Perit Dial Int
27(Supplement_2):
35-41
2007
© 2007 International Society for Peritoneal Dialysis
Part 1: PD Development and Enhancement of PD
Programs |
30 YEARS OF PERITONEAL DIALYSIS DEVELOPMENT: THE PAST AND THE FUTURE
Raymond T. Krediet
Division of Nephrology, Department of Medicine, Academic Medical Centre,
University of Amsterdam, Amsterdam, Netherlands
Correspondence to: R.T. Krediet, Academic Medical Center, Division of
Nephrology, Department of Medicine, P.O. Box 22700, Amsterdam 1100 DE
Netherlands.
C.N.deboer{at}amc.uva.nl
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ABSTRACT
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A review is given of 30 years of development in peritoneal dialysis
(PD). After a short description of the first 20 years, the main emphasis is
put on the last 10 years. Subjects discussed are the increasing use of PD in
high-risk populations, peritonitis and other catheter-related problems,
adequacy of dialysis and nutrition, patient outcomes in comparison with
hemodialysis, and peritoneal membrane changes with time on PD. Topics that
have emerged during the last decade and the challenges for the next decennium
are discussed. The great importance of quality assurance in fast-growing PD
populations and of prevention of long-term membrane alterations are
emphasized.
KEY WORDS: Peritonitis; adequacy; outcomes; membrane changes; inflammation.
Popovich, Moncrief, and colleagues submitted their abstract "The
definition of a novel portable/wearable equilibrium peritoneal dialysis
technique" to the American Society for Artificial Internal Organs in
1976, 30 years ago (1). The
abstract was rejected. Nevertheless, the authors persisted with their
technique, changed the name to continuous ambulatory peritoneal dialysis
(CAPD), and two years later, published the first results in the Annals of
Internal Medicine (2). And
so, in retrospect, CAPD was born in 1976.
Before that time, peritoneal dialysis (PD) had been applied mainly for the
treatment of acute renal failure. Intermittent PD for the treatment of chronic
renal failure never became very popular because of the risk of underdialysis
and malnutrition, although good results were obtained in some dedicated units
(3). Yet in 1977, a total of
only 789 patients on chronic PD could be traced worldwide
(4).
The invention of CAPD caused enormous growth in utilization of the PD
technique. The number of dialysis units in Europe providing CAPD was 0 in
1977, but had increased to almost 160 by 1979
(5). The first overall results
were rather discouraging. In 1979, the combined 2-year patient and technique
survival in 1728 patients was only 32%
(5).
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DEVELOPMENTS OF THE FIRST 20 YEARS
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A number of studies were published at the beginning of the 1980s on various
clinical aspects of CAPD: biochemical control, improvement of anemia,
peritonitis
(6,7).
A number of important international initiatives were also undertaken to deal
with the early challenges: the extremely high drop-out rates and the use of
CAPD as a final option in high-risk patients with renal failure. In 1980,
Oreopoulos started a journal titled Peritoneal Dialysis
Bulletin—which was later changed to Peritoneal Dialysis
International—aimed at spreading knowledge about PD worldwide.
The first national conference on CAPD was organized in 1981 in Kansas City
(8). In the years that
followed, that conference was transformed into an international meeting,
currently called the annual dialysis conference. Proceedings of these meetings
are published as Advances in Peritoneal Dialysis.
The first International Course on PD was organized in Vicenza in 1982 by
LaGreca and colleagues. Since then, the Course has been repeated every three
years. The proceedings of the Course were originally published as books, then
later as supplements of Peritoneal Dialysis International, and
currently in Contributions to Nephrology.
In 1984, the International Society for Peritoneal Dialysis was founded. The
objectives of the ISPD were to stimulate good-quality PD worldwide by
organizing a congress (originally to be held every thee years), by developing
guidelines, by publishing Peritoneal Dialysis International, and by
establishing training scholarships.
