Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.
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Baggio Sara, Pagnesi Matteo, Kim Won-Keun, Scotti Andrea, Barbanti Marco, Costa Giuliano, Adamo Marianna, Kornowski Ran, Vaknin Assa Hana, Estévez-Loureiro Rodrigo, Cedeño Robert Alarcón, De Marco Federico, Casenghi Matteo, Toggweiler Stefan, Veulemans Verena, Mylotte Darren, Lunardi Mattia, Regazzoli Damiano, Reimers Bernhard, Sondergaard Lars, Vanhaverbeke Maarten, Nuyens Philippe, Maffeo Diego, Buono Andrea, Saccocci Matteo, Giannini Francesco, Di Ienno Luca, Ferlini Marco, Lanzillo Giuseppe, Ielasi Alfonso, Schofer Joachim, Brinkmann Christina, Van Der Heyden Jan, Buysschaert Ian, Eitan Amnon, Wolf Alexander, Adamaszek Martin Marian, Colombo Antonio, Latib Azeem, Mangieri Antonio
Аннотация
AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices.
METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification.
RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001).
CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.