Dialysis from the sharp end of the needle

Dialysis Goes Solar Down Under

By Peter Laird, MD

Nearly fifty years after the advent of chronic hemodialysis, a simple experiment in Australia stands to substantially reduce the cost of hemodialysis through applied solar technology.  Dr. John Agar of Geelong Australia began the first home based nocturnal dialysis (NHHD) program in 2000 modeled after the Toronto protocol of Pierratos and Uldall.  A recent cost analysis of home self-management revealed annual expenditures were $24,000/pt/year compared to $52,000/pt/year for incenter.  

Nevertheless, one of the major barriers for patients utilizing NHHD is water usage and energy usage.  Dr. Agar implemented a water conservation program resulting in up to 80% reduction in water bills for the average home patient.  In addition, electricity usage remains high especially when applied to more frequent and longer duration dialysis sessions of NHHD. Dr. Agar proposed a pilot study funded by Fresenius Medical Care by applying proven solar technology to further reduce the financial burden of extended hemodialysis and the early results are very promising.

Current data (short term)

Despite starting during winter (July 2010) in the coldest, cloudiest, wettest 3 months for >10yrs, the following operative data has been achieved:

• Days of data collection 49 days
• Machine Hours 554 hrs
• Power used (machines + R/O’s) 714 kWh = 14.57 kWh/day
• Power made (solar panels) 544 kWh = 13.35 kWh/day
• kWh used/machine/hr 1.289 kWh

Despite a period of poorer than usual solarexposure and higher than usual service use, our array is already making 91.5% of power needed. Over summer, the system should prove a highly efficient power source.

Dr. Agar plans to assess this pilot project over a full 12 month period to take advantage of the Australian summers with the hope that this program will not only pay for itselfwith in 5-8 years, but actually generate a stable income stream during the projected 25-30 years of solar panel life. Application of this technology worldwide could potentially offer improved access of lifesaving dialysis to countries unable to afford dialysis in the past.

“The ramifications of this are huge. If our project proves successful – and so far it has – then Fresenius intend to roll-out solar power for their dialysis units around Australia and even the world, modelled on our system,” Prof Agar said. 

This is just one more example of how the best medicine is still the cheapest medicine.  Working smarter saves lives and money.

Is Optimal Dialysis Ignored by American Nephrology Training Programs?

By Peter Laird, MD

Many advocates of optimal dialysis routinely note the lack of training in dialysis related issues in American nephrology fellowships. In many ways, dialysis is a task supervised by nephrologists but acted upon by nursing staff. Many patients have only brief Medicare mandated monthly visits with their nephrologist. Many of the issues of dialysis are taken care of over the telephone by the nephrologist and prearranged dialysis standing orders.

The new Medicare conditions and coverages caused quite a stir among many nephrologists when they were declared the medical director in charge of all aspects of dialysis care.  Yet, if the Renal Fellow Network can be used as a measuring stick, the abundance of published quotidian dialysis studies in the last several years appears to have been equally ignored by nephrology fellows.

The late Nathan Helman was a fellow at Mass General Hospital in Boston, Massachusetts and is arguable one of the premier training hospitals not only in America, but in the world. He started the Renal Fellow Network for the shared education of other renal fellows and today, it has a large following among young nephrologists in training. I noted the lack of attention to optimal dialysis in a post he wrote in 2008 on intradialytic hypotension which completely ignored the basic physiology of elevated ultrafiltration rates as the basic cause of precipitous drops in blood pressure during dialysis in the majority of patients.

Dr. Hellman listed several accepted methods of treating intradialytic hypotension with the noted exception of increasing the frequency and duration of dialysis which completely obviates the need for any further intervention in the majority of patients. I wrote a series of posts on this issue detailing the causes and treatment options using optimal dialysis strategies for intradialytic hypotension. (here, here and here)

Since Dr. Hellman's untimely demise earlier this year, fellows and attendings at Mass General Hospital continue his work. Unfortunately, reviewing all seventy posts in RFN under the title of dialysis reveals a trend in my opinion to overlook optimal dialysis strategies. Moreover, they readily admit their bias by characterizing optimal dialysis strategies as controversial.

Sudden Cardiac Death Rates in ESRD Patients
There are numerous potential explanations for these findings. Intradialytic weight gain is understandably higher over a 72-hour period compared to a 48-hour period, and fluid shifts during ultrafiltration might be more liable to result in hypotensive episodes that would be predicted to be particularly dangerous in those with underlying cardiovascular disease. Potassium or calcium levels may fluctuate more and therefore be more likely to result in arrhythmia.Overall, the Monday/Tuesday "mortality spike" in ESRD patients appears to reflect the intermittent nature of the currently popular three days a week dialysis strategy, and potentially points to a benefit for a more constant (e.g., daily, 6x/week, PD, etc) dialysis schedule, though this latter point remains a controversial one.

I reviewed several additional topics in the RFN dialysis section noting those same issues that DSEN and other advocates of daily dialysis write about on a frequent basis. Unfortunately, in one of the most prestigious renal fellowships in America, optimal dialysis is largely and possibly overtly ignored.

Short Daily Dialysis Improves Restless Leg Syndrome - Ignored by RFN (here)

Scribner/Oreopoulos Hemodialysis Product - Ignored by RFN (here)

Nocturnal Hemodialysis Improves LVH - Ignored by RFN (here)

Ultrapure Dialysate Improves Dialysis Related Inflammation - Ignored by RFN (here, here, here and here)

Nocturnal Dialysis Increases Middle Molecule Clearance - Ignored by RFN (here, here)  

I am very fond of the Renal Fellow Network and include it as one of my frequently read sources of nephrology related information. However, the nearly complete lack of information on any forms of optimal dialysis calls into question nephrology dialysis training in America since Mass General Hospital is a reputable leader in the field.

I suspect that attending nephrologists in many developed nations outside of America would give the posts listed above a failing grade. In my opinion, the blatant disregard of hundreds of peer reviewed papers displaying favorable outcomes for each of the conditions listed above by optimal dialysis strategies gives clear evidence that we are losing the battle for optimal dialysis in the nephrology training programs themselves. Any improvement in American dialysis outcomes must first begin during renal fellowship training if hemodialysis patients in America have any chance of attaining survival equal to the other developed nations.

Are American Dialysis Patients the new Tuskegee Syphilis Group?

By Peter Laird, MD

In 1932, the US Public Health Service in Tuskegee, Alabama commenced the ill fated Tuskegee Syphilis Trial on the natural progression of the disease when they recruited 399 African-American sharecroppers already infected with syphilis.  None of the participants were ever told what the study was about and when penicillin became the accepted treatment in 1947, none of the participants were treated.  In addition, the government took active steps to prevent any of the participants from being treated in a study that only ended in 1972 after leaks to the press caused widespread public outrage.

Tuskegee Syphylis Study

The study, which lasted for 40 years included only sporadic clinical reexaminations when a Public Health physician came to Tuskegee and denied the individuals any form of anti-syphilitic therapy. In fact, in 1942 when it was brought to the attention of the then Assistant Surgeon General, Vonderlehr that some of the syphilitic subjects were being called for examination prior to induction into the Armed Forces and were being directed to undergo treatment systematic steps were taken to preserve the investigation. To prevent the draftees from receiving anti-syphilitic treatment, the investigators provided the Macon County Selective Service Board with a list of 256 names of men under the age of 45 years who were to be excluded from the list of draftees needing treatment. The Board agreed to exclude these men. Furthermore, when the modern-era of anti-syphilitc therapy began in 1943 with the introduction of penicillin as an effective drug, the Public Health Service did not use the drug on the Tuskegee participants unless they asked for it.

