HemoDoc, From Doctor to Patient

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.

 

Are American Nephrologists Dialysis Money Sucking Leaches?

By Peter Laird, MD

In a recent post on HemoDoc, (here) I evaluated calls by some in nephrology to increase payment for their services. There is no doubt that many American physicians truly earn their pay and I have no doubt that my colleagues in nephrology do likewise work hard. However, at least one person took exception to my essay and categorically stated that nephrologists are not "dialysis money sucking leaches." However, the unfortunate historical record of American dialysis care does not corroborate that statement. (here)

While we can look to multifactorial improvement in cardiovascular outcomes not simply from revascularization alone as correctly pointed out in the above comment, but instead by a combination of advances in the pharmacologic interventions of myocardial infarction and improvements in revascularization techniques as well which I duly noted in my post; sadly I cannot state the same about dialysis outcomes in the US.

The point of comparison is the measurable advances we see in the treatment of cardiovascular disease in the general population vs. the stagnation of dialysis outcomes in the United States in particular.  When I see the median longevity on dialysis of 36-38 months, (here) which has not improved substantially for decades despite a concerted effort by many to promote optimal dialysis techniques, I must question the American nephrologist individually and collectively who are the only doctors legally able to prescribe dialysis treatments.

Indeed, what technological advances can we point to in the standard in-center treatment of the majority of American dialysis patients that has relieved pain and suffering of our patients in as dramatic a fashion as in many other areas of medicine?

As a dialysis patient myself, I do not take lightly the denial of individualized care I have seen in many units personally. I have been subject to cattle call dialysis sessions where I was yelled at for coming 25 minutes early instead of 30 minutes and suffered inadequate clearances simply because that unit refused my standard treatment at my home center. (here) To deny the existence of money sucking leaches in the field of nephrology is to remain in denial of the truth of the for-profit dialysis industry of the last 40 years.

Clinics Pad Kidney Dialysis Costs

By Jack Anderson

"Washington - Of all the corporate Scrooges in the world, none is lower than one that would squeeze profits form the sick and debilitated."

Today, the American nephrologist cannot stand up and proclaim significant improvements in the treatment of ESRD in the same manner that you can for a broad segment of other high tech specialties. 2012 was supposed to be a year when we saw new dialysis technologies approved by the FDA but 2012 has come and gone and we are not doing any better today than we did in 2011.

I could easily have cited improvements in the treatment of childhood leukemia or peptic ulcer disease or a myriad of other conditions but only used improvements in cardiovascular outcomes as one ready example. Focusing on my one example renders no justice at all to the deficiencies of dialysis care in America that lie entombed in stagnation and an intransigent resolution to not change the system whatsoever. In the meantime, patients on hemodialysis in America have a worse prognosis than AIDS patients and many cancer patients. Shall we gain any benefit by criticizing those who stand up and ask simply why cannot we do better today than we did yesterday?

This remains a uniquely American debate since the rest of the developed world has long since embraced the basic tenants of optimal dialysis. America remains paralyzed by an industry that is one of the most profitable in the US, (here) that is unless you are one of the unfortunate patients beginning dialysis today that only has 36-38 months of median life expectancy remaining. I believe that the American nephrologists have much that they need to account. We could do better and we should do better but shall we do better is the unanswered question.  There remain many champions of dialysis improvement in America, but sadly in my own venture as a dialysis patient, they appear to be few in number collectively. What then do we call the many American nephrologists who do not advocate for documented improvements in basic dialysis outcomes in America?

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 DaVita Difference: The Transfusion King

By Peter Laird, MD

The major concern voiced about the renal bundle prior to implementation was withholding needed medications to maintain basic vital processes. The renal bundle is largely due to the abuse of EPO for the maintenance of hemoglobin levels in dialysis patients. Erythropoietin comes from health renal tissues that are absent in the majority of patients on hemodialysis with the exception of many with polycystic kidney disease. Under the renal bundle, EPO went from a separately billable income generator to a cost center for dialysis centers.

In the latest USRDS report noted by Gary Peterson on RenalWeb, blood transfusions increased throughout the industry, but the greatest increase is among patients at DaVita, a for-profit dialysis company.

"Since adoption of the bundled payment system, the number of transfusion events has increased, reaching 24 percent by September, 2011. Some providers are associated with a significant increase in transfusion rates over the one-year time period (the rate increased 46 percent in DaVita units), while others show minimal changes (4 and 7 percent in Fresenius and hospital-based units, respectively)."

