HemoDoc, From Doctor to Patient

Should Dialysis Patients Take Statins to lower Heart Risk?

By Peter Laird, MD

The debate over cholesterol management of dialysis patients is filled with divergent data from several studies. Some studies actually indicate an increased rate of survival with higher cholesterol levels, but these outcomes are clouded by the effect that malnutrition/inflammation has on mortality. In this case, the findings of elevated cholesterol and higher survival are more likely a secondary measure of poor nutrition and higher death rates from the malnutrition/inflammation connection:

Association Between Cholesterol Level and Mortality in Dialysis Patients: Role of Inflammation and Malnutrition

Conclusions The inverse association of total cholesterol level with mortality in dialysis patients is likely due to the cholesterol-lowering effect of systemic inflammation and malnutrition, not to a protective effect of high cholesterol concentrations. These findings support treatment of hypercholesterolemia in this population. 

However, further randomized and controlled studies found no benefits to dialysis patients with statin therapy. The 4D trial was a double blind, placebo controlled RCT evaluating 1255 patient on dialysis that also had Type II diabetes. After four years comparing Artovastin (lipitor) to placebo, there was no difference in mortality even though there were fewer cardiac events due to a higher than expected number of cerebrovascular events. In 2009, many nephrologist believed that the AURORA trial, the second major clinical trial of statins in dialysis patients, settled the issue for good when it likewise found no survival benefit in dialysis patients:

AUROROA Trial Results

A total of 804 patients had a major cardiovascular event during the followup period, of which 396 were in the rosuvastatin group and 408 were in the placebo group (9.2 and 9.5 events per 100 person-years of followup respectively). There was no significant effect of treatment with rosuvastatin on the primary combined endpoint (HR 0.96; 95% CI 0.84 to 1.11; p = 0.59). There was also no significant effect of treatment with rosuvastatin on the individual components of the primary endpoint. A summary of the AURORA trial results can be found in the Table. The lack of effect of rosuvastatin on the primary endpoint was consistent among all subgroups including those with diabetes, high LDL-C level, elevated hsCRP, hypertension and preexisting CVD. The lack of effect of rosuvastatin on the primary endpoint was also not influenced by overall time on hemodialysis.

The latest study evaluating cholesterol lowering in patients with chronic kidney disease to include dialysis patients is the SHARP trial.  It is the first study showing any benefit to cholesterol lowering in this population. Granted, patients not yet on dialysis had a greater benefit than those on dialysis, the results remain provocative.

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomized placebo-controlled trial

After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10 000 patients per year of treatment with this combination (9 [0·2%] vs 5 [0·1%]). There was no evidence of excess risks of hepatitis (21 [0·5%] vs 18 [0·4%]), gallstones (106 [2·3%] vs 106 [2·3%]), or cancer (438 [9·4%] vs 439 [9·5%], p=0·89) and there was no significant excess of death from any non-vascular cause (668 [14·4%] vs 612 [13·2%], p=0·13).

Interpretation

Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease.

One of the difficulties of studying the cardiovascular benefits of statins in dialysis patients is that most cardiac events in dialysis patients appear to from a different mechanism of action than plaque rupture and thrombosis leading to acute coronary syndrome and myocardial infarction.

High ultrafiltration rates, short dialysis treatment times, mineral-bone disorders, rapid electrolyte shifts and underlying LVH are all factors leading to myocardial stunning, hybernation and myocardial ischemia during the dialysis procedure. These confounding cardiac factors have never been controlled and eliminated in dialysis patients who have a significantly higher risk of sudden cardiac death. The results of the SHARP trial showing significant benefits in CKD patients not on dialysis should not lead to dismissing the use of statins in dialysis patients from studies not designed to eliminate these other factors. Instead, there is no reason physiologically for an improved clinical outcome especially in daily, home dialysis patients who are at lower risk of LVH, rapid electrolyte shifts and myocardial ischemia than those that are in-center patients.

