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

Abstract

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.

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

“…Patients’ perspectives also appeared to be improved throughout the study follow-up period. The patient perception and satisfaction survey previously reported by our group confirmed that the S 3 system was easy to use, easily implemented at home, and facilitated patients’ mobility [ 13 ]. Despite the short daily treatment schedule, the S 3 system was considered as a less intrusive treatment modality than previously experienced with in-center hemodialysis treatments.…”

“…The Physidia S 3 system (named the S 3 system) is a bagged delivery cycler and portable communicating dialysis monitoring device specifically designed for short daily hemodialysis (HHD) and self-administered treatment [ 13 ]. The S 3 device has a compact and portable cubic design (dimension 40 × 40 × 40 cm), weighing less than 25 kg and being specifically designed for short daily low-dialysate-flow HHD (dialysate flow rates of 150 to 200 mL/min).…”

“…The Physidia S 3 system was developed in France few years later with the aim of further reducing the burden of home HD treatment both for patients and care providers by keeping the concept of more intensive dialysis relying on a low flow and more frequent approach [ 13 ].…”

Exploring the impact of short daily haemodialysis on muscle strength and bone health in end‐stage kidney disease patients

“…9 There is now increasing evidence that the prognosis of HD patients can be improved by increasing the number or duration of HD sessions. [10][11][12][13][14] In this regard, the application of short-daily in-center HD (SDH) (2-3 h, five or more sessions per week) may provide promising advantages compared with CHD as it appears to attenuate HD-related adverse effects. [10][11][12][14][15][16] SHD appears to reduce chronic inflammation and left ventricular hypertrophy and is associated with better phosphorus control when compared with CHD.…”

Portable, wearable and implantable artificial kidney systems: needs, opportunities and challenges

“…Several devices, including the Physidia S3 (ref. 19 ), Quanta SC 20 and NxStage 21 , are in clinical use and the DIMI 22 device is undergoing clinical testing. Various initiatives to improve and/or miniaturize home haemodialysis devices are currently underway 23 , including the development of dialysis membranes to enable longer and more effective blood purification, systems to mimic selective ion transport in the nephron 24 and sorbents and membranes for dialysate regeneration 25 .…”