Design and Validation of a Commercially Viable IVUS/IVPA Imaging System

DESCRIPTION provided by applicant Coronary heart disease is responsible for greater than one in six deaths and related healthcare costs well in excess of one hundred billion dollars within the United States alone Approximately of these deaths result from rupture of plaques considered andquot insignificantandquot on an angiographic evaluation the current gold standard diagnostic technique Exacerbating the challenges of diagnosing high risk atherosclerotic plaques nearly one third of patients with acute coronary syndrome who undergo revascularization procedures are rehospitalized within months Therefore there is a definite and urgent clinical need for an interventional imaging technique that can identify and characterize rupture prone atherosclerotic plaques enabling improved diagnosis and treatment guidance during coronary artery interventions OBJECTIVE The overall goal of our research program is to transfer a new imaging technology intravascular photoacoustic IVPA imaging from its current proof of concept laboratory setting to the development of a commercially viable clinical imaging modality which is capable of visualizing both morphological and compositional properties of atherosclerotic plaques The underlying hypothesis of this project is that IVPA imaging provides a safe and economically feasible means of improving patient outcomes without significant change to current interventional protocols PRELIMINARY DATA The technical feasibility of imaging lipid rich regions of atherosclerotic plaques a hallmark indicato acute coronary event risk has been demonstrated through the combination of intravascular ultrasound IVUS and IVPA imaging using ex vivo human artery samples and in vivo in animal models using prohibitively expensive and low frame rate prototype systems However critical commercial and clinical uncertainties which may drastically impact the clinical viability of IVPA imaging remain unaddressed SPECIFIC AIMS This project entails the design and assessment of two previously unaddressed risks to the translation of IVPA imaging into the cardiac cath lab In Specific Aim we will design and build a prototype laser system with an output wavelength and technical specifications suitable for real time in vivo IVPA imaging of lipid at an economically feasible price point In Specific Aim we will utilize the developed real time laser prototype to characterize IVPA laser tissue interactions and safety Measurement of potential bulk or local heating will be complimented by in vitro ex vivo and in vivo evaluation of photothermal effects within the blood and vascular wall Together these studies will address fundamental and previously unassessed risks of IVPA imaging thereby evaluating its commercial viability as a clinical imaging modality for interventional cardiologists PUBLIC HEALTH RELEVANCE Coronary artery disease is the leading cause of death in the developed world Our overall goal is to transfer a minimally invasive imaging technology combined intravascular ultrasound and photoacoustic IVUS IVPA imaging into a commercially viable clinical imaging modality capable of assessing the presence and vulnerability of atherosclerotic plaques In the current project we will address two previously unassessed risks potentially effecting clinical feasibility of IVPA imaging the design and validation of an economically viable laser for real time in vivo IVPA imaging and the characterization of potential IVPA induced laser tissue interactions