Dialysis from the sharp end of the needle

Learning From Criticism

By Peter Laird, MD

As humans, many offer advice and sometimes outright criticism which is a painful but necessary step in learning for all of us. I don't know anyone that enjoys criticism and most of us develop defensive mechanisms in dealing with it. Yet, at times it is the only way in which we can over come an individual flaw brought to our attention that we overlook in our own egocentric views of our personal worth.

Institutions and cultures are no less subject to learning from criticism and even more so when it comes from within the culture or institution itself. "Physician heal thyself" is a reminder for each of us to engage in introspection brought on often through external criticism. It is a painful process at times, but it does reap the rewards of overcoming our shortcomings when fully engaged and acted upon.

The American dialysphere as Bill coins it is in great need of introspection and learning from external sources. DOPPS is an interesting ongoing study of the different patterns in dialysis practices in the developed nations. We have learned much about dialysis practices through this large, multi-nation effort, yet little has changed or been applied directly to American dialysis practices to date./p>

One such example is the findings of a DOPPS study on fistula creation outcomes in America and how adverse complications are often related to lack of training among vascular surgeons in America who perform less than 25 total during their fellowship. I wrote a post on this very issue back in 2008 called: Fistula First, American Surgeons Still Last.RenalWeb posted a new article today from AJKD that brings into remembrance the DOPPS study on this issue:

Hemodialysis Vascular Access Training and Practices Are Key to Improved Access Outcomes
This article reviews major findings from these data sources, focusing on specific practices and characteristics associated with greater arteriovenous fistula use in dialysis facilities worldwide. Important and often overlooked characteristics that are discussed in detail include specific preferences of dialysis staff regarding access type and the emphasis placed on fistula primacy and the number of fistulas created during surgical training. For example, in the DOPPS, the risk of initial fistula failure was 34% lower when fistulas were placed by surgeons who had created at least 25 fistulas during training (P= 0.002). It is imperative that dialysis clinicians advocate actively for specific dialysis access types on behalf of individual patients. Vascular surgery teaching programs must supervise adequate numbers of fistula procedures for every trainee.

I am thankful for the many caring people who have bravely stepped forward in my life to speak of weaknesses and deficiencies that I need to overcome. It is never anything but difficult to look inward, but it is a profitable venture for those that do.

America is in great need of engaging in a long and meaningful evaluation of all of our dialysis practices. DOPPS is a good starting point for many of our dialysis related issues, yet, will America hear, or shall we put up our egocentric defenses and refuse to learn from the external criticisms that want nothing but to improve our outcomes and will be the first on the sidelines cheering if we ever do. The data is before us, what shall we do with it?

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.

What’s new at ADC - An update from Seattle

By Jim Smith

As this years ADC comes to an end in Seattle, I had a chance to reflect on what was said and shown to many of the attendees during the last 4 days.

On the professional side there were two significant developments first announced on Saturday during the Successful Home Hemodialysis preconference seminars:

1. Dr Robert Lockridge disclosed his research after 12 years, showing strong evidence that long term nocturnal dialysis produces mortality results approximating those of cadaveric transplant recipients. In other words, the life expectancy of in center patients is the lowest of all dialysis patients, with short daily dialysis next and cadaveric transplant along with long term nocturnal dialysis patients enjoying the best and almost equal life expectancy.


2. Two reasons for this longevity include significant reduction in phosphorous levels and the reduction and in some cases elimination of the need for hypertension meds. Looks like it is time to consider nocturnal if you haven’t already. As for this writer, having recently found out that I am no longer a candidate for a transplant, I will be switching to nocturnal as soon as possible.
   

Dr. Jon Agar from Geelong, Australia, introduced a new way of measuring adequacy of dialysis. While the traditional measure of Kt/V has long been the accepted method , Dr Agar, has proposed a more extensive 20 point system that includes many more factors than just Kt/V. The additional areas of review include various non-quantitative measures that reflect quality of life issues. This is a survey you can complete yourself and take with you when visiting your own nephrologist and use as a starting point for improved discussion and review of your own condition and care. Look for the 20 question review in another posting in the near future.

