NxStage Solution One questions

Hello to all on the board and thanks for sharing your personal experiences and knowledge of dialysis. Your information has been very helpful in researching dialysis.

I have had ESRD since I was 3 (I am now 37). I was very fortunate to receive 2 kidney transplants and was able to avoid dialysis for many years (I did have six months in-center via Perma Cath prior to my second transplant.) The six months in-center were the worse six months in my life. I am glad to have the option of home dialysis and all the advantages it offers.

My second kidney transplant is failing due to the nasty BK virus. Because there is no approved treatment for the virus, I may be required to be on dialysis for the rest of my life. And because I want a long and healthy “rest of life”, I am researching like a madman to determine the best modality for me and my lifestyle.

I have narrowed my selections down to two; Fresenius 2008 and the NxStage Solution One Machines.

I like the Fresenius machine because of the longer dialysis times and flexibility. I also like that diet restrictions are lessened. I have two major problems (personally) with the unit. The first problem is that I am a mobile sleeper. I move around alot while sleeping and I just can’t wrap my mind around being tied down in one position during nocturnal dialysis with the access and the blood pressure cuff. I also do not want to bother my beautiful wife during my sessions. I enjoy being close to my wife in bed and want to be ready if the mood strikes!

The second problem is that the unit is not portable. I do alot of traveling. I travel with my business (full-time)and for pleasure. I understand that I will have to curtail my travel because of dialysis but I like the idea of a portable machine, like NxStage.

I am favoring the NxStage machine. I like the ease and portability of the NxStage unit over the Fresenius. I am prepared to dialyze 6 days a week (3.5 hours per) as per my Davita clinic in Philadelphia. However, I would greatly appreciate any feedback from patients that have been using the NxStage unit. This includes diet, energy levels, ease of use and travel, storage space requirements and any personal feelings versus other modalitites.

For Example, I am under the impression that diet restrictions are limited with noctural dialysis (Fresenius). I hope some users of the NxStage can share with me their diet restrictions with NxStage (especially compared to in-center 3x/week).

I thank you in advance for any feedback you have on your experiences using the NxStage machine. I welcome all feedback, good or bad. Thanks again to everyone who shares themselves on this board. I welcome any questions.

Thankfully,

Michael

Gus,

Thanks for the quick response to my questions. Your posts have been quite helpful in my research. I also like your web page. I hope to participate in this message board and your site when I start dialysis.

I am still leaning toward the NxStage. I will let all know of my decision and my experiences including training.

I wish you continued success and good health. Your success gives me hope about my future with home dialysis.

Take Care,

Michael

I’m pre-dialysis and am hoping that NxStage training will become available within a reasonable daily commuting distance (by car) from my home when my Neph says I’m ready. I am at ground zero education-wise regarding hemo besides what I’ve read on this great Message Board and Home Dialysis Central and Kidneyschool.com (and thanks to Dori and Beth for all three!). I’ve also been reading the Dialysis_Support Forum for about a year. I’ve had a fistula for almost a year which a Fistulagram recently determined needs repair. I see my vascular surgeon tomorrow. He has the Fistulagram report and I’m bringing the film.

ASSUMING by the time I’m ready to begin NxStage training I have a mature working fistula (or a graft if this fistula can’t be repaired and there’s no better place to try for a new fistula), can anyone give me a rough estimate of how long NxStage training (with self-cannulation) will take, in terms of 8-hour days?

I realize this is dependent on learning speed. I’m not a “straight A” student but I am a solid B. I’m 61 years young, retired with no obligations nor stress, as alert as I’ve ever been, and in good health except for the ESRD. I’m not Diabetic and thank goodness have never had any physical symptoms in the seven years since I was diagnosed ESRD (at 30%) nor at 15% where I’ve been hovering for the past 14 months. My next lab evaluation is 8/29. I still drink lots of water and I urinate every 1-2 hours (including through the night).

Thanks again to Pierre, Cathy, and Gus for educating me on nocturnal home hemo. Thanks to you I’ve learned that 6X daily is the best solution for me. Obviously if NxStage training isn’t available in my area I’ll be in-center hemo 3X per week. Cathy mentioned physical size. I’m 5’8" and 200 lbs (CONSTANTLY trying to lose- ideal for me would be 180 which I haven’t seen in years). Do you think 200 presents a problem for being a candidate for NxStage?

