Outcomes of Transcatheter Closure of Secundum Atrial Septal Defect Guided by Three-dimensional Transesophageal Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure
研究概览
简要总结
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance during percutaneous transcatheter closure. Proper device size selection is important for success of ASD device closure. 3D-TEE can assess the ASD morphology, maximal diameter, area and determine the device size without balloon sizing during percutaneous closure.There are some adverse outcomes reported in previous studies following transcatheter secundum ASD closure as: residual shunt, new onset atrial fibrillation(AF) and mitral regurgitation(MR)deterioration . These adverse outcomes are responsible for morbidity and mortality following transcatheter ASD closure, so it is essential to study risk factors associated with these adverse outcomes in order to minimize their incidence.The investigators will study the role of 3D-TEE in proper device size selection, also the percentage and predictors of adverse outcomes after device closure guided by 3D-TEE.
详细描述
The investigators will include 80 patients in a prospective cohort study .
For all patients the following study tools will be done:
- Written consent.
- Detailed history including Age, sex, symptoms (NYHA class).
- Clinical examination.
- Electrocardiogram (ECG) (to detect baseline rhythm).
- Two-dimensional transthoracic echocardiography (2D TTE):
All patients will undergo 2D TTE before device closure to assess:
- ASD (type, size, shunt direction).
- Pulsed Doppler quantification of the pulmonary (Qp) to systemic (Qs) blood flow ratio
- Right ventricle (RV) enlargement: RV linear dimensions are best measured from a RV-focused apical four-chamber view.
- RV systolic function by :
- Tricuspid annular plane systolic excursion(TAPSE) ,
- 2D RV fractional area change (FAC)= 100 X [(end-diastolic area - end-systolic area)/end-diastolic area)].
- Pulmonary artery systolic pressure (PASP).
- Grade of MR by Color Doppler: The color Doppler jet area of MR and left atrial area at the time of midsystole will be measured by the area trace method in the apical 4-chamber view, and the ratio of MR jet area to left atrial area will be calculated. The grade of MR will be determined by the ratio, where 0% to 10%>> none/trivial, 10% to 20% >> mild, 20% to 40% >>moderate, and >40% >> severe.
- Left ventricle (LV) systolic function by m-mode,
- LV diastolic function :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suitable indication for ASD closure according to recent guidelines :
- •Impaired functional capacity.
- •Right atrial and/or RV enlargement.
- •Left-to-right shunt with [Qp: Qs] ≥1.5:
- •Paradoxical embolism.
- •Patients with isolated secundum ASD with sufficient rims suitable for device closure.
排除标准
- •Small ASD with Qp/Qs <1.5:1 or no signs of RV volume overload
- •A single defect too large for closure (>38 mm)
- •Multiple ASDs unsuitable for percutaneous closure.
- •Anterior, posterior, superior, or inferior rim <5 mm.
- •Abnormal pulmonary venous drainage.
- •Associated structural heart disease requiring cardiac surgery.
- •ASD with severe pulmonary arterial hypertension and bidirectional or right-to-left shunting.
- •Intracardiac thrombi diagnosed by echocardiography.
结局指标
主要结局
Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure
时间窗: six months
Detection of residual shunt and MR deterioration by 2D-TTE and new-onset AF by ECG at six month follow up after ASD device closure
次要结局
- Clinical outcomes after six months(six months)
研究者
Mohamed Aboelkasem Ali Mousa
Assistant lecturer
Assiut University