While there were many presentations during the 4 days of conference, the Monday afternoon session on the future of dialysis proved quite interesting. A number of speakers discussed their continuing research and development of various aspects of dialysis in the near future. Here are a few highlights:

Dr Andrew Davenport of the London College, brought all of us up to date on the development of the wear-able kidney ( WAK ) . The various problems of power and filtering seem to be well on the way towards solving. New rechargeable battery technology along with miniaturization of pump mechanisms and filters have resulted in an effective unit weighing a mere 3 pounds. The problem of effluent disposal is one area still to be worked -on. The stoma-sack arrangement leaves something to be desired but overall progress is good. Regardless with the requirements of FDA, don’t look for something for a number of years yet.

Dr Eli Friedman, discussed his extended Micro-biotic theory of using the stomach and intestine as a filter for Urea and waste. Using empirical evidence dating back as far as 46 BC, he proposes that not unlike PD, the use of Pro-biotic substances can successfully sustain life in humans who have lost all renal function. This is based on research done on cows with their ruminant stomachs and no kidneys. They pass waste that eliminates the build up of toxins and fluids usually handled by the kidneys. I am not sure a diet of alfalfa and charcoal sounds appetizing.

Following on the discussions of improved health as a result of longer term nocturnal dialysis, Jim Curtis of Home Dialysis Plus in Portland, Oregon discussed his next generation dialyzor that would utilize advanced water saving technology that could regenerate dialysate and reduce the water used in a conventional dialysis session from 140 liters to a only 6 liters. The horizon shows the ability to use almost any water source without the need for ultra-pure H2O. While this has more impact for dialysis centers, HD+ is working on a home machine that uses your own tap water in nocturnal dialysis.

Also David Updyke from Fresenius discussed their ongoing work to improve the absorbent as well as adsorbent qualities of various filters for water and dialysate regeneration.

Lastly The NxStage group isn’t standing still either. A new model 172 cartridge is now available which allows for the connection of a heparin pump thus solving the problem of anti-coagulents during nocturnal runs. For those of you using Pure-Flow, it looks like NxStage will be starting up business in England, Holland and Scandinavia later this year. Maybe someday soon we will be able to travel to parts of Europe and realize the possibility of venturing beyond the 48 states with our machines.

Next years ADC will be in Phoenix, Arizona, February 20-22 with the Home Hemo conference on February 19. Usually the Feb 19 gathering is open to the public at minimal cost. Keeping abreast of the new trends and research in Dialysis and Nephrology is one of the best ways to keep yourself informed and prepared to live your life to the fullest on dialysis.

Comments or questions ? Let me hear from you.

The Wearable Artificial Kidney progress report

By Bill Peckham

RenalWeb links to an article on medGadget, An Update On The Progress of Wearable Artificial Kidney, about a wearable hemodialysis device being developed at UCLA. This is one of several wearable dialysis devices that are in development, including at least one that uses peritoneal dialysis and others (h/t Kaply) where the process is not clear (PD or hemo?). I wish all these researchers God's speed in developing new technology designed to improve my life but I have to wonder.

Let me preface this comment by saying I have never been a good judge of new product ideas. I saw no point in cell phones or bottled water back in the '80s. My buddy had to drag me down to the first internet cafe in Seattle after I disparaged the usefulness of the internet. That being said I can't see myself on dialysis, with needles in my arm, as I go about my day. PD maybe but hemo?

The issues around accessing the blood would seem to be too great. I'll be happy to be proved wrong.

PD Yesterday, Today and Tomorrow

By Bill Peckham

Baxter's front page marks:

30 Years of Peritoneal Dialysis Innovation

"Peritoneal dialysis home therapy (PD) was introduced 30 years ago to offer kidney failure patients a better way to filter toxins and fluids from the body overnight or several times a day in the convenience of their home. Today, we celebrate Baxter’s role in developing every major milestone in the therapy since 1978.

That is all true but it doesn't tell the whole story. In 1978, in the US, Medicare extended dialysis reimbursement to peritoneal dialysis which led to its much wider use. However, we don't say that hemodialysis was introduced in 1973 when Medicare extended coverage to people with CKD5. As with Medicare's acceptance of HD, Medicare's reimbursement of PD was only possible after many years of hard work and inspired creativity by a number of individuals. And, as with HD, Seattle Washington, the University of Washington and the Seattle Artificial Kidney Center (later renamed the Northwest Kidney Centers (NKC)) played a critical role.

