Evaluation of BAV in Different Hemodynamic Entities of Severe AS

Study Overview
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Brief Summary
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The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.

Detailed Description
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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.

Official Title
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Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: BAV
* Procedure: BAV + TAVR
* Procedure: SAVR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Severe Aortic Stenosos who underwent BAV Exclusion Criteria: insufficient echocardiographic parameters before BAV

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 97 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-Gradient Aortic Stenosis (HG-AS)<br>(Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s) | Procedure: BAV<br>* BAV<br>Procedure: BAV + TAVR<br>* BAV + TAVR<br>Procedure: SAVR<br>* Surgical aortic valve replacement (SAVR)<br>|
| Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)<br>(Pmean <40mmHg, AVA <1cm^2, Vmax <4m/s, EF <50%) | Procedure: BAV<br>* BAV<br>Procedure: BAV + TAVR<br>* BAV + TAVR<br>Procedure: SAVR<br>* Surgical aortic valve replacement (SAVR)<br>|
| Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)<br>Pmean <40mmHg, AVA <1cm^2, Vmax < 4m/s, EF >50%) | Procedure: BAV<br>* BAV<br>Procedure: BAV + TAVR<br>* BAV + TAVR<br>Procedure: SAVR<br>* Surgical aortic valve replacement (SAVR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality |  | 1-Year post BAV | 
| Post-Procedure Hemodynamic Changes | dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR | 24 - 72 h after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with myocardial infarction | Evaluation by using the VARC-2 definition | 30 days after intervention | 
| Number of patients with stroke | Evaluation by using the VARC-2 definition | 30 days after intervention | 
| Number of patients with bleeding complications | Evaluation by using the VARC-2 definition | 30 days after intervention | 
| Number of patients with acute kidney injury | Evaluation by using the VARC-2 definition | 30 days after intervention | 
| Number of patients with vascular complications | Evaluation by using the VARC-2 definition | 30 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon Aortic Valvuloplasty, Severe Aortic Valve Stenosis, Surgical aortic valve replacement (SAVR)