Dialysis from the sharp end of the needle

Nocturnal Hemodialysis: Promising or Proven?

By Peter Laird, MD

I continue to marvel at the dialysis medical literature that in many instances completely ignores the history of dialysis. This is especially true when it comes to the subject of "alternative" dialysis strategies, such as daily dialysis or nocturnal dialysis. It is sad indeed when the pioneers of such life saving modalities are not even remembered. 

Dr. Stanley Shaldon has been overlooked for years as the original investigator of home nocturnal hemodialysis. He not only initiated the first overnight or nocturnal home dialysis treatments, but also published his results extensively in the early 1960's. We've all had access to his results for nearly fifty years!

Dr. Shaldon has reminded readers of his early work through letters to the editor in Kidney International and Blood Purification, Origin of Nocturnal Home Haemodialysis:

Dear Sir,

Precedent claims are rarely correct, thus the statement by Drs Schlapper and Diaz-Buxo in the January issue of Blood and Purification ^[1], that Uldall et al. ^[2] established the first nightly home haemodialysis program in 1993, cannot go unchallenged.  I believe that my group was the first to develop this technique 30 years earlier and that we published extensively in the period of 1963-1968 on this subject ^[3-7]. In addition, visual proof of my claim can be seen in a video of self unattended overnight home haemodialysis in 1968 by any of your readers at http://www.youtube.com/user/stanleyshaldon ^[8].

(Ed: I have updated Dr Shaldon's video link with his YouTube page URL.)

I recently read with interest another article that speaks of the promise of nocturnal dialysis, yet why is it referred to as a promising therapy nearly fifty years after its first use?

Deja Vu? Salt Causes Hypertension in Dialysis Patients

By Peter Laird, MD

As a physician, one of the most interesting aspects of watching the nightly news is to hear of some "new" research paper telling us of a "new and novel" finding that is worthy of mention on a news cast. Many times I get a feeling of Deja Vu about the alleged "new" report because it is an issue that I had learned in my training many years before.  If this had only happened once or twice, I might have an eerie feeling about such a report, but instead it appears to be a pattern of modern medical research to simply spin its wheels on rehashed subjects.  NephrOnline has one such report that caught my attention today: Lowering sodium intake might be the best way to manage hypertensioin in dialysis patients:

The investigators found that dry-weight can be assessed inexpensively through relative plasma volume monitoring (which uses photo-optical technology to assess changes in volume of a patient’s blood) and body impedance analysis (which determines lean body mass). They also discovered that restricting salt intake can help control blood pressure and make it easier for patients to get down to a proper dry-weight.

While in medical school, I learned of the relationship between sodium intake and volume expansion of the intravascular space.  Throughout my career, in hundreds of patients, I used this information in critically ill patients in the ICU to support inadequate blood pressures with the proper saline solution. I understand the role sodium plays in hypertension, particularly the effect of high sodium on the blood pressure of dialyzors with decreased or no urine output. I understand sodium's role because it has been understood for a long time. Dr. Belding Scribner saw blood pressure control as a primary marker of adequate dialysis and as a result Scribner for decades educated and chided his patients to limit sodium as the key to successfully using dialysis. There is no doubt that confirmatory studies are important and should be done, but it is even more important to accept the original studies in hand, such as the experience in Tassin which has been preaching this very issue since the 1970's with dozens of published reports on the subject.

In the meantime, I eagerly await many unanswered questions about dialysis that I ponder every day that I hook up to my portable NxStage machine.  Here is a partial list of my own questions that I look forward to seeing in a new and novel study one day:

• What is the optimal frequency, duration and intensity of dialysis?
• What is the optimal water soluble vitamin replacement dosage?
• What is the cause of sudden cardiac death in dialysis patients?
• What is the cause of myocardial ischemia during hemodialysis sessions?
• What is the optimal hemoglobin level?
• What is the optimal renal diet?

I am sure that there are dozens of questions that researchers would likewise wish to be answered that could be easily added to my short list.  However, noting the correlation between salt intake and hypertension is not on my short or long list since that has long since been answered to my satisfaction years ago. 

When, my fellow medical colleagues, will the true issues of dialysis ever be addressed?  I have now been on hemodialysis for nearly four years and the same questions that I wondered about every time the needle enters my arm I still wonder about.  Is it time for more deja vu, or is it instead time to wake up and answer the difficult questions we have had for nearly fifty years?

DSEN Goes To College

By Peter Laird, MD

Those that contribute to DSEN strive to find interesting topics and articles to comment on in the realm of all aspects of chronic renal disease advocacy ranging from prevention, to the various renal replacement options.  I have enjoyed the two recent posts by Anna Bennett on renal transplantation issues (here and here ) and look forward to her further comments on this important issue (here).  

Interestingly, Bill sent me a link to an assignment using one of my posts.  My command of English is such that I look forward to the days that Bill does not raise his great red pencil to my posts and I get through unscathed.  After all, I am a doctor and Bill is the writer. So I was greatly surprised to see my essay When Altruism Isn't Moral isn't right as part of a college level English writing class. Weblog 5 Assignment:

Print out the following essays and read both with a pen or pencil in hand. Annotate as you read, making marginal notations about each text's main idea, thesis, supporting evidence, places where you agree or disagree and why, unclear or confusing passages you want to reread, unfamiliar words or phrases you want to look up later, memorable images, comparisons, or metaphors.

• When Altruism Isn't Moral By Sally Satel
• When Altruism Isn't Moral isn't right By Peter Laird, MD

After you have read the essays, write a blog entry of at least 300 words in which you summarize what each writer is saying about the effects of the Internet on reading and writing and explain whose position you agree with most. Give reasons and examples to support your position.

I have sent an email to Professor Jolemore inviting comments and perhaps even displaying the best pro and con essays here at DSEN on the issue of payment for renal donation from her class.  

To date, DSEN has placed 66 posts in the transplant category covering many aspects of this topic from renal transplantation medical complications to the medical ethics of renal transplantation in a substantial body of literature, much of which preceeded the article in question. I did not address many of the other complex renal transplant issues related to a paid organ donor system for sake of brevity of this post and the fact that I had covered that aspect in several prior posts (examples: here, here, and here). 

Making the point that altruism is immoral is a large task for Dr. Satel to achieve, especially given the case that she chose to highlight. The former Christian missionary Matt Thompson applied the virtue of altruism in one of the greatest stories of selfless sacrifice in response to the simple plea of a man in need.  Dr. Satel's accusation that this was an immoral act on the part of the Kaiser transplant surgeons is not in my opinion supported by the facts. 

If we are going to stand on strong arguments in the debate of the merits of one renal donation system over another, it must first be predicated on the truth and not in prejudicial presumptions shown to be without merit. I found another article discussing the ethics of this case that may be quite instructive to all interested in this debate and it offers a third view for the students in Dr. Jolemore's class to consider. 

ORGAN TRANSPLANT REQUIRED BONDING BEFORE SURGEONS WOULD PERFORM A KIDNEY TRANSPLANT, THEY WANTED THE DONOR AND THE RECIPIENT TO GET TO KNOW ONE ANOTHER:

Medicine's "do no harm" principle requires doctors to justify performing risky surgery on a healthy donor. The closer the relationship, "the more medicine feels comfortable saying, We'll subject you to risk,'" said University of Pennsylvania bioethicist Arthur Caplan.

But what is an acceptable relationship between donor and patient, and who defines it? Is it ethical if some people "jump ahead" of other, sicker patients on organ waiting lists simply because they are able to find a donor?

Some transplant programs do allow strangers to donate organs after rigorous medical and psychiatric screenings. Others, however, restrict donations to family and close friends, relying on a proven bond to justify the risk. Strangers too, they worry, might have mental problems or might be secretly paid, which is illegal in the United States.

"Kidney donation is not like giving blood," said Dr. John Scandling, medical director of the adult kidney and pancreas transplant program at Stanford University Medical Center. "It's major surgery. You can die."

The best that those in favor of the paid donor system can use as an example on a large scale is that of Iran. 

Unfortunately, Iran excludes patients over the age of 50 as well as women.  Further, we only have data from a few selected medical institutions in Iran and not the entire system as we do in America with UNOS. In addition, there is evidence that most of the donors in the Iranian system would not donate a kidney again if they could do it over. If all we have to date are the examples of Iran and what I believe is a misguided and prejudicial depiction of the Sonny Davis and Matt Thompson story by Dr. Satel, then simply telling every one that there is an organ shortage so we need to pay donors is not offering a viable solution based on evidence.  The debate continues as does education. Let both have the basis of unbiased truth leading to the best outcomes.

(This discussion is the opinion of the author and DSEN on the complex issue of paid renal donation. DSEN welcomes dissenting opinions in the comment section below)

Is Dialysis Medicine’s Least Loved Treatment?

By Peter Laird, MD

A recent article featured on Gary Peterson’s RenalWeb, Stakes in kidneys from The Economist, is a throwback to the days of unceremonious insolence towards dialysis treatments seen before the accolades of optimal dialysis became the standard of medical reporting in the last two years. Stakes in kidneys:

The battle over one of medicine’s fastest-growing and least loved markets:
DIALYSIS—the use of machinery to make up for malfunctioning kidneys—is among medicine’s least loved treatments, both to endure and to administer. Patients have to be hooked to machines for hours at a time every few days. Those providing care often find it difficult, too: as many as a fifth of their patients die each year, many of them after choosing to stop their treatment. But it is also a fast-growing and lucrative market, and one that provides valuable lessons about making health care affordable.

Yet, the reality of the reason why America has slipped into a dialysis free fall with poor outcomes and skyrocketing costs is clearly evident in the text of this short article that focuses on why America is the largest dialysis market in the world, it is simply a lucrative business.

Some 2m people receive regular dialysis to clean their blood of impurities that build up as a result of kidney failure. About a quarter of them are in America, which has one of the highest rates of dialysis in the world. This is less because Americans are especially unhealthy (although high rates of obesity and diabetes do play a role) and more because American health policy is to provide dialysis to anyone who needs it, regardless of their ability to pay or their chances of surviving much more than a few months. It is also the world’s most lucrative dialysis market, with the government spending $24 billion a year, or $71,000 a year per patient, on dialysis, and private insurers paying yet more.

Thus, the business of dialysis sealed the fate of the American dialysis patient that became a commodity in the global dialysis economy instead of a cherished patient given the opportunity to live life in what was previously a universally fatal condition.  I am grateful for the nearly four years of additional life given to me by a simple machine since I started on dialysis in early 2007. In that time I have had the joy of seeing my son enter and excel in college and a new grand child enter into this world.

The failed American model will continue as long as biased accounts of American dialysis permeate the medical literature such as this prejudiced account.  Dialysis is perhaps the greatest gift of life ever developed by medical science.  It is time that the truth of this lifesaving advancement shine forth in the appreciation that I and millions of people the world over share for another chance to live beyond our foreshortened lives that we never would have had without the miracle of modern dialysis.  The only sadness about dialysis is how America's dialysis business model has produced untold wealth for dialysis profiteers yet at the same time failing to keep pace with the advances that are standard care in all of the other developed nations.  The way we think and talk about this treatment influences how it is delivered here in America in a less than optimal way, but at maximum profit.

Renal Policy Changes: Do They Go Far Enough?

By Peter Laird, MD

CMS, as part of the process of developing new quality measures for Medciare beneficiaries who use dialysis, called for Technical Expert Panel (TEP). CMS certainly has the potential of improving dialysis related care in America if many of the known optimal dialysis techniques can be incorporated into routine practice.  In addition, other private groups and institutions are likewise looking at how dialysis care can be improved and in fact, there is much overlap between the government TEP and these private groups:

End-Stage Renal Disease (ESRD) Quality Measure Development and Maintenance
The Centers for Medicare & Medicaid Services (CMS) has contracted with the Arbor Research Collaborative for Health and the University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) to develop Quality Measures (QMs) for ESRD for the following six measure areas:

• Anemia Management (Target value for Serum Ferritin, Target value for Transferrin Saturation);
• Mineral Metabolism (Target value for Calcium, Target value for Phosphorus)
• Vascular Access Infection Rate (Catheter Infection Rate)
• Pediatric Adequacy (Hemodialysis [HD], Peritoneal Dialysis [PD])
• Pediatric Anemia (Anemia Management)
• Fluid Weight Management

Tom F. Parker, III MD is a very vocal advocate of reform in the dialysis industry and his views are a breath of fresh air compared to the stale accusations that dialysis patients cause their own demise through noncompliance issues and poor substrate caused by years of poor diabetes control and HTN.

In a recent editorial, Renal Policy: Changing the models and measurements of dialysis care, Dr. Parker and Dr. Steinman, made several recommended policy changes, which will have, if implemented, an immediate impact on our far too high dialysis related mortality in America:

The problem is in the left ventricle. Left ventricular hypertrophy (LVH) results from either pressure or volume overload. As the process continues, the increased oxygen demand by the hypertrophied heart will potentially exceed perfusion. Cardiomyopathy is the end consequence of this process because of cardiomyocyte death. Subsequently, LV fibrosis occurs. LV decompensation results in congestive heart failure (CHF) and fibrosis, the latter being highly arrythmogenic. About 70% to 90% of patients entering Stage 5 CKD have LVH. Approximately 60% of CVD deaths in dialysis patients can be linked to sudden death (presumed arrythmias) or CHF, originating in the left ventricle.

The only issue that I have with both the TEP and the editorial by Dr. Parker and Dr. Steinman is whether these recommended measures will directly address the issue of myocardial ischemia and myocardial stunning which have been shown to be independent of hypovolemia or anemia status and are present at the beginning of dialysis. 

To date, there are no proven causes of myocardial ischemia and myocardial stunning even though there are several likely areas of investigation.  LVH is an important marker of sudden cardiac death and should be addressed along with the other areas of policy change outlined above. However, you can have a dialysis patient with well compensated anemia without ESA usage, without LVH, who has minimal inflammation and normal nutritional parameters and excellent fluid and weight control without ever having intradialytic hypotension who still has myocardial ischemia and myocardial stunning during their dialysis sessions no matter how slow the blood pump speed is. 

