Outcomes of transcatheter patent ductus arteriosus closure in infants weighing 2 to 6 kg
Year: 2025
Type: article
Study design: Observational Study
Abstract: INTRODUCTION AND OBJECTIVES: Transcatheter patent ductus arteriosus (PDA) closure is safe in<2-kg infants and in≥6-kg patients, but major safety concerns remain when applied to the intermediate weight range. We aimed to assess outcomes of transcatheter PDA closure in 2- to 6-kg infants. METHODS: An international, multicenter, retrospective cohort study was conducted in 31 tertiary hospitals in 17 countries between 2000 and 2023, investigating all infants who underwent attempted transcatheter PDA closure with a procedural weight of 2-to-6kg. RESULTS: Attempted transcatheter PDA closure was performed in 1231 infants (median [Q1-Q3] weight, 4747 [3700-5300] g; median age, 132 [83-194] days; ex-preterm, n=581 [56.8%]) with a 95.0% success rate. A composite outcome of procedural failure or major adverse events was observed in 173 (14%) patients, including device embolization in 64 (3.7%), device-induced left pulmonary artery stenosis in 47 (2.7%), and procedural death in 2 (0.2%). Logistic regression model analysis identified a 2- to 3.9-kg procedural weight, increased pulmonary artery pressure, and window-type or tubular ductal morphologies as independent predictors of the composite outcome. Based on propensity score matching analysis, 2- to 3.9-kg infants had a risk ratio of 2.19 (95%CI, 1.25-3.83) for experiencing the composite outcome, compared with 4- to 5.9-kg infants. CONCLUSIONS: Transcatheter PDA closure in 2- to 6-kg infants was feasible in most patients. Procedural failure or major adverse events occurred in 14% and several independent risk factors were identified, including the 2- to 3.9-kg weight range identified as a higher-risk subgroup. These findings may improve risk stratification and the decision-making process.
Authors: Sophie Malekzadeh-Milani, Paul Padovani, Kothandam Sivakumar, Thomas Goronflot, Mathilde Méot, Matthew I. Jones, Naychi Lwin, Caroline Ovaert, Sébastien Hascoët, Zakaria Jalal, Carles Bautista-Rodriguez, Marc Gewillig, Hugues Lucron, Konstantin Averin, Béatrice Susanne Kahl, Janus Freyr Gudnason, Alejandro J. Torres, Bruno Lefort, Zakhia Saliba, Ali Houeijeh, Michal Galeczka, Hasri Samion, Sonia El Saiedi, Juan Manuel Lange, Nurit Yaakobi-Simhayoff, Alessia Callegari, Anders Haugom Christensen, Martin B. Ystgaard, Jean-Bernard Selly, Hélène Bouvaist, Deborah Neil, Domenico Sirico, Clément Karsenty, Catalina Vargas-Acevedo, Ernesto Mejia, Eric Rosenthal, Céline Grunenwald, Nadir Benbrik, Oscar Werner, Anne Chauvire-Drouard, Marine Gloanec, Antoine Moktadir, Jean-Benoit Thambo, Mélanie Brard, Gérald Laforest, Pramod Sagar, Anu Joseph, Thejaswi Puthiyedath, Henrik Holmstrom, Roland Fiszer, Håkan Wåhlander, Ina Michel-Behnke, Damien Bonnet, Pierre-Antoine Gourraud, Gianfranco Butera, Shakeel A. Qureshi, Alain Fraisse, Gareth J. Morgan, Alban-Elouen Baruteau
Institutions: Hôpital Necker-Enfants Malades, Université Paris Cité, Assistance Publique – Hôpitaux de Paris, Inserm, Centre Hospitalier Universitaire de Nantes, Centre d'Investigation Clinique de Nantes, Université de Nantes, Nantes Université, Madras Medical Mission, Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Healthcare, Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone, Université Paris-Saclay, Hôpital Marie Lannelongue, Hôpital Paris Saint-Joseph, Centre Hospitalier Universitaire de Bordeaux, Harefield Hospital, Royal Brompton Hospital, Universitair Ziekenhuis Leuven, University Hospital of Geneva, Northwell Health, Cohen Children's Medical Center, Medical University of Vienna, Drottning Silvias barn- och ungdomssjukhus, Morgan Stanley Children's Hospital, Columbia University Irving Medical Center, Centre Hospitalier Universitaire de Tours, Saint Joseph University, Hôtel-Dieu de France, Centre Hospitalier Universitaire de Lille, Medical University of Silesia, Silesian Center for Heart Disease, National Heart Institute, Cairo University, Hebrew University of Jerusalem, Hadassah Medical Center, University Children's Hospital Zurich, Oslo University Hospital, Centre Hospitalier Saint-Denis, Centre Hospitalier Universitaire de Grenoble, Instituto Nacional de Cardiologia, University of Padua, Azienda Ospedale - Università Padova, Centre Hospitalier Universitaire de Toulouse, Children's Hospital Colorado, University of Colorado Anschutz, Centre Hospitalier Universitaire de Martinique, University of Gothenburg, Bambino Gesù Children's Hospital, Centre National de la Recherche Scientifique, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Institut du Thorax, PhysioPathologie des Adaptations Nutritionnelles
Language: Spanish
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,160
Award: NExT (I-SITE)
OpenAlex ID: W4414710481