Whipple's cephalic pancreaticoduodenectomy versus pyloric-preserving pancreaticoduodenectomy. Retrospective study.

INTRODUCTION: Controversy exists in the literature as to the best technique for pancreaticoduodenectomy (PD), whether pyloric preservation (PP-CPD) or Whipple's technique (with antrectomy [W-CPD]), the former being associated with a higher frequency of delayed gastric emptying (DGE). METHODS: Retrospective and comparative study between PP-CPD technique (n = 124 patients) and W-CPD technique (n = 126 patients), in patients who were operated for tumors of the pancreatic head and periampullary region between the period 2012 and 2023. RESULTS: Surgical time was longer, although not significant, with the W-CPD technique. Pancreatic and peripancreatic tumor invasion (p = 0.031) and number of lymph nodes resected (p < 0.0001) reached statistical significance in W-CPD, although there was no significant difference between the groups in terms of lymph node tumor invasion. Regarding postoperative morbimortality (medical complications, postoperative pancreatic fistula [POPF], hemorrhage, RVG, re-interventions, in-hospital mortality, Clavien-Dindo complications), ICU and hospital stay, no statistically significant differences were observed between the groups. During follow-up, no significant differences were observed between the groups for morbidity and mortality at 90 days and survival at 1, 3 and 5 years. Binary logistic regression analysis for DGE showed that binary relevant POPF grade B/C was a significant risk factor for DGE. CONCLUSIONS: Postoperative morbidity and mortality and long-term survival were not significantly different with PP-CPD and W-CPD, but POPF grade B/C was a risk factor for DGE grade C.

Risk factors of massive blood transfusion in liver transplantation: consequences and a new index for prediction including the donor / Factores de riesgo de transfusión masiva en trasplante hepático: consecuencias y creación de un nuevo índice teniendo en cuenta el tipo de donante

Background: Massive blood transfusion (MBT) is a common occurrence in liver transplant (LT) patients. Recipient-related risk factors include cirrhosis, history of multiple surgeries and suboptimal donors. Despite advances in surgical techniques, anesthetic management and graft preservation have decreased the need for transfusions, this complication has not been completely eliminated. Methods: One thousand four hundred and sixty-nine LT were performed at our institution between May 2003 and December 2020, and data was available regarding transfusion for 1198 of them. We divided the patients into two groups, with regards to transfusion of 6 or more units of packed red blood cells in the first 24 h posttransplant, and we analyzed the differences between the groups. Results: Out of the 1198 patients, 607 (50.7%) met criteria for MBT. Survival was statistically lower at 1, 3, and 5 years when comparing the groups that had MBT to those that did not (92.6%, 85.2% and 79.7%, respectively, in the non MBT group, vs. 78.1%, 71.6% y 66.8%, respectively, in the MBT group). MBT was associated with a 1.5 mortality risk as opposed to non-MBT patients. Logistical regression analysis of our variables yielded the following results for a new model, including serum creatinine (OR 1.97), sodium (OR 1.73), hemoglobin (OR 1.99), platelets (OR 1.37), INR (OR 1.4), uDCD (OR 2.13) and split liver donation. Conclusion: Massive blood transfusion impacts patient survival in a statistically significant way. The most significant risk factors are preoperative hemoglobin, INR and serum creatinine. (AU)

Introducción: La transfusión masiva de hemoderivados (TMH) es un hecho frecuente en el trasplante hepático (TH). A pesar de los avances en la técnica quirúrgica, manejo anestésico y preservación de órganos, la politransfusión no ha desaparecido. Métodos: 1469 TH fueron realizados en nuestro centro entre mayo de 2003 y diciembre de 2020, obteniéndose datos completos de trasfusión de 1198. Dividimos a los pacientes en dos grupos de acuerdo a la necesidad de trasfusión de 6 o más unidades de sangre en las primeras 24 horas después del trasplante, y analizamos las diferencias entre los grupos. Resultados: De los 1198 pacientes, 607 (50.7%) cumplieron criterios de TMH· La supervivencia fue estadísticamente inferior a 1, 3, y 5 años cuando comparamos los grupos en función de TMH o no (92·6%, 85·2% y 79·7%, respectivamente, en el no TMH, vs. 78·1%, 71·6% y 66·8%, respectivamente, en el grupo de TMH). Respecto al análisis de supervivencia, la TMH se asoció a un riesgo 1.5 veces mayor de mortalidad en contra de los pacientes sin TMH· El análisis de regresión logística nos permitió la creación de un nuevo modelo incluyendo creatinina sérica (OR 1.97), sodio (OR 1.73), hemoglobina (OR 1.99), plaquetas (OR 1.37), INR (OR 1.4), uDCD (OR 2.13) y trasplante procedente de split. Conclusión: La transfusión masiva de hemoderivados impacta en la supervivencia del paciente de forma estadísticamente significative. Los factores de riesgo preoperatorios más significativos han sido la hemoglobina, el INR y la creatinine. (AU)

