Dialysis from the sharp end of the needle

Finish line crossed

By Bill Peckham

I made it to the health insurance finish line, but not until the finish line had moved. After consulting with the Carpenter's Trust of Western Washington I came to understand that there is a whole new system for qualifying for healthcare benefits, which will be an advantage going forward, and now getting initial access is the odd number of 358.05 hours in a three month period ... basically 360; maybe it's just as well I didn't know what I needed at the beginning but as of today I have 364+ hours worked Jan - Mar.

54 hours, about a seventh of that total, was overtime of one kind or another, either hours over eight in a day/forty in a week or working a weekend (a lot were all three: long weekend shifts after a long week). It's the nature of the job that the work load ebbs and flows, so you have to be able to clock the hours when they are there to be worked. One thing is for sure, there is no way I would have been able to get across the health insurance finish line if I had been doing any other type of hemodialysis.

It is only by dialyzing at home, more frequently, while I slept, that I was able to cover all my shifts and earn insurance to supplement my Medicare coverage.

Now it is on to step two, Travel. DSEN will follow my planning for a trip to Argentina. During the trip I will dialyze incenter, in Buenos Aires and near Iguazu Falls (after which I will have dialyzed on six of the seven continents - watch out Antarctica). My Mom is going to go too! We're aiming to go in the second half of August, towards the end of their rainy season, hoping to catch the falls in maximum flow and during what is normally a particularly slow period at work.

The five month countdown begins ... Now.

Wall Street Journal spotlights home dialysis options

By Bill Peckham

Wall Street Journal Health Journal columnist Melinda Beck has an upbeat article available online, A Dialysis Treatment For The Busy Patient. The article reports on home dialysis, peritoneal dialysis (PD) and home hemodialysis (HHD), and gives a fair assessment of the current situation.  I'm quoted, along with friends of DSEN MEI's Dori Schatell and Northwest Kidney Centers' CEO Joyce Jackson, and several other dialyzors and MDs. 

It's a pretty complicated topic to cover within the confines of a news story, even harder covering both PD and HHD in the same article. While both are home modalities, they really are very different. The modalities are different with regard to the new bundle and they have different clinical advantages. Though I was glad to see mention of one clinical advantage they share:

experts worry that getting dialysis at a center makes patients more complacent about their treatment, and less careful with their health.

This is the learned dependence that is the bane of incenter dialysis.

Also confusing is that some of the details in the article don't apply to both modalities - for instance the need for a helper - and some of the info is not true for the featured devices. The NxStage System One and all PD cyclers can run on a normal 110 circuit. It's only the standard hemodialysis machines (the type used incenter) that need dedicated power.

From a financial point of view (it is the WSJ) the world does get complicated when it comes to the financial incentives and it would have been hard to adequately cover them in the space available (it's hard to explain in the nearly unlimited space of this blog). One complication is that the new PPS promotes both types of home dialysis but in different ways. The medically justified additional payments aren't available for those doing PD, and it is unlikely (though it does happen) for a person to start HHD in the first 120 day of starting dialysis.

Still considering the interest level of a typical WSJ reader and the space constraints, it's a great article.

Nocturnal Hemodialysis: Promising or Proven?

By Peter Laird, MD

I continue to marvel at the dialysis medical literature that in many instances completely ignores the history of dialysis. This is especially true when it comes to the subject of "alternative" dialysis strategies, such as daily dialysis or nocturnal dialysis. It is sad indeed when the pioneers of such life saving modalities are not even remembered. 

Dr. Stanley Shaldon has been overlooked for years as the original investigator of home nocturnal hemodialysis. He not only initiated the first overnight or nocturnal home dialysis treatments, but also published his results extensively in the early 1960's. We've all had access to his results for nearly fifty years!

Dr. Shaldon has reminded readers of his early work through letters to the editor in Kidney International and Blood Purification, Origin of Nocturnal Home Haemodialysis:

Dear Sir,

Precedent claims are rarely correct, thus the statement by Drs Schlapper and Diaz-Buxo in the January issue of Blood and Purification ^[1], that Uldall et al. ^[2] established the first nightly home haemodialysis program in 1993, cannot go unchallenged.  I believe that my group was the first to develop this technique 30 years earlier and that we published extensively in the period of 1963-1968 on this subject ^[3-7]. In addition, visual proof of my claim can be seen in a video of self unattended overnight home haemodialysis in 1968 by any of your readers at http://www.youtube.com/user/stanleyshaldon ^[8].

(Ed: I have updated Dr Shaldon's video link with his YouTube page URL.)

I recently read with interest another article that speaks of the promise of nocturnal dialysis, yet why is it referred to as a promising therapy nearly fifty years after its first use?

PPS Comments to Medicare show the way forward: higher dialysis doses for better health

By Bill Peckham

I noted in my PPS comment to CMS the level of distrust that I heard as I read them in mass. Reading them one after another, as they were posted started making me feel cynical. However, there is another narrative in those nearly 1,200 comments, another story. A story of hope.

Here are excerpts from 23 comments submitted by those using frequent home hemodialysis (these comments were mostly submitted through regulations.gov, which limited text box submissions to 2,000 characters (not even 15 twitter messages). The process also stripped away paragraph formatting. I, for the sake of readability, added paragraph breaks to the messages and let my spell check correct some obvious typos. You can read these and all comments in their posted form here or download a continuously updated Excel file). The stories excepted below offer a glimpse of a brighter dialysis future. A future that can be achieved today, without waiting for a scientific breakthrough or the FDA approval process.

Read these and hear what they are saying. Taken together these comments offer as strong an endorsement of more frequent dialysis as I've ever seen. Story, after story of being cured of the symptoms of too little dialysis. All of the symptoms that people mistakenly attribute to dialysis, are reported cured. And not one of these commentators talk of urea.

Read through these personal testimonies, and then look around a dialysis unit. Should those people, those individuals really be there?  People with CKD5 don't have to feel that sick - there is an alternative to conventional incenter dialysis.

CA Dialyzor
Dear Sir/madam, I am a 42 year old home hemo patient of 5 years, I work 9 hours every day and exercise regularly.

I am also extremely grateful to be able to dialyse 6 times per week for 6 hours every night as a result I have no pressing need for a transplant, and climbed Mt Witney in August.

I used to have in center dialysis 3x per week and was not able to work a full day or keep myself fit. I feel that others may not be able to enjoy a productive life if sufficient encouragement to move patients home is not created by the new payment system. ...

GA Dialysis Mom
Thank you for the opportunity to share my thoughts on the Proposed ESRD Rule. While I am a healthcare professional, I never thought I would have an interest in dialysis- but that changed when my daughter developed kidney failure.

She was transplanted at age 11, but the new kidney did not last. After that, she tried peritoneal dialysis, but had many infections. Incenter dialysis was the only other option we were given, and it did keep her alive- but it put our whole family in survival mode. I had to quit working to take her to all her treatments and be here when she slept afterwards. We thought that was the only way. But, in 2007 I heard about home hemodialysis. This therapy has given us back our daughter and given our family back a life. ...

CA Care Partner
My husband returned to dialysis in 2006 when his kidney transplant failed. While dialysis was much improved since his experiences 1990-91, the most marked improvement was what we experienced when we began home hemodialysis in 2007.

His general health and quality of life increased enormously. It was more than worth the effort, even considering the fact that home hemo includes a lot of work for the patient and caregiver, particularly when compared to clinic hemodialysis. ...

CA Dialyzor
I am a kidney dialysis patient for almost 20 years & a home dialysis patient for the last 3 years. As a result of home dialysis I am off many of the medicines I had to take when going in center for treatment because doing dialysis at home is almost like having my kidneys function again. ...

