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

Abstract

Rationale & Objective Most kidney failure patients receive hemodialysis three 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 healthcare 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 Non-randomized, 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 spKt/V of 1.2 was exceeded in 96.6 percent of treatments in patients receiving three-times weekly regimens, while the threshold stdKt/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 outcome associated with these modalities.

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