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: 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. : 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. : 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 cm. 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. : 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.
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http://dx.doi.org/10.3390/jcm14134677 | DOI Listing |
Catheter Cardiovasc Interv
September 2025
Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Background: With transcatheter aortic valve implantation (TAVI) now extending to lower-risk and younger patients, optimizing procedural and hemodynamic outcomes is critical. The Myval Octacor, a new balloon-expandable valve (BEV), was developed to improve outcomes by reducing paravalvular regurgitation (PVL), minimizing pacemaker implantation (PPI) rates, and enhancing hemodynamic performance. However, limited data are available comparing Myval Octacor to contemporary self-expanding supra-annular valves (SEVs) Evolut PRO/PRO+ and Acurate Neo2.
View Article and Find Full Text PDFCatheter Cardiovasc Interv
August 2025
Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.
The recent voluntary withdrawal of the ACURATE neo2 transcatheter aortic valve replacement device by Boston Scientific offers a compelling case study in the complex interplay of device design, clinical evidence, regulatory requirements, and market dynamics in modern structural heart interventions. Despite promising performance in European and Canadian registries, the ACURATE neo2 valve failed to demonstrate non-inferiority compared with commercially available balloon-expandable and self-expanding platforms in the pivotal ACURATE IDE randomized controlled trial. These results, coupled with introduction of a new regulatory requirements by the European notified body ultimately led to the global discontinuation of the platform.
View Article and Find Full Text PDFJ Clin Med
August 2025
Department of Cardiology, Meir Medical Center, Kfar Saba 4428164, Israel.
: Aortic stenosis (AS) is the most common valvular heart disease, associated with poor outcomes if left untreated. Current guidelines recommend that transcatheter aortic valve implantation (TAVI) procedures be performed in hospitals with an on-site cardiac surgery unit due to potential complications requiring surgical intervention. : Based on our experience, we evaluated the feasibility and outcomes of implementing a TAVI program in a cardiology department without an on-site cardiac surgery unit, in collaboration with a remote hospital for surgical backup.
View Article and Find Full Text PDFCatheter Cardiovasc Interv
September 2025
Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain.
Background: Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV.
View Article and Find Full Text PDFJ Am Coll Cardiol
July 2025
Department of Cardiovascular Diseases, TUM University Hospital German Heart Center, Technical University Munich University Hospital, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.