Today, once again in America, under a government controlled program, dialysis patients are the subject of intense study, but at present, only approximately one percent of us have access to optimal hemodialysis delivered in the comfort of our own homes.  A recent article quantitating mid arm muscle mass and survival concluded with the following statement:

Mid-Arm Muscle Circumference and Quality of Life and Survival in Maintenance Hemodialysis Patients

Conclusions: Higher MAMC is a a surrogate of larger LBM and an independent predictor of better mental health and greater survival in MHD patients. Sarcopenia-correcting interventions to improve clinical outcomes in this patient population warrant controlled trials.

American dialysis patients have a worse projected survival at time of diagnosis and intervention than the average breast cancer or prostate cancer patient.  Although the need for confirming treatment options is real, we already know much on how to impact survival in a cost effective package that somehow never translates into actual patient care.  I could easily list dozens of well done observational dialysis studies that have a similar conclusion for more study, yet the mortality rate in American dialysis patients remains unchanged for decades.  It is time to implement and not simply study effective measures now as many patients do not have the time to wait for a randomized and controlled trial to confirm what we already know.  

The deaths of those poor sharecroppers allowed to die for the sake of knowledge in the Tuskegee study haunts us today as we watch another government controlled patient population languish while we do nothing to change their fate.  There is not a single nephrologist today in America who could not immediately impact all of his patients by the simple stroke of his prescription pen.  Yet, instead, the American nephrology community continues to wait for the randomized and controlled studies that will likely never come. I would hope that the American academic nephrology community would not only call for more studies, but better yet, call their nephrology colleagues to action. Lives are lost daily because we have yet to act upon that which we already know.

NxStageUsers Conference Pioneers Home Hemodialysis

By Peter Laird, MD

I just returned from my quick trip over to Las Vegas for the NxStageUsers conference where RIch Berkowitz put together an impressive list of home dialysis leaders including Dr. Alan Hull, Medical Director of NxStage, Dr. Robert Lockridge who has the largest nocturnal dialysis cohort in America and Dr. Michael Kraus, lead investigator of the FREEDOM study on outcomes in a NxStage cohort of 500 patients.  The take away message from all of their talks on the opening morning of the conference is that more frequent, longer duration dialysis needs to supplant the usual incenter care of short, rapid and unfortunately high mortality dialysis as practiced in America.

I was able to meet Dori Schatell of the Medical Education Institute in person for the first time.  She has been involved in the renal community for years and is someone instrumental in my education on home dialysis issues.  Gary Peterson of RenalWeb will be talking as the last speaker of the conference on Tuesday the 12th. Many patients and care partners are participating in this conference and it was great to be able to meet up with Patricia Colongione, Linda Upchurch, Denise Eilers, Harvey Wells, Rich Berkowitz, Dan Larabee, David Rosenbloom and so many other kind and involved patients and advocates. The heart of the conference is the pioneering spirit of all of the NxStage users waging the battle against American style dialysis by taking it home.

Joe Turk, Senior Vice President of NxStage gave an overview of the history of NxStage in its development phase as well as to the point of profitability in the last quarter for the first time since beginning operations.  NxStage is the first commercially successful home dialysis venture to date. This company and this little machine is singlehandedly keeping the issue of home dialysis at the forefront of American nephrology when all other home modalities continue to diminish.  At the same time, home dialysis in some nations is the preferred option.  NxStage is leading the way to economically viable home dialysis in America and their story should serve as encouragement to all patients considering this option.

The NxStageUsers group is composed of a diverse population of patients, care partners and health care professionals all who share the single common goal of broadcasting the benefits of more frequent and longer duration dialysis therapy.  It is time for their voice to be heard loud and clear.  It is time for America to embrace the concept that more dialysis is better dialysis.  Dr. Allan Hull I believe it was that pointed out that dialysis patients have never come together before as a united group in a conference like this.  It is time that the patients themselves take center stage in demanding better dialysis outcomes that can truly only be achieved through home hemodialysis in those patients unable to undergo renal transplantation.  It is an alternative whose time is 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.

Glenn Chertow, MD to give ADC 2011 Keynote Address

By Peter Laird, MD

The Annual Dialysis Conference is the best place to watch and learn about optimal dialysis trends not only in America but from around the globe. The tone of the conference is often highlighted in the key note address by one of many leading researchers and dialysis advocates. Past key note addresses in prior conferences still resonate in the lecture halls as data and information is not only presented but at times debated with great passion. Carl Kjellstrand spoke with great conviction two years ago in his keynote address against randomized controlled dialysis trials (RCT) and how they were not needed nor ethical in dialysis patients with over 40 years of solid evidence from observational studies showing great benefit of longer and more frequent dialysis schedules.

The legacy of Dr. Belding Scribner's dedication to bringing about optimal dialysis in America is often the subtext of the keynote address. Perhaps no where else is optimal dialysis championed as eloquently than at the Annual Dialysis Conference put on by the University of Missouri for over 30 years. I recently reviewed the upcoming program for the ADC meeting in February 2011 in Phoenix and found that the keynote address will come from Dr. Glenn Chertow. Dr. Chertow is a renowned nephrologist now at Stanford University and researcher involved in many of the dominant studies of the last two decades.

The HEMO study is a randomized, controlled trial that showed no benefit to high flux, high intensity hemodialysis maximizing Kt/V in conventional hemodialysis regimens. The result of this study and it's negative outcome led to questioning of the entire optimal dialysis strategy that was just gaining ground at that time with the the results of the Toronto group's nocturnal dialysis program. Dr. Chertow vocally championed the cause of further randomized and controlled trials to prove all aspects of optimal dialysis before adopting more frequent and longer duration sessions in America. In fact, DSEN has written several posts (here, here and here) in opposition to his dependence on randomized and controlled trials before going forward with the same type of programs that are already used with great success in Japan, Europe, Australia and New Zealand.

Dr. Chertow's upcoming keynote address is based on another study published in Kidney International earlier this year titled: Shorter dialysis times are associated with higher mortality among incident hemodialysis patients. The interesting aspect of this study is not only the astounding conclusion that shortened dialysis times less than 4 hours/session resulted in over 42% increased mortality, but that the conclusions were obtained not from a RCT, but from an observational trial. The simple fact that the Keynote address is by Dr. Chertow using an observational trial and not waiting for confirmation from a RCT is in my opinion big news for the dialysis industry.

Are the winds of time changing in the American dialysis community? Is this also prognostication of the results of the soon to be released Frequent Hemodialysis Network studies on short daily hemodialysis as well as daily nocturnal dialysis in which Dr. Chertow is a principle investigator? Perhaps my optimism for implementing optimal dialysis is overwhelming me with hope, or perhaps we are about to experience the paradigm shift that Mel Hodge wrote about so eloquently earlier this year. The path to a paradigm shift in hemodialysis:

About 1 out of 4 American conventional dialysis patients die in the first year and 3 out of 5 die within 5 years with no favorable trend in sight. Largely ignored in practice is the evidence accumulated over decades that longer, more frequent dialysis can immediately slash this grim result in half or more. Pierratos has called for a paradigm shift—a disruptive change—in dialysis practice from conventional treatment to daily nocturnal dialysis, performed at home, to realize this dramatic improvement. We examine here how such a paradigm shift might be brought about and suggest that changes in 3 perspectives must occur. First, new dialysis guidelines must be recast from the old goal of minimally adequate to a new goal of best possible. Second, the body of dialysis research must be interpreted through the lens of best possible patient survival and well being, and the near-impossibility of demonstrating dialysis survival advantage through randomized clinical trials must be acknowledged. Finally, dialysis modality must be seen as, most importantly, a survival and well-being choice, not merely a “Lifestyle” choice; hence, it must be the nondelegatable responsibility of the physician, not dialysis center personnel, to advise and prescribe. Many old perspectives, which might stand in the way of this sorely needed paradigm shift are also examined. These old perspectives make up a fabric of excuses that has delayed—and, if not discarded, will continue to delay—progress toward a survival and well-being outlook for dialysis patients just as favorable as might be achieved through kidney transplant.

