the end of follow-up (106 months). CONCLUSION: CAPD is a viable option for end-stage renal disease in children from developing countries with a lack of access to automated PD and pediatric hemodialysis centers.
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Sobrevivência de Enxerto , Falência Renal Crônica/terapia , Diálise Peritoneal Ambulatorial Contínua/efeitos adversos , Peritonite/epidemiologia , Adolescente , Catéteres/efeitos adversos , Criança , Países em Desenvolvimento/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Incidência , Índia/epidemiologia , Estimativa de Kaplan-Meier , Falência Renal Crônica/mortalidade , Masculino , Diálise Peritoneal Ambulatorial Contínua/instrumentação , Diálise Peritoneal Ambulatorial Contínua/estatística & dados numéricos , Peritonite/etiologia , Estudos Retrospectivos , Falha de TratamentoRESUMO
Antibodies to complement factor H are an uncommon cause of hemolytic uremic syndrome (HUS). Information on clinical features and outcomes in children is limited. In order to explore this we studied a multicenter cohort of 138 Indian children with anti-complement factor H antibody associated HUS, constituting 56% of patients with HUS. Antibody titers were high (mean 7054 AU/ml) and correlated inversely with levels of complement C3, but not complement factor H. Homozygous deletion of the CFHR1 gene was found in 60 of 68 patients. Therapies included dialysis in 119 children, 105 receiving plasma exchanges and 26 intravenous immunoglobulin. Induction immunosuppression consisted of 87 children receiving prednisolone with or without intravenous cyclophosphamide or rituximab. Antibody titers fell significantly following plasma exchanges and increased during relapses. Adverse outcome (stage 4-5 CKD or death) was seen in 36 at 3 months and 41 by last follow up, with relapse in 14 of 122 available children. Significant independent risk factors for adverse outcome were an antibody titer over 8000 AU/ml, low C3 and delay in plasma exchange. Combined plasma exchanges and induction immunosuppression resulted in significantly improved renal survival: one adverse outcome prevented for every 2.6 patients treated. Maintenance immunosuppressive therapy, of prednisolone with either mycophenolate mofetil or azathioprine, significantly reduced the risk of relapses. Thus, prompt use of immunosuppressive agents and plasma exchanges are useful for improving outcomes in pediatric patients with anti-complement factor H-associated HUS.
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Autoanticorpos/sangue , Proteínas Sanguíneas/imunologia , Proteínas Inativadoras do Complemento C3b/imunologia , Síndrome Hemolítico-Urêmica/terapia , Imunossupressores/uso terapêutico , Troca Plasmática , Tempo para o Tratamento , Fatores Etários , Anticorpos Monoclonais Murinos/uso terapêutico , Azatioprina/uso terapêutico , Biomarcadores/sangue , Proteínas Sanguíneas/genética , Estudos de Casos e Controles , Criança , Pré-Escolar , Terapia Combinada , Proteínas Inativadoras do Complemento C3b/genética , Ciclofosfamida/uso terapêutico , Quimioterapia Combinada , Feminino , Deleção de Genes , Síndrome Hemolítico-Urêmica/sangue , Síndrome Hemolítico-Urêmica/diagnóstico , Síndrome Hemolítico-Urêmica/genética , Síndrome Hemolítico-Urêmica/imunologia , Homozigoto , Humanos , Imunossupressores/efeitos adversos , Índia , Lactente , Masculino , Ácido Micofenólico/análogos & derivados , Ácido Micofenólico/uso terapêutico , Troca Plasmática/efeitos adversos , Prednisolona/uso terapêutico , Recidiva , Fatores de Risco , Rituximab , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The authors tested the hypothesis that physiological information from sensors within a minimally invasive, subcutaneous, insertable cardiac monitor (ICM) could be used to develop an ambulatory heart failure risk score (HFRS) to accurately identify heart failure (HF) patients, across the ejection fraction spectrum, at high risk of an impending worsening heart failure event (HFE). OBJECTIVES: The purpose of this study was to examine performance of