HemoDoc, From Doctor to Patient

A Monopoly, A Duopoly, And a Free Market: Which Economy Provides "Optimal" Dialysis?

Two companies, Fresenius and DaVita, control over 80% of the US in-center Hemodialysis market, and Fresenius further has "monopolistic" control of the US Home Hemodialysis market since it's acquisition of NxStage Medical in 2019.

FMCNA COMPLETES ACQUISITION OF NXSTAGE MEDICAL

WALTHAM, MASS. – Feb. 26, 2019 – Fresenius Medical Care, the world’s largest provider of dialysis products and services, has successfully completed the acquisition of NxStage Medical, Inc. (NxStage), following approval by antitrust authorities in the United States. . .

. . . “The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality,” said Rice Powell, Chief Executive Officer of Fresenius Medical Care. “By combining NxStage’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”

However, I strongly protest Fresenius CEO Rice Powell's assertion that the acquistion of NxStage Medical Home Hemodialysis program "enhances" patient's choices of treatment modality. Since this acquisition, other Home Hemodialysis machines vying to enter this promising market such as Outset Medical Tablo and Quanta have met stiff competition not only from Fresenius, but also paradoxically, with the joint efforts of Fresenius and DaVita together trying to establish another duopolistic control of this market as well.

DaVita Kidney Care Expands Use of NxStage Home Hemodialysis Machines from Fresenius Medical Care

New Agreement Supports Efforts to Empower More People Living with Kidney Failure to Choose Home Dialysis

WALTHAM, Mass. and DENVER – March 23, 2021 – Fresenius Medical Care North America (FMCNA) and DaVita Kidney Care today announced an expanded agreement to provide home dialysis technology—including NxStage home hemodialysis (HHD) machines, dialysis supplies, and a connected health platform—to DaVita patients across the United States. The agreement supports both companies’ goals to empower more patients to choose home dialysis, which can provide a higher quality of life for people living with chronic kidney failure*1.

“For patients choosing home dialysis, it can mean more freedom and also active participation in their care, which is why we’re always looking for new solutions that ease the burden on our patients,” said Keith Hartman, group vice president for DaVita home modalities. “We’re expanding our use of NxStage home hemodialysis machines that have invaluable remote capabilities and connectivity for our patients. By transmitting treatment information, we hope to help identify irregularities and prevent avoidable complications, thus supporting patients’ desire to stay on their treatment of choice longer.”

Empowering patients to develop "independent" control of their own treatments is always a step in the right direction, but is NxStage the best machine available today to provide for that independence? Certainly, for myself, the NxStage System One or the new NxStage VersiHD, while granting it is the only portable dialysis machine widely available in the US today, does have limitations such as a fixed sodium of 140 mmol/L. In my case, this caused sodium loading for which I no longer tolerate the fixed sodium of 140 mmol/L  There came a point that I had to change to the Fresenius K@Home Dialysis system which has flexible sodium, bicarb and other settings allowing individual adjustments. 

Today, we have the Outset Medical Tablo Home Hemodialysis machine which has flexible settings of sodium (130 mmol/L to 145 mmol/L), bicarb and TIME that, in my opinion, will accommodate more patients than the NxStage machine . This provides a better match of sodium levels, which, also in my opinion, is a key to  help reduce HTN and LVH in longstanding dialysis patients. Reducing dialysate sodium levels helps decrease the sodium gradients during dialysis. NxStage, with its fixed sodium levels is relatively contraindicated in my case with the loss of residual renal function over the last 5 years and the development of high output cardiac failure from my high flow, brachiocephalic fistula. This one issue ended my 6 years of treatment with the NxStage System One in 2015 due to their fixed sodium levels in all their dialysate products available. (Note: Fortunately, plication of my fistula anastomosis in 2022 of the first 3 cm has completely reversed my High Output Cardiac failure and "right-sized" my fistula, but I still remain very sodium sensitive.)

Scribner showed in his first patient, Clyde Shields, that HTN was related to an expanded extracellular space size and controlled BP with sodium reduction and sufficient UF. There are, however, clinical situations where cardiac ejection fractions result in low pre-dialysis BP and metabolic effects of high, intracellular sodium levels contributes to hyponatremia in the plasma. Many approach this combined low EF, low BP and low sodium with a positive sodium gradient to prevent intradialytic hypotension. In reality, that only perpetuates the expanded extracellular space volume, thus continuing the cycle of hyponatremia and low BP with poor outcomes from excessive intradialytic UF.