If we are looking at quality measures, why has the nephrology community so boldly ignored myocardial ischemia which in every other setting is considered a medical emergency.  It appears that LVH may be in part due to myocardial ischemia and myocardial stunning, yet even with progressive dialysis policy making groups, their silence on this issue that may be the central cause of sudden cardiac death in hemodialysis remains puzzling to me personally. 

In a couple of hours, I will hook up to my NxStage System One machine, and if statistics are effectively related to my own case, I will experience four hours of silent myocardial ischemia due to my dialysis session.  In any other setting, I would be placed in the ICU/CCU with multiple specialty consultants and immediate evaluation of the causation of my myocardial ischemia.  Yet in the nephrology world, policy makers with the best interest of dialysis patients at heart don't address or acknowledge the issue of myocardial ischemia even with recommendations for future studies. It is likewise not addressed by any of the ongoing frequent hemodialysis studies. Yet in every other setting, myocardial ischemia is the single largest known contributor to sudden cardiac death. I believe that when this issue is finally addressed openly by the nephrology community, we will finally see a significant decline in dialysis associated mortality.

In the Dialysis Unit, Who is in Charge?

By Peter Laird, MD

Renal Fellow Network (RFN) is a great source of up to date information on renal issues at the level of a renal fellow.  In such, I have learned much since the late Nathan Hellman, MD started his blog.  However, there have been a couple of occasions where I believe that RFN needed to go deeper, especially on home dialysis issues. 

The Renal Fellow Network is now a joint venture with the fellows and attending physicians at Mass General Hospital which is considered one of the leaders of quality medical care in America.  In a recent post on the RFN, The Nephrologist as Team Leader, Dr. David Steele spoke about the new leadership role that a nephrologist is required to perform by the new CMS conditions of coverage:

In order to prepare for the eventuality of one of these surveys, I received a memo this week with a reminder of my responsibilities as the Hemodialysis Unit Medical Director:

"By virtue of the Medical Director's leadership of the facility's Governing Body, his/her responsibilities extend beyond the primary focus on improving quality of care delivered in the facility and extends to the general management and operations of the facility. As such, all condition level citations are linked to /and are the responsibility of the Medical Director according to CMS".

Dr Steele goes on to explain some of the newly mandated regulatory requirements, but in doing so, he freely points to the fact that the mentality of nephrology practice is that the dialysis unit runs itself with its nurses, techs and administrators. 

What does this all mean? At first glance these citations/conditions may seem to be out of the realm of the practicing clinician whose focus is elsewhere, but in actuality they are integral to the proper care of our patients and the infection control lapses certainly should raise a high level of concern. We all have a natural disinclination to being surveyed but maybe these surveys are useful if they encourage us to put into place processes which ensure these lapses do not occur and if we develop systems of self assessment and quality improvement within our domain of responsibility.

Which brings me to the point of this blog. It's all about the team, and as Physicians we assume a natural leadership role when we deliver care to our patients and some of us are eventually appointed to leadership positions as our career advances. The usual dialysis unit personnel resources include Nurses, Patient Care Technologists, Dieticians, Social Workers and Administrative Staff. CMS is telling us we are responsible for the performance of this team on multiple levels. Traditionally our training has not focused much attention on preparing us for such leadership. (Emphasis Added)

When I was a practicing physician in the Army, we had many extra duties serving as medical director of different services in our hospital.  In such, it was an excellent arena to develop leadership skills which were not only a requirement of being a physician in the hospital but it was also a requirement of an officer in the Army as well.  The titles that I held clearly indicated who had the final authority and responsibility for that department: "Medical Director." 

Yet somehow, the role of final authority as medical director of dialysis units has escaped this profession in many ways. This engenders several questions that need answers: Do American nephrologists traditionally focus on running a dialysis unit as a part of their nephrology training?  Do American nephrologists get directed training as a team leader? According to this post on Renal Fellow Network, it appears that the answer is that this is a new role brought upon nephrology by CMS regulations. If CMS must tell the nephrologist to take charge, then who has been running the show up until now?

1974 Physiology Article: Local Hypokalemia Produces Dramatic Coronary Vasoconstriction

By Peter Laird, MD

Since going to the ADC last week and seeing the reports on myocardial stunning and on myocardial ischemia, I have entered a quest to see if there are any studies done on animal models that might explain these findings in the majority of hemodialysis patients.  I wondered if there is a connection between the known pro-arrhythmic effects of low K dialysate as well as the known vasoconstriction effects of clinical hypokalemia that could be a causative factor in myocardial ischemia.

Interestingly, two recent nephrology blogs posted on the dangers of hypokalemia as well. (Precious Bodily Fluids, Uremic Frost) However, I had not been able to find any direct studies that would show local hypokalemia producing significant coronary artery vasoconstriction that could be a contributing factor in the ubiquitous myocardial ischemia found in dialysis patients.

After looking through hundreds of articles, I finally came across an article from 1974 that actually demonstrated that exact effect.  In addition to coronary vasoconstriction from artificial local hypokalemia, the low potassium infusion also increased myocardial contractions which in the setting of coronary vasoconstriction would also increase myocardial oxygen demand that could lead to ischemia.

Lastly, the same study noted a considerable reduction in oxygenation in the coronary sinus.  The issue of myocardial ischemia and  myocardial stunning in dialysis patients needs immediate attention beyond the meager studies to date. I believe that we have a basis to conduct further studies in animal models looking directly at the etiology of dialysis related myocardial ischemia in an expeditious manner and whether the method of removing potassium plays a role.  My life and thousands of others are at risk today:

AMERICAN JOURNAL OF PHYSIOLOGY
Vol. 227, No. 3, September 1974. Printed in U.S.A.
Local effects of hypokalemia on coronary resistance and myocardial contractile force
ROBERT A. BRACE, DONALD K. ANDERSON, WANG-TSAU CHEN, JERRY B. SCOTT,
AND FRANCIS J. HADDY
Departments of Physiology and Chemical Engineering,
Michigan State University,
East Lansing, Michigan 4882

Discussion:

It is evident from these experiments that acute local hypokalemia produces dramatic effects on both coronary blood vessels and myocardial cells. During constant-flow or constant-pressure perfusion of the left common coronary artery, both ventricular contractile force and coronary vascular resistance increased greatly and, with constant- pressure perfusion, coronary sinus oxygen tension decreased significantly during the first few minutes of hypokalemic perfusion. The initial increase in resistance to blood flow seen during the constant-pressure perfusion waned with time and actually became less than the control resistance, even though contractile force remained elevated.

The increases in coronary vascular resistance seen during local hypokalemia may result from both passive and active vasoconstriction. The mechanical effect of increased contractile force might increase resistance to flow by passively reducing vessel caliber. While it is difficult to assess whether the increase in resistance is due to active or passive vasoconstriction, we have shown in previous experiments (2, 10) that hypokalemic perfusion of the canine gracilis muscle also increases vascular resistance to blood flow. In those experiments, there was no comparable mechanical effect such as that produced by the beating heart. More likely, most of the increase in coronary vascular resistance is produced by an active mechanism elicited by the changes in [K+]. We have hypothesized (2, 10) that hypokalemia increases resistance to blood flow in skeletal muscle by inhibition of the membrane Na-K+-ATPase and slowing of the electrogenic pump in the vascular smooth muscle. This leads to depolarization of the smooth muscle cells and thus active vasoconstriction.

Understanding that local hypokalemia constricts coronary blood flow and increases oxygen demand at the same time presents a potential area of intervention that may significantly reduce the prevailing risks of sudden cardiac death if the same phenomenon is shown in patients on hemodialysis.  To date, the causative factors for increased sudden cardiac death have defied definition in the dialysis population.  Certainly the known arrhythmogenic effects of low potassium dialysate baths documents a physiologic and dose related effect of dialysate potassium concentrations.

This 1974 physiology study on the effect of low potassium concentrations directly on the coronary arteries is an intriguing and interesting putative causation of the well documented myocardial ischemia and myocardial stunning seen in dialysis patients. Since low potassium dialysate has electrocardiographic effects on the heart, and low potassium has coronary vasoconstrictive effects and increases the oxygen demand, is it possible that low potassium dialysate also has a vasoconstrictive effect that could cause myocardial ischemia in the usual dialysis setting?  I believe it is a question that demands an immediate verdict.

What is the Cause of Dialysis Related Myocardial Ischemia?

By Peter Laird, MD

Dialysis induced myocardial ischemia (myocardial ischemia is the condition where the blood supply is inadequate for the heart's oxygen demand. Typically this can lead to symptoms of angina, but during hemodialysis it seems to be silent i.e. without symptoms) is found in the majority of patients tested in several small cohort studies to date, as well as the secondary sequelae of myocardial stunning and hybernation.  Of note is that the patients selected in this study, Haemodialysis is associated with a pronounced fall in myocardial perfusion, had no clinical evidence of coronary artery disease but this was not confirmed with coronary angiogram.

This article is of interest because the historical risk of sudden cardiac death is greater in dialysis patients than myocardial infarction, so even though small and lacking confirmatory data, the results of the paper present an intriguing postulate of what is the cause of this ubiquitous phenomenon of myocardial ischemia.

Several complex factors leading to myocardial fibrosis may create an intrinsic cardiac substrate in dialysis patients, perhaps dating from the earlier CKD stages, increasing their susceptibility to external hemodynamic stressors as well as complex fluid and electrolyte balances. Higher than normally recommend blood pressure reduces the risk of death in hemodialysis patients which is a paradoxical finding to the general population.  However, in light of the prevalent myocardial ischemia during dialysis sessions, this makes intuitive sense since the coronary arteries are the only arteries in the body that fill during diastole when the heart muscle relaxes and not during systole when the heart muscle contracts.  A higher mean arterial pressure translates into higher perfusion pressures in the coronary arteries.  This may be a protective mechanism against myocardial ischemia that is not present in patients with lower average blood pressures.

Another interesting datum is that cooling of the dialysate from the standard 37C to 35 C has been shown to reduce regional wall motion abnormalities and heart arrhythmias during dialysis. How this happens is understood reasonably well. Reducing the dialysate temperature promotes vascular reflexes in the extremities constricting those blood vessels which secondarily raises the mean arterial blood pressures.  It is quite possible that the beneficial effects of cooling the dialysate is directly related to the beneficial effects of higher than normal blood pressures as well. Dialysis-Induced Regional Left Ventricular Dysfunction Is Ameliorated by Cooling the Dialysate:

Forty-nine new RWMA developed in nine patients during hemodialysis with dialysate at 37°C (HD37), compared with thirteen [Regional Wall Motion Abnormalities] RWMA that developed in four patients during [dialysate at 35°C] HD35 (odds ratio 3.8; 95% confidence interval 2.1 to 6.9). The majority of RWMA displayed improved function by 30 min after dialysis. Overall, regional systolic LV function was significantly more impaired during HD37 (P < 0.001). BP was higher during HD35, with fewer episodes of hypotension as a result of a higher peripheral resistance and no difference in stroke volume.

A recent article by Kidney Disease: Improving Global Outcomes (KDIGO) on blood pressure controversies offers a unique clue to a possible contributor to an increased risk of sudden cardiac death: Blood pressure in chronic kidney disease stage 5D—report from a Kidney Disease: Improving Global Outcomes controversies conference (PDF link):

Cardiac deaths account for the majority of CV deaths in dialysis patients. The exact etiologies of these cardiac deaths are often unknown and likely include primary and secondary arrhythmias, cardiomyopathy, and coronary artery disease, and involve complex pathogeneses. Although fluid overload, increased afterload from HTN and vascular calcification, calcified valvular disease, and ischemia are probably important contributory factors, uremia per se seems to be an additional factor. To what extent hyperkalemia and hypokalemia, frequently present in these patients, contribute to the high incidence of sudden death in dialysis patients is not certain, but recent papers suggested the greater danger of hypokalemia.

Hypokalemia not only increases the risk of cardiac arrhythmias, it can also directly impair skeletal muscle contraction and contribute to vascular constriction through its action on vascular smooth muscle.

Low potassium baths correlate directly with an increased risk of cardiac arrhythmias that can be attenuated by potassium profiling. The issue that has not been clarified is whether rapid removal of potassium with low K baths could produce vascular constriction and ischemia to not only the heart but other vascular beds such as the cerebral and mesenteric.  Hypokalemia (a lower-than-normal amount of potassium in the blood) experimentally produced in dogs can cause such severe vascular constriction that rhabdomyolysis occurs. Is it possible that the near universal myocardial ischemia seen in conventional hemodialysis patients is a combination of myocardial fibrosis which predisposes dialysis patients to hemodynamic and electrolyte shifts seen in dialysis, combined with severe and progressive vascular constriction as the potassium levels progressively fall during a dialysis session?

There is no direct evidence that hypokalemia is the cause of myocardial ischemia in dialysis patients, but the confluence of progressive arrhythmias with lower levels of potassium in the dialysate and hypokalemia causing severe vascular constriction capable of cerebral ischemia and rhabdomyolysis is a potentially actionable etiology if present.  I believe it is time to return to basic laboratory studies with animal models to test the effects of potassium concentrates during dialysis looking specifically for myocardial ischemia.

My review of papers since the ADC suggests there is telling, though indirect, evidence to implicate a component intrinsic to high speed conventional dialysis as causing myocardial ischemia universally in conventional hemodialysis patients. This initial insult then causes a cascade of problems leading to LVH, and CHF and is also associated with sudden cardiac death.  It is a progressive finding that appears to worsen during the course of dialysis in a near linear manner, which does parallel the removal of potassium during conventional HD. Conversely potassium profiling has shown success in reducing episodes of ventricular ectopy and other forms of cardiac arrhythmias, which are markers of a higher risk of sudden cardiac death.

The vasoconstrictive effects of hypokalemia require that this single factor have its day in court as it were. Research is needed now to tease out whether to include or exclude it as a putative cause. If we are looking for a single entity that can cause both arrhythmias and vascular constriction in the coronary arteries, then hypokalemia related to low potassium mixtures in dialysate is the most logical first place to look.

Is Hemodialysis Dangerous?

