HemoDoc, From Doctor to Patient

The Kt/V Kinetics Deception

By Peter Laird, MD

The NCDS introduced urea kinetics to the dialysis world as the most important measurable factor in the prescription of dialysis even though there was no financial disclosure by the authors including the fact that Edmund G. Lowrie was then the Vice President of National Medical Care Inc., the largest for-profit dialysis corporation in America at that time. Since the publication of the secondary analysis in 1985 introducing the Kt/V concept by Gotch and Sargent, dialysis outcomes in America have plummeted to the lowest survival of any in the industrialized world. As Gary Peterson noted in today's lead story on RenalWeb, the discussion and controversy continues unabated as seen in a recent editorial in MedScape by Joel D. Glickman, a respected nephrologist who has served as a consultant for both Davita and NxStage.

Nephrologists Unite: Time to Put the 't' back in Kt/V.

It all started with the NCDS published in the New England Journal of Medicine in 1981.^[1] This study randomly assigned just 151 hemodialysis patients into 4 treatment groups to measure the effect of 2 variables on survival: time on dialysis (short or long) and time average urea concentration (high or low). The authors of the study concluded that morbidity was worse in the group with high blood urea nitrogen, but time on dialysis was not a significant determinant of outcomes. Patients who received longer dialysis treatments had a trend to less time to first hospitalization, but the P value was .06.

Commenting on the article, Chertow and colleagues said, "It is difficult to conclude from the NCDS that session length is not meaningful; the authors presciently stated that the study conclusions should be interpreted cautiously, given the design and limited powers of NCDS. In retrospect, one might argue that the NCDS' session length P = .06 was the most significant (important) "nonsignificant'" (statistically) effect in the history of dialysis research."^[2]  Regardless of the interpretation of the study results, we must recognize that the long treatment time was 4:30 + 3 minutes and the short treatment time was 3:15 + 3 minutes. The effects of shorter treatment times, such as the 3 hours K.R. was prescribed, were not studied.

Where could we have gone wrong when these results which were both significant and randomized in a controlled study? Simply put, Kt/V and urea kinetics from the NCDS not only ignores the influence of TIME in dialysis outcomes in what I believe was a flawed analysis, it completely ignores the founding principles of optimal dialysis: the Middle Molecule Hypothesis by Dr. AL Babb, et al (here) and Dr. Carl Kjellstrand's Unphysiology Hypothesis (here), both known at that time. Urea is a small molecule easily cleared by dialysis that many argue has no clinical impact in the physiology of the uremic condition. It is a marker but probably not a direct player in the damage done by uremia. Better dialysis markers are problematic to measure such as B-2 microglobulin which has complicated kinetics that are TIME dependent. Fortunately, many researchers are revisiting the middle molecule theory identifying several of the toxic molecules of uremia:

The middle-molecule hypothesis 30 year after: lost and rediscovered in the universe of uremic toxicity?

Clinical dialysis studies should from now on be focused on more efficient, convective removal strategies, first searching for the most adequate applications and then evaluating their clinical impact. The next step then should be to develop more specific removal strategies (e.g., adsorption) aimed at the compounds which are classified as the most important ones. This might emanate in less costly removaloptions than the empiric strategies applied as of today, and such systems might also be regenerated, hence enabling an earlier start of removal than currently applied. 

The measurement of urea and the subsequent mathematical mental masturbation we call the Kt/V that makes researchers, clinicians and patients feel good about the "adequate" dialysis they deliver fails to have an underlying theoretical physiologic basis other than the transfer of urea. High Kt/V's can be manufactured in dialysis units by manipulating ultra-filtration rates, blood flow rates and other factors that foreshorten dialysis treatments especially in patients with a small total surface area and total body volume such as many petite female patients who often receive the shortest dialysis sessions of any patients, yet have the highest Kt/V's paradoxically. Kt/V measures the clearance of a clinically unimportant molecule masquerading as the arbiter of dialysis outcomes. 

Dr. Kjellstrand's Unphysiology theory should instead also be one of the guiding factors in improving dialysis outcomes through more frequent and longer duration dialysis thus eliminating the unphysiology of dialysis from infrequent, rapid and short dialysis sessions common in American dialysis units today. The NCDS neglected this theory as did the HEMO study two decades later bringing death by randomized and controlled study from adherence to the failed concepts of Kt/V. Each month, dialysis patients anxiously await the results of blood tests. Each month, the renal staff and physicians pronounce their dialysis adequate by a magical wand without dimensions called the Kt/V. Yet, each month, these same patients die at a rate 2.5 times that of patients undergoing chronic hemodialysis in Japan. This is the cost of ignoring Dr. Kjellstrand and Dr. Babb for over 35 years:

The Rationale for More Frequent Hemodialysis – ‘Unphysiology’ 

In the early 1970s, Kjellstrand et al. [12, 13] investigated factors related the untoward effects of dialysis. They showed that large fluctuations in body weight, electrolytes, osmolality, and urea concentration were more important with respect to morbidity than concentrations of small uremic toxins or middle molecules. This led them to formulate the ‘unphysiology’ hypothesis which suggested that wide swings of solutes and fluids in the body were significant causes of morbidity in dialysis patients. Daily or continuous dialysis would more closely mimic the function of the native kidney by reducing the magnitude of solute and fluid oscillations and so would be expected to be superior to the usual intermittent dialysis regimens.

