HemoDoc, From Doctor to Patient

Most US Dialysis Patients Participate in Regular Exercise

By Peter Laird, MD

Exercise is one of the most important methods of improving outcomes in both the general population as well as in the dialysis population. Despite the claims that American dialysis patients are less healthy and more inactive than their Japanese, European and Australian counterparts, a recent study by DOPPS points out an excellent exercise participation by the majority of American dialysis patients:

Physical Exercise among Participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS): Predictors and Associated Outcomes.

RESULTS: Regular exercise frequency varied widely across countries and across dialysis facilities within a country. Overall, 47.4% of participants were categorized as regular exercisers. The odds of regular exercise was 38% higher for patients from facilities offering exercise programmes (adjusted odds ratio = 1.38 [95% confidence interval: 1.03-1.84]; P = 0.03). Regular exercisers had higher HRQoL, physical functioning and sleep quality scores; reported fewer limitations in physical activities; and were less bothered by bodily pain or lack of appetite.

Despite this excellent survey of American dialysis patients compared to their cohorts in other nations, exercise alone does not mitigate the other factors that attribute to our last place mortality compared to other nations:

Why Is the Mortality of Dialysis Patients in the United States Much Higher than the Rest of the World?

Studies reported by DOPPS consistently show a marked difference in crude mortality between different countries, with the mortality in the United States being one of the highest. For example, in 2003, DOPPS reported the crude 1-yr mortality rates were 6.6% in Japan, 15.6% in Europe, and 21.7% in the United States. After adjustment for age, gender, race, and 25 comorbid conditions, including cardiovascular comorbidity, the relative risk (RR) for mortality was 2.84 for Europe compared with Japan and 3.78 for the United States compared with Japan. Thus, variability in demographic and comorbid conditions at dialysis inception explains only part of the variances in mortality between countries.

The recent study by DOPPS of the exercise habits among patients in different nations would not suggest a more sedentary population in the United States which is often one of the excuses many nephrologists juxtapose for these poor mortality outcomes. This study, while encouraging in the fact that most American dialysis patients do participate in frequent exercise, begs the question asked in the second article, why is the mortality of dialysis patients in the United States higher than the rest of the world?

Nocturnal Dialysis Patients have similar Employment as Transplant Patients

By Peter Laird, MD

Home Dialysis Central  listed an important study from Finland in their monthly newsletter showing significant improvement of employment among home hemodialysis patients compared to usual in-center dialysis patients. This should not be a surprise since the practice of thrice weekly home hemodialysis for 6-8 in the 1960's was the dose of dialysis that fostered renal rehabilitation. Unfortunately, National Medical Care opposed home hemodialysis options in the 1970's in part due to the adverse payment schedules of the original ESRD program against home hemodialysis despite the facts that it was significantly cheaper and had much better outcomes. Nearly fifty years later, we are still discussing the so called new found benefits of nocturnal dialysis:

Employment of Patients Recieving Maintenance Dialysis and After Kidney Transplant: A Cross-sectional Study From Finland

RESULTS:

19% of hemodialysis patients, 31% of peritoneal dialysis patients, and 40% of patients with a functioning transplant were employed; the overall employment rate for the Finnish population aged 15-64 years is 67%. Home hemodialysis patients and those treated with automated peritoneal dialysis had employment rates of 39% and 44%, respectively. In adjusted analysis, patients on home hemodialysis therapy (PRR, 1.87), on automated peritoneal dialysis therapy (PRR, 2.14), or with a kidney transplant (PRR, 2.30) had higher probabilities of employment than in-center hemodialysis patients. Patients with type 1 or 2 diabetes as the cause of ESRD had the lowest probability of employment (PRR, 0.48-0.60 compared with glomerulonephritis). Patients aged 25-54 years more frequently were employed than those younger than 25 or older than 54 years. Sex did not predict employment. For transplant recipients, longer time since transplant was associated with higher employment in addition to the mentioned factors.

CONCLUSIONS:

Employment rate of home dialysis patients was similar to that of transplant recipients and higher than that of in-center hemodialysis patients. Patients with diabetes were less likely to be employed.

While it is not in any sense news that well dialyzed patients are better rehabilitated, Dr. Scribner and his colleagues taught us that in the 1960's, it would be news if the United States ever put into practice the clinical goals that Dr. Scribner developed so many years earlier. This was in the days when nephrologists were more concerned about the clinical well being of their patients instead of the financial portfolio of their dialysis center. Yet today,  we are still plagued with academic nephrology calling for further and further study while Europe continues to put into practice the proven methods of the pioneers of dialysis. Perhaps some day we shall all wake up from this bad dream, but until then, the nightmare of for-profit dialysis will render more and more able bodied patients who develop renal disease to the waste bin of un-rehabilitated patients devouring resources when other nations keep them as a healthy part of the economic work force. Sadly, this is one event that can truly said to be, only in America.

