NxStage Gaining Ground On Growing Adoption Of Home Hemodialysis

[okarol]

NxStage Gaining Ground On Growing Adoption Of Home Hemodialysis
Jan. 7, 2014 12:33 PM ET |  4 comments |  About: NXTM
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

NxStage Medical (NXTM) is a medical device company in the dialysis therapy market that develops, manufactures and markets innovative products for the treatment of kidney failure, fluid overload and related blood treatments and procedures. It is a smaller company in the market compared to established players, such as Fresenius (FMS) and DaVita (DVA). These two companies account for more than half of the conventional dialysis market segment in the United States. However, NxStage Medical's System One is currently the only portable system specifically indicated for use in the home hemodialysis market segment in the United States.

NXTM debuted in the stock market in late 2005. In 2011 NXTM crossed $25 before witnessing a secular downtrend in the next two years. In 2013 the shares of the company offered flat returns to investors. NXTM introduced home-based hemodialysis solutions in an immature market with limited adoptions. As a result, the company could never deliver positive earnings since its IPO. However, over the past few years the market has gradually become mature with adoption picking up slowly but steadily. I believe this year could be a blockbuster for the company with increasing demand for its System One home-based hemodialysis equipment.

NXTM Chart

NXTM data by YCharts

What Does NxStage Do?

NxStage operates in two segments, System One and In-Center. Its primary product, the NxStage System One, is a portable hemodialysis system designed to satisfy an unmet clinical need for a system that can deliver the therapeutic flexibility and clinical benefits associated with traditional dialysis machines in a smaller, portable, easy-to-use form that can be used by healthcare professionals as well as trained lay users in a variety of settings, including patient homes, hospitals and dialysis clinics.

The System One is approved for sale in the United States, Canada and certain other markets for the treatment of acute and chronic kidney failure and fluid overload. The company also obtained CE mark to sell the product in the European Union for treating the same diseases. The FDA has approved System One specifically for home hemodialysis as well as therapeutic plasma exchange ("TPE") in a clinical environment.

The company also sells a line of extracorporeal disposable products, such as needles and blood tubing sets, primarily for in-center dialysis treatments for patients with end-stage renal disease ("ESRD"). However, the company's largest market opportunity is for its System One equipment used in the home dialysis market for the treatment of ESRD.

NxStage Offers An Excellent Product

NXTM's innovative approach to treat renal care is creating significant opportunities for the company. Its home-based hemodialysis device System One, as mentioned above, has been designed to enable patients to perform hemodialysis on a daily basis in their homes, using simple plumbing and standard electrical connections. Its easy-to-use drop-in cartridge allows for easy and wipe-down disinfection after each use. See what the Clinical Kidney Journal ("CKJ") says about System One:

It embodies new concepts in dialysis machine design. Dialysis fluid is lactate based (like CAPD fluid) and flows are reduced to ∼120 mL/min while high blood flows are maintained. The efficiency of small solute clearance is thus maximized and approximates the volume of fluid used. The design is modular and the footprint is small, similar to that of an automated peritoneal dialysis ("APD") machine, which it resembles. Dialyser and lines are provided in a cartridge to simplify set-up and clean. For home use, a dialysate preparation system is used which is also cartridge based, thus avoiding the need for extensive building and plumbing work and to reduce the volume of fluid storage that can be problematic in peritoneal dialysis. The machine is portable and, when traveling, utilizes bagged dialysis fluid. Short daily dialysis is the standard mode, but nocturnal treatment, say, every other night, is also supported.

The primary advantage of System One lies in its frequent use in home hemodialysis therapy by dialysis patients who are seeking freedom, increased energy, and logistical benefits. Clinical data suggests that hemodialysis therapy administered five or six times per week, commonly referred to as more frequent therapy, better mimics the natural functioning of the human kidney and can lead to improved clinical outcomes, including lower mortality and improved survival, significant improvements in left ventricular mass, reductions in antihypertensive medications, reduced fluid overload, reduced depression and improvements in health-related quality of life.