Post-transplant biliary complications using liver grafts from deceased donors older than 70 years: Retrospective case-control study.

BACKGROUND: The shortage of liver grafts and subsequent waitlist mortality led us to expand the donor pool using liver grafts from older donors. AIM: To determine the incidence, outcomes, and risk factors for biliary complications (BC) in liver transplantation (LT) using liver grafts from donors aged > 70 years. METHODS: Between January 1994 and December 31, 2019, 297 LTs were performed using donors older than 70 years. After excluding 47 LT for several reasons, we divided 250 LTs into two groups, namely post-LT BC (n = 21) and without BC (n = 229). This retrospective case-control study compared both groups. RESULTS: Choledocho-choledochostomy without T-tube was the most frequent technique (76.2% in the BC group vs 92.6% in the non-BC group). Twenty-one patients (8.4%) developed BC (13 anastomotic strictures, 7 biliary leakages, and 1 non-anastomotic biliary stricture). Nine patients underwent percutaneous balloon dilation and nine required a Roux-en-Y hepaticojejunostomy because of dilation failure. The incidence of post-LT complications (graft dysfunction, rejection, renal failure, and non-BC reoperations) was similar in both groups. There were no significant differences in the patient and graft survival between the groups. Moreover, only three deaths were attributed to BC. While female donors were protective factors for BC, donor cardiac arrest was a risk factor. CONCLUSION: The incidence of BC was relatively low on using liver grafts > 70 years. It could be managed in most cases by percutaneous dilation or Roux-en-Y hepaticojejunostomy, without significant differences in the patient or graft survival between the groups.

Risk factors of massive blood transfusion in liver transplantation: consequences and a new index for prediction including the donor.

BACKGROUND: Massive blood transfusion (MBT) is a common occurrence in liver transplant (LT) patients. Recipient-related risk factors include cirrhosis, history of multiple surgeries and suboptimal donors. Despite advances in surgical techniques, anesthetic management and graft preservation have decreased the need for transfusions, this complication has not been completely eliminated. METHODS: One thousand four hundred and sixty-nine LT were performed at our institution between May 2003 and December 2020, and data was available regarding transfusion for 1198 of them. We divided the patients into two groups, with regards to transfusion of 6 or more units of packed red blood cells in the first 24 h posttransplant, and we analyzed the differences between the groups. RESULTS: Out of the 1198 patients, 607 (50.7%) met criteria for MBT. Survival was statistically lower at 1, 3, and 5 years when comparing the groups that had MBT to those that did not (92.6%, 85.2% and 79.7%, respectively, in the non MBT group, vs. 78.1%, 71.6% y 66.8%, respectively, in the MBT group). MBT was associated with a 1.5 mortality risk as opposed to non-MBT patients. Logistical regression analysis of our variables yielded the following results for a new model, including serum creatinine (OR 1.97), sodium (OR 1.73), hemoglobin (OR 1.99), platelets (OR 1.37), INR (OR 1.4), uDCD (OR 2.13) and split liver donation. CONCLUSION: Massive blood transfusion impacts patient survival in a statistically significant way. The most significant risk factors are preoperative hemoglobin, INR and serum creatinine.

