HemoDoc, From Doctor to Patient

Patient Demand Leads Boom in Home Hemodialysis

By Peter Laird, MD

Home hemodialysis, the preferred  renal replacement modality prior to the beginning of the ESRD program in 1973 here is re-emerging today by the power of individual patients seeking a viable alternative to conventional in-center hemodialysis. This is evident in a graph (here) provided by Dori Schatell of the Medical Education Institute and Home Dialysis Central that compiled the number of dialysis centers offering home hemdodialysis options over the last eight years. The greatest growth is in those centers offering short daily hemodialysis facilitated by the ease and popularity of the NxStage System One portable hemdialysis machine. Evaluating the reasons behind the renewed interest in home hemodialysis is revealed in an Australian study that asked patients and care partners why they chose home hemodialysis:

Characteristics of dialysis important to patients and family caregivers: a mixed methods approach

Results. Thirty-four participants from two Australian hospitals attended six ‘nominal group’ focus groups between September 2009 and February 2010. Two groups involved pre-dialysis patients (total n = 8), two involved peritoneal and haemodialysis patients, respectively (n = 9) and two involved caregivers of dialysis patients (n = 17). We identified 28 characteristics of dialysis important to patients and caregivers. Patient groups agreed that the most important characteristics were (i) survival, (ii) convenience of dialysis at home and (iii) dialysis-free days. For caregivers, the most important were (i) convenience of dialysis at home, (ii) respite and (iii) the ability to travel.

Conclusions. Patients and family caregivers highly value treatment that enhances survival and can be performed at home. Future planning of dialysis services could better reflect these priorities through provision of increased home dialysis support services and planned respite for caregivers.

Improved survival came highest on the list of variables that attracted patients to home hemodialysis options in Australia. While the pundits of dialysis hierarchy here in America continue to contest the merits of "non-conventional" dialysis, informed patients are not waiting for them to place the imprimatur of America's academic nephrology elite. The market place and patient demand for travel, survival benefit and convenience is bypassing what in my opinion is the stodgy behemoth industry infested academic nephrology community that continues instead to rubber stamp the American dialysis holocaust while waiting for the holy grail RCT that likely will never come.  

As the evidence mounts, the truth that we have abandoned the right path over forty years ago at the hands of the business of dialysis is the inevitable conclusion. The blood of dialysis patients bathes this for-profit dominated industry that continuous it's gluttonous rape of patients trust and hopes for continued life to only instead receive a counterfeit death sentence filled with the pain and anguish of short, rapid and violent sessions while suffering with nausea, vomiting, severe cramps and syncope in inflexible cattle call dialysis units across America. We can do better. We should do better.

 

"Extra Cheese Dialysis" or the Gold Standard?

By Peter Laird, MD

Dr. Ajay Singh started The Kidney Doctor blog recently and has already developed discussions on many important renal related topics. In addition to his own, posts, he has had several top experts post on selected topics. Participation with follow up comments is perhaps the most active at this time of any online renal blog. Interestingly, diverse opinions are the norm in the comment section of the The Kidney Doctor making the intersection between professional nephrologists to ordinary patients a rare phenomenon not encountered on most blogs.  This lends itself to extreme positions at times. One example is by Noshi Ishak, MD of Laconia, NH where he coined the phrase "Extra Cheese Dialysis" in response to the negative findings of the FHN nocturnal study, but improved phosphorus control:

Dialysis Unplugged: "Waiting for Godot"

I hope CMS and the FDA will keep its eyes open and will not be sucked into another Amgen like scheme. Our country is deep in debt and has no money to waist on “Extra Cheese Dialysis”.

If ever the FDA will give any guidelines for hemodialysis under the information we have today it should be as follows:

1. All patients are to be dialyzed 3x/week, whether in center or at home, and the duration of the treatment and choice of dialyzer are to be prescribed by their Nephrologists in order to achieve the recommended clearances and adequate fluid removal according to the patient’s needs and body size.

2. For transplant candidates with expected prolonged wait for an organ and patients who failed their transplants, a more intensive dialysis such as daily dialysis or daily nocturnal dialysis is recommended.

The logic behind his comment is an analogy to the EPO debacle where the industry utilized higher doses for the benefit of huge profits at the expense of patient outcomes. Although, the EPO over utilization in American dialysis institutions is well documented, Dr. Ishak, is over looking several issues in what in my opinion is a false analogy.

