Faculty of Medicine Ain Shams University
Abbasia, Cairo Governorate, 11517, Egypt
NCT Number: NCT06834828
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).
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Notify Me60 year and older
All sexes
Observational
Abbasia, Cairo Governorate, 11517, Egypt
All patients will be subjected to:
Pre-procedural data:
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:
Post-procedural data:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: With in 30 days from indexed procedure
Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia
Ain Shams University
Other
Prevalence of Cusp Asymmetry , Coronary Ostial Eccentricity in Patients Undergoing Trans Catheter Aortic Valve Implantation and Their Impact on Coronary Ostial OverlaP Risk Assessment: an Egyptian CO-OPRA Cohort Study
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