Whatever the outcome of Dr. Chertow's keynote address, I believe that a true paradigm shift is in the making. The standard of dialysis care can no longer be that of minimum standards but instead that of maximizing patient survival and rehabilitation which are precisely the goals of therapy long advocated by Dr. Scribner. It is time to come full circle and realize that the pioneers of dialysis did it right by focusing on patient rehabilitation as the objective measure of dialysis adequacy instead of reliance on the laboratory based Kt/V. Dr. Chertow's keynote address on length of dialysis sessions is a welcome addition to the Annual Dialysis Conference not only for the data and evidence that he shall present, but more importantly because of the underlying message that he will send loud and clear in presenting evidence from an observational study as the basis of the 2011 ADC keynote address.

Vindication for the Hemodialysis Product

By Peter Laird, MD

RenalWeb's Gary Peterson posted a recent article that in many ways is a vindication of the HemoDialysis Product proposed several years ago by Dr. Scribner and Dr. Oreopoulos in an article titled: The Hemodialysis Product (HDP) A better index of dialysis Adequacy than Kt/V.  

The underlying premise for the HDP is Babb's Middle Molecule theory of dialysis which is not accounted for by the Kt/V concept of adequacy.  Scribner and Oreopoulos argued that the Kt/V measurement is inadequate in that it only deals with the fast diffusing urea, arguably a nontoxic molecule, and it fails to take into account time dependent molecules such as B-2 microglobulin and phosphorus which acts like a middle molecule.  

Removal of these time dependent middle molecules depends on the duration of exposure to the dialysis membrane. Removal is independent of blood flow rates, ultrafiltration rates and even, to an extent, the clearance rates of the artificial kidney. Time is the key variable and this is what allows for the elegant simplicity of the HDP.

HDP = (hours of dialysis per session) x (sessions per week)²

However, despite the theoretically application of the Hemodialysis product as a measure in support of the Middle Molecule time and frequency dependent theory, it never caught on in the dialysis community and in fact was widely rejected for the widely used Kt/V adequacy measurement. However, a recent article in Hemodialysis International by Kjellstrand, et, al brings the Hemodialysis Product back to the forefront of dialysis measurements:

Survival with short-daily hemodialysis:  Association of time, site, and dose of dialysis

Short-daily hemodialysis can be too short. In this series of patients, every extra hour spent on dialysis was associated with better survival. This finding is in agreement with those of others analyzing thrice-weekly dialysis and interestingly is seen in patients treated by long night hemodialysis, where the weekly dialysis hours are 2 to 4 times long than in our patients on SDHD.

The dose of dialysis as expressed by Kt/V was not associated with survival. This finding is in agreement with similar results reported in patients on long-nightly dialysis.  I has to be tempered with the fact that theses daily hemodialysis patients, except for 2, had weekly stdKt/V of 2 or higher and almost one-third had a Kt/V of 3, much above that recommend Kt/V of 2, to for "adequate dialysis" in the United States. Particularly in the United States, Kt/V, while reasonable to compare dialyzer efficiency, has taken too much precedence over the fact that a very important role of the kidneys is to maintain homeostasis. . .

We have over forty years of experience with SDHD with all of the studies revealing more frequent and longer weekly duration of dialysis reduces morbidity and mortality as well as promoting patient rehabilitation.  The goal of the pioneers of dialysis was quite simple, to render a fatal disease treatable at last and to return the patient back to a productive life.  The greed based, American style, short, rapid and violent hemodialysis sessions as practiced in the majority of incenter dialysis units is the cause of our excessive mortality in the last three decades as compared to Japanese, European and Australian/New Zealand providers that offer longer duration dialysis as the common standard.

It is time to put Kt/V into its proper perspective and adopt instead the Scribner/Oreopoulos Hemodialysis Product as our basic objective measure in combination with the most important measure of all, rehabilitation of the dialysis patient.  Time and time again, the practices of the dialysis pioneers with longer sessions in the comfort of the patients home is the only manner in which America shall once again mitigate the shame of our excessive mortality rate among dialysis patients. Indeed, it is not only the excessive mortality rate that cries out to us from studies such as this, but the loss of quality of life that could easily be restored within the framework of "cost effectiveness" in the savings from preventing the prevalent complications of dialysis.  The spirit of Dr. Scribner sounds out loud and true to do that which is right and just for our patients.

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?

Taking NxStage System One to the Max

By Peter Laird, MD

Since starting on the NxStage System One in June of 2009, I have continued to look for its maximum efficiency in my own personal treatments just as I did while doing self care incenter.  One of the frustrating aspects of using the NxStage machine is the lack of available medical studies on specific issues. The Nxstage literature base is quite incomplete at this time and many more studies need to be completed. Fortunately, we have a recent publication from Hemodialysis International that begins to answer some of these questions of how effective is the NxStage System One when compared to the standard incenter thrice weekly dialysis at the level of solute kinetics (thanks to RenalWEB for highlighting these articles). Solute kinetics with short-daily home hemodialysis using slow dialysate flow rate:

The weekly treatment time for the patients averaged 17.4 h/wk, a figure higher than the average weekly treatment time embraced by many US in-center dialysis units where a thrice-weekly regimen is practiced. The removal rates and clearance values in the present study should therefore be interpreted in the context of increased weekly dialysis time. While the low dialysate flow rate reduces urea removal, the increase in the frequency of the treatments improves it. In the case of phosphorus and β2M, increased dialysis time is more critical for their removal and compensates for the low dialysate volume.

In my own review prior to starting the NxStage System One last June, I noted that the relationship between NxStage dialysis flow rates and clearance is nearly linear until you go over a dialysate flow rate of 200 ml/min.  Most recommendations for the dosage of NxStage are based on the Filtration Fraction (FF) or percent dialysate flow rate compared to blood flow rate.  However, when looking at the actual flow rates instead of the FF, it is my belief that the recommended NxStage dosages are simply too low.  In my case, at 90 kg, the NxStage dosage recommendation is 20L with a FF of 35%.  In my training, I started on this dosage which I did not find adequate for improving my symptoms and my energy levels even though I did hit the targeted Kt/V of 0.5 with 20L.

When I went home, we started at 30L, FF 35% with my Kt/V improving to 0.77.  With a blood flow rate of 360 to minimize my venous and arterial pressures, the actual dialysate flow rate is 126 ml/minute completing treatment in 238 minutes (3 hours and 58 minutes).  My phosphorus (PO4) level increased by 30% from my usual incenter values on the 20L regimen despite continuing the same restrictive diet. Dr. Scott Rasgon likewise found this in his published data of NxStage users in their program at Kaiser Permanente Sunset medical center. Due to the concern of long term PO4 elevations and looking at the clearance charts for NxStage, I approached my nephrologist about going outside of standard NxStage parameters to maximize the effective volume of dialysate to see if I could improve my PO4 levels, which act like a middle molecule.  He agreed to increase my dosage to 40L of dialysate at a FF of 45% (162 ml/min dialysate flow rate) to keep the treatment time near the four hour level of my 30L treatments.  I was pleased to find my energy levels improved as well as increasing my spKt/V to 0.93, 86% higher than at my 20L dosage, and my PO4 levels returned to my pre-NxStage levels at 3.5 from the 4.6 level on the lower 20L dosage without any binders which I have not ever been on to date.

20L Time 158 minutes  FF 35%  (BFR 360/min - DFR 126/min) spKt/V- 0.5
30L Time 238 minutes  FF 35%  (BFR 360/min - DFR 126/min) spKt/V- 0.77
40L Time 246 minutes  FF 45%  (BFR 360/min - DFR 162/min) spKt/V- 0.93

NxStage dosing is supported by the Standardized Kt/V value of 2.0/week with in center thrice weekly dialysis per KDOQI standards.  The single pooled Kt/V (spKt/V) values are not linear which means you can’t simply add the daily values to obtain a weekly value.  The level of spKt/V of 0.5 comes from the fact that this will produce a Standard weekly Kt/V (stKt/V) of 2.1 which falls within the recommended KDOQI standards. Northwest Kidney Centers has set their weekly stKt/V at 2.5 (PDF link) which is also the standard weekly Kt/V goal of the Frequent Hemodialysis Network as well.

