Heart attacks (i.e. myocardial infarction or MI) occur in more than 1.2 million patients annually. Advances in pharmacological therapy have dramatically improved survival following the initial MI. Consequently, the number of patients with previous MI continues to increase, and as a result, put in jeopardy millions of patients for development of heart failure. In these patients with a previous MI, despite optimal standard-of-care, a scar can form in the portion of the heart muscle (myocardium) that was injured from the MI. Formation of a myocardial scar following MI is associated with a malignant remodeling process with respect to changes in the structure and shape of the MI region (infarct expansion). This adverse remodeling after MI can lead to increased morbidity and mortality in these patients. Unfortunately, there are no current pharmacological / therapeutic means to specifically target the myocardial scar as a means to halt and/or reverse the adverse remodeling post-MI. The technology to be advanced in this application directly addresses this unmet medical need by expanding previously performed proof-of-concept studies whereby localized high frequency stimulation (LHFS) beneficially altered the course of post-MI myocardial remodeling. This fast track technology transfer application is intended to move forward the LHFS technology by finalizing the prototype of this technology, and then optimizing efficacy of this technology in a preclinical animal model of MI. These studies will be undertaken in two phases: Phase I: optimize electrical stimulation parameters for LHFS using a validated in vitro test bed, and Phase II: in vivo testing of a selected LHFS device in a preclinical large animal model of MI. The outcomes from these combined Phase I / Phase II projects will move the LHFS technology to establish readiness for clinical feasibility studies.
The number of patients with an existing heart attack is anticipated to exceed 20 million by next year. Unfortunately, there is no current pharmacological / therapeutic means to treat the area of the heart muscle that is affected by the heart attack. This project will optimize parameters of a newly developed electrical technique to target the heart attack region and establish readiness of this novel technique for implementation in patients.