The deception of "adequate" hemodialysis is at the center of our horrific American dialysis mortality rates now debated for the last four decades, yet so little is done to correct this situation. As much as I appreciate the commentary by Dr. Joel Glickman to focus on longer dialysis treatments, I believe that the error of his opinion is to continue to utilize the current urea kinetics model as the basic standard of care. Putting the 't' back in Kt/V will only impede implementation of physiologic based dialysis treatments. Nephrology is perhaps the most highly dependent specialty based on physiology. Ironically, dialysis, the most recognized nephrology procedure ignores the unphysiology of dialysis for the majority patients nor does it correct the middle molecule millieu of uremia.

I would hope nephrology will one day unite and recognize that Scribner, Kjellstrand and their colleagues were right all along. I suspect that pride shall prevent that epiphany for many years to come at the cost of hundreds of thousands of lives unless the patients themselves one day learn enough to refuse the substandard conventional American dialysis protocols. The popularity of medical blogs coupled with market pressures from new and innovative dialysis machines is more likely to become the instrument of change than decades of reason and logic. What a sad commentary from a discipline that pays frightful attention to the most minute changes of urine physiology thereby diagnosing complex renal disease from human waste, while at the same time ignoring the basic physiology of their most important medical procedure rendering their patients lives wasted and disposable to the system. Perhaps, instead it will be the patients who one day unite and overcome the enslavement of the large dialysis organizations that use our pain and suffering to their advantage. Perhaps one day.

A Fresh Perspective or More of the Same?

By Peter Laird, MD

In 2006, as my own renal function declined and dialysis became a certainty, I researched the best treatment options for my own situation and settled on daily home hemodialysis with consideration of my relative contraindications for renal transplant. However, I did not become a dialysis advocate until 2008 when Dori Schattell of MEI and Home Dialysis Central taught me the historical context of optimal dialysis where the patients dialyzed 8-9 hours thrice weekly for 24-27 hours a week of dialysis and despite obsolete technology, enjoyed better outcomes.  After the advent of the 1973 ESRD program, for-profit dialysis became the driving force behind "ultra-short" dialysis studies that many allege were profit motivated. Yet today, few recognize that the gold standard of care for dialysis was 8-12 hours thrice weekly when Congress enacted the ESRD program:

Long, 3x8hr/week, hemodialysis : A three-decade summary

Long hemodialysis (HD) 3x8 to 12 hours per week, using 1 m2 flat plate cuprophan dialysers, was, in the 70’s, the most common form of empirical dialysis, the “gold standard”1. Technical advances, changing scientific views on uremia pathophysiology, as well as social and economic pressure (to make better use of the scarce dialysis stations) have led HD to apparition and the to development of shorter dialysis sessions.

In the late 1970's, treatment times dropped dramatically without the benefit of any randomized and controlled trials comparing outcomes between the "gold standard" of 8-12 hour dialysis sessions and the new standard of 3-4 hours.  Urea kinetics became enshrined by the NCDS which in reality compared four suboptimal modalities and then sold the American public and congress that this was the best we could offer patients. Many stood in opposition to these changes, but their voices were ignored. The debate over treatment times continues today over thirty years later. Despite the fact that the current standard of care never underwent an RCT to prove its efficacy, any changes to this business based model continue to be delayed by calls for more and more studies. The latest evaluation of this from the for-profit industry continues to ignore the original gold standard which was established by clinical parameters, not biochemical profiles. 

Hemodialysis Treatment Time: A Fresh Perspective

Moving Forward

. . . In the interim, inadequate short dialysis treatments likely lead to complications, increased hospitalization, and decreased survival and may have a negative effect on the total cost of therapy. We suggest that in the setting of three-times-per-week HD, a new minimum adequacy prescription target can be established by physicians to include specifications for TT ≥4 hours, with anything less becoming the exception rather than the rule.

The authors of this influential article in a widely read nephrology journal essentially dismiss in-center nocturnal hemodialysis and home hemodialysis options maintaining that "moving forward" will only be within the context of in-center models of care. Certainly, eliminating dialysis sessions less than 4 hours will be a giant step forward, yet it continues to fall short of the gold standard of the 1970's where people on dialysis continued to work and participate in all aspects of life.  They likewise dismissed every other day dialysis options which would eliminate the long interdialytic period every weekend which in itself would significantly improve survival. As much as I long to hear a "fresh perspective" from the dialysis industry, in the final analysis, this article does not contain anything but more of the same.

 

For the Love of Money: The DaVita Investigations

By Peter Laird, MD

Davita continues to encounter more allegations of improper business dealings in civil, state and Federal investigations. (here, here and here)  The allegations are augmented by whistle-blower civil lawsuits recently filed against the dialysis giant. The main thrust of the alleged illegal business arrangements focusses on the issue of improving Davita's bottom line at all costs but doing nothing to improve patient outcomes:

Whistleblowers file suit against dialysis provider DaVita Inc.

"The complaint makes clear that for years, DaVita has used different sets of rules to game the Medicare system and illegally inflate their government reimbursements at taxpayer and patient expense," said L. Lin Wood, attorney for the whistleblowers. "Taxpayers and patients should feel a sense of outrage when they read the complaint and learn how DaVita has become a multi-billion dollar business due in large part to corporate strategies and protocols focused on extracting every dollar possible from the government rather than on improving the care of chronically ill patients."  

The allegations against the dialysis industry as a whole of placing greed and profits above patient outcomes is not new. Belding Scribner, the inspiration behind chronic hemodialysis spoke out against the for-profit dialysis practices that have resulted in the developed world's worst patient outcomes . Dr Scribner spent his last remaining years critizing the emphasis on profits instead of saving lives with this unique technology. Dr. Scribner ironically gave up the riches of his shunt invention and instead focussed on simply saving lives when he gave his shunt freely to the world lending his criticism more relevance:

Belding Scribner: The Inventor of Shunt Dialysis

A less known aspect of Scribner's world-view was his abhorrence for the contaminating effects of the profit motive on medical care. He felt strongly that a physician's commitment to a patient should not be tainted by profits. “He was disturbed that what had been a ‘noble experiment’ was degenerating into a rush for profits,” says Dr Christopher Blagg, professor emeritus of medicine at the University of Washington. “In 1960 it wasn't usual for academic physicians to patent inventions. They sort of gave them away. He joked that if he'd patented the shunt he could have bought an island,” said Dr Blagg. “He was upset that academia was becoming more and more involved with commercial entities.”

Today, many aspects of the American dialysis experience of rapid patient turnover, short treatment times compared to other nations and overly aggressive ultrafiltration are directly attributable to the for-profit dialysis industry which has worse outcomes than the non-profit dialysis providers as noted in a recent study.

Dialysis Center Choice Makes Difference in Death Risk

Newswise — If you need dialysis for advanced kidney disease, where you get it could make a big difference. A large study found that patients in certain large chain facilities are significantly more likely to die than those treated elsewhere. Mortality was also higher in for-profit than non-profit dialysis centers.

“The differences were not minor,” said Yi Zhang, Ph.D., lead study author. “We need to find out what caused them.”

Whatever the outcomes of all of the DaVita investigations is, America is already under an indictment of the love of money more than the love of man in many aspects of health care. In my opinion, the love of money is most noted especially in the American dialysis industry that continues to reap the benefits of huge profits while delivering the highest mortality and worst outcomes of all the developed nations. It is time to place saving lives as the highest goal of dialysis treatment. Americans are not getting their money's worth out of delivering huge profits to these large dialysis organizations that dominate the provision of dialysis today. Many note that where there is smoke there is fire. If so, DaVita certainly may be on fire today.

America's Dialysis RCT's: Clinical Trials or Economic Assessments?

By Peter Laird, MD

The debate over dialysis  treatment frequency and duration and its associated outcomes started with the original inception of chronic dialysis by Belding Scribner in the 1960's. Thrice weekly dialysis came about essential from limited resources and the need to treat as many patients as possible with the few available machines and supplies. The researchers initially started with once weekly dialysis, then twice weekly sessions sometimes lasting as long as 24 hours. Three times a week dialysis for 8-9 hours was the minimum dosage that allowed patients to return to a rehabilitated life. In the 1960's, that was the most important the measure of dialysis adequacy.  Dr. Shaldon relayed his success with nocturnal treatments in England which soon became the standard treatment in Seattle and throughout the United States.

Shortly after the Federal government funded the ESRD program in 1973, Congress became increasingly interested in studies to show the best utilization of their funding coupled with outcomes. The first randomized and controlled dialysis trial was  the NCDS published in 1981 which compared high flux vs low flux and short (3-3.5 hours) vs longer times (4.5 - 5 hours). Mortality and hospitalization were the two main outcomes of this study which concluded that treatment times were not as important as maximzing urea clearances.  

Effect of the Hemodialysis Prescription on Patient Morbidity - Report from the National Cooperative Dialysis Study

This report summarizes morbidity in 151 patients in a cooperative trial designed to evaluate the clinical effects of different dialysis prescriptions. Four treatment groups were divided along two dimensions: dialysis treatment time (long or short), and blood urea nitrogen (BUN) concentration averaged with respect to time (TAC_urea) (high or low). Dietary protein was not restricted. There was no difference in mortality between the groups. Withdrawal of patients from the high-BUN groups for medical reasons was significantly greater than withdrawal from the lowBUN groups. Hospitalization was also greater in the high-BUN groups, but dialysis treatment time had no significant effects.

The data indicate that the occurrence of morbid events is affected by the dialysis prescription. Increased morbidity appears to accompany prescriptions associated with a relatively high BUN. Conversely, morbidity may be decreased by prescriptions associated with more efficient removal of urea if the dietary intake of protein and other nutrients is adequate. (N Engl J Med. 1981; 305:1176–81.)

Gotch and Sargent followed this report with a post hoc analysis of the data in 1985 introducing Kt/V as a measure of urea clearance setting minimal adequacy measures as the standard of care.  The NCDS and the post hoc analysis never rendered a true test of Kjellstrand's Unphysiology theory and with the element of dialysis time reduced to a brief comment in the report and summarily dismissed, the nightmare of short, violent dialysis sessions in America became the standard of care.

