Full text of DOI:10.1111/j.1755-6686.2003.tb00301.x

COMPLICATIONS OF VASCULAR ACCESS: RESULTS OF A EUROPEAN
MULTI CENTRE STUDY OF THE EDTNA/ERCA RESEARCH BOARD
Monique M. Elseviers and Jean-Pierre Van Waeleghem
On behalf of the Research Board of EDTNA/ERCA
SUMMARY
The pilot project of the Research Board of EDTNA/ERCA handled the management of vascular accesses (VA) in
European dialysis centres. In the first part of the study, centre policies related to VA management were investigated.
In the second part of the study, individual patients were followed prospectively during one year. This paper reports on
several topics of the second part of the project, investigating complications of the VA related to centre, patient
characteristics and dialysis techniques. used.
Complications most frequently observed were thrombosis, stenosis, infection, bleeding and flow problems. Gradually
more infections and flow problems were observed if the centre size and the patients/nurse ratio went up.
Complication rate was not significantly influenced by age, gender, renal diagnosis, time on dialysis or medication used
by the patient. In contrast, the number of vascular accesses in the past and interventions in the VA before first use
resulted in an increased number of complications.
Nurses have a key role in the prevention, manipulation and outcome of vascular access related complications.
KEY WORDS
• Haemodialysis
• Vascular access
• AV fistula
• Graft, catheter
• Complication
INTRODUCTION
Complications of vascular access (VA) remain a significant clini-
cal problem in the chronic treatment of patients with end-stage
BIODATAS
renal disease. The Research Board of the European Dialysis and
Transplant Nurses Association/European Renal Care Association
(EDTNA/ERCA) selected the management and outcome of VA as
their pilot research project.
The first part of the project studied centre-focused policies for the
management of VA in 103 European dialysis centres (1). Results
showed that large differences were observed in VA care and
hygienic procedures used. It was concluded that it would be
extremely interesting to relate the large differences observed in
M. Elseviers
J.-P. Van Waeleghem
the centre policies of VA management to individual patient’s out-
come parameters.
The second part of the project studied VA related complications
in individual patients during a one-year observational prospec-
tive study. In a previous article in this journal, the population stud-
ied, types of VA used and complication rates observed in differ-
ent types of VA, were described (2). At the start of the observation
period, 77% of the patients had a native AV fistula, 10% had an
AV graft and 13% a catheter. A total of 489 complications were
noted documented. Most frequently observed were thrombosis,
stenosis, infection, bleeding and flow problems. Hospitalisation
Jean-Pierre Van Waeleghem is a nephrology nurse manger at
the University Hospital Antwerp, Belgium. He has been working in
dialysis for 37 years. He is a past president of the EDTNA/ERCA and
ORPADT (Flemish nurses association). In 1994, he received the
Lenin Tolstoy award for his work in Armenia. He has presented and
published numerous papers at national and international level.
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COMPLICATIONS OF VASCULAR ACCESS: RESULTS OF A EUROPEAN
MULTI CENTRE STUDY OF THE EDTNA/ERCA RESEARCH BOARD
was required in 39% of complications and 29% of complications
Haemodialysis patients included:
n=1380
resulted in a definitive loss of VA. Complications were more fre-
quently observed in catheters (27%) and AV grafts (37%) com-
pared to AV fistulae (15%). When compared with AV fistulae, the
risk for thrombosis was more than four times higher and for bleed-
ing more than six times higher if an AV graft was used. Catheters
showed an eightfold-increased risk to develop infections and
flow problems. This study revealed the high complication rate in
VA and strengthened the actions to promote AV fistulae as first
choice VA.
This second article of the European multi-centre study of the
Research Board will focus on the observed complications in rela-
tion to the patient and centre characteristics and the dialysis
techniques used.
Age: median (range)
Sex: (% males)
Duration of treatment for ESRD: median (range)
Primary renal diagnosis:
Glomerulonephritis
64 years (15-90)
56%
37 months (6-370)
19.1%
12.9%
11.7%
10.0%
9.2%
8.7%
20.4%
8.0%
Diabetic nephropathy
Renal vascular disease
Polycystic kidney disease
Pyelo-interstitial nephritis
Other systemic disease
Other
Unknown, undefined
Medication used at baseline:
Erythropoietin
84.5%
53.3%
29.4%
Anti-hypertensives
Anti-coagulation
Antibiotics
3.9%
Age of vascular access in use: median (range)
Previous permanent VA used:
No previous
30 months (0-300)
MATERIAL AND METHODS
In all participating European dialysis centres, 30 chronic haemodial-
ysis patients were randomly selected and were followed for one
year. All adult patients who started a chronic haemodialysis pro-
gramme at least six months before the start of the study were
included for random selection. Data concerning the type of VA
in use and related parameters were selected at the start of the
study period and after six and twelve months. All VA related com-
plications requiring intervention were registered at the time of
occurrence using an electronic data collection system.