ICM-based, multiparameter, dynamic HFRS to predict HFEs in patients with NYHA functional class II/III HF. METHODS: In 2 observational cohorts, HF patients were implanted with an ICM; subcutaneous impedance, respiratory rate, heart rate and variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, and activity duration were combined into an HFRS to identify the probability of HFE within 30 days. Patients and providers were blinded to the data. HFRS sensitivity and unexplained detection rate were defined in 2 independent patient population data sets. HFEs were defined as hospitalization, observation unit, or emergency department visit with a primary diagnosis of HF, and intravenous diuretic treatment. RESULTS: First data set (development): 42 patients had 19 HFE; second data set (validation): 94 patients had 19 HFE (mean age 66 ± 11 years, 63% men, 50% with LVEF ≥40%, 80% NYHA functional class III). Using a high-risk threshold = 7.5%, development and validation data sets: sensitivity was 73.7% and 68.4%; unexplained detection rate of 1.4 and 1.5 per patient-year; median 47 and 64 days early warning before HFE. CONCLUSIONS: ICM-HFRS provides a multiparameter, integrated diagnostic method with the ability to identify when HF patients are at increased risk of heart failure events. (Reveal LINQ Evaluation of Fluid [REEF]; NCT02275923, Reveal LINQ Heart Failure [LINQ HF]; NCT02758301, Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure [ALLEVIATE-HF]; NCT04452149).
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Fibrilação Atrial , Insuficiência Cardíaca , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnóstico , Frequência Cardíaca , Monitorização Fisiológica , Fatores de Risco , Estudos Observacionais como AssuntoRESUMO
BACKGROUND: Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices. METHODS: A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio. RESULTS: The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively. CONCLUSIONS: The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3.
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Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Humanos , Coração Auxiliar/efeitos adversos , Estudos Prospectivos , Insuficiência Cardíaca/cirurgia , Ventrículos do Coração , Resultado do TratamentoRESUMO
GOALS: To describe our experience with coronary artery stenting and antiplatelet therapy in cirrhotic patients and compare rates of bleeding with a control group. BACKGROUND: Although there are data on cardiac evaluation and perioperative cardiac risk in cirrhotic patients, there is a paucity of information on outcomes in cirrhotic patients with coronary artery stents. Cirrhotic patients may be at increased risk for complications, including gastrointestinal bleeding as a result of antiplatelet therapy prescribed after stenting. STUDY: We performed a retrospective study of complications in cirrhotics that received a coronary artery stent followed by clopidogrel and aspirin prescribed to prevent stent occlusion. Cirrhotics with stents were compared with an age and sex-matched control group with cirrhosis without stents and not on aspirin. RESULTS: Among 423 cirrhotic patients who underwent liver transplant evaluation, 16 patients (3.8%) received a stent of which 9 underwent liver transplant. Two patients with varices (12.5%) in the stent group had fatal variceal bleeding and 2 controls (6.3%) had nonfatal variceal bleeding during follow-up while on antiplatelet therapy (P=0.86). There were no significant differences in transfusion requirements between the 9 liver transplant recipients with stents compared with the control group, P=0.69 for packed red blood cells. CONCLUSIONS: In our experience, it is safe for cirrhotic patients without varices to receive a coronary artery stent and for cirrhotic patients with coronary artery stents to be considered for liver transplantation. Larger prospective studies are needed to confirm these results and evaluate the risk of bleeding in cirrhotics with varices who receive coronary artery stents and antiplatelet therapy.