Before eliminating statin therapy from dialysis patients as many nephrologists now advocate, any further studies should consider Dr. Kjellstrand's Unphysiology theory leading to testing statins in the most stable dialysis population, home dialysis patients on daily, nocturnal dialysis. These patients have documented reversal of LVH and significantly lower mortality than standard in-center patients that the prior cholesterol studies have used as their study population. For myself, I personally believe that statin therapy is just as important in dialysis patients as in any other patient at risk for acute cardiovascular outcomes. It may be the large number of confounding factors leading by a different path to cardiovascular deaths that confounds any benefit of statin therapy. If we are to answer this question definitively, designing a trial in well nourished patients at lower risk of cardiovascular outcomes in the first place might significantly highlight the need not only for statins but optimal dialysis as well.

Taking BP Medications at Night May lower Stroke and Heart Attack Risk

By Peter Laird, MD

A recent study published in JASN reveals significantly reduced rates of cardiovascular outcomes when patients take their anti-hypertensive medications at bedtime. Understanding that the the early morning to mid morning hours have the highest risk of heart attack and stroke. Many believe that the circadian rhyths and endocrine realeases of cortisol and other hormones may contribute to acute cardiovascular events. This latest study explored whether taking anti-hypertensive medications at night would have any influence on these events:

Bedtime Dosing of Antihpertensive Medications Reduces Cardiovascular Risk in CKD

After a median follow-up of 5.4 years, patients who took at least one BP-lowering medication at bedtime had an adjusted risk for total cardiovascular events (a composite of death, myocardial infarction, angina pectoris, revascularization, heart failure, arterial occlusion of lower extremities, occlusion of the retinal artery, and stroke) that was approximately one-third that of patients who took all medications upon awakening (adjusted HR 0.31; 95% CI 0.21 to 0.46; P < 0.001).

Bedtime dosing demonstrated a similar significant reduction in risk for a composite outcome of cardiovascular death, myocardial infarction, and stroke (adjusted HR 0.28; 95% CI 0.13 to 0.61; P < 0.001). Furthermore, patients on bedtime treatment had a significantly lower mean sleep-time BP and a greater proportion demonstrated control of their ambulatory BP (56% versus 45%, P = 0.003). Each 5-mmHg decrease in mean sleep-time systolic BP was associated with a 14% reduction in the risk for cardiovascular events during follow-up (P < 0.001).

In conclusion, among patients with CKD and hypertension, taking at least one antihypertensive medication at bedtime improves control of BP and reduces the risk for cardiovascular events.

 

Dialysis Patients May be at Higher Risk for Listeria Food Poisoning

By Peter Laird, MD

The news over the last month chronicles the still increasing death toll from a deadly bacteria called Listeria Monocytogenes. The culprit in this attack stems from cantaloupe at a farm in Colorado (here).  There are now over 28 confirmed deaths since the outbreak of listeriosis became evident in the middle of August. Listeria is one of the most feared bacteria due to its unique method of invading other cells, it is rocket powered: 

The gram-positive bacterium Listeria monocytogenes is the causative agent of listeriosis, a
severe food-borne infection characterised by abortion, septicaemia, or meningoencephalitis. L. monocytogenes causes outbreaks of febrile gastroenteritis and accounts for up to 10% of community-acquired bacterial meningitis in humans. It is the primary cause of central nervous system infection in domestic ruminants. Listeriosis has one of the highest hospitalisation (90%) and mortality rates of all food-borne infections.

Dialysis patients may be at an increased risk of this infection according to prior studies. In one study from 1984, patients on hemodialysis who received multiple blood transfusions causing elevated iron uptake had several cases of Listeria compared to dialysis patients who had not received blood transfusions. 

Listeriosis in patients with long-term hemodialysis and transfusional iron overlaod

Over a four-year interval, four cases of Listeria monocytogenes bacteremia were observed among a population of 127 patients undergoing long-term hemodialysis. None had an underlying malignancy or were recently receiving immunosuppressive medications. A search for a predisposing factor suggested a relationship to transfusional iron overload. Although still a rare infection, the possibility of listeriosis must be kept in mind by physicians caring for patients undergoing hemodialysis, particularly those requiring blood transfusions.

