Valvular & structural heart disease
Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation
Authors' conclusion
Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.
Study context
- Population
- Patients with symptomatic severe non-calcified aortic regurgitation (NCAR) undergoing transcatheter aortic valve replacement (TAVR)
- Participants
- 113 patients
- Outcome
- Safety and feasibility of Myval in NCAR
Methodological detailsinternational, multicentre, consecutive patients, central image analysis, Images centrally analysed
- International
- Multicentre
- Consecutive patients
- Central image analysis
- Images centrally analysed
Main finding
As reported in the abstract
Technical success, residual ≥moderate AR, pacemaker
Technical success rate
94.7%
Residual ≥moderate aortic regurgitation
8.9%
Pacemaker rate
22.2%
Observational data: associations, not effects.
Further findings
Mortality · 30 days and 1 year
- 30-day mortality
- 5.3%
- 1-year mortality
- 9.7%
- Survival with vs without technical success
- 97.1% vs 72.7%; p=0.012
- Valve embolisation main determinant of mortality
- P = 0.047
Extra-large valve sizes and oversizing
- Extra-large sizes used
- 95 patients (84.1%)
- Mean oversizing
- 17.9±11.0%
- Additional volume added
- 92% (median 4 cc, up to 9 cc)
Safety
Valve embolisation
- Valve embolisation (1 antegrade, 3 ventricular), all with tapered LV outflow tract
- 4 patients (3.5%); p=0.007
Annular rupture, cardiac tamponade, aortic dissection
- No cases of annular rupture, cardiac tamponade or aortic dissection
Original publication
Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention. Published 18 September 2023. doi:10.
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