Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: Postprocedural Hemodynamic and Short-Term Clinical Outcomes.
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Buono Andrea, Gorla Riccardo, Ielasi Alfonso, Costa Giuliano, Cozzi Ottavia, Ancona Marco, Soriano Francesco, De Carlo Marco, Ferrara Erica, Giannini Francesco, Massussi Mauro, Fovino Luca Nai, Pero Gaetano, Bettari Luca, Acerbi Elena, Messina Antonio, Sgroi Carmelo, Pellicano Mariano, Sun Jinwei, Gallo Francesco, Franchina Antonio Gabriele, Bruno Francesco, Nerla Roberto, Saccocci Matteo, Villa Emmanuel, D'Ascenzo Fabrizio, Conrotto Federico, Cuccia Claudio, Tarantini Giuseppe, Fiorina Claudia, Castriota Fausto, Poli Arnaldo, Petronio Anna Sonia, Oreglia Jacopo, Montorfano Matteo, Regazzoli Damiano, Reimers Bernhard, Tamburino Corrado, Tespili Maurizio, Bedogni Francesco, Barbanti Marco, Maffeo Diego, ITAL-neo Investigators
Аннотация
OBJECTIVES: The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis.
METHODS: ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety.
RESULTS: Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P < 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days.
CONCLUSIONS: Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.