Transcatheter PDA closure is safe and effective in infants ≤ 4 kg, but the > 1.5-4 kg group has a higher risk of major adverse events, particularly device embolization.
In this retrospective multicenter cohort of 358 infants ≤ 4 kg undergoing transcatheter PDA closure, 191 weighed ≤ 1.5 kg (group 1) and 167 weighed > 1.5-4 kg (group 2).
Procedural success was higher in infants ≤ 1.5 kg than in infants > 1.5-4 kg.
Major adverse events were more frequent in the > 1.5-4 kg group than in the ≤ 1.5 kg group.
Device embolization occurred only in infants > 1.5-4 kg.
The Amplatzer Piccolo Occluder was used far more often in the smaller weight group, while larger infants more often received other devices off-label.
The authors conclude that transcatheter PDA closure is safe and effective in infants ≤ 4 kg, but that larger infants carry higher risk, supporting better patient selection and dedicated devices.
This study looked at 358 babies weighing up to 4 kg, most born prematurely, who had a heart duct called the patent ductus arteriosus (PDA) closed through a catheter rather than open surgery. The procedures were done at five major children's heart centers between 2016 and 2024. The researchers compared babies weighing 1.5 kg or less with babies weighing more than 1.5 up to 4 kg. The closure procedure worked in most babies in both groups, but results were somewhat better in the smallest babies. Success was 98.4% in the smallest group versus 94.0% in the larger group. Serious complications were about three times as likely in the larger babies (9.6% vs 3.1%). The device slipping out of position (embolization) happened only in the larger group (5.4% of those babies). The smallest babies almost always received a device designed for them (the Amplatzer Piccolo Occluder), while larger babies more often got other devices not specifically approved for this use. This research suggests catheter closure is generally safe and effective in small infants, but larger infants in this range may face higher risks, possibly because suitable devices are lacking. The authors suggest more careful assessment of each baby's anatomy and the development of devices designed for larger infants might improve safety. Because the study was retrospective, it shows associations rather than proving cause.
Librandi K, Bautista-Rodriguez C, Butera G, Annoni G, Padovani P, Foldvari S, et al.. (2026). Comparison of outcomes after transcatheter patent ductus arteriosus closure in infants weighing ≤ 1.5 kg and > 1.5-4 kg.. European journal of pediatrics. https://doi.org/10.1007/s00431-026-07581-3