MN Dialyzor
I am a 22 year old home dialysis patient, and "going home" when I do treatments has changed my life dramatically, in only the best ways. I want to first thank everyone for still supporting this treatment option, because it has been in integral piece to my continued health and life satisfaction. I was diagnosed when I was 7 with MPGN type two, and have been on some form of dialysis since 1997.

I remember the days when I had to go into a center to do dialysis, and having to do my treatments on their schedule and how it fit into their day, actually worked against my ultimate goal of living as "normal" a life as possible. When I learned that I would be starting to do it at home, both me and my family were very excited. We had some amazing nurses who trained us, and who were there for us in a one on one fashion to learn how to be independent, and because the training is one of the most important pieces to the puzzle, I think that making it "part of the package" would only be detrimental to the program. I want all of those people out there that are just as scared and nervous as I was when I began to have the same experience that I did with amazing trainers who will help them feel comfortable enough to take it home, and live an amazing fulfilled life just as I am!

UT Dialyzor
I have been on NxStage home hemodialysis for 3 1/2 years. My health has improved remarkably. I live 90 miles from a dialysis center and I made that trip 3 times a week for one year and the trip itself almost killed me. I did it or 4 years in Montana and had to drive nearly the same distance. Home Hemo gives us the patient freedom and better health.

My health is remarkable as if have been fighting ESRD for 22 years. Had I not been enabled to do NxStage home hemo I would have certainly met my demise by this juncture. In center is good but home hemo is so much better. The care one gets from their loved one as the service provider is unfounded anywhere. The peace and saftey from infection is also reflected in my health with home hemo. I just cannot say enough that Home Hemo has saved my life! If I had to go back to in center and drive 180 miles 3 times a week I would soon be dead in body and spirit.

Home hemo renews one's spirit and the ability to stay at home and not make that awful trip cannot be traded for anything. If you were to take a photo of me now and 4 years ago before I started NxStage home hemo you would not know it was the same person. My health has been renewed. ...

OH Dialyzor
i have been on dialysis since 2002. in 2006, i started going downhill. my wife drove me to dialysis and got a wheel chair to take me into dialysis. we found out about nextstage on the internet and looked into it. we began training in January of 2007. after just a week of the training i felt good enough to drive and my wife and i stopped for lunch for the first time in over 2 years. NxStage dialysis has given me and my wife a much fuller life.

UT Care Partner
To whom it may concern, My husband Brad has Alport's Syndrome which is ESRD, he was diagnosed when he was only 34. We have 4 children and have spent the last 9 years learning how to best deal with this disease. It was life altering as you can imagine.

First I would like to say without Medicare we would have less than we have now. It has enabled our family to continue moving forward. We heard of the changes that will be taking place and want to make sure our voices are heard. Brad has been a Home hemodialysis patient for the last 7 years, 2 which have been on the NX stage Nocturnal program, meaning he dialyzes at night for 8 hours.

This has enabled Brad to hold down a full time job, go off of his high blood pressure meds, and forgo Aranesp shots because his body is functioning on a more normal level. ...

KS Dialyzor
To Whom It May Concern' As a current home dialysis patient and a past in-center patient I want to thank you for the availability of home dialysis. The difference in how I feel on HD as opposed to in-center is remarkable.

My high blood pressure which was at the stroke levels previous to HD is now completely under control allowing me to take less medications. The frequency of dialysis has also helped me to feel better, sleep better and eat better resulting in an overall improvement of my health.

My lab values particularly phosphorus and potassium have lowered significantly. I can only assume this is due to the frequent dialysis treatments I receive which HD. My only concern is with the possible bundling of treatment which would eliminate training sessions for some units. I ask you to think carefully about the change in this rule as it may keep others from reaping the many healthful benefits from this type of dialysis.

NE Dialyzor
I have done all forms of dialysis: PD and hemo. Over 8 years of surviving this way at 42 years old. I struggled along for a very long time until it was suggested that I try home hemo and overcoming the fear of poking myself I tried.

I have since avoided being in the hospital every year around July for quiet some time. I feel better and can function at a higher degree due to my fluid being removed more often. I walk and ride my bike and love it. I don't just survive, but I live!!!! Trust me living and enjoying life is huge when you have kidney failure. The windows of how often you feel good is small and even smaller when you are required to go to in clinic dialysis.

There is great freedom given when you allow me to stay home and hook up and not go by the clinics clock, but mine. I get to attend meetings and family fatherings and church functions because I choose when I do dialysis. I love this freedom. Please do not take this from me. I can travel and visit friends and not have to worry about setting up chair times so far in advance. I am an active person and am so pleased to have better health and am able to participate with gatherings and groups where as before I was very limited. ...

CA Dialyzor
I am a home dialysis patient. Home dialysis has made my life bearable. The more frequent and gentle treatments have done wonders.

Before with dialysis in the Dialysis Center four times a week, I had a tremor that made it difficult to even use a computer and I had small seizures several times a minute. These symptoms of subtle uremic poisoning did not go away with regular in center dialysis but did with daily home dialysis. Please support daily home dialysis. ...

WI Care Partner
CMS, THANK YOU FOR PAST SUPPORT. BECAUSE OF HOME DIALYSIS I HAVE BEEN ABLE TO TREAT MY HUSBAND AND STILL WORK MYSELF.OUR DR. ENCOURAGED US AND THE NURSES TRAINED ME( I'M NOT A NURSE) AND ARE AVAILABLE 24/7. HIS HEALTH HAS IMPROVED BECAUSE OF DIALYSIS 6 NIGHTS A WEEK. HIS CARDIOLOGIST SAYS HIS HEART IS EVEN STRONGER. SOME MEDICATION DOSES HAVE BEEN ELIMINATED OR LESSENED. THERE IS NO FEAR OF CATCHING FLU OR COLDS FROM OTHERS BECAUSE WE ARE HOME IT'S BEEN WONDERFUL HE IS 82 AND SAFE AT HOME. ...

CA Dialyzor
I live in a remote area near Willits and about 30 to 40 miles from a HD treatment center. With out HHD I would not be able to live where I do for many reasons.

When I was in a Treatment Center with treatment 3 times/week I never really felt good (It was like a light bulb being on but not giving off as much light as it was designed to). I got sick more often and not able to do anything else that day due to travel, treatment time, and fatigue.

I have been doing HHD 6 days/wk for the past 5 years. For the past year + I have been doing NOCTURNAL which frees up my days. I love it, I FEEL GREAT! My check ups and blood workups are always very good. So, thank you CMS for supporting HHD treatment. ...

AR Dialyzor
I would like to thank CMS for the continued support of home hemodialysis. I completed my training in June 2009 and have been utilizing HHD since that time.

I am 40 years old, married, and have two (2) young children. My wife went through the training with me and is my care giver. Being able to perform my dialysis on my schedule has allowed me much greater flexibility and time with my family. I utilized in-center hemodialysis for approximately six (6) months prior to HHD training and I feel much better on HHD.

HHD also allows me to travel - we have taken two (2) trips where I simply take my machine with me. This has been incredibly important for my job as a work 40+ hours/ week. ...

KS Dialyzor
Dear CMS, I am a home Hemo Dialysis patient. I am on the NxStage system. I have been on dialysis since 10/08 and started home dialysis in 6/09. I must say the initial training for this services was quite extensive, lasting over two weeks but it was very worthwhile and highly effective.

Being on home dialysis has allowed me to return to work full time, 8 hrs a day, 5 days a week. I also have been able to resume normal activities on my 22 acre farm. ...

MA Dialyzor
I have been a HHD paitent for the past 3 years and I feel that anyone who can do it at home should do it .