ESRD is an irreversible, life-threatening loss of kidney function that is treated predominantly with dialysis, an essential therapy that removes toxins and excess fluids from the bloodstream. Unless a patient receives a kidney transplant, dialysis is required for the remainder of the patient's life. The most widely prescribed type of dialysis is hemodialysis, which typically consists of treatments in a dialysis clinic three times per week. ESRD affects over 550,000 people in the United States and 2 million people worldwide. Approximately 8% of the ESRD patients in the United States receive some form of dialysis treatment at home, most of whom are treated with peritoneal dialysis. Hemodialysis and peritoneal dialysis are both used to treat kidney failure. The difference is that hemodialysis uses a man-made membrane (dialyzer) to filter wastes and remove extra fluid from the blood, while peritoneal dialysis uses the lining of the abdominal cavity (peritoneal membrane) and a solution (dialysate) to remove wastes and extra fluid from the body.

Adoption Not Impressive, But Outlook Is Changing

Despite the fact that nocturnal home hemodialysis ("NHHD") can significantly improve patient health outcomes compared to conventional hemodialysis ("CHD") at health care institutions, the adoption of NHHD remains limited. Findings from various studies within the industry have shown that compared to CHD, self-care NHHD can lead to important health improvements in:

• Dialysis Adequacy / Effectiveness
• Survival / Mortality
• Anemia Status
• Blood Pressure
• Hospitalization Rates
• Fluid and Dietary Restrictions
• Prescription Drug Use

If the benefits of NHHD were just what the above list specifies, it would still be considered as a remarkable therapy option. But in practice, NHHD leads to an overall improved quality of life, including enhanced energy, improved appetite, sleep quality and sexual function, and increased rate of employment.

To understand why NHHD has not been widely adopted despite these huge benefits, a study was conducted by the researchers from the University Health Network and the University of Toronto. The study concluded that various patient-perceived barriers, such as fears of self-cannulation, a catastrophic event, and unknown burden on the patient's family, are responsible for the limited adoption of NHHD.

If this is bad news, the good news is that physicians and researchers are now increasingly trying to educate patients and their family members about the benefits of self-care home-based hemodialysis and associated hazards. It is expected that within a short span of time they would be able to fully convince the patient community the benefits of NHHD and impart necessary knowledge for its adoption.

Zero Competition

In addition to NxStage, Fresenius has also developed its own home-based hemodialysis system, apart from offering its customers the NxStage System One equipment. The most significant competitive advantage of System One over Fresenius' 2008K@home system is that it offers patients the freedom to travel and dialyze on the road or dialyze throughout their home. The 2008K@home is a simplified home-based machine, which offers visual support through step-by-step setup and treatment tutorials. The machine includes a wireless wetness detector and alarm, the "Diasafe Plus" filter to eliminate contaminates, and remote monitoring and data capture. But unfortunately the 2008K@home system does not offer portability.

Risk Versus Reward

The balance sheet of NXTM has no apparent weakness. The company is cash-rich with cash and cash equivalents of $83 million as of the third quarter of 2013. Cash burn is not alarming; in the third quarter cash burn was $11 million and included $5 million of capital expenditures associated with its manufacturing operations and its centers of excellence and approximately $2 million associated with the acquisition of its home business in the UK. Moreover, the company has no significant debt.

With a fairly robust balance sheet in hand, let's assess the risk-reward profile of the company.

Risk

The first risk is that NXTM is not yet profitable even after eight full years of existence. The company's full-year 2013 revenue is expected to be within the range of $261 to $262.5 million and net loss within the range of $19.5 to $18.5 million, or ($0.32) to ($0.31) per share.
NXTM depends heavily on two of its customers, which I feel is another risk associated with the company. Currently DaVita and Fresenius are two of NXTM's largest and most significant customers in the System One segment. Direct sales to DaVita represented 31%, 31% and 34% of its System One segment revenues during 2012, 2011 and 2010, respectively. Further, DaVita constitutes over 40% of its home hemodialysis patients. Direct sales to Fresenius represented 17%, 14% and 10% of the company's System One segment revenues during 2012, 2011 and 2010, respectively.
In my investment thesis, I assume that NXTM would soon become a profitable entity. In fact, this is what the thesis is based on. The purpose of the discussion I presented above is to establish that there is a very good chance that NXTM would soon become EPS positive with its System One equipment.

