AMSTERDAM – Baxter International Inc. announced the presentation of clinical data supporting the safety and efficacy of the VIVIA haemodialysis (HD) system. Results from two studies conducted in a clinical setting showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional hemodialysis devices. The VIVIA system, designed to deliver High Dose hemodialysis in the home, completed the CE marking process (market approval) in Europe in December 2013. The system is being introduced on a limited basis in select European dialysis clinics in 2014 to allow patients and health care providers experience with the system.
These data for the VIVIA HD system were shared for the first time with the European nephrology community at the 51st Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA), May 31 to June 3 in Amsterdam.
High Dose hemodialysis therapy is a more frequent therapy usually performed as short daily treatments at least five days per week for sessions that typically run less than four hours, or as nocturnal treatments where sessions are conducted for greater than six hours while the patient sleeps with no consecutive days off from therapy.
The first in-human study was a prospective, single arm clinical study (Abstract #SP415) conducted in hemodialysis centers in the United States, in which 22 patients received four HD treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each HD treatment was 3.8 hours. A mean weekly standard measure of urea clearance (Kt/V) and dialysis adequacy, was 2.97. No device-related serious adverse events occurred during the study. The feasibility of multiple use of the same dialyzer on the same patient was also established.
In a second prospective, single arm clinical study (Abstract #SP431) conducted in hemodialysis centers in Canada, 17 patients received nocturnal HD treatments with the VIVIA HD system three times per week, for six weeks. The mean duration of nocturnal HD treatment was 7.0 hours. The feasibility of multiple use of the same dialyzer on the same patient during long HD treatments was also established. No device-related serious adverse events occurred during the study. Both studies provided support of the VIVIA HD system's capability to accurately remove excess body fluid, as shown by the strong correlation between fluid weight removed, as measured by the VIVIA HD system, and weight change (R2 0.97 in both studies).
A more sustainable therapy
Additional data presented at the congress support non-clinical advantages for High Dose HD performed in the home, including a study demonstrating the VIVIA HD system had a smaller carbon footprint compared to a currently-available home HD device and to a conventional in-center HD device that can be used for home dialysis. The study used the life cycle assessment method to calculate emissions including consumable supplies, energy and water used during treatment, people transportation and waste disposal. Due in part to multiple uses of its dialyzer and blood set, the VIVIA HD system generated the lowest amount of carbon emissions.
A more cost-effective therapy
Other studies included analyses on cost effectiveness and cost savings attributable to High Dose HD at home. A review of the scientific literature found High Dose HD at home to be either cost saving or cost effective compared to conventional in-center HD, while High Dose in-center was not cost effective (Abstract #MP562). Two separate analyses of High Dose HD in the U.K. demonstrated that increased usage could lead to potential cost savings (Abstract #SP615) and an increase in quality-adjusted, life-years gained (Abstract #SP607).
ERA-EDTA presentations may be available on the congress website following the conclusion of the meeting. For more information, log visits era-edta2014.era-edta.org.
About High Dose HD
An estimated 1.9 million end-stage renal disease (ESRD) patients worldwide undergo haemodialysis, with the vast majority receiving conventional haemodialysis (CHD), which is usually performed three times a week for three to five hours per session in a centre or clinic.1