A Prospective Observational Study on Multiplate^®-, ROTEM^®- and Thrombin Generation Examinations Before and Early After Implantation of a Left Ventricular Assist Device (LVAD)

Background: Heart failure patients are frequently on coagulation-active medications before LVAD implantation and perioperative bleeding is a frequent complication after left ventricular assist device (LVAD) implantation. The role of point-of-care coagulation tests in assessing bleeding risk for LVAD implantation and the early postoperative time course of these tests is not well established.

Methods: We prospectively enrolled 25 patients with terminal heart failure undergoing LVAD implantation. Study related TRAP-, ASPI- and ADP- tests of Multiplate^® platelet aggregometry, ROTEM^® rotational thromboelastometry (INTEM, EXTEM, FIBTEM), thrombin generation assay and conventional laboratory studies were measured at 11 predefined time-points during the first 21 postoperative days. We examined if preoperative TRAP-, ASPI-, ADP- and ROTEM values are correlated with estimated total blood loss (primary outcome parameter) during the first 21 days after LVAD implantation and compared the baseline values of these measurements between patients with a bleeding event to those without. We performed Spearman's correlation and non-parametric tests for paired and non-paired comparisons.

Results: 7 out of 25 (28%) patients experienced a bleeding event of which 4 required surgical revision. Of the preoperatively performed measurements the TRAP test [Spearman's Rho (ρ) = -0.5, p = 0.01], INTEM CFT (ρ = 0.72, p < 0.001), INTEM alpha (-0.7, p < 0.001), EXTEM MCF (ρ = -0.63; p < 0.001), EXTEM alpha (ρ = -0.67; p < 0.001), FIBTEM MCF (ρ = -0.41; p = 0.042), Fibrinogen (Clauss) (ρ = -0.5; p = 0.011), Anti-thrombin activity (ρ = -0.49; p = 0.013) and platelet count (ρ = -0.42; p = 0.034) were significantly correlated to total blood loss. Patients undergoing a surgical bleeding revision had significantly reduced values in TRAP-[31.5 IQR (17.25-43.5U) vs. 69 IQR (52.5-87U); p = 0.004], ASPI-[16.5 IQR (5.5-35.7U) vs. 39 IQR (24.5-62.5U); p = 0.038], ADP-[30 IQR (22-69U) vs. 12.5 IQR (8.7-21.5U); p = 0.01], EXTEM MCF-[63 IQR (57.7-63.7) vs. 67 IQR (65-75.5); p = 0.019] and EXTEM alpha [74 IQR (68.75-74) vs. 79 IQR (78-80.5); p = 0.002] values before LVAD implantation.

Conclusion: Multiplate^® and ROTEM^® measurements before LVAD implantation may identify LVAD candidates with platelet dysfunction and alterations of the primary hemostasis and could guide anesthetists and intensive care practitioners in bleeding risk stratification and in the perioperative clinical management.