Precision Medicine in Peritoneal Dialysis: An Expert Opinion on the Application of the Sharesource Platform for the Remote Management of Patients.

The management of end-stage kidney disease (ESKD) has been constantly evolving over the last decade with the development of targeted approaches. In this field, telemedicine and remote monitoring are based on the availability of new cyclers that allow for bidirectional communication (between patient and physician) and for the application of the Sharesource cloud-based platform. These technologies allow patients with ESKD to undergo automated peritoneal dialysis (APD) at home. However, these approaches are not well standardized and largely applied yet. Therefore, this study aimed to elaborate a protocol for the utilization of the Sharesource platform to facilitate the practical management of patients treated with APD. A series of expert meetings were held between September 2022 and January 2023 in Italy. The participants (ten nephrologists and five nurses) from nine Italian public dialysis centers shared their opinions, examined the current scientific literature in the field, and reviewed the key characteristics of the Sharesource system to achieve a common position on this topic. A detailed and practical document containing experts' opinions and suggestions on the use of the Sharesource platform for the management of patients treated with APD was produced. This expert opinion might represent a new useful instrument in clinical practice for managing patients undergoing home-based peritoneal dialysis (PD) through the Sharesource platform, which is valid not only for Italy. These recommendations pave the way to novel patient-centered and personalized therapeutic approaches for ESKD and highlight the advantages of telemedicine and remote monitoring in the management of patients with ESKD undergoing PD and its positive impact on their quality of life.

Study of genotoxic and cytotoxic effects induced in human fibroblasts by exposure to pulsed and continuous 1.6 GHz radiofrequency.

Background: The widespread use of radiofrequency (RF) sources, ranging from household appliances to telecommunications devices and military equipment, raises concerns among people and regulatory agencies about the potential health risks of RF exposure. Consequently, several in vitro and in vivo studies have been done to investigate the biological effects, in particular non-thermal, of this non-ionizing radiation. To date, this issue is still being debated due to the controversial results that have been reported. Furthermore, the impact of different RF signal modulations on biological systems remains poorly investigated. The present in vitro study aims to evaluate the cytotoxicity and genotoxicity of continuous or pulsed 1.6 GHz RF in human dermal fibroblasts (HDF). Methods: HDF cultures were exposed to continuous and pulsed 1.6 GHz RF, for 2 h, with Specific Absorption Rate (SAR) of 0.4 W/kg. The potential biological effects of 1.6 GHz RF on HDF were assessed with a multi-methodological approach, analyzing the effects on cell cycle, ultrastructure, protein expression, mitotic spindle, CREST stained micronuclei, chromosome segregation and γ-H2AX/53BP1 foci. Results: 1.6 GHz RF exposure modified proteins expression and morphology of HDF. Specifically, the expression of different heat-shock proteins (HSP) (i.e., HSP-90, HSP-60, and HSP-25) and phospho-AKT were affected. In addition, both continuous and pulsed RF modified the cytoskeletal organization in HDF and increased the number of lysosomes, while the formation of autophagosomes was observed only after pulsed RF exposure. Mitotic spindle anomalies were also found after exposure. However, no significant effect was observed on cell cycle, chromosome segregation, CREST-stained micronuclei and γ-H2AX/53BP1 foci. Conclusion: The results of the present study show the absence of genotoxic damage in 1.6 GHz RF exposed HDF and, although mitotic spindle alterations were observed, they did not have an aneugenic effect. On the other hand, changes in some proteins expression and cell ultrastructure in exposed HDF suggest that RF can potentially induce cell alterations at the morphological and molecular levels.

Combining telemedicine and in-person visits to deliver care to patients with severe chronic kidney disease (CKD): Lessons learned from COVID-19.