First, he stated that most studies have not shown any improvement in mortality with nocturnal "extra cheese hemodialysis," which is not a factual statement. A recent study by Pauly in 2009 showed equivalent mortality between Nocturnal Home Hemodialysis (NHHD) and cadaveric transplant:

Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients

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

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

Secondly, Dr. Ishak incorrectly states that nocturnal home hemodialysis is more expensive than standard in-center hemodialysis which has never been the case. Richard Rettig noted that home hemodialysis in the 1970's was a little over $14,000 for the first year and $7000 each year thereafter while in-center patients averaged around $29,000 with much inferior outcomes. Northwest Kidney Centers is one of the most outspoken advocates of more frequent and longer duration dialysis and their experience is that home hemodialysis patients save over 40% in expenses compared to in-center patients:

Home Hemodialysis --- The Best Dialysis Treatment

Even so, for-profit corporations have neglected the financial advantages of home hemodialysis although these have been known for 40 years. For example, in the Northwest Kidney Centers’ program,the cost of providing hemodialysis in the home is only approximately 60% of the cost of dialysis in the facility. Finally, Da Vita, one of the two largest dialysis corporations, has begun to encourage home hemodialysis aggressively.

Europe, Japan and Australia routinely encourage nocturnal home hemodialysis and their programs enjoy significant cost savings compared to our for-profit dominated dialysis industry with signifcantly improved outcomes at the same time. The dose response curve of optimal hemodialysis does not show the deleterious effects of higher EPO dosages. That is the critical flaw of Dr. Ishak's analogy. In fact, modern era NHHD started in Toronto in the 1990's came about as a treatment option for patients with severe cardiac conditions who did not tolerate short, violent sessions with high ultrafiltration rates.  Patients with severe co-morbidities often thrive with more frequent and gentler dialysis sessions.

Thirdly, Dr. Ishak advised selected use of frequent home hemodialysis to those with limited co-morbidities and transplant eligibility. Rich Berkowitz is one of the patients he would exclude from NHHD. Rich readily testifies that he would not be alive today without the benefit of NHHD on the NxStage System One. Several years ago, on the way home from a conventional in-center dialysis session, Rich experienced a severe heart attack and nearly died. Today, he is a leading dailysis advocate still kicking way beyond any discernible life expectancies of a dialysis patient at his age and with his medical history. Dr. Ishak would pull the plug on his home hemodialysis. Bill Peckham suffered from FSGS and a failed early transplant from his brother. After over 20 years on dialysis, Dr. Ishak would pull the plug on Bill and condemn him to standard in-center suboptimal clearances completely ignoring the benefits of his home hemodialysis that allows him to continue to work full time in a difficult and physically demanding job.

Lastly, Dr. Ishak is guilty in my opinion of not employing the standards of evaluating the value of any given study taking into account it's strength and weaknesses. Yes, the FHN nocturnal study failed to reach the expected outcomes, but that is due to serious internal flaws of the study, (here, here, and here) not the dialysis modality itself.  There is no adverse increased dose response with dialysis, just the opposite, more dialysis is better dialysis. Home dialysis patients with CHF, LVH and cardiovascular limitations are ideal candidates for longer and slower treatments. I would hope that Dr. Ishak is in the minority opinion in America, but after forty years of a concerted effort to over come the for-profit dominated American market, he unfortunately is most likely just the tip of an iceberg.

Sadly, the American nephrologist is more often than not the nemesis to optimal dialysis when they should instead be our chief advocate. Thankfully, many remain vigilent in this long and protracted battle waged against the illogical conclusions of American nephrologists that ignore decades of positive findings in study after study of optimal dialysis. We have an uphill battle but the truth in the end shall prevail. Despite the null and void outcomes of the FHN nocturnal study, there are other studies still in the pipeline outside of the United States that will hopefully put this hegemony to rest once and for all. Dr. Ishak should also include one more group in his flawed assessment, the American nephrologist who overwhelmingly chooses NHHD when they themselves are in need of renal replacement therapy.  

Extra cheese dialysis? No my friend, NHHD is life saving, cost cutting and what should be America's gold standard dialysis modality as it is in so many other nations. Perhaps one day, the American nephrologist will have eyes to see what the rest of the world has recognized for decades. More dialysis is better dialysis.

Is Frequent and Nocturnal Hemodialysis Trendy?

By Peter Laird, MD

The ASN Kidney Week conference in Philadelphia this year from November 8-13th is the largest nephrology meeting in the United States each year attended by thousands of nephrologists. Topics cover the entire range of renal practice including issues in dialysis. Unfortunately, I don't often look to the ASN to define optimal dialysis practices. Sadly, despite decades of positive outcomes for quotidian dialysis, ASN considers these proven treatment modalities as part of the topic in "Controversies in Dialysis." 

