NxStage Gaining Ground On Growing Adoption Of Home Hemodialysis

[MooseMom]

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.

Oh, I so hope you are wrong!

I did not know that there are now NxStage clinics!  Where are they, and when did they open?  What do you think made them decide to become for-profit dialysis providers?  That's interesting and unnerving at the same time.

We read a fair amount about the research that is going on where "ghost" organs are being created and where bits and pieces are being "built" using stem cells/pluripotent cells.  It seems that we are getting closer to the day when dialysis as we know it will be obsolete (and, for that matter, transplantation).  What do you see happening to those companies that make money off dialysis patients, the Davitas and the Fresenii of the world?  Just hypothesizing and extrapolating from what you have seen and have experienced, how do you see the post-dialysis/post-transplantation world?  What do you think such a world might look like financially?

[KatieV]

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.

....

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%

Your post makes complete sense.  Why do you think America is so backwards on the dialysis issues? 

I was on Short Daily NxStage for 16 months with a blood flow rate of 450!  I used 20 liters of dialysate and my treatments were about 4 hours long.  I learned about Nocturnal through IHD, so I was surprised when I switched over to Nocturnal and they wanted me to run at 400 BFR.  I ran for about 2 months before having access issues, got an infection in the fistula, and had a chest catheter installed.  Even the very experienced nurses have problems with my twisty, branchy, deep diving fistula.  I successfully used the chest catheter at home for about 7 months before receiving a transplant on November 16, 2013.

I'd definitely talk to the dialysis team about this if I was still on dialysis.  I was thrilled when my cycler left; unfortunately, I traded a known set of issues/time constraints for some serious side effects.   

[Hemodoc]

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.

Oh, I so hope you are wrong!

I did not know that there are now NxStage clinics!  Where are they, and when did they open?  What do you think made them decide to become for-profit dialysis providers?  That's interesting and unnerving at the same time.

We read a fair amount about the research that is going on where "ghost" organs are being created and where bits and pieces are being "built" using stem cells/pluripotent cells.  It seems that we are getting closer to the day when dialysis as we know it will be obsolete (and, for that matter, transplantation).  What do you see happening to those companies that make money off dialysis patients, the Davitas and the Fresenii of the world?  Just hypothesizing and extrapolating from what you have seen and have experienced, how do you see the post-dialysis/post-transplantation world?  What do you think such a world might look like financially?

NxStage has more than one I believe. Here is I think the first:

http://ir.nxstage.com/releasedetail.cfm?releaseid=797232

As far a FMC and DaVita, they are investing heavily in the new technologies. Don't expect them to disappear any time soon.

[Hemodoc]

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.

....

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%

Your post makes complete sense.  Why do you think America is so backwards on the dialysis issues? 

I was on Short Daily NxStage for 16 months with a blood flow rate of 450!  I used 20 liters of dialysate and my treatments were about 4 hours long.  I learned about Nocturnal through IHD, so I was surprised when I switched over to Nocturnal and they wanted me to run at 400 BFR.  I ran for about 2 months before having access issues, got an infection in the fistula, and had a chest catheter installed.  Even the very experienced nurses have problems with my twisty, branchy, deep diving fistula.  I successfully used the chest catheter at home for about 7 months before receiving a transplant on November 16, 2013.

I'd definitely talk to the dialysis team about this if I was still on dialysis.  I was thrilled when my cycler left; unfortunately, I traded a known set of issues/time constraints for some serious side effects.   

Sorry to hear about your NxStage experience. Your story is exactly why I stated that America is quite backwards in its approach to dialysis. The rest of the developed world knows you must run longer, slower and more frequently than the American experience. The US dialysis system is based on a business model, not a medical model of ideal care. That really explains why America is backwards. Here, they want short, infrequent sessions on and off the needle as quickly as possible to run as many patients through the machine.

Telling you to run at 450 is a result of how NxStage designed their machine based on the American model of short dialysis, as short as possible. Many patients are told to INCREASE blood pump speed above what they ran in-center. That defies the logic of preserving fistulas with lower pump speeds as especially practiced in Japan where 250 is a common speed for in-center patients as well.