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Doença da Artéria Coronariana/cirurgia , Cirrose Hepática/fisiopatologia , Inibidores da Agregação Plaquetária/uso terapêutico , Stents , Idoso , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Clopidogrel , Fígado Gorduroso/complicações , Feminino , Seguimentos , Hemorragia Gastrointestinal/etiologia , Humanos , Transplante de Fígado/métodos , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêuticoAssuntos
Hipertensão/complicações , Hipertensão/terapia , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/terapia , Algoritmos , Anti-Hipertensivos/uso terapêutico , Determinação da Pressão Arterial/normas , Consenso , Humanos , Hipertensão/diagnóstico , Hipertensão/epidemiologia , Índia/epidemiologia , Transplante de Rim , Estilo de Vida , Nefrologia , Planejamento de Assistência ao Paciente , Guias de Prática Clínica como Assunto , Prevalência , Diálise Renal , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologiaRESUMO
Multisystem inflammatory syndrome is a rarely reported post-COVID (coronavirus disease) phenomenon in adults. Our understanding of the multisystem inflammatory syndrome- adult (MIS-A) is based on multiple case reports that have demonstrated heterogeneous clinical presentations and treatment options. Rhabdomyolysis is an unusual presentation of MIS-A. We report the case of a 61-year-old man who presented with rhabdomyolysis with acute kidney injury (AKI), acute inflammatory demyelinating polyneuropathy (AIDP), myocarditis, disseminated intravascular coagulation, and minimal respiratory symptoms. The patient was found to have post-COVID inflammatory syndrome and recovered with supportive treatment and intravenous immunoglobulin (2 g/kg over 5 days). COVID-19 (coronavirus disease 2019) antibody positivity played a significant role in making the diagnosis of MIS-A and in providing prompt treatment.
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OBJECTIVES: There is no systematic review and meta- analysis for pediatric solid-organ transplants in India. The objective of the study was to collect high-evidence data in this regard. MATERIALS AND METHODS: A systematic review and meta- analysis was performed for pediatric solid-organ transplants in India. We used the search engines of PubMed, Google Scholar, PubMed Central, Embase, and MEDLINE from beginning of data availability until April 26, 2022. Data from 2 participating centers were also used. Analyses were performed by the DerSimonian random model. RESULTS: Of 50 000 primary searches, only 31 studies were included for analysis. In total, data for pediatric kidney (n = 1057), liver (n = 914), and heart (n = 117) were reported. For the pediatric kidney, the 1-year, 5-year, and 10-year patient survival rates were 96% (range, 93%-99%; I² = 91.17%, H² = 11.33, P < .01), 90% (range, 85%-94%; I² = 93.54%, H² = 15.47, P < .01), and 75% (range, 62%-88%; I² = 97.36%, H² = 37.82, P < .01), respectively. The 1-year, 5-year, and 10-year renal graft survival rates were 93% (range, 90%-96%; I² = 63.82, H² = 2.76, P < .01), 83% (range, 76%-89%; I² = 86.39%, H² = 7.35, P < .01), and 66% (range, 57%-75%; I² = 81.68%, H² = 5.46, P < .01), respectively. The acute rejection rate was 23% (range, 20%-27%; I² = 5.44%, H² = 1.06, P = .39). For the pediatric liver transplant, the 1-year and 5-year survival rates were 92% (range, 89%-95%; I² = 49.96%, H² = 2, P < .04) and 88% (range, 85%-90%; I² = 0; H² = 1, P = .72), respectively. CONCLUSIONS: The outcomes of pediatric solid-organ transplants in India are comparable to those of the Western world. However, cause of graft loss and patient death is largely attributed to infections, unlike the experiences reported in the West. An effective registry is a primary pillar to expand pediatric solid- organ transplants in India.
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Rejeição de Enxerto , Transplante de Órgãos , Criança , Humanos , Rim , Fígado , Pulmão , Sobrevivência de Enxerto , Sistema de RegistrosRESUMO
Worldwide, India ranks number 2 and 3 for COVID-19 burden and absolute transplant numbers, respectively. Here, we summarized our single and multicenter Indian studies on solid-organ transplant during the COVID-19 pandemic. During the pandemic, solid-organ transplants declined 40% to 50%. The mortality rate in COVID-19-positive kidney transplant recipients (11.6%) was lower in India compared with the developed world during the first wave and lower compared with maintenance hemodialysis patients (13% to 38%) but significantly higher compared with the nonimmunosuppressed general population (1% to 3%) in India. We contributed to National Organ and Tissue Transplant Organization transplant-related guidelines to increase safety and access to solid-organ transplant. We reported the safety and feasibility of remdesivir (n = 57) and convalescent plasma therapy (n = 10) in kidney transplant recipients. We reported 100% patient and graft survival without any complications related to COVID-19 in a large cohort of kidney transplant recipients who recovered from COVID-19 (n = 372) and a large cohort of kidney transplant recipients of living donors (n = 31) who recovered from COVID-19 without any change in induction and maintenance immunosuppression. COVID-19 disease severity and mortality in the second episode (reoccurring infection) was higher (46%) compared with the first episode (11.6%). There was 4.4% incidence of COVID-19-associated mucormycosis in kidney transplant recipients with mortality of 46% in the second wave. We reported COVID-19 vaccine safety with suboptimal efficacy in kidney transplant recipients and dialysis patients compared with the general population. Our report suggested that transplant with carefully selected COVID-19-recovered donors and patients may be feasible and safe, at least over the short term. Continued research is needed on vaccine efficacy, booster doses, and long-term follow up sequelae.
