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Validation of a new arterial pulse contour-based cardiac output device

Eric E. C. de Waal, MD; Cor J. Kalkman, MD, PhD; Steffen Rex, MD; Wolfgang F. Buhre, MD

Objective: To evaluate the accuracy and precision of an arterial


pulse contour-based continuous cardiac output device (Vigileo).
Vigileo cardiac output (VigileoCO) was compared with intermittent
transpulmonary thermodilution cardiac output (TPCO) and an established arterial pulse contour-based cardiac output (PCCO).
Design: Prospective clinical study.
Setting: University hospital.
Patients: Twenty-two patients undergoing coronary artery bypass graft surgery.
Interventions: Defined volume load during surgery and in the
postoperative period.
Measurements and Main Results: We obtained 184 pairs of
VigileoCO and TPCO, 140 pairs of VigileoCO and PCCO, and 140
pairs of PCCO and TPCO. Measurements were performed after
induction of anesthesia (T1), after sternotomy (T2), immediately
after (T3) and 20 mins after volume challenge with 10 mLkg1
hydroxyethyl starch 6% (T4), 15 mins after coronary pulmonary
bypass (T5), after retransfusion of autologous blood (T6), after
arrival at the intensive care unit (T7), and immediately after (T8)
and 20 mins after (T9) a second volume load with 10 mLkg1

he measurement of cardiac
output (CO) is still an important technique in the hemodynamic management of perioperative and critically ill patients. Until
now, bolus pulmonary artery thermodilution using the pulmonary artery catheter has remained the clinical reference
technique of CO monitoring (1, 2). However, pulmonary artery catheterization is
highly invasive and time consuming and
is associated with a considerable risk of

From the Division of Perioperative and Emergency


Care (EECdW, CJK, WFB) and Department of Intensive
Care (EECdW), University Medical Center, Utrecht, The
Netherlands; and Department of Anesthesiology (SR),
University Hospital of Aachen, Aachen, Germany.
Supported solely by institutional grants.
Dr. Buhre is member of the Medical Advisory
Board from Pulsion Medical Systems, the manufacturer of the PiCCO System, and has received honoraria
for lectures from Pulsion Medical Systems. The remaining authors have not disclosed any potential conflicts of interest.
For information regarding this article, E-mail:
e.e.c.dewaal@azu.nl
Copyright 2007 by the Society of Critical Care
Medicine and Lippincott Williams & Wilkins
DOI: 10.1097/01.CCM.0000275429.45312.8C

Crit Care Med 2007 Vol. 35, No. 8

hydroxyethyl starch 6%. TPCO was used to calibrate PCCO. For


pooled data, including uncalibrated PCCO data immediately after
weaning from coronary pulmonary bypass (T5), the correlation
coefficient of TPCO vs. VigileoCO, PCCO vs. VigileoCO, and TPCO
vs. PCCO was 0.75, 0.60, and 0.75 respectively. Bland-Altman
analysis showed a bias of 0.00, 0.01, and 0.02 Lmin1, the
precision (SD) was 0.87, 1.08, and 0.93 Lmin1, and the mean
error was 33%, 40%, and 35%. When we compared calibrated
PCCO values (T2T4, T6, T79), the correlation coefficients of
PCCO-VigileoCO and TPCO-PCCO were 0.72 and 0.85, bias was
0.16 and 0.19 Lmin1, and mean error was 33% and 27%,
respectively. Best correlations and the least differences between
TPCO and VigileoCO were observed in postbypass closed-chest
conditions and in the intensive care unit period.
Conclusions: Our results showed that VigileoCO enables clinically acceptable assessment of cardiac output in postbypass
closed-chest conditions and during stable conditions in the intensive care unit. (Crit Care Med 2007; 35:)
KEY WORDS: method comparison; cardiac output; arterial pulse
contour analysis; transpulmonary thermodilution; cardiac surgery