Looking at further indicators of why DaVita has such an outrageous transfusion rate, one of the answers to that issue is not only in the 37% reduction of EPO use, but much more in their concomitant severe reduction of IV iron products by a factor of 42%.

Tracing the history of EPO abuse at DaVita leading to the moniker, the King of EPO, their gratuitous allegiance to profiteering, now evidenced by the 46% increased transfusion rate is nothing short of a shocking indictment of this company and their business plan. We all understood that the renal bundle would dramatically lower the usage of EPO, but the majority of practitioners expected an increased usage of IV iron products to maintain quality of life in dialysis patients.

Scott Rasgon at Kaiser Sunset maintained stable Hb levels with simple over the counter Vitamin D-3 supplementation while greatly reducing EPO usage. I have been fortunate to maintain my Hb levels with IV iron supplementation for nearly six years of dialysis to date. Patients understand well the quality of life issues associated with higher Hb levels. Sadly, there are absolutely no studies comparing the risk and benefits of EPO to the risk and benefits of transfusions.

Since transfusions are no longer allowed in many free standing dialysis units, hospitals and third party insurance companies pick up the tab on most of the transfusions that DaVita generated since implementing the bundle. This may make great business sense for DaVita generating further profits for their investors, but it makes no sense at all for the dialysis patients suffering with such severe anemia that they need such a large number of transfusions. As a practicing physician, I readily understood the risks of blood transfusions not the least of which is the risk of transmissible agents such as hepatitis and HIV. It was my goal to minimize the need for transfusions whenever possible.

Alan Nissenson has promoted the benefits of the DaVita model securing high quality of care as their model. In this instance, I must challenge their allegations of high quality care when they not only severely reduced EPO usage, but also withheld IV iron which is an effective and safe alternative and adjunctive therapy for renal associated anemia. I am sure that this has greatly increased DaVita profits, but at what expense to their patients.

Are DaVita Patients among the Village of the Damned?

By Peter Laird, MD

The Denver based magazine, 5280 published an expose on the CEO of DaVita, Kent Thiry called The Strangest Show on Earth. Luc Hatlestad spent several weeks embedded in the DaVita operation following the daily endeavors of Kent Thiry including his very controversial style of leadership at DaVita employee meetings.  He promotes the theme of the three musketeers in all of these meetings often entering in costumes in character shouting "all for one, one for all."

However, the shocking detail that patients fail to understand is that the DaVita "village" is only that of the employees and not the patients. The high fives create a culture of loyalty not to patients, but to the company. Kent Thiry has openly admitted that the business of DaVita is not about the patients. Many critics of DaVita understand these dynamics well:

DaVita has wider health care ambitions: patients wary

"I just don't see this ending well," said Bill Peckham, a Seattle dialysis patient who writes a blog popular in the kidney care field. "You're substituting business ethics for medical ethics, and I think that's a bad deal," said Peckham, who gets his dialysis from a nonprofit center.

Though the government is emphasizing its quality mandates in the ACO contracts it has issued so far, Peckham said the model encourages withholding of care to save money and create profit-sharing. DaVita faces legal challenges to its use of the critical dialysis drug Epogen, and to its business relationships with doctors.

Thiry calls himself "The Mayor," and employees "citizens" of the DaVita "Village," Peckham noted.

"Where does that leave the patients? We're the 'crop.' We're the 'ore' in the mines. That's not a fun place to be if you're the person who needs dialysis," he said.

Ironically, I am currently a DaVita patient on home hemodialysis after my DSI unit was taken over by DaVita. Already, there are major changes I have observed that leave me less than confident that my health care in this company is about me. I am tired of getting one roll of tape for an entire month of dialysis where I can easily use that one roll in a single session. I now must send in my clinic notes by fax on a daily basis once again, not for clinical oversight, but for billing purposes even though Kaiser only pays DaVita on a monthly basis.

DaVita further is in charge of my monthly labs. With their history of putting profits ahead of patient safety as evidenced by their alleged blind allegiance to increasing EPO dosages to maximize profits witnessed in recent legal actions against DaVita, I lack the personal confidence in DaVita to plaee my interests ahead of their own. After all, I am not part of their village, that belongs only to the employees.

One statistic that is difficult to document is the allegations of increased involuntary patient dismissals. For these unfortunate patients, speaking up against failings of the DaVita system in their own personal care often ends with an involuntary dismissal leaving some patients with no alternative units for their care. For these patients, life becomes a day by day struggle where the local emergency room is their only option. Unfortunately, most emergency units will only dialyze the patient if they are in immediate danger.  High potassium levels do not always earn them an intermittent dialysis session. Some ER doctors will give these patients a dose of Kayexolate to lower the potassium levels and send them home.  For these DaVita patients, an involuntary dismissal is tantamount to a death sentence leaving them truly in the village of the damned.