Bill Peckham Responds to Dr. Ishak's Kidney Doctor Opinions and Hemodoc Rebuttal

By Bill Peckham (DSEN)

Why would you use $160 as the Medicare allowed cost? There is no situation under which Medicare pays $160. The base allowed rate is $230, the average is $250. The fact that Medicare now includes anemia management in with their routine payment (along with the other formerly separately billable services) doesn't change the math.

Additionally, to calculate the average per year per beneficiary allowed reimbursement you'd need to know the average number of treatments per year, per beneficiary. I think for beneficiaries who start and finish the year using dialysis, they average about 148 treatments a year. Thus, 148 x $250 x .8 gives the average per year, per beneficiary cost to Medicare for someone who uses dialysis.

The cost to Medicare is the same, whether the person dialyzes at home or incenter, whether the person dialyzes for 3 hours or 5. Medicare's dialysis cost increases only with frequency. However, Medicare can lower the cost of a beneficiary using dialysis by looking at the Part A side. And in fact there is a lot of money to be saved on hospitalizations. As much as Medicare spends on dialysis, it spends an equal amount on hospitalizations and skilled nursing.

D. Ishak, in your http://www.thekidneydoctor.org/2011/10/dialysis-unplugged-waiting-for-godot.html?showComment=1320817885323#c4408236234879080109 original comment to Dr. Singh's Waiting for Godot post you made the claim that, aside from a select group of dialyzors (represented improbably by myself and Rich B) higher dose dialysis would only benefit "The new Amgens and their agents!!"

You continue "There is a whole new industry for home dialysis and the more patients they have the more machines they will sell and the more treatments per patient the more supplies they will sell." (you point to the "home dialysis" industry but since PD has not been part of this discussion I will assume that you meant home hemodialysis). That is a false equivalency.

Prior to the expanded bundle the way to maximize EPO revenue (and profits) was to increase people's dose of EPO without increasing their hemoglobin. That is bad enough but combined with concerns about high EPO induced hemoglobins, or perhaps, with high doses of EPO, in and of themselves, there is reason to believe reimbursement led to medical harm. Tell me where the analogous dynamic is at work in home hemodialysis (HHD)?

Unlike EPO, HHD has a constraint built in: the dialyzor's willingness to preform the treatment. If someone feels well dialyzing every other day then that is the schedule they will freely select, leaving another dialyzor, another individual, to dialyze seven days a week, over night. Each person is perfectly able to identify their preferred dose, striking their own balance between pros and cons.

The other glaring difference betwen EPO and HHD, is that HHD, unlike EPO, evinces no evidence of harm. Indeed, as most recently spelled out in September by http://www.nejm.org/doi/full/10.1056/NEJMoa1103313 a paper in the New England Journal of Medicine, there is evidence of harm associated with the conventional three day a week schedule. If there had been evidence of harm associated with a 'Hgb less than 10' the situation would be analogous to HHD, instead the situation is exactly opposite.

If people want to dialyze at home they should be supported in that choice. If they want to dilayze more frequently than 3 times a week they should be supported in that choice as well. The FHN study was not powered to differentiate the benefit of HHD among various comorbidities, but it did demonstrate the absence of harm.

The question of what dialysis modality would nephrologist use is predicated on the assumption that transplant is not an option. In fact not being eligible for transplant is the only characteristic given: if you were among those who must use dialysis because a transplant is not being pursued, what modality would you choose? Nephrologist would choose to dialyze more frequently.

Since the not pursuing transplant group includes tens of thousands current Medicare beneficiaries, using a conventional incenter dialysis schedule, that are as healthy as an average nephrologists, how do you explain this dissonance?

The Nephrology Oral History project is a great resource. Dr Maddux interviews a nephrology luminary and reports their answer. On page 27 of the Gotch interview transcript (PDF linkhttp://www.voiceexpeditions.com/assets/media/noh/fag/gotch.pdf ), Dr. Maddux asks a great question. If you needed dialysis (a transplant not being an option) what would you choose?

I thought Gotch's answer was very revealing. He says he isn't sure he'd choose to dialyze at all but you can hear his approach to the question in his answer... that he'd want dialysis to take as little time as possible, that he'd want to feel well enough to still be able to do things that mattered to him, for example, going on a favorite hike, and that he'd want to evaluate the short daily dialysis option to see if it was a better choice in his case. He'd want to see how well he did, how well he felt and then decide.