The second dialysis RCT in America was the HEMO trial published in the NEJM in 2002. The HEMO trial tested whether more intensive urea removal would improve outcomes compared to lower Kt/V targets.  The Europeans took a critical look at the HEMO trial and concluded that time and frequency of dialysis was not adequately tested as one of the independent factors as noted in one analysis of the study:

Dose of dialysis, convection and haemodialysis pateints outcome - what the HEMO study doesn't tell us: the European viewpoint

The HEMO results demonstrate that an increase of the dialysis dose above the currently recommended minimum dose (spKt/V of 1.3) or the use of high‐flux membranes do not improve patient outcomes. However, each of these high dose and high‐flux dialysis were associated with a trend towards a decrease in mortality. While this did not reach statistical significance, the trend could be relevant in clinical practice. The lack of a statistically significant difference does not imply equivalence; rather, there was not enough evidence to conclude for high‐dose and/or high‐flux superiority. Therefore, we should try to avoid making the same mistake we made in interpreting the NCDS results: as time of dialysis was not significantly associated with an improved outcome, its importance was neglected and time on dialysis was shortened, without considering the associated risks (difficulties in reaching ‘dry body weight’ and blood pressure control with related potential increase in cardiovascular morbidity and mortality). Therefore, the HEMO study results should not be used to justify reducing dose of dialysis; after our experience in interpreting the NCDS study results we should avoid P‐values being used to kill more patients!

The latest RCT is the Frequent Hemodialysis Network Trial Group (FHN) which had siginificant difficulties recruiting enough participants especially in the nocturnal portion of the trial. Due to the limited study parameters and combined end points, a true evaluation of the middle molecule theory and Kjellstrand's Unphysiology theory has never been adequately tested. In many ways, the lack of acceptance of a cohesive theory to test may be in part at fault with the American dialysis RCT's outcomes. The NCDS and the HEMO studies conducted their evaluations within the confines of the standard of care set forth by business decisions in the For Profit dialysis corporations in conjuction with the Federal governments cost containment ventures. The FHN attempted to evaluate alternative schedules but failed to recruit an adequate number of participants especially for the nocturnal study.

The short daily arm of the trial also confounded interpretation of the results by using composite outcomes of mortality or change in LVH as well as mortality change in RAND 36-item health survey. Many nephrologists dismiss the results due to this combined outcome that does not allow a separate analysis of each endpoint individually. The short time frame of this study also renders many of the questions unanswered that may have been answered by simply extending the time frame as the trends were already beginning to separate but did not reach statistical significance of each individual parameter.

To date, despite the heated debate on these issues of dialysis frequency and duration for over four decades, no large RCT has ever successfully evaluated Dr. Kjellstrand's Unphysiology theory specifically and methodically. If there is a better theory of adverse dialysis outcomes that is better fitted to testing, then that clinical theory and hypothesis should be the foundation of any further attempts to answer these longstanding questions. Submitting patients to scientific study in the guise of clinical questions that in reality are better suited to answering the business aspects of dialysis practice does not do justice to those willing to submit to these trials.  

It is time to rally behind a single theory and test it specifically and methodically finding the best clincial solution without forethought of what business model it currently fits into. If that theory fails to produce improved results, it should be abandoned and another explored. Once a clear clinical hypothesis surpasses the current standard in-center practice, the business models to fit that clnical parameter can then be developed to maximize utilization of limited resources. Focussing on the business aspects firsts in my opinion has clouded the clinical picture for decades here in America.

The Long Dialysis Weekend Might Kill You, But We Won't Change

By Peter Laird, MD

The NEJM of medicine recently published an article on evidence of the long dialysis weekend associated with an increased risk of cardiac death. This is not new information, in fact, Dr. Carl Kjellstrand noted the "unphysiology" of thrice weekly, short dialysis back in 1975 (here).  In his treatise nearly 40 years ago, Dr. Kjellstrand showed convincing data that the then newly adopted thrice weekly short dialysis schedule popularized by large dialysis organizations is harmful to patients. In a historical review by Dr. Blagg, Dr. Ing, Dr. Berry and Dr. Kjellstrand, the rational basis of more frequent hemodialysis is described in part due to the discoveries of unphysiology by Dr. Kjellstrand in the early 1970's:

The Rationale for More Frequent Hemodialysis – ‘Unphysiology’ 

In the early 1970s, Kjellstrand et al. [12, 13] investigated factors related the untoward effects of dialysis. They showed that large fluctuations in body weight, electrolytes, osmolality, and urea concentration were more important with respect to morbidity than concentrations of small uremic toxins or middle molecules. This led them to formulate the ‘unphysiology’ hypothesis which suggested that wide swings of solutes and fluids in the body were significant causes of morbidity in dialysis patients. Daily or continuous dialysis would more closely mimic the function of the native kidney by reducing the magnitude of solute and fluid oscillations and so would be expected to be superior to the usual intermittent dialysis regimens.

