Heart failure (HF) is a condition in which the heart cannot pump enough blood to meet the body's needs. HF can affect the right or left side of the heart, or it can affect both sides of the heart. Congenital heart disease (CHD) is one the leading causes of HF in children and young adults. According to the Centers for Disease Control and Prevention, CHDs affect nearly 1% (or about 40,000) of births per year among general population in the United States. However, studies of birth defects among infants conceived in military families, in particular Gulf War Veterans, suggested higher prevalence of CHD. These factors contribute to a significant clinical and growing problem for dependents of military personnel and Veterans.

For end-stage HF, the most effective treatment is heart, lung or heart-lung transplantation. Mechanical circulatory support (MCS) devices have become accepted as a therapeutic solution, when a donor organ is not available. Fundamentally, however, currently available MCS devices represent pumps that move blood through an artificial surface, bypassing or accelerating flow within the failed left and/or right heart, which requires permanent use of anticoagulation (blood thinning medications). This is associated with bleeding/thromboembolic complications. We propose an implantable intracardiac (positioned inside the heart) device that is tailored specifically to support blood ejection from the left of right ventricle of the heart and requires much less anticoagulation. The device is based on soft robotic actuation and delivers a dynamic pulsatile force timed to the heart contraction, which effectively augments pumping function of a failed heart. The proposed device is intended for rapid implantation via minimal incision of the chest into the beating heart, which reduces invasiveness and cost of the procedure. The proposed device will be designed, prototyped, and then tested on a bench-top model, a tissue model of the heart and, finally, on large animal models of the right heart failure and the left heart failure.

Following the Discovery project, a device fitting study and a computer modeling study using clinical data will be needed. In addition, the approach will be evaluated in a long-term safety animal study. Further, use of the proposed device can be scaled beyond therapy of end-stage HF due to CHD. The device may be used in adult patients with HF after open-heart surgery, due to heart injury and myocardial infarction. In addition, this concept may be potentially used in treatment of combat zone casualties. Development of such a novel device and ultimately bringing this technology to clinic will provide better alternative to current therapies, while avoiding severe complications.