BACKGROUND: Telemedicine has been widely used to deliver healthcare to outpatients during the COVID-19 pandemic. The effectiveness of this modality is unclear in patients with a pre-dialysis stage of chronic kidney disease (CKD). This study aims to describe the clinical characteristics and management of CKD patients receiving telemedicine care during the COVID-19 pandemic. MATERIALS AND METHODS: A retrospective single-center cohort study enrolled outpatients with pre-dialytic stage of CKD from March 9 to June 21, 2020. Telemedicine was proposed for all patients with a stable CKD to reduce the risk of in-hospital transmission whereas in-person visit was performed for patients requiring urgent evaluation. RESULTS: In a 15-week period, 97 patients received 116 nephrological visits. According to the modality of healthcare delivery, the patients were subdivided into telemedicine (66%) and in-person visit (34%) groups. Mean age of all CKD patients was 72.8 ± 12.5 years and males were 50.5% of the population. The average estimated glomerular filtration rate (eGFR) was 14.6 ± 6 mL/min. Patients evaluated by telemedicine had better kidney function (GFR, 16.2 ± 6.4 vs. 13.6 ± 5.9 mL/min/1.73m2; p = 0.037), a lower body mass index (BMI) (24.1 ± 1.7 vs. 30.6 ± 5.7; p = 0.019), and a lower risk of CKD progression (51.1 vs. 25.4%, p = 0.017) than patients requiring in-person visit. Telemedicine-visit patients experienced a significantly lower number of pharmacological changes than patients managed in the ambulatory setting. Telemedicine was also used to conduct 20% of educational meetings on the choice of dialysis modality and 18.9% of pre-eligibility visits for kidney transplantation. CONCLUSION: Telemedicine made it possible to provide care to and maintain close monitoring of 2/3 of patients with pre-dialytic stage of CKD during the COVID-19 pandemic.

["Green" Hemodialysis: The Centralized Acidic Concentrate from the Dialysis Center of Policlinico of Modena].

Introduction and aim of the study. The centralized preparation and distribution system of acidic concentrate represents a true innovation in hemodialysis, when compared to acid bags, in terms of convenience and eco-sustainability. The aim of this study is to compare the use of traditional acid bags with the centralized distribution system of acidic concentrate, with particular attention to differences in terms of eco-sustainability and convenience. Methods. At the Nephrology Dialysis and Renal Transplantation Unit of the University Hospital of Modena was installed the Granumix system® (Fresenius Medical Care, Bad Homburg, Germany). Data collected before the introduction of the Granumix® system (including the used acid bags, boxes and pallets used for their packaging, liters of acid solution used and kilograms of waste generated from wood, plastic, cardboard and residual acid solution) were compared with those collected after the implementation of the Granumix® system. Factors such as material consumption, volume of waste generated, unused and wasted products, time required for dialysis session preparation and nurses' satisfaction were analyzed to document which system was more environmentally sustainable. Results. Data collected in 2019 at our Dialysis Center showed a consumption of 30,000 acid bags, which generated over 20,000 kg of waste from wood, plastic and cardboard, and approximately 12,000 liters of residual acid solution to be disposed of, with a handling weight by operators reaching nearly 160,000 kg. The use of the centralized distribution system of acidic concentrate resulted in a significant reduction in waste generated (2,642 kg vs 13,617 kg), residual acid solution to be disposed of (2,351 liters vs 12,100 liters) and weights handled by operators (71,522 kg vs 158,117 kg). Conclusions. The acidic concentrate appears to be better suited to the sustainability challenge that dialysis must faces today, particularly due to the significant increase in the number of patients, which leads to a higher number of treatments and, therefore, a growing demand for eco-sustainable products.

Treatment strategies of the thromboembolic risk in kidney failure patients with atrial fibrillation.