I wish you well.

Mel

umm…really? I can appreciate this could be a touchy (pun intended) subject but are you saying that dialysis is not impacting normal marital relations?

[quote=“Bill_Peckham”]

umm…really? I can appreciate this could be a touchy (pun intended) subject but are you saying that dialysis is not impacting normal marital relations?[/quote]

Subject to some common sense constraints – yes!

Hi y’all,

Michael and Mel, welcome to Home Dialysis Central! I’ve enjoyed your posts.

For anyone who is wondering about how dialysis affects sexuality and/or fertility in women and men, please check out our on-line Kidney School http://www.homedialysis.org, which has an entire module on that topic (#11). You can go through it “live,” (it’s interactive) or download the pdf to read.

Of course, we mostly had PD and in-center hemo in mind when we wrote that module, while daily–and probably to a greater extent, nocturnal–home hemo patients would be much more like transplant patients in terms of the ability to function and remain fertile. I’ve read that patients on nocturnal home hemo have reported improvements in sexual function, which really isn’t surprising, given that they are getting so much more dialysis.

If you haven’t read this week’s “Innovative Paper” on “unphysiology” (you can find it at: http://www.homedialysis.org/v1/research/articles/20050617.shtml, please do–the issues of keeping body chemistries constant through longer and/or more frequent treatment affect sexuality along with heart function, nerve function, and many other bodily systems.

p.s. - if anyone could explain to me how to code text as a URL, I’d be endlessly grateful!

I’ve found that even short daily greatly helped restore sexual function. I don’t know what it is that does it exactly, but for me, the difference between 3/week hemo and daily hemo has been nothing short of remarkable.
Pierre

having done both my preference would be the NxStage and Phoslo with meals. 6X a week NxStage treatments kept the potassium under control but the phosphorous was not completely controlled. taking a pill with meals was the tradeoff and it was worth it for me.
of course I had a Fresenius experimental model which gave me a lot of trouble and because my veins weren’t great I had alarms every time I moved. didn’t make for great zzzzzz’s. also I had to mix the bicarb by hand which was a major hassle. I did not have the strength I used to and mixing a 30 lb. bottle was not easy.
also it used loads of water and electricity. the NxStage doesn’t use water, it uses a packaged solution.
preparation of both systems will convince you of the preferability of the NxStage which has a prime time of roughly 20 minutes. nocturnal took well over an hour if you threw in the bicarb mixing.
lots of luck with whatever you choose, that is if you need it. maybe you can hang onto the kidney you have.

I would like to take this opportunity to thank everyone who responded to my question. Your input along with additional info has been quite helpful in my decision process.

I have chosen to use the NxStage system, mostly due to portability and ease of set-up and use. I also feel good that I can change my decision if the NxStage unit does not meet my dialysis goals.

I am currently in the hospital, just having had an upper arm AV fistula placed in my left arm. Based on my recent blood work results, I may also need a perma cath placed in my chest before my fistula matures.

The entire process has been difficult but many of you have made my decision easier and your stories and experiences have been encouraging. I thank you all. I will update you on my experience with the NxStage training.

Best of health to all.

Michael

I have been following this thread with interest for the past couple of months and based primarily on Debby’s comments, I now feel compelled to contribute regarding the comparison of the Aksys PHD system to the NxStage System One. I am a Certified Nephrology Nurse with more years of experience in the business of dialysis than I care to admit. I have worked for several different dialysis companies including Aksys for a short time but that was a while ago. First I’d like to tackle the subject of backflushes which Debby reports had an adverse effect on her.

To preface this discussion, the participants on this thread should understand that the NxStage product was not originally designed for daily hemodialysis. Rather, it was designed (and originally launched) first for continuous hemofiltration of acute renal failure patients in the ICU and later for daily home hemofiltration for chronic kidney failure patients. Hemodialysis and hemofiltration are very different. With hemodialysis, the nitrogen-containing waste products in the blood are removed primarily by diffusion, a process by which mostly small molecules “vibrate” their way through the dialyzer membrane from the side of high concentration (blood) to the side of low concentration (dialysate). With this process, the larger the molecule, the less likely it is to find its way through the membrane and less of it is removed. Consequently, pure hemodialysis has fairly poor removal of middle and large toxins. One of these is beta 2 microglobulin which is the culprit behind carpal tunnel syndrome (amyloidosis).