The Strangest Show on Earth

Some former patients have even accused DaVita of blackballing them to other non-DaVita dialysis clinics, which, if true, would be another federal privacy violation. “DaVita is number one in dumping patients,” says Arlene Mullin, an advocate in Battleground, Washington, who shared dozens of emails with me detailing alleged abuses of the patients she represents. She contends that DaVita clinics operate with virtually no accountability or oversight. “I’ve gotten notarized statements from patients so I can advocate for them, and neither ESRD Networks nor DaVita has recognized any of them. [ESRD Networks and the government] have no authority over these clinics. None.” Mullin claims that DaVita’s insider connections to CMS and ESRD Networks allow clinics to get tipped off about what should be surprise inspections. (She says this also happens at non-DaVita clinics.) The patient advocates I spoke with uniformly believe that ESRD Networks and CMS respond to grievances by stonewalling, burying them in bureaucracy, or ignoring them altogether. “Of all the patients I’ve helped to file complaints, in 100 percent of the cases, ESRD Networks has sided with the dialysis companies,” Mullin says. “Medicare has allowed this industry to oversee itself.”

Bill Peckham, a longtime dialysis patient turned activist blogger, goes a step further, saying the “all for one” DaVita Village concept simply doesn’t include patients. He likens the company to a village that mines coal. “We patients don’t have the voice of a citizenry; we’re just the coal.”

For anyone that understands that these kind of intermittent treatments place patients at high risk of death and other adverse outcomes, these patients truly are living in the village of the damned condemned to uncertainty, suffering and rapid decline in their health often imposing a sure death sentence. Sadly, DaVita is often the only dialysis unit in isolated communities leaving patients at the mercy of the DaVita business practices which by their own admission are not about the patients.

I suspect that my time at DaVita will be short lived and I am currently exploring other options for my long term care in the Pacific northwest area.  I have heard directly from DaVita employees who are uncomfortable with DaVita business practices and requirements. For a dialysis company to promote the village concept for their employees only but not for their patients leaves me with the same question that Bill Peckham has posed, where does that leave the patients?  For some of those that dared to stand up to DaVita and speak out, the involuntary dismissals that they earned truly leaves them in the village of the damned.

Cholesterol Studies for Dialysis Patients Fail to Control for Important Confounding Variables

By Peter Laird, MD

Joel Topf is a leading nephrologist who posts excellent commentaries on a wide range of nephrology topics on his blog, Precious Body Fluids. In a post from 2009, he described several studies on cardiovascular prevention using proven pharmaceutical agents for this in the general population including aspirin, blood pressure control and statins.

Statins fail again Statins have a tortured relationship with nephrology. Our patients have accelerated atherosclerosis and they die overwhelmingly of cardiovascular disease. So one of my primary jobs is to continually optimize cardiovascular risk factors to save my patients

Control blood pressure, start an aspirin, and maximize the statin are the lather, rinse, repeat of my world.

That said we have little data that this makes a whit of difference, at least in our dialysis patients.

Only the SHARP study has shown any benefit of statins in CKD patients which was published after Dr. Topf's 2009 post.

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomized placebo-controlled trial

Findings

4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0·85 mmol/L (SE 0·02; with about two-thirds compliance) during a median follow-up of 4·9 years and produced a 17% proportional reduction in major atherosclerotic events (526 [11·3%] simvastatin plus ezetimibe&vs619 [13·4%] placebo; rate ratio [RR] 0·83, 95% CI 0·74—0·94; log-rank p=0·0021). Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infarction or died from coronary heart disease (213 [4·6%]vs230 [5·0%]; RR 0·92, 95% CI 0·76—1·11; p=0·37) and there were significant reductions in non-haemorrhagic stroke (131 [2·8%]vs174 [3·8%]; RR 0·75, 95% CI 0·60—0·94; p=0·01) and arterial revascularisation procedures (284 [6·1%]vs 352 [7·6%]; RR 0·79, 95% CI 0·68—0·93; p=0·0036). After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10&000 patients per year of treatment with this combination (9 [0·2%]vs5 [0·1%]). There was no evidence of excess risks of hepatitis (21 [0·5%]vs18 [0·4%]), gallstones (106 [2·3%]vs106 [2·3%]), or cancer (438 [9·4%]vs439 [9·5%], p=0·89) and there was no significant excess of death from any non-vascular cause (668 [14·4%]vs 612 [13·2%], p=0·13).

