TY - JOUR
T1 - Off-Label Use of the Multifunctional Occluder for Transcatheter Patent Ductus Arteriosus Closure
T2 - An International Experience
AU - Lwin, Naychi
AU - Ovaert, Caroline
AU - Malekzadeh-Milani, Sophie
AU - Padovani, Paul
AU - Krasemann, Thomas
AU - Georgiev, Stanimir
AU - Werner, Oscar
AU - Houeijeh, Ali
AU - Douchin, Stéphanie
AU - Kramer, Peter
AU - Scarduelli, Lorenzo
AU - Bianco, Lisa
AU - Grunenwald, Céline
AU - Hascoët, Sébastien
AU - Jalal, Zakaria
AU - Benbrik, Nadir
AU - Lefort, Bruno
AU - Navarro Castellanos, Iñaki
AU - Schubert, Stephan
AU - Fraisse, Alain
AU - Baruteau, Alban Elouen
PY - 2025/10/21
Y1 - 2025/10/21
N2 - BACKGROUND: Transcatheter 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. METHODS: A 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.RESULTS: A 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.CONCLUSIONS: The off-label use of the multifunctional occluder device is a promising option for transcatheter PDA closure, demonstrating safety and efficacy in this series.
AB - BACKGROUND: Transcatheter 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. METHODS: A 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.RESULTS: A 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.CONCLUSIONS: The off-label use of the multifunctional occluder device is a promising option for transcatheter PDA closure, demonstrating safety and efficacy in this series.
UR - https://www.scopus.com/pages/publications/105019730629
U2 - 10.1161/JAHA.125.043468
DO - 10.1161/JAHA.125.043468
M3 - Article
C2 - 41120817
AN - SCOPUS:105019730629
SN - 2047-9980
VL - 14
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 20
M1 - e043468
ER -