In vitro thrombogenic evaluation of centrifugal pumps

One of the major considerations in the development of a circulatory assist device is its antithrombogenecity. Although the precise evaluation should be accomplished by in vivo tests, these tests are costly and require a relatively long period. In this study, we established a simple in vitro test and assessed feasibility using 2 clinically available centrifugal pumps, the BioMedicus and Nikkiso pumps. Two identical mock loops were fabricated, and fresh heparinized human blood (activated clotting time of 150-250 s) was circulated at 5 L/min against a total pressure head of 100 mm Hg. After 3 h of pumping, only the BioMedicus pumps had thrombi while the Nikkiso pumps were thrombus free. Following 6 h of pumping, thrombi were observed in both pumps. Clotting patterns and locations were reproducible in each pump and similar to the results of clinical or ex vivo studies. This simple in vitro test was considered to be feasible as a pilot study, particularly to predict thrombogenic sites.