HemoDoc, From Doctor to Patient

Confessions of a Nephrologist: Is Withholding Information Part of the Art of Medicine?

By Peter Laird, MD

As a practicing internal medicine specialist, applying the legal requirement of informed consent at times appeared to be an act of absurdity with many common ailments. I clearly documented and performed the legally required informed consent many times over for treatments as mundane as ear infections and other illnesses that often times are self limited and would resolve without any treatment at all rendered. Comfort of the patient at times became the motivating force behind these treatments. For myself and my colleagues, the complaint of negligent care by tort law most often came in the failure of proper informed consent or lack of informed consent. The legal basis of informed consent is summarized well in an essay on this subject:

An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a "Standard" of Disclosure

The prototypical informed consent case arises when a patient suffers an injurious, nonnegligently-caused outcome of a diagnostic or therapeutic medical procedure.20 An outcome that is nonnegligently caused is one which arises in a certain percentage of cases regardless of the care of the physician, due to physiological differences from the norm or particular susceptibilities of a patient, or one that arises from an act or failure to act of the physician but such act or failure to act is within the standard of care.21 In order to recover damages for that outcome, the plaintiff must establish the elements of negligence, that: (1) the physician had a duty to disclose particular information to the patient; (2) disclosure did not occur; (3) (a) but for the nondisclosure, the tendered procedure would have been refused, and (b) that the tendered procedure was the cause in fact of plaintiff's injury; and (4) the plaintiff suffered a compensable injury.22

The legal requirement is that all medical treatments must be understood and accepted by the patient or the legal guardian and consent to each medical intervention. The risks, benefits and alternative treatments must be explained and in addition, the physician must ascertain that the patient understood these issues. I have read and heard my colleagues in the various specialties spell out very specific risks and benefits that were then duly documented in the medical record, many in precise and at times graphic detail. Many surgical specialists have gone so far as to video tape standardized informed consents for routine procedures such as elective hip replacements and having the patient attend pre-surgical patient education classes. In these classes, all conceivable outcomes and expectations are listed with documentation of pertinent studies when indicated.

Since entering the world of American style dialysis, the first culture shock I encountered was the number of decisions made by the medical team with little clear and precise informed consent such as sodium modeling or ultrafiltration rates for instance. Because the legal standard for informed consent is a community standard, all that a nephrologist must do to meet that requirement is to do what the average nephrologist would discuss and advise. Sadly, the record for the American nephrology community is greatly lacking compared to all other informed consent procedures I have encountered in my professional life as a physician. Several surveys have documented this unique American nephrology failing:

Patient education and access of ESRD patients to renal replacement therapies beyond in-center hemodialysis

RESULTS: Substantial proportions of patients were unaware of their kidney disease (36%) or were not seeing a nephrologist (36%) until <4 months before first dialysis. The presentation of treatment options was delayed (48% either after or < 1 month before the first dialysis). The majority of ESRD patients were not presented with chronic peritoneal dialysis, home hemodialysis, or renal transplantation as options (66%, 88%, and 74%, respectively). Using multivariate analyses, variables significantly associated with selection of chronic peritoneal dialysis as dialysis modality were the probability of chronic peritoneal dialysis being presented as a treatment option and the time spent on patient education.

CONCLUSION: An incomplete presentation of treatment options is an important reason for under-utilization of home dialysis therapies and probably delays access to transplantation. Improvements in and reimbursement for pre-ESRD education could provide an equal and timely access for all medically suitable patients to various RRTs.