Interpretation

Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease.

There is one common factor that I believe is a fatal flaw in all of the statin trials for CKD patients, the failure to control for the many known non-thrombotic cardiovascular risk factors. CKD patients are much more likely to die from complications related to LVH and disorders of mineral bone metabolism than they are to die from thrombosis of a coronary  artery that we commonly call a heart attack. Sadly, none of the statin prevention trials in CKD patients controlled for these factors rendering their results suspect in my opinion.

The FHN short daily dialysis trial showed a significant reduction in LVH between the control group and treatment group. In addtion, the failed nocturnal FHN study did show significant improvement of mineral bone disease factors. Both of these elements are known cardiovascular risks in the dialysis population.Failure to control for these factors in the CKD population is tantamount to failing to control for smoking or a sedentary lifestyle risk factors in studies of cholesterol reduction in the general population.

We would not accept the results of any study that did not control for those confounding factors in the general polation, yet we readily dismiss the known confounding factors for CKD and dialysis patients. My own personal approach is to reduce my ultrafiltration rates with reduced blood flow rates, increased frequency and duration of dialysis and take my statin for cholesterol control. I cannot produce any study that shows that any of these factors with definitively reduce my risk of death by adopting this approach, but I can show the strengths and weaknesses of this approach from both observational studies and from evaluating the deficiencies of the statin trials in CKD patients.

Perhaps someday, the specific cardiovascular pathology known in the dialysis population will be the basis for future studies on this very important topic. Studying daily nocturnal home hemodialysis patients with a well concieved RCT would reduce if not eliminate the confoudning factors of LVH and poor mineral bone disease control prevalent in the conventional in-center hemodialysis population. In the mean time, taking my statin on a daily basis is and will remain part of my own prevention program. I remain convinced it is the correct approach.

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.

The Genius of Stuart Mott: Solving Buttonhole Infections

By Peter Laird, MD

Buttonhole cannulation is an underutilized resource in the hemodialysis setting that recently has come into further question due to studies showing higher rates of infection than standard cannulation techniques. I have long believed that proper hygiene and disinfection can circumvent this higher infection risk leading me to conclude that it simply may be a failure of infection control techniques rather than a failure with buttonhole methodology itself.  Recently, Stuart Mott addressed these issues and developed a new approach and technique that may prove to be the solution to this problem of higher infection rates with the constant site techniques.

Milestone has been reached in buttonhole infections

1. At the end of June 2012 a milestone was reached with 4 000, cannulation of buttonholes. This projected was started in June of 2009 with just two patients and a lot of doters noted at the time. In January of 2010 two more patients where add as a resulted of the first two. No infections and buttonhole integrity remained in tactated.The use of shower scrubbers were initially used but in the summer of 2010 while getting more shower scrubbers at the local Wal-Mart I notice the exfoliating facial buffs. When first trying them out I notice a result that was far better than the shower scrubbers. Faster cleaning and better cleaning of the buttonhole site. The removal of dead skin as well as the oil around the site leads me to believe that his technique was the way to go. Immedelty after using the exfoliating facial buffers the scab remove became the key to the elimination of the infections problem. All the scab material was removed from the buttonhole site and only in rare occasions was there any scab left. What is left is the buttonhole plug. This is removed by using the pickers that come with the needles. 
2. The use of the technique is as followed.  Non-sterile, clean gloves. Cut the pad in half for longer use. You will notice after 30 to 40 uses the pad becomes compacted, it time to use the other half
3. Place the exfoliating facial pad under hot water for 30 to 45 seconds to warm and moisten the pad prior to applying to skin.
4. Apply one to two drops of antibacterial soap to the pad.  Using your fingers spread the soap around on the pad to provide even distribution of the soap.
5. Using a circular motion, the staff or patient scrubs the buttonhole site/scab in a circular motion using moderate pressure approximately 10-12 times.
6.  using a clean paper towel dry the site and throw the paper towel away , don’t use water to rise the site off.
7. Examine site to determine if all scab material around buttonhole site is removed.
8. If scab material remains in the buttonhole track, remove using a sterile needle that is provided in the needle kit.
9. Betadine will be utilized to cleanse buttonhole site immediately prior to cannulation with fistula needles.

Air dry exfoliating pad during treatment by placing pad on top of the dialysis machine.

