NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).

Inclusion Criteria:

1. Age ≥ 18 years.
2. NYHA ≥ 2 and/or syncope and/or angina.
3. Symptomatic severe calcified aortic stenosis with AVA < 1 cm2 AND peak velocity > 4 m/s or mean gradient > 40 mmHg or DVI < 0.25'.
4. Patient judged by the Heart Team as indicated for TAVI.
5. Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
6. Estimated life-expectancy > 1 year.

Exclusion Criteria:

1. Age < 18 years
2. Asymptomatic patients
3. Estimated life expectancy < 1 year
4. Pure aortic regurgitation.
5. LVEF < 20%
6. No baseline MSCT evaluation.
7. Unsuitable aortic root anatomy for Navitor.
8. Unsuitable peripheral vasculature for transfemoral Navitor.
9. Type 2 bicuspid aortic valve
10. Excessive leaflet calcifications
11. Moderate or severe raphe calcifications
12. Severe LVOT calcifications
13. Perimeter-derived annular dimension exceeding IFU recommendation
14. Dilated ascending aorta >45 mm