The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population

Abstract

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.