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials:

The target weekly or standard Kt/V for urea in the current frequent hemodialysis trials will be approximately 2.5 in the conventional thrice-weekly arm, 3.8 in the daily in-center hemodialysis arm, and 5.6 in the nocturnal arm.

I greatly appreciate the recent study from Hemodialysis International on the solute kinetics of the NxStage at standard recommended dosages.  However, I must question from my own personal experiences with the NxStage System One whether maximizing the efficiency of dialysate flow rates paradoxically reduces the maximum clearances at the patients level.  It is certainly a wonderful thing to watch numbers and efficiencies improve, but if it does not translate to maximum patient benefits then we should abandon this approach and look at maximizing total dialysate dosage for patients on the NxStage instead.  For an increase of dialysis time by over 30%, I gained an 86% increased spKt/V and ~25% reduction of my phosphorus levels by exceeding standard NxStage dosage recommendations as well as using a higher Filtration Fraction.  The theoretical loss of dialysate efficiency at higher dialysate flow rates and Filtration Fractions may be offset by a simple increase dialysis dosage that translates into higher urea, phosphorus and B2M kinetics as I found in my personal NxStage experiences.  This simply question has not yet been answered in the NxStage literature, but it needs to be considered.

How good can the NxStage machine be if taken to the max?  Indeed, optimal dialysis paradigms operate on the simple concept of maximizing frequency, time and clearances in standard machines.  It is time for investigators to explore this aspect of the NxStage System One noting urea, phosphorus and B2M clearances over a broader range of dialysate flow rates and Filtration Fractions which will allow higher total clearances comparable to standard incenter machines.  My own anecdotal experience suggests that there is significant room for improvement over standard NxStage dosage paradigms (PDF link) published to date that should be explored to eliminate the low clearance shortfall that has kept many nephrologists from recommending the NxStage to their patients despite the advantages of having a portable machine.  It is time to take the NxStage System One to the max.

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.

Is Evidence Based Medicine the Main Barrier to Optimal Dialysis in America?

By Peter Laird, MD

Since the advent of hemodialysis availability in the 1960’s, practitioners have searched for the most optimal way to utilize this life saving technology.  Historical reviews of the pioneering days of hemodialysis reveals experimentation on how frequent and how long we should administer dialysis to patients in need of renal replacement therapy to optimize outcomes.  Surprisingly, the modalities that we now refer to as new and novel were actually described and utilized very early in the course of dialysis experimentation.  Dr. Shaldon was the first nephrologist to prescribe home, nocturnal hemodialysis in 1964 both in London and in Germany followed shortly by Dr. Scribner in Seattle. Dr. Bernard Charra continued overnight hemodialysis in Tassin, France in the 70’s and 80’s with excellent results that were largely overlooked for decades.

The modern era of home, nocturnal hemodialysis reemerged in 1993 in Toronto, Canada by Drs Robert Uldall and Andreas Pierratos. The published observational data from multiple centers utilizing home, nocturnal hemodialysis 3-7 times/week reveals improved anemia control, normalized blood pressure, normalized mineral bone metabolism, normalized functionality and reduced mortality and morbidity compared to conventional incenter dialysis. A recent study with twelve years of follow up showed equal survival with daily, nocturnal hemodialysis as compared to cadaveric transplant. Despite an abundance of observational data and practical experience from Canada, Australia, New Zealand and other nations that have adopted the concept of optimal hemodialysis modalities, America continues to view optimal dialysis modalities with skepticism.

Today, America stands alone as the only developed nation not convinced of the overwhelming evidence that more frequent and longer duration dialysis saves lives.  America also stands alone with an alarming mortality rate among dialysis patients 2.5 times higher than Japan. American healthcare continues to insist on randomized, controlled trials showing the benefits of these alternative dialysis strategies over conventional incenter care even though they readily admit that it is impossible to randomize the 3000 to 5000 patients needed for such a study.  The Frequent Hemodialysis Network is actually unable to recruit even 250 patients for their ongoing nocturnal dialysis study let alone a study with enough statistical power to show a 30% difference in mortality from conventional incenter dialysis. Patients that are knowledgeable of the benefits of extended dialysis are routinely denied access to these life changing home therapies by their insurance companies who allege a lack of evidence of their benefit.

Group Health - Clinical Review Criteria:

Frequent Home Dialysis, Nocturnal or Short Daily
There is insufficient evidence that home nocturnal dialysis improves important health outcomes compared to in-center dialysis. An RCT found improvement in LV mass and phosphate level, intermediate outcomes, and mixed findings in QOL. There is weak evidence from a single cohort study that nocturnal dialysis lowers the rate of dialysis-related or cardiovascular- related hospitalizations. In this cohort study, all-cause hospitalizations did not decrease significantly.  

To date, we have the benefit of only one small RCT on nocturnal hemodialysis which confirmed many of the findings of prior observational studies showing significant benefits of more frequent and longer duration dialysis. America continues to stand alone in it’s call for the highest academic standards of dialysis healthcare, while paradoxically delivering the worst dialysis outcomes anywhere in the civilized world.  America’s search for the holy grail of dialysis evidence based medicine with an optimal randomized  controlled trial that is admittedly impossible to ever complete is nothing but tilting at windmills. 

While America charges ahead with protests of academic purity before accepting the proven benefits of optimal dialysis, patients are needlessly dying at the hands of our own nephrologists who blindly forgo these lifesaving treatments.  While the world embraces optimal dialysis, America instead worships at the altar of optimal randomized controlled dialysis trials which shall never be completed.  It is time to end this quixotic quest, we must stop fighting the windmills of academic purity. Instead let us be inspired by the great pioneers of dialysis in the fight against our true foe, the uremic milieu of too little dialysis and simply ask the dialyzed what frequency and duration of dialysis makes them feel better.

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.

Baxter takes first steps towards home hemodialysis 510K

By Bill Peckham

On Thursday Baxter reported third quarter results and activity highlights including:

Filing an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) to begin a clinical study to collect safety and effectiveness data required for a 510(k) application for a new home hemodialysis system.

A new home hemodialysis system. How exciting.

How does the proposed expanded bundle effect home dialysis?

By Bill Peckham

Sign up for Nephrology News & Issues' webinar on Wednesday October 21, 3PM EDT -  Can home dialysis survive in the bundled payment era?: 

With dialysis payment reform approaching, some concerns have been raised in the renal community about how home therapies will be reimbursed. Will the proposed "bundled"payment provide enough financial incentive for dialysis providers to offer home therapies? This hour-long Webinar will examine the value of home vs. in-center therapy, how to set up and manage such programs, and how Medicare plans to compensate providers.

It's going to be an action packed hour and I'll be one of the people talking.

It's a new format from the webinars I've been a part of at Home Dialysis Central, this will be my first webinar panel. Mark Neumann, Executive Editor, Nephrology News & Issues will moderate essentially a panel of five: four people from industry and me. After you sign up to attend the webinar check out the E-Poll on the NN&I home page - the results are only surprising in that nearly 10% would choose incenter hemodialysis. I'll assume they were thinking of incenter nocturnal.

Lessons to be learned from advances in Type 1 Diabetes Care.

By Brian Steele-Sierk

In the Early 1970's type 1 diabetes care and stage 5 chronic kidney disease (CKD5) care in the United States were very similar.  Both used infrequent therapies (1 insulin shot per day, 3X4 in center hemodialysis), monthly blood chemistry tests (indirectly, in the case of urine glucose sampling), and both carried an expectation of severe long term complications.  In the intervening decade, diabetes care and outcomes have changed and advanced rapidly, to the point where University of Washington Researcher Dr. Irl Hirsch can say "people diagnosed with Type 1 diabetes today will not have to deal with significant complications later in life."

