Evidence map›Paper›PMID 38799801›Full record

ReviewStructural heart : the journal of the Heart Team2024

Short-Term Outcomes of ACURATE neo2.

Akihiro Tobe, Scot Garg, Helge Möllmann, Andreas Rück, Won-Keun Kim, Andrea Buono, Andrea Scotti, Azeem Latib, Stefan Toggweiler, Antonio Mangieri and 8 more

Abstract readReview
In one paragraph

Review in Structural heart : the journal of the Heart Team, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Akihiro TobeDepartment of Cardiology, University of Galway, Galway, Ireland.
Scot GargDepartment of Cardiology, Royal Blackburn Hospital, Blackburn, UK.
Helge MöllmannDepartment of Cardiology, St. Johannes Hospital, Dortmund, Germany.
Andreas RückDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Won-Keun KimDepartment of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany.
Andrea BuonoCardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Institute, Brescia, Italy.
Andrea ScottiMontefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Azeem LatibMontefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Stefan ToggweilerHeart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
Antonio MangieriCardio Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Mika LaineDepartment of Cardiology, Heart and Lung Center, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland.
Christopher U MeduriDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Tobias RheudeDepartment of Cardiovascular Diseases, German Heart Center Munich, Technical University Munich, Munich, Germany.
Ivan WongDivision of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.
Chenniganahosahalli Revaiah PruthviDepartment of Cardiology, University of Galway, Galway, Ireland.
Tsung-Ying TsaiDepartment of Cardiology, University of Galway, Galway, Ireland.
Yoshinobu OnumaDepartment of Cardiology, University of Galway, Galway, Ireland.
Patrick W SerruysDepartment of Cardiology, University of Galway, Galway, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

ACURATE neoACURATE neo2ACURATE TASelf-expandingTAVITAVR

Identifiers

PMID38799801
PMCPMC11121741

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.