Observational studyCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2019
One-year clinical outcome with a novel self-expanding transcatheter heart valve.
Observational study in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
6 citing papers in PubMed, 11 citations in OpenAlex.
- The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Article
- Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021Article
- Comparison of latest generation supra-annular and intra-annular self-expanding transcatheter heart valves.Journal of thoracic disease · 2020Article
- ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?Current cardiology reports · 2020Review
- One-year clinical outcome with a novel self-expanding transcatheter heart valve.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2019Observational
- One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Article
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate 1-year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC-2) with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety".
backgroundInitial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one-year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC-2.
methodsOne hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow-up were calculated as the Kaplan-Meier estimates.
resultsMean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one-year, all-cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The "clinical efficacy after 30 days" was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. "Time-related valve safety" occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases.
conclusionsUsing the ACURATE neo, we found a favorable safety profile with low all-cause mortality at 1 year. The reported VARC-2 defined composite endpoints at 1 year reveal low rates of "clinical efficacy after 30 days" and "time-related valve safety".
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