Evaluation of BAV in Different Hemodynamic Entities of Severe AS
- Conditions
- Aortic Valve Stenosis
- Interventions
- Procedure: BAVProcedure: BAV + TAVRProcedure: SAVR
- Registration Number
- NCT04053192
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- Patients with Severe Aortic Stenosos who underwent BAV
- insufficient echocardiographic parameters before BAV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) BAV + TAVR Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%) Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) SAVR Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%) High-Gradient Aortic Stenosis (HG-AS) SAVR (Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s) Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) SAVR (Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%) Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) BAV + TAVR (Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%) Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) BAV (Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%) High-Gradient Aortic Stenosis (HG-AS) BAV (Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s) High-Gradient Aortic Stenosis (HG-AS) BAV + TAVR (Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s) Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) BAV Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%)
- Primary Outcome Measures
Name Time Method Post-Procedure Hemodynamic Changes 24 - 72 h after procedure dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
All-cause Mortality 1-Year post BAV
- Secondary Outcome Measures
Name Time Method Number of patients with acute kidney injury 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 myocardial infarction 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 vascular complications 30 days after intervention Evaluation by using the VARC-2 definition
Trial Locations
- Locations (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
🇩🇪Dusseldorf, Germany