HemoDoc, From Doctor to Patient

NxStage Aluminum Contamination: Is Rockwell Medical Inc. at Fault?

By Peter Laird, MD

On May 14, 2014, NxStage Medical Inc. issued a voluntary FDA recall of 140,000 to 150,000 concentrated dialysate SAKs from elevated levels of Aluminum in lots manufactured from April 2013 to February 2014. NxStage produces the only FDA approved portable home dialysis machine and is a popular choice for many patients who wish to maintain an active and independent lifestyle.

To date, NxStage has not revealed details on how this significant failure occurred. I recently discussed the aluminum event with a high ranking NxStage officer who stated that they are constrained by FDA regulatory provisions that prohibit full disclosure until the FDA investigation is complete.

NxStage outsources all of their lactated dialysate products to two companies, PiSA, the largest pharmaceutical group in Mexico and Rockwell Medical Inc. which signed an agreement with NxStage on March 8, 2013 to produce concentrated dialysate. Shortly after this agreement, the first contaminated lots of concentrated dialysate contaminated with high levels of aluminum appeared in April 2013. Many patients allege that Rockwell new to the NxStage lactated dialysate manufacturing process is the likely source of the contaminated concentrates.

Rockwell Medical Inc. produces mainly bicarbonate dialysate in competition with Fresenius dialysis products for the American dialysis market. Incorporated in 1995, my review of  Rockwell public records reveals that this company has limited experience with lactate dialysis products which are produced in a  complex process through fermentation.

The largest producer of lactate products in the world is Purac which has exceptionally low tolerances for aluminum and heavy metals. Purac manufactures pharmaceutical grade lactate with a max tolerance of 0.1 ppm (0.11 mcg/L) and is considered the gold standard producer of lactate products through out the entire world. In an extensive review of NxStage, Rockwell and PiSA public records, none of these documents listed the source of their lactate products, nor could I find direct agreements in public records with Purac. In addition, Rockwell has not responded to date to my queries for comments on this event.

While NxStage will not confirm that Rockwell is the producer of the tainted product, circumstantial evidence points directly to Rockwell as the source. 

Should the FDA investigation conclude that Rockwell Medical is the source of the NxStage Aluminum contamination, investor relations may suffer in light of what many consider a solid future for this company nearing completion of a New Drug Application for their iron dialysate product, Triferic.  It would also mark continued safety and quality concerns that has haunted Rockwell over the last several years.

In 2008,  state inspectors at a South Carolina Rockwell plant found major safety and manufacturing violations in follow up to multiple customer complaints. (here) In 2009, thousands of cases of shipped dialysate was recalled after finding excessive levels of bacterial growth. (here and here)

In 2012, Dr. Richard Yocum,  a former Rockwell senior vice president in charge of Rockwell's Triferic research alleged SEC reporting violations and fraudulant claims for their drug in development in a wrongful termination lawsuit. (here)  Triferic is expected to soon enter an annual 700 million market for iron replacement. Although Rockwell prevailed in this lawsuit, the judge limited his ruling to the narrow question of whether Rockwell had the right to terminate Dr. Yocum's "at will" employment. (here) A private law firm initiated a secondary investigation into these allegations in 2013. (here) 

With the ready availability of high grade, ultra-pure lactate products from Purac with levels at a fraction of those found in the NxStage lactate concentrated dialysate, the ensuing FDA investigation needs to uncover all of the details of this preventable event. However, should Rockwell Medical Inc. become the focus of this active FDA investigation, many will rightly, I believe, question their dedication to quality products.

In light of the impending FDA approval of Triferic after exhuberant results in their recent PRIME study, I myself will take the advice of a trusted colleague who once told me, don't be the first doctor to prescribe a new drug, nor the last. Until we have extensive evidence from Triferic's post marketing results assuming it will soon be approved, I certainly will not be one of the first patients seeking this companies new drugs.

CMS and Home Hemodialysis: The Story of 40 Years of Neglect

By Peter Laird, MD

The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering.  The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.

End Stage Renal Disease Program

In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973. 

At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home. 

On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients  were on home dialysis including 59 PD patients at home.

The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program. 

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.

The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.

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

R.A. Rettig (pages 132-133)

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

But the political damage had been done. 

Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.

NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD  - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD  patient was at least $4000.

The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)

Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.

This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere  and at some time one who can make a difference inside our government will.

Home Hemodialysis Competency is Lacking in American Nephrology Training Programs

By Peter Laird, MD

Home hemodialysis was at the forefront of bringing into account hemodialysis modality as an accepted medical procedure in the early 1960's. The financial constraints of chronic hemodialysis especially in-center were beyond the resources of most institutions shortly after Belding Scribner, MD revolutionized the treatment of chronic renal failure with the "Scribner" Shunt. By the time that the 1973 ESRD program provided financial relief for all eligible US patients with renal failure, nearly half of the patients treated at that time dialyzed in the comfort of the their own home. Sadly, far too many new nephrology graduates have forgotten these lessons from the history of dialysis.

In a recent CJASN publication written by Jeffrey Berns, MD, the editor of the Medscape nephrology news section, notes that 65% of recent nephrology graduates lacked competent training in managing home hemodialysis patients. Only 15% of these fellows surveyed felt competent to manage home hemodialysis pateints:

A Survey-Based Evaluation of Self-Perceived Competency after Nephrology Fellowship Training

Areas in which more than 25% of fellows during their second or later year of training answered “No” included cystic kidney diseases (50.1%), plasmapheresis (60.1%), renal US (51.8%), PD (36.5%), home HD (65.0%), arte- riovenous access management (34.4%), nephrolithiasis (34.7%), geriatrics (25.2%), and palliative care (37.4.%) (M. Rosner, personal communication). Thus, several of the areas cited by respondents to the survey reported here as not providing adequate training were similarly cited by fellows still in training, emphasizing the need to address these areas of training.

I had an  interesting encounter with an expert in transplant nephrology when I had an iron infusion at Kaiser Sunset in Los Angeles last year. While rounding  during the hemodialysis session, I asked him if he was familiar with Pauly's study on nocturnal hemodialysis outcomes vs. transplant finding comparable outcomes in mortality. (here) This nephrologist who had just completed a prestigious transplant nephrology training program at Cedar-Sinai and was able to advocate credibly for transplantation but he was not able to discern how daily nocturnal dialysis faired against his preferred renal replacement modality. If a transplant nephrologist from such a well respected institution cannot truly give informed consent on transplant vs nocturnal hemodialsyis even as a bridge to transplant, how then shall we expect the average training program to rise to a level of proficiency in home hemodialysis modalities?

The true repository of home hemodialysis knowledge is not found in the majority of nephrology programs in this nation but it instead resides within the collective patient advocacy sites and foreign nephrology programs much more so than the average nephrology program in the United States.  Dr. John Agar has long advocated for home hemodialysis utilization as a first choice for the majority of patients new to dialysis. Many patients in Australian nephrology practices dialyze in the comfort of their homes and have much better outcomes than those in conventional in-center treatment centers.

The fact that most American nephrologists are ignorant of the history of dialysis nor do they have a concerted interest in this modality does not bode well for the future of improving American dialysis outcomes.  The grave of Belding Scribner who freely gave of his invention to save lives haunts the halls of all of these nephrology programs that find it incredulous that the majority of patients dialyzed at home in the 1960's with primitive equipment by today's standards.

The truth remains that there is a major generational gap between the pioneers of dialysis and the current graduates who view dialysis as a futile and unworthy treatment option for the majority of patients when in fact if employed in a quotidian fashion with increased frequency and duration can and does offer a return of useful life.

Perhaps some day, Scribner's dream of an informed and enthusiastic acceptance of this "noble experiment" will come to pass in America despite the fact that one of the greatest medical technologies remains in the hands of a profession truly unworthy of how well they could but don't use this modern medical miracle. Perhaps someday, restoration of whole individuals will be commonplace instead of the unusal oddity when it comes to dialysis.  That day is one nephrology progam at a time away from acceptance even in the best institutions. Perhaps someday. We can only hope.

 

The DaVita Difference: The Billing King

By Peter Laird, MD

Each month, Kaiser sends an explanation of benefits for my dialysis services. I see my dialysis team once a month, I do all of my inventory ordering, I perform all of my own medical treatments and I draw my own labs. My wife often wonders why she doesn't get paid to be my assistant since "we do all of the work." Her question is even more pointed when we saw the bill to Kaiser for August 2012 in the amount of $72,490.40.

