Aortic Stenosis, Mitral Regurgitation, Transcatheter Aortic Valve Implantation (TAVI), Tricuspid Regurgitation
Conditions
Keywords
Aortic stenosis, Transcatheter aortic valve implantation (TAVI), Multivalvular heart disease, Mitral regurgitation, Tricuspid regurgitation, Structural heart disease, Valve disease management algorithm
Brief summary
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk. Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat. In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures. This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve. The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up. The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life. The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Age \>18 years. * Patients with severe AS undergoing transarterial TAVI. * Concomitant significant MR and/or TR (≥3+).
Exclusion criteria
* Life expectancy \<1 year due to noncardiac conditions. * Any prior mitral or tricuspid valve surgery. * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. * Active endocarditis. * Subjects in whom transesophageal echocardiography is contraindicated or high risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality or re-hospitalization for worsening heart failure | Minimum of 1 year | Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality or re-hospitalization for worsening heart failure | 1 Year | Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up. |
| All-cause mortality | 1 year | All-cause mortality at 1 year |
| Heart failure re-hospitalization | 1 year | Heart failure re-hospitalization at 1 year |
| Cardiovascular mortality | 1 year | Cardiovascular mortality at 1 year |
| All-cause mortality or heart failure re-hospitalization | 1 year | Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort. |
| MR severity | 1 year | MR severity at 1 year |
| TR severity | 1 year | TR severity at 1 year |
| LVEF | 1 year | LVEF at 1 year |
Contacts
IUCPQ-UL