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COVID-19 , Transplante de Rim , Transplante de Órgãos , COVID-19/terapia , Vacinas contra COVID-19 , Humanos , Imunização Passiva , Doadores Vivos , Estudos Multicêntricos como Assunto , Pandemias , Transplantados , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
INTRODUCTION: Large-scale Indian data on the use of anti-T-lymphocyte globulin (ATLG) (Grafalon®) as induction therapy in kidney transplantation (KT) patients is lacking. The aim of this study was to determine the 1-year patient and graft survival outcomes with the use of ATLG as induction regimen in KT. METHODS: In a prospective, multicentric, observational study, adult patients who underwent ABO-compatible KT and had received ATLG as a part of induction were included in the study. The primary outcome measure was overall survival and death-censored graft survival at 12 months. The primary safety outcome was assessed by development of infectious complications and graft rejection. RESULTS: In total, 359 patients were included in this study. The mean age was 42.77 ± 12.30 years and 83% were male. The average ATLG dose per patient was 6.2 ± 2.2 mg/kg whereas average cumulative dose per patient was 389.6 ± 149.8 mg. The rate of graft dysfunction was 13.4% of patients and 6.7% had biopsy-proven acute rejection (BPAR). There were a total of 12 (3.3%) deaths and one graft loss. Overall survival and death-censored graft survival at 12 months were 96.65% and 99.44%, respectively. The rate of infections was 13.6% with urinary tract infections being most common. CONCLUSION: ATLG at an average dose of 6 mg/kg is an effective and safe induction regimen immunosuppressant for ABO-compatible KT with favourable impact on survival and graft function in Indian patients.
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Transplante de Rim , Adulto , Feminino , Rejeição de Enxerto/prevenção & controle , Humanos , Imunossupressores/uso terapêutico , Transplante de Rim/efeitos adversos , Linfócitos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Background: There is an enormous knowledge gap on management strategies, clinical outcomes, and follow-up after kidney transplantation (KT) in recipients that have recovered from coronavirus disease (COVID-19). Methods: We conducted a multi-center, retrospective analysis in 23 Indian transplant centres between June 26, 2020 to December 1, 2021 on KT recipients who recovered after COVID-19 infections. We analyzed clinical and biopsy-confirmed acute rejection (AR) incidence and used cox-proportional modeling to estimate multivariate-adjusted hazard ratios (HR) for predictors of AR. We also performed competing risk analysis. Additional outcome measures included graft loss, all-cause mortality, waiting time from a positive real-time polymerase test (RT-PCR) to KT, laboratory parameters, and quality of life in follow-up. Findings: Among 372 KT which included 38(10·21%) ABO-incompatible, 12(3·22%) sensitized, 64(17·20%) coexisting donors with COVID-19 history and 20 (5·37%) recipients with residual radiographic abnormalities, the incidence of AR was 34 (9·1%) with 1(0·26%) death censored graft loss, and 4(1·07%) all-cause mortality over a median (interquartile range) follow-up of 241 (106-350) days. In our cox hazard proportional analysis, absence of oxygen requirement during COVID-19 compared to oxygen need [HR = 0·14(0·03-0·59); p-value = 0·0071], and use of thymoglobulin use compared to other induction strategies [HR = 0·17(0·03-0.95); p-value = 0·044] had a lower risk for AR. Degree of Human leukocyte antigen (HLA) DR mismatch had the highest risk of AR [HR = 10.2(1·74-65·83); p-value = 0·011]. With competing risk analysis, with death as a competing event, HLA DR mismatch, and oxygen requirement continued to be associated with AR. Age, gender, obesity, inflammatory markers, dialysis vintage, steroid use, sensitization and ABO-incompatibility have not been associated with a higher risk of AR. The median duration between COVID-19 real time polymerase test negativity to transplant was 88(40-145) days (overall), and ranged from 88(40-137), 65(42-120), 110(49-190), and 127(64-161) days in World Health Organization ordinal scale ≤ 3, 4, 5, and 6-7, respectively. There was no difference in quality of life, tacrolimus levels, blood counts, and mean serum creatinine assessed in patients with a past COVID-19 infection independent of severity. Interpretation: Our findings support that the outcomes of KT after COVID-19 recovery are excellent with absence of COVID-19 sequelae during follow-up. Additionally, there does not seem to be a need for changes in the induction/immunosuppression regimen based on the severity of COVID-19. Funding: Sanofi.