By Peter Laird, MD

Since returning from the ADC and I have engaged in extensive literature searches on the issue of myocardial stunning and its associated causes and complications, a related issue is myocardial ischemia (inadequate blood flow to the heart) in dialysis patients with no known coronary artery disease, CHF or LVH.  Silent ischemia is present in a much larger percentage of patients undergoing dialysis than what would intuitively be evident. In a small but well conducted study on myocardial blood flow, researchers were surprised to find that all subjects tested had profound reductions in myocardial blood flow (MBF). Haemodialysis is associated with a pronounced fall in myocardial perfusion:

This study demonstrates that the HD procedure is associated with a significant fall in myocardial perfusion. This was observed in ‘relatively healthy’ dialysis patients that were selected for having a low cardiovascular risk, e.g. non-diabetic patients with stable HD sessions and uneventful cardiac histories. Two of the seven patients who were studied developed regional LV dysfunction in regions with the greatest fall in MBF. Notably, these cardiac derangements were clinically silent.

The most surprising aspect of this study is that the reduction in myocardial blood flow was not related to hypovolemia.  The onset of reduced myocardial blood flow occurred in the first thirty minutes of dialysis in all of the subjects tested despite the fact that they had less than 100 ml of ultrafiltration at that point:

Contrary to our expectations, we observed a significant reduction in MBF already shortly after the start of HD. At this time hypovolaemia was not prominent since only 100 ml of fluid had been filtered during the first 30 min of HD although filling of the extracorporal circuit led to some additional blood loss from the circulation. Notably, at 30 min of HD the diastolic (the main determinant of coronary blood flow) and systolic blood pressure as well as the cardiac output were identical in comparison with baseline. All in all, hypovolaemia seems an unlikely explanation for the decrease in MBF this early during HD.

The implications of this study is that there may be an intrinsic myocardial defect in hemodialysis patients despite no evidence of structural damage or coronary artery occlusions which some researchers have postulated, or on the other hand, there may be an extrinsic or dialysis related effect separate from ultrafiltration that is the cause. Most likely, it is a combination of both intrinsic CKD host factors coupled together with extrinsic dialysis factors.

To date, the issue is not settled other than to note that there is a pronounced reduction in myocardial blood flow at the onset of hemodialysis as well as several studies showing a high incidence of silent myocardial ischemia proceeding to myocardial stunning which is a known precursor of arrhythmias and sudden cardiac death.

Is hemodialysis dangerous?  From the perspective of myocardial blood flow, the answer is possibly yes especially in those patients with known coronary artery disease or other cardiovascular disability which is likewise already a well known caution in these patients from a clinical perspective.  In my opinion, intradialytic hypotension should be diligently avoided in all dialysis patients especially in those patients with known cardiac disease.

Understanding that silent myocardial ischemia is present in the majority of well compensated dialysis patients makes avoidance of any further hemodynamic insult mandatory in all patients, not just those with known cardiovascular disease.  Ultrafiltration rates above 10-12ml/hr/kg add a devastating insult to an already compromised myocardial burden of ischemia.  No matter what the cause is of the original myocardial ischemia in dialysis patients, avoiding intradialytic hypotension from short, violent dialysis sessions should no longer be any part of conventional dialysis care.

Choosing peritoneal dialysis may be the most prudent approach for some patients who are not candidates for renal transplant and have underlying cardiovascular disease.  I believe that informed consent of renal replacement options should include these issues before a patient makes his personal choice. Despite the fact that myocardial ischemia had already been documented in dialysis patients prior to my starting date, I am only now becoming aware of this important issue by my own research after first hearing of the issue of dialysis related myocardial stunning at the ADC. In the end analysis, none of our renal replacement choices are risk free.  Nevertheless, patients have a right to understand what is the true risk, benefit and alternative to each modality. 

From the perspective of renal replacement therapy, the outcomes in high dose optimal dialysis settings with mortality rates that rival cadaveric transplant, the answer to whether hemodialysis is dangerous is no. The results of nocturnal dialysis compared to cadaveric transplant are essentially the same over a 14 year period of time. Understanding that the majority of dialysis patients have a continuum of reduced myocardial blood flow leading to silent ischemia and myocardial stunning should be the most important dialysis issue on the forefront of research in my opinion. 

Look for future posts exploring this important dialysis complication; it is my hope that it will receive the due attention it deserves. Our lives are dependent perhaps more than anything else on this single complication of dialysis.  Sudden cardiac death is the most frequent dialysis death and it may be directly attributable to underlying episodes of myocardial ischemia now documented in the majority of dialysis patients.

Myocardial Stunning is Common in Dialysis Patients

By Peter Laird, MD

Myocardial stunning results from episodes of low blood flow to the heart from systemic drops in blood pressure which is now found to be common in dialysis patients.  In a recent study, 64% of dialysis patients tested had significant episodes of myocardial stunning during hemodialysis.

Hemodialysis-induced cardiac injury: determinants and associated outcomes:

RESULTS: Sixty-four percent of patients had significant myocardial stunning during HD. Age, ultrafiltration volumes, intradialytic hypotension, and cardiac troponin-T (cTnT) levels were independent determinants associated with its presence. Myocardial stunning was associated with increased relative mortality at 12 mo (P = 0.019). . . Patients with myocardial stunning who survived 12 mo had significantly lower LV ejection fractions at rest and on HD (P < 0.001).

CONCLUSIONS: HD-induced myocardial stunning is common, and may contribute to the development of heart failure and increased mortality in HD patients. Enhanced understanding of dialysis-induced cardiac injury may provide novel therapeutic targets to reduce currently excessive rates of cardiovascular morbidity and mortality.

The results in a smaller study in pediatric patients is even more astounding, finding 11/12 patients with significant myocardial stunning.  The implications of these findings in a pediatric dialysis population without the age dependent co-morbidities found in many adult dialysis patients implies a treatment effect of the dialysis itself and not an underlying host factor. Pediatric Myocardial Stunning Underscores the Cardiac Toxicity of Conventional Hemodialysis Treatments:

Results: Eleven of 12 patients developed myocardial stunning with varying degrees of compensatory hyperkinesis in unaffected segments, maintaining left ventricular ejection fraction throughout HD. The mean segmental %shortening fraction (SF)_[Overall] and %SF_{[reduction in regional wall motion (RRWM)]} fell during HD (2.19 to 1.77 and 2.72 to 1.37, respectively). Intradialytic BP reduction was significantly associated with mean segmental %SF_[RRWM]

Myocardial stunning resulting from markedly reduced blood flow in the heart tissues is a common and lethal condition that has not received its fair share of attention in the dialysis population.  The simple fact that it is found in the majority of dialysis patients and is associated directly to high ultrafiltration rates demands a verdict.

While I was in practice, letting a patient leave your office in active myocardial ischemia (lack of blood flow to the heart) who subsequently suffered a cardiac event would not be defensible in a malpractice situation.  One of the most frequent reasons for malpractice cases involves failing to diagnose myocardial ischemia in the emergency room setting.

It appears in 2010, that the only place where it is not malpractice or negligence to allow a patient with myocardial ischemia to leave ones clinical care is in the dialysis unit. It now appears that this distressed state is the condition of 60-70%, or more, of dialysis patients as they complete their treatment. It is not a mystery as to why many never return due to sudden cardiac death.  Why is this not a problem to the majority of nephrologists in America?

Is The Nephrologist to Blame for Intradialytic Hypotension?

By Peter Laird, MD

Dear Dori, thank you once again, for making possible my participation in the ADC this year.  It was an incredible one day experience for me and I wish I was able to take in more. I am already looking at Phoenix for next year, just a seven hour drive from home in CA.

I concur with your comment to my Annual Dialysis Conference 2010: The Take Home Message of Myocardial Stunning post, that CMS is the biggest barrier to optimal dialysis strategies in America but they do not stand alone.  Having dialyzed in 7 units in 6 different states, I can report that there is a great disparity in treatment paradigms between the units that I have personally experienced.  Bill is fond of stating that dialysis survival is dependent on your zip code and in that he is correct.

My worst experience was when I spent 6 weeks in Cape Cod where my mother lives. The unit's nephrologist refused to honor my prescription for a larger artificial kidney which is needed to keep my usual clearances. This is a unit wide policy, he did not allow this for any of his patients as a stated policy.  I felt completely terrible during my entire visit.  I believe this decision is completely based on making money for his own pocket; Kaiser (my primary insurer) reimburses each session more than fairly, certainly enough to meet my prescription. 

An extra two dollars per session would not have impacted upon the dialysis budget in his unit to any more than $40.00 for the entire month.  My clearance dropped by 15% yet he was happy with a spKt/V of 1.22 and would not adjust it despite telling him I didn't feel well with a smaller kidney. This experience informed my post,  The Red Eye Shuffle - Nephrologists Are Accountable:

With the rare exception of a team of professionals dedicated to optimizing patient outcomes, were it not for my zip code, I would most likely continue to be a red eyed shuffler slumbering through to an early date with my grave. It is time that we return to traditional values of the doctor patient relationship where our own physicians our our best advocates, not our worst enemies.

In fact, the short, fast and violent American style sessions are based on cranking out the Kt/V over 1.2 or 1.4 in the shortest period of time to meet the CMS requirements and get to the next patient. Survival differences between Japan and America are not based on patient characteristics as Dr. Blagg noted in a prior article, Differences in Dialysis Practice Are the Main Reasons for the High Mortality Rate in the United States Compared to Japan:

I contacted Dr. Christopher Blagg for any information he might have to Zach's question and he was kind enough to contact a colleague in Japan to answer Zach's question:

My friend says that "A dialysis program is paid per session, and the nephrologist is paid per session in Japan." I understand that Japanese patients dialyze for 4 hours three times a week, weigh significantly less than usual US patients and are much more disciplined  and usually carefully follow the instructions from the doctor and facility.

Fortunately, I have also been in several units where patient outcomes are tied into physician compensation and in those units, the high flux artificial kidney that met my goals was always used as well as attention to several other parameters that matter in survival.

All of these issues are at the discretion of the individual nephrologist, yet many choose to max their own pocket income instead of maximizing their patient outcomes.  CMS is complicit with this in that they promoted regulations that incentivize this behavior, yet it is still the individual nephrologist that makes the actual dialysis prescription.

I believe it is possible even under current reimbursement to provide home dialysis far more widely. The problem is that many of the nephrologists that I have talked to are quite unlearned in many aspects of home dialysis. For instance, I have met more than one nephrologist completely unaware of buttonhole cannulation and some were fearful to have patients at home, expressing fears that they cannot intervene in a timely manner if something does go wrong.  This is just my own anecdotal experience when discussing home dialysis with those that prior to my current nephrologist were handling my care.

The issue of requiring an RCT is absolutely a red herring and that is why I believe showing that the usual approach to American dialysis with short, fast and violent sessions is dangerous with objective evidence of "mini heart attacks" in those patients with frequent episodes of intradialytic hypotension caused by ignoring the simple relationship between plasma refill rates and ultrafiltration rates.

Having gone through the tasks of presenting to nephrologists during my training and the attention to details that is quite unique to their specialty, I am appalled by the complete disregard of plasma refill rates by many nephrologists and the reliance on secondary treatment options instead for this iatrogenic condition caused by elevated ultrafiltration rates.  When the ultrafiltration rates exceed by a large factor the plasma refill rates, the patient will become hypotensive especially if they already have underlying cardiovascular conditions which may in fact be iatrogenic as well.  

I had an interaction (here, here) with the late Nathan Hellman of the Renal Fellow Network last year on a post that he did on intradialytic hypotension and its remedies which included sodium modeling that arguably could be part of the cycle leading to intradialytic hypotension with the added salt load from this procedure leading to excessive interdialytic weight gains that are then blamed on the patient.

The fact remains that this has been a much overlooked aspect of dialysis care in America, while in Australia it is one of the key considerations in dialysis prescriptions. Longer dialysis times, lower blood pump speeds, lower ultrafiltration rates are a simple fix to a seeming complex problem. This approach is already the standard dialysis prescriptions in Australia, Europe and Japan.

As a fellow physician, we are to do no harm to our patients.  There is only one specialist who can prescribe dialysis care in America and that is the nephrologist.  My discussion of intradialytic hypotension and the responses to my criticism of the post on the Renal Fellow Network last year readily shows the different approach to dialysis in America from that of Australia with replies from someone like Dr. John Agar (PDF link) on the same issue.

Here's Dr. Prince at Uremic Frost, Interdialytic Weight Gain:

" agree that interdialytic weight gain and the underlying cardiovascular status are the set up for recurrent bouts of intradialytic hypotension. Intradialytic hypotension is indeed as Dr Laird states, "a direct complication of rapid, violent fluid removal by short and high intensity dialysis regimens especially in the frail and elderly patient with LVH from chronic fluid overload". But, is the nephrologist to blame as Dr Laird suggests?

I can't get around the fact that there is a quite different philosophy of dialysis in America that although it is evolving, I don't believe it has completely arrived, even though those that attend the ADC do accept this different philosophy more so than many of their colleagues.  Hopefully this core group of influential nephrologists at the ADC will have more influence over their colleagues in the general community.  I cannot get around the fact that in a true medico-legal and fiduciary sense,  American nephrologists are accountable for the last place American survival rate. 

To blame our patients for the bad outcomes is to continue putting our head in the sand.  The answer to Dr. Prince's question to me above in my opinion with my new awareness that intradialytic hypotension is a direct cause of myocardial stunning, is Yes. I believe that many of Dr. Prince's and my colleagues should shoulder  blame for simply ignoring the relationship between plasma refill rates and ultrafiltration rates.

The experience of Tassin speaks powerfully. High Ultrafiltration rates on HD: Do they impact cardio-vascular outcome? Charles Chazot, MD, NephroCare Tassin, France:

• A high UF rate is frequent, reported in 15-20% of HD patients
• A high UF rate -above 10-12ml/hr/kg-is associated with overall mortality in HD patients
• A high UF rate is associated with an increased rate of patients with cardiovascular complications present with higher UF rate
• A high UF is associated with cardiac stunning and potential long-term cardiac damage and increased mortality

The knowledge that myocardial stunning is associated with intradialytic hypotension from elevated ultrafiltration rates above 10-12ml/hr/kg implies directly that this is an iatrogenic condition amenable to correction by simply noting the basic relationship between plasma refill rates and ultrafiltration rates. Who but the nephrologist?

