Barry OM, Gudausky TM, Balzer DT, Bocks ML, Boe BA, Callahan R, El-Said H, Farias MJ, Foerster S, Goldstein BH, Holzer RJ, Janssen D, Levy P, O’Byrne ML, Rahman G, Sathanandam S, Shahanavaz S, Whiteside W, Turner ME.Pediatr Cardiol. 2023 Aug;44(6):1406-1413. doi: 10.1007/s00246-023-03147-4. Epub 2023 Mar 30.PMID: 36995404
Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch:
Take home points:
- Transcatheter PDA closure can be effectively and safely performed in infants <2.5 kg, even in low-volume centers.
- Adverse events are associated with the presence of non-cardiac problems and the use of multiple devices during the procedure.
Despite ongoing controversy as to the indications and timing of the procedure, transcatheter closure of a hemodynamically significant patent ductus arteriosus (PDA) in premature infants is being increasingly performed across centers. The authors present findings from the largest multi-center retrospective review of PDA device closure in infants weighing less than 2.5 kg using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry.
Data were collected from April 2019 to December 2020 across 13 participating centers. A total of 300 cases were analyzed with an emphasis on procedural success, defined as effective device placement at the conclusion of the catheterization, and the occurrence of adverse events (AEs). Characteristics associated with outcomes were additionally explored.
The results show a remarkable procedural success rate of 98.7% (on the first attempt in 92% of cases), predominantly with the Amplatzer Piccolo Occluder, used in 78% of cases. The incidence of moderate severity (level 3) AEs was 5.6%, including 4 device embolizations, and there were five cases (1.7%) with major/catastrophic (level 4/5) AEs, including one patient who died 12 h after the procedure due to post ligation syndrome and urosepsis (Table 1). There was no significant association between procedural success or AEs and factors such as patient age, weight, or institutional volume. However, a higher risk of AEs was associated with patients who had non-cardiac problems and procedures where multiple devices were attempted.
This study showcases the high success rate of PDA device closure in very small infants across various institutions, paving the way for more widespread adoption of this procedure. It highlights the importance of careful patient and device selection to minimize the risk of serious adverse events in this vulnerable population. Long-term follow-up is necessary to fully understand the implications of early PDA device closure.
Table 1. Adverse events by severity level
| Adverse events | n (% of total cases) |
| Level 3 (moderate) adverse events | 17 (5.6) |
| Device embolization | 4 (1.3) |
| Depressed cardiac output | 2 (0.7) |
| Systemic arterial thrombosis | 2 (0.7) |
| Atrial arrhythmia | 1 (0.3) |
| Hypotension | 1 (0.3) |
| Hypoxia | 1 (0.3) |
| Medication error | 1 (0.3) |
| Post-extubation stridor | 1 (0.3) |
| Respiratory distress | 1 (0.3) |
| Sinus tachycardia | 1 (0.3) |
| Tricuspid regurgitation | 1 (0.3) |
| Vessel trauma | 1 (0.3) |
| Level 4/5 (major/catastrophic) adverse events | 5 (1.7) |
| Device malposition | 2 (0.7) |
| Respiratory arrest | 2 (0.7) |
| Death | 1 (0.3) |
*Two cases had two level 3/4/5 events each