In Australia and other nations, patients are given financial incentives to perform dialysis at home since it saves the health system tens of thousands of dollars every year. I am sure that is a non-starter politically here in America, but where can a dialysis provider supervising home hemodialysis patients only on a monthly basis have the audacity to generate such an outrageous bill? Indeed, my entire annual cost of dialysis and related medical costs is well below $72,000 each year.

At the same time, DaVita denies me enough supplies to last that one month period with one box of masks, 50 in each, which is less than needed for both my wife and I. One box of alcohol pads likewise fails to cover my monthly needs.  They further provide my dialysis needles on a one month basis compromising their integrity since they are not shipped in their original packaging of a box of 100. Did they use gloves and wash their hands before they placed them in a cardboard box not intended for this purpose and then shipped it to me through the mail system? Does this compromise my clean supply table every day as I attend my dialysis set up diligently in accordance to rules of sanitation?

Needless to say, Kaiser does not pay that bill in entirety due to contractual agreement. Yet for some health care providers, they do not have the ability to deny all of these claims which would total over $800,000.00 for a year of home hemodialysis treatment. With Kent Thiry publicly stating in a recent presentation that the business of DaVita is not about the patients, their greed and profiteering is evident each and every month when I obtain my explanation of benefits.

I understand that it is not about the patient each and every day that I fax my daily dialysis flow sheet so that the nurses at my unit can enter it into the DaVita billing system. Yes, DaVita is the king of dialysis billing. My impression of their entire system is that it is geared to billing much more so than to patient care. After all, Kent is right, it is not about the patient. That is the DaVita difference.

The FHN Raises it's Ugly Head One More Time

By Peter Laird, MD

The FHN daily and nocturnal studies were conducted by researchers who have exhibited contempt and disdain in earlier writings against frequent hemodialysis protocols. Certainly the writings of the lead investigator, Glen Chertow, give one pause. His key note address at the Annual Dialysis Conference shortly after the publication of the daily FHN results could hardly be called heartfelt endorsement of more frequent hemodialysis even though his study did show significant benefits.

Since the publication of the failed FHN nocturnal study that only recruited approximately one third of the expected patients, the continued negative rhetoric from the FHN trial group authors is baseless and lacks intellectual evaluation of their own study. This provides further evidence of their innate bias against this technology that does have a proven clinical track record for improving lives, focusing benefits of cardiovascular preservation and significantly improved patients activities of daily living. Any patient that has endured conventional in-center hemodialysis and then converted to daily nocturnal hemodialysis will so attest.

The latest assault against frequent hemodialysis sadly comes once again from one of the principle authors of the FHN nocturnal study, Yoshio Hall, MD.

Value of Frequent Dialysis for Physical Health Questioned: An Interview With Yoshio Hall, MD

The Frequent Hemodialysis Network Trial Group recently found that compared with conventional in-center hemodialysis (HD) that is performed three times a week, frequent in-center HD (6 times a week) improved self-reported physical health and functioning for patients with end-stage renal disease (ESRD) but had no significant effect on objective physical performance, according to a report in the Clinical Journal of the American Society of Nephrology 2012;7:782-794).

Frequent nocturnal dialysis, for its part, showed no significant effects on any of these physical metrics. Nephrologist and study coauthor Yoshio Hall, MD, Assistant Professor of Medicine at the University of Washington, Seattle, discusses his team's findings with Renal & Urology News.

Were you Surprised and/or diasppointed by these findings?

Dr. Hall:  We hypothesized that increasing the frequency of hemodialysis might further improve overall physical capacity through perhaps better control of uremia, preservation of nutritional status and muscle mass, correction of acid-base imbalances, and reduction of interdialytic weight gain and volume overload.

If the above description of why the investigators hypothesized frequent hemodialysis, especially noctural daily hemodialysis would improve physical function was the operative theory leading to the flawed design of the FHN nocturnal study, then I must question their understanding of the proposed benefits of nocturnal dialysis from the confluence of observational studies over several decades. The greatest detriment to chronic hemodialysis patients physical function is from cardiovascular disease, especially LVH leading to poor fluid control and CHF. What Dr. Hall did not mention in his negative diatribe against frequent dialysis is that reduction in LVH was an important finding of the short daily FHN trial.