Annual Dialysis Conference 2010: The Take Home Message of Myocardial Stunning

By Peter Laird, MD

The most important lesson that I have learned from this years Annual Dialysis Conference 2010 is that of myocardial stunning related to current conventional dialysis practices, especially as seen in America. Although the debate over the need or lack of need for further randomized and controlled trials once again stole the headlines of this conference, the issue of myocardial stunning may be the trump card that brings into practice more frequent and less violent dialysis sessions long before the debate on RCTs is settled.

Myocardial stunning is an unexplained phenomenon related to reversible ischemia in the heart or more simply put, inadequate blood flow to the heart tissues that does not result in permanent damage.  Dr. Charles Chazot presented a late afternoon discussion on how high ultrafiltration rates negatively impact cardiovascular outcomes by inducing intradialytic hypotension that the leads to reversible ischemia and myocardial stunning.  An ultrafiltration rate higher than 10-12ml/hr/kg is associated with higher mortality, higher rates of intradialytic hypotension and higher rates of myocardial stunning. High Ultrafiltration rates on HD: Do they impact cardio-vascular outcome? Do they impact cardio-vascular outcome? Charles Chazot, MD, NephroCare Tassin, France:

• A high UF rate is frequent, reported in 15-20% of HD patients
• A high UF rate -above 10-12ml/hr/kg-is associated with overall mortality in HD patients
• A high UF rate is associated with an increased rate of patients with cardiovascular complications present with higher UF rate
• A high UF is associated with cardiac stunning and potential long-term cardiac damage and increased mortality
• A high UF rate is associated with an increased rate of intradialytic hypotension but the association between IDH and increased mortality is not confirmed

Perhaps the most alarming news at the ADC is that this is an important phenomenon in pediatric dialysis patients as well.  American dialysis practices largely ignore the simple physiologic parameter of plasma refill rates with ultrafiltration rates often exceeding this by a large factor leading to intradialytic hypotension and reversible cardiac ischemia/cardiac stunning.  Treatment times greater than or equal to 240 minutes have significantly lower episodes of intradialytic hypotension with average American treatment times falling short of this parameter according to DOPPS, Longer treatment time and slower ultrafiltration in hemodialysis: associations with reduced mortality in the DOPPS:

Europe and Japan had significantly longer (P < 0.0001) average TT than the US (232 and 244 min vs 211 in DOPPS I; 235 and 240 min vs 221 in DOPPS II). Kt/V increased concomitantly with TT in all three regions with the largest absolute difference observed in Japan. TT > 240 min was independently associated with significantly lower relative risk (RR) of mortality (RR = 0.81; P = 0.0005). Every 30 min longer on HD was associated with a 7% lower RR of mortality (RR = 0.93; P < 0.0001). . . UFR > 10 ml/h/kg was associated with higher odds of intradialytic hypotension (odds ratio = 1.30; P = 0.045) and a higher risk of mortality (RR = 1.09; P = 0.02).

The HEMO study is a RCT that allegedly proved that higher intensity dialysis did not have any survival benefit, but it did not take into account ultrafiltration rates as an independent survival factor. Understanding the importance of reversible myocardial ischemia and myocardial stunning and how they relate as a prognostic factor in the incidence of sudden cardiac death of dialysis patients may turn out to be the most important survival factor in this longstanding debate. Dose of dialysis, convection and haemodialysis patients outcome—what the HEMO study doesn't tell us: the European viewpoint:

Body water volume
In the HEMO study, urea clearance was normalized by urea distribution volume. The use of Kt/V as a measure of outcome has been criticized since V independently predicts mortality when used as a surrogate for body mass and nutritional status. This could represent a drawback in the HEMO study design. However, among the HEMO study participants body water volume after dialysis did not significantly differ in any of the four arms. Therefore, from a practical point of view, this problem does not exist for the interpretation of the study results.

The solution to myocardial stunning is found in increased treatment times and frequency with concomitant reductions in ultrafiltration rates. Correlating ultrafiltration rates to plasma refill rates may turn out to be the single most important survival paradigm in dialysis treatments. Attempts to use sodium profiling to increase plasma refill rates has failed due to elevated salt loads from profiling leading to increased incidence of LVH which is also associated with increased cardiovascular death rates in dialysis patients.

The rest of the world already embraces the concept of slow and gentle dialysis with lower ultrafiltration rates, yet the American nephrology community is still waiting for a RCT to dictate practice patterns. Reversible myocardial ischemia leading to myocardial stunning renders conventional American incenter rapid ultrafiltration rates in randomized controlled studies unethical in my opinion. If the usual therapy control group therapy is unethical, then the entire RCT is likewise unethical. Myocardial stunning in dialysis patients may become the final trump card in the frequent dialysis debate once its prevalence and adverse affects become well known. For me, that was the take home message of the Annual Dialysis Conference 2010.

The Annual Dialysis Conference: Seattle 2010 - A Day of Hope

By Peter Laird, MD

I met Bill at the top of the escalator minutes before the morning session opened with my conference pass that Dori Schatell of the Medical Education Institute and Home Dialysis Central made available to me for today.  The Annual Dialysis Conference is one of the best organized conferences that I have been to and they stayed precisely on time the entire day which is no small accomplishment with doctors that usually like to hear the sound of their own voice of which I am quite guilty as charged as well. 

We started the morning session with a report on why the American experience with fistulas remains quite low compared to the the majority of westernized and developed nations. Although there are many factors that are important, one stood out to me from the lecture, that of the disparity of cases that vascular surgeons perform during their training.  I reported on this issue last year in a post called Fistula First? American surgeons are still last

In a recent article listed by DOPPS, one potential reason for our continued last place fistula placement rate may be directly related to the lack of emphasis that vascular surgery training programs place on fistula procedures:

During training, US surgeons created fewer fistulae (US mean = 16 vs. 39-426 in other countries) and noted less emphasis on vascular access placement compared with surgeons elsewhere.(Download slide presentation)

It is my opinion that until America’s surgeons put Fistula First into practice during their vascular surgery training, America will fail to recover the preeminence we once held as the leading innovator of dialysis access practices.  The progress to date in improving our fistula placement statistics should not lead us to become complacent with this initial success. America still needs to seek an even higher level of achievement starting first with our vascular surgery training programs.

Bill and I then sat in later in the morning on the updates of the Frequent Hemodialysis Network short daily and nocturnal studies.  However, it was the biggest disappointment of the morning for me since they did not go into any of the preliminary results which I had mistakingly expected to see. (see comments below by Dr. John Daugirdas. Corrections made based on his comments)

The most interesting aspect of the frequent hemodialysis update is actually that of the NxStage FREEDOM study which has nearly completed all of its enrollment of 500 patients.  I have personally looked at increasing the dosage of NxStage to maximize the efficiency of this very portable machine, but the recommended dosage of spKt/V of 0.5 with a weekly sdKt/V of 2.0-2.2 which is comparable to conventional incenter hemodialysis weekly dosages may actually give us some of the most interesting data to date in quotidian dialysis studies since the total dosage of both modalities is similar, but the only real difference is in that of the frequency of treatments.  After this presentation, I am now most eager to hear the results of the FREEDOM study since this will look directly at the factor of frequency in the dialysis equation. 

Lastly, it was a day of meeting many of the people that have influenced my education on dialysis related issues.  After joining Bill this morning, I met Gary Peterson of RenalWeb in the opening session, as well as Joyce Jackson of the NKC, and Jim Curtis of Home Dialysis Plus who are developing a new portable dialysis machine. I then saw Dr. Christopher Blagg meeting him in person for the first time briefly in the hallway, and then I met Denise Eilers after the frequent dialysis talk as well as Mark Neumann of NephrOnline and NNI.  Bill then introduced me to Dr. Carl Kjellstrand who developed the "unphysiology" theory of dialysis in the 1970's. Likewise, Rich Berkowitz of NxStageUsers then introduced me to several NxStage management including Joe Turk. 

I was able to discuss my own personal goals for home dialysis and how the NxStage is meeting them today. Joe Turk discussed some of their goals and directions for future improvements of their portable home dialysis machine.  I later met Nancy Spaeth before the end of the day.  Learning her story of surviving renal disease since the 1960's and seeing her energy in person was perhaps the most inspiring of the many inspirational and devoted people I met throughout the day.  It is her story that is the real story of renal replacement options in America.

It was an amazing day of discussions, information, making friendships and keeping the raison d'etre focussed on the real issue of optimal dialysis for all Americans. It is a conference that all renal professionals and patients should attend.  I am looking at the next meeting in Phoenix already. There remains much work to be completed and mindsets to be changed.  The time has come for optimal dialysis and it is before us as never before.  If anyone has lost hope while on dialysis, I would highly recommend simply looking at the work of the individuals listed above and know that there is much to hope for.  Perhaps I will actually be able to meet Dori Schatell in person the next time if not sooner at another meeting.

I took my wife to Morton's Steakhouse after the conference and met Darren whose father has been on dialysis for about five years.  He told me his father struggled with dialysis and often didn't feel well. Yet it doesn't have to be that way with the many talented people working to bring about practical options that are available widely in many other parts of the world.  There is much that a dialysis patient must do for themselves, but some of these optimal dialysis options make patient compliance a much easier chore than conventional incenter  gives in most instances.  Seeing Nancy Spaeth going up into the Space Needle with Denise Eilers as we were coming down to go home to bed shows what over forty years of self advocacy can do for a renal patient.  As Lori Hartwell says so eloquently, "an illness is too demanding when you don't have hope." There was much hope in what I saw today at the ADC.

Thank you Dori once again for making today possible.

NxStage System One: Saying Goodbye to Headaches

By Peter Laird, MD

One of the most difficult symptoms that I dealt with while doing conventional incenter hemodialysis were the frequent headaches. Headaches which were especially worse on Monday night, after my long dialysis weekend. As many as 70% of hemodialysis patients complain of headaches before, during or immediately after completing a dialysis session. This does not have to happen, you can say goodbye to headaches.

The most commonly noted type of headache is related to the dialysis disequilibrium syndrome (DDS) which remains an unproven cause to date. Most investigators believe that DDS is related to cerebral swelling after removing high levels of urea during dialysis and slowly compensated cerebral fluid shifts.  For myself, it is likely that the throbbing, Monday night headaches, which were centered in my frontal region, were related to this phenomena, since I seldom experienced them on any other dialysis day. I also noted that the headaches on Monday were always worse if I had coffee during our Sunday outings.  Caffeine is an important factor in any headache management attempt, Caffeine Withdrawal Headache Explained: Your Brain On - And Off - Caffeine:

The team demonstrated that stopping daily caffeine consumption produces changes in cerebral blood flow velocity and quantitative EEG that are likely related to the classic caffeine withdrawal symptoms of headache, drowsiness and decreased alertness. More specifically, acute caffeine abstinence increased brain blood flow, an effect that may account for commonly reported withdrawal headaches. Acute caffeine abstinence also produced changes in EEG (increased theta rhythm) that has previously been linked to the common withdrawal symptom of fatigue. Consistent with this, volunteers reported increases in measures of "tired," "fatigue," "sluggish" and "weary." Overall, these findings provide the most rigorous demonstration to date of physiological effects of caffeine withdrawal.

Aside from caffeine withdrawal, several other causative factors are associated with headaches among people who use dialysis, including: hypertension, high sodium intake, intradialytic hypotension and a possible connection with low magnesium. Because rare cases are associated with glaucoma, it is mandated that all recurring headaches be taken seriously and have a thorough investigation as to the precise cause. 

For people who use dialysis, controlling hypertension is one of the most important treatment factors to consider. Especially when headache complaints are seen in conjunction with high blood pressure.  Volume control through sodium reduction and appropriate blood pressure medications are effective in reducing both headaches and high blood pressure. This was demonstrated by Dr. Bernard Charra of Tassin France (PDF link), in several studies since the 1980’s.

Perhaps the greatest benefit I have personally gleaned from switching to the NxStage System One is an almost complete absence of headaches.  At present, dietary indiscretions with too much sodium in foods  or too much caffeine trigger the few headaches that I do experience, but I no longer have to take long, hot showers once or twice at night after dialysis.  These showers were once part of my conventional dialysis routine - no longer! With more frequent dialysis, I experience less frequent headaches. 

In addition, the relation of my headaches to sinus congestion for some reason has diminished since starting on NxStage.  I am certain that reducing the fluctuation of dialysis associated toxins by doing dialysis five days a week and avoiding the long dialysis weekend are key elements in reducing my headaches. Occasionally this is confirmed, since I do still experience headaches on the few occasions when I have had to skip dialysis two days in a row.  In addition, the ultra-pure dialysate used with the NxStage System One  may reduce inflammation, inflammation which can directly exacerbate sinus conditions caused by my allergies.

Having access to the NxStage System One and saying goodbye to my headaches is a welcome benefit of taking charge of my own dialysis treatments at home.  It is just one of the many blessings I enjoy since leaving behind conventional incenter dialysis. If you suffer headaches during or after hemodialysis, considering daily dialysis. Once other common causes of headaches are excluded by your medical team, you may find more dialysis to be the best defense against dialysis headaches.

H1N1 Pandemic Flu 2009 in Review:The Deadly Facts

By Peter Laird, MD

Many have incorrectly listed the 2009 H1N1 pandemic flu as a mild outbreak. It is true that the usual march of death through the elderly population never materialized, as well we did not see large outbreak among the dialysis population, however, what we did see was the loss of life in the young and often healthy. There are many theories on why the elderly were spared this time, such as, prior exposure to similar viruses decades ago, but the fact remains that this pandemic was a pandemic of the young.  That is why comparing this flu outbreak to the usual seasonal flu is not correct.  The average deaths among children with the seasonal flu is in the range of 40-50 children a year. However, to date the 2009 H1N1 pandemic flu has killed up to an estimated 1800 children in America.

Swine flu has killed up to 17,000 in U.S.:

"CDC estimates that between 41 million and 84 million cases of 2009 H1N1 occurred between April 2009 and January 16, 2010," the agency said in a statement. Usually the CDC goes with a middle number, which it puts at about 57 million people infected.

Between 8,330 and 17,160 people died during that time from H1N1, with a middle range of about 12,000, the CDC said. But between 880 and 1,800 children died, up to 13,000 adults under the age of 65 and only 1,000 to 2,000 elderly.

