Trial design of the MOTheR HDx study: a multicenter, open-label, prospective, randomized study to explore the morbidity and mortality in patients dialyzed with the Theranova HDx in comparison with online hemodiafiltration.

Background: Dialysis patients have been maintaining a high rate of cardiovascular morbidity and mortality. For this reason, it is to introduce necessary new technical advances in clinical practice. There is a relation between toxins retention and inflammation, mortality and morbidity. Medium cut-off (MCO) membranes are a new generation of membranes that allow the removal of a greater number of medium-sized molecules compared with high-flux hemodialysis (HF-HD), but retaining albumin. MCO membranes have an increased permeability and the presence of internal filtration. Because of these special properties, MCO generated a new concept of therapy called expanded HD (HDx). Until now, online hemodiafiltration (OL-HDF) has demonstrated its superiority, in terms of survival, compared with HF-HD. However, the comparison between OL-HDF and HDx remains an unsolved question. Methods: The MOTheR HDx study trial (NCT03714386) is an open-label, multicenter, prospective, 1:1 randomized, parallel-group trial designed to evaluate the efficacy and safety of HDx compared with OL-HDF in patients treated for dialysis in Spain for up to 36 months. The main endpoint is to determinate whether HDx is non inferior to OL-HDF at reducing the combined outcome of all-cause death and stroke (ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial infarction), peripheral arterial disease (amputation or revascularization) and ischemic colitis (mesenteric thrombosis). Results: The trial has already started.

Transitions in an integrated model of renal replacement therapy in a regional health system.

INTRODUCTION AND OBJECTIVES: The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT¼ that implies new questions about the best sequence of techniques. MATERIAL AND METHODS: The study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008-2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition. RESULTS: A total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KT). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p < 0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs KTX group 8.3%, p < 0.001) and less access to a transplant (HD group 30.4% vs PD group 51.6%; p < 0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD â†’ PD: 0.7 years (SD 1.1) vs PD â†’ HD: 1.5 years (SD 1.4) p < 0.001), are younger (HD â†’ PD: 53.5 years (SD 16.7) vs PD â†’ HD: 61.6 years (SD 14.6); p < 0.001), presented less mortality (HD â†’ PD: 24.5% vs PD â†’ HD: 32.0%; p < 0.001) and higher access to a transplant (HD â†’ PD: 49.4% vs PD â†’ HD: 31.7%; p < 0.001). Survival analysis by competitive risks is essential for integrated RRT models, especially in groups such as PD patients, where 51.6% of the patients were considered as lost follow-up (received a KTX after during the first 2.5 years on PD). In this analysis, survival of patients who change from one technique to another, is more similar to the destination modality than the origin one. CONCLUSION: Our data suggest that transitions between RRT-techniques describes different patients, who associate different risks, and could be analyzed in an integrated manner to define improvement actions. This approach should be incorporated into the analysis and reports of renal registries.

Impact of different COVID-19 waves on kidney replacement therapy epidemiology and mortality: REMER 2020.

BACKGROUND: Kidney replacement therapy (KRT) confers the highest risk of death from coronavirus disease 2019 (COVID-19). However, most data refer to the early pandemic waves. Whole-year analysis compared with prior secular trends are scarce. METHODS: We present the 2020 REMER Madrid KRT registry, corresponding to the Spanish Region hardest hit by COVID-19. RESULTS: In 2020, KRT incidence decreased 12% versus 2019, while KRT prevalence decreased by 1.75% for the first time since records began and the number of kidney transplants (KTs) decreased by 16%. Mortality on KRT was 10.2% (34% higher than the mean for 2008-2019). The 2019-2020 increase in mortality was larger for KTs (+68%) than for haemodialysis (+24%) or peritoneal dialysis (+38%). The most common cause of death was infection [n = 419 (48% of deaths)], followed by cardiovascular [n = 200 (23%)]. Deaths from infection increased by 167% year over year and accounted for 95% of excess deaths in 2020 over 2019. COVID-19 was the most common cause of death (68% of infection deaths, 33% of total deaths). The bulk of COVID-19 deaths [209/285 (73%)] occurred during the first COVID-19 wave, which roughly accounted for the increased mortality in 2020. Being a KT recipient was an independent risk factor for COVID-19 death. CONCLUSIONS: COVID-19 negatively impacted the incidence and prevalence of KRT, but the increase in KRT deaths was localized to the first wave of the pandemic. The increased annual mortality argues against COVID-19 accelerating the death of patients with short life expectancy and the temporal pattern of COVID-19 mortality suggests that appropriate healthcare may improve outcomes.