It gives you more freedom and helps keep your life as close to normal as possible. ...

FL Care Partner
A year ago my husband and I were barely familiar with Dialysis nor did we even consider the ramifications of kidney failure. The funding of the programs via Medicare and terms e.g. bundling, composite rates, etc. were furthest from our minds. However, fast forwarding to the present, we have learned in the last eight months that without dialysis my husband would cease to exist.

While our medical bills were piling up we were introduced to a home hemodialysis program that provides him with life saving dialysis at home with me as his caretaker. Do you have any idea how valuable it was to have an excellent training nurse instructing us for home hemodialysis? I am close to 70 yrs. old with no medical background and with our excellent training from a dedicated dialysis nurse we were able to start his dialysis in our home.

We have been able to keep my husband out of the hospital and gave him back the gift of living. The difference in his health is amazing, he has reduced his blood pressure meds and the daily home hemodialysis training is priceless. ...

NC Family/Care Partner
I am writing to share my concerns about your proposed changes to the way dialysis is covered and paid.
...
2. Home Hemodialysis training- thank you for being aware of home hemodialysis. It is the real thing and has totally changed our lives. Seriously, my brother was in a wheelchair and slept most of the time when he was treated in the unit. He was in the hospital regularly.

Since going home on hemodialysis, he has not been in the hospital a single time! He even volunteers at the hospital now!!! It has been life changing for our whole family. I have returned to teaching, after having stopped to care for my brother when he was in the unit. ...

TX Dialyzor
I am on hemodialysis in a home administered plan. Because of the individualized training my wife and I received we are able to successfully perform my dialysis in the comfort and privacy of my own home.

I went to the center for treatment for two months. During that time I was washed out every other day after in center dialysis. At home, I have dialysis 6 days a week and feel wonderful the minute I'm finished. I can travel any time and at almost a moment's notice. I've taken 3 to 4 week vacations across the country to visit family members that can no longer travel, and I went with my whole family on a cruise. I would not have been able to do that without the home hemodialysis.

Because we were well trained on an individual basis, we feel comfortable and capable of performing the treatment no matter where we are. Because we can set our own schedule, we are able to participate in community, church, and family events. We do not feel like we are missing out on life.

I had my yearly evaluation last week and it was wonderful. My health is good and I'm living my life to the fullest. I pick up my grandson every day after school and recently got a new granddaughter. As quickly as children grow I could not have had this time to spend with my children, grandchildren and siblings.

Spouse of above Dialyzor
My husband is on home hemodialysis. I am not a medical professional and when I first heard about home hemodialysis I thought it would be impossible for us to do that. I received individual training and because of that I was able to learn what I needed to be comfortable enough to perform hemodialysis in my home.

My husband went to in center dialysis for a couple of months. During that time he was terribly depressed. He would drive himself to the center but was unable to drive home (It was a 40 minute drive and we were at the center approximately 5 to 6 hours). I was unable to work during that time because I had to drive him home from the clinic. When he finished his treatment he was barely able to walk to the car.

He had no appetite and was losing weight. His blood counts were going down because of his lack of appetite. Now when he finishes his treatment (6 days a week instead of 3) he has plenty of energy. He can get dressed and be ready for anything. We vacation, spend time with family and friends, and participate in church activities.

My husband also belongs to the local Exchange Club and the Lions Club. He was not able to do that when he went to the in center dialysis unit. Please don't change anything. This has allowed my husband to live a fuller life and to feel so much better than he did in center.

MA Dialyzor
Response for Proposed Medicare Bundling Rule Thank you CMS for making all options available I agree per treatment payment is best way to support frequent hemodialysis.

Since being on frequent home hemodialysis I have noticed a tremendous change in how I feel physically and emotionally. Physically I have more energy, my diet is more liberal and I have more time to enjoy life. My life has changed significantly since starting on frequent home hemodialysis, instead of dialysis being my whole life it know is a part of my life.

I ask that you not punish clinics that offer more frequent hemodialysis but make it more available and financially acceptable. Since being on frequent home hemodialysis I have noticed decreased illness which brings down any potential hospital stays that I might have had. Since being on frequent home hemodialysis I have decreased my B/P meds significantly. ...

AK Dialyzor
To whom it may concern, Thank you for allowing me the opportunity to comment. My name is Stan and I have been on dialysis since May 2009.

I was initially on in-center for the first 3 months and have been on home hemo since. I lead a very active lifestyle with my children. I also continue to work full time. I really appreciate the rules allowing for home hemodialysis and short daily treatments.
...
I hope it will be possible to make modifications to ensure that every dialysis patients is able to receive the optimum treatment, and not just the minimum required to keep them alive. It is important to many of us to remain healthy enough to continue to be a contributing member of society

VA Dialyzor
Making all dialysis options available in the bundle rule certainly makes sense. I am very appreciative of the many different types of dialysis that is offered in this setting.

Seven years ago, my kidneys began to fail & my doctor advised dialysis. One of the options was home dialysis. Choosing this, I signed up for the class. However, before I could start the training, I suffered a heart attack & congestive heart failure. My dialysis then became an urgent necessity & I began dialysis in the hospital setting.

After my release from the hospital, I continued my dialysis treatments at the center, 3 days/week, and 4 hours/day. I did not feel very well after treatments; I itched, was cold, had cramping all the time & felt very weak. I have an IJ catheter. In the center they would run 500 speed to get a good clearance, but my machine's alarm would constantly go off. The motor speed was reduced, resulting in the poisons not taken off, as they should be.

I was 81 when I started dialysis & my wife (helper) was 74. Although skeptical of home training, we completed the training & all went well. I have been on home dialysis for 7 years and feel great. I am able to cut 4 acres of grass, visit with family, tend a garden, can vegetables and keep up with and order supplies. I eat what I want & my lab results are normally great.

I dialyze 5 nights/week, 8 hrs/night. Because each person is different, I believe CMS's per treatment plan options are best suited for everyone. Dialyzing this slow, long way is much better for my catheter & my well being.

I am now retired, but I know w/ home dialysis, my quality of life is much improved. This is reflected in my activities, my diet & my lack of hospitalizations.

I feel better all around & have been taken off blood pressure medication. I have only been hospitalized once in 7 yrs. for anything other than catheter problems.

These selected comments are in addition to the long home dialyzor submissions via Word or PDF document.

There are over 90 times as many people on conventional incenter dialysis as are on frequent home hemo, yet I can think of very few who, by any stretch, wrote to endorse their care. Only those at home, dialyzing more frequently, were moved to do so.  They know the truth, their stories tell of a better way.

Optimal Dialysis: Are we losing the Battle in America?

By Peter Laird, MD

A little over a week ago I had my home dialysis monthly check-in with a nephrologist that I was meeting  for the first time.  I found him very knowledgeable and supportive of alternative dialysis strategies including the NxStage System One as well as nocturnal dialysis in its various forms.  He recently opened his unit to incenter nocturnal dialysis patients, achieving excellent results with several of those patients who transferred from conventional dialysis care.  Unfortunately, one of those patients is now at jeopardy of returning to conventional dialysis care by the decision of their HMO. This, despite the widespread acceptance of the benefits of incenter nocturnal dialysis especially in Canada just to the north and down south in Australia, America continues to dismiss the overwhelming evidence of improved outcomes with this modality.

Remarkably, despite the widespread knowledge that dialysis pioneers originally used eight hour sessions nearly fifty years ago instead of the conventional 3-4 hours sessions we are now familiar with, many health insurance providers perversely consider these alternative strategies unproven and experimental and will not pay for them.  They continue to insist upon randomized controlled trials as the only standard of proof which at this time still do not exist.  They fail to acknowledge that the current standard of care, 3-4 hours sessions thrice a week, was a business decision unsupported by any randomized controlled trials as well.  