Methodological details of the study were described in the first arti-
cle (2).
Basic statistical techniques were used to describe the types of VA
used, complications observed and hygienic handling applied.
Students’ t-test was used for comparison of continuous vari-
ables and chi-square test for comparison of percentages, con-
sidering a p-value of p < 0.05 as the significance level.
For complications, in-depth analysis was only performed on com-
plications occurring frequently: thrombosis, stenosis, infection,
bleeding and flow problems. Per patient, each reported compli-
cation was only counted once, also when it occurred more than
one time during the study period. Differences in complication rates
were related to patient characteristics, type of VA and puncture
techniques used. Risk ratios for complications were calculated using
logistic regression analysis enabling control for confounding fac-
tors.
59.2%
22.9%
17.9%
One
More than one
Table 1: Demographic and medical characteristics of study
population.
| CENTRE CHARACTERISTICS AND COMPLICATION RATE |
Complications were more frequently observed in hospital centres
compared to satellite units. Additionally, centre size as well as
patients/nurse per ratio influenced the complication rate. Gradually
more infections and flow problems were observed if the centre
size went up to more than 200 patients. The same trend was
observed considering the patient/nurse ratio, with a significant
increase in infection and flow problems if this ratio went up to
more than seven patients per nurse (Figure 1).
thrombosis,
infection
bleeding
stenosis
Centre in hospital
% with complications
no
yes
Centre size
< 50
50-100
101-200
> 200
infection
flow problems
Patients per nurse
infection
flow problems
RESULTS
< 4
4-7
>7
The questionnaire was distributed to 108 centres, 47 centres in
16 European countries completed the study. Participating centres
were mainly from United Kingdom (n=11), Belgium (n=9) and
Germany (n=6). A total of 1380 patients were included.
Demographic and medical characteristics of the study population
are summarised in table 1.
0
5
10
15
20
25
Figure 1: Complications of vascular access related to
characteristics of the centre: centre size and patient/nurse ratio.
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COMPLICATIONS OF VASCULAR ACCESS: RESULTS OF A EUROPEAN
MULTI CENTRE STUDY OF THE EDTNA/ERCA RESEARCH BOARD
nificantly increased complication rate of 25% compared to 15%
in those without intervention.
MORE:
thrombosis
infection
| COMPLICATIONS RELATED TO DIALYSIS TECHNIQUES
USED IN AV FISTULAE AND AV GRAFTS |
n=922
n=374
AV fistulae and grafts, localised in the forearm, showed a lower
complication rate compared to VA localised in the upper arm and
particularly to those placed in the elbow. If only the first VA was
considered, differences between forearm and upper arm disap-
peared. For the elbow localisation, thrombosis, infection, steno-
sis and flow problems were significantly increased. Controlled for
patient/nurse ratio and previous number of VA, risk ratios for the
elbow VA remained significantly increased for stenosis (OR=2.3)
> 1 temporary VA
> 1 permanent VA
n=792
n=546
0
5
10
15
20
25
30
% with complications
Figure 2: Complications of vascular access related to number and
type of previous vascular accesses.
and flow problems (OR=5.2) compared to VA placed in the
forearm (Table 2A).
Additionally, frequency of thrombosis and stenosis increased sig-
nificantly with increasing venous pressure. Comparing patients
dialysed with venous pressure below 100mmHg with those of more
than 180 mmHg, increased risk for thrombosis (OR=2.9) and
stenosis (OR=4.4) was found in the latter group (Table 2B).
Using the rope ladder technique for puncturing the VA gave sig-
nificantly less complications compared to other puncture tech-
niques with 32% reduction of total complication rate and par-
ticularly 53% reduction of thrombosis (Table 2C).
| PATIENT CHARACTERISTICS AND COMPLICATIONS |
Complication rate was not significantly influenced by age, gen-
der, renal diagnosis or time on dialysis. No increased complica-
tion rate was observed in patients with more pronounced vas-
cular pathology i.e. patients with renal vascular disease or diabetes.