Análisis de las transiciones en el modelo integrado de tratamiento sustitutivo renal en un sistema regional de salud / Transitions in an integrated model of renal replacement therapy in a regional health system

Introducción y objetivos : La elección del tratamiento sustitutivo renal (TSR) es una decisión importante que determina la calidad de vida y la supervivencia. La mayoría de los pacientes cambiará de una modalidad de TSR a otra para adaptarla a sus necesidades dentro de lo que se conoce como modelo de TSR integrado. En estas circunstancias surgen nuevas preguntas sobre la mejor secuencia de técnicas o las consecuencias de las transiciones.Material y métodosDescribimos las transiciones entre técnicas de TSR y su impacto en la supervivencia a partir del Registro Madrileño de Enfermos Renales (REMER), durante un periodo de 11 años. Se utilizaron los modelos de riesgos proporcionales y de riesgos competitivos para realizar un análisis por intención de tratar (ITT) según su 1.er tratamiento y como tratado (AT) considerando la 1.ª transición.ResultadosUn total de 8.971 pacientes iniciaron su primer TSR durante este periodo en Madrid (6,6 millones habitantes): 7.207 (80,3%) en hemodiálisis (HD), 1.401 (15,6%) en diálisis peritoneal (DP) y 363 (4,1%) recibieron un trasplante renal anticipado (TXR). En el análisis ITT, los pacientes incidentes en HD eran mayores (HD 65,3 años (DE 15,3) vs. DP 58,1 años [DE 14,8] vs. TXR 52,0 años (DE 17,2); p<0,001) y tenían más comorbilidades. Presentaron mayor mortalidad (HD 40,9% vs. DP 22,8% vs. TXR 8,3%, p<0,001) y menor acceso a trasplante (HD 30,4% vs. DP 51,6%; p<0,001). Las transiciones entre las técnicas de diálisis identifican diferentes fenotipos de pacientes con diferentes resultados clínicos en el análisis AT. Los pacientes que cambiaban de HD a DP lo hacían más precozmente (HD→DP: 0,7 años (DE 1,1) vs. DP→HD: 1,5 años [(DE 1,4); p<0,001), eran más jóvenes (HD→DP: 53,5 años (DE 16,7) vs. DP→HD: 61,6 años, (DE 14,6) p<0,001), sufrían menor mortalidad (HD→DP: 24,5% vs. DP→HD: 32%, p<0,001) y tenían mayor acceso al TXR (HD→DP: 49,4% vs. DP→HD: 31,7%, p<0,001). ... (AU)

Introduction and objectives : The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT» that implies new questions about the best sequence of techniques.Material and methodsThe study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008–2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition.ResultsA total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KTX). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p<0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs 8.3% KTX group, p<0.001) and less access to a transplant (HD group 30.4% vs DP group 51.6%; p<0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD→PD: 0.7 years (SD 1.1) vs PD→HD: 1.5 years (SD 1.4) p<0.001), are younger (HD→PD: 53.5 years (SD 16.7) vs PD→HD: 61.6 years (SD 14.6); p<0.001), presented less mortality (HD→PD: 24.5% vs PD→HD: 32.0%; p<0.001) and higher access to a transplant (HD→PD: 49.4% vs PD→HD: 31.7%; p<0.001). ... (AU)

Transitions in an integrated model of renal replacement therapy in a regional health system. / Análisis de las transiciones en el modelo integrado de tratamiento sustitutivo renal en un sistema regional de salud.

INTRODUCTION AND OBJECTIVES: The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT¼ that implies new questions about the best sequence of techniques. MATERIAL AND METHODS: The study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008-2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition. RESULTS: A total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KTX). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p<0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs 8.3% KTX group, p<0.001) and less access to a transplant (HD group 30.4% vs DP group 51.6%; p<0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD→PD: 0.7 years (SD 1.1) vs PD→HD: 1.5 years (SD 1.4) p<0.001), are younger (HD→PD: 53.5 years (SD 16.7) vs PD→HD: 61.6 years (SD 14.6); p<0.001), presented less mortality (HD→PD: 24.5% vs PD→HD: 32.0%; p<0.001) and higher access to a transplant (HD→PD: 49.4% vs PD→HD: 31.7%; p<0.001). Survival analysis by competitive risks is essential for integrated RRT models, especially in groups such as PD patients, where 51.6% of the patients were considered as lost follow-up (received a KTX after during the first 2.5 years on PD). In this analysis, survival of patients who change from one technique to another, is more similar to the destination modality than the origin one. CONCLUSION: Our data suggest that transitions between RRT-techniques describes different patients, who associate different risks, and could be analyzed in an integrated manner to define improvement actions. This approach should be incorporated into the analysis and reports of renal registries.