This may be more relevant today now that EPO recommendations are to increase the reliance of blood transfusions in chronic hemodialysis patients who are not candidates for transplant (here). Another population that may be at risk is the peritoneal dialysis patients. There have been several outbreaks of Listeriosis from contaminated PD solutions documented over the years.

Listeria Monocytogenes Peritonitis in a Peritoneal Dialysis Patient with Severe Heart Failure

Listeria monocytogenes has rarely been reported to cause peritonitis in peritoneal dialysis (PD) patients. Listeriosis is usually a severe disease with a mortality rate of 20 to 40% in humans despite early antibiotic treatment. In this report we present the first case in Greece of peritonitis caused by L. monocytogenes, in a chronic PD patient with severe cardiac failure. The patient received prolonged antibiotic therapy with vancomycin and netilmicin which resulted in peritonitis resolution. Unfortunately however, the listeria infection caused decompensation of the patient’s cardiac failure and led to his death, despite appropriate antibiotic treatment. When peritoneal fluid cultures yield gram positive rods in an immune-compromised patient or on a patient with severe underlying diseases who regularly consumes dairy products, the clinical suspicion of this rare infection must be immediately evaluated. Listeriosis can be fatal despite effective antibiotic therapy, since it affects patients with severe underlying pathologies.

Listeria is a lethal pathogen that rears its head in many different settings and is difficult to treat and at times difficult to diagnose due to its similar features to other "gram positive" bacteria. With its unique mode of rocket powered propulsion, it is not only a deadly invader, it is one of the marvels of God's creation. Truly, there is nothing new under the sun as Solomon stated over 3000 years ago.

BPA May Increase Diabetes Risk

By Peter Laird, MD

BIsphenol A (BPA), a byproduct of plastics manufacturing is significantly elevated in dialysis patients who are constantly exposed to plastic products during dialysis. New research shows an association between elevated levels of BPA and the onset of Type II diabetes:

Relationship between Urinary Bisphenol A Levels and Diabetes Mellitus

Results: Overall, we observed a positive association between increasing levels of urinary BPA and diabetes mellitus, independent of confounding factors such as age, gender, race/ethnicity, body mass index, and serum cholesterol levels. Compared to quartile 1 (referent), the multivariate-adjusted odds ratio (95% confidence interval) of diabetes associated with quartile 4 was 1.50 (1.05–2.14) (p-trend = 0.03). The association was present among normal-weight as well as overweight and obese subjects.

Conclusions: Urinary BPA levels are found to be associated with diabetes mellitus independent of traditional diabetes risk factors. Future prospective studies are needed to confirm or disprove this finding.

Further research is needed to define not only any possible link with diabetes, but also the health related effects BPA might play in the dialysis population which has one of the highest exposures to these chemicals.

Will Studies Of Patient "Noncompliance" Justify Cherry Picking?

By Peter Laird, MD

The for-profit dialysis industry is scrambling to put together new strategies on how to maximize their profits in the new CMS Medicare renal dialysis bundled payment system. This is the first time since the inception of the 1973 ESRD program that pay for performance has been part of the reimbursement structure. Even so, it will only put at risk up to 2% of total payments to any center in one year based on anemia management and urea reduction ratio (URR).  With the onset of the QIP in only a couple more months, some in the industry are looking for excuses to avoid the penalties.  A recent study illustrates the frustration that some are expressing about meeting even minimal quality indicators:

Patients who don't follow treatments hurt dialysis clinics' pay

Recently, Medicare implemented a pay for performance program for reimbursing dialysis clinics that provide care to kidney disease patients. One goal consists of achieving adequate dialysis dose (the amount of blood that is purified) in > 96% of patients in every clinic. Therefore, clinics that don't meet the 96% goal would get financially penalized.