The same can in no way be said about people today receiving a CKD5 diagnosis.  The vast majority will suffer from and die from complications arising from insufficient dialysis resulting in poor control of the disease.

I am a type 1 diabetic, as is my father, brother, and daughter.  My father and I are also CKD5 patients as a result of our diabetes.  He received a Simultaneous Kidney/Pancreas transplant in 1995, and  I am currently dialyzing with the NxStage System One at home, doing extended daily home hemodialysis.  I have seen firsthand the development in diabetes care from the early 80's to the present. I have also seen a lack of significant development in the care of CKD5 in the same time frame. I can't speak definitively as to the causes of the disparity in development, but I think there are some things that Dialysis can learn from Diabetes.

First, diabetes therapy has sought to more closely mimic the natural processes that it seeks to replicate.  Natural insulin is released at a low level constantly, and at greater quantities (a bolus) when triggered by ingestion of carbohydrates.  Insulin therapy has gone from one shot a day to multiple shots of differing insulin that have different medication profiles, to wearable pumps that constantly infuse insulin.  The huge majority of dialyzors are still stuck on a 3x4 incenter hemodialysis regime that is as far from natural kidney function as you can get while not being dead. Extended home hemodialysis is much closer to natural function than 3x4 incenter, but has  a miniscule adoption rate, and is still viewed as experimental by many in the field.

Second, the external feedback loop in diabetes therapy has gotten much smaller.  Glucose testing has gone from monthly urine collection, to daily urine collection, to daily strip testing, to daily digital monitoring, to constant glucose monitoring.

The testing in CKD5 care is still on a monthly basis. This is in spite of the fact that potassium, sodium and urea levels vary widely based on diet activity, dialysis prescription, etc. Care will improve when we as dialyzors can know that we are hypo- or hyper-kalemic instead of just guessing or suspecting that we are.

Third, the expectation of caregivers must change. When my daughter was diagnosed with Type 1 diabetes in 2008, the expectation was there that she would test 5-6 times a day, and that she would prepare to get a pump, and maybe a constant glucose monitor.  When I was in the hospital for kidney failure, I was told that I would dialyze 3 days a week, even though my nephrologist and technicians giving me dialysis were aware of home hemodialysis.  It is true that many type 1 diabetics are non compliant patients, and do not seek the top level of care available to them. However, the top level of care is seen as the goal, and non compliance, while possibly the norm, is labeled as such. In treating severe kidney disease, those that seek daily, nocturnal home dialysis are seen as outliers, and people getting 3x4 hemo in center, which we know is insufficient, are seen as the norm.

Here's to hoping that technology can make this discussion obsolete.  Until then we need to keep pushing for better therapy, tighter feedback, and higher expectations of patients and care.

National Review Online misunderstands USA Today article

By Bill Peckham

John Graham has a post up on the National Review Online healthcare blog, Critical Condition. Kidney Dialysis: The Price of Government Monopoly works hard to draw incorrect conclusions about the provision of dialysis in the United States.

Graham takes issue with Rita Rubin's USA Today article contention that in 1972, before the launch of dialysis coverage under Medicare "Only the wealthy could afford long-term treatment." (I'd say that's true. Aside from those with strong community support, only the wealthy (or well insured) could afford the long term costs.) Graham finds fault writing:

The truth is different, according to a fascinating chapter by Richard A. Rettig in the book Biomedical Politics (pp. 176-214). Dr. Rettig reports that effective dialysis was an emerging technology in the 1960s.  The innovators founded the American Society of Nephrology in 1966 (p. 181).  "Nephrologists trooped to Seattle in the early 1960s to learn how to perform dialysis, and programs sprang up across the country, each growing over time as means were found to finance treatment." In the late 1960s, "there were fewer than 1,000 patients being dialyzed in the entire country, but that number had been increased to approximately 10,000 by the time the 1972 legislation was adopted" (p. 182)"

USA Today reports that there are 350,000 patients undergoing dialysis today. The overall population has increased by 45% (from 210 million to 305 million), so we can reasonably assert that the eligible population for dialysis in 1972 was about 240,000 patients. At the rate of growth prevalent until 1972, it would have taken seven more years, until 1979, for the private sector to cover everyone. But it's reasonable to assert with confidence that the pace would likely have accelerated as the technology was broadly accepted as effective.

I can't say I understand the point he was trying to make, it was largely the nonprofit sector (not the "private sector") that had steeped up to cover those 10,000 people in 1972, but I can say his idea of a reasonable assertion is spectacularly wrong.

A quick check of the USRDS Annual Data Report for 1994 presents some actual numbers. There weren't even 240,000 people on dialysis in 1991, it was 1981 before the 75,000 mark was broken. It's a reasonable assertion that Graham knows nothing about the provision of dialysis generally or in the US specifically but that isn't going to stop him from continuing to dig:

So, things were actually progressing pretty well until the government crowded out private coverage.  I suppose dialysis patients were just unlucky, that significant medical breakthroughs were happening just as the government succeeded in its first phase of taking over Americans' access to medical services.

If President Obama achieves his goal of completing the government's take-over of Americans' access to medical services, expect every medical treatment available in 2049 to be (at best) unchanged from those available in 2009.

Graham wants to use the ESRD program to reinforce his preferred healthcare policies but as with his previous numbers assertions this too has obvious problems.

The reason we in the US know we are under preforming in the provision of dialysis is that our industrial world peers are getting much better results. Our peers and allies, who mandate healthcare access for all citizens, achieve better clinical outcomes while spending less money. Graham's explanation for our under achieving dialysis outcomes, that government crowded out private coverage, isn't correct. What is missing from Graham's history is the other shift that happened with the advent of the dialysis entitlement under Medicare. The shift from community based nonprofit dialysis, to corporate, for profit dialysis.

When those "Nephrologists trooped to Seattle in the early 1960s" what they saw at the Northwest Kidney Centers (then the Seattle Artificial Kidney Center) was dialysis based on volume control and how the patient felt; provided through a nonprofit community based outpatient dialysis unit. That was Scribner's vision, a vision for optimal dialysis.

What took over in the US after Medicare came in was for profit dialysis. Dialysis as it was imagined at the Brigham and based on the clearance of urea - a harmless, tiny and therefore easy to remove molecule. First with National Medical (now Fresenius), for profit dialysis centers today provide over 80% of US dialysis treatments. The cost of profit and an acceptance of adequate is a better explanation for the US's dialysis under performance.

CMS responds to Harvard letter; continues to punt

By Bill Peckham

RenalWEB and NephrOnline has CMS's response to the Harvard letter . The undated letter from Dr Straube, CMS's chief medical officer, is about what I expected but for those of us advocating for optimal dialysis it is disappointing none the less.

Straube list four points; it's point number two that gets to the heart of the matter:

There is disagreement, often due to a lack of sufficient evidence, for many of the proposed clinical interventions and initiatives that patients, providers and suppliers sometimes raise as solutions to ESRD treatment shortcomings. Any major changes we consider in the ESRD treatment and payment arena should, as a general rule, be based on sound, documented evidence, not opinion.

This is the randomized controlled trial issue.

I think DSEN's position should be clear by now - RCTs weren't used to entrench the three day a week schedule and doing one now has innumerable technical problems. A RCT is not going to happen soon, and maybe can't happen short of introducing renal replacement into a naive population (a country that currently has no renal replacement) and randomizing people there.

Peter's post on Tuesday said it best, Optimal Dialysis Deserves a Trial of Life in America. It is a matter of life and death. Waiting for some imagined perfectly executed RCT is not an acceptable option.

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.

USA Today reframes what ESRD program success would look like

By Bill Peckham

RenalWEB linked to a USA Today article by Rita Rubin Dialysis treatment in USA: High costs, high death rates. I think Rubin did as good a job explaining the unexplainable as anyone I've read - certainly in the mainstream media. I have to admit I thought the paper skimmed issues, boiling them down to a graph but this was an in depth article. I'm looking at USA Today in a new light and not just because they quoted me, I think the article broke new ground.

