Background

Aortic stenosis is a heart disease characterized by aortic valve calcification, stiffening the valve and reducing blood flow to the rest of the body. Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive approach for expanding and implanting a prosthetic heart valve within a patient’s native valve, restoring normal aortic valve function. TAVR has a 1% mortality rate following aortic valve replacement, even in medium to high risk elderly patients. When calcified deposits prevent the prosthetic valve from expanding flush against the native valve, some of the blood flow passes around the valve implant, in what is called Paravalvular Leak (PVL). PVL forms fast moving jets that lead to hemolysis (red blood cell destruction), causing fatigue and anemia, which could lead to early mortality. PVL is the leading cause of early mortality seen in TAVR procedures, and 10-25% of patients have moderate PVL, leading to decreased survivability and cardiac function, which can also reduce quality of life. There are currently no solutions that directly, effectively, and safely target and treat PVL. We are developing a polymer filled nitinol mesh plug which is implanted post-TAVR and is inserted into the leakage to block PVL. We are conducting a series of tests with our in-vitro vasculature at Edwards Lifesciences Corporation to ensure that our plug is safe and effective. Our plug or future iterations that improve on our design could potentially resolve paravalvular leak, which has been an issue in TAVR for over 15 years.