Valvular & structural heart disease
Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry
Authors' conclusion
BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.
Study context
- Population
- Patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI), 14 countries
- Participants
- 149 patients14 countries
- Outcome
- Intended valve performance (VARC-3)
- Follow-up
- 30 days
Methodological detailsinternational, multicentre, Endpoints adjudicated per VARC-3 criteria
- International
- Multicentre
- Endpoints adjudicated per VARC-3 criteria
Main finding
As reported in the abstract
Intended valve performance at 30 days
142 of 149
95.3%
Observational data: associations, not effects.
Secondary outcomes
Cardiac death · 30 days and 1 year
- 30-day cardiac death rate
- 2.6%
- 1-year cardiac death rate
- 11.0%
Haemodynamics post-TAVI
- Mean aortic valve area, cm²
- 2.1 (1.8-2.6)
- Mean aortic gradient, mmHg
- 7.2 (5.4-9.5)
More than moderate aortic regurgitation · 30 days
- Patients with more than moderate aortic regurgitation
- 0
Patient-prosthesis mismatch (PPM) (surviving patients)
- PPM
- 13/143 (9.1%)
- Severe PPM
- 2 (1.6%)
Valve function · 1 year
- Valve function maintained at 1 year
Ellipticity index
- Mean ellipticity index (IQR 1.2-1.4)
- 1.3
Outcomes by computed tomography (CT) sizing strategy · 30 days and 1 year
- Clinical and echocardiography outcomes similar between the two sizing strategies
Original publication
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