Aortic Valve Regurgitation, Aortic Valve Stenosis
Conditions
Keywords
TAVI, TAVR, Balloon-Expandable transcatheter heart valve
Brief summary
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3. The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM. Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).
Interventions
DEVICESapien 3 Transcather Aortic Valve Implant
Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.
DEVICEMyval Transcather Aortic Valve Implant
Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.
Sponsors
Ignacio J. Amat Santos
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients diagnosed with aortic stenosis (effective aortic\<1.0 cm2) accepted for a TAVI procedure by the Heart Team. * Implantation of Sapien-3 transfemoral valve or Myval transfemoral prosthesis. * Availability of the variables selected for the matching process: Left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index. * Availability of imaging studies at baseline and at discharge or 30-day follow up.
Exclusion criteria
* Failure to comply with matching criteria. * Failure to properly analyse images in the echo core-lab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean transvalvular gradients | 30 days | Mean Gradients measured in doppler echography are calculated based on the mean velocity of the tracing. The velocities are converted to pressure gradients using the Bernoulli equation. |
| Aortic valve area | 30 days | Echography measured Aortic valve area |
| Aortic valve perivalvular leak | 30 days | Echography measured perivalvular leak |
| Aortic valve central leak | 30 days | Echography measured central leak |
| Aortic valve global leak | 30 days | Echography measured global leak |
Secondary
| Measure | Time frame |
|---|---|
| Vascular complications rate | 30 days |
| Conduction disorder rate | 30 days |
| Cardiovascular mortality rate | 30 days |
| Need for permanent pacemaker rate | 30 days |
| New York Heart Association (NYHA) functional class | 30 days |
| Re-hospitalization rate | 30 days |
| All-cause mortality rate | 30 days |
| Myocardial infarction rate | 30 days |
| Bleeding complications rate | 30 days |
| Acute kidney injury rate | 30 days |
Countries
Italy, Spain
Outcome results
None listed