Two Years' Experience of Intensive Home Hemodialysis with the Physidia S3 System: Results from the RECAP Study.

The RECAP study reports results and outcomes (clinical performances, patient acceptance, cardiac outcomes, and technical survival) achieved with the S3 system used as an intensive home hemodialysis (HHD) platform over a three-year French multicenter study. Ninety-four dialysis patients issued from ten dialysis centers and treated more than 6 months (mean follow-up: 24 months) with S3 were included. A two-hour treatment time was maintained in 2/3 of patients to deliver 25 L of dialysis fluid, while 1/3 required up to 3 h to achieve 30 L. The additional convection volume produced by means of the SeCoHD tool (internal filtration backfiltration) was 3 L/session, and the net ultrafiltration produced to achieve dry weight was 1.4 L/session. On a weekly basis, an average 156 L of dialysate corresponding to 94 L of urea clearance when considering 85% dialysate saturation under low flow conditions was delivered. Such urea clearance was equivalent to 9.2 [8.0-13.0] mL/min weekly urea clearance and a standardized Kt/V of 2.5 [1.1-4.5]. The predialysis concentration of selected uremic markers remained remarkably stable over time. Fluid volume status and blood pressure were adequately controlled by means of a relatively low ultrafiltration rate (7.9 mL/h/kg). Technical survival on S3 was 72% and 58% at 1 and 2 years, respectively. The S3 system was easily handled and kept by patients at home, as indicated by technical survival. Patient perception was improved, while treatment burden was reduced. Cardiac features (assessed in a subset of patients) tended to improve over time. Intensive hemodialysis relying on the S3 system offers a very appealing option for home treatment with quite satisfactory results, as shown in the RECAP study throughout a two-year follow-up time, and offers the best bridging solution to kidney transplantation.

Estimating the cost of home dialysis in Tunisia: Application of the Activity-based costing methodology.

INTRODUCTION: In Tunisia, in-centre haemodialysis (ICHD) is the most common type of dialysis. Despite the increasing demand, the number of haemodialysis machines per 100,000 inhabitants is still low. Home Haemodialysis (HHD) is a candidate solution to this problem. Despite its confirmed benefits over ICHD, HHD has not taken place in Tunisia. AIM: To describe the processes of home dialysis modalities, especially HHD, evaluate their costs, analyse them, in the context of medical practice in public health structures in Tunisia. METHOD: The Activity-Based Costing technique was applied: the processes of home dialysis modalities were modelled, the main activity and resource cost drivers identified, and cost equations developed. Based on data from the nephrology department of Sahloul hospital, the cost per session and annual costs for each home dialysis modality were calculated and analyzed. RESULTS: Home Peritoneal Dialysis, already implemented in Tunisia; presented the lowest annual cost per patient 25344 TND versus 29232 TND for Conventional HHD and 54144 TND for Short-Daily HHD. The cost per session of the Short-Daily HHD (188,8 TND) was comparable to ICHD (180 TND). Consumables presented the most expensive resource for these modalities. Finally, the cost structure of HHD was comparable in Tunisia and France as well as in previous costing studies. CONCLUSION: The cost of one session of HHD is estimated to 188,8 TND. The Tunisian ministry of health could adopt a flexible policy to start HHD program by implementing Conventional HHD first.

Safety and Efficacy of Short Daily Hemodialysis with Physidia S3 System: Clinical Performance Assessment during the Training Period.

BACKGROUND: A growing body of scientific evidence indicates that clinical outcomes of hemodialysis patients can be improved with short daily dialysis treatment. Current in-center hemodialysis machines do not fulfill the requirements needed for self-care home hemodialysis (HHD) treatment. In line with the reviviscence of home therapy, several hemodialysis devices have been developed and deployed for treatment. Physidia S3 is one of these new dialysis delivery systems featuring an appealing design and functionalities intended for daily HHD treatment. METHODS: In this French multicenter proof-of-concept study enrolling 13 training centers, we report our preliminary experience with a special focus on quantifying clinical performances in short daily HHD treatment performed during the training period of the patients. RESULTS: Among the 80 patients included in this study, a total of 249 sessions could be analyzed. Dialysis dose, estimated from weekly standardized Kt/V, was maintained at 2.22 [1.95-2.61] with a normalized protein catabolic rate of 0.93 [0.73-1.18] g/kg/24 h. Furthermore, anemia and nutritional status were adequately controlled as indicated by 11.6 ± 1.4 g/dL of hemoglobin level and 39.4 ± 5.7 g/L of serum albumin as well as electrolyte disorders. CONCLUSIONS: The safety and efficacy of the S3 therapy concept relying on a short daily hemodialysis treatment using a bagged delivery system are in total agreement with daily HHD recommendations. Clinical performances are aligned to the metabolic needs of the vast majority of HHD patients. Currently ongoing studies at home will provide further evidence and value of this therapeutic approach.

