An Intracardiac Soft Robotic Device for Augmentation of Blood Ejection from the Failing Right Ventricle.

We introduce an implantable intracardiac soft robotic right ventricular ejection device (RVED) for dynamic approximation of the right ventricular (RV) free wall and the interventricular septum (IVS) in synchrony with the cardiac cycle to augment blood ejection in right heart failure (RHF). The RVED is designed for safe and effective intracardiac operation and consists of an anchoring system deployed across the IVS, an RV free wall anchor, and a pneumatic artificial muscle linear actuator that spans the RV chamber between the two anchors. Using a ventricular simulator and a custom controller, we characterized ventricular volume ejection, linear approximation against different loads and the effect of varying device actuation periods on volume ejection. The RVED was then tested in vivo in adult pigs (n = 5). First, we successfully deployed the device into the beating heart under 3D echocardiography guidance (n = 4). Next, we performed a feasibility study to evaluate the device's ability to augment RV ejection in an experimental model of RHF (n = 1). RVED actuation augmented RV ejection during RHF; while further chronic animal studies will provide details about the efficacy of this support device. These results demonstrate successful design and implementation of the RVED and its deployment into the beating heart. This soft robotic ejection device has potential to serve as a rapidly deployable system for mechanical circulatory assistance in RHF.