Long-term in vivo left ventricular assist device study for 284 days with Gyro PI pump

Area of Science:

• Biomedical Engineering
• Cardiovascular Surgery

Background:

• Development of a novel totally implantable centrifugal artificial heart.
• Previous prototype (Gyro PI 601) demonstrated initial feasibility and hemocompatibility.

Purpose of the Study:

• To evaluate the long-term in vivo performance of the metallic Gyro PI 700 series as a left ventricular assist device (LVAD).
• To assess the biocompatibility and functional reliability of the centrifugal pump design.

Main Methods:

• Implantation of the Gyro PI 700 series pump-actuator package in the preperitoneal space of 3 calves, functioning as an LVAD.
• Hemodynamic testing, anti-thrombogenicity screening, and system feasibility studies were conducted.
• Long-term in vivo studies monitored survival, pump function, and physiological parameters.

Main Results:

• One calf survived for 284 days with the LVAD.
• No instances of blood clots within the pump were observed in any of the cases.
• Case 2 experienced early euthanasia due to inlet port obstruction from calf growth, not device failure.
• Physiological abnormalities were absent in all cases during the study periods.

Conclusions:

• The Gyro PI 700 series metallic centrifugal pump is a viable option for long-term implantation as a left ventricular assist device.
• The device exhibits excellent hemocompatibility and functional durability in a large animal model.
• Further development is warranted based on promising long-term performance and biocompatibility results.