Duodenopancreatectomía cefálica en pacientes octogenarios con tumores de páncreas / Cephalic duodenopancreatectomy in octogenarium patients with pancreatic tumors

Introducción: Según estudios previos, la duodenopancreatectomía cefálica (DPC) por cáncer de páncreas (CP) se asocia a un incremento de la supervivencia mediana tanto en pacientes octogenarios como en pacientes de menor edad. Métodos: Estudio retrospectivo y comparativo de la DPC realizada en 30 pacientes≥80 años con CP y en 159 pacientes<80 años. Resultados: Los pacientes octogenarios presentaban una tasa significativamente mayor de morbilidad cardiovascular preoperatoria y un comportamiento tumoral más agresivo (mayor anemia, ictericia y CA 19-9 preoperatorios, invasión vascular y neural y menor frecuencia de resección R0 a pesar de utilizar la misma técnica quirúrgica). No hubo diferencias significativas en cuanto a complicaciones postoperatorias. La mortalidad postoperatoria fue similar en ambos grupos (3,3% en octogenarios versus 3,1% en <80 años). Las causas de mortalidad durante el seguimiento fueron fundamentalmente por recidiva tumoral, complicaciones cardiovasculares y COVID-19 (2 octogenarios). La supervivencia actuarial a 1, 3 y 5 años fue significativamente mayor en pacientes <80 años que en octogenarios (el 85,9%, el 61,1% y el 39,2% versus el 72,7%, el 28,9% y el 9,6%, respectivamente; p=0,001). En el estudio multivariable, la presencia de una fístula pancreática y la no utilización de tutor externo del Wirsung influyeron de forma estadísticamente significativa sobre la mortalidad a 90 días post-DPC. Conclusiones: La morbimortalidad post-DPC es similar en octogenarios y <80 años, aunque la supervivencia a largo plazo es menor por la agresividad tumoral y comorbilidad asociada a la edad avanzada. (AU)

Introduction: Current literature supports the claim that performing a cephalic pancreaticoduodenectomy (CPD) as treatment for pancreatic cancer (PC) is associated with an increase in median survival, both in octogenarian (≥80 years) patients as well as younger patients. Methods: This is a retrospective and comparative trial, comparing results for CPD performed on 30 patients ≥80 years with PC and 159 patients <80 years. Results: The patients in the octogenarian group showed a significantly higher rate of preoperative cardiovascular morbidity and a more aggressive tumoral behaviour, including more significant preoperative anemia, jaundice and levels of CA 19-9, higher vascular and neural invasion, and a lower rate of R0 resection despite using the same surgical technique. There were no significant differences in terms of postoperative complications. Postoperative mortality was similar in both groups (3.3% in octogenarians vs. 3.1% in patients <80 years). Mortality during follow-up was mainly due to tumour recurrence, cardiovascular complications and COVID-19 in 2elderly patients. Actuarial survival at 1, 3 and 5 years was significantly larger for patients <80 years old, as compared to octogenarians (85.9%, 61.1% and 39.2% versus 72.7%, 28.9% and 9.6%, respectively; P=0.001). The presence of a pancreatic fistula and not using external Wirsung stenting were significantly associated with 90-day postoperative mortality after a CPD. Conclusions: Morbidity and mortality post-CPD is similar in octogenarians and patients younger than 80, although long-term survival is shorter due to more aggressive tumours and comorbidities associated with older age. (AU)

“Long-term follow-up of liver transplantation in incidental intrahepatic cholangiocarcinoma and mixed hepatocellular-cholangiocarcinoma” / “Seguimiento a largo plazo del trasplante hepático en el colangiocarcinoma y hepatocolangiocarcinoma mixto incidentales”

Introduction: The standard treatment for intrahepatic cholangiocarcinoma (iCCA) and mixed hepatocellular-cholangiocarcinoma (HCC-CC) is surgical resection, nevertheless, recent studies show adequate survival rates in selected patients with iCCA or HCC-CC undergoing liver transplantation (LT). Methods: A retrospective cohort study was design including all patients undergoing LT at our center between January, 2006 and December, 2019 with incidentally diagnosed iCCA or HCC-CC after pathological examination of the explanted liver (n = 13). Results: There were no iCCA or HCC-CC recurrences during the follow-up, and hence, there were no tumor related deaths. Global and disease-free survival were the same. The 1, 3 and 5-years patient survival were 92.3%, 76.9% and 76.9%, respectively. Survival rates in the “early-stage tumor group” at 1, 3 and 5 years were 100%, 83.3% and 83.3%, respectively, with no significant differences as compared to the “advanced-stage tumors group”. No statistically significant differences in terms of 5-year survival were found when comparing tumor histology (85.7% for iCCA and 66.7% for HCC-CC). Conclusions: These results suggest that LT could be an option in patients with chronic liver disease who develop an iCCA or HCC-CC, even in highly selected advanced tumors, but we must be cautious when analyzing these results because of the small sample size of the series and its retrospective nature. (AU)

