RenalWEB Perspective

2009 Boston ESRD Conference Summary
by Gary Peterson, RenalWEB™
April 30, 2009 (with some additions and edits made May 2nd)

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This article is only meant to be a summary of personal observations and impressions formed at the April 23-26, 2009 conference “ESRD: State of the Art and Charting the Challenges for the Future” which was held in Boston and was sponsored by the Harvard Medical School Department of Continuing Education. This article is for general information purposes only and does not constitute business, medical, or professional advice. In the spirit of the conference, it is meant to be somewhat provocative. Other conference attendees may have differing opinions. However, I believe nearly everyone appreciates someone sharing their personal views and ideas on complex topics. A final word to patients: medical and therapeutic decisions should be made with a qualified health care provider, …but be careful who you trust.

You will be reading and hearing about this conference in the days, weeks, months, and years to come. I believe tens of thousands of patient lives will be saved each year due to practice changes arising from outputs of this conference. It was evident that there are several things we can do to make immediate improvements in patient survival in our dialysis facilities. As usual, the meeting identified several more areas where randomized clinical trials are needed. It also planted the seeds for badly needed change in dialysis care.

Including faculty, there were 165 attendees. I was struck by the amount of white hair in the audience. There were very few young nephrologists. I did see a few nurses, but no patients. The historical depth and scientific breadth of the presentations was impressive, but I had to wonder how interesting or relevant it was for the young nephrologists who don’t even know who Frank Gotch is. I think they just wanted to know what they should do.

The conference was held because so little progress has been made since a similar conference was held in 1989 in Dallas. 20% of dialysis facility patients still die each year. Mortality rates in the US are higher than in Europe and are much higher than in Japan. We spend $34 billion/year on ESRD in the US. $20,000/yr per patient is spent on hospitalizations. Less than 20% of patients are rehabilitated. The survival rate is no better than that for colon cancer patients.

115,000 patients will start/restart dialysis this year. There are now about 400,000 dialysis patients in the US. The incidence rate has slowed. The projection for 2020 is that there will be 533,800 dialysis patients. Patients are living a little longer on dialysis, but the first year mortality rate has not changed in 12 years.

Good treatment? Good doctors?

Kt/V and short, three-times-a-week hemodialysis treatments were cumulatively trashed. There were no defenders. Kt/V was portrayed as bad science and bad for smaller patients. As examples, longer treatment times (t) improve survival, even when the Kt/V remains the same. Larger body water volumes (V) by themselves also improve survival. Yet, our government regulations are defined in terms of Kt/V. It also may have led to the mis-design of the HEMO study, which failed to show statistically significant benefits of longer dialysis.

The traditional clinical outcome measures, biochemical markers and treatment parameters, only account for 14% of the mortality differences seen in dialysis facilities. Instead of looking only at traditional data reported to central databases, we need to be looking at more variables at the clinic and patient level. There’s a lot we don’t know or consider. A whole lot of things like depression, patient comfort, care post-hospitalization, staff and patient education, family factors, spirituality, and much, much more.

The one-formula-fits-all approach of prescribing dialysis therapy is finally being questioned. An individualized approach that delivers appropriate care to those that need it is long overdue. A young, employed person on dialysis obviously needs to get longer and/or more frequent dialysis treatments than a cancer patient receiving palliative care. Also consider that Europe is increasingly using hemodiafiltration, which significantly lowers morbidity and mortality.

So many problems disappear when patients are dialyzed more. Short, 3/wk hemodialysis treatments stack the odds against the patient living a long, productive life. The Frequent Hemodialysis Network studies that are expected to show substantial benefits of more frequent hemodialysis won’t be out until late 2010/early 2011. Until then, it appears many will continue to use outdated clinical guidelines based on bad science. However, many clinicians have figured out on their own that Kt/V just doesn’t work for many of their patients. Sometimes the best medicine is just using common sense.

Dr. Alan Hull stated that he believed nearly all medical directors would choose NOT to dialyze in their own facilities if they were facing ESRD. Instead, they would choose home dialysis. Another speaker questioned exactly for whom the medical director is an advocate: the patient or the clinic or even himself? Is patient advocacy best served by regulation or the professionals’ culture? Another speaker stressed that we should view monopolies circumspectly.

Dr. Hull bluntly asked, “Why do you tolerate 3-times-a-week in-center hemodialysis?” The corrupting influence of corporate medical director fees was raised. To drive the point home, perhaps he should have mentioned the history of EPO doses and their reimbursement, too.

Dr. Hull noted that today there are important personal touches missing from the patient/physician relationship. Dr. Ray Hakim said simply doing rounds from a sitting position rather than standing over the patient makes a difference. In controlling hypertension, a powerful predictor of mortality in dialysis, Dr. George Bakris stressed that patient motivation is an essential factor that improves when patients have positive experiences and trust the clinician. Empathy builds trust and is a potent motivator.

