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From the Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Germany.
Address correspondence and reprint requests to Dr. med. Jochen Mayer, Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstr. 79, 67063 Ludwigshafen, Germany. Address e-mail to j-mayer{at}gmx.de.
| Abstract |
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METHODS: Forty ASA III patients scheduled for elective coronary artery bypass grafting with cardiopulmonary bypass (CPB) were studied. Simultaneous CO measurements by bolus thermodilution and the FloTrac/Vigileo device were obtained after induction of anesthesia (T1), before CPB (T2), after CPB (T3), after sternal closure (T4), on arrival in the intensive care unit (T5), 4 h (T6), 8 h (T7), and 24 h after surgery (T8). CO was indexed to the body surface area (cardiac index, CI). A percentage error of 30% or less was established as the criterion for method interchangeability.
RESULTS: Two hundred and eighty-two data pairs were analyzed. Thermodilution CI ranged from 1.2 to 4.1 L · min–1 · m–2 (mean 2.5 ± 0.54 L · min–1 · m–2). Bias and precision (1.96 sd of the bias) were 0.19 L · min–1 · m–2 and ± 0.60 L · min–1 · m–2, resulting in an overall percentage error of 24.6%. Subgroup analysis revealed a percentage error of 28.3% for data pairs obtained intraoperatively (T1–4) and 20.7% in intensive care unit (T5–8).
CONCLUSION: CI values obtained by the improved, second generation semiinvasive arterial waveform device showed good intraoperative and postoperative agreement with intermittent pulmonary artery thermodilution CI measurements in patients undergoing coronary artery bypass graft surgery.
| Introduction |
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| METHODS |
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Premedication consisted of 0.1 mg/kg midazolam orally. Routine access to the left or right radial artery was established (Leadercath 20G, Vygon, Ecouen, France) and connected to the VigileoTM monitor (Edwards Lifesciences, Irvine, CA; software version 1.10) via the FloTracTM pressure transducer. Induction of anesthesia was performed with sufentanil 1.5 µg/kg, midazolam 0.07 mg/kg, and pancuronium 0.01 mg/kg. After intubation of the trachea, the lungs were ventilated with 50% oxygen in air. Ventilation was controlled with a tidal volume of 10 mL/kg and a positive end-expiratory pressure (PEEP) of 5 mm Hg. The ventilatory rate was adjusted to maintain an arterial partial pressure of carbon dioxide of 32–42 mm Hg and arterial pH between 7.35 and 7.45. A balloon tipped, flow-directed PAC (7.5F, Edwards, Irvine, CA) was placed via the right internal jugular vein and the correct position was confirmed by pressure tracings and by routine chest radiograph immediately after admission to the intensive care unit (ICU). CPB was provided using a nonpulsatile flow rate of 2.4 L · min–1 · m–2 and temperature was kept at mild hypothermia (bladder temperature >33°C). All intravascular pressure measurements were referenced to the midchest level and thermodilution CO measurements with the PAC were performed by experienced staff with constant injections of 10 mL of ice-cold 0.9% saline. The validity of every temperature curve was judged visually on the attached monitor. A minimum of four consecutive measurements over the entire respiratory cycle was obtained and a difference of <10% between the measurements was accepted for data collection. The mean thermodilution CO was calculated and compared with the mean CO value derived from the Vigileo monitor over the same period. The shape of the arterial curve was checked visually to reduce the chance of error because of damping. If arrhythmias occurred during the measurements, the results were discarded and measurements were repeated. The measured CO values were indexed to the body surface area (cardiac index, CI) by dividing the CO by the body surface area.
Postoperatively, all patients were transferred to the ICU and controlled mechanical ventilation was continued for at least 4 h. Peak airway pressures were adjusted to deliver a constant tidal volume of 10 mL/kg body weight; inspiratory/expiratory time ratio was set to 1:2, and a PEEP of 5 mm Hg was used. Sedation consisted of a continuous propofol infusion of 0.5–1.5 mg · kg–1 · h–1. Tracheal extubation was performed when body temperature was >36°C, the patients breathed spontaneously with adequate blood gas variables, and hemodynamics were stable.
Thermodilution CI (TDCI) and CI measurements using the FloTrac/Vigileo monitor (APCI) were obtained simultaneously after induction of anesthesia (T1), before (T2) and after (T3) CPB, after sternal closure (T4), on arrival in ICU (T5), after 4 h (T6), after 8 h (T7), and 24 h after surgery (T8). CI measurements and data collection were performed by two anesthesiologists who were blinded to the corresponding CO measurement of the other method.
Statistical analysis was performed using the method described by Bland and Altman.13 Bias was defined as the mean difference between TDCI and APCI values. Precision was represented by the upper and lower limits of agreement. The limits of agreement were calculated as the bias (1.96 sd) defining the range in which 95% of the differences between the two methods were expected to lie. The percentage error (2 sd of the bias/mean CI100) was calculated according to Critchley and Critchley for comparison of CO values,14 and set as the decisive criterion for interchangeability of the two methods. The mean CI values derived from thermodilution versus arterial waveform analysis were compared using a paired Student's t-test. Data are presented as mean (sd), unless otherwise stated. P < 0.05 was considered statistically significant.
| RESULTS |
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2.0 L · min–1 · m–2 (n = 52) showed a percentage error of 27.9% with a mean CI difference of 0.32 L · min–1 · m–2 and a precision of ± 0.53 L · min–1 · m–2 (Fig. 2).
