Efficacy and Safety of ACURATE neo2 in Valve-in-Valve TAVI: A Prospective Single-Center Study

Abstract

Background/Objectives: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a key approach for treating degenerated surgical bioprosthetic valves. The ACURATE neo2 valve, with its advanced sealing technology and optimized coronary access, represents a promising solution for the challenges of ViV TAVI. This study evaluates the procedural and 30-day and 1-year follow-up outcomes of the ACURATE neo2 valve in ViV TAVI. Methods: This single-center, single-operator prospective study included patients with symptomatic bioprosthetic valve dysfunction, classified in New York Heart Association (NYHA) class III or IV, who underwent ViV TAVI with ACURATE neo2 at our center between July 2022 and February 2024. Outcomes were assessed using VARC-3 criteria. Results: Fifty-five patients (51% females, median (IQR) age 76 (8) years) were included. The technical success rate was 98.2%. No patients experienced in-hospital mortality, stroke, MI, bleeding, vascular complications, renal failure, or new pacemaker implantation. Three patients (5.5%) underwent elective chimney stenting for coronary protection. The postprocedural mean aortic gradient was 6.7 ± 1 mmHg, with a mean aortic valve area (AVA) of 2.0 ± 0.1 cm². Over a median follow-up period of 1.2 years, no deaths (0%) were observed, heart failure hospitalization rate was 3.6%, and NYHA class improved to ≤II in 100% of patients. Conclusions: ACURATE neo2 demonstrated excellent technical success, sustained hemodynamic performance, and significant clinical improvement in ViV TAVI. The absence of major adverse events reinforces its safety, efficacy, and durability as a treatment for degenerated surgical bioprostheses.

Keywords: ACURATE neo2; bioprosthetic valve failure; interventional cardiology; structural heart disease; transcatheter aortic valve implantation; valve-in-valve.

Figure 1

Structural design and functional features of the ACURATE neo2 transcatheter aortic valve. This self-expanding, supra-annular valve system is constructed from a nitinol frame that provides radial force and conforms to the native annulus. The valve incorporates supra-annular porcine pericardial leaflets, which optimize effective orifice area and reduce transvalvular gradients—particularly important in valve-in-valve (ViV) applications. The arches at the top of the frame serve to stabilize the valve axially during deployment and positioning. The open-cell frame architecture allows for enhanced visibility and improved coronary access post-implantation, while the commissural alignment markers facilitate optimal rotational orientation. The upper crown aids in anchoring while minimizing the risk of coronary obstruction, and the lower crown reduces left ventricular outflow tract (LVOT) protrusion. Both inner and outer pericardial sealing skirts contribute to minimizing paravalvular leak (PVL), a common concern in ViV TAVI procedures. Together, these features enable precise deployment, excellent hemodynamics, and high procedural safety in the context of treating degenerated surgical bioprostheses. Abbreviations: LVOT: left ventricular outflow tract; PVL: paravalvular leak.

Figure 2

Mean aortic gradient over time following ViV TAVI with the ACURATE neo2 valve. Data are presented as mean ± standard deviation. Mean aortic gradient significantly decreased from preprocedure to postprocedure and remained stable at 30-day and 1-year follow-up.

Figure 3

Mean aortic valve area (AVA) over time following ViV TAVI with the ACURATE neo2 valve. Data are presented as mean ± standard deviation. AVA significantly increased postprocedure and remained stable over time. Abbreviations: AVA: aortic valve area.

Figure 4

Mean New York Heart Association (NYHA) distribution over time following ViV TAVI with the ACURATE neo2 valve. All patients achieved NYHA class ≤ II at 30-day and 1-year follow-up. Abbreviations: NYHA: New York Heart Association.