Association Between Changes in Aortic Valve Area and Pulmonary Congestion in Patients Undergoing Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
研究概览
简要总结
This prospective, single-center observational study aims to evaluate the relationship between changes in aortic valve hemodynamics and pulmonary congestion in patients undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis. Pulmonary congestion will be assessed non-invasively using lung ultrasound, with particular emphasis on B-lines, at predefined time points before and after TAVI. Changes in aortic valve area and other echocardiographic parameters will be evaluated in relation to changes in lung ultrasound findings. The primary objective is to determine the association between improvement in aortic valve area following TAVI and changes in pulmonary congestion.
详细描述
Patients with severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI will be prospectively enrolled in this single-center observational cohort study. A total of 52 patients are planned to be included.
Pulmonary congestion will be assessed using standardized lung ultrasound examinations performed at predefined time points during the peri-procedural period. Lung ultrasound assessment will primarily quantify B-lines and will also document relevant findings such as pleural effusion and consolidation. Assessments will be performed before TAVI and repeated after the procedure to characterize temporal changes in pulmonary congestion.
Aortic valve hemodynamics, including aortic valve area, will be assessed by transthoracic echocardiography. The principal analysis will evaluate the relationship between the change in aortic valve area after TAVI and the corresponding change in lung ultrasound findings. In particular, the association between the change in aortic valve area and the change in lung ultrasound findings at 24 hours will be evaluated.
By integrating echocardiographic assessment of valve hemodynamics with serial lung ultrasound, the study aims to characterize the relationship between hemodynamic improvement following TAVI and early changes in pulmonary congestion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of severe symptomatic aortic stenosis
- •Scheduled for elective transfemoral transcatheter aortic valve implantation (TAVI)
- •Availability of preprocedural transthoracic echocardiography
- •Feasibility of lung ultrasound examination
- •Provision of written informed consent
排除标准
- •Active pneumonia
- •Interstitial lung disease or pulmonary fibrosis
- •Massive pleural effusion
- •Acute decompensated heart failure
- •Severe exacerbation of chronic obstructive pulmonary disease (COPD)
- •Conditions precluding adequate thoracic ultrasound examination
- •Severe mitral stenosis
- •Clinically significant severe mitral regurgitation
- •Development of a major complication during the procedure
研究组 & 干预措施
TAVI Cohort
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Lung ultrasound and echocardiographic assessments will be performed at predefined time points to evaluate changes in pulmonary congestion and aortic valve hemodynamics.
干预措施: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
结局指标
主要结局
Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
时间窗: From preprocedural baseline to 24 hours after TAVI
The primary outcome is the correlation between the change in aortic valve area (AVA), measured by transthoracic echocardiography and expressed in cm², and the change in total lung ultrasound (LUS) score after TAVI. Lung ultrasound will be performed at three time points: immediately before anesthesia (T1), immediately after TAVI (T2), and 24 hours after the procedure (T3). Both hemithoraces will be examined in 12 thoracic zones. Each zone will be scored from 0 to 3 according to the degree of loss of aeration: 0 = normal aeration, characterized by A-lines or fewer than 2 B-lines with lung sliding; 1 = mild alveolar-interstitial pattern, characterized by 3 or more well-spaced B-lines with lung sliding; 2 = severe alveolar-interstitial pattern, characterized by multiple crowded and coalescent B-lines occupying \>50% of the scanned intercostal space with lung sliding; and 3 = severe loss of aeration, characterized by a tissue-like pattern or consolidation. The scores from all 12 zones will
次要结局
- Change in B-Line Count After TAVI(From preprocedural baseline to 24 hours after TAVI)
研究者
Metin İlteray Kıkılı
Anesthesiologist
Istanbul University - Cerrahpasa