Running at 400 ml/min for nocturnal shows a lack of understanding of how nocturnal works. It is completely based on TIME not Urea clearances. Middle molecule clearance as well as PO4 is TIME dependent. There is an element of volume of dialysate, but the most important factor even with low volumes of dialysate is TIME. That is why many patients on 20 liter of dialysate on NxStage need phosphorus supplements with nocturnal regimens that they didn't need with the same volume on short daily dialysis.

So that in simple terms is the major reasons I made the statements in the prior post.

I wish you well with your transplant. It is not worry free but it does offer many advantages.

[Simon Dog]

I did not know that there are now NxStage clinics!  Where are they, and when did they open?  What do you think made them decide to become for-profit dialysis providers?  That's interesting and unnerving at the same time.

Why is it unnerving?  NxStage is a for profit company that was leasing machines, not a charity.    They are just offering more services using the same business model.

It's like the bumper sticker on trucks "cash, grass or ass .... no one rides for free".

[obsidianom]

After reading and emailing Dr. Agar and talking to NxStage people and my own experiences, I came to the realization that NXStage really comes down to dialysate volume and time on machine. The whole flow fraction idea is ridiculous as it is irrelevant. I just set our default FF  at maximum and dont even look at where we actually are in each treatment. What I do care about is time on machine, blood speed and dialysate volume. The dialysate speed only is important interms of final time on machine . The faster I run the dailysate speed the less time on machine and vice versa. 
Where Nxstage has its advantage is in the extra number of days of treatment per week, and the flexibility of running it as fast or slow as I want.  I keep the blood speed down to 340 now but still get 63 liters of blood cleared through by slowing down the dialysate and getting a longer treatment. We run about 3:08 now. Thats 15 hours and 40 minutes per week.
There is no reason to run the blood speed over 350.
Nxstage weakness is volumes over 30 liters up to 50. Since the saks are 50 or 60 , there are problems with wasting dialysate over 30 and under 50. WE run 30 liters and I would hesitate to run over 30 or less than 50 or 60. They need more flexibility. I would love to tgry 35 to 40 liters but it wouldnt be easy on this system.
I dont understand any one at home running a blood speed over 350. The centers do it for time expediency to get people out faster but at home we can run longer and slower. I do like Nxstage for the ability to do that. Short of nocturnal which I cant do easily , NxStage offers the most time on machine daily treatment offers.

[MooseMom]

I did not know that there are now NxStage clinics!  Where are they, and when did they open?  What do you think made them decide to become for-profit dialysis providers?  That's interesting and unnerving at the same time.

Why is it unnerving?  NxStage is a for profit company that was leasing machines, not a charity.    They are just offering more services using the same business model.

It's like the bumper sticker on trucks "cash, grass or ass .... no one rides for free".

Because dialysis shouldn't be based on a "business model" and should not be "for-profit'.  The US dialysis industry is rotten from top to bottom.  We all know that.  Imagine some company telling you that you can have your life saving treatment only on certain days.  They get cash for putting your ass under the grass.  Do you really want your treatment following the philosophy you read off of a truck's bumper sticker?  Good luck with that.

[Simon Dog]

Because dialysis shouldn't be based on a "business model" and should not be "for-profit'.

Do you really think the NxStage would have been designed and brought through FDA approval by a bunch of volunteers, or that investors would have fronted the large amount of cash required (think IPO) to bring a new machine to market absent an expectation of ROI?

The US dialysis industry is rotten from top to bottom.

No doubt true in any business where there is a conflict between "best treatment" and "profit maximization"

Do you really want your treatment following the philosophy you read off of a truck's bumper sticker?  Good luck with that.

It is not about what one "wants", but the reality of economics.   I would love it if centers would dialyze me fore free, but then, I would also love it if Exxon would fill my tank for free.    Both are equally likely.

I don't know of any dialysis center where the doctors, nurses and techs work for free, or suppliers that give away their machines and supplies.   Non-profits can be every bit as ruthless as for-profit centers when it comes to "no payment, no service", and the distinction between the two is largely meaningless to the patient who is told "you won't be treated here until you,  your insurance company or medicare agrees to pay us."