Scribner warned about this many times being caused by not only expansion of the extracellular space but also the for-profit motivated short TIME of dialysis in the US. Scribner further believed and showed that TIME was a necessary component of controlling HTN. Bernard Charra in Tassin, France, reproduced Scribner's long and slow dialysis protocol for over 30 years with excellent BP control using the Drug Free Dry Weight method. 

However, despite the clinical benefits of the flexibility of the Outset Medical Tablo over the NxStage, it has found poor market penetration which, in my opinion, is in large part due to the "undue" influence of the Home Hemodialysis "monopoly" reigned over by Fresenius through NxStage ownership. 

Contrary to the Home Hemodialysis and In-center Hemodialysis market controlled by monopolies and duopolies, is the truly remarkable free market competition of the Acute Kidney Injury market in hospital based ICU's. Here, we see not only market competition, but all innovative dialysis strategies giving providers full access to all possible combinations of TIME, Frequency, Convection modalities and high flux artificial kidneys. It is a market that is not controlled entirely by Nephrology alone, nor large dialysis organizations. Here Outset Medical with their Tablo dialysis machine is making popular headway in the acute renal treatment market. 

In fact, other new dialysis machines such as Quanta are entering the US market through the ICU acute care market to gain acceptance. Although Tablo has had FDA warnings on marketing info that included unapproved 24 hour data to challenge the CRRT market, Tablo is well poised to dominate the market of SLED, SLEDD, SLEDD-f and CRRT with its quick, simple set up and small size compared to the RO systems. But for patients, economic competition leading to provider freedom in the ICU is giving patients the best choices, the best options and the best outcomes possible that dialysis can offer. In the ICU, there are many US and international companies providing doctors true choice in dialysis modality and a very interesting competition between critical care doctors and nephrologists on who controls this market.

This same free market competition is completely lacking in both the in-center and home hemodialysis markets. We find here instead, a monopoly in Home Hemodialysis and a Duopoly with in-center dialysis, that stifles physician and patient control over treatment paradigms. Today, Fresenius and DaVita have overt control over dialysis prescriptions, machines, supplies and protocols. Fortunately, in the Acute Kidney Dialysis Market, freedom is still a word you can use truthfully and appropriately, when we consider the freedom that critical care doctors, ICU nurses and nephrologists have because of economic competition in the Acute Kidney care realm of dialysis in the ICU.

While it may be too late to positively impact free market competition in the chronic dialysis population short of anti-trade actions by the FTC and the DOJ, we should cherish the freedom found in the ICU for dialysis care. It is easy to recognize the cognitive dissonance between the hundreds of academic articles debating dialysis protocols that deny TIME as an independent factor of ESRD, dialysis mortality in chronic kidney care ICU dialysis protocols. The ICU docs understand well that longer, slower and more frequent is the winning dialysis protocol for patient survival. Perhaps, some of the nephrologists advocating that TIME and Frequency do not impact mortality will one day carry over what they learn in the ICU to their chronic patients suffering the effects of "for-profit greed" that leads to Death and Deficiency in Kidney Treatment across this nation. 

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.

Men Will Live as Long as Women by 2030

By Peter Laird, MD

Historically, during the twentieth century, women lived longer than men by an average of over five years.  Finally, the statisticians are now offering men a ray of hope that they will actually live as long as their mates. Projecting current trends predicts a convergence of life expectancies for men and woman in the year 2030.

Heart disease classically affects men about tens years earlier than woman providing a partial answer as to why women live longer on average than men in the western nations.  Improvements in the treatment of heart disease is also at the center of the projected convergence. The good news for women is that their life expectancy is also continuing to increase, just not as rapidly as men.  That is the good news for all concerned.

The bad news is that the increased longevitys will pose more burdens upon the health care system. Medicare beginning at the age of 65 was initiated at a time when the average life span was not much longer than the retirement age itself. Today, many in their mid-sixties are still actively engaged and turn retirement into a time of leisure activities and travel. Improvements in health care are behind the progressive increase in longevity, but likewise comes at the price of ever increasing health care costs. While the convergence of longevity is good news for men, those that calculate actuarial costs in health care are left with one more paradox brought about by our own success in modern medicine.  

