Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Summary
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,
Description
This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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…
Interventions
- ProcedureDoppler-echocardiography
The 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.
- ProcedureInvasive hemodynamic measurements
The 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.
Locations (7)
- University of CaliforniaSan Francisco, California
- South Broward Hospital Disctrict D/B/A Memorial Healthcare SystemHollywood, Florida
- William Beaumont HospitalRoyal Oak, Michigan
- Mayo ClinicRochester, Minnesota
- St-Joseph's Health INCSyracuse, New York
- The Christ Hospital Health NetworkCincinnati, Ohio