Many patients falsely enter into the dialysis unit believing that conventional in-center dialysis will restore and extend their lives significantly. In my opinion, the American nephrologist fails miserably in the standards of informed consent that I practiced and observed in all aspects of my medical career. Similar studies subsequent to Mehotra's study reveals no improvement in this situation. Sadly, one of the rare randomized and controlled dialysis trials is essentially ignored today despite a significant finding of increased self care dialysis choices for those with improved informed consent:

The impact of education on chronic kidney disease pateints' plans to initiate dialysis with self-care dialysis: a randomized trial

Methods Seventy patients with CKD who were receiving care in a multidisciplinary predialysis clinic were randomized to receive either (1) a two-phase patient-centered educational intervention (phase 1 included educational booklets and a 15-minute video on self-care dialysis; phase 2 included a 90-minute small group interactive educational session on self-care dialysis) in addition to their regular multidisciplinary care, or (2) ongoing standard care and education in the multidisciplinary predialysis clinic. The primary outcome was patients' intention to initiate dialysis with self-care dialysis, assessed by questionnaire.

Results Thirty-five patients were randomized to standard care; 34 completed the study. Thirty-five patients were randomized to the educational intervention; 30 completed phase 1 and 28 completed phase 2. By study end, significantly more patients in the intervention group (82.1%) intended to start dialysis with self-care dialysis compared with the standard care group (50%, P = 0.015). This difference persisted after controlling for the small baseline differences among patients in the two study groups (P = 0.004).

Conclusion A two-phase educational intervention can increase the proportion of patients who intend to initiate dialysis with self-care dialysis.

Despite the positive findings of a randomized and controlled trial increasing patients choice of self care dialysis and the dismal record the American nephrologist has accomplished in the area of informed consent, the intractable attitudes among nephrologists has not budged. I have wondered for several years now how this dichotomy between American nephrology and the other specialties is so diverse and uniformly ignored by this specialty.  I have been puzzled even more so is the complete lack of accountability for ignoring such a fundamental fiduciary physician responsibility with few if any consequences for this failure. After all, informed consent is required by law for dialysis patients:

§ 405.2138   Condition: Patients' rights and responsibilities.

The governing body of the ESRD facility adopts written policies regarding the rights and responsibilities of patients and, through the chief executive officer, is responsible for development of, and adherence to, procedures implementing such policies. These policies and procedures are made available to patients and any guardians, next of kin, sponsoring agency(ies), representative payees (selected pursuant to section 205(j) of the Social Security Act and subpart Q of 20 CFR part 404), and to the public. The staff of the facility is trained and involved in the execution of such policies and procedures. The patients' rights policies and procedures ensure at least the following:

(a) Standard: informed patients. All patients in the facility:

(1) Are fully informed of these rights and responsibilities, and of all rules and regulations governing patient conduct and responsibilities;

(2) Are fully informed of services available in the facility and of related charges including any charges for services not covered under title XVIII of the Social Security Act;

(3) Are fully informed by a physician of their medical condition unless medically contraindicated (as documented in their medical records);

(4) Are fully informed regarding the facility's reuse of dialysis supplies, including hemodialyzers. If printed materials such as brochures are utilized to describe a facility and its services, they must contain a statement with respect to reuse; and

(5) Are fully informed regarding their suitability for transplantation and home dialysis.

Once again, for each specialty, it is a community standard set by the specialists themselves of what an average nephrologist believes his patients need to hear. For the American nephrologist, CMS spells out in great detail what is required. It appears that there may be more philosophical barriers to true informed consent amongst the American nephrology community as evidenced by a posting by Dr. Ajay Singh on his The Kidney Doctor blog:

Dialysis Unplugged: Compassionate Withholding of Information, Damned if You Do, Damned if You Don't

I can tell you right off the bat that I do not routinely tell my patients starting dialysis that on average they have a 20% chance of dying in the first year of starting dialysis. Nor, for that matter, do I tell my 70 year stage 5 CKD patient, who I am preparing for  initiation of dialysis, that she or he has, on average, 2 to 3 years longevity of dialysis. Of course I want to be truthful to my dialysis patients, but averages are misleading, and ESRD is not a terminal disease. Moreover, two or three additional years of life aren’t something to ignore. . . 

