Objective: To investigate technical success and safety of percutaneous patent ductus arteriosus closure in infants ≤1.5 kg.
Study design: A systematic review and meta-analysis was performed. Data sources included Scopus, Web of Science, Embase, CINAHL, Cochrane, and PubMed from inception to April 2020. Publications were included if they had a clear definition of the intervention as percutaneous patent ductus arteriosus closure in infants ≤1.5 kg. Data extraction was independently performed by multiple observers. Primary outcome was technical success and secondary outcomes were adverse events (AEs). Subgroup analysis was performed in infants ≤6.0 kg. Data were pooled by using a random-effects model.
Results: We included 28 studies, including 373 infants ≤1.5 kg and 69 studies enrolling 1794 infants ≤6.0 kg. In patients ≤1.5 kg, technical success was 96% (95% CI, 93%-98%; P = .16; I2 = 23%). The overall incidence of AE was 27% (95% CI, 17%-38%; P < .001; I2 = 70%) and major AEs was 8% (95% CI, 5%-10%; P = .63; I2 = 0%). There were 5 deaths related to the procedure (2%; 95% CI, 1%-4%; P = .99; I2 = 0%); 4 of these deaths occurred in infants <0.8 kg. The probability of technical failure was inversely related to age at the time of the procedure (OR, 0.9; 95% CI, 0.830-0.974; P = .009). Weight at intervention has decreased over time and procedural success has increased.
Conclusions: Percutaneous patent ductus arteriosus closure is feasible in infants ≤1.5 kg with few major AEs. The procedural success rate is high, despite performing the intervention in smaller patients.
Prospero registration: CRD42020145230.
Keywords: adverse outcomes; catheter; patent ductus arteriosus; percutaneous; technical success; transcatheter.
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