HemoDoc, From Doctor to Patient

The FDA ESRD Challenge: Is This an Omen of Good Things to Come?

By Peter Laird, MD

Innovation in health care devices must pass the scrutiny of the FDA process which is by many accounts arduous and overly expensive. Today, the FDA announced the formation of an ESRD Innovation challenge where medical devices for use in the ESRD population will be undergo and expedited review in the hopes of bringing these devices to the market quickly.

• Developing a New Approach to Device Review
• Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

The question that proceeds from this announcement is why would the FDA introduce such a program if it was not needed by virtue of innovations already in development for years by several companies here in the US and abroad that are now ready for introduction? At this point, there are no public announcements by those who have previously secured venture capital for the development of several new and innovative hemodialysis devices, but perhaps the FDA ESRD challenge is the harbinger foreshadowing the long awaited hemodialysis device entries by several companies known to have active research and development investments. We can only hope but in the least, this is a very intriguing development.

"I Need to have Control In my Life" - Celebrating Five Years of Borrowed Time

by Peter Laird, MD

On February 1, 2007, I entered into a new life that was difficult and wonderful all at the same time. I developed IgA nephropathy diagnosed by one of my colleagues in 1998 when I failed an insurance physical exam. They found protein in my urine. I found protein and blood. After consultation with my nephrology colleague, the diagnosis of IgA nephropathy became the prime suspect which was confirmed later by renal biopsy.

My first experience with dialysis was rather benign with a shortened session at low blood flow rates. My dialysis tech happened to be my own patient who I had know for several years. Krystal knew her trade well and I am grateful for her compassionate care in my early months on dialysis.  I learned many aspects of dialysis from her that I still use in my own self care practice. Recently, a friend forwarded the story of man in Sweden who insisted on learning self care to help avoid many of the symptoms of dialysis because he wanted to have control of his life. Interestingly, his example proved the inspiration for 60% of the current patients in his unit who likewise do their own self care HD and PD:

A Patient Directs His Own Care

Farman received a kidney transplant, but in 2005 he was back on dialysis. On the first day of treatment, he spoke with Britt-Mari Banck, a nurse in the Ryhov County Hospital hemodialysis clinic in Jönköping, Sweden. Farman said to her, “You have to help me treat myself. I need to have control in my life.” He had researched self dialysis and became convinced that if he could manage his own treatment, the side effects would disappear.

In many dialysis centers, the story would have ended there. But Farman’s unusual request was met with an unusual response. “I said, ‘Yes, how shall we start?’” recalls Banck, now acting head nurse for the hospital’s self-care dialysis unit.

Banck showed Farman how to use the dialysis machine, read and interpret lab results, and document his care in his chart. Within five weeks, Farman was managing his dialysis independently. He discovered that self-dialysis resulted in fewer side effects.

Christian Farman's hospital based unit now plans to push their goal of self care patients to 75%. American has paid even les attention to self care dialysis practices than even home dialysis options. For patients who do not have the option to do self care at home, self care in-center is a viable option. I did self care in my dialysis unit for nearly two years before going to the NxStage System One and the Laird hemodialysis unit came into existence. 

I am thankful to Dr. Belding Scribner for his vision of hope and life from a machine. I am grateful to NxStage for opening up the home hemodialysis  market where several others had toiled and failed. My five years of borrowed life have been some of the most production, perhaps not by shear volume, but in quality. The clear facts are that without dialysis, I would never have met my youngest granddaughter or the many friends and colleagues I have come to know in these last five years. I could not imagine the journey I started on that day in 2007, but I would not trade these last five years for anything. Having control of your life through self care, home hemodialysis fulfills the vision that Dr. Scribner brought to life all those years ago. There are many people to thank for my added five years of borrowed time, but of them all, the vision and perseverance of Dr. Scribner is the one that I continually am most grateful

I would hope all those that "hate dialysis" could one day have the opportunity that Christian Farman and I have had to regain control of our lives. Dialysis need not be a procedure filled with discomfort and dread, but instead in celebration of life. To all those that have labored to keep people like me and Christian alive, my heart felt gratitude is beyond words. 

Should Nephrologists Earn More Money?

By Peter Laird, MD

Physician pay is an ever present preoccupation within our profession. The long years of schooling and deprivation of ordinary activities at an age when most of our peers enjoy the fruits of young and active bodies not ravaged by time pursuing sports and other forms of entertainment while doctors and medical students are instead locked into long hours of study and challenging clinical schedules. That lost freedom of youth reaches forth in later years in yearnings of compensation for time lost that can never be recovered. I believe all professionals in some manner or another feel that they are worth more than they are paid which is not surprising that those in the nephrology field would also harbor such sentiments. Dr. A.K. Singh spoke on this issue of compensation and incentives following my own post on incentives in nephrology:

Dialysis Unplugged: "Cutting off Your Nose to Spite Your Face"

There is no debate about the fact that dialysis patients are generally older, have several co-morbidities, are on many medications, and are frequently hospitalized. The nephrologist frequently becomes the principal care giver. However, the cost of the nephrologists professional fee is a fraction of the total cost of a dialysis to the payor; and, it doesn't reflect the amount of time and effort that goes into patient care and coordination (Fig.1). Being frugal with nephrologists means that less time is spent with individual patients, reducing the time for emotional support. All of this degrades the patient experience. As well, nephrologists have less time for coordination and thinking pro-actively about how to keep the patient out of the hospital (note: one-half of dialysis patient costs relate to hospital charges). Not paying nephrologists appropriately for the time that is really needed to take a patient-centered approach is a case of “cutting your nose to spite your face”.  

