KIDNEYBLOG

Don't lose sight of the big picture in health care

2011-10-31T09:38:00.000-07:00

I went to the Okavango Delta this summer. We were supposed to be hearing a discussion about the indigenous grasses of South Africa. Somehow I just couldn't focus. This photo typifies health care in the USA. We are all trying to follow an agenda, which is at best a blur when one gets sight of the big picture. We complain about the high costs of the transition to dialysis, yet...

82 percent of patients start dialysis with a catheter instead of a permanent access.

SOURCE: USRDS

Dialysis is the end stage of a disease that all too often with proper nutrition, medications and care could have been avoided.

Qais Al-Awqati's KI Editorial 2006 Kidney International 69:1707-1708, 2006
Tufts - Sweetening the Pot GDAE Policy Brief No. 09 - 01 February 2009

Some elderly patients do not do well with dialysis because of multiple comorbid conditions. Starting patients too early does not help

Dialysis or not? A comparative survival study of patients over 75 years with chronic kidney disease stage 5 Nephrol. Dial. Transplant. (2007) 22 (7): 1955-1962.
Predialysis nephrology care of older patients approaching end-stage renal disease. Arch Intern Med. 2011 Aug 8;171(15):1371-8.

We have a shortage of nurses, yet are not doing well in promoting home care or self care for our patients

SOURCE: USRDS
American Association of Colleges of Nursing Nursing Shortage

We fail to adequately correct for volume in dialysis patients

Dick Glassock's CJASN article CJASN December 2009 vol. 4 no. Supplement 1 S79-S91

CKD 2011 (The Fadem Symposium) A huge Success

2011-10-15T13:18:00.000-07:00

Since 1988 the National Kidney Foundation has sponsored a symposium in Houston. It has always featured top experts. This year was no exception. Many new concepts were revealed to the Houston community of nephrologists, nurses, administrators, social workers and dietitians. Myles Wolf started the sessions, and presented key new data from his recently published JCI article J Clin Invest doi10.1172/JCI46122. This showed that FGF-23, a hormone that rises to keep the serum phosphorus in balance in CKD, was directly toxic to cardiomyocytes, leading to an increase in cardiomyocyte, hence left ventricular hypertrophy. This was independent of klotho, previously thought to be needed for FGF-23 activity. It was demonstrated with an antibody that neutralized FGF-23. Also, in animals treated with that antibody, 1,25 OH D3 levels normalized. This has several implications: 1) it makes it desirable to want to keep FGF-23 levels low in CKD – and since the antibody is not available as a pharmaceutical (yet), we should try to minimize inorganic phosphorus intake. 2) it suggests that vitamin D activation is impaired by FGF-23, not because of reduced renal mass.

Tom Golper’s talk highlighted a paradigm shift in thinking of long term strategies when planning dialysis therapy. He also brought out that in the elderly population with multiple comorbidities, the outcomes were no better with dialysis than without. There are now several studies demonstrating this NDT (2007) 22(7):1955-1962..

Allen Nissenson outlined the need to integrate health care. The current health delivery system that splits care among a variety of different providers and competing resources is wasteful, and even with the strictest varieties of health reform, will never be cost effective. It is not sustainable. The best system is to have an accountable organization manage the patient’s health care. Concerns that large non-renal groups, be they hospitals or health plans, will not focus on the care that our patients require, and that decision making is best made by those providers and physicians who are highly familiar with kidney patients' special needs.

Amy Friedman started her lecture by asking each of us to look around for a spare kidney, under chairs in bags - and they must be live kidneys. (None found). If we could not find any, she would have to give her talk. She started with the UNOS dialysis trends – there are over 112,000 people waiting for a transplant (UNOS). In her discussion, she went over terminology changes that were more sensitive to the feelings of donor family members whose loss led to the gains some of our patients enjoyed. (The concept of mourning transcends human experience, as evidenced by the National Geographic quality photographs she took in Puerto Rico of a gila monster grieving over the death of another). She focused on the need for more organ donation, particularly through using extended criteria donors – matching older patients who needed a transplant with kidneys that were recovered from a like population that might be too risky for a younger population. She also focused on the barriers to a successful transplant. Sadly, some of these barriers are regulatory. Doing special viral testing within a few hours of a transplant would only increase ischemia time, and lessen the changes for a successful kidney. Another conundrum revolves around outcomes management. According to outcomes criteria the late Steve Jobs, the well loved founder and CEO of Apple, would have been a poor choice for the liver transplant he received June 23, 2009 because he did not survive for three years afterwards. However, in the two years he did survive he introduced to the world amazing products, including the iPad many of us are using at this moment. There is, however, no app to tell us exactly who will and will not do well with a liver or kidney, and human input and sound clinical judgment are still invaluable.

The day ended with Dr. Emil Abdulhayoglu talking about the various types of AV access. In addition to the standard definitions, however, he explained in a simple and understandable way, the physics that leads to varying outcomes between the different types of access. He very skillfully explained the clinical assessment of a fistula, emphasizing the need to feel the thrill along the fistula tract. The consequences of venous scar build up are venous stenosis or obstruction. Scar formation can appear very early after surgery. One drawback is that the resultant stenosis interferes with the normal maturation of the fistula wall, and the venous wall never develops the muscular change that enables it to seal off after a needle stick. All too often we encounter an infiltration when attempting to cannulate a young fistula that has not properly matured. This failure to mature is likely the result of obstruction that is easily repaired through early intervention prior to the initial cannuation attempt.

A few hiccups with audiovisual equipment not working properly were mostly a nuisance, but did not interfere with the speakers' messages. Unfortunately, Tom Parker was unable to make the symposium as planned, and the audience missed hearing one of the finest doctors in our profession speak to how we can improve the care of our patients. But, Dr. Parker promises to reschedule his trip to Houston, and will be welcome at CKD2012.

Stay tuned for information about the next symposium.

Steve

The Dimensions of Dialysis

2010-11-10T21:38:00.000-08:00

The Dimensions of Dialysis
by Stephen Z. Fadem, M.D., FASN
A Response to God Help You, You're on Dialysis
Atlantic Magazine, December 2010

God Help You, You’re on Dialysis is an investigative journalism article that appeared in the December 2010, Atlantic Magazine. It tries to explicitly highlight everything that is wrong with dialysis. This dismal picture, however, is strictly one-dimensional.

Dialysis has emerged and progressed since 1972 as a life-saving gift to people who earlier would have died. In 1969, while in medical school, I saw a four-year-old African American child die with uremia because he did not qualify for dialysis. Through the years since then we have honed our skills and greatly expanded the dialysis program. In many countries, there is no government financial support of dialysis therapy, and as a result those patients who cannot afford care succumb to their illness. We now dialyze an older set of patients and have less hospital time. We are identifying outcome measures that simply do not work, and creating plans to identify and strongly support those that do. We are looking at what is best about dialysis in other countries and incorporating that into our efforts to care for patients. At the same time, we are now more focused on the quality of life and on educating patients well before they ever require dialysis. In this fashion many patients can select to preemptively undergo a kidney transplant or choose a home dialysis modality. Other patients with concurrent morbid conditions may elect not to choose dialysis at all. All of this progress is made despite wanton cuts in funding and critical nurse shortages. Sadly, many patients who enter a dialysis program missed an opportunity earlier in their lives to control their lifestyles and eating habits. The results of uncontrolled obesity, cardiovascular disease, diabetes or hypertension are comingled with inexorably progressive kidney failure.

Like the muckrackers of the early 1900s, whose model was to selectively report the sensational negative aspects within an industry, the author of this paper only looks in one direction. The name muckracker was attributed to Theodore Roosevelt. It is memorialized in a speech that is just as timely today as it was 100 years ago.

“... you may recall the description of the Man with the Muck-rake, the man who could look no way but downward with the muck-rake in his hands; Who was offered a celestial crown for his muck-rake, but who would neither look up nor regard the crown he was offered, but continued to rake to himself the filth of the floor.”

The facts are there; there are problems within the dialysis profession. Many patients come to dialysis poorly prepared, having been poorly educated as to what to expect. Alternate therapies have not been explained to them; they do not have an appropriate access placed, and are unaware of their responsibilities toward their care.

The have been cuts in the program; it is an entitlement and thus engenders a negative reaction among those who are trying to create a fiscally responsible government. Worse, the fear of what will happen next, as new cost containment initiatives are rolled out, has been very unsettling.

In dealing with very human issues, mistakes happen. Unfortunately catastrophes occur in a small minority of instances. Our profession at large is very aware that the potential for an accident or an infection is high by the nature of what we do, and we strive hard to meet our task with an abundance of caution. Most instances are “near misses” and lead to quality improvement processes that improve the system. Ineptitude is strongly addressed internally through counseling, retraining and sometimes employee termination. Some instances of negligence lead to unexpected outcomes, and are dealt with in the court system, and sometimes through state or federal sanctions.

Dialysis facility inspections are performed less frequently because of the lack of well-trained surveyors at the state or federal level. However, internal surveys are regularly performed. A survey at any level is very helpful to a dialysis center – we welcome it an important tool in pointing out deficiencies and weaknesses. It serves to enable the team to receive extra help and advice from outside experts. In the majority of instances there is a period of corrective action followed by another survey. During this time the facility retrains its employees and works through process to develop a stronger infrastructure. Many of these facilities go on to become model units. In some situations, they must close because they fail to meet the standards that not just surveyors, but peers and colleagues expect. Mischaracterization of these inspections through the media by investigative reporters is exciting copy, but harms the scope of a process intended to be corrective, not punitive.

Sadly, the author of this article missed an opportunity to look around at all the dimensions of dialysis, and instead chose the path of the muckrakers of the past, just looking downward and raking filth.

Fadem's Flu Shot

2009-10-07T19:50:00.001-07:00

We had a lot of fun making this brief video, but the message is important: Patients with kidney failure and their health care workers need to minimize the spread of the flu in dialysis units. The flu is contagious, and can be deadly. Health care workers, like patients, should take the seasonal flu vaccine. This is because if we contract it, we can spread it to patients, who often because of an attenuated immune system, are at a high risk of having a complicated course and a bad outcome. Although low grade fever, aches, soreness, site redness and swelling may occur, these symptoms are self limiting, lasting only one to two days.

The flu shot is made with killed, inactivated virus, so it cannot give you the flu. The side effects of the flu far outweigh the one to two in a million chance of having a serious adverse reaction like Guillain-Barre Syndrome.

Patients undergoing dialysis, as well as those who care for them, should be vaccinated to minimize the risk of the flu's consequences and spread. If you would like more information about the flu shot please contact the CDC - http://www.cdc.gov/flu

The flu shot that I took in the video was the seasonal flu shot. It should start working in about two weeks. This vaccine contains the H3N2 influenze A virus, the seasonal H1N1 virus (not the 2009 Swine Flu H1N1) and a B virus. This vaccine does not protect against the H1N1 2009 swine flu. That is a different vaccine. It was just issued, and is currently available as a nasal inhalant. Right now we are not in flu season so those who develop flu-like symptoms most likely have the actual swine flu. There is an online H1N1 flu self assessment test that one can take to determine the likelihood of having the H1N1 Swine flu. Here is the best resource for swine flu: http://www.cdc.gov/H1N1FLU/

Are You Ready For Disaster

2009-07-21T17:11:00.000-07:00

THE KCER PATIENT ASSISTANCE VIDEO

There are several types of disasters - hurricanes, tornadoes, icestorms, floods, earthquakes, wild fires. If you are a dialysis patient these present an extra set of circumstances because you may not have access to a dialysis center. Patients should prepare in advance for a disaster regardless of the type, know exactly what they will need to do during the disaster, and have a plan for afterward.