Introducción: El tratamiento de elección del colangiocarcinoma intrahepático (iCCA) y el hepato-colangiocarcinoma mixto (HCC-CC) es la resección quirúrgica, sin embargo, estudios recientes han demostrado buenos resultados en pacientes seleccionados sometidos a un trasplante hepático (TH). Métodos: Estudio retrospectivo de una cohorte formada por todos los pacientes que recibieron un TH en nuestro centro entre Enero 2006 y Diciembre 2019 con hallazgo incidental de un iCCA o un HCC-CC durante el estudio histopatológico después del trasplante (n = 13). Resultados: Después de una mediana de seguimiento de 65 meses no hubo ninguna recurrencia tumoral, por lo que la supervivencia global y libre de enfermedad fueron iguales. La supervivencia a 1, 3 y 5 años de la muestra fue del 92.3%, 76.9% y 76.9%, respectivamente. La supervivencia de los pacientes con un ‘early stage’ a 1, 3 y 5 años fue del 100%, 83.3% y 83.3%, respectivamente; sin encontrar diferencias estadísticamente significativas al compararla con la de los pacientes con un ‘advanced stage’. Aunque la supervivencia de los pacientes con iCCA fue mayor que la de los pacientes con HCC-CC (85.7% vs. 66.7% a 5 años, respectivamente), las diferencias no fueron estadísticamente significativas. Conclusiones: El TH podría ser una opción de tratamiento en pacientes con enfermedad hepática terminal que desarrollan un iCCA o un HCC-CC, incluso en estadios avanzados seleccionados, pero estos resultados deben ser analizado con precaución dada la naturaleza retrospectiva del estudio y el escaso tamaño muestral. (AU)

Capsule endoscopy diagnosis of gastrointestinal melanoma.

Melanoma is a cancer that frequently metastasises to the small bowel, but most cases are asymptomatic and are diagnosed postmortem. Therefore, CT and PET CT cannot detect all lesions and conventional endoscopic study only detects 10-20% of lesions. In this study, we present the case of a 68-year-old patient with a history of cutaneous melanoma and a diagnosis of intestinal melanoma. Thanks to capsule endoscopy, two lesions compatible with cutaneous melanoma metastasis to the small bowel were detected, allowing a much more effective surgical planning. Capsule endoscopy is an innovative technique that improves preoperative diagnosis, as it is able to detect bowel segments that cannot be inspected by conventional endoscopy. It also has a better resolution than conventional CT, improving sensitivity in the detection of lesions.

Cephalic pancreatoduodenectomy in octogenarian patients with pancreatic tumors.

INTRODUCTION: Current literature supports the claim that performing a cephalic pancreaticoduodenectomy (CPD) as treatment for pancreatic cancer (PC) is associated with an increase in median survival, both in octogenarian (≥80 years) patients as well as younger patients. METHODS: This is a retrospective and comparative trial, comparing results for CPD performed on 30 patients ≥80 years with PC and 159 patients <80 years. RESULTS: The patients in the octogenarian group showed a significantly higher rate of preoperative cardiovascular morbidity and a more aggressive tumoral behaviour, including more significant preoperative anemia, jaundice and levels of CA 19-9, higher vascular and neural invasion, and a lower rate of R0 resection despite using the same surgical technique. There were no significant differences in terms of postoperative complications. Postoperative mortality was similar in both groups (3.3% in octogenarians vs 3.1% in patients <80 years). Mortality during follow-up was mainly due to tumour recurrence, cardiovascular complications and COVID-19 in 2 elderly patients. Actuarial survival at 1, 3 and 5 years was significantly larger for patients <80 years old, as compared to octogenarians (85.9%, 61.1% and 39.2% versus 72.7%, 28.9% and 9.6%, respectively; P = 0.001). The presence of a pancreatic fistula and not using external Wirsung stenting were significantly associated with 90-day postoperative mortality after a CPD. CONCLUSIONS: Morbidity and mortality post-CPD is similar in octogenarians and patients younger than 80, although long-term survival is shorter due to more aggressive tumours and comorbidities associated with older age.

