Valvular & structural heart disease
Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry
Authors' conclusion
In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction.
Study context
- Population
- Patients undergoing transfemoral TAVR with small aortic annuli (annular area <430 mm²), OPERA-TAVI registry
- Participants
- 3,516 patients · 251 matched pairs
- Exposure
- Self-expanding Evolut PRO/PRO+ vs balloon-expandable SAPIEN ULTRA
- SEn = 251
- Balloon-expandable (BE)n = 251reference
- Outcome
- 1-year effectiveness composite (all-cause mortality, disabling stroke or HF hospitalization) and 30-day device-related outcome (hemodynamic structural and nonstructural valve dysfunction)
- Follow-up
- 1 year; 30 days
Methodological details1:1 propensity-score matched
- 1:1 propensity-score matched
Main finding
As reported in the abstract
1-year effectiveness composite
P = 0.91
30-day device-oriented composite
P = 0.027
Observational data: associations, not effects.
Further findings
Paravalvular leak
Mild or greater
Moderate
Prosthesis-patient mismatch
Moderate or greater
Severe
Residual mean gradient >20 mm Hg
P < 0.001
- Paravalvular leak: mild or greater P < 0.001
- Paravalvular leak: moderate P = 0.070
- Prosthesis-patient mismatch: moderate or greater P < 0.001
- Prosthesis-patient mismatch: severe P = 0.197
Safety
Disabling stroke
P < 0.01
Paravalvular leak
Mild or greater
P < 0.001
Moderate
P = 0.070
Prosthesis-patient mismatch
Moderate or greater
P < 0.001
Severe
P = 0.197
Residual mean gradient >20 mm Hg
P < 0.001
Original publication
Summarised from the published abstract; every number is checked against it