Proactive Modulation of Strain for Ventricular Recovery

DESCRIPTION (provided by applicant): Congestive heart failure (CHF) is a debilitating condition that afflicts nearly 5 million Americans, and it has an increasing incidence. Despite improvements and enormous research efforts (both federally and commercially), pharmacological treatments are ineffective in many patients such that the demand for donor hearts is far greater than the supply. A primary reason why pharmacological, electrical, and/or stem cell treatments are ineffective in many patients may be that they do not directly modulate mechanics in the wall of the heart and strain has recently been shown to be a fundamental stimulus of myocyte gene expression and growth and remodeling. Basically, aberrant growth and remodeling should be anticipated when the strain pattern or mechanical environment is grossly abnormal as in borderzone myocardium post infarction (i.e., dyskinesia) and in CHF (i.e., hypokinesia). To eliminate dyskinetic and hypokinetic motions, Corlnnova Incorporated is developing a novel direct cardiac compression device that can be collapsed and then implanted in a minimally invasive manner. The overall goal of this fast-track proposal is to test the treatment hypothesis in an Ovine model that elimination of dyskinesia in the borderzone of infarcts will preserve borderzone myocardium and thus reduce infarct expansion and scar formation. Prior to testing this hypothesis in phase II, the following phase I milestones will need to be met: 1) Successful implantation into adult sheep via a minimally invasive procedure, 2) Demonstrate an ability of the device to modulate filling of the right ventricle (RV) to compensate for an expected increase in RV ejection, and 3) Demonstrate an ability of the device to eliminate or significantly reduce dyskinesis in an Ovine infarct model. The engineering work will be performed at Corlnnova by the inventor and another experienced engineer. The animal studies will be conducted at the Texas A&M College of Veterinary Medicine by the PI and colleagues who have performed similar animal tests of early stage, assist devices.