Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography

Study Summary

The American College of Cardiology/American Heart Association guidelines place symptomatic severe Aortic Stenosis as a class I indication for aortic valve replacement. With the recently approved Edwards-Sapien TAVR device and the ongoing investigations using the CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now eligible to undergo TAVR. Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which may result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of patients depending on associated clinical risk factors. There is a need to consolidate this pre-operative testing whenever possible, and with real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac acquisition in the cath lab angiography suite during the coronary angiography, there may be a benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA). We would like to make a comparison of aortic valve and root measurements using CTA and DynaCT to affirm the accuracy of DynaCT vs the CTA gold standard.

Primary Outcome

Each patient will undergo non-invasive CT scan for aortic annulus measurement (in order to choose appropriate TAVR size) as per standard of care. They will then undergo invasive dyna CT for aortic annulus measurement during their clinically-indicated invasive coronary angiogram. The primary outcome is correlation between the aortic annulus dimension measurement made on dyna CT and non-invasive CT.

Interventions

• RADIATION Real-time 3-dimensional DynaCT