It is no myth that the benefits of home-based hemodialysis far outweigh the risks associated with it. Currently the most widely adopted form of dialysis therapy used in a setting other than a dialysis clinic is peritoneal dialysis. With physicians and researchers beginning to understand the benefits of more frequent home-based hemodialysis therapy at a significantly lower cost, which only System One can provide compared to its competitors offering peritoneal dialysis or conventional hemodialysis, I believe NXTM would seize a meaningful market share from its competitors in the treatment of ESRD. NxStage believes that approximately 10-15% of the over 385,000 ESRD patients in the United States currently receiving dialysis treatment would be appropriate candidates for home hemodialysis with the NxStage System One. This represents a huge opportunity that the company could tap with its System One device.

Reward

NXTM's long-term growth depends on the number of patients who adopt home-based hemodialysis and how quickly they adopt it, which in turn is driven by the number of physicians willing to prescribe home hemodialysis and the number of dialysis clinics able or willing to establish and support home hemodialysis therapies. If the company can convince the physician community and dialysis clinics by successful sales promotion, I estimate that the annual revenue of the company would cross $500 million within FY2015. If the industry average EBITDA margin of 17% is applied on the estimated revenue figure, NXTM's EBITDA would cross $85 million by FY2015. Now if we assign the industry average EV to EBITDA of 10x on NXTM's EBITDA, we can expect that its enterprise value will cross $850 million, currently which is $561 million. Let's add another $100 million of cash on that figure, and we get $950 million as the company's market cap, which translates into approximately $15.59 per share of NXTM. That represents ~50% upside from the current level around $10.50. I believe this could be a reasonable reward against a slim risk associated with the time frame when NXTM would become profitable.

NXTM Enterprise Value Chart

NXTM data by YCharts

Conclusion

I have no doubt in my mind that home-based hemodialysis will become the standard therapy one day, because it is very hard to ignore the benefits of self-care therapy in the treatment of ESRD. However, it is interesting to see how the industry matures, overcoming the various patient-perceived barriers.

http://seekingalpha.com/article/1932581-nxstage-gaining-ground-on-growing-adoption-of-home-hemodialysis

[obsidianom]

As doctor and care partner to my wife , I am a big fan of Nxstage. I dont own any stock and remain with no financial ties to the company.
I do beleive their system has some big advantages over the  competing Fresenius system for many patients . While portability is a plus, I feel the big advantage is the ability to do near daily dialysis which more closely mimics the actual kidneys. 5 days per week is a big improvement over 3 or 4 days per week. (6 would even be better). There is less build up of toxins and fluid and dialysis is less harsh and feels better. 
The system is not perfect but is the best we have currently.
For anyone incenter now I would suggest trying a week or two on 5 days per week NxStage. Our clinic is offering that as a trial in center now. The first 2 patients just switched over to NxStage from in center as they felt so much better on Nxstage ,5 days per week.  I always say the proof is in the pudding, and it has proved itself so far quite well. My wife is the first patient our clinic had on Nxstage and she also saw the huge improvement in how she felt switching over. She has been using it for a year and a half now.

[Simon Dog]

A huge NxStage risk (speaking from an investment, not a medical, perspective) is the Fresenius PAK (Portable Artificial Kidney).  The PAK appears to be sorbent technology small system similar to NxStage, but reportedly capable of generating URRs on par with the conventional machines like the 2008K and BabyK.

[Hemodoc]

A huge NxStage risk (speaking from an investment, not a medical, perspective) is the Fresenius PAK (Portable Artificial Kidney).  The PAK appears to be sorbent technology small system similar to NxStage, but reportedly capable of generating URRs on par with the conventional machines like the 2008K and BabyK.

I can't talk about the PAK due to 5 year NGA, but the NxStage System One upgrade to high flow is a substantial answer to that. From the RSI and noted by Dr. John Agar who is a medical advisor for the PAK, the dialysate is "near" ultra-pure while the NxStage reaches ultra-pure dialysate.

http://www.nocturnaldialysis.org/technology_whats_coming.htm

In my opinion, any system that is ultra-pure has significant benefits clinically for patients as documented in several studies. The NxStage will now get up to 300 ml/min dialysate which if you look at the dialysate flow curves, it is on the plateau section of the curve and approximates in-center clearances. Since this is now FDA approved, it is quite a significant improvement and rivals the other systems Since NxStage is FDA approved, the other machines are at a great disadvantage at present. I welcome the soon arriving competition in the market place among dialysis machine manufacturers, but it is still a ways off apparently.  We will have to see how the new additions affect the market place.

