Research Design The cardiac engineering group has experience with the development, design, conduct, and analysis of clinical and laboratory research. We are able to produce and care for chronically instrumented large animals. We have a chronic model of left ventricular infarction and left ventricular aneurysm and subsequent repair. We have designed and conducted studies for minimally invasive coronary artery bypass surgery, minimally invasive aneurysm repair, and cardiac monitor development. We have extensive experience with flow probes, vascular occluders, multi-dimensional digital sonomicrometry, intra-vascular and endotracheal impedance measurements, volume conductance catheters, cardiopulmonary bypass, finite element analysis, MRI scanning, cardiovascular monitor development and bi-axial tissue mechanics. We also are able to design and conduct small, medium, and large (multi-centered) clinical perioperative cardiovascular research. Data Analysis We have extensive experience with computerized data acquisition, signal processing, and algorithm development. Research and Development Clinical Trials PTSD Smoking Cessation Acadesine Draflazine Mivazerol Warm Cardioplegia EPI-1 EPI-2 Atenolol Clonidine L-Arginine ECOM Hearten AVX Biomedical Engineering Development of Techniques for Minimally Invasive Cardiac Surgery Cardiovascular Monitor Design and Development Quantitative Cardiovascular Physiology Finite Element Analysis Signal Processing and Algorithm Design Device Development ECOM is a minimally invasive cardiac output monitor designed and tested in the Cardiac Engineering lab. It has received FDA 510K approval and is marketed by Conmed DownloadsECOM BrochureAbstract of ECOM device in Anesthesia & Analgesia 2008;106ECOM Transducer Set-Up Guide Literature: "ECOM: Endotracheal Cardiac Output Monitor" Wallace A, Salahieh A, Lawrence A, Spector K, Alonso D. Anesthesiology 2000;92:1-12. This study represents four years of physics and computer science; electrical, mechanical, and biomedical engineering; as well as chronic animal and human testing for the development of a new clinical device for the measurement of cardiac output. The ECOM device has received FDA 510K approval and is now being marketed. ECOM Monitor Images The ECOM device is a minimally invasive cardiac output monitordesigned and tested in the Cardiac Engineering lab. It has received FDA 510K approval and is beginning to be marketed by Conmed. The ECOM development project required physics, mechanical engineering, electrical engineering, manufacturing engineering, software design, time and frequency domain signal processing, artificial intelligence, adaptive filters, fuzzy logic, algorithm design, applied math, chronic animal experimentation, and clinical trial design and execution. We produced more than 100 chronically instrumented pigs that survived for 30 to 90 days. We designed, manufactured, and tested 33 separate device designs. We have designed, built, and tested five separate versions of the measuring electronics each with high speed computerized data acquisition. We have tested numerous different algorithm designs. The design and the animal work has been published in Anesthesiology. We then conducted a 330 patient multicentered clinical trial in patients undergoing cardiac surgery. The system have several patents and is FDA 510K approved for clinical use. AVD system: We have completed a 103-patient clinical trial of the AVD system. Hearten: The Hearten Project was a radiofrequency device designed to allow treatment of left ventricular aneurysms without use of cardiopulmonary bypass. We tested the system in an animal model of heart failure and then assisted in clinical testing in patients undergoing CABG surgery.
