British Journal of Anaesthesia 101 (2): 27986 (2008)

Correspondence
Performance of a minimally invasive cardiac output monitoring system (Flotrac/Vigileo)
EditorWe read with great interest the study by Compton and colleagues1 comparing minimal invasive measurements of cardiac output obtained with two devices, the PiCCOTM and the FloTracTM /VigileoTM system. The latter has been introduced into clinical practice in 2005, and early studies comparing this device with established methods to determine cardiac output have shown limited agreement only. As a consequence, the algorithm for calculating stroke volume, heart rate, and hence cardiac output derived from the arterial pressure waveform ( pulse contour analysis) has been modied and several software updates have been released. Compton and colleagues claim that they used the new, improved software version named 1.10, which was released in November 2006, and not in spring 2006 as stated. On the other hand, patients were included between July 2006 and May 2007. Thus, the question arises which software version was really used or how many of their 25 patients were studied using the latest software update. This question is of importance as the updated software resulted in an improved percentage error of measurement values compared with standard techniques (Table 1, which updates Table 4 from the original article). One of the software updates refers to the detection of arrhythmias, eliminating one of the study limitations raised by the authors. A second point refers to the data presentation. In the Method section, the authors claim that both the transpulmonary thermodilution-derived cardiac output and the pulse contour-derived continuous cardiac output values of the PiCCOTM system were used for comparison with the new device. However, in the Results section, no comparison between both pulse contourderived methods is presented. Instead, PiCCOTM data obtained from transpulmonary thermodilution and pulse contour analysis were pooled. It would be interesting to see the agreement between data obtained from transpulmonary thermodilution and pulse contour analysis obtained with the PiCCOTM . Finally, we wonder if transpulmonary thermodilution is a good choice for obtaining reference values for cardiac output, particularly in patients with acute lung injury, as the femoral thermodilution curve is likely affected by pulmonary oedema. In the Compton study, 19 of the 25 patients suffered from acute respiratory failure. The authors state that re-calibration of the PiCCOTM device was done at least every 24 h. A recent paper has shown that the accuracy of obtained values exceeds the accepted percentage error of 30%2 as early as 60 min after re-calibration.3 Hence, a frequent recalibration of the PiCCOTM device (every 20 30 min) is required to obtain reliable results, particularly in the presence of vasopressor therapy.4 In their discussion, the authors state that arrhythmia was a limitation, but provide no information regarding its incidence. In this respect, it is noteworthy that the key feature of the latest software version (v1.10) is the improved performance during arrhythmia.5 6 In conclusion, we challenge the conclusions presented by the authors concerning the (lack of ) accuracy of the FloTracTM /VigileoTM system since they obviously did not consistently use the improved new software version throughout their study as stated. Furthermore, the inappropriate choice and use of the reference method precludes expecting a close agreement between the two techniques. T. W. L. Scheeren* C. Wiesenack Rostock and Regensburg, Germany *E-mail: thomas.scheeren@uni-rostock.de
Table 1 Clinical evaluation studies on FloTracTM accuracy of cardiac output measurement. CABG, coronary artery bypass grafting; ICU, intensive care unit; SD, standard deviation; 2SD/mean, percentage error2 Author deWaal and colleagues Mayer and colleagues Opdam and colleagues Sander and colleagues Manecke and Auger Prasser and colleagues McGee and colleagues Breukers and colleagues Sakka and colleagues Lorsomradee and colleagues Button and colleagues Cannesson and colleagues Prasser and colleagues Mayer and colleagues Compton and colleagues Year Patients 2007 CABG 2007 Cardiac 2006 Cardiac 2006 CABG 2007 Cardiac 2007 Neuro-ICU 2007 Mixed 2007 Cardiac 2007 Septic 2007 Cardiac Software V 1.01 V 1.01 V 1.03 V 1.03 V 1.03 V 1.03 V 1.03 V 1.03 V 1.07 V 1.07 2SD/mean 33% 46% 40% 54% 33% 49% 50% 36% 35% 29 56% Reference 7 8 9 10 11 12 13 14 15 16
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2007 Cardiac 2007 CABG