The incidence and prevalence of atrial fibrillation (AF) in patients affected by kidney failure, i.e. glomerular filtration rate <15 ml/min/1.73 m2, is high and probably underestimated. Numerous uncertainties remain regarding how to prevent thromboembolic events in this population because both cardiology and nephrology guidelines do not provide clear recommendations. The efficacy and safety of oral anticoagulant therapy (OAC) in preventing thromboembolism in patients with kidney failure and AF has not been demonstrated for either vitamin K antagonists (VKAs) or direct anticoagulants (DOACs). Moreover, it remains unclear which is more effective and safer, because estimated creatinine clearance <25-30 ml/min was an exclusion criterion in the randomized controlled trials (RCTs). Three RCTs comparing DOACs and VKAs in kidney failure failed to reach the primary endpoint, as they were underpowered. The left atrial appendage is the main source of thromboembolism in the presence of AF. Left atrial appendage closure (LAAC) has recently been proposed as an alternative to OAC. RCTs comparing the efficacy and safety of LAAC versus OAC in kidney failure were terminated prematurely due to recruitment failure. A recent prospective study showed a reduction in thromboembolic events in haemodialysis patients with AF and undergoing LAAC compared with patients taking or not taking OAC. We review current treatment standards and discuss recent developments in managing the thromboembolic risk in kidney failure patients with AF. The importance of shared decision-making with the multidisciplinary team and the patient to consider individual risks and benefits of each treatment option is underlined.

Exploring the Role of Cell-Free Nucleic Acids and Peritoneal Dialysis: A Narrative Review.

INTRODUCTION: Cell-free nucleic acids (cf-NAs) represent a promising biomarker of various pathological and physiological conditions. Since its discovery in 1948, cf-NAs gained prognostic value in oncology, immunology, and other relevant fields. In peritoneal dialysis (PD), blood purification is performed by exposing the peritoneal membrane. Relevant sections: Complications of PD such as acute peritonitis and peritoneal membrane aging are often critical in PD patient management. In this review, we focused on bacterial DNA, cell-free DNA, mitochondrial DNA (mtDNA), microRNA (miRNA), and their potential uses as biomarkers for monitoring PD and its complications. For instance, the isolation of bacterial DNA in early acute peritonitis allows bacterial identification and subsequent therapy implementation. Cell-free DNA in peritoneal dialysis effluent (PDE) represents a marker of stress of the peritoneal membrane in both acute and chronic PD complications. Moreover, miRNA are promising hallmarks of peritoneal membrane remodeling and aging, even before its manifestation. In this scenario, with multiple cytokines involved, mtDNA could be considered equally meaningful to determine tissue inflammation. CONCLUSIONS: This review explores the relevance of cf-NAs in PD, demonstrating its promising role for both diagnosis and treatment. Further studies are necessary to implement the use of cf-NAs in PD clinical practice.

Capacity for the management of kidney failure in the International Society of Nephrology Western Europe region: report from the 2023 ISN Global Kidney Health Atlas (ISN-GKHA).

Western Europe boasts advanced health care systems, robust kidney care guidelines, and a well-established health care workforce. Despite this, significant disparities in kidney replacement therapy incidence, prevalence, and transplant access exist. This paper presents the third International Society of Nephrology Global Kidney Health Atlas's findings on kidney care availability, accessibility, affordability, and quality in 22 Western European countries, representing 99% of the region's population. The known chronic kidney disease (CKD) prevalence across Western Europe averages 10.6%, slightly above the global median. Cardiovascular diseases account for a substantial portion of CKD-related deaths. Kidney failure incidence varies. Government health expenditure differs; however, most countries offer government-funded acute kidney injury, dialysis, and kidney transplantation care. Hemodialysis and peritoneal dialysis are universally available, with variations in the number of dialysis centers. Kidney transplantation is available in all countries (except for 3 microstates), with variable transplant center prevalence. Conservative kidney management (CKM) is increasingly accessible. The region's kidney care workforce is substantial, exceeding global averages; however, workforce shortages are reported. Barriers to optimal kidney care include limited workforce capacity, lack of surveillance mechanisms, and suboptimal integration into national noncommunicable disease (NCD) strategies. Policy recognition of CKD as a health priority varies across countries. Although Western Europe exhibits strong kidney care infrastructure, opportunities for improvement exist, particularly in CKD prevention, surveillance, awareness, and policy implementation. Efforts to improve CKD care should include automated detection, educational support, and enhanced workflows. Based on these findings, health care professionals, stakeholders, and policymakers are called to act to enhance kidney care across the region.

Risk of infections related to endovascular catheters and cardiac implantable devices in hemodialysis patients.

