A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.
Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
Written informed consent
Temporary or chronic oral anticoagulation use after TAVI
Known severe renal insufficiency
Known severe paravalvular regurgitation
History of valve-in-valve procedure
Patients who underwent TAVI about five years ago will be consecutively screened for eligibility from the ongoing, prospective, TAVI registries of the participating study sites and will be asked to undergo hybrid PET-CT imaging and transthoracic echocardiography.
Cohort
Cross-sectional
18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
Diagnostic testPatients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI
Quantified bioprosthetic micro-calcification activity
18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Subclinical Leaflet Thrombosis
Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Valve dysfunction
Transvalvular gradients assessed with transthoracic echocardiography
Click on the lead sponsor to view all of their trials.