The debate over the long dialysis weekend is not a new argument at all. It is a forty year debate based not on clinical evidence in the end ananlysis but instead on the business of dialysis.  The thrice weekly dialysis schedule came about through the need to spread limited resources to keep as many people alive as possible. There has never been a single randomized and controlled trial setting this "standard" schedule, it was a business and financial decision that holds dialysis patients in America today prisoners of these fatal long weekends. Yet, instead of discussing how we can change this situation, many bloggers and influential nephrologists are calling for more studies before we change anything.

Interdialysis interval and mortality - dangers of a long weekend?

The data provides a compelling reason to do an adequately powered randomised controlled trial examing the impact of dialysis frequency and duration on clinical outcomes - though the logistical and funding issues around such a trial would be challenging to say the least.

How bad is the long break for dialysis patients?

What's next?: Further research is NEEDED before wide-spread practice alteration is warranted particularly given the profound policy implications, but our patients deserve this now. Specifically, we must determine:

o Optimal dialysis scheduling

o Patient preferences regarding frequency and duration (i.e.... will they come??)

o Cost-effectivness analyses (will more frequent HD reduce morbidity and thus cost?)

Mortlity Increases After 2-Day Interdialytic Intervals

Despite the study's limitations, the authors conclude the results provide sufficient clinical rationale for conducting a controlled trial assessing how dialysis services are provided.

It is time for action instead of further studies. The issue of more frequent and longer duration hemodialysis is a settled body of literature dating back to the 1960's and includes the recent FHN randomized and controlled trial which is largely ignored. Daily dialyis is a better solution and when applied in the setting of the home, it becomes the most cost effective and clinically beneficial dialysis modality.  

I am grateful for one more well done study, but I see no need for any delay in implementing more frequent hemodialysis. In the study in question from the NEJM, the most important statistic to consider is that 41% of the patients in this study died over a two year period of time. With more frequent hemodialysis and of longer duration, that number could have been reduced by more than 60% according to several observation studies. It is time to place wasted lives at a higher importance than maximizing profit margins for Fresenius, Davita and the other giants of the dialysis industry.

How quickly we forget that the Frequent Hemodialysis Network Trial came about by observational data suggesting higher mortality with thrice weekly hemodialysis back in the 1990's. Here we are nearly 20 years later and all that the dialysis pundits can state after a compelling study showing further evidence that the long dialysis weekend kills the patients that dialysis is meant to keep alive is a call to more studies.  When will we wake up to the circle of death surrounding all of these studies that continue to propagate more government grants for further study yet never apply the findings to saving lives.

The definititive randomized and controlled trial of adequate power is an impossible request since it would involve over 5000 patients, a number equal to the number of home hemodialysis patients in America today. 

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials

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. He urged that the primary outcome of such a trial should be mortality alone or mortality combined with a major morbid event. . .

When these investigators considered study design, it became increasingly clear that a study that is powered to detect a mortality effect was not feasible at this time. We estimate that currently 55 centers in the United States and Canada are performing frequent hemodialysis five times per week or more. These centers are dialyzing a total of approximately 600 patients with high-frequency hemodialysis at home or in-center. 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. 

Ten years after the calls for the FHN randomized and controlled trial, forty years after Dr. Kjellstrand's unphysiology reports and over firty years since Dr. Scribner urged America to save lives, we can progress no further than to call for more study. History will not look kindly on this part of our American history that gave us the highest mortality rate for dialysis patients in the developed world. It is time indeed to apply what we have already learned and stop the catch 22 debates on more frequent hemodialysis that only propagate further study and little or no corrective action.

Stepping Back in Time for Optimal Dialysis

By Peter Laird, MD

Forty years after the for-profit dialysis industry in America exterminated the pioneering schedule of 8-9 hours of thrice weekly nocturnal dialysis, a recent study revisits this schedule showing compelling data that the original thrice weekly 8 hour dialysis sessions have improved outcomes over the conventional 4 hour thrice weekly sessions that are now standard care:

Comparison of 4- and 8-h dialysis sessions in thrice-weekly in-cntre haemodialysis: A prospective, case-controlled study.

METHODS: Two-hundred and forty-seven HD patients who agreed to participate in a thrice-weekly 8-h in-centre nocturnal HD (NHD) treatment and 247 age-, sex-, diabetes status- and HD duration-matched control cases to 4-h conventional HD (CHD) were enrolled in this prospective controlled study. Echocardiography and psychometric measurements were performed at baseline and at the 12th month. The primary outcome was 1-year overall mortality. Results. Overall mortality rates were 1.77 (NHD) and 6.23 (CHD) per 100 patient-years (P = 0.01) during a mean 11.3 ± 4.7 months of follow-up. NHD treatment was associated with a 72% risk reduction for overall mortality compared to the CHD treatment (hazard ratio = 0.28, 95% confidence interval 0.09-0.85, P = 0.02). Hospitalization rate was lower in the NHD arm. Post-HD body weight and serum albumin levels increased in the NHD group. Use of antihypertensive medications and erythropoietin declined in the NHD group. In the NHD group, left atrium and left ventricular end-diastolic diameters decreased and left ventricular mass index regressed. Both use of phosphate binders and serum phosphate level decreased in the NHD group. Cognitive functions improved in the NHD group, and quality of life scores deteriorated in the CHD group.