With hemofiltration, on the other hand, the toxins are “dragged” through the membrane with the water that is squeezed out of the blood under pressure. In this process, there is no diffusion because there is no dialysate being pumped through the dialyzer. Consequently, there is poorer removal of small molecule toxins such as urea and creatinine. In order to get adequate dialysis with hemofiltration, a large volume of water has to be removed from the blood in each session; much more than could be physiologically tolerated. Therefore, injectable quality replacement solution has to be continuously infused directly into the blood stream to keep the patient’s blood volume at normal levels.

In order to establish what volume of replacement solution would translate into adequate therapy on a daily basis, NxStage commissioned a theoretical analysis publication by some well known research nephrologists which concluded that 18 liters of replacement solution would be required for an average-sized person. They reasoned that this amount of hemofiltration on a six day per week schedule would provide about the same small molecule removal as three-day-per-week hemodialysis but better middle and large molecule removal. They also stated that daily hemofiltration would result in far less small molecule removal compared to daily hemodialysis and still less middle and large molecule removal compared to nocturnal hemodialysis. They also stated that accomplishing this amount of water removal in a short (2.5 – 3 hour) session would necessitate a blood flow rate of 500 ml/minute. The premise of NxStage’s marketing of daily hemofiltration was that the larger molecules were of greater clinical importance than the smaller ones and that having this component of large molecule removal more than made up for any shortfall in small molecule removal.

Performing this kind of treatment means that 100 ml/minute of replacement solution from bags would be required to be infused into a patient’s bloodstream continuously over a three hour treatment. That’s 1500 ml every 15 minutes which makes the PHD’s backflushes of 200 ml every 15 minutes look quite small in comparison. I guess Debbie should be glad that NxStage’s plans to commercialize daily hemofiltration were derailed when the FDA required their product to be recalled about six weeks after initiation of their clinical trial. If her cardiovascular system gets worn out with 200 ml every 15 minutes, she would have had great difficulty with daily hemofiltration.

She won’t have to worry about that, however. Although they had contacted every company that produces sterile solutions in flexible containers, NxStage was never able to convince one of them to make hemofiltration replacement solution for them. Since they had already committed lots of money to developing their hardware, they had to resort to hiring local pharmacists make up the replacement solution from where it was sent to the home patients participating in the clinical trial. It did not take long for serious bloodstream infections to occur since it is nearly impossible for a pharmacist to produce that volume of solution and assure complete sterility. This lead to the recall.

In order to salvage the company, NxStage hatched a strategy to market their device for daily hemodialysis instead of daily hemofiltration. Hemodialysis requires no sterile replacement solution and the dialysate doesn’t even need to be sterile. The problem with that strategy is that you need a lot more than 15-18 liters of hemodialysate in order to achieve even the minimum standards for adequate dialysis. By comparison, the PHD provides 53 liters of dialysate every day and can achieve a weekly standard Kt/V of 2.1 on patients weighing up to 275 pounds in three hours six days per week. The NxStage System One on the other hand can not achieve this same target with the same regimen using 15 liters of dialysate per day on anybody weighing more than 132 pounds. If you elevate the amount of dialysate to 20 liters per day, then the upper weight limit becomes 165 pounds.

I don’t know how much Debbie weighs, but if a 155 pound man were to convert from a PHD to a NxStage System One, and his daily intake of protein of 1.1grams/Kg body weight did not change, his average weekly BUN would rise from 44 milligrams per 100ml to 66 milligrams per 100 ml or 50% higher.

What is more likely to happen is the same thing that happened in the late 70’s with a modality called Intermittent Peritoneal Dialysis. This modality provided insufficient dialysis meaning insufficient removal of nitrogen from the blood. When the physicians examined these patients’ BUN (blood urea nitrogen) levels every month, the values seemed in a reasonable range. What was actually occurring, however, was not that the dialysis was adequate, rather the patients subconsciously self-regulated their BUN by reducing the amount of protein they were eating. In other words, the excess nitrogen in the blood signaled the brain to reduce the patients’ appetite for protein. The result was an alarmingly high mortality rate in these patients due to malnutrition.