It's a perfectly reasonable answer - find the best renal replacement to fit your life and then decide if it is worth the trouble. That's what we wish for everyone. The reason Gotch's answer stings, though, is that it is at odds with what he advocated during his long professional career boosting the importance of urea.

It is not enough to say Nephrologists wouldn't do what we routinely prescribe because nephrologists are special. It turns out that nephrologists are just like everyone else; everyone else deserves a nephrologist's level of informed consent.

Dr. Ishak Rebuttal: "Extra Cheese Dialysis" or the Gold Standard?

By Noshi Ishak, MD

Dr. Laird, let me explain few issues so that your enthusiasm and energy can be directed the right way.  First, let me reiterate what I said in my first response which is that there is no doubt that home Hemo and more frequent dialysis are superior to traditional 3x/week dialysis to many, exactly like transplant is superior to traditional dialysis, BUT, the question is who will really benefit from more aggressive and prolonged daily dialysis. The answer to this question is vital if we are to make those modalities credible so that the resources will be directed towards the people who will really benefit from it.  You can’t, for example, give a transplant to a patient with lung cancer whose has less than 2 years life expectancy. Likewise, will it be right to put a patient like this on a 30 hrs/week dialysis!! Or will you be taking away from him very precious time with no benefit….well, may be “Extra Cheese”!!

Now, in regards to the issue of mortality of nocturnal dialysis, we all know that FHN is a credible study, and that study did compare apples to apples. The study compared patients with multiple co-morbidities doing their frequent home Hemodialysis to their peers with similar co-morbidities doing the traditional 3x/week in-unit dialysis. The study proved that both groups had equal mortality. In a sense, what you are trying to do is compare the mortality rate of transplant candidates with the mortality rate of non transplant candidates. But this makes no sense because the non transplant candidates have an obvious reason that will limit their prolonged survival chances. You cannot just compare apples and oranges. That’s why even the study you quoted Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients  honestly compared the selected group on nocturnal dialysis with kidney transplant recipients, they did not compare them with the general dialysis population.  In other words, they compared relatively healthy patients to relatively healthy patients. Their conclusion was “ this intensive dialysis modality may be a bridge to transplantation or even a suitable alternative in the absence of LTX in the current era of growing transplant waiting lists and organ shortage.”   This only confirms and supports what I said, and which you yourself quoted, which is that “For transplant candidates with expected prolonged wait for an organ and patients who failed their transplants, a more intensive dialysis such as daily dialysis or daily nocturnal dialysis is recommended.”

In regards to the second issue which has to do with cost, I have no doubt that home dialysis is cheaper than in center dialysis. That’s why all the LDO’s are scrambling to develop home programs. The story is completely different when it comes to in-center short daily or nocturnal daily dialysis, because, in this case, the cost will be prohibitive, and those are the kind of treatments that we have to be very selective and offer only to patients who will get real benefit not just “Extra Cheese”.  Let me also clarify the real cost of dialysis for Medicare, because I keep seeing different number tossed around that have no bases. For example, I read that “ in-center patients averaged around $29,000”  in 70’s. I also read that “ the new expanded bundle - per year amount to, on average, about $36,000 of which Medicare pays about $30,000.”  To my knowledge, Medicare only paid $120.00/dialysis in the 70’s through 2000. Multiplying this $120 x 13 treatments/month  x 12 month = $$18,720.00 From what Medicare paid 80%, which means the total of Medicare payment was $14,976.00/year per patient.  With the new bundle, Medicare pays about $160.00 for the dialysis treatment only.  Multiplying the 160x13x12x80%= $19,968/ year( current yearly cost of dialysis for Medicare).  This at a time where Medicare pays $130.00 to a hospital for a nurse to supervise IV infusion of medication for 1 hour, and which does not include the price of the drug or the supplies used. So, whereas Medicare pays that for a nurse to supervise IV infusion in a hospital setting, Medicare allows $160.00 for 4 hours of dialysis including nursing supervision, supplies, dialyzer, Heparin, dietician……What a deal? No wonder then even the Non Profit Major Medical Centers sold their dialysis units to LDO’s. None of them was able to sustain a financially viable dialysis unit. What a shame…. All the potential innovations of the medical and nursing staff of our best institutions are being chocked by the cook books of the LDO’s. Thanks to all the people who kept whining about their doctors or hospitals making money from dialysis, they did all the work for the LDO’s and the day the last Non-profit dialysis unit to be sold for an LDO is not far away. On that day the LDO’s will have a celebration and all their whining partners will have access for free Hot Air Balloon rides and free buffet, All You Can Eat Cheese. Also thanks to our politicians and their priorities, the same year our taxpayers paid $5 billion for dialysis treatments, they paid $2billion for Epogen alone. Yes for every $10 spent towards a dialysis treatment they gave Amgen $4. What a shame. I wish I can hear what our politicians were telling their brokers about Amgen!!

