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Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.
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http://dx.doi.org/10.1016/j.shj.2023.100277 | DOI Listing |
J Am Coll Cardiol
September 2025
Cedars-Sinai Medical Center, Los Angeles, California, USA. Electronic address:
J Am Coll Cardiol
September 2025
European University Cyprus, Nicosia, Cyprus; Euroclinic of Athens, Athens, Greece.
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.
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