There is no doubt that nephrologists work hard and have a very complex patient mix. However, I would point out some interesting statistics that will place this discussion in its proper perspective. When looking at all of the sub-specialty pay, nephrology interestingly is the highest paid, non-procedure based specialty. In this slide from Medscape, if we look to the specialties higher paid than nephrology, they are all surgical or procedure oriented specialties starting with OB/GYN making about $240,000 per year compared to $210,000 for nephrology. Of all my physician colleagues, the most sleep deprived and beleaguered specialty with an 18 year malpractice tail in my opinion is the OB/GYN specialist who makes only a marginally better salary than nephrology with far much more at risk day in and day out.

The lowest paid internal medicine sub-specialty is rheumatology which paradoxically has in my opinion the most complex illness subsets and difficulty in diagnoses coupled with the most complex cytotoxic regimens outside of oncologists. They spend several years in additional training with great rigor and are paid equal to primary care physicians such as myself with half the years of post graduate education. If I were to make a plea for a pay raise for any of my colleagues, I would be impassioned about these highly trained and grossly underpaid specialists.

The highest paid internal medicine sub-specialty is cardiology which earns high pay mainly from their high risk cardiac interventions we are all familiar with. I would recommend that Dr. Singh and his nephrology colleagues learn some lessons on relative value from their cardiology colleagues who have produced excellent results from their high pay. In relative terms, there interventions are worth the gold we pay. Their bread and butter intervention is angioplasty and stenting patients during acute myocardial infarctions (heart attacks). In an eleven year study period from 1995 to 2006 looking at 30-day all cause survival, my colleagues in cardiology have improved outcomes substantially. Death from myocardial infarction especially in the first twenty four hours continues to decline dramatically at the hands of cardiology innovations in technology, pharmacology and procedural proficiency and training. The risk of dying from a heart attack today is dramatically less than when I first started practice in 1990 and continues to improve. In a very real sense, cardiology has earned it's top pay.

Best Practices in STEMI Management: The Cross Roads of Bleeding and Outcomes Condition: ACS

First, we have made tremendous progress in the management of acute myocardial infarction [AMI] in the past 20 years, and there have been serious improvements in morbidity and mortality outcomes. However, the hospital mortality and the 30-day mortality that are faced in everyday practice are probably higher than what is reflected in the ideal world of randomized clinical trials that we are constantly referring to. Although, it is common in randomized trials to have outcomes of a mortality in the range of 3%-5% at hospital discharge or 30 days, recent data from the US-wide database of hospitals show that the mortality overall, at 30 days in the United States in 2006, was still in the range of 15%. Therefore, we still have a long way to go before we bring the actual real-world mortality of 15% down to the ideal outcome of less than 5% mortality.

On the other hand, if we evaluate the effectiveness of nephrology and their bread and butter intervention, dialysis we enter into a world of stagnation and bitter debates over matters long since settled in the practical world on dialysis dosage and frequency while reaping huge profits from patients who admittedly are the sickest of any medical patient population, even more so than many "deadly" cancers. Many would rightly place the blame for these terrible outcomes at the hands of American nephrologists themselves when considered in a historical context as well as compared to other nations. The survival rates for dialysis patients in the last twenty years are essentially the same as they were when I graduated medical school in 1990. In fact, it is not inaccurate to state that nephrology has failed to improve its dialysis technology and outcomes in any substantial manner in the last twenty years. Dr Robert Lockridge noted no change in mortality rates in a ten year period of time. (here) 

I agree with Dr. A.K. Singh on two issues. First, I believe that nephrology has cut off its nose to spite its face for nearly four decades by failing to improve dialysis technology and producing lower mortality for their patients unlike nearly every other major medical specialty. Unlike their cardiology colleagues with their old fashioned approach, nephrology has instead squandered one of the most amazing life saving technologies in a lust filled, greed based exploitation of their dialysis patients that they were charged to serve and protect. I also believe that we should incentivize outcomes and pay nephrologists for improved survival and reduction of hospitalizations which if accomplished would result in higher pay for nephrology. Instead of endless and useless debates on how to proceed, it is time to put aside the excuses including crying that they are underpaid when in fact the data does not support that claim and move forward to serve and protect their patients with ever improving outcomes. How do they make money? The old fashioned way... they earn it.

Parade Calls Hemodialysis a Grueling and Painful Procedure

By Peter Laird, MD

While practicing internal medicine, I had the opportunity to treat many hemodialysis patients in the hospital setting and in my office practice. In the days that my own kidneys were healthy, I was blissfully unaware of the rigors of dialysis therapy that these patients endured in the conventional in-center unit. I must state shamefully, that I expected these patients to do poorly and most of us blamed their terrible outcomes on the underlying renal disease itself. 