A little over a year ago, I contacted the physician overseeing the committee at Southern California Kaiser that evaluates new and evolving technologies after hearing that they were considering nocturnal hemodialysis at that time.  After reviewing the available literature mainly from Canada and Australia, they determined that that data was insufficient to support adopting it as a covered benefit for all patients, but they did recommend setting a pilot study which is now in progress.  Yet there are many such as Dr. Carl Kjellstrand and Dr. Christopher Blagg who have advocated  for optimal dialysis here in America for decades citing the improved outcomes in several other nations that have been able to incorporate this in dialysis practice.

The case of my fellow patient at my center now battling for coverage of optimal dialysis through a well run incenter nocturnal dialysis program takes me back to the current status of many patients in America who still do not have access to these life saving modalities.  After observing the positively changing mindset among many in the nephrology community over the last two years that I have been involved in dialysis advocacy, this case reminds us that the battle is not yet won here in America.  With the uncertainties that the new prospective payment system could bring to American dialysis patients and these alternative treatment options, I can only wonder whether we are winning or losing this battle.  Dr. Belding Scribner spent the last two decades of his life fighting this battle only to tragically die in 2003 before he saw it come to fruition. 

Certainly, in the nearly seven years since Dr. Scribner death, dozens of studies have brought forth the profound benefits of daily hemodialysis, especially in regard to daily nocturnal hemodialysis. Many who support these modalities continue to wage the battle against this American dialysis hegemony hoping that we shall never again hear that a patient was denied access to these life changing treatments.  It is a battle that one of our fellow dialyzors is waging today, unfortunately it seems, with very little chance of success.  A vocal dialysis advocate that I asked to assist in this case summed it up by simply saying, “That's truly appalling!”  I agree.  The battle continues locally and nationally.

Optimal Dialysis Deserves a Trial of Life in America

By Peter Laird, MD

Looking back upon my training in Internal Medicine, it is interesting how several simple remarks by my mentors became important standards in my own clinical practice.  One singular remark stands out above all of the rest in my mind.  Dr. Marin Kollef, ICU director for Fitzsimons Army Medical Center during my residency had a favorite saying for patients that had stabilized on a ventilator but were not progressing to the point that it could be removed.  In some cases where the patient’s weaning parameters were ambiguous, he would make a clinical judgment that the patient deserved a "trial of life" before the complications of long term life support took away all hope.

Today, many in American nephrology remain unconvinced about the benefits of extended dialysis in its many forms.  Perhaps the most vocal critic of adopting daily dialysis therapies without a randomized controlled trial (RCT) is Dr. Glenn Chertow:

Given these uncertainties, we do not have sufficient data on the effects of daily and nocturnal hemodialysis to advocate for its widespread use and underwrite its cost. In 2001, Chertow (19) argued that a RCT of frequent hemodialysis was necessary to answer the fundamental questions of whether these treatments improve outcomes and, if so, by how much. . .

The current evidence does not support the widespread implementation of daily or nocturnal hemodialysis, also suggesting that an RCT is needed (16,17). In addition, there has been little information published on the feasibility, safety, and possible adverse effects of frequent hemodialysis. An RCT will test the feasibility and the safety of these treatments using a rigorous protocol. It also will enable us to perform an economic analysis of frequent hemodialysis compared with conventional therapy.

However, both of the two current dialysis related RCT will be too small (too few people enrolled) to answer the questions posed by researchers such as Dr. Chertow and CMS which continues to insist upon RCTs before funding high intensity dialysis regimens.  

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials
Power analysis showed us that with 1 yr of follow-up, we would need to enroll >3500 patients in the daily study and >5000 in the nocturnal study to achieve 90% power to detect a relatively substantial 30% reduction in mortality. These numbers are several fold higher than the total number of patients in North America who are receiving this treatment. With intensive recruitment efforts, we estimate that we will be able to enroll a total of 500 patients for the two RCT: 250 in the nocturnal study and 250 in the daily trial.

America continues in this dance of death with usual dialysis care, seeking a RCT that shall never be completed even with the current ongoing studies.  CMS continues to insist upon RCT generated evidence of the benefit of extended dose dialysis completely overlooking the simple fact that dialysis started with extended doses at home:

Why "Adequate" Kt/V Does Not Provide "Optimal" Dialysis
Dr. Kjellstrand told the audience that "adequate" is defined as "barely satisfactory" and asked: "Is that what we want to give our patients?" He noted that in the United States, with the current "adequate" dialysis target of Kt/V of 1.2, the dialysis patient death rate is 25%, the rehabilitation rate is less than 10%, and "every fifth patient finds life so miserable he prefers to be dead."

"The goals we should have for our patients are comfortable dialysis, normal blood pressure, high quality of life, and a survival that should rival that of transplantation, since it did that early on," he said.

America has a further chance to redeem the errors of ignoring our historical successes as pioneers in dialysis therapy and once again reclaim our rightful position as the champion of optimal dialysis. Waiting for the holy grail of a randomized controlled trial to show us what we already known for 40 years, from the pioneering days of dialysis, doesn't make any sense. Sometimes the only option when faced with a hopeful but uncertain situation is to just give the patient a trial of life. This reach for optimal is long overdue in American dialysis units.  My prayer is that it will come soon for all.

How Dialysis Fits into My Daily Routine?

By Bill Peckham

The third question I was asked to address at the conference on Saturday How Dialysis Fits into My Daily Routine? gets to the issue of logistics. There is of course some overlap with the answers to the previous two questions here and here but rather than answer as I did on Saturday I'll recount my day today.

Last night's dialysis treatment finished about 7:15 this morning. I was making coffee by 7:45. I have a four hour shift today but it's a flexible start so I'll go in after I receive my monthly NxStage supply order. While waiting I write a blog report, feed my internet habit, do a load of laundry and take care of emails. 72 boxes of dialysate arrive and it's off to work.

Before starting I walk the dog along the river (the dog works when I work and he'll be at work Thursday and Friday while I'm in LA - he has way more hours than me). Work is an easy day - I'm training to use a new piece of equipment - a very elaborate flat bed printer and there aren't any real signs to produce - I print Watchmen posters for the walls and over thirty posters for NKC that I'll cut out next week. At the end of the shift I can operate the new printer. It's pretty cool - it can print directly on Plexiglas.

After work I am busy on the internet and the phone, posting about the petition and returning calls. The dog eats and with daylight savings time there is about an hour of daylight so the dog and I head to the beach to watch the sun set behind the Olympic mountains. We take a 20 minute walk up into a green belt and then loop back to Duke's as the sky turns red. I order a bowl of crab chowder to go, down a strawberry lemon drop while watching Seton Hall and Syracuse and head home.

Back on the internet while eating delicious chowder and then about an hour of TV. I set up my NxStage for tonight's treatment with the TV on and the my second load of laundry in the wash. After the machine is set up I figure out what to pack and now I'm writing this post. In about 30 minutes I'll walk the dog and then I'll finish the day watching the Daily Show as I get on dialysis. 

The trade off is the more I work the less I blog and I give volunteer activities a high priority so all of this is scheduled around meeting commitments. This week is also different because of the travel. Tonight will be my forth treatment in a row. Normally I go 3 on one off, 2 on one off. If I wasn't dialyzing tonight I would, ideally, have spent more time on life chores - bills, the yard, the kitchen, etc. - some nights it turns into more time on the internet, or eating at the bar and a second drink.