morbidity and mortality (3, 4). To avoid


the complications of the pulmonary artery
catheter, a number of efforts have been
made to develop alternative, less invasive
techniques of intermittent or continuous
CO monitoring. The ideal CO monitor
should be noninvasive, valid, and reliable
under various pathologic hemodynamic
conditions; operator independent; easy to
use; continuous; and cost-effective (5). The
PiCCO technique (Pulsion, Munich, Germany) uses a special arterial thermodilution catheter in the femoral, axillary, or
brachial artery and measures continuous
CO by analysis of the arterial pulse contour.
An initial calibration and subsequent recalibration using transpulmonary thermodilution (TPCO) is mandatory (6). The accuracy of the PiCCO algorithm has been
proven both clinically and experimentally
(6, 7). A good agreement between TPCO and
pulmonary artery thermodilution CO has
been demonstrated (8, 9), even during offpump coronary artery bypass surgery (10).
Recently, the Vigileo system (Edwards
Lifesciences, Irvine, CA) has been introduced into clinical practice. This system
includes a newly developed algorithm for

arterial pulse contour analysis using a


special blood flow sensor (FloTrac Sensor, Edwards Lifesciences, Irvine, CA)
that can be used with every arterial catheter. No thermodilution CO is needed for
calibration of this technique (11, 12).
Until now, no clinical data comparing
the results of the Vigileo and the PiCCO
as the reference technique of known accuracy have been available. Therefore, we
performed a clinical trial to investigate the
accuracy and precision of this new arterial
pulse contour device compared with a standard technique of known accuracy in coronary artery bypass graft (CABG) patients.

MATERIALS AND METHODS


Patients. After approval by the institutional
review board and written informed consent,
22 patients undergoing elective CABG surgery
were included. Patients with severely reduced
left ventricular function (ejection fraction
35%), intracardiac shunts, significant valvular heart disease, or occlusive peripheral arterial disease or patients undergoing emergency
surgery were excluded. All cardiac medications were continued until the day of surgery,
except digitalis, angiotensin converting enzyme inhibitors, and diuretics.

Anesthesia. Patients were premedicated


with midazolam 7.515 mg orally 1 hr before
induction of anesthesia. General anesthesia
was induced with sufentanil (2 gkg1) and
midazolam (0.05 mgkg1). Tracheal intubation was facilitated by pancuronium bromide
(0.1 mgkg1). After endotracheal intubation,
anesthesia was maintained with a continuous
infusion of sufentanil (0.5 gkg1h1) and
0.51.0 MAC Sevoflurane. All patients were
mechanically ventilated with an inspired oxygen concentration of 0.4 and a positive endexpiratory pressure of 5 cm H2O. After induction of anesthesia, a 5-Fr thermistor-tipped
catheter (Pulsiocath PV2015L20A, Pulsion
Medical systems, Munich, Germany) was inserted into the femoral artery. A double-lumen
central venous catheter was inserted into the
right internal jugular vein. Patients were in
the supine position throughout the entire
study period.
Cardiopulmonary Bypass (CPB). The CPB
circuit was primed with a crystalloid-colloid
mixture: 250 mL of Mannitol 10%, 500 mL of
hydroxyethyl starch 10%, 1500 mL of Ringers
lactate, and 100 mL of sodium hydrogen carbonate 8.4%. Before CPB, 300 IUkg1 heparin
was administered to achieve an activated clotting time 480 secs. After clamping of the
aorta, cardiac arrest was induced using crystalloid or blood cardioplegia at the discretion
of the attending surgeon. CPB was managed
according to the -stat principle with a minimal nasopharyngeal temperature of 32C and
a nonpulsatile flow of 2.0 to 2.4 Lmin1m2.
After termination of CPB, protamine was administered to antagonize the heparin effect.
Transpulmonary Thermodilution and
Pulse Contour Cardiac Output. The arterial
thermistor catheter was connected via a threeway stopcock to the PiCCO pressure transducer,
positioned at the level of the midaxillary catheter
for monitoring of arterial pressure, TPCO, and
pulse contour cardiac output (PCCO).
Four central venous bolus injections of 15
mL of cold isotonic saline were injected within
3 secs for the measurement of TPCO at every
time point. The first set of measurements was
used for initial calibration of PCCO (8). In
addition, the Vigileo system was connected via
the FloTrac sensor to the femoral artery catheter. Calculation of CO via the Vigileo system
is based on the patients height, weight, gender, age, and arterial blood pressure (13). The
underlying algorithm is the property of the
manufacturer.
Study Protocol. Hemodynamic measurements included recordings of heart rate, mean
arterial pressure (MAP), central venous pressure (CVP), TPCO, PCCO, and Vigileo cardiac
output (VigileoCO), which were measured intra- and postoperatively at the following time
points: after induction of anesthesia (T1), after
sternotomy (T2), immediately after a volume
load of 10 mLkg1 hydroxyethyl starch 6% (T3),
20 mins after this volume load (T4), 15 mins
after weaning from CPB (T5), after retransfusion
of autologous blood (from the extracorporeal