Once I began my own journey with renal disease, my views slowly changed as I realized that many of the complications we saw in those dialysis patients we admitted to the hospital were actually iatrogenic in nature. The septic dialysis patient maintained by catheter without a fistula, congestive heart failure secondary to LVH from aggressive ultrafiltration rates over several years, syncopal episodes (passing out) following dialysis and chest pain during dialysis were common causes of seeing these patients in the emergency room that are all potentially prevented with longer duration and more frequent hemodialyis. The misperceptions about this lifesaving treatment continue unabated despite the knowledge that there is a better way to do hemodialysis. One of the more recent example is in the Parade magazine:

The Miracle of Life: How One Woman Turned Tragedy into the Ultimate Gift

Kidney failure, which can be caused by conditions ranging from infection to diabetes to injury, affects 485,000 people in this country, killing more than 70,000 every year. The vast majority of those who survive do so by chaining themselves to a grueling, painful treatment known as hemodialysis (or simply dialysis), which requires being hooked up to a machine that filters waste from the blood for hours at a time. Still, thanks to dialysis, the parents, siblings, spouses, and friends of those receiving the treatment can put off grieving, at least for a while. The patient has no choice but to endure it until a flesh-and-blood kidney becomes available for transplant — a wait typically lasting five years, which is also when the odds of survival on dialysis begin to drop dramatically.  

As I write this post, I am undergoing a home hemodialysis treatment. Other than a momentary needle prick when placing my needles, I would not call my treatments painful, nor are they in any sense grueling. While it is true that I do this procedure for hours at a time, I am able to do so in the comfort of my home thanks to a portable dialysis machine called the NxStage System One. Bill Peckham spent a great deal of time dealing with negative perceptions about dialysis on his blog, Dialysis from the Sharp End of the Needle. There is no doubt that dialysis as a medical procedure is associated with preventable complications that add to the burdens of dialysis and renal disease but most can be prevented.

The quest to move forward with renal transplantation is a viable option for many patients, but the demand for available organs reduces the number of beneficiaries to only a fraction of the total transplant waiting list each year. In the zeal to implore people to participate in organ donation, media reports on renal transplants frequently resort to particularly odious descriptions of the hemodialysis procedure but at the same time provide little knowledge of the complications of renal transplant. Nor do these journalists have any information on how optimal dialysis compares to renal transplant outcomes such as the nearly identical survival when comparing nocturnal daily hemodialysis and cadaveric transplant noted by Pauly in 2009.

This is a continuation of the great transplant love affair and the jilted procedure we call hemodialysis that has never been fully appreciated since the days of Dr. Scribner and his shunt. When I first began writing on DSEN, it was quite easy to find articles such as the one above which portrays dialysis in dire terms. Today, with the growing popularity of home hemodialysis options, these types of articles are fewer and far between. It is time that not only journalists but health care practitioners and patients alike not only understand but appreciate the lifesaving qualities of optimal hemodialysis that are not painful or grueling.  

There will always remain those that are simply unaware, but today, there is really no excuse for misinformed portrayals of hemodialysis. There is likewise no excuse for the American nephrologist that prescribes any painful or grueling sessions marked by cramping, nausea, vomiting and severe headaches any longer as well. The days of ingorance of beneficial hemodialysis need to come to an end, and patients should feel no discomfort whatsoever during dialysis sessions. If any of thes symptoms do occur, dialysis patients should address their providers to eliminate this distress. There really remains no excuse any longer.

Incentives of Death: The CMS Payment Systems

By Peter Laird, MD

When we look at the American dialysis systems in place today and who is responsible for our poor outcomes, there is no doubt that the greed and avarice of the dialysis industry and the abandonment of fiduciary duties and obligations by the American nephrology community are at the top of the list. But few will venture into the most intransigent agent of death in the American dialysis apocalypse before us, that of the agent who controls the monetary conditions which give incentives of death to nephrologists and the industry as a whole. For over twenty years, separately billable items pushed the profits of nephrologist and providers higher with over utilization of EPO and vitamin D analogs earning billions of dollars a year for the industry while they did nothing to stem the flow of misery and death in the same patients that brought so much filthy lucre to their hands.

Today, with the renal bundle, we are now seeing reports of increasing PTH indicating poorly controlled secondary hyperparathyroidism which inevitably will lead to more parathyroidectomes, a difficult surgery fraught with the complication of nerve damage, especially to the voice box which will leave many with severe speech difficulties. EPO use is dropping as well as Hb levels and now with no bottom floor to the Hb target, shall dialysis patients once again become the most heavily transfused population and placed at risk of hepatitis, HIV and other transmissible agents as well as the potential of severe transfusion reactions. Yet, behind all  of these issues is a single and simple driving force that creates incentives of death and misery instead of life  and health with avoidance of complications. The wall between Part A and Part B of Medicare creates a perverse game of reducing utilzation of resourses at the point of service in the dialysis unit which explodes into mountains of hospital, procedural and co-morbidity associated costs which are entirely preventable with optimal dialysis modalities.

Understanding the cause of many of the common complications of dialysis  symptons with cramping, nausea, vomiting, passing out and severe fatigue for hours after each dialysis session that could be ameliorated by avoiding high ultrafiltration rates by simply extending the number hours per week a patient undergoes dialysis is ultimately the fault of the people who design, oversee and fund the American dialysis system. The blame should squarely fall upon CMS who is charged with overseeing and protectiing the 400,000 patients on dialysis each year. Yet, for decades, despite the calls from advocacy groups to break down the wall between Part A and Part B, despite industry calls to incentivize outcomes including lowering hospitalizations and external dialysis costs, CMS and congress have not lifted a finger to improve the situation.