If I wasn't dialyzing overnight I would have had to walk the dog on the way home from work, pack and make myself something to eat. I'd get on dialysis by 7 if all went well. For the next three+ hours, during the six + years I was on short daily (9/2001 - 1/2008) I'd watch TV, and idly surf the internet. Maybe a friend would come over, or I would be on the phone, or slowly typing out one handed responses to emails or discussion board posts. DSEN would not exist or would be very different. There would be no petition effort.

Home extended overnight hemodialysis fits well into my busy and enjoyable life. As I wrote my dialysis gives me the freedom to struggle and it is what has opened the door for me to provide a new view.

How Does Home Hemodialysis Influence My Quality of Life?

By Bill Peckham

As I said yesterday I did well while I was on incenter dialysis but at home I am doing better, particularly now that I am doing frequent extended overnight hemodialysis. At the conference I reported that my Quality of Life (QoL) improved every time I increased my dose. Now 18+ years after taking up hemodialysis to manage my stage 5 chronic kidney disease (CKD5) I am enjoying my highest QoL yet. Dialyzing over night gives me both better clinical results and more free time. My already high QoL improved when I switched to extended treatments overnight. 

By improving my clinical experience of dialysis, frequent home hemodialysis has eliminated the post dialysis feeling of being hung over. After incenter dialysis I often felt literally hung over - headache, food doesn't sound good, dry mouth, weariness - I coped with this by going to bed. I'm fortunate to dialyze through the Northwest Kidney Centers which operates each one of their units with shifts starting after 5PM; dialyzing after work meant by the time I got home from dialysis it was time to go to bed.

When my dialysis frequency increased the hangovers went away. In place of nausea I felt hunger. I've gained 14kg since switch from incenter to frequent home hemo. I was under weight incenter, spicy food made me nauseous - mild salsa only. Dialyzing at home has made food more appealing while removing nearly all my dietary restrictions. I can have cereal with milk in the morning; with my nachos I love the hottest salsas. Getting more dialysis at home ended the hangovers and it also cleared the uremic fog.

I could think more clearly. My reading comprehension improved. I could win more consecutive games of Freecell once I started dialyzing frequently at home. These are solvable card puzzles that come with the Windows operating system. While I was incenter it was rare for me to be able to complete five games at a time. Once I was getting more dialysis I became bored with the game as I was able to win again and again. My ability to concentrate had returned.

Then with my latest increase in dose, provided by moving to extended overnight dialysis using the NxStage System One, not only have those areas improved once again but I have my evenings free. I haven't had my evenings free for over 18 years. This blog is due to my having my evenings free. As someone who self dialyzes I am very aware of the time and effort home dialysis requires - extended overnight dialysis requires less time and effort then any other modality I have tried - incenter included. Less effort. Feel better. Live longer. Extended overnight dialysis at home is a positive influence on my Quality of Life.

Longer dialysis is better

By Bill Peckham

RenalWEB links to an advance access abstract from NDT Prospective Evaluation of an In-Centre Conversion from Conventional Hemodialysis to an Intensified Nocturnal Strategy. The study switches 13 people who had been doing conventional incenter dialysis (3/week, 4  to 5 hours) to nocturnal incenter dialsyis (3/week 8 hours). 12 months later they compare outcomes.

There was significant improvement across categories. Participant's blood pressure, medication use and certain blood measures all improved. This is more evidence that it would be a good idea to offer more dialysis to those that can't go home. And it is an even better idea for US units to offer this option.

This was a German study. The abstract states that people are "usually dialyzed only 12–15h/week."  Only 12–15h/week! Here in the US there are units routinely dialyzing people for only 2.5 hours, 3x week. Units where one has to fight for 4 hour runs.

If the data looks good under European standards it would be stunning for US dialyzors that are currently dialyzing for 3 hours or less.

EDIT 2/12/2009 Originally this post indicated that the abstract was a Canadian study but it is a study from the Division of Nephrology, Department of Medicine, Medical School Hanover, Hanover, Germany. I am sorry for the error.

Selfdialysis program opens for overnight treatments in Vancouver, BC

By Bill Peckham

Renal Business Today reports on a new program up in Canada, Nocturnal Dialysis Patients Manage Own Care at Vancouver Hospital. This program is intended to address the concerns Peter voiced and Zack seconded "but what about all those fellow dialyzors that I will leave behind? Those that can't go home." The Vancouver program is a model to provide more dialysis to those that can't go home. It does this in an economic way by using existing infrastructure and little additional labor.

The Vancouver program together with the Hana, Maui model represent a rethinking of the incenter conventional dialysis status quo. These programs are conventional dialysis hybrids. Both programs represent solutions to a problem with conventional dialysis. In the process of addressing their separate problems, Vancouver and Hana took steps that decreased their control over the dialysis treatment and by extension the patient. It'll be interesting to watch how these programs preform but I think it bodes well that in both cases dialysis providers saw that the way forward was to get patients more involved in their own care.

What should we expect from optimal dialsyis?

By Bill Peckham

On Friday RenalWEB linked to an advance online abstract from Kidney International: Nocturnal Hemodialysis Does Not Improve Overall Measures of Quality of Life Compared to Conventional Hemodialysis. The headline raised a number of questions which the abstract doesn't answer. I wrote the contact for the paper, Dr. Manns who helped provide context by pointing to a paper published in JAMA, September 19, 2007—Vol 298, No. 11: Effect of Frequent Nocturnal Hemodialysis vs Conventional Hemodialysis on Left Ventricular Mass and Quality of Life, which is available online. Both articles are based on the same randomized control trial.

This new article goes into the quality of life measures more completely but I think the author's comments from the September 2007 paper still stand:

While our study could be criticized for measuring surrogate end points that have not been validated in ESRD, it is important to note that we also measured HRQOL, an important outcome in a chronic disease such as ESRD. We found no difference in the primary quality of life measure comparing change from baseline to 6 months, but noted statistically and clinically significant improvements in 2 of 4 kidney-specific measures of quality of life comparing change from baseline to 6 months. For our primary quality of life end point, we found that scores appeared to deteriorate consistently over time in patients randomized to conventional hemodialysis and be maintained or increase slightly in patients randomized to nocturnal hemodialysis. These changes, which were observed at baseline and before exposure to the intervention, may have resulted from the subjective nature of "overall" quality of life measures such as the EQ-5D index score, and might represent an artificial anticipatory effect, rather than a true effect from nocturnal hemodialysis per se. It is interesting to note that these results (a slight increase in the quality of life in nocturnal hemodialysis patients and a reduction in quality of life in control patients) was also noted in a previous nonrandomized report³¹ and warrants further study, given that our study was not powered for quality of life outcomes. These limitations acknowledged, the magnitude of the change noted in utility scores comparing 6 months and randomization is similar to the mean change observed in dialysis patients who receive a kidney transplant, suggesting this difference in quality of life could be very clinically significant.³²

The Kidney International paper should be out in a few weeks (hopefully it will be freely available) but I'm not sure what will change. I think the authors will still concede their study's shortcomings. Measuring Quality of Life is a tricky business.

The Kidney Disease Quality of Life Short Form is available online (PDF link). Reading through the self administered survey I asked myself how many answers would I expect to change after six months of daily home hemo? I don't go to the effort of getting a high dose of hemodialysis for the impact on my life today, I choose high dose hemodialysis for the benefit it provides over time. I agree with Peter that followup studies over years would show variation. The longer I do high dose dialysis the better it looks.

Thinking about this abstract and how it has been received brought to mind my Thanksgiving post. We should be careful to not over sell any renal replacement therapy. I absolutely believe that frequent nocturnal dialysis is the safest, healthiest form of dialysis. Of the available options, daily nocturnal most completely treats CKD5. I think it can make having CKD5 less of a burden but it will still be a burden, it is still a hard row to hoe. Optimal dialysis is good but it's not that good.

