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The goal of this observational study is to measure the prevalence of Cusps asymmetry, coronary Ostial eccentricity in patients with severe aortic stenosis undergoing Trans-catheter Aortic Valve Implantation (TAVI) and measure the degree of coronary ostia overlap with trans-catheter neo-commissure. The main question it aims to answer is:
Do coronary ostial eccentricity or cusp asymmetry have impact on coronary ostia overlap with trans-catheter neo-commissure? Participants already taking TAVI as part of their regular medical care for severe symptomatic aortic stenosis will do post procedural ECG-gated non contrast Multi-detector Computed Tomographic Angiography (MDCTA).
All patients will be subjected to:
Pre-procedural data:
Proper history taking including:
12-lead surface electrocardiogram (ECG):
Transthoracic echocardiography:
Multi-detector Computed Tomographic Angiography (MDCTA) using pre-TAVI protocol:
Pre-procedural contrast enhanced MD cardiac CT imaging will be performed in all patients, Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
All the following parameter and data will be collected pre-procedural:
After identifying the aortic annulus on cardiac CT imaging, a parallel plane few millimeters above the aortic annulus, where all 3 commissures are clearly visible, will be used to evaluate cusp symmetry.
The angle between both commissures of each cusp will be measured and the largest cusp will be identified and classified into 4 categories according to the angle of the largest cusp.
Based on the angle deviation between each coronary ostium and the bisector of the corresponding cusp, the eccentricity of coronary ostia will be classified as:
Centered (0°-10°).
Mildly eccentric (10-20°).
Moderately eccentric (20°-30°).
Severely eccentric (>30°)
Post-procedural data:
12-lead surface electrocardiogram (ECG) immediate post procedure and pre discharge:
Transthoracic echocardiography immediate post procedure and pre-discharge:
ECG gated MDCT post TAVI:
Post-procedural non contrast enhanced MD cardiac CT imaging will be performed in all patients; Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
Based on identification of neo-commissures by commissural markers (CM) (i.e. commissural posts in Acurate neo 2 and C tap in Evolut R /Pro) assessment of coronary overlap (CO) and commissural misalignment (CMA) can be possible as following:
- Coronary overlap (CO): By measuring the angle between each coronary ostium (RCA and LCA) and nearest neo-commissure and categorize CO into 3 groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Aortic stenosis patients underwent trans catheter Aortic valve Implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Coronary Ostia Overlap with neo-commissures | Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia | With in 30 days from indexed procedure |
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Inclusion Criteria:
Exclusion Criteria:
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- Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ain Shams University | Abbasia | Cairo Governorate | 11517 | Egypt |
share individual participant data may requires participant approval
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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