In a normal flu season, the CDC estimates that 36,000 Americans die of flu, but 90 percent are over the age of 65. The CDC estimates that 200,000 go into the hospital, again mostly frail elderly people with other health conditions.

The swine flu pandemic has affected much younger people.

The H1N1 2009 pandemic flu is one of the deadliest flu epidemics seen in the younger generation and had many key features resembling the 1918 epidemic that killed millions worldwide. Why the elderly were spared is a subject of great interest, yet the facts remain that some nations had much higher death rates than others.  Japan for instance closed schools and used a Tamiflu blanket as their national strategy to reduce the toll of death to their population while America blindly let the disease rampage through the population that in retrospect were most at risk.

In fact, the death rate of American children soared up to 3600% while among the elderly it fell to only 6% of usual seasonal rates.  Among the young, the 2009 H1N1 rampaged through the population leaving death and destruction in its path. The only mystery is why the elderly were spared when compared to usual seasonal flu outbreaks. Epidemiological characteristics and low case fatality rate of pandemic (H1N1) 2009 in Japan:

In Japan, suspension of classes is commonly implemented even for seasonal influenza^[14]. For example, during the 2006–7 influenza season, 14,103 institutions (including day care centers, kindergartens and primary, junior high, and high schools) suspended classes^[15]. An even more aggressive suspension of class policy has been implemented for pandemic H1N1 in 2009. Between October 25 and December 5, 2009, 94,781 institutions had implemented suspension of classes^[16]. On the other hand, the CDC of the United States is not recommending such aggressive measures in the school setting^[17].

The policies of the CDC should be soundly compared to those of countries such as Japan lest we once again sacrifice the young and healthy children, who are the future of this country, to failed policies from those responsible for protecting their health. 

The deadly facts stand firm that the CDC failed our children.  It was God alone that spared the elderly.  We could and should have done better for our children.  Unfortunately, the short memory of Americans preoccupied with the latest and greatest fashions and fads may actually look back at the 2009 H1N1 pandemic believing that the dangers of this virus was simply media hysteria and fail to prepare any better for the next pandemic that shall surely come.  Implementing the same tactics with the next pandemic that does affect the sick and elderly could lead to death and misery of biblical proportions.

The deadly facts are in and we failed our children.  It is time for the CDC to renew this historic failure to those that they are charged with protecting and not make the same mistakes the next time we face a deadly flu virus.  It is time to learn from Japan and other nations who protected the young and innocent children.

Taking NxStage System One to the Max

By Peter Laird, MD

Since starting on the NxStage System One in June of 2009, I have continued to look for its maximum efficiency in my own personal treatments just as I did while doing self care incenter.  One of the frustrating aspects of using the NxStage machine is the lack of available medical studies on specific issues. The Nxstage literature base is quite incomplete at this time and many more studies need to be completed. Fortunately, we have a recent publication from Hemodialysis International that begins to answer some of these questions of how effective is the NxStage System One when compared to the standard incenter thrice weekly dialysis at the level of solute kinetics (thanks to RenalWEB for highlighting these articles). Solute kinetics with short-daily home hemodialysis using slow dialysate flow rate:

The weekly treatment time for the patients averaged 17.4 h/wk, a figure higher than the average weekly treatment time embraced by many US in-center dialysis units where a thrice-weekly regimen is practiced. The removal rates and clearance values in the present study should therefore be interpreted in the context of increased weekly dialysis time. While the low dialysate flow rate reduces urea removal, the increase in the frequency of the treatments improves it. In the case of phosphorus and β2M, increased dialysis time is more critical for their removal and compensates for the low dialysate volume.

In my own review prior to starting the NxStage System One last June, I noted that the relationship between NxStage dialysis flow rates and clearance is nearly linear until you go over a dialysate flow rate of 200 ml/min.  Most recommendations for the dosage of NxStage are based on the Filtration Fraction (FF) or percent dialysate flow rate compared to blood flow rate.  However, when looking at the actual flow rates instead of the FF, it is my belief that the recommended NxStage dosages are simply too low.  In my case, at 90 kg, the NxStage dosage recommendation is 20L with a FF of 35%.  In my training, I started on this dosage which I did not find adequate for improving my symptoms and my energy levels even though I did hit the targeted Kt/V of 0.5 with 20L.

When I went home, we started at 30L, FF 35% with my Kt/V improving to 0.77.  With a blood flow rate of 360 to minimize my venous and arterial pressures, the actual dialysate flow rate is 126 ml/minute completing treatment in 238 minutes (3 hours and 58 minutes).  My phosphorus (PO4) level increased by 30% from my usual incenter values on the 20L regimen despite continuing the same restrictive diet. Dr. Scott Rasgon likewise found this in his published data of NxStage users in their program at Kaiser Permanente Sunset medical center. Due to the concern of long term PO4 elevations and looking at the clearance charts for NxStage, I approached my nephrologist about going outside of standard NxStage parameters to maximize the effective volume of dialysate to see if I could improve my PO4 levels, which act like a middle molecule.  He agreed to increase my dosage to 40L of dialysate at a FF of 45% (162 ml/min dialysate flow rate) to keep the treatment time near the four hour level of my 30L treatments.  I was pleased to find my energy levels improved as well as increasing my spKt/V to 0.93, 86% higher than at my 20L dosage, and my PO4 levels returned to my pre-NxStage levels at 3.5 from the 4.6 level on the lower 20L dosage without any binders which I have not ever been on to date.

20L Time 158 minutes  FF 35%  (BFR 360/min - DFR 126/min) spKt/V- 0.5
30L Time 238 minutes  FF 35%  (BFR 360/min - DFR 126/min) spKt/V- 0.77
40L Time 246 minutes  FF 45%  (BFR 360/min - DFR 162/min) spKt/V- 0.93

NxStage dosing is supported by the Standardized Kt/V value of 2.0/week with in center thrice weekly dialysis per KDOQI standards.  The single pooled Kt/V (spKt/V) values are not linear which means you can’t simply add the daily values to obtain a weekly value.  The level of spKt/V of 0.5 comes from the fact that this will produce a Standard weekly Kt/V (stKt/V) of 2.1 which falls within the recommended KDOQI standards. Northwest Kidney Centers has set their weekly stKt/V at 2.5 (PDF link) which is also the standard weekly Kt/V goal of the Frequent Hemodialysis Network as well.

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials:

The target weekly or standard Kt/V for urea in the current frequent hemodialysis trials will be approximately 2.5 in the conventional thrice-weekly arm, 3.8 in the daily in-center hemodialysis arm, and 5.6 in the nocturnal arm.

I greatly appreciate the recent study from Hemodialysis International on the solute kinetics of the NxStage at standard recommended dosages.  However, I must question from my own personal experiences with the NxStage System One whether maximizing the efficiency of dialysate flow rates paradoxically reduces the maximum clearances at the patients level.  It is certainly a wonderful thing to watch numbers and efficiencies improve, but if it does not translate to maximum patient benefits then we should abandon this approach and look at maximizing total dialysate dosage for patients on the NxStage instead.  For an increase of dialysis time by over 30%, I gained an 86% increased spKt/V and ~25% reduction of my phosphorus levels by exceeding standard NxStage dosage recommendations as well as using a higher Filtration Fraction.  The theoretical loss of dialysate efficiency at higher dialysate flow rates and Filtration Fractions may be offset by a simple increase dialysis dosage that translates into higher urea, phosphorus and B2M kinetics as I found in my personal NxStage experiences.  This simply question has not yet been answered in the NxStage literature, but it needs to be considered.

How good can the NxStage machine be if taken to the max?  Indeed, optimal dialysis paradigms operate on the simple concept of maximizing frequency, time and clearances in standard machines.  It is time for investigators to explore this aspect of the NxStage System One noting urea, phosphorus and B2M clearances over a broader range of dialysate flow rates and Filtration Fractions which will allow higher total clearances comparable to standard incenter machines.  My own anecdotal experience suggests that there is significant room for improvement over standard NxStage dosage paradigms (PDF link) published to date that should be explored to eliminate the low clearance shortfall that has kept many nephrologists from recommending the NxStage to their patients despite the advantages of having a portable machine.  It is time to take the NxStage System One to the max.

KidneyTimes: Gout and CKD - A New Era of Hope

By Peter Laird, MD

KidneyTimes will feature an article on gout in the CKD population that I wrote for the Renal Support Network and Lori Hartwell called Gout and CKD -  A New Era of Hope. This was a difficult article to write in many ways since the topic is quite complex even for medical professionals who deal with these issues on a regular basis, while at the same trying to give important information to those without a medical background.

Gout is unfortunately not only a bothersome and painful condition, but for those with declining renal function, the onset of gout and hyperuricemia (elevated uric acid that usually proceeds the onset of clinical gout symptoms) can actually accelerate the decline in renal function. This is especially true in the renal transplant community who must also deal with multiple drug interactions and side effects that not only promote the development of gout, but make the management with usual medications more complicated.

For all those that have chronic kidney disease at whatever stage will benefit from a better understanding of how gout can affect each of us.  Fortunately, there are new medications that may make dealing with gout an easier management issue than it has been in the past, thus ushering in a new era of hope. Gout and CKD - A New Era of Hope:

The New England Journal of Medicine recently published studies on a new and more effective medicine related to Allopurinol that may change how gout is treated in the near future. Febuxostat is a potent alternative to Allopurinol even in patients with mild to moderate renal insufficiency. Febuxostat cannot be used in renal transplant patients treated with Azathioprine since it has the same interaction as Allopurinol who would then need to switch to Mycophenolate mofetil or choose another treatment option for their gout attacks. Yet for those with refractory gout episodes and hyperuricemia, the hope is that this new medicine may not only alleviate one of the most painful maladies known to mankind, but it may also help slow the progression in the decline of renal function which can be adversely affected by high urate levels.

In summary, it is important to properly diagnose and manage gout to prevent long term complications which are even more prevalent in the chronic kidney disease patient and even more so in patients treated by renal transplant due to drug interactions and declining renal function throughout the life of the donated organ. Treatment options for renal transplant patients are tempered by the many drug-drug interactions with the most widely used anti-gout medications and the usual anti-rejection regimens. Recent studies give hope to chronic kidney disease patients that we can utilize a new medication called Febuxostat to prevent and treat high uric acid levels and symptomatic gout attacks. Further information of this complex subject can be found in the articles listed at the end of this article. Preventing and treating symptomatic gout is entering a new era of hope that this dreaded malady may not only be controlled but reversed.

Due to the complex nature of this subject, anyone suffering from gout and CKD will want to read this article and discuss these issues with their health care team to see if any of the newer treatments may apply to your own case. DSEN welcomes comments and questions on this article that hopefully may serve as a source of basic information on gout and how it affects the CKD population.

Is Evidence Based Medicine the Main Barrier to Optimal Dialysis in America?

By Peter Laird, MD

Since the advent of hemodialysis availability in the 1960’s, practitioners have searched for the most optimal way to utilize this life saving technology.  Historical reviews of the pioneering days of hemodialysis reveals experimentation on how frequent and how long we should administer dialysis to patients in need of renal replacement therapy to optimize outcomes.  Surprisingly, the modalities that we now refer to as new and novel were actually described and utilized very early in the course of dialysis experimentation.  Dr. Shaldon was the first nephrologist to prescribe home, nocturnal hemodialysis in 1964 both in London and in Germany followed shortly by Dr. Scribner in Seattle. Dr. Bernard Charra continued overnight hemodialysis in Tassin, France in the 70’s and 80’s with excellent results that were largely overlooked for decades.

The modern era of home, nocturnal hemodialysis reemerged in 1993 in Toronto, Canada by Drs Robert Uldall and Andreas Pierratos. The published observational data from multiple centers utilizing home, nocturnal hemodialysis 3-7 times/week reveals improved anemia control, normalized blood pressure, normalized mineral bone metabolism, normalized functionality and reduced mortality and morbidity compared to conventional incenter dialysis. A recent study with twelve years of follow up showed equal survival with daily, nocturnal hemodialysis as compared to cadaveric transplant. Despite an abundance of observational data and practical experience from Canada, Australia, New Zealand and other nations that have adopted the concept of optimal hemodialysis modalities, America continues to view optimal dialysis modalities with skepticism.

Today, America stands alone as the only developed nation not convinced of the overwhelming evidence that more frequent and longer duration dialysis saves lives.  America also stands alone with an alarming mortality rate among dialysis patients 2.5 times higher than Japan. American healthcare continues to insist on randomized, controlled trials showing the benefits of these alternative dialysis strategies over conventional incenter care even though they readily admit that it is impossible to randomize the 3000 to 5000 patients needed for such a study.  The Frequent Hemodialysis Network is actually unable to recruit even 250 patients for their ongoing nocturnal dialysis study let alone a study with enough statistical power to show a 30% difference in mortality from conventional incenter dialysis. Patients that are knowledgeable of the benefits of extended dialysis are routinely denied access to these life changing home therapies by their insurance companies who allege a lack of evidence of their benefit.

Group Health - Clinical Review Criteria:

Frequent Home Dialysis, Nocturnal or Short Daily
There is insufficient evidence that home nocturnal dialysis improves important health outcomes compared to in-center dialysis. An RCT found improvement in LV mass and phosphate level, intermediate outcomes, and mixed findings in QOL. There is weak evidence from a single cohort study that nocturnal dialysis lowers the rate of dialysis-related or cardiovascular- related hospitalizations. In this cohort study, all-cause hospitalizations did not decrease significantly.  

To date, we have the benefit of only one small RCT on nocturnal hemodialysis which confirmed many of the findings of prior observational studies showing significant benefits of more frequent and longer duration dialysis. America continues to stand alone in it’s call for the highest academic standards of dialysis healthcare, while paradoxically delivering the worst dialysis outcomes anywhere in the civilized world.  America’s search for the holy grail of dialysis evidence based medicine with an optimal randomized  controlled trial that is admittedly impossible to ever complete is nothing but tilting at windmills. 

While America charges ahead with protests of academic purity before accepting the proven benefits of optimal dialysis, patients are needlessly dying at the hands of our own nephrologists who blindly forgo these lifesaving treatments.  While the world embraces optimal dialysis, America instead worships at the altar of optimal randomized controlled dialysis trials which shall never be completed.  It is time to end this quixotic quest, we must stop fighting the windmills of academic purity. Instead let us be inspired by the great pioneers of dialysis in the fight against our true foe, the uremic milieu of too little dialysis and simply ask the dialyzed what frequency and duration of dialysis makes them feel better.