Emeritus Executive Director of NKC Dr. Christopher Blagg is, among other areas of expertise, an historian of dialysis. While he is not yet posting directly to this blog, this is what he had to say regarding PD's beginning:

What they should have said was that this is the 30th anniversary of the FDA approval of continuous ambulatory peritoneal dialysis (CAPD). While  Baxter deserves great credit for making CAPD (and later automated peritoneal dialysis (APD)) readily available, techniques used worldwide today, the first use of home peritoneal dialysis in a patient with end stage renal disease was in 1964 in Seattle, and so 2008 is the 44th anniversary, and it seems appropriate to provide a brief review of the early history of home PD.

In 1964, Fred Boen and Henry Tenckhoff, working in Belding Scribner’s Division of Nephrology at the University of Washington in Seattle, sent the first patient home on PD using a closed system containing sterile dialysate in a 40 liter glass carboy, a system developed by Boen for hospital use in 1962. Because the indwelling access devices available at that time inevitably became infected, they had been using repeated punctures for access to the peritoneal cavity and so one of them went to the patient’s home three times a week to insert the catheter so she could dialyze overnight. This treatment proved successful and a small number of patients were treated in this way.

By 1968, Tenckhoff had developed the silastic catheter that solved the infection problem and that became the most widely used form of peritoneal access today. The following year he reported on a pressure boiler tank he had developed that could be used to sterilize dialysate for home PD. A number of these tanks were built by Cobe Laboratories in Denver and used by home PD patients in the Seattle area and in some hospitals, but the device was heavy and bulky. By 1972, with advances in water treatment technology, Tenckhoff had developed a more compact machine that used reverse osmosis and ultraviolet light to sterilize water that was then mixed with concentrate to form dialysate. This machine, manufactured by the Physio-Control Corporation in Redmond, Washington, proved very successful. As a result, Tenckhoff reported on 69 PD patients in 1971, and by 1977 161 PD patients had been treated in the Seattle area, many for more than 4 years and one for more than 8 years.

Everything changed in 1976 when Bob Popovich and Jack Moncrieff in Austin, Texas first reported on the technique for continuous PD they had developed that later became called continuous ambulatory peritoneal dialysis and which was developed so successfully by Baxter. As this was such a simple technique, the use of cycling PD machines initially declined, but with development of new devices for APD by Baxter and other companies, cycling PD has increased steadily and now is used by about three fifths of all PD patients in the United States.

PD can be taught in a few days, has similar patient benefits to home hemodialysis for patients who want independence and control of their own treatment, and most patients who use it are happy with their choice. Unfortunately, as with home hemodialysis, most US ESRD patients are either not told of these treatment options or do not have access to them, although this should change with the new Medicare ESRD Conditions of Coverage. Even so, for reasons that are unclear, the percentage of patients treated by PD is slowly dropping in the US and elsewhere.

It will be interesting to see how simply telling people about different forms of dialysis changes which type of dialysis people end up using. Will people's collective preference change the provision of dialysis? When Nephrologists are asked which modality they would choose if they need renal replacement and a kidney transplant is not available, it is my understanding that 100% choose home dialysis (either home hemodialysis or home peritoneal dialysis). None would choose conventional incenter hemodialysis, the primary mode of renal replacement in the United States, and all seem to assume they would have access to whatever modality they wanted. Access and knowledge of that access, limits the use of PD today. Limits its use at a time when the future looks bright. Smart and creative people are still working hard to improve the provision of renal replacement.

At ASN there was this Renal Solutions booth with a mock-up of what a Wearable PD Belt could look like - it looks like a utility belt, something I might see at work. Add a couple pockets for a cell phone and iPod and don't leave home without it (this approach makes a lot more sense to me then the wearable hemodialysis systems that would require blood access). I think people will want this new technology. A lot of people. 

We should mark this 30th Anniversary. Ultimately it is reimbursement that allows access to these life saving devices. Indeed let's remember innovation when creating our reimbursement framework (I'm looking at you CMS). And let's remember where we've been as we look to an exciting future.

Wearable peritoneal dialysis device coming to market?