Navdeep Tangri, MD (at Tufts Medical Center during the study and currently at the University of Manitoba in Winnipeg, Canada) and his colleagues looked to see if patient characteristics affect whether dialysis clinic achieve this goal. By analyzing electronic health records from 10,069 dialysis patients across 173 clinics and using advanced statistical methods, the researchers found that patient characteristics—particularly how well they followed their prescribed treatments—had a tremendous impact on a facility's achievement of the pay for performance measure. For example, patients who shortened or skipped dialysis treatments or gained weight between treatments played a major role in determining whether dialysis clinics fell short of reaching their goal.

The findings indicate that dialysis clinics that provide care to a greater proportion of patients who don't follow their prescribed treatments—which tend to cluster in low-income urban areas—would get unfairly penalized under the current payment system. "We believe that these penalties may lead to cherry picking against disadvantaged patients, and therefore widen disparities in care," said Dr. Tangri. The authors noted that alternatives to penalizing clinics that care for patients with complex medical and/or social problems are needed.

Unfortunately, cherry picking of the best dialysis patients with employer based health care plans is deeply engrained in dialysis practices already.  No where else in medicine are the rules of patient abandonment pushed to the limits as that of American dialysis units that at times dismiss patients from their units with the only alternative these patients have is to seek treatment at the local emergency rooms.

It is quite easy to be labeled a non-compliant patient. When I traveled to see my parents a year after starting dialysis, the new unit on the first day came to me and bluntly stated, "you refused EPO" based on what was written in my transfer summary. The true story is that I didn't need any EPO with a Hb over 12.0 on iron supplements alone coupled with my prior history of cancer. Not only was EPO not indicated in my case, it was also contraindicated, yet I was labeled by my home unit as a patient who had "refused" EPO which implied an underlying noncompliance. Nothing could be further from the truth. I was instead a well informed patient exercising my right to choose my own treatment options. In many cases, patients who seek to maximize their own treatment choices are quickly labeled non-compliant and documentation to that effect occurs.

On the other hand, the usual in-center dialysis treatment is one of short treatment times and high ultrafiltration rates that cause severe vascular compartment fluid loss rapidly leading to early signs of circulatory collapse and shock with nausea, lightheadedness, dizziness, vomiting, severe cramping and at times hypotension leading to syncope. In many units, supplies are chronically limited and staff are severely overworked. Many patients end a dialysis treatment strapped to an ambulance gurney en-route to the nearest emergency room. Is it any wonder that many patients simply don't want to participate with every scheduled patient given the true torments that they suffer at the hands of those pledged to secure their health.

I am not surprised that the reaction to the QIP is to seek routes of escape from the loss of even 2% of pay for a poor performance instead of seeking to overcome these deficiencies. That was not the intent of the QIP which instead was instituted to improve quality and activate quality improvement processes in the dialysis units. If this article is any indication of the response of the for-profit dialysis industry, then cherry picking appears to be their response to these newly imposed minimal quality standards instead of dealing with these known problems. That would be a sad testimony of our dysfunctional American dialysis industry. Unfortunately, it is the most likely response that we will see.

 

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

A Fresh Perspective or More of the Same?

By Peter Laird, MD

In 2006, as my own renal function declined and dialysis became a certainty, I researched the best treatment options for my own situation and settled on daily home hemodialysis with consideration of my relative contraindications for renal transplant. However, I did not become a dialysis advocate until 2008 when Dori Schattell of MEI and Home Dialysis Central taught me the historical context of optimal dialysis where the patients dialyzed 8-9 hours thrice weekly for 24-27 hours a week of dialysis and despite obsolete technology, enjoyed better outcomes.  After the advent of the 1973 ESRD program, for-profit dialysis became the driving force behind "ultra-short" dialysis studies that many allege were profit motivated. Yet today, few recognize that the gold standard of care for dialysis was 8-12 hours thrice weekly when Congress enacted the ESRD program:

Long, 3x8hr/week, hemodialysis : A three-decade summary

Long hemodialysis (HD) 3x8 to 12 hours per week, using 1 m2 flat plate cuprophan dialysers, was, in the 70’s, the most common form of empirical dialysis, the “gold standard”1. Technical advances, changing scientific views on uremia pathophysiology, as well as social and economic pressure (to make better use of the scarce dialysis stations) have led HD to apparition and the to development of shorter dialysis sessions.