Neither the use of anti-hypertensives or oral anti-coagulation
therapy was associated with a higher complication rate.
In patients with a higher number of vascular accesses in their med-
ical history, a higher number of complications could be observed
(Figure 2). Particularly, thrombosis and infections were more fre-
quently noted in these patients. Moreover, patients with an AV
fistula that required an intervention before first use showed a sig-
| COMPLICATIONS RELATED TO CATHETER
CHARACTERISTICS |
Comparing catheters localised in the jugular vein and the sub-
(2)
(3)
A. Localisation of VA:
Forearm
n=837
15.6%
1.8%
Elbow
n=95
29.5%
6.3%
Upper arm
n=224
21.0%
0.9%
p-value
RR (95% CI)
elbow vs. forearm:
1.75 (1.04–2.96)
2.49 (0.80–7.73)
2.32 (1.01–5.35)
5.23 (1.23–22.2)
Total complications
Infection
0.001
0.005
0.056
0.003
Stenosis
4.1%
9.5%
5.4%
Flow problems
0.7%
4.2%
0.4%
(2)
(3)
B. Venous pressure:
<100 mmHg
n=230
16.1%
100-180 mmHg
n=723
>180 mmHg
n=227
p-value
RR (95% CI)
>180 vs. <100 mmHg:
1.72 (1.03–2.87)
Total complications
Thrombosis
15.8%
27.3%
0.000
0.001
0.001
3.9%
5.9%
12.3%
2.92 (1.30–6.52)
Stenosis
2.2%
4.3%
9.3%
4.37 (1.44–13.2)
(2)
(3)
C. Puncture technique:
Rope ladder
n=334
Other
n=868
19.1%
7.6%
p-value
RR (95% CI)
rope ladder vs. other:
0.68 (0.46–0.99)
0.47 (0.25–0.89)
Total complications
Thrombosis
14.1%
0.040
0.034
4.2%
Table 2: Complications related to dialysis techniques used in AV fistulae and grafts(1).
(1) Only complications showing significant differences are presented.
(2) P-values are based on univariate analysis and resulted from chi-square test or Fisher exact test.
(3) Relative risk (RR) and 95% confidence intervals (95% CI) are controlled for patient/nurse ratio and the number of previous vascular accesses.
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MULTI CENTRE STUDY OF THE EDTNA/ERCA RESEARCH BOARD
clavian vein, no differences could be observed with a complica-
tion rate of 24% and 25% respectively. In contrast, the type of
catheter was associated with the development of complications.
In double lumen catheters, a complication rate of 38% was
observed compared to 16% in single lumen catheters. Particularly
infection rates doubled in double lumen catheters but also throm-
bosis, stenosis and flow problems were observed more frequently
(Table 3A).
hospital and satellite units with the latter showing a lower com-
plication rate. Moreover, we have to take into account that
patients are more or less selected for treatment in satellite units.
One of the criteria is a good functional vascular access. In addi-
tion, the centre size and the patient/nurse ratio varied consider-
ably among participants, resulting in higher complication rates
in large centres and in centres with a high number of patients
per nurse.
Additionally, results showed a higher complication rate in 12 french
catheters compared to 10 french, also with an increased risk for
infections. It has to be noted however, that two thirds of dou-
ble lumen catheters had a diameter of 12 french explaining that
comparable high complication rates were observed for both
characteristics (Table 3B).
Further on, wearing nose/mouth protection when handling
catheters, played an important role with only 4% of infections
observed if nurses were wearing a mask compared to 27% if masks
were not used (Table 3C).
Age and vascular disease was not associated with complications
in this study. It is a common experience in the elderly and in vas-
cularly compromised patients that the creation of a VA is rather
complicated (3,4). Since only patients on dialysis for more than
six months were included, early failure of first VA, frequently occur-
ring in the elderly, was not taken into account in this study.
We found no evidence to support the DOQI viewpoint (5) that
VA is preferably placed in the forearm and in the elbow. Although
we found the lowest complication rate for VA localised in the fore-
arm, increased risk of complications, particularly infection, steno-
sis and flow problems were observed in elbow localisations. In
contrast, we did not observe a higher risk of complications in VA
localised in the upper arm if only first VA was considered.
It is difficult to formulate clear conclusions concerning the occur-
rence of VA complications in relation to the puncture technique
used in AV fistulae. In this study, the complication rate varied
between less than 15% using the rope ladder technique (=
planned insertion of the needles at fixed intervals along the entire
puncturable length of the VA) to more than 20% using the but-
ton hole technique (= use of a single site with two to three places
for puncturing) or selecting a puncture site at each puncture time.