DSEN Podcast: Nocturnal Dialysis, Anna and Bill

By Anna Bennett

Dialysis from the Sharp End of the Needle is already multimedia with a video section, and now, with podcasts.  Today's podcast is Bill and I talking about nocturnal dialysis.

I had some questions for Bill, and he was glad to answer:

Why did you make the switch to Nocturnal Dialysis?

What are the technical aspects of Nocturnal versus high dose daily home dialysis?

What adjustments did you make to your diet?

Here is the podcast:

We believe the player requires that you have QuickTime installed, download here or download the MP3 file by right clicking here, and selecting save as.

Here are links to resources that Bill mentions in the podcast:

• Paper by Charles Chazot (MD Tassin) and Guillaume Jean
• Tassin France Study of Nocturnal Dialysis
• External Heparin Pump
• DSEN posts about Nocturnal Dialysis
• Nocturnal Dialysis in Australia (Dr. John Agar)
• Extended Dialysis Rivals Deceased Donor Transplant

Bill's video of his nocturnal taping technique (and testing the leak detector)  you may have to turn up the volume on the videos

And finally, here is a video of Bill's nocturnal set up while he is on vacation, on a boat off the coast of Washington State

As always comments and questions are welcome. Too long? Too short? I think this will be an ongoing effort.

Why do we need high dose dialysis gatekeepers?

By Bill Peckham

Anna highlighted a disappointing quote in a recent Forbes article:

There's also no proof from randomized trials that more frequent treatment saves lives or prevents hospitalizations. "I don't think there is sufficient evidence to justify a widespread change to six-times-a-week dialysis," says Stanford University nephrologist Glenn Chertow, who is running a big, randomized trial on more frequent in-center treatment.

It is hard to square this call for sufficient evidence with the reports that nephrologists and renal nurses would choose high dose home hemodialysis for themselves. That is dissonance.

A question I would like to ask Dr. Chertow is - if there were no logistical or financial constraints - would he customize the dialysis frequency of his patients? Putting aside, all questions of cost or capacity/all accommodation of patient, payer and provider expectations, would he have all of his patients dialyzing 3 days a week? I have to think that without imagined and/or real logistical and financial constraints, people would be getting more dialysis then they are today. That if dialysis dose was based on the clinical judgment of nephrologists alone people with severe chronic kidney disease would receive more dialysis than is routine in 2008.

Peter wishes his peers were advocating with a single voice for access to higher doses of dialysis for their patients. I wish that too and I think that dialysis is the problem thinking  is widespread in the nephrology community. I'm disapointed because this high profile quote in Forbes will be seen as based on a purely clinical judgment. To my ears it is legitimizing Medicare inertia by defining sufficient evidence as requiring a perfectly executed RCT. There isn't a clinical contraindication to more dialysis, the need for a RCT is to justify Medicare payment stepping aside as a gatekeeper to higher doses.

In my view there is no need for a gatekeeper (Medicare or nephrologist) because no one needing dialysis is going to willing increase their frequency if there is no benefit or if the clinical benefit to their lives is to their reckoning outweighed by the increased logistical burden. It is time for payers to step out of the way and allow patients and physicians to decide the proper dose on a case by case basis. Medicare payment should let patients, in consultation with their doctors be their own gatekeeper to higher doses.

(rev by BP for typo 11/29/08)

When an emotional view of dialysis distorts the clinical perspective

By Peter Laird, MD

Anna summarized well the prevailing attitude by many nephrologists against not only daily dialysis but in reality, dialysis of all modalities. I have wondered for several years why nephrologists take such a negative attitude towards what should be a celebration of life from a machine that will not only extend but give life to those who are well dialyzed.

My own opinion is that the failure of a patient's kidneys represents a psychological failure for the treating nephrologist. After all, the goal of every nephrology/patient relationship is to prevent "END Stage Renal Disease" (ESRD) and to keep the patient off of dialysis. The exploration of chemotherapeutic agents in the diverse renal disease process belies the simple fact that the goal is to prevent the need for dialysis in the first place. There is no doubt that America could do better with preventive care for diabetes, obesity and HTN which then lead to CKD-5, yet the simple fact remains that we have no other organ replacement in medicine by a machine that gives years of life to someone that would have expired much earlier.

A cardiologist that has a patient with end stage heart failure does not have that patient remaining behind to remind him of his "failure" to prevent the termination of the organ he was trying to protect. Likewise, a liver that no longer supports life leaves its patient dead without a transplant. There is no transplant for a failed brain.

Yet with renal patients who reach "ESRD", the nephrologist has the reminder for years of their "failure" to prevent the demise of the kidneys.

Thus, it is not the least surprising to me to hear of a lead nephrology investigator that has a negative outlook on daily dialysis. I have found in my own years of practice a negative attitude towards dialysis patients throughout many disciplines of medicine. This may stem from our exposure in residency to only the sickest patients on dialysis who are in and out of the hospital repeatedly. In addition, dialysis patients treated in hospitals often have the worst outcomes of any patient treated.

I believe that nephrology may not have failed in the primary prevention of CKD-5 since much of this relates to factors a doctor cannot control with patients lifestyes leading directly to failure of their kidneys, but it is my personal opinion that nephrologists are failing to treat CKD-5 with a high enough dose of therapy due in part to the completely negative outlook I have personally observed in my many years of practice of internal medicine.

What a sad commentary on a group of physicians given the greatest treatment option of any specialty with a machine that will sustain and in high enough doses, return a thriving life to a patient that would die early without it.

Yes, it is my opinion that nephrologists are accountable for poor use of one of the greatest gifts of life ever given to mankind.

Frequent Dialysis Studies: Questioning the Investigator

By Anna Bennett

Okarol over on IHD tracks dialysis related news articles, and I noticed one from forbes.com Creating an at-home blood dialysis industry has been a struggle

At first, I thought that it was a standard - more dialysis is good for you and here is why - story.  I applaud those stories.  But disturbingly, there were some lines that caused me to hang my head - the most shocking was:

There's also no proof from randomized trials that more frequent treatment saves lives or prevents hospitalizations. "I don't think there is sufficient evidence to justify a widespread change to six-times-a-week dialysis," says Stanford University nephrologist Glenn Chertow, who is running a big, randomized trial on more frequent in-center treatment.

I had to read that twice, and then I just shook my head.  Dr. Glenn Chertow was the principal investigator in the Frequent Hemodialysis Clinical Trials NIH Grant: DK-03-005 (reissued as RFA-DK-07-503)

With one off hand quote, this esteemed clinician has doomed thousands to a red-eye shuffle existence.  Here we are, Bill, Peter, Mel & I are trying to show people with CKD5 that more is better - Bill and I are living examples, as are so many others who have taken their health care into their own hands and pushed for more frequent home hemodialysis - and why does Dr. Chertow not see sufficient evidence for a widespread change?  I was on a 5x a week course of treatment at home on NxStage, and I started to feel the difference in my first week.  I wonder, were he to be suffering from CKD5, would Dr. Chertow be happy 3x a week in center?

And what person would submit to a randomized trial when there is nothing random about high dose dialysis outcomes?  Why be forced to be randomly assigned when there are plenty of studies out there showing that more is better?  And, home hemodialysis saves money. 

From Kaiser partners for dialysis savings:

The theory is that as patients' overall health and kidney function improves, they need fewer standard medications for anemia and other ailments that they take while on dialysis. Combined with less medical staff time, the savings could offset the cost of increased dialysis treatments.

"The observations hold promise," Branson said regarding early studies of daily in-home hemodialysis. In one study over a two-year period, for example, hospitalization for patients receiving hemodialysis at home was about 3.3 days compared with 15 days for those going to centers.