In a time of ever increasing budget constraints especially in health care, the costs of living longer may in itself adversely affect these trends. No one can predict the future with any degree of accuracy, but I would rather have to deal with living longer and wondering how to pay to stay alive, than to not have to worry about the latter issue.  Sadly, there is no convergence expected for when men will be as intelligent as women as my wife will readily attest.

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.

EPO: Lighting the Fires of Cancer

By Peter Laird, MD

Erythropoietin (EPO) is a natural hormone that mediates the production of red blood cells (RBC's) that is primarily produced in the renal cortex and small amounts in the liver. Studies over the last decade evaluated the effects of  EPO in diverse populations at risk of anemia outside of the renal dialysis patients, especially in patients undergoing chemotherapy for a variety of cancers. Unfortunately, these studies revealed adverse survival with more rapidly progressive cancers and shortened survival. In addition, in the CKD population, patients were more likely to experience cardiovascular events and death bringing the CHOIR study to an early close as well.  The TREAT trial followed shortly with a higher risk of stroke for patients treated with EPO for CKD related anemia.

Many patients sustained with EPO for years on dialysis vocally protested the new FDA labelling changes and the removal of minimum Hb levels in the QIP. Despite the increased risk of cardiovascular outcomes with EPO and the suspected increased cancer risk for chemotherapy trials, the correction of anemia for many patients overcame the potential risks. However, a new study highlighed by Gary Peterson of RenalWEB sheds light on the role of EPO not only in promoting cancer, but it is actually involved in the development of cancers as well:

PDGF-BB modulates hematopoiesis and tumor angiogenesis by inducing erythropoietin production in stromal cells

At the molecular level, we show that the PDGF-BB–PDGFR-bβ signaling system activates the EPO promoter, acting in part through transcriptional regulation by the transcription factor Atf3, possibly through its association with two additional transcription factors, c-Jun and Sp1. Our findings suggest that PDGF-BB–induced EPO promotes tumor growth through two mechanisms: first, paracrine stimulation of tumor angiogenesis by direct induction of endothelial cell proliferation, migration, sprouting and tube formation, and second, endocrine stimulation of extramedullary hematopoiesis leading to increased oxygen perfusion and protection against tumor-associated anemia.

Blood protein EPO involved in origin and spread of cancer

Angiogenesis is the formation of new blood vessels from pre-existing ones, and is one of the most important research fields in the treatment of such diverse conditions as cancer, metastases, obesity, heart disease, stroke, diabetes and chronic inflammation. The process is also important in healthy individuals for wound healing, the menstrual cycle and other normal processes. Professor Yihai Cao and his team are researching into angiogenesis and its links to cancer and other diseases, and in the present study show the significant role played by a growth factor, PDGF-BB.

"It's a member of the PDGF family and significantly contributes to blood vessel development, which is one of the characteristic signs of cancer, says Professor Yihai Cao. Our preclinical findings suggest that PDGF-BB causes systemic effects in the body, which is to say that rather than being active locally it goes into the blood and interferes with the function of several organs so that the entire body is affected."

As a cancer survivor in addition to my IgA nephropathy and dialysis, I have been very leery of EPO right from the time I first started on dialysis in 2007. My first confrontation with my health care team at dialysis came about when I refused to continue EPO shortly after beginning dialysis. In retrospect of current guidelines, I never needed EPO with a Hb over 12.0 with only iron infusions alone. The issue of adverse cardiovascular outcomes and now this new basic science information that EPO is involved in cancer formation leaves dialysis patients with hard choices. EPO prevents the need for blood transfusions and their associated complications, but at what price?

