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NxStage System One home dialysis

Source agency:

HPACT

Date of Submission:

17/11/2008

Date of Printing:

21/05/2013

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

NxStage System One

Technology - description:

The portable and self contained NxStage System One allows home-based haemodialysis. The NxStage System One is the size of a computer monitor and weighs approximately 30 kg. The unit does not need the water supply modifications that other home haemodialysis units require as it uses bagged sterile dialysate fluid. Alternatively, with accessories, the NxStage System One can produce dyalysate fluid from purified tap water. The unit is also portable allowing dialysis outside of the home. This device may improve the quality of life of haemodialysis patients.

Company or developer:

NxStage Medical

Reason for database entry:

This device may improve the quality of life of haemodialysis patients.

Technology - stage in early warning process:

Assessment complete

Technology - stage of development:

Other

Licensing, reimbursement and other approval:

FDA approval

Technology - type(s):

Device

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

Patients waiting for kidney transplantation who require regular dialysis.

Disease description and associated mortality and morbidity:

Chronic kidney disease is a major burden to the Australian healthcare system and is rapidly increasing in its prevalence. In Australia one in three people are at risk of developing chronic kidney disease (CKD), with one in seven having CKD and one in 1,400 requiring dialysis or a kidney transplant. CKD is the 7th highest cause of death in Australia. The need for dialysis is increasing within the Australian population due to the increasing incidence of diabetes and the ageing population. Over 25 years Australian population growth has been less than 40 per cent yet the need for dialysis and kidney transplants has increased 400 per cent. In 2006 there were 9,182 dialysis patients in Australia (Kerr et al 2008). In 2005 around 13 per cent (800) of haemodialysis patients dialysed at home (KHA 2005). It is estimated that the current cost of providing dialysis for one patient for a year costs AUD$60,000. Including transplants the cost of end stage kidney disease is estimated to be at least AUD$570 million annually (KHA 2006b; KHA 2006a).

Number of Patients:

In 2006 there were 9,182 dialysis patients in Australia (Kerr et al 2008). In 2005 around 13 per cent (800) of haemodialysis patients dialysed at home (KHA 2005).

Technology - specialities(s):

Renal disease & urology

Technology - setting(s):

Community and primary care

Setting - further information:

 

Impact

Alternative and/or complementary technology:

Additive and substitution

Current Technology:

Despite Australia and New Zealand having the highest rates of home dialysis in the world, the majority of dialysis is still centre (hospital or clinic) based (Agar 2008). It is increasingly recognised that centre based haemodialysis is not the optimum patient management strategy regarding both health outcomes and patient survival times (ANZDATA 2006). It is currently thought that the optimum strategy for maximal health and lifespan is nocturnal haemodialysis where the patient has haemodialysis more frequently and for longer periods (8 hours a night up to 6 or 7 times a week). This increased frequency and duration paradigm has been shown to be associated with decreases in mortality and RRT associated morbidity such as cardiovascular disease (Masterson 2008).

Health Impact:

 

Diffusion:

There was no evidence found to indicate the diffusion of this device into the Australian market.

Cost, infrastructure and economic consequences:

The manufacturer of the NxStage System One was contacted for pricing on the device but no information was forthcoming at the time of publication. No research literature examined the costs associated with NxStage System One utilisation.

Ethical, social, legal, political and cultural impact:

No issues were identified/raised in the sources examined.

Evidence & Policy

Clinical evidence and safety:

A study of 19 patients assessed the basic markers of haemodialysis for patients using the NxStage System One and reported that greater than 85 per cent achieved recommended urea clearance. Medications for secondary complications of chronic kidney disease (high blood pressure, anaemia) were reduced in more than 50 per cent of patients. Patients reported increased energy, appetite, sleep quality and fewer symptoms when treated with the NxStage System One (Floramo 2006) (Level III-3 Intervention evidence).

