Publications

30 septembre 2025

Rev Esp Cardiol (Engl Ed). 2025 Sep 30:S1885-5857(25)00271-3. doi: 10.1016/j.rec.2025.09.011. Online ahead of print.

Sophie Malekzadeh-Milani ¹ , Paul Padovani ² , Kothandam Sivakumar ³ , Thomas Goronflot ⁴ , Mathilde Méot ¹ , Matthew I Jones ⁵ , Naychi Lwin ⁶ , Caroline Ovaert ⁷ , Sébastien Hascoët ⁸ , Zakaria Jalal ⁹ , Carles Bautista-Rodriguez ¹⁰ , Marc Gewillig ¹¹ , Hugues Lucron ¹² , Konstantin Averin ¹³ , Béatrice Susanne Kahl ¹⁴ , Janus Freyr Gudnason ¹⁵ , Alejandro J Torres ¹⁶ , Bruno Lefort ¹⁷ , Zakhia Saliba ¹⁸ , Ali Houeijeh ¹⁹ , Michal Galeczka ²⁰ , Hasri Samion ²¹ , Sonia El Saiedi ²² , Juan Manuel Lange ²³ , Nurit Yaakobi-Simhayoff ²⁴ , Alessia Callegari ²⁵ , Anders Haugom Christensen ²⁶ , Martin B Ystgaard ²⁶ , Jean-Bernard Selly ²⁷ , Hélène Bouvaist ²⁸ , Deborah Neil ²⁹ , Domenico Sirico ³⁰ , Clément Karsenty ³¹ , Catalina Vargas-Acevedo ³² , Ernesto Mejia ³² , Eric Rosenthal ⁵ , Céline Grunenwald ⁶ , Nadir Benbrik ⁶ , Oscar Werner ² , Anne Chauvire Drouard ³³ , Marine Gloanec ⁷ , Antoine Moktadir ³⁴ , Jean-Benoit Thambo ⁹ , Mélanie Brard ³⁵ , Gérald Laforest ²⁷ , Pramod Sagar ³ , Anu Joseph ³ , Thejaswi Puthiyedath ³ , Henrik Holmstrom ²⁶ , Roland Fiszer ²⁰ , Håkan Wåhlander ³⁶ , Ina Michel-Behnke ¹⁴ , Damien Bonnet ¹ , Pierre-Antoine Gourraud ⁴ , Gianfranco Butera ³⁷ , Shakeel A Qureshi ⁵ , Alain Fraisse ¹⁰ , Gareth J Morgan ³² , Alban-Elouen Baruteau ³⁸

PMID: 41038445 DOI: 10.1016/j.rec.2025.09.011

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-6 kg.

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.

Keywords: Bajo peso al nacer; Cardiac catheterization; Cardiopatía congénita; Cateterismo cardiaco; Congenital heart disease; Ductus arterioso; Ductus arteriosus; Infant; Lactante; Low birth weight; Patent; Persistente.

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