Renal Embolization-Induced Uremic Swine Model for Assessment of Next-Generation Implantable Hemodialyzers.

Reliable models of renal failure in large animals are critical to the successful translation of the next generation of renal replacement therapies (RRT) into humans. While models exist for the induction of renal failure, none are optimized for the implantation of devices to the retroperitoneal vasculature. We successfully piloted an embolization-to-implantation protocol enabling the first implant of a silicon nanopore membrane hemodialyzer (SNMHD) in a swine renal failure model. Renal arterial embolization is a non-invasive approach to near-total nephrectomy that preserves retroperitoneal anatomy for device implants. Silicon nanopore membranes (SNM) are efficient blood-compatible membranes that enable novel approaches to RRT. Yucatan minipigs underwent staged bilateral renal arterial embolization to induce renal failure, managed by intermittent hemodialysis. A small-scale arteriovenous SNMHD prototype was implanted into the retroperitoneum. Dialysate catheters were tunneled externally for connection to a dialysate recirculation pump. SNMHD clearance was determined by intermittent sampling of recirculating dialysate. Creatinine and urea clearance through the SNMHD were 76-105 mL/min/m2 and 140-165 mL/min/m2, respectively, without albumin leakage. Normalized creatinine and urea clearance measured in the SNMHD may translate to a fully implantable clinical-scale device. This pilot study establishes a path toward therapeutic testing of the clinical-scale SNMHD and other implantable RRT devices.

Home Dialysis in the Coronavirus Disease 2019 Era.

The coronavirus disease 2019 pandemic has had a significant impact on patients with end-stage kidney disease and their care, especially given the potential for severe coronavirus disease 2019 in those with a depressed immune status. Patients receiving in-center hemodialysis have been particularly affected by this pandemic because of their need to travel multiple times a week to receive treatment. Although patients on home dialysis are able to avoid such exposure, they face their own unique challenges. In this review, we will discuss the challenges posed by the coronavirus disease 2019 pandemic for patients on home dialysis, the impact of coronavirus disease 2019 on various aspects of their care, and the resultant rapid adaptations in policy/health-care delivery mechanisms with implications for the future care of patients on home dialysis.

The current and future landscape of dialysis.

The development of dialysis by early pioneers such as Willem Kolff and Belding Scribner set in motion several dramatic changes in the epidemiology, economics and ethical frameworks for the treatment of kidney failure. However, despite a rapid expansion in the provision of dialysis - particularly haemodialysis and most notably in high-income countries (HICs) - the rate of true patient-centred innovation has slowed. Current trends are particularly concerning from a global perspective: current costs are not sustainable, even for HICs, and globally, most people who develop kidney failure forego treatment, resulting in millions of deaths every year. Thus, there is an urgent need to develop new approaches and dialysis modalities that are cost-effective, accessible and offer improved patient outcomes. Nephrology researchers are increasingly engaging with patients to determine their priorities for meaningful outcomes that should be used to measure progress. The overarching message from this engagement is that while patients value longevity, reducing symptom burden and achieving maximal functional and social rehabilitation are prioritized more highly. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value, which can only come about through true patient-centred innovation that supports high-quality, high-value care. Substantial efforts are now underway to support requisite transformative changes. These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization.

Medical waste management - how industry can help us to protect environment and money?

Background: The global climate change and its consequences force us to remodel our processes and rethink the current model of providing the HD treatments. Waste management have a massive impact on the environment and the economy. Every HD session produces above 1 kg of medical waste, which should be properly stored and destroyed. In particular in the pandemia time we should improve the dialysis unit budget as well as decrease CO2 emission produced during the waste elimination.Materials and Methods: The checked the weight of different dialyzers used regularly in dialysis centers in Poland. The Kern CM 320-IN scale was used for the measurement. The measurement accuracy was 0.1 g. Also the filling volume of each dialyzer has been taken into consideration.Results: The dialyzers were divided into four groups depending on the surface. 1,4m2 in group one, 1.5-1.6 m2 in group two, 1.7-1.8 m2 in group three and finally 2.0-2.2 m2 in group four. FX class dialyzers were lightest in every group. The heaviest ones were Polyflux dialyzers. The difference between the lightest and heaviest dialyzers was about 95 g. The filling volume was lowest in FX dialyzers and the highest in Elisio dialyzers. The difference was 20 mL.Conclusions: The weight of different dialyzers available on the market differs. The decision-makers should take into account this fact as the additional quality feature. In extreme cases the weight difference reaches 95 g. In yearly perspective, the usage of the lighter dialysis set can cause the 17 million kg decrease of medical waste and significant savings.