Controversies in Dialysis

November 10, 2011 | 02:00 PM - 04:00 PM

Location: Ballroom B

Session Description

After decades of performing chronic dialysis, the optimal time to initiation is unclear. The randomized trial (IDEAL) on this issue has recently been completed and published. Frequent and nocturnal hemodialysis is trendy, and many observational studies suggest that this practice is superior to conventional dialysis. The NIH FHN randomized clinical trials shine more light on this issue.

Session Objectives

Upon completion of this session, the participant will be able to: 1) learn when to initiate chronic dialysis; 2) learn how strong the evidence is for the benefits of quotidian hemodialysis; and 3) make editorial comments on where chronic dialysis is heading medically.

While it is true that that FHN short daily dialysis treatment arm did show significant benefits to more frequent dialysis, the nocturnal arm failed to recruit enough patients to have a high enough powered study to answer these issues. In many ways, the nocturnal study sheds no light on the issue of improved outcomes. Instead, it is truly a null and void, seriously flawed medical study that did not answer any of the questions it was allegedly designed to answer. Academic American nephrologists routinely label quotidian dialysis strategies as controversial even though they uniformly reject standard in-center hemodialysis should they themselves need renal replacement therapy and instead choose daily or every other day nocturnal dialysis at home if they could not secure a pre-emptive renal transplant.

The manner in which frequent and nocturnal dialysis is belittled by calling it trendy sadly shows how this live saving dialysis modality is viewed in the eyes of the most influential nephrologists in America. Is it trendy, or instead is frequent and nocturnal hemodialysis truly the optimal manner to perform dialysis. Patients have already answered this so called "controversial" issue by dramatically increasing home hemodialysis as their first choice renal replacement while waiting for a renal transplant or as their primary long term treatment option.

The only controversy is why America continues to debate this issue while the rest of the developed worlds moves foreword strongly to engage as many patients as they can with these home treatment options.  While ASN debates quotidian dialysis once again, the home hemodialysis market continues to grow. ASN risks becoming irrelevant to this discussion as patients bypass this influential organization and demand this option. For patients, quotidian dialysis is already a settled issue. Perhaps one day, the American nephrologist will know as much as their patients. 

Taking Hemodialysis Home Safely

By Peter Laird, MD

Home hemodialysis is undergoing a renaissance in the United Stated with over 5000 patients now utilizing this flexible and convenient therapy in the comfort of their own homes. Safety in the home dialysis environment is a diverse topic with patients having varying skill levels coupled with no standardized training programs. Nevertheless, there are many common safety elements when applied uniformly that will assure the best outcomes and reduction of complications.

Patient safety in the home begins with an attitude towards safety. When a pilot steps into the cockpit of a plane or a surgeon into the operating theatre, there is an expectation of safety as the first and highest priority.  Likewise, the home dialysis patient needs to adopt this same reliance on safety first. However, since it is also the place where we live, patients face a difficult compromise between basic living quarters and tending our own dialysis unit. The first step is to have a separate, dedicated space for dialysis and supplies when possible.  Supplies should be inspected upon delivery for damage and loss of integrity, discarding any that are compromised. The storage area should minimize exposure to sunlight, moisture, dust and extreme temperature fluctuations.  Pets and young children should not enter the supply area. 

The daily dialysis session starts with proper setup of the equipment and inspection of all supplies. Crimped bloodlines can lead to hemolysis which can be life threatening. Patients need to examine all prepackaged dialysate for discoloration of the fluid and check for proper prescription. The artificial kidney should not contain any cracks and you should only use supplies that have not expired or had any external damage to the protective coverings. Always check for any leaks of the cartridge or bloodlines prior to starting dialysis while the machine is priming. Review all machine settings to assure that they are correct.

All dialysis machines monitor for internal system failures during the priming session and any alarms should be addressed prior to hooking up. The operators instruction manual must be within easy reach at all times as well as phone numbers for technical support of your specific machine. If there are any unusual sounds or obvious dysfunction of the machine, notify the technical support staff before proceeding with your dialysis session. Inspect all connections to make sure none are loose.  Assure that the proper lines are open or closed depending on the system used with all caps in place Lastly, keep emergency supplies for disconnecting the blood lines in the event of an emergency within easy reach including scissors, hemostats, needle nosed pliers as well as a telephone to call for emergency medical attention.

Infection Prevention:

Infection control in the home setting originates with healthful living and general cleanliness. Pathogens abound in un-kept homes especially staphylococcus bacteria that can live on exposed living surfaces for several days. Routine hand washing is the anchor to safe performance of dialysis in the home. Unfortunately, proper hand hygiene is also one of the most ignored tasks leaving home dialysis patients at increased risk.  Johns Hopkins revolutionized infection control in the intensive care unit several years ago by developing a “bundled” checklist for central line insertion and after care. This same attention to basic hygiene principles could mitigate many of the common infectious complications associated with hemodialysis.

