Cost of the quanta SC+ hemodialysis system for self-care in the United Kingdom.

INTRODUCTION: New personal hemodialysis systems, such as the quanta SC+, are being developed; these systems are smaller and simpler to use while providing the clearances of conventional systems. Increasing the uptake of lower-intensity assistance and full self-care dialysis may provide economic benefits to the public health payer. In the United Kingdom, most hemodialysis patients currently receive facility-based dialysis costing more than £36,350 per year including patient transport. As such, we aimed to describe the annual costs of using the SC+ hemodialysis system in the United Kingdom for 3×-weekly and 3.5×-weekly dialysis regimens, for self-care hemodialysis provided both in-center and at home. METHODS: We applied a cost minimization approach. Costs for human resources, equipment, and consumables were sourced from the dialysis machine developer (Quanta Dialysis Technologies) based upon discussions with dialysis providers. Facility overhead expenses and transport costs were taken from a review of the literature. FINDINGS: Annual costs associated with the use of the SC+ hemodialysis system were estimated to be £26,642 for hemodialysis provided 3× weekly as home self-care; £30,235 for hemodialysis provided 3× weekly as self-care in-center; £29,866 for hemodialysis provided 3.5× weekly as home self-care; and £36,185 for hemodialysis provided 3.5× weekly as self-care in-center. DISCUSSION: We found that the SC+ hemodialysis system offers improved cost-effectiveness for both 3×-weekly and 3.5×-weekly self-care dialysis performed at home or as self-care in-center versus fully assisted dialysis provided 3× weekly with conventional machines in facilities.

Flow balance optimization and fluid removal accuracy with the Quanta SC+ hemodialysis system.

BACKGROUND: Fluid management is integral to hemodialysis, both to correct abnormalities in a patient's plasma composition and to maintain fluid balance. Consequently, accurate net fluid removal during treatment is a critical design element of hemodialysis machines. As dialyzers have evolved, with increased ranges of ultrafiltration coefficients available, it has become more challenging for dialysis machines to minimize errors in flow balance and net fluid removal. RESEARCH DESIGN AND METHODS: This paper describes the design, evaluation and experimental performance of the flow balance and ultrafiltration module of the SC+ system to deliver clinically specified fluid removal with both passive and active control measures, in laboratory conditions designed to simulate a wide range of therapies. RESULTS: The use of passive and active control allows the errors to be minimized across a wider dynamic range of conditions. For the SC+ system, the average flow balance error was 1 mL/hr with an SD of 19 mL/hr and with ultrafiltration it was 13 mL/hr and an SD of 20 ml/hr across all conditions. CONCLUSIONS: This paper demonstrates that the SC+ hemodialysis system, a small, simple and versatile CE marked device, operates within the limits required by international standards across a wide range of experimental conditions.

Enhancement of solute clearance using pulsatile push-pull dialysate flow for the Quanta SC+: A novel clinic-to-home haemodialysis system.

BACKGROUND AND OBJECTIVE: The SC+ haemodialysis system developed by Quanta Dialysis Technologies is a small, easy-to-use dialysis system designed to improve patient access to self-care and home haemodialysis. A prototype variant of the standard SC+ device with a modified fluidic management system generating a pulsatile push-pull dialysate flow through the dialyser during use has been developed for evaluation. It was hypothesized that, as a consequence of the pulsatile push-pull flow through the dialyser, the boundary layers at the membrane surface would be disrupted, thereby enhancing solute transport across the membrane, modifying protein fouling and maintaining the surface area available for mass and fluid transport throughout the whole treatment, leading to solute transport (clearance) enhancement compared to normal haemodialysis (HD) operation. METHODS: The pumping action of the SC+ system was modified by altering the sequence and timings of the valves and pumps associated with the flow balancing chambers that push and pull dialysis fluid to and from the dialyser. Using this unique prototype device, solute clearance performance was assessed across a range of molecular weights in two related series of laboratory bench studies. The first measured dialysis fluid moving across the dialyser membrane using ultrasonic flowmeters to establish the validity of the approach; solute clearance was subsequently measured using fluorescently tagged dextran molecules as surrogates for uraemic toxins. The second study used human blood doped with uraemic toxins collected from the spent dialysate of dialysis patients to quantify solute transport. In both, the performance of the SC+ prototype was assessed alongside reference devices operating in HD and pre-dilution haemodiafiltration (HDF) modes. RESULTS: Initial testing with fluorescein-tagged dextran molecules (0.3 kDa, 4 kDa, 10 kDa and 20 kDa) established the validity of the experimental pulsatile push-pull operation in the SC+ system to enhance clearance and demonstrated a 10 to 15% improvement above the current HD mode used in clinic today. The magnitude of the observed enhancement compared favourably with that achieved using pre-dilution HDF with a substitution fluid flow rate of 60 mL/min (equivalent to a substitution volume of 14.4 L in a 4-hour session) with the same dialyser and marker molecules. Additional testing using human blood indicated a comparable performance to pre-dilution HDF; however, in contrast with HDF, which demonstrated a gradual decrease in solute removal, the clearance values using the pulsatile push-pull method on the SC+ system were maintained over the entire duration of treatment. Overall albumin losses were not different. CONCLUSIONS: Results obtained using an experimental pulsatile push-pull dialysis flow configuration with an aqueous blood analogue and human blood ex vivo demonstrate an enhancement of solute transport across the dialyser membrane. The level of enhancement makes this approach comparable with that achieved using pre-dilution HDF with a substitution fluid flow rate of 60 mL/min (equivalent to a substitution volume of 14.4 L in a 4-hour session). The observed enhancement of solute transport is attributed to the disruption of the boundary layers at the fluid-membrane interface which, when used with blood, minimizes protein fouling and maintains the surface area.