Patients requiring dialysis are extremely vulnerable to infectious diseases. The high burden of comorbidities and weakened immune system due to uremia and previous immunosuppressive therapy expose the patient on dialysis to more infectious events than the general population. The infectious risk is further increased by the presence of endovascular catheters and implantable cardiologic devices. The former is generally placed as urgent vascular access for dialysis and in subjects requiring hemodialysis treatments without autogenous arteriovenous fistula. The high frequency of cardiovascular events also increases the likelihood of implanting indwelling implantable cardiac devices (CIED) such as pacemakers (PMs) and defibrillators (ICDs). The simultaneous presence of CVC and CIED yields an increased risk of developing severe prosthetic device-associated bloodstream infections often progressing to septicemia. Although, antibiotic therapy is the mainstay of prosthetic device-related infections, antibiotic resistance of biofilm-residing bacteria reduces the choice of infection eradication. In these cases, the resolution of the infection process relies on the removal of the prosthetic device. Compared to CVC removal, the extraction of leads is a more complex procedure and poses an increased risk of vessel tearing. As a result, the prevention of prosthetic device-related infection is of utmost importance in hemodialysis (HD) patients and relies principally on avoiding CVC as vascular access for HD and placement of a new class of wireless implantable medical devices. When the combination of CVC and CIED is inevitable, prevention of infection, mainly due translocation of skin bacteria, should be a mandatory priority for healthcare workers.

Scheduling of Remote Monitoring for Peritoneal Dialysis Patients.

Peritoneal dialysis (PD) is performed as a home-based treatment and in this context, telemedicine has been proven helpful for improving clinicians' surveillance and maintaining PD patients in their home setting. The new e-health devices make remote patient monitoring (RPM) for automated peritoneal dialysis (APD) treatment possible, evaluating the data at the end of every treatment and adapting the prescription at distance if necessary. This paper aims to share a method for improving clinical surveillance and enabling PD patients to receive their treatment at home. In the present case series, we delineate the clinical protocol of the Vicenza PD Center regarding patient characteristics, timing, and the purpose of the APD-RPM. We present the Vicenza PD Center's experience, illustrating its application through three case reports as exemplars. Telemedicine helps to carefully allocate healthcare resources while removing the barriers to accessing care. However, there is a risk of data overload, as some data might not be analyzed because of an increased workload for healthcare professionals. A proactive physician's attitude towards the e-health system has to be supported by clinical instructions and legislative rules. International and national guidelines may suggest which patients should be candidates for RPM, which parameters should be monitored, and with what timing. According to our experience, we suggest that the care team should define a workflow that helps in formulating a correct approach to RPM, adequately utilizing resources. The workflow has to consider the different needs of patients, in order to assure frequent remote control for incident or unstable patients, while prevalent and stable patients can perform their home treatment more independently, helped by periodic and deferred clinical supervision.

Ongoing Peritoneal Dialysis Training at Home Allows for the Improvement of Patients' Empowerment: A Single Center Experience.

INTRODUCTION: Peritoneal dialysis (PD), as a home treatment, ensures better patient autonomy and lower intrusiveness compared to hemodialysis. However, choosing PD comes with an increased burden of responsibility that the patient may not always be able to bear, due to advanced age and deteriorating health condition. Various approaches have been explored to address this issue and mitigate its primary complications. In this study, we aim to present the ongoing PD training at-home program implemented by the Vicenza PD Center, and evaluate its impact on patients' prognoses. MATERIAL AND METHODS: We enrolled 210 patients who underwent PD at Vicenza Hospital between 1 January 2019 and 1 January 2022 for a minimum of 90 days. Each patient was observed retrospectively for one year. We categorized the patients into three groups based on their level of autonomy regarding their PD management: completely independent patients; patients able to perform some parts of the PD method on their own, while the remaining aspects were carried out by a caregiver; and patients who required complete assistance from a caregiver, like in the assisted PD program (asPD). RESULTS: A total of 70% of the PD population were autonomous regarding their PD therapy, 14% had an intermediate degree of autonomy, and 16% were entirely dependent on caregivers. The PD nurses performed a median of four home visits per patient per year, with a tendency to make more visits to patients with a lower degree of autonomy. All the groups achieved similar clinical outcomes. At the end of the year of observation, only 6% of the patients witnessed a decline in their autonomy level, whereas 7% demonstrated an enhancement in their level of autonomy, and 87% remained stable. CONCLUSIONS: A home care assistance program ensures clinical support to a household with the purpose of improving the empowerment of the PD population and reducing the prevalence of assisted PD. Ongoing PD training at home helps patients to maintain a stable degree of autonomy and stay in their home setting, even though they present with relative attitudinal or social barriers.

