The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
Age >18 years
Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
Single group
Assession of complete coronary physiology
Procedure/SurgeryAssession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio. The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).
Diagnostic accuracy by considering FFR values of >0.80 as normal
diagnostic accuracy (sensitivity, specificity, positive predictive value \[PPV\] and negative predictive value \[NPV\]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering FFR values of \>0.80 as normal
Diagnostic accuracy by considering RFR values of >0.89 as normal
diagnostic accuracy (sensitivity, specificity, positive predictive value \[PPV\] and negative predictive value \[NPV\]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering RFR values of \>0.89 as normal
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Helios Health Institute GmbH
Lead sponsor
Heart Center Leipzig - University Hospital
Collaborator
