Evidence map›Paper›PMID 41120817›Full record

ArticleJournal of the American Heart Association2025

Off-Label Use of the Multifunctional Occluder for Transcatheter Patent Ductus Arteriosus Closure: An International Experience.

Naychi Lwin, Caroline Ovaert, Sophie Malekzadeh-Milani, Paul Padovani, Thomas Krasemann, Stanimir Georgiev, Oscar Werner, Ali Houeijeh, Stéphanie Douchin, Peter Kramer and 11 more

Abstract readMulticenter Study
In one paragraph

Article 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Comparison of KONAR-multifunctional occluder and Amplatzer occluders in transcatheter closure of patent arterial ducts and ventricular septal defects.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2026
    Article
  3. Simultaneous Repair of Iatrogenic Left Atrial and Aortic Perforations Using Ductus Arteriosus Occluders: A Case Report.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Article
  4. 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

21 authors.

Naychi LwinDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0009-0009-1703-6695
Caroline OvaertPediatric and Congenital Cardiology Department APHM La Timone Hospital Marseille France.ORCID 0000-0002-2277-2760
Sophie Malekzadeh-MilaniM3C-Necker, Department of Pediatric and Congenital Cardiology Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris (AP-HP) Paris France.ORCID 0000-0002-9527-3671
Paul PadovaniDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0000-0001-6170-3103
Thomas KrasemannDepartment of Paediatric Cardiology Sophia Children's Hospital Rotterdam The Netherlands.ORCID 0000-0003-4900-1576
Stanimir GeorgievDepartment of Congenital Heart Disease and Pediatric Cardiology German Heart Center Munich at the Technical University of Munich Germany.ORCID 0000-0002-6239-8160
Oscar WernerDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0000-0002-3741-0498
Ali HoueijehCHRU Lille, Pediatric Cardiology Department Institut Coeur Poumon Lille France.ORCID 0000-0002-8116-0887
Stéphanie DouchinDepartment of Pediatric and Congenital Cardiology CHU Grenoble Alpes, Université Grenoble Alpes Grenoble France.ORCID 0000-0002-6437-4648
Peter KramerDepartment of Congenital Heart Disease - Pediatric Cardiology Deutsches Herzzentrum der Charité (DHZC) Berlin Germany.ORCID 0000-0003-4780-5271
Lorenzo ScarduelliPediatric and Congenital Cardiology Department APHM La Timone Hospital Marseille France.
Lisa BiancoRoyal Brompton Hospital and the National & Heart Institute Imperial College London UK.ORCID 0009-0007-5307-4854
Céline GrunenwaldDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0009-0001-3003-7723
Sébastien HascoëtM3C-Marie Lannelongue, Pediatric and Congenital Cardiology Department Marie-Lannelongue Hospital Le Plessis-Robinson France.ORCID 0000-0002-8695-0503
Zakaria JalalDepartment of Paediatric and Adult Congenital Cardiology CHU Bordeaux Pessac France.ORCID 0000-0002-4968-8526
Nadir BenbrikDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0000-0002-1698-3860
Bruno LefortCHU Tours, Department of Pediatric Cardiology and Pediatric Cardiac Surgery, Institut des Cardiopathies Congénitales FHU PreciCare Tours France.
Iñaki Navarro CastellanosInstituto de Seguridad y Servicios Sociales de Los Trabajadores del Estado Mexico City Mexico.ORCID 0000-0002-7680-0835
Stephan SchubertCenter of Congenital Heart Disease and Pediatric Cardiology Heart and Diabetes Center NRW University Hospital of the Ruhr University Bochum, Medical Faculty OWL (University of Bielefeld) Bad Oeynhausen Germany.ORCID 0000-0003-2894-6490
Alain FraisseRoyal Brompton Hospital and the National & Heart Institute Imperial College London UK.ORCID 0000-0003-1969-421X
Alban-Elouen BaruteauDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery Nantes Université, CHU Nantes Nantes France.ORCID 0000-0003-2548-7858

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter patent ductus arteriosus (PDA) closure can be challenging in cases of large PDA, complex anatomy, and small patient size. We aimed to assess the feasibility, efficacy and safety of the off-label use of the multifunctional occluder in transcatheter PDA closure.

methodsA retrospective analysis was conducted on patients who underwent transcatheter PDA closure with the multifunctional occluder in 14 pediatric cardiology centers (5 countries) from 2018 to 2025.

resultsA total of 77 procedures were performed on 75 patients, including 5 adults (6.7%). Among the 70 children (93.3%; median age: 0.8 years [range, 0.1-10 years], median procedural weight: 6.9 kg [range, 2.1-32.0 kg]), 35 (50.0%) weighed ≤6 kg (median procedural weight: 4.0 kg [range, 2.1-5.9 kg]). The PDA was large, with a minimal ductal diameter of 3.8 mm (range, 1.5-7.0 mm), short in 54.5%, and unrestrictive with increased pulmonary artery pressures in 51.6% of patients. The morphology was predominantly conical (Krichenko type A: 51.9%), with window-type or complex morphologies representing 26.7% (Type B: 18.2%, Type D: 7.8%). Both arterial and venous femoral accesses were obtained in 87.0% cases, with deployment being antegrade in 77.9% and retrograde in 22.1%. Successful device deployment and release were achieved in 74 cases (96.1%). The rate of major adverse events was 5.2% including 1 early (1.3%) and 3 late complications (3.9%). No other adverse events were reported.

conclusionsThe off-label use of the multifunctional occluder device is a promising option for transcatheter PDA closure, demonstrating safety and efficacy in this series.

Indexed as

Cardiac CatheterizationDuctus Arteriosus, PatentOff-Label UseSeptal Occluder DeviceAdultChildChild, PreschoolFeasibility StudiesFemaleHumansInfantInfant, NewbornMaleProsthesis DesignRetrospective StudiesTreatment Outcomecongenital heart diseaseDoppler echocardiographyoff labeloutcomespediatric cardiology

Identifiers

PMID41120817
PMCPMC12684515

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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.