Comparison of the resonance sonorheometry based Quantra® system with rotational thromboelastometry ROTEM® sigma in cardiac surgery - a prospective observational study

Werner Baulig, Samira Akbas, Philipp K Schütt, Wolfgang Keul, Marija Jovic, Pascal Berdat, Stefanie von Felten, Klaus Steigmiller, Michael Thomas Ganter, Oliver M Theusinger, Werner Baulig, Samira Akbas, Philipp K Schütt, Wolfgang Keul, Marija Jovic, Pascal Berdat, Stefanie von Felten, Klaus Steigmiller, Michael Thomas Ganter, Oliver M Theusinger

Abstract

Background: Measures of the sonorheometry based Quantra® viscoelastic hemostatic analyzer (HemoSonics, LCC, Charlottesville, VA, USA) were compared with corresponding results of the ROTEM® sigma device (Instrumentation Laboratory, Bedford, MA, USA).

Methods: In thirty-eight patients scheduled for elective cardiac surgery between December 2018 and October 2019, blood samples were taken after induction of anesthesia (sample 1) and after heparin neutralization (sample 2) and measured on Quantra (QPlus® Cartridge) and ROTEM sigma (ROTEM® sigma complete + hep Cartridge). Clot times and clot stiffness values were recorded. Clot stiffness values of ROTEM amplitudes (A in mm) were converted to shear modulus (G) in hectoPascal (hPa): G (hPa) = (5 x A)/(100-A). Additionally, time-to-results was recorded. Spearman rank test correlation and Bland Altman analysis were performed.

Results: Clot stiffness parameters of the Quantra correlated strongly with corresponding measurements of the ROTEM with r = 0.93 and 0.94 for EXTEM A10 vs CS and r = 0.94 and 0.96 for FIBTEM A10 vs FCS for sample 1 and 2, respectively. Quantra clot time correlated strongly with ROTEM INTEM CT with r = 0.71 for sample 1 and r = 0.75 for sample 2. However, Bland Altman analysis showed no agreement in all compared assays of both methods. The median time to delivery of first and complete results was significantly shorter for Quantra (412 and 658 s) compared to ROTEM sigma (839 and 1290 s).

Conclusions: The Quantra showed a strong correlation with the ROTEM sigma for determining clot times and clot stiffness and the parameters assess similar aspects of clot development. However, these parameters are not directly interchangeable and implicate that separate cut-off values need to be established for users of the Quantra device. Word count: 278.

Trial registration: The study was retrospectively registered with ClinicalTrials.gov (ID: NCT04210830 ) at December 20th 2019.

Keywords: Quantra; ROTEM sigma, cardiac surgery; Resonance Sonorheometry; Viscoelastic testing.

Conflict of interest statement

Werner Baulig (WB), Samira Akbas (SA), Philipp K. Schütt (PKS), Wolfgang Keul (WK), Marija Jovic (MJ), Pascal Berdat (PB), Stefanie von Felten (SvF), Klaus Steigmiller (KS), Michael T. Ganter (MTG) and Oliver M. Theusinger (OMT) declare that they have a financial competing interest (conflict of interest), because the study was supported by HemoSonics LLC (Charlottesville, VA, USA): Quantra equipment and QPlus cartridges were provided by HemoSonics at no charge and one study nurse was partly funded by HemoSonics.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flow chart of the study
Fig. 2
Fig. 2
Operational times. Comparing the three different time intervals in seconds (s) of Quantra and ROTEM sigma: time to cartridge, time needed from blood sampling until insertion of the Cartridge; time to first results, time until first result was available; time to end result, time until all results were available. For both devices, boxplots in dark gray represent times for sample 1 and boxplots in light gray represent times for sample 2
Fig. 3
Fig. 3
Scatterplots. Comparing Quantra and ROTEM sigma measurements as well as between Quantra/ROTEM sigma and platelet count for sample 1 and 2. Black filled circles represent measurements of sample 1, open circles represent measurements of sample 2. Abbreviations: CS, Clot Stiffness of the Quantra in hectopascal (hPa); FCS, Fibrinogen Contribution to Clot Stiffness of the Quantra (hPa); CT, Clot Time in seconds (sec) of the Quantra; CTH, Heparinase Clot Time (sec) of the Quantra; PCS, Platelet Contribution to Clot Stiffness (hPa) calculated by subtracting FCS from CS of the Quantra. EXTEM A10, clot stiffness of the ROTEM after 10 min running time (hPa); FIBTEM A10, fibrinogen contribution to clot stiffness of the ROTEM after 10 min running time (hPa); INTEM CT, Clot time of intrinsic pathway of the ROTEM (sec); HEPTEM CT, Clot time of the intrinsic pathway after neutralization of heparin of the ROTEM (sec); EXTEM A10 – FIBTEM A10, Platelet contribution to clot stiffness of the ROTEM after 10 min running time (hPa); Platelets, platelet count (109/L).
Fig. 4
Fig. 4
Bland Altman analysis. Plots for comparison of corresponding measurements of the Quantra and ROTEM sigma for sample 1 and 2 (EXTEM A10 and CS; FIBTEM A10 and FCS, INTEM CT and CT, HEPTEM CT and CTH; EXTEM A10-FIBTEM A10 and PCS). Data pairs of sample 1 are presented as solid circles and data pairs of sample 2 are presented as open circles. Y-axis represents the bias (difference of the methods) and X-axis the mean of both measurements. The mean bias (mean difference of the methods) is shown as solid line and the 95% limits of agreement is shown by the dashed lines. Abbreviations: CS, Clot Stiffness of the Quantra in hectopascal (hPa); FCS, Fibrinogen Contribution to Clot Stiffness of the Quantra (hPa); CT, Clot Time in seconds (sec) of the Quantra; CTH, Heparinase Clot Time (sec) of the Quantra; PCS, Platelet Contribution to Clot Stiffness (hPa) calculated by subtracting FCS from CS of the Quantra. EXTEM A10, clot stiffness of the ROTEM after 10 min running time (hPa); FIBTEM A10, fibrinogen contribution to clot stiffness of the ROTEM after 10 min running time (hPa); INTEM CT, Clot time of intrinsic pathway of the ROTEM (sec); HEPTEM CT, Clot time of the intrinsic pathway after neutralization of heparin of the ROTEM (sec); EXTEM A10 – FIBTEM A10, Platelet contribution to clot stiffness of the ROTEM after 10 min running time (hPa); Platelets, platelet count (109/L)

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Source: PubMed

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