[amanda100wilson]

What is the benefit of the high flow NxStage machine over the existing one?  When it comes to the physics of these machines, I find it hard to understand.  When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine, and that I would be no advantage to me.  I like to be armed with knowledge so that I can aim to get the best treatment.

[Simon Dog]

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

[cattlekid]

I was 95kg EDW when I was on NxStage and had no problems with clearances. 

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

[obsidianom]

What is the benefit of the high flow NxStage machine over the existing one?  When it comes to the physics of these machines, I find it hard to understand.  When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine, and that I would be no advantage to me.  I like to be armed with knowledge so that I can aim to get the best treatment.

The regular machine runs up to 12 liters dialysate per hour. The high flow runs up to 18 liters per hour. There is no advantage to small people to switch. The larger patients will benefit as they can run larger amounts of dialysate quicker. It simply allows faster dialysis. If you are doing well at current amounts and run under 4 hours (not nocturnal) then there is no reason to switch. I do not plan to switch my wife.
If you are large and say need 60 liters per treatment, then speeding up from 12 liters per hour which takes 5 hours to new faster machine at say, 15 liters per hour would cut the time to 4 hours. At 18 liters per hour it would be 3hours, and 20 minutes. So there is advantage for larger volume patients.
Dont forget that time on machine is most important. Going too,fast is not good either. I woudnt go less than 3 hours , 5 days per week.
NXstage is all about total volume of dialysate used.  The larger the person, the more volume required. My wife is small and only needs 30 liters to get a URR of around 60% usually. 

[obsidianom]

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

You should be able to get good clearances at your weight . I dont have all your particulars but based on a very generic person with your weight you could run 50 to 60 liters per treatment . Again that is very generic,  you may need less . I looked at it with very good clearances and high KV/t.  You would benefit from the high flow system but could also use the regular system at slower rates. Your nurse or doctor can run your profile on the on line calculator and give you exact figures on dialysate volume, blood and dialysate speed, and time on machine.
The pure flow system has saks of 50 and 60 liters. You get ultra pure dialysate with this which is purer than standard dialysis. That is anothe radvantageas it leads to less inflammation and cell damage.

[Simon Dog]

You would benefit from the high flow system but could also use the regular system at slower rates.

If I decide to switch, I will push for the high flow system and contact NxStage if my clinic has problems getting one for me, as I will lose all negotiating ability once the sale is made.

I know that NxStage will get directly involved to make a sale.   One of the patients at my clinic was not considered a great home hemo candidate (non-compliant, always late for treatments).   He contacted NxStage directly and asked "how do I get one" - and NxStage pressured the clinic to get him on home hemo.  Word is he was a very successful home hemo patient and went from non-compliant to totally compliant once spared the indignities of the center.

[Hemodoc]

What is the benefit of the high flow NxStage machine over the existing one?  When it comes to the physics of these machines, I find it hard to understand.  When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine, and that I would be no advantage to me.  I like to be armed with knowledge so that I can aim to get the best treatment.

Well, let's talk about the physiology of dialysis so that understanding these issues is pretty simple. Dialysis is based on the principles of osmosis involving semi-permeable membranes and solutes. For instance, potassium in a solution of higher concentration on one side of the semipermeable membrane will pass potassium molecules through the membrane from higher to lower gradient and water molecules on the other side passes through to the high potassium side until both are equal.

In dialysis, the same concept applies to a wide number of molecules. That is why your dialysis "bath" or otherwise called dialysate has specific concentrations of potassium, magnesium, calcium, sodium, glucose and buffers which in the NxStage is lactate. Urea is not part of the "bath" so the blood will always have a higher concentration than the "bath."

