Preclinical Efficacy of an Epicardial Heart Assist Device

Abstract

Of the millions of Americans with heart failure, a significant portion are end-stage and experience symptoms even at rest. Moreover, around half of people with heart failure die within 5 years of diagnosis. The ideal treatment option for these patients is a heart transplant. However, fewer than 3000 donor hearts are available for transplant in North America each year. Given the significant disparity in number of donor hearts and end-stage failure patients, there is great clinical need for heart assist technology that supports heart function, and for improved approaches that lead to heart recovery.

The current leading device therapy for advanced heart failure patients is a Ventricular Assist Device (VAD). While these devices have been clinically available in the United States since 2003, they are associated with severe complications – including a high risk for stroke and gastrointestinal bleeding. As an alternative to mechanical blood pumps, direct cardiac compression (DCC) devices have been developed for heart assist. The investigation described herein includes the development, simulation, and preclinical testing of a novel DCC device – coined the EpicHeart™ (Epicardial Heart Assist Device).

First, engineering design improvements were required to allow for synchronization between device activation and the native contraction of the heart. The methods to accomplish this goal are described with results of in vivo testing. Then, the hemodynamic effects of the device in an acute heart failure model were investigated. Finally, the results of the in vivo testing of the device were applied for technical specification verification of a simulation platform developed to model the clinical effects of the EpicHeart™ Device.

The outcomes of this study have yielded an improved preclinical medical device that will proceed with future investigations over longer study durations as well as other heart failure etiologies – while continuing to explore potential for heart recovery. Additionally, the pilot study of simulating this technology is unique and has provided support for future validation of a clinical simulation tool. This simulation is anticipated for use in a clinical environment to predict patient outcomes of the EpicHeart™ Device for treatment of heart disease.