Clinical safety and performance of VIVIA: a novel home hemodialysis system

Bernardo, Angelito; Marbury, Thomas; McFarlane, Phil; Amdahl, Michael; Demers, Jason; Hutchcraft, Audrey; Leypoldt, John K.; Minkus, Mark; Muller, Matt; Stallard, Ruth; Culleton, Bruce F.

doi:10.1093/ndt/gfw044

Cited by 3 publications

(3 citation statements)

References 23 publications

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“… 36 Many recently developed devices with strong patient focus have not been successfully brought to market. 37 , 38 In addition, some ostensibly patient-centric devices designed by industry have had surprisingly poor resonance with patients after commercial release. 39 A strong contributor to this quandary is that patient-centric design is not acknowledged by health care payers or providers and that these aspects are seen as value-added features rather than core ones.…”

Section: Discussionmentioning

confidence: 99%

Peritoneal Dialysis (PD) Patient and Nurse Preferences around Novel and Standard Automated PD Device Features

Sloand,

Marshall,

Barnard

et al. 2024

Kidney360

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Background: Despite offering greater lifestyle benefits to patients with end stage kidney disease (ESKD), adoption of peritoneal dialysis (PD) remains low globally, particularly among minorities and the socioeconomically disadvantaged. While automated PD (APD) affords a high potential for reducing the burden of kidney replacement therapy, understanding patient preferences is critical to guiding development of new and improved APD devices to better accommodate use in their daily lives. Methods: A quantitative cross-sectional survey study was performed using adaptive conjoint analysis (ACA) to quantify APD feature preferences among PD patients, PD nurses (RNs, and non-PD patients to ascertain the relative importance of eight specific cycler attributes including portability, noise, setup time, device size, setup directions, battery power, consumables, and PD RN control (PD RNs only), each with 2-3 descriptive feature levels. Results: 42 PD patients, 24 non-PD patients, and 52 PD RNs were surveyed. Preference shares spanned nearly the entire range from 0% to 100%, indicating strong preference discrimination. For all groups, “Portability in the Home”, “Noise Level”, and “Setup time” were the most important features. PD patients gave highest priority to these features compared to other study participants, plausibly as features enabling improved lifestyle. A simulated “coat rack” style cycler with extended battery-power that was easy to move in the home, silent, required only 10-minute setup, and had a fully animated instruction screen was preferred by all groups > 90% compared to features present in existing cyclers. Conclusions: Addressing APD cycler technical and therapy-related issues to improve usability, comfort and convenience within the home may affect PD uptake and retention. Attention and priority must be given to patient centric APD cycler design directed at including features that improve quality of life for the device end-user.

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Section: Discussionmentioning

confidence: 99%

Peritoneal Dialysis (PD) Patient and Nurse Preferences around Novel and Standard Automated PD Device Features

Sloand,

Marshall,

Barnard

et al. 2024

Kidney360

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“…The second aim of this study was to test whether activated carbon could increase the clearances of proteinbound uremic solutes in systems that use low dialysate flows. The desire to make hemodialysis available at home has motivated the development of several such systems (24)(25)(26). All of these systems provide adequate treatment, as assessed by the clearance of urea.…”

Section: Discussionmentioning

confidence: 99%

Removal of Uremic Solutes from Dialysate by Activated Carbon

Lee

Sirich

Blanco

et al. 2022

CJASN

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Background and objectivesAdsorption of uremic solutes to activated carbon provides a potential means to limit dialysate volumes required for new dialysis systems. The ability of activated carbon to take up uremic solutes has, however, not been adequately assessed.Design, setting, participants, & measurementsGraded volumes of waste dialysate collected from clinical hemodialysis treatments were passed through activated carbon blocks. Metabolomic analysis assessed the adsorption by activated carbon of a wide range of uremic solutes. Additional experiments tested the ability of the activated carbon to increase the clearance of selected solutes at low dialysate flow rates.ResultsActivated carbon initially adsorbed the majority, but not all, of 264 uremic solutes examined. Solute adsorption fell, however, as increasing volumes of dialysate were processed. Moreover, activated carbon added some uremic solutes to the dialysate, including methylguanidine. Activated carbon was particularly effective in adsorbing uremic solutes that bind to plasma proteins. In vitro dialysis experiments showed that introduction of activated carbon into the dialysate stream increased the clearance of the protein-bound solutes indoxyl sulfate and p-cresol sulfate by 77%±12% (mean±SD) and 73%±12%, respectively, at a dialysate flow rate of 200 ml/min, but had a much lesser effect on the clearance of the unbound solute phenylacetylglutamine.ConclusionsActivated carbon adsorbs many but not all uremic solutes. Introduction of activated carbon into the dialysate stream increased the clearance of those solutes that it does adsorb.

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“…Such machines are typically large, cumbersome, intimidating and intrusive in the home setting. Although some have been adapted for home use, more recently manufacturers have begun focusing on machines specifically developed for home therapy use and patient operation [11,12]. Such an approach has necessitated an improved understanding of industrial design, human factors and ergonomics to ensure that the burden of undertaking treatment in the home is reduced for the patient and their care partner [13,14].…”

Section: Plos Onementioning

confidence: 99%

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

Buckberry¹,

Hoenich

Krieter

et al. 2020

PLoS ONE

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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.

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Clinical safety and performance of VIVIA: a novel home hemodialysis system

Abstract: These results confirm the safety and expected performance of VIVIA.

Cited by 3 publications

References 23 publications

Peritoneal Dialysis (PD) Patient and Nurse Preferences around Novel and Standard Automated PD Device Features

Peritoneal Dialysis (PD) Patient and Nurse Preferences around Novel and Standard Automated PD Device Features

Removal of Uremic Solutes from Dialysate by Activated Carbon

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

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