As the rate of dialysate increases, the urea clearance goes up in a linear fashion until about 200 ml/min. After that, it begins to plateau or flatten out the curve as the efficiency of removing urea drops. However, at all rates of dialysate, the higher you go, the higher the urea clearance is. Going from 100 to 200 ml/min, the efficiency is essentially the same. NxStage calls this "100%" dialysate efficiency at this part of the curve. They marketed their system on the mantra that 1 liter of dialysate is 1 liter of clearance. What they are not telling you is how efficient the dialysate is from the patient perspective. In other words, even if you run at 100% efficiency, but with too low a volume, you will not get as much urea clearance running at a "less efficient" 600 ml/min as in-center by far. It is a NxStage marketing scheme not a clinical outcome scheme.

I placed an excellent graph of this from Wellbound on a post I wrote a while back for DSEN:

http://www.billpeckham.com/from_the_sharp_end_of_the/2009/01/nxstage-dialysate-flow-rates.html

So in short, I personally believe EVERYONE on NxStage should max out their therapy and I know of no one according to the power of this graph showing increasing benefit at each step in higher dialysate flow rates who would not benefit from the high flow NxStage System One upgrade. However, the LDO's love NxStage for giving us a substantially lower "standard of care" on low volume home treatments. Without NxStage, dialysate volumes and rates would have continued at the conventional in-center rates of 1.5 to 2.0 times blood flow rates. The question then becomes, what will the legacy of NxStage become? One where we gained, or one where we lost? Looking at it from the dialysate flow rate alone and efficiency of dialysis based on urea clearances per TIME on the machine, we have clearly lost and the LDO's will not budge in getting it back. You can calculate how much dialysate volume and flow rates you would have at in-center rates just by multiplying your Blood Flow Rate (BFR) by a factor of 1.5 to 2.0. Putting it in NxStage terms that would be an FF of 150% to 200%. Looking at an FF of 35% that is quite usual with NxStage shows the power of in-center dialysate flow rates compared to the standard flow rates of NxStage on the old System One.

That is the new battle before us. With about 10 years of literature supporting low flow dialysate systems and information from the FREEDOM studies, we will be sore pressed to ever see the new upgrade UNLESS it is to reduce the frequency of dialysis by the LDO's. In fact, that is exactly how NxStage marketed their new high flow capacities last April.

"This latest regulatory milestone reflects strong and systematic execution against our product pipeline," said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. "With this new capability, NxStage therapy may be prescribed less frequently, for example 3 times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today.  We're strong believers in longer and more frequent dialysis for the clinical benefits; still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency."[/b]

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

This leaves NxStage speaking out of both sides of their mouth. On the old side is higher frequency is important, on this side, higher volume is important and more frequency is not. Where NxStage will stand in the future as dialysis "advocates" remains to be defined in the coming years.

[Hemodoc]

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

I weigh about 90 kg and run 40 liters for 4 hours at a time. I am hoping to increase my volume. Volume and TIME on the machine are the biggest issues if you are considering switching to NxStage. If you can run nocturnal at 60 liters, doing the math of BFR of 250 for 8 hours, that is a BLP of 120 liters. with an FF of 50%, you will easily run the 60 liters at 125 ml/min, easily within the capabilities of the old System One and find that your clearances rival in-center and your phosphorus might need some supplementation which I believe is best done by diet means. Why take a pill when you could have a pizza for instance or a glass of chocolate milk. Think about it.

[Zach]

This leaves NxStage speaking out of both sides of their mouth. On the old side is higher frequency is important, on this side, higher volume is important and more frequency is not. Where NxStage will stand in the future as dialysis "advocates" remains to be defined in the coming years.

Excellent point.
 

[Simon Dog]

This leaves NxStage speaking out of both sides of their mouth. On the old side is higher frequency is important, on this side, higher volume is important and more frequency is not. Where NxStage will stand in the future as dialysis "advocates" remains to be defined in the coming years.

Assume the following:

1.  Higher flow rates are an improvement for people who do near-daily NxStage
2.  Higher flow rates are essential for persons doing NxStage on an 3x or EOD protocol
3.  NxStage has a s--tload of low flow rate machines in use
4.  NxStage generally rents, rather than sells, machines - so an upgrade for an existing user is a cost, not an extra sale.

Now, the problem for NxStage becomes how to promote the new machine without motivating everyone to upgrade.   