"Long-term follow-up of liver transplantation in incidental intrahepatic cholangiocarcinoma and mixed hepatocellular-cholangiocarcinoma".

INTRODUCTION: The standard treatment for intrahepatic cholangiocarcinoma (iCCA) and mixed hepatocellular-cholangiocarcinoma (HCC-CC) is surgical resection, nevertheless, recent studies show adequate survival rates in selected patients with iCCA or HCC-CC undergoing liver transplantation (LT). METHODS: A retrospective cohort study was design including all patients undergoing LT at our center between January, 2006 and December, 2019 with incidentally diagnosed iCCA or HCC-CC after pathological examination of the explanted liver (n = 13). RESULTS: There were no iCCA or HCC-CC recurrences during the follow-up, and hence, there were no tumor related deaths. Global and disease-free survival were the same. The 1, 3 and 5-years patient survival were 92.3%, 76.9% and 76.9%, respectively. Survival rates in the "early-stage tumor group" at 1, 3 and 5 years were 100%, 83.3% and 83.3%, respectively, with no significant differences as compared to the "advanced-stage tumors group". No statistically significant differences in terms of 5-year survival were found when comparing tumor histology (85.7% for iCCA and 66.7% for HCC-CC). CONCLUSIONS: These results suggest that LT could be an option in patients with chronic liver disease who develop an iCCA or HCC-CC, even in highly selected advanced tumors, but we must be cautious when analyzing these results because of the small sample size of the series and its retrospective nature.

Pyogenic liver abscesses in liver transplant recipients versus non-transplant population. Outcome and risk factors of patient survival.

Pyogenic liver abscess (PLA) is a life-threatening infection in both liver transplant (LT) and non-LT patients. Several risk factors, such as benign and malignant hepatopancreatobiliary diseases and colorectal tumors have been associated with PLA in the non-LT population, and hepatic artery stricture/thrombosis, biliary stricture, and hepaticojejunostomy in the LT patients. The objective of this study is to compare the outcomes of patients with PLA in LT and non-LT patients and to determine the risk factors associated with patient survival. From January 2000 to November 2020, a total of 296 adult patients were diagnosed of PLA in our institution, of whom 26 patients had previously undergone liver transplantation (LTA group), whereas 263 patients corresponded to the non-LTA population. Seven patients with PLA who had undergone previous kidney transplantation were excluded from this retrospective study. Twenty-six patients out of 1503 LT developed PLA (incidence of 1.7%). Median age was significantly higher in non-LTA patients (p = .001). No significant differences were observed in therapy. PLA recurrence was significantly higher in LTA than in non-LTA (34.6% vs. 14.8%; p = .008). In-hospital mortality was greater in the LT group than in the non-LT group (19.2% vs. 9.1% p = .10) and was identified in multivariable analysis as a risk factor for mortality (p = .027). Mortality rate during follow-up did not show significant differences between the groups: 34.6% in LTA patients versus 26.2% in non-LTA patients (p = .10). The most common causes of mortality during follow-up were malignancies, Covid-19 infection, and neurologic disease. 1-, 3-, and 5-year actuarial patient survival rates were 87.0%, 64.1%, and 50.4%, respectively, in patients of LTA group, and 84.5%, 66.5%, and 51.0%, respectively, in patients with liver abscesses in non-LTA population (p = .53). In conclusion, LT was a risk factor for in hospital mortality, but not during long-term follow-up.

Risk factors indicating the need for surgical therapy in patients with pyogenic liver abscesses.

