Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Conditions
Brief summary
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up
Detailed description
Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.
Interventions
PROCEDURESAPIEN 3 Ultra RESILIA Valve
Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve. * Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve. VARC-3- defined technical success 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 permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.
Exclusion criteria
* Age \>80 years * Severe pulmonary disease (FEV1 \<50% predicted or need for home oxygen) * Severe renal dysfunction (eGFR \<30 ml/min/1.73m2) * Frailty (Clinical Frailty Scale \> 4) * Severe coronary disease (SYNTAX score \>32) * Left ventricular ejection fraction ≤30% * Moderate-to-severe mitral regurgitation * Severe tricuspid regurgitation * Pulmonary systolic pressure \>60 mmHg * STS-PROM \>5% * Any disease leading to a life expectancy \<5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transvalvular gradient | 1-3 months | Residual (peak and mean) transvalvular gradient |
| Effective orifice area (EOA) | 1-3 months | EOA evaluated by echocardiography imaging |
| Prosthesis-patient mismatch | 1-3 months | 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). |
| Paravalvular leaks | 1-3 months | Paravalvular leaks evaluated by echocardiography imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transvalvular gradient | 1-, 3-5-, 6-8-, and 9-10-year follow-up. | Residual (maximal and mean) transvalvular gradient |
| Effective orifice area (EOA) | 1-, 3-5-, 6-8-, and 9-10-year follow-up. | EOA evaluated by echocardiography imaging |
| Bioprosthetic valve dysfunction | 1-, 3-5-, 6-8-, and 9-10-year follow-up. | Bioprosthetic valve dysfunction evaluated by VARC3 criteria |
| Paravalvular leaks | 1-, 3-5-, 6-8-, and 9-10-year follow-up. | Paravalvular leaks evaluated by echocardiography imaging |
| Bioprosthetic valve failure | yearly | Incidence rate (per 100 patient-years) of bioprosthetic valve failure |
| Clinical events | 1month and yearly up to 10-year | Individual: mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization |
| Valve thrombosis | 1-3 months and yearly up to 10-year | Number of patients with valve thrombosis |
| Valve endocarditis | 1-3 months and yearly up to 10-year | Number of patients with valve endocarditis |
Countries
Canada
Contacts
CONTACTJosep Rodés-Cabau, MD
CONTACTEmilie Pelletier beaumont, MSc
PRINCIPAL_INVESTIGATORJosep Rodés-Cabau, MD
IUCPQ-UL
STUDY_DIRECTOREmilie Pelletier beaumont, MSc
Fondation IUCPQ
Outcome results
None listed