Modulating Cardiac Hemodynamics Using Tunable Soft Robotic Sleeves in a Porcine Model of HFpEF Physiology for Device Testing Applications

Heart failure with preserved ejection fraction (HFpEF) is a major challenge in cardiovascular medicine, accounting for approximate to 50% of all cases of heart failure. Despite the ongoing efforts, no medical device has yet received FDA approval. This is largely due to the lack of an in vivo model of the HFpEF hemodynamics, resulting in the inability to evaluate device effectiveness in vivo prior to clinical trials. Here, the development of a highly tunable porcine model of HFpEF hemodynamics is described using implantable soft robotic sleeves, where controlled actuation of a left ventricular and an aortic sleeve can recapitulate changes in ventricular compliance and afterload associated with a broad spectrum of HFpEF hemodynamic phenotypes. The feasibility of the proposed model in preclinical testing is demonstrated by evaluating the hemodynamic response of the model post-implantation of an interatrial shunt device, which is found to be consistent with findings from in silico studies and clinical trials. This work overcomes limitations of prior HFpEF models, such as low hemodynamic accuracy, high costs, and long development phases. The versatile and adjustable platform introduced can transform HFpEF device development, aiming to enhance the lives of the 32 million people affected globally. This work presents a tunable porcine model of the hemodynamics of heart failure with preserved ejection fraction (HFpEF) using implantable soft robotic left ventricular and aortic sleeves that modulate cardiac compliance and afterload. This research addresses the lack of a disease model for high-fidelity preclinical evaluation of device-based solutions for HFpEF.image