Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.
The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.
Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.
Consenting adult patient (≥18 years)
Procedural success of the first TAVI
TAVI device failure of the index THV, irrespective of SVD severity
Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
Life expectancy below 12 months
Patients with largely incomplete data with respect to the aims of the project
Pregnant women at the time of the redo-TAVI
Institut für Pharmakologie und Präventive Medizin
Lead sponsor
Edwards Lifesciences
Collaborator