Dialysis from the sharp end of the needle

Wall Street Journal spotlights home dialysis options

By Bill Peckham

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

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

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

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

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

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

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

Taking Peritoneal Dialysis to Sea: Jean Louis Clémendot Crosses Atlantic Alone; Eyes Tour of the US East Coast and then the Pacific!

By Bill Peckham

UPDATED 2/14
The Kidney Foundation of Canada has a brief article (in English) about the remarkable Jean Louis Clémendot who successfully made a solo crossing of the Atlantic, while administering his own peritoneal dialysis treatments:

A 59 year-old sailing enthusiast and continuous ambulatory peritoneal dialysis (CAPD) patient, Jean-Louis Clémendot left the island of Lanzarote in Spain on November 30, 2009 to sail solo across the Atlantic, heading for the Carribean island of Martinique. He completed his journey in less than four weeks, as expected, arriving at his destination on December 24, 2009.

What a trip!

Clémendot has a website with updates in French and a companion site in English. Unfortunately for we mono linguists, the English site is at times a bit behind in translating Clémendot's posts (Google translate does a fair job, though not nearly as good a job as Clémendot's own translations). To follow the entire saga check out his history page. The journal begins in September 2009, French on the left of the page, English on the right.

The trip begins with an initial run from Marseilles to Lanzarote (the eastern most Canary Island, off the NW coast of Africa), for this leg he is accompanied by two friends. Clémendot then waits about a month for the winds to take him alone to the Caribbean. Before leaving he has "a biology internship to learn what to do in the event I contract peritonitis" and buys a microscope so that he can identify which antibiotics would be best in the event of an event. This is but one of the logistic challenges he faces and overcomes.

He has what he calls the longest Atlantic crossing in history but there are many exciting moments and he shares a number of pictures and video. Clémendot's goal is to raise awareness of peritoneal dialysis and his website links to a number of interviews and articles, one with his doctor is available via Google translate. His December 29th entry led me to believe his next destination was the East Coast of the United States after a sail along the eastern arc of the Caribbean. That sounded like a great trip, however, via email correspondence he pointed me to his later posts (particularly from 1/18, available as of yet only in French) and wrote that his plan is to now leave for the Pacific.

He writes that he "will start from Martinique on the midle of mars and i expect to reach Tahiti on mi mai." Through the Panama Canal, to the Galapagos on to the Marquesas Islands and then to Tahiti by mid May. That's an epic voyage. He speaks of having crew for the canal, after that I am not sure. I'll definitely be keeping track of his adventure as it continues to unfold.

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

By Bill Peckham

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

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

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

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

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

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

Why aren't home dialysis modalities more popular? Why should they be more popular?

By Bill Peckham

Renal and Urology News has a new article up by Delicia Honen Yard, Why Use of Home-Based Dialysis Lags. It's a good article mainly focusing on peritoneal dialysis (PD) but I think at least two important points are left unsaid. The article quotes Dr. Rajnish Mehrotra, associate professor of medicine at the David Geffen School of Medicine, University of California-Los Angeles (UCLA) and associate chief and director for peritoneal dialysis in the division of nephrology and hypertension at Harbor-UCLA Medical Center. He lists four reasons that PD isn't used as much as he reckons it should be, one of his reasons is "Lack of infrastructure".

I think he is thinking of the number of programs offering PD and the number of skilled trainers available to teach patients how to safely do PD in the home. Patient access to PD programs and PD training slots. Left unsaid is that there is another piece of missing infrastructure that decreases the number of people using PD. The lack of inpatient PD availability.

Many hospitals can provide inpatient hemodialysis (HD) for people with stage 5 chronic kidney disease (CKD5) who are in the hospital for any reason, however, at some of these same hospitals PD is a complete mystery. I've heard stories of family members having to stay with their loved one in order to do the exchanges, bringing supplies from home. Alternatively the hospital might place a catheter, and do HD if the patient is too ill to do the treatments and there is no one else able and willing to step up. I am sure a doctor doesn't have to deal with this problem too many times before manifesting a bias away from PD  and towards HD.