I would not count NxStage out of the competition by any measure used.

[obsidianom]

Nephron Clin Pract. 2013;123(3-4):246-53. doi: 10.1159/000354714. Epub 2013 Sep 4.

Effect of using ultrapure dialysate for hemodialysis on the level of circulating bacterial fragment in renal failure patients.

Kwan BC, Chow KM, Ma TK, Cheng PM, Leung CB, Li PK, Szeto CC.


Author information


abstract


Background: Cardiovascular disease is the major cause of mortality and morbidity in dialysis patients. Recently, circulating endotoxin is found to associate with the systemic inflammatory state and cardiovascular disease of dialysis patients. Previous studies showed that the use of ultrapure dialysate for hemodialysis could reduce the exposure to exogenous endotoxin. We studied the effect of using ultrapure dialysate for hemodialysis on circulating endotoxin and bacterial DNA fragment levels and vascular stiffness. Methods: This is an open-labeled prospective study of 25 patients (14 male). Circulating endotoxin and bacterial DNA level, vascular stiffness as represented by arterial pulse wave velocity (PWV), nutrition and hydration status were monitored before and repeatedly throughout 12 months after the use of ultrapure dialysate for hemodialysis. Results: The average age was 58.9 ± 10.2 years; 21 patients completed the study. Within 4 weeks of conversion to ultrapure dialysate for hemodialysis, the plasma endotoxin level fell from 0.302 ± 0.083 to 0.209 ± 0.044 EU/ml (p < 0.0001) and then remained static, while serum bacterial DNA level remained similar. Furthermore, the time-averaged plasma endotoxin level during the study period significantly correlated with serum C-reactive protein level (r = 0.483, p = 0.017), carotid-femoral PWV (r = 0.455, p = 0.033), and malnutrition inflammation score (r = 0.461, p = 0.031). The time-averaged serum bacterial DNA level significantly correlated with malnutrition inflammation score (r = 0.550, p = 0.008) and inversely with subjective global assessment score (r = -0.543, p = 0.009), but not with PWV. Conclusions: In hemodialysis patients, circulating endotoxin level is associated with vascular stiffness and systemic inflammation. Using ultrapure dialysate for hemodialysis effectively reduces circulating endotoxin level in hemodialysis patients. The long-term benefit of using ultrapure dialysate for hemodialysis requires further study. © 2013 S. Karger AG, Basel.


PMID: 24008429 [PubMed - in process] Free full text

[obsidianom]

Hemodial Int. 2010 Jan;14(1):39-46. doi: 10.1111/j.1542-4758.2009.00399.x. Epub 2009 Sep 16.

Solute kinetics with short-daily home hemodialysis using slow dialysate flow rate.

Kohn OF, Coe FL, Ing TS.


Author information

Abstract


"NxStage System One()" is increasingly used for daily home hemodialysis. The ultrapure dialysate volumes are typically between 15 L and 30 L per dialysis, substantially smaller than the volumes used in conventional dialysis. In this study, the impact of the use of low dialysate volumes on the removal rates of solutes of different molecular weights and volumes of distribution was evaluated. Serum measurements before and after dialysis and total dialysate collection were performed over 30 times in 5 functionally anephric patients undergoing short-daily home hemodialysis (6 d/wk) over the course of 8 to 16 months. Measured solutes included beta(2) microglobulin (beta(2)M), phosphorus, urea nitrogen, and potassium. The average spent dialysate volume (dialysate plus ultrafiltrate) was 25.4+/-4.7 L and the dialysis duration was 175+/-15 min. beta(2) microglobulin clearance of the polyethersulfone dialyzer averaged 53+/-14 mL/min. Total beta(2)M recovered in the dialysate was 106+/-42 mg per treatment (n=38). Predialysis serum beta(2)M levels remained stable over the observation period. Phosphorus removal averaged 694+/-343 mg per treatment with a mean predialysis serum phosphorus of 5.2+/-1.8 mg/dL (n=34). Standard Kt/V averaged 2.5+/-0.3 per week and correlated with the dialysate-based weekly Kt/V. Weekly beta(2)M, phosphorus, and urea nitrogen removal in patients dialyzing 6 d/wk with these relatively low dialysate volumes compared favorably with values published for thrice weekly conventional and with short-daily hemodialysis performed with machines using much higher dialysate flow rates. Results of the present study were achieved, however, with an average of 17.5 hours of dialysis per week.


