REdo Transcatheter Aortic VALVE Implantation for the management of Transcatheter Aortic Valve Failure: REVALVE

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace a faulty (narrowed and/or leaking) aortic heart valve. The replacement aortic valve is delivered to the heart through tubes inserted in a main artery (usually the artery in the groin). Over the past 15 years TAVI has rapidly grown and has taken over from open-heart surgery (surgical aortic valve replacement (SAVR)) to become the most commonly used technique for aortic heart valve replacement. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a ‘tissue’ valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a ‘Redo TAVI’ procedure, implanting a second TAVI valve inside the first failing valve. However, very little is known about the outcomes of Redo TAVI, or about the best way to do such a procedure. The purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure and in order to obtain information about which factors predict those outcomes. The study will also collect data on patients who present with failure of a TAVI valve but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery or by medication. These additional parts of the study will provide an understanding of the proportion of patients presenting with TAVI valve failure who are not suitable for Redo TAVI, and of the outcomes with alternative treatment strategies.