In the late 1970's, treatment times dropped dramatically without the benefit of any randomized and controlled trials comparing outcomes between the "gold standard" of 8-12 hour dialysis sessions and the new standard of 3-4 hours.  Urea kinetics became enshrined by the NCDS which in reality compared four suboptimal modalities and then sold the American public and congress that this was the best we could offer patients. Many stood in opposition to these changes, but their voices were ignored. The debate over treatment times continues today over thirty years later. Despite the fact that the current standard of care never underwent an RCT to prove its efficacy, any changes to this business based model continue to be delayed by calls for more and more studies. The latest evaluation of this from the for-profit industry continues to ignore the original gold standard which was established by clinical parameters, not biochemical profiles. 

Hemodialysis Treatment Time: A Fresh Perspective

Moving Forward

. . . In the interim, inadequate short dialysis treatments likely lead to complications, increased hospitalization, and decreased survival and may have a negative effect on the total cost of therapy. We suggest that in the setting of three-times-per-week HD, a new minimum adequacy prescription target can be established by physicians to include specifications for TT ≥4 hours, with anything less becoming the exception rather than the rule.

The authors of this influential article in a widely read nephrology journal essentially dismiss in-center nocturnal hemodialysis and home hemodialysis options maintaining that "moving forward" will only be within the context of in-center models of care. Certainly, eliminating dialysis sessions less than 4 hours will be a giant step forward, yet it continues to fall short of the gold standard of the 1970's where people on dialysis continued to work and participate in all aspects of life.  They likewise dismissed every other day dialysis options which would eliminate the long interdialytic period every weekend which in itself would significantly improve survival. As much as I long to hear a "fresh perspective" from the dialysis industry, in the final analysis, this article does not contain anything but more of the same.

 

What Further Dialysis Studies are Needed? The Fox is Still in the Hen House

By Peter Laird, MD

Dr. Ajay Singh on his  The Kidney Doctor blog invited several people to comment on Robin Fields Atlantic Weekly article, "God Help You, You're on Dialysis." I was fortunate to have one of those invitations along with Bill Peckham of DSEN in side by side commentaries. (here and here)  Of a certainty, dialysis care in America is a much different entity than other nations that have long had a narrow focus on improved outcomes. Japan leads the developed nations with a rate 2.5 times less than our own and with reduced complications also enjoys lower per capita expenditures as well.

This is not a new finding but it has remained constant over several decades of practice. In many ways, America focused on one study, the National Cooperative Dialysis Study (NCDS) which, in my opinion, wrongly excluded TIME as an independent predictor of outcomes.  We should keep in mind that this study was motivated by the for-profit dialysis organizations that wanted to shorten treatment times to maximize profits. Evidence of this is that the lead author, Edmond G. Lowrie was the vice president of National Medical Care, Inc. and later became its president. At the time of the NCDS, the standard of care for dialysis patients was thrice weekly hemodialysis for 8-9 hours. However, the for-profit dialysis industry pushed "ultra-short" treatment times, some only of 2 hours length, thrice weekly.

Evaluation of ultra-short dialysis

A study was carried out to compare the effects of three dialysis regimens of different durations. Nineteen patients dialysed over 1975--7 for an average of only 11.2 hours per week were compared with nine dialysed for 24 hours per week (1974--6) and 10 dialysed for 27 hours (1971--3). Clinical, biochemical, and haematological results showed that the short dialysis regimen was as effective as the longer regimens, except that patients had to take a phosphate binder regularly, and that it was considerably cheaper.

Short dialysis has social and economic benefits, since patients have more free time and more patients can be treated with the same number of staff and dialysis stations. As in many areas there is a shortage of places for patients needing dialysis, a short regimen is recommended.

