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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
The Effect on Extubation of Early vs. Late Definitive Closure of the Patent Ductus Arteriosus in Premature Infants: A
Zhou Du1, Craig R Wheeler2,3, Michael Farias1,4
1Harvard Medical School, Boston, MA 02115, USA.
Insights
Expedited closure of the patent ductus arteriosus (PDA) in premature infants may lead to earlier extubation. However, overall mechanical ventilation needs were similar between early and late closure groups at 45 days.
Area of Science:
- Neonatalogy
- Pediatric Cardiology
- Critical Care Medicine
Background:
- Premature infants often require patent ductus arteriosus (PDA) closure when pharmacotherapy fails or is contraindicated.
- The optimal timing for definitive PDA closure (surgical or device) in this population remains unclear.
- Early identification of PDA closure need does not guarantee expedited intervention, impacting respiratory outcomes.
Purpose of the Study:
- To compare the impact of early versus late definitive PDA closure on early respiratory outcomes in premature infants.
- To emulate a target randomized trial using real-world registry data to assess extubation timing.
- To evaluate the effect of intervention timing on the need for mechanical ventilation.
Main Methods:
- Emulation of a hypothetical randomized trial using a single-institution registry.
- Inclusion criteria: premature infants (<30 weeks gestation or <1500g birth weight) undergoing definitive PDA closure.
- Comparison of early (0-4 days) vs. late (5-14 days) closure strategies based on referral date.
Main Results:
- 131 infants were included; 70 adhered to early closure, 38 to late closure.
- Higher cumulative incidence of extubation in the early closure group until day 40 (max risk difference: 22 percentage points at day 13).
- No significant difference in extubation rates or need for mechanical ventilation at 45-day follow-up between groups.
Conclusions:
- Infants undergoing early PDA closure were extubated sooner than those in the late closure group.
- The overall need for mechanical ventilation was similar between early and late PDA closure strategies at 45 days.
- Timing of definitive PDA closure may influence the rate of extubation but not the ultimate need for ventilation support.
Abstract:
Background/Objectives: Premature infants are often referred for the definitive procedural closure of the patent ductus arteriosus (PDA) with the failure of, or contraindication to, pharmacotherapy and the inability to wean respiratory support. However, once this need is identified, the importance of expedited closure is unclear. The objective of this study was to compare the effect of the timing of definitive closure (i.e., surgical ligation or device occlusion) on early respiratory outcomes in premature infants. Method: We first specify a hypothetical randomized trial (the "target trial") that would estimate the effect on extubation of early (0-4 days from referral) vs. late (5-14 days from referral) definitive PDA closure. We then emulate this target trial using a single-institution registry of premature infants (born <30 weeks or with a birth weight < 1500 g) who underwent the definitive closure of PDA between January 2014 and October 2023. Results: We identify 131 eligible infants. At the end of the follow-up, 70 and 38 infants were adherent to early and late PDA closure strategies, respectively. The cumulative incidence of extubation in the early group was higher than that in the late group until day 40 (maximum risk difference: 22 percentage points at day 13; 95% CI: -11 to 56). Outcomes were similar at the end of the 45-day follow-up period (risk difference: -1 percentage point; 95% CI: -46 to 42). Conclusions: The need for mechanical ventilation was equivalent between early and late PDA closure strategies at the end of a 45-day follow-up period although infants in the early intervention group were extubated sooner.
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