Further, when you say, “Thirdly, Dr. Ishak advised selected use of frequent home hemodialysis to those with limited co-morbidities and transplant eligibility,” you gave examples of patients you think will benefit from aggressive dialysis. The examples you gave are exactly as the ones I was suggesting, so we are in complete agreement here. I don’t see how or from where you get the idea that I will pull the plug on them!!!!! Dr Laird this is nothing but a flawed misreading of my assessment, I recommend you go back and re-read what I wrote!!      

Bill Peckham had a failed transplant and Rich Berkowitz had an MI that he recovered from, which is a limited co-morbidity.  Those are exactly examples of the kind of patients I support for aggressive therapy. But for the patients who had severe cardiomyopathy, vascular disease and other significant co-morbidities, aggressive dialysis will make no significant difference in their outcome. For example you need to prove to me that a patient with an Ejection Fraction of 20% will benefit by being converted from CKD 5-4 to CKD 4-3? This patient will die from his cardiac disease even if you give him a transplant. You cannot give him false hope. And you better not use this patient as an excuse to bill for more dialysis unless you have Solid Evidence that your extra dialysis will really give him real benefit, other than the“Extra Cheese”. This patient has precious limited time and you don’t want to waste it on a dialysis machine just for “Extra Cheese”.

You also add,“Dr. Ishak should also include one more group in his flawed assessment, the American nephrologist who overwhelmingly chooses NHHD when they themselves are in need of renal replacement therapy”.    

Dr. Laird, here you go again, you keep missing the point, the majority of the American Nephrologists are transplant candidates and if they cannot get their transplant on a timely manner, they will choose NHHD or daily hemo. No doubt about that. I will, too. They fit exactly in the criteria of patients I have always recommended for the daily Home Hemo.

But when I am a 70 years old with few stents in my legs and heart and few other things I will tell you, No Thanks I’ll Skip the Cheese!

 

NxStage Launches Find a Doctor

By Peter Laird, MD

NxStage System One is a portable dialysis machine that is taking patients into a new future on home hemodialysis. Unfortunately, with a little over 5000 current patients, many nephrologists lack experience over seeing patients maintained on this new machine. NxStage is launching a new program to find doctors who are familiar with this machine making the search to find an accepting physician easier for patients interested in NxStage:

Find a Doctor

The NxStage Find a Doctor directory is provided by NxStage for use by the general public to help locate a nephrologist who has experience caring for home hemodialysis patients treated with the NxStage System One™. The Find a Doctor directory is not intended as a tool for verifying the credentials, qualifications, or abilities of any physician contained therein. The use of the Find a Doctor directory by any entity or individual to verify the credentials of listed physicians is prohibited. Inclusion in the Find a Doctor directory does not imply recommendation or endorsement by NxStage nor does omission in the Find a Doctor directory imply NxStage disapproval.

This is a welcome addition not only for patients looking to try this machine, but also for patients traveling to specific areas who already utilize NxStage for their preferred therapy. Simply typing in the desired zip code will give the results of any nephrologist in that immediate area who has clinical experience with this device. As NxStage gains more market share, any information on actively participating nephrologists will bring many more patients into the home hemodialysis experience. NxStage continues to excell not only in an ingenious design, but in continued excellent patient support.

Large Dialysis Organizations: Capitalism or Cronyism?

By Peter Laird, MD

The recent revelations that congressmen are exempt from insider trading is a shocking statement of the corruption in Washington D. C. elevated to a new height. Studying the history of democracies, they always end in the same manner when the electorate discovers that they can vote their way into the treasury. Members of both parties share this one true bipartisan trait of gaining millions of dollars while in office, often from insider trading type of interactions for which they are completely exempt of any criminal charges by their own legislative action. It is ultimately an exercise in self defeatism since this type of behavior among elected officials is unsustainable.

Since 1973 with the advent of the ESRD program, congress and the dialysis industry have danced a double sided sword of declaring actions to improve patient outcomes that have never materialized over a forty year period of time. During that time, two large dialysis organizations (LDO's) have emerged in the United States that now dominate the entire industry, Fresenius and DaVita. The new bundled payment system is not an unwelcome guest at least to Fresenius who actively lobbied congress for it's approval while at the same time, years in advance of it's passage, FMC began to integrate basic dialysis and pharmaceutical supply companies under it's ever widening umbrella. 

