Assessment of the safety, efficacy and usability of the Quanta SC+ Haemodialysis System, in-centre in 23 patients during 77 dialysis treatments.
BACKGROUND: The CE-marked Quanta SelfCare+ (SC+) cartridge-based haemodialysis system is a portable, compact system providing clinical efficacy utilising flow rates typically used on traditional in-centre machines. This study assessed the safety, efficacy and usability of the system in-centre at 1 UK site in 23 patients during 77 dialysis treatments in the haemodialysis-dependent, end-stage renal disease (ERSD) patient population.
STUDY DESIGN: An open-label, single-arm, post market clinical follow-up study on ERSD patients meeting the criteria of a body mass above 50Kg, male or female and an age of ≥18 years. The clinic’s principle investigator selected the patients and informed consent was obtained. Each dialysis therapy was performed on an outpatient basis with a target dialysis time of 4 hours using a bicarbonate-based dialysate at a flow rate of 500 mL/min and a blood flow rates of between 300450 ml/min. Vital signs were nominally recorded every 30 minutes and subject symptoms were monitored during every treatment. Blood samples were collected during 27 treatments, from 18 patients, on pre and post-dialysis and system usability comments were captured from the patients and study nurse-operators.
RESULTS: 21 patients on a 3-times-per-week dialysis regimen and 2 patients on a 5-times-per-week completed 77 dialysis treatments in total with no adverse events or safety issues. Clinical and technical performance of the Quanta SC+ system was assessed by patient urea reduction ratio (URR), Kt/V, percentage of scheduled dialysis treatments completed without premature termination and performance of the Quanta SC+ within the normal operating range. The average URR achieved for patients on the 3x schedule was 73.7% and 61.1% for the 5x schedule. The stdKt/V was 2.3 and 3.1 for the 3x and 5x schedules respectively. In 85.2% of the treatments, where blood was collected, the stdKt/V attained was >2.1, as recommended as a weekly adequacy equivalence by Gotch. The maximum achieved stdKt/V for the study population was 3.34.
CONCLUSIONS: All 77 treatments were completed on the Quanta SC+ system without premature termination or complications with the patient, in a safe manner with no adverse events to report. Clinical performance of the system was demonstrated by 90.9% of the total treatments on the 3x schedule having a URR result of greater than 65% as per the UK Renal Association and KDOQI guidelines. Review of the usability comments collected from the patient and study nurse operators during the treatments were positive. The system was described as compact, intuitive to use with positive feedback regarding the use of the disposable cartridge component; allowing for a fast turnaround time between different patient treatments, scheduled on the same system on the same day. Further studies continue to assess performance of the system in larger patient populations in several UK and European sites.