Aortic Valve Stenosis
Conditions
Keywords
TAVI, TAVR, Subclinical Leaflet Thrombosis, Bioprosthetic Valve Deterioration, Intra-annular, Supra-annular
Brief summary
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.
Detailed description
Subclinical leaflet thrombosis (SCLT) occurs frequently after TAVI and has been associated with an increased risk of valve dysfunction. A persistent form of SCLT may lead to thrombus calcification and valve degeneration and increase the long-term risk of symptomatic bioprosthetic valve deterioration. Intra-annular in comparison to supra-annular TAVI valves have been associated with a higher risk of SCLT and valve thrombosis. Intra-annular valves may create larger neo-sinuses and flow stagnation zones, which favour local thrombogenicity. Whether different prosthesis types lead to a higher degree of transcatheter valve calcification and degeneration is currently unexplored. Recently, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET) has emerged as a non-invasive modality capable of imaging bioprosthetic micro-calcification activity, which is an early and powerful predictor of valvular dysfunction and eventually valve failure. In the present study, we investigate for the first time, the differences in quantified bioprosthetic micro-calcification activity with 18F-NaF PET as early marker of transcatheter valve degeneration between patients with and without SCLT and between patients with intra-annular vs. supra-annular prostheses at five years after TAVI.
Interventions
DIAGNOSTIC_TEST18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI
Sponsors
St. Antonius Hospital
St. Antonius Research Fund
Medtronic
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* Temporary or chronic oral anticoagulation use after TAVI * Known severe renal insufficiency * Known severe paravalvular regurgitation * History of valve-in-valve procedure * History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantified bioprosthetic micro-calcification activity | 5 years after TAVI | 18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography |
| Subclinical Leaflet Thrombosis | 5 years after TAVI | Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography |
| Valve dysfunction | 5 years after TAVI | Transvalvular gradients assessed with transthoracic echocardiography |
Countries
Denmark, Netherlands, United Kingdom
Contacts
CONTACTDirk-Jan van Ginkel, MD
CONTACTProf. J.M. ten Berg, MD, PhD, MSc
Outcome results
None listed