In December 2014 the US Food and Drug Administration (FDA) granted clearance for a dialysis device to be used for nocturnal home dialysis. This step should open the door for patients with ESRD to have access to a full array of dialysis modalities, including in-center therapies of self-care, thrice-weekly and nocturnal dialysis, and home therapies consisting of continuous cycling peritoneal dialysis, continuous ambulatory peritoneal dialysis, conventional home hemodialysis, portable low-flow hemodialysis, short daily dialysis, and nocturnal home dialysis 3.5 to 6 nights per week. Multiple devices are on the horizon, and flexibility of therapy should be an option for a majority of ESRD patients.
A properly educated family and patient can decide which therapy offers the greatest advantage to the patient. The patient and family can balance the issues of frequency, timing, quality of life, and mortality. It is appropriate to empower patients with the honest outcomes of dialysis and help them determine the best individualized course of action.
Although there has been an increase in home hemodialysis since 2004, many more patients could benefit from the improved quality of life and flexibility offered by increased-frequency home dialysis. It is interesting that when queried, health care providers in the dialysis industry would overwhelmingly choose a home therapy for themselves. The nephrology community is left trying to explain the disparity between our own desires and how patients are treated in the United States.
Since 2004 there has been a steady gain in the use of home dialysis in the United States associated with FDA clearance of the NxStage System One, a low-flow dialysate system for home use. This device has brought increased ease of use, lower utility costs, and portability. Home dialysis in the United States has become a predominantly short daily therapy with increased frequency but remains limited in its use. Data from the United States Renal Data System show an increase in use from 1831 prevalent ESRD patients in 2004 to 7923 in 2012, or an increase of just 0.5 percent to 1.8 percent of the prevalent ESRD patient population.
Thrice-weekly in-center dialysis has shown an improvement in premature mortality recently, but the mortality still is around 20% yearly. In-center patients experience postdialysis fatigue, increasing left ventricular hypertrophy (LVH), sleep apnea, restless legs, hypertension with multiple agents, high hospitalization rates, increasing rates of infection and death, and increases in hospitalization with the 48-hour intradialysis period.
Increased-frequency dialysis has been demonstrated to improve quality of life scores, decrease postdialysis recovery, improve sleep, improve BP with decreased medications, decrease LVH, and improve mortality when compared with in-center or peritoneal dialysis. Increased-frequency nocturnal dialysis also improves these factors. In addition, nocturnal dialysis improves sleep apnea and allows a normalized diet with the discontinuation of phosphate binders. Nocturnal dialysis moves the burden of therapy to bedtime, increasing freedom from therapy during daylight hours and decreasing the overall burden of therapy for patients and their partners. Both therapies can eliminate the 48-hour break from the dialysis schedule. Increasing use of increased-frequency home therapies will require better knowledge among nephrologists, improved education and communication with patients, and removal of barriers to use by patients and health care givers.
Nocturnal dialysis is not just more of the same. Prescriptions for nocturnal dialysis vary based on frequency and device. Nocturnal therapy can be delivered in the patient’s home with the low-dialysate device (FDA cleared with NxStage System One) or a conventional hemodialysis device.
Conventional dialysis requires electrical and plumbing changes to the home. A dedicated 20-A circuit for dialysis must be hardwired, and water treatment with a softener, charcoal filter, and reverse osmosis or DI (deionization) treatment is required. The differences between nocturnal dialysis and thrice-weekly in-center dialysis are decreased blood flow, decreased dialysate flow, and a higher calcium bath with increased frequency.
Low-flow dialysis with the NxStage System One is a different prescription. It uses lower dialysate volumes of 20 to 60 L per treatment. The lower dialysate flow increases the saturation of dialysate composition and allows for lower volumes. No studies have determined the best dialysate volumes. At Indiana University, for short daily treatments, we prescribe a minimum of 20 L for all patients and roughly 20% of body weight for women and 25% for men. We increase this for 5 days versus 6 days. Generally, nocturnal dialysis at home is prescribed with increased frequency. If 5 days or more are prescribed, we prescribe 30 L for smaller patients and 45 to 60 L for larger patients. The dialysate volume can be increased if phosphorus is not controlled. Conversely, the dialysate volume can be decreased if phosphorus is low despite increasing dietary intake of phosphorus. For nocturnal dialysis, a heparin pump is generally used, and the dialysate bath is 2K and 40 to 45 lactate. Blood speed is 250 to 300 mL/min, and the dialysate flow is adjusted to allow for 6 to 8 hours of dialysis to meet the patient’s needs. Water treatment occurs with online generation and storage of ultrapure dialysate. This requires much less water and electricity.
Despite the many advantages of increased-frequency home dialysis, there are significant concerns. Access infection and necessity for procedures are increased in some studies. Dislodgement of venous access is a potentially fatal complication and must be avoided, particularly in the sleeping patient. Infection can be addressed by proper education and reeducation on technique and the importance of proper technique. We have markedly decreased infection by addressing these factors in training and reeducation monthly in the clinic. Noninfectious complications are expensive and morbid. A thorough physical examination in the clinic and education of patients in the signs of decreased flow are mandatory.
With proper education, reeducation, and training at Indiana University Health Dialysis, our home program enjoys a very low rate of infectious and noninfectious complications. Over the past 18 months, the Indiana University Health home program has had a rate of 4 thromboses in 97 patient months (1 thrombosis every 24.25 months) for arteriovenous (AV) grafts and 5 thromboses in 841 patient months (1 thrombosis every 168.2 months) for AV fistulas. During the same period, the two in-center units have had a rate of 48 thromboses in 762 patient months (1 every 15.88 patient months) for AV grafts and 75 events in 2091 patient months (1 every 27.8 patient months) for AV fistula. Fistulas fared better than AV grafts, and increased-frequency home access fared better than in-center access with thrombosis.
The infection rate in the home dialysis unit is better than expected as well. Over the past 18 months, the home unit AV fistula infection rate is 1 episode every 210.2 months (4/841 months). The AV graft infection rate is 1 every 19.4 months (5/97 months), and the central venous catheter infection rate is 1 every 34.3 months (6/206). Also, in the first 6 months of calendar year 2015 we have had no AVG infections.
The potentially fatal noninfectious complication of venous dislodgement must be avoided. It is life threatening in all forms of hemodialysis but is particularly worrisome in the sleeping patient at home. Traditionally, taping has been used to secure the needle sites. An incontinence alarm can be taped to the venous needle site; the alarm when activated by wetness will wake the patient. A fiberoptic device to sense a blood leak (Redsense, Redsense Medical AB, Chicago, IL) is also available. More recently, Fresenius Medical Care has added a wireless wetness device for use with the 2008K at home. If the device senses moisture it shuts down the blood pump and sets off an alarm. Finally, Medisystems has recently received FDA clearance for a dual-lumen single-needle for use with dialysis. Its use differs from traditional single-needle dialysis in that it is actually two separate needles in one. It is available for the rope-and ladder-technique or the buttonhole technique. If the needle dislodges, the dialysis machine will shut off and give an alarm. The characteristics of this needle limit blood flow to 250 to 300/min. We have found excellent patient acceptance and improved burden of therapy, with reduction in cannulation by half.
Nocturnal dialysis at home with increased frequency can now be added to the available therapies for patients in the United States. Work to decrease complications should continue. Proper education of the patient and dialysis team is essential while novel therapies are being adapted. Work is needed to improve patient education and assurance of appropriate care and assistance 24 hours a day. Physicians need to understand and communicate the options, benefits, and risks of all modalities.