Should NxStage:

1.  Promote the new options made possible by the high flow machine
or
2.  Do the above, but also remind patients that the new machine will result in "improved treatment" for persons already getting "adequate treatment"? (and, in doing so, initiate returns of their 12L machines, and assure that new patients will universally demand the 18L units, thus orphaning the inventory of 12L systems)

In days of old, a genius names Chet Osborne came out with one of the first personal computers - the Osborne One.  It sold well, he was making a fortune, and all was well.   His company then proceeded to announce a newer and improved model - before that product was ready for sale, and when there were still lots of Osborne One's in the distribution channel.  That one mistake effectively killed his company. 

I suspect the NxStage lack of emphasis on improvement for existing customers is to avoid what is commonly referred to cannibalism in business, and in cases of pre-announcement causing the cannibalism, is known as the "Osborne Effect".

[obsidianom]

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

I weigh about 90 kg and run 40 liters for 4 hours at a time. I am hoping to increase my volume. Volume and TIME on the machine are the biggest issues if you are considering switching to NxStage. If you can run nocturnal at 60 liters, doing the math of BFR of 250 for 8 hours, that is a BLP of 120 liters. with an FF of 50%, you will easily run the 60 liters at 125 ml/min, easily within the capabilities of the old System One and find that your clearances rival in-center and your phosphorus might need some supplementation which I believe is best done by diet means. Why take a pill when you could have a pizza for instance or a glass of chocolate milk. Think about it.

You sort of made my point about the low flow machine being adaquate for many patients. Even at the maximum of 60 liters per treatment, the low flow machine can handle it if you spend anough time on the machine (5 hours for 60 liters at 12 liters per hour). Time on machine is one of  the most important factor in dialysis . So the system can work .
Based on your size (90 kg) a generic patient like you would need 40 to 50 liters at 5 days per week. If you ran 50 liters at maximum 12 liters per hour, that would give a treatment time of slightly over 4 hours. 50 liters makes more sense as the sak holds 50 liters anyway. That would give you about 25% more dialysis volume. You could still use the low flow system .
I dont think NxStage is talking out of both sides of their mouths as much as dealing with reality. A lot of patients dont want to do more than 3 days per week of dialysis even though it is poor dialysis. So by offering this as an option they are opening up their system to more potential patients . Thats simply good business. They still stand by the option of more frequent dialysis as preferable.

[Simon Dog]

I dont think NxStage is talking out of both sides of their mouths as much as dealing with reality. A lot of patients dont want to do more than 3 days per week of dialysis even though it is poor dialysis. So by offering this as an option they are opening up their system to more potential patients . Thats simply good business. They still stand by the option of more frequent dialysis as preferable.

They are dodging the question: Does upgrading from a 12L to 18L and increasing flow for existing patients, who are receiving adequate dialysis, improve their treatment?   If the answer is yes, the best thing for patients is an upgrade - but that may not be best for NxStage.

[obsidianom]

I dont think NxStage is talking out of both sides of their mouths as much as dealing with reality. A lot of patients dont want to do more than 3 days per week of dialysis even though it is poor dialysis. So by offering this as an option they are opening up their system to more potential patients . Thats simply good business. They still stand by the option of more frequent dialysis as preferable.

They are dodging the question: Does upgrading from a 12L to 18L and increasing flow for existing patients, who are receiving adequate dialysis, improve their treatment?   If the answer is yes, the best thing for patients is an upgrade - but that may not be best for NxStage.

You are stll missing the point. Its not the speed or flow rate that matters, its the VOLUME of dialysate. The high flow machine simply goes faster and is useful for patients who need higher volumes (60 liters) who want shorter dialysis. There is no advantage at all to others who are on lower volumes and need the speed at a slower rate to get enough time on machine.
Dr. Agar talks about the "waterfall effect" which in simple terms means more time on machine gets better clearance of the middle molecules. Going too fast with shorter times loses this effect. Time is critical , not speed.

[Simon Dog]

There is no advantage at all to others who are on lower volumes and need the speed at a slower rate to get enough time on machine.
Dr. Agar talks about the "waterfall effect" which in simple terms means more time on machine gets better clearance of the middle molecules. Going too fast with shorter times loses this effect. Time is critical , not speed.

