APPROACHES TO QUOTIDIAN DIALYSIS

The Aksys Personal Hemodialysis System

Blackwell Publishing, Ltd.

Carl M. Kjellstrand,* Christopher R. Blagg,† John Bower,‡ and Zbylut J. Twardowski§

*Aksys Ltd., Lincolnshire, Illinois, †Department of Medicine, University of Washington, Seattle, Washington,
‡
Department of Medicine, University of Mississippi, Jackson, Mississippi, and §Department of Medicine,
University of Missouri, Columbia, Missouri

ABSTRACT

The Aksys personal hemodialysis system empowers patients patient is the master, not the slave of the dialysis machine,
to dialyze where, when, and how they want. It allows them giving patients their lives back), needing no bulky disposables
to easily do the best dialysis—daily hemodialysis—in the (patients have their homes back), reducing emergencies during
safest place—at home—by simplifying operation (almost dialysis, and performing immediate fluid resuscitation on
anyone can do it), doing the drudgery work of dialysis (the demand.

Daily hemodialysis is the best dialysis method machines at home (2822 dialyses) and then on the Aksys
Address correspondence to: Carl M. Kjellstrand, MD, PhD, 5317 S. Palouse Hwy., Apt. 218, Spokane, WA 99223, or e-mail: ckjellstrand@aksys.com.