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BACKGROUND: Patients with chronic kidney disease (CKD) and coronary artery disease frequently undergo preemptive revascularization before kidney transplant listing. OBJECTIVES: In this post hoc analysis from ISCHEMIA-CKD (International Study of Comparative Health Effectiveness of Medical and Invasive Approaches-Chronic Kidney Disease), we compared outcomes of patients not listed versus those listed according to management strategy. METHODS: In the ISCHEMIA-CKD trial (n = 777), 194 patients (25%) with chronic coronary syndromes and at least moderate ischemia were listed for transplant. The primary (all-cause mortality or nonfatal myocardial infarction) and secondary (death, nonfatal myocardial infarction, hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, or stroke) outcomes were analyzed using Cox multivariable modeling. Heterogeneity of randomized treatment effect between listed versus not listed groups was assessed. RESULTS: Compared with those not listed, listed patients were younger (60 years vs 65 years), were less likely to be of Asian race (15% vs 29%), were more likely to be on dialysis (83% vs 44%), had fewer anginal symptoms, and were more likely to have coronary angiography and coronary revascularization irrespective of treatment assignment. Among patients assigned to an invasive strategy versus conservative strategy, the adjusted hazard ratios for the primary outcome were 0.91 (95% confidence interval [CI]: 0.54-1.54) and 1.03 (95% CI: 0.78-1.37) for those listed and not listed, respectively (pinteraction= 0.68). Adjusted hazard ratios for secondary outcomes were 0.89 (95% CI: 0.55-1.46) in listed and 1.17 (95% CI: 0.89-1.53) in those not listed (pinteraction = 0.35). CONCLUSIONS: In ISCHEMIA-CKD, an invasive strategy in kidney transplant candidates did not improve outcomes compared with conservative management. These data do not support routine coronary angiography or revascularization in patients with advanced CKD and chronic coronary syndromes listed for transplant. (ISCHEMIA-Chronic Kidney Disease Trial [ISCHEMIA-CKD]; NCT01985360).
Assuntos
Tratamento Conservador/métodos , Doença da Artéria Coronariana/epidemiologia , Transplante de Rim/estatística & dados numéricos , Insuficiência Renal Crônica/epidemiologia , Listas de Espera , Idoso , Comorbidade , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica , Diálise Renal/métodos , Insuficiência Renal Crônica/terapia , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: There is lack of data on feasibility and safety of kidney transplants from living donors who recovered from COVID-19. METHODS: Here, we present a retrospective cohort study of 31 kidney transplant recipients (KTR) from living donors who recovered from polymerase chain reaction confirmed COVID-19 across 19 transplant centers in India from July 3, 2020, to December 5, 2020. We detailed demographics, clinical manifestations, immunosuppression regimen, treatment, and outcomes. Donors with a previous diagnosis of COVID-19 were accepted after documenting 2 negative polymerase chain reaction tests with complete symptom resolution for at least 28 days and significant social distancing for 14 days before surgery. RESULTS: COVID-19 clinical severity in donors ranged from completely asymptomatic (71%, n = 22) to mild infection (29%, n = 9). None progressed to moderate or severe stages of the disease in the entire clinical course of home treatment. Patient and graft survival was 100%, respectively, with acute cellular rejection being reported in 6.4% (n = 2) recipient. All recipients and donors were asymptomatic with normal creatinine at median follow-up of 44 days after surgery without any complications relating to surgery and COVID-19. CONCLUSIONS: Our data support safety of proceeding with living donation for asymptomatic individuals with comprehensive donor, recipients screening before surgery, using a combination of clinical, radiologic, and laboratory criteria. It could provide new insights into the management of KTR from living donors who have recovered from COVID-19 in India. To the best of our knowledge, this remains the largest cohort of KTR from living donors who recovered from COVID-19.