circulation) (T6), after arrival at the intensive


care unit (ICU) (T7), immediately after a second
volume load of 10 mLkg1 hydroxyethyl starch
6% (T8), and 20 mins later (T9). At each time
point, PCCO and VigileoCO were recorded before
the four transpulmonary thermodilution procedures, that is, before recalibration of the PiCCO
device. After the four transpulmonary thermodilution procedures, VigileoCO was recorded again
and averaged with the earlier obtained value. At
T1 and T5, no PCCO values were obtained because of starting or restarting the system in the
operating room and the ICU. Systemic vascular
resistance was calculated according to the following formula: systemic vascular resistance
(MAP CVP) 79.9/CO, in which TPCO was
used.
Data Analysis and Statistics. After gathering the data for this study, we performed a
power analysis. The sample size calculation
was performed to limit the width of a 95%
confidence interval for the mean error. Based
on a mean cardiac output of 5.0 Lmin1, a
mean error of 30% (14), and a desired total
width of the confidence interval of 20%, a
sample size of 22 was needed.
Statistical analysis was performed using
GraphPad PRISM (version 4.0., GraphPad software, San Diego, CA). All data are expressed as
mean SD unless otherwise stated. Hemodynamic variables at each time point were compared with baseline by analysis of variance for
repeated measurements. If the analysis of variance revealed a significant interaction, post
hoc analysis was performed using pairedsamples t-test. Pearsons correlation coefficient was used to describe the correlation between the three techniques. Bias, precision,
and limits of agreement were calculated according to Bland and Altman (15). Mean error
was calculated from 2precision divided by
mean TPCO (or PCCO) and expressed as percentage (14). Mean TPCO was used when
TPCO was the reference technique, while
mean PCCO was used when PCCO was the
reference technique.

RESULTS
Patient characteristics, patient history, and home medications are given in
Table 1. The time course of heart rate,
CVP, systemic vascular resistance, TPCO,
PCCO, VigileoCO, and blood and rectal
temperatures are presented in Table 2.
After induction of anesthesia and before
surgery, a phenylephrine bolus was administered if MAP was 60 mm Hg.
From the 22 patients studied, three patients received low-dose dopamine (mean
4 gkg1min1) during weaning from
CPB, and two patients received dopamine
(2.7 and 5.7 gkg1min1) during postoperative measurements. Moreover, six
patients were paced via atrial leads because of sinus bradycardia at time points

Table 1. Patient characteristics, relevant history,


and home medication

Patient characteristics
Age, yrs
Weight, kg
Height, cm
BSA, m2
BMI, kgm2
CPB time, mins
Cross-clamp time,
mins
Gender

Mean SD

Range

66 8
80 10
174 9
1.95 0.14
26.3 3.3
85 18
61 15

5182
6699
153190
1.692.20
19.432.9
49114
3188

18 M/4 F
No. of Patients

Relevant history
Diabetes
Hypertension
Myocardial infarction
COPD
Medication
-blocker
Calcium blocker
ACE inhibitor
AR blocker
Nitrates
Diuretics

7
15
11
6
18
9
10
2
11
7

BSA, body surface area; BMI, body mass index; CPB, cardiopulmonary bypass; COPD,
chronic obstructive pulmonary disease; ACE, angiotensin converting enzyme; AR, angiotensin receptor.
n 22.

