Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Post-Procedure Hemodynamic Changes
研究概览
简要总结
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 97 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Severe Aortic Stenosos who underwent BAV
排除标准
- •insufficient echocardiographic parameters before BAV
结局指标
主要结局
Post-Procedure Hemodynamic Changes
时间窗: 24 - 72 h after procedure
dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
All-cause Mortality
时间窗: 1-Year post BAV
次要结局
- Number of patients with stroke(30 days after intervention)
- Number of patients with myocardial infarction(30 days after intervention)
- Number of patients with bleeding complications(30 days after intervention)
- Number of patients with acute kidney injury(30 days after intervention)
- Number of patients with vascular complications(30 days after intervention)
