Thoracic aortic aneurysm (TAA) is a chronic condition that carries the risk of developing life-threatening complications such as aortic dissection (i.e., delamination of the aortic wall) and rupture (i.e., transmural tearing). The primary management objectives for TAA are to identify aortic dilation early and to surgically replace the aorta before it reaches a size that predicts future complications. It is estimated that 3 million patients in the US alone would meet criteria for aortic imaging surveillance based on current guidelines. Improved imaging surveillance strategies are needed to address the health and economic impacts of TAA. However, the reliability of standard aortic diameter measurements from CT images remains low. In this proposal, we will utilize a recently developed image analysis technique, Vascular Deformation Mapping (VDM), to perform semi-automated, three-dimensional assessment of aortic growth in patients with TAA undergoing imaging surveillance. This novel approach utilizes advanced computerized analysis techniques that make full use of the rich, high-resolution, volumetric data generated by modern CT scanners, to generate a more comprehensive and reliable assessment of aortic growth. VDM has the ability to significantly improve the speed and reliability of TAA growth analysis, facilitate the communication of aortic growth assessment between radiologists, care-providers and patients, and generate new biomarkers of disease progression that can be used to improve patient management decisions, and ultimately patient outcomes. In this grant effort, we propose to achieve the goals of this project through our close partnership between University of Michigan (UM) and Imbio, LLC investigators. Thus the Specific Aims of this Fast-Track proposal will develop a commercial VDM software application, including the product testing and data acquisition necessary for a FDA 510(k) application.
( (( Thoracic aortic aneurysm (TAA) is a chronic condition that carries the risk of developing life- threatening complications. It is estimated that 3 million patients in the US alone would meet criteria for aortic imaging surveillance based on current guidelines. Standard methods of monitoring aortic growth are unreliable. Vascular Deformation Mapping (VDM) is a new technology that can reliably track and display aortic growth in 3D. This project will implement VDM as clinical grade software and validate the technique in a large cohort of patients in preparation of an application for FDA approval. !
