Nocturnal- optimal dialysis

Can someone give me a concise overview of the latest developments in nocturnal txs?

What sort of developments are you thinking of, Jane?

I know that I can not call it nocturnal…in my clinic… we have to call it extended…

Hi Kathy,
At least they’re doing it, whatever they call it this week. :slight_smile: The problem is that NxStage submitted its machine for review by the FDA to get an “indication” for nocturnal hemo. If (hopefully when) they get it, they can market the machine for nocturnal. FDA approval is NOT for safety–nocturnal HD has been done safely since the 1960s. It’s for marketing. The machine IS FDA-approved–just not yet for nocturnal. (The FDA does not generally approve treatments–just machines and medicines).

The problem is, since the machine is now in review, lawyers have gotten involved from the dialysis providers. The lawyers worry that if someone has a problem at home with nocturnal and the machine is not yet “FDA-approved” for nocturnal, the company will be sued. So, some clinics don’t allow it, some don’t even tell people about it, or some do offer it but they call it “extended” instead of nocturnal. :wink:

With luck that approval will come through VERY soon and everything will shake loose for nocturnal.

Interested in hearing any developments at all. What is the word at professional and patient seminars? Are U.S. nephrologists embracing the concept that nocturnal txs are safe and superior or are only a minority of lone voices speaking out on it’s merits and the necessity of turning things around as far as how dialysis is done in this country? What does CMS, the corps and other providers think of the impact NxStage has made with more and more patients being given the opportunity to do nocturnal txs at home thus regaining their lives? Any efforts to educate patients that nocturnal is the best choice for most? Any efforts to educate the professionals that many, if not most patients, are fully capable of doing txs at home, and if not, professionals are doing patients a great disservice by promoting learned helplessness (I still speak with patients in my own unit who have never heard of nocturnal)? Any news on nocturnal as far as the tx. itself, what units offer it, equipment choices, how to better carry out txs, methodology and accessory improvements?

I absolutely agree that much improvement is needed in all areas of education and promotion of home dialysis - both daily and nocturnal. One thing I will never quite understand is when people ‘never hear about it’. Today, there is little reason, with the availabiltiy of information via the internet, that people remain unaware of their options. People go to the internet every day for directions from point A to point B, instructions on how to build things, repairs things, find things, research things, buy things, sell things etc. etc. All they have to do is search for a major event affecting their lives (dialysis) and they inevitably will see somewhere the words home dialysis.

Today people should be taking more responsibility for their lives. It’s easier than ever to become educated, if you want, on practically anything. I wonder if those incapable of doing so would be candidates for home dialysis in the first place. But again, yes, I totally agree on the need to educate others via different avenues as well.

Wendy, you are so right that the education is available, but unfortunately so few take advantage of the sources freely given. I fully agree that dialysis patients should take more responsibility for their own care if they are capable of doing that. Many are not able to unfortunately because of other conditions besides renal failure.

I had hoped that the FHN study released in November would spur discussion and acceptance, but I have seen little to date to indicate that nephrologists are changing their practice patterns.

Until CMS, Congress, the dialysis industry or organized nephrology embraces the concepts of optimal dialysis, we will have a headlong fight to implement what is so blatantly right. It will take one of the major players to advance the cause for all. I have yet to see who that shall be.

I do understand that even when/if a patient is aware of and wants home dialysis, that unless they have a certain personality to push for what they want, they won’t in the face of a nephrologist or diaysis unit who is uneducated themselves on the benefits of home dialysis. I see a need for home dialysis advocates to speak to centers and nephrologists on their behalf. How are health insurance companies? Does anyone know if some or most are in agreement to cover home dialysis without a fight?

I also think another impact would be if more patients left their centers or nephrologists who do not support home dialysis. The only way I got “extended” home dialysis is because I was truly going to transfer out to a center that offered it. I am still on private insurance and I know the only reason they granted such a huge exception for me was a purely financial reason. Even if people aren’t on private insurance, I think whenever it’s feasible, leaving a non-supportive center or nephrologist is important. It’s a statement that says clearly “Your standard of care is not acceptable”. If enough people do that, it will be noticed.

Jane, all of the things you’ve mentioned are things we’ve been doing for years and continue to do–including reaching out to dialyzors and professionals about better treatments, and keeping a database of clinics that train people for them. I think the FHN studies definitely had an impact for more frequent treatments. The nocturnal branch of the study wasn’t significant (oddly, once folks were convinced that nocturnal was worth striving for, they were unwilling to be randomized to poor treatment, so they couldn’t recruit a large enough sample!).