PMID: 19758296 [PubMed - indexed for MEDLINE]


MeSH Terms, Substances

[Simon Dog]

The NxStage will now get up to 300 ml/min dialysate which if you look at the dialysate flow curves, it is on the plateau section of the curve and approximates in-center clearances.

Thanks for the information.   I am on the BabyK EOD (though usually 4 days a week, Tues/Thurs/Fri/Sun) and my last URR was 76%.   The Rn tells me their URR goal on NxStage is 40% for a 5 day patient, 38% for a 6 day patient.  What URR is the high flow NxStage getting that "approximates" in-center clearance.   If I can get something approximating the BabyK, it may be worth a switch.

Also, do you have any thoughts on the Fresenius 5008 hemo diafiltration system?  (www.highvolumehdf.com)

[obsidianom]

My wife gets 63% URR on 5 day per week NxStage at 30 liters dialysate. It is just about the same as in center now. If we needed better clearance we could raise the amount of dialysate. We dont run that fast either. Blood flow 340 , dailysate 10 liters per hour.

[Simon Dog]

My wife gets 63% URR on 5 day per week NxStage at 30 liters dialysate. It is just about the same as in center now. If we needed better clearance we could raise the amount of dialysate. We dont run that fast either. Blood flow 340 , dailysate 10 liters per hour.

How long do her 30 liter runs take?

I am going to try to arrange for a test run on the NxStage w/labs to see what sort of URR I get on the kind of treatment my doc would prescribe.

[obsidianom]

We do 3 hours . It can be done faster or slower based on settings on machine. There is some flexibility.

[Simon Dog]

We do 3 hours . It can be done faster or slower based on settings on machine. There is some flexibility.

You are doing a great job of getting me interested in NxStage.  I've been told to expect 45% URR with 3 hours; you are seeing 63%.   I'm going to ask for pre/post BUN labs with my test drive so I see what I get.   Thanks for the info.

[Hemodoc]

We do 3 hours . It can be done faster or slower based on settings on machine. There is some flexibility.

You are doing a great job of getting me interested in NxStage.  I've been told to expect 45% URR with 3 hours; you are seeing 63%.   I'm going to ask for pre/post BUN labs with my test drive so I see what I get.   Thanks for the info.

URR all depends on how much you weigh and how much dialysate volume used. However, America spends way too much time focussing on URR and Kt/V which really have little to do with real dialysis optimization.

If you are going to the NxStage, avoid the American style dialysis philosophy that I am sure the trainer will tell you. Run the blood pump as fast as you can and crank it up to 500 ml/min if you can so you can get done as quickly as you can. That is just wrong if you wish to live longer.

Japan has the best outcomes and they have URR and Kt/V's far below those of the US. Total time on dialysis is by far a more important parameter to consider.

[Simon Dog]

I am pushing my doc to let me go nocturnal, but he says that has to wait until Fresenius has real time monitoring in place - which is supposedly "soon".

[Hemodoc]

I am pushing my doc to let me go nocturnal, but he says that has to wait until Fresenius has real time monitoring in place - which is supposedly "soon".

The America experience is sadly vastly inferior to many nations such as Canada just to the north. Nocturnal dialysis, extended dialysis with no partner is quite common. I guess with 1/4 of the world's lawyers, we will remain a backwoods dialysis provider to our patients in America for quite some time.

Bill Peckham dialyzes home alone and all he has is a medic alert alarm. With Nocturnal, you run so slowly that problems with access and issues with the machine are not common as long as you tape up and hook up correctly. I am not the least bit happy with FMC at present. I wish you luck getting the care you need. At least you have a nephrologist who is willing to go the nocturnal route. Time is the most important factor due to middle molecule clearances.

