Evidence map›Paper›PMID 41147394›Full record

SynthesisJournal of the American Heart Association2025

Dedicated Versus Conventional Devices in Patients With Pure Native Aortic Regurgitation: A Systematic Review and Meta-Analysis.

Elena Bacigalupi, Luca Scorpiglione, Bernard D Prendergast, Francesco Radico, Emanuele Gallinoro, Antonio L Bartorelli, Ignacio Amat-Santos, Marco Barbanti, Ole De Backer, Azeem Latib and 11 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Journal of the American Heart Association, 2025. 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. Review
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

21 authors.

Elena BacigalupiDepartment of Neuroscience, Imaging and Clinical Sciences "G. D'Annunzio" University of Chieti-Pescara Chieti Italy.
Luca ScorpiglioneDepartment of Neuroscience, Imaging and Clinical Sciences "G. D'Annunzio" University of Chieti-Pescara Chieti Italy.
Bernard D PrendergastDepartment of Cardiology St Thomas' Hospital and Cleveland Clinic London London United Kingdom.
Francesco RadicoCardiology Department SS. Annunziata Hospital Chieti Italy.ORCID 0000-0001-9177-9547
Emanuele GallinoroDivision of University Cardiology IRCCS Ospedale Galeazzi-Sant'Ambrogio Milan Italy.ORCID 0000-0002-5519-2818
Antonio L BartorelliIRCCS Ospedale Galeazzi-Sant'Ambrogio Milan Italy.
Ignacio Amat-SantosDepartamento de Cardiología Hospital Clínico Universitario de Valladolid Valladolid Spain.ORCID 0000-0002-2311-4129
Marco BarbantiUniversità degli Studi di Enna "Kore," Enna Italy.ORCID 0000-0002-4903-5437
Ole De BackerRigshospitalet Copenhagen University Hospital Copenhagen Denmark.ORCID 0000-0002-9674-0278
Azeem LatibMontefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center Albert Einstein College of Medicine Bronx New York USA.ORCID 0000-0001-9035-343X
Jacopo PizzicannellaDepartment of Neuroscience, Imaging and Clinical Sciences "G. D'Annunzio" University of Chieti-Pescara Chieti Italy.ORCID 0000-0003-3318-3758
Simona ChiusoloCardio-Thoracic and Vascular Department Pisa University Hospital Pisa Italy.ORCID 0009-0003-1131-2755
Nicolas M Van MieghemDepartment of Cardiology, Thoraxcenter Erasmus University Medical Center Rotterdam The Netherlands.ORCID 0000-0002-2732-1205
Matteo PerfettiCardiology Department SS. Annunziata Hospital Chieti Italy.ORCID 0000-0002-3741-6179
Luca TestaDepartment of Cardiology IRCCS Policlinico San Donato Milan Italy.ORCID 0000-0003-4687-3686
Ron WaksmanMedStar Washington Hospital Center Washington DC USA.ORCID 0000-0002-4063-9226
Francesco PellicciaDepartment of Cardiovascular Sciences University Sapienza Rome Italy.ORCID 0000-0003-1260-1308
Fabio MiraldiDepartment of Cardiovascular Sciences University Sapienza Rome Italy.ORCID 0000-0002-2404-3369
George DangasThe Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York New York USA.ORCID 0000-0001-7502-8049
Marco ZimarinoDepartment of Neuroscience, Imaging and Clinical Sciences "G. D'Annunzio" University of Chieti-Pescara Chieti Italy.ORCID 0000-0001-5455-6010
Heart Team study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgical aortic valve replacement is the gold standard for treating pure native aortic regurgitation. However, many patients have unacceptable surgical risk. Increasing evidence supports the use of transcatheter aortic valve replacement in this subset. This metanalysis aims to evaluate transcatheter aortic valve replacement efficacy in pure native aortic regurgitation.

methodsWe systematically searched MEDLINE/PubMed, Embase, the Cochrane Database, Google Scholar, ClinicalTrials.gov, and major cardiology conference abstracts from inception to April 1, 2024, and included 19 observational studies with ≥20 patients with pure native aortic regurgitation undergoing transcatheter aortic valve replacement. The primary end point was 30-day all-cause mortality; secondary end points were device success, valve migration, and 1-year all-cause mortality. Pooled estimates were calculated using random-effects meta-analysis. Risk of bias was assessed using the Newcastle-Ottawa Scale and publication bias with funnel plots and Egger's test. The study protocol was registered in International Prospective Register of Systematic Reviews (CRD42024534117).

resultsThe pooled 30-day mortality was 8.7% (95% CI, 5.8%-10.7%), and decreased from first (16.9% [95% CI, 13.2%-18.9%]) to second generation (7.2% [95% CI, 6.1%-9.2%]) and dedicated devices (4.7% [95% CI, 1.8%-8.9%;

conclusionsAlthough the observational design, lack of patient-level data, device heterogeneity, and potential publication bias limit definitive conclusions, transcatheter aortic valve replacement using dedicated devices may be considered a safe and effective therapeutic option for patients with pure native aortic regurgitation and unacceptable risk for surgery. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42024534117.

Indexed as

Aortic ValveAortic Valve InsufficiencyHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementHumansProsthesis DesignTreatment Outcomededicated devicespure native aortic valve regurgitationtranscatheter aortic valve replacement

Identifiers

PMID41147394
PMCPMC12684578

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.