Many were hopeful that the bundle would begin to improve some of the faults of the prior payment system, but the news from initial reporst with higher PTH, lower Hb and higher hospitalization rates is not encouraging as we evaluate the first year of the bundle. It is apparent that CMS  and congress has failed one more time to make the right choices that will impact positive changes in the great American dialysis debacle of the last thirty years. Many nephrology experts in dialysis are confused and offer only further questions with no solutions to where we need to proceed to overcome the high rates of death and misery in American dialysis units. In the end, it is the lack of incentives to prevent hospitalizations and death with a continued wall between part A and part B that is at the center of our terrible outcomes.

Only when CMS and congress enact incentives to prevent hospitalizations and death shall we make any progress in this nation at solving this dance with death when a person enters a dialysis unit. Technology may provide part of the answer, but the core problem is in the CMS payment system to those that they contract to provide dialysis services. It is time for CMS to step forward and meet the obligations before them. I am a firm believer that we shall give account before God when we pass on to the other side of eternity. I am also a firm believer in redemption and repentance.

It is never too late to do the right thing, unless of course you wait too long to prolong the lives of your patients you are charged to serve and protect. It is too late for thousands of patients every year as CMS and congress fail to do the obvious. Today could be the first day of a new life for so many. Today would not be too late. The choice is in the hands of the people who oversee and render payment. Today is not too late to begin anew. I hope and pray that which they know to do if only they would do it could be the start of a new era of American dialysis that we could all be proud to be a part instead of the constant shame that will not evade the anals of our history. It is not too late to admit the errors of the past and move forward with a bold new path of incentives for life instead of incentives of death. We can only hope.

The Japanese Dialysis Survival Debate: Ignoring the Evidence

By Peter Laird, MD

The survival differences between Japan and the United States are well documented and extensively researched with the preponderance of the evidence focusing on dialysis practice difference.  I have written on this issue several times in the past three years. (here, here and here) Many have wrongly in my opinion put forth the low incidence of renal transplant in Japan and alleged exclusion criteria coupled with lower co-morbid conditions that have not withstood the light of day as the explanation of these differences. Dr. A.K. Singh entered this debate a few days ago on his Kidney Doctor Blog:

Global Nephrology: Better Cars in Japan Maybe, but also Better Dialysis? The bottom-line?

There are a number of differences in dialysis practice that alone or together could explain the difference in mortality. While the very low transplantation rate in Japan, i.e. selection bias, might be a part of the explanation, it does not explain the two-fold higher mortality rate in the US. In Japan, like the US, there is a highly prevalent diabetic population on dialysis with an average age in the 60s that similarly dialyzes 3 times a week in center. It's either better dialysis or some other factor, but not just differences in transplant rates, nor is it because the Japanese are very selective in who they treat on dialysis.

The underlying untold story line to the great Japanese dialysis survival debate is the allegation that we could never take a group of patients in America and duplicate the Japanese survival outcomes with only a change in dialysis practice due to alleged higher co-morbidities, alleged lower incidence of diabetes, and alleged selection bias. I would urge all to consider that we actually have these answers already starting first of all historically when home dialysis patients and in-center dialysis patients had outcomes as equal or better than the current Japanese survival data. Dr. Lowrie boasted of a mortality rate as low as 7% in 1972:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 receivedcadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Many would state that the dialysis patient of 1972 was younger and diabetics were excluded explaining the historical data by selection bias and exclusion criteria. I won't debate the merits or lack of merit of that type of argument at this point, but let us move on to the real issue; if we changed dialysis practices here in America, could we duplicate the Japanese survival data with a large cohort of American dialysis patients. The answer to that question is yes with 5000 dialysis patients in a CMS demonstration project by Fresenius  which recorded a 9.3% annual mortality rate on thrice weekly in-center dialysis:

The first three years of the demonstration (2006 through 2008) were evaluated and the case-mix adjusted results indicate the following for Fresenius Medical Care (FMC) patients enrolled in the demonstration:

• A significantly larger percentage of patients in the FMC program survived to the one year and two year time points.
  • Patient survival at the one year time point for FMC was 90.7% vs 85.4% for the comparison group. Patient survival at the two year time point for FMC was 80.1% vs 73.9% for the comparison group. This equates to mortality improvement for FMC versus the comparison group of 36.3% at the one year time point (9.3% vs 14.6%) and 23.8% at the two year time point (19.9% vs 26.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “all causes” at one year of 13.6% (51.1% vs 59.1%) and at two years 20.5% (60.5% vs 76.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for cardiovascular disease for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “cardiovascular disease” at one year of 14.1% (50.0% vs 58.2%) and at two years 20.7% (59.7% vs 75.2%).

This project utilizing the Medicare Advantage allocation which has no wall between Part A and Part B in a capitated system allowing Fresenius to eliminate the extra profit centers in fee for service practice at the hospital and other points of care that standard Medicare cannot eliminate. This study has not received broad attention especially given that this was with standard 3.5 hours thrice weekly dialysis in-center. What is also not published nor recognized widely is that Fresenius accomplished similar outcomes in their joint Kaiser/FMC ventures in Southern California which I was able to observe firsthand for two years as a patient. Changing practices by first of all aligning cost incentives to prevent hospitalization and outside medical utilization results in cost containment and improved survival. The principle investigator for Fresenius offered detailed analysis of why they were able to achieve these results in an interview with Medscape:

Battling ESRD With Nutrition and Monitoring: Fresenius Project: the Interview

Mr. Farrell: We really think this is right in the sweet spot of where CMS wants to take health reform. One point about our demonstration program was that this was individual enrollment of patients, so at any given dialysis clinic you might have a handful of patients who choose to enroll in this program. This presents an opportunity when you move to a broader accountable care structure. What we have proposed with CMS is the concept of the integrated care health home, with the nephrologist as the principal care physician for these patients and the dialysis clinic provider and our integrated care program providing the data systems and care program infrastructure of the medical home. We'd like to see CMS give us an opportunity to deploy this kind of a model on a full clinic basis rather than individual patient enrollment. This would give us the opportunity to operationalize this model in a more integrated and efficient manner with our clinics and nephrologists in support of our patients. We're very encouraged by the results we were able to achieve in this demonstration project, even in this individual enrollment environment, but see a huge opportunity for ESRD patients if we are able to deploy this model on a larger scale.