"There are patients now that can hold jobs, have hobbies, go back to school," Branson said.

And, in center Nocturnal seems to be working as well.

From ASN via Newswire Medical News  Overnight Hemodialysis Dramatically Improves Survival:

For hemodialysis patients, undergoing dialysis for eight hours overnight, three times weekly, reduces the risk of death by nearly 80 percent, compared to conventional, four-hour dialysis, according to research being presented at the American Society of Nephrology's 41st Annual Meeting and Scientific Exposition in Philadelphia, Pennsylvania.

So, let's cut to the nuts and bolts, nocturnal/extended dialysis keeps you healthier (per the Fresenius/Turkey study cited above), what about actual cost savings?

Well, with that question, I'll cite our Patron Saint of Nocturnal, Dr. John Agar who was lead author on ‘Flexible’ or ‘lifestyle’ dialysis: Is this the way forward? Nephrology (Carlton) 2005;10, 525-9 Agar JW, Mahadevan K, Knight R, Antonis ML, Somerville CA.

After first introducing long, slow, quotidian NHHD in Geelong, Victoria, Australia, the authors recognised early and significant financial savings accruing from their NHHD program. NHHD is cost-efficient—even when delivered, as in the Geelong program, at a 6 nights/week frequency. NHHD performed on alternate nights, though perhaps less clinically ideal when compared to 6 nights/week treatment, leads to even greater cost-effectiveness.

Though the Geelong NHHD program demands one machine/patient and 6 nights/week and thus doubles the consumable expenditure in comparison with conventional daytime 3/week facility-based HD, the added machine and consumable costs were soon seen to be far less than the extra wage and infrastructure costs attached to the building and maintenance of a
viable HD facility.

Commentary by Todd S. Ing, MD
Dr. Agar and associates present their excellent experience in short daily and long nocturnal hemodialysis therapies. What is more, by using the resources saved from their home long nocturnal program to support their in-center and satellite short daily programs, these authors were able to stay within a budget similar to that provided to a conventional dialysis program offering thrice weekly (3-4 hours per session) regular dialysis treatments and taking care of the same number of patients. As a result of this innovative approach, patients are given the flexibility of selecting the dialysis modality (including peritoneal dialysis) of their choice— hence, the designation, flexible or lifestyle dialysis!

I'd like to say that I get it Dr. Chertow, but I don't get it.  Why is it that we, The United States of America are so behind in our therapies?  Why are our people suffering and dying when there is a modality that works to keep them healthier?  Why are we spending tax dollars in randomized trials - when the trials have been done?  Why isn't the medical profession shouting from the rooftops "HIGH DOSE HEMODIALYSIS WORKS!"  Why is NxStage struggling in the market place?  Because our chief investigators are MIRED in an antiquated therapy.  Keeping us alive should not be the standard.  Allowing us to thrive on renal replacement therapy should be the standard of medical care.

There will always be people with varying degrees of CKD5 co-morbidities, some will only be viable for in-center therapy. In-center nocturnal has been slow to grow as well (which I believe was what was a part of Dr. Chertow's study)  But the rest of us need to be educated that there are working alternatives out there, we can lead productive lives.

KidneyTimes article dialysis dose overview

Brenda Kurnik, MD has an article up on KidneyTimes I Want More Dialysis...Please! that is a response to people asking for more dialysis, more than three times a week and/or more than 4 hours a treatment, more than what is typically offered incenter. Dr. Kurnik gives a neutral overview of the situation, giving this history without much comment:

The transition from the long thrice weekly schedule to the current schedule was probably a product of several factors.  With the advent of the 1973 Medicare coverage of dialysis there was a proliferation of free standing dialysis units and for-profit dialysis companies.  The population changed to include older patients and those with diabetes mellitus as well as other medical conditions. Dialysis times were reduced in order to accommodate three and sometimes four shifts of patients per day with a thrice weekly schedule.  High flux/more efficient dialyzers became available and the result was to reduce dialysis time in order to treat more patients in shorter treatments. The patients preferred this also, since it optimized convenience though not necessarily health.

I think a fuller accounting of this period is needed. Dialysis times were cut in persuit of economic efficiencies. There were fine words said about how high flux artificial kidneys would keep the clinical outcomes stable but in fact outcomes deteriorated. Who owned the clinics? Who decided that two hours of dialysis could ever be enough? A lot of money was taken out of the dialysis care system in the 1980s and 1990s; dialyzors are still paying the price for their greed.

Whatever the history I think Peter is right when he says it is his peers, the doctors who prescribe the dose of dialysis; our doctors must put an end to modality neutrality.

The Battle Begins (Again)

The battle for optimal dialysis here in the US is not one due to lack of evidence, but instead, the government's focus on money and not on outcomes.  Home dialysis was actually started back in the 1960's here in America for cost containment purposes in the days before Medicare funding.  Dr. Charra, who was recently honored by ISHD,  showed that nocturnal dialysis saves lives nearly thirty years ago, yet today it is talked about as a "new" way of doing dialysis. For instance, take a look at the recent article on nocturnal dialysis from news-press.com.

Nevertheless, Japan, Europe and Australia have shown that daily dialysis saves lives for decades.  Yet, here in America, the government funded program sought the minimal effective dose of dialysis and that was where the funding stopped, at three days a week with the length of dialysis so shamefully low that many over the years died for lack of effective dialysis which could have easily been provided as it was in so many other nations.  Critics of daily dialysis often cite the fact that no large randomized and controlled studies have show daily dialysis more effective than conventional, at the same time ignoring the multitude of observational studies that have shown exactly that as well as many smaller trials.  They further are completely unaware of the fact that conventional dialysis has likewise never been shown to be the most effective dosage by randomized trials as well.  All that they have are observational studies which show a horrific death rate compared to many other nations with Japan having the highest rate of survival and the lowest rate of transplant.  Is transplant really the answer for ALL CKD 5 patients?

Yet, for those that do know the benefits of this very simple treatment modality, the battle has been uphill in my opinion due in part to the relatively small numbers of people needing renal replacement therapies.  Yes, CKD affects millions, yet at any given time, most sources place the number with CKD 5 at ~350,000.  Yes, in politics, the numbers of people affected may be the most important denominator for action at the level of Washington D.C. 

Thus, in the end, even though articles such as the one above are completely in error calling nocturnal dialysis a "new" treatment, it is part of the battle for the popular press and the general public to begin a grass roots movement and then perhaps the internists and nephrologists in this nation may actually learn about the benefits of daily/nocturnal dialysis from the newspapers, their patients or the popular press.  It is clear that they are not learning it from their peers or from their training programs.  Yes, we need to educate not only the politicians in America, yet again, we need to educate the physicians who take care of all of us CKD 5 patients.  We must remember that there is not any politician that ever orders a prescription for dialysis, it is all done by physicians.  Perhaps it is time for a well educated physcian population to take back control of dialysis here in America and start treating with proven methods used by other physicians in these other nations that are not hampered by short sighted political oversight from the politicians.

Yes, the battle begins (AGAIN).

May God bless,

Peter blogging for Bill, the dialysis explorer.

More on Kjellstrand paper

Mark at Nephrology News & Issues writes about the Kjellstrand et al paper which compared daily short hemodialysis to incenter hemodialysis and cadaveric transplant. Mark does a good job explaining the paper's conclusions and what it might mean to the community and he has some correspondence from Kjellstrand including this:

If he had to go on dialysis, the Swedish-born nephrologist wrote, “I would advice long night dialysis as the first choice, short daily as the second and a transplant as the third and only if the dialysis did not go well.”

That is an unambiguous statement from a highly informed individual.