BACKGROUND: Percutaneous drainage (PD) and antibiotics are the therapy of choice (non-surgical therapy [non-ST]) for pyogenic liver abscesses (PLA), reserving surgical therapy (ST) for PD failure. The aim of this retrospective study was to identify risk factors that indicate the need for ST. METHODS: We reviewed the medical charts of all of our institution's adult patients with a diagnosis of PLA between January 2000 and November 2020. A series of 296 patients with PLA was divided into two groups according to the therapy used: ST (n = 41 patients) and non-ST (n = 255). A comparison between groups was performed. RESULTS: The overall median age was 68 years. Demographics, clinical history, underlying pathology, and laboratory variables were similar in both groups, except for the duration of PLA symptoms < 10 days and leukocyte count which were significantly higher in the ST group. The in-hospital mortality rate in the ST group was 12.2% vs. 10.2% in the non-ST group (p = 0.783), with biliary sepsis and tumor-related abscesses as the most frequent causes of death. Hospital stay and PLA recurrence were statistically insignificant between groups. One-year actuarial patient survival was 80.2% in the ST group vs. 84.6% in the non-ST (p = 0.625) group. The presence of underlying biliary disease, intra-abdominal tumor, and duration of symptoms for less than 10 days on presentation comprised the risk factors that indicated the need to perform ST. CONCLUSIONS: There is little evidence regarding the decision to perform ST, but according to this study, the presence of underlying biliary disease or an intra-abdominal tumor and the duration of PLA symptoms < 10 days upon presentation are risk factors that should sway the surgeons to perform ST instead of PD.

Modifications in Abdominal Wall Graft Retrieval: When the Donor Closure Is Not Guaranteed.

BACKGROUND: Twenty percent of intestinal transplant recipients will require a surgical alternative to conventional primary abdominal wall closure. Abdominal wall transplant is a developing technique that is increasingly performed for this purpose in isolated intestinal or multivisceral recipients; however, adequate closure of the donor is paramount while simultaneously obtaining a large enough graft. The aim of this study is to describe alternative surgical techniques for closure of the donor in cases in which abdominal wall graft extraction hinders subsequent donor abdominal closure. METHODS: We describe the cases of 2 young donors in whom intestinal extraction was not carried out and in whom wall closure was not feasible, following standard techniques after abdominal wall graft extraction. We performed 2 different procedures to obtain adequate closure. 1. Hemifascia and hemiabdominal wall graft extraction: It is an option when the recipients require an extension of the abdominal aponeurosis yet have enough skin to guarantee skin closure. The perfusion of both epigastric arteries is needed. The remaining cutaneous half is used for closing the donor's abdomen.2. Hemiabdominal wall graft extraction: Full-thickness abdominal wall is harvested from the donor, selecting the most vascularized half. It is an alternative for recipients who need a skin implant in addition to an aponeurosis extension. This option should be used for recipients who do not require a large fascial graft but do require a significant cutaneous graft. The nontransplanted half of full-thickness abdominal wall is used for donor closure. RESULTS: Abdominal wall transplant allows for expansion of the abdominal cavity in organ recipients and reduces the risk of compartmental syndrome and subsequent ischemia. However, the donor wall defect must be considered. The choice of donation technique was based on the magnitude of the defect in the donor as well as the size of defect to be covered in the recipient while ensuring a tight and complete closure of the donor's abdomen. CONCLUSIONS: Abdominal wall graft extraction can be performed using nonconventional techniques that account for the extension and type of coverage needed by the recipient while guaranteeing proper closure of the donor.

Liver Transplantation in Sexagenarian Patients Using Grafts From Uncontrolled Circulatory Death Versus Grafts From Brain Death Donation.

BACKGROUND: An increased number of older recipients underwent liver transplantation in recent years, and consequently needing to obtain more liver grafts. In order to increase this pool, in 2006, we initiated the use of livers from uncontrolled circulatory death (uDCD). We analyzed the use of uDCD livers in sexagenarian recipients and their effect on overall survival. METHODS: A retrospective and comparative study was performed among 4 groups according to recipient age (less or greater than 60 years) and donor type (donor brain death [DBD] or uDCD): Group A: DBD livers in recipients aged <60 years (n = 169); Group B: uDCD livers in recipients aged <60 years (n = 36); Group C: DBD livers in recipients aged >60 years (n = 96); and Group D: uDCD livers in recipients aged >60 years(n = 39). RESULTS: Intraoperative transfusion, biliary complications, primary non-function, acute rejection, chronic renal dysfunction, retransplantation, and mortality during follow-up (cardiovascular diseases in 3 patients, hepatitis C virus recurrence in 4 patients, and de novo malignancies in 3 patients) were significantly higher, and 5-year patient and graft survival was significantly lower in sexagenarian recipients. Bilirubin and packed red blood cells transfusion were risk factors for patient survival, whereas hepatocelular carcinoma, creatinine, and packed red blood cells transfusion were risk factors for patient survival. Recipient age (<60 years) was confirmed as protective factor for patient and graft survival, whereas the use of uDCD was not a risk factor for patient or graft survival. CONCLUSIONS: Use of a uDCD liver did not demonstrate as a risk factor for patient and graft survival, and recipient age (<60 years) was a protective factor for patient and graft survival.