Here’s where I disagree. Linda Emanuel is taking what is often a complex situation and simplifying it. Worse still, she is arguing that deliberate withholding of information is unethical.  Of course we all agree that we need to provide a realistic assessment of prognosis to our patient’s and their families. However, there is a fine line between “realistic assessment” and “scaring people”. This is where knowing the patient and their family and applying the Oslerian “the art of medicine” comes into play. Compassion is important (read this story to know why). For example, I don’t tell all my dialysis patient’s that their prognosis is worse than if they had some forms of cancer. It might be on average, but it is certainly not true for everyone. Dr. Paul Beeson once said: “Our profession, after all, deals partly with guess work; we do not deal in absolutes.”

I am frankly appalled at the open disregard by a prominent American nephrologist in not explaining the most basic aspect of ESRD, that of mortality with conventional in-center dialysis care to each and every competent patient. I find this completely at odds with my entire medical training and practice and that of my colleagues in high risk specialties where adverse outcomes are common.  The most important information that a patient and their family needs is exactly what sort of illness and outcomes they are dealing with at the onset of treatment. The issue of informed consent becomes even more apparent with the publication of intensive dialysis outcomes in JASN today showing significant survival benefits for these renal replacement therapy options. For patients that never hear of the grave risk of death from ESRD, what will motivate patients to seek treatment options that entail sacrifice and great personal effort to accomplish?

In my opinion, the slothful approach to informed consent amongst the American nephrology community is at great odds with many recent studies proving the benefits of alternative dialysis treatment options. If the American dialysis hegemony will ever end, it must first start with a paradigm shift in the attitudes of American nephrologists towards their patients and incorporate respect for patient autonomy into their daily practice much more so than is evident today. It is my opinion and that of available evidence based medical studies on informed consent in the American dialysis industry that change is needed.  It must begin one nephrologist at a time. After all, if the American nephrologist is too ashamed to relate mortality to dialysis patients, they may wish to consider modalities that improve this dismal result with each and every competent patient. After all, it is the law.

JASN Intensive Dialysis Series: More is Better

By Peter Laird, MD

JASN featured four new articles evaluating the clinical effects of intensive dialysis on mortality and other outcomes. Not surprisingly, each article showed positive effects of more intensive dialysis. The debate over more intensive dialysis continues to favor more being better. Interestingly, one of the studies evaluated thrice weekly in-center hemodialysis which is analogous to the work of Dr. Scribner where the majority of his patients dialyzed thrice weekly nocturnally at home.

Survival with Three-Times Weekly In-Center Nocturnal Versus Conventional Hemodialysis

Two-year mortality was 19% among nocturnal hemodialysis patients compared with 27% among conventional patients. Nocturnal hemodialysis associated with a 25% reduction in the risk for death after adjustment for age, body mass index, and dialysis vintage (hazard ratio=0.75, 95% confidence interval=0.61–0.91, P=0.004). With respect to clinical features, interdialytic weight gain, albumin, hemoglobin, dialysis dose, and calcium increased on nocturnal therapy, whereas postdialysis weight, predialysis systolic blood pressure, ultrafiltration rate, phosphorus, and white blood cell count declined (all P<0.001). In summary, notwithstanding the possibility of residual selection bias, conversion to treatment with nocturnal hemodialysis associates with favorable clinical features, laboratory biomarkers, and improved survival compared with propensity score–matched controls. The potential impact of extended treatment time on clinical outcomes while maintaining a three times per week hemodialysis schedule requires evaluation in future clinical trials.

The greatest survival advantage was found with more intensive dialysis greater than 5.5 hours, 3-7 times a week. In this retrospective study, mortality improved from 21% in the control group to 13%. The interesting aspect of this study is that the effectiveness of more intensive dialysis modalities was found throughout all subgroups:

Intensive Hemodialysis Associates with Improved Survival Compared with Conventional Hemodialysis