The lecturer on this infection of buttonholes is limited with in formation. But with this in mind the lowest reported was 0.16 per thousand cannulation(Doss, Schiller, & Moran, 2008; Marticorena et al., 2006, 2009; van Loon, Goovaerts, Kessels, van der Sande, & Tordoir, 2009; Verhallen, Kooistra, & Van Jaarsveld, 2007).  The Mott method for cleaning buttonholes  use somewhat different approach in that it cleans the whole area and not just the area around the buttonhole.

Since February a multiply content approach using this technique is in play, Australia, Canada and Europe are in different phase of getting this approved. The outcomes will be written about in the next year.

Stuart and his team has achieved an incridible 4000 buttonhole cannulations withour a single infection using this novel technique. Stuart is now engaged in an international, multi-center study to validate his initial observations in a study now commencing. Should the initial results Stuart obtained in his home unit be duplicated with a significant reduction in infections, one of the biggest considerations against using buttonhole cannulation will evaporate.

Buttonhole cannulation in my opinion should be the standard of care using Touch Cannulation to eliminate the variance between multiple cannulators. With these preliminary results, Stuart may single handedly be on course to solve the remaining issues that prevent universal acceptance of constant site cannulation which is known to reduce aneurysm development. The results of this ongoing study will hopefully confirm and promote a standard process for scab removal. With over 4000 infection free scab removals and cannulations, it is certainly a process that demands further study.

DaVita Faces Opposition to Eastern Maine Medical Center Dialysis Sale

By Peter Laird, MD

DaVita and Eastern Maine Medical Center (EMMC) are seeking permission from the Maine regulatory agencies to approve a pending sale of three dialysis centers now run and owned by EMMC. However, they are facing opposition from the nurses unions due to concerns about alleged quality of care issues with DaVita which is currently under investigation by several agencies. The opposing sides met in a public hearing to decide the fate of this sale:

 

The allegations that DaVita places profits ahead of patient care is not helped by their own CEO, Kent Thiry, who has publicly stated that DaVita is not about the patients, it is about the company and their teammates. (go to 109 minutes and 35 seconds on the following video) Since I just became a DaVita patient myself after my DSI unit was bought out over a year ago by DaVita, my impression is that billing and financial accountability are at the heart of their corporate concern for my treatments.  

 

DaVita is so obsessed with billing for my home dialysis sessions that they have given me a fax machine so that my nurse can do daily reports to the DaVita corporate headquarters even though Kaiser pays only on a monthly basis. Other than daily billing and the burden of sending off a daily fax, I see absolutely no new benefits from DaVita on my behalf. Instead, I am locked into a relationship now with big brother DaVita reviewing my treatments day by day and their mayor securing each and every billable moment. What part of DaVita's village do I now belong and if it is one for all all for one for the mayor and the teammate citizens, who then is my advocate in this huge corporate megalith?

The DaVita village and its citizens who are "all for one and one for all" don't have any place at all for the patient in their company philosophy. This is the chief failing of DaVita in my opinion, as Bill Peckham pointed out recently, if they are the village and Kent Thiry is the mayor, what does that make us patients?  I would hope that the patients serviced today at EMMC take the opportunity to learn more about DaVita and their aggressive business tactics that in my opinion come at the expense of the patient. Certainly, for anyone that listens to Kent Thiry state clearly that it is not about the patients, you must wonder what it is that motivates Kent and DaVita if it is not about the patient?

Sadly, there is little that the nurses unions or patients can do to prevent the sale of the EMMC dialysis units to DaVita. This is even more imperative since EMMC is the sole dialysis provider for Bangor Maine and the huge rural area it services. Any patinet who is involuntarily discharged from DaVita will have no other alternative treatment options other than emergency room services which for most patients is an inevitable death sentence. The people of Maine have the evidence before them to reject DaVita and seek alternative assistance for their dialysis needs. Whether the government agencies involved will question the integrity of this corporation and what I consider empty DaVita promises will only be known in its own time.

My thoughts and prayers go out to the people of Maine who include my own close relatives who live in this area and could in the future depend on the outcome of these decisions.

Pushing Organ Procurement Ethics Over the Slippery Slope

By Peter Laird, MD

The dead donor rule serves organ donors protecting those that can no longer speak for themselves. Tragic cases of death by organ donation are not talked about especially in the renal community yet they are documented and continue to occur in large part due to the lack of uniform brain death criteria throughout the US. Though fortunately rare in occurrence, anyone that has seen the NBC news report on the Zack Dunlap case should seek legislation assuring that no one would ever die as a result of death by organ donation. (here)

Unfortunately, coupled with paradoxical outrage at a Wall Street Journal article documenting the rare cases of death by organ donation, medical ethicists recently turned the discussion to procuring organs prior to the death of the donor. Although there were some ethicists who spoke against this newly proposed donation policy, many supported this new medical ethics paradigm.

