TY - JOUR

T1 - The Early neo2 Registry

T2 - Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population

AU - Rück, Andreas

AU - Kim, Won Keun

AU - Abdel-Wahab, Mohamed

AU - Thiele, Holger

AU - Rudolph, Tanja K.

AU - Wolf, Alexander

AU - Wambach, Jan Martin

AU - Backer, Ole De

AU - Sondergaard, Lars

AU - Hengstenberg, Christian

AU - Laine, Mika

AU - Miyashita, Hirokazu

AU - Bjursten, Henrik

AU - Götberg, Matthias

AU - Pellegrini, Costanza

AU - Toggweiler, Stefan

AU - Wykrzykowska, Joanna J.

AU - Soliman, Osama

AU - Saleh, Nawzad

AU - Meduri, Christopher U.

N1 - Funding Information: The Early neo2 registry was supported in part by a grant from Boston Scientific Corporation. Publisher Copyright: © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

PY - 2023

Y1 - 2023

N2 - BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.

AB - BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.

KW - aortic regurgitation

KW - aortic stenosis

KW - TAVI

U2 - 10.1161/JAHA.122.029464

DO - 10.1161/JAHA.122.029464

M3 - Journal article

C2 - 37489732

AN - SCOPUS:85166742506

VL - 12

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

SN - 2047-9980

IS - 15

M1 - e029464

ER -