This announcement of a:

licensing agreement with the Singapore-based company AWAK Technologies Pte. Ltd. to develop a commercial wearable kidney based on the design by Martin Roberts, an assistant professor of clinical medicine at the David Geffen School of Medicine at UCLA and a dialysis consultant with the VA Healthcare System, and David B.N. Lee, a professor of medicine at the Geffen School and a consultant nephrologist at the VA

Sounds like a significant step in bringing to market an alternative to conventional incenter hemodialysis. This is another wearable peritoneal dialysis system, that unlike the one I described last March, would use a sorbent system. The sorbent approach is used by the Alliant hemodialysis system; the sorbent column in this device would do the same job: clean the dialysate so it can be reused.

An article abstract from 2007 discribes the new device as “waterless.” Does the sorbent column also remove excess fluid? How does it determine the rate of fluid removal? This rate of fluid removal question is fundamental to all of these imagined wearable dialysis systems that are meant to be used continuously. A healthy kidney varies it's fluid removal based on biofeedbacks i.e. fluid intake, body usage (sweating). How would these continuous wearable kidneys know the correct fluid removal rate? I can think of solutions but I wonder what the actual engineers have come up with?

Rereading about nanotechnology

I was rereading my January post about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . I rewatched this second video featuring Dr. Steinman. I'm glad I reread it and watched the video - the post is one of my favorite posts. I just hope we see it in the real world. Soon.

Wearable peritoneal dialysis device

This is an interesting patent for an artificial kidney dialysis system, which in fact combines waste removal and "an implantable fluid removing device". It seems to propose to use the sort nanoengineered dialysis membrane that Dr. Steinman described in video two of the CIMIT presentation. They use the phrase "another embodiment" often in the filing which I take to mean that this is in the early stages.

I was interested because I had not considered peritoneal dialysis as a way to make wearable dialysis practical. The nanoengineered filters cleanse the dialysate not the blood directly. This eliminates the blood access issue which I think is wearable hemodialysis's biggest challenge. Wearable peritoneal sounds more practical.

It's also interesting to consider the advantages of an implantable device that removes only fluid. I wonder if such a device could be used temporarily to get people to their dry or to eliminate the need for fluid control. Dialysis would be much less of a burden if people did not have to remove fluid. It's the buildup and rapid removal of fluid that causes the heart so much stress. Continuous fluid removal would make blood pressure control less complicated.

Rather than trying to match a kidney feature for feature, maybe the best approach is an incremental approach. First create an internal device to remove water only while, the current technology is used to cleanse the blood.

Dialysis nanotechnology forum Q & A, video five

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

On Saturday I wrote The future of dialysis: T and G membranes about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . The forum is broken up into five video segments; this week I'm reviewing one video segment a day. On Monday video one CKD overview video: Dr. Bonvertre. Tuesday video two Dialysis: a future with nanotechnology. Wednesday Dialysis nanotechnology forum, video 3. Thursday Dialysis nanotechnology forum, video 4.

The fifth and final video is a question and answer session about eighteen minutes long. This was helpful because of the extended answer to the first question reinforced why you need both the T and the G membrane. If you can only remove middle molecules by allowing middle molecules and everything smaller across the membrane you need the T membranes to let the good stuff back in along with a large percentage of water. This discussion also reinforced that the core library of membrane pores sounds like an approach that we'll be hearing about for the next decade.

Some of this was sobering because they emphasized the limitations inherent in this technology; that an artficial nephron is still a foreign object. There is still the issue with blood access and there is still the problems caused by clotting. If it was easy it would have already happened.

And if the science wasn't hard enough new technology also has to be cost effective. Not only does the new technology have to improve lives it also has to improve a number of financial bottom lines - Medicare's, provider's, insurer's.

It will be a tough nut to crack.

I'm very appreciative of CIMIT for putting on the forum online. As the technology develops I am looking forward to more opportunities to hear from the people pushing the boundaries of dialysis.

Dialysis nanotechnology forum, video 4

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

On Saturday I wrote The future of dialysis: T and G membranes about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . The forum is broken up into five video segments; this week I'm reviewing one video segment a day. On Monday video one CKD overview video: Dr. Bonvertre. Tuesday video two Dialysis: a future with nanotechnology. Wednesday Dialysis nanotechnology forum, video 3.