A small study of four paediatric patients has assessed a program of frequent dialysis (6 times weekly), rather than the standard centre based treatment of three times weekly. Patients were on standard dialysis before the trial, which ran for 16 weeks. Over the trial period the patients showed reductions in blood pressure and were removed from anti-hypertensive medications. Patients also had improved serum phosphorous levels without increased medication. A negative side effect attributed to the more frequent dialysis regimen was the lower haematocrit levels which required increased erythropoietin (Goldstein et al 2008) (Level III-3 Intervention evidence).

A small, multi-centre prospective cross-over treatment study (n=32) was conducted comparing the NxStage System One to centre based dialysis. The treatment protocol consisted of eight weeks of centre treatment (6 conventional dialysis sessions per week), a two week in centre transition treatment (6 NxStage System One dialysis sessions per week), and an eight week at home treatment (6 NxStage System One dialysis sessions per week). There were significantly more adverse events associated with the centre based treatment (5.3 adverse events per 100 treatments) versus the home based NxStage System One treatment (2.1 adverse events per 100 treatments; p=0.007). Compared to baseline, patients experienced weight gain, had reduced blood pressure and reduced use of anti-hypertensive medications. This effect was not solely due to the NxStage System One device as the effect was also noted in the in centre based part of the study. This was attributed to increased dialysis treatments (6/week) over the average baseline dialysis treatments (3/week) (Kraus et al 2007) (Level III-2 Intervention evidence).

The data on the NxStage System One are from small, low to medium quality studies. Despite this the NxStage System One shows promise for improved patient health and convenience. Additionally it is well established that standard home dialysis is far more cost effective than centre based treatment. If this holds true for the NxStage System One then it may have a large impact on a rapidly growing population of patients requiring RRT.

Economic evaluation:

No cost information was found for the cost of NxStage System One.

Ongoing research:

A large trial of 5,000 RRT patients is underway with the NxStage System One (6 dialysis periods per week) being compared to conventional centre based haemodialysis (3 dialysis periods per week). The trial will run over three years (Jaber et al 2008).

Ongoing or planned HTA:

The NxStage System One provides greater versatility for patients requiring dialysis and may be especially useful in rural and remote populations. Based on the increasing need in the Australian and New Zealand population, HealthPACT have requested more information from the evaluators in the short term and have recommended that this technology be monitored.

Web link:

http://www.horizonscanning.gov.au/

References and sources:

Floramo, S. (2006). 'Use of the NxStage system one for daily home hemodialysis', Nephrol News Issues, 20 (11), 48-50, 52-43.

Kraus, M., Burkart, J. et al (2007). 'A comparison of center-based vs. home-based daily hemodialysis for patients with end-stage renal disease', Hemodialysis International, 11 (4), 468-477.

Goldstein, S. L., Silverstein, D. M. et al (2008). 'Frequent hemodialysis with NxStage system in pediatric patients receiving maintenance hemodialysis', Pediatr Nephrol, 23 (1), 129-135.

Jaber, B. L., Finkelstein, F. O. et al (2008). 'Scope and Design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study', Am J Kidney Dis.

Kerr, P. G., Polkinghorne, K. R. & McDonald, S. P. (2008). 'Home hemodialysis in Australia: Current perspective', Hemodialysis International, 12 (SUPPL. 1), S6-S10.

KHA (2005). Home haemodialysis: a treatment option [Internet]. Kidney Health Australia. Available from: http://www.kidney.org.au/LinkClick.aspx?fileticket=EWealRHD26U%3d&tabid=609&mid=882 [Accessed 15th October].

KHA (2006a). The Economic Impact of End-Stage Kidney Disease in Australia, Kidney Health Australia.http://www.kidney.org.au/assets/documents/Economic%20Impact%20of%20ESKD%20in%20Australia%20Published%202006.pdf

KHA (2006b). National chronic kidney disease strategy, Kidney Health Australia.http://www.kidney.org.au/LinkClick.aspx?fileticket=Q96sqCSVqzQ%3d&tabid=635&mid=1590

Notes: