HemoDoc, From Doctor to Patient

Should America Measure Dialysis Outcomes Based on Employment Rates?

By Peter Laird, MD

The American dialysis experience especially in the last three decades is at great variance to the outcomes of all of the other industrialized nations with large dialysis programs.  Many inside the US dialysis industry squarely place the blame on the patients themselves citing higher levels of diabetes, HTN and elderly patients than other nations. However, extensive studies over the last two decades by DOPPS and other organizations came to a different conclusion. While there are differences in patient demographics, these alone do not entirely explain the differences in outcomes and higher mortality rates. DOPPS concluded that practice variations of vascular access, treatment times and ultrafiltration rates better explained many of these differences in outcomes.

International Hemodialysis Patient Outcomes Comparisons Revisted: The Role of Practice Patterns and Other Factors

Survival among HD patients in Japan, Europe, and the United States: Data from DOPPS I (1997 through 2001). *Cox proportional hazards model adjusted for age, male gender, black race, coronary artery disease, congestive heart failure, other cardiac disease, left ventricular hypertrophy, cardiomegaly by x-ray, hypertension, cardiovascular disease, peripheral vascular disease, diabetes, lung disease, dyspnea, smoking, cancer, HIV/AIDS, gastrointestinal bleed, peptic ulcer disease, hepatitis B, hepatitis C, neurologic disorder, psychiatric disease, recurrent cellulitis or gangrene, and vision problems. **P < 0.001.

Saran et al found a direct correlation between increased treatment time and a 7% reduction in mortality with every thirty minutes of addition dialysis per session:

Longer treatment time and slower ultrafiltration in hemodialysis: associations with reduced mortality in the DOPPS.

Figure 2.

Longer treatment time (TT) and slower ultrafiltration rate (UFR) are considered advantageous for hemodialysis (HD) patients. The study included 22,000 HD patients from seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Logistic regression was used to study predictors of TT > 240 min and UFR > 10 ml/h/kg bodyweight. Cox regression was used for survival analyses. Statistical adjustments were made for patient demographics, comorbidities, dose of dialysis (Kt/V), and body size. Europe and Japan had significantly longer (P < 0.0001) average TT than the US (232 and 244 min vs 211 in DOPPS I; 235 and 240 min vs 221 in DOPPS II). Kt/V increased concomitantly with TT in all three regions with the largest absolute difference observed in Japan. TT > 240 min was independently associated with significantly lower relative risk (RR) of mortality (RR = 0.81; P = 0.0005). Every 30 min longer on HD was associated with a 7% lower RR of mortality (RR = 0.93; P < 0.0001). The RR reduction with longer TT was greatest in Japan. A synergistic interaction occurred between Kt/V and TT (P = 0.007) toward mortality reduction. UFR > 10 ml/h/kg was associated with higher odds of intradialytic hypotension (odds ratio = 1.30; P = 0.045) and a higher risk of mortality (RR = 1.09; P = 0.02). Longer TT and higher Kt/V were independently as well as synergistically associated with lower mortality. Rapid UFR during HD was also associated with higher mortality risk. These results warrant a randomized clinical trial of longer dialysis sessions in thrice-weekly HD.

For over forty years, Belding Scribner and many of the pioneers of dialysis in America advocated changing  our practice patterns as the central focus of change in the US dialysis industry. While I applaud the efforts of Gary Peterson, Rich Berkowitz and Denise Eilers in their lobbying efforts to educate congress on the dysfunctional US renal system, focusing on employment as the most important measure of dialysis outcomes may have unintended consequences that could paradoxically damage the ESRD program and its funding.

On the other hand, the ESRD demographics are important indicators of the total rehabilitation potential in this population. In the 1960's and early 1970's, with limited resources, diabetic patients and elderly patients were excluded from treatment. In addition, those that were granted access to dialysis treatment were expected to learn and preform self care dialysis at home much more so than in-center treatments once again due to limited resources. This highly selected ESRD population had a very high rehabilitation potential and most were able to continue working. Many such as Nancy Spaeth raised a family and worked as a nurse and continue to remain very active in dialysis education and advocacy today after being diagnosed with CKD in 1959. 

Today, approximately 44% of the incident and prevalent US dialysis patients suffer from diabetes.
Diabetes affects the cardiovascular system from the small to large blood vessels and this is the primary mechanism of disabling conditions leading to strokes, heart attacks, blindness, amputations, chronic skin ulcers and infections as well as numbness and tingling from peripheral neuropathies. It is a systemic disease where early measures of damage to the kidney correlate with a higher risk of stroke and heart attack. Many consider microalbuminuria a direct marker of cardiovascular disease risk in diabetic patients. For diabetic patients with ESRD, many if not most of these patients have serious comorbid conditions that unfortunately are irreversible and difficult to treat. (here)

In addition, the median age of the incident ESRD population is 64.2 and the median age of the prevalent ESRD population is 59.4 .  For those considering emplyment as the main focus of lobbying congress to change dialysis outcomes,  the fact that we have at least half of the ESRD patients in the US above the working ages limits its application except to a fraction of the current population. The demographics at the time of the origins of the ESRD program in 1973 no longer exist. I believe we have rightly extended coverage to all patients who wish to be treated and should continue to do so. There are certainly renal replacement candidates that will not benefit from dialysis due to excessive burdens of disease but that is an individual question for each patient and their families to decide. I do believe we have a societal duty to prevent death and suffering when we have that ability.

Currently, there are only ~18% of the working age dialysis patients that continue to engage in active employment. (here) One aspect that has not yet been completely elicidated is what are the modifiable factors that could improve employment rates among dialysis patients. Patient characteristics such as educational status and occupation prior to iniating dialysis are fixed. Evaluating employment based on facility characteristics is an area in need of further study. Two variables found by Kutner et al in 2008 were access to evening dialysis sessions as well as facilities that have a home dialysis program. Both factors significantly correlate to higher levels of employment. There are likely many other factors that should be explored. 

Taking into consideration the burden of comorbid diseases, we must ask what goal of employment is reasonable? We are currently employing 35-40% of working age dialysis patients. If the goal is set too high in such a system of evaluating dialysis units according to employment rates of eligible patients, those truly that are disabled with irreversible conditions could be forced into a situation where their safety net is removed. Even if we increased employment rates by a factor of 100% (70-80% of working age patients) from current levels which I doubt anyone believes is achievable, the total unemployment rate among dialysis patients would still be near 65%. Focussing on employment alone does not achieve the desired results since the majority of dialysis patients by age or severe disability are not candidates to continue or return to work.

I do believe that we can and should improve all quality of life indicators but do so the same way that Dr. Scribner advocated over forty years ago, by applying physiologic renal replacement strategies best deliniated by Dr. Carl Kjellstrand in his "Unphysiology Hypothesis" in 1975. More frequent and longer duration dialysis improves mortality, reduces hospitalizations, significantly reduces the costs of treatment and conversely also raises the number of patients who are able to return to work. (here)  Employment in the end analysis is one indicator of optimal dialysis. Lower mortality, reduced depression, improved sexual function and many other indicators likewise optimize when patients obtain longer duration and more frequent dialysis. 

I would hope that we continue in Dr. Scribner's tradition of calling for incentives for home hemodialysis, avoidance of high ultrafiltration rates and longer and more frequent dialysis sessions as all other nations around the world have already practiced for decades. Setting employment quotas gains nothing at all if you don't first fix the underlying problem, our unique American dialysis practices. That has and should continue to remain our focus as dialysis advocates seeking reform. Under employment is the symptom, not the disease.

Designing an entire medical program around one symptom alone is not prudent in my opinion. Designing the system as Dr. Scribner advocated for decades remains our one and true course we should all join together to support. Indeed, there are many indicators that Dr. Scribners life long advocacy was not and is not in vain.  His message matters today more than ever as we begin a dialogue among all involved in the care of dialysis patients. Simply breaking down the wall between part A and Part B would drive the financial incentives to avoidance of hospitalizations and complications. In the end, the best medicine once again turns out to be the cheapest medicine.

Utilizing our current resources with improved financial incentives offers much more hope of true dialysis reform than any other method. Interestingly, that is the message that the large dialysis organizations are also lobbying for with CMS/Congress at the present time. I believe that a convergence of the LDO's, CMS/Congress and patient organizations is not only possible, but it will happen. Putting that system together should be the dominant goal of our outreach and advocacy.

LDO's and for-profit medicine are a reality of American medicine whether people are satisfied with that answer or not. Unleashing the properly incentivised goals of dialysis care will bring about the corporate response we wish to see with better outcomes for all patients, not just a select few who are capable of employment. Recent CMS demonstration projects show that this is not only feasible, it is desirable. (here) Interestingly, FMC already demonstrated these same types of outcomes with their joint Kaiser/FMC dialysis partnership in Southern California. I can readily assert that I have personally witnessed the results at my own dialysis unit as both a physician and a patient where my nephrologist was able to reduce annual mortality from over 20% down to only 7% in 2009.  

We already have the tools available today to more efficiently utilize our current resources in a better fashion for all patients. Applying these simple concepts to dialysis care was the basis for Dr. Scribner's visionary recommendations. It remains my central core strategy and goal as well. 

Dialysis Related Infections: Peritoneal Dialysis Poses more Dangers

By Peter Laird, MD

Every patient with ESRD by law is required to have education at the start of treatment on all of the differing options of renal replacement therapy including in-center conventional hemodialysis, in-center nocturnal hemodialysis, home hemodialysis either short daily, nocturnal and standard, peritoneal dialysis and renal transplantation options.  Each modality carries with it a unique set of risks and benefits that fit the lifestyle choices of individual patients.  One of the major risks of renal replacement therapy no matter the choice are serious infections often requiring hospitalization to treat. The second leading cause of death in dialysis patients is infection causing approximately 15% of all deaths, second only to cardiovascular related deaths. 

Vascular Access-Related Infections: Definitions, Incidence Rates and and Risk Factors

Hemodialysis is associated with a high risk of morbidity and mortality, often caused by infections. Infections account for approximately 15% of all deaths in this patient population (the second leading cause after cardiovascular events) and for about one-fifth of admissions. Approximately one-fourth of infection-related admissions are caused by dialysis-associated peritonitis or vascular access infection that may lead to such significant complications as endocarditis or death.

A recent study by Jean-Philippe Lafrance, MD, of the University of Montreal revealed a surprising finding that peritoneal dialysis patients are at much higher risk of a serious infection requiring hospitalization than hemodialysis patients with access related infections. As recently reported in Renal Urology News, peritoneal dialysis patients had a 51% increased risk of hospitalization from infections compared to a similar hemodialysis control group:

Hospitalization Risk for Infections Higher with PD

Twenty-one percent of the PD patients had been hospitalized once in the previous year (not counting the hospitalization during which dialysis was initiated) compared with 16% of the matched HD patients. PD patients were also more likely than HD patients to have two or more and three or more hospitalizations (8% vs. 5% and 8% vs. 3%, respectively).

PD was associated with a nearly 2.9-fold higher risk compared to HD of hospitalization due to dialysis-related infections, a twofold increased risk of other hospitalizations due to other infections, including a 1.6-fold higher risk of hospitalization due to abdominal infections. However, PD also was associated with 70% and 40% lower probabilities of being hospitalized for septicemia or pneumonia, respectively.

In a previous retrospective cohort study of 168 patients initiating outpatient dialysis (71 on PD and 97 on HD), researchers at Sunnybrook Health Sciences Centre in Toronto found that patients who initiate outpatient PD do not have a significantly increased risk of infection-related hospitalization compared with patients who initiate outpatient HD, according to a report published in Peritoneal Dialysis International (2011;31:440-449). The study, however, showed that patients starting outpatient treatment on PD were significantly more likely than those starting on HD to be hospitalized for peritonitis.

The risks of peritoneal dialysis vs. hemodialysis must be assessed and weighed against the intended benefits  of PD which includes ease of use, independence, greater mobility, fewer dietary restrictions, preservation of residual renal function and no need for vascular access. Researchers need to evaluate and develop further strategies to prevent PD related infections to maximize the benefits of this treatment option that many patients prefer over hemodialysis. The quest for the perfect renal replacement treatment options continues unabated but remains still in the future. 

For patients initiating dialysis, adherence to proper technique can further diminish infection risks but cannot eliminate them completely no matter how diligent and careful the practitioner is. Infection is a reality that all that have ESRD must consider and design their technique with that sobering thought in mind. Many patients have successfully avoided any infection for years, but with the nature of chronic kidney disease and poor immune function, we shall always be at higher risk that the general population. Certainly it is true however that we can do much better than we do today most often by failing to promote and practice safe and proper infection control techniques. Sadly, one of the greatest failures found during state and CMS inspections is improper hand hygiene and infection control. We can and must do better. Proper technique does lend optimism to infection avoidance as many patients doing self care can testify.

Choosing which modality is best for any given patient comes down to personal preference in many instances. The goals of therapy should not only be ease of use but consider all aspects especially in reguard to survival and avoiding hospitalizations. Despite the many benefits of PD, the infection risk is and has been one of the most difficult issues to resolve.

Standing Tall with Shad Ireland: Kona Inspired

By Peter Laird, MD

Shad Ireland is one step closer to a lifelong dream of competing in the Ironman World Championship at Kailua-Kona, Hawaii by charging into first place in the Kona Inspired competition. A little of two weeks ago, Shad was a long shot with over 25,000 votes to make up. In a remarkable turn around, Shad leaped into first place today now with over 43,000 votes and climbing. The dream of competing in the Kona Ironman World Championship saved Shad's life through inspiration. Shad remembers where he came from and wants to use the Ironman competition as platform to bring attention to the plight of the American dialysis patient languishing in disability. Many well known athletes are already standing tall with Shad as he prepares to re-enter the triathalon racing circuit. (here) In 2004, Shad became the first dialysis patient to complete a full Ironman competition and is still the only one.

IronShad the Ironman

I am proud of my Ironman accomplishment. It was one of the hardest things I have ever earned in my life. Yes friends I earned the right to be included into a very special group of athletes, athletes who understand pain, dedication, perseverance, and sacrifice. We all bleed on that 140.6-mile journey together. The mind leads and the body painfully follows. Ironman training taught me to become comfortable with being uncomfortable for long periods of time. It also saved my life, and it made me the man that I am today. A man dedicated to the service of others. A man who understands the gift of athletics and the influence we yield as athletes.

A close friend said to me last week, “Why are you returning to Ironman? You have already climbed that mountain. It’s not like you have to climb it every week. What are you trying to prove?” My return to Ironman is personal and public. Personally, I am returning to the sport of triathlon and specifically Ironman distance because I made a promise to myself and I have a dream to fulfill. We all chase Kona in our dreams! Publicly I am trying to inspire a community that has for the most part become disconnected and given up. I see my reflection in the eyes of the patients I meet everyday. I see the debilitated man I used to be and I feel a responsibility to reach out and take every hand and lead them out of the nightmare that a CKD/ESRD diagnosis delivers.

Life expectancy for someone given this diagnosis is only 2-5 years without a kidney transplant. The median wait time for a transplant is now almost 6 years! The odds are stacked against us but if I can continue to pursue my dreams after 3 decades with this disease then the 1o year old boy who I met two weeks ago who sits connected to a dialysis machine 6 hours a day, 3 days a week can hold on tightly to his dream of becoming an athlete, a Fireman, an Actor, and President of the United States!

I am now coming into my 30th year of living with this disease. My return to racing represents the possibility of it all! At the end of the day I want others to understand that despite my diagnosis I am pursuing my dreams and living my life. I am living the Ironman mantra, ANYTHING IS POSSIBLE!

(See Shad's Schedule here)

Several companies are now sponsoring Shad including Argon Bicycles, Rudy Project, and Shimano. Sadly, to date, despite all that Shad has done for the renal community, he has no sponsors currently from any of the dialysis industry outside of Amgen and Ascend Clinical who are supporting Baseline, an interactive self help program for renal patients through the Shad Ireland Foundation. Shad continues to demonstrate his perseverance to accomplish his goals and to help others do the same. Join me in voting for Shad who is our representative for renal disease and wants to bring his message of hope to Kona. If you haven't voted yet, please do vote for our own dialysis champion now in first place at Kona Inspired. I know Shad appreciates all of your support which he deserves and much more.

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.

Dialysis Urban Legends: The Minimum Ultrafiltration Rate

By Peter Laird, MD

Two days ago, I went in for my iron infusion which I do in conjunction with dialysis and not in an infusion center. This time, techs did not want to place me on my usual low ultrafiltration volume because they have been taught that there is a minimum level of ultrafiltration that will prevent backfiltration of dialysate.  This is not the first time I have heard dialysis techs and nurses bring up this issue. However, it is simply a dialysis urban legend. Increasing ultrafiltration rates to a "minimum" of 300 ml/hour does not prevent backfiltration.

Measurement of back clearance

With improvement in dialysis membranes, back filtration becomes the focus of study. Because new membranes that remove low molecular weight proteins, such as beta 2-microglobulin by diffusion are now available for clinical use, both back filtration and back diffusion become problems. This paper gives the mass transfer rate of solutes from the dialysate to blood compartment. As markers of toxic or antigenic substances, inulin (MW 5,200), lysozyme (MW 14,300), and alpha-lactoalbumin (MW 14,400) were used. The dialyzers tested were the CLSU-12W, AM-FP10, BK-1.0P, and FB-110U. The UFR controller set the flow rate on the blood side at 200, dialysate at 500, and ultrafiltration (QF) as 0 to 50 ml/min. Under these conditions, the inulin back clearance is 16 (CLSU) to 26 ml/min (FB), even if the QF is 50 ml/min, and is 10 to 34 ml/min for lysozyme at QF = 0 ml/min. Although a substantial amount of solute moves into the blood compartment, back clearance does not drastically decrease with increase in QF. To avoid contamination of the blood side, clean-up techniques for the dialysis line or online protein adsorber should be followed.

This is a pervasive dialysis urban legend that can impact those dialysis patients who still have enough residual renal function that they are able to control fluids without ultrafiltration. For most dialysis patients, they take off a minimum of 1 liter of fluids with dialysis and are not affected by any alleged minimum ultrafiltration rates. Backfiltration occurs at all normal ultrafiltration levels with high flux dialyzors and it is not prevented by a minimum level. For the select few who still control fluids with their own residual renal function, placing the ultrafiltration level on 500 ml covering only the priming fluids and some of the rinse back places you at no more risk than dialyzing with the so called "minimum" ultrafiltration rates. It is time to put this urban legend to rest once and for all.

Victor Gura's Wearable Artificial Kidney: The FDA Approval Path

By Peter Laird, MD

The FDA Innovation Pathway recently selected three new technologies for this new program. Dr. Victor Gura has been testing prototypes of his WAK for several years and now will focus his future efforts through a collaboration with the University of Washington in Seattle. Many patients have expressed interest in this new and exciting technology that promises a new level of renal replacement therapy rivaling transplant. Looking at data from an earlier prototype compared to standard therapies illustrates well the potential of this modality.

In this graphic representation, the prior WAK prototype achieved 25 ml/min clearances. Keep  in mind that his latest prototype achieved 40 ml/min clearances specifically designed to deliver a large enough clearance to allow children to grow. Even at 25 ml/min clearances, the WAK would deliver more total daily clearance than daily nocturnal treatments currently achieve. The FDA path to approval was also considered in the application for the FDA Innovation Pathway. 

These five successive clinical studies will have to show significant benefit and no harm to the patients as the trials progress through these individual stages. All of these proposed trials will be randomized and controlled. The FDA approval of the path to marketing this device sends an important message throughout the dialysis industry. The future of renal replacement treatments not only with this device but many other proposed medical devices also working their way through the system should give all with ESRD a new hope of a promising future.

There were thirty two new technologies submitted for approval of this program and the FDA chose these three as the starting point of the new Innovation Pathway.  The fact that we have over thirty new devices developed far enough to consider human trials gives us all hope that the treatments of today shall soon be eclipsed by superior devices. Dr. Gura's WAK opens the doors for a new future and I look forward to seeing the developments of this technology in the next few years.

(Slides courtesy of Dr. Victor Gura)

Shad Ireland is Kona Inspired

By Peter Laird, MD

Shad Ireland is living the dream he has had for years as he seeks to participate in the Ironman world championships in Hawaii. Shad was told that he would never be an athlete, that he would never graduate college and that he would never get married. As Shad states, he has accomplished all of these things. As he lay on his mothers couch as a young man after a failed transplant weighing only seventy five pounds, he saw an Ironman competition on TV which inspired him. Several years later, he became the only dialysis patient in the world to compete and finish and ironman competition earning in toil and sweat the nickname, IronShad.

Shad is now Kona Inspired and needs your vote to be able to complete his lifelong dream to enter and complete the Hawiian championship Ironman. Shad has inspired me for several years. Not only has Shad completed ironman competitions, he has also given back to the renal community inspiring other dialysis patients to engage in regular exercise which can be life changing as it was for Shad. Help Shad achieve this lifelong goal by going to his Facebook Kona Inspired page and voting for him over and over again. Shad has paid his dues to the renal community.

I hope that the renal community will stand up in support of IronShad who continues to be an inspiration for so many. I have placed my vote, it is time for all to now send this champion of dialysis and fulfill his lifelong dream. Time is of the essence as the chance to vote will soon come to a close and you can vote more than once. I plan to vote several times a day and help send Shad to Kona. IronShad deserves our support as one of us lives his dream.

Star fruit: The Death Fruit for Dialysis Patients

By Peter Laird, MD

Dialysis patients limit potassium, phosphorus and salt and are advised to eat several servings of fruits and vegetables, but their is one fruit that should never find its way onto your menus. The star fruit is a popular fruit especially in the Philippines and the south Pacific and it is now becoming a popular fruit in America as well. However, for dialysis patients, the star fruit could be deadly.

Intoxication by star fruit (Averrhoa carambola) in 32 ueaemic patients:

Background. Clinical symptoms and outcomes of uraemic patients ingesting star fruit are quite variable and may progress to death. The purpose of the present report was to discuss the neurotoxic effects of star fruit intoxication in uraemic patients and to present the efficacy of different therapeutic approaches.

Results. The most common symptoms were persistent and intractable hiccups in 30 patients (93.75%), vomiting in 22 (68.7%), variable degrees of disturbed consciousness (mental confusion, psychomotor agitation) in 21 (65.6%), decreased muscle power, limb numbness, paresis, insomnia and paresthesias in 13 (40.6%) and seizures in seven (21.8%). Patients who were promptly treated with haemodialysis, including those with severe intoxication, recovered without sequelae. Patients with severe intoxication who were not treated or treated with peritoneal dialysis did not survive.

Conclusions. Haemodialysis, especially on a daily basis, is the ideal treatment for star fruit intoxication. In severe cases, continuous methods of replacement therapy may provide a superior initial procedure, since rebound effects are a common event. Peritoneal dialysis is of no use as a treatment, especially when consciousness disorders ensue.

Daily hemodialysis is the only effective treatment for star fruit intoxication, but the best treatment alternative for this neurotoxic fruit is to simply avoid it completely. My Filipino wife enjoys this fruit but won't bring it into the house at all since it is a potentially deadly toxin to me. Just one small price we pay for extending our lives with dialysis. The star fruit is one fruit to scratch from your diet and not temp yourself at any time. Testing the limits of this neurotoxic fruit is not advisable if you are on dialysis or have chronic kidney disease. Fortunately, I wasn't that adventuresome when I visited the Philippines several years ago before I was aware of the deadly consequences. For once, my simple tastes turned out to be my best friend.

FDA Announces Renal Disease Device Pilot Programs

By Peter Laird, MD

The first projects of the new FDA Innovation Pathway went into effect today with the announcement of three pilot programs for ESRD.

FDA announces plans to pilot end-stage kidney disease technology in new program

Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.

The three products are:

• An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
• A Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
• A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

The majority of the 32 applications came from small, start-up business or academic institutions. 

Dr. Victor Gura invented the Wearable Artificial Kidney (WAK) and has already successfully tested this device prototype in Italy and London. (here and here) With 168 hours of total dialysis per week, it achieved creatinine clearances of 40 ml/min. The importance of a creatinine clearance this high is this is the level that is predicted to allow children with ESRD to grow normally, which was one of Dr. Gura's goals in developing this device. 

The FDA Innovation Pathway is a welcome addition to the renal community and adds a new layer of market place developments that will push the entire industry to a new level never seen before.  With current weekly Kt/V goals of 2.0, this device will push the limits to over 7.0, equivalent and at times exceeding the creatinine clearances of patients with renal transplants. I look forward to the brave new world of renal disease medical devices now coming to the forefront of renal replacement technology that has stagnated for several decades.

The FDA Innovation Pathway promises reduce the death and suffering associated with the standard in-center treatments.  The large dialysis organizations (LDO's) will need to reply in kind as renal replacement therapies now enters a new generation of device innovations. The promise of living independently and unshackled from the burdens of renal disease may soon become the standard treatments for those unfortunate to have irreversible loss of renal function. The news from Washington D.C. today begins a new era of dialysis therapies that the renal community shall surely welcome.

Is American Nephrology Falling Behind Asia?

By Peter Laird, MD

Renal and Urology News recently had an opinion article on dialysis practices in Asia and America where the American nephrology practices for dialysis are no longer cutting edge. America appears to be in a state of limbo as far as dialysis practices compared to other nations, even those that we would ordinarily consider "third world" countries.

Is U.S. Nephrology Laggin Behind?

On the dialysis front, too, other countries appear to be ahead of us. In this country most of us have no clear idea what so-called “on-line hemofiltration” is, whereas in many other countries it has been practiced routinely in outpatient dialysis clinics for years. Our dialysis machines are outdated compared with those of some other nations. We do not allow our patients to eat during dialysis treatment, whereas meals are served routinely in many outpatient dialysis centers in other countries.

We appear to be disconnected from the rest of the world and uninterested in knowing why other nephrology communities are moving forward faster than we are. In terms of income, we feel that we are paid relatively well in this country, yet we do not realize that even Canadian nephrologists, on average, earn 20% to 40% higher income than their counterparts here.

There is no doubt that when it comes to dialysis practices, America has adopted stagnation as their motto. Since the advent of high flux artificial kidneys, the actual technology for dialysis in America has remained essentially unchanged for decades. If we didn't have the highest mortality and cost per capita for dialysis patients, the status quo could be justified. But since our outcomes are so far out of variance from other nations, our intransigence is as noticeable as Rudolf's red nose on Christmas Eve. Sadly, it appears that some American nephrologists think that our system of deterence to new technology is the best in the world.

Brief Comment: Is U.S. Nephrology Lagging Behind

My response to Kam is that the US taking a more measured approach compared to Asian countries represents a strength not a weakness. After all, we have evolved from an era of norstrum and other so-called "magic cures" (e.g., see Warner's Kidney and Liver Cure ad) to a more organized marketplace of treatments that are backed by evidence. We should seek data from randomized trials wherever possible to support treatment recommendations rather than simply using interventions based on limited data and whims.

It is interesting that one of the great difference of American dialysis practices compared to Europe and Asia-Pacific is that thirty years ago, America embraced the NCDS as the champion of evidence based medicine while Europe and Asia-Pacific nations uniformly rejected this flawed RCT and it's illogical conclusions that TIME is not an important determinant of outcomes.  In fact, you could readily conclude that the adherence of American nephrology to these flawed RCT's and blatant diregard of excellent observational dialysis studies is at the center of our failed dialysis practices which are motivated more by profit and greed than any so called evidence based medicine.

Interestingly, the NCDS had a non-significant effect from time on dialysis and the HEMO study did not test time as one of the variables. The FHN short daily study focussed more on differences in frequency and the failed FHN nocturnal study failed to recruit enough patients, it failed to separate the treatment group parameters far enough and it had too highly selected patients with only one third the mortality of the USRDS dialysis population to be able to be generalized to a sicker population.

Time and duriation of dialysis treatments has never yet been properly tested in an RCT to date, nor do I believe it is necessary. In fact, you could argue very determinedly that adherence to RCT's in America is the cause of our stubborn refusal to advance treatment options since many of the questions can never be sufficiently answered with a large enough and powerful enough study. The optimal dialysis RCT is simply a castle in the sky that the academic American nephrology will never realize since it would involve thousands of patients who refuse randomization as seen in the FHN studies.

In such a case, the call for further RCT's suceeds in only inducing further treading of water and maintaining the current status without improving outcomes whatsoever.  It should be immediately obvious that Rudolf's nose which shines so bright is there for all to see, except it appears, the American nephrologist who glorifies in our mediocrity. I appreciate Dr. Kalantar-Zadeh having the courage to speak truthfully. Unfortunately, it was predictable that many in the American nephrology community would take umbrage to his observations and rest on their laurels. After all, nothing is improving despite the serious deficiencies in dialysis practices that DOPPS has documented over the last two decades between America, Japan and Europe. Yes, Rudolf does have a red nose and America is lagging behind in its dialysis practices. Both are implicitly obvious.