Today the fourth video. This 20 minute video features Jeffrey Borenstein, PhD, Director, Biomedical Engineering Center; Distinguished Member of the Technical Staff, Charles Stark Draper Laboratory; Program Leader for Biomaterials and Tissue Engineering and Draper Laboratory Site Miner.

This was hard to follow. Not being able to see his slides was a real disadvantage and it sounded like some interesting slides. CIMIT should put the PowerPoints up with the videos. What I understood was this research grew out of a project in tissue engineering. While that technology is a decade or more away CIMIT saw that micro-fabrication could be used to improve dialysis in the near(er) term.

There was talk of (spelling questionable) endothelization, poly glicerol serveca, micro-capulari network, endotheilial, optimizing the diffusion distances for middle molecule clearance, mathematical modeling. I can't say I understand all that was said - if anyone took more away from it please comment. Sounded like they were looking at the unique properties of the cells that line veins and arteries for use in these devices but I wasn't clear on the approach.

There was also talk of a complete renal replacement system using a cell based loop of henley. I'd like to hear more about that and will look for information to share. After watching this I had the impression I get when I go to national renal industry meetings, I feel hopeful because of the brain power being brought to bear on the challenge of improving the lives of people with CKD. It'll take a lot of brain power to meet the challenges to make some kind of continuous filtering artificial nephron that works - it sounds like that is happening. Thanks CIMIT for bringing us this new kidney research.

Dialysis nanotechnology forum, video 3

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

On Saturday I wrote The future of dialysis: T and G membranes about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . The forum is broken up into five video segments; I thought this week I would review one video segment a day. On Monday video one CKD overview video: Dr. Bonvertre. Tuesday video two Dialysis: a future with nanotechnology. Video three  (about 23 minute run time) looks at the business side of improving the provision of dialysis.

Greg Erman, MBA, Serial Entrepreneur and former President & CEO, Renalworks Medical Corporation is featured in video three. He  goes over the business challenges of bring a continuous mode of dialysis to market. He is speaking from a private equity perspective, a venture capital perspective. This is a critical point of view since funding is required to bring any product to market. However, I was surprised that his presentation missed many of the ESRD program's funding subtleties.

He starts with the premise that Medicare spends on average $100,000 a year per dialysis patient. That's not the number. Medical expenses for all dialyzors form a bi-modal distribution. There is the average cost for people that are Medicare primary and another average cost (much higher) for people with private insurance primary. The United States Renal Data System publishes Medicare's dialysis cost data. The 2005 data is available here (pdf link). There is a lot of detail available.

From USRDS table K2: Total Medicare cost for ESRD (dialysis and transplant) is 19.3 billion dollars in 2005: total outpatient 7.15 billion (almost all dialysis); total inpatient 6.96 billion (transplant and dialysis); total physician/supplier 4.1 billion (transplant and dialysis, includes post transplant medications). 75% of the people on dialysis have this cost profile (remembering that Medicare pays 80% so total medical cost per Medicare primary patient would be 125% of Medicare expenditures).

On the per patient per year level it's $24,000 outpatient, $20,000 inpatient and $14,000 physician/supplier. To get to that $100,000 per patient average for the whole program you can work backwards to calculate the average cost to private insurers to support someone who is on dialysis. With just 10% of the patient population their average cost would be on the order of $300,000 with the about the same distribution among inpatient, outpatient and physician. A classic bimodal distribution with very few people in between the two modes.

The problem from the equity perspective is that you have to work under the Medicare cost structure. The private pay cost structure is far more generous but Medicare is the ESRD rule setter in the United States. Many products could thrive under the private reimbursement constraints but in the US it has to work under the Medicare reimbursement framework. Instead of $100,000 the relevant number is Medicare's share of the their beneficiary's cost, a more modest $55 -$60,000 for those not in skilled nursing facilities.

One thing that Mr. Erman said that was wrong and offensive was his description of the  ESRD program under Medicare as "the last social welfare program left in the country for healthcare.  Anybody is entitled to get covered for dialysis if they lose their kidney function." Medicare is insurance. It is not means tested, you earn it through working enough quarters. If you don't have the quarters of paid employment (and therefor the quarters of paying FICA taxes) you don't qualify for the Medicare ESRD program. True it is subsidized insurance but Erman mischaracterizes the program.