T5 and T6, five patients of that six were


paced at T7 and T8, and four of that five
were paced at T9. No significant differences were observed when we compared
bias, precision, and mean error in patients with atrial pacing compared with
patients with sinus rhythm.
CVP and TPCO increased significantly
after volume load in the operating room
(T3, T4) and in the ICU (T8, T9), whereas
MAP and VigileoCO increased significantly only after volume load in the ICU.
After weaning from CPB, MAP was decreased compared with pre-CPB values.
The decrease in MAP was accompanied by
a significant decrease in TPCO (and a
decrease in VigileoCO) compared with
pre-CPB values. One patient died the second day after surgery due to pericardial
tamponade and subsequent cardiac failure.
A total of 184 sets of CO measurements
were available for comparison of TPCO and
VigileoCO. The analysis of pooled data according to Bland-Altman is presented in
Table 3. Ninety-five percent of the data
were within 2 SD of the bias. Bias between
TPCO and VigileoCO was 0.00 Lmin1
with a precision of 0.87 Lmin1. The limits
Crit Care Med 2007 Vol. 35, No. 8

Table 2. Hemodynamic data obtained at each time point

HR, beats/min
MAP, mm Hg
CVP, mm Hg
TPCO, Lmin1
PCCO, Lmin1
VigileoCO, Lmin1
SVR, dyneseccm5
Blood temp, C
Rectal temp, C

T1

T2

T3

T4

T5

T6

T7

T8

T9

59 9
63 15
62
4.02 0.87

3.95 0.96
1194 395
35.9 0.4
36.2 0.4

62 10
67 10
73
4.22 0.92
4.06 1.05
4.77 0.86
1187 273
35.5 0.4
36.0 0.4

61 8
66 11
10 3a
5.59 1.22a
5.15 1.08
5.45 0.87
830 188a
35.3 0.6a
35.9 0.5a

61 9
67 13
93
5.71 1.08a
5.67 1.09a
5.37 0.70
837 205a
35.3 0.6a
35.7 0.5a

72 11
51 8a
72
4.96 0.92a
5.79 1.58a
5.03 0.88
721 118a
36.4 0.4a
36.4 0.5

71 12
60 11b
10 3b
5.60 1.23
5.33 1.16
5.57 0.87
754 165
36.2 0.4b
36.4 0.4

71 12
69 12c
83
5.25 1.01

5.38 0.75
952 259c
35.8 0.5c
36.0 0.5c

72 12
78 13d
13 3d
6.15 1.28d
6.01 1.08
6.27 0.98d
868 186
35.4 0.5d
35.9 0.5d

72 12
80 15d
11 3d
6.17 1.38d
6.07 1.32
6.03 1.00d
921 227
35.5 0.5d
35.7 0.5d

T1, after induction of anesthesia; T2, after sternotomy; T3, immediately after a volume load of 10 mLkg1 hydroxyethyl starch 6%; T4, 20 mins after
this volume load; T5, 15 mins after weaning from cardiopulmonary bypass; T6, after retransfusion of autologous blood (from the extracorporeal circulation);
T7, after arrival at the intensive care unit; T8, immediately after a second volume load of 10 mLkg1 hydroxyethyl starch 6%; T9, 20 mins later; HR, heart
rate; MAP, mean arterial pressure; CVP, central venous pressure; TPCO, transpulmonary thermodilution cardiac output; PCCO, pulse contour-based cardiac
output; SVR, systemic vascular resistance.
a
p .06 (vs. T2); bp .05 (vs. T5); cp .05 (vs. T6); dp .05 (vs. T7).
Table 3. Bland-Altman analysis and Pearsons correlation coefficient for data per time moment and for pooled data
TPCO vs. VigileoCO