This video was written, created and produced for KCER by Drs. Steve Fadem and Garry Hagstrom. Drs. Fadem and Hagstrom are both veteran nephrologists who have been through several hurricanes and floods. Dr. Fadem has also participated in earthquake rescue seminars in Nepal and Israel.

Preparing for a disaster follows five easy steps - and can be remembered by the five letters R.E.A.D.Y. READY was first coined by the Texas ESRD Emergency Coalition, and is a simple way to remember how to get organized with your disaster plan.

R - RX (prescriptions) - have two weeks worth of medications ready to go, as well as prescriptions, physician numbers, allergies, and information that another facility will need (hepatitis B, tuberculosis status)

E - Emergency room - remember they will be backed up during the disaster. If you are volume overloaded or acutely ill, however, you might have to go there, so you must be familiar with their locations.

A - Access - this is not your fistula, but your phone numbers - key personnel in the dialysis unit, family members and others who will be able to help. Establish means of communication in advance. During a disaster your phone service and electricity may not work.

D - Diet and Fluids - Have a stockpile of nonperishable canned foods appropriate for you diet, and some fluids. Don't forget the can opener.

Y - You - these are the things you need to have. The public, your civic resources, Networks and dialysis units will all have plans in operation, but there are certain items that you are responsible for: where are you going to meet if you cannot get in touch with anyone by pone, and where are you going to go if you must evacuate? Don't forget you pet - its crate and food. You should have a packed bag of certain items you will need at a moment's notice. This is called the "Go" kit. Don't forget your batteries.

One gallon of water per day (8 bottles)
Ready to eat, non perishable food (don’t forget the can opener)
Plates, utensils and feeding supplies
Work gloves
Disposable camera
Personal hygiene items (soap, deodorant, cosmetics, toothbrush/paste and shaving equipment)
Hand sanitizer
Duct tape, hammer, nails and tools
Sleeping bag
Flashlights and batteries
Battery operated radio/TV
Whistle
Dust mask
Pocket knife
Cash
Sturdy shoes, clothing, hat and coat
Map, paper, sharpie
Waste bucket, toilet paper, plastic bags and a small shovel
One week supply of medications
Extra pair of eye glasses
Extra keys for your house (and car)

Prescriptions
Allergies
Dialysis Prescription
Immunization record (hepatitis B, antibodies, tuberculosis, flu shot, Pneumovax)
Contact numbers for doctors, dialysis personnel, your Network, NKF and KCER help lines, your dialysis company
Health Insurance Card

DaVita Joins EPA Green Power Partnership

2009-05-25T13:27:00.000-07:00

On May 12, 2009 DaVita, a large provider of dialysis services, announced that it is the first Fortune 500 health care services company to join the EPA (Environmental Protection Agency) Green Power Partnership. Through the use of renewable wind energy, the company will offset 10 million kilowatts of energy.

The Green Power Partnership is a voluntary program that supports the use of green power (renewable energy as opposed to fossil fuels) through offering technical support, expert advice, tools and resources. Through its cooperation with EPA, DaVita will be able to save enough energy to power 1,000 homes.

DaVita has made major efforts in the past to conserve energy – one of the most notable being the electronic signing of orders and rounding sheets, saving around 3 million sheets of paper, and more recently e-prescribing. In 2007 they developed “DaVita Village Green” and have focused on environmentally thoughtful purchasing, extensive use of e-mail, recycling of paper, as well as dialyzers and conservation of resources. Their reduction in the routine printing of data in their data centers is expected to save 20 million pieces of paper. Overall, their efforts will probably save around 3,000 trees per year.

DaVita stands in good company with its initiative; the Empire State Building just announced an effort to cut energy use by 38%, launching a 20 million dollar project. It is estimated that buildings use 40% of all energy consumed – and this is worldwide!!

This is quite belated for Thomas Edison, who in 1931 – the year the Empire State Building was completed, reportedly stated “I’d put my money on the sun and solar energy. What a source of power! I hope we don’t have to wait until oil and coal run out before we tackle that."