Effects of everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study

Background and aim: reduction in calcineurin inhibitor levels is considered crucial to decrease the incidence of kidney dysfunction in liver transplant (LT) recipients. The aim of this study was to evaluate the safety and impact of everolimus plus reduced tacrolimus (EVR + rTAC) vs. mycophenolate mofetil plus tacrolimus (MMF + TAC) on kidney function in LT recipients from Spain.Methods: the REDUCE study was a 52-week, multicenter, randomized, controlled, open-label, phase 3b study in de novo LT recipients. Eligible patients were randomized (1:1) 28 days post-transplantation to receive EVR + rTAC (TAC levels ≤ 5 ng/mL) or to continue with MMF + TAC (TAC levels = 6-10 ng/mL). Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety were evaluated.Results: in the EVR + rTAC group (n = 105), eGFR increased from randomization to week 52 (82.2 [28.5] mL/min/1.73 m2 to 86.1 [27.9] mL/min/1.73 m2) whereas it decreased in the MMF + TAC (n = 106) group (88.4 [34.3] mL/min/1.73 m2 to 83.2 [25.2] mL/min/1.73 m2), with significant (p < 0.05) differences in eGFR throughout the study. However, both groups had a similar clinical benefit regarding renal function (improvement in 18.6 % vs. 19.1 %, and stabilization in 81.4 % vs. 80.9 % of patients in the EVR + rTAC vs. MMF + TAC groups, respectively). There were no significant differences in the incidence of acute rejection (5.7 % vs. 3.8 %), deaths (5.7 % vs. 2.8 %), and serious adverse events (51.9 % vs. 44.0 %) between the 2 groups.Conclusion: EVR + rTAC allows a safe reduction in tacrolimus exposure in de novo liver transplant recipients, with a significant improvement in eGFR but without significant differences in renal clinical benefit 1 year after liver transplantation. (AU)

Effects of everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study.

BACKGROUND AND AIM: reduction in calcineurin inhibitor levels is considered crucial to decrease the incidence of kidney dysfunction in liver transplant (LT) recipients. The aim of this study was to evaluate the safety and impact of everolimus plus reduced tacrolimus (EVR + rTAC) vs. mycophenolate mofetil plus tacrolimus (MMF + TAC) on kidney function in LT recipients from Spain. METHODS: the REDUCE study was a 52-week, multicenter, randomized, controlled, open-label, phase 3b study in de novo LT recipients. Eligible patients were randomized (1:1) 28 days post-transplantation to receive EVR + rTAC (TAC levels ≤ 5 ng/mL) or to continue with MMF + TAC (TAC levels = 6-10 ng/mL). Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety were evaluated. RESULTS: in the EVR + rTAC group (n = 105), eGFR increased from randomization to week 52 (82.2 [28.5] mL/min/1.73 m2 to 86.1 [27.9] mL/min/1.73 m2) whereas it decreased in the MMF + TAC (n = 106) group (88.4 [34.3] mL/min/1.73 m2 to 83.2 [25.2] mL/min/1.73 m2), with significant (p < 0.05) differences in eGFR throughout the study. However, both groups had a similar clinical benefit regarding renal function (improvement in 18.6 % vs. 19.1 %, and stabilization in 81.4 % vs. 80.9 % of patients in the EVR + rTAC vs. MMF + TAC groups, respectively). There were no significant differences in the incidence of acute rejection (5.7 % vs. 3.8 %), deaths (5.7 % vs. 2.8 %), and serious adverse events (51.9 % vs. 44.0 %) between the 2 groups. CONCLUSION: EVR + rTAC allows a safe reduction in tacrolimus exposure in de novo liver transplant recipients, with a significant improvement in eGFR but without significant differences in renal clinical benefit 1 year after liver transplantation.