Daily dialysis outcomes rival a cadaveric kidney transplant

RenalWEB links to an advance access abstract from Nephrology Dialysis Transplantation. Short daily haemodialysis: survival in 415 patients treated for 1006 patient-years Kjellstrand et al, concludes:

Survival of patients on short daily haemodialysis was 2–3 times better than that of matched three times weekly haemodialysis patients reported by the USRDS.

A 2 to 3 times mortality advantage doing short daily dialysis suggests that long extended overnight dialysis will offer an even greater benefit. One result:

Survival of patients dialyzing daily at home was similar to that of age-matched recipients of deceased donor renal transplants.

does raise my question asked previously - should we now sell the idea of frequent home hemodialysis as enthusiastically as transplant is sold?

FDA document imagines nocturnal home hemodialysis machine

RenalWEB linked to the FDA document Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis which offers recommendations to industry about submitting a machine for the first steps towards nocturnal home hemodialysis (NHHD) approval. The FDA provides a list of:

"inherent design and operational properties, we recommend the NHHD system include several key design features, associated alarms, and fail-safe responses. We recommend you incorporate the following features:

• disinfection, cleaning, and reprocessing capabilities and cycles;
• dialysate conductivity monitor, if your device contains a dialysate mixing system;
• water conductivity monitor; if your device contains a water treatment system;
• pH sensor;
• ultrafiltration controller;
• air detector system;
• blood leak detector;
• patient disconnect preventers and detectors;
• temperature monitor;
• anticoagulant administration system;
• access port for external remote patient monitoring device;
• integrated remote patient monitor, if a component of your system; and
• fail-safe design features in the event of power failure."

I'm not sure what "patient disconnect preventers and detectors" could be built into a device but the FDA does seem keen on having numerous monitoring systems integrated into the design. I know it is a fear when one first contemplates home hemodialysis but how often does inadvertent disconnect happen (particularly excluding during the processes of cannulation or decannulaiton)? The FDA did introduce me to a new word: exsanguination. I share their desire to avoid exsanguination but where is the FDA's data to justify their fear? Many people are dialyzing over night at home, around the world and in the US - if this was a clinical concern wouldn't there be examples to point to? Wouldn't there be a case history?

The danger is that by requiring expensive and unnecessary features the FDA will make daily home nocturnal less available. Forcing people to stay with conventional dialysis is far more dangerous. Dialysis isn't deadly, kidney disease is deadly. Dialysis is the solution. The FDA should evaluate machines on their merits and the data.

Frequent nocturnal dialysis is comparably better

Renal and Urology News has an article up that looks to have come out of the recent Annual Dialysis Conference in Orlando, Long Nocturnal Hemodialysis Superior. This reports data from Wellbound about people who switched from short daily hemodialysis (SDHD) to nocturnal daily hemodialysis (NDHD). They felt better!

This matches my own experience over the last three months. However, the deniers and the haters will say the n (meaning the number of people in the study) isn't big enough and that the difference could have been due to a selection bias. But that argument gets hard to make with each new study.

Eventually, modality neutrality will end but we're not there yet.

Is daily hemodialysis a new idea?

We sometimes think challenges to the Planetary Hegemony Of Conventional  Kidney Dialysis (the PHOCK'D challenges) are something new; that it was only recently that nephrologists have suspected that more frequent and longer dialysis is significantly better for someone with CKD5 than less frequent, shorter dialysis.

From its innovate papers section Home Dialysis Central is highlighting this month an abstract of a paper originally published in 1975. Effect of long-term increase in the frequency and/or prolongation of dialysis duration on certain clinical manifestations and results of laboratory investigations in patients with chronic renal failure is by Zbylut Twardowski, MD, PhD. I suppose if he had called his paper Would more dialysis cause people with severe kidney disease to feel better? it would not have been published, but that's the question he asks. His conclusion?

In conclusion, these astounding improvements in clinical status and laboratory parameters after increased HD frequency suggests that, in the near future, a basic form of therapy in patients with chronic renal failure will be daily HD.

Near is a relative term.

If dramatic puffery should be endorsed for transplant promotion then why not for daily nocturnal?

The discussion in favor of pushing kidney donation by touting dramatic wait list numbers (discussion here but also on the CKD discussion boards), using language that describes a kidney transplant as routinely "life saving" and language that highlights the pitiful quality of life of people on dialysis hinges on comparing successful kidney transplants with conventional dialysis. Indeed with conventional 3 day a week, 3 hour dialysis the outcomes are largely dire and transplant is a much better treatment.

However, this framework begs a question. Would the many determined advocates for kidney donation also advocate for expanding the use of daily nocturnal home hemodialysis (DNHH)? The outcomes are highly similar. One would expect a 2% mortality per year on DNHH for many of the same people who expect a 2%/year post transplant mortality rate. Like kidney transplant DNHH offers a better quality of life than conventional incenter dialysis. There are trade offs, it takes me about an hour a night to set up, a minus against DNHH, but in DNHH's favor it offers the chance to take fewer medications and certainly not the powerful immune system suppressors needed with kidney transplants.

By the vocabulary logic of the kidney donation advocates DNHH is as life saving as a kidney transplant. We could say there are 60,000 people on the waiting list for DNHH (if we assume 20% of the US dialysis population should be dialyzing every night at home). "60,000 people waiting for the opportunity to be saved by a better treatment", sound familiar? DNHH you'd only need Congress to pass some laws , of course that is about as hard as talking someone out of a kidney.

The final point brought up in favor of kidney transplant, as an aside, is cost. But there again there are trade offs. DNHH offers no additional outlays by Medicare on the Part B side (and offers the chance for savings on separately billable medications) and DNHH offers savings on the Part A side (I'm assuming, that data doesn't seem to be collected). Most advocates for increased donation would also support extending the federal responsibility for post transplant medications and medical care. Right now there is no data to compare the total medical costs of someone in the forth year of a kidney transplant to someone four years into DNHH.

Now understand, would I work to have a transplant if I didn't have recurring FSGS? Sure. Even as I remember the emotional strain a failed transplant puts on recipient and donor - I would take the risk if my odds were "normal". I know what a bad transplant is like, I remember OKT3, but if I thought I had a normal shot I'd take it. I think everyone is saying that kidney donation is a good thing - the question is how accurate should be the statements from the organ procurement programs and we donation advocates? And: If it is alright to routinely call a kidney transplant life saving can we call DNHH routinely life saving too?

Try it; you'll like it. If only it was that easy.

Last Sunday Michael Fraase at Hasten Down the Wire shared his changing calculus in deciding which dialysis modality is best for his situation. No matter what comes of the process this is an important thing we should all do - take a fresh look at the options. Reevaluate. Things change - the equipment changes, attitudes change, you change.

I was sure that extended overnight treatments would not be a good fit for me. I wouldn't be able to sleep; being sleepy I would be less functional than if I just dialyzed in the evening, as was my habit. However, I was in position to try it without incurring any great costs. It turns out that I can sleep and dialyzing five nights a week is fitting very well with my life; I would not willingly change back. It's great.

I wish Michael could try home dialysis on. Take home hemodialysis for a test drive in Mel's phrase. It's no small thing to commit to training without really knowing how you'll feel and whether it fits in with all the members of the family (when I first started dialyzing at home my dog wanted to lie on my lap once I was all hooked up - which is not usual. Over time he just needed to lie in the room. Now he only comes in if he hears me getting a snack). Unfortunately daily nocturnal or short daily dialysis trial  periods are not being offered as far as I know. It would be great if dialyzors had a chance to feel it for themselves.

When weighing the options, the costs (I live in 1,000sq ft), give weight to feeling good. A lot of people, myself included, feel good most of the time. Sometimes even well.