Hemodialysis With the Quanta SC+: Efficacy and Safety of a Self-care Hemodialysis Machine.

RATIONALE & OBJECTIVE: Most patients with kidney failure receive hemodialysis 3 times per week in a facility. More frequent and longer duration dialysis prescriptions improve a number of key outcome measures. These prescriptions are best suited to self-care and home regimens. The Quanta SC+ hemodialysis system is a novel device with demonstrated ease of use for patients and health care practitioners through human factors testing. The primary objective of this study is to report the efficacy and safety of the SC+ system using conventional hemodialysis prescriptions. STUDY DESIGN: Nonrandomized observational study. SETTING & PARTICIPANTS: Prevalent hemodialysis patients in 4 sites in the United Kingdom were recruited to switch from their current device to the SC+ system with no other changes to their prescription. INTERVENTIONS: SC+ hemodialysis system. OUTCOMES: Efficacy data were collected in terms of dialysis adequacy, urea reduction ratios, and net fluid removal accuracy. RESULTS: 60 patients were enrolled in the study, resulting in 1,333 evaluable treatments. The threshold single-pool Kt/V of 1.2 was exceeded in 96.6% of treatments in patients receiving 3-times-weekly regimens, whereas the threshold standard Kt/V of 2.1 was exceeded in 94% of treatments and 97.6% of treatments in patients without significant residual kidney function. Ultrafiltration accuracy was determined by measuring net fluid removal and validated to be within acceptable limits. The adverse event profile during treatment was typical of hemodialysis. There were no serious adverse events. LIMITATIONS: Few patients on high-frequency treatment regimens were enrolled. CONCLUSIONS: The SC+ system delivers safe and effective hemodialysis across a range of patients and dialysis prescriptions. It is one of the smallest systems available and has validated usability for patients to perform self-care safely with minimal training. This device may encourage patients to feel empowered to take on home hemodialysis, unlocking beneficial clinical and patient-reported outcomes associated with these modalities.

Human factors testing of the Quanta SC+ hemodialysis system: An innovative system for home and clinic use.

INTRODUCTION: Uptake rates of home hemodialysis are the lowest among all modality types, despite providing patients with clinical and quality of life benefits at a lower cost to providers. Currently, there is a need to develop dialysis systems that are appealing to patients while also being suitable for use across the continuum of care. The SC+ hemodialysis system was developed by Quanta Dialysis Technologies Ltd. to provide patients with a dialysis system that is small, simple to use, and powerful enough to deliver acceptable dialysis adequacy. METHODS: As part of the SC+ design validation, human factors testing was performed with 17 Healthcare Professionals (nephrology nurses and healthcare assistants) and 15 Home Users (patients and caregivers). To assess usability and safety, the human factors testing involved between 4.5 and 6 hours of training and, after a period of training decay, a subsequent test session in which participants independently performed tasks on SC+. FINDINGS: Between the two user groups, there were only 29 errors observed out of 1216 opportunities for errors, despite minimal training. Errors that did occur were minor and attributed to an initial lack of familiarity with the device; none were safety related. DISCUSSION: Among prevalent dialysis patients and healthcare professionals, the SC+ hemodialysis system was easy to use, even with minimal training and a learning decay period, and had a high level of use safety. By taking into account human factors to optimize the user experience, SC+ has the potential to address systemic and patient barriers, allowing for wider self-care and home hemodialysis adoption.