[obsidianom]

I agree with Hemodoc on time on machine. I would suggest trying to get the most dialysate you can approved for Nxstage and run it slower like we do . That way you can get more time on machine if you can manage it.  We run our blood at only 340 and are now slowing down the dialysate a bit (down to 9.6) too to get more time on machine. The other key is number of days on the machine. The more the better. We do 5 days and some do 6 days . Others only do 4.
If you look at another way of calculating dialysis adaquacy put out a few years ago, it takes the number of days per week squared times hours per day. A "good adaquacy"would be around 60 to 80 and higher. If for example you do 5 days for 3 hours per day you get 5 squared times 3 which equals 75. That would be considered good dailysis. Standard in center is only 3 times per week for about 4 hours which gives a number of 36 which is poor dialysis.
So Nxstage helps with that formula as dialyisis frequency  is a big factor in the calculation.  By upping from 4 days to 5 you get a big jump in the calculation.  4 days squared times 3 hours only gives 48 which is fair dialysis only.

[Simon Dog]

If you look at another way of calculating dialysis adaquacy put out a few years ago, it takes the number of days per week squared times hours per day. A "good adaquacy"would be around 60 to 80 and higher.

By that measure, I'm hitting 60 exactly.   

One thing that is frustrating about treatment is the widespread acceptance of mediocrity from even the so called "good" doctors.   Patients on 3x/in center are not even told how woefully inadequate the treatment is.    I'm on "conventional home" and I believe I would be on 3x rather than EOD if I had not brought the subject up with my doc - who was most supportive once I asked.   Maybe there is an unwritten rule among docs "do not disrupt the status quo".

[obsidianom]

Our big problem in the US is the vast majority of dialysis patients are on  Medicare for insurance.  Medicare only pays for 3 days per week dialysis. That means any one who dialyzes more is effectively costing the company money as they dont get reimbursed for the extra days. That is why we had to fight so hard at first to get our clinic to allow us NxStage. We do 5 days per week on NxStage and they only get paid for 3 days by Medicare.
The US lets the insurance (medicare ) basically set the standard for dialysis . Its backwards. The insurance should not be deciding what is medically neccessary for patients. Also once size fits all with medicare. Theyt pay the same number of days for each patient (3) and do not allow individualization. So the doctors are trained in the US with this standard. It becomes their default for patients. It is hard to break habits in many cases for more dialysis.
 Dr. John Agar in Australia , a world renouned  nephrologist, feels the US is very backwards(stone age) in our dialysis methods. We get far less time at far faster blood speeds then is best for patients. The faster blood speeds damage fistulas and can stun the heart. He beleives time is the key. It takes more time to get to the middle molocules and to deal with fluid compartments. We dont do enough time in the US.
That is one reason we chose NxStage. WE get more days and hours on the machine . It is gentler that way also.

[KatieV]

I'm hoping to see Nocturnal become more available.  I had to move to a clinic 2.5 hours away in order to Nocturnal NxStage.  That clinic's standard procedure is to run the blood pump at 400, which I did while using 60 liters of dialysate over 8 hours.  I did 5 or 6 days a week (6 days is 288 using the above formula).

I believe one nephrologist up at the local hospital is trying to get in-center nocturnal and another is looking to get Nocturnal NxStage.  I'm sure part of problem/delay is the Medicare issue.  The new transplant surgeon told me that Nocturnal is the way to go.  Maybe he'll have some influence to get the ball rolling...

[obsidianom]

I'm hoping to see Nocturnal become more available.  I had to move to a clinic 2.5 hours away in order to Nocturnal NxStage.  That clinic's standard procedure is to run the blood pump at 400, which I did while using 60 liters of dialysate over 8 hours.  I did 5 or 6 days a week (6 days is 288 using the above formula).

I believe one nephrologist up at the local hospital is trying to get in-center nocturnal and another is looking to get Nocturnal NxStage.  I'm sure part of problem/delay is the Medicare issue.  The new transplant surgeon told me that Nocturnal is the way to go.  Maybe he'll have some influence to get the ball rolling...

