RESUMO
OBJECTIVES: Cell saver reinfusate ideally should contain low, clinically insignificant heparin concentrations. The American Association of Blood Banks has defined the clinically insignificant threshold as 0.5 IU/mL. Furthermore, there is uncertainty about the meaning of cell saver "heparin elimination rates." These concerns prompted the authors' independent investigation of reinfusate heparin concentrations of devices used in their institution. It was hypothesized that cell saver reinfusates contain clinically insignificant heparin concentrations. DESIGN: Two prospective, pragmatic, sequential, observational, single-center studies. SETTING: University teaching hospital. PARTICIPANTS: A total of 32 and 31 patients for on-pump cardiac surgery were enrolled in the Sorin (Dideco) Electa and Sorin Xtra studies, respectively. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Postcardiac surgery reinfusate heparin concentrations were measured using a modified anti-Xa chromogenic assay. Heparin concentrations above 0.5 IU/mL were present in 56% (95% confidence interval, 35% to 68%) of Sorin Xtra reinfusates. Heparin concentrations in the Sorin (Dideco) Electa reinfusates were lower than recommended in 29 of 32 reinfusates. Only 3 of 32 Sorin (Dideco) Electa reinfusates (9.4%; 95% confidence interval 3.2% to 24%) exhibited heparin concentrations exceeding 0.5 IU/mL. CONCLUSIONS: Sorin (Dideco) Electa reinfusates contained heparin concentrations below the American Association of Blood Banks recommended threshold in 90.6% of cases, while Sorin Xtra reinfusate heparin concentrations exceeded this recommendation in 56% of cases. Measurement of cell saver reinfusate heparin concentrations necessitates the use of a modified chromogenic assay. Studies explicitly should confirm that such a modification was indeed used. Periodic quality control of reinfusate composition is recommended.