Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

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  • Sara Baggio
  • Matteo Pagnesi
  • Won Keun Kim
  • Andrea Scotti
  • Marco Barbanti
  • Giuliano Costa
  • Marianna Adamo
  • Ran Kornowski
  • Hana Vaknin-Assa
  • Rodrigo Estévez-Loureiro
  • Robert Alarcón Cedeño
  • Federico De Marco
  • Matteo Casenghi
  • Stefan Toggweiler
  • Verena Veulemans
  • Darren Mylotte
  • Mattia Lunardi
  • Damiano Regazzoli
  • Bernhard Reimers
  • Maarten Vanhaverbeke
  • Philippe Nuyens
  • Diego Maffeo
  • Andrea Buono
  • Matteo Saccocci
  • Francesco Giannini
  • Luca Di Ienno
  • Marco Ferlini
  • Giuseppe Lanzillo
  • Alfonso Ielasi
  • Joachim Schofer
  • Christina Brinkmann
  • Jan Van Der Heyden
  • Ian Buysschaert
  • Amnon Eitan
  • Alexander Wolf
  • Martin Marian Adamaszek
  • Antonio Colombo
  • Azeem Latib
  • Antonio Mangieri
Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR).

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.
OriginalsprogEngelsk
TidsskriftEuroIntervention
Vol/bind18
Udgave nummer12
Sider (fra-til)977-986
Antal sider10
ISSN1774-024X
DOI
StatusUdgivet - 2023

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