In vitro thrombogenicity testing of artificial organs

Area of Science:

• Biomaterials Science
• Medical Devices
• Hematology

Background:

• Thromboembolic complications are a major challenge for blood-contacting artificial organs.
• In vitro thrombogenesis evaluation is complex and not standard for device prototypes.
• Existing methods for assessing thrombotic potential are difficult due to the intricate blood coagulation system.

Purpose of the Study:

• To present an in vitro testing procedure for accelerated examination of thrombogenic potential in blood pumps.
• To evaluate the reliability of this accelerated clotting test for mechanical heart valves.
• To facilitate early-stage, cost-effective assessment of thrombus formation in artificial organs.

Main Methods:

• Development of an accelerated in vitro clotting test procedure.
• Testing the procedure on centrifugal (BioMedicus) and microaxial blood pumps.
• Application of the test to assess mechanical heart valves.

Main Results:

• Demonstrated typical thrombus formation in blood pump components like bearings.
• Provided initial results indicating the reliability of the accelerated clotting test for mechanical heart valves.
• Showcased the potential for early-stage identification of thrombotic hotspots.

Conclusions:

• The accelerated in vitro clotting test is a reliable and cost-effective method for evaluating thrombogenesis in artificial organs.
• This test complements expensive animal testing and allows for precise investigation of device areas prone to thrombus formation.
• Early in vitro evaluation aids in the development of safer blood-contacting medical devices.