Evaluation of BAV in Different Hemodynamic Entities of Severe AS

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: BAV + TAVR; Procedure: BAV; Procedure: SAVR

Study type: Observational

Funder types: Other

Identifiers

NCT04053192

19-003 BAV

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 50 to 97 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Severe Aortic Stenosos who underwent BAV

Exclusion criteria

• insufficient echocardiographic parameters before BAV

Trial design

166 participants in 3 patient groups

High-Gradient Aortic Stenosis (HG-AS)

Description:

(Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s)

Treatment:

Procedure: SAVR

Procedure: BAV + TAVR

Procedure: BAV

Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)

Description:

(Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%)

Treatment:

Procedure: SAVR

Procedure: BAV + TAVR

Procedure: BAV

Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)

Description:

Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%)

Treatment:

Procedure: SAVR

Procedure: BAV + TAVR

Procedure: BAV