Project Grant R43FD007809

BEDSIDE RIGHT-HEART CATHETERIZATION FOR EARLY DIAGNOSIS AND MORE EFFECTIVE MANAGEMENT OF PATIENTS WITH HEART FAILURE AND PRIMARY PULMONARY HYPERTENSION - PROJECT SUMMARY OVER 3 MILLION PEOPLE ARE DIAGNOSED WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF) ANNUALLY IN THE US. DESPITE ITS HIGH INCIDENCE, HFPEF IS OFTEN NOT DIAGNOSED UNTIL LATE IN ITS COURSE BECAUSE THE PRIMARY SYMPTOM, DYSPNEA, IS COMMON TO OTHER CONDITIONS INCLUDING ATRIAL FIBRILLATION, LUNG DISEASE, AND/OR OBESITY. THEREFORE, DOCTORS ORDER MULTIPLE EXAMINATIONS INCLUDING BRAIN NATRIURETIC (BNP) BLOOD TESTS, CHEST RADIOGRAPHY, ELECTROCARDIOGRAM, ECHOCARDIOGRAM, AND RIGHT HEART CATHETERIZATION (RHC) TO DETERMINE UNDERLYING CAUSES OF SYMPTOMS BEFORE STARTING A TREATMENT REGIMEN. THE MOST DEFINITIVE DIAGNOSTIC TOOL FOR HFPEF IS RHC, A PROCEDURE IN WHICH A FLOW-DIRECTED CATHETER IS INSERTED INTO THE INTRAJUGULAR (IJ) OR FEMORAL VEIN, GUIDED TO THE HEART, AND USED TO TAKE RIGHT HEART HEMODYNAMIC MEASUREMENTS. DESPITE THE HIGH DIAGNOSTIC UTILITY OF RHC, IT IS TYPICALLY THE LAST DIAGNOSTIC STEP, AS IT MUST BE PERFORMED IN A CATHETERIZATION LABORATORY (CATH LAB), WHICH IS ASSOCIATED WITH LIMITED AVAILABILITY AND HIGH FACILITY COSTS. THESE FACTORS TYPICALLY RESULT IN A LONG DELAY IN OBTAINING A RHC DIAGNOSTIC PROCEDURE, WHICH CAN DELAY DIAGNOSIS AND TREATMENT. TO ADDRESS THIS NEED, THE PROPOSED CYGNET SYSTEM IS A FLOW-DIRECTED RIGHT HEART MICROCATHETER AND DEPLOYMENT SYSTEM FOR MEASURING PULMONARY CAPILLARY WEDGE PRESSURE (PCWP). IT IS ADAPTED FOR USE OUTSIDE THE CATH LAB FOR POINT-OF-CARE RIGHT HEART HEMODYNAMIC ASSESSMENT BY DEPLOYING A STERILE MICROCATHETER INTO AN ANTECUBITAL FOSSA VEIN THROUGH AN 18- GAUGE IV SHEATH. A CARDIOLOGIST CONTROLS THE SYSTEM TO DRIVE THE MICROCATHETER TOWARDS THE PULMONARY ARTERY. THE CYGNET DESIGN FOR THE ANTECUBITAL ACCESS CONTAINED IN A SMALL STERILE FIELD, ENABLES A MORE ACCESSIBLE RHC THAT CAN BE SAFELY PERFORMED IN ANY NON-CATH LAB SETTING. FANNIN INNOVATION STUDIO IS COLLABORATING WITH DR. REYNOLDS DELGADO OF THE TEXAS HEART INSTITUTE TO DEVELOP THE CYGNET MICROCATHETER SYSTEM. THE CYGNET SYSTEM CAN ENABLE A MORE ACCESSIBLE RHC SUCH THAT A HEMODYNAMIC ASSESSMENT CAN BE PERFORMED EARLY IN THE DIAGNOSTIC PATHWAY, THUS EXPEDITING THE DIAGNOSIS AND MANAGEMENT OF HFPEF. SPECIFIC AIMS: (1) MICROCATHETER AND GUIDE DESIGN AND DEVELOPMENT; (2) PRESSURE SENSOR DESIGN AND DEVELOPMENT; (3) BENCHTOP MODEL AND ACUTE SWINE STUDY VERIFICATION TESTING. COMPLETION OF THIS PHASE I PROJECT WILL DEMONSTRATE FEASIBILITY OF THE CYGNET MICROCATHETER PROTOTYPE FOR PERFORMING RHC IN A NON-CATH LAB SETTING, WHICH WILL PREPARE FOR A PHASE II PROJECT TO DEVELOP THE DEPLOYMENT SYSTEM, REFINE CATHETER CONTROLS SOFTWARE, DEVELOP A TORQUING ASSEMBLY, PERFORM REGULATORY ACTIVITIES, AND PREPARE FOR COMMERCIALIZATION. THE CYGNET MICROCATHETER SYSTEM WILL HAVE A SUBSTANTIAL IMPACT ON THE EARLY HFPEF DIAGNOSIS, CLASSIFICATION, AND MANAGEMENT BY MAKING THIS IMPORTANT DIAGNOSTIC TOOL AVAILABLE AT BEDSIDE.