PCCO vs. VigileoCO

Time

Bias,
Lmin1

Precision,
Lmin1

Mean
Error, %

T1
T2
T3
T4
T5
T6
T7
T8
T9
Pooled data, T5
Pooled data

.53
.65
.62
.56
.58
.72
.80
.74
.74
.76
.75

0.08
0.57
0.14
0.42
0.05
0.09
0.12
0.11
0.14
0.01
0.00

0.90
0.74
0.98
0.93
0.83
0.85
0.64
0.86
0.92
0.88
0.87

45
35
35
33
33
30
24
28
30
33
33

TPCO vs. PCCO

Bias,
Lmin1

Precision,
Lmin1

Mean
Error, %

Bias,
Lmin1

Precision,
Lmin1

Mean
Error, %

.78
.51
.45
.21
.69

0.58
0.23
0.30
0.81
0.24

0.65
0.98
1.00
1.63
0.84

32
38
35
56
32

.87
.65
.87
.48
.62

0.07
0.36
0.12
1.00
0.33

0.52
0.96
0.58
1.32
1.04

25
34
20
53
37

.71
.72
.72
.60

0.25
0.04
0.16
0.01

0.79
0.93
0.89
1.08

26
31
33
40

.88
.96
.85
.75

0.14
0.10
0.19
0.02

0.60
0.38
0.72
0.93

20
12
27
35

TPCO, transpulmonary thermodilution cardiac output; PCCO, pulse contour-based cardiac output; T1, after induction of anesthesia; T2, after
sternotomy; T3, immediately after a volume load of 10 mLkg1 hydroxyethyl starch 6%; T4, 20 mins after this volume load; T5, 15 mins after weaning
from cardiopulmonary bypass; T6, after retransfusion of autologous blood (from the extracorporeal circulation); T7, after arrival at the intensive care unit;
T8, immediately after a second volume load of 10 mLkg1 hydroxyethyl starch 6%; T9, 20 mins later.

of agreement were 1.74 Lmin1 1.74


Lmin1 with a mean error of 33%. The
bias of PCCO and VigileoCO was 0.01
Lmin1, the precision being 1.08 Lmin1,
resulting in limits of agreement of 2.18
Lmin1 2.16 Lmin1 and a mean error
of 40%. The bias between TPCO and PCCO
was 0.02 Lmin1, the precision 0.93
Lmin1, the limits of agreement 1.83
Lmin1 1.87 Lmin1, and the mean
error 35%.
Analyses of data for every defined measurement point are given in Table 3. The
correlation coefficient between TPCO and
VigileoCO varied between 0.53 and 0.80.
The mean error between both methods
varied between 24% and 45%. The best
correlations and the least differences between TPCO and VigileoCO were observed
in patients in post-CPB closed-chest conditions and during the postoperative ICU period. The correlation coefficient between
Crit Care Med 2007 Vol. 35, No. 8

PCCO and VigileoCO varied between 0.21


and 0.78, with a mean error between 26%
and 56%. As with TPCO and VigileoCO,
the best correlation between PCCO and
VigileoCO was observed in the postoperative period.
At T5, after weaning from CPB, we
observed a worse correlation (r .48)
between TPCO and noncalibrated PCCO
values with a mean error of 53%. In contrast, the correlation between TPCO and
VigileoCO at that time point was 0.58 and
the mean error was 33%, respectively.
If noncalibrated PCCO values obtained
at T5 were not included in the analysis (as
recommended by the manufacturer), the
respective correlation coefficients of TPCOVigileoCO, PCCO-VigileoCO, and TPCOPCCO were 0.76, 0.72 and 0.85 with a bias
of 0.01, 0.16, and 0.19 Lmin1 and a
mean error of 33%, 33%, and 27%, respectively (Table 3 and Figs. 1 and 2).

DISCUSSION
In this controlled clinical trial, we studied a recently introduced, pulse-contour
based continuous CO monitor (Vigileo)
during the perioperative time course in patients undergoing CABG surgery. Our results suggest an acceptable bias and precision between TPCO and arterial pulse
contour-based VigileoCO during post-CPB
closed-chest conditions and in the ICU. The
accuracy of the Vigileo device was found to
be clinically acceptable, except for pre-CPB
values, when patients received bolus doses
of vasopressors resulting in a sudden increase in vascular tone.
The mean error of the established PCCO
system (PiCCO, version 7.0, Pulsion Medical Systems, Munich, Germany) in comparison to TPCO was 30% at all time points
except T3, T5, and T6. When we compared
the PCCO with VigileoCO, mean errors
3

Figure 1. Bias 2 SD according to Bland-Altman for pooled data excluding data obtained at T5 (15 mins
after weaning from cardiopulmonary bypass). TCPO, transpulmonary thermodilution cardiac output;
PCCO, pulse contour continuous cardiac output.