CONCLUSIONS:

Eight-hour thrice-weekly in-centre NHD provides morbidity and possibly mortality benefits compared to conventional 4-h HD.

A recent letter to the editor of the Nephrology Dialysis Transplantation Journal echoes the rusults of the 2010 study above. It is not a randomized and controlled trial such as the FHN or upcoming Active Trial, yet the conclusions are worthy of note with significant reductions in mortality, hospitalization and improved cognition with the longer dialysis sessions. Indeed, the news showing improved outcomes is better with this thrice weekly 8-h session schedule is not news at all. The data has clearly shown improved outcomes with longer and more frequent dialysis since the beginning of widespread dialysis programs in the 1960's.

The story of how we ended up with the more expensive in-center, poor outcome, short dialysis schedules remains untold to a large extent. My own questions are how and why did congress accept the more expensive and worse outcome choice as noted by reports of the 1978 congressional hearings on dialysis? That is a story that I would like to see the inside reports. Finding optimal dialysis in America today means stepping back into time when we already knew the benefits of longer dialysis schedules. 

Classic Belding Scribner Interview - 2002

By Peter Laird, MD

In 2002, Dr. Belding Scribner recieved the Albert Lasker Clinical Medical Research Award for his lifelong work in the area of hemodialysis. In this interview shortly after recieving this award, Dr. Scribner reviews how the idea for the Scribner shunt came into existence through a collaberation with other colleagues in a "combination of good fortune." This is a must see video for all dialysis patients to gain an understanding of the true life saving nature of hemodialysis through the eyes of it's earliest pioneer. Please join me in praising the work that Dr. Scribner and his colleagues offered not only to America, but truly to the entire world.

An Interview with Belding Scribner

What is the Expected Lifespan on Daily Nocturnal Dialysis

By Peter Laird, MD

Nocturnal dialysis became the standard of care early in the course of dialysis as Dr. Stanley Shaldon introduced it to Dr. Scribner in 1964. By the time the ESRD program came into existence in 1973, the majority of patients on dialysis, dialyzed at home, thrice weekly for 8-9 hours each session. Utilizing this schedule, the majority of dialysis patients continued to work and had less than 10% annual mortality. We then entered the era of for-profit dominated in-center dialysis where providers shortened the sessions by increasing the ultrafiltration rates as well as the advent of the high flux artificial kidneys.  Since that time, our mortality surpassed those of the other developed nations by a rate of 2.5 times that seen in Japan today. While renal transplant made great strides improving their outcomes, dialysis patients lagged behind in the crowded open ward dialysis clinics. However, one medical group in Tassin France led by Dr. Bernard Charra, a protege of Dr. Scribner, kept the original schedule continuously for the last 40 years with excellent outcomes:

Long Slow Hemodialysis

Long slow hemodialysis (3×8 hours/week) has been used in Tassin for 30 years without significant change in the method. It provides excellent results in terms of morbidity and mortality. The better survival than usually reported on shorter dialysis is mainly due to lower cardiovascular mortality. The nutritional state of the patient is good, as well as the correction of anemia with low doses of EPO. But the main feature concerns blood pressure; hypertension is very well controlled without need for antihypertensive medications. The gentle ultrafiltration provided by a long session time associated with a low salt diet and a moderate interdialytic weight gain allows for normalization of the extracellular fluid space in most patients (dry weight) without important intradialytic morbidity. This low salt diet has paradoxically been forgotten in recent years while shortened dialysis time renders it more necessary than ever.

In the early 1990's, the Toronto medical group led by Dr. Uldall and Dr. Pierratos revived the concept of nocturnal dialysis here in North America and took the next step of increasing not only the duration of dialysis, but  also the frequency of dialysis from 6-7 sessions per week, creating the first daily nocturnal dialysis program. The initial published reports astounded the renal community with normalized phosphorus levels, reduced dosages of Epogen and prolonged survival in these patients.

Nocturnal dialysis: three-year experience

There is evidence that high frequency, as well as long duration, hemodialysis provides better clinical outcomes. We developed nocturnal hemodialysis, a new innovative form of renal replacement therapy, which is performed six to seven nights per week for 8 to 10 h during sleep at home. Blood flow was set at 300 ml/min and dialysate flow at 100 ml/min. . . There was hemodynamic stability and significant subjective improvement in patient well being. Nightly Kt/V was 0.99. Weekly removal of phosphate was twice as high and beta2 microglobulin 4 times as high as conventional hemodialysis. All patients have discontinued their phosphate binders and have increased dietary phosphate and protein intake. BP control was achieved with fewer medications. . . Nocturnal hemodialysis represents the most efficient form of dialysis at low cost and should be considered as an option for patients who can be trained for home hemodialysis.

By the end of the decade, Dr. Lockridge in Virginia and Dr. Agar in Australia converted many of their patients to daily, nocturnal dialysis with the same magnitude of beneficial outcomes as seen in the original studies by Dr. Uldall and Pierratos. In 2009, Dr. Pauly and his colleagues gathered 177 nocturnal hemodialysis patients from two Canadian centers showing that this treatment had equal survival to cadaveric transplant patients:

Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients

Results. The total study population consisted of 177 NHD patients matched to 1062 DTX and LTX recipients (total 1239 patients) followed for a maximum of 12.4 years. During the follow-up period, the proportion of deaths among NHD, DTX and LTX patients was 14.7%, 14.3% and 8.5%, respectively (P = 0.006). We found no difference in the adjusted survival between NHD and DTX (HR 0.87, 95% CI 0.50–1.51; NHD reference group), while LTX survival was better (HR 0.51, 95% CI 0.28–0.91).

