Von Willebrand Factor to Guide Management of Paravalvular Regurgitation during TAVI in Real-Life Practice - REVITALISANTE TRIAL

Transcatheter Aortic Valve Implantation (TAVI) is a less invasive technic to achieve the replacement of diseased aortic valve compared to standard surgery (open heart surgery). Indeed, this procedure does not need extracorporeal circulation or opening the chest and the heart and is increasingly performed under conscious sedation instead of general anesthesia. TAVI procedure my however be complicated by the presence of paravalvular regurgitation or leakage (PVR) due to an incomplete sealing around the implanted prosthetic valve, a serious complication that is associated with increased risk of death following TAVI. This complication may be identified using different imaging modalities (echo, angiography...) and then corrected. However, these imaging modalities are not enough accurate to quantitate severity of PVR. Consequently, PVR severity may be underestimated and miss-corrected (with a poor prognosis) or overestimated leading to the use of futile and dangerous corrective procedure (risk of aorta rupture, stroke). The objective of this study is to use a simple blood biomarker of Von Willebrand factor known as CT-ADP that have been recently shown to be extremely affected by the severity of leakage and then can be used to identify severe leakage and to select patients who will really need additional corrective procedures. Yet, the utility of this biomarker in real life need further validation. This study aims particularly to investigate whether the monitoring of CT-ADP during the procedure changes decision making in the management of the leakage and if its measurement at the end of the procedure improves prediction of patient prognosis following TAVI. The validation of this tool will be helpful to accurately detect the main complication of the procedure (leakage), select patients who will need additional corrective procedures following TAVI, and to avoid a considerable number of unjustified diagnostic tests and futile, dangerous, and expensive therapeutic procedures.