were generally higher compared with the


comparisons of TPCO with VigileoCO
alone. Immediately after weaning from
CPB, there was a worse correlation between
PCCO and VigileoCO as well as between
PCCO and TPCO.
Pulmonary artery thermodilution CO
is still the accepted reference technique
for clinical assessment of CO (1, 2). However, the pulmonary artery catheter is a
highly invasive monitoring technique,
and subsequent efforts have been made to
develop alternative, minimally invasive
CO monitoring devices. One of the less
invasive alternatives is TPCO. The accuracy and precision of the TPCO technique
are comparable to classic pulmonary ar4

tery thermodilution (6 8, 10). Moreover,


when TPCO is used in conjunction with
the PiCCO system, measurement of continuous PCCO is available (9). Both the
PiCCO system and the Vigileo system are
arterial pressure curve-based CO monitoring systems. Therefore, we used TPCO
as the reference technique in the present
study.
We compared both techniques with arterial pressure curves obtained in the femoral artery. CO determination via the femoral artery seems to be superior to CO
determination in the radial artery, particularly due to less damping of the femoral
arterial pressure curve during the first few
hours after weaning from CPB. However,

the incidence of infection in femoral artery


cannulation is higher (0.44% vs. 0.13% for
radial artery cannulation), while the main
complication rate of radial artery cannulation is temporary occlusion (19.7% vs.
1.18% for femoral artery cannulation) (16).
Another major problem with studying
different methods for CO monitoring is
the fact that usually no real reference
technique (e.g., an electromagnetic flow
meter) is available in a clinical setting.
Therefore, the true CO is unknown, as
the reference technique in the underlying
study (transpulmonary thermodilution)
has an inherent bias of approximately
10% to 20% (6, 7). In 1999, Critchley and
Critchley (14) performed a meta-analysis
of studies comparing different techniques
of CO monitoring. They analyzed the percentage errors of different methods
against the clinical reference technique
and used the data to determine clinically
acceptable limits of agreements between
methods. According to this type of analysis, mean errors up to 30% are acceptable for clinical purposes. Therefore, we
calculated not only bias, precision, and
limits of agreement according to BlandAltman but also the mean error between the three different techniques. In
the present study, analysis between
VigileoCO and TPCO as the reference
technique showed a mean error of 33%,
which is relatively close to the upper
acceptable limit of 30%. The highest
difference between VigileoCO and TPCO
was found after induction of anesthesia,
which may be attributable to the fact that
patients received boluses of phenylephrine in that period due to a decrease in
mean arterial pressure to 60 mm Hg.
No patients received vasopressor support
after weaning from CPB; therefore, it is
not likely that drug-induced changes in
vascular tone affected the results of the
present study.
However, during situations with rapidly
changing cardiovascular conditions (e.g.,
after induction of anesthesia and sternotomy), the difference between methods was
increased. Most likely, the increased difference in CO may be caused by the algorithms for calculating of CO incorporated
in the Vigileo device. As far as we know, the
Vigileo system calculates stroke volume using arterial pulsatility (SD of the pressure
wave over a 20-sec interval), according to
the equation stroke volume Kpulsatility
(11). K is a constant quantifying arterial
compliance and vascular resistance. K is
derived from patient characteristics (gender, age, height, and weight) according to
Crit Care Med 2007 Vol. 35, No. 8

Figure 2. Pearsons correlation coefficients for pooled data excluding data obtained at T5 (15 mins after
weaning from cardiopulmonary bypass). TPCO, transpulmonary thermodilution cardiac output; PCCO,
pulse contour continuous cardiac output; r, Pearsons correlation coefficient.

