Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.
JACC Cardiovasc Interv
; 17(5): 681-692, 2024 Mar 11.
Article
in En
| MEDLINE
| ID: mdl-38479968
ABSTRACT
BACKGROUND:
The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored.OBJECTIVES:
The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli.METHODS:
Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 11 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes.RESULTS:
Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater SE 48.5% vs BE 18.6% [P < 0.001]; moderate SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater SE 16.0% vs BE 47.1% [P < 0.001]; severe SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001).CONCLUSIONS:
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. Randomized data are needed to validate these findings and guide informed device selection.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Aortic Valve Stenosis
/
Heart Valve Prosthesis
/
Stroke
/
Transcatheter Aortic Valve Replacement
Limits:
Humans
Language:
En
Journal:
JACC Cardiovasc Interv
/
JACC cardiovasc. interv
/
JACC. cardiovascular interventions (Print)
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
Year:
2024
Type:
Article
Affiliation country:
United States