Risk of bleeding after percutaneous native kidney biopsy in patients receiving low-dose aspirin: a single-center retrospective study.

BACKGROUND: Although discontinuation of antiplatelet agents at least 5 days before kidney biopsy is commonly recommended, the evidence behind this practice is of low level. Indeed, few non-randomized studies previously showed an equivalent risk of bleeding in patients receiving aspirin therapy. METHODS: We conducted a single center retrospective study comparing the risk of complications after percutaneous native kidney biopsy in patients who received low-dose aspirin (ASA) within 5 days from biopsy and those who did not. The main outcome was the difference in the incidence of major complications (red blood cell transfusion, need for selective arterial embolization, surgery, nephrectomy). Secondary outcomes included difference in minor complications, comparison between patients who received ASA within 48 h or within 3-5 days, identification of independent factors predictive of major complications. RESULTS: We analyzed data on 750 patients, of whom 94 received ASA within 5 days from biopsy. There were no significant differences in the proportion of major complications in patients receiving or not receiving ASA (2.59% and 3.19%, respectively, percentage point difference 1%, 95% CI - 3 to 4%, p = 0.74). Groups were also comparable for minor complications; among patients receiving ASA, there were no differences in major bleeding between those who received ASA within 48 h or 3-5 days from biopsy. Significant baseline predictors of major bleeding in our cohort were platelet count lower than 120*103/microliter, higher diastolic blood pressure and higher blood urea. CONCLUSIONS: Treatment with low-dose ASA within 5 days from kidney biopsy did not increase the risk of complications after the procedure.

Prevalence, clinical course and outcomes of COVID-19 in peritoneal dialysis (PD) patients: a single-center experience.

INTRODUCTION: There are limited data on the effects of COVID-19 on peritoneal dialysis (PD) patients. This study aimed to describe the impact of COVID-19 on the PD population. METHODS: A monocentric retrospective observational study was conducted on 146 consecutive PD patients followed from January 2020 to March 2022 at the University Hospital of Modena, Italy. RESULTS: Twenty-seven (18.4%) PD patients experienced 29 episodes of SARS-CoV-2 infection, corresponding to an incidence rate of 0.16 episodes/patient-year. Median age of COVID-19 patients was 60.4 (interquartile range [IQR] 50.2-66.5) years. In unvaccinated patients (n. 9), COVID-19 was always symptomatic and manifested with fever (100%) and cough (77.7%). COVID-19 caused hospital admission of three (33.3%) patients and two (22.2%) died of septic shock. COVID-19 was symptomatic in 83.3% of vaccinated subjects (n.18) and manifested with fever (61.1%) and cough (55.6%). Hospital admission occurred in 27.8% of the subjects but all were discharged home. Median SARS-CoV-2 shedding was 32 and 26 days in the unvaccinated and vaccinated groups, respectively. At the end of the follow-up, COVID-19 triggered the shift from PD to HD in two subjects without affecting the residual renal function of the remaining patients. Overall, COVID-19 caused an excess death of 22.2%. COVID-19 vaccination refusal accounted for only 1.6% in this cohort of patients. CONCLUSION: COVID-19 incident rate was 0.16 episodes/patient-year in the PD population. About one-third of the patients were hospitalized for severe infection. Fatal outcome occurred in two (7.4%) unvaccinated patients. A low vaccination refusal rate was observed in this population.

Skin reaction with Eosinophilia and Systemic Symptoms after lenalidomide in peritoneal Dialysis.

