The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.
Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency);
Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of < 8%);
Age > 18 and < 75 years;
Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team
Multiple valvular disease requiring surgical intervention;
High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;
Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score > 32) and Heart Team assessment that optimal revascularization cannot be performed;
Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);
Parallel
Transfemoral transcatheter valve-in-valve implantation
Procedure/SurgeryThe intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.
Surgical redo aortic valve replacement
Procedure/SurgerySurgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.
based on VARC-3
Each of the individual components of the primary composite endpoint
based on VARC-3
Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia
VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no)
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)
BARC-based bleeding complications (qualitative ordinal variable; 3b-5)
New York Heart Association classification III or IV
New York Heart Association classification (qualitative variable; III or IV)
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Heart Center Leipzig - University Hospital
Lead sponsor
University of Leipzig
Collaborator
Helios Health Institute GmbH
Collaborator