Consulta de acceso vascular: resultados antes y después de la instauración de un programa multidisciplinar con realización de ecografía doppler de rutina / Vascular access clinic results before and after implementing a multidisciplinary approach adding routine Doppler ultrasound

ANTECEDENTES Y OBJETIVO: El abordaje multidisciplinar y el uso de ecografía doppler (ED) en la creación y vigilancia del acceso vascular (AV) puede mejorar la prevalencia y permeabilidad de las fístulas arteriovenosas (FAV) para hemodiálisis. El objetivo de este estudio es analizar el impacto de una nueva consulta multidisciplinar (CMD) de AV con ED de rutina. MATERIAL Y MÉTODOS: Evaluamos los resultados de la consulta de AV en 2014 (pre-CMD) y 2015 (CMD), antes y después de la implantación de un equipo multidisciplinar (cirujano vascular/nefrólogo) con ED de rutina en mapeo prequirúrgico y FAV prevalente. RESULTADOS: Se evaluaron 345 pacientes en 2014 (pre-CMD) y 364 pacientes en 2015 (CMD). En ambos periodos se realizó un número similar de cirugías, 172 vs. 198, p = 0,289, con tendencia a aumentar las cirugías preventivas de reparación de FAV en el periodo CMD, 17 vs. 29 (p = 0,098). En FAV de nueva creación (155 vs. 169), disminuyó la tasa de fallo primario en el periodo CMD, 26,4 vs. 15,3%, p = 0,015 y aumentó de forma no significativa la realización de FAV radiocefálicas distales, 25,8 vs. 33,2% (n = 40 vs. 56), p = 0,159. También aumentó la concordancia entre la indicación quirúrgica en la consulta y la cirugía realizada (81,3 vs. 93,5%, p = 0,001). En el periodo CMD se solicitaron menos exploraciones radiológicas desde la consulta, 78 vs. 35 (p < 0,001), con una reducción del gasto sanitario (81.716€ vs. 59.445€). CONCLUSIONES: El manejo multidisciplinar y la utilización del ED de rutina permiten mejorar los resultados de AV, con disminución de la tasa de fallo primario de FAV, más opciones de FAV distal nativa, mejor manejo de la FAV prevalente disfuncionante y menor coste en exploraciones radiológicas

BACKGROUND: A multidisciplinary approach and Doppler ultrasound (DU) assessment for the creation and maintenance of arteriovenous fistulas (AVF) for haemodialysis can improve prevalence and patency. The aim of this study was to analyse the impact of a new multidisciplinary vascular access (VA) clinic with routine DU. MATERIAL AND METHODS: We analysed the VA clinic results from 2014 and 2015, before and after the implementation of a multidisciplinary team protocol (vascular surgeon/nephrologist) with routine DU in preoperative mapping and prevalent AVF. RESULTS: We analysed 345 and 364 patients from 2014 and 2015 respectively. The number of surgical interventions was similar in both periods (p = .289), with a trend towards an increase in preventive surgical repair of AVF in 2015 (17 vs. 29, p = .098). 155 vs. 169 new AVF were performed in 2014 and 2015, with a significantly lower primary failure rate in 2015 (26.4 vs. 15.3%, p = .015), and a non-significant increase in radiocephalic AVF, 25.8 vs. 33.2% (n = 40 vs. 56), p = .159. The concordance between the indication at the clinic and the surgery performed also increased (81.3 vs. 93.5%, p = .001). Throughout 2015 fewer complementary imaging test were requested from the clinic (78 vs. 35, p < .001), with a corresponding reduction in costs (€87,716 vs. €59,445). CONCLUSIONS: Multidisciplinary approach with routine DU can improve VA results, with a decrease in primary failure rate, higher likelihood of radiocephalic AVF, better management of dis-functioning AVF and lower radiological test costs

Vascular access clinic results before and after implementing a multidisciplinary approach adding routine Doppler ultrasound. / Consulta de acceso vascular: resultados antes y después de la instauración de un programa multidisciplinar con realización de ecografía doppler de rutina.

BACKGROUND: A multidisciplinary approach and Doppler ultrasound (DU) assessment for the creation and maintenance of arteriovenous fistulas (AVF) for haemodialysis can improve prevalence and patency. The aim of this study was to analyse the impact of a new multidisciplinary vascular access (VA) clinic with routine DU. MATERIAL AND METHODS: We analysed the VA clinic results from 2014 and 2015, before and after the implementation of a multidisciplinary team protocol (vascular surgeon/nephrologist) with routine DU in preoperative mapping and prevalent AVF. RESULTS: We analysed 345 and 364 patients from 2014 and 2015 respectively. The number of surgical interventions was similar in both periods (p=.289), with a trend towards an increase in preventive surgical repair of AVF in 2015 (17 vs. 29, p=.098). 155 vs. 169 new AVF were performed in 2014 and 2015, with a significantly lower primary failure rate in 2015 (26.4 vs. 15.3%, p=.015), and a non-significant increase in radiocephalic AVF, 25.8 vs. 33.2% (n=40 vs. 56), p=.159. The concordance between the indication at the clinic and the surgery performed also increased (81.3 vs. 93.5%, p=.001). Throughout 2015 fewer complementary imaging test were requested from the clinic (78 vs. 35, p <.001), with a corresponding reduction in costs (€87,716 vs. €59,445). CONCLUSIONS: Multidisciplinary approach with routine DU can improve VA results, with a decrease in primary failure rate, higher likelihood of radiocephalic AVF, better management of dis-functioning AVF and lower radiological test costs.