The debate today never utilizes the correct term, ultra-short dialylsis, for what we now call "standard" in-center dialysis treatment times. It was only after the NCDS labeled TIME as an unimportant dialysis treatment factor, and instead focused on urea kinetics alone that the debate ended between the dialysis industry and CMS. However, for those that knew the power of longer and more frequent treatments, the debate never ended. Instead, academic nephrology dominated by Harvard Medical School ignored these respected researchers that included Belding Scribner, the father of chronic hemodialysis. This started the rampage of death and misery amongst American dialysis patients. Other nations focused on extended dialysis treatment times ignoring the results of the NCDS that has dominated the American dialysis industry ever since even until today.

Sadly, the NCDS is one of the prime examples in medical history of how asking the wrong question in a RCT leads to the wrong answer. In this case, the NCDS is the basis for the poor medical outcomes of America compared to the rest of the developed world. Few question the impropriety of the vice president of National Medical Care Edmond G. Lowrie, which later merged becoming FMC North America, and this trial outcome. The simple fact remains that in my opinion, the fox was in the henhouse and no one sought to expel him from robbing them. The NCDS was the key that unlocked the economic benefits of ultra-short dialysis for the American for-profit dialysis industry at the price of patient outomes.

Today, the influence of National Medical Care and Harvard Medical School lives on in a close relationship with FMCNA. As the data continues to mount that ultra-short dialysis practices result in adverse clinical outcomes for hundreds of thousands of American dialysis patients, after waiting nearly ten years for the much ignored results of the FHN, all that academic nephrology in America can offer to us dialysis patients is a call for further studies:

Dialysis Unplugged: Dialysis Treatment Time - Is More Better?

Further research is needed to better delineate potential benefits of extended/frequent dialysis and to determine how best to integrate them into widespread clinical practice. In the meantime, the best available evidence suggests that for patients who remain on traditional hemodialysis, it is best to target both adequate urea clearance and treatment time of 4+ hours (in the majority of patients) to maximize health benefits.

Dr. Brunelli is a renal epidemiologist at Brigham and Women's Hospital and Harvard Medical School. He research focuses on identification of potentially modifiable risk factors for cardiovascular morbidity and mortality among hemodialysis patients. He also serves as the Director of Dialysis Services at Brigham and Women's Hospital. Dr. Eduardo Lacson is a nephrologist and epidemiologist at Fresenius Medical Care North America (FMCNA) and Vice President, Clinical Science Epidemiology & Research (FMCNA).

The inescapable answer to this question, is more dialysis better is an absolute yes according to several decades of observational studies and at least two RCTs. Yet, today, all that academic American nephrology can offer with its close ties to the largest dialysis organization is that we need to study this issue more. I contend that the fox is still in the hen house as it was back in 1981 with Edmond G. Lowrie, the vice president of NMC and now today with those in FMCNA. I no longer feel that we have equipoise in juxtaposing the clinical trial of more frequent or longer duration dialysis. And even if we did pursue further testing, what would that trial encompass?

The FHN allegedly was designed to answer these questions that academic nephrology is still asking. However, the FHN had significant dificulties enrolling patients to be randomized. In addition, those that were randomized were so highly selected that they had less than 30% of the expected mortality amongst URSDS outcomes making significant differences between the study groups even less  likely. Fortunately, despite the low event rate in the FHN study group, significant differences were found that should no longer be ignored.  It is not time for further study, it is time to reject ultra-short dialysis which NEVER underwent a RCT evaluating standard dialysis times of 8-9 hours thrice weekly. An imposter now rises up and continues to rear its ugly head even though it was never proven in the first place. 

Edmond G. Lowrie and his two co-authors in the NCDS since 1981 have inflicted death and misery upon millions of American dialysis patients by dismissing too quickly TIME as an independent predictor of dialysis outcomes. The only thing that remains intact is the relationship between Harvard Medical School and FMC calling for more and more studies in what I believe is simply an effective delaying tactic. It is time to call them out and begin to place patient outcomes at higher importance than economic and financial outcomes for these multi-billion dollar companies which are rich in profits, but poor in patient survival.

