Abstract:BackgroundThe technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences.Methods and ResultsOutcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and Ju… Show more
“…Although an exact lower weight limit for the safe closure of a PDA has not been established, previous studies have excluded preterm infants <4 kg or reported no cases of percutaneous PDA closure below this weight threshold 11, 12, 13, 14. While recent case reports suggest catheter‐based PDA closure is feasible among infants <4 kg,15, 16 data on the safety of the procedure, including adverse events beyond the immediate catheterization period (eg, posthospitalization), are lacking 17. Since very premature infants <4 kg are more complex and medically fragile than are their more mature counterparts,18 a separate consideration of the short‐ and long‐term risks and benefits of percutaneous PDA closure in this unique subgroup is needed.…”
BackgroundPercutaneous closure of patent ductus arteriosus (PDA) in term neonates is established, but data regarding outcomes in infants born very preterm (<32 weeks of gestation) are minimal, and no published criteria exist establishing a minimal weight of 4 kg as a suitable cutoff. We sought to analyze outcomes of percutaneous PDA occlusion in infants born very preterm and referred for PDA closure at weights <4 kg.Methods and ResultsRetrospective analysis (January 2005–January 2014) was done at a single pediatric center. Procedural successes and adverse events were recorded. Markers of respiratory status (need for mechanical ventilation) were determined, with comparisons made before and after catheterization. A total of 52 very preterm infants with a median procedural weight of 2.9 kg (range 1.2–3.9 kg) underwent attempted PDA closure. Twenty‐five percent (13/52) of infants were <2.5 kg. Successful device placement was achieved in 46/52 (88%) of infants. An adverse event occurred in 33% of cases, with an acute arterial injury the most common complication. We observed no association between weight at time of procedure and the risk of an adverse event. No deaths were attributable to the PDA closure. Compared to precatheterization trends, percutaneous PDA closure resulted in improved respiratory status, including less exposure to mechanical ventilation (mixed effects logistic model, P<0.01).ConclusionsAmong infants born very preterm, percutaneous PDA closure at weights <4 kg is generally safe and may improve respiratory health, but risk of arterial injury is noteworthy. Randomized clinical trials are needed to assess clinically relevant differences in outcomes following percutaneous PDA closure versus alternative (surgical ligation) management strategies.
“…Although an exact lower weight limit for the safe closure of a PDA has not been established, previous studies have excluded preterm infants <4 kg or reported no cases of percutaneous PDA closure below this weight threshold 11, 12, 13, 14. While recent case reports suggest catheter‐based PDA closure is feasible among infants <4 kg,15, 16 data on the safety of the procedure, including adverse events beyond the immediate catheterization period (eg, posthospitalization), are lacking 17. Since very premature infants <4 kg are more complex and medically fragile than are their more mature counterparts,18 a separate consideration of the short‐ and long‐term risks and benefits of percutaneous PDA closure in this unique subgroup is needed.…”
BackgroundPercutaneous closure of patent ductus arteriosus (PDA) in term neonates is established, but data regarding outcomes in infants born very preterm (<32 weeks of gestation) are minimal, and no published criteria exist establishing a minimal weight of 4 kg as a suitable cutoff. We sought to analyze outcomes of percutaneous PDA occlusion in infants born very preterm and referred for PDA closure at weights <4 kg.Methods and ResultsRetrospective analysis (January 2005–January 2014) was done at a single pediatric center. Procedural successes and adverse events were recorded. Markers of respiratory status (need for mechanical ventilation) were determined, with comparisons made before and after catheterization. A total of 52 very preterm infants with a median procedural weight of 2.9 kg (range 1.2–3.9 kg) underwent attempted PDA closure. Twenty‐five percent (13/52) of infants were <2.5 kg. Successful device placement was achieved in 46/52 (88%) of infants. An adverse event occurred in 33% of cases, with an acute arterial injury the most common complication. We observed no association between weight at time of procedure and the risk of an adverse event. No deaths were attributable to the PDA closure. Compared to precatheterization trends, percutaneous PDA closure resulted in improved respiratory status, including less exposure to mechanical ventilation (mixed effects logistic model, P<0.01).ConclusionsAmong infants born very preterm, percutaneous PDA closure at weights <4 kg is generally safe and may improve respiratory health, but risk of arterial injury is noteworthy. Randomized clinical trials are needed to assess clinically relevant differences in outcomes following percutaneous PDA closure versus alternative (surgical ligation) management strategies.
“…Transcatheter closure of PDA is a safe and effective alternative therapeutic modality to surgical intervention . In large PDA of infants, there is a narrow margin of safety between undersized device (embolization, residual flow) and oversized device (PA or DTA obstruction) . Device selection is crucial with respect to type and size of the device.…”
A 7-month-old boy was admitted for the device closure of symptomatic patent ductus arteriosus (PDA) with moderate pulmonary hypertension. The PDA measured 4.2 mm with adequate ampulla. It was closed with an 8-6 mm Heart R device from pulmonary artery (PA) end. Post extubation, the device embolized to proximal descending thoracic aorta just distal to PDA ampulla. While attempting to snare from the venous side, the device self-repositioned to PDA. It was stable thereafter and patient was discharged after 2 days. We report a complication, which got self-corrected.
“…Percutaneous closure of the PDA is among the safest of interventional cardiac procedures and is considered to be the procedure of choice for PDA closure beyond infancy (≥5 kg) . Robust evidence among older and more mature patients has led investigators to study the feasibility and safety profile of catheter‐based interventions to close the PDA during infancy .…”
The optimal treatment method for infants with a patent ductus arteriosus (PDA) necessitating closure remains a subject of controversy and debate. While the risks associated with surgical PDA ligation are well described, the available evidence base for alternative management strategies during infancy, including percutaneous closure or conservative (nonintervention) management, are not well explored. Among infants, the goals of this review are to: (a) use rigorous systematic review methodology to assess the quality and quantity of published reports on percutaneous closure vs surgical ligation; (b) compare outcomes of percutaneous closure vs conservative management; and (c) based on recommendations from the International PDA symposium, to elucidate needs and opportunities for future research and interdisciplinary collaboration. The available evidence base, as well as on broad consensus reached at the International PDA Symposium, suggests that a contemporary, pragmatic clinical trial comparing PDA treatment strategies is warranted. Additionally, quality assurance safeguards are necessary in the implementation of newer PDA closure devices. Finally, to determine best approaches to treatment for infants with PDA, tools for consistent data collection and reporting across centers and disciplines are needed to minimize heterogeneity and permit pooled analysis.
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