Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,
Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
Surgical stented bioprosthetic valve (label size ≤25 mm)
TAVR with the SAPIEN 3 Ultra valve
Stentless or sutureless surgical valves
Trifecta bioprosthesis
Hancock II bioprosthesis
High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT <4 mm or based on the criterion of the heart team responsible for the procedure).
Parallel
Doppler-echocardiography
Procedure/SurgeryThe TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.
Invasive hemodynamic measurements
Procedure/SurgeryThe TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.
Changes in Quality of life (Efficacy)
Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.
Periprocedural complications (Safety)
Periprocedural complications including in-hospital mortality, stroke, annular rupture, coronary obstruction, new-onset left bundle branch block, need for permanent pacemaker implantation and conversion to open heart surgery.
Residual transvalvular gradient
Residual (maximal and mean) transvalvular gradient
Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)
Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).
Heart failure
Evaluated by the New York Heart Association (NYHA) Functional Classification
Exercise capacity
Exercise capacity as evaluated by the six-minute wlak test.
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