Optimal Dialysis: Are we losing the Battle in America?

By Peter Laird, MD

A little over a week ago I had my home dialysis monthly check-in with a nephrologist that I was meeting  for the first time.  I found him very knowledgeable and supportive of alternative dialysis strategies including the NxStage System One as well as nocturnal dialysis in its various forms.  He recently opened his unit to incenter nocturnal dialysis patients, achieving excellent results with several of those patients who transferred from conventional dialysis care.  Unfortunately, one of those patients is now at jeopardy of returning to conventional dialysis care by the decision of their HMO. This, despite the widespread acceptance of the benefits of incenter nocturnal dialysis especially in Canada just to the north and down south in Australia, America continues to dismiss the overwhelming evidence of improved outcomes with this modality.

Remarkably, despite the widespread knowledge that dialysis pioneers originally used eight hour sessions nearly fifty years ago instead of the conventional 3-4 hours sessions we are now familiar with, many health insurance providers perversely consider these alternative strategies unproven and experimental and will not pay for them.  They continue to insist upon randomized controlled trials as the only standard of proof which at this time still do not exist.  They fail to acknowledge that the current standard of care, 3-4 hours sessions thrice a week, was a business decision unsupported by any randomized controlled trials as well.  

A little over a year ago, I contacted the physician overseeing the committee at Southern California Kaiser that evaluates new and evolving technologies after hearing that they were considering nocturnal hemodialysis at that time.  After reviewing the available literature mainly from Canada and Australia, they determined that that data was insufficient to support adopting it as a covered benefit for all patients, but they did recommend setting a pilot study which is now in progress.  Yet there are many such as Dr. Carl Kjellstrand and Dr. Christopher Blagg who have advocated  for optimal dialysis here in America for decades citing the improved outcomes in several other nations that have been able to incorporate this in dialysis practice.

The case of my fellow patient at my center now battling for coverage of optimal dialysis through a well run incenter nocturnal dialysis program takes me back to the current status of many patients in America who still do not have access to these life saving modalities.  After observing the positively changing mindset among many in the nephrology community over the last two years that I have been involved in dialysis advocacy, this case reminds us that the battle is not yet won here in America.  With the uncertainties that the new prospective payment system could bring to American dialysis patients and these alternative treatment options, I can only wonder whether we are winning or losing this battle.  Dr. Belding Scribner spent the last two decades of his life fighting this battle only to tragically die in 2003 before he saw it come to fruition. 

Certainly, in the nearly seven years since Dr. Scribner death, dozens of studies have brought forth the profound benefits of daily hemodialysis, especially in regard to daily nocturnal hemodialysis. Many who support these modalities continue to wage the battle against this American dialysis hegemony hoping that we shall never again hear that a patient was denied access to these life changing treatments.  It is a battle that one of our fellow dialyzors is waging today, unfortunately it seems, with very little chance of success.  A vocal dialysis advocate that I asked to assist in this case summed it up by simply saying, “That's truly appalling!”  I agree.  The battle continues locally and nationally.

Expanded Dialysis Bundle Will Increase Administrative Costs

By Peter Laird, MD

MIPPA legislation in 2008 mandated an expanded bundled payment system for Medicare dialysis patients. In doing so, the proposed rule will rely upon a higher base payment calculated to be about $198 with case mix adjusters to fill in any variations in costs between patients of higher or lower complexity.  At the outset, this system appears to take advantage of social and medical factors that could lead to inequality in care among patients.  However, what CMS has not addressed in any of their comments or discussions are the hidden administrative costs for physician and dialysis providers Medicare compliance.

Under current Medicare laws and regulations, the physician or dialysis provider must comply with all Medicare regulations and offer compliance training to all of their employees.  As a physician who has undergone such compliance training and who has been involved in documentation efforts over many years, the unforeseen implications of the increased complexity of the case mix adjusters with the propose bundle rule will lead to increased time at the point of service for dialysis technicians, nurses, physicians, social workers, pharmacists and dietitians to remain in compliance with each pay per session data collection.

Provider Risks for Fraud & Abuse (PDF link)

• Billing for services/supplies that were not provided
• Incorrectly reporting diagnoses or procedures to maximize payment
• Billing for services/supplies or writing prescriptions for drugs that are not medically necessary
• Remuneration schemes that unlawfully induce or reward the provider to bill for services/supplies or write prescriptions
• Provision of false information (e.g. falsifying info on a prior authorization request, misrepresenting dates of service, etc.)
• Unbundling charges
• Violating the assignment agreement, Fee Schedule, or Maximum Allowable Actual Charge Limits

To accomplish this point of service daily session task, there will need to be intensive training modules likely conducted by outside consultation firms.  In addition, the dialysis providers will need to hire compliance officers to oversee and implement these programs.  This is an additional administrative position and cost not detailed in the CMS bundle rule.  In addition, due to the complexity of case mix adjusters that can change from session to session and must be properly recorded and documented, I cannot perceive any manner in which this could be done accurately with manual input.  In such, I believe that we will see a growth in Medicare Renal Bundle software programs which will also come with payed consultants to implement and oversee the accuracy of Medicare compliance.  With low level trained employees responsible for the majority of data input in dialysis centers, pre-designed templates will be the only way in which the data can be properly collected with point of service computer prompts.

The case mix adjusters also have several key inpatient factors that will need to have close data recall and sharing between inpatient and point of outpatient care parties. This will increase the secretarial administrative duties with the dialysis unit and most likely will be accomplished by added employee positions.

In addition, the physician who wishes to stay in compliance will need to update their training on an annual basis since it is likely that CMS will change the allowed case mix adjusters on a yearly basis as they already to with payable DRGs we see in the inpatient and outpatient settings.  With a fixed rate of payment and no compensation in kind for these hidden administrative costs, the setting is in place for competition of funds between administrative layouts and clinically required treatment costs.  Without upfront costs adjustments for these hidden administrative costs, patient care is at risk of further decline in quality with the likelihood of adverse outcome increases in a population already at the highest risk of adverse outcomes in the western world.

I would suggest a simplified single payment without complex case mix adjusters as many private capitated contracts already do very successfully.  The only winner with increased bundle complexity will be CMS itself which will need to add to their employment ranks to oversee the compliance of such a complex system.  Those at the sharp end of the needle are at great risk of higher rates of complications due to competition between administrative costs and treatment costs.  The current CMS bundle rule should be simplified to reduce and eliminate these new and hidden administrative costs while at the same time complying with the intents of MIPPA.

Experts Warn: America Has Limited H1N1 Flu Resources (Except For Their Own Children)

By Peter Laird, MD

Since the H1N1 flu broke out in late spring, while many prepared and warned about the dangers of this fast moving pandemic, others chose instead to mock those preparations, calling them an over reaction.  The alleged but yet unproven knowledge that the majority of patients have a limited and mild H1N1 course does not mitigate the fact that this flu affects a different population than the seasonal flu.  Pregnant women, children and young adults are at the top of the list of those who have died.  Paradoxically, the elderly have fared better from a presumed latent antibody protection from prior flu outbreaks before 1957.

A recent article goes so far as to call these “exaggerated fears” the greatest threat above and beyond the actual expected impact that the H1N1 virus will have.

Could Swine Flu Panic Be Worse Than Outbreak Itself?

With infections typically causing only mild illness, experts point to exaggerated fears as the real threat

"We have limited resources in the U.S. -- if this [swine flu] captures our negative imagination, it's going to hurt our health-care system," said Dr. Marc Siegel, associate professor of medicine at New York University School of Medicine in New York City. "Our emergency rooms will be flooded with worried people, doctors' phones will be hanging off the hook, everyone will be afraid of every sniffle and wanting to get tested for the flu."

Overwhelming hospital capacity is a very real issue as I have discussed earlier, but not because concerned parents will seek medical care for their sick children, but instead because America has diminished its ability to deal with unexpected health demands and surges through a systematic destruction of our hospital infrastructure over the last three decades.

Hospital Capacity: The Silent H1N1 Waterloo

America’s health infrastructure is smaller and in many ways less effective than it was in the 1970’s at its peak capacity.  In my town of Antelope Valley California, in the early 1990’s there were four active, full service hospitals and 200,000 residents. Now in 2009, we have only two active hospitals and over 400,000 residents.  

Resource rationing is the survival mode of all American ER’s today with many facing severe physician staffing shortages.  Patients who would have been admitted routinely even ten years ago are returned to their primary care physician for continuation of out patient care. However, with a severe primary care shortage, many patients languish in limbo between urgent care centers and overflowing emergency rooms.

Yet, when the experts themselves encounter H1N1 face to face, there are no limits to resource expenditures. Monotreme's blog ventured into this discussion by pointing out the alleged hypocrisy that Dr. Siegel noted above poses when he not only prescribed Tamiflu for his son but then went so far as to recommend prophylactic treatment for all of the campers.  In doing so, Camp Modine spent $45,000 fighting this virus to protect his son and his fellow campers:

Summer Camp ’09: A Swim, a Cough, a Quarantine

Camp Modin brought the outbreak to a dead halt by offering prophylactic Tamiflu to all of the campers and counselors, a move it took on the advice of one of the parents, Dr. Marc Siegel.

“Tamiflu is used prophylactically in nursing homes quite successfully,” said Dr. Siegel, an associate professor of medicine at N.Y.U. Langone Medical Center. “And I think when there’s a big outbreak in summer camp, where kids live very close together in their bunks, it makes sense to follow the same protocol.”

“We’ve taken 6,000 temperatures this summer,” said Howard Salzberg, the camp director. “We’ve bought all the Clorox wipes in every Wal-Mart we could drive to. We’ve spent about $45,000 on this, $30,000 on Tamiflu alone, and probably another $15,000 on the masks, the gloves, the games for the kids in isolation.”

The CDC continues to advocate against the prophylactic use of Tamiflu except for certain high risk patients where even there they advise watchful waiting.  However, the take home message from Dr. Siegals correct intervention at his son's summer camp is that this approach worked:

Almost 300 campers and 100 staff members went on prophylactic Tamiflu for 10 days, Mr. Salzberg said, and the H1N1 virus stopped spreading.

When the H1N1 virus has finally run its full course during the next two years, the differences in case fatality rates between the developed nations will likely fall into the categories of those that used a Tamiflu blanket, and those that depended on herd immunity and let happen, what happens. Understanding the effectiveness of Tamiflu especially in close group environments such as our children's schools, with no vaccine readily available for weeks, refusing to use prophylactic Tamiflu will result in the unexpected deaths of many healthy children and young adults, nothing to speak of those with CKD and other chronic medical illnesses.  

Instead of speaking out about "negative imagination" that could result in panic, in my opinion, Dr. Siegel would do better to instead speak out against the CDC mindset of withholding widespread use of Tamiflu and instead advocate for delivering large quantities of Tamiflu at the first sign of a local and regional outbreak. After all, if his recommendations expended a large amount of Camp Modine's limited resources, don't your children deserve the same expenditure as they head back to school and face outbreaks of H1N1?  My question to Dr. Siegel is how shall history remember him?

H1N1 Spreads After the Fever Breaks: Time to Reevaluate the CDC Guidelines

By Peter Laird, MD

The H1N1 virus may be even more contagious than CDC guidelines suggest long after the fever abates in H1N1 patients.  In three related studies scientists have discovered that patients with H1N1 continue to shed the virus after the fever resolves but are still symptomatic, especially coughing.  This draws into question the wisdom of the recent CDC updated guidelines on how long H1N1 patients should be isolated at home:

CDC recommends that people with influenza-like illness remain at home until at least 24 hours after they are free of fever (100° F [37.8°C]), or signs of a fever without the use of fever-reducing medications.

This is a change from the previous recommendation that ill persons stay home for 7 days after illness onset or until 24 hours after the resolution of symptoms, whichever was longer. The new recommendation applies to camps, schools, businesses, mass gatherings, and other community settings where the majority of people are not at increased risk for influenza complications

Researchers in Seattle analyzed epidemiological data from the H1N1 outbreak in New York City last spring showing the likelihood of catching the virus at home and at school is higher than the seasonal flu:

The researchers analyzed reported data about the past spring's swine flu pandemic and concluded that — barring mutations in the virus — a person has about a one-in-four chance of catching it from an infected family member.

And based on the earlier H1N1 outbreak at New York's St. Francis Preparatory School, researchers estimate the likelihood is that a typical infected student will pass it on to a maximum of 2.4 classmates.

Many have rightly criticized the CDC for their lack of urgency regarding the spread of H1N1 by returning school children.  The recommendations that children may return to school 24 hours after the fever breaks and the recommendations to keep schools open despite outbreaks must be reevaluated in light of these recent studies on the length of time that H1N1 is shed.  The lessons from prior pandemic flu is that social distancing and isolation of symptomatic patients is still one of the most effective practices to slow the spread of illness.  Certainly, with the delayed deployment of H1N1 vaccine, parents and school officials should consider waiting until the student is at least no longer coughing.

CDC: Swine Flu 'Never Went Away'

By Peter Laird, MD

Three weeks ago, I placed the post, When Did the H1N1 Flu Bug Go Away?  The main purpose was to show the approach of the CDC in mitigating the potential impact that the H1N1 may have instead of the approach DSEN took to educate, warn and urge people to prepare for that which may come even if it never does.  Now, three weeks later, my post is even more important in the language that the CDC is now using.  Then it was, the H1N1 virus will return.  Now it is, the swine flu never went away:

Bill has dedicated a significant amount of time and effort educating all those that grace the pages of DSEN on the potential dangers of a pandemic flu especially to the dialysis/CKD population.  His posts and mine following in his example have bared the truth of the true potential for great loss of life due to poor preparation in the advent of a widespread influenza virus.  Words matter.  Words can bring to action effective strategies to prepare in time and avoid adverse outcomes if given in a timely enough manner.