Insanity In Dialysis Research: i.e., Doing the Same Thing Again and Expecting Different Results

By Peter Laird, MD

Reviewing recently published reports is interesting when comparing them to prior reports, sometimes covering the same subjects in years past.  At times, the outcomes are well known and not in duspute leaving the reader wondering why the authors conducted another study. Some define insanity as doing the same thing over and over again expecting different results. Kidney international published a report in 2003 showing a clear risk to ESRD patients with congestive heart failure (CHF) employing peritoneal dialysis compared to standard hemodialysis. In this analysis of over 107,000 USRDS patients, peritoneal dialysis  (PD) patients with congestive heart failure had significantly worse outcomes than those with CHF on hemodialysis (HD).

Impact of dialysis modality on survival of new ESRD patients with congestive heart failure in the United States

Results The overall prevalence of CHF was 33% at ESRD initiation. There were 27,149 deaths (25.2%), 5423 transplants (5%), and 3753 (3.5%) patients lost to follow-up over 2 years. Adjusted mortality risks were significantly higher for patients with CHF treated with peritoneal dialysis than hemodialysis [diabetics, relative risk (RR) = 1.30, 95% confidence interval (CI) 1.20 to 1.41; nondiabetics, RR = 1.24, 95% CI 1.14 to 1.35]. Among patients without CHF, adjusted mortality risk were higher only for diabetic patients treated with peritoneal dialysis compared with hemodialysis (RR = 1.11, 95% CI 1.02 to 1.21) while nondiabetics had similar survival on peritoneal dialysis or hemodialysis (RR = 0.97, 95% CI 0.91 to 1.04).

Conclusion New ESRD patients with a clinical history of CHF experienced poorer survival when treated with peritoneal dialysis compared with hemodialysis. These data suggest that peritoneal dialysis may not be the optimal choice for new ESRD patients with CHF perhaps through impaired volume regulation and worsening cardiomyopathy.

Now eight years later, the same outcome was observed in a study from the French registry after evaluating patients from 2002-2008. The authors justified the need for this study based on the short f0llow up of only two years from the American study.  Despite the known  difficulties with fluid removal in PD patients, some nephrologists continue to propose the PD will improve outcomes in CHF patients needing renal replacement therapy. The findings of this latest study are no surprise, patients with CHF have worse outcomes on PD than on HD:

Survival advantage of hemodialysis relative to peritoneal dialysis in patients with end-stage renal disease and congestive heart failure

Peritoneal dialysis (PD) has been proposed as a therapeutic option for patients with end-stage renal disease and associated congestive heart failure (CHF). Here, we compare mortality risks in these patients by dialysis modality by including all patients who started planned chronic dialysis with associated congestive heart failure and were prospectively enrolled in the French REIN Registry. . . Thus, mortality risk was higher with PD than with HD among incident patients with end-stage renal disease and congestive heart failure. These results may help guide clinical decisions and also highlight the need for randomized clinical trials.

This is just one more example of insanity in dialysis studies where a very large study of over 107,00 patients over a two year period of study led to a much smaller study but of longer duration to answer a question that in my opinion defies the sanity of dialysis research by testing PD in CHF patients.  Clinically, patients with CHF have significant dificulties controlling fluid excess which is also one of the known weaknesses of PD treatments even in ESRD patients without CHF.  The 2003 study showed no benefit of PD in CHF patients which is not surprising given the difficulties of controlling fluids in many PD patients. The most insane aspect of the current study is their conclusion: These results may help guide clinical decisions and also highlight the need for randomized clinical trials.

It may not be insane to conduct further trials of a question that could have important clinical findings, but I believe it is insane to continue to conduct trials of an issue expecting a different outcome. We have seen this with longer duration and more frequent hemodialysis for over forty years. For the last four decades, American dialysis researchers observe better outcomes in study after study with daily dialysis, yet they remain unconvinced. We now have two randomized and controlled trials of daily dialysis where the outcomes confirmed the prior observational studies. The nocturnal arm of the FHN is simply inconclusive due to the inability to recruit an adequate number of patients.