CI was calculated separately for each method and data comparison revealed a bias of 0.04 L · min–1 · m–2 and a precision of ± 0.91 L · min–1 · m–2 (Fig. 2). Bias, precision and percentage error for every data point (T1–8) are summarized in Figure 3.
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| DISCUSSION |
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We used the method described by Critchley and Critchley14 to compare CO measurements, as this not only incorporates the error of the method to be tested, but also adjustments for errors in the reference method itself. These authors concluded that a percentage error of 30% between the test and reference method indicates that the test method is no less accurate than the reference method. In our study, we found an overall percentage error of 24.6% for all data pairs, and it can therefore be characterized as comparable with TDCI. A percentage error of <30% implies, based on an absolute error of 10%–20% of the TDCI method, an absolute error of 20% or less for the APCI device. Separate analysis of CO data obtained during the ICU period showed better agreement with a percentage error of 20.7%, whereas intraoperative measurements revealed a percentage error of 28.3%. This is still below the 30% limit of acceptance but displays differences in performance we found in the perioperative time course. As described previously,11 vessel impedance, peripheral vascular resistance, and arterial compliance are the basis of arterial waveform analysis for measuring CO. Sources of error include interindividual differences in aortic impedance, an important variable to calculate stroke volume,16 or reflections of the arterial pulse contour due to vessel tapering, bifurcations and caliber changes, which may corrupt the peripheral arterial pulsewave signal.17 Since the percentage error shows that the agreement of the APCI with TDCI is within our ability to measure the error, the aforementioned malfunction sources of uncalibrated arterial waveform analysis seem to be attenuated by the improved algorithm of the APCI device. Peripheral arterial pulse wave is interaction between the left ventricular output and the capacitance of the vascular tree18 and, apart from fluid status or temperature, the use of vasoactive drugs causes changes in the systemic vascular system. This might result in a higher bias of the APCI device in times of higher vasoactive drug usage. Nonetheless, no restrictions were made in the study protocol with regard to cardiocirculatory treatment to be able to analyze the clinical relevance of this effect.
After weaning from CPB, bolus administration of inotropes (epinephrine and norepinephrine 2.5–10 µg) was associated with the lowest agreement between APCI and TDCI, leading to a percentage error of 32.2%. After separation from CPB with cardiac arrest, central–peripheral arterial pressure gradients have been shown, resulting in differences in the shape of the arterial pressure wave.19,20 This may be another reason for the higher bias after CPB. This mechanism was observed to resolve after approximately 20 min.21 Other potential causes for the increased error immediately after CPB could be the sensitivity of TDCI to thermal changes as fluids are administered and the patient rewarms. Also, the comparison of an intermittent measurement (TDCI) to a continuous measurement (APCI) has inherently more error in a rapidly fluctuating environment. In the ICU, where alterations in fluid input, patient temperature, and continuous infusion of inotropes are less dynamic, the error between APCI and TDCI was reduced when compared with intraoperative CI data. Patients with low CI often have a higher demand of inotropes, which might explain the slightly higher bias in this subgroup. Mechanical ventilation appears to have no impact on the bias of APCI with the ventilator settings used in our study (tidal volume 10 mL/kg body weight, PEEP max 5 mm H2O, and an inspiratory/ expiratory time ratio of 1:2).
Results of other studies dealing with the same APCI device showed varying results. Sander et al.9 found a total percentage error of 54% between FloTrac/ Vigileo-derived CO and CO measured by bolus thermodilution in 108 data pairs. The authors did not state the software version of the FloTrac/Vigileo used, but as their results are overall comparable with the results of our previous study,11 they most probably used a first generation device. They also found a better agreement for patients in the ICU than intraoperatively, which supports the aforementioned thesis that the bias is markedly influenced by changes in arterial vascular tone. Opdam et al.12 investigated the performance of APCI compared with TDCI after CABG surgery in the ICU and reported a limited correlation of r2 = 0.26. They also tested different arterial sites and found the femoral artery to be superior to the brachial and radial insertion site. However, only six patients were enrolled, the software version used was not provided and the percentage error was not calculated in this study. Manecke and Auger10 compared 295 measurement pairs of CO in patients who did not receive any vasoactive treatment and found a bias of 0.55 L/min and a precision of 0.98 L/min. Unfortunately, they did not state the software version of the algorithm and percentage error was not given.
In light of our previous study11 that provided a comparable setting, the refined algorithm of the FloTrac/Vigileo device showed a significantly improved performance. The detected bias of 0.19 L · min–1 · m–2 for all CI data pairs is an improvement of almost 60% compared with 0.46 L · min–1 · m–2,11 and the percentage error decreased from 45.9% to 24.6%. In patients with low CI, bias and percentage error decreased from 0.67 L · min–1 · m–2 and 56.4% to 0.32 L · min–1 · m–2 and 27.9% respectively.
Apart from CO, the different, less invasive technique of the FloTrac/Vigileo device cannot provide data about cardiac filling pressures, such as pulmonary artery pressure, pulmonary artery occlusion pressure, and mixed venous oxygen saturation, which might be useful in particular patients.
In conclusion, the second generation FloTrac/ Vigileo device offers less invasive and overall reliable measurement of CO combined with easy usability during sinus rhythm in patients undergoing CABG surgery compared with pulmonary artery thermodilution. However, additional work should be done to improve the response after bolus application of vasoactive drugs, and to prove reliability in different clinical settings.
| Footnotes |
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| REFERENCES |
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