If this model sounds familiar, it is because it is the integrated medical care system that Kaiser pioneered over fifty years ago which allows the provider to capitalize on economies of scale and to capture the health care savings by preventing illness and undo utilization of resources. In addition, I have reported on the benefits of nutritional supplementation in the dialysis unit nearly three years ago on DSEN:

Food Insecurity: The Shameful Secret Affecting Dialysis Patients

In the vacuum left by Medicare, some nephrologists have taken matters into their own hands. One exceptional example is Dr. Phillip Tuso, a nephrologist with Kaiser Permanente who created FIRN in response to the high number of his own patients with food insecurity that were dying at an alarming rate from malnutrition. Dr. Tuso started this non profit organization dedicated to relieving food insecurity within his dialysis population which has succeeded greatly in reducing mortality among his dialysis patients. Hospitalizations are likewise over 50% lower than before he began this intervention in 2004 saving Kaiser Permanente millions of dollars from one dialysis unit alone.

One nephrologist who was motivated by the knowledge of a simple and cost effective intervention with nutritional supplements serves as a outstanding model for how America could once again regain the threshold of humane care of those at risk of food insecurity in our dialysis population. It is time for America to save both lives and money with a simple intervention with oral nutritional supplements. The best medicine is once again the cheapest medicine.

I believe the Japanese survival debate is a false debate clouded by a lack of evaluation of known data and by ignoring extensive studies revealing that the cause of our different outcomes is our different dialysis practices. The American dialysis patient is not the cause of our terrible outcomes as many academic American nephrologists would like all of us to believe. In addition,  Japan also has a different payment system where nephrologists are paid per hour of dialysis not per session of dialysis. I have spoken to many leaders in the dialysis industry in the last three years and many place the blame of our outcomes squarely on our perverse payment system that does not reward dialysis providers for keeping patients out of the hospital and avoiding complications.

I believe it is time to go beyond vacuous debates that fail to examine all of the evidence and instead to move forward with concrete practice changes already demonstrated in Europe, Japan, Australia and even right here in America that I have witnessed firsthand. Practice patterns will change when CMS creates incentives for outcomes instead of processes or biochemical profiles. Practice patterns differences are the reason for the excellent Japanese survival on dialysis and I believe that we can not only duplicate but surpass their survival rates by combining the practice changes that Fresenius utilized in an integrated care system with standard thrice weekly in-center dialysis and nutrition and holistic support and then surpassing that model by incorporating daily dialysis. That is the experiment and the direction that we need to take and stop endless and useless debates long since settled by the preponderance of the evidence.

Buttonhole Cannulation: Avoiding Fistula Infections

By Peter Laird, MD

Buttonhole cannulation is a beneficial procedure in prolonging the health of  dialysis fistulas in the home hemodialysis population. Known also as constant site cannulation, it is useful especially in patients who have limited sites for rotation on a fistula. Recent concerns from the FHN revealed an increased risk of vascular access procedures and infections.  Part of the difficulty with the FHN data is a lack of documentation on how many of these complications occured in patients self cannulating or in those that had nurses cannulating with the buttonhole technique. In many ways, buttonhole cannulation is only an option when a patient or one dedicated care giver acceses the site. Even minor changes in the angle of entry will render the buttonhole unusable. An old video from Dr. Stanley Shaldon is a reminder of how far we have come since the early days of self cannulation. (Not for the faint of heart)

 

I have been fortunate to utilize buttonhole cannulation for nearly five years without any complications to date other than a very small thrombosis which required me to move to another buttonhole location.  By God's grace, I have yet to have a single infection in my dialysis access. I believe that there are several factors that contribute to this fortunate outcome, not the least of which is my my medical training on how to perform minor surgical procedures and the importance of proper skin preparation techniques.

I start my dialysis session by setting up my home hemodialysis machine and then let it "cook" while doing other pre-dialysis chores. I always shower prior to dialysis and place clean clothes. I have an upper arm fistula also called a brachiocephalic fistual for the  brachial artery and cephalic vein used to create this access. My first step when beginning my buttonhole cannulation is "pick" the scabs.  I use a bit of an unorthodox technique for scab removal with a 21 ga needle that many experts on cannulation don't recommend, but it works for me by being diligent and very gentle with the needle and essentially peeling the scab away without digging or creating a larger wound. Other techniques for softening the scab work well for many patients, but didn't seem to soften my scabs enough to work in my situation. The key in any of these techniques is to avoid excess trauma to the buttonhole site with scab removal which opens the door to infection through tissue damage.