Developing nephrology services in low income countries: a case of Tanzania.

BACKGROUND: The burden of kidney diseases is reported to be higher in lower- and middle-income countries as compared to developed countries, and countries in sub-Saharan Africa are reported to be most affected. Health systems in most sub-Sahara African countries have limited capacity in the form of trained and skilled health care providers, diagnostic support, equipment and policies to provide nephrology services. Several initiatives have been implemented to support establishment of these services. METHODS: This is a situation analysis to examine the nephrology services in Tanzania. It was conducted by interviewing key personnel in institutions providing nephrology services aiming at describing available services and international collaborators supporting nephrology services. RESULTS: Tanzania is a low-income country in Sub-Saharan Africa with a population of more than 55 million that has seen remarkable improvement in the provision of nephrology services and these include increase in the number of nephrologists to 14 in 2018 from one in 2006, increase in number of dialysis units from one unit (0.03 unit per million) before 2007 to 28 units (0.5 units per million) in 2018 and improved diagnostic services with introduction of nephropathology services. Government of Tanzania has been providing kidney transplantation services by funding referral of donor and recipients abroad and has now introduced local transplantation services in two hospitals. There have been strong international collaborators who have supported nephrology services and establishment of nephrology training in Tanzania. CONCLUSION: Tanzania has seen remarkable achievement in provision of nephrology services and provides an interesting model to be used in supporting nephrology services in low income countries.

Reusing dialyzer in low income countries: A good cost saving tactic with complex ethics.

Despite almost universal practice of dialyzer reuse from the earliest days of haemodialysis, reusing dialyzer always remains a controversial issue and several ethical concerns have been raised. Some of the important are safety of reuse over single use, informed consent of the patient, conflict of interest on the part of physician or manufacturer, fiscal responsibility and environmental stewardship. Indeed, at the beginning of this century, there was a drastic shift of practice in favour of single use in developed countries due to availability of biocompatible haemodialyzers, at favourable price. Despite this mega shift, dialyzer reuse is still widely practised in low-income countries. Considering cost inflation and limited medical resources in such countries, dialyzer reuse may be justified as a cost-saving strategy for this part of world. However, it poses the same ethical questions to us which were a matter of debate for the western world in the 1980s and 1990s. This review of literature was planned to revisit and highlight these concerns.

[Experimental development and rationale for a renal decellularization protocol with subsequent comprehensive assessment of the biological scaffold].

Chronic renal failure (CRF) is one of the most challenging problems of contemporary medicine. Patients with chronic renal failure usually need renal replacement therapy as either hemodialysis, peritoneal dialysis or a kidney transplant. The latter is the most promising option for end-stage kidney disease. However, the shortage of donor organs, the complexity of their delivery, the difficulty in finding an immunologically compatible donor and the need for lifelong immunosuppression triggered advances in modern tissue engineering. In this field, the primary priority is focused on developing bioengineered scaffolds with subsequent recellularization with autologous cells. Using such constructs would allow for solving both ethical and immunological problems of transplantation. The aim of this pilot study was to develop a new method of renal decellularization using small laboratory animals. MATERIALS AND METHODS: The study investigated the morphological structure of the obtained decellularized matrix and quantitatively tested DNA residues in the resulting scaffold. We proposed a new biophysical method for assessing the matrix quality using the EPR spectroscopy and conducted experiments on the matrix recellularization with mesenchymal multipotent stem cells to estimate cytotoxicity, cell viability and metabolic activity. RESULTS: The obtained decellularized renal matrix retained the native tissue architecture after a complete removal of the cell material, had no cytotoxic properties and supported cell adhesion and proliferation. CONCLUSION: All the above suggests that the proposed decellularization protocol is a promising method to produce tissue-engineered kidney constructs with possible clinical application in the foreseeable future.