Conclusions. These results indicate that NHD and DTX survival is comparable, and suggest that this intensive dialysis modality may be a bridge to transplantation or even a suitable alternative in the absence of LTX in the current era of growing transplant waiting lists and organ shortage.

We have now returned full circle to the basic tenants of the pioneers of hemodialysis who gave increasing dosages at more frequent sessions each week until they rehabilitated their patients. When a patient regressed, they increased the time on dialysis until the patient improved again. Dr. Uldall and Pierratos took up where the pioneers had left off with long, gentle nocturnal treatments and completed what the early researchers were unable to complete due to lack of funds and available machines, they evaluated hemodialysis maximum duration and maximum frequency coupled together for the first time. The fact that survival with daily nocturnal dialysis is  now equivalent to cadaveric transplant survival opened the doors to optimal dialysis strategies throughout the world.

In truth, this is Dr. Scribner's vision completed, yet far too many patients in need of home hemodialysis and its proven benefits cannot overcome the many barriers to access this modality, not the least of which is the ponderously slow acceptance by the American nephrology community as well as many insurance companies. The expected lifespan of over 70% survival after 10 years of nocturnal home hemodialysis demands an answer to those unable to remove the barriers to care.  It is time to bring this lifesaving procedure the real full circle by now making it available to all capable patients who request it.

NY Times Dialysis Article Provokes Fear

By Peter Laird, MD

The NY Times stirred up the waters of debate on the Federal ESRD with it's provocative article titled When Ailments Pile Up, Asking Patients to Rethink Free Dialysis. The author, Gina Kolata in my opinion promotes the concept that the Federal ESRD program is essentially a failure in that far too many of the patients treated are at the end of their lives and are given futile and costly care that does not extend any meaningful life:

Dialysis is difficult, especially for the old and sick. Most of the nation’s 400,000 dialysis patients spend several hours, three days a week, hooked up to a machine, and additional time traveling back and forth to the clinic.

They have to restrict salt and fluids, and the procedure is so exhausting that some patients rest for the remainder of the day. Although dialysis may alleviate symptoms like fluid accumulation in the legs or lungs, it can lead to dizziness, weakness, leg cramps, nausea and other problems. Complications like bloodstream infections or clogged blood vessels where the dialysis needles are placed are common, often requiring surgery or hospital stays. Ultimately, about one patient in five is unwilling to go on with it. . .

Meanwhile, costs are soaring — end-stage kidney disease will cost the nation an estimated $40 billion to $50 billion this year. And doctors are recommending dialysis sooner, even though recent studies have found that an early start confers no additional benefit.

The author's statement that the ESRD program adds $40 billion to $50 billion this year when in actuality the costs for the Federal government are half that number, around $20 billion, about 6-7% of the total Medicare budget. Certainly this is a large sum, but the remainder is from private insurance coverage which private citizens have paid through their own contributions.

In addition, the ESRD program is a limited program for patients less than 65 who are not already enrolled in Medicare. Bill Peckham had a very interesting post a short while back breaking down the fact that of the 400,000 dialysis patients in America, only about 24,000 are less than the age of 65. Those over the age of 65 are covered by the Medicare bill passed in 1965 by Lyndon Johnson.  Thus, by Bill's account, the total ESRD program costs are in the neighborhood of $1 billion, and certainly less than $2 billion. Further, the NY Times graph on this issue starts at the age of 65, once again, all of these dialysis patients are covered by ordinary Medicare, not the ESRD program for patients less than the age of 65 .

In addition, the NY Times lists the common complications of the current American style dialysis therapy predominated by the large for-profit dialysis organizations correctly, but fails to show that was not the original intent of the ESRD program either. In 1973, the in-center costs for hemodialysis were ~$30,000 per year, while the home dialysis costs were ~$7000 a year for an established patient and double that for the first year of home dialysis noted in an article by Richard Rettig, yet, America abandoned the home program in favor of the in-center "lousy care" we have today.  In addition, the standard of care was dialysis in home thrice weekly, overnight for 8-9 hours yielding rehabilitated patients most of whom still worked. If we are going to discuss the original intentions of the ESRD program, let's likewise discuss the initial conditions and what the program has degenerated into by virtue of the undue influence of for-profit dialysis companies.

Lastly, reading through the responses and comments to this NY Times article I was struck by the number of people who genuinely fear the loss of autonomous control over end of life decisions if the government were to act upon the ideas promoted by this author. The benefits of optimally performed dialysis restores life at a significant cost savings.  

Instead of focusing on the small percentage of elderly patients who truly have in many ways come to the end of their life with difficult decisions to make, let us keep our focus on the overwhelming majority of patients who benefit from this life saving treatment and return to the principles present at the origin of the ESRD program in 1973. Short sighted cost cutting is what got us into this mess in the first place being penny wise and pound foolish with a shadow of the intended dosage of dialysis now the standard of care. No wonder we keep discussing our poor outcomes, how could they be otherwise when you give too little and not enough of proper dialysis as practiced in the 1960's. If there are any stories that the NY Times needs to tell, that is the one we should hear.

