Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

Scotti, Andrea; Sturla, Matteo; Costa, Giuliano; Saia, Francesco; Pilgrim, Thomas; Abdel-Wahab, Mohamed; Garot, Philippe; Gandolfo, Caterina; Branca, Luca; Santos, Ignacio Amat; Mylotte, Darren; Bedogni, Francesco; De Backer, Ole; Nombela Franco, Luis; Webb, John; Ribichini, Flavio Luciano; Mainardi, Andrea; Andreaggi, Stefano; Mazzapicchi, Alessandro; Tomii, Daijiro; ... (2024). Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry. JACC. Cardiovascular Interventions, 17(5), pp. 681-692. Elsevier 10.1016/j.jcin.2024.01.006

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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 1:1 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.

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