Take the example of a patient who is getting nice long times.  Does increasing the speed, without decreasing the time, offer any benefit to the patient?

[Hemodoc]

When I asked my nurse, she just said that they would only benefit bigger patients who require more time on the machine,

You've indirectly hit on one of my concerns about switching to NxStage.  I'm 103kg EDW and concerned that lower clearances of NxStage will be really low given that I am on the large size (given how many patients I saw weighing at 70kg or so at the clinic).

I weigh about 90 kg and run 40 liters for 4 hours at a time. I am hoping to increase my volume. Volume and TIME on the machine are the biggest issues if you are considering switching to NxStage. If you can run nocturnal at 60 liters, doing the math of BFR of 250 for 8 hours, that is a BLP of 120 liters. with an FF of 50%, you will easily run the 60 liters at 125 ml/min, easily within the capabilities of the old System One and find that your clearances rival in-center and your phosphorus might need some supplementation which I believe is best done by diet means. Why take a pill when you could have a pizza for instance or a glass of chocolate milk. Think about it.

You sort of made my point about the low flow machine being adaquate for many patients. Even at the maximum of 60 liters per treatment, the low flow machine can handle it if you spend anough time on the machine (5 hours for 60 liters at 12 liters per hour). Time on machine is one of  the most important factor in dialysis . So the system can work .
Based on your size (90 kg) a generic patient like you would need 40 to 50 liters at 5 days per week. If you ran 50 liters at maximum 12 liters per hour, that would give a treatment time of slightly over 4 hours. 50 liters makes more sense as the sak holds 50 liters anyway. That would give you about 25% more dialysis volume. You could still use the low flow system .
I dont think NxStage is talking out of both sides of their mouths as much as dealing with reality. A lot of patients dont want to do more than 3 days per week of dialysis even though it is poor dialysis. So by offering this as an option they are opening up their system to more potential patients . Thats simply good business. They still stand by the option of more frequent dialysis as preferable.

If you look at the future of artificial renal replacement options, all that I have spoken to in person involved in these endeavors is looking at weekly Kt/V's of 7-8 which is manifold higher levels than the defined "adequacy" of 2.0 weekly Kt/V that is the standard of care today. For anyone that understands these issues, then the issue of what is the optimal NxStage volume comes into view quite easily.

Where NxStage will venture is completely up in the air right now with their statement announcing the System One upgrade to high flow which was FDA approved last April. As noted previously, this is their statement:

This latest regulatory milestone reflects strong and systematic execution against our product pipeline," said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. "With this new capability, NxStage therapy may be prescribed less frequently, for example 3 times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today.  We're strong believers in longer and more frequent dialysis for the clinical benefits; still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency."

How far NxStage takes the "at in-center frequency" is completely undefined at the moment. I know one very prominent nephrologist who will be addressing this issue in one of his 4 talks at the upcoming ADC next month.  This would be a step back for a company that has cut it's teeth on the high frequency daily market standing as an "advocate" for dialysis patients. As I stated, it is an undefined marketing strategy the remains for the future to see where they will really stand on this ESPECIALLY once they begin to open more and more free standing dialysis centers.  Will NxStage be the next Rubin dialysis, or will they be the next FMC or DaVita. It is for NxStage to define this themselves.

When looking at the Baxter machine already in use in Europe for home use, they provide in-center dialysate flow rates. In such, for myself, a 4 hour treatment at a blood flow rate of 350 ml/min would mean 525 ml/min dialysate using a factor of 1.5 for calculation. That would be 126 liters of dialysate for the Baxter VIVIA system. I believe that they are already directly targeting NxStage's low flow system by calling this new machine High Dose Dialysis. Bill Peckham dialyzed on the Aksys machine for I believe 2 years and states it is the best he has ever felt while on dialysis.

http://www.baxter.com/press_room/press_releases/2013/12_20_13_vivia.html

The advent of this machine obtaining the CE mark in Europe which is the counterpart of America's FDA is one reason why NxStage has responded with their "High Flow" NxStage System One upgrade. NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One Yet, NxStage still falls far short of the VIVIA in dialysate clearances. Baxter also achieves much higher Endotoxin clearance than the American AAMI guidelines for standard in-center machines here in the US.