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

By Peter Laird, MD

NBC news followed it's recent series on dialysis with a commentary online by Arthur Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania where he characterized dialysis as lousy, unnecessary and cruel:

Dialysis payment program is costly in too many ways

Last, it is hard to die in an American hospital without being put on dialysis. Because kidney failure is such a frequent complication of terminal illness, the population of people needing dialysis is far larger than Shep Glazer or the lawmakers who authorized the benefit ever imagined. Because there is guaranteed money to be made putting the ill on dialysis, that's often exactly what happens.

The End-Stage Renal Dialysis program was an act of noble compassion. But ripping off the American people by allowing too many people to receive lousy or unnecessary care is not compassionate at all. It is cruel.

Once again, in the short space of a few days, NBC news has gone down the path of what I consider to be biased reports that casts a shadow over all dialysis patients who benefit from the 1972 ESRD Medicare program. While there are many patients who develop renal failure as a part of a terminal illness, Dr. Caplan should be well aware that the mortality for such patients is greater than 50-60% during that hospitalization alone which persists for those that survive and are discharged especially to nursing homes after such an acute illness.  

Proper informed consent with patients and family members keeps many patients who truly will not benefit from acute renal dialysis in this situation from becoming chronic patients. Many patients in this situation that survive the hospitalization choose hospice over dialysis. Once again, when it came time to comment on dialysis issues, NBC chose a transplant expert showing a continued and openly biased approach to a dialysis story.

DESCRIPTION OF BIOETHICS EXPERTISE

Arthur Caplan, Ph.D - RESEARCH INTEREST:
Transplantation research ethics, genetics, reproductive technologies, health policy, and general bioethics

ABOUT:
Currently, the Emmanuel and Robert Hart Director of the Center for Bioethics and the Sydney D Caplan Professor of Bioethics at the University of Pennsylvania in Philadelphia.

If we return to the true history of the Medicare ESRD program, the fact that government officials and industry leaders are responsible for the uniquely America poor outcomes. Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.  Dr. Caplan failed to use the correct figures in his report which shows continued bias in my opinion since at that time 80% of patients by some accounts dialyzed at home. Similar cost differentials  by magnitude of differences still prevail today between in-center dialysis and home based dialysis modalities, yet the outcomes are as much as 60% better with the home programs.

Nevertheless, in 1978 congressional hearings, led by what in my opinion was false or at the very least incorrect testimony by Dr. Edmund G. Lowrie, a high ranking official at that time in the National Medical Care Inc., the large for profit dialysis corporation, congress paradoxically adopted in-center, ultra-short dialysis as the standard treatment of choice. Shortly thereafter, the NCDS led once again by Dr. Lowrie cemented the standard of care for dialysis in America in-center as ultra-short, fast paced, "efficient" hemodialysis that is now responsible for the 2.5 times higher mortality than with a similar elderly population with many diabetic patients in Japan.

If NBC news wishes to continue what are in my opinion biased reports, I am not in a position to do any more than report these facts.  My largest concern is that any future actions by congress and CMS would take a clearer picture of the dialysis industry than NBC has certainly demonstrated in the last few days on any future considerations for the Medicare ESRD program. If cuts are to be made in the program, let it be due to improvements of care and economies of scale taking advantage of the home dialysis option before any politician or physician fails to prescribe care to elderly and infirm patients who may benefit as much as younger and more fit patients when dialysis is done in a compassionate and caring manner, longer, slower and gentler.

For those with a poor prognosis, hospice remains the better option, but fortunately, this is a small segement of the Medicare ESRD program. Dr. Caplan's commentary in my opinion lends a false impression that they are single handedly responsible for the cost and outcomes of the program. The real reason the program is so expensive is because we have only 1-2% of patients on home dialysis when as many as 30% or more could utilize this safe and more effective option.

In addition, those in-center recieve shortened sessions filled with rapid fluid removal which leads to cramping, nausea, vomiting and at times completely passing out. Instead of slowing down the machine and adding as little as 30 minutes more to a session, the American nephrologist often resorts to adding salt to the cleansing fluid which causes patients to gain too much fluid between sessions and damages the heart. Many have concluded that it is the way America practices dialysis that led to our poor outcomes, not because of our patient population.

I invite NBC news to interview patients such as Bill Peckham and and Dan Larabee and review their videos on the Rogue River last summer setting up portable dialysis units all the way down this wilderness river that is a challenge to young and healthy people let alone, a "dialysis" patient.  

 

It is time to tell the truth about dialysis as the noble experiment it truly is as the first real gift of life to thousands of uremic patients instead of what is, in my opinion, continued media and political lies about how dialysis truly impacts the lives of dialysis patients. Perhaps instead of perpetuating the myths of dialysis, NBC and Dr. Arthur Caplan would add more to the commentary by exploring the corruption of congressional actions by dialysis industry insiders that reaped the huge profits that make the American dialysis experience the most expensive in the world with the worlds worst outcomes.