In vitro thrombogenicity testing of artificial organs.
Thromboembolic complications remain as one of the main problems for blood contacting artificial organs such as heart valves, bloodpumps and others. In vitro evaluation of thrombogenesis in prototypes has not previously been part of the standard evaluation of these devices. In comparison to hemolysis testing, evaluation of the thrombogenic potential is more difficult to perform because of the complexity of the blood coagulation system. We present an in vitro testing procedure that allows the accelerated examination of the thrombogenic potential of different types of blood pumps. Additionally, first results are presented that indicate the reliability of the accelerated clotting test for mechanical heart valves. Results for the centrifugal pump BioMedicus and two microaxial pumps have shown typical thrombus formation at locations such as bearings. The results indicate that the accelerated clotting test is an excellent addition to the much more expensive animal testing of artificial organs or assist devices. In vitro testing permits studies of thrombus formation to be performed at an early stage and at low costs and also facilitates a more precise investigation of device areas known to be potential hot spots for thrombus formation.
Paul
R
R
Helmholtz-Institute for Biomedical Engineering, Aachen, Germany.
Marseille
O
O
Hintze
E
E
Huber
L
L
Schima
H
H
Reul
H
H
Rau
G
G
D000818:Animals; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D066298:In Vitro Techniques; D008422:Materials Testing; D013552:Swine; D013927:Thrombosis / Q000209:etiology*