Computer models tell us that if that same 155 pound patient switched from PHD to NxStage but his BUN stayed the same, his daily protein intake would have to fall by 40%. Since chronic malnutrition is one of the strongest predictors of mortality in kidney failure patients, this is an issue to be taken very seriously.

Of course, under-dialysis and malnutrition can be avoided by simply increasing the volume of dialysate that is consumed on a daily basis. This however, presents a different problem to NxStage and their patients. NxStage acquires their dialysate from Germany and due to the fact that water is very heavy and shipping costs are based on weight, their shipping costs are such that they have no possibility of making a profit even when only 15 liters per day is used. I know this from some previous experiences at yet a couple of other dialysis companies in the peritoneal dialysis business. For those companies, shipping costs were by far and away the major cost component of providing peritoneal dialysis supplies and they were only shipping 8 liters per day per patient. Not only is NxStage shipping more than twice that amount, they also have a dialyzer and a blood tubing cassette plus ancillaries to include.

So, to MMiller who admonished us to be concerned about Aksys’ financial health, I suggest that the bigger concern by far is for NxStage. Last time I looked, Aksys still had something like $30 million in the bank and is already a public company making raising more money easier. Acquaintances of mine who have left NxStage (which is financed privately) assure me that their nest egg compared to their burn rate leaves them in no better condition.

So how, you ask, does NxStage propose to stay in business? Why make the dialysate in the patients’ homes of course just like all the other home hemodialysis machines do. They have already applied for and received clearance from the FDA for their “Dialysate Preparation Module”. Here is the link to the actual application and response from the FDA: http://www.fda.gov/cdrh/pdf4/K043436.pdf

This device will require the same things as all of the rest of the dialysis machines do, e.g.:
 Plumbing and electrical modifications to the home
 Water pre-treatment filters and carbon canisters
 A reverse osmosis membrane
 Dialysate concentrates
 Pumps, valves, heaters, sensors, etc.
 A separate cleaning and disinfection regimen.
Dialysate made by this machine will then be fed up to the dialyzer on the current System One module.

Because using this dialysate prep module is the only way they can be profitable, it is likely that they will price the bags in such a way as to make their routine daily home use too expensive for the clinics to earn a profit on your treatment. This, in turn, will likely force the clinics to insist that the NxStage patients use the dialysate prep module in their homes and only use bags when they are traveling and even then, the clinics may require the patients to pay for the extra cost.

From the patients’ standpoint, the use of 25-30 liters of dialysate per day in bags has much different concerns. These solutions are stored in polyvinylchloride (PVC) bags. In order to make these bags flexible, the use of platicizers is required and the most common one is called DEHP. This is broken down into MEHP by the body which is more toxic than DEHP. There are also other chemicals used in the manufacturing process. To my knowledge, daily use of this much dialysate in PVC bags every week for the rest of one’s life is unprecedented and the consequences of infusing this much DEHP would bother me. That may be why we are hearing reports of patients having a funny taste in their mouths after dialyzing on this system.

However, the biggest long-term problem that all patients face in doing daily hemodialysis is chronic inflammation. Over the past 10-15 years more and more clinical evidence is being presented in the nephrology journals that this may be the biggest problem to be managed in all dialysis patients because chronic inflammation in turn leads to the two biggest contributors of mortality in this patient population; hardening of the arteries (atherosclerosis) and malnutrition. Furthermore, chronic inflammation also is likely the primary culprit causing amyloidosis which is like having carpal tunnel syndrome in most of your joints and is a disease that shows up slowly after 8-12 years on dialysis. You all may find the most recent issue of Newsweek very interesting in this regard since it has a major story on how inflammation is now being discovered to be a major cause or contributor to many of our most common health care problems. Here is a link to the article: http://www.msnbc.msn.com/id/8271053/site/newsweek/

Chronic inflammation in dialysis patients results from three things: being more uremic than less (i.e. being inadequately dialyzed), having your blood exposed to the foreign surfaces of the blood tubing and dialyzer, and having your blood exposed to dialysate that contains endotoxin, a byproduct of dead bacteria (which it is allowed to contain according to the American National Standard for dialysate purity).