• Shower or wash access site just before the session begins.
• Employ diligent hand hygiene from a combination of hand washing and use of alcohol gels during the different steps of home hemodialysis.
• Wear gloves and facemasks at all times when inserting needles, hooking up bloodlines and disconnecting at the end of a dialysis session.
• Use sterile bandages instead of communal supplies from multi-use dispensers that are easily contaminated.
• Disinfect cannulation sites preferentially with chlorhexidine instead of iodine if not allergic to chlorhexidine.
• Avoid long-term catheter access and utilize fistulas when possible which significantly reduce all cause complications.

Many patients on home hemodialysis access their fistulas using the constant site cannulation technique also known as buttonhole cannulation. There are several benefits to buttonhole cannulation including reduction in aneurysm formation, reduced pain with needle insertion and significant reduction in infiltration with cannulation. However, recent studies reveal an increased risk of access site infections with buttonhole cannulation versus rope ladder cannulation techniques, especially in the setting of in-center dialysis units.  Proper technique may mitigate these infections:

• Wash arm and disinfect site with an antimicrobial agent before picking scabs.
• Consider single use, sterile disposable tweezers for each buttonhole site instead of reusable metal tweezers that are difficult to disinfect.
• Soften scabs prior to removal with alcohol gel or pads covered by warm compresses for several minutes.
• Avoid using sterile needles to pick scabs since they can increase tissue damage that then serves as a nidus for infection.
• Re-prep buttonhole sites with an antimicrobial agent before cannulation.

Preventing Dialysis Emergencies:

Cafazzo, et al, in 2009(1) noted that the fear of a catastrophic event is one of the most important patient-perceived barriers to home hemodialysis.  Air embolism and exsanguination from venous needle dislodgement are the most serious immediate medical emergencies that can occur during hemodialysis, albeit rarely documented.  With the popularity of nocturnal home hemodialysis, venous needle dislodgement gains even more importance to prevent since many home nocturnal dialysis patients sleep alone. Unfortunately, venous needle dislodgement remains the most common cause of preventable death in the dialysis unit and is a serious risk for the home hemodialysis patient.

The FDA recently approved the Redsense monitor to detect blood loss during hemodialysis. Many home hemodialysis patients have used bed wetting monitors to protect against undetected venous needle dislodgement in an off label use that is not recommended.  Nocturnal hemodialysis patients especially need to utilize an approved moisture alarm device during each session in addition to the usual precautions:

• Tape the bloodlines securely before initiating dialysis.
• Keep bloodlines and needle insertion sites visible at all times. Never cover with blankets or clothing.
• Never tape bloodlines to chairs, tables or other objects that could cause the venous needle to dislodge.
• Utilize FDA approved moisture detectors and test frequently to make sure the device is functioning properly.
• Never disable pressure alarms designed to detect a sudden change of pressure from venous needle dislodgement.
• Never cut the dialysis needle lines during emergencies, you will bleed to death. Clamp and cut above the dialysis needle lines. 

Air embolism during hemodialysis occurs when atmospheric gas is introduced into the venous system. As little as 20 ml of air can be fatal when introduced directly into the blood system. Modern home hemodialysis machines all detect small amounts of air and automatically shut down the machine. One of the most common risks for venous air embolism is an empty IV saline bag during rapid infusions for cramps and during the final rinse-back especially if bypassing the machine in a manual rinse-back maneuver.  Careful attention observing saline levels will prevent this error. If a saline bag runs dry and introduces air, remove all introduced air in the line before proceeding with any further saline infusion. If the lines cannot be cleared, abort any further infusions since the air can be fatal or cause severe complications. Long-term exposure to even small levels of air bubbles can cause significant clinical effects from micro-bubbles, which can be reduced by up to 75% with careful priming.

Dialysis patients utilizing catheter-based treatments are at the highest risk of venous air embolism since any air is introduced directly into the central blood vessels immediately. Assuring that the catheter is clamped securely before connecting or disconnecting bloodlines limits the risk of venous air embolism. However, a venous catheter crack or disconnection that goes unnoticed can be rapidly fatal. Safely measures to prevent air embolism include:

• Use the vascular catheter only for hemodialysis access.
• Keep all bloodlines visible during dialysis at all times.
• Monitor for cracks, tears or breaks of the catheter hub and Luer lock disconnection during hemodialysis.
• Replace saline bags before they become empty.
• Suspect air embolism if the patient complains of shortness of breath or has any unusual symptoms during or immediately after a hemodialysis session.