Peter thinks MDs haven’t yet changed their practice, but switching folks from one type of treatment to another isn’t as easy as prescribing one drug instead of another one. There are system factors that have to line up to make it easier for docs to prescribe home therapies. They DO believe in them, though, as evidenced by the huge proportions who would choose a home treatment for themselves if their kidneys failed and they had to wait for a transplant.

So, IMHO, part of the problem is lack of MD faith in dialyzors–the more dialyzors who prove them wrong, the more they’ll believe. Training capacity is another potential barrier that we’ll be looking at soon.

Wendy, I believe most insurance companies do cover home dialysis without a fight–to the extent that they cover ANY treatment without a fight. It’s been a while since we’ve had to step in with an insurance company, anyway.

[QUOTE=Dori Schatell;20611]Jane, all of the things you’ve mentioned are things we’ve been doing for years and continue to do–including reaching out to dialyzors and professionals about better treatments, and keeping a database of clinics that train people for them. I think the FHN studies definitely had an impact for more frequent treatments. The nocturnal branch of the study wasn’t significant (oddly, once folks were convinced that nocturnal was worth striving for, they were unwilling to be randomized to poor treatment, so they couldn’t recruit a large enough sample!).

Peter thinks MDs haven’t yet changed their practice, but switching folks from one type of treatment to another isn’t as easy as prescribing one drug instead of another one. There are system factors that have to line up to make it easier for docs to prescribe home therapies. They DO believe in them, though, as evidenced by the huge proportions who would choose a home treatment for themselves if their kidneys failed and they had to wait for a transplant.

So, IMHO, part of the problem is lack of MD faith in dialyzors–the more dialyzors who prove them wrong, the more they’ll believe. Training capacity is another potential barrier that we’ll be looking at soon.

Wendy, I believe most insurance companies do cover home dialysis without a fight–to the extent that they cover ANY treatment without a fight. It’s been a while since we’ve had to step in with an insurance company, anyway.[/QUOTE]

Dori, my disappointment is not that we have made the switch, but I have yet to see an attitude change among the many nephrologists I know personally, nor have I seen the calls to implement immediately the findings of the FHN. Yes, it is not as easy as changing medications, yet where is the movement to date except among the choir that has preached optimal dialysis for decades?

All I see at present is a movement towards PD, not Home Hemo as evidenced in several articles the last month. PD is a great option for many, but it has its drawbacks and in many patients it is a self limited treatment option. Those that do best with PD still have significant residual renal function. For many, PD is the better option especially if there are issues of vascular access. Home, nocturnal Hemodialysis is the only modality with reliable data showing equal survival as cadaveric transplant. I would hope that the ethical boundaries in the nephrology profession would work quickly toward changing the standard of care for dialysis to the best survival option, not the worst. I just don’t see that movement yet.

Wow. You probably have already seen this post that I’m including here below. How very horrible. How do insurance companies get away with this still today? I remember before I went to home dialysis, Boeing Blue Cross said they would deny it as well. The wording was really strange for the description of home dialysis. Ultimately, it was covered without a fight. Mark, however has been flat out denied.

This thread is located at:
http://forums.homedialysis.org/showthread.php/2025-Insurance-Co.-Will-Not-Support-Home-Hemo?goto=newpost

Here is the message that has just been posted:


For several years, I have suffered from Kidney Disease. In July of 2006, I was placed on in-center hemodialysis. This treatment was a mixed blessing. On the positive side, my overall health greatly improved. On the minus side, I suffered numerous infections - including a bout with osteomyelitis of the spine that almost claimed my life and left me disabled. Additionally, the 3 time per week, in-center dialysis would frequently leave me feeling tired and wrung out. This caused difficulty on my job and added stress to my family.
In December of 2009, my wife and I attended training and became certified to perform home hemodialysis. This 5 time per week schedule allowed for more gentle cleansing of my blood and greatly reduced the side-effects I’d felt in-center. My employer was delighted as dialysis no longer controlled my schedule and I could even work during dialysis. Also, since the machine is portable, we took the first long vacation in years last summer, camping in the Olympic Peninsula in our travel-trailer.

In January of 2911, various concerns prompted me to change my employer-provided health insurance to Group Health. The Dialysis support staff at DaVita warned me that Group Health did not cover this treatment. However, that seemed contrary to the Group Health reputation as an innovator in the medical care field. Additionally, I was in great need of the managed care for my diabetes that Group Health could provide.

On January 23’rd, I received notice that my request for Group Health coverage of my frequent home hemodialysis was denied and that I would have to switch back to 3 day per week in-center dialysis.
I have appealed this decision, but doctors at Group Health have told me that it will not be overturned.

