Couette shearing device for the investigation of shear-induced damage of the primary hemostasis by left ventricular assist devices.

INTRODUCTION:: Continuous-flow left ventricular assist devices have evolved from short-time therapy into permanent or so-called destination therapy. One complication in long-term usage is bleeding, which is presumably attributed to shear-induced interference of left ventricular assist devices with the coagulation system.

METHODS:: The influence of dynamic shear stresses on primary hemostasis by single or multiple passes through left ventricular assist devices was investigated. A novel Couette-type shearing device, especially fitted to simulate left ventricular assist devices with highly dynamic and repetitive stresses, was developed. To evaluate the clotting ability of the blood and thus the bleeding tendency, the closure time of the platelet function analyzer (PFA-100® , Dade Behring, Marburg, Germany) was used. The relationship of the PFA-100 closure time was fitted to measurement points with shear stress and exposure time as parameters.

RESULTS:: 76 samples of human blood collected from four different healthy donors in sodium-citrate anticoagulant solution were tested, including 20 control samples. A damage model according to the power law approach could be developed. A linear correlation of shear stress and exposure time to the PFA-100 closure time could be determined. In addition, a model was developed to calculate the increase in the PFA closure time on the basis of shear stress over time curves.

DISCUSSION:: With the shearing device, half-sine-wave-shaped shear stress patterns relevant to rotary blood pumps can be achieved with very good repeatability. The proposed damage model could be used to compare and optimize left ventricular assist devices under development. The tests showed a significant decrease in coagulability after only a few repetitions.