Harvi Cardiovascular Modeling Accurately Predicts Hemodynamic Improvements Produced by a New Direct Cardiac...

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Device Development

Background:

• Mechanical circulatory support (MCS) faces challenges with blood-contact complications.
• Direct cardiac compression (DCC) offers a non-blood-contacting alternative.
• CorInnova is developing a DCC device for safer MCS.

Purpose of the Study:

• To validate a simulation platform (Harvi) for predicting clinical outcomes of the CorInnova DCC device.
• To guide patient selection for upcoming clinical trials.
• To assess the device's hemodynamic effects in heart failure.

Main Methods:

• Developed and validated the Harvi simulation platform using preclinical in vivo ovine data (n=4, 28 hemodynamic samples).
• Simulated hemodynamic outcomes including cardiac output, blood pressure, and pressures within the heart and pulmonary artery.
• Compared simulation predictions against experimental animal data.

Main Results:

• The Harvi simulation demonstrated high accuracy, with no significant differences (p > 0.050) compared to animal data for key hemodynamic parameters.
• Validated parameters included cardiac output, systemic arterial blood pressure, mean pulmonary artery pressure, central venous pressure, and left ventricular pressure.
• The simulation successfully predicted hemodynamic outcomes not captured in animal studies.

Conclusions:

• The Harvi simulation platform is a validated tool for predicting the hemodynamic effects of the CorInnova DCC device.
• This simulation capability is crucial for supporting product development and preparing for clinical trials.
• The CorInnova DCC device shows promise as a safer MCS alternative for heart failure patients.