Catheters/Infections

Fistula use is increasing, but catheters are being used longer. 82% of patients start dialysis with catheters. Hemodialysis catheters are the most frequent sources of serious infections. Infectious hospitalizations in the first year of dialysis have increased nearly two fold, which ordinarily would be considered a public health disaster. The number of hospitalizations for infections now equals those for cardiovascular causes. Once a patient is hospitalized for an infection, they have an increased risk of death that gradually falls, but never reaches the risk prior to the infection. The hemodialysis catheters have to come out. In peritoneal dialysis, catheter infection rates are much lower and are not seen as a problem. (PD continues to be a greatly underutilized therapy in the US.)

It was stated that differences in vascular access practices explain most of the mortality differences between Europe and the US. (I’m not completely sure about that.) This is, however, an obvious opportunity to improve care and outcomes in the US.

Most patients seen by nephrologists in the twelve months before dialysis initiation are not starting dialysis on fistulas. Dr. Tom Parker, one of the conference’s co-chairs, said nephrologists should not tolerate catheters and should get rid of surgeons who do. Another speaker said AV fistulas should be created at the same time hemodialysis catheters are inserted.

Unrecognized infections usually include vascular access infections, biofilm, periodontal disease, tunnel infections, and urinary tract infections. Infections greatly increase the risk of first myocardial infarctions and strokes.

Dialysis patients need to get their vaccinations. Less than 60% of dialysis patients get the flu vaccine. It should be over 90%.

Transitions in care

My opinion is that most nephrologists just don’t understand how important this is for patients. Life transitions, grieving, the depression, are all major parts of the ESRD experience. Dr. Hakim said that patients often need time to grieve the death of their kidneys. Dr. Parker has said that patients rarely complain that they are not getting evidence-based medicine. Dr. Hakim said patients want information, compassion, attitude, responsiveness, and (finally) expertise (using the first letter of each word, that spells “I CARE”). It appears that to be healthy mentally — and motivated to be medically compliant — patients need talk with their doctors about what is important to them individually. Not about lab tests.

There are very high death rates in months 2, 3 and 4 after starting dialysis. These abnormally high death rates decrease by the end of the first year. Some strongly feel the reason why the 1st year mortality has not changed for 12 years is that patients are being referred to nephrologists too late in their chronic kidney disease (CKD) stages. Hopefully, the CKD Toolkit developed by the Renal Physician Association will play a role in fixing this.

The FMC RightStart program has shown a 41% improvement in mortality for patients in the first three months of hemodialysis. It is individualized care focused on anemia, low albumin, high phosphorus, and the high catheter rate. Extra benefits can be gained by combining it with diabetes programs and including foot checks, eye exams, and examination of home glucose readings.

Many patients die shortly after returning to their dialysis facility after a hospitalization. FMC has started the RightReturn program to address this.

Cardiovascular

The biggest surprise of the conference was discovering what kind of heart disease is killing dialysis patients. It is NOT atherosclerotic (plaques and arterial stiffening) disease. It is uremic cardiomyopathy, characterized by left ventricular hypertrophy (LVH), LV dysfunction, and LV dilatation. The enlarged muscle walls of the left ventricle become fibrotic and fail to conduct electrical impulses correctly. With conventional treatment, the increased LV mass can regress to normal in only about 50% of patients. Treatments include more frequent dialysis, keeping the patient replete with vitamin D, and controlling phosphorus. Rapamycin and other emerging pharmaceuticals appears promising in helping treat this cardiac fibrosis.

Cardiac fibrosis is the most powerful predictor of survival in hemodialysis patients. Thus, sudden cardiac death is the #1 cause of death for dialysis patients, accounting for 59% of cardiovascular-related deaths. It occurs most frequently on the day after the “two-days off” from a typical 3x/wk hemodialysis treatment schedule. Our prevalent modality (92% of patients) is deadly.

In terms of evidence-based medicine, the goal of ESRD care should be to save the left ventricle and lower LV mass. This fibrotic disease in the left ventricle is mainly caused by poor blood pressure control, poor volume control (interdialytic weight gains and not low enough dry weights), and too much salt. LVH is lower in PD patients. Longer and more frequent hemodialysis is strongly associated with much lower LVH. In Europe, they no longer use sodium modeling during conventional hemodialysis, as it is likely exacerbating the problem. High ultrafiltration rates (UFR>10ml/h/kg) also increase mortality risk

Rigorous control of blood pressure and volume is needed, and you simply can’t get there with conventional hemodialysis therapy (short 3x/week). Perhaps the combination of PD and HD could do it. A modest decrease in dry weight corrects blood pressures. The government should consider paying for monitoring devices. The aldosterone antagonist Spironoactone appears to help lower BPs with no change in serum potassium.

In terms of predialysis blood pressure levels and survival, higher systolic BP (>160) and lower systolic BP (<130) are associated with elevated mortality risk. If you have stiff ventricles, a lower BP is worse than a higher BP. This is not consistent with current KDOQI Guidelines (<140).