In-Center Hemodialysis Six Times per Week versus Three Times per Week

Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access.

The FHN nocturnal study is a failed study that should not be the basis for questioning the value of daily nocturnal hemodialysis. The FHN nocturnal study unexpectedly failed to show any benefit in the composite outcomes measured. When evaluating this surprising finding, one must keep in mind that the FHN nocturnal study has several disabling flaws, not the least of which was their well-publicized difficulty in recruiting patients.  Recruitment only improved when patients were offered two different forms of home hemodialysis instead of baseline comparison to conventional in-center hemodialysis.

Despite the fact that many American dialysis researcher’s believe that there is still a need to carry out a randomized control trial of nocturnal dialysis vs. conventional in-center dialysis, the majority of patients offered participation in the FHN nocturnal trial declined because they desired nocturnal home hemodialysis (NHHD) and refused randomization.  In addition, we have over forty years of well done observational studies which are all in agreement of the benefits of NHHD.  Nevertheless, researchers noted that failing to eliminate selection bias could explain the positive outcomes, thus justifying the call for further study.

Aside from recruiting only 87 of the needed 275 patients randomized to this trial, several other factors limit the ability to utilize any meaningful results. Of those randomized, nearly 50% of these patients were "incident" patients without LVH, limiting the possibility of "regression" of left ventricular mass by nocturnal hemodialysis in such a short study period. In addition, of those randomized to the nocturnal arm only 87% completed the 12 months study period and nearly 25% of those that did participate in the nocturnal arm failed to adhere to the five times a week nocturnal schedule demonstrating a surprising degree of noncompliance.

Studying subjects who were much younger and healthier at baseline looking for LVH regression is an exercise in absurdity. Unfortunately, many may use this failed study as a basis for excluding nocturnal dialysis treatment availability by calling it negative when it is null and void because it is underpowered, over selected and seriously flawed.

There is no reason to doubt the benefits of NHHD even with this publication. Despite the lack of a significant finding in this trial, the result is not because of a treatment failure, but instead due to severe flaws within the study itself, some of which I have noted above.  There truly is no need for further studies before offering NHHD to more American patients.  The biggest failure of the FHN nocturnal study is that they called for it in the first place. We have wasted nearly ten years waiting for this study to only find disappointment in its serious shortcomings. Many opposed this study from the outset, they were right then, they are right today. It is time to proceed with our best evidence, even if much of it is observational.

I am greatly sadened that such a respected researcher from of all places, the University of Washington in Seattle where Scribner lead the charge promoting longer and more frequent hemodialysis would venture such an unsupported opinion from such a failed RCT. It appears that any result that comes from a randomized and controlled trial must be accepted as gospel truth even though there are fatal errors in execution and design of this study. 

I believe the lack of a cogent hypothesis may be the root cause of researchers such as Dr. Hall making absurd recommendations against more frequent hemodialysis. We know and understand that short, infrequent hemodialysis results in serious cardiovascular decline and poor fluid management over a period of years on convention in-center hemodialysis. How can a researcher expect to find differences among 87 patients who have a significantly lower mortality to start than the standard USRDS population, higher residual urine function than the original FHN nocturnal protocol specified, higher levels of incident dialysis and less vintage patients who would have had the opportunity to develop LVH and cardiovascular compromise in the first place.

Understanding the demographics of the study population of the FHN nocturnal study, it is not surprising at all that there were no significant differences in LVH and physical activity scores in the study subjects. After all, these were healthier than normal patients at the onset of the study without enough time on dialysis to develop the types of cardiovascular morbidity and pathology that nocturnal dialysis best prevents. Perhaps one day, a major medical journal will publish a McMaster type review of the FHN nocturnal study so that the nephrology community can place this study in it's proper place as a failed and poorly executed randomized and controlled trial that did not meet its set goals or standards. Until that time, it appears that we will be subject to more and more negative diatribes from the FHN authors. I find that a sad use of millions of dollars and patients lives.