Avantages cliniques de l'hémodialyse à domicile et les obstacles à son développement: Clinical benefits of home hemodialysis and barriers to its development.

In 2023, home hemodialysis (HHD) is a dialysis modality used safely and performed independently at home by patients with chronic kidney disease (CKD). HHD requires adequate training and appropriate installation which includes the management of medical devices and consumables in the environment of each patient. According to each patient, HHD can be performed daily, every other day or overnight (nocturnal). The duration of the session varies from a few hours (less than three) during the day to several hours (six to ten) during the night. Over the past 10 years, we have been part of a revival in HHD with the availability of small machines better suited to homes and patients. Few controlled interventional studies and extensive registry data support the hypothesis that increase of frequency and duration of dialysis is associated with improved patient survival, cardiovascular risk profile, and quality of life. In addition to the physiological benefits of HDD, there are clear quality of life, social and economic benefits. There are, however, some disadvantages of HHD, including the application and time required for training, the risk of burnout, and the reluctance to "hospitalize" at home. Overall, these limits can be anticipated and overcome by appropriate training, multidisciplinary monitoring, and a dedicated organization. This review recalls the main clinical advantages of HDD related to both physiology and lifestyle as well as the main obstacles and proposes perspectives to guarantee its development. © 2022 Société francophone de néphrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.

Unmet needs for CKD care: from the general population to the CKD clinics-how many patients are we missing?

INTRODUCTION: Prevalence of chronic kidney disease (CKD) varies around the world. Little is known about the discrepancy between the general population's needs and nephrology care offered. We aimed to contribute to filling this gap and propose a means to infer the number of patients needing follow-up. METHODS: All patients undergoing at least one nephrology consultation in 2019 were enrolled. We used the ratio between CKD Stages 3 and 4 reported in the literature, and considered that only 25-50% of CKD Stage 3 patients have progressive CKD, to hypothesize different scenarios to estimate the number of CKD Stage 3 patients still needing nephrology follow-up. RESULTS: The 1992 CKD patients were followed-up in our centre (56.93% males; age 66.71 ± 18.32 years; 16.82% Stage 1; 14.66% Stage 2; 39.46% Stage 3; 19.88% Stage 4; 7.68% Stage 5). The ratio between Stages 3 and 4 in population studies ranged from 7.72 to 51.29, being 1.98 in our centre. Hypothesizing that we followed-up 100, 70 or 50% of CKD Stage 4 patients, 528-2506 CKD Stage 3 patients in our area would need nephrology follow-up [1885-8946 per million population (p.m.p.)]. Three to 17 additional nephrologists p.m.p. would be necessary to fully cover the need for care. CONCLUSIONS: The number of patients with CKD Stage 3 who would benefit from nephrology care is high. Considering that one patient-year of delay of dialysis could cover a nephrologist's annual salary, interventions aimed to improve the care of advanced CKD may be economically sound.

Toward an individualized determination of dialysis adequacy: a narrative review with special emphasis on incremental hemodialysis.

INTRODUCTION: The search for the 'perfect' renal replacement therapy has been paralleled by the search for the perfect biomarkers for assessing dialysis adequacy. Three main families of markers have been assessed: small molecules (prototype: urea); middle molecules (prototype ß2-microglobulin); comprehensive and nutritional markers (prototype of the simplified assessment, albumin levels; composite indexes as malnutrition-inflammation score). After an era of standardization of dialysis treatment, personalized dialysis schedules are increasingly proposed, challenging the dogma of thrice-weekly hemodialysis. AREAS COVERED: In this review, we describe the advantages and limitations of the approaches mentioned above, focusing on the open questions regarding personalized schedules and incremental hemodialysis. EXPERT OPINION: In the era of personalized dialysis, the assessment of dialysis adequacy should be likewise personalized, due to the limits of 'one size fits all' approaches. We have tried to summarize some of the relevant issues regarding the determination of dialysis adequacy, attempting to adapt them to an elderly, highly comorbidity population, which would probably benefit from tailor-made dialysis prescriptions. While no single biomarker allows precisely tailoring the dialysis dose, we suggest using a combination of clinical and biological markers to prescribe dialysis according to comorbidity, life expectancy, residual kidney function, and small and medium-size molecule depuration.

COVID-19 Vaccine Hesitancy in Patients on Dialysis in Italy and France.

