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

Discussions for Patients, Family, and Friends HD For Patients
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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.

http://www.hemodoc.com/2011/09/the-long-dialysis-weekend-might-kill-you-but-we-wont-change-.html

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So are other countries doing more frequent dialysis - Italy, Australia maybe?

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Plugger, we agree, more dialysis is better, Amen! I wonder how these people in the clinics would function on three days of dialysis per week? As you well know, I do not have any love for the dialysis industry, none, zip, and zero. However, I want to use the laws of economics to make things better for everyone on dialysis, to control some of these clowns. The dialysis industry can subvert government control, but, they cannot subvert the laws of Economics. I want a system where they cannot mistreat dialysis clients, therefore with much more profit, will come tons of competition, enabling dialysis clients to fire arrogant dialysis providers, I like that situation. In any area of the economy, more profit will equal greatly enhance competition, even for dialysis providers. Low profit equals a small number of dialysis providers and arrogant dialysis workers, Nurses, techs, etc. My point is that use the laws of Economics to force these people to change.

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Imagine we both can agree these non-compete agreements doctors and nurses sign really ought to go!

http://www.gazette.com/articles/davita-57449-dialysis-doctors.html#ixzz1YsZOgkWx

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I’m not aware that ANY other country has upped the frequency of dialysis. But what they HAVE done–and it has saved countless lives–is they do longer HD runs. In the US, per the DOPPS study (Saran R et al, Kidney Int. 2006, 69:1222-28), the average treatment time was just 211 minutes (3.5 hours), vs. 232 minutes in Europe (3.86 hours) and 244 minutes in Japan (4 hours). In that study, getting a minimum of 4 hours of treatment improved survival by 30%–and each extra 30 minutes beyond that further improved survival by another 7%. I’ve seen that survival on dialysis in Japan is triple that of the US, and in Europe it is double. Time matters, too! So, in the U.S., we have two marks against us: too-short treatments AND the 2-day gap. In other countries, they only have the gap.

For logistic/transportation reasons, I think it will be very difficult for in-center programs to do a 2-week rotation of Mon-Weds-Fri-Sun-Tues-Thurs-Sat to get rid of the 2-day killer gap. (Some transportation companies only operate on weekdays.) They’d have to be 100% in or 100% out–imagine trying to run a clinic where some folks come every other day and some 3x/week. The scheduling would be a nightmare! So, more frequent treatments are best done at home, or perhaps in areas with multiple clinics, some could offer 3x/week and some every-other-day…

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Thank you Peter for your excellent post. As always, this information is very disturbing. It’s also disturbing that something like the schedule of transportation companies could affect patient mortality. I was asked to take part in a patient education event for home dialysis on the 25th. I am tempted to bring your post along for those who want to read it. It is such a teeny tiny part for me to offer but it’s something. If all the people went to home dialysis that could that would free up the centers so much there shouldn’t be a problem of funding, staffing or scheduling in-center dialysis at least 4 times a week. I feel bad that healthy, capable dialysis patients are still in-center when I know in my gut that it’s simply lack of information. If they only knew the advantages and improvement in their life that home dialysis would give them. I greatly admire and appreciate all of you who have and continue to put in the time and effort to advocate for home dialysis. You are saving lives.

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I know CKD educators who are frustrated in educating CKD patients about dialysis options because even though just about everyone agrees that more is better, Medicare only covers 3 times a week dialysis. Unless there is strong medical justification for additional treatments some dialysis companies will not approve home training nurses to put Medicare patients on more frequent treatments. So how do you tell patients on Medicare they may not have options that patients with employer group health plans (EGHPs) have? What happens when Medicare becomes the primary payer after 30 months after the EGHP paid large amounts of money for 5-6 treatments a week? Does the dialysis provider bill Medicare for 3 treatments a week and the EGHP for the extra treatments? Does the dialysis provider tell the patient he/she must now switch to 3 treatments a week since that’s what Medicare will cover without justification? Now that the Affordable Care Act has removed limits on lifetime benefits (there can still be annual caps on benefits), what happens if the EGHP has an annual cap on benefits and extra treatments exhaust that limit? Will the provider allow the person to continue to do >3 treatments a week or will he/she be limited to 3 treatments a week? Will providers encourage those interested in daily dialysis to do every other day or to choose nocturnal dialysis so they can get more dialysis without going too far over Medicare’s day limit?

BTW, NxStage is expanding its market and selling machines in multiple foreign countries so I suspect patients are doing more frequent dialysis in those countries.

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The story remains the same with CMS and employer insurance making life and death decisions that they would not choose for themself. It is not likely anything will change until those with the power to make decisions for us make the decision to allow all to have the same options that they would choose.

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I thought private insurance caps were removed with the Obama care. I was one of those patients reaching my lifetime max before going on Medicare. Oddly, my insurance company changed my max from 1 million to 2 million just before Obama care stepped in. I was at the 1 million mark. I also do dialysis 6 - 7 nights/week. Issues with fluid fluctuation has always been the reason for more dialysis - which is the issue for everyone isn’t it? I was never allowed to do more than 3 times/week while in center. How could Medicare deny one patient more treatment with the same reason given as another patient who is allowed more treatment?

Or do you think Davita is only getting paid for 3 and ‘eating’ the rest? If that is the case, why are they promoting home dialysis?

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If I never hear the term “Obamacare” again, I’d be happy. The plan has been demonized by those who appear to want to keep the status quo, which was working well for some (including elected officials) but not so well for others.

The Affordable Care Act did remove lifetime benefit caps from most benefits on policies that were for plan years starting 9/23/2010. The law also started regulating what annual caps job-related plans and individual plans could set for plan years staring 9/23/2010.

  • 9/23/2010-9/22/2011, the annual cap was $750,000
  • 9/23/2011-9/22/2012, the annual cap is $1.25 million
  • 9/23/2012-12/31/2013, the annual cap is $2 million
  • 1/1/2014 all annual caps will be eliminated

Of course this depends on whether the ACA will stand after court challenges. The insurance industry has a very strong lobby and the individual mandate is what motivated the industry to go along with other changes that would help those whose healthcare costs more and who could reach these annual and lifetime benefit caps. BTW, the elimination of caps applies to “essential” not non-essential benefits.

Maybe Medicare isn’t refusing to cover patients. Maybe dialysis providers are afraid Medicare won’t pay them for providing extra treatments so they refuse to allow Medicare patients to have the extra treatments and don’t even try to bill for them. Why might this happen? The insurance companies that Medicare contracts with to pay claims do not have a consistent policy about when to pay and when not to pay for extra treatments (i.e., what is appropriate medical justification). Some of Medicare payers (called Medicare Administrative Contractors or legacy Fiscal Intermediaries) routinely pay for more treatments for certain diagnoses and others that service other areas of the country may require different justification or are more stringent about what they allow. Naturally this would make large dialysis providers that serve patients across the country leery about whether more treatmetns will or won’t be covered. Perhaps one of the ways that patient groups might advocate would be to demand consistency among these Medicare payers. The downside might be that those that have been more lenient might become more stringent rather than vice versa.

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Sorry, I didn’t mean to take the thread into a discussion on health insurance issues, instead, my point was to reiterate the obvious that the clinical decisions made by industry insiders should they end up on dialysis are diametrical opposed to what they offer their own patients. It is the utmost in hypocrisy.

Quick question, Dori, did you publish your survey findings on this topic. I seem to recall that it is published somewhere. If so, could you post a link to the survey on what treatments leaders in the industry would choose if they needed dialysis.

Thank you,

Peter

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I’d like to hear more of an explanation about why you think this would be a nightmare. Think of a 24 station unit. Half go EOD. Let’s assume that the people who opt in are perfectly distributed across all shifts - though I don’t think it would matter.

What’s the problem?

You have a 12 station conventional unit running in the same building as a 12 station EOD unit. The challenges of scheduling seems identical to me - the unit would be getting a $70 premium for each treatment delivered on a Sunday. That ought to be enough to pay someone at an LDO to sit down and actually think the implications of EOD through rather than assume that because no one is doing it must be impossible to do.

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The logistics of EOD are not nearly as daunting as overcoming the complacency to keep the status quo no matter what the evidence. Indeed, the long dialysis weekend may kill you, but the dialysis industry seems sorely possessed to not change.

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I agree that the dialysis industry has not been very innovative or proactive in considering how to schedule patients for dialysis. However, as a social worker who helped arrange transportation for patients who had no vehicle, no family to drive them, and no public transportation, I knew those patients who chose in-center HD had to be scheduled on a shift when they could get to dialysis. In my county the paratransit (reduced cost) transportation service for elderly and disabled operates weekdays only. I encouraged patients without transportation to seriously consider some type of home dialysis. I knew that doing home dialysis would allow them to schedule their dialysis around other responsibilities. I had patients that did every other day dialysis and felt great. I don’t think our clinic was denied payment for any of those treatments.

Too few clinics operate evening shifts and I believe our rehabilitation rate suffers for it. Thankfully more dialysis clinics are beginning to see the advantages of nocturnal dialysis and are operating Sunday, Tuesday, and Thursday nights in my area. This allows patients and staff to have Friday and Saturday nights off to do things with family and friends. I don’t know if 2 days off for nocturnal has the same negative outcomes as 2 days off for standard HD. That should be studied too.

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Many patients that could cope with home therapy simply don’t for what ever reasons. Other nations foster more independent living through various means. New Zealand has nearly 25% of patients on dialysis at home on hemodialysis. Many estimate that America could likewise have that many or more at home which would reduce the burdens on other patients and staff. In my opinion, focussing on the home hemodialysis option is our best method of bringing about improved overall outcomes and reduced costs in America. It is time for a change.

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A big part of why patients don’t do home HD or PD is that in the past (and possibly even now) doctors haven’t encouraged patients to do home dialysis. They underestimate patients’ abilities and ignore psychosocial barriers and clinical benefits for why home therapy may be better for many patients. In addition, staff in dialysis clinics who may know nothing about home therapies are charged with “educating” dialysis patients about treatment options. They may share what they’ve heard or believe (biases) that scare patients. Patients are often led to believe it takes a “professional” to perform home HD and that PD has a higher risk of infection than HD. I’ve actually heard these statements from patients who are choosing a treatment or planning to do in-center dialysis. These statements ignore the fact that patients who choose to do home HD or PD are trained to be their own technicians, which means they become as competent as the day-to-day caregivers in a dialysis clinic. The doctors and staff may not have kept up with the research that now shows that infection rate for PD has declined now to where it is somewhat less than for HD according to the 2010 USRDS Annual Data Report (www.usrds.org).

NOTE: Since ESRD surveyors cite so many breaches of requirements for infection control in the ESRD regulations I’d bet money that the infection rate is lower in home HD patients compared to in-center HD patients, but this isn’t reported anywhere.

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[QUOTE=Beth Witten MSW ACSW;21738]I agree that the dialysis industry has not been very innovative or proactive in considering how to schedule patients for dialysis. However, as a social worker who helped arrange transportation for patients who had no vehicle, no family to drive them, and no public transportation, I knew those patients who chose in-center HD had to be scheduled on a shift when they could get to dialysis. In my county the paratransit (reduced cost) transportation service for elderly and disabled operates weekdays only. I encouraged patients without transportation to seriously consider some type of home dialysis. I knew that doing home dialysis would allow them to schedule their dialysis around other responsibilities. I had patients that did every other day dialysis and felt great. I don’t think our clinic was denied payment for any of those treatments.
[/QUOTE]

The transportation issue is always going to be a problem. Even more than dialysis it depends on your zip code.

However, the fact that transportation is an issue is another reason why it makes great business sense to offer EOD - because as a provider your case mix will skew towards those with EGHP. Generally those who get themselves to dialysis will have better insurance than those who rely on funded transportation, so offering a service that appeals to those who get themselves to dialysis will create a selection bias for those with EGHP coverage.

To put it in business terms EOD schedules would allow a unit to increase sales to existing customers and those customers would have a more lucrative case mix than the unit as a whole. EOD schedules are a tremendous business opportunity, yet providers don’t even want to consider it. It just makes no sense to me. The reluctance to provide EOD schedules is inexplicable.

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We’re at the “revise and resubmit” stage, and are revising. :slight_smile:

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I don’t think it’s inexplicable at all. It’s hard to recruit staff for “off” days–even harder than it is for the regular schedule. Diffuculty finding staff is one of the reasons that some popular in-center nocturnal programs close. And while it may seem to make sense to break up a clinic into two sections and have one do EOD and one do a standard schedule, the reality is that this burden will fall entirely on the clinic manager, who is likely already stressed and unwilling to take this one.

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Seriously? The reason dialyzors have to live with very risky schedules is that unit managers are too stressed to consider changing the way they provide dialysis and hiring people is difficult?

Excuse me while I go roll my eyes for the rest of the day.