The for-profit dialysis industry made billions of dollars pushing higher and higher dosages of EPO to their patients prior to the bundle. The cardinal duty of physicians is to first do no harm. As we evaluate each and every aspect of dialysis care in America, it keeps coming up short every time.  The irony is that we are spending billions of dollars for a genetically engineered medicine that is supposed to reduce pain, suffering and enhance our lives. Instead, the evidence is mounting on the dangers of EPO. The debate will continue especially since many dialysis patients fail to respond to iron supplementation alone. Blood transfusions for many are an unacceptable rescue method.  In an era of uncertainty, EPO may be too risky to justify it's continued use. Adding the risks of cardiovascular disease and cancer  together may render the issue of informed consent between doctor and patient on whether to use EPO instead in the hands of the FDA and further black box warnings.

 

America's Children Will Die Earlier than their Parents From Heart Disease

By Peter Laird, MD

America aggressively addressed our high rates of cardiovascular disease beginning in earnest with the Framingham Study that derived many of the known cardiac risk factors.  Aggressive control of these risk factors has lowered the prevailing rates of heart disease through dietary moderation, smoke cessation, cholesterol lowering, exercise and reducing diabetes complications. However, there are several areas of concern for the teenagers of today who are already beginning to show the signs of early cardiovascular disease.

Childhood obesity and adult onset diabetes during the teen years are now commonplace. Children today lack the daily exercise from play as was common in the past nor are they eating diets from fresh vegetables and produce. Sedentary lifestyles and processed foods are to blame for many of these findings. The NEJM published a recent report on the obesity epidemic among the young and predict that these characteristics can be reversed:

Childhood Adiposity, Adult Adiposity, and Cardiovascular Risk Factors

CONCLUSIONS

Overweight or obese children who were obese as adults had increased risks of type 2 diabetes, hypertension, dyslipidemia, and carotid-artery atherosclerosis. The risks of these outcomes among overweight or obese children who became nonobese by adulthood were similar to those among persons who were never obese. (Funded by the Academy of Finland and others.)

Despite the fact that reversal of adiposity early in life can also reverse the cardiovascular risk, there is little evidence that the interventions designed to combat childhood obesity have had any positive effects:

Today's Teens Will Die Younger of Heart Disease, Study Finds

"Cardiovascular disease is a lifelong process," Lloyd-Jones said. "The plaques that kill us in our 40s and 50s start to form in adolescence and young adulthood. These risk factors really matter."

"After four decades of declining deaths from heart disease, we are starting to lose the battle again," Lloyd-Jones added.

The American Heart Association (AHA) defines ideal cardiovascular health as having optimum levels of seven well-established cardiovascular risk factors, noted lead study author Christina Shay, who did the research while she was a postdoctoral fellow in preventive medicine at Northwestern's Feinberg School. Shay now is an assistant professor of epidemiology at the University of Oklahoma Health Sciences Center.

"What was most alarming about the findings of this study is that zero children or adolescents surveyed met the criteria for ideal cardiovascular health," Shay said. "These data indicate ideal cardiovascular health is being lost as early as, if not earlier than the teenage years."

Dealing with heart disease in the 30's and 40's is fortunately rather rare today, but will become the new norm in decades to come. Sadly, the ability to counteract this growing epidemic is readily at hand by promoting healthy eating habits, exercise and weight loss. In many ways, the older generations are now more physically fit than their children and grandchildren who spend many of their waking hours with electronic toys and devices. Lack of cardiovascular health will not only cost America precious lives, but will also tax the health care system  with the younger generations chronic health conditions at the very time that the majority of the baby boomers face their own health issues.

The financial crises that is generated by this medical calamity will leave few untouched. It is time for parents to take account of physicial activity as one of our most important national treasures for our children. It is time for individuals to reverse this legacy and simply do what is right. The solutions are at hand, if only we have the will.

Is Peritoneal Dialysis the Optimal Choice for America?

By Peter Laird

In the last several weeks, there have been several medical journal reports on the benefits of peritoneal dialysis (PD) for patients and for the American ESRD program. Patients on PD have similar outcomes to patients treated with standard in-center hemodialysis at a much reduced cost to the tax payers funding the ESRD program.  Many are advocating that PD become the default dialysis modality of choice.

The Path Not Taken On Dialysis

If half the new dialysis patients in the U.S. chose PD over HD, Medicare could save more than $5 billion a year. The additional counseling needed to get to those rates might even jump-start the long overdue conversation about why so many people do so poorly once they’re on dialysis; why so many have failing kidneys in the first place; and what preventive measures can be taken to deal with this burgeoning public health fiasco.