Beyond implying that dialyzors are uniquely on the dole he states that dialyzors are "very suicidal" and "a large percentage of patients are suicidal". Now it is true that depression is a problem in many chronic illnesses but it is wrong to imagine that dialyzors need to be on a suicide watch. Depression can be a consequence of Chronic Renal Under Dialysis and/or untreated anemia but I haven't seen data to suggest "a large percentage of patients are suicidal". Mr. Erman seems to take this as a given and a reason why NxStage and other healthier home modalities don't have more adopters.

Australia and New Zealand have much higher adoption rates of home hemodialysis (13%) and peritoneal dialysis (25%) than the US. Here in the US the Northwest Kidney Centers in Seattle has 5% on home hemodialysis and 9% on PD. Obviously there is something else generally preventing people in the United States from adopting home therapies. Home Dialysis Central works hard to promote home therapies, compiles and studies the barriers to going home and being suicidal is not on the list.

Another point Erman makes is that unlike cardiovascular patients, dialysis patients don't offer savings from fewer hospitalizations. That was a surprise to hear. The USRDS data shows that Medicare spends nearly as much on inpatient ESRD procedures as it does on outpatient procedures. Looking at the sample Dialysis Facility Report the national average number of days in the hospital per admission for people on dialysis is 8.1 days. On average dialyzors spend 16 days a year in the hospital. A significant number of those admissions are due to access issues but over half are for something else.

The problem isn't that there isn't money to be saved it's that because of the artificial accounting wall between Medicare Part A and Medicare Part B savings on hospitalizations can not pay for additional Part B dialysis. The problem is not with the dialyzors. I think the problem is that our system of venture capitol funded innovation does not work when it comes to a condition dominated by Medicare. The difference between the cardiac market and the dialysis market isn't based on the personalities of the patients and doctors, the difference is due to the funding models.

Venture capitalists look to replace labor expenses with technology expenses. I believe on average a dialysis patient consumes 5 to 10 hours of labor a week. How many hours of labor would continuous dialysis consume a week? Currently home therapies like NxStage have an economic model that depends on labor savings. The bigger pot of money to be saved would be in hospitalizations but for Part A spending to enter the calculus it would require a change in DC.

60 years of dialysis. 60 years of progress?

RenalWeb links to The monthly thought of the Editor in the International Journal of Artificial Organs (Vol. 30, no. 12, 2007, pp. 1029-1030): Hemodialysis 1947-2007: Six decades of achievements and challenges (pdf link). Dr. Claudio Ronco gives a summary review of how the provision of dialysis has changed since "Alwall and Willhelm (Pim) Kolff developed new machines utilizing dialysis as a blood cleansing modality" in the late '40s. Sixty years of renal replacement therapy.

The quibble I have with this survey is its acceptance of the three day a week model of dialysis. The three day a week regime has been a feature of dialysis since the early '70s but it was never selected for its clinical efficacy. The advantages of three day week dialysis are business related, as are the advantages of shortening the length of the treatment. Is there another area of medicine where for thirty five years business expediency has trumped clinical efficacy? It is here that the history of dialysis constrains the future of dialysis.

The provision of dialysis is reaching retirement age; it is time to give the three day a week schedule a gold watch and to move on to healthier schedules.

Dialysis: a future with nanotechnology

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

On Saturday I wrote The future of dialysis: T and G membranes about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . The forum is broken up into five video segments; I thought this week I would review one video segment a day. On Monday I wrote CKD overview video: Dr. Bonvertre about the first video segment of the forum.  This second video is about 45 minutes long and features Theodore I. Steinman, MD, Clinical Professor of Medicine, Harvard Medical School; Beth Israel Deaconess Medical Center.

Dr. Steinman gives a fascinating talk picking up the story where Dr. Bonvertre left it. Dr. Steinman looks to what the future of dialysis may hold as work proceeds on "developing a new type of functioning artificial nephron". At one point in the video he gives a tour of the human nephron but for the most part this video segment covers nanotechnology and the sort of impact nanotechnology is expected to make on the provision of dialysis.

