Excerpt of FDA Activity Report to US Congress

Critical Path:  Biomarker Development for Evaluation of Device Interventions After Heart Failure

Heart failure (HF) is estimated to cost $37.2 billion in 2009. It is the one form of heart disease on the rise in the U.S. with a 171% increase between 1979 and 2006. Between 1993 and 2003 there was a 20% increase in deaths due to heart failure, even as the overall death rate declined by 2%. The project is developing an evaluation tool to assess HF recovery in clinical trials. The marker being developed takes advantage of the magneto-hydrodynamic (MHD) signal that is seen on the electrocardiogram (ECG) when a patient is in a MRI magnet. The components of the signal relate to blood flow magnitude, direction and location. The information contained in this signal will supplement present-day non-invasive blood flow measurements, such as ultrasound, for the assessment of heart failure. During the first year of the study, FDA collaborated with IT’IS Foundation to develop a MHD solver. The MHD solver calculates the surface signals on anatomical models in a static magnetic field caused by the blood flow in the thorax. This model predicts the MHD signal (specific to blood flow) at any location on the body. These signals are being experimentally measured and verified using ECG leads. Manipulations of blood-flow parameters are determining the limits of resolution and solutions for different flow rates, velocities, and anatomical locations and the minimum static magnetic field required for a useful MHD signal. We have shown the necessity of a MRI magnet to detect MHD signals. Four of the six milestones (related to MHD simulation) have been met, and the completion date is set in 2010. The deliverables include a computational MHD simulation model (completed), MHD signal analysis to provide refinement of sensitivity and specificity of each signal component due to blood flow variation (completed), and an optimized 12-lead MHD signal detection method (underway). The project's findings shall be applied to improve outcome measures for clinical trials related to heart failure treatments.