The Case for Kidney Donation Before End-of-Life Care

Donation after cardiac death (DCD) is associated with many problems, including ischemic injury, high rates of delayed allograft function, and frequent organ discard. Furthermore, many potential DCD donors fail to progress to asystole in a manner that would enable safe organ transplantation and no organs are recovered. DCD protocols are based upon the principle that the donor must be declared dead prior to organ recovery. A new protocol is proposed whereby after a donor family agrees to withdrawal of life-sustaining treatments, premortem nephrectomy is performed in advance of end-of-life management. Since nephrectomy should not cause the donor's death, this approach satisfies the dead donor rule. The donor family's wishes are best met by organ donation, successful outcomes for the recipients, and a dignified death for the deceased. This proposal improves the likelihood of achieving these objectives.

As a renal disease sufferer, I initially considered pre-emptive renal transplant with donation from my wife. However, after considering both my prior history of cancer and risk of cancer recurrence after renal transplant and the risks entailed for my wife, I declined to pursue that option and then focused on optimal dialysis considerations. After all, renal disease is my disease and my responsibility. I do regret the loss of the kidneys that God granted to me, but I do not believe I have any right to another persons kidney whether dead or alive. It is a gift, it is not a right of any person with renal disease. 

It appears to me that in many ways, the renal community has transformed renal donation into a right over the last two decades. Presumed consent at its heart gives ownership of vital organs by the state for all those that don't opt out of this system utilized in Spain and other nations. While I value the gift of organ donation, I still cherish my civil liberties and I would hope that the demand for renal donation would never preclude our right to liberty and self determination. Once again, it is my disease, not someone else who is a complete stranger to me who has their own right to life, liberty and the pursuit of happiness.  In many ways, I personally would much rather die from my renal disease than see my renal disease used as a means of of encroaching another man's civil liberties.

I fear that I am in the minority opinion among my friends and colleagues in the renal community. It appears that just about any means of increasing renal donation no matter what the ethical implications of those policies and procedures is gladly welcomed by the renal community at large. Presumed consent, abandonment of the dead donor rule, donation by cardiac death and now kidney donation before end of life care infringe civil liberties for society in general and push the organ procurement ethical framework over the slippery slope endangering individual societal rights.

While I am sure that I will likely be in the minority opinion on this issue among the renal community, I must still question whether there are limits we should not cross in providing all available ethical renal donations? Changing the definition of what is ethical is a dangerous slippery slope that poses risks to society at large. Should we not who are most at risk in this society from our own renal disease support the protection of others who can no longer speak for themselves in their own tragic circumstances and forgo our greed for their organs by ever changing medical ethics?

American society decades ago saw the dangers of euthanizing anencephalic children and harvesting their organs recognizing the sanctity of person-hood in these children doomed to a sure death shortly after birth. I suspect our current modern society will re-evaluate that decision as well one day. I don't see these changes in our medical ethics as a positive change in any manner. I believe it shows a callous disregard of our human condition and respect and dignity for the individual and life in general.

We in the renal community must consider that same callous disregard for individual lives could in the end be the same sort of justification given to terminate treatment of those with renal disease as well. We are on the high price, low benefit scale according to many medical ethicists with some questioning how we perform dialysis in America. (here)  The renal community needs to be very careful what we ask for as there are always consequences of seemingly small decisions. 

Donation prior to death should never be the standard for organ procurement. I would hope that the renal community would understand this better than the general population since it was the respect for individual life that spurred the 1973 ESRD program funding in the first place. Losing this fundamental ethical paradigm could have untoward outcomes on continued ESRD funding in the future. The demand for kidneys today should not subvert the ethical foundations that secure our future especially in a time of limited resources.

I personally call upon the renal community to stand up and firmly disengage from the pursuit of renal donors at any cost through alteration of long held ethical paradigms. I would hope that the renal community will instead reaffirm the dead donor rule and set limits on the ethics of organ procurement. Respect for all life begins by recognizing the importance of the individual no matter what circumstances they encounter. Is that not the story of the ESRD program in 1973? If we won't stand up for those at risk of death from trauma and other illnesses, who will stand up for us in our time of need that the future shall surely bring.