Disclaimer: Dr. Fadem is a DaVita Medical Director and Joint Venture Partner

What happens when doctors rely on invalid data?

2009-05-24T19:39:00.000-07:00

On April 15, 2009, the government announced that a 302 million dollars “qui tam” whistleblower settlement against Quest Diagnostics, Inc. The relator (whistleblower), Tom Cantor, will receive approximately $45 million dollars. Cantor is the owner of Scantibodies. This lawsuit was based upon parathyroid hormone assay kits sold to third party laboratories from 2000 through 2006 by now defunct Nichols Institute Diagnostics, Inc. Nichols was purchased and then shut down by Quest. The False Claims Act dates back to the Civil War, and permits private citizens to sue on behalf of the government and receive a reward if it can be demonstrated that the government has been defrauded.

The relator was able to successfully allege that Nichols continued to distribute these kits despite problems leading to inaccurate test results. In September 2005, Cantor published that as a consequence of a drift in parathyroid hormone (PTH) values, the dose of vitamin D analog required to suppress parathyroid hormone in ESRD patients and the number of subtotal parathyroidectomies increased.

The observations that Dr. Cantor demonstrated in Seminars in Dialysis, September, 2005 (1) are a sad example of just how frail our science can be when one relies just on a laboratory value and does not correlate it with the clinical picture. We are always taught, and continue to teach that one should look at the patient first and if the lab tests do not fit the clinical picture, repeat them. We should also rely on ranges that are assay specific and laboratory specific. What is normal in one lab may not be normal in another. This is not only true for PTH, but for many other tests – even the serum creatinine level!!

Since his article, the PTH assay has continued to be challenging. Serum biomarkers have always been unreliable as markers of bone pathology in renal disease (2, 3). Most doctors realize that PTH levels are neither accurate nor precise. PTH is cleaved to an 84 amino acid peptide within the parathyroid gland and stored in secretory granules until released. Non intact fragments are also secreted from the gland. Once released, PTH has a half life is only 2 to 4 minutes, and it is quickly fragmented further then metabolized. Bioassays cross react with these fragments, which may or may not have bioactivity. The NKF KDOQI Guidelines relied on the Nichol’s Allegro intact PTH assay and the range of 150 to 300 pg/m was best correlated with normal turnover. The allegro assay used an immunoreactive “sandwich” with two antibodies each directed against a different portion of the peptide. This assay did not specifically target the active N terminal. A third generation bio intact assay used an antibody which did target amino acids in the first 6 to 8 N terminal residues. Other assays have used a ratio between the 1-84 and 7-84 residues. The widely used 3^rd generation bio-intact PTH Advantage by Nichols Institute was ultimately withdrawn because of assay reliability. (4)The large dialysis organizations now use a variety of tests – the Bayer AdviaCentaur, DPC Immulite, Roche Elecys PTH and Diasorin LIAISON are all second generations. Ca-PTH IRMA by Scantibodies is a third generation assay. When compared with the original Allegro-intact PTH level, median bias or in plain English, assay variability, can be very large.

These assays were compared with one another in a very well written article from France, published in July, 2006 in Kidney International(5), and confirm what Dr. Cantor said several years ago – that there continues to be variation.

With the development of newer medications like cinacalcet to suppress PTH, the need for surgery has been drastically diminished, but the risk of oversuppression became a great problem.

It was shown in a correlation between bioassay and bone biopsy that at levels deemed “normal” by the original Allegro intact PTH assay 150-300 pg/ml, African Americans had over suppression of their bones, and that the cut off for this population should be higher. Bone turnover assessment may be more valid when using the ratio of PTH-(1-84)/N-terminally truncated fragments in African Americans, where “normal” PTH levels may lead to oversuppression of bone (6). Recent observational studies indicate that 300 pg/ml may be too low of a target. DOPPS data suggests that mortality risks do not increase until the PTH values are over 600 pg/ml (7).