Neglected cardiovascular risks include depression, sleep apnea, and disrupted biorhythm. Sleep apnea and the associated oxygen desaturation is a huge problem causing many deaths. Nocturnal dialysis appears to have a huge impact on improving this.

Nutrition/Inflammation

True malnutrition (not eating enough) in dialysis patients is rare. Almost all malnutrition seen in dialysis patients is due to inflammation. Inflammation is episodic in dialysis patients.

Malnutrition in dialysis patients is best addressed by reducing inflammation. Low albumin levels greatly increase the risk of death, but albumin is an insensitive marker of inflammation. However, even small changes in the albumin level have a huge effect on mortality. Efforts to raise albumin should include a lot of dietary counseling (tell patients to eat well and stay well-dialyzed, instead of emphasizing what not to eat), and possibly IDPN and oral supplementation. Albumin synthesis actually decreases when albumin levels decline. High flux membranes help patients with low albumins. And just giving IV albumin doesn’t help in the long run.

C-reactive protein (CRP) is a marker of inflammation, not an actual risk factor. IL-6, a greater risk factor when elevated, predicts poor outcomes in ESRD. Inflammation biomarkers consistently predict poor outcomes in dialysis patients. Inflammation is a multiplier of mortality risk.

Low LDL and low total cholesterol are associated with inflammation, both of which lower survival in dialysis patients. Muscle wasting and frailty are associated with inflammation. Studies over the decades have shown better survival is always strongly associated with higher albumins and creatinines.

ESA utilization (EPO resistance) and anemia are markers of inflammation. Both iron absorption and iron recirculation are affected by inflammation. As humans beings, we have evolved over millions of years to NOT absorb iron when we are inflamed, but that doesn’t keep nephrologists from trying.

Less inflammation is seen in Asian dialysis patients.

Inflammation may cause depression and loss of appetite.

Short, daily hemodialysis therapy greatly reduces CRP. Getting rid of HD catheters significantly reduces inflammation, and to lesser degrees, so does ultrapure water/dialysate and biocompatible dialyzers. These interventions also reduce EPO requirements.

Among the easy things to do to reduce inflammation is to get patients to their dentists and to do foot exams, especially in diabetics. Exams or self-exams of feet once a week will reduce amputations by 50%. If necessary, buy mirrors for patients.

Omissions

EPO overuse was not discussed nor considered as a cause of mortality! Considering the program sponsors, I guess no one is ready to talk about this yet.

There was insufficient mention of the work being done at UCLA by Dr. Brennan Spiegal and his colleagues. They found that you can take two facilities with the same case mix, Kt/V, time on dialysis, albumin levels, etc – all the usual biochemical and treatment measurements – the outcomes can vary as much as 39%. It was hinted they have examined over 150 variables such as personnel issues, communication patterns, patient education, facility environment, staff morale, etc. – and have found many of them have significant impacts on patient survival.

The psycho-social factors in patient survival and well-being were not discussed in any detail. The effects of the patient/physician relationship were only mentioned briefly. Several speakers mentioned the need to address depression, but only Dr. Ritz spoke of this in detail during his talk on cardiovascular-renal problems. How important is it? When patients self-diagnose depression, they have a 48% higher risk of death.

In private conversations I found many nephrologists were willing to say that they found the patient’s “will to live” and “reasons to live” to be immensely important factors in survival. In the end, I believe that we will find that psychological, cultural, spiritual, and other non-biochemical factors actually make up more than half of the overall picture in dialysis patient survival. Evidence-based medicine doesn't address the whole patient. Patient-to-patient mentoring could have a huge impact.

There was no mention of profit vs. non-profits.

As for financial incentives, I believe a one-size-fits-all pay-for-performance system will do a great disservice to patients. There should be financial incentives for nephrologists and providers to help more patients return to work and participate in their communities.

There were no presentations by long-term patients.

Final comments

86% of the variables that effect patient outcomes are currently not known or routinely considered in the routine corporate reports. Talk about opportunities for improvement. Anyone that claims they are providing the highest possible quality care for patients simply doesn’t know what they don't know.

This conference was held because the survival rate for dialysis patients has not significantly improved in the last twenty years. I think it is always good advice to “follow the money” in trying to understand a complex situation. Currently, corporate profit-sharing with doctors and nurses probably works against the patients. The corporate model that dominates US dialysis care today is based on paying back enormous junk-bond debt, keeping the stock price up by minimizing spending on patient care, and ultimately serving stockholders instead of patients. Not unlike the financial markets, it will fail us spectacularly, if it hasn’t already.

If you consider the bad science, poor transitional care, high mortality rate, a deadly prevalent modality, excessive catheter use, and the fact that virtually no US nephrology professional would dialyze in their own facilities, I think everyone in this industry has to ask themselves whether we are worthy of the patients’ trust …or respect.

Gary Peterson, RenalWEB
April 30, 2009
(some additions and edits made May 2, 2009)

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The opinions and beliefs expressed in this article are solely those of the author.


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