NKF Launches Your Treatment, Your Choice

NEW YORK, NY--Helping patients make informed choices about their own health is the rationale behind the new Medicare pre-dialysis education benefit and NKF has developed a comprehensive curriculum to assist professionals in providing this patient education. NKF’s newest program, Your Treatment, Your Choice was designed to meet CMS guidelines for reimbursement under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), and is free to qualified professionals, including physicians, physician assistants, nurse practitioners and clinical nurse specialist.

Your Treatment, Your Choice offers a comprehensive adult education approach, and includes all the materials needed for implementation and evaluation such as an implementation guide, detailed lesson plans, outcomes data collection tools and a variety of practical tools that actively involve and motivate the patient to reinforce learning, such as “Check Yourself!” word games, puzzles, quizzes, “Take Home” handouts and educational checklists. All materials are presented in downloadable format on a CD-ROM.

For more information or to register for Your Treatment, Your Choice, visit www.kidney.org/ytyc

Sorafenib Shrinks Renal Cancer Tumors

The optimal therapy for someone with renal cell carcinoma is uncertain. If the cancerous tumor is contained within the kidney, surgical intervention can be curative. The prognosis worsens with the size of the tumor and stage of the cancer.

Sorafenib is a multitargeted tyrosine kinase inhibitor used in advanced stage renal cell carcinoma (RCC). A small prospective trial (30 patients with stage II or higher RCC) in the Journal of Clinical Oncology took a look at the safety and feasiblity of sorafenib in the preoperative setting.

Authors found that administering sorafenib prior to nephrectomy forRCC can reduce the size of the primary tumor without adding to the risk of surgery.

“We found that primary kidney tumors responded to this therapy, shrinking up to 40% prior to surgery,” said principal investigator Kimryn Rathmell, MD, PhD, Assistant Professor of Medicine. “What this means for kidney cancer patients is that their surgery may be less extensive.”

Again, this is a small study with limitations. Although it does look promising.. is it cost effective?

ACE-i + Thiazide Vs. ACE-i + CCB

Nowadays, it is more or less agreed upon that patients with Stage 2 Hypertension (and many with Stage 1) are better served with initial combination therapy as opposed to a solo anti-hypertensive agent. Acknowledging the complexities of individual patients and agreeing that one-size does not fit all as a backdrop.. Overall, which combination is best? It is a tough question and one may argue that is too simplistic. In reality we cannot merely generalize as there are too many variables. Nevertheless, we have a new study to chew on, the ACCOMPLISH trial.

 The Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial was a double-blind, randomized trial undertaken in five countries (USA, Sweden, Norway, Denmark, and Finland). 11 506 patients with hypertension who were at high risk for cardiovascular events were randomly assigned via a central, telephone-based interactive voice response system in a 1:1 ratio to receive benazepril (20 mg) plus amlodipine (5 mg; n=5744) or benazepril (20 mg) plus hydrochlorothiazide (12·5 mg; n=5762), orally once daily. Drug doses were force-titrated for patients to attain recommended blood pressure goals. Progression of chronic kidney disease, a prespecified endpoint, was defined as doubling of serum creatinine concentration or end-stage renal disease (estimated glomerular filtration rate <15 mL/min or needing dialysis).

The trial was terminated early (mean follow-up 2·9 years [SD 0·4]) because of superior efficacy of benazepril plus amlodipine compared with benazepril plus hydrochlorothiazide.There were 113 (2·0%) events of chronic kidney disease progression in the benazepril plus amlodipine group compared with 215 (3·7%) in the benazepril plus hydrochlorothiazide group (HR 0·52, 0·41—0·65, p<0·0001).

The conclusion the authors offer is that initial antihypertensive treatment with benazepril plus amlodipine should be considered in preference to benazepril plus hydrochlorothiazide since it slows progression of nephropathy to a greater extent.

There are many questions that remain. Is an ACE-inhibitor and calcium channel blocker really the preferred choice? Is there something special about benazepril and/or amlodipine or can we extrapolate to other ACE i and CCBs? What about the newer ARB plus CCB (amlodipine) combination drugs (Azor, Exforge and Twynsta)? Do these offer similiar benefits? Are there other specific patient populations that need to be considered?  Surely there will be more to follow...

Will Crit-Line Catch On?

As all nephrologists know, and many dialyzors suspect the guestimate of a true EDW (estimated dry weight) is an inexact science at best. There is a lot of trial and error along with a healthy sprinkling of a 'fudge-factor' to get to an EDW. This EDW is then used as the 'ideal weight' to aim for post dialysis treatment. Taking too much or too little fluid out of a dialyzor can have obvious consequences.

Accordingly, getting a handle on a more accurate way to measure intravascular status non-invasively and using a more objective means of determining the EDW would be welcomed by the nephrology community. Enter, Crit-Line... Crit-Line is a fluid management and access monitoring tool incorporating photo-optical technology to non-invasively measure absolute hematocrit, percent blood volume change, continuous oxygen saturation and access recirculation.

Last week Hema Metrics put out a press release announcing that a new article has been released in the February 1 edition of Hypertension which indicates that relative plasma volume monitoring during hemodialysis aids the assessment of Dry Weight. The article, written by Arjun D. Sinha, Robert P. Light and Rajiv Agarwal, concludes that the Crit-Line is a simple and widely available tool that can aid in the evaluation of dry weight. Furthermore, the article states that periodic monitoring of relative plasma volume may assist in the management of dry weight and control hypertension among long-term hemodialysis patients.  


"We are excited that a peer reviewed article with such positive results has been published in a respected Journal such as Hypertension" said Patrick Moriarty, CEO of Hema Metrics. "The evidence keeps mounting that the Crit-Line, when used correctly, is a very valuable tool for assessing accurate dry weights and managing hypertension".

Nevertheless, the economics may dampen some of the enthusiasm for the Hema Metrics offering. It appears measuring the relative plamsa volume with Crit-Line to more accurately obtain an EDW is not reimbursable. Furthermore, I doubt the good people at Hema Metrics in their benevolence are giving away their devices for free. So, in this environment of cost containment and cloudy reimbursement rates for hemodialysis, despite the joy for the theoretic possibility of helping patient care with this device, it is unclear how it will be embraced in our community.

Can Low Sodium Intake Lead to an Increased Mortality?

It is common knowledge that low sodium intake is beneficial, right? Well, not so fast. There is an interesting article in the Clinical Journal of the American Society of Nephrology which speaks of a possible link to an INCREASE in mortality with low salt intake in one segment of the population. Which patient population is this? The peritoneal dialysis population.

The study was a single center cohort of 305 peritoneal dialysis patients in China who started PD between 2002 and 2007.

This study has limitations, but the conclusion was that low dietary salt intake in this Chinese PD population was an independent risk factor for high overall and cardiovascular mortality.

Nathan Hellman Rest In Peace

I AM SHOCKED AND DEEPLY SADDENED BY THIS TRAGIC NEWS... I SHARE WITH YOU A RE-POST FROM THE RENAL FELLOW NETWORK. 

It is with great sadness and sorrow that I am writing to inform you of the passing of Nathan Hellman, MD, PhD, and founder of the Renal Fellow Network Blog. I worked with Nathan in the Division of Nephrology of the Department of Medicine, Massachusetts General Hospital (MGH), Boston, where we were both fellows. He passed away on February 13, 2010 at the Massachusetts General Hospital after a short illness.

Born in Houston, Texas, on December 8, 1973, Nathan grew up in Duluth, Minnesota. He attended Yale University, graduating magna cum laude. After Yale, he went to Washington University, where he obtained his MD/PhD. He did his residency training in Internal Medicine at University of Pennsylvania and became a member of the Division of Nephrology in 2007 as a clinical fellow in Nephrology. He was completing his fellowship as a research fellow and member of Iain Drummond’s research group. He was to be appointed a faculty member in July 2010.

Nathan was most importantly a wonderful husband, father, son and brother. At work, he touched all of our lives with his warm heart and spirit, great sense of humor and remarkable intellect. He was an exceptional scientist, a talented and insightful clinician and a remarkably kind and humble human being. He is survived by his wife, Claire, his two children, Sophie and Max, his parents, Dr. and Mrs. Hellman, his two sisters, and their families.

A Memorial Service will be held to celebrate his achievements and commemorate his contributions to the MGH community at the O’Keefe Auditorium on Wednesday, February 17th at 2pm, followed by a reception in the Thier Conference Room at 3.30pm.

In lieu of flowers, memorials can be sent to:

Nathan Hellman Memorial Fund
PO Box 471044
Brookline Village, MA 02447

NEJM Study on AVG Stent Follow Up Commentary from MedPage

NEJM: Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access Grafts

Fistual maybe first (Fistula First), but sometimes there is a need to use an alternative and that is usually synthetic vascular graft. Arteriovenous (AV) grafts are commonly used as a second choice for vascular access for hemodialysis. One of the main reasons we do not prefer AV grafts is because these foreign bodies placed under the skin have the propensity to clot. The AVG usually clots at the venous anastamosis and the management of this is angioplasty. Angioplasty can be used early when signs appear that the AVG may be closing down, or late to open up a clotted access.

This week in the New England Journal of Medicine there is a prospective, randomized, multi-center trial of 190 hemodialysis patients with AVG clotting at the venous anastamosis. The patients were assigned to undergo either balloon angioplasty alone, or balloon angioplasty with the addition of a stent. Primary endpoints were the patency of the treatment area and patency of the entire graft circuit.

Stents are used commonly to improve patency in other vessels after angioplasty but have been controversial in this setting. This study however demonstrated that in the setting of clotting at the venous anastamosis of an AVG, the addition of a stent led to an improved the long term patency as well as freedom from repeat interventions when compared with angioplasty alone.

Low Carbohydrate Diet Lowers Blood Pressure

Low Carb! Low Fat! Low Carb! Low Fat! .... the debate continues. A recent randomized trial in the Archives of Internal Medicine examines the differences in weight loss between a diet low in carbohydrates versus one low in fat with the addition of Orlistat.

146 overweight or obese patients (mean age 52 and BMI 39.3) from the VA in Durham, North Carolina were randomized to either a diet low in carbohydrates or a diet low in fat plus Orlistat 120 mg three times a day. The patients were followed for 48 weeks and the main outcome meaures were body weight, blood pressure, fasting lipid and glycemic parameters.

Patients on the low carbohydrate diet had similar improvements to the low fat plus Orlistat group in body weight, lipid and glycemic parameters. But, compared to the low fat / Orlistat group, the low carbohydrate group had statistically significant improvement in systolic (-5.9 vs. 1.5 mmHg) and diastolic (-4.5 vs. 0.4 mmHg) blood pressure (both P <0.001).

Just How Safe is Feraheme?

NEW YORK (Dow Jones)--AMAG Pharmaceuticals Inc. (AMAG) shares gained in after-hours trading Friday as the biopharmaceutical company gave a safety update on its anemia drug, Feraheme, that appears to have reassured investors.

Concerns about the drug's safety were sparked Thursday by an analyst report that said field checks show there have been serious adverse events with the drug, and it was unclear if those events were occurring at a rate consistent with that on the drug's label.

AMAG's release after the market's close Friday said serious adverse events have been reported at a rate consistent with that contained in the U.S. package insert. Of the estimated 35,000 patient exposures to date, 40 serious adverse events have been reported, an approximate rate of 0.1%.

The company also said Friday that no mortality signal has been observed. A single reported death occurred in a patient two days post-Feraheme treatment, which the company does not believe was the result of Feraheme.

It has been a roller coaster for AMAG. Full disclosure, I stock and administer Feraheme in my office. I have had a couple of reactions which has caused me to question the safety as well. I am not completely satisfied with the adverse events and believe there may be some merit to rechecking the safety of this agent. I am glad for AMAG and their shareholders with the rebound in stock price... but, my office will be switching to another IV iron drug.

KDOQI To Update Diabetes Guideline

NEW YORK—The National Kidney Foundation announced Feb. 9  plans to update its KDOQI Clinical Practice Guideline for Diabetes and Chronic Kidney Disease, which were first published in 2007. 

“A revised diabetes and chronic kidney disease guideline will include recent studies focusing on the management of hyperglycemia such as the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial; we are aiming to complete the update process within a year, to ensure that practitioners and patients benefit from new knowledge as soon as possible,” said KDOQI Chair, Michael Rocco, MD of Wake Forest School of Medicine in North Carolina. “A draft is expected to be available for public review by January 2011.”

The work group is currently being assembled by Co-Chairs, Drs. Katherine Tuttle and Robert Nelson, who will return to their leadership positions. More to follow....

Hypokalemia in Setting of CKD and CHF May Be More Dangerous Than Anticipated

BIRMINGHAM, Ala. - New research from the University of Alabama at Birmingham (UAB) says low potassium levels produce an increased risk of death or hospitalization in patients with heart failure and chronic kidney disease (CKD).

In findings reported in January in Circulation: Heart Failure, a journal of the American Heart Association, the researchers say that even a mild decrease in serum potassium level increased the risk of death in this patient group.

"Hypokalemia, or low potassium, is common in heart-failure patients and is associated with poor outcomes, as is chronic kidney disease," said C. Barrett Bowling, M.D., a fellow in the UAB Division of Gerontology, Geriatrics and Palliative Care. "But little is known about the prevalence and effect of hypokalemia in heart-failure patients who also have CKD."

The UAB researchers studied data from 1,044 patients with heart failure and CKD in the Digitalis Investigation Group study, sponsored by the National Heart, Lung and Blood Institute, one of the National Institutes of Health. Normal potassium levels were expressed at between 4 and 4.9 mEq/L. Mild hypokalemia was defined as between 3.5 to 3.9 mEq/L and low hypokalemia as below 3.5 mEq/L.

Death occurred in 48 percent of the patients with hypokalemia during the 57-month follow-up period, compared with only 36 percent of patients with normal potassium. The vast majority of subjects, 87 percent, had mild hypokalemia. Hospitalization also was slightly higher for subjects with low potassium, 59 percent compared with 53 percent for those with normal potassium levels.
"It has long been considered that high potassium levels were more common in heart-failure patients with CKD," said Ali Ahmed, M.D., senior author of the study and associate professor of medicine in the Divisions of Gerontology, Geriatrics and Palliative Care and Cardiovascular Disease. "Our findings indicate that low potassium may be even more common in these patients, and clinicians need to be aware of the risks associated with even mildly low potassium levels and monitor and treat their patients accordingly."

This is certainly interesting. Clinicians are often reluctant to add ACE inhibitors, angiotensin receptor blockers or aldosterone antagonists in the setting of chronic kidney disease. Even in cases of congestive heart failure or chronic left ventricular dysfunction when these agents are widely recognized as being routine indicated interventions they are withheld due to the fear of hyperkalemia.  Most of these patients however are on loop diuretics and hypokalemia can often ensue... the consequence of this hypokalemia has traditionally been minimized... maybe it is time to rethink this approproach.

CBS's Undercover Boss Premieres with Dialysis Subplot

I admit I crashed pretty soon after the Super Bowl last night. I actually had some interest in this new CBS show that was highly publicized during the game called, Undercover Boss. Unfortunately the baby needed to be taken upstairs and my wife was more interested in the Karashians which replaced CBS as soon as I turned around after the tenth post-game interview.

Tragically, I missed the premier episode of Undercover Boss. But why am I writing about it? Why should you care? I am glad you asked...

Zipping through some of the blogs I read, I came across an entry in Dialysis From the Sharp End of the Needle. It looks like I indeed missed something interesting last night on this CBS TV show. This new reality show offers different corporate leaders who take entry level jobs at their companies. The premier shows Waste Management (WM) President Larry O'Donnell going undercover as Randy and working a range of job within the organization.

During the episode one of Larry's supervisor is a long time dialysis patient by the name of Walter Settles. Walter winds up firing Larry, the company President and COO. Some of the transcript from the show from DESN:

Walter: I'm on dialysis and that take up three days .. three nights anyway I lost the functions in my kidneys
Randy: I would have never guessed that you have that kinda health issue. I've been marching up and down those hills picking up trash - you come marching up there. How do you do all that?
Walter: I let my spirit tell my body what's going to happen what I'm going to do what I'm not going to do because if I let my body tell me what I'm going to do I'm not going to do very much.
Randy: You have such a positive attitude do you work with other people on dialysis?
Walter: I would like to but as long as I can work and I'm able to work I'm going to work ... when I see a perfectly healthy person dragging around and I can go out there and work circles around them and he can't do this and can't do that really pisses me off there, because I wish I was healthy ... you should be able to do more than I do if I can get out there and fill two bags in 10 minutes then I'm expecting you to do three bags three

I have not have time to watch the show yet, but will. Nevertheless, it is certainly nice to have a dialyzor being portrayed in this way.. working a physically demanding job in a reality show, not a fictional written part (DESN in my opinion correctly points out this never would have been written into a fictional show).

Uric Acid, Fructose and Hypertension

A presentation by Dr Joel Topf from one of my favorite Nephrology blogs, Precious Bodily Fluids

Uric Acid, Fructose and Hypertension

View more presentations from Joel Topf.

Fistula First Resource

The Fistula First Web site has added audio clips of blood flow through arteriovenous fistulas (AVF) to help dialysis patients and staff learn what to listen for when monitoring the health of vascular accesses.

To listen to the bruit audio clips visit the Fistula First website at www.fistulafirst.org under What’s New. There is a section for patients as well as for health care professionals.

North Korean Leader Kim Jong-il on Dialysis

PYONGYANG, North Korea— Arirang News is reporting that North Korean leader Kim Jong-il is receiving regular dialysis treatments and may be a consequence of diabetes. The 68-year-old's health has been the subject of international interest because he has not formally named someone to succeed him as the head of the Communist state.

AJKD and the Proposed Rule for Prospective ESRD Payment

This month the American Journal of Kidney Disease (AJKD) has six editorials regarding the 2009 proposed rule for the prospective ESRD payment.

The six editorials spread out over twenty pages of the journal are well worth reviewing. After an initial overview there are five more editorials from different perspectives:

•  Large Dialysis Organization
• Medium Sized Dialysis Organization
• Small For-Profit Dialysis Organization
• Small Not-For-Profit Dialysis Organization
• Forum of ESRD Networks

Responses to the prospective payment system (PPS) have been submitted, and CMS will consider many of these advantages and disadvantages as they craft their final version of the proposed rule. The points made above and in the accompanying editorials only touch on some of the remarkable issues that have arisen from the proposed payment system for ESRD care, all of which will require both hard work and innovation to practically implement. The commentary contained within this series intends to assists with the upcoming debate and helps to create the best possible system to provide dialysis care.

Dangers of Herbal Meds