We matched 338 of these patients to 1388 patients in the Dialysis Outcomes and Practice Patterns Study who received in-center conventional hemodialysis during the same time period by country, ESRD duration, and propensity score. The intensive hemodialysis group received a mean (SD) 4.8 (1.1) sessions per week with a mean treatment time of 7.4 (0.87) hours per session; the conventional group received three sessions per week with a mean treatment time of 3.9 (0.32) hours per session. During 3008 patient-years of follow-up, 45 (13%) of 338 patients receiving intensive hemodialysis died compared with 293 (21%) of 1388 patients receiving conventional hemodialysis (6.1 versus 10.5 deaths per 100 person-years; hazard ratio, 0.55 [95% confidence interval, 0.34–0.87]). The strength and direction of the observed association between intensive hemodialysis and improved survival were consistent across all prespecified subgroups and sensitivity analyses. In conclusion, there is a strong association between intensive home hemodialysis and improved survival, but whether this relationship is causal remains unknown.

Nearly fifty years after the pioneers of dialysis understood that more is better, America continues locked into an endless debate and circle of more and more studies. For those that have undertaken home hemodialysis with intensive dialysis modalities, there is no debate. For the academic American nephrology community, even after this series of studies, the take home message is once again, we need further studies. "The potential impact of extended treatment time on clinical outcomes while maintaining a three times per week hemodialysis schedule requires evaluation in future clinical trials." (here)  We have now come full circle back to where Dr. Scribner started fifty years ago with thrice weekly hemodialysis.

Even with these new studies, tomorrow morning, hundreds of thousands of American dialysis patients will continue with conventional in-center dialysis as if nothing was published today and indeed, as if we had not learned anything in the last fifty years.  In the last four years, dozens of similar articles have been published with no change in dialysis practices in America to date.  At some point in time, practices need to change. We don't need more studies, especially those showing better outcomes that takes us back to the pioneering days of dialysis. I am grateful for one more set of encouraging studies, but I would be more grateful that the American nephrology community embraced the results.

The Lufkin Davita Bleach Murder Case: What is 3-chlorotyrosine?

By Peter Laird, MD

The long awaited Lufkin DaVita bleach murder case is on the verge of commencing with the early salvos by the prosecution and the defense coming to light in a recent hearing on the admissibility of evidence. (here) An immediate question that arises out of an early report is what is 3-chlorotyrosine and why is it an important part of the prosecution evidence?

State, defense in Saenz case argue over validity of evidence

“The court needs to understand that at no time did the state or prosecution find bleach in blood, but instead found 3-chlorotyrosine,” Deaton said.

In addressing Deaton’s issues with the research’s validity, Angelina County District Attorney Clyde Herrington chronicled the death of one of Saenz’s alleged victims, a man the prosecutor said entered the dialysis center in good shape but did not leave that way.

“He was carried by his wife that morning (to the center). He was in good spirits. He laughed, he joked, he ate a boiled egg. He’s doing fine and the next thing you know, he’s unconscious,” Herrington said. “He died three to four months later.”

“Massive levels” of 3-chlorotyrosine were present in the man’s body, Herrington said. Defense team member Thomas W. Deaton attributed the patient’s  3-chlorotyrosine level to a “massive infection.”

There is no pathogneumonic test for bleach infusion. (A sign or symptom that is so characteristic of a disease that it makes the diagnosis).  The prosecution and the defense have already started to square off over the issue of 3-chlorotyrosine allegedly found in some of the alleged victims of Kimberly Saenz. 3-cholortyrosine is not an ordinary blood test performed in a doctors office or in a dialysis clinic. It is a very obscure research tool for elucidating exposure to chlorinating agents. There are only a handful of clinical studies measuring both the natural levels of 3-chlorotyrosine as a marker of inflammation and infections for instance. 