available (1–3). Realistically it needs to be done at home. PHD system (1623 dialyses). Extensive biochemical testing,
Logistical problems facing patients that want daily home surveillance of problems, and monitoring of vital signs
hemodialysis include during dialysis was performed. More than 6000 dialyses
Time for preparation and performance of dialysis. have now been performed with the Aksys PHD system
Complicated dialysis machines. without any serious machine-related incidents.
Bulky, heavy disposables.
Emergencies during dialysis.
Resuscitation with fluids for emergencies. Solving the Time Demand of Daily
To solve all these problems, a system is needed that Hemodialysis
replaces the work of a dialysis nurse/helper/technician.
This requires five different machines: a dialysis machine, The Aksys PHD system uses three technical inno-
a reuse apparatus, a dialysis preparation system, a maker vations to save patients preparation time before and clean-
of fluids for intravenous use, and a maker of ultrapure up time after dialysis.
water. • Both the dialysis filter and blood tubing are part
Presently only the Aksys personal hemodialysis (PHD) of the system and are changed only once a month.
system meets all these demands. It was constructed using At the end of each dialysis session, the connectors
five principles: simplicity, safety, doing the peridialysis on the blood tubing are put into two ports on the
slave labor, economics, and fewer supplies. The advan- machine. The machine then cleans out and heat
tages of the Aksys PHD system are shown in Table 1. sanitizes not only the dialyzer and blood tubing, but
Fig. 1 outlines the technical solutions; detailed descrip- also the dialysate side of the machine.
tions have been published elsewhere (4,5). The plain • The machine mixes the dialysate before a treatment.
arrows indicate a primary function of the technical solu- The patient simply replaces two soda can-size plastic
tions; dotted arrows indicate secondary “helper” functions. chemical containers at the end of dialysis.
• The machine sets aside up to 4 L of dialysate solu-
tion in a separate ultrafiltration tank. This is used for
Clinical Studies of the Aksys PHD System priming, backflushing, resuscitation fluid, and to
push the blood in the dialyzer into the patient at the
The successes of the technical solutions were evalu- end of dialysis. There is no need to hang and manipu-
ated during a 3-year U.S. Food and Drug Administration late bags of sterile solution.
(FDA)-mandated clinical trial. Twenty-three patients During the clinical trial, it took 1 hour to prepare and
first used short daily hemodialysis on their conventional 30 minutes to clean up after dialysis with conventional
machines, despite the fact that the patients had used
these machines for more than 5 years. The PHD machine
Address correspondence to: Carl M. Kjellstrand, MD, PhD,
5317 S. Palouse Hwy., Apt. 218, Spokane, WA 99223, or sits ready for dialysis, waiting for the patient to connect.
e-mail: ckjellstrand@aksys.com. After dialysis, it takes only minutes to disconnect, return
Seminars in Dialysis —Vol 17, No 2 (March –April) 2004 the blood tubing ends to the machine, and replace the
pp. 151–153 two chemical bottles. Thus 1.5 hours is saved every day,
151
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TABLE 1. The advantages of the Aksys PHD system
Simplifies use: most patients can do it at home.
Needs very few supplies: patients have their homes back.
Reuses filters and blood tubing for a month: reduces labor,
bulk, and cost.
Makes all necessary intravenous fluids: reduces supplies,
labor, cost, and bulk.
Automatic dialysate preparation: reduces labor and cost.
Ultrapure dialysate and filters: fewer dialysis problems.
Offers immediate resuscitation: greater safety.
or 10.5 hours per week. Of the “personal” time a patient has
every week, peridialysis slave labor is reduced from 18%
on conventional machines to 2.7% for the PHD system.
No Bulky Supplies
With the PHD system, only 12 dialysis filters and
blood tubing sets, not 360, are used in a year of daily
hemodialysis. There is no need for intravenous fluid
bags, compared to more than 900 kg of fluid bags for a
conventional dialysis machine. The dialysate chemicals
come in dry form. The PHD system needs only 200
pounds and 20 cubic feet of supplies for 1 year of use; a
conventional machine needs some 5300 pounds and 260
cubic feet of supplies. Comments by patients when they
changed to the PHD system included, “I have my home
back” and “I do not live in a warehouse any more.”
There was no statistically significant decrease in urea
clearance over 25 reuses of filters, measured as total urea
clearance over 640 dialyses. Ultrafiltration or albumin
leak did not change in up to 15 reuses, while the β2-
microglobulin reduction rate declined by 10% (6). There
was no decline in pumping capacity of the blood tubing
in more than 25 reuses (7).
Decreasing Emergencies During Dialysis
The PHD system uses six methods to achieve biocom-
patible, toxin-free dialyses to prevent cardiovascular irri-
tability and dialysis complications:
Kjellstrand et al.
Ultrapure dialysate.
Biocompatible filters.
Open membranes.
Extra filter and blood tubing cleaning with hot water,
not dangerous chemicals.
Combines hemodialysis and hemofiltration.
Uses no polyvinyl chloride (PVC)-containing materials.
Before the first use and after each use, the PHD system
is washed on both sides of the entire extracorporeal and
dialysate side with more than 40 L of fluid and the entire
system in contact with fluid is heat sanitized for 4 hours
at 85°C. This eradicates Escherichia coli, Staphylococ-
cus, and Candida in both in vitro and in vivo studies
(8,9). It also kills all known viruses (10).
The dialysate and all fluids are exceptionally clean.
During the clinical trial, the conventional machines’
dialysate failed the European and proposed U.S. stan-
dards of less than 0.25 EU endotoxin/ml in 57% of the
samples, while the PHD system showed no detectable
endotoxin in assays down to 0.0005 EU/ml (11). Thor-
ough washing of the filters is accomplished with more
than 40 L of ultrapure, sanitized water, compared to the
usual 0.5–3 L rinse in single-use or chemical reuse. This
should also result in much less phthalic acid metabolites
and spallated particles. Thirteen dialysate samples
from the PHD system failed to show any bacterial or
fungi detritus in the sensitive silkworm larva plasma test
(12).
The exceptional purity of the PHD system results in
many fewer symptoms during dialysis. If one compares
14 symptoms registered by patients during 2500 conven-
tional dialyses and 1170 dialyses on the PHD system, all
but one were much less common on the PHD system. For
seven symptoms this was statistically significant. Hypo-
tensive crashes, cardiac irregularity, cramps, backache,
headache, nausea, and access problems were reduced
to 5–67% of their incidence on conventional dialysis
machines (13). Blood pressure dropped a mean of only
8 mmHg during PHD compared to 17 mmHg during
conventional dialysis. The incidence of a pulse rate
of more than 90/minute was 23% during conventional
dialysis compared to 8% during PHD (14). Thus the
ultraclean, “biocompatible dialysis” of the PHD system
results in smoother and relatively complication-free
Fig. 1. Goals and technical solutions.
 THE AKSYS PERSONAL HEMODIALYSIS SYSTEM
dialysis when compared to dialysis on conventional
machines.
Rapid Resuscitation
Patients sometimes need fluid infusions for emergen-
cies and symptoms during dialysis, although much less
frequently during daily hemodialysis with the PHD
system. The PHD system sets aside sanitized dialysate
in the ultrafiltration tank. When fluids are needed, the
patient simply pushes a button on the screen; the ultrafil-
tration pump then reverses and in 1 minute infuses a
preset volume up to 300 ml into the patient. When done,
the screen asks the patient if more fluid is needed. This is
accomplished by another button push. The patient gets
fluid immediately; no need to cry out for help or wait for
assistance; no need to open up or hang intravenous fluid
bags.
Simplicity of Operation
A graphical user interface (GUI) screen asks the
patient questions and prompts them to use various but-
tons while displaying the results of the dialysis. In the
morning the machine is ready for use and asks if, as
agreed the day before, dialysis is desired at a specified
time. It then asks the patient to connect, to check connect
sites, and to verify that all clamps are removed. During
dialysis it displays volume removed and time of dialysis.
When dialysis is finished the machine asks the patient to
replace chemical bottles and return the blood tubing to
the ports, informs the patient where it is in the cleaning
cycle, and reminds the patient of the time of the next
dialysis session.
During the clinical trial, patients were asked after
each dialysis how easy it was to use the conventional and
PHD systems on a scale of 1 to 5: 1, very easy; 5, very
153
complicated. The PHD system was assigned a difficulty
of 1.9 ± 0.6 compared to 2.3 ± 0.6 for conventional dialysis
machines ( p < 0.0001). The patients had used their con-
ventional machine for a mean of 5 years at home, while
the PHD system was completely new to them. After the
clinical trial was over, 90% of the patients preferred the
PHD system to their own conventional machines.
References
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