Crit Care Med 2007 Vol. 35, No. 8

the method described by Langewouters et


al. (13) and waveform characteristics (skewness and kurtosis of individual arterial pulse
waves) (11). The calibration constant K is
automatically recalculated (software version 01.01) every 10 mins. Therefore, under
conditions of rapidly changing vascular resistance, the response of the Vigileo device
in the time domain will probably be delayed. However, the manufacturer recently
provided a new software version (01.07)
that recalibrates the system every minute.
This may improve the accuracy and precision during rapid changes in vasomotor
tone. Changes of CO by a defined volume
challenge were detected adequately under
open- (T3, T4) and closed-chest conditions
(T8, T9).
Recently, Manecke et al. (11) compared
the Vigileo monitor with intermittent CO
measurements by pulmonary artery thermodilution. Over a wide range of CO (2.77
9.60 Lmin1), they found a close agreement (bias 0.04 Lmin1, precision 0.99
Lmin1) between both techniques. These
results are in line with the present study.
However, one major limitation of the
study from Manecke et al. is that no standardized changes in volume status were
done. Mayer and colleagues (17) compared the VigileoCO with pulmonary artery thermodilution CO in patients undergoing CABG and/or valve repair. In
their study, the overall mean error was
46%, which was substantially higher than
the overall mean error of 33% obtained in
our study. However, the recent study of
Mayer et al. differed from our study in
several important points, which may explain the diverging results. First, the patient population differed considerably.
Whereas Mayer et al. included a heterogeneous patient population (patients undergoing CABG and/or valve surgery),
our study population was homogeneous
(CABG patients). Second, in our study the
FloTrac sensor was connected to a femoral arterial catheter, whereas Mayer et al.
connected the FloTrac sensor to the radial arterial catheter, which may also influence the results in particular after
CPB. Moreover, Mayer et al. conducted
no definitive fluid challenge. It seems
possible that these differences in study
design may have influenced the results of
the study from Mayer et al. and at least in
part can explain the increased mean error
comparing VigileoCO and pulmonary artery thermodilution CO.
We used the PiCCO system as the reference technique, which was already
studied under a variety of experimental
5

and clinical circumstances (6 10, 18).


We obtained a good agreement between
PCCO and TPCO, enabling continuous
measurement of CO with the PCCO technology. The mean error of pooled data
was 27% if uncalibrated data obtained at
T5 were excluded from the analysis. In
contrast to Vigileo, measurement of arterial pulse contour-derived CO by the
PiCCO is dependent on recalibration if
hemodynamic conditions change rapidly.
However, some authors claimed that
PCCO can be measured with acceptable
agreement without recalibration even
for a longer period of time (9). In the
present study, PCCO values obtained
immediately after CPB (T5) without
recalibration showed a worse agreement with TPCO values obtained by
thermodilution immediately thereafter.
Therefore, we conclude that recalibration after profound changes in hemodynamics is a prerequisite for adequate
measurement of CO with the PCCO
technique. The results of the present
study confirmed the findings from
Sander et al. (18), who observed also a
good agreement between TPCO and
PCCO before CPB but found less good
agreement between TPCO and PCCO
after CPB. When comparing both arterial pulse contour-derived techniques
(VigileoCO vs. PCCO), we found bias,
precision, limits of agreement, and
mean error to be increased compared
with the results obtained for the comparison between the Vigileo device and
the reference technique (TPCO). The
most pronounced changes were found
immediately after weaning from CPB,
which at least in part may be explained
by the fact that uncalibrated PCCO values were obtained. Moreover, VigileoCO
after sternotomy was different from
PCCO and TPCO values. During the remaining time points, both minor invasive techniques offer comparable accuracy and precision. The lowest mean
error was observed during the ICU period; this holds true for both the Vigileo
and the PCCO technique. A second volume load maneuver resulted in a significant increase in CO.

CONCLUSIONS
The results of the present study suggest that the new arterial pulse contour
device enables assessment of CO in patients undergoing CABG surgery with
clinically acceptable bias and precision in
the post-CPB period under closed-chest
conditions and in the ICU. PiCCO and
Vigileo are interchangeable in the postoperative period. The latter technique is
of particular interest as no calibration
is needed and the flow sensor can be
used with any common arterial catheter. VigileoCO was found to exceed
TPCO in the pre-CPB period and openchest condition, which makes the techniques not interchangeable under these
circumstances. Thereby, during rapidly
changing hemodynamic conditions, the
accuracy and precision are not acceptable. Further refinement of the algorithm resulting in decreased response
time may improve the accuracy under
such hemodynamic conditions.

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Crit Care Med 2007 Vol. 35, No. 8

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