Touch Cannulation: The Genius of Stuart Mott

By Peter Laird, MD

Many aspects of dialysis care that is beneficial for patients came about by serendipitous application of chance observations. The buttonhole technique came into practice when Dr. Twardowski had little option on some patients with only short areas on fistulas for cannulation. He began using a single site cannulation that developed scar tissue and a track. In the days before highly available access to disposable needles was the rule, multiple reuse of needles created dull points. After successfully establishing buttonhole or constant site cannulation, the observation that new sharp needles caused more difficulties than the old dull needles when accessing established buttonholes.

The battle between the use of sharp and dull needles became part of the usual difficulties associated with buttonhole cannulation. I have now utilized this proven technique for nearly five years. In that time, I have been able to establish reliable tracks that worked well for weeks or months, but inevitably, I would have to every once in a while use a sharp needle even on the best buttonholes. Over the last six months, my arterial site needed more frequent cannulation with sharps.

I had heard of "Touch Cannnulation" in the last two years, but had done well learning how to place my dull buttonhole needles following the same exact angle each time. Initially, I had no reason to try to refine my technique any further, it  had worked well the overwhelming percentage of attempts. The last few months changed my attitude and I reconsidered the Touch Cannulation method when I needed to use sharp needles more and more frequently. I was skeptical it would work but decided to try it out of frustration of frequent sharps cannulations. (Please review the detailed directions by Stuart Mott on how to perform Touch Cannulation in the link above.)

To my greatest surprise, not only did holding the tubing behind the "wings" of the dialysis needle work but it worked well.  I have now been using Stuart Motts' Touch Cannulation for over three weeks and the method has worked each and every time. All it takes is to place your thumb and index finger behind the wings on the tubing and line up the right angles and then let the needle find its own path. For those of us who are parents, there may be an object lesson for us to learn as well about guiding but letting them when at the right age seek their own ways in life.

My skepticism has now come full circle to enthusiastic support of this little known method. Stuart Mott continues to be the most sought after expert on cannulation and with good reason. I wish to personally thank Stuart for helping me overcome one of my own difficulties that added to the stress and discomfort of dialysis. My wife also appreciates the ease of cannulation and being able to avoid sharp needles once you have an established buttonhole track.

This may also prove to be one of the solutions to the difficult problems of utilizing buttonhole cannulation in an in-center dialysis unit where multiple techs over time will cannulate the patient. Many units disparage the buttonhole method becuase it is operator dependent. I suspect that if the Touch Cannulation method were applied widely, the disparity between different cannulators may disappear if everyone involved learns how to let the needle find its own way. Witht  the Touch Cannulation method, that is exactly what the needle does each and every time. The only complaint I have is that I did not try it sooner.

Dialyzing at Home Alone: Is There Not a Cause?

By Peter Laird, MD

Dialysis in America is different than the other developed nations. The focus in America is very much industry centric instead of patient centric. One of the most profound examples of the differences between dialysis in the United States and other developed nations is the nearly universal prohibition against patients dialyzing at home alone. Canada, England and Australia not only allow patients to dialyze at home alone, the entire focus in those nations is on self care as a responsibility of the patient and not the care takers.  There are many barriers to dialyzing at home alone including companies such as NxStage which included the provision of a care partner in their FDA approval as well as dialysis providers. Some States also prohibit dialyzing at home alone.

Physicians bear the brunt of the responsibility in ensuring safe dialysis practice. From my own experience, the overwhelming impression among my colleagues in internal medicine is that dialysis is a dangerous procedure. Certainly, it is an invasive procedure but I believe the instinctive reaction of most physicians including nephrologists comes from the iatrogenic complications seen daily in dialysis units where patients routinely collapse from rapid volume depletion due to excessive ultrafiltration rates. The stable dialysis patient is a foreign consideration in most dialysis units. The reaction of most providers when discussing dialyzing home alone is as astonishing as Macaulay Culkin's iconic realization he was home alone.

When I first started dialysis, I was surprised that I survived each treatment when I considered my own professional bias against dialysis learned in the intensive care units where more than one dialysis patient "crashed." As I learned more about optimal dialysis and applied that knowledge to my own treatments, I slowly realized that the philosophical approach and application of treatment is the most important stabilizing factor. In five years of dialysis, I have never once vomited, passed out or even become lightheaded except for the one time that my dialysis technician set my ultrafiltration for 5000 ml instead of 500 ml. After 2.3 liters, I began to be nauseous and lightheaded. Two liters of normal saline reversed that medical error.