BGR Client Case Studies

When the world’s largest dialysis provider—Fresenius Medical Care (FMC)—sought reform in the Medicare payment system for patients with End Stage Renal Dialysis (ESRD), it reached out to BGR’s experienced healthcare lobbyists. FMC wanted Medicare to move from a model of paying separately for dialysis treatments and billable drugs to a system of bundled prospective payment. MedPAC and the Government Accounting Office already embraced this reform, citing improved quality and stability of care for ESRD patients. But the issue never came before Congress for enactment.

Capitalism is based on the premise of free and open market competition. Today, we have a market dominated by two dialysis industrial giants completely entwined in a circle of entanglement with our congress, CMS and Medicare/Medicaid over sight agencies. This is not capitalism at all where all companies are on an equal playing field competing against each other through successive improvements of quality and economies of scale. In such a system, it would be the non-profit companies that come out ahead each and every time with all other aspects equal. Yet today, we have fewer and fewer non-profit dialysis organizations which deliver superior medical care to their patients according to several studies while DaVita and FMC grow ever larger.

The question we must ask without the evidence available is whether this massive growth is by superior applications of the principles of capitalism, or is it something quite different instead. How do we explain the movement of congress in 1978 to accept the testimony of Dr. Edmund G. Lowrie, one of the vice presidents of National Medical Care at that time, dismissing the experience of Northwest Kidney Center's home dialysis program and selling a much more expensive in-center modality to congross for four times the cost?  Dr. Lowrie had a vested interest in the outcome of that decision monetarily, yet congress chose a treatment costing $29,000 a year over a treatment that was more effective clinically at the cost of about $7000 a year after the first year on home dialysis. 

The politics of health cost containment: end-stage renal disease

R.A. Rettig (pages 132-133)

Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival ofhome patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers.⁵⁰"When we look at patient survival on home dialysis ," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .

But the political damage had been done. 

I have yet to see an investigate report tying all of these elements together in a single verified report and perhaps we never shall. That simply leaves us with the unaswered question: are the LDO's thriving because of superior capitalism, or instead is this just one more unverified example of cronyism in our corrupt congress? I suspect that these questions will remain unanswered as the LDO's market share continues to increase. Who is our watch dog to prevent abuse when congress can exempt its own members from insider trading that would send any other citizen to jail? The fox truly is in control of the hen house.

"Extra Cheese Dialysis" or the Gold Standard?

By Peter Laird, MD

Dr. Ajay Singh started The Kidney Doctor blog recently and has already developed discussions on many important renal related topics. In addition to his own, posts, he has had several top experts post on selected topics. Participation with follow up comments is perhaps the most active at this time of any online renal blog. Interestingly, diverse opinions are the norm in the comment section of the The Kidney Doctor making the intersection between professional nephrologists to ordinary patients a rare phenomenon not encountered on most blogs.  This lends itself to extreme positions at times. One example is by Noshi Ishak, MD of Laconia, NH where he coined the phrase "Extra Cheese Dialysis" in response to the negative findings of the FHN nocturnal study, but improved phosphorus control:

Dialysis Unplugged: "Waiting for Godot"

I hope CMS and the FDA will keep its eyes open and will not be sucked into another Amgen like scheme. Our country is deep in debt and has no money to waist on “Extra Cheese Dialysis”.

If ever the FDA will give any guidelines for hemodialysis under the information we have today it should be as follows:

1. All patients are to be dialyzed 3x/week, whether in center or at home, and the duration of the treatment and choice of dialyzer are to be prescribed by their Nephrologists in order to achieve the recommended clearances and adequate fluid removal according to the patient’s needs and body size.

2. For transplant candidates with expected prolonged wait for an organ and patients who failed their transplants, a more intensive dialysis such as daily dialysis or daily nocturnal dialysis is recommended.

The logic behind his comment is an analogy to the EPO debacle where the industry utilized higher doses for the benefit of huge profits at the expense of patient outcomes. Although, the EPO over utilization in American dialysis institutions is well documented, Dr. Ishak, is over looking several issues in what in my opinion is a false analogy.