A Primer on Hemodialysis From an Interventional Radiology Perspective.

Interventional radiologists play a central role in the care of patients with end-stage renal disease receiving renal replacement therapy. Ensuring that a patient׳s dialysis access remains suitable for high-quality dialysis is of paramount importance. However, although much has been spoken and written about endovascular techniques and outcomes based on angiographic criteria, little is generally known regarding the function and therefore the requirements of hemodialysis. In this article, we provide a heuristic overview of the mechanics of hemodialysis, with an emphasis on the "breaking points" in the extracorporeal circuit that trigger a patient׳s referral to Interventional Radiology. We also describe how dialysis quality is increasingly becoming linked with dialysis reimbursements. It is thus becoming progressively incumbent on the interventional radiologist to not only ensure that a patient receives high-quality outpatient dialysis but also that the patient׳s dialysis center meets its performance metrics.

Reuse and Biocompatibility of Hemodialysis Membranes: Clinically Relevant?

The practice of reprocessing dialyzers for reuse, once predominant in the United States, has been steadily declining over the last 20 years. The professed roles of reuse in improving dialyzer membrane biocompatibility and lowering the risk of first-use syndrome have lost relevance with the advent of biocompatible dialyzer membranes and favorable sterilization techniques. The potential for cost-savings from reuse is also called into question by the easy availability of comparatively cheaper dialyzers and rising regulatory demands and operational cost of reprocessing systems. While the environmental concerns from additional dialyzer-related solid waste from rising single-use practice remains pertinent and requires development of safer dialyzer disposable system technologies, there is no meaningful medical rationale for the continued practice of dialyzer reuse in the twenty-first century.

Dialisador capilar reutilizado e de uso único em hemodiálise: implicações na saúde dos profissionais, em desfechos clínicos e custos

A reutilização do dialisador capilar em hemodiálise é uma prática realizada em muitos países, apesar de não haver consenso sobre sua segurança e eficácia em comparação ao dialisador de uso único. Em relação ao uso único, apontam-se os custos como grande entrave e a preocupação com o aumento do lixo hospitalar. No que se refere aos riscos do reuso, aponta-se a exposição dos profissionais aos produtos químicos necessários à realização do processo de reutilização, assim como movimentos repetitivos envolvidos na dinâmica dessa técnica; somadas a isto, a redução da eficiência da membrana, a contaminação do sistema, as infecções cruzadas, as reações pirogênicas e as bacteremias. Nesse sentido, tornam-se relevantes estudos que investiguem o efeito da adoção desses métodos nesses desfechos. Objetivos: Comparar as implicações do dialisador reutilizado (reuso) com as do utilizado uma única vez (uso único) na saúde dos profissionais, nos desfechos clínicos e custos de pacientes em hemodiálise. Métodos: Estudo longitudinal, com coleta de dados retrospectiva, realizado em um Hospital Público Universitário (Janeiro de 2015 a Fevereiro de 2016). Foram incluídos 18 técnicos de enfermagem e 34 pacientes renais crônicos submetidos à hemodiálise nos dois períodos do estudo (período de reuso e período de uso único), por meio de cateter, fístula ou enxerto, com fluxo de sangue de pelo menos 300 ml/min. e tempo de diálise definido entre três a quatro horas por sessão. Considerou-se como desfechos primários os distúrbios osteomusculares, irritação ocular, as dermatoses, afastamento do trabalho e uso de medicações. Como secundários, hemodinâmica, volemia, exames laboratoriais, reações pirogênicas, bacteremias, uso de antibióticos e custos diretos e indiretos do procedimento. Projeto aprovado no Comitê de Ética da instituição...