Myeloperoxidase: friend and foe

Neutrophilic polymorphonuclear leukocytes (neutrophils) are highly specialized for their primary function, the phagocytosis and destruction of microorganisms. When coated with opsonins (generally complement and/or antibody), microorganisms bind to specific receptors on the surface of the phagocyte and invagination of the cell membrane occurs with the incorporation of the microorganism into an intracellular phagosome. There follows a burst of oxygen consumption, and much, if not all, of the extra oxygen consumed is converted to highly reactive oxygen species. In addition, the cytoplasmic granules discharge their contents into the phagosome, and death of the ingested microorganism soon follows. Among the antimicrobial systems formed in the phagosome is one consisting of myeloperoxidase (MPO), released into the phagosome during the degranulation process, hydrogen peroxide (H₂O₂), formed by the respiratory burst and a halide, particularly chloride. The initial product of the MPO-H₂O₂-chloride system is hypochlorous acid, and subsequent formation of chlorine, chloramines, hydroxyl radicals, singlet oxygen, and ozone has been proposed. These same toxic agents can be released to the outside of the cell, where they may attack normal tissue and thus contribute to the pathogenesis of disease. This review will consider the potential sources of H₂O₂ for the MPO-H₂O₂-halide system; the toxic products of the MPO system; the evidence for MPO involvement in the microbicidal activity of neutrophils; the involvement of MPO-independent antimicrobial systems; and the role of the MPO system in tissue injury. It is concluded that the MPO system plays an important role in the microbicidal activity of phagocytes.

There is only one study I am aware of at this point looking at naturally occuring 3-chlorotyrosine levels in dialysis patients by Dr. Himmlefarb. 

Myeloperoxidase-catalyzed 3-chlorotyrosine formation in dialysis patients

Oxidative stress has been implicated in the cardiovascular complications that affect chronic renal failure patients on hemodialysis, though the physiologically relevant pathways mediating oxidative damage are poorly understood. It is known, however, that hemodialysis activates neutrophils, a well-characterized source of hydrogen peroxide and myeloperoxidase. The phagocyte-derived myeloperoxidase-hydrogen peroxide-chloride system generates hypochlorous acid, which reacts with tyrosine residues of proteins to form 3-chlorotyrosine. To explore the role of activated phagocytes in oxidative stress in chronic renal failure, we used 3-chlorotyrosine as a specific marker of myeloperoxidase activity. Utilizing isotope dilution gas chromatography-mass spectrometry, we compared 3-chlorotyrosine levels in plasma proteins of five patients on chronic hemodialysis therapy with those of age- and sex-matched healthy controls. The oxidized amino acid was present in the plasma proteins of 4 of the hemodialysis patients (3.5 +/- 0.8 micromol per mol tyrosine) but was undetectable in the healthy subjects. Therefore, one pathway for oxidative stress in hemodialysis patients appears to involve hypochlorous acid generated by the myeloperoxidase system of activated phagocytes. We also examined intradialytic 3-chlorotyrosine levels using membranes that activate white blood cells and the alternative pathway of complement. Hemodialysis increased plasma myeloperoxidase and the expression of CD11b/CD18 by circulating phagocytes, but failed to demonstrably increase 3-chlorotyrosine levels. 3-chlorotyrosine was detectable in 12 of 19 samples in total, with significant intrasubject variability. Our observations suggest that oxidants generated by myeloperoxidase contribute to the increased oxidative stress observed in renal-failure patients but do not damage plasma proteins during the hemodialysis procedure itself.

This complex little known clinical entity is suddenly thrust on the stage of a prominent murder case where it may promise more confusion than clarity. One of the questions immediately present is how well will the jurors correlate studies on chlorine gas in rats causing 3-chlorotyrosine levels compared to complex dialysis patients with multiple co-morbid conditions where naturally occurring 3-chlorotyrosine levels are already documented and applying that as evidence to proof of murder. This is only the beginning of a very long, complex case.

The Lufkin Davita Bleach Murder Case: Opening Salvos

By Peter Laird, MD

Kimberly Saenz is under indictment for the alleged murder of five dialysis patients and five other patients allegedly harmed by bleach infusion. In an interesting opening evidence hearing on the admissibility of a study on rats exposed to chlorine gas, the defense argued against hearing this evidence as it has never been duplicated in humans. In this opening salvo of evidence by the prosecution and counter moves by the defense, the one issue clear in this case is that it will be a difficult and complex medical and science laden, circumstantial evidence case. 