First, he stated that most studies have not shown any improvement in mortality with nocturnal "extra cheese hemodialysis," which is not a factual statement. A recent study by Pauly in 2009 showed equivalent mortality between Nocturnal Home Hemodialysis (NHHD) and cadaveric transplant:

Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients

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

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

Secondly, Dr. Ishak incorrectly states that nocturnal home hemodialysis is more expensive than standard in-center hemodialysis which has never been the case. Richard Rettig noted that home hemodialysis in the 1970's was a little over $14,000 for the first year and $7000 each year thereafter while in-center patients averaged around $29,000 with much inferior outcomes. Northwest Kidney Centers is one of the most outspoken advocates of more frequent and longer duration dialysis and their experience is that home hemodialysis patients save over 40% in expenses compared to in-center patients:

Home Hemodialysis --- The Best Dialysis Treatment

Even so, for-profit corporations have neglected the financial advantages of home hemodialysis although these have been known for 40 years. For example, in the Northwest Kidney Centers’ program,the cost of providing hemodialysis in the home is only approximately 60% of the cost of dialysis in the facility. Finally, Da Vita, one of the two largest dialysis corporations, has begun to encourage home hemodialysis aggressively.

Europe, Japan and Australia routinely encourage nocturnal home hemodialysis and their programs enjoy significant cost savings compared to our for-profit dominated dialysis industry with signifcantly improved outcomes at the same time. The dose response curve of optimal hemodialysis does not show the deleterious effects of higher EPO dosages. That is the critical flaw of Dr. Ishak's analogy. In fact, modern era NHHD started in Toronto in the 1990's came about as a treatment option for patients with severe cardiac conditions who did not tolerate short, violent sessions with high ultrafiltration rates.  Patients with severe co-morbidities often thrive with more frequent and gentler dialysis sessions.

Thirdly, Dr. Ishak advised selected use of frequent home hemodialysis to those with limited co-morbidities and transplant eligibility. Rich Berkowitz is one of the patients he would exclude from NHHD. Rich readily testifies that he would not be alive today without the benefit of NHHD on the NxStage System One. Several years ago, on the way home from a conventional in-center dialysis session, Rich experienced a severe heart attack and nearly died. Today, he is a leading dailysis advocate still kicking way beyond any discernible life expectancies of a dialysis patient at his age and with his medical history. Dr. Ishak would pull the plug on his home hemodialysis. Bill Peckham suffered from FSGS and a failed early transplant from his brother. After over 20 years on dialysis, Dr. Ishak would pull the plug on Bill and condemn him to standard in-center suboptimal clearances completely ignoring the benefits of his home hemodialysis that allows him to continue to work full time in a difficult and physically demanding job.

Lastly, Dr. Ishak is guilty in my opinion of not employing the standards of evaluating the value of any given study taking into account it's strength and weaknesses. Yes, the FHN nocturnal study failed to reach the expected outcomes, but that is due to serious internal flaws of the study, (here, here, and here) not the dialysis modality itself.  There is no adverse increased dose response with dialysis, just the opposite, more dialysis is better dialysis. Home dialysis patients with CHF, LVH and cardiovascular limitations are ideal candidates for longer and slower treatments. I would hope that Dr. Ishak is in the minority opinion in America, but after forty years of a concerted effort to over come the for-profit dominated American market, he unfortunately is most likely just the tip of an iceberg.

Sadly, the American nephrologist is more often than not the nemesis to optimal dialysis when they should instead be our chief advocate. Thankfully, many remain vigilent in this long and protracted battle waged against the illogical conclusions of American nephrologists that ignore decades of positive findings in study after study of optimal dialysis. We have an uphill battle but the truth in the end shall prevail. Despite the null and void outcomes of the FHN nocturnal study, there are other studies still in the pipeline outside of the United States that will hopefully put this hegemony to rest once and for all. Dr. Ishak should also include one more group in his flawed assessment, the American nephrologist who overwhelmingly chooses NHHD when they themselves are in need of renal replacement therapy.  

Extra cheese dialysis? No my friend, NHHD is life saving, cost cutting and what should be America's gold standard dialysis modality as it is in so many other nations. Perhaps one day, the American nephrologist will have eyes to see what the rest of the world has recognized for decades. More dialysis is better dialysis.

Transplant Candidates Aided by Bariatric Surgery

By Peter Laird, MD

Many patients with end organ damage face the challenges of staying alive with only the hope that they will receive a transplant in time. For obese patients in need of a healthy organ to stay alive, many are without any hope due to weight restrictions for transplant candidates. However, with the advent of bariatric surgery for weight loss, some transplant centers are expanding the pool of eligible candidates by utilizing weight loss surgery prior to graft donation. In one remarkable case, a patient in need of a heart transplant underwent bariatric surgery while supported by an artificial heart.

Weight-loss surgery aids transplant candidates

Martha Magdaleno suffered from an enlarged heart that left her perennially breathless.

"I couldn't do anything, like shower," the 55-year-old mother of four in Inglewood said through an interpreter. "Even when I brushed my teeth, I would be out of breath."

