Cardiac valve replacement using prosthetic valves is indicated when progression of degenerative disease or bacterial infection of the native valve results in valvular dysfunction, thereby impacting on cardiac output. Bacterial infection is a major complication associated with implantation of these prosthetic valves. Infections are localized to the prosthesis/tissue interface at the sewing cuff leading to cuff and annular abscess formation. The goal of this phase I project is to develop an infection-resistant knitted Dacron cuff material in vitro with optimum antimicrobial properties via thermofixation (pad/heat) dyeing of the antibiotic ciprofloxacin (Cipro). Our hypothesis is application of quinolone antibiotics to Dacron biomaterials via dyeing technology can be optimized, resulting in slow, sustained antibiotic release without the use of exogenous binders.
The specific aims of this proposal are to: optimize Cipro dyeing conditions to knitted Dacron, characterize the physical properties of Cipro-dyed Dacron, determine antibiotic release over time via spectrophotometry, examine in vitro antimicrobial properties and assess antibiotic release pharmacokinetics under simulated arterial flow conditions. Phase II of this project will evaluate this novel technology in an in vivo prosthetic valve model. This technology, if successful, will be become the standard of care in the treatment of all forms of prosthetic endocarditis.
Current projections indicate that a greater number of cardiac prosthetic mechanical valves will be implanted over the next ten years, with estimates in excess of 50,000 valves per year. This technology, if applied to only mechanical heart valves, could have an annual market in excess of $25-75 million. This technology can also be applied to vascular grafts, carotid patch material, wound dressings and suture material. Additionally, this technology may have commercial application in areas such as veterinary medicine, apparel or domestic items.
