Development of an implantable small right ventricular assist device

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Devices

Background:

• Right ventricular failure affects 25-30% of patients needing ventricular assist devices.
• Currently, no small implantable right ventricular assist device (RVAD) is clinically available.
• Biventricular assist is crucial for patients with combined ventricular failure.

Purpose of the Study:

• To develop and evaluate a small, atraumatic, and antithrombogenic RVAD.
• To assess the feasibility and performance of the Gyro PI pump as a standalone RVAD and as part of a biventricular assist device (BiVAD) system.

Main Methods:

• Development of the Gyro PI pump, a small centrifugal blood pump with unique features to prevent thrombus formation (sealless design, secondary vanes, eccentric inlet).
• Inflow conduit designed with a biolized, thrombus-resistant tip.
• Biocompatibility and performance testing in calves, including long-term LVAD implantation and short-term RVAD feasibility studies.

Main Results:

• The Gyro PI pump demonstrated thrombus-free function as an LVAD for up to 284 days in calves.
• Short-term RVAD implantation in calves showed satisfactory operation without thromboembolic events.
• The pump maintained adequate blood flow and gas exchange, with no significant abnormalities in explanted organs.

Conclusions:

• The Gyro PI pump is suitable as a single implantable RVAD.
• The device is a feasible component for BiVAD systems, showing excellent pump performance and thrombus resistance.