V 1.07 V 1.07

40% 37%

17 18

2007 CABG 2008 CABG

V 1.10 V 1.10

26.9% 24.6% 51.7%

5 6 1

2008 Medical-ICU V 1.07/V 1.10

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Correspondence

EditorWe would like to thank Drs Scheeren and Wiesenack for their interest in our work. It is correct that two versions of the FloTracTM /VigileoTM software were used in the study. Despite our timely inquiries, we were only informed after publication that six of our patients were not measured using the latest version (1.10). According to Edwards Lifesciences, the software was updated sometime in August 2006. Omitting those six patients (57 measurement pairs) and recalculating the data, however, yield comparable lack of success, as can be seen below. Our results and thus our conclusions remain unchanged. Agreement between arterial pressures: MAPfem/MAPrad bias 3 mm Hg, limits of agreement (LOA) 12 to 18 mm Hg. Comparison of radial and femoral artery pressures: systolic arterial pressures P0.2517, mean arterial pressures P,0.001, and diastolic arterial pressures P,0.001. Agreement between cardiac indexes: reference-CI/ AP-CI bias 0.69 litre min21 m22, LOA 21.22 to 2.62 litre min21 m22; TD-CI/AP-CI bias 0.77 litre min21 m22, LOA 21.11 to 2.65 litre min21 m22. As suggested by Scheeren and Wiesenack, we also calculated agreement between PiCCO pulse contour values only (PC-CI) and the corresponding FloTrac/ Vigileo measurements (AP-CI): PC-CI/AP-CI bias 0.72 litre min21 m22, LOA 21.23 to 2.66 litre min21 m22. Re-analysis of subgroups and DCI values did not yield signicant changes either. We regret any confusion concerning the measurements in our study. F. D. Compton* B. Zukunft C. Hoffmann W. Zidek J.-H. Schaefer Berlin, Germany *E-mail: friederike.compton@charite.de
1 Compton FD, Zukunft B, Hoffmann C, Zidek W, Schaefer JH. Performance of a minimally invasive uncalibrated cardiac output monitoring system (Flotrac/Vigileo) in haemodynamically unstable patients. Br J Anaesth 2008; 100: 451 6 2 Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput 1999; 15: 85 91 3 Hamzaoui O, Monnet X, Richard C, Osman D, Chemla D, Teboul JL. Effects of changes in vascular tone on the agreement between pulse contour and transpulmonary thermodilution cardiac output measurements within an up to 6-hour calibrationfree period. Crit Care Med 2008; 36: 434 40 4 Bein B, Meybohm P, Cavus E, et al. The reliability of pulse contour-derived cardiac output during hemorrhage and after vasopressor administration. Anesth Analg 2007; 105: 107 13

5 Prasser C, Trabold B, Schwab A, Keyl C, Ziegler S, Wiesenack C. Evaluation of an improved algorithm for arterial pressure-based cardiac output assessment without external calibration. Intensive Care Med 2007; 33: 2223 5 6 Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg 2008; 106: 867 72 7 de Waal EE, Kalkman CJ, Rex S, Buhre WF. Validation of a new arterial pulse contour-based cardiac output device. Crit Care Med 2007; 35: 1904 9 8 Mayer J, Boldt J, Schollhorn T, Rohm KD, Mengistu AM, Suttner S. Semi-invasive monitoring of cardiac output by a new device using arterial pressure waveform analysis: a comparison with intermittent pulmonary artery thermodilution in patients undergoing cardiac surgery. Br J Anaesth 2007; 98: 176 82 9 Opdam HI, Wan L, Bellomo R. A pilot assessment of the FloTrac(TM) cardiac output monitoring system. Intensive Care Med 2007; 33: 344 9 10 Sander M, Spies CD, Grubitzsch H, Foer A, Muller M, von Heymann C. Comparison of uncalibrated arterial waveform analysis in cardiac surgery patients with thermodilution cardiac output measurements. Crit Care 2006; 10: R164 11 Manecke GR Jr, Auger WR. Cardiac output determination from the arterial pressure wave: clinical testing of a novel algorithm that does not require calibration. J Cardiothorac Vasc Anesth 2007; 21: 3 7 12 Prasser C, Bele S, Keyl C, et al. Evaluation of a new arterial pressure-based cardiac output device requiring no external calibration. BMC Anesthesiol 2007; 7: 9 13 McGee WT, Horswell JL, Calderon J, et al. Validation of a continuous, arterial pressure-based cardiac output measurement: a multicenter, prospective clinical trial. Crit Care 2007; 11: R105 14 Breukers RM, Sepehrkhouy S, Spiegelenberg SR, Groeneveld AB. Cardiac output measured by a new arterial pressure waveform analysis method without calibration compared with thermodilution after cardiac surgery. J Cardiothorac Vasc Anesth 2007; 21: 632 5 15 Sakka SG, Kozieras J, Thuemer O, van Hout N. Measurement of cardiac output: a comparison between transpulmonary thermodilution and uncalibrated pulse contour analysis. Br J Anaesth 2007; 99: 337 42 16 Lorsomradee S, Lorsomradee S, Cromheecke S, De Hert SG. Uncalibrated arterial pulse contour analysis versus continuous thermodilution technique: effects of alterations in arterial waveform. J Cardiothorac Vasc Anesth 2007; 21: 636 43 17 Button D, Weibel L, Reuthebuch O, Genoni M, Zollinger A, Hofer CK. Clinical evaluation of the FloTrac/VigileoTM system and two established continuous cardiac output monitoring devices in patients undergoing cardiac surgery. Br J Anaesth 2007; 99: 329 36 18 Cannesson M, Attof Y, Rosamel P, Joseph P, Bastien O, Lehot JJ. Comparison of FloTracTM cardiac output monitoring system in patients undergoing coronary artery bypass grafting with pulmonary artery cardiac output measurements. Eur J Anaesthesiol 2007; 24: 832 9

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