Kaiser's coverage of the USA Today's article makes clear that the failure of the ESRD Program is the low use of optimal dialysis. The USA Today article even used the word optimal in reference to dialysis:

The vast majority of the more than 350,000 Americans on dialysis are treated in centers, where three treatments a week, three or four hours each, is the norm — not because it's optimal but because that's the way it has been done for nearly four decades.

That's as close as we've been to having the main stream media identify optimal dialysis as our goal.

Rubin did give the context against which CMS is demanding a Randomized Controlled Trial (RCT):

When Medicare's kidney-failure program started in the early 1970s, "the science was such that somewhere between three and six hours of dialysis three days a week was sufficient. Things sort of settled into that pattern," says Dallas nephrologist Thomas Parker III, co-organizer of the conference at Harvard's Beth Israel Deaconess Medical Center.

So in order to improve on a regime settled upon because it was sufficient we need a RCT? Under the circumstances observational data coupled with properly credited savings, due to fewer hospitalizations, should be all we need to go forward with accommodating more frequent dialysis in the new expanded bundle payment framework.

US News & World Report article reports benefits of nocturnal hemodialysis

By Bill Peckham

Okarol at IHD links to an article in US News & World Report For Some Kidney Patients, Home Dialysis Is Better Evidence suggests nighttime treatment yields better results. My experience matches the results reported in the article which is generally very good. The article does a good job backing most statements with references to current research. However, starting with the title it is clear that the writers at US News aren't completely sold on the nocturnal option.

"For Some Kidney Patients ..." why just for some? In the article they claim in regard to nocturnal home hemodialysis:

Experts say it's not for everyone, particularly people with other serious medical problems, such as cardiovascular disease.

What experts say that? What study showed that?

If anything frequent nocturnal home hemodialysis should be the first choice of people with cardiovascular disease and CKD5. One of the ways nocturnal hemodialysis is healthier is that is let's you remove fluid slowly, this combined with higher frequencies makes the modality the most heart friendly form of dialysis. With frequent nocturnal hemodialysis fluid buildup/rapid removal does not routinely strain the heart, which can happen with conventional dialysis. Change that sentence to "Experts say it is for everyone, particularly people with other serious medical problems, such as cardiovascular disease" and you would have an A+ article.

KidneyTalk explains the significance of the dialysis bundle & CMS's rule making process

By Bill Peckham

A new KidneyTalk is up with Lori Hartwell and Mike Paget talking about the pending change to the way Medicare reimburses for dialysis. This KidneyTalk gives a good overview of the history of Medicare reimbursement for dialysis and the process that will unfold over the next few months. While reading the dialysis bundling Q&A, listen to the podcast:

Congress passed legislation last year that will require CMS to write the rules on the payment policy for dialysis services. Mike Paget, who has many years experience in the dialysis community will explain how the renal community can be sure to be involved in the process. Any day now CMS will publish a "proposed rule" on the new payment policy for dialysis care, in the Federal Register. The community will have 60 days to comment, after which CMS will review the comments to establish the final rule. Listen to the show and learn how you an make an impact and what some of the key issues are.

It's a good show. There is a lot to cover. At the 6:30 minute mark Lori gets into the meat of the process by asking how Centers for Medicare & Medicaid Services (CMS) and Congress interact. Mike outlines the point of interaction: the comment period after the rule change has been published in the Federal Register.

At the 15:40 Lori outlines the changes around how quality measures are used. These changes are meant to create incentives for quality care by threatening to deduct 2% from payments. An important question for CMS to decide is what has to happen for 2% of reimbursement to be withheld? There are about 6 quality measures. The rule making will establish the quality targets and the repercussions for not meeting the targets. Mike and Lori do a good job explaining the process and putting CMS's pending action in the context of legislation, HR 6331, the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008.

The MIPPA legislation is the framework that will guide CMS through their process of crafting rules to implement the legislation. You can scroll through the whole MIPPA, or just check out the tiny bit that directly impacts the provision of dialysis: Section 152 and Section 153. The legislation left these key issues for CMS to sort out through its rule making process:

• Unit of payment: Will the bundle be per treatment, per week, or per month of services? Most in the renal community would prefer payment to be made per treatment.
• Scope of services: Exactly which lab tests, drugs, and other services will be included in the bundle? This is not yet clear, but will be included in the Proposed Rule from Medicare expected this summer.
• Home training: Training is a resource-intensive, one-time patient course. Home dialysis supporters want training payment to stay outside of the bundle. If included in the bundle, there is a risk that clinics will not want to go to the expense of training patients and caregivers to go home with their dialysis.
• More-frequent dialysis: Will Medicare continue to let providers be paid for treatments beyond three per week? Current Medicare policy allows extra treatments to be paid for when there is a medical reason. It is unclear whether this will still be the case under the new bundle.
• Home treatments: Congress passed a law that requires Medicare to encourage home dialysis. It is vital that when they create a new bundle, they don't accidentally make it harder for clinics to offer home treatments or for people to choose them.

Mike makes the point that these structural changes to reimbursement do not come along very often, it's been 26 years. This is going to be a one time opportunity to advocate for reimbursement that supports the care you want. There are choices that have to be made, if we get up to speed on the process and the issues, we can help CMS make the right choices.

Q&A to prepare for the implementation of Medicare's expanded dialysis payment bundle

By Rich Berkowitz, Bill Peckham and Dori Schatell

Dori, Rich and I have been participating with a diverse group of Home Dialysis advocates for a few months to prepare information for dialyzors so that we can all present feedback on the pending changes to dialysis reimbursement. I think the letter below stands on its own. We all expect that CMS will be publishing a notice this summer which then opens a 60 day comment period. This will be a chance for dialysis advocates to provide feedback

Start with this letter and then follow the link at the bottom of this post to read the Q&A. DSEN will be tracking this issue for the foreseeable future. Stay tuned for updates as this develops.

Dear Patient/Care Partner,

As you may know, the Centers for Medicare & Medicaid Services (CMS) is now working on making changes to the way dialysis is paid for. Congress passed a law last summer that requires Medicare to make a plan to improve the quality of dialysis care and reduce costs of dialysis treatment.

This will have a direct impact on YOUR dialysis. It is vital for you to stay informed and get involved to ensure that your treatment will not be affected.

While details of the new bundle are not yet known, the issues that could affect your treatment include:

• Whether the cost of dialysis will be looked at per treatment, per week, or per month
• Which lab tests, drugs, and other services will be part of the payment bundle
• Whether the cost of home training will stay outside of the payment bundle
• Whether Medicare will still allow providers to be paid for treatments beyond three per week based on medical reasons

We expect the new draft plan for dialysis to come out this summer. Medicare, which pays for most people's dialysis, wants to hear from YOU to help them finalize the plan.

Congress and the leaders in Medicare are not experts on the needs of people with kidney disease. YOU are the expert and YOUR input can give these leaders the chance to make better-informed decisions.

To help you better understand the policy issues that can affect people with kidney failure, we have written the Q&A. We hope this will help you to get involved and share your stories and ideas. After the proposal is released, we will have a follow-up letter with next steps.

Thank you for your efforts to ensure that the needs of people on dialysis are addressed in the new bill.

Sincerely,
Dialysis from the Sharp End of the Needle
Medical Education Institute, Inc. (Home Dialysis Central)
NxStageUsers

Click here to read the QA

The Obama administration should respond to the Harvard letter

By Bill Peckham

With regard to the letter (see WORD document or web page and RenalWEB discussion) from the Steering Committee of the April 23-26, 2009 conference “ESRD: State of the Art and Charting the Challenges for the Future”, (the conference was held in Boston and was sponsored by the Harvard Medical School Department of Continuing Education).