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COVID-19/transmissão , Transplante de Rim/efeitos adversos , SARS-CoV-2 , Obtenção de Tecidos e Órgãos , Adolescente , Adulto , Idoso , COVID-19/diagnóstico , COVID-19/epidemiologia , Teste para COVID-19 , Criança , Estudos de Coortes , Transmissão de Doença Infecciosa , Feminino , Humanos , Índia/epidemiologia , Doadores Vivos , Masculino , Pessoa de Meia-Idade , Pandemias , Estudos Retrospectivos , Fatores de Risco , Segurança , Transplantados , Adulto JovemRESUMO
BACKGROUND: There is limited current knowledge on feasibility and safety of kidney transplantation in coronavirus disease-19 (COVID-19) survivors. METHODS: We present a retrospective cohort study of 75 kidney transplants in patients who recovered from polymerase chain reaction (PCR)-confirmed COVID-19 performed across 22 transplant centers in India from July 3, 2020, to January 31, 2021. We detail demographics, clinical manifestations, immunosuppression regimen, laboratory findings, treatment, and outcomes. Patients with a previous diagnosis of COVID-19 were accepted after documenting 2 negative severe acute respiratory syndrome coronavirus 2 PCR tests, normal chest imaging with complete resolution of symptom for at least 28 d and significant social distancing for 14 d before surgery. RESULTS: Clinical severity in patients ranged from asymptomatic (n = 17, 22.7%), mild (n = 36.48%), moderate (n = 15.20%), and severe (n = 7.9.3%) disease. Median duration between PCR positive to transplant was 60 d (overall) and increased significantly from asymptomatic, mild, moderate, and severe disease (49, 57, 83, 94 d, P 0.019), respectively. All recipients and donors were asymptomatic with normal creatinine after surgery at a median (interquartile range) follow-up of 81 (56-117) d without any complications relating to surgery or COVID-19. Patient and graft survival was 100%, and acute rejection was reported in 6.6%. CONCLUSIONS: Prospective kidney transplant recipients post-COVID-19 can be considered for transplantation after comprehensive donor and recipient screening before surgery using a combination of clinical, radiologic, and laboratory criteria, careful pretransplant evaluation, and individualized risk-benefit analysis. Further large-scale prospective studies with longer follow-up will better clarify our initial findings. To date, this remains the first and the largest study of kidney transplantation in COVID-19 survivors.
Assuntos
COVID-19/complicações , Falência Renal Crônica/cirurgia , Transplante de Rim , Adulto , Idoso , COVID-19/diagnóstico , Seleção do Doador/métodos , Feminino , Seguimentos , Humanos , Índia , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Retrospectivos , Sobreviventes , Resultado do TratamentoRESUMO
COVID pandemic affected every individual across the world. Patients with primary glomerular disease and glomerular disease secondary to systemic diseases who are on moderate to high doses of immunosuppression are at an increased risk of COVID because of their immunosuppressed state. The data to quantify the degree of risk in relation to the amount of immunosuppression or their duration of use is not robust. The patients on immunosuppression need to modify the drugs balancing the risk relapse and flare of the disease, simultaneously minimizing the risk of developing COVID. We tried to develop a guideline about the modification of the treatment regimen in such conditions.