This proposed Phase I effort will evaluate the feasibility of developing an implantable device for telemetric monitoring of blood flow in palliative shunts in children as small as neonates with congenital heart disease. In these patients, these surgically placed shunts represent a lifeline through which all pulmonary circulation flows. Further, an imbalance between pulmonary and systemic blood flow in these patients due to stenosis of the shunt, growth of the patient, or inappropriate systemic or pulmonary vascular resistance can be life-threatening. We believe that serial quantitative measurements of volume shunt flow will lead to improved management of these patients and will result in reduced mortality, morbidity, and cost of care. Currently, the only method available to measure quantitative flow in these shunts is angiography, an invasive procedure that is suitable only in limited circumstances. As part of this effort, we will evaluate the feasibility of implementing the proposed device using an innovative flexible and adaptable architecture that has broad application for telemetering not only blood flow, but blood pressure, ECG, temperature, and cardio thoracic other signals. A highly qualified DSI staff and surgeon will team to investigate this new technology and to establish the potential for Phase II and Phase III success.
Successful completion will build the foundation for implementation of a valuable new tool for chronic clinical assessment of blood flow in human beings. Such a tool is currently unavailable and without precedence. Moreover, sucess in this effort should lead to development of additional telemetry devices for key human health applications.