The bottom line is, the higher your state of chronic inflammation, the sooner you will get amyloidosis, the less you will eat, the more muscle wasting you will experience and the sooner calcium deposits in your arteries will lead to a heart attack.

So, how do you lower your state of inflammation? First, use the highest purity of dialysate. The dialysate normally used in dialysis clinics is pretty “dirty” and has been shown to be a significant contributor to inflammation. However, it can be made “ultrapure” by passing it through a final filter called an ultrafilter just before it enters the dialyzer. Most clinics don’t do this because it adds extra cost to each treatment. However, they might consider it for a home patient since there are not many such patients and the cumulative costs would be more tolerable. The Aksys PHD actually makes dialysate that is twice as pure as ultrapure. It falls into a different category called “injectable quality” which means that it can be infused directly into your blood. It is the only machine in the U.S. that has been cleared by the FDA to do so. This is why the PHD can automatically prime the blood circuit, give you fluid during a treatment without using a bag of saline, and rinse your blood back while you just sit and watch. This also means that it is also the least likely to stimulate inflammation.

The second key to reducing your level of inflammation is not to expose your blood to the foreign surfaces of the blood tubing sets and the dialyzer membrane. This may sound impossible and still dialyze but actually it is not. During the first several minutes of dialysis when your blood is flowing through a brand new dialyzer and tubing sets, there is an immediate and strong inflammatory and immune system response in your body. After about 20 minutes, this reaction subsides for two reasons. One is that your body starts to send out down-regulating molecular signals that subdue the acute inflammatory response but the other is that your blood leaves behind a coating on these surfaces of its own protein/fat/carbohydrates that insulates it from further inflammatory stimulating effects.

When a new dialyzer and tubing set is used with each dialysis, the inflammatory cascade is triggered all over again. Doubling treatment frequency from three to six per week would obviously then result in doubling the inflammatory insult that daily hemodialysis patients suffer; unless you use the same blood circuit over and over and disinfect it in such a way that the protective coating is preserved. This is exactly what the Aksys PHD system does. It uses only hot water for disinfection and avoids the use of any chemicals such as bleach or peracetic acid which strip away this protective coating. Preserving this coating, along with the injectable quality dialysate, result in this machine providing the world’s most biocompatible dialysis. The ramification is that the machine is much more complex than most resulting in more service calls, and it is obviously not portable, but patients who use it for the rest of their lives can count on living longer with better nutrition, less atherosclerosis, and amyloidosis. It comes down to a trade off between short term convenience and the possibility of traveling with a device, versus long term health consequences.

This brings me full circle back to the topic of backflushes. Since Aksys wanted to preserve this protective coating, they also had to ensure that the coating did not clog the dialyzer’s membrane and reduce its ability to transport the toxic molecules out of the blood. The primary reason for the backflushes, therefore, is to keep the dialyzer operating at near its original state. By backflushing the membrane, the pores in the membrane are periodically cleaned out but the coating on the inner surface of the membrane is left intact; pretty clever. In practice, it appears to work very well since the urea clearance for most patients stays near normal throughout a full month’s worth of uses. The side benefit is that diluting the blood periodically has long been used as a method of minimizing the need for heparin.

I am surprised that it never occurred to Debby that she could completely turn off the backflushes. I wouldn’t, however, advise doing this unless your physician really thinks it’s causing a clinical problem. Not only will your dialyzer clearance suffer, but you won’t be taking advantage of the fact that every backflush is actually an instance of push-pull hemodiafiltration which will contribute to the removal of middle and large molecules such as beta 2 microglobulin. In fact, maximizing the backflushes, especially over an eight hour nocturnal procedure, would result in very significant middle/large molecule removal; about 50% more than NxStage would have achieved had they been able to market the daily hemofiltration modality but without giving up the small molecule removal since hemodialysis will be occurring simultaneously. I wouldn’t be surprised if Aksys doesn’t eventually begin seriously pushing this modality since they would be able to tout all of the advantages of middle molecule removal that NxStage originally based their sales pitch on. It doesn’t appear that NxStage will ever be able to get back to the hemofiltration technique since, even with their dialysate prep module, they will not be able to infuse the solution in a patient’s blood.

