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Updated: Jun 6, 2025
Technique and Patient Selection Criteria of Right Anterior Mini-Thoracotomy for Minimal Access Aortic Valve Replacement
Published on: March 26, 2018
Comparison of ROTEM® Delta and ROTEM® Sigma transfusion algorithm performance in thoracic aortic surgery: a
Maite M T van Haeren1, Jenni S Breel1, Jimmy Schenk2
1Department of Anaesthesiology, Amsterdam University Medical Centres, AMC, Amsterdam, The Netherlands.
Background:
Thromboelastometry plays a key role in many transfusion algorithms. ROTEM® Sigma is the fully automated successor of ROTEM® Delta. Compatibility with current ROTEM® Delta-based algorithms remains uncertain. This study compares ROTEM® Delta with ROTEM® Sigma in patients undergoing thoracic aortic surgery.
Methods:
Three ROTEM® measurements in duplicate (one Delta and one Sigma) per patient were performed during aortic surgery. The primary outcome was the percentage of patients who would have received a different haemostatic intervention after protamine reversal based on the institutional ROTEM®-guided transfusion algorithm ('deviation'). A 10% deviation was deemed acceptable. Secondary outcomes were differences in numerical values assessed by Passing-Bablok regressions, Bland-Altman plots, and correlations with conventional coagulation tests.
Results:
Of 111 patients, 102 had matched post-protamine ROTEM® measurements. There were 43 algorithm deviations. Most deviations (29) were attributable to conflicting advice on CT EXTEM-based plasma or prothrombin complex concentrate (PCC) administration; in 25 patients, Delta results advised the administration of plasma or PCC, whereas Sigma did not, and vice versa in four patients. Deviations on additional protamine, fibrinogen concentrate, or platelet administration were acceptable. All numerical ROTEM® variables examined passed the criteria for equivalence, except for A10 FIBTEM at baseline and A10 EXTEM in heparinised and post-protamine samples, which would not have led to clinical consequences. Correlations with conventional coagulation tests were similar or better for Sigma compared with Delta.
Conclusions:
ROTEM® Sigma can be used with existing ROTEM-guided transfusion algorithms in cardiothoracic surgery except for the advice for administration of plasma or PCC.
Clinical Trial Registration:
Netherlands trial register NL8273.