Your blood speed is quite high, especially for nocturnal. The whole idea of nocturnal is to run SLOWER and gentler. Most patients in Australia run 225 nocturnal according to Dr. Agar.  Running 400 puts a huge stress on the heart and fistula. Dr. Agar mentioned to me that 350 is the high end range he would consider and lower is better. We run 340 now and plan to try even slower.

[MooseMom]

Dr. Agar is the global king of nocturnal dialysis, in my very humble opinion.  My conversations with him have always been so incredibly enlightening.

Let's face it.  Healthcare philosophy in the US has always been reactive as opposed to being preventative.  What we don't seem to understand (or what Medicare doesn't understand) is that 3xweekly incenter dialysis causes expensive problems.  What we think we save in dialysis costs we more that doubly spend on treating the problems that this modality causes.  It's stupid.

[Hemodoc]

If you look at another way of calculating dialysis adaquacy put out a few years ago, it takes the number of days per week squared times hours per day. A "good adaquacy"would be around 60 to 80 and higher.

By that measure, I'm hitting 60 exactly.   

One thing that is frustrating about treatment is the widespread acceptance of mediocrity from even the so called "good" doctors.   Patients on 3x/in center are not even told how woefully inadequate the treatment is.    I'm on "conventional home" and I believe I would be on 3x rather than EOD if I had not brought the subject up with my doc - who was most supportive once I asked.   Maybe there is an unwritten rule among docs "do not disrupt the status quo".

This is the Hemodialysis Product by Belding H. Scribner, MD; Dimitrios G. Oreopoulos, MD.

http://www.therenalnetwork.org/qi/resources/HDP.pdf

[Hemodoc]

I'm hoping to see Nocturnal become more available.  I had to move to a clinic 2.5 hours away in order to Nocturnal NxStage.  That clinic's standard procedure is to run the blood pump at 400, which I did while using 60 liters of dialysate over 8 hours.  I did 5 or 6 days a week (6 days is 288 using the above formula).

I believe one nephrologist up at the local hospital is trying to get in-center nocturnal and another is looking to get Nocturnal NxStage.  I'm sure part of problem/delay is the Medicare issue.  The new transplant surgeon told me that Nocturnal is the way to go.  Maybe he'll have some influence to get the ball rolling...

If you run a blood pump speed of 400 ml/min for 8 hours, that is 192 liters of blood. Coupled with 60 liters of dialysate, your FF is then 31.25. For nocturnal, that is a very high blood flow rate. One of the advantages of nocturnal is the ability to turn down the blood flow rate and still gain the power of TIME for middle molecule clearance. America is stuck on fast, high volume, violent dialysis sessions that damage the fistula, the heart and the entire cardiovascular system.

Most programs around the world run around 250 ml/min blood pump speeds for nocturnal. Japan does that with just about all of their patients. The reason that they get better outcomes is that America is stuck on Urea clearances that clinically have very little relevance while the rest of the world understands well that TIME and FREQUENCY are the two most important factors of middle molecule solute clearances which is what also matters clinically. In other worlds, America is a backwards nation as far as dialysis issues are concerned.

I addition, when NxStage first entered the home hemodialysis market, they had a motto of "one liter of dialysate is one liter of clearance." What were they talking about? They introduced a "MARKETING" mantra that sounded good of utilizing 100% efficiency of the dialysate. That is fine as it sounds, however, in reality, it is just a gimmick since at the same time, the low FF which correlate directly with dialysate flow rates is remarkably low. What does this mean to the patient? Solute clearances under the old NxStage recommendations are remarkably below standard in-center solute clearances.

So no matter how "efficient" the dialysate is with these NxStage recommendations, the efficiency of one dialysis session is horribly low when you figure in TIME as a factor.  For instance, I run an FF of 45% which translates into a dialysate flow rate of about 167 ml/min with a blood pump speed of 370 for 4.1 hours. My Kt/V is about 0.8 with this regimen.

In-center, I run a blood pump speed of 380 for 4.0 hours and my Kt/V was 1.2-1.4.  NxStage is simply a low volume system that especially at 20 or 25 liters is actually in my opinion just too low.