There is a valuable lesson here: Physicians must depend upon their clinical judgment when assessing patients, and not just the laboratory. When we do so, we are in a sense validating laboratory values. As we expand beyond the patient, laboratory accuracy and precision becomes even more critical. Clinical judgment uses skills that cannot be quantitated, leaving only laboratory data for systems, analytics and trends, as the safeguards of clinical assessment are stripped away. Laboratory values are essential in analyzing trends, judging performance, assessing reimbursement, public reporting and sanctioning providers who fall outside accepted norms. If we are expected to rely so heavily upon this data, should we not assure it will be accurate?

The Nichols debacle demonstrates what happens when data validation fails. Laboratory and data validation are our only safeguards against a repeat of this disaster.

References

1. Cantor, T: Parathyroid hormone assay drift: an unappreciated problem in dialysis patient management. Semin Dial, 18:359-64, 2005.

2. Gal-Moscovici, A & Popovtzer, MM: New worldwide trends in presentation of renal osteodystrophy and its relationship to parathyroid hormone levels. Clin Nephrol, 63:284-9, 2005.

3. Malluche, HH, Langub, MC & Monier-Faugere, MC: The role of bone biopsy in clinical practice and research. Kidney Int Suppl, 73:S20-5, 1999.

4. Fadem, SZ & Moe, SM: Management of chronic kidney disease mineral-bone disorder. Adv Chronic Kidney Dis, 14:44-53, 2007.

5. Souberbielle, JC, Boutten, A, Carlier, MC, Chevenne, D, Coumaros, G, Lawson-Body, E, Massart, C, Monge, M, Myara, J, Parent, X, Plouvier, E & Houillier, P: Inter-method variability in PTH measurement: implication for the care of CKD patients. Kidney Int, 70:345-50, 2006.

6. Fehmi, H, Osman, Y, Bhat, S, Nguyen, K, Daramola, O, Cantor, T, Monier-Faugere, MC, Yee, J & Malluche, HH: Absence of adynamic bone disease in African-Americans with CKD stage 5 after 3 years of vitamin D therapy guided by iPTH and the PTH-(1-84)/N-terminally truncated PTH fragments ratio. Clin Nephrol, 71:267-75, 2009.

7. Tentori, F, Blayney, MJ, Albert, JM, Gillespie, BW, Kerr, PG, Bommer, J, Young, EW, Akizawa, T, Akiba, T, Pisoni, RL, Robinson, BM & Port, FK: Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis, 52:519-30, 2008.

Introducing CKD to Primary Care Physicians

2009-05-06T22:29:00.000-07:00

What does a busy doctor want to know about kidney disease?
1. Definition and classification?
a) The intrinsics of kidney disease
b) Why the incidence changed - NHANES III meets MDRD
c) Why “kidney”
d) What happened to the creatinine clearance?
2. What the trends in care are?
a) prevention through blood pressure, diabetes and ARB
b) Drugs which harm the kidney
c) Drugs which harm the body in kidney disease
d) Lifestyle changes - exercise, BMI, diet
e) Inflammation - CRP
f) vitamin D - emerging
3. What is the evidence?
a) MDRD
b) HOPE, MICROHOPE, MRFIT
c) ALLHAT, AASK
d) ABCD, DCCT, Collaborative Study Group, RENAAL, IRMA
e) SysEUR, REIN,
4. What are the guidelines?
a) NKF KDOQI
b) JNC VII
c) ADA, AHA,
4. Why refer patients to disease management?
a) Structured to provide patient support
b) Implementation of knowledge the biggest challenge
c) Primary physician role is expanded as patient motivation increases
d) Nephrologist as coach to primary physician who coaches patient
e) Nurse specialists, dietitians, PAs, RNs as trainers
f) Continued reinforcement crucial to any lifestyle change

5. Reinforcement initiatives

a) Vein Preservation

b) Modality Selection

c) Avoiding nephrotoxic medications and therapies

d) Reducing co-morbidity

e) Treating complications

f) Preserving kidney function