Peritonitis and exit-site infection were the most prominent complications
in the early days. Skin bacteria such as Staphylococcus epidermidis
were the most frequent causative micro-organisms. Knowledge about the
treatment of peritonitis was spread by guidelines published under the auspices
of the ISPD, first in 1987 (9)
and regularly revised and updated since.
The introduction of "flush before fill" systems led to a marked
improvement in the incidence of peritonitis
(10). These data were later
confirmed in a multicenter randomized controlled trial
(11). The peritonitis
incidence in the latter study decreased to 1 episode in every 21.5
patient–months from 1 episode in every 9.9 patient–months—a
reduction in peritonitis risk of 61%.
In the first 20 years, infectious complications remained the major reason
for discontinuation of CAPD, but surgical complications, concerns about
nutrition status, loss of ultrafiltration capacity, and concerns about the
adequacy of the PD dose also contributed to the lower technique survival rate
for PD as compared with hemodialysis (HD)
(12). A review by Nolph et
al. in 1988 stated that "neither peritoneal dialysis nor
hemodialysis is the superior long-term dialysis therapy for all patients; the
choice depends on numerous medical, social, geographic, and life-style
considerations"
(13).
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PERITONEAL DIALYSIS SINCE THE MID-1990s
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In a "state-of-the art lecture" at the congress of the European
Renal Association in 1996, Gokal formulated five important issues in PD:
- The increasing use of PD in high-risk populations
- Peritonitis and catheter-related problems
- Adequacy of dialysis and nutrition
- Patient outcomes in comparison with HD
- Peritoneal membrane changes with time
Increasing Use of PD in High-Risk Populations: Many centers that
started CAPD in the late 1970s and mid-1980s performed the treatment in
patients who had complications and for whom no other replacement therapy was
available. As experience increased, this situation changed in many dialysis
units, but the fear of using PD, especially in high-risk patients, remained
present. However, this fear appeared to be unrealistic in many Western
European countries. For instance, patients participating in the Netherlands
Cooperative Study on the Adequacy of Dialysis Treatment part 1 (NECOSAD
1) showed that the age of
incident patients between 1993 and 1995 was, on average, 7 years higher in the
HD group than in the PD group
(14). A more recent analysis
by the Registry of the European Renal Association reported that comorbidity in
the participating countries was generally somewhat lower in PD patients than
in patients treated with HD
(15).
Peritonitis and Catheter-related Problems: Since the mid-1990s,
peritonitis rates as low as 0.23 episodes per patient–year have been
reported (16). The use of
double-bag systems helped in the achievement of these low rates
(17). A number of studies
reported lower peritonitis rates in automated PD (APD) than in CAPD
(18–21);
however, the opposite was also described
(22). Comparison of nightly
intermittent PD (NIPD) with continuous cycling PD (CCPD), found lower
peritonitis rates for patients treated with NIPD
(23). The most marked
reductions in peritonitis incidence have been found for gram-positive
micro-organisms such as S. epidermidis and S. aureus
(24). These various data
resulted in the creation of a guideline stating that a center's peritonitis
rate should be no more than 0.67 episodes per year at risk
(25).
Patients who have S. aureus nasal carriage show an increased risk
for exit-site infection. Daily application of mupirocin cream to the skin
around the exit site has been effective in reducing exit-site infections and
peritonitis (26). Although
resistance against mupirocin has been reported
(27), it is not a major
problem at present (28).
Recently, gentamicin cream around the exit site has appeared to be very
effective, especially in reducing infections with Pseudomonas
aeruginosa (29).
It can be concluded that major improvements have taken place in the
incidence of both peritonitis and exit-site infections. Nevertheless risks
remain for a selection of difficult-to-treat micro-organisms and for the
development of antibiotic resistance.
Adequacy of Dialysis and Nutrition: In 1996, the CANUSA study was
published (30). This
prospective cohort study in incident PD patients from dialysis units in Canada
and the United States reported associations between higher renal and
peritoneal small-solute transport values (such as Kt/Vurea and
creatinine clearance) and better patient survival. Those observations were
used to formulate guidelines on the adequacy of PD.
