Aortic Stenosis, Bicuspid-related Aortopathy
Conditions
Keywords
BAV, TAVI, Aortopathy
Brief summary
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7). The main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.
Interventions
DIAGNOSTIC_TESTCT follow-up
Computed tomography angiography assessment of BAV-related aorthopathy
Sponsors
University of Catania
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing TAVI with native BAV from January 2018 to December 2019
Exclusion criteria
* Patients undergoing TAVI without native BAV * Patients receiving first generation TAVI device * Patients undergoing TAVI before January 2018 or after December 2019
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute difference in maximum aortic diameters at multiple levels of ascending aorta | 5 years | Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death, stroke or rehospitalization for heart failure | 5 years | Death, stroke or rehospitalization for heart failure |
| Aortic events leading to urgent intervention or elective aortic root replacement | 5 years | Aortic events (i.e. fissuration, dissection) after the index intervention leading to aortic intervention, or elective aortic root replacement. |
| Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment) | 5 years | Presence of hypo-attenuated leaflet thickening (HALT)/reduced leaflet motion (RLM) at follow-up four-dimensional CTA assessment |
Countries
Italy
Contacts
Primary ContactGiuliano Costa, MD
Backup ContactMarco Barbanti, MD
Outcome results
None listed