A Proof-of-Concept Demonstration for a Novel Soft Ventricular Assist Device

Abstract

Patients treated by current ventricular assist devices (VADs) suffer from various post implantation complications including gastrointestinal bleeding and arteriovenous malformation. These issues are related to intrinsically mismatch of generated flow by VADs and the physiological flow. In addition, the common primary drawback of available VADs is excessive surgical dissection during implantation, which limits these devices to less morbid patients. We investigated an alternative soft VAD (SVAD) system that generates physiological flow, and designed to be implanted using minimally invasive surgery by leveraging soft materials. A soft VAD (which is an application of intraventricular balloon pump) is developed by utilizing a polyurethane balloon, which generates pulsatile flow by displacing volume within the left ventricle during its inflation and deflation phases. Our results show that the SVAD system generates an average ejection fraction of 50.18 ± 1.52% (n = 6 ± SD) in explanted porcine hearts. Since the SVAD is implanted via the apex of the heart, only a minithoracotomy should be required for implantation. Our results suggest that the SVAD system has the performance characteristics that could potentially make it useful for patients in acute and/or chronic heart failure, thus serving as a bridge-to-transplantation or bridge-to-recovery.