So should the message be that 30, 40 liters, 50 liters or 60 liters is "optimal." Absolutely not. That remains a competitive disadvantage for NxStage. It will be interesting how this plays out but for myself, NxStage is not gaining my favor with low flow dialysis. The very first thing I did when I started NxStage was to double the dose of my bags from 20 liter to 40 liters at my insistence over the objections of my nephrologist and the entire medical team. I feel justified that NxStage is doing exactly the same thing 4 years later with their "new" High Flow capacity.

http://www.billpeckham.com/from_the_sharp_end_of_the/2010/02/taking-nxstage-system-one-to-the-max.html

It is is mistake in their design that all the researchers looking into the new generations of renal replacement therapy disdain. In fact, one such researcher well know for his device stated to me flatly, NxStage is a lousy machine. Why, due to the low dialysate flow rates. They are quite puny compared to all other home dialysis machines in development and some already in the market place in other places around the world. I believe NxStage will have to do better than 60 liters total volume and 300 ml/min to compete in the new world of dialysis machines soon to come, well if the FDA ever gets around to approving any of them that is.

[Hemodoc]

There is no advantage at all to others who are on lower volumes and need the speed at a slower rate to get enough time on machine.
Dr. Agar talks about the "waterfall effect" which in simple terms means more time on machine gets better clearance of the middle molecules. Going too fast with shorter times loses this effect. Time is critical , not speed.

Take the example of a patient who is getting nice long times.  Does increasing the speed, without decreasing the time, offer any benefit to the patient?

You must clarify which "speed" you are referring.  Blood flow rates should be kept to a minimum with Japan finding 250 ml/min ideal even in-center. Dialysate flow rates are optimal at a ratio of 1.5 to 2.0 x the BFR. NxStage cannot approach that ratio even in the "High Flow" upgrade. BTW, Dr. Agar is NOT a fan of NxStage at all due to their low dialysate volumes and flow rates and is not advocating this machine for his patients in Australia.

The main focus of Dr. Agar's talk on the "waterfall of dialysis" is not about dialysate flow rates, but instead about avoiding high ultrafiltration rates that leads to collapse of the cardiovascular system by greatly exceeding the plasma refill rates.

http://www.homedialysis.org/news-and-research/blog/27-dialysis-waterfall-forget-urea

So in short, the optimal dialysis prescription is low BFR, dialysate flow rates 1.5 to 2.0 x BFR and enough TIME on dialysis to keep UF rates near the physiologic extracellular refill rates back into the cardiovascular system. Dr. Agar is planning further articles on these issues at the HDC site in the near future and John has an excellent ability to communicate these complex physiology issues in very simple terms that even accomplished researchers can appreciate. Add in Ultra-pure dialysate with the lowest endotoxin levels practically possible and those are the chief components of a single dialysis session that matters the most.

[obsidianom]

That waterfall is not only rate-limited for fluid, it is rate limited for solutes, too, and different solutes move down that waterfall at different rates. Some zing down the gradients but others get stuck...like sticks on the rock face of a real waterfall...and take longer to be shaken loose.

THis is also part of the waterfall theory from John Agar. I beleive it is equally important, especially for patients that dont remove fluid during dialysis . Again it is time on machine , not speed to get to the middle molocules.
John talks about 3 compartments . The first is intra cellular, the second is extracellular, the third is blood.
Fluid and toxins(urea, middle molocules) all start in effect at the intracellular level where metabolisim occurs. Then via osmosis _diffusion etc. , they move across the cell membranes to the extra cellular space outside the cells but not in the blood. (interstitial). Then finally they diffuse into the blood. This all is rate limited and takes time.
Now as John talks about, we only can access the blood in dialysis . That is the furthest down the waterfall or third compartment. If we try to go too fast we clear out only the blood but dont get to the cellular level as that diffusuion takes TIME.  Going too fast, we reduce the blood water levels too fast . Faster than they can be replenished by the diffusion from the cells to the interstitial to the blood. This can lead to collapse of the circulatory system. So again time is important.
If we go too fast we reuce the toxins in only the blood but not the cells.