The difficulty that I have with the language of the CDC and the government's in general regarding the H1N1 2009 pandemic is that it appears to me that the choice was made to placate the population to prevent panic but it may come at the price of poor preparation for those placated, but not fairly warned.  I believe the CDC H1N1 briefing today forebodes what shall follow.  From the epidemiology of over 500 deaths, we should already have a clear understanding of the at risk populations.   Not warning those populations and instead pandering to complacency and avoiding panic will not prepare these at risk populations.  Bill and I believe that this is the wrong approach.

The CDC in both the Bush and Obama administrations spoke of the great and effective preparations that they have taken with pandemic planning.  I have reviewed many articles on this preparation and it is my opinion that most of their preparation has been in the ethical and legal ramifications of overwhelming our meager hospital surge capacity.  Medical personal are protesting the lack of PPE’s for nurses and health care workers.  The CDC talks about treating people with a vaccine that is likely to be available to the majority of at risk patients after the virus has already peaked when it “returns” in the fall.  

Where are the boots on the ground so to speak that we usually associate with the words pandemic flu planning and preparation?  Words in a legal or ethical document directing health care workers on who to exclude from treatment when resource allocation demands difficult decisions is not the type of preparation most would consider when we hear of pandemic flu planning.

Words matter.  They call people to action if used properly as a warning to prepare.  They are useless once the pandemic has already caused widespread death and morbidity. Other nations may have a better approach in the truthfulness of the challenge that we may soon face.  My post of three weeks ago reflected the discord between the official statements of the CDC and the blatant fact that the H1N1 virus never went away over the summer.  This of course in retrospect was an understatement.

The CDC has also been less than forthcoming in publishing up to date details of which populations are most affected by the H1N1 virus.  Today at the news briefing, we learned some details about the risk to the older pediatric and adolescent population.  In all of the CDC sites, I have yet to hear any detailed risk assessment of the chronic renal disease population from the over 500 deaths to date.  Bill has decried this lack of information that should be readily available in several of his posts.  The truth is the best warning.  We still do not have these important details and important warnings for the renal population.  What good will these statistics be after the at risk populations are already decimated should poor preparation lead to adverse outcomes.

I am grateful that my post three weeks ago was accurate, but my fear is that many of the things that DSEN has warned about with pandemic flu preparation will likewise be the headlines weeks from now as well.  Preparing the nation for ethical and legal absolutions for denying specific populations care in an overwhelming flu surge is not preparing to keep those populations alive.  It is simply double speak that gives people false hope and leaves them poorly prepared.  Words matter.  My fear is that when the CDC finally speaks bluntly, it will be about the different risk factors that placed people in the morgue instead of keeping them at home alive and well.

Optimal Dialysis Deserves a Trial of Life in America

By Peter Laird, MD

Looking back upon my training in Internal Medicine, it is interesting how several simple remarks by my mentors became important standards in my own clinical practice.  One singular remark stands out above all of the rest in my mind.  Dr. Marin Kollef, ICU director for Fitzsimons Army Medical Center during my residency had a favorite saying for patients that had stabilized on a ventilator but were not progressing to the point that it could be removed.  In some cases where the patient’s weaning parameters were ambiguous, he would make a clinical judgment that the patient deserved a "trial of life" before the complications of long term life support took away all hope.

Today, many in American nephrology remain unconvinced about the benefits of extended dialysis in its many forms.  Perhaps the most vocal critic of adopting daily dialysis therapies without a randomized controlled trial (RCT) is Dr. Glenn Chertow:

Given these uncertainties, we do not have sufficient data on the effects of daily and nocturnal hemodialysis to advocate for its widespread use and underwrite its cost. In 2001, Chertow (19) argued that a RCT of frequent hemodialysis was necessary to answer the fundamental questions of whether these treatments improve outcomes and, if so, by how much. . .

The current evidence does not support the widespread implementation of daily or nocturnal hemodialysis, also suggesting that an RCT is needed (16,17). In addition, there has been little information published on the feasibility, safety, and possible adverse effects of frequent hemodialysis. An RCT will test the feasibility and the safety of these treatments using a rigorous protocol. It also will enable us to perform an economic analysis of frequent hemodialysis compared with conventional therapy.

However, both of the two current dialysis related RCT will be too small (too few people enrolled) to answer the questions posed by researchers such as Dr. Chertow and CMS which continues to insist upon RCTs before funding high intensity dialysis regimens.  

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials
Power analysis showed us that with 1 yr of follow-up, we would need to enroll >3500 patients in the daily study and >5000 in the nocturnal study to achieve 90% power to detect a relatively substantial 30% reduction in mortality. These numbers are several fold higher than the total number of patients in North America who are receiving this treatment. With intensive recruitment efforts, we estimate that we will be able to enroll a total of 500 patients for the two RCT: 250 in the nocturnal study and 250 in the daily trial.

America continues in this dance of death with usual dialysis care, seeking a RCT that shall never be completed even with the current ongoing studies.  CMS continues to insist upon RCT generated evidence of the benefit of extended dose dialysis completely overlooking the simple fact that dialysis started with extended doses at home:

Why "Adequate" Kt/V Does Not Provide "Optimal" Dialysis
Dr. Kjellstrand told the audience that "adequate" is defined as "barely satisfactory" and asked: "Is that what we want to give our patients?" He noted that in the United States, with the current "adequate" dialysis target of Kt/V of 1.2, the dialysis patient death rate is 25%, the rehabilitation rate is less than 10%, and "every fifth patient finds life so miserable he prefers to be dead."

"The goals we should have for our patients are comfortable dialysis, normal blood pressure, high quality of life, and a survival that should rival that of transplantation, since it did that early on," he said.

America has a further chance to redeem the errors of ignoring our historical successes as pioneers in dialysis therapy and once again reclaim our rightful position as the champion of optimal dialysis. Waiting for the holy grail of a randomized controlled trial to show us what we already known for 40 years, from the pioneering days of dialysis, doesn't make any sense. Sometimes the only option when faced with a hopeful but uncertain situation is to just give the patient a trial of life. This reach for optimal is long overdue in American dialysis units.  My prayer is that it will come soon for all.

H1N1 ICU Triage Rules: Who Lives?

By Peter Laird, MD

In early April of this year, the first reports of a new flu hit the news. Slowly over a period of weeks, the reality came home that the world was dealing with its first influenza pandemic since 1968. The fear of a repeat of the deadly 1918 Spanish Flu were mitigated by the reports that the vast majority of infected patients had a mild clinical course with complete recovery. However, the reports aren't entirely accurate and the 2009 H1N1 pandemic flu has characteristics similar in many aspects to the 1918 flu. These worrying facts, including continued spread during the summer months and severe pneumonia affecting a number of young and healthy patients, is why the H1N1 virus should be taken very seriously.

The World Health Organization, CDC and other US Federal organizations have spent several years preparing a coordinated response to a pandemic disease. These preparations began in earnest under the Bush administration after the rapid spread and high case fatality rate of the SARS corona virus and the emergence of the high CFR H5N1 bird flu virus. It has always been the case that a deadly virus could arise and devastate the world's population as it did at the beginning of the 20th century so we always should have been planning. However, it was the recent emergence of pandemic potential viruses that truly spurred planning.

Then came H1N1. Television and online media outlets give us regular updates on how the current H1N1 pandemic flu is affecting people in America and most especially in the southern hemisphere as their flu season continues unabated. The planning and organization at the national level has been coordinated with every state in the union with many stockpiling large amounts of personal protective equipment and Tamiflu which remains effective against this virus. However, it is unclear how effective this national and state wide planning has been implemented on the local level and especially in vulnerable populations such as dialysis patients.

Northwest Kidney Centers is a model for participation in local and statewide pandemic planning as well as preparing to prevent the spread of H1N1 among both their staff and their patients. I suspect that few dialysis providers are as well prepared to weather this storm coming soon to our dialysis units. Bill has sought diligently to find any data showing how severe H1N1 affects renal patients, but to date the CDC has not been forthcoming with all of the current case fatality distribution of risk factors. Much is still unknown on how many we can expect to be infected as well as how many of those will have a severe reaction. However, planning best practices requires us to consider dire scenarios. For people on dialysis we should understand how the entities we rely on, e.g. doctors, dialysis providers, hospitals, will respond to a worst case.

For instance, few people are aware of some of the Federal guidelines for our hospitals should a major pandemic overcome the hospital surge capacity. In the event that our hospital capacity is overwhelmed tough decisions will have to be made. Triage guidelines have been developed and accepted widely as a strategy for resource allocation in times of severe shortages. These widely accepted guidelines include exclusion of care categories. In a mass casualty situation, hard decisions are made on resource allocation that would never be made in ordinary times. In a flu pandemic emergency this would mean less care for those patients with dim survival prospects even with maximal care.

An example can be found in this California Department of Health Services draft discussion, Guidelines Regarding the Transition from Patient-Based to Population-Based Outcomes (PDF link):

When a physician graduates from medical school, he / she swears to an oath that embodies the ethics and ideals of Hippocrates, the acknowledged father of modern medicine. Translated from the traditional Greek version, the Hippocratic Oath emphatically states that a physician should "Above all, do no harm" to the patients he / she serves. An excerpt from this oath reads, "I will remember that I remain a member of society, with special obligations to all my fellow human beings."  In the current state of medicine, each licensed provider of care has an overarching obligation to treat every individual patient to the best of his or her abilities. . .

Surge capacity planning for such resource poor environments must therefore consider a departure from the individual patient-based outcomes that physicians have been long conditioned to uphold in favor of an approach that saves the most lives. In other words, 'clinicians will need to balance the obligation to save the greatest possible number of lives against that of the obligation to care for each single patient.
...
A healthcare provider may determine that an individual will not receive care, or that care currently being provided to an individual will be discontinued or withdrawn, based on the criteria identified in Section V below. Examples of care that may be denied or discontinued or withdrawn in order to allocate limited resources in accordance with the criteria identified in Section V, include but are not limited to ventilator support, antibiotics, hydration and life-sustaining nutritional support, ICU and other facility beds and supplies, and blood.
...
Exclusion Criteria for Ventilator Access*

• Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrest  
• Metastatic malignancy with poor prognosis  
• Severe burn: body surface area >40%, severe inhalation injury  
• End-stage organ failure: 
• • Cardiac: NY Heart Association class III or IV  
  • Pulmonary: severe chronic lung disease with FEV1** < 25%  
  • Hepatic: MELD*** score > 20  
  • Renal: dialysis dependent 
  • Neurologic: severe, irreversible neurologic event/condition with high expected mortality

*Adapted from OHPIP guidelines  
** Forced Expiratory Volume in 1 second, a measure of lung function  
*** Model of end stage liver disease

These ICU pandemic triage rules could come into play if the current H1N1 2009 pandemic causes widespread and severe illness.

What the California DOH is contemplating is the reality of population outcome based pandemic planning and the exclusion criteria that could come to be. Knowing these policies could come into effect is what motivated Bill to be concerned about emergency planning. Given these policies, dialysis patients have to stay away from hospitals during a pandemic. That's the insight that has fueled Bill's advocacy. If every dialysis center was as prepared to maintain operations as the Northwest Kidney Centers I would be far less concerned. Unfortunately most patients and staff do not have access to Tamiflu or even personal protective equipment (PPE). Unfortunately current preparations rely on this being a mild event. If this should instead develop into a severe pandemic outbreak, closer to 1918 that to 1968, then the nation will have its first widespread experience with this new population based medical ethics.

My main hope is  that the current H1N1 flu will remain mild. I pray that the majority of cases will be mild and our medical infrastructure can handle the demand on their services. I pray that widespread shortages remain theoretical. DSEN's pandemic flu posts promoting pandemic planning is an ongoing effort in the hope that dialysis providers will take pandemic flu planning seriously. People on dialysis are at tremendous risk in this and any other unmitigated virus outbreak in the future. Providers have an obligation to take preparation seriously, which means taking dire scenarios seriously.

Dialysis patients need to be able to feed themselves if their dialysis schedule is interrupted. You need to have at least a weeks worth of the Emergency Diet. You need to have the ability to take your blood pressure, your temperature and your weight. Dialysis patients, if they can, should obtain personal protective equipment and further, discuss with their nephrologist and dialysis providers what steps have been taken to protect their patients.

It is certainly more prudent to be prepared than to be caught short in an emergency situation, it is a routine adult responsibility.

When Did the H1N1 Flu Bug Go Away?

By Peter Laird, MD

It's inexplicable to hear many of the H1N1 flu commentators talk about swine flu returning in the fall and their continuing to downplay the impact that this virus will have. That sort of commentary makes no sense. H1N1 has never gone away and it has continued to spread rapidly during what is normally flu's off season. Here in North America's summer months, where flu's spread should have abated by past experience we continue to have a drum beat of illness and death.

Despite this ongoing crises many experts continue to sound the all clear, announcing the end of the current H1N1 pandemic before we have seen the full brunt of its fall/winter rampage:

Harsh second H1N1 wave not inevitable: U.S. experts
We do think -- everybody thinks -- the virus will come back in the (northern hemisphere) fall," Morens said.

"Beyond that, it's hard to say what will happen -- whether it will be more severe, less severe or just the same. If you look at past pandemics, any one of those things happened at a particular time," he said.

This calming proclamation came as we saw a 24% increased mortality in one week alone here in the United States. During the summer!  The United States continues be a global hot spot for H1N1 flu deaths and hospitalizations even as the flu season in the southern hemisphere is picking up strength. 

The news that H1N1 flu is spreading rapidly during the usual flu free summer months here in America is a bad omen of the unabated and unrelenting assault we can expect to see in the coming months.  The initial attack rate in the spring disproportionately affected children who have the lowest rate of death giving a misleadingly low total death rate.  

Age Structure and Case Fatality Rate
The new H1N1 virus is very different. The vast majority of the deaths have been in people under the age of 65.  Perhaps the most detailed calculation of case fatality rates by age was provided in a leaked CDC Director’s brief (from July 16, 2009) that was apparently uploaded to Cryptome (PDF link). According to this document, here are the case fatality rates for different ages (n = 262):

• 0 -4 years: 0.17%
• 5-24 years: 0.22%
• 25-49 years: 1.5%
• 50-64 years: 3.33%
• 65 years and over: 5.24%

In the Spring and early Summer, most of the cases in the US were in children because the virus was spreading rapidly in schools and summer camps. Note, the case fatality rate for this age range is 0.22%. However, in the Fall, we can expect that although the virus will likely primarily affect school children in the beginning, it will eventually spread to the older age groups.