Her condition grew so severe that, in 2006, cardiologists implanted an artificial heart to assist her failing organ and put her on the waiting list for a transplant. That pump died after eight months, and doctors had to replace it. . .

But Dr. Jon Kobashigawa, director of the heart transplant program at the Cedars-Sinai Heart Institute in Los Angeles and Magdaleno's cardiologist, was determined to get his patient back in shape for a transplant. He sent her to the Khalili Center for Bariatric Care in Beverly Hills, where Dr. Theodore Khalili performed a gastric bypass operation on her in early 2010. As far as anyone knows, it is the only time such weight-loss surgery has been performed on a patient with an artificial heart.

The risky procedure paid off. Magdaleno began losing weight, "about a pound or 2 a week," she said. By February, her weight had dropped to 165 pounds, and Kobashigawa placed her back on the waiting list. On a Sunday afternoon in June, she had a successful heart transplant, receiving a new organ from a 27-year-old man who died in an accident.

This procedure may become a standard treatment for ESRD patients who fail the initial assessment due to obesity. For patients to experience the full benefits of bariatric surgery, the patient must understand that it is a tool to combat obesity, but it is not a cure. Many patients will regain all or most of the weight lost initially if they do not change unhealthy habits and learn to eat well and exercise. Unfortunately, obesity is also a significant cause of ESRD combined with the co-morbidities most often associated with obesity, diabetes and HTN.

After observing several patients undergo bariatric surgery and the many complications that can occur, despite the utility of this procedure, the better part of valour is to avoid morbid obesity at an early age when life style changes have their most dramatic effects. Unfortunately, as efficacious as bariatric surgery is in the case of Martha Magdaleno, it will inevitably add to the financialy burden of a population already at the highest end of medical care utilization. That in the end may become the most important determinant of how often this combined surgical treatment will become.

 

America's Children Will Die Earlier than their Parents From Heart Disease

By Peter Laird, MD

America aggressively addressed our high rates of cardiovascular disease beginning in earnest with the Framingham Study that derived many of the known cardiac risk factors.  Aggressive control of these risk factors has lowered the prevailing rates of heart disease through dietary moderation, smoke cessation, cholesterol lowering, exercise and reducing diabetes complications. However, there are several areas of concern for the teenagers of today who are already beginning to show the signs of early cardiovascular disease.

Childhood obesity and adult onset diabetes during the teen years are now commonplace. Children today lack the daily exercise from play as was common in the past nor are they eating diets from fresh vegetables and produce. Sedentary lifestyles and processed foods are to blame for many of these findings. The NEJM published a recent report on the obesity epidemic among the young and predict that these characteristics can be reversed:

Childhood Adiposity, Adult Adiposity, and Cardiovascular Risk Factors

CONCLUSIONS

Overweight or obese children who were obese as adults had increased risks of type 2 diabetes, hypertension, dyslipidemia, and carotid-artery atherosclerosis. The risks of these outcomes among overweight or obese children who became nonobese by adulthood were similar to those among persons who were never obese. (Funded by the Academy of Finland and others.)

Despite the fact that reversal of adiposity early in life can also reverse the cardiovascular risk, there is little evidence that the interventions designed to combat childhood obesity have had any positive effects:

Today's Teens Will Die Younger of Heart Disease, Study Finds

"Cardiovascular disease is a lifelong process," Lloyd-Jones said. "The plaques that kill us in our 40s and 50s start to form in adolescence and young adulthood. These risk factors really matter."

"After four decades of declining deaths from heart disease, we are starting to lose the battle again," Lloyd-Jones added.

The American Heart Association (AHA) defines ideal cardiovascular health as having optimum levels of seven well-established cardiovascular risk factors, noted lead study author Christina Shay, who did the research while she was a postdoctoral fellow in preventive medicine at Northwestern's Feinberg School. Shay now is an assistant professor of epidemiology at the University of Oklahoma Health Sciences Center.

"What was most alarming about the findings of this study is that zero children or adolescents surveyed met the criteria for ideal cardiovascular health," Shay said. "These data indicate ideal cardiovascular health is being lost as early as, if not earlier than the teenage years."

Dealing with heart disease in the 30's and 40's is fortunately rather rare today, but will become the new norm in decades to come. Sadly, the ability to counteract this growing epidemic is readily at hand by promoting healthy eating habits, exercise and weight loss. In many ways, the older generations are now more physically fit than their children and grandchildren who spend many of their waking hours with electronic toys and devices. Lack of cardiovascular health will not only cost America precious lives, but will also tax the health care system  with the younger generations chronic health conditions at the very time that the majority of the baby boomers face their own health issues.