The guidelines included a weekly Kt/Vurea of at least 2.0 and a
weekly creatinine clearance of at least 60 L/1.73 m2 body surface
area (31). Those targets are
impossible to reach in most anuric CAPD patients, which appears to be a major
reason for the current decline in the use of PD, especially in the United
States. And yet, no study performed since has been able to show an effect of
peritoneal solute clearances on survival
(32–39).
In retrospect, the results of the CANUSA study could be fully explained by
the magnitude of residual renal function
(38). Two randomized
controlled trials also failed to show an effect for an increase in the
dialysis dose from the values normally obtained in CAPD to those recommended
in the DOQI guidelines
(40,41).
Evidently, the contribution of dialysis dose is overruled by that of
residual renal function in patients who still produce urine. However, the
survival of anuric patients depends, by definition, on dialysis dose. A
retrospective analysis suggested that a Kt/Vurea above or below
1.85 has some effect on survival, but that finding did not reach statistical
significance (42).
A prospective cohort study in Hong Kong found that, when
Kt/Vurea and creatinine clearance were analyzed as continuous
variables, associations with survival emerged
(43). That result could not be
confirmed in the Netherlands Study on the Adequacy of Dialysis, but a
definition of values below which mortality is significantly increased appeared
to be possible (44). Those
values were determined to be a weekly Kt/Vurea of less than 1.5 and
a weekly creatinine clearance of less than 40 L/1.73 m2. Although
significant associations have been reported for peritoneal fluid removal and
survival
(44–46),
definition of target values is currently impossible.
Many studies in the last decade have focused on dialysis adequacy. It is
evident now that the importance of small-solute removal has been overestimated
and that clinical assessment has received insufficient attention. Most anuric
CAPD patients are likely to be adequately dialyzed with a weekly
Kt/Vurea of 1.7, with APD patients possibly needing an additional
target for a weekly peritoneal creatinine clearance of at least 45 L/1.73
m2. These considerations have been formulated into the recently
published ISPD guidelines on targets for solute and fluid removal in adult PD
patients (47).
Patient Outcomes in Comparison with HD: Some studies from the U.S.
Renal Data System at the beginning of the 1990s suggested that mortality rates
were higher in CAPD patients than in HD patients, especially in certain
subgroups—for instance, female patients 55 years and older with diabetes
mellitus
(48,49).
The CANUSA study showed that the relative risk of death for incident PD
patients in the United States as compared with those in Canada was 1.95
(30).
Studies since the mid-1990s have generally shown that, as compared with HD
outcomes, PD outcomes in the United States are generally poorer than they are
in other parts of the world. No significant difference in mortality rates was
found in some studies
(50–52),
but an initial survival benefit for PD was observed
(53–57).
A randomized controlled trial, although underpowered, found better survival
for PD patients (58). That
benefit was likely to have been at least partly attributable to better
preservation residual renal function in CAPD, as confirmed in a number of
studies over the last ten years
(59,60).
The use of an angiotensin converting enzyme inhibitor also leads to better
preservation of residual renal function
(61).
It can be concluded that the survival of PD patients is superior to that of
HD patients during the first years of PD. That finding may be attributable to
better preservation of the glomerular filtration rate (GFR). The balance
changes with longer duration on PD, which may be attributable to the
development of functional and morphologic peritoneal alterations with time on
the modality.
Changes in the Peritoneal Membrane with Time: Loss of
ultrafiltration can develop during the time course of PD
(62,63).
This phenomenon was originally attributed to an increase in small-solute
transport, leading to rapid disappearance of the osmotic gradient. It suggests
an increase in the vascular peritoneal surface area and, concomitantly, in the
number of perfused peritoneal capillaries. This peritoneal change has indeed
been found in studies performed during the last decade
(64,65).