Of course there is a major additional benefit to automatically reusing the whole blood circuit for a month; the patients don’t have to tear down and replace the entire blood circuit with each and every treatment. Not only does that save them significant time and effort but it reduces the amount of supplies that they need to store in their homes and also significantly reduces the amount of garbage that is generated every week.

I understand that each individual is motivated by different things but as a nurse, I am often dismayed and frustrated by decisions made by patients that are motivated by short term convenience when I know that there will be long term negative clinical consequences. That is why I felt compelled to share what I have learned about the respective consequences of each of these systems since I didn’t see anyone else discussing them.

It looks from your most recent message that this may be a little late but I hope you will give it some consideration. I sincerely hope this helps.

Acquaintances of mine who have left NxStage (which is financed privately) assure me that their nest egg compared to their burn rate leaves them in no better condition.

Sounds more like disgruntled employees trying to cause some revenge… :twisted:

I think “Nephnurse’s” post is a very interesting one. It does seem more polished than the average message board post, as if a public relations or communications department might have worked it over with great care. I read it with great interest, and I preface this by stating I don’t use either NxStage or Aksys for my daily home hemodialysis, but this and many of the previous posts about the advantages or failings of both NxStage and Aksys leads me to suspect these companies are waging a clever marketing war via this board.

My dialysis unit rejected both, and I’m sticking with the tried and true. At least, there is more than a decade of experience with daily nocturnal hemodialysis using conventional dialysis machines. It’s a huge myth that these machines are too complicated. In some ways, they are actually simpler and easier for the patient to troubleshoot if there’s a problem, because how they work is very easy to understand. Contrary to what is often stated here, it does not take long to install the tubing on the front of these machines. That just takes a few minutes (maybe 5 minutes, at most) once you have a bit of experience under your belt. What makes up that hour of pre-prep is the water test prior to even turning on the machine, priming, alarm test and recirculation. The machine does these things on its own, and the role of the operator is simply to close or open one or two appropriate clamps, and press the button. It’s not really wasted time, because while these things are going on, the patient has time to prepare the needle tray and tapes, do his or her pre-treatment evaluation, wash hands and arm, prepare food and/or drink for during the treatment, etc. This is something that all home hemo patients have to do, no matter what the machine is, and then there’s the 10 minutes or so it takes to fiddle with buttonhole needle insertion and taping. So, a good 30 minutes at least of the preparation time is concurrent with other things that home hemo patients do anyway with any machine, and, there’s no price to pay in terms of technical limitations the machine must have in order to “simplify” things for the patient.

I don’t have an axe to grind for or pro any specific company. As I’ve said before, I just want good dialysis, and I also want to fully understand the process and everything the machine is doing. Having been trained to use a conventional dialysis machine, and having gained experience doing so, I can walk into any dialysis centre on the continent and feel confident that I can understand the process, no matter what make of machine they use. If I move and have to use a different machine, it would only take a day, maybe two to familiarize myself with it before being able to use it on my own.

Pierre

Hmm, interesting indeed…

Though it is a fact that in-center has its quirks as well, like the non-unltrapure dialysate and chemical cancer causing environment…and worst of all some poorly trained techs, now that’s VERY DANGEROUS!! :roll:

For the most part, both Aksys and NxStage are on a mission and I think along the way they will both learn new things and improve their own. There’s just too many patients to share among…we really need more home machines and with the new Alient Sorbent coming in then true competition is just begining to start…

Yes indeed, the old “new” sorbent system will add some competition once it’s available. Funny how old things become new again :slight_smile:
Pierre

It’s quite exciting to see this happening and also I assure you there will be more critics coming in against the Sorbent with myths and opinions of all kinds…

However, my advice to any home dialysis machine designer is to think SMALL

NxStage is the first to achieve that goal in designing their machine to be small and I hope they keep that strategy of keeping it small or making it smaller and any other additions and improvements should not make the patient work harder just to have therapy.

Aksys has a fantastic machine but it falls short in some areas that need addressing. Importantly the problem of breaking down often, 2nd portability. If they can redesign their machine to be smaller and more portable then it can be a very nice choice there.

I know both companies are striving to offer the best and they will encounter themselves with difficult challenges and once they achieve their goal to their fullest, home dialysis will never be the same and the quality of the treatment at home will be many more times higher than in-center…

It’s hard to argue with smaller and portable if the treatment is the same, no doubt about it.
Pierre