Preparing for Non-medical Emergencies:

All home hemodialysis patients should prepare for local disasters including adverse weather, home fires, earthquakes and epidemics. In addition, during the hot summer months, loss of electricity is a common disruption during dialysis. Patients need to understand manual rinse-back procedures and should have emergency lighting available if dialyzing at night. Emergency preparedness includes keeping supplies available for food, water and shelter in the event of a local disaster as well as having available travel arrangements if they must evacuate the area. There are several basic measures of emergency preparedness that all home dialysis patients need to adapt to their own specific situations. 

• Keep personal medical information available and consider medical alert bracelets. Keep basic proof of ID and insurance information on hand as well as credit cards and banking information.
• Register your home with water and power companies to increase priority restoration in times of emergency.
• Have flashlights, batteries, medications, emergency food and water supplies and cell phones charged.
• Know the phone number to the backup dialysis unit you are assigned.
• Prepare an emergency dialysis supply kit filled with tape, masks, needles, syringes, heparin, saline, gloves, hand sanitizers, betadine and medications.
• Trash bags for waste disposal.
• Bleach to decontaminate equipment if using the portable NxStage System One and related supplies.
• Keep a three-day emergency diet on hand in case you are not able to re-establish your dialysis routine in that time.

All home hemodialysis patients need to spend time developing their own individual emergency preparedness plan and implement that plan upon completion of their dialysis-training program. Fortunately, there are several excellent resources available online.  Those that I find helpful include: 

• Home Dialysis Central:  Disaster Planning for PD and Home HD (http://www.homedialysis.org/article/life_at_home/disaster_planning_for_pd_and_home_hd)
• KCER: Kidney Community Emergency Response Coalition (http://www.kcercoalition.com/resources.htm)
• National Kidney Foundation: Planning for Emergencies (http://www.kidney.org/atoz/pdf/DisasterBrochure.pdf) 

Water Safety:

Dialysis patients require large amounts of water to perform dialysis making water safety one of the most important elements of a dialysis safety program. There are currently two FDA approved systems for home dialysis that utilize different processes to prepare the cleansing dialysate, the Fresenius 2008K@home dialysis machine and the NxStage System One. The first step for all home hemodialysis patients is to have their tap water analyzed to make sure it adheres to basic water purity for drinking water and does not contain certain heavy metals such as arsenic, other elements or excessive bacteria. Dialysis patients are exposed to higher levels of water each week through their treatments than normal drinking making even small levels of contaminants that are tolerated in drinking water dangerous for the home dialysis patient.  Patients should diligently follow the prescribed water testing schedules that your home dialysis trainer sets up.

The Fresenius 2008K@home dialysis machine relies on technology used in conventional in-center dialysis units with a reverse osmosis machine that removes most chemicals and metals from the water.  However, it does not remove chlorine and chloramines used by city water systems to purify drinking water or all of the bacteria and their breakdown products called endotoxins. Activated charcoal filters remove the chlorine before the RO system processes the water. Bacteria and endotoxins are removed by specials microfilters.

Patients learn how to test and maintain these systems during the extended training for home dialysis. The key element of water safety is to maintain accurate records and correctly perform all maintenance on schedule. Daily testing for chloramines is a necessary task to prevent serious adverse effects during dialysis.  Many patients find daily maintenance of the water systems the most difficult part of home hemodialysis when dialyzing with the standard RO process.

The NxStage System One utilizes ultrapure dialysate that is either pre-packaged in ready to use bags or from the PureFlow SL machine that takes tap water, purifies it with a multi-step process and combines this purified water with sterile dialysate concentrate making 60L of dialysate with each batch. Patients must test daily for chloramines and maintain scheduled testing of the water quality for metals and bacteria levels to ensure safety. Water safety in dialysis is one of the most technically complex aspects of dialysis care in the home requiring close communication with the supporting dialysis unit and continued testing and maintenance of all equipment in conjunction with professional oversight by qualified technicians.

Dialysis Waste Disposal:

Dialysis waste includes used needles, syringes, bandages, bloodlines, artificial kidneys and other biohazards. Proper waste disposal completes the circle started with proper infection control practices in the home hemodialysis setting. One of the greatest safety hazards is proper disposal of used needles that become a biohazard risk to care takers, family members and waste management personnel.  Each state has their own guidelines and regulations on proper disposal of all home medical wastes in conjunction with the environmental protection agency (EPA). Patients should enquire from their supporting dialysis unit how to dispose of these wastes safely and in compliance with state, local and federal regulations.  Needle safety starts first with a standard sharps disposal container in the home environment that is kept safely away from children and other members of the household.  

Fall Prevention:

Many hemodialysis patients have several co-morbid conditions and restricted mobility that places them at higher risk of death or injury from falls in the house. In addition, hemodialysis with high ultrafiltration rates increases the risk of falling from low blood pressure during and immediately after finishing a dialysis session. Adhering to low sodium diets and carefully monitoring for excess intradialytic weight gain is part of home dialysis safety. For patients with congestive heart failure and other cardio-pulmonary diseases that increase fluid retention, physicians and patients should consider daily, nocturnal home hemodialysis that minimizes the amount of fluid removed with each session and in addition removes the fluid slowly over a longer period of time. Many studies reveal less intradialytic hypotension and normalization of blood pressure with this approach making the risk of falling less likely.

Lastly, care partners should be able to perform basic emergency procedures such as placing the hypotensive patient in reverse trendelenberg, give a rapid saline bolus also being able to change the IV bag safely, have emergency numbers available as well as basic medical information to give to the responding paramedics. Hemodialysis in the early pioneering days of dialysis was by necessity a home-based therapy. Today we are rediscovering the benefits of dialyzing in the comfort and safety of the home environment with significantly improved mortality and a lower burden of complications than conventional in-center hemodialysis. As America continues to expand this needed home therapy, home dialysis training programs need to instill basic safety guidelines into the routine practice of dialysis in the home. Patients considering home hemodialysis need to embrace the responsibility of their own treatments and at the same time know that they shall enjoy the benefits of increased freedom to travel and an improved quality of life.

1) Patient-Perceived Barriers to the Adoption of Nocturnal Home Hemodialysis - CJASN (April 2009)(4) 784-789, Cafazzo et al

AJKD Article: A Cause with Solutions

By Peter Laird, MD

AJKD just published a testimonial essay on my own journey with kidney disease in which I also advocate for optimal home hemodialysis 0ptions, the one ignored gift of life for renal patients in America.

A Cause with Solutions: An American Hemodialysis Story

America continues to deny access to life-saving treatments proven by decades of observational studies which have been confirmed by at least 2 randomized and controlled trials. The ACTIVE trial (ClinicalTrials.gov identifier NCT00649298) testing the differences between more than 24 h/wk versus fewer than 18 h/wk of hemodialysis should be completed in the next couple of years, but in my opinion, we already have overwhelming evidence of the benefits of more frequent and longer duration hemodialysis rivaling deceased donor transplant survival.

Yet today, access to improved dialysis techniques is a little-heralded cause, especially in comparison to the frequent coverage in both the medical and popular press of transplant issues. Whereas the current standard of care requires all patients with ESRD to be evaluated for eligibility for transplant, only 1%-2% of the 400,000 hemodialysis patients in America have access to potentially life-saving home hemodialysis options. The ESRD “Conditions of Coverage” mandate a discussion regarding home dialysis options, but in reality this option is available only in limited areas. We have a long way to travel to match the nearly 25% home hemodialysis population seen in New Zealand and Australia. This is a cause with solutions, a cause that I will continue to champion. It is time for America to return to our pioneering days and reveal the true potential of this life-saving treatment.

Sadly, few American dialysis patients have access to the same hemodialysis options that I now enjoy in the comfort of my own home. It is time that the vision of home hemodialysis from Dr. Scribner and his many colleagues  come full circle and begin to save hundreds of thousands of lives every year.  The technology is now available, what is lacking is the will to purpose in our hearts to carry this vision to completion. 

Understanding the NxStage Filtration Fraction

By Peter Laird, MD

Perhaps the single most commonly asked question by patients on home dialysis with the NxStage System One is "what is your FF?" The answers vary greatly without anyone in consensus over what is the best filtration fraction (FF). To answer that question, defining the terms is in order. The filtration fraction is actually a fixed ratio between the blood flow rate (BFR) and the dialysate flow rate (DFR) expressed in a fraction. For example if you have a BFR of 400 ml/min and you set your dialysate flow rate at 35% of that figure, the actual dialysate flow rate is 140 ml/min.  The filtration fraction is thus expressed in this example as 35%.

The NxStage System One is designed on a low dialysate flow rate to theoretically maximize the dialysate at a "100%" efficiency.  Anyone that studies physics understands readily that there is never a system that is 100% efficient. However, looking at dialysate flow curves and levels of urea removal, there are higher and lower levels of efficiency depending on how fast the dialysate flow rate is set. 

