Volume 24, Issue 2 , Pages 250-256, April 2010
Validity of an Arterial Pressure Waveform Analysis Device: Does the Puncture Site Play a Role in the Agreement With Intermittent Pulmonary Artery Catheter Thermodilution Measurements?
Objective
The measurement of cardiac output is a key element in the assessment of cardiac function. Recently, a pulse contour analysis-based device without need for calibration became available (FloTrac/Vigileo, Edwards Lifescience, Irvine, CA). This study was conducted to determine if there is an impact of the arterial catheter site and to investigate the accuracy of this system when compared with the pulmonary artery catheter using the bolus thermodilution technique (PAC).
Design
Prospective study.
Setting
The operating room of 1 university hospital.
Participants
Twenty patients undergoing cardiac surgery.
Interventions
CO was determined in parallel by the use of the Flotrac/Vigileo systems in the radial and femoral position (CO_rad and CO_fem) and by PAC as the reference method. Data triplets were recorded at defined time points. The primary endpoint was the comparison of CO_rad and CO_fem, and the secondary endpoint was the comparison with the PAC.
Measurements and Main Results
Seventy-eight simultaneous data recordings were obtained. The Bland-Altman analysis for CO_fem and CO_rad showed a bias of 0.46 L/min, precision was 0.85 L/min, and the percentage error was 34%. The Bland-Altman analysis for CO_rad and PAC showed a bias of −0.35 L/min, the precision was 1.88 L/min, and the percentage error was 76%. The Bland-Altman analysis for CO_fem and PAC showed a bias of 0.11 L/min, the precision was 1.8 L/min, and the percentage error was 69%.
Conclusion
The FloTrac/Vigileo system was shown to not produce exactly the same CO data when used in radial and femoral arteries, even though the percentage error was close to the clinically acceptable range. Thus, the impact of the introduction site of the arterial catheter is not negligible. The agreement with thermodilution was low.
Key Words: cardiac output, arterial waveform analysis, pulmonary artery catheter, thermodilution
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Supported by departmental funds and Edwards Lifescience, LLC (Irvine, CA) who delivered the Vigileo monitors and the FloTrac transducers.
The impact of the arterial puncture site is not negligible, when the FloTrac/Vigileo system is used to measure hemodynamic data. Compared with the thermodilution bolus technique using the pulmonary artery catheter, large differences were observed. Therefore, the use of this device should be questioned in cardiac surgery.
In the past 5 years, D.R.S. has received honoraria or travel support for consulting or lecturing from the following companies: Abbott AG, Baar, Switzerland; Alliance Pharmaceutical Corp, San Diego, CA; AstraZeneca AG, Zug, Switzerland; Bayer (Schweiz) AG, Zürich, Switzerland; B. Braun Melsungen AG, Melsungen, Germany; CSL Behring GmbH, Hattersheim am Main, Germany; Fresenius SE, Bad Homburg v.d.H., Germany; Galenica AG, Bern, Switzerland (including Vifor SA, Villars-sur-Glâne, Switzerland); GlaxoSmithKline GmbH & Co KG, Hamburg, Germany; Janssen-Cilag AG, Baar, Switzerland; Novo Nordisk A/S, Bagsvärd, Denmark; Octapharma AG, Lachen, Switzerland; Organon AG, Pfäffikon/SZ, Switzerland; and Roche Pharma (Schweiz) AG, Reinach, Switzerland.
PII: S1053-0770(09)00211-0
doi:10.1053/j.jvca.2009.05.029
© 2010 Elsevier Inc. All rights reserved.
Volume 24, Issue 2 , Pages 250-256, April 2010
