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

## TL;DR

This study shows that the ACURATE neo2 valve is safe and effective for treating degenerated heart valves with minimal complications and improved patient outcomes.

## Contribution

The study provides new evidence on the safety and efficacy of the ACURATE neo2 valve in valve-in-valve TAVI procedures.

## Key findings

- The ACURATE neo2 valve achieved a 98.2% technical success rate with no in-hospital mortality.
- Patients showed significant clinical improvement with 100% achieving NYHA class ≤II after treatment.
- No major adverse events were observed during a median 1.2-year follow-up period.

## 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.