Although a decreased risk of complications was demonstrated
using the rope ladder technique, it can be argued that this tech-
DISCUSSION
During this one-year observation period, 489 VA related com-
plications requiring intervention were observed in a cohort of 1380
patients. Particularly thrombosis, stenosis, infection, bleeding
and flow problems were frequently noted.
Frequency of complications as well as the number of patients suffer-
ing a complication varied considerably among centres. Although
the observed differences in complication rate per centre is sug-
gestive of an underscoring in some centres, we could not observe
centre differences in the quality of the other data collected at base-
line, month six and month twelve. Differences can be partly
explained by the expected differences in complication rate between
A. Lumen:
Single lumen
n=80
Double lumen
n=94
p-value (2)
RR (95% CI) (3)
double vs. single lumen:
3.34 (1.54–7.24)
Total complications
Infection
16.3%
38.3%
0.001
0.045
7.5%
18.1%
2.10 (0.68–6.39)
B. Size:
10 french
n=54
12 french
n=67
p-value (2)
RR (95% CI) (3)
12 french vs. 10 french:
2.27 (0.81–6.33)
Total complications
Infection
13.0%
1.9%
29.9%
0.030
0.012
16.4%
5.83 (0.58–58.8)
C. Nurse wearing nose/mouth protection:
Yes
No
p-value (2)
RR (95% CI) (3)
no protection vs. yes:
3.21 (0.64–16.1)
n=84
3.6%
n=41
26.8%
Infection
0.000
Table 3: Complications related to dialysis techniques used in catheters (1).
(1) Only complications showing significant differences are presented.
(2) P-values are based on univariate analysis and resulted from chi-square test or Fisher exact test.
(3) Relative risk (RR) and 95% confidence intervals (95% CI) are controlled for patient/nurse ratio and the number of previous vascular accesses.
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COMPLICATIONS OF VASCULAR ACCESS: RESULTS OF A EUROPEAN
MULTI CENTRE STUDY OF THE EDTNA/ERCA RESEARCH BOARD
nique can only be used in well-developed and functioning VA.
ing nephrologists, surgeons, radiologists and nurses are needed
to avoid VA complications. Primary prevention will consist of
making the exact choice of type and localisation of VA well in
advance and using dialysis techniques with a low risk for com-
plications. Moreover, nurses have a key role in the prevention of
VA infections, respecting strict hygienic precautions when han-
dling fistulae/grafts and catheters.
In patients dialysed with catheters, the use of a single lumen
catheter showed a markedly lower complication rate of 16%
compared to 38% in double lumen catheters. In Europe, single
lumen catheters were used in about half of the patients where-
as this type of catheter was not promoted and seldom used in
the US (5, 6). One of the reasons may be that in some European
countries, e.g. Belgium, the use of an arterio-venous blood pump
is quite popular. As shown in table 3, complication rates related
to dialysis techniques used in catheters revealed less conclusive
results. Although p-values for differences between complication
rates were significant, risk ratios lost significance mainly due to
the small sample sizes and the high influence of confounding fac-
tors such as patient/nurse ratio and previous VA.
Hygienic precautions showed no positive results for preventing
VA related infections, except for nurses wearing nose/mouth
protection when handling catheters. This was the normal prac-
tice in 40 to 50% of centres when handling respectively fistu-
lae/grafts and catheters (1). From the first part of this study, we
learned that in all centres gloves were used when handling VA,
that these gloves were always changed between patients and that
they were sterile when puncturing VA in half of the centres.
Unfortunately, we did not collect any information on hand-
washing practices of the nurses before handling VA or the
patients’ practice of wearing masks if they were dialysed with a
catheter. Positive results of these hygienic measures were shown
in other publications (7).
ACKNOWLEDGEMENT
The project questionnaire was developed with the help of all mem-
bers of the Research Board. Technical and administrative help was
provided by Colin Aldridge, Jan Aldridge and Jago Taylor (MedIQal,
Stevenage, United Kingdom) and by Dirk De Weerdt and Eddy
Van Hout (Department of Nephrology, University of Antwerp,
Belgium). We would like to thank all the participants of this
study. Without their sustained effort of data collection over a whole
year, this study could never have been realised.
CONCLUSIONS
This study demonstrated once more that complication rates of
VA are unacceptably high. In view of prevention, it can be con-
cluded that common actions of the multidisciplinary team includ-
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