State, defense in Saenz case argue over validity of evidence

“The court needs to understand that at no time did the state or prosecution find bleach in blood, but instead found 3-chlorotyrosine,” Deaton said.

In addressing Deaton’s issues with the research’s validity, Angelina County District Attorney Clyde Herrington chronicled the death of one of Saenz’s alleged victims, a man the prosecutor said entered the dialysis center in good shape but did not leave that way.

“He was carried by his wife that morning (to the center). He was in good spirits. He laughed, he joked, he ate a boiled egg. He’s doing fine and the next thing you know, he’s unconscious,” Herrington said. “He died three to four months later.”

“Massive levels” of 3-chlorotyrosine were present in the man’s body, Herrington said. Defense team member Thomas W. Deaton attributed the patient’s  3-chlorotyrosine level to a “massive infection.”

“If ever there were a poster boy for a massive infection, it would have been (this patient). He came in with one prosthesis and lost another leg in the hospital,” Deaton Sr. said. “To give the jury that testimony to show a cause ... It’s bad science.”

The simple fact remains that there is no single, definitive and pathogneumonic test (A sign or symptom that is so characteristic of a disease that it makes the diagnosis) for bleach infusion. Of all the poisons and toxic chemicals, it is quite unique in that the body manufactures chemicals quite similar to bleach used mainly in immune cell reactions. Bleach is broken down by naturally occurring enzymes in the body. When we think of poisoning cases, most of the time it is a simple matter to run very precise tests showing evidence of a specific chemical. Not so in this case. Evidence of bleach infusion and its effects on the body is not directly measurable. In such, this entire case will depend on secondary tests that the prosecution will claim are evidence of bleach infusion. 

The defense has publicly stated from the beginning that they believe Kimberly Saenz is a scapegoat for DaVita and the alleged clinical mistakes by DaVita.

State, defense in Saenz case argue over validity of evidence

From the beginning, Deaton has maintained that Saenz is merely a scapegoat for the company’s oversights and clinical mistakes. On March 5, a dozen jurors and two alternates will walk into Bryan’s courtroom to decide whether she is to blame.

For those expecting a quick and straight forward case, the fact that surrogate markers of bleach are the only evidence of bleach infusion places this case at its onset as one that is going to be complex, filled with high tech science most likely never used before in a murder case and complex patient medical records on top of allegations by the defense of clinical failures by DaVita. In the end, DaVita may be on trial as much as Kimberly Saenz. We will have to wait for the full case to develop in the news reports, but it will likely not be a straight forward case and assigning guilt or innocence is going to be a very difficult position for the jury to consider.  

Consider that the prosecution is using chlorine gas exposure on rats without any human counterpart testing as evidence of murder. Many reading the Lufkin article above have probably already asked, what is 3-chlorotyrosine and what do rats have to do with a murder case? The answers to these questions and how complex the science is behind this case are daunting for trained medical specialists none of whom are likely to find their way on this jury of her peers. This will likely prove to be on of the most complex, circumstantial murder cases known to date.

Coach Tom Martinez: Never Quit

By Peter Laird, MD

Tom Martinez is a man that has spent his life motivating and teaching thousands of college and high school athletes throughout his long career. During this time, he has not only secured his place as one of the most successful college level coaches, but his dedication to never quiting and always pushing forward is an inspiration not only to those involved in sports, most notably, his prodigy, Tom Brady of the New England Patriots, but for all that face life threatening diseases. Sadly, Tom lost his battle, but his words of encouragement remind all struggling against the ravages of diabetes, heart disease and chronic kidney disease that at times, it is the simply the will to live that endures:

 

Sadly, the testimony of his wife is one repeated over and over in America where she stated matter of factly that dialysis was killing him:

Tom Brady's QB guru, Tom Martinez, dies from heart attack on 66th birthday

Martinez suffered through continuous kidney issues and complications from Type 2 diabetes as he continued to be consumed by football and coach protégés ranging from Brady to current college prospects. His health declined precipitously over the summer as he sought a kidney transplant, but the dialysis — a process that alternately weakened and sustained him — left him drained in recent days. 