I would highly recommend that you consider discussing with your medical team the benefits of lowering your BFR to the 250 level and increasing your FF to a level that will allow you to dialyze your 8 hours with the time exactly the same. That would be with a BFR of 250 ml/min a total of 120 liters of blood during an 8 hour session making 60 liters of total dialysis volume run at an FF of 50%.

The good news that I suspect your medical team is unaware perhaps is that the FDA approved a NxStage system upgrade in April that should change medical practice for ALL NxStage patients but has not had any real impact to date. In this, the NxStage System One highflow will now be able to run a dialysate flow rate of 300 ml/min or 18 liters/hour.

http://ir.nxstage.com/releasedetail.cfm?ReleaseID=760385

In your case, a BFR of 250 ml/min with an FF of 50% would result in a 125 ml/min dialysate flow rate for 8 hours. If your medical team still wishes to maximize your dialysate under the marketing mantra of "one liter of fluid is a liter of clearance," looking at the solute flow curves, you are still way under the 200 ml/min "max" rate under the old NxStage guidance. For your medical team, this means that they would not need to get the new upgraded high flow NxStage System One since the current machine would work just fine at 125 ml/min. (Remember, the FDA approval is for a new machine that exceeds the old machine by a factor of 200 ml/min on the old to 300 ml/min on the new upgraded version)

Once again, remember, that this was a sales pitch, not a clinical reality since the only thing that matters is what the patient sees not what the dialysate sees in efficiencies. It is now outdate by the updated FDA approval of high flow dialysate system and practices SHOULD change but haven't as of yet.

[Hemodoc]

Dr. Agar is the global king of nocturnal dialysis, in my very humble opinion.  My conversations with him have always been so incredibly enlightening.

Let's face it.  Healthcare philosophy in the US has always been reactive as opposed to being preventative.  What we don't seem to understand (or what Medicare doesn't understand) is that 3xweekly incenter dialysis causes expensive problems.  What we think we save in dialysis costs we more that doubly spend on treating the problems that this modality causes.  It's stupid.

I believe it is more than stupid, I believe it is actually a calculated evil on the part of our government. I believe that they don't want long term survival on dialysis and that at about 36 months average survival for all dialysis patients, they save money by dialysis patients dropping dead despite the high hospital costs associated with this. I cannot prove this but there was an abstract at I believe the 2010 ADC that was from a Canadian province. They calculated that if dialysis patients improved survival, they would bankrupt their entire allotment for all patients. That is the closest I have heard of any studies or any government policies expressing what I believe is the underlying logic of "WHY" they allow the current situation to continue and actually augment this with their policy decisions at the CMS level.

[Simon Dog]

The good news that I suspect your medical team is unaware perhaps is that the FDA approved a NxStage system upgrade in April that should change medical practice for ALL NxStage patients but has not had any real impact to date. In this, the NxStage System One highflow will now be able to run a dialysate flow rate of 300 ml/min or 18 liters/hour.

I wonder how the economic practicalities will play out - there are a lot of 12 liter NxStage units out there, and I would expect that there would be some resistance to replacing all of these with 18 litre units, since either (a) NxStage will not be able to charge extra for this, thus creating an incentive for NxStage to limit availability, or (b) NxStage will be allowed to charge clinics extra, thus creating clinic level resistance.

[Hemodoc]

The good news that I suspect your medical team is unaware perhaps is that the FDA approved a NxStage system upgrade in April that should change medical practice for ALL NxStage patients but has not had any real impact to date. In this, the NxStage System One highflow will now be able to run a dialysate flow rate of 300 ml/min or 18 liters/hour.

I wonder how the economic practicalities will play out - there are a lot of 12 liter NxStage units out there, and I would expect that there would be some resistance to replacing all of these with 18 litre units, since either (a) NxStage will not be able to charge extra for this, thus creating an incentive for NxStage to limit availability, or (b) NxStage will be allowed to charge clinics extra, thus creating clinic level resistance.

NxStage has been seen as friendly to dialysis patients. However, in reality, they are a for-profit dialysis provider now that they are opening independent treatment units directly to patients. We will see soon the real character of this company and whether they are as "patient friendly" as they would like us to believe.

As far as getting the upgrade, good luck. I have been trying for 6 months myself already and I won't hold my breath waiting.