INTRODUCTION: Patients on dialysis (HDPs) are a category at high risk from COVID-19 and thus a high-priority group for vaccination. COVID-19 vaccine hesitancy has been a concern since the availability of the first vaccine. The objective of this study was to determine hesitancy rates and factors associated with hesitancy toward COVID-19 vaccination in HDP. METHODS: HDP were surveyed with an ad hoc questionnaire in 4 large dialysis facilities in Europe: Le Mans and Paris, in France, and Cagliari and Pavia, in Italy. The questionnaire explored different domains associated with vaccine hesitancy, such as perception of disease severity, sources of information about the vaccine and the disease, and confidence in the health care system. RESULTS: A total of 417 patients (average age 69 years, 60% men) agreed to answer the questionnaire. Hesitancy was associated with younger age (P = 0.003), lower perception of disease severity (P < 0.001) and vaccine efficacy (P < 0.001), and lower trust in vaccination (P < 0.001) and in the health care system and scientists (P < 0.001) in the univariate analysis. In the multivariate models, concerns about side effects (P = 0.004) and vaccine efficacy (P < 0.001) and living in France (P = 0.04) remained associated with higher vaccine hesitancy, whereas having received an influenza vaccine (P = 0.032) and trusting scientists (P = 0.032) were associated with a more positive attitude toward vaccination. CONCLUSIONS: HDPs have a good understanding of the risks associated with COVID-19. Vaccine hesitancy was not associated with educational level, age, or gender but rather with lack of confidence in vaccine efficacy and concerns about safety. HDPs were quite skeptical about the health care system but generally trusted scientists.

Why and how should we promote home dialysis for patients with end-stage kidney disease during and after the coronavirus 2019 disease pandemic? A French perspective.

The health crisis induced by the pandemic of coronavirus 2019 disease (COVID-19) has had a major impact on dialysis patients in France. The incidence of infection with acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first wave of the COVID-19 epidemic was 3.3% among dialysis patients-13 times higher than in the general population. The corresponding mortality rate was high, reaching 21%. As of 19th April, 2021, the cumulative prevalence of SARS-CoV-2 infection in French dialysis patients was 14%. Convergent scientific data from France, Italy, the United Kingdom and Canada show that home dialysis reduces the risk of SARS-CoV-2 infection by a factor of at least two. Unfortunately, home dialysis in France is not sufficiently developed: the proportion of dialysis patients being treated at home is only 7%. The obstacles to the provision of home care for patients with end-stage kidney disease in France include (i) an unfavourable pricing policy for home haemodialysis and nurse visits for assisted peritoneal dialysis (PD), (ii) insufficient training in home dialysis for nephrologists, (iii) the small number of administrative authorizations for home dialysis programs, and (iv) a lack of structured, objective information on renal replacement therapies for patients with advanced chronic kidney disease (CKD). We propose a number of pragmatic initiatives that could be simultaneously enacted to improve the situation in three areas: (i) the provision of objective information on renal replacement therapies for patients with advanced CKD, (ii) wider authorization of home dialysis networks and (iii) price increases in favour of home dialysis procedures.

[Psychological impact of lockdown and the COVID-19 epidemic on haemodialysis patients and carers in France]. / Répercussions psychologiques du confinement et de l'épidémie à COVID-19 chez les patients et soignants en hémodialyse en France.

INTRODUCTION: The health crisis linked to the COVID-19 epidemic has required lockdown measures in France and changes in practices in dialysis centers. The objective was to assess the depressive and anxiety symptoms during lockdown in hemodialysis patients and their caregivers. METHODS: We sent, during lockdown period, between April and May 2020, self-questionnaires to voluntary subjects (patients and caregivers), treated by hemodialysis or who worked in hemodialysis in one of the 14 participating centers in France. We analyzed their perception of dialysis sessions (beneficial or worrying), their stress level (VAS rated from 0 to 10), their anxiety and depressive symptoms (Hospital anxiety and depression scale). Factors associated with stress, anxiety and depression were analyzed with multiple linear regression models. RESULTS: 669 patients and 325 caregivers agreed to participate. 70 % of participants found it beneficial to come to dialysis during confinement. The proportions of subjects with a stress level ≥ 6 linked to the epidemic, confinement, fear of contracting COVID-19 and fear of infecting a loved one were respectively 23.9%, 26.2%, 33.4% and 42%. 39.2% presented with certain (13.7%) or doubtful (19.2%) anxious symptoms. 21.2% presented a certain (7.9%) or doubtful (13.3%) depressive symptomatology. Age, gender, history of psychological disorders and perception of dialysis sessions were associated with levels of stress, anxiety and depression. CONCLUSION: During the lockdown period, in France, the majority of hemodialysis patients and caregivers found it beneficial to come to dialysis. One in three subjects had anxiety symptoms and one in five subjects had depressive symptoms.

Elderly Patients in a Large Nephrology Unit: Who Are Our Old, Old-Old and Oldest-Old Patients?

