Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States.

INTRODUCTION: The Theranova 400 is a medium cut-off dialyzer that allows for superior clearance of larger middle molecules than traditional high-flux dialyzers. This study evaluates the association of expanded hemodialysis (HDx) using the Theranova dialyzer versus conventional hemodialysis (HD) with a high-flux dialyzer on hospitalization rates and healthcare costs as compared to conventional HD in a post hoc analysis of a randomized controlled trial. METHODS: In a non-concealed, 24-week clinical trial, maintenance HD patients were randomized to receive treatment with either Theranova 400 or a similar size high-flux dialyzer. Hospitalization rate and average length of stay were calculated from trial data. Use of erythropoiesis-stimulating agents and iron were assumed to be equal and therefore excluded from the model. Average cost per inpatient day was obtained from a publicly available published source. Probabilistic sensitivity analyses were conducted to account for variability in model inputs. FINDINGS: There were 86 patients (389 patient-months) in the Theranova group and 85 patients (366 patient-months) in the high-flux HD group. All-cause hospitalization rate was 45% lower with Theranova compared to high-flux HD (IRR = 0.55; p = 0.05). Average annual estimated cost of hospitalization was $6098 lower with Theranova compared to high-flux HD. Compared to high-flux HD, average annual estimated cost associated with Theranova use was $4772 lower per patient. Hospitalization rate and hospital length of stay were the main drivers of cost. CONCLUSIONS: Use of the Theranova dialyzer is associated with lower estimated costs of care among maintenance HD patients, driven by fewer hospitalization events.

Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment. RESULTS: Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and ß2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment. CONCLUSIONS: Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.

Experimental and theoretical study on the microparticle trapping and release in a deformable nano-sieve channel.

Deformable microfluidics may be potentially used in cell manipulation, optical sensing, and imaging applications, and have drawn considerable scientific interests in the recent past. The excellent tunability of deformable microfluidic devices can provide controllable capture, deposition, and target release. We demonstrated a one-dimensional nano-sieve device to capture microparticles from suspensions. Size-selective capturing and release of micro- and nanoparticles was achieved by simply adjusting the flow rate. Almost all the microparticles were trapped in the nano-sieve device at a flow rate of 20 µl min-1. Increasing the flow rate induces a hydrodynamic deformation of the roof of the compliant device and allows most of the microparticles to pass through the channel. We also established a theoretical model based on computational fluid dynamics to reveal the relationship of the hydrodynamically induced deformation, channel dimensions, and capture efficiency that supports and rationalizes the experimental data. We have predicted the capture efficiency of micro-and nanoparticles in a nano-sieve device with various geometries and flow rates. This study may be important to the optimization of next generation deformable microfluidics for efficient micro- and nanostructure manipulations.