Dr. Steinman goes over some of the common clinical impacts of standard dialysis; he suspects that chronic inflammation may be at the heart of the cardiovascular problems associated with dialysis. He makes the point that "advances at the margin" in the provision of dialysis do not address some of the major problems that we need to address to improve the quality of patients lives.

Dr. Steinman gives some nanotechnology background. Which for the most part I feel hopeful when he talks about manipulating pore size of the semipermeable membrane to make a better dialyzer but when he talks about microscopic nano-robots, nano drug delivery devices and multipurpose nano particles ... well I wonder if society is prepared for injectable nano particles, let alone nano-robots. Thankfully that is not an issue dialyzors will have to pioneer. The nanotechnology that will revolutionize dialysis has to do with a nano-engineered dialysis membrane with specially devised nanoscale pores.

As a dialysis geek or wonk I have to say, I was in heaven when he started talking about membrane pores. This is where dialysis actually happens. Right there at the semi permeable membrane a molecule moves across from the blood space into the dialysate. That moment is the key, repeated many times. Here Dr. Steinman talks about unselective pores v highly selective pores and his plan to selectively filter and then selectively reabsorb just the molecules we want, he describes a pore library that will offer just the right membrane pore for each component of plasma, good and bad.

He lists the faults of today's modern dialyzers:

unselective transport; wide distribution of pore sizes leads to statistical filtration
relatively thick, often low flux
no opportunity for precise atomic placement
long pore pathways
tortuous path

Thats an interesting concept "statistical filtration". Today dialysis is based on the concept that it's bound to work. That the size and shape of the membrane pores vary enough that statistically you're bound have some proportion of pores that are suitable. heh

If that wasn't enough for one video he then comes to the meat of his talk on the Continuous Functioning Artificial Nephron (CFAN). This is the device that uses the G and T membranes to create a highly efficient dialyzer. G stands for glomerulus, T stands for tubular together the mimic the human nephron. Dialysis using this new technology (and running 12 hours a day 7 days a week) could provide a GFR equivalent to 30 - that's barely stage 4 CKD. Someday the technology could provide a GFR equivalent of 60 - barely stage 3.

So the G membrane would take stuff out, the T membrane would allow stuff back. What each membrane would do exactly would depend on which pores you incorporate into the membrane - the membranes would be customized based on prescription. Fluid removal based on pores chosen. This could work on a standard machine but the technology opens up many possibilities in design because it doesn't use dialysate. Solute transport occurs by convection - passive transport.

With no dialysate an implantable device looks more practical and certainly a wearable kidney is easier to create. However a wearable kidney again brings cannulation into play and about five slide from the end Dr. Steinman shows what a double lumen needle and immobilization device looks like. Double lumen so you use one needle for venous and arterial duties but how can it be immobilize? It looks to be a tape based contraption with a portal in the tape that presumable is centered on a buttonhole. Then once the needle is in, it looks like a cap disengages from the tape to snap over the needle "locking" it to the tape? Maybe. And then there might be a tab of sur-seal material in a circle that covers the cannulation site on ex-cannulation. It would be helpful to see this system demonstrated. I'm good at making stuff up. Still not sure about wearing it for 12 hours a day. Maybe.

So many things come to mind but for one thing they're imagining a waste bag taped to the thigh. Clearly the better way would be to wear it like a shoulder holster and run the drain line down to the zipper. I hope that highly efficient, engineered membranes are coming; the next video segment touches on the business side of the equation. One problem Dr. Steinman mentions is coagulation and how to keep it from clotting up. I guess that is where the nano-robots come in or maybe nano heparin dispensers. Unless cost is prohibitive we should be seeing nano-engineered membranes someday. Maybe they can be reused if they are expensive. Cleaned between treatments by nano pore cleaners. Endless possibilities. All very hopeful.

CKD overview video: Dr. Bonvertre

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

On Saturday I wrote The future of dialysis: T and G membranes about CIMIT's forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? . This forum seems to be one of a series of forums on various medical topics. They're open to the public (wish I lived in Boston)  and are put on by CIMT to further their mission of improving medical care by spreading knowledge. The forum weaves in an evaluation of the technology from a business perspective which is critical. As was seen with the Aksys PHD and early efforts to improve the artificial kidney the speakers mention.