“We were convinced the dialysis was slowly killing him,” said his wife of 46 years. “UCLA (Medical Center) just couldn’t be bothered to take someone at such high risk.”

My condolences go out to his family and his friends, but I would hope that the message of dialysis is not tainted as a life taking procedure from this sad account. When done properly, it can and does sustain and restore life for thousands of patients. Unfortunately, with the stated heart, diabetes and kidney problems, Tom Martinez was at the highest risk of cardiovascular death at the onset of his dialysis treatment. The media is not discussing his dialysis modality, but it goes without saying that the majority of dialysis patients in America who could benefit from  the longer and slower nocturnal treatments pioneered in Canada for exactly this type of patient most likely was not presented to him if he fell within the usual informed consent where as little as 12% of patients hear of optimal dialysis modalities.

The world has lost a wonderful coach, father and husband when Tom Martinez succumbed to his long battle against diabetic complications with his heart attack. There are many battles worth fighting, not the least of which is the battle to overcome the American dialysis hegemony in opposing optimal dialysis practices in favor of for-profit, greed motivated short, violent and debilitating dialysis sessions most patients experience daily. I truly understand why many "hate dialysis." Sadly, Tom Martinez widow may have sagely spoken well that the dialysis was slowly killing him. What a sad testimony for such a nobel experiment suborned by profiteering  and greed.

This is just one more case, one more reminder that we need to never quit until dialysis modalities do as they were envisioned by Dr. Scribner when his serendipitous invention of the Scribner shunt brought the promise of his predecessors to life. Tom Martinez appears by his widow's report to possibly be one of many thousands of patients ill served by dialysis. Never quiting as Tom Martinez encouraged in life, let his death inspire those in the dialysis industry to just "win one for the gipper" and bring to an end the type of dialysis in America that leads widows to speak bitterly of this therapy. Instead, let it be that people on dialysis had never quit and were grateful for all. We can only dream.

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.

Altruistic Donor Leads 60 Person Transplant Chain

By Peter Laird, MD

Altruistic renal donation is the underlying ethical framework for our current donor system in America. Many have prematurely declared altruism dead, but the news highlighted in the New York Times speaks loudly that we have yet to see the full power of a complete stranger willing to offer himself as a gift of life. In this case, it started a chain that will now benefit over thirty renal transplant recipients. His story is worth sharing and extolling the benefits of altruistic donation.

60 Lives, 30 Kidneys, All Linked

What made the domino chain of 60 operations possible was the willingness of a Good Samaritan, Mr. Ruzzamenti, to give the initial kidney, expecting nothing in return. Its momentum was then fueled by a mix of selflessness and self- interest among donors who gave a kidney to a stranger after learning they could not donate to a loved one because of incompatible blood types or antibodies. Their loved ones, in turn, were offered compatible kidneys as part of the exchange. . . 

Dr. Robert A. Montgomery, a pioneering transplant surgeon at Johns Hopkins Hospital, which was not involved in the chain, called it a “momentous feat” that demonstrated the potential for kidney exchanges to transform the field. “We are realizing the dream of extending the miracle of transplantation to thousands of additional patients each year,” he said.

Dr. Montgomery is correct that kidney chains have the potential of transforming the field, but they all begin with a complete stranger willing to give of himself for nothing in return but a scar. The miracle of altruistic donation should never become too frequent to celebrate each and every sacrifice instance. Thank you Mr. Ruzzamenti, you have done well.

Home Hemodialysis: Overcoming the Insurance Barrier

By Peter Laird, MD

Rich Berkowitz of Home Dialyzors United posted an important news report on United Healthcare and their policy change in support of home hemodialysis. I concur with Rich Berkowitz that the policy change by United Healthcare is an important milestone for all dialysis patients. This is one of the few insurance groups in America that support and accepts both observational data and the FHN randomized and controlled study. Perhaps the most important phrase in their policy change is the following:

Home Hemodialysis Medical Policy

Home hemodialysis (HHD) is a proven therapy as an alternative to facility-based hemodialysis for patients with end-stage renal disease. 