Peter talks about dialysate speed at 1.5 to 2 times blood speed as "ideal". How do we know that. ?  I would like to see studies proving this is true and not just accepted "fact" without soild proof scientifically. Is it possible that at those rates we are actually going too fast  for some patients ,if not all. ? Is it possible that by going this fast we are removing molocules faster than we can diffuse them across the three compartments and thereby clearing blood mainly but not getting to the cells that effectively UNLESS WE RUN VERY LONG HOURS LIKE NOCTURNAL thereby giving enough time to finally diffuse the three compartments.
The basis of NXStage is by slowing the dialysate we go slower with the dialysate but due to the increased contact with the blood get more saturation of the dialysate giving proper clearance of the blood. BUT could there be another benefit?
By going slower with the dialysate we are giving the natural diffusion across the compartments more time to work effectively? In effect we are not just clearing the blood fast but slowely clearing all 3 compartments at a more natural physiological speed that is GENTLER to the body and patient.
My point is many patients immediatly feel better clinically on NxStage then traditional dialysis. I know of quite a few just here in my area where that has ocurred. The reason may come down to a slower gentler more physiologically compatible dialyisis that works WITH the three compartments not faster than difussion can occur.
I have seen far too many patients on standard dialysis that feel sick after each treatment. It is too fast and harsh. It is  as simple as pulling from the blood too fast , before the diffusuion can occur across the compartments thus creating strong osmotic pulls that are way faster then the body is used to , and the sick feelings, cramps , nausea , headaches are all related to this.
My wife has NO water taken off ever yet even she felt awful on standard dialysis. It wasnt the water coming off too fast . I beleive it was the movement of ions and molocules TOO FAST across the 3 compartments . On Nxsatge she feels better each minute on dialysis and by the end is ready to exercise on the treadmill for 30 minutes. IT is the slow steady dialysis that allows this. It clearly is at a speed that the body can handle without stressing the natural physiology.
Now if you want to talk standard measuremets, however how crude , her URR runs around 60% so clearly we are doing the job compared with traditional faster dialysis.
I set her prescription up with a kt/v at 3.0 when I did the online calculater. That is higher then "required" by most clinics. She is getting good quality dialysis on 5 days of NxStage. In fact when I do any calculations on the online calculater on Nxstage I routinely use 3.0 as my kt/v. So far Nxstage has met that number with their prescription, so their theory is holding up. My wife is measuring out at over 3.0 when her blood work is done.  (in her case it is at 30 liters dialysate only, so we have a lot of room to grow if needed).
Nxstage with the higher speeds coming out will be available to larger patients now. 60 liters can be done as fast as  3 hours 20 minutes at new maximum speed, and easily 4 hours for more time. I dont intend to switch to it as we are doing fine at our current speed of dialysate of 9.7 to 10 for 3 plus hour treatments. Clinically she is doing fine which as a doctor is my most important criteria. I see nothing to gain with faster treatments.
Something I have learned in 25 years of medicine practice, more is not always better. Sometimes less is far better. Too many people think if a little helps, more is better. This is generally not true. Sometimes it is actually far worse.
I may be proved wrong, but I do have a good understanding of physiology and the body . I beleive that we may be trying to go too fast with dialysis .; Not the time alone but the speed we actually try to clear molocules and of course water. WE may be causing untold trauma to the various organs and systems causing a cascade of changes and events that eventually damage the body.  I know the Japanese run far slower then we do and perhaps their data will prove my point. but their dialysate speeds may be too fast.
I would like to see long term studies(over 10 years) when possible of NxStage and the slower dialysate principle. It may have been a marketing tool for them but THEY MAY HAVE INADVERTENTLY STUMBLED ON A CRITICAL IDEA THAT SLOWER DIALYSATE SPEEDS MAY IN FACT BE BENEFICIAL.  We will see. So far I have at least seen this clinically in a few patients. They simply feel better.