Based on the leaked information on case fatality rates from the CDC and the known population structure of the US, it is reasonable to project that the unmitigated case fatality rate for the US in the Fall/Winter will be much higher than in the Spring, even with no change in the killing power of the virus.

With rapidly increasing deaths across America long before the start of school that many predict will cause the H1N1 virus to return, speaking of the return of this virus belies the simple fact it has never left us.  

H1N1 Death Rate Surges

By Peter Laird, MD

While health officials talk about the expected H1N1 surge this fall when children return to school, the H1N1 virus has not taken any time off - H1N1 has been quite active through July. In a dramatic surge of death before the school year has even started, the CDC this week reports an 18% increase in hospitalizations for H1N1 related illness (5,515 to 6,506) and a staggering 24% increased death toll (353 to 436) in only one week.  

The World Health Organization (WHO) likewise revised the projected impact on the world’s population to over 2 billion people who will develop H1N1 infection in the next two years.  The continued media reports of mild H1N1 illness in the majority of people infected belies the true magnitude of death that this virus will reap, as it rampages around the world at a record pace. Although the majority of people infected will recover quickly, millions will succumb.

The CDC's report of the 24% increased death toll in America in the middle of summer is not good news. There seems to be mounting data that planning on an H1N1 case fatality rate of 0.4% is too optimistic; there is data is pointing to a higher rate:

H1N1 Mortality Rate Increases
As of July 31st, the World Health Organization reports 1154 deaths due to the H1N1 virus among a global total of 162,380 cases, for an overall mortality rate of 0.71%. Consequently the H1N1 death rate has increased more than 60% after holding steady at about 0.44% since mid-June. The current H1N1 death rate also surpasses the death rate from early June (0.66%). Among the tabulated deaths, 87% (1008) have occurred in North and South America.

The trends are not good.

The facts are emerging that H1N1 will soon explode in ever increasing numbers as the summer months give into the cooler and less humid fall.  The experiences in our summer camps captures the true nature that this pandemic is a real threat especially to renal patients and we should all take special precautions as Bill has advised for several years to first avoid and if needed, treat the coming flu.

The New Medical Ethics: Population Based Outcomes

By Peter Laird, MD

The debate over health care reform out of Washington DC is underscored by a new medical ethics that is seldom discussed  and even fewer that understand it in the general public. It is called population based medicine. Harvard medical students recently protested the closing of their Primary Care Department and instituting instead the Department of Population Medicine as several other medical schools have already done previously. The ivory towers of Harvard were never the champions of primary care as evidenced by the meager $200,000 funding to their now defunct primary care department which is essentially the salary of one primary care physician and one primary care nurse.

My first profound experience with this new medical ethics came several years ago when I was reviewing a newly revised tuberculosis treatment guideline from the CDC. Isoniazid (INH) is the most often prescribed medication for latent TB which most would know simply as a positive PPD/TB test. For the majority of my medical career counseling patients on the risk, benefits and alternative treatment options of latent TB, I had followed a very standard risk protocol based on a 1978 study by Kopanoff  finding significant risk based on increasing age:

According to a USPHS study reported by Kopanoff and workers in 1978, of 13,838 patients on prophylactic isoniazid therapy, hepatitis was uncommon in patients younger than 20 years and occurred in 0.3% of patients aged 20-34 years, 1.2% of patients aged 35-49 years, and 2.3% of patients aged 50-64 years (see chart). Although the rate of hepatotoxicity is lower in more recent studies, age remains an important risk factor.

In fact, the risk of INH treatment based on age listed above was exactly the information that I provided since 1993 to all of my patients with a positive TB test. Several patients chose not to take the prophylactic medication after coming to an understanding of the number of patients who will at some time develop active TB versus the number of patients that will possibly develop at times fatal INH induced hepatitis. However, current CDC latent TB treatment guidelines no longer mention INH risks in their treatment recommendations. The reason, we are now treating the herd in an attempt to eliminate or mitigate the effects of Tuberculosis in our entire population at the expense of a few individuals who may die from IHN induced hepatitis. The risks to the individual based on their age is now supplanted by the risks to the population. In other words, the CDC has switched from the ethics of treating the individual to the ethics of treating the population. This is only one of many examples of the new medical ethics that could be cited today.

The current debate on health care reform in America is simply the debate on completely changing from that of treating the individual to that of the population as a national choice. The healthcare systems of Canada and England have long since shed the medical ethics of Hippocrates (PDF link) in serving the individual patient to the maximum extent of the talents of the physicians to that of population based outcomes that often deny the individual treatments that could extend, prolong or improve their remaining life.

When I graduated Boston University School of Medicine, my class chose the Oath of Maimonides instead of the Hippocratic Oath. Staying true to this oath and having suffered myself in pain, it would behoove the American physician of today to truly recall the true calling of a physician to his individual patients.

Oath of Maimonides
The eternal providence has appointed me to watch over the life and health of Thy creatures. May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.

May I never see in the patient anything but a fellow creature in pain.

Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements.

Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today. Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling.

To understand this new medical ethics of population based outcomes is to understand what the true healthcare reform debate in Washington DC is all about. As evidenced by the example of the new latent TB treatment guidelines, the new medical ethics is already entrenched in our institutions and most especially, in all of the new medical school graduates. No wonder many patients wonder why they are not receiving the same care as they once did from those of us in the medical profession with much gray hair if we have any hair at all. As for me, I will always remember each time I self cannulate with a large 15 ga needle that I am simply a fellow creature in pain.

For Better or for Worse

By Peter Laird, MD

In 1998, I sat down to tell my wife that I had found blood and protein in my urine.  The life insurance report had shown a high urine protein level which I did not expect when I filled out the forms. I was even more shocked when I found not only protein, but high levels of blood in the sample that I tested myself.  With tears in her eyes, she asked me if I was going to die. At that moment, I didn't have the answer to that question.  Over time and after several tests, my nephrologist and colleague settled on the diagnosis of IgA nephropathy.  A renal biopsy several years later confirmed this long held suspicion. At first, from the several patients I had treated with IgA nephropathy myself and their benign course, I concluded it would be more of a nuisance than a serious health issue for me and for my wife. However, each year my creatinine began to climb and the reality of significant renal injury began to sink into my conscience slowly but inevitably.

In 2005, it became clear that my IgA nephropathy would lead soon to renal failure and dialysis. I consulted with a nephrologist at Kaiser Sunset who is also a UCLA professor for a second opinion.  He recommended home hemodialysis using a buttonhole technique if I was not able to have a preemptive transplant.  That was the first time that my wife truly realized the impact this would have upon our lives.  She soon offered me her kidney if it would help keep me alive.

A few months before I started hemodialysis, my wife and I sat through our class on renal transplantation as one of the steps to being placed on the renal transplant list and consideration of living donation.  It all seemed a bit surreal since I had several of my own patients go through the same process. My professional detachment from the personal costs of disease hit a brick wall. Marilou and I discussed the different side effects of the transplant immunosuppressive drugs and soon realized we would be trading one disease for another, even with a preemptive transplant. There would be no cure for my disease, only different treatment options, all with their own unique set of risks and benefits.

Renal disease had now begun to enter into our lives and into our marriage.  The care free lifestyle of taking our health for granted came to an abrupt end the day I started hemodialysis on February 1, 2007.  My wife was beside me that day as they hooked me up to the machine for a two hour run at 150 ml/min.  A month later, the issue of transplant took a back seat to the diagnosis of an early malignant melanoma from my days of fun in the sun on the shores of Cape Cod at my grandmother's house. Those bothersome sunburns now came home to roost years later.  A tee-shirt or sunscreen was the difference now between me and a life threatening bout with cancer.  My concern over immunosuppression and increased cancer risk became an overwhelming impediment to the transplant option for me and my wife. I decided to set my eyes on optimal dialysis, especially the home dialysis option.

Marilou stood by my side as we learned to do self care in center with her daily overcoming her fears that something deadly would happen at any moment.  The responsibility of being my assistant left her sleepless many nights. Nevertheless, she continued to stand by my side seeing the lack of concern by many of the techs for standard hygiene practices in simply washing their hands before they came to me for treatments.  She realized that it would only be a matter of time before I suffered an adverse event at the hands of those that didn't have the same love and concern for me that she had.  In the last two years, I have watched my wife overcome her fears of the needles and the machine and the complications that can occur to becoming a confident and competent partner in my medical care.

During our NxStage training, her careful eye on the details of the venous and arterial pressures resolved our first complication with this new machine.  The arterial pressure dropped over two cycles. The fix was easy, simply re-inflating the pressure pod, but the transformation from fear to capable dialysis partner became apparent to me and our trainer that day.  Rita complimented my wife and said she was the best training partner she had ever trained. "You really pay attention don't you."

A little over a month ago, we brought our NxStage System One machine into our house. Marilou embraced snapping and tapping, boxes of supplies and daily adventures into the realm of renal care options right in our own home with calm and aplomb.  Our marriage has changed in so many ways. The reality of death is an ever present presence as all who face chronic illness of any form will surely tell you.  We have no guarantees of tomorrow, but the option of daily dialysis gives me the hope of a continued future with my wife beside me not only as a companion, wife and mother, but now as my personal care partner. It is not a job that my wife sought or even cherishes.  I know she struggles with the reality of large needles sticking out of my arms since she prefers not to look at the needles as I cannulate my buttonholes. She tells me she can feel it as if it was her own arm when she dares to look. Marilou nevertheless is still by my side with every treatment despite the fears and the concerns of what I am going through.

Marilou and I just celebrated our 16th wedding anniversary today even though our anniversary was two days ago.  It was the first time we celebrated an anniversary on a day other than the actual date.  Last Friday she was by my side doing my NxStage treatment with me late into the evening. I did manage to take her out for breakfast at IHOP, but that was not the usual dinner date we have kept as a standard celebration of our marriage.  My renal disease is now the new reality in our marriage.  In many ways, we have grown closer and appreciate each day we have together.  The knowledge that the person sleeping next to you may not be there in the morning gives us a greater appreciation of even small moments of time.  Marilou herself has had her bouts with illness where she could have succumbed with out quick interventions.  Death knows no bounds and has no respect of any person.

There is no one that I would rather have beside me when I am hooking up for another dialysis session. There is no one I would rather spend my time with day in and day out. It is my hope that with rest, exercise, and 20 hours a week of dialysis at home, I will continue to see the best of my wife in the worst of my health.  I am grateful for the time that the Lord has given us.  It is my hope that I will not leave my wife as a young widow. Marilou continues to be a source of great comfort and encouragement to me, but even more so as we jointly prepare and administer dialysis treatments together at home. Life is precious and sharing that life with my wife is the most important incentive I have to keep going, day after day and treatment after treatment.  Knowing that my wife feels my pain and shares my burdens lessens the impact of renal disease for me. Spending our time side by side is the greatest gift I have doing dialysis at the Laird dialysis unit in my own home.  It is the best of the worst.

Ironman Shad Ireland Inspires to the Finish

By Peter Laird, MD

Ironman Shad Ireland, a professional ironman competitor has completed his 4000 mile What Inspires You Tour.  What makes this feat so remarkable is from where Shad came to overcome the ravages of death and coma, to that of a man that is an inspiration to me and those that suffer with renal failure.  As Shad celebrates the completion of his cross country journey, I believe remembering what Shad stated before he started this epic adventure sums up in many ways the spirit that inspired Shad.

In an article from diablo magazine, Shad told the story of what inspired him to begin an exercise routine shortly after coming face to face with death:

“At age 10 I began dialysis, and at age 16 I was told I wouldn’t live past 25,” Ireland said. Later, at age 18, Ireland underwent a failed kidney transplant that resulted in him weighing only 75 pounds and falling into a coma. He said that when he was finally released from the hospital, his parents were told that he would only have six months to live and to plan funeral arrangements.

“Dialysis was difficult for me. I really struggled. I was your quintessential non-compliant patient. I had no hope,” Ireland said.

He explained that the turning point came later and gradually. Ireland mentioned one experience that stood out in his mind. It came while he was recuperating from his coma. He said that he remembers watching the 1997 Ironman competition on TV for the first time and being inspired by triathletes Sian Welch and Wendy Ingraham as they collapsed yards from the finish line and crawled the remaining distance:


Ireland said that when those runners began to crawl forward, that’s when something jumped inside him.

“At that moment I remember sitting on the couch and thinking to myself, just cheering for her and wanting to know what drove her. At that moment, whatever it was she had, I wanted. And it was that afternoon that I made a promise to myself that that was going to be me someday,” Ireland said.

The spirit that lives within us to overcome obstacles and challenges to our bodies whether by illness, brutal races or a 4000 mile bike tour is what Shad has inspired all of us, healthy or not to reach for the optimal limit of our endurance.  American's on dialysis face the dread of death daily.  America finishes in last place keeping American's with severe renal disease barely alive, let alone thriving as Shad now is. Shad inspires all to reach out and go beyond their limits.  It is my hope that many who believe living on dialysis is worse than the curse of death will look at what this man has accomplished and know and understand that we can do better as a nation in providing optimal renal care.

It is time for all American nephrologists to wake up out of their dialysis adequacy coma and fight against government imposed obstacles to optimal care. There is more than one gift of life to those such as myself with renal failure.  Daily dialysis restores health and hope to those that are fortunate enough to have it.  Daily dialysis saves costs from reduced secondary health care expenditures. Daily dialysis should by a source of inspiration to all nephrologists in America that could change thousands of lives overnight by simply embracing this old paradigm. It was in fact the original protocol that started our venture into dialysis in the 1960's with 8 hour sessions, three times a week. Today, we call this a novel and new way to do dialysis.

It is time to inspire.  It is time for the example that Shad gave to all of us with renal disease to stand up and ask when your nephrologist and his colleagues will inspire America to return to the starting line of the 1960's and give all patients optimal, life restoring dialysis and not the usual, adequate dialysis that destroys the lives of those whose nephrologists withhold the precious waters of life from known dialysis protocols proven to save lives. Nephrologists are accountable.

DSEN salutes the example, courage and endurance of our champion Shad Ireland.