There remains much work left to overcome the insurance barrier to home hemodialysis such as Aetna and other insurance companies that have yet to embrace this technology. Reading through the policy discussion by United Healthcare brings to mind many well written treatises by home hemodialysis advocates. In light of the success of NxStage bringing portable hemodialysis technology into the home, the market forces may have played a substantial part in the United Healthcare decision since the evidence has been present for decades. 

All too many patients remain in-center when they could instead enjoy the benefits of home therapies. far too many never hear of these options from their health care team. I am pleased the United Healthcare has taken this important step with in offering a proven therapy and declaring it so. Perhaps we have a bit more sanity today in the dialysis industry today. At the least, this is welcome news. I want to thank Rich Berkowitz for bringing us this information and congratulate Rich for his new webpage albeit still in development.

Help, I Need Dialysis! Now Available at HDC

By Peter Laird, MD

Dori Schatell and Dr. John Agar recently published a new book on dealing with dialysis that is an excellent resource not only for patients and families facing renal replacement therapy, but also for professionals discussing optimal dialysis options. The book is to be released on March 1, 2012, but it is available on order now. I highly recommend this well written book for all renal patients:

Help, I Need Dialysis!
How to have a good future with kidney disease

By Dori Schatell, MS and Dr. John Agar  Paperback, 202 pages

An internationally known nephrologist and life-long kidney patient educator explain how dialysis works, each of the ways to do it, and how your treatment choice may affect your diet, energy level, work, travel, sexuality and fertility, sleep, and survival. Comprehensive and fully referenced, this book is a must-read if you face the life-changing choices that come with kidney failure.

Preorder your copy today! Shipping March 1 via US Postal Service.

About the Authors

Dori Schatell, MS

Executive Director of the non-profit Medical Education Institute, Ms. Schatell has more than 23 years of experience researching and developing educational programs for people with kidney disease. She has published numerous peer-reviewed articles and launched several award-winning websites, including Life Options, Kidney School, and Home Dialysis Central.

John Agar, MD

Director of Nephrology and Chief of Service (Medicine) at Barwon Health in Geelong, Australia. Dr. Agar is Clinical Associate Professor of Medicine, University of Melbourne, has published numerous articles about dialysis, and is a passionate advocate and thought leader for green dialysis, using solar power and recycled water. He runs the popular website,nocturnaldialysis.org.

 

The MP3 Study: Mupirocin Tops Polysporin for PD Infection Prophylaxis

By Peter Laird, MD

Patients undergoing peritoneal dialysis (PD) are prone to peritonitis as well as exit site infections (ESI) from various organisms. Unfortunately, PD related infections is one of the limiting factors in the effectiveness of peritoneal dialysis with most patients experiencing at least one episode of peritonitis annually. The most common pathogens are those that grow on the skin called gram positive bacteria. These are bacteria that stain dark when placed in Gram's dark stain. The most virulent skin organism in these infections is Staph Aureus which many people carry in there nose. Several prior studies have shown that Mupirocin (Bactroban) is an effective antibiotic for preventing ESI and peritonitis in PD patients. The MP³ Study compared Polysporin triple anibiotic (P³) to Mupirocin:

A Randomized Controlled Trial Comparing Mupirocin and Polysporin Triple Ointments in Peritoneal Dialysis Patients: The MP³ Study

Results Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P³ (13.2 months; 95% confidence interval, 11.9–14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7–15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P³ group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P³ (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05).

Conclusions This study shows that P³ is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P³ over mupirocin is not advocated in the prophylaxis of PD-related infections.

There are many techniques useful in mitigating the risk of infection including careful hand washing, wear gloves when changing bandages, check the tubing for any signs of cracks daily as well as observing any redness or discharge from the PD tunnel, and avoiding hot tubs and public pools. Placing antibiotic creams are effective. When compared to Polysporin, Mupirocin is more effective at preventing PD related infections.