I think Dr. Blagg professor emeritus of medicine at the University of Washington in Seattle, executive director emeritus of Northwest Kidney Centers in Seattle, and editor-in-chief of Hemodialysis International, charts the best transition into CKD5:

Dr. Blagg has some important advice on preparing for this eventuality [when PD no longer provides enough dialysis]: “To do hemodialysis you need blood access, which means undergoing surgery to put in a fistula in your arm. I believe very strongly that if somebody starts on peritoneal dialysis, once they're stable and doing well, they should have surgery so that they have an access.”

Dr. Blagg theorizes that because a fistula can take several weeks or even two to three months to mature, having it ready well in advance will enable PD patients to go much more safely and simply to HD.

The idea would be that even if the CKD is diagnosed late in the disease process and dialysis has to be started - PD can be used right away and the person can be sent home to manage their own treatments after as little as a week of training. Then, while managing their CKD5 with PD the patient can have a fistula placed so that when it is time to transition to HD there will be a mature fistula ready to be used from day one. Left unsaid is the thread that runs through this optimal transition and connects the two modalities - selfcare at home.

Taking dialysis home avoids the infantalization that often happens when a person spends as little as a few months on incenter HD. This has been a much remarked on process which was first described in The Patient with Chronic Renal Failure: "A Marginal Man" by Melanie K. Landsman, ACSW, published in the "Annals of Internal Medicine" in 1975. The learned dependency inadvertently instilled incenter compounds the burden of CKD. For this reason alone home should be the dialysis venue of first resort. I think all the docs quoted in the article could agree with that.

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?

Focus on peritoneal dialysis

This week's Kidney Talk with Sherai Onibasa is a good one. Sherai is the sort of remarkable person you meet when you get involved with RSN. In this Kidney Talk Sherai gives the insider's view of PD and shares some her interesting back story (including a travel tale). I probably don't give PD its due - there isn't an agenda at work, I just don't know much about it. It's good to keep this very work compatible form of treatment in mind when we think about dialysis.

Peritoneal dialysis facts

The Home Dialysis Central topic of the month is Saying yes to PD: Separating myth from fact . I have to admit that after 20 years (this July) with stage 5 CKD I really don't know much about PD but I believe the dialyzors who say it's a great fit for them; I agree that PD should be more widely used.

Peritoneal dialysis video - how to hook up for CCPD

This video is from Shay, www.KidneyFun.com owner and shows how she set up, hooked up, and unhooked from her Continuous Cycling Peritoneal Dialysis machine -  this is an overnight  dialysis modality that does not involve needles. The video is a bit over 6 minutes - some of the captions are hard to read but after watching the video you'll know what's involved in hooking up each night. One thing I wondered is without edits how long does it takes from start to finish?

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.

Affirmations from Patient's Pride

This video is different - it's from Sheila Shaw founder/President of Patient's Pride and is a series of positive thinking personal empowerment thoughts to start your day. I, of course, would use the word dialyzor instead of patient but the sentiment would be the same.

New Automated Peritoneal Dialysis Cycler from FMC

Fresenius Medical Care has rolled out a new Automated       Peritoneal Dialysis Cycler. They're introducing it at the Annual Dialysis Conference opening today in Orlando, Florida.

The Peritoneal Equilibrium Test

Home Dialysis Central has an article up on the Peritoneal Equilibrium Test which is used to determine the suitability of peritoneal dialysis modalities. Just one example of the wealth of home dialysis information available from Home Dialysis Central.

Patient's Pride founder tells her story

This four minute YouTube video is from Sheila Shaw. She "was diagnosed with Lupus, ESRD, Osteoporosis, ... experienced chemotherapy [and] 3 Grand Mal seizures" but that didn't keep her down, "she was able to move forward and take back control." Sheila has had to over come a lot in her young life. She now works to spread a message of self empowerment to others facing chronic diseases. That's the message of this video.

You might not go out and race motorcycles or start your own company but if you follow Sheila's example and advise you can achieve whatever goals you set for yourself.