Quest for a Wearable Kidney: Will Nanotechnology Make a Difference? looks at work to improve dialysis by improving the artificial kidney, the dialyzer. The whole forum is very good and there is a lot to it - five video segments; I thought this week I would review one video segment a day. The first video, about ten minutes, long features Joseph Bonventre, MD, PhD, Robert Ebert Professor of Medicine and Health Sciences and Technology, Harvard Medical School; Director, Renal Division, Brigham and Women's Hospital.

Dr. Bonvertre gives the overview of the kidney, CKD, and previous "new approaches" to improving the dialysis experience. I think Dr. Bonvetre is presenting the case for relevance and establishing that there is a market for new and better devices: the US already spends a lot of money treating this disease; there are a lot of people in the dialysis pipeline. Usually I see this sort of presentation it is at a renal industry event so often the relevance piece is taken for granted or addressed in passing.

CIMIT is trying to catalyze development of innovative technology, emphasizing minimally invasive diagnosis and therapy. If any therapy is invasive it's hemodialysis, particularly incenter hemodialysis, so welcome CIMIT we can use the help. Video one gives a good overview of CKD and dialysis but it misses one salient point. After 45 years the incenter dialysis model has worn a deep rut in the course of CKD; it will take a novel approach to get the provision of dialysis out of that rut.

The future of dialysis: T and G membranes

By Bill Peckham

The videos are no longer available at the links in this post, instead all the videos are embedded and can be watched at the CIMIT blog in this post. The five videos are embedded in the same order as they were presented in 2008. My review of the videos are all listed in the Future of Dialysis Category on DSEN.

This is a great lecture class forum: Quest for a Wearable Kidney: Will Nanotechnology Make a Difference?  presented as five videos. Totaling about two hours in length the videos present a comprehensive look at the sort of technology being developed to improve the effectiveness of hemodialysis. Specifically they look at nanotechnology, surveying where the field has been and where nanotechnology is going, with particular emphasis on hemodialysis.

This comes from the Center for Integration of Medicine & Innovative Technology (CIMIT).  CIMIT's mission is to improve patient care by bringing scientists, engineers, and clinicians together to catalyze development of innovative technology, emphasizing minimally invasive diagnosis and therapy. The presentation seems to be to an audience of no particular background - I believe the forum is open to the public - so for the most part the information is accessible. Over all it is well done.

The first video is Joseph Bonventre, MD, PhD, Robert Ebert Professor of Medicine and Health Sciences and Technology, Harvard Medical School; Director, Renal Division, Brigham and Women's Hospital. He gives the background explanation of dialysis and outlines the clinical need for improved hemodialysis.(video one review)

The second video is Theodore I. Steinman, MD, Clinical Professor of Medicine, Harvard Medical School; Beth Israel Deaconess Medical Center. His presentation on Human Nephron Filters and a Continuous Functioning Artificial Nephron is pretty exciting. A lot of new information. One concept I had not heard before is the idea that this could work without dialysate - on a nano-scale solute transport would occur due to convection. So called passive transport. One concern I have always had regarding a wearable kidney is the blood access. Towards the end of the video he shows a slide and references a "double lumen needle and immobilization device" the slide is intriguing. It shows that there is a proposed solution but the details remain to be seen.(video two review)

The third video is Greg Erman, MBA, Serial Entrepreneur and former President & CEO, Renalworks Medical Corporation who goes over the business challenges of bring a continuous mode of dialysis to market and he addresses the issue of blood access by pointing out that implanting the device solves the issues around needles and catheters. I can't understand his point about dialysis costing Medicare 100,000 a year - that would have to be total costs, Medicare's share is about $70,000. However, he contends that there isn't enough money to be saved through more dialysis. I look at those numbers and reach the opposite conclusion.(video three review)

The forth video is Jeffrey Borenstein, PhD, Director, Biomedical Engineering Center; Distinguished Member of the Technical Staff, Charles Stark Draper Laboratory; Program Leader for Biomaterials and Tissue Engineering and Draper Laboratory Site Miner. He goes over where the technology is and what is left to do - unfortuantely the slides are not in view through most of the video (I looked for the PowerPoints online with no luck). (video four review)

The fifth video is a question and answer session with some good questions and a bit of industry gossip.(video five review)

This is all very encouraging.