Capillary dialyzer reuse in hemodialysis is a practice carried out in many countries, although there is no consensus about its safety and effectiveness in comparison with the single-use dialyzer. Regarding the single-use dialyzer, costs are considered a major obstacle, as is the concern with the increase in medical waste. In what concerns the risks of reuse, the exposure of the professionals to chemicals needed to carry out the process of reuse, as well as the repetitive movements involved in the dynamics of this technique stand out; added to this, there are the reduced efficiency of the membrane, the contamination of the system, crossinfections, pyrogenic reactions and bacteremia. In this sense, a study which investigates the effect of the adoption of these methods in these outcomes becomes relevant. Objectives: To compare the implications of reused dialyzer with single-use dialyzer on the health of professionals, clinical outcomes and costs of patients in hemodialysis. Methods: Longitudinal study with retrospective data collection, carried out in a Public University Hospital (January 2015 to February 2016). Participated in the study 18 nursing technicians and 34 chronic kidney patients subjected to hemodialysis in the two periods of the study (reuse and single-use periods), through catheter, fistula or graft, with blood flow of at least 300 mL/min, dialysis time set between three to four hours per session. Musculoskeletal disorders, eye irritation, skin diseases, work leave and the use of medications were considered as primary outcomes. Secondary included hemodynamics, blood volume, laboratory tests, pyrogenic reactions, bacteremia, antibiotic use, direct and indirect costs of the procedure. The project was approved by the Ethics Committee of the institution...

Clinical evaluation of an expert system for arteriovenous fistula assessment.

The monitoring of ionic dialysance in hemodialysis allows early detection of arterio-venous fistula stenosis. One limitation to the practical use of ionic dialysance is that the analysis is very time consuming on a majority of normal cases.The purpose of the study is to evaluate the utility of an expert system reproducing a human analysis and allowing continuous monitoring of the ionic dialysance by helping the physician to focus his or her expertise on the abnormal cases.The method is based on a Bayesian model that analyzes the blood flow rate, the ionic dialysance, and the venous and arterial pressures measured on the extra corporeal circuit.The clinical evaluation was performed on 90 dialysis patients at the hospital dialysis center of Saint Brieux in France with a history of at least four consecutive months of validated recording. The retrospective automated analysis was evaluated in comparison to vascular access problems identified from invasive investigation or treatment. The sensitivity of the automated analysis is 92% with a specificity of 75%.As a conclusion we suggest that this expert system could be used in a continuous vascular access monitoring procedure consisting in a weekly review of the patient population at the dialysis center. The patients with the highest risk score need a further investigation of their historical data and their medical history in order to decide whether or not to perform an invasive intervention.

Home telehealth in high-risk dialysis patients: a 3-year study.

OBJECTIVE: This study is a continuation of a previous pilot project that demonstrated improved health outcomes and significant cost savings using home telehealth with nurse oversight in patients with end-stage renal disease undergoing chronic dialysis. We are reporting the results of a larger sample size over a 3-year study period to test the validity of our original observations. SUBJECTS AND METHODS: Ninety-nine patients were included in this study; 43 (18 females, 25 males) with a mean age of 58.6 years were enrolled in the remote technology (RT) group, and 56 (26 females, 30 males) with a mean age of 63.1 years were enrolled in the usual-care (UC) group. Health resource outcome measures included hospitalizations, emergency room (ER) visits, and number of days hospitalized. Economic analysis was conducted on hospital and ER charges. RESULTS: Hospitalizations (RT, 1.8; UC, 3.0), hospital days (RT, 11.6; UC, 25.0), and hospital and ER charges (RT, $66,000; UC, $157,000) were significantly lower in the RT group, as were hospital and ER charges per study day (RT, $159; UC, $317). CONCLUSIONS: The results support our previous findings, that is, home telehealth can contribute to improved health outcomes and cost of care in high-risk dialysis patients.