NEW ORLEANS – When big events occur in home dialysis, you need to celebrate—particularly in the United States, where home dialysis represents less than 12% of the total dialysis patient population. The Annual Dialysis Conference, held here this past week, had some significant announcements for those interested in dialyzing at home.
NxStage Medical demonstrated nocturnal home hemodialysis with its System One portable hemodialysis machine. The U.S. Food and Drug Administration approved the device for nocturnal home hemodialysis in December. NxStage Medical's booth in the exhibit hall included a full-sized bed and two NxStage nocturnal home dialysis patients. NxStage, which has been working for some time on getting the indication approved, says there are a number of benefits of a longer, overnight therapy.
“Home nocturnal hemodialysis allows for expanded flexibility in dialysis dose and schedule, better enabling physicians to match individual dialysis prescriptions to each patient’s health care and lifestyle needs. By performing therapy while sleeping, patients are able to clear their schedules for other activities, and reduce the overall burden of therapy.”
Home hemodialysis machines at the Annual Dialysis Conference
One study has shown that performing more frequent nocturnal home hemodialysis offers the same 5-year survivability as deceased donor transplantation. Nocturnal home hemodialysis is associated with less dialysis-induced myocardial stunning compared with standard thrice weekly in-center hemodialysis, and may help control blood pressure and reduce the need for blood pressure medications, NxStage said.
Baxter Health Care
Baxter Health Care’s renal division displayed new technology for peritoneal dialysis and hemodialysis patients during the conference. At the company’s booth, the dialysis machine manufacturer offered attendees a peak at its new PD cycler, Amia, Baxter says the machine is more user-friendly by including a touch pad system for patients and it is about 10 lbs. lighter than Baxter’s current PD cycler. While the device is FDA approved, company officials could not say when the machine would be available to the renal community.
Baxter also showed off for the first time in the United States its new VIVIA home hemodialysis system. The machine was one of several that were on display for home hemodialysis during a four-hour session on the devices.
Results from two studies conducted in the United States and Canada showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD 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 data for the VIVIA HD system was presented for the first time to the European nephrology community at the 51st Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA) last May.
"We conducted the studies to evaluate the efficacy and safety of the VIVIA HD system, which demonstrated its ability to provide acceptable clearance of uremic toxins, safely and reliably," said Bruce Culleton, MD, vice president, renal therapeutic area lead for Baxter at the time of the ERA-EDTA presentation. "This research, in combination with the VIVIA HD system's patient-friendly design features, may allow a greater number of dialysis patients suited for home HD to access high dose HD therapy in the home environment."
The first in-human study was a prospective, single arm clinical study conducted in hemodialysis centers in the United States, in which 22 patients received four hemodialysis treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each hemodialysis 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 dialyser on the same patient was also established.
In a second prospective, single arm clinical study conducted in hemodialysis centers in Canada, 17 patients received hemodialysis treatments with the VIVIA HD system three times per week, for six weeks. The mean duration of nocturnal hemodialysis treatment was 7 hours. The feasibility of multiple use of the same dialyzer on the same patient during long hemodialysis treatments was also established. No device-related serious adverse events occurred during the study.
At the ADC, Baxter researchers again reviewed the trial results and offered detailed descriptions on how the machine operated. The trial in the U.S. included 817 treatments; the nocturnal trial in Canada included 298 treatments.