I find this unreasonable, unfair, and outrageous for the following reasons:

  1. This decision is made by a review board that does not have a Kidney specialist as a member
  2. Their decision is based on antiquated research( please see instead http://www.nature.com/ki/journal/v62/n6/full/4493344a.html, http://www.davita.com/home/physicians/research/1657 )
  3. I will not be able to keep my job if I have to transition to in-center dialysis. My responsibilities include conducting many teleconferences during business hours. This is simply not possible from a dialysis center.
  4. While on in-center dialysis, I was hospitalized 6 times over the space of less than 18 months for a total of more than 25 days. In the year since transitioning to home hemodialysis, I have been hospitalized a total of 4 days - quite an improvement
    Group Health does cover daily peritoneal dialysis but I am not a good candidate for that. Nor am I a good candidate for kidney transplant at this time - hemodialysis is my only option.
    If I am denied frequent home hemodialysis I firmly believe that my quality of life will be severely degraded, I will lose my job and perhaps my life

Mark R. Pennington
mrmarkus41@yahoo.com

I think there are a few important reasons why you’re not seeing a wholesale move toward nocturnal HD, Peter:
1). The FHN study was wildly positive for short daily HD, but, while the nocturnal results were in the right direction, they were not statistically significant due to the small sample size. So, that gives MDs an excuse to still say, “it hasn’t been proven yet.”
2). Many nephrologists are not fully prepared to deal with any type of dialysis–even standard in-center HD! It’s not emphasized in many nephrology programs, due to a historical prejudice against hands-on clinical care vs. elevated research. So, if they’ve been relying on the in-center system and nurses to really care for these folks, they don’t know HOW to proceed. (Who do you think is doing all that PD? Nurses!)
3). Admitting that more dialysis is better means acknowledging that they were delivering inferior care for a good part of their careers. That’s a tough nut to swallow–and the reason I believe that the actions of the Harvard group that has come out so strongly are truly courageous.

Here are two brand new abstracts from the Harvard group. Note the authors. This is HUGE!:

Clin J Am Soc Nephrol. 2010 Dec 9. [Epub ahead of print]
Dialysis at a Crossroads: 50 Years Later.
Parker T 3rd, Hakim R, Nissenson AR, Steinman T, Glassock RJ.

Abstract
The ability to offer repetitive hemodialysis for treatment of chronic kidney failure has now reached its half-century anniversary. Although millions of patients have benefited from this life-extending procedure, current results in the United States have now stagnated with only small annual improvements in survival and continued high hospitalization rates. Recognition that this stagnation may be, at least in part, the result of inadequacies of current and prior paths utilized in dialysis treatment has led to the concept that dialysis therapy is at a crossroads and that new paths need to be articulated, explored, and applied. This article proposes some of these new paths and their rationale. Two elements of the new paths are emphasized: avoidance of indwelling catheters for vascular access and meticulous attention to control of extracellular volume and mitigation of left ventricular hypertrophy and fibrosis. It is postulated that progress in these two areas, along with continued attention to other elements embodied in the new and old paths, will unlock the stagnation in outcomes of dialysis therapy of end-stage kidney failure and allow it to realize its full potential of prolonging life and alleviating disability.


Curr Opin Nephrol Hypertens. 2010 Dec 21. [Epub ahead of print]
Dialysis time: does it matter? A reappraisal of existing literature.
Lacson E Jr, Lazarus M.
Fresenius Medical Care North America, Waltham, Massachusetts, USA.
Abstract
PURPOSE OF REVIEW: The length of time (Td) required for adequate maintenance hemodialysis therapy is perceived as a substantial patient burden. Technological advancements have allowed shortening Td over the past three decades. However, failure to detect improved outcomes with higher dialysis dose has prompted renewed interest in the potential impact of longer Td.
RECENT FINDINGS: Ongoing trials are focused on increasing the frequency of treatments, although the feasibility of having most patients agreeing to more than five treatments per week remain doubtful. Furthermore, survival was better in short daily hemodialysis with Td of 180 vs. 90 min. Within thrice weekly dialysis, several recent epidemiological studies have shown improved survival associated with Td more than 4 h. Improved outcomes for long in-center nocturnal hemodialysis (6-8 h, 3×/week), similar to what has been performed in Tassin for the last 30 years, have also been reported.
SUMMARY: Compelling rationale and recent outcome data support use of longer Td. Improved management of salt and water may be the cause for the dissociation of dialysis time and small molecule clearance. In most industrialized countries, hemodialysis care systems in place have the capacity to accommodate it. Until such time that results from prospective randomized trials are available, we believe that physicians should prescribe and exert all efforts to convince thrice weekly hemodialysis patients to accept 4 h as minimum Td.


The Medical Director of Fresenius is calling for no treatments 3x/week to be shorter than 4 hours?! Now if only CMS would follow suit, we might start to get somewhere…