However, it has also become increasingly evident that long-term PD is likely
associated with a reduction in osmotic conductance to glucose, leading to
impaired free-water transport
(66–68).
The morphology alterations consist not only of an increase in the number of
vessels, but also of pathologic changes in those vessels. This vasculopathy
includes an increase in wall thickness, arteriosclerotic and diabeti-form
arteriolar changes, and post-capillary venular subendothelial hyalinosis
(65)—the latter being
especially unique to PD. Submesothelial and overall fibrosis are also present.
In general, a relationship is present between the vascular abnormalities and
fibrosis
(64,65).
Continuous exposure to bioincompatible dialysis solutions, with or without
recurrent peritonitis, is the most important cause of alterations in the
peritoneum. These findings have led to the development of new solutions.
Icodextrin solution has been available in Europe since 1996 and is especially
useful in patients with ultrafiltration failure. The
"biocompatible" solutions—characterized by a reduction in
glucose degradation products and a buffer of lactate, or bicarbonate, or a
combination of both—have been available in Europe since 2000. These new
dialysis solutions have been well reviewed
(69).
It is impossible to conduct repeated human peritoneal biopsies to assess
the potential beneficial effects of the more biocompatible dialysis solutions
on the peritoneum. Animal models can be used instead, but these need to be
long-term models if they are to reflect the situation in PD patients.
Longitudinal studies in patients will have to focus on changes in peritoneal
transport with duration of PD. In addition, dialysate effluent
markers—for example, cancer antigen 125 (CA125), which can be considered
a marker of mesothelial cell mass or turnover [reviewed in
(70)]—can be used.
Since the 1980s, peritoneal transport has usually been measured with the
peritoneal equilibration test (PET), using a 2.27%/2.5% glucose-based dialysis
solution (71). To improve the
value of the PET with regard to assessment of fluid transport, the ISPD
guidelines now recommend that it be performed with 3.86%/4.25% glucose and
that dialysate sodium be measured after 1 hour
(72). An elegant method for
assessing free-water transport based on transport of fluid and sodium during
the first hour of a dwell has recently been described
(73).
The new biocompatible dialysis solutions have no acute effects on
peritoneal transport, but follow-up shows increased effluent CA125 with
continuing use (74). One
solution showed a protective effect on the morphology of the peritoneum in a
long-term peritoneal exposure model in rats
(75). No long-term studies in
PD patients are yet available.
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TOPICS THAT HAVE EMERGED SINCE THE MID-1990S
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Table 1 summarizes the
changes that have occurred in various aspects of PD since the mid-1990s. In
addition, a number of new topics have emerged. These include the importance of
residual GFR for survival, which has resulted in the integrated care concept
(12). The importance of GFR
implies the use of PD as initial renal replacement therapy in incident
patients to preserve renal function, with a subsequent switch to HD for those
who develop complications of PD. The role of inflammation in the excess
mortality of dialysis patients has received much recent focus, leading to the
identification of the malnutrition, inflammation, and atherosclerosis syndrome
(76). Interest in basic
science has also increased during the last decade, although some of the
results of in vitro studies are difficult to translate to the
clinical situation. In recent years especially, the utilization of PD has
increased markedly in some Asian countries—for example, India and China.
The number of PD patients in India increased to 6000 in 2005 from 712 in 1999.
It will be a challenge for the ISPD to help ensure that all patients receive
treatment of high quality provided by well-educated nurses and
nephrologists.
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CHALLENGES FOR THE NEXT DECENNIUM
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Important subjects for the next decade include the prevention of membrane
alterations, either by better dialysis solutions, or by drugs, or both. Better
markers for dialysis adequacy—such as sodium removal and removal of
molecules larger than urea and creatinine—will have to be investigated.
The role of APD versus CAPD will have to be established. Strategies to reduce
inflammation and cardiovascular death will have to be explored. Studies in
basic science should, as far as possible, have a clinical focus. And finally,
quality assurance in fast-growing PD populations is of major importance.
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