Evaluation of BAV in Different Hemodynamic Entities of Severe AS
Study Details
Study Description
Brief Summary
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.
Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.
The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High-Gradient Aortic Stenosis (HG-AS) (Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s) |
Procedure: BAV
BAV
Procedure: BAV + TAVR
BAV + TAVR
Procedure: SAVR
Surgical aortic valve replacement (SAVR)
|
| Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) (Pmean <40mmHg, AVA <1cm^2, Vmax <4m/s, EF <50%) |
Procedure: BAV
BAV
Procedure: BAV + TAVR
BAV + TAVR
Procedure: SAVR
Surgical aortic valve replacement (SAVR)
|
| Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) Pmean <40mmHg, AVA <1cm^2, Vmax < 4m/s, EF >50%) |
Procedure: BAV
BAV
Procedure: BAV + TAVR
BAV + TAVR
Procedure: SAVR
Surgical aortic valve replacement (SAVR)
|
Outcome Measures
Primary Outcome Measures
- All-cause Mortality [1-Year post BAV]
- Post-Procedure Hemodynamic Changes [24 - 72 h after procedure]
dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
Secondary Outcome Measures
- Number of patients with myocardial infarction [30 days after intervention]
Evaluation by using the VARC-2 definition
- Number of patients with stroke [30 days after intervention]
Evaluation by using the VARC-2 definition
- Number of patients with bleeding complications [30 days after intervention]
Evaluation by using the VARC-2 definition
- Number of patients with acute kidney injury [30 days after intervention]
Evaluation by using the VARC-2 definition
- Number of patients with vascular complications [30 days after intervention]
Evaluation by using the VARC-2 definition
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with Severe Aortic Stenosos who underwent BAV
Exclusion Criteria:
- insufficient echocardiographic parameters before BAV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Dusseldorf | Germany | 40225 |
Sponsors and Collaborators
- Heinrich-Heine University, Duesseldorf
Investigators
- Principal Investigator: Tobias Zeus, MD, Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-003 BAV