Evaluation of BAV in Different Hemodynamic Entities of Severe AS (BAV)

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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: BAV; Procedure: BAV + TAVR; Procedure: SAVR

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 Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the heart failure program of the University of Duesseldorf

Description

Inclusion Criteria:

• Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria:

• insufficient echocardiographic parameters before BAV

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Tobias Zeus, MD, Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Balloon Aortic Valvuloplasty; Severe Aortic Valve Stenosis; Surgical aortic valve replacement (SAVR)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 19-003 BAV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No