The financial crises that is generated by this medical calamity will leave few untouched. It is time for parents to take account of physicial activity as one of our most important national treasures for our children. It is time for individuals to reverse this legacy and simply do what is right. The solutions are at hand, if only we have the will.

A Mad Tea Party

By Peter Laird, MD

For an American dialysis patient, the transition from the old prospective payment system where dialysis units made huge profits from separately billable items such as ESA and Vitamin D analogs, to the new bundled payment system is tantamount to the confusion and irrational logic of Alice in Wonderland at the mad tea party. In the first few months of the new CMS bundle, ESA use is dropping dramatically according to initial reports and Hemoglobin levels are likewise plummeting. Then CMS shocked the renal world by issuing the final rule for the QIP that does not include any minimum Hb standard leaving clinicians guessing as how to proceed.  The LDO's have no question on how they are proceeding, for the average dialysis patient not on the transplant list, frequent blood transfusions and chronically low Hb levels will be the new norm. 

Uncontrolled secondary hypertension is now raging in the black hemodialysis population which historically requires higher levels of Vitamin D analogs to control PTH levels. 

Uncontrolled SHPT On the Rise in Blacks Since Debut of 'Bundling'

Using data from the DOPPS Practice Monitor, which follows a nationally representative sample of about 140 U.S. dialysis centers serving 20 or more chronic HD patients, researchers examined trends in parathyroid hormone (PTH) values and SHPT therapies from July 2010 to February 2011.

The median PTH value increased from 296 to 379 pg/mL among blacks and from 244 to 283 pg/mL among non-black. The prevalence of severe uncontrolled SHPT (defined as a PTH level above 600 pg/mL) increased sharply from 16% on July 2010 to 26% on February 2011, but only slightly from 9% to 11% among non-blacks.

The business of dialysis always comes before the outcomes of dialysis here in America and the new CMS renal bundle will be championed by the academic nephrology community touting its ability to save money. 

Implications of a Reduction in the Hemoglobin Target in Erythropoiesis-Stimulating Agent-Treated Hemodialysis Patients

The data demonstrate that by reducing Hb levels to 9–11 g/dl, we decreased the chance of having Hb levels rise to values >12 g/dl (fig. 1). At the same time, there was a decrease in ESA usage: from January to December 2009, the average EPO dose per week decreased from 9,500 to 5,600 units. This result yielded an approximately 40% reduction in ESA usage per dose per week. In 2009, we saved more than USD 60,000 for the approximately 35 patients we cared for.

Shabbily completed research studies with no distinct conclusions are now the basis for questioning the efficacy of extended and more frequent hemodialysis sessions with the FHN nocturnal study leading the pack. Since when does an underpowered, over selected, inconclusive study demonstrate actionable logic to call for an end to nocturnal home hemodialysis? 

Dialysis: Nocturnal hemodialysis - should we still provide this therapy?

Frequent nocturnal hemodialysis has emerged as a promising option for patients, with some studies demonstrating that it improves clinical outcomes. However, the negative results of a recent randomized trial have cast some doubt on whether nocturnal home hemodialysis has any advantages over conventional hemodialysis.

America struggles to stop dialyzing patients with rapid, short and violent sessions guaranteed by the simple physiology of third space fluid mechanics to cause intradialytic hypotension when they could avoid the entire problem in the majority of dialysis patients by simply slowing down blood flow rates and ultrafiltration rates with longer dialysis sessions. The "rocket science" of avoiding intradialytic hypotension in America is predicated on the false premise that we have to continue to place the business of dialysis before the outcomes of dialysis. In addition, both anemia and mineral bone disease parameters improve with NHHD lowering the requirements for ESA and Vitamin D analogs. Yet, the logical answer to all of these questions is dismissed by the LDO's and CMS.

The mad hatter we call CMS continues to demand a randomized and controlled trial demonstrating superior morbidity and mortality from quotidian dialysis before approving payment for this well documented life saving modality. Ultimately, we are left with a vacuous conversation based on an illogical and irrational discourse. No wonder dialysis patients are as perplexed as Alice at the mad tea party.

A Mad Tea Party

Alice felt dreadfully puzzled. The Hatter's remark seemed to have no sort of meaning in it, and yet it was certainly English. `I don't quite understand you,' she said, as politely as she could.

`The Dormouse is asleep again,' said the Hatter, and he poured a little hot tea upon its nose.

The Dormouse shook its head impatiently, and said, without opening its eyes, `Of course, of course; just what I was going to remark myself.'

`Have you guessed the riddle yet?' the Hatter said, turning to Alice again.

`No, I give it up,' Alice replied: `what's the answer?'

`I haven't the slightest idea,' said the Hatter.