In Vitro Hemocompatibility of the BiVACOR Total Artificial Heart in Continuous and Pulsatile Flow

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Devices

Background:

• Heart transplantation is limited by donor organ availability.
• Mechanical circulatory support devices are crucial alternatives for advanced heart failure.
• BiVACOR's total artificial heart (TAH) offers full heart replacement using a novel centrifugal rotor design.

Purpose of the Study:

• To assess the in vitro hemocompatibility of BiVACOR's TAH.
• To compare hemocompatibility in continuous flow (CF) versus pulsatile flow (PF) modes.
• To evaluate blood compatibility against a clinically approved reference pump.

Main Methods:

• Cattle blood was circulated in an in vitro loop at 5 L/min and 100 mmHg for 6 hours.
• The TAH was tested in both CF and PF modes, with comparisons to the CentriMag reference pump.
• Blood analysis included hematology, plasma free-hemoglobin, and von Willebrand factor (vWF) multimers.

Main Results:

• Normalized hemolysis indexes were comparable across TAH (CF and PF) and the reference pump.
• Basic hematology and vWF multimers showed linear changes but no significant variation between flow regimes or devices.
• Hemolysis levels were low, indicating good hemocompatibility for the TAH.

Conclusions:

• BiVACOR's TAH demonstrates in vitro blood compatibility comparable to a clinically approved reference pump.
• The device effectively supports systemic and pulmonary circulation.
• Hemocompatibility was not negatively impacted by pulsatile flow, suggesting suitability for future applications.