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Abstract
Kelly Robinson

Fellow – Kelly Robinson

Mentor – Bradley Weeks, Fred Clubb

Project – Use of Integrative Pathology Techniques in Evaluation of an Implantable Left Atrial Pressure Monitoring Sensor (Animal and Human Studies)

Translational research is defined as the application of basic scientific discoveries into clinically useful results.  This process involves animal testing followed by human testing. In studies conducted by St. Jude Medical (Sylmar, California), an implantable sensor lead placed across the inter-atrial septum is being used to monitor left atrial pressure. Increased left atrial pressure is an early indicator of left-sided backward congestive heart failure, often occurring before perceptible clinical signs. By monitoring pressure variations, clinicians can rapidly and accurately modify drug therapy to reduce excess fluid volume and avoid episodes of pulmonary edema. An important component of these studies is the pathology evaluation. One of the challenges for pathologists, study directors, bioengineers and principal investigators is maximizing and validating information from an animal study, as well as from limited human studies. Some microscopic techniques available to examine host/device interactions are mutually exclusive and do not allow for overlap. However, we have developed a system (Integrative Pathology Techniques, IPT) that combines what were mutually exclusive techniques. IPT has proven to be an excellent means of maximizing tissue evaluation for both human and animal studies. Results have shown the validity of animal studies in predicting safety for human implantations.