Bill Peckham recently celebrated ten years of home hemodialysis, nine of which have been self dialyzing home alone. The benefits of home dialysis far outweigh any associated risks especially when compared to the risks of standard care. In the time Bill has been dialyzing self sufficiently, he has accomplished more than many people accomplish with intact kidneys. This is a picture of Bill dialyzing on board his boat that he captained north of Seattle.  For the average nephrologist practicing in America, Bill would be a nightmare of medical legal risk in their skewed views of the usual dialysis patient. Living a life well is a goal all of us have.  Adding the burden of renal disease makes this endeavor a daily struggle, but the example that Bill has set for the entire renal community should not go unnoticed. I must confess that the idea of strapping a generator and a dialysis machine to an inflatable white water raft going down the Rogue River is not my idea of a self care dialysis unit. But the truth is that this is not only possible, but it is safe. In fact, dialyzing on terra firma with a generator in many ways is much safer than floating down a wild river on a piece of rubberized plastic. (here)

 

With the resurgence of home hemodialysis after decades of suboptimal dialysis care languishing in for-profit dialysis units, the plight of those who are capable of self care yet are hindered by arbitrary standards requiring a care partner is a cause worth fighting. It is time to evaluate the stable dialysis patient and note that life itself is not risk free, but it is worth living well. For patients on dialysis, living well in many ways means taking charge of your own care at home. As the market place opens the door to thousands of new home hemodialysis patients, the American dialysis industry needs to grow with their patients as they overcome their own fears and anxiety inherent in doing self care. The last issue a patient needs in this circumstance is physicians and providers more concerned about their own anxiety over dialysis. The reality is that dialysis can be safe and stable even when dialyzing home alone not only in Canada, England or Australia, but right here in the United States as well.

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.

NxStage, Bringing Dialysis Home - Thank you

By Peter Laird, MD

In the 1970's prior to the advent of the ESRD program in 1973, the majority of patients on dialysis, dialyzed at home 6-8 hours thrice weekly and enjoyed excellent rehabilitation and better survival than the current morbidity and mortality of conventional in-center dialysis today. Unfortunately, the Congressional mandate adversely impacted reimbursement for home hemodialysis and with other factors, home hemodialysis soon became a forgotten entity that many today now wrongly call experimental and unproven.

Dr. Scribner spent the last three decades of his life working to educate the public and his nephrology colleagues about the virtues of daily, home hemodialysis and went to his grave disgraced by the profession that he himself embraced and freely gave his inventions to save lives. Thankfully, history is kind to such men as Dr. Scribner who out of love for the lives of his fellow men freely gave not only of himself, but sought that others would likewise seek the betterment of those suffering with renal disease. In an industry now dominated by individual and corporate greed, his memory continues to point the way to a better dialysis treatment.

In the 1990's, renewed interest in home hemodialysis came into effect with our neighbor to the north and today, Canada is a leading advocate of more directed home hemodialysis therapy. However, innovations in dialysis machines hampered the growth of the home hemodialysis market, until NxStage entered with little hope of taking on the corporate dialysis giants with their tiny machine in comparison to the huge immovable home devices still promoted today by these companies. Yet, during the last decade, NxStage has bridged the gap that others have attempted and failed to captivate.

For anyone that has had the opportunity to dialyze for any length of time in a conventional dialysis unit and then bring their treatments home with the NxStage machine, I am sure all are grateful for the opportunity to do so provided by this supportive and innovative company. The testimony of so many patients is that NxStage gave them their life back. I second that testimony and only wish to say, thank you.

Has Anybody Here, Seen my Old Friend Allient? Can you Tell me Where he's Gone?

By Peter Laird, MD

In June of 2006, Renal Solutions achieved FDA approval of their new sorbent dialysis machine that uses potable tap water to generate dialysate. The REDY system came out of the NASA space program that regenerated potable drinking water from the astronauts urine. Clinical applications of this process resulted in the REDY system which many early dialysis patients used successfully for temporary travel. Renal Solutions redeveloped this process with new and updated technology ready for the market by the end of 2005. However, we are still waiting the first patient use of this new technology today.