The "news" that PD has similar outcomes to HD is not really a new report at all.  Similar outcomes have been documented for more than two decades. What is new according to the latest study is that the 5 year survival remained equal instead of dropping off after two years in prior reports. While this is good news for those that choose PD as their primary dialysis modality, the grim news is that the median survival for PD patients on average is only three years.

Similar Outcomes With Hemodialysis and Peritoneal Dialysis in Patients with End-Stage Renal Disease

Results  There was progressive attenuation in the higher risk fo death seen patients treated with PD in earlier cohorts; for the 2002-2004 cohort, there was no significant difference in the risk of death for HD and PD patients through 5 years of follow-up. THe median life expectancy of HD and PD patients was 38.4 and 36.6 months, respectively. Analysis in 8 subgroups based on age (<65 and  65 years), diabetic status and baselinecomorbidity (none and  1) showed greater improvement in surval among patients treated with PD relative to HD at all follow-up periods.

Once again, while this is good news, it is not the same level of improved survival that we see with the recent short daily hemodialysis report in the FHN, nor is it at the level of cadaveric transplant survival that we have seen with nocturnal hemodialysis on a daily basis that Pauly reported on in 2009 where median survival is greater than 10 years.

Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients

Results. The total study population consisted of 177 NHD patients matched to 1062 DTX and LTX recipients (total 1239 patients) followed for a maximum of 12.4 years. During the follow-up period, the proportion of deaths among NHD, DTX and LTX patients was 14.7%, 14.3% and 8.5%, respectively (P = 0.006). We found no difference in the adjusted survival between NHD and DTX (HR 0.87, 95% CI 0.50–1.51; NHD reference group), while LTX survival was better (HR 0.51, 95% CI 0.28–0.91).

Conclusions. These results indicate that NHD and DTX survival is comparable, and suggest that this intensive dialysis modality may be a bridge to transplantation or even a suitable alternative in the absence of LTX in the current era of growing transplant waiting lists and organ shortage.

In addition, home hemodialysis compares very favorably with home PD for cost savings benefits when the direct and indirect costs of care such as preventable hospitalizations is utilized in the analysis.

Cost savings of home nocturnal versus conventional in-center hemodialysis

HNHD provides about three times as many treatment hours at nearly a one-fifth lower cost, with savings evident even when only program and funding-specific costs are considered.

Dr. Victoria Kumar, et al, at Kaiser Permanente in Southern California reported a direct comparison of observational results of their home PD and home SDHD patients showing a significant benefit to the home hemodialysis cohort in reduced hospitalizations and over all complication rates.

Costs of Home Hemodialysis Offset by Better Health, Fewer Hospitalizations

Daily hemodialysis administered in patients’ homes is associated with better health outcomes compared with peritoneal dialysis, according to an article in the October issue of the American Journal of Kidney Diseases, the official journal of the National Kidney Foundation. . .

Dr. Kumar’s group treated the 22 patients in the daily hemodialysis group and the 64 in the peritoneal dialysis group for at least 6 months between 2003 and 2007. The groups were comparable in age, the number of patients with diabetes, and causes of kidney failure..

Despite these similarities, patients treated by peritoneal dialysis spent nearly twice as many days each year in the hospital compared with patients treated with home hemodialysis (average 5.6 days/patient-year versus 3.3 days/patient-year).

Those treated by daily home hemodialysis were also able to reduce the number of medications required to keep their blood pressure under control, and had better nutritional status than they did prior to starting treatment, as shown by higher serum albumin levels.

In addition, there are certain patient groups who do substantially worse on PD than on HD.  These include morbidly obese patients and patients with CHF, which is the number one complication noted in hospitalized ESRD patients.

Impact of dialysis modality on survival of new ESRD patients with congestive heart failure in the United States

Results The overall prevalence of CHF was 33% at ESRD initiation. There were 27,149 deaths (25.2%), 5423 transplants (5%), and 3753 (3.5%) patients lost to follow-up over 2 years. Adjusted mortality risks were significantly higher for patients with CHF treated with peritoneal dialysis than hemodialysis [diabetics, relative risk (RR) = 1.30, 95% confidence interval (CI) 1.20 to 1.41; nondiabetics, RR = 1.24, 95% CI 1.14 to 1.35]. Among patients without CHF, adjusted mortality risk were higher only for diabetic patients treated with peritoneal dialysis compared with hemodialysis (RR = 1.11, 95% CI 1.02 to 1.21) while nondiabetics had similar survival on peritoneal dialysis or hemodialysis (RR = 0.97, 95% CI 0.91 to 1.04).