The world population is aging, and the prevalence of chronic kidney disease (CKD) is increasing. Whether this increase is also due to the methods currently being used to assess kidney function in the elderly is still a matter of discussion. We aimed to describe the actual referral pattern of CKD patients in a large nephrology unit and test whether the use of different formulae to estimate kidney function could affect the staging and the need for specialist care in the older subset of our population. In 2019, 1992 patients were referred to our center. Almost 28% of the patients were aged ≥80 and about 6% were ≥90 years old. Among the causes of kidney disease, glomerulonephritis displayed a higher prevalence in younger patients whereas hypertensive or diabetic kidney disease were more prevalent in older patients. The prevalence of referred patients in advanced CKD stages increased with age; estimated glomerular filtration rate (eGFR) decreased with age regardless of which equation was used (chronic kidney disease epidemiology collaboration (CKD-EPI), Lund-Malmö Revised (LMR), modification of diet in renal disease (MDRD), Full Age Spectrum (FAS), or Berlin Initiative Study 1 (BIS)). With CKD-EPI as a reference, MDRD and FAS underestimated the CKD stage while LMR overestimated it. The BIS showed the highest heterogeneity. Considering an eGFR threshold limit of 45 mL/min for defining "significant" CKD in patients over 65 years of age, the variability in CKD staging was 10% no matter which equation was used. Our study quantified the weight of "old" and "old-old" patients on follow-up in a large nephrology outpatient unit and suggested that with the current referral pattern, the type of formula used does not affect the need for CKD care within the context of a relatively late referral, particularly in elderly patients.

Using more frequent haemodialysis to manage volume overload in dialysis patients with heart failure, obesity or pregnancy.

Managing dialysis in patients with heart failure, pregnancy or obesity is complex. More frequent haemodialysis 5-6 days/week in randomized clinical trials has shown benefits for controlling volume overload, blood pressure and phosphorus, reducing left ventricular hypertrophy (LVH), and improving patient tolerance to therapy. Therapy prescriptions were guided by volume of urea cleared, time-integrated fluid loading control and increased phosphate-ß2 microglobulin removal, with greater treatment frequency to address clinical efficacy targets. Case studies in all three categories show that treatment with more frequent haemodialysis in low-dialysate flow systems (Qd <200 mL/min, dialysate of 25-30 L/session, 5-7 days/week for 2.5-3.0 h/session) improves control of heart failure. In pregnancy, treatment 7 days/week with 30 L and 3 h/session of dialysis enabled successful delivery of infants at 32-34 weeks, with all doing well 2-5 years after birth. Obese patients with a body mass index (BMI) >35 achieved control of volume, blood pressure and uraemic symptoms compared to their prior 3 times/week in-centre haemodialysis. Greater application of more frequent haemodialysis should be considered, particularly in high-risk populations, to improve clinical care.

Home hemodialysis treatment and outcomes: retrospective analysis of the Knowledge to Improve Home Dialysis Network in Europe (KIHDNEy) cohort.

BACKGROUND: Utilization of home hemodialysis (HHD) is low in Europe. The Knowledge to Improve Home Dialysis Network in Europe (KIHDNEy) is a multi-center study of HHD patients who have used a transportable hemodialysis machine that employs a low volume of lactate-buffered, ultrapure dialysate per session. In this retrospective cohort analysis, we describe patient factors, HHD prescription factors, and biochemistry and medication use during the first 6 months of HHD and rates of clinical outcomes thereafter. METHODS: Using a standardized digital form, we recorded data from 7 centers in 4 Western European countries. We retained patients who completed ≥6 months of HHD. We summarized patient and HHD prescription factors with descriptive statistics and used mixed modeling to assess trends in biochemistry and medication use. We also estimated long-term rates of kidney transplant and death. RESULTS: We identified 129 HHD patients; 104 (81%) were followed for ≥6 months. Mean age was 49 years and 66% were male. Over 70% of patients were prescribed 6 sessions per week, and the mean treatment duration was 15.0 h per week. Median HHD training duration was 2.5 weeks. Mean standard Kt/Vurea was nearly 2.7 at months 3 and 6. Pre-dialysis biochemistry was generally stable. Between baseline and month 6, mean serum bicarbonate increased from 23.1 to 24.1 mmol/L (P = 0.01), mean serum albumin increased from 36.8 to 37.8 g/L (P = 0.03), mean serum C-reactive protein increased from 7.3 to 12.4 mg/L (P = 0.05), and mean serum potassium decreased from 4.80 to 4.59 mmol/L (P = 0.01). Regarding medication use, the mean number of antihypertensive medications fell from 1.46 agents per day at HHD initiation to 1.01 agents per day at 6 months (P < 0.001), but phosphate binder use and erythropoiesis-stimulating agent dose were stable. Long-term rates of kidney transplant and death were 15.3 and 5.4 events per 100 patient-years, respectively. CONCLUSIONS: Intensive HHD with low-flow dialysate delivers adequate urea clearance and good biochemical outcomes in Western European patients. Intensive HHD coincided with a large decrease in antihypertensive medication use. With relatively rapid training, HHD should be considered in more patients.