Dr. Blagg's note to RenalWEB should be read before reading Renal Business Today's followup on the lack of response from the letter's recipients, Nancy-Ann DeParle, director of the White House Office of Health Reform, and Barry Straube, MD, chief medical officer of the Centers for Medicare & Medicaid Services. The RBT article makes clear that the docs who wrote the letter expected their support would have immediate effect and that they are disappointed that people don't seem interested in making the provision of dialysis better.

I'm glad the new docs are not the same as the old docs. Still let us remember. Scribner was booed. Scribner's ideas were ridiculed. Scribner was disparaged by the docs who preceded the authors. I think Scribner is owed an apology. However, I agree with the larger point, that the Obama administration should act on the letter's message. Scribner would not give a wit who got the credit and Scribner would undoubtedly be as charitable as Blagg in welcoming all comers to his point of view. Clearly, Scribner and Blagg are better men than I.

It's too bad this letter wasn't written 30 years ago. It's too bad that 30 years ago docs from National Medical and the esteemed Harvard Medical institutions were disparaging home dialysis and the need for more dialysis. It is too bad that they were doing this back in the late '70s when their support would have made a huge difference. It is too bad that when it mattered 30 years ago the east coast medical establishment came to a very different conclusion about volume control and instead focused on hemodialysis adequacy as measured by urea removal.

I have an urge to hold the East coast establishment in a headlock and force them to admit Scribner was right. I agree with everything in their letter and I am delighted that the conventional nephrology point of view is moving away from Gotch and towards Scribner. Hopefully, it's not too late.

Fail: Clinical Therapeutics paper gets the math wrong and misses the point

By Bill Peckham

Both RenalWEB and NephrOnline link to an article available online from Clinical Therapeutics: The Financial Implications for Medicare of Greater Use of Peritoneal Dialysis (pdf link). The headline is that Medicare could save 1 billion dollars a year if PD use increased to 15% of those with CKD5 who require dialysis. There is a problem with the authors' numbers.

The authors use the top line numbers from the 2007 (meaning 2005 numbers) USRDS Annual Dialysis Report of total average Medicare cost for someone using hemodialysis ($69,758) vs. the total average cost to medicare of someone using peritoneal dialysis ($50,847). They then assume that that on average someone who transitions from CKD 4 into the PD group instead of the HD group would save nearly $19,000 ($18,911) each year, as compared to the status quo or a trending decrease in PD use. That's not the right number for the sake of their scenario and they actually present the data that should have raised a red flag on their analysis.

That $69,758 average cost figure includes the cost of caring for people in nursing homes - skilled nursing facilities. Excluding those in SNF the difference in cost to Medicare of someone on HD vs. PD is about $11,400 which the authors breakdown in the paper - about $4,600 in saved hospitalization costs, $5,800 in separately billable medication costs and $1,000 in access management savings. However, it should be noted that some of the separately billable medication savings comes from having people who dialyze at home take oral Vitamin D rather than the more effective injectable Vitamin D.

Providing PD to people in SNF is highly problematic so you have to assume that growing the percent of people who use PD would create savings from switching people who are not in a SNF and who would have otherwise used HD. This would suggest $11,400 in savings rather than the $18,900 the authors use to get their savings of one billion dollars over five years. I agree that in general it would be a good thing if more people transitioning from stage 4 CKD to stage 5 CKD started with PD instead of conventional incenter HD but the savings touted in this paper are being overstated by about 60%. Still saving $600 million dollars over 5 years is a worthy goal. Which brings up another issue.

When I read the paper (which I very much appreciate having available online, in full) what I understand is how once again conventional incenter HD is expensive when compared to any other form of dialysis that provides a higher dose of renal replacement. Once again we have a paper showing better care under Medicare Part B results in Part A savings. Once again more dialysis saves money. Once again what we have here is a Part A/Part B issue and yet another paper highlighting Medicare's cruel accounting structure that inflicts needless costs and human misery because of President Johnson's and Wilber Mills' political scheme to expand access to healthcare.

It isn't that the use of peritoneal dialysis should grow so much as the routine use of conventional incenter hemodialysis has to stop. Three day a week conventional incenter hemodialysis isn't enough renal replacement - even PD is better.

Northwest Kidney Centers offers all incenter patients opportunity to try frequent dialysis

By Bill Peckham

The Northwest Kidney Centers May/June patient newsletter, Output, has an article announcing a new program that allows people to "test drive" more frequent dialysis:

What is the main benefit of dialyzing five days a week? You will feel much better. That's why the Home Hemodialysis department at Northwest Kidney Centers would like to give you a chance to take home hemodialysis for a "test drive." Starting in May in NKC's Eastside centers, daily hemodialysis is available on a trial bases, with no strings attached.

I hope this is very successful. It's a challenge to get people already incenter to consider going home, and dialyzing more frequently. The hope is that after two weeks of frequent dialysis along with first hand experience with the equipment they will be better informed to evaluate the home hemodialysis option.

If all dialyzors were fully and accurately informed about their dialysis options how many would choose to dialyze at home frequently? It's an open question but I do think being fully informed does include first hand experience with how it feels to be frequently dialyzed. With out that first hand experience I don't know how you could be fully informed to make the comparison to a conventional incenter dose.

What's the problem with KDOQI?

By Bill Peckham

The KDOQI guidelines on dialysis adequacy are evidence based, but all the evidence is the result of current  practices i.e. three times a week dialysis; three times a week dialysis is current practice based on current reimbursement i.e. 156 treatments a year; 156 treatments a year is current reimbursement because units are able to achieve the KDOQI guidelines by running people short, fast and infrequently. Repeat feedback loop.

Does anyone else see a problem with this construct? Does it matter how people feel while dialyzing to achieve KDOQI minimums? Under the system that KDOQI shields, dialysis is violent and deadly. That should be enough to conclude that something is wrong with the whole construct.

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.

Renal Transplantation: Is it the Primary or Secondary Treatment for CKD-5?

By Peter Laird, MD

Until the time that we are able to regrow our kidneys in a petri dish, the debate will continue over allocation of a limited supply of donated living and deceased kidneys. Some castigate unfairly, in my opinion, those that have altruistically given their very flesh to family and stranger alike in an effort to stem the dance of death renal patients abide in. The gift of life of a living renal donation makes headline news on a regular basis. Complete strangers have stepped forward to give this gift of life to those in need. Yes, despite the many detractors of altruistic living donation, it does exist. The fact that we have even one stranger willing to give selflessly to another should always be applauded, especially by those that have so received.

Many continue to strive for a commercial system of financial reward in exchange for these extreme acts of altruism. Yet, in my mind, the debate on renal donations and various methods of increasing altruistic donations, financial compensation for vendor donations and deceased organ donations procured by opt out systems of presumed consent miss the central issue at hand, is kidney transplantation the primary treatment for CKD-5 or is it the secondary treatment option?

In the case of a patient that has a living related donor that gives this gift before the start of dialysis, many would argue reasonably that preemptive renal transplantation is the primary treatment option. Nevertheless, not all renal patients are transplant eligible. Issues of cardiovascular risk, cancer risk, obesity and co-morbid disease states eliminate thousands from the transplant list every year. Many choose not to place family or friends at jeopardy by asking for their healthy organs. I for one have a combination of relative medical risk and refusal to place my two willing donors at risk, my wife and my daughter who both came forward willing and eager to give me one of their healthy kidneys.

While I was exploring my own personal options, I had a great unease at accepting their gift if there was another viable option available to me. Certainly the diagnosis of malignant melanoma one month after I started dialysis settled the issue once and for all for me. The advent of cancer spreading out of control by aggressive immunosuppression augmented by my own willingness to bear my own disease without endangering my loved ones won out in my decision to pursue home, daily dialysis as my primary treatment option.

In the end, the issue of whether dialysis is the primary treatment option or renal transplant is turns out to be an individual decision based on many factors. Yet today, even though the overwhelming majority of patients will either choose to forgo transplant or not be eligible for transplant, the only consideration given publicity is that of renal transplant. We have about 1% of the hemodialysis census dialyzing in the comfort of their own home when other nations have up to one third taking advantage of this option.

For the majority of people with CKD-5 dialysis is their primary treatment option whether, home hemodialysis, home PD or incenter and they should be hopeful when reading the information that optimal dialysis has survival rates that rival living related transplant. These two CKD5 realities should place the primary treatment option of dialysis at the forefront of the discussion.

We continue to hear of those that die on the transplant waiting list. Yet, I have not seen one advocate of the various transplant procurement options come forth publicly in support of optimal dialysis even for those on the transplant list. Australia and other nations have a high transition rate from home hemodialysis to transplant with improved outcomes in their optimally dialysis patients awaiting their secondary treatment option of transplant.

Why are these very vocal advocates of renal transplantation so silent on the issue of optimal dialysis? I have my own private theories on why they remain silent publicly, but for those that understand that optimal dialysis is medically available but not socially promoted here in America, the tragedy that Belding Scribner sought to prevent overwhelms the benefit of all of our directed efforts for increasing renal transplantation when we consider those that could have survived if they had only had access to optimal dialysis.

Our short sighted efforts to focus all of our primary treatments in the renal transplantation option alone when the supply shall likely never meet the total demand from all who would wish a kidney, leads me to ask again, is renal transplantation a primary or secondary treatment option for the majority of American CKD-5 patients? If it is a secondary treatment option for the majority of our renal patients, then Dr. Scribner’s work was left unfinished. Perhaps answering this simple question first about dialysis and renal transplant will better focus our future efforts against this deadly condition.

An Open Challenge to All Dialysis Researchers

By Peter Laird, MD

The American approach to dialysis become entrenched with the usual care of 3-4 hour sessions, three times a week ever since Medicare started paying for dialysis treatment in 1973.  This standard of dialysis was chosen due mainly to the business model since the actual treatment standard of care at that time was 8 hour sessions, three times a week. Dialysis patients treated for 8 hours, three times a week had a 10% mortality statistic when Medicare intervened.  This has skyrocketed here in America to 24% per year after business models sought their best return of money with shorter and shorter treatments despite worsening patient outcomes.

Today, Medicare demands a randomized controlled trial (RCT) to prove that longer is better so that many can return to the old standard of care of 8 hours, three times a week that we see with the in center nocturnal movement. Glenn Chertow has set out that we need 3500 - 5000 patients to randomize into a usual care dialysis population RCT to show a true benefit in a study with enough statistical power.  Glenn Chertow further goes on to explain how this will likely never happen since we don't even have that number of patients on home dialysis in North America doing alternative dialysis treatments and thus justifies his smaller attempts at RCT's.  Medicare remains insistent that the only proof that they will accept is an RCT. This catch 22 has stymied optimal renal care in America for decades and it looks as if this shall continue unless we can prove the efficacy of this to the level of proof that Medicare demands.

I have a simple challenge to all dialysis researchers around the world to overcome this American hegemony.  Part of the need for a large number of patients in the usual care dialysis setting is the annual mortality statistics.  In this case, they are paradoxically too low to find the results with a smaller number of patients.  A possible solution to proving to America what all the other western nations already know would be to find a dialysis population with a higher rate of mortality and then produce a study on that subset population showing by RCT the true benefit of more dialysis frequency and duration.

I propose an open challenge to all dialysis researchers worldwide to consider conducting a randomized, controlled trial among dialysis patients with left ventricular hypertrophy  (LVH) (16% of usual care dialysis patients develop significant LVH) and then to secondarily screen those patients for high interdialytic weight gains.  This is the highest risk dialysis population who have a combination of LVH and high interdialytic weight gain placing them at an exceedingly high risk of sudden cardiac death.  

The next step is to randomly assign these selected patients to usual care and the treatment arm which is quite simple: 5 hour sessions in center/four times per week. For those units that already have nocturnal dialysis, another approach could be 8 hour sessions three times a week. I believe that the frequency should be above 3.5 times per week, but we already have much survival data for the 8 hour three times a week nocturnal studies to consider this as well.  Certainly the large integrated health care systems can more than pay for the upfront costs of increased dialysis by all the money that will be saved internally by preventing hospitalizations and other adverse complications. Many observational studies including several excellent cohort studies have shown significant survival advantage for dialysis frequency more than 3.5 per week and total dialysis duration of 20 hours/week.

In a large integrated health care organization with the economy of scale to realize internal cost savings, large numbers of patients could be quickly entered into such a study and 6 and 12 month data accumulated within 18 - 24 months.  I predict that such a study would come to an early conclusion based on ethical oversight showing a significant survival advantage making further randomization unethical. After all, do we really need an RCT at this point to prove beyond any reasonable doubt the benefits of quotidian dialysis?

I further call upon health care administrators, CMS administrators, nephrologists, internists, dialysis nursing personal and most importantly all of our combined CKD-5 patients to urge their own health care teams to accomplish this easily randomized and controlled study.  It is time to end the gridlock CMS has imposed upon payment of these treatment options shown overwhelmingly beneficial by numerous studies world wide. It is time to devise a reasonable study that can be accomplished quickly, ethically and conclusively to bring about optimal dialysis here in America. Sadly, the only notoriety that America has recently offered to the dialysis community internationally is its last place finish in survival statistics. America continues to offer excuses for this last place finish while all of the other nations instead offer evidence of optimal dialysis benefit. If it is a randomized, controlled study they want, it is a randomized, controlled study that someone should give.  Here lies my open challenge to all dialysis researchers world wide.

Hemodiafiltration - coming to a dialysis unit near you

By Bill Peckham

When we think of dialysis and the removal of waste - solutes - we are usually just thinking of diffusion. The blood passes through the hollow fibers of the dialyzer, against the fiber's semipermeable membrane. Solutes are drawn out of the blood and through the membrane because there is a solute gradient. For instance there is a higher density of urea in the blood then in the dialysate; that's the gradient: the different density of molecules in the blood vs the dialysate. The greater the difference in densities, the greater the gradient, the more movement of molecules that will occur. More diffusion. The other way to remove the molecular waste, especially larger molecules like β2-microglobulin, is to draw the molecules through the membrane by convective force. 

When fluid is removed from the blood it drags some molecules with it - you can increase this convective cleaning by increasing the amount of fluid removed. Hemodiafiltration adds ultrapure dialysate to the blood circuit so that more fluid can be removed, and more fluid removed means more convective solute removal. But there is a problem to solve.

If you add the extra fluid after the artificial kidney then the blood can get too thick in the kidney and clot the fibers. Adding the fluid post kidney limits how much extra fluid can be used, which limits the potential convective cleaning. If you add the fluid before the kidney then there isn't a clotting problem but you impact the gradient because when blood is diluted, the concentration of waste molecules is diluted and the gradient is lower. With a lower gradient diffusion is less efficient and fewer molecules will cross the membrane.

The Nephros's OLpur MD220 diafilter gets around this by adding fluid half way through the kidney:

Nephros's OLpur MD220 filter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module enables existing dialysis machines to be used for HDF therapy. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.

Mid-Dilution? How could you do that? Check out their brochure (pdf link). The cap, the top of the kidney, has an inner ring of plastic, this sends the blood down the outer half of the fibers, at the base of the artificial kidney the blood is turned around and sent up the center half of fibers along with the infusion fluid. The total blood path is down and back, the fluid comes in mid course. Mid-Dilution.

The Nephros press release is in reference to the company's 510K application. It looks like they are on track to have a product on the market in 2010 just in time for the expanded bundle in 2011. Nephros should be able to show that the combination of ultrapure dialysate and convective clearances leads to less Epo use. Today less Epo use means less profit; in 2011 under the expanded bundle less Epo use means more profit. I think hemodiafiltration/ultrapure dialysate is coming ... in just about 22 months.