Conclusion New ESRD patients with a clinical history of CHF experienced poorer survival when treated with peritoneal dialysis compared with hemodialysis. These data suggest that peritoneal dialysis may not be the optimal choice for new ESRD patients with CHF perhaps through impaired volume regulation and worsening cardiomyopathy.

When cost savings and survival benefits are fitted into the same discussion, home nocturnal hemodialysis is very comparable to PD for overall costs at the same time it is also very comparable to cadaveric renal transplant survival. Looking at the issue of what should be America's default dialysis treatment modality when patients are not able to do a preemptive transplant, in my opinion, that default standard of care should be first line home nocturnal hemodialysis.

Home nocturnal hemodialysis is not the treatment of choice for all patients due to underlying factors including the ability to self cannulate and having supportive family resources available, but as many as 30% of patients starting dialysis could utilize this life saving technology by many estimates. New Zealand has over 25% of its ESRD population on home hemodialysis as proof that high numbers of people can be helped in this manner.

When comparing all aspects of renal replacement therapy, although PD is an excellent and right choice for many, using it as the default standard of care in America is not going to correct our high mortality rate that home nocturnal dialysis does address at a significant cost savings to the system and significant health benefits to the patient. In my opinion, home, nocturnal hemodialysis is the firstline treatment that should be the gold standard of care offered to all eligible patients at the onset of renal replacement therapy for ESRD when transplant is not an immediate option.

Get a Flu Shot and Avoid a Heart Attack

By Peter Laird, MD

The Canadian Medical Association Journal has an interesting report on preventing heart attacks during the cold and flu season by a simple adherence to obtaining the annual seasonal influenza vaccine.  Siriwardena, et al report their findings in the article: Influenza vaccination, pneumococcal vaccination and risk of acute myocardial infarction: matched case-control study.

Influenza vaccination within the past year was associated with a 19% reduction in the rate of acute myocardial infarction among patients aged 40 years and over. Influenza vaccination administered within influenza season was also associated with a significant reduction (20%) in the rate of acute myocardial infarction. We found that early vaccination within the influenza season (i.e., September to mid-November) was associated with greater benefit than vaccination later in the season (21% v. 12% reduction in the rate of acute myocardial infarction compared with no vaccination). Pneumococcal vaccination or combined vaccination had no additional benefit compared with influenza vaccination alone. 

Influenza vaccines are well tolerated by the majority of patients and work well to also prevent the secondary pneumonia that often follows the flu.  It does so by protecting the internal lining of the lungs that is damaged by the influenza virus. We can now add the further benefit of preventing heart attacks in those that obtain flu vaccines, especially those in the very beginning of the flu season.  I am no fan of needles in general, but a shot in the arm is good protection especially for high risk patients such as those with diabetes or chronic kidney disease.

 

Reducing side effects of Statins

By Peter Laird, MD

One of the most difficult aspects of cholesterol management for both the patient and the doctor is dealing with the several different side effects of statin therapy.  In all of the years of prescribing statins, I only had one patient that developed myositis from the statin therapy which was stopped in time to prevent serious injury, but he never fully recovered his prior strength.  He was quite  a remarkable man.  I first met him while doing a hospital intake during the middle of the night.  

I did a complete examination, but only with him in his bed.  The next morning, I came back to reevaluate his status and this time he was standing up beside his bed. It was the biggest double take I have ever taken.  Standing before me was a man who was in his words, "5 foot 20 inches," yup 6 feet and 8 inches tall, most of it in his legs.  He tells me he was the tallest man allowed in the Navy in WWII.  Who can argue with someone "5 foot, 20 inches tall." 

Yet, for many patients, stopping statins is all too frequent.  The Mayo clinic established a specialty clinic dealing specifically with Statin Intolerance.  Listen to Dr. Kopecky describe some of his findings in this research: