Clinical outcomes of the ACURATE neo2 transcatheter heart valve:&amp;nbsp;a prospective, multicentre, observational, post-market surveillance study

Kim, Won-Keun; Tamburino, Corrado; Möllmann, Helge; Montorfano, Matteo; Ellert-Gregersen, Julia; Rudolph, Tanja K.; Mieghem, Nicolás M. Van; Hilker, Michael; Amat‐Santos, Ignacio J.; Terkelsen, Christian Juhl; Petronio, Anna Sonia; Stella, Pieter R.; Götberg, Matthias; Rück, Andreas; Kasel, Albert Markus; Trillo, Ramiro; Appleby, Clare; Barbanti, Marco; Blanke, Philipp; Modolo, Rodrigo; Allocco, Dominic J.; Søndergaard, Lise

doi:10.4244/eij-d-22-00914

Cited by 11 publications

(2 citation statements)

References 33 publications

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“…Paravalvular leak with the ACURATE neo2 is improved over the first generation ACURATE neo, with postmarket surveillance studies reporting low rates of significant PVR with the ACURATE neo2 (1.9% moderate or greater AR). 16 In accordance, the overall presence of AR in this unselected COMALIGN-neo2 patient cohort was low; moderate AR occurred in less than 1.0% and none/trace was noted in 65%. However, TAVs implanted with severe CMA exhibited a 1.5 higher rate of ≥mild AR as compared to valves in which severe CMA was avoided.…”

Section: Discussionsupporting

confidence: 72%

Commissural alignment and the ACURATE neo2 transcatheter aortic valve: Impact on valve performance

Travieso,

Toggweiler,

Montarello

et al. 2024

Cathet Cardio Intervent

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BackgroundTranscatheter aortic valve replacement (TAVR) is increasingly being used to treat severe aortic stenosis in younger patients. Accordingly, lifetime management regarding future reintervention and coronary access is a concern.AimsTo assess the impact of commissural alignment on ACURATE neo2 transcatheter aortic valve (TAV) performance.MethodsCOMALIGN‐neo2 was an observational, retrospective study enrolling consecutive TAVR patients treated with the ACURATE neo2 (October 2021 to October 2022). The degree of commissural (mis)‐alignment (CMA) with the native aortic valve commissures was determined and transvalvular gradient, effective orifice area, patient‐prosthesis mismatch (PPM), and aortic regurgitation (AR) were assessed.ResultsAmong 825 patients, the mean age was 80.7 years and 42% were female. Commissural alignment was achieved in 60% of cases; mild (26%), moderate (9%), and severe misalignment (5%) were found less often. Severe PPM occurred more frequently in patients with severe CMA (14.7%) compared to aligned valves (p = 0.034). By multivariate analysis, severe CMA (odds ratio [OR]: 3.12, 95% confidence interval [CI] [1.09–8.90]; p = 0.033) and lack of postdilatation (OR: 3.85, [1.33–11.1]; p = 0.012) were associated with severe PPM. Higher rates of ≥mild AR (51.4%) were found in TAVs implanted with severe CMA compared to aligned (34.3%), mildly (38.1%) or moderately (36.0%) misaligned TAVs (p = 0.030). Multivariate analysis identified severe CMA (OR: 2.05, [1.05–4.02]; p = 0.037) to be an independent predictor of ≥mild AR.ConclusionsCOMALIGN‐neo2 is the largest study to date assessing the impact of commissural alignment on acute TAV performance. Severe CMA with the ACURATE neo2 platform was associated with worse valve hemodynamics and increased risk for mild AR.

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Section: Discussionsupporting

confidence: 72%

Commissural alignment and the ACURATE neo2 transcatheter aortic valve: Impact on valve performance

Travieso,

Toggweiler,

Montarello

et al. 2024

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

“… 12 The ACURATE neo2 PMCF study and SOURCE 3 registry reported 30-day new PPI rates lower than their respective premarket rates of 6.5 and 12.0%. 13 , 14 Due to the variation of PPI rates across studies, either due to sample size, chance, or other factors, cross-study comparisons should be considered with caution.…”

Section: Discussionmentioning

confidence: 99%

Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study

Sultan,

Reardon,

Søndergaard

et al. 2024

Structural Heart

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Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Implantation: The Research Around HALT Does Not Halt

McInerney

Bagur

2023

The American Journal of Cardiology

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Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study

Cited by 11 publications

References 33 publications

Commissural alignment and the ACURATE neo2 transcatheter aortic valve: Impact on valve performance

Commissural alignment and the ACURATE neo2 transcatheter aortic valve: Impact on valve performance

Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study

Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Implantation: The Research Around HALT Does Not Halt

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