Journal of the American Heart Association · 2025
Off-Label Use of the Multifunctional Occluder for Transcatheter Patent Ductus Arteriosus Closure: An International Experience.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Lwin Naychi, Ovaert Caroline, Malekzadeh-Milani Sophie, Padovani Paul, Krasemann Thomas, Georgiev Stanimir, Werner Oscar, Houeijeh Ali, Douchin Stéphanie, Kramer Peter, Scarduelli Lorenzo, Bianco Lisa, Grunenwald Céline, Hascoët Sébastien, Jalal Zakaria, Benbrik Nadir, Lefort Bruno, Navarro Castellanos Iñaki, Schubert Stephan, Fraisse Alain, Baruteau Alban-Elouen
Аннотация
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.
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.