Evaluating this well done slide by Wellbound, it is evident that at the right side of the curve, the efficiencies plateau so that increasing the dialysate flow rate does not increase urea clearances. Likewise, on the left side of the curve, as the flow rate is increased, there is a corresponding degree of increased urea clearance. The NxStage System One utilizes this increased efficiency of solute clearance for their low dialysate volumes compared to in-center machines. The line begins to diverge from highly efficient to lower efficiency around 200 ml/min dialysate flow rates. It is thus reasonable to set a maximum dialysate flow rate of 200 ml/min as the upper boundary.

I personally utilized this information in the design of my own NxStage short daily dialysis program where I started not with the FF or filtration fraction but with the dialysate flow rate directly.   Keeping the goal of less than 200 ml/min in agreement with the underlying goals of the NxStage System One, I took the FF to it's maximum parameters and kept my blood flow rate at a lower level. In many ways, time on the machine per week is the most important factor since phosphorus (PO4) and many of the middle molecules such as B-2 microglobulin are time dependent unlike urea which is easily cleared quickly.

Fitting the NxStage System One into your daily life is in large part predicated on the amount of time per session and how many days a week it is completed. Many papers over the last two decades show conclusively that the longer per session a patient stays on the machine, the better the outcomes, short daily dialysis can be too short. Discussing all of the factors involved in deciding what your "best FF" will be is determined by your goals of therapy, time allowed to these treatments as well as the configuration of the NxStage System One. Finding the optimal FF is thus a very personal quest in conjunction with the recommendations of your medical team taking into consideration how the NxStage System One dialysate flow rates are designed.

Harvey Wells Doing Well after Kidney Transplant

By Peter Laird, MD

Harvey Wells, the traveling NxStage patient opening the doors of his RV to dialysis patients across the country recently underwent a renal transplant and is going well. Harvey has single handedly opened dialysis patients to the home dialysis option in his personal testimony and hands on demonstrations.  Take a look at a recent video in the Wall Street Journal that chronicled Harvey's journeys.

 

Harvey credits his kidney transplant to the good health from using the NxStage System One for the last 4 years. 

I certainly don't think I would have been transplant material if I had stayed in-center for 5 1/2 years.  I probably would never have gone for a transplant if it hadn't of been for NxStage.

We wish Harvey the best in his newest renal replacement and look forward to his continuing testimony to optimal dialysis options.

God bless and get back soon Harvey.

The American Dialysis Experience: How do we Create Patient Centered Care?

By Peter Laird, MD

I started in-center hemodialysis in February of 2007 and entered a new world of very large needles, headaches, especially after the long weekend and severe restrictions in my diet. It has been a journey that my wife has taken with me, side by side which finally led to our decision to take my treatments home. I am one of the fortunate 1% of hemodialysis patients in America able to create my own patient centered care by being at the forefront of my health care team in the comfort of my own home. Unfortunately, we are leaving too many fellow patients behind in many units that value the payment more than the patient.  Many thoughtful, bright and caring advocates have long wondered how we can restore the focus back to the patient as the center of care, instead of the business as usual we see in all too many American dialysis units today.  Where do we begin?

Looking at these issues over the last three years not only as a physician but as a dialyzor, I believe we are on the verge of a confluence of trends coming together in rapid fashion that could dramatically change the American dialysis experience very quickly. Focussing on this convergence may yield the greatest rewards in our collective efforts. Categorizing these trends into the framework of Alignment, Avoidance and Enforcement is helpful:

A) ALIGN:

    1) The Historical Application:  Pioneers of dialysis used rehabilitation as the marker of patient treatment outcomes with more dialysis applied when patients were unable to return to work and life activities.

    2)  Market Forces: Competition among FMC, Baxter, NxStage and others for the home Hemo market will be fierce.  We should align with these forces that will utilize intensive campaigns to increase patient demand for these new machines, thus expanding the home hemodialysis market as well as the already expanding home peritoneal dialysis market.

    3)  Bundle: Align and Reduce per capita health care costs of dialysis by increased utilizing of self-care and home dialysis modalities.

    4)  Conditions for Coverage, 2008:

            Rehab Elements already in place in the regulations. (Thank you Dori and Beth)
            Mental Health coverage already included in Medicare Part A, B and D
            Mental Health evaluations already mandated in the CfC’s
            Informed Consent Mandated in the CfC’s
                    Legally Required
                    Malpractice potential for not adhering to these regulations

    5)  Medical literature:       

            Current literature supports more frequent and longer duration dialysis, once again in accord with the original data from the pioneering days of dialysis in the 1960's. FHN and other studies are converging upon a unified approach to optimal dialysis best summarized years ago in the Scribner-Oreopoulos Hemodialysis Product. Duration of dialysis together with frequency of dialysis gives us the best measurement of expected outcomes.

    6) Focus on CQI driven reviews of current practices to eliminate medical errors and iatrogenic conditions in dialysis centers in accordance with the IOM Triple Aim.

    7) Reduce unnecessary admissions and readmissions by adhering to best dialysis practices learned in the last fifty years of this lifesaving treatment.                        

 B) AVOID:

    1)  Avoid Re-use of Artificial Kidneys.

    2)  Avoid High Ultrafiltration Rates greater than 10mL/hr/kg.

    3)  Avoid Sodium Modeling.

    4)  Avoid Short Dialysis Times less than 4 hours for thrice weekly hemodialysis .

    5)  Avoid Catheter Use, especially new onset dialysis patients by early referral for fistula placement.

    6)  Avoid the long weekend, support Every Other Day (EOD) petition.

    7)  Avoid Late Referrals:

            Improve education of Primary Care Physicians and Patients to optimize referals to Nephrology in a more timely manner.

 C) ENFORCE:

     1)  Annual Dialysis Inspections - State and Federal level

            QIP
            CfC’s 2008
            Bundle

Enforcement of these regulations will need state legislative or congressional action. We already have many excellent regulations and statutes in place, but there are no effective inclusions of true enforcement language in these regulations.

This is my own short list of actions that would restore patient centered care to the American dialysis experience that is only afforded to the smallest percentage of dialyzors. As we move forward with the emerging postitive trends in the market place, I for one do not want to leave anyone behind. With worse survival statistics than breast cancer, prostate cancer and HIV, the American dialysis patient is a vastly underserved population not because of lack of resources, but because of the lack of patient centered care that would actually be cost saving as well.

 

Short Daily Dialysis Can be Too Short

By Peter Laird, MD

The Frequent Hemodialysis Network Trial Group results published in November 2010 has focused many providers interest in short daily dialysis since the results of this randomized and controlled trial dramatically showed the benefits of short daily dialysis. The study endpoints of reduced LVH and improved physical-health composite score is a long awaited result from a randomized and controlled trial.  In addition, the long standing argument of how much dialysis and at what dose is best for patients stands on the side of the dozens of observational studies showing a benefit to more frequent and longer duration dialysis.  The gold standard of dialysis care is daily, nocturnal dialysis of 6-8 hours duration done at low blood flow and low ultrafiltration rates.

The NxStage System One portable home dialysis machine introduced a new wave of interest in home based therapies especially in the last five years.  Many now use the NxStage machine as short daily hemodialysis.  Combined with the ease of learning and using this system, patients are now free to dialyze in the comfort of their own home. However, many patients will be tempted to shorten their daily treatments to augment lifestyle changes and freedom.  Dr. Kjellstrand, et al published an important paper in September 2010 looking at the total weekly duration of dialysis and mortality. They found that sometimes, short daily dialysis can be too short:

Survival with short-daily hemodialysis: Association of time, site, and dose of dialysis

Short-daily hemodialysis can be too short. In this series of patients, every extra hour spent on dialysis was associated with better survival. This finding is in agreement with those of others analyzing thrice-weekly dialysis^5–8 and interestingly is seen even in patients treated by long night hemodialysis, where the weekly dialysis hours are 2 to 4 times longer than in our patients on SDHD.¹²

Patients considering home hemodialysis should bear in mind that time on dialysis correlates directly to survival.  For those considering short daily dialysis, avoiding total dialysis times less than 15 hours each week should be in the forefront of discussions with your medical team.  When coupled with the information of the FHN showing more frequent dialysis benefits, the optimal approach is to maximize time and frequency of sessions individualized to patients schedules and lifestyles.  We are once again coming full circle back to Dr. Scribner's wisdom of the Hemodialysis Product where he correlated survival based on a simple calculation of frequency and time on dialysis back in 2002.

NxStage On The Doctors TV Show

By Peter Laird, MD

The Doctors is a patient oriented doctors news show highlighting different advances in medicine.  A recent episode featured the NxStage System one Dialysis Machine:

 

The show also featured a brief interview with a NxStage patient named Vanessa who stated that the portable machine has transformed her life.   She is using this as  a bridge to transplant, but not all patients on the NxStage are eligible for transplant such as Rich Berkowitz, Bill Peckham and myself. They did make a statement that dialysis is not meant to be permanent, yet for the majority of patients it is. Oh well, at least they discussed the NxStage and got almost everything correct, sometimes you just have to give credit where credit is due.