Renal Solutions Ready for Commercial Sales

August 9, 2005

With preliminary FDA approval in hand, the Pittsburgh Business Times reports that Renal Solutions is set to receive the first of its portable kidney dialysis system this week to begin testing to ensure they were built to the company's specifications. Insitutional sales to nursing homes and hospitals will begin over the next several months. Sales to the home user market will wait until further trials are run and final FDA approval is granted. The Company expects final approval for sale to home users early in 2006.

Xcorporeal developed another sorbent based innovative dialysis machine that expected to market their product by 2009 opening the door to even more patients having access to home hemodialysis. Now, in 2012, neither Renal Solutions or Xcorporeal have been seen by any home dialysis patients to date.

New Machine Makes Home-Based Dialysis a Reality for Millions of Patients Worldwide

LOS ANGELES--(BUSINESS WIRE)--Xcorporeal, Inc. (AMEX:XCR) announced today the XCR-6 Dialysis Platform for self-directed kidney hemodialysis. The XCR-6 will be the smallest, lightest, and easiest to use dialysis machine ever conceived, using Xcorporeal’s proprietary closed loop, regenerated dialysate technology platform. The Company is currently preparing for unattended/home use clinical trials of the XCR-6 in anticipation of commercialization in the near future.

Xcorporeal's Wearable Artificial Kidney Prototype Device Featured in Los Angeles Times Article

For the RRT market, Xcorporeal is developing a portable, multifunctional renal replacement device that will offer cost effective therapy for those patients suffering from Acute Renal Failure (ARF) which causes a rapid decline in kidney function. In the U.S., the disease affects more than 200,000 patients annually, with a mortality rate of 50%. The Xcorporeal platform technology is a natural fit for the hospital market of renal replacement therapy since the technology is designed to provide cost-effective, continuous therapy without the need for expensive replacement fluids. The projected 2007 market opportunity for the U.S. is approximately $1.4 billion. The disposable market is expected to grow at 10% per year. The devices typically need to be replaced every five years. The Company intends to commercialize this device during the first half of 2009.

Where have these machines all gone? The answer is apparent when we realize that a corporate giant bought both of these companies several years ago with the alleged hope that the infusion of capital would promote more rapid development of this new technology, yet today, we are still waiting for any sign of progress. The corporation now holding the patents to these innovative machines is Fresenius Medical Care, the largest manufacturer of dialysis machines in the world.

Fresenius Medical Care acquire techology to advance home hemodialysis and create a platform for development of a wearable kidney

Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care commented, “The acquisition of RSI is an important step to advance the technology required for strong future growth in this field. The combination offers us the long-term opportunity to extend our leadership to home and acute dialysis products. Furthermore, by combining our equipment and membrane technology with the SORB technology, we can provide innovative solutions in the future such as a possible wearable kidney. With this acquisition, Fresenius Medical Care expects to increase its annual R&D spending by approximately $10 million starting in 2008. Our mid-term financial targets for the years 2007 through 2010 remain unchanged.”

Fresenius Buys Xcorporeal for $8 million

LOS ANGELES—Fresenius has agreed to purchase Xcorporeal Inc., which is developing a wearable artificial kidney, for $8 million.

Xcorporeal is a medical device company developing an extra-corporeal platform technology to be used in devices to replace the function of various human organs. The platform includes three initial products: a Portable Artificial Kidney (PAK) for hospital-based renal replacement therapy, the XCR-6 for home hemodialysis, and a Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis.

Month after month, year after year, the machines that had FDA approval for clinical use in 2006 still continue in shrouded mystery as to when they will actually be released. Several experts state that the technology is an improvement and a solution to many in need of home dialysis options here in the US and around the world. The fruits of the NASA space program lie dormant to date for the hope of the future of dialysis hidden within the confines of the secretive bureaucracy of the largest dialysis organization in America. The jury is still out on whether FMC bought these companies to expand home dialysis options or instead to stifle competition with their own dialysis oligarchy. The only proof of the former will be the actual release of sorbent technology for clinical testing and rapid penetration of the home dialysis market. Until then, all we can ask is where have they gone for we know that the good, they die young.