The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a fatal and immune-mediated idiosyncratic drug reaction, with symptoms of fever, skin eruptions (that involves more than half of the body surface), facial oedema and hematological disorders, all presenting within the latent period following drug intake. Effects can also be seen on multiple organs, most notably hepatitis in liver and acute interstitial nephritis in kidney, generally post-administration of allopurinol. The European Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) classifies the DRESS Syndrome cases as "definite", "probable" or "possible", based on clinical and laboratory features. Different pathogenetic mechanisms have been involved in this disease, including immunological reactions and HHV-6 reactivation. In our experience, a 72-year-old male, affected by myeloma in peritoneal dialysis, developed a rare case of DRESS syndrome after lenalidomide administration (less than ten cases are known) with HHV-6 reactivation. According to literature, we withdrew the drug and gave methylprednisolone 0,8 mg/kg orally and IVIG 1 gr/kg for two days. Despite this therapy, DRESS syndrome relapsed during steroid taper with rash, thrombocytopenia, hepatitis and high troponin level. A single cycle of intravenous immunoglobulin 0,5 g/kg for four days was enough for syndrome remission. Only few cases are reported in literature, but because of the increasing use of lenalidomide and the autoimmune sequelae of DRESS syndrome, a broad workup and a multidisciplinar careful approach could help in diagnosis, treatment and follow-up.

Rethinking Chronic Kidney Disease in the Aging Population.

The process of aging population will inevitably increase age-related comorbidities including chronic kidney disease (CKD). In light of this demographic transition, the lack of an age-adjusted CKD classification may enormously increase the number of new diagnoses of CKD in old subjects with an indolent decline in kidney function. Overdiagnosis of CKD will inevitably lead to important clinical consequences and pronounced negative effects on the health-related quality of life of these patients. Based on these data, an appropriate workup for the diagnosis of CKD is critical in reducing the burden of CKD worldwide. Optimal management of CKD should be based on prevention and reduction of risk factors associated with kidney injury. Once the diagnosis of CKD has been made, an appropriate staging of kidney disease and timely prescriptions of promising nephroprotective drugs (e.g., RAAS, SGLT-2 inhibitors, finerenone) appear crucial to slow down the progression toward end-stage kidney disease (ESKD). The management of elderly, comorbid and frail patients also opens new questions on the appropriate renal replacement therapy for this subset of the population. The non-dialytic management of CKD in old subjects with short life expectancy features as a valid option in patient-centered care programs. Considering the multiple implications of CKD for global public health, this review examines the prevalence, diagnosis and principles of treatment of kidney disease in the aging population.

Weekly Rapid Antigen Test Screening for COVID-19 in Patients on Hemodialysis.

BACKGROUND/AIM: COVID-19 is a concerning issue among in-center hemodialysis (HD) patients. To prevent COVID-19 diffusion in our HD facility, weekly rapid nasal antigen test screening was performed for all asymptomatic patients on chronic HD. This study aimed to assess the performance of weekly rapid antigen test in detecting SARS-CoV-2 infection among asymptomatic patients receiving HD. PATIENTS AND METHODS: A retrospective analysis was conducted in HD patients who underwent rapid antigen test screening from December 2021 to March 2022. The diagnosis of COVID-19 with rapid antigen test was always confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR). RESULTS: During the observational period, 1,748 rapid antigen tests were performed in 220 HD patients. Mean age was 68.4±14.6 years. Fifteen (8.5%) patients resulted positive for SARS-CoV-2 infection using rapid antigen tests. The diagnosis was subsequently confirmed in 14 (93.3%) patients by RT-PCR. During the same period, 12 (5.4%) symptomatic patients, regularly screened with weekly rapid antigen test, resulted positive for SARS-CoV-2 infection using RT-PCR. Overall, weekly rapid antigen test screening identified 14 out of 26 (53.8%) COVID-19 cases and showed a positive predictive value of 93%. CONCLUSION: Weekly antigen test screening of asymptomatic patients on chronic HD detected around half of the COVID-19 cases in our population.