Despite these findings, there is never a call to act upon what we know, instead, the call is always for further studies. Insanity is doing the same thing over and over again and expecting a different outcome.  Even if many of these dialysis researchers fail to understand the true clinical implications of their own studies, patients themselves have answered many of these issues for their own treatment decisions.

The entire issue of lack of equipoise for many of these continued studies called for by dialysis researchers is at the heart of the recuritment problem for RCTs on daily dialysis. Patients are simply not willing to take a 50% chance of not doing daily dialysis and thus refuse to sign up for these randomized  studies. That is the real take home message of the Frequent Hemodialyis Network Trial Group. Insanity in dialysis research in my opinion is the biggest barrier to implementing optimal dialysis strategies in America. It appears that the insanity found in dialysis research has also affected CMS and the dialysis industry as a whole since they readily accept the call for further studies. Do they expect different outcomes as well?

 

For the Love of Money: The DaVita Investigations

By Peter Laird, MD

Davita continues to encounter more allegations of improper business dealings in civil, state and Federal investigations. (here, here and here)  The allegations are augmented by whistle-blower civil lawsuits recently filed against the dialysis giant. The main thrust of the alleged illegal business arrangements focusses on the issue of improving Davita's bottom line at all costs but doing nothing to improve patient outcomes:

Whistleblowers file suit against dialysis provider DaVita Inc.

"The complaint makes clear that for years, DaVita has used different sets of rules to game the Medicare system and illegally inflate their government reimbursements at taxpayer and patient expense," said L. Lin Wood, attorney for the whistleblowers. "Taxpayers and patients should feel a sense of outrage when they read the complaint and learn how DaVita has become a multi-billion dollar business due in large part to corporate strategies and protocols focused on extracting every dollar possible from the government rather than on improving the care of chronically ill patients."  

The allegations against the dialysis industry as a whole of placing greed and profits above patient outcomes is not new. Belding Scribner, the inspiration behind chronic hemodialysis spoke out against the for-profit dialysis practices that have resulted in the developed world's worst patient outcomes . Dr Scribner spent his last remaining years critizing the emphasis on profits instead of saving lives with this unique technology. Dr. Scribner ironically gave up the riches of his shunt invention and instead focussed on simply saving lives when he gave his shunt freely to the world lending his criticism more relevance:

Belding Scribner: The Inventor of Shunt Dialysis

A less known aspect of Scribner's world-view was his abhorrence for the contaminating effects of the profit motive on medical care. He felt strongly that a physician's commitment to a patient should not be tainted by profits. “He was disturbed that what had been a ‘noble experiment’ was degenerating into a rush for profits,” says Dr Christopher Blagg, professor emeritus of medicine at the University of Washington. “In 1960 it wasn't usual for academic physicians to patent inventions. They sort of gave them away. He joked that if he'd patented the shunt he could have bought an island,” said Dr Blagg. “He was upset that academia was becoming more and more involved with commercial entities.”

Today, many aspects of the American dialysis experience of rapid patient turnover, short treatment times compared to other nations and overly aggressive ultrafiltration are directly attributable to the for-profit dialysis industry which has worse outcomes than the non-profit dialysis providers as noted in a recent study.

Dialysis Center Choice Makes Difference in Death Risk

Newswise — If you need dialysis for advanced kidney disease, where you get it could make a big difference. A large study found that patients in certain large chain facilities are significantly more likely to die than those treated elsewhere. Mortality was also higher in for-profit than non-profit dialysis centers.

“The differences were not minor,” said Yi Zhang, Ph.D., lead study author. “We need to find out what caused them.”

Whatever the outcomes of all of the DaVita investigations is, America is already under an indictment of the love of money more than the love of man in many aspects of health care. In my opinion, the love of money is most noted especially in the American dialysis industry that continues to reap the benefits of huge profits while delivering the highest mortality and worst outcomes of all the developed nations. It is time to place saving lives as the highest goal of dialysis treatment. Americans are not getting their money's worth out of delivering huge profits to these large dialysis organizations that dominate the provision of dialysis today. Many note that where there is smoke there is fire. If so, DaVita certainly may be on fire today.