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
Patients with an indication for a redo-TAVI procedure considered eligible by the Local Heart Team and the Case Review Board for a SAPIEN family valve implantation.
Case-only
Prospective
Elective redo transcatheter aortic valve implantation (redo-TAVI)
Procedure/SurgeryElective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)
Efficacy: VARC-3 defined device success at 30 days
Determine VARC-3 defined device success at 30 days * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) (Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored) These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Technical success: Technical success (at exit from procedure room)
Technical success at exit from procedure room defined as: * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding pacemaker) or to a major vascular or access-related, or cardiac structural complication Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented.
Safety: VARC-3 defined early safety at 30 days
Determine VARC-3 defined early safety at 30 days: * Freedom from all-cause mortality * Freedom from all Stroke * Freedom from all VARC type 2-4 bleeding * Freedom from all major vascular, access-related, or cardiac structural complication * Freedom from all acute kidney injury stage III/IV * Freedom from all moderate/severe aortic regurgitation * Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities * Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Procedural Outcomes (30 days)
Procedural outcomes at 30 days, defined as: * Clinical and anatomical predictors of technical success (type of SVD \[stenosis vs. regurgitation\], valve size, implant depth, redo-TAVI balloon dilation, CT and echo-derived variables, etc.) * Rate of central and paravalvular regurgitation * Valve performance, including residual mean gradient * Risk and predictors of coronary obstruction Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented.
Compliance with recommendation
It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary).
Impact of alterations to published recommendations
The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.
Discretionary longer-term follow-up
Discretionary longer-term follow-up in terms of durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis * Clinically symptomatic transcatheter heart valve thrombosis * All-cause mortality, stroke, and cardiovascular hospitalization * Stage II or III structural valve degeneration according to VARC 3 definitions For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria with up to 5 years follow-up, along with individual component of the success, will be presented.
Exploratory objectives
Further, not predefined research questions will be explored based on the dataset such as: * Hemodynamic outcome of the intervention * Applicability of VARC-3 criteria for the redo-TAVI situation * Coronary artery obstruction due to valve implantation * Coronary artery cannulation (in particular in case of risk plane above ostia) * Early and late THV failure predictors (after TAVI and redo-TAVI procedures) * CT findings related to THV failure (SVD)
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Institut für Pharmakologie und Präventive Medizin
Lead sponsor
Edwards Lifesciences
Collaborator