I always start first prior to scab removal by cleaning the entire area with an alcohol pad. One issue that many do not consider is that the arterial and venous sites are essentially two separate wounds and you should avoid cross contamination. I use one needle for the arterial and a new needle for the venous site. In addition, many use metal, reusable tweezers to assist in picking the scabs once they start to peel. This can be a source of serious infections with drug resistant bacteria that are difficult to completely clean from metal objects. I use a plastic, disposable but sterile tweezers for each buttonhole and never use one on both buttonholes.  Lastly, once I have peeled my scabs off, I keep the area free of all clothing by taping the shirt sleeve to my shoulder prior to removing the scabs.

In addition, I avoid excess dust in the dialysis area by closing the heating and cooling vents on our central air system in the dialysis room. My wife is a great help in this area since she was a supervisor in housekeeping at the hospital where we met. After twenty years in this relationship, I have had to adapt to her hygiene expectations of picking up my clothes and making the bed in the morning since I am usually the last one up. I truly hate the smell of bleach, but it is a regular ingredient in all of our bathrooms, I just ask that she let me leave the house first. My wife has always hated clutter and it makes for a perfect home dialysis setting.

After I have finished the final preparation of the machine and am ready to cannulate, I start once again by cleaning the entire area with alcohol pads being careful to avoid touching the cleansed skin with my hands in any manner. Many dialysis units now send us very small and skimpy alcohol pads and I must simply use two at a time to avoid contaminating the skin while trying to clean it. At this point I have surgical mask and non-latex gloves as does my wife. Once the alcohol has dried, I use betadine pads that I apply in a circular manner to a large area around both buttonholes. My dialysis nurses and my wife believe that my excessive application of betadine paint to such a large area is over kill, but with nearly five years of infection free daily cannulation, who can argue with success.

The key here is to use the standard surgical prep technique of starting from the center and work to the outside of the area cleansed in larger and larger circular motion where you NEVER go from the outside back to the center. I utilize betadine due to an allergic skin reaction to other more effective agents. When using betadine, there are two more precautions to keep in mind with this topical cleanser. First, you must let it dry completely before cannulation and lastly, betadine is irritating to open wounds so I also remove it carfully with several alcohol pads until the skin directly surround the buttonholes has only a faint trace of yellow. The chemical irritation of betadine in a catheter or needle tract can lead to inflammation that increases the risk of infections.

At this point, I use a very careful technique to avoid contaminating the cleansed buttonhole and gently insert the needle along the established track while at the same time pulling the skin taught with my fourth and fifth fingers of the same hand. I hold the needle between my thumb and index finger in a modified touch cannulation. I would point out that I cannot cannulate using this techique in a few seconds as I see many nurses in dialysis centers attempt with a quick swab of alcohol and jam the needle away. It is a bit time consuming to say the least. However, despite some studies suggesting increased complications with buttonholes, I suspect that they are in part due to lack of diligent technique especially when used in a dialysis center with a high patient turnover every day. Buttonhole cannulation is a safe and effective manner of preserving the fistula from aneurysm formation and it is easy to learn how to develop your own sites should you need to abandon an established site once you are home using sharp needles temporally.

Last of all, I place a clean bandaide over the buttonhole before I pull the needles out and then a pressure bandage on top. One issue I have done since starting dialysis is to avoid placing any tape directly over the insertion site.  Anyone that has medical tape on their arm for any length of time understands that the adhesive to the tape stays even after washing and scrubbing with alcohol. Preventing tape on the open hole keeps that adhesive from gathering dirt and bacteria. After I have the pressure bandage on for two hours after dialysis, I take it off, clean off the remaining betadine with alcohol and replace the soiled bandaids with clean bandaides that I keep on for another 8 hours while the protective scab is reforming.

I believe that this is the final culmination of all the previous steps I take to avoid infections. Blood is a great food source for bacteria as noted in the popular blood agar used in microbiology labs for bacterial cultures.  I must confess to being quite paranoid about these issues since I have spent a great deal of my professional life caring for serious access related infections in septic dialysis patients. You can become critically ill in a matter of only a few hours for simply neglecting to be diligent at all times. 

I cherish the independence that buttonhole cannulation offers. It can be challenging at times and as with any procedure, there are specific complications that can occur no matter how careful you are. But for myself, with nearly five years and only a very small aneurysm on my venous site that is clinically unimportant, not a single infection and not a single vascular intervention, I recommend that all patients who are capable of self cannulation should consider this as an optimal access method.  My wife hates my methodical approach to cannulation and rolls her eyes from time to time, but at this point, it is too late to teach an old dog any new tricks. I believe that slow and methodical is the only approach when you continually use a constant site to cannulate. I am continually amazed by the lack of any infection in two continuously open wounds in my arm that defies all of my medical training, but it simply works and works well when done well.

The Kjellstrand Lecture: The Deadly Delay - Part IV: Survival

By Peter Laird, MD

Since the advent of hemodialysis with the Scribner Shunt in 1960, chronic hemodialysis became the most widely utilized renal replacement therapy which is still true until today. Prior to the ESRD program in 1973, dialysis survival rates were substantially higher than today as noted by Edmund G. Lowrie in a NEJM article on transplant and dialysis survival rates:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 received cadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Survival rates prior to the ESRD program were on the average of around 10% annual mortality in many centers around this nation; the equivalent of the annual Japanese dialysis population today. However, since the NCDS instituted urea kinetics as the standard of care in the early 1980's and shorter and more violent dialysis sessions became the norm in America, annual mortality rates have more than doubled and have hovered around 22% as they are today with no significant improvement in the last twenty years. Many fail to realize that the five year survival for dialysis patients is worse than many of our most dreaded cancers and other ailments.

Sadly, the American nephrology community as a whole has ignored the pioneering work of Scribner and his colleagues for nearly three decades as preventable deaths soared. Many fail to remember that Dr. Lowrie recorded annual mortality as low as 7% in 1972 as the gold standard renal replacement therapy, even better than renal transplant at that time. Beginning in the 1990's with the investigation of daily, nocturnal home hemodialysis by Uldall and Pierratos, short daily and nocturnal dialysis modalities have shown significant survival benefit in line with the original survival in the 1960's and early 1970's.

Today, we have several well done observation studies following patients on daily dialysis for several years. These results are not center specific and have been duplicated in the United States, Australia and Canada. Dr. Carl Kjellstrand has supported daily dialysis for nearly forty years while instead, his colleagues adopted shorter and shorter dialysis sessions supported by the measurement of urea kinetics.

After all, the randomized and controlled trial, the NCDS had "proven" that the length of a dialysis session as measured in "TIME" had no statistically significant correlation with outcomes. Amazingly, the NCDS is still quoted widely by dialysis experts debating the outcomes of these observational studies yet fail to question why the dialysis outcomes forty years ago with inferior equipment, inferior knowledge of secondary morbidity associated with dialysis and inferior pharmaceutical support had paradoxically far superior outcomes.

Just as in 1973, without the benefit of randomized and controlled trials, the standard of comparison for the effectiveness of the renal replacement therapies was a direct comparison between the modalities.  Just as in 1973, dialysis and renal transplant which by the way has NEVER had a single randomized and controlled trial compared to dialysis outcomes is one measure of renal replacement therapy that does give comparative meaningful values.  Dr. Kjellstrand compared his own short daily dialysis studies with over twenty years of data to the USRDS in-center PD and HD patients as well as the renal transplant revealing equal survival with the daily dialysis options.

In 2009, Pauly, et al likewise utilized the measuring stick of transplant survival and compared their results directly to the average survival of living donor transplant and cadaveric transplants. Despite the number of earlier studies showing equal results as well as the original outcomes all the way back to the time of Dr. Lowrie's 1973 article with 7% annual mortality, many continue to question the validity of Dr. Pauly's results since they are observational in nature and not from a randomized and controlled trial.

After fifty years of data collection, the American nephrology community remains in a catatonic state paralyzed by indecision on what is the basic and standard dialysis dosage. Urea kinetics has brainwashed the American nephrologist into an altered state of consciousness in blissful ignorance of the damage done to millions of patients by poorly conducted and openly accepted randomized and controlled trials including the HEMO study which simply asked the wrong question: is a higher Kt/V the answer for survival. They likewise never question the lack of RCT studies proving thrice weekly, 3-4 hour treatments against the standard of thrice weekly 6-8 hour treatments.

The American nephrologist is religiously vested in the irrational belief that urea removal has clinical importance when we know that higher blood flows, higher ultrafiltration rates, high flux kidneys and other factors which completely ignore the underlying "unphysiology" of dialysis can all be manipulated to "improve" urea kinetics while at the same time our average annual survival is double the rate prior to the introduction of urea kinetics in the 1970's and early 1980's especially after the NCDS.

The early pioneers utlized very simple clinical monitors of how "adequate" the dialysis was for an individual patient, that of survival and rehabilitation. If the patient didn't feel well enough to return to work and a have viable life, the pioneers of dialysis simply increased their dosage in time on dialysis. That is how they derived the minimum standard dosage of thrice weekly 6-8 hour sessions most of which were done at home ovenight.

Now, a year and a half after the publication of the FHN short daily dialysis study, all that the American nephrologist can offer as advice is that we need larger and clearer endpoints in another randomized and controlled trial looking at mortality. Certainly ASN and the RPA have not in any manner stated that the standard of care for all dialysis patients should be daily dialysis with the best results from NHHD. Some illogically utilize the known results of the "killer" weekend to suggest we have equipoise, the genuine uncertainty over whether a treatment will be beneficial, to justify such a study. It appears that they are the only group that believes we have clinical uncertainty in daily dialysis. They have certainly forgotten that the NEJM and Dr. Lowrie used dialysis outcomes as the gold standard to compare mortality to renal transplant with dialysis outcomes better in those days, double the survival of transplant in its early years. We now have double the survival with transplant, but only if we don't compare it directly to optimal dialysis strategies that return us to the historical mortality rate noted by Lowrie in 1972.  A short memory of the history of dialysis is in many ways our worst enemy of the truth.

In 2001, those that supported the FHN promised it would be the arbiter of these questions. Although the short daily dialysis study did offer up a positive result, many American nephrologists reject its conclusions based on the coprimary outcomes that do not differentiate the contributions of death and LVMI separately for individual analysis, thus rendering its positive outcomes wasted. Likewise, the failed recruitment and changes to the exclusion criteria of the nocturnal study leave us without any direct conclusions from the FHN nocturnal arm. After ten years of a deadly delay, the FHN has not lived up to its promise and the American nephrology community remains unconvinced. At this point, I am not sure that CMS or the American academic nephrology community will ever be convinced. Instead, it will be the market place and patient demand that turn the tide on the economics of daily dialysis that will lead to a rebound of optimal therapy.

Hopefully, the American nephrologist will return to the patient and ask the simple questions that Dr. Scribner and his colleagues asked? How do you feel? Can you work? Have we restored your life? Until those simple questions once again become the measure of adequacy, the mental masturbation of making the nephrologist feel good about the patient's Kt/V while the patients life paradoxically slips away may one day come to an end. We can only hope that we avoid any further deadly delays.

Slides courtesy of Dr. Carl Kjellstrand.

Cognitive Impairment on Dialysis: The Microbubble Connection

By Peter Laird, MD

Hemodialysis has been the mainstay of renal replacement treatments since the early 1960's and when given in high enough dosage by increased frequency, duration or a combination of both factors, it can not only save lives, but restore lives as well. However, there are still many complications of hemodialysis that have not been studied or addressed adequately even after fifty years with millions of patients treated. Cognitive impairment is a well described complication seen in hemodialysis patients with little known on its causes. A recent study in 2010 sheds new light on a potential cause.

Microemboli, developed during haemodialysis, pass the lung barrier and may cause ischaemic lesions in organs such as the brain

In conclusion, this data shows that the infusing and returning of fluid from HD devices to the patient contains air microbubbles that enter the patient without triggering an alarm. The small emboli pass t he lung and may cause ischaemic lesions in organs supported by the arterial circuit, such as the brain. In addition to patients with HD, the problem should also be considered in patients who receive frequent infusions, especially if the infusion speed and viscosity are higher, as is the case with albumin and dextran infusions, and blood transfusions. 

Despite the knowledge since 1975 that microbubbles shower the patient throughout the session, little if any research has accomplished reduction in this complication despite several reviews describing the dangers to patients:

Pathophysiology and clinical implications of microbubbles during hemodialysis

Microbubbles have been detected in the human circulation of end-stage renal disease patients who are treated by hemodialysis throughout the past decade as a result of advanced ultrasound and Doppler technology. These detection tools uncovered signals of microbubbles, which originate in extracorporeal lines and tubing of hemodialysis machine, circulate in the blood stream until lodging in the capillary bed of various organs, mainly the lungs. During its course within the capillary, a bubble abrades the glycocalyx layer lining the surface of the vessels and thereafter obstructs blood flow through the capillary. This causes tissue ischemia, inflammatory response, and complement activation. Aggregation of platelets and clot formation occurs as well, leading to further obstruction of the microcirculation and subsequent tissue damage. In this review, we describe the biological and clinical effects of microbubbles during hemodialysis and discuss management with regard to prevention and treatment.

Patients on PD and those who have had transplants have less cognitive dysfunction than those on hemodialysis. Studies have shown reduced microbble during priming can eliminate as much as 75% of microbubbles during dialysis, but to date, the dialysis industry has failed to address this important iatrogenic complication of hemodialysis. I suspect that the technical solution to eliminating microbubbles from the venous return to the patient is not only feasible but also financially viable. Several prototype devices are known, but none to date utilized clinically.

After enjoying the financial benefits of hemodialysis for over fifty years, it is time for the nephrology community to earnestly update and improve this life saving technology that still suffers from many of the technical limitations it had when first developed. Certainly hollow fiber artificial kidneys, improved membranes and many other advances do yield reduced complications, but failing to address such an important element of hemodialysis care for nearly forty years is one of many areas of continued concern for this field. It is time for nephrology to perfect their most noted medical procedure with the same concerted efforts that their colleagues in other medical fields continue to excell. It is time to bring hemodialysis into the 21st century and realize its full potential instead of relying on the basic elements of the 1960's era technology.

Emerging DOPPS Dialysis Trends in America

By Peter Laird, MD

DOPPS conducted an online webinar sponsored through the Nephrology News and Issues outlining recent trends in clinical outcomes in dialysis practices. Rising hospitalization rates may signal the beginning of complications since the implementation of the ESRD Bundle a year ago, but it is too early to make definite predictions of how the Bundle is affecting patient care. One area of concern is the trend in raising blood flow rates which helps providers increase clearance while on dialysis, but this remains one area in dialysis that has little if any reliable studies on the effects of high dialysis blood flow rates on fistula complications as well as other cardiovascular events. 

Some hypothesize that elevated blood flow rates place significant stress on the vascular access and may be a cause of stenosis from turbulent blood flow. Performing a medical literature search on this issue currently is an exercise of futility trying to find any useful information. Elevated blood flow rates remain an unstudied outcome in the dialysis arena.

Yet today, with the emphasis on meeting clearances as measured by Kt/V and URR is clearly pushing the limits on blood flow rates. Perhaps one day, this procedure now fifty years old will have basic information on optimal blood flow rates as well as the much debated optimal dialysis schedules. I am quite surprised that I cannot easily find even a retrospective analysis on blood flow rates and access complications as well as potential cardiovascular compromise given the high percentage of dialysis patients with LVH. Basic physiology such as the degree of ischemic changes incurred if any with elevating blood flow rates is absent from the literature.

I would suggest that if we are going to make significant changes in dialysis practices as the result of meeting the QIP indicators, then basic research needs to be a part of this brave new experiment beginning with a simple retrospective analysis of patients at high and low blood flow rates to see if there are any associated complications. I would hope that these simple questions would be answered soon.  In the meantime, I believe the approach utilized in extended daily hemodialysis with lowered blood flow rates is the most prudent approach. Sadly, patients dialyzing